By HUMPHREYS, Lyn

A NEW PLYMOUTH rest home resident has died as a result of contracting the virulent norovirus stomach bug, Taranaki’s medical officer of health confirmed yesterday.

Outbreaks of the gastroenteritis bug, which causes fever, vomiting and diarrhoea for 24-48 hours, have been sweeping through at least three New Plymouth rest homes since November.

Strict Ministry of Health guidelines require the homes to isolate affected patients and so contain the highly contagious virus.

“We are aware of one death where the certifying doctor has said the patient died directly of gastroenteritis,” Dr Richard Hoskins said.

The person who died was a resident of Riverview, he said.

The elderly were more at risk from the effects of the virus because older people had weakened immune systems and might suffer additional health problems.

Chalmers Elderly Care, Riverview Lodge Rest Home and Hospital, and most recently the Maida Vale complex at Bell Block, all had outbreaks, Dr Richard Hoskins said.

Chalmers, affected sporadically since last November, has had 40 residents and staff taken ill, and was still getting new cases, he said.

Dr Hoskins repeated his concerns about Chalmers being disappointingly slow to notify health authorities of the outbreak, something it denies.

“We do think their first response was less than optimal.

“We are disappointed it has gone on for so long. They have taken on board the advice we’ve given them.,” he said.

“This is a very difficult virus outbreak to manage.”

Dr Hoskins pointed out public health inspectors were making sure rest homes had the latest guidelines and were provided with as much information as they needed to battle the virus.

Some, such as Tainui Village and Rhapsody, have taken successful action to keep the virus at bay.

Tainui Village general manager Glendyr Field and a Rhapsody spokesman said preventive measures in place included everyone coming into the resthomes washing their hands with an alcohol preparation.

Tainui was also giving out information brochures.

Yesterday, the Taranaki Daily News was contacted by a woman who declined to give her name, saying she was worried Maida Vale hospital patients were being kept in isolation, suffering a lack of care because of a lack of staff and not getting physiotherapy or exercise. Maida Vale Village manager Heather Marshall said the rest home was taking advice from health protection officers and working to Ministry of Health guidelines.

These included isolating residents with norovirus.

“We do have reduced staff because they are ill too. We are doing our best to ensure no resident’s care has been compromised,” Ms Marshall said.

Dr Hoskins advised those with concerns about appropriate levels of care to make a complaint to the relevant authorities, such as the Health and Disability Commissioner.

(c) 2008 Daily News; New Plymouth, New Zealand. Provided by ProQuest Information and Learning. All rights Reserved.

Australian stem cell scientists will build on the recent discovery that stem cells can be made from skin cells in a new collaborative research program, Victorian Innovation Minister Gavin Jennings and NSW Minister for Science and Medical Research Verity Firth announced today at the BIO International Convention.

The Australian scientists will spearhead a program to compare cells generated from skin cells, known as induced pluripotent stem (iPS) cells, with human embryo derived stem cells and stem cells derived from a somatic cell nuclear transfer (SCNT) process using clinically unusable eggs, in a bid to develop a routine repeatable way of making patient-specific stem cells within the nationally approved legislative guidelines.

Sydney IVF Limited and the Australian Stem Cell Centre have received $550,000 from the NSW and Victorian Governments to progress this new frontier of stem cell research.

This pioneering work has only become possible due to the new funding and recent changes to legislation in both Victoria and NSW, opening up opportunities for SCNT research to occur in Australia.

SCNT uses a patient’s own cells to create a source of individually tailored embryonic stem cells. For patients with a specific disease these stem cells will have unique characteristics that may be used to better understand and treat the disease process.

“This important initiative will put Australian scientists yet again at the forefront of stem cell research,” said Mr. Jennings.

“The promise of pluripotent stem cells is vast because they have the potential to develop into specialised cells that could be used as replacement cells and tissues to treat many diseases and conditions, help us to understand what causes birth defects and cancer and change the way we develop and test drugs,” Mr. Jennings said.

Scientists from Japan and America made the discovery that stem cell-like cells could be made from human skin cells in late 2007.

Sydney IVF, one of Australia’s premier assisted reproduction facilities, will undertake the SCNT work in this program. Since 2004, Sydney IVF has obtained five National Health and Medical Research Council embryo research licenses and produced over 20 human embryonic stem cell lines.

The Australian Stem Cell Centre, the Biotechnology Centre of Excellence based in Melbourne, will perform the characterisation and comparison of the stem cell-like cells.

“The combination of the international quality talent and significant resources of these two collaborative partners gives this project the potential to provide world first advancements in these new biological frontiers,” said Ms. Firth.

Recent US research has turned embryonic stem cells into insulin producing cells in mice, representing a possible cure for type 1 diabetes and there is already proof of concept that stem cells can restore function to damaged tissues in models of Parkinson’s disease and immuno-deficiency.

Victoria and NSW have led the way nationally in stem cell research and are already global leaders in the field.

“Victoria and NSW have now come together to extend our leadership into new stem cell technologies which have the potential to transform how we treat major and growing diseases like diabetes, heart disease, cancer and Parkinson’s,” the Ministers said.

The amended Victorian Infertility Treatment Act and the NSW Human Cloning and Other Prohibited Practices Act were introduced in 2007 and provide a clear regulatory framework for stem cell research.

By Sheryl Ubelacker, Health Reporter, THE CANADIAN PRESS

TORONTO – More than four million Canadians aged 12 or older are without a family doctor, either because they can’t find one or have chosen not to look, Statistics Canada said in a report released Wednesday.

The 2007 Canadian Community Health Survey found that among those without a primary-care physician, 1.7 million had tried but were unsuccessful at being taken on by a doctor as a regular patient, while 2.4 million weren’t even trying.

However, about 78 per cent of those without a regular doctor – or 3.3 million people – reported having an alternative they usually turn to when they are ill, require tests or need prescriptions.

The annual survey of 65,000 Canadians found 64 per cent of those without a regular physician reported going to a walk-in or appointment clinic, 12 per cent went to a hospital emergency room and about 10 per cent went to a community health centre.

The remaining 14 per cent chose to use other types of health-care facilities or services such as hospital out-patient clinics, telephone health lines or doctor’s offices.

Where people go for care varies by region, said Sylvain Tremblay, a project manager for CCHS.

“When we looked at the west part of the country (and Ontario), most people tended to use the clinics,” Tremblay said from Ottawa.

“But as you move toward Quebec and the east part of the country, especially in Quebec and Newfoundland and Labrador, it’s more the community health centres,” he said, explaining that these group practices often include doctors, social workers and physical therapists.

In New Brunswick and Nova Scotia, nearly one-quarter of residents without a regular doctor sought help in a hospital emergency room, the survey found.

That figure would come as no surprise to Phil and Deborah Sellars, who recently moved to Sussex, N.B., from Calgary and have not been able to find a family doctor.

“If we need health care, we have to go and sit in emergency for half a day,” said Phil Sellars, who must have his blood tested monthly for a medical condition and has waited for as long as four hours to be seen.

“I’m sure that everyone that’s in the same situation is frustrated about it,” said Sellars, who operates a bed and breakfast inn with his wife.

“I guess the only good feeling I have is I know there’s an emergency near in case something critical happens. But certainly for anything we would normally see a doctor for on a regular basis, that’s not going to work.”

“I guess the best word is we’re left out of the mix.”

Dr. Ruth Wilson, president of the College of Family Physicians of Canada, said the number of primary-care practitioners in Canada is starting to improve as more medical school graduates are now choosing family practice as a specialty, compared with the last decade.

But she agreed many Canadians are still forced to use walk-in clinics and hospital emergency departments as a “back door” to health care – and that can be especially problematic for people with chronic conditions like diabetes or high blood pressure, who need continuity of care.

“The wonderful thing is we do at least have that as an absolute safety valve, if you like, so if there’s no other way of getting care, that’s there,” Wilson, a family practitioner in Kingston, Ont., said of clinics and ERs. “But it’s certainly not a great way for the patient or for the health-care system to provide care.”

“I’m always disturbed when I hear about diabetics or people with heart disease having to get care in walk-in clinics or emerg because that kind of chronic disease really needs consistent, careful followup over time, tracking medications carefully … and managing the chronic disease well.”

She said patients need to be able to go to a doctor with a list of issues to discuss, such as: “How is my diabetes? How is my hypertension? How’s my heart disease? What were my last blood test results? Do I need a mammogram? How about my Pap?”

Dr. Alan Drummond, a spokesman for the Canadian Association of Emergency Physicians, said that while people without family doctors contribute to overcrowding in ER waiting rooms, generally these “orphan patients” are not a major problem for staff.

A bigger concern is the backlog of seriously or chronically ill patients who need to be admitted to hospital or transferred to another facility, but a lack of beds in those centres keeps them on stretchers in the ER – sometimes for days – and less seriously ill patients waiting.

“If we had appropriate capacity to see people in a timely manner, they would be seen in a timely manner,” Drummond said from Perth, Ont., where he practises. “It’s nothing for an emerg doc to see anybody with a cough, cold, diarrhea, rash or sprain. It’s really not a major burden for us.”

But there is no quick fix for patients with potentially life-threatening conditions like heart disease – and that can add to already long waits for other patients seeking help at emergency departments, he said.

“The ones that have chronic disease states really are there because they’ve got nowhere else to go. And when they do come to us, by definition, we’re going to take our time and make sure we’ve got things sorted out. Because a 92-year-old who’s weak and dizzy could be just weak and dizzy, or 92, or they could have an ongoing heart attack or stroke, so they require prolonged evaluation.”

“So that’s where the absence of a family doctor really does matter,” Drummond said, stressing that primary-care physicians provide the followup that ER doctors aren’t able to.

“The concern here is, yes, we can provide primary care to a select group of patients who don’t have a family doctor, but by no means can it be considered the same level of care.”

DUSSELDORF, Germany, June 18 /PRNewswire-FirstCall/ —

   - Sale of Consumer Healthcare Business   - Concentration on Core Business of Pharmaceutics and Life Science  

Gerresheimer AG, the leading manufacturer of glass and plastic products for the pharma & life science industry, is selling its consumer healthcare business. As previously announced, the Dusseldorf company is thereby discontinuing operations which are not part of the core business of pharmaceutics and life science.

“The consumer healthcare business did not fit in with our strategy of focussing on the fields of pharmaceutics and life science. In addition, because of the lack of synergies with the core business, our return requirements for the consumer healthcare business were not fulfilled,” says Gerresheimer CEO Dr. Axel Herberg.

The consumer healthcare business, which comprises the production of toothbrushes and other interdental articles and most recently achieved annual sales of EUR24m, was part of the Wilden Group, which was acquired in January 2007. The purchaser is the Krallmann Group. Through the acquisition, Krallmann intends to expand its own plastic processing division and to continue the business under the traditional “Interbros” trademark. The transaction takes place with effect on 1 June 2008. The contractual parties have agreed to keep further details confidential.

Early this year, Gerresheimer already discontinued the marginal business of aluminium packaging with sales of EUR3.3m.

About Gerresheimer

Gerresheimer employs more than 10,800 people in 41 locations in Europe, America and Asia. In the financial year 2007, worldwide sales totalled EUR957.7m. The product portfolio ranges from pharma-ceutical vials made of glass and plastic through to complex drug-delivery systems for the pharma & life science industry. These include sterile syringes, inhalers and other system-based approaches for safe dosage and application of medications. The Group enjoys a leading position in markets which are characterised by high technical and regulatory barriers.

   Contact Press                       Contact Investor Relations   Burkhard Lingenberg                 Anke Linnartz   Director Corporate PR & Marketing   Director Corporate Investor Relations   Telephone +49-211-6181-250          Telephone +49-211-6181-314   Telefax +49-211-6181-241            Telefax +49-211-6181-121   E-mail                              E-mail   [email protected]       [email protected]  

Gerresheimer AG

CONTACT: Contact Press, Burkhard Lingenberg, Director Corporate PR &Marketing, Telephone +49-211-6181-250, Telefax +49-211-6181-241, [email protected]; Contact Investor Relations, Anke Linnartz,Director Corporate Investor Relations, Telephone +49-211-6181-314, Telefax+49-211-6181-121, E-mail [email protected]

I AGREE with Professor Hugh McLachlan’s views on the issue of presumed consent in organ donation (Letters, June 17). However, as I understand it, consent is no more than a humanitarian expression of intent. Organs of a deceased person are the property (lawful possession) of the next of kin. It is only their decision which matters. It is always hoped, of course, that they will comply with the instructions of the deceased relative – but they might not. A present problem is that sometimes these wishes are circumscribed. For example, the deceased may not want their organs to be given to someone of a particular religion, sex, age or colour. I gather this can present difficulties.

Dr William O Thomson, 7 Silverwells Court, Bothwell.

MAY I point out a practical problem with the current system of “opting in”: How do you register as a donor? I gave a pint of blood last week and asked if I could get a new organ donor card. The blood transfusion offices in Nelson Mandela Place do not keep them. They suggested I try my GP surgery and they said I should try my local post office, which I will do. Can someone with the authority please do something now at least to make the present system work?

Richard MacKinnon, Flat 0/1, 131 Shuna Street, Glasgow.

Originally published by Newsquest Media Group.

(c) 2008 Herald, The; Glasgow (UK). Provided by ProQuest Information and Learning. All rights Reserved.

BridgePoint Medical has acquired Asheville Orthotic Prosthetic Center and retained Greg Straub and Steve Hagler as owner-operators.

Other owners, Andrew Adkisson and Emily Wilder, will also remain with the company. Mr Adkisson will be responsible for the company’s central fabrication operations and Ms Wilder assumes management responsibilities of Asheville Orthotic Prosthetic Center’s (AOPC’s) North Carolina facilities.

The acquired entity will retain its name and locations in Asheville, Hendersonville and Charlotte, North Carolina and will continue to offer patient care without interruption, said BridgePoint Medical. The company’s Charlotte facility operates under the name of Charlotte Orthotic Prosthetic Center.

Clint McKinley, president of BridgePoint Medical, said: “BridgePoint Medical is developing a broadening network of companies and relationships in the North Carolina market and we see a great opportunity to leverage the company’s market presence with our relationships and contacts.”

WOONSOCKET, R.I., June 18 /PRNewswire/ — According to a recent study(1), more than 6.1 million Americans are currently enrolled in health savings account (HSA)-eligible insurance plans, a 35 percent increase since last year. Consumers are increasingly turning to health savings and flexible spending accounts (FSAs) to cut costs associated with health care. CVS/pharmacy, America’s largest retail pharmacy with 6,300 convenient locations nationwide, is making it easier for shoppers enrolled in HSAs and FSAs to save money and track eligible health purchases as part of its ExtraCare rewards program.

As part of a new system rolled-out nationwide in early 2008, CVS/pharmacy checkout counters now provide shoppers with easy-to-read register receipts. The new receipts highlight prescription medicines, over-the-counter (OTC) remedies and other qualifying purchases so they can be easily identified and tracked with a special symbol indicating which items are HSA/FSA-eligible. To make redemption of HSA/FSA funds as easy as possible, CVS/pharmacy register receipts also present separate sub-totals for items that are HSA/FSA-eligible.

HSA/FSA participants save money by setting aside pre-tax dollars for prescription co-pays, OTC medications and other health-related purchases. ExtraCare members who choose CVS/pharmacy for HSA/FSA-eligible purchases save money and time by eliminating the hassle previously associated with validation of HSA/FSA claims. ExtraCare cardholders still receive quarterly Extra Bucks earned for HSA/FSA-eligible transactions, as well as any applicable instant rewards.

“The use of health savings accounts and flexible savings programs has grown dramatically over the past two years,” said Rob Price, senior vice president of marketing for CVS/pharmacy. “But many consumers don’t realize that managing their funds throughout the year can be simple and, more importantly, can result in significant cost-savings, particularly for those with chronic conditions. CVS/pharmacy remains committed to improving the lives of our customers, and helping them save money on everyday health costs is a major component of that mission.”

Easier than ever to use “flex cards” at the register

An increasing number of consumers participating in FSAs rely on FSA debit cards loaded with predetermined limits. Consumers who present these “flex cards” to complete a transaction at CVS/pharmacy will experience the immediate benefit of the FSA sub-total being deducted directly from the shopper’s flex card, while the remaining total for non-FSA items will be organized for the shopper to purchase with an alternative method of payment. Some FSA programs or third-party administrators may request proof of an automatically submitted claim by way of receipt, so participants are encouraged to save receipts that contain FSA-eligible purchases made with a flex card.

Organizing and tracking spend throughout the year

Cardholders can call a toll-free number (1-800-SHOP-CVS) to receive a list of HSA/FSA-eligible purchases made with their ExtraCare card. This statement can be used to substantiate FSA-eligible purchases made with an ExtraCare card going back 14 months. Cardholders receive their HSA/FSA-purchase statement by U.S. mail within five business days of making the request (or sooner, if callers request an email version of the statement). CVS/pharmacy provides this service free of charge to ExtraCare cardholders. Cardholders that do not participate in FSAs may still receive a free list of FSA-eligible purchases. These lists help shoppers by supplying enough information to forecast HSA/FSA-eligible spending for future HSA/FSA withholdings or to substantiate tax deductions pertaining to health and medical expenses.

Details: FSAs and HSAs

Health savings accounts and flexible spending accounts are made available by many U.S. employers as part of company health benefits. HSAs and FSAs allow an employee to set aside a portion of his or her pre-tax earnings to pay for health care expenses not covered by health insurance plans. Money deducted from an employee’s pay into a HSA/FSA is not subject to payroll taxes, resulting in substantial payroll tax savings. Common costs covered by HSAs and FSAs include prescription drug co-payments and OTC products ranging from cold and flu remedies and allergy treatments to eye care products and blood pressure monitors.

Virtually all FSAs have “use it or lose it” policies which establish annual deadlines for redemption of the available funds; these policies are determined by employers but a majority are arranged to correspond with the calendar year, meaning that all funds not used on or before December 31 are lost to the account holder. Some HSAs are automatically rolled over for future medical expenses but policies may vary.

ExtraCare basics

CVS/pharmacy’s ExtraCare program is the largest consumer rewards program, with more than 50 million cardholders. Cardholders receive 2% of most purchases back quarterly, delivered in the form of free “CVS money” called Extra Bucks. Additionally, members receive benefits such as instant targeted offers on register receipts. More than ten million ExtraCare members have enrolled in CVS/pharmacy’s email alerts program, which delivers additional coupons and health and beauty information directly to shoppers’ email inboxes.

About CVS/pharmacy

CVS/pharmacy, the retail division of CVS Caremark Corporation , is America’s largest retail pharmacy with 6,300 retail locations. CVS/pharmacy is committed to improving the lives of those we serve by making innovative and high-quality health and pharmacy services safe, affordable and easy to access, both in its stores and online at CVS.com. General information about CVS/pharmacy and CVS Caremark is available at http://www.cvs.com/pressroom, as well as http://investor.cvs.com/.

(1) 2008 census released by America’s Health Insurance Plans (AHIP), available online at: http://www.ahipresearch.org/pdfs/2008_HSA_Census.pdf.

Contact: Mike DeAngelis of CVS/pharmacy, +1-401-770-2645, [email protected]

CVS/pharmacy

CONTACT: Mike DeAngelis of CVS-pharmacy, +1-401-770-2645,[email protected]

Web site: http://www.cvs.com/http://investor.cvs.com/http://www.cvs.com/pressroomhttp://www.ahipresearch.org/pdfs/2008_HSA_Census.pdf

To: HEALTH EDITORS

Contact: Darren Spinck, +1-202-486-2008, [email protected], for the Movement Against Cancer

MOSCOW, June 18 /PRNewswire-USNewswire/ — Movement Against Cancer (MAC), cancer patient advocacy group in Russia, will conduct a public education campaign to urge people in Russia to undergo early screening tests and diagnostic procedures to detect breast cancer, colon cancer, stomach cancer, prostate cancer and cervical cancer — the types of cancer that could be cured if detected early.

One of the most serious problems with cancer treatment in Russia is a very low rate of early detection (stage I and stage II tumors), while in most cases the disease is diagnosed at very advanced stages when treatment options are less effective and much more costly. MAC efforts will be supported by the Russian government, which has launched a program to reduce cancer mortality rates.

The launch of the public education campaign is the initial stage of the Movement Against Cancer activity program for 2008.

We are starting this campaign because cancer death rates remain very high in Russia, said Antonina Gromova, leader of the Moscow- based MAC activists group. The situation with breast cancer is quite revealing.

We could cut cancer death rates if people in Russia were aware of modern treatment and screening methods, that could help cure cancer at early stages, said Gromova. Each year, 50,000 women in Russia are diagnosed with breast cancer and every year the disease kills 25,000 women.

Oncologists in Russia point out that one of the main reasons for such high cancer death rates is that patients are often diagnosed with the disease once it is too late. This catastrophic situation is not limited to breast cancer. For example, prostate cancer is number two among cancers diagnosed among men and is the fifth killer among all cancers in Russia.

During our campaign we will focus our efforts on screening such types of cancer that could be easily cured at early stages such as breast cancer, colon cancer, stomach cancer and prostate cancer, Gromova added.

The second stage of MACs 2008 program will be a nation-wide effort to create an electronic registry of all breast cancer patients in Russia, which will assist the Russian Health Ministry make the budgetary assessment of the actual costs of treating breast cancer in Russia. The registry will also help determine the budgetary need for innovative treatment options against breast cancer, including targeted therapies with monoclonal anti-bodies, as well as the scale of their current use in Russian hospitals.

Currently health officials arent aware of the real amount of patients that need treatment, said Julia Shestakova, MAC activist, Moscow. Oncology clinics and hospitals have their own numbers, health ministry officials and patient organizations have their own. In the end thousands of women are left without effective treatment and innovative drugs.

The Movement Against Cancer unites patients and doctors to inform cancer patients about their rights for access to effective and innovative cancer treatments. The Movement seeks to broaden the understanding of Russian society and the Russian government of the problems cancer patients, survivors and family members face when encountering the disease and what should be done on a public policy level to improve cancer patient care and patient access to effective treatment. The anti-cancer group disseminates reliable information about modern cancer treatment methods, protects cancer patients’ rights, and advocates for patients’ equal and guaranteed access to innovative cancer treatments.

SOURCE Movement Against Cancer

(c) 2008 U.S. Newswire. Provided by ProQuest Information and Learning. All rights Reserved.

MADISON, N.J., June 18 /PRNewswire-FirstCall/ — HemoCue(R) AB, a global point-of-care diagnostic test manufacturer and wholly owned subsidiary of Quest Diagnostics Incorporated , today announced that its HemoCue Albumin 201 System is the first quantitative point-of-care test for screening for, diagnosing and monitoring microalbuminuria to be granted a CLIA waiver by the U.S. Food and Drug Administration (FDA). With the FDA CLIA waiver, non-laboratory trained physicians and other health care professionals in any health care facility with a CLIA Certificate of Waiver in the U.S. will be able to use the HemoCue Albumin 201 System to screen patients for microalbuminuria and begin treatment based on the test’s results during a single office visit.

Microalbuminuria may indicate the presence of chronic kidney disease (CKD), a life-threatening condition that affects approximately 26 million Americans. Diabetes and hypertension are the two leading risk factors for developing CKD. Microalbuminuria also is an independent risk factor for developing cardiovascular disease in patients with or without diabetes or hypertension.

“Given that microalbuminuria is a risk marker for cardiovascular disease, and its increase over time can indicate kidney disease, it is important that physicians have a fast, easy, reliable test to assess changes in their patients,” said professor George L. Bakris, M.D., Director of the Hypertensive Diseases Unit at the University of Chicago-Pritzker School of Medicine. “The availability of a point-of-care test that accurately measures albumin in urine is expected to have a positive impact on physicians’ ability to screen in-office and then begin treatment for patients at risk for microalbuminuria, such as those with diabetes or hypertension.”

Microalbuminuria is a condition characterized by the presence of albumin, a protein, excreted in urine. As the albumin excretion increases, so does the risk of CKD or cardiovascular disease onset and progression. The HemoCue Albumin 201 System, which produces results within 90 seconds, enables physicians to identify and quantify low levels of albumin at the point of care for the purpose of screening for, diagnosing, monitoring and to supplement clinical evidence in the treatment of microalbuminuria. Unlike semiquantitative urine “dipstick” methods, which indicate if a patient’s microalbumin levels fall within pre-defined ranges, the HemoCue Albumin 201 System provides the actual concentration present in the sample. Using the HemoCue Albumin 201 System, physicians may monitor changes in microalbumin excretion in a patient over time.

A study in the American Journal of Nephrology (2008;28:324-329) published online in November 2007 concluded that the “HemoCue Albumin 201 System is a valid and precise method for UAE (urinary albumin excretion) determination, exhibiting a performance similar to laboratory ACR (albumin-to-creatinine) estimations and far better than the widely used dipsticks … the HemoCue Albumin 201 System appears to be a convenient solution for detection of abnormal UAE levels.” The study involved 165 adult subjects under treatment for hypertension at the Rush University Medical Center in Chicago. Dr. Bakris was the study’s lead investigator. HemoCue AB financially supported the study.

According to the American Diabetes Association (ADA) and the National Kidney Foundation (NKF), physicians should assess urine albumin excretion annually in patients with type 2 diabetes commencing at the time of diagnosis as well as in patients with type 1 diabetes who have had the disease for five years. The NKF further recommends that patients at increased risk for chronic kidney disease, such as those with hypertension, be offered microalbumin screening during periodic health evaluations. Microalbuminuria screening can help physicians detect CKD in the early stages — before symptoms appear — when treatment can halt or reverse its progression.

Despite evidence-based medical guidelines, a March 2008 Quest Diagnostics Health Trends Report on Chronic Kidney Disease found that only 32.7 percent of patients with type 1 or type 2 diabetes and/or hypertension received a microalbumin test for CKD during the twelve-month period ending in October 2006. The study is based on results of tests performed by Quest Diagnostics on patients in the U.S. Diabetes affects seven percent of the U.S. population and more than 21 percent of adults over age 60. Hypertension affects approximately 30 percent of American adults and more than half of those over age 60.

“Our recent Health Trends data suggest that fewer at-risk patients are receiving microalbumin tests than would be expected if the established medical guidelines were universally applied,” said Stephen C. Suffin, M.D., interim chief laboratory officer and corporate clinical pathologist — science and technology, Quest Diagnostics. “The availability of a fast, reliable point-of-care test that physicians can perform in their own offices to quantitatively assess microalbumin may help patients at risk for CKD to begin receiving the care they need at the time of their appointment with their physician.”

In addition to CKD and cardiovascular disease, microalbuminuria may also suggest the potential development of preeclampsia, a potentially life-threatening condition that can affect a pregnant woman, particularly those with type 1 diabetes, and her fetus. In patients with diabetes, microalbuminuria may suggest the potential to develop diabetic retinopathy, the leading cause of blindness among adults in the U.S.

The HemoCue Albumin 201 System received FDA 510(k) clearance in the first quarter of 2006. It was CE marked for distribution to more than 30 countries in Europe during the fourth quarter of 2005.

About CLIA Waiver

The U.S. Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988 to establish federal quality standards for the clinical laboratory testing industry. The FDA grants CLIA waivers to FDA 510(k)-cleared tests that are “simple” and have an “insignificant risk of producing an erroneous result.” CLIA waived tests may be performed by non-laboratory trained health care workers at any facility that fulfills certain minimal requirements, such as holding a CLIA Certificate of Waiver and following manufacturer instructions.

About HemoCue

HemoCue, a Quest Diagnostics company, is a leading global company in a field of diagnostics known as near patient, or point-of-care, testing. In 1982, HemoCue introduced the first system making accurate hemoglobin testing possible in near patient settings. The system consists of a handheld instrument and a disposable microcuvette (micro sample collection system) used with each test. Since then, HemoCue has sold more than 250,000 systems worldwide and sells more than 100 million test cuvettes annually. The company has subsidiaries and affiliates in the U.S., Germany, Finland, Switzerland, the Netherlands, and the UK, with franchises and third-party distributors generating revenue in more than 100 countries. Quest Diagnostics acquired HemoCue in 2007. HemoCue is based in Angelholm, Sweden. Additional information is available at http://www.hemocue.com/.

About Quest Diagnostics

Quest Diagnostics is the leading provider of diagnostic testing, information and services that patients and doctors need to make better healthcare decisions. The company offers the broadest access to diagnostic testing services through its national network of laboratories and patient service centers, and provides interpretive consultation through its extensive medical and scientific staff. Quest Diagnostics is a pioneer in developing innovative new diagnostic tests and advanced healthcare information technology solutions that help improve patient care. Additional company information is available at: http://www.questdiagnostics.com/.

The statements in this press release that are not historical facts or information may be forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause actual results and outcomes to be materially different. Certain of these risks and uncertainties may include, but are not limited to, competitive environment, changes in government regulations, changing relationships with customers, payers, suppliers and strategic partners and other factors described in the Quest Diagnostics Incorporated 2007 Form 10-K and subsequent SEC filings.

Quest Diagnostics Incorporated

CONTACT: Investors, Laure Park, +1-973-520-2900, or Media, Wendy Bost,+1-973-520-2800, both of Quest Diagnostics

Web site: http://www.questdiagnostics.com/http://www.hemocue.com/

Research and Markets (http://www.researchandmarkets.com/research/7d8fd8/keywordpharma_conf) has announced the addition of the “KeywordPharma Conference Insights – Accelerating Patient Recruitment in Clinical Trials” report to their offering.

The 2nd Annual Conference on Accelerating Patient Recruitment in Clinical Trials, held in London 27-28 March 2006 and organised by SMi, brought together speakers and delegates from a wide range of pharmaceutical and medical device companies and Contract Research Organisations (CROs). Many of the speakers enjoy direct responsibilities for ensuring patient studies are optimised within their companies, and that they run to budget and to agreed timelines. Over the course of the conference it emerged that, although speakers often shared similar patient recruitment problems, the approaches they take to address these issues now vary considerably between companies, as do their relative success rates. Some companies have replaced inefficient large advertising campaigns (that seldom produced sufficient patients anyway) with streamlined evidence-based patient recruitment methodologies that are adaptively agile to the particular requirements of each individual trial. Further, it became clear that, to assist both patient recruitment and investigator support and morale, ‘best-practice’ companies have been able to identify optimum managerial structures for handling their multinational clinical trials across large numbers of investigator sites across many countries. They have also been able to identify the factors that predispose to higher levels of patient recruitment and retention in different countries, and the most cost-effective solutions. Several companies shared how they benefit by the use of a range of support tools (patient databases, metrics and benchmarking, and cost-effectiveness analyses) to make better choices about their patient recruitment strategies (and their selection of investigator site where this impinges on rates of recruitment). Subsequently, some have now found out what works well and what doesn’t. The audience seemed fascinated to learn by these experiences.

The issue of public and patient perceptions of clinical trials was at the forefront of many of the presentations, since a very high-profile incident during a drug trial, news of which immediately reached television and newspaper audiences globally, had occurred only days before in a nearby hospital. Everyone was aware that this crucially important new public image onslaught poignantly affects the livelihoods of almost all the speakers and delegates in the auditorium. This is because, as industry patient recruitment specialists, and as individuals, their future success depends on their own abilities to try to regain supportive perceptions of clinical trials within the general public. They are also aware that they now need to come up with the most effective reasoning for their patients to ensure they remain enrolled in existing trials, and to find the best ways to persuade patients to enrol in adequate numbers in all of their new prospective studies.

Executive Summary:

All pharmaceutical companies want to find cost savings. The industry conducts large numbers of clinical trials each year. Regulatory requirements, as well as other scientific and marketing needs, mean that many of these studies continue to need ever-larger numbers of patients. The cost of running trials is now approaching 30% of pharmaceutical companies’ entire drug development budgets. However, 75% of patient studies fail to make their timelines, often causing expensive delays in regulatory approval and market launch. Slow patient recruitment represents a major reason for this, as does poor retention of patients within ongoing clinical trials. Close scrutiny of, and adherence to, a variety of factors that promote timely patient recruitment, however, mean that pharmaceutical companies have tangible mechanisms that can substantially enhance their profitability. The 2nd Annual Conference on Accelerating Patient Recruitment in Clinical Trials, held in London 27-28 March 2006, organised by SMi, discussed a diverse range of approaches now used by some companies and their Contract Research Organisations to adhere to timelines, to shorten them, and to try to identify recently evolving best practices.

This Conference Insights review provides analysis of the pertinent issues raised in selected presentations made at this event, discussing proven strategies to maximise patient recruitment, tools to assist the process, investigator-site selection and public perceptions of clinical trials. It makes clear why the old method of opportunism in patient recruitment is not effective, and looks at why companies are starting to abandon expensive advertising campaigns in favour of evidence-based patient recruitment strategies.

From a business point of view, optimising patient recruitment and retention, with the aim of getting new products on the market as soon as possible, now represents an important, achievable goal for all pharmaceutical companies.

Key Topics Covered:

-2nd Annual Conference on Accelerating Patient Recruitment in Clinical Trials – Programme

-Introduction

-About the author

-Background

-The importance of influencing public and patient perceptions of clinical trials on global and local levels

-Strategies for accelerating patient recruitment

-Strategies for increasing patient retention

-Conclusions

-References

-Further reading

For more information visit http://www.researchandmarkets.com/research/7d8fd8/keywordpharma_conf

Conmed Healthcare Management, Inc. (OTCBB:CMHM), a leading full service provider of correctional facility healthcare services to county detention centers, today announced that Richard W. Turner, PhD, the Company’s President, Chief Executive Officer and one of its directors, has been named Chairman of the Board effective immediately. John Pappajohn, the former Chairman, remains as a Director of the Company. Dr. Turner became a director of Conmed in January 2007

Prior to joining PACE (the predecessor company to Conmed) in May 2006 as President and CEO, Dr. Turner held executive leadership positions in the medical industry for approximately 25 years, including President and CEO of Eyetel Imaging, President and CEO of BEI Medical, and President of the Healthcare Group for Cooper Companies.

John Pappajohn, Conmed’s former Chairman commented, “Dick’s experience and managerial talent have been instrumental to the development and execution of our growth strategy since he joined the Conmed team. The Board is delighted he has accepted this position and we are confident in his ability to continue to lead the Company and represent the interests of our stockholders as the new Chairman of the Board.”

About Conmed

Conmed has provided correctional healthcare services since 1984, beginning in the State of Maryland, and currently services detention centers and correctional facilities in thirty counties in five states, including Washington, Oregon, Kansas, Virginia, and Maryland. Conmed’s services have expanded to include mental health, pharmacy and out-of-facility healthcare services.

Forward Looking Statements

This press release may contain, among other things, certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, (i) statements with respect to the company’s plans, objectives, expectations and intentions; and (ii) other statements identified by words such as “may”, “could”, “would”, “should”, “believes”, “expects”, “anticipates”, “estimates”, “intends”, “plans”, “projects”, “potentially” or similar expressions. These statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks and uncertainties including those contained in its public filings. Actual results may differ from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company’s control including, without limitation, the Company’s ability to increase revenue and to continue to obtain contract renewals and extensions.

By Sarah Rothwell, Tampa Tribune, Fla.

Jun. 18–UNIVERSITY AREA — Bishop Bruce Wright is a source of hope and comfort to patients at University Community Hospital.

As the hospital’s chaplain, he shares in the celebration of births and grieves with families when a patient dies. He counsels the terminally ill and consoles the injured. Wright, 56, spends countless hours attending to the spiritual needs of men, women and children at UCH, UCH-Carrollwood, Pepin Heart Hospital and Helen Ellis Memorial Hospital.

“He’s an inspiration,” said Maria Delgado of New Port Richey, manager of cancer services at UCH. “We all love Bishop Wright. He’s always willing to listen. He’s there for the patients and for the staff.”

Wright, a consecrated Anglican bishop, began his work at UCH in 2000, when a brief volunteer stint inspired him to take on a full-time job at the hospital. In 2005, he helped start the hospital’s Palliative Care Program. The program, led by Wright, physician Chad Farmer and registered nurse Alan Shukman, offers comfort care to terminally ill patients, their families and caregivers.

The palliative care team consists of 18 hospital staff members from 15 disciplines, including oncology, nursing and case management. Wright heads the Spiritual Care Department, which is one facet of the program.

“When a patient is terminal, the focus shifts from trying to cure the patient to trying to make them as comfortable as possible,” Wright said. “I approach the end of life from a spiritual perspective.”

Wright visits 15 to 20 patients a day, within and outside the Palliative Care Program, making stops in the emergency room and the intensive care unit and on the oncology floor. His office is a few paces down the hall from ICU.

On June 11, he visited Kenneth Parks of Temple Terrace, a nonterminal patient recovering from surgery to remove part of his colon. Wright prayed with Parks’ family. He asked God to watch over the patient and give him strength.

“It’s always helpful to pray,” said Parks’ wife, Cathy. “It’s nice to be with someone like the bishop, who is empathetic, sympathetic and caring.”

Clinical professionals also appreciate Wright’s ability to help ease patient suffering.

“When a patient is in pain, I can give them medicine, but I can’t fix their spiritual pain,” said Farmer, a resident of South Tampa. “I need help. That is why Bishop Wright is so important. He addresses the issues I can’t. “

Wright caters to patients’ personal spiritual needs. He doesn’t push a specific religious philosophy. If needed, he will just sit and listen.

“I’m not here to convert people to my beliefs,” he said. “I’m here to help people find what it is in their belief system that brings them hope and peace.”

Wright oversees four chaplains, including his son, Jonathan Wright, 32, of Plant City. In addition, he invites visiting members of the clergy and spiritual leaders of all faiths to visit patients.

“People of different faiths have very specific and different ways of dealing with health care,” said emergency room assistant Phyllis Hoover of Carrollwood. “Bishop Wright is great with people because he is open-minded and respects everyone.”

Wright has a simple philosophy when visiting people who are losing a loved one.

“I believe in the three H’s: hug, hush and hang around,” he said.

Pat Black, a Church of Christ minister from Wesley Chapel, considers Wright a spiritual mentor.

“Bishop Wright is like my older brother,” Black, 67, said with a laugh. “We talk a lot and we work well together. He does a great job here.”

Registered nurse Suzy O’Neill of Plant City also works closely with Wright. She is one of 130 nurses he trained to assist with spiritual care. She considers the role a privilege.

“It’s important to provide spiritual support to patients,” she said. “We all need hope. We want to know that our lives can have meaning, even in our dying.”

Under Wright’s supervision, O’Neill set up a corner on the hospital’s third floor where patients’ families can sit, unwind and read spiritual books. If possible, she brings patients out to the area for a change of scenery. There is a similar area on the oncology floor called “the quiet room.”

“It’s important for families to have a quiet area, outside the hospital room, where they can relax,” Wright said. “People may forget what you did or said to help them, but they never forget how you made them feel.”

Wright aspires to make people feel at ease. He talks to patients about their interests, tells tasteful jokes and welcomes people into his office with a smile.

“Whenever I need advice or just to get away, I go to his office,” O’Neill said. “First and foremost, he is my friend.”

When Wright isn’t at the hospital, he spends time at home with his wife in Plant City. He has three children and five grandchildren. He likes gardening and taking care of two pet goats, CoCo and Daisy. He picked up the goats after performing a wedding ceremony on a farm.

Wright also works at Life- Spring Community Church in Forest Hills, where son Jonathan is the senior pastor. As bishop, the elder Wright oversees the church and speaks biweekly at Sunday services. He is happy to work with his son and the feeling is mutual. At the hospital, they sometimes visit patients together.

“My father always taught my sisters and I to put others’ needs above our own, to listen to people in need and spread the message of hope,” Jonathan Wright said. “That’s why he does so well at the hospital, because he listens. He is a gentle, kind and considerate man.”

Reporter Sarah Rothwell can be reached at (813) 865-4845 or [email protected].

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To see more of the Tampa Tribune or to subscribe to the newspaper, go to http://www.tampatrib.com.

Copyright (c) 2008, Tampa Tribune, Fla.

Distributed by McClatchy-Tribune Information Services.

For reprints, email [email protected], call 800-374-7985 or 847-635-6550, send a fax to 847-635-6968, or write to The Permissions Group Inc., 1247 Milwaukee Ave., Suite 303, Glenview, IL 60025, USA.

Text of report in English by state-run North Korean news agency KCNA

Pyongyang, June 18 (KCNA) – A special attention is paid to the reproductive health of people in the DPRK.

The Korean Family Planning & Maternal and Child Health Association, founded on January 25, juche [chuch’e] 79 (1990), is working to solve urgent problems arising in reproductive health.

The association has project sites including family planning clinics and mobile service teams in various provinces.

It undertakes comprehensive services and information, education and communication activities concerning reproductive health including family planning.

In June 1991, the association gained associate membership of the International Planned Parenthood Federation and in November 1995, full membership.

It keeps cooperation with such UN agencies as the World Health Organization and the UN Population Fund, the European Union, governments and non-governmental organizations of various countries.

Originally published by KCNA, Pyongyang, in English 0736 18 Jun 08.

(c) 2008 BBC Monitoring Asia Pacific. Provided by ProQuest Information and Learning. All rights Reserved.

By Emily Bregel, Chattanooga Times/Free Press, Tenn.

Jun. 18–Chattanooga dentist Dr. Ruth Lima shakes her head when recalling teeth she has seen in the mouths of elementary school students.

“Some of them are very, very badly broken down,” she said. “They’ve been going to class. They’re in pain.”

Recently Dr. Lima had to remove six of a student’s baby teeth that were rotted “down to the gumline,” she said.

“Here we are in this day and age with fluoride and all the education — you would think you wouldn’t see that,” she said. “My focus is to try to get this child back to good oral health.”

Dr. Lima, the dentist for the Ronald McDonald Care Mobile dental clinic, spent three days last week at Brown Academy treating about 20 children who don’t have private dental insurance. The Care Mobile visits 22 Hamilton County schools on a rotating schedule. About half the children treated are uninsured and half have TennCare, the state’s managed Medicaid program that provides comprehensive preventive and dental services to enrolled children under age 21.

In recent years, dental health initiatives such as the Care Mobile have gained traction in Tennessee, public health advocates and state officials said.

A March study by researchers at the National Academy for State Health Policy pointed to Tennessee, Michigan and Virginia as states that drastically have overhauled their Medicaid dental programs in recent years, resulting in significant improvements.

The Tennessee Department of Health has given more than $1 million in grants in the past year to support adult emergency dental services, said Dr. Veronica Gunn, chief medical officer for the state health department, in an e-mail.

Dental health programs and grants to public health providers have boosted dental hygiene options for the uninsured and TennCare populations in a number of ways. Among those is the Care Mobile’s mobile dental clinic, which launched in 2003 as a collaboration between T.C. Thompson Children’s Hospital and the Chattanooga Ronald McDonald House.

In the past year, the mobile dental clinic has treated more than 1,900 kids and provided $400,000 in free care, said Ray Lallier, Care Mobile supervisor and an employee of T.C. Thompson.

Children who come to the Care Mobile typically have no other health care provider to treat their dental needs, Mr. Lallier said.

“The kids that we see are children that don’t see a provider,” he said. “Either because of financial issues or other issues, dental hygiene is just not high on the priority list. Families are struggling to make sure the kids are eating and other things.”

Poor oral hygiene has been linked to heart disease, diabetes and premature births, Dr. Lima said.

“It’s a systemic thing,” she said. “There are so many issues I think people don’t really correlate” with dental hygiene.

The February 2007 death of a 12-year-old Maryland boy from a lack of dental care brought the often-overlooked issue into the spotlight. The boy, Deamonte Driver, died after an infection from an abscessed tooth spread to his brain, the National Academy for State Health Policy study noted.

TENNCARE IMPROVEMENTS

The recent study by the Academy for State Health Policy pointed to TennCare as one of a few state Medicaid programs whose broad reforms to its dental benefit resulted in young enrollees using those dental services more frequently. The TennCare changes also sparked growth in the number of dental health care providers accepting TennCare patients, the study noted.

In 2002, TennCare increased its reimbursement for dental services, nearly doubling reimbursements rates to be as high or higher than the retail fees for 75 percent of dentists in the area in 1999, said Andrew Synder, one of the study’s authors and policy specialist with the National Academy for State Health Policy.

TennCare also bid out a contract for administration of the program, selecting Doral Dental to administer and manage the program, decreasing administrative hassles faced by dental offices that previously had to work with multiple managed-care organizations, he said.

“Instead of being faced with a program that they felt had bad administration and fees that weren’t adequate for them, (Tennessee dentists) were facing a program that had much more friendly administration and fees that were much more conducive to them participating in the program,” Mr. Snyder said in a telephone interview last week.

As a result, the number of dentists who participated in TennCare doubled from 386 to 700 in the first two years after the reform, increasing to 851 by 2007, the study said. In addition, the percentage of children making dental visits at least once a year increased from 26 percent in 2002 to 36 percent in 2006, the study found.

Between 50 and 60 percent of privately insured children typically receive dental care in a one-year period, Mr. Snyder said.

Dr. Jim Gillcrist, TennCare dental director, said that in the early 2000s TennCare officials worked with the state department of health and Tennessee Dental Association to improve the state’s dental public health program. A settlement in a 1998 class-action lawsuit alleging that the state was failing to provide adequate health services also raised the standard for what dental services TennCare would provide for children, he said.

“There was a confluence of events that really prompted changes,” Dr. Gillcrist said. “It’s been enormously successful. … We want to make this one of the best programs in the nation, and we’re constantly trying to improve it.”

DENTAL HYGIENE OVERLOOKED

Even among those with regular health insurance, dental coverage often is overlooked, experts said.

In 2006, 47 million people — or 15.8 percent of the population– did not have health insurance, according to the U.S. Census Bureau. But the number of Americans without dental insurance is more than twice that, Mr. Snyder said.

In Tennessee, a great need exists for adult dental health services, dentists here said.

“There’s a lot of adults that get cut off at 21,” said Dr. James Wheeler, dentist at the Dodson Avenue Community Health Center, which treats mostly uninsured and Medicaid patients who pay based on a sliding scale.

“Some of the patients have (teeth in) very bad condition. They have dental neglect that has occurred for many, many years. If the state had some system to pay for cleanings that would greatly help,” he said.

TennCare provides dental services for all enrollees up to age 21, but since TennCare reforms in 2005 the bureau does not offer dental coverage for adults, TennCare officials said.

The Chattanooga-Hamilton County Health Department this month received a $50,000 state grant to expand the minimal dental services it offers to adults. Now included in its services are exams, extractions, X-rays and some other services, said Dr. Andy Thomas, the local health department’s dental program manager.

“Throughout the state, adult dental (care) has been a problem, but I think we’re making good progress,” Dr. Thomas said.

—–

To see more of the Chattanooga Times/Free Press, or to subscribe to the newspaper, go to http://www.timesfreepress.com.

Copyright (c) 2008, Chattanooga Times/Free Press, Tenn.

Distributed by McClatchy-Tribune Information Services.

For reprints, email [email protected], call 800-374-7985 or 847-635-6550, send a fax to 847-635-6968, or write to The Permissions Group Inc., 1247 Milwaukee Ave., Suite 303, Glenview, IL 60025, USA.

SAN DIEGO, June 18, 2008 (PRIME NEWSWIRE) — TRACON Pharmaceuticals, Inc., announced that the first cancer patient has been treated in a Phase 1 clinical trial with oral TRC102, a novel anti-cancer drug intended to reverse resistance to Alimta(r) chemotherapy by targeting a specific DNA repair pathway.

“TRACON is taking the lead in developing oral dosing of TRC102, which will provide better patient flexibility in treatments for advanced cancers. TRC102 provides potent interruption of a key mechanism used by cancer cells to evade chemotherapy. We have shown in preclinical systems that TRC102 can increase the effectiveness of both alkylating agents and the antimetabolite chemotherapy Alimta(r),” said Dr. Stan Gerson, M.D., Director of the Ireland Cancer Center at University Hospitals Case Medical Center and Case Western Reserve University Comprehensive Cancer Center (Cleveland, OH), and co-inventor of TRC102.

TRC102 is a small molecule that has been shown to reverse resistance to the chemotherapy agent Alimta(r) in models of human cancer, by targeting the base excision repair pathway used to repair chemotherapy-induced DNA damage. Intravenous TRC102 is also being dosed to cancer patients in a Phase 1 clinical trial in combination with Temodar(r) being conducted at University Hospitals Case Medical Center.

“Dosing a therapeutic that has the potential to improve the activity of both antimetabolite and alkylating chemotherapy is a major milestone for TRACON, and represents initiation of the fourth Phase 1 clinical trial of a TRACON product within the past eleven months,” said Charles Theuer, M.D., Ph.D., President and Chief Executive Officer of TRACON Pharmaceuticals, Inc.

The Phase 1 trial is designed to assess the safety, tolerability and pharmacokinetics, as well as preliminary anti-tumor activity of TRC102 in patients with advanced cancer who also receive Alimta(r).

About TRACON Pharmaceuticals

TRACON Pharmaceuticals, Inc. (www.traconpharma.com) is a privately held biopharmaceutical company focused on the development of products for oncology and ophthalmology treatment, including agents that inhibit angiogenesis. TRACON addresses unmet needs in these areas with product candidates that use established platforms that will complement existing therapies. TRC093 is a monoclonal antibody that binds to cleaved collagen to inhibit angiogenesis and tumor growth that began dosing in a Phase 1 trial in July, 2007. TRC105 is a monoclonal antibody that binds CD105 to inhibit angiogenesis that began dosing in a Phase 1 trial in January, 2008. TRC102 is a small molecule intended to reverse resistance to chemotherapeutics that began dosing in a Phase 1 trial in combination with Temodar(r) in February, 2008 and in combination with Alimta(r) in June, 2008. TRC101 is a nanoliposome embedded with ceramide used to improve the activity and delivery of chemotherapeutics. TRACON Pharmaceuticals was founded by Paramount BioSciences, LLC.

About Paramount BioSciences

Paramount BioSciences, LLC is a global pharmaceutical development and healthcare investment firm that conceives, nurtures, and supports new biotechnology and life-sciences companies. For additional information about Paramount BioSciences, visit www.paramountbio.com.

About University Hospitals Case Medical Center

With 150 locations throughout Northeast Ohio, University Hospitals serves the needs of patients through an integrated network of hospitals, outpatient centers and primary care physicians. At the core of our Health System is University Hospitals Case Medical Center. The primary affiliate of Case Western Reserve University School of Medicine, University Hospitals Case Medical Center is home to some of the most prestigious clinical and research centers of excellence in the nation and the world, including cancer, pediatrics, women’s health, orthopedics and spine, radiology and radiation oncology, neurosurgery and neuroscience, cardiology and cardiovascular surgery, organ transplantation and human genetics. Its main campus includes the internationally celebrated Rainbow Babies & Children’s Hospital, ranked best in the Midwest and first in the nation for the care of critically ill newborns; MacDonald Women’s Hospital, Ohio’s only hospital for women; and Ireland Cancer Center, which holds the nation’s highest designation by the National Cancer Institute of Comprehensive Cancer Center. For more information, go to www.uhhospitals.org

This news release was distributed by PrimeNewswire, www.primenewswire.com

 CONTACT: TRACON Pharmaceuticals, Inc.          Alison Fishman          (858) 550-0780 ext. 229          [email protected] 

CLEVELAND, June 18 /PRNewswire/ — Synapse Biomedical Inc. (http://www.synapsebiomedical.com/) announced today it has received approval from the U.S. Food and Drug Administration (FDA) for its NeuRx DPS(TM) for ventilator-dependent Spinal Cord Injury (SCI) patients who lack voluntary control of their diaphragms. With the FDA’s approval, SCI patients and their caregivers throughout the U.S. can now access this technology that was previously only available to clinical trial participants.

(Photo: http://www.newscom.com/cgi-bin/prnh/20080618/CLW020 )

(Fact sheets, patient testimonial, product video and images: http://www.synapsebiomedical.com/news/media)

The device implanted through minimally invasive laparoscopic surgery, provides electrical stimulation to muscle and nerves that run through the diaphragm. When stimulated by the NeuRx DPS(TM), the diaphragm contracts, mimicking natural breathing, and allows air to fill the upper and lower parts of the lungs rather than forcing air in with a mechanical ventilator.

The NeuRx DPS(TM) received the CE Mark (CE Registration #518356) on November 20, 2007 and is approved for treating patients with diaphragm dysfunction in the European Union. Seven successful implants have occurred at leading European hospitals including: Charite – Univeritatsmedizin (Berlin); Groupe Hospitalier Pitie-Salpetrier (Paris) and Institut GUTTMANN – Hospital De Neuro Rehabilitacio (Barcelona) since that date.

The FDA decision was completed after clinical testing, which began with clinical trials starting in 2000 under Investigational Device Exemption #G920162.

The FDA approval is based on 50 patients implanted with the device in clinical trials at hospitals in the U.S. and Canada – University Hospitals Case Medical Center, Ohio; Shepherd Center, Atlanta, Ga.; Methodist, Houston, Texas; and Vancouver General Hospital, Vancouver. All of the implanting surgeons were trained in the device under the direction of Dr. Raymond Onders, director of minimally invasive surgery at University Hospitals, Cleveland, and a founder, board member and shareholder of Synapse Biomedical. Dr. Onders will continue to proctor initial surgeries as regional trauma centers begin to offer the NeuRx DPS(TM) to spinal cord patients.

“We are pleased the FDA has given approval to NeuRx DPS(TM) so we can now offer individuals throughout the United States the ability to breathe on their own once again,” said Anthony R. Ignani, Synapse President and Chief Executive Officer. “The national launch of the NeuRx DPS(TM) represents Synapse’s first step in applying its NeuRx(TM) neurostimulation platform to U.S. patients with chronic and acute respiratory insufficiency which has the promise of reducing healthcare costs while improving outcomes.”

Technical description

In the clinical trial, NeuRx DPS(TM) provided 98% of SCI patients who had been dependent on mechanical ventilation via a tracheostomy with an alternative that allowed them to breathe normally and live more active lives. To date, over 50% were able to be completely eliminate their need for mechanical ventilation.

Patients may be able to transfer from ventilator wards to home or assisted living, and even travel. Speech patterns, often laborious and strained in ventilator-dependent patients, return to normal. The senses of taste and smell, severely diminished in ventilator-dependent patients, return.

Controlled through a four-channel battery-powered external pulse generator, the NeuRx DPS(TM) eliminates the need for a source of electricity and the concern for power outages. Patients and caregivers are easily trained in the use of the NeuRx DPS(TM) reducing the need for external medical supervision. Elimination and reduction of the use of a mechanical ventilator also greatly reduces the patient’s risk of a serious complication: Ventilator Acquired Pneumonia (VAP). In a peer review 2007 report in Physical Medicine and Rehabilitation Clinical of North America by Stephen P. Burns MD, the incidence of SCI pneumonia for initial admitted patients was reported to be as high as 50 percent. The associated mortality from pneumonia was reported as 28% in the first year.

Background

The NeuRx DPS(TM) was developed over the course of 20 years through a joint effort of physicians and engineers at several institutions, including University Hospitals Case Medical Center, Case Western Reserve University (a shareholder of Synapse Biomedical) and the Veterans Administration (VA) Medical Center. Funding assistance was provided by the Food and Drug Administration, U.S. Surgical Corporation (a Division of Covidian), University Hospitals Case Medical Center, the VA, and the National Center for Research Resources of the National Institutes of Health. Synapse Biomedical, headquartered in Oberlin, OH., was founded in 2002 to bring its NeuRx(TM) platform of Diaphragm Pacing technologies to market. These technology platforms resolve a number of respiratory clinical needs and create a neurostimulation market segment for these treatments. Clinical studies and research for other applications are ongoing.

Candidates for this U.S. approval of the NeuRx DPS(TM) are:

— Patients with stable, high level spinal cord injury with stimulatable diaphragms, but lack control of their diaphragm, resulting in the need for mechanical ventilation

— For use only in patients 18 years of age or older

The majority of eligible patients have suffered injury through motor vehicle accidents and sports injuries. An estimated 3,700 individuals in the U.S. live with high (C1-C3) SCI injuries that require tracheostomy and mechanical ventilation. Approximately 500 new cases occur each year.

Surgical procedure

Using a form of minimally invasive laparoscopic surgery, a surgeon creates four dime-size holes in the abdominal region and inserts a laparoscope so that the diaphragm muscle can be seen. The surgeon then places small electrodes in the diaphragm. The electrodes are attached through wires under the skin to a small external battery-powered pulse generator that stimulates contraction of the diaphragm muscle which allows the patient to breathe.

The surgery is done on an outpatient basis, with a short rehabilitation period. The patient then has the NeuRx DPS(TM) programmed to allow an effective and comfortable breath. Because of the patient’s injury, the diaphragm is weak and at first the patient can use the NeuRx DPS(TM) to breathe for a short period of time. The patient must condition and strengthen the diaphragm to allow increasing amount of time off the ventilator. Over time, many patients are able to free themselves completely from the ventilator. For more information on the surgical procedure, please visit http://www.synapsebiomedical.com/news/media.

Where Patients Can Go For Help

Patients and caregivers who want to find a doctor who can evaluate their case for possible treatment with the NeuRx DPS(TM) should visit http://www.synapsebiomedical.com/ for more information. To read the stories of successfully implanted patients, visit http://www.synapsebiomedical.com/news/success/ .

ALS Clinical Trials Also Underway

Amyotrophic Lateral Sclerosis (ALS), commonly referred to as Lou Gehrig’s disease, is a rapidly progressing, incurable and fatal neuromuscular disease characterized by progressive muscle weakness that results in paralysis. All voluntary control muscles are weakened, and, as a result, diaphragm muscles fail. Patients lose the ability to breathe without ventilator support.

Approximately 30,000 people in the U.S. live with ALS. Over 5,000 new cases are diagnosed each year. It is estimated that fewer than five percent of ALS patients choose to be placed on ventilators.

The NeuRx DPS(TM) received IDE #G040142 status in October 2005 for use in clinical trials on ALS patients. The pilot study accomplished in 16 patients was initiated in January 2005. It demonstrated the feasibility of the NeuRx DPS(TM) to slow the decline of a patient’s respiratory function as measured by Forced Vital Capacity and as a result delays the onset of respiratory failure.

The following medical sites are participating in NeuRx DPS(TM) clinical testing for ALS:

   -- University Hospitals Case Medical Center, Cleveland, Ohio   -- Johns Hopkins, Baltimore, Md.   -- Stanford University, Stanford, Calif.   -- Methodist Neurological Institute, Houston, Texas   -- Henry Ford Health System, Detroit, Mich.   -- Mayo Clinic, Jacksonville, Fla.   -- California Pacific Medical Center, San Francisco, Calif.   -- Mount Sinai Medical Center, NY, N.Y.    

Clinical trials for use of the NeuRx DPS(TM) for ALS are also underway in Europe. For more information on ALS, please visit the Synapse newsroom at http://www.synapsebiomedical.com/news/media.

About Synapse Biomedical

Founded in 2002, Synapse Biomedical’s mission is to commercialize our life-transforming neurostimulation platform used to treat people with respiratory insufficiency. Synapse is based in Oberlin, Ohio, approximately 30 miles west of Cleveland. For more information, including fact sheets, frequently asked questions, high-resolution images and broadcast quality video, please visit http://www.synapsebiomedical.com/news/media.

About University Hospitals Case Medical Center

University Hospitals Case Medical Center is a community-based health care system which serves patients at more than 150 locations throughout Northern Ohio, including seven wholly owned and four affiliated hospitals.

Committed to advanced care and advanced caring, UH encompasses the region’s largest network of primary care physicians, outpatient centers and hospitals. The network also offers specialty care physicians to treat almost every disease and condition, skilled nursing, elder health, rehabilitation and home care services, and occupational health and wellness.

University Hospitals is the second largest private sector employer in Northeast Ohio and is within the top five largest private sector employers in the state of Ohio.

Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20080618/CLW020AP Archive: http://photoarchive.ap.org/AP PhotoExpress Network: PRN5PRN Photo Desk, [email protected]

Synapse Biomedical Inc.

CONTACT: Allen Pfenninger, [email protected], or MelissaKoski, [email protected], both of Edward Howard, +1-216-781-2400

Web site: http://www.synapsebiomedical.com/http://www.synapsebiomedical.com/news/successhttp://www.synapsebiomedical.com/news/media

More than 70 million Americans suffer with chronic pain, and many of them depend on drugs just to get through the day. But according to Julian Whitaker, MD, of the Whitaker Wellness Institute in Newport Beach, CA, “Permanent relief is possible without resorting to drugs or surgery.” Dr. Whitaker will be discussing details of a new program for treating chronic pain during a free seminar on Saturday, June 28, 2008, at the Hilton Hotel Irvine near the Orange County airport.

A cornerstone of the program is microcurrent therapy, a novel treatment that delivers extremely low-level electrical currents to problem areas. Microcurrents restore normal frequencies within injured cells, resulting in rapid improvements in pain, inflammation, and function. In a study of patients with fibromyalgia, pain scores fell from an average of 7.3 to 1.4 following treatment.

For Lorraine G., the results were remarkable. “I’d suffered with the constant pain of fibromyalgia for more than 10 years before I heard about microcurrent therapy. From the very first session I felt substantial relief. I am so thankful.”

Microcurrent therapy is just one component of the Whitaker Wellness Institute’s Multi-Modality Pain Relief Program, which also includes prolotherapy, hyperbaric oxygen, infrared light, acupuncture, and chiropractic therapy. These integrative treatments are helping patients with back pain, neuropathy, sports injuries, fibromyalgia, arthritis, and other conditions get rid of chronic pain — for good.

“People who come to the clinic often ask why their physicians never told them about these safe, effective therapies. There’s no logical reason, other than the fact that drugs, and surgery have become so entrenched — and profitable.”

To attend Dr. Whitaker’s free seminar, “Drug-Free Solutions for Chronic Pain,” on June 28, call (800) 488-1500.

To learn more about Dr. Whitaker and his clinic, visit www.whitakerwellness.com.

About Julian Whitaker, MD: Dr. Whitaker, America’s Wellness Doctor, is author of the popular newsletter, “Health & Healing,” and founder of the largest alternative medical clinic in the US, the Whitaker Wellness Institute in Newport Beach, CA. Since 1979, the clinic has helped more than 40,000 patients reverse serious health problems.

Interview Requests: Dr. Whitaker is available for television, radio, and newspaper interviews.

 Contact:  Lorena Barragan Email:  Email Contact Phone:  (714) 619-1600 Website:  www.whitakerwellness.com

SOURCE: Whitaker Wellness Institute

Molecular Insight Pharmaceuticals, Inc. (NASDAQ: MIPI) reported on two preclinical studies that demonstrated the potential of indium-111-edotreotide as an imaging tool to predict Onalta (yttrium-90-edotreotide) absorption in body tissues and to aid in determining appropriate patient dose. Onalta is in development as a targeted radiotherapeutic for the treatment of carcinoid and pancreatic neuroendocrine tumors. The in vitro and in vivo studies are part of Molecular Insight’s clinical program to support a planned U.S. dosimetry trial later this year. Results were presented at the Society of Nuclear Medicine (SNM) 55th Annual Meeting in New Orleans, LA.

Onalta is a radiolabeled analog of the naturally occurring peptide, somatostatin. Somatostatin receptors are overexpressed in carcinoid and certain other neuroendocrine tumors. Onalta binds specifically to somatostatin receptors and serves as a carrier for targeted delivery of the therapeutic radioisotope, yttrium-90, to the tumor.

“These studies compared the tissue distribution and pharmacokinetic profiles of induim-111- and yttruim-90- labeled edotreotide in order to determine whether indium-111-edotreotide is a suitable imaging predictor for the organ distribution of yttrium-90-edotreotide, the radiotherapeutic peptide,” said John W. Babich, Ph.D., President and Chief Scientific Officer of Molecular Insight. “Yttrium-90 delivers therapeutic radiation for tumor kill, but it does not emit gamma rays that would enable imaging with standard gamma cameras. Therefore, a surrogate imaging isotope such as indium-111 is necessary to help inform appropriate patient dosing. We believe that these studies support the suitability of indium-111-edotreotide as an appropriate surrogate imaging marker for Onalta.”

“Onalta is a cornerstone of Molecular Insight’s oncology portfolio of targeted radiotherapeutics for the treatment of neuroendocrine tumors,” said David S. Barlow, Chairman and Chief Executive Officer of Molecular Insight. “Onalta and Azedra(TM) are complementary radiotherapeutic candidates that may have the potential to offer patients and physicians a range of options to treat neuroendocrine tumors such as carcinoid, pheochromocytoma and neuroblastoma. We in-licensed Onalta last year from Novartis Pharma AG where it underwent three Phase 1 and three Phase 2 clinical trials in more than 300 patients, and we expect to initiate a U.S. dosimetry trial in the second half of this year.”

The studies evaluated the tissue distribution and pharmacokinetics of indium-111-edotreotide in two animal models. One study included in vitro studies and evaluated another potential imaging surrogate, indium-111-pentetreotide (Octreotide). Tissue distribution comparisons of the compounds in all organs were virtually identical except in the kidneys, where indium-111-edotreotide predictably and consistently overestimated the Onalta absorbed radiation dose.

One presentation is a poster study, entitled “Determination of the Ability of (111)In Onalta (Edotreotide) to be Used as an Imaging Surrogate for the Accurate Prediction of (90)Y Onalta Radiation Absorbed Dose.” Authors are: John A. Barrett, Shawn M. Hillier, Katherine Kacena, John L. Joyal, and John W. Babich, of Molecular Insight Pharmaceuticals; Tamara L. Anderson, Daniel J. Irwin, and Jeffrey P. Norenberg, of the University of New Mexico Health Sciences Center, College of Pharmacy; and Michael G. Stabin and James B. Stubbs, of Radiation Dosimetry Systems, Palo Alto, CA. The second study is an oral presentation entitled, “Comparative Analysis of (111)In edotreotide, (90)Y edotreotide and (111)I pentetreotide In Vivo and In Vitro.” Authors are: John C. Marquis, Shawn M. Hillier, Travis Besanger, James F. Kronauge, John A. Barrett, John L. Joyal, and John W. Babich, of Molecular Insight Pharmaceuticals; Tamara L. Anderson, Daniel J. Irwin and Jeffery P. Norenberg, of the University of New Mexico Health Sciences Center, College of Pharmacy.

About Molecular Insight Pharmaceuticals, Inc.

Molecular Insight Pharmaceuticals (NASDAQ: MIPI) is a biopharmaceutical company specializing in the emerging field of molecular medicine, applying innovations in the identification and targeting of disease at the molecular level to improve healthcare for patients with life-threatening diseases. The company is focused on discovering, developing and commercializing innovative, molecular radiotherapeutics and molecular imaging pharmaceuticals with initial applications in the areas of oncology and cardiology. Its lead molecular radiotherapeutic product candidates, Azedra and Onalta, are being developed for detection and treatment of cancer. The company’s lead molecular imaging pharmaceutical product candidate, Zemiva, is being developed for the diagnosis of cardiac ischemia, or insufficient blood flow to the heart. In addition, the company has a growing pipeline of product candidates resulting from application of its proprietary platform technologies to new and existing compounds. Molecular Insight Pharmaceuticals is based in Cambridge, Massachusetts and its website address is: www.molecularinsight.com.

Forward-Looking Statements

Statements in this release that are not strictly historical in nature constitute “forward-looking statements.” Such statements include, but are not limited to, statements about the development of Azedra(TM), Onalta(TM), Zemiva(TM) and our other product candidates. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause the actual results of Molecular Insight to be materially different from historical results or from any results expressed or implied by such forward-looking statements. These factors include, but are not limited to, risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval for product candidates; competition from other pharmaceutical or biotechnology companies; and the additional risks discussed in filings with the Securities and Exchange Commission. All forward-looking statements are qualified in their entirety by this cautionary statement, and Molecular Insight undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof.

By Lauren Stanforth, Albany Times Union, N.Y.

Jun. 18–SCHENECTADY — The CEO of Hometown Health Center sent an e-mail to city officials criticizing the condition of an intersection where the health center’s optometrist was struck by a truck while walking to work Tuesday.

Schenectady police Lt. Brian Kilcullen said the accident occurred around 9 a.m. Tuesday when a vehicle eastbound on State Street hit Marc Hecker as he was crossing between Hometown Health’s employee lot at the former Fratello’s Restaurant and Rite Aid at Brandywine Avenue. A Hometown Health spokesman said Hecker had several injuries and he was listed in fair condition at Albany Medical Center on Tuesday afternoon.

Kilcullen said police are investigating whether the driver had a green light and what crosswalk signals were flashing at the time. The driver was ticketed for having a suspended license, Kilcullen said.

Hometown Health CEO John Silva forwarded an e-mail to Schenectady Mayor Brian U. Stratton and City Council members that said he sent a letter to City Council two years ago raising concerns about the need for a pedestrian crosswalk between Rite Aid and the Trustco Bank.

He also said the crossing signals where Hecker was hit flash too quickly for people to get across. Silva couldn’t be reached for comment Tuesday afternoon about the e-mail.

“Hundreds of parents with children, coming or leaving HHC on foot, attempt to cross Brandywine at that location each week. Other adults and children attempt to cross at other corners of this intersection using the crosswalks and can not safely cross before the lights change,” Silva said in his e-mail. “HHC, our patients, staff, and the community really need the city’s immediate attention and assistance. … Please help remedy this dangerous situation before another tragedy occurs.”

On Tuesday afternoon, Hacker’s daughter Jenna said her father is being treated for a broken arm, collapsed lung and other injuries.

Schenectady Corporation Counsel L. John Van Norden said that until the investigation is complete, the city won’t know what happened and can’t comment. Lauren Stanforth can be reached at 454-5697 or by e-mail at [email protected].

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To see more of the Albany Times Union, or to subscribe to the newspaper, go to http://www.timesunion.com.

Copyright (c) 2008, Albany Times Union, N.Y.

Distributed by McClatchy-Tribune Information Services.

For reprints, email [email protected], call 800-374-7985 or 847-635-6550, send a fax to 847-635-6968, or write to The Permissions Group Inc., 1247 Milwaukee Ave., Suite 303, Glenview, IL 60025, USA.

NYSE:RAD, NASDAQ-NMS:TRST,

SOUTH SAN FRANCISCO, Calif., June 18 /PRNewswire-FirstCall/ — Monogram Biosciences, Inc., announced today that the Company has signed an agreement with Gilead Sciences, Inc. to provide resistance testing and consultative services for Gilead’s Elvitegravir Phase III studies. Monogram assays will be used to screen patients for study enrollment and help select drugs to be given in conjunction with Elvitegravir during the study. Both Monogram’s Integrase phenotype and genotype assays were used in Elvitegravir preclinical and Phase II studies, and will be used to evaluate Phase III patient outcomes. The Phase III studies are anticipated to begin enrolling patients later this year.

Elvitegravir is the most recent Gilead drug to enter Phase III and is the latest drug in the promising new class of drugs known as “Integrase inhibitors.” Integrase is a viral enzyme that helps HIV integrate its genetic material into a healthy cell’s DNA, allowing that cell to begin producing genetic material for new viruses. Integrase inhibitors block the action of this enzyme, interrupting the HIV life cycle before it can begin reproducing.

“Momentum in new ways to combat HIV, such as Integrase inhibitors, is vital to dealing with a virus that is becoming increasingly difficult to treat,” said Bill Young, Monogram’s chief executive officer. “The Elvitegravir development program shows the importance of strong collaborations between diagnostic and drug makers to more quickly get powerful new treatments into the hands of those who need them most.”

About Monogram

Monogram is a biotechnology company advancing individualized medicine by discovering, developing and marketing innovative products to guide and improve treatment of serious infectious diseases and cancer. The Company’s products are designed to help doctors optimize treatment regimens for their patients that lead to better outcomes and reduced costs. The Company’s technology is also being used by numerous biopharmaceutical companies to develop new and improved antiviral therapeutics and vaccines as well as targeted cancer therapeutics. More information about the Company and its technology can be found on its web site at http://www.monogrambio.com/.

About Monogram’s Assays

As recommended by the U.S. FDA Antiviral Drugs Advisory Committee, biopharmaceutical companies use HIV resistance testing technology to support and enhance next-generation HIV drug development. Monogram’s proprietary technology is being applied to new HIV drug targets for screening and in subsequent clinical development programs for optimization of background therapy, patient monitoring and, in the case of CCR5 antagonists, for patient selection. Monogram is a leader in providing drug susceptibility and tropism assays for pharmaceutical development. PhenoSense GT(TM) is the only assay combining actual phenotype and genotype drug results in a single report. PhenoSense GT also includes a measure of replication capacity (RC), sometimes called viral fitness, and HIV-1 subtype. PhenoSense Entry(TM) is the only commercially available phenotypic test for measuring susceptibility to entry inhibitors. Similarly, PhenoSense Integrase(TM), which is a phenotypic test for measuring susceptibility to integrase inhibitors, is expected to be introduced commercially soon. Trofile(TM) is a patient selection co-receptor tropism assay that determines whether a patient is infected with a strain of HIV that uses the CCR5 co-receptor, the CXCR4 co-receptor, or a combination of CCR5 and CXCR4 to enter cells. Trofile is the only clinically validated tropism assay and has been used to select patients in all phase II and phase III studies of CCR5 antagonists to date. Together these assays provide the most complete picture of susceptibility to antiretroviral medications. These assays are used by physicians as an aide to guiding therapy selection decisions. They are also frequently used by pharmaceutical companies in phase II and phase III clinical trials for optimization of background therapy.

Forward Looking Statements

Certain statements in this press release are forward-looking. These forward-looking statements include references to the demand for our resistance and tropism assays, the size and timing of clinical trials utilizing our products and the use of our assays by physicians in guiding patient therapy decisions. These forward-looking statements are subject to risks and uncertainties and other factors, which may cause actual results to differ materially from the anticipated results or other expectations expressed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that physicians may not use a molecular diagnostic for patient selection for CCR5 antagonists or other HIV drugs; the risk that physicians may not use our resistance tests to monitor patients being treated with an integrase inhibitor; risks and uncertainties relating to the performance of our products; the growth in revenues; the size, timing and success or failure of any clinical trials for integrase inhibitors; our ability to establish reliable, high-volume operations at commercially reasonable costs; expected reliance on a few customers for the majority of our revenues; the annual renewal of certain customer agreements; actual market acceptance of our products and adoption of our technological approach and products by pharmaceutical and biotechnology companies; our estimate of the size of our markets; our estimates of the levels of demand for our products; the impact of competition; the timing and ultimate size of pharmaceutical company clinical trials; whether payers will authorize reimbursement for our products and services and the amount of such reimbursement that may be allowed; whether the FDA or any other agency will decide to further regulate our products or services, including Trofile; whether the draft guidance on Multivariate Index Assays issued by FDA will be subsequently determined to apply to our current or planned products; whether we will encounter problems or delays in automating our processes; the ultimate validity and enforceability of our patent applications and patents; the possible infringement of the intellectual property of others; whether licenses to third party technology will be available; whether we are able to build brand loyalty and expand revenues; restrictions on the conduct of our business imposed by the Pfizer, Merrill Lynch and other debt agreements; the impact of additional dilution if our convertible debt is converted to equity; and whether we will be able to raise sufficient capital in the future, if required. For a discussion of other factors that may cause actual events to differ from those projected, please refer to our most recent annual report on Form 10-K and quarterly reports on Form 10-Q, as well as other subsequent filings with the Securities and Exchange Commission. We do not undertake, and specifically disclaim any obligation, to revise any forward-looking statements to reflect the occurrence of anticipated or unanticipated events or circumstances after the date of such statements.

   Trofile is a trademark of Monogram Biosciences, Inc.     contacts:   Alfred G. Merriweather           Jeremiah Hall                Chief Financial Officer          Feinstein Kean Healthcare                Tel: 650 624 4576                Tel: 415 677 2700                amerriweather@                   jeremiah.hall@                monogrambio.com                  fkhealth.com  

Monogram Biosciences, Inc.

CONTACT: Alfred G. Merriweather, Chief Financial Officer of MonogramBiosciences, Inc., +1-650-624-4576, [email protected]; or JeremiahHall of Feinstein Kean Healthcare for Monogram Biosciences, Inc.,+1-415-677-2700, [email protected]

Web site: http://www.monogrambio.com/

Regulatory News:

Vitrolife (STO:VITR) has obtained sales approval in Australia for STEEN Solution(TM), a solution for functional testing and preservation of lungs outside the body before transplantation. “It is a great success for Vitrolife that this unique product has now been approved by the Australian authorities,” says Magnus Nilsson, CEO of Vitrolife.

Vitrolife’s product STEEN Solution(TM) is part of a new method for functional testing and preservation of lungs outside the body. The technology makes it possible for the first time to test the function of donated lungs outside the body by pumping STEEN Solution(TM) into the organ’s system of vessels before possible use.

With the STEEN Solution(TM) method, the number of potential organs that can be transplanted increases considerably. In the USA, for example, less than 20 percent of the lungs donated are transplanted today, due to uncertainty about the function of the organ. In time the STEEN Solution(TM) method can lead to a fivefold to tenfold increase in the number of lung transplantations carried out, as the need for donated organs using today’s methods considerably exceeds supply. So far 8 transplantations have been performed using this method, all at the University Hospital of Lund.

Vitrolife is today the market leader within the area of lung preservation solutions with its product Perfadex(R) and more than 90 percent of all lung transplantations in the world are performed using this product. Together with STEEN Solution(TM), Perfadex(R) is also part of the new method for functional testing and preservation of lungs outside the body.

STEEN Solution(TM) has already been approved for sales in Europe. The patent has so far been approved in Australia and the USA. During 2007 work was done to develop peripheral equipment, such as a box for storage of the lung in order to further facilitate the method using STEEN Solution(TM), as well as education and training of a large number of clinics in Europe and the USA. Work has also been ongoing on the study in North America which will form the basis of sales approval for STEEN Solution(TM) in the USA, a study that it is estimated will begin shortly.

Vitrolife is a global biotechnology/medical device Group that works with developing, manufacturing and selling advanced products and systems for the preparation, cultivation and storage of human cells, tissue and organs. The company has business activities within three product areas: Fertility, Transplantation and Stem Cell Cultivation. The Fertility product area works with nutrient solutions (media) and advanced consumable instruments such as needles and pipettes, for the treatment of human infertility. The Transplantation product area works with solutions and systems to maintain tissue in optimal condition outside the body for the required time while waiting for transplantation. The Stem Cell Cultivation product area works with media and instruments to enable the use and handling of stem cells for therapeutic purposes.

Vitrolife today has approximately 140 employees and the company’s products are sold in more than 80 markets. The head office is in Kungsbacka, Sweden, and there are subsidiaries in Sweden, USA, Australia and Italy. The Vitrolife share is listed on the OMX Nordic Exchange Stockholm’s Nordic Small Cap list.

Vitrolife AB (publ), Faktorvagen 13, SE-434 37 Kungsbacka, Sweden. Corporate identity number 556354-3452.

Tel: +46 31 721 80 00. Fax: +46 31 721 80 90. E-mail: [email protected]. Homepage: www.vitrolife.com.

This is a translation of the Swedish version of the press release. When in doubt, the Swedish wording prevails.

This information was brought to you by Cision http://newsroom.cision.com

By Jennifer Reeger, Tribune-Review, Greensburg, Pa.

Jun. 18–A five-year pilot project to treat wounded military personnel with traumatic brain injury has found a home in Johnstown.

Dr. George A. Zitnay, co-founder of the Defense and Veterans Brain Injury Center who will serve as a national consultant for the program, will develop an assisted-living program at the Hiram G. Andrews Center in Johnstown.

The program will treat military members who have suffered severe to moderate brain trauma and need intensive rehabilitation after their hospital stays.

“They’re going to take a longer period of time to recover,” Zitnay said. “They’re going to need more intensive care. They’re going to need a lot of technical assistance with high-tech equipment.”

The unnamed center is expected to open in late fall with room for 25 patients.

“These are the individuals that go home and their parents are struggling and their wives are struggling because they have no help,” Zitnay said.

“A recent study found that nearly 320,000 U.S. military personnel who have been deployed to Iraq or Afghanistan reported a probable traumatic brain injury during deployment,” Rep. John P. Murtha, D-Johnstown, said in a news release. “Traumatic brain injuries are the signature wound of this war, and we must provide our wounded warriors and veterans with first-class treatment and care. Our area has been at the forefront of this issue, and I’m pleased that Johnstown has been selected as the site for this pilot treatment program.”

The patients can stay up to a year, and their families will be able to stay in Johnstown for some periods of their treatment. Zitnay said a teleconference link will enable families to stay in touch and watch their loved one’s recovery.

Five beds will be set aside for respite care, allowing patients living at home to come for a month to give their families a break.

“That’s a very important service to have so that families feel they can get the rest and support they need,” Zitnay said.

The facility will be housed in space formerly occupied by a rehabilitation center, which Conemaugh Health System moved to another location.

“Frankly, you’d have to look hard and long to find a facility like that which is available. If we had to build a facility or retrofit a facility, it would be extremely exorbitant in terms of cost,” Zitnay said.

The center is working with the University of Pittsburgh School of Health Science and Rehabilitation on high-tech innovations for the facility.

“The goal here in this program is to get them as independent as possible. In other words, to get them so they can live with their families, to get them to be able to assist themselves, perhaps even be able to hold a job,” Zitnay said.

The center in Johnstown joins the Defense and Veterans Brain Injury Center’s network of 16 program sites across the United States and at the Landstuhl Regional Medical Center in Germany. The sites have treated about 7,000 patients with traumatic brain injury.

The Veterans Administration has identified more than 187 veterans who are in need of the assisted-living program planned for Johnstown, Zitnay said.

Johnstown is also home to another site. Laurel Highlands Neuro-Rehabilitation Center offers a community reintegration program for military personnel, veterans and their dependents with traumatic brain injury.

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To see more of the Tribune-Review or to subscribe to the newspaper, go to http://www.pittsburghlive.com/x/tribunereview/.

Copyright (c) 2008, Tribune-Review, Greensburg, Pa.

Distributed by McClatchy-Tribune Information Services.

For reprints, email [email protected], call 800-374-7985 or 847-635-6550, send a fax to 847-635-6968, or write to The Permissions Group Inc., 1247 Milwaukee Ave., Suite 303, Glenview, IL 60025, USA.

HOUSTON and OTTAWA, June 18 /PRNewswire-FirstCall/ — InterACTIVE Nutrition International Inc., a subsidiary of Natural Nutrition Inc. (OTC Bulletin Board: NTNI – News) http://www.naturalnutritioninc.com/ , has recently shipped its first order to Pakistan. The first order was shipped to Gilani Brothers, who are the leading importers and distributors for sports nutritional supplements in Pakistan.

“Our International marketing division is pleased to announce their first order in Pakistan after a year of negotiations and registration processes. Gilani Brothers are committed to expand the Interactive Nutrition brand across Pakistan and their goal is to make it the number one sports nutrition supplement in a short period of time. The demand for sports nutritional supplements from international markets has grown in the last year and we have received an overwhelming response from our existing distributors and many new inquiries from potential clients across the globe,” said Dharmendra Aneja, Director of International Marketing for InterACTIVE Nutrition International Inc.

InterACTIVE Nutrition products are widely accepted in Canada and exported to over eighteen countries abroad. The brand has created a niche for itself in the UK, Netherlands, Middle East, India, Chile and Australia, to name a few. Natural Nutrition drives growth of our products in the international markets with our in-house R&D and graphic design department, and a team of educated and knowledgeable individuals. Thorough study and market research has enabled Natural Nutrition to determine the tastes of consumers in a variety of countries throughout the world.

About Natural Nutrition Inc.

iNutrition.com and InterACTIVE Nutrition International Inc. are wholly owned subsidiaries of Natural Nutrition, Inc. (BULLETIN BOARD: NTNI) and was previously minority owned by Corporate Strategies Merchant Bankers. InterACTIVE Nutrition is a manufacturer and international leader in sports and nutritional supplements backed by over 12 years of research, development and sales of sports nutrition products in over twenty countries throughout the world. For more information on any of InterACTIVE Nutrition’s products, please visit http://www.interactivenutrition.com/

This press release contains forward-looking statements, which involve known and unknown risks, uncertainties or other factors that could cause actual results to materially differ from the results, performance or other expectations implied by these forward-looking statements. Natural Nutrition’s expectations regarding future sales and profitability assume, among other things, stability in the economy and reasonable growth in the demand for its products, the continued availability of raw materials at affordable prices, retention of its key management and operating personnel, as well as other factors detailed in Natural Nutrition’s filings with the Securities and Exchange Commission. The forward-looking statements, assumptions and factors stated or referred to in this press release are based on information available to Natural Nutrition today. Natural Nutrition expressly disclaims any duty to provide updates to these forward-looking statements, assumptions and other factors after the day of this release to reflect the occurrence of events or circumstances or changes in expectations.

Natural Nutrition Inc.

CONTACT: Marcy Dorotik, Natural Nutrition, Inc., +1-713-337-3717,[email protected]

Web site: http://www.naturalnutritioninc.com/http://www.interactivenutrition.com/

By David Allen, The Shelby Star, N.C.

Jun. 18–Updated at 10:21

KINGS MOUNTAIN –Two people were thrown from a Buick Park Avenue Tuesday evening during a single-car wreck along Dixon School Road.

Two females and one male were taken to Cleveland Regional Medical Center with unknown injuries, according to Bethlehem Volunteer Fire Chief Daryl Philbeck.

“They were in pretty critical condition when they left here from what I saw,” he said. The initial call came out at 7:57 p.m., he added.

With one headlight still on, the car, which was flipped during the incident, came to rest on the asphalt after several dozen feet of skid marks both on and off the road. A single sandal sat next to the front bumper. A black hat was tangled in nearby bushes.

Additional information was unavailable as of 9:30 p.m.

Bethlehem Volunteer Fire Department, Grover Rescue, Highway Patrol, Cleveland County EMS and Sheriff’s Office deputies responded to the wreck.

Kirsten Thomas contributed to this report.

Updated 10:07 p.m.

Watch video of the wreck by clicking the multimedia link under photos.

Allen said three people were taken to Cleveland Regional Medical Center with, according to Bethlehem Volunteer Fire Department Chief Daryl Philbeck, critical injuries. Two women and a man were inside the vehicle and one of the women and the man were thrown from the Buick upon impact, Philbeck said. The other female was driving. The first call came in at 7:57 p.m.

Cleveland County Communications is reporting a wreck at Dixon School Road and Stewart Road in Kings Mountain. Several injuries are reported and one passenger has been reported as being ejected from the car.

Reporters Kirsten Thomas and David Allen are on their way to the scene in the Star Car.

—–

To see more of The Shelby Star or to subscribe to the newspaper, go to http://www.shelbystar.com/.

Copyright (c) 2008, The Shelby Star, N.C.

Distributed by McClatchy-Tribune Information Services.

For reprints, email [email protected], call 800-374-7985 or 847-635-6550, send a fax to 847-635-6968, or write to The Permissions Group Inc., 1247 Milwaukee Ave., Suite 303, Glenview, IL 60025, USA.

BIOTIE THERAPIES CORP. STOCK EXCHANGE RELEASE June 18, 2008 at 10.15 a.m.

BIOTIE’S VAP-1 ANTIBODY PROGRAM TO PROCEED TO CLINICAL STUDIES IN RHEUMATOID ARTHRITIS AND PSORIASIS PATIENTS

Top-line data from the first-in-man study with Biotie’s fully human VAP-1 monoclonal antibody BTT-1023 have become available. The study was conducted in a clinical pharmacology unit in the United Kingdom and investigated the safety, tolerability and pharmacokinetic characteristics of single intravenous doses of BTT-1023 in healthy volunteer subjects.

A total of 35 subjects, of whom 29 received BTT-1023, were enrolled into the placebo-controlled study. BTT-1023 was generally well tolerated and no serious adverse events were reported in the study. Among the five subjects who received the highest dose, facial flushing was reported by two subjects with accompanying facial oedema in one of the two. These were reported during or shortly after the infusion and are not uncommon events in association with intravenous administration of therapeutic protein drugs. No cytokine release or fever was observed in any subject. All adverse events were fully reversible and required no particular intervention.

The data from the study support proceeding to clinical studies with repeated doses of the antibody. These studies are expected to be carried out in rheumatoid arthritis and psoriasis patients and will aim to establish appropriate dosing regimens for subsequent therapeutic studies and provide initial information on the therapeutic potential of BTT-1023. The studies are expected to start in the end of 2008.

Turku June 18, 2008

Biotie Therapies Corp.

 Timo Veromaa President and CEO For further information, please contact: Timo Veromaa, President and CEO, Biotie Therapies Corp. tel. +358 2 274 8901, e-mail: [email protected] www.biotie.com Distribution: OMX Nordic Exchange Helsinki Main Media 

Biotie and Roche have signed an option agreement for the antibody program targeting VAP-1. Under the terms of the agreement, Roche has paid an option initiation fee of EUR 5 million, which grants Roche an exclusive option right to an exclusive, worldwide license agreement for Biotie’s fully human antibody targeting VAP-1, excluding Japan, Taiwan, Singapore, New Zealand, and Australia. The initial option right will end upon completion of Phase I. Roche may extend the option right to later development points by paying additional fees. Biotie will retain all rights to the program until a license is granted to Roche.

The company does not expect Roche to use its option during 2008.

Inhibiting VAP-1 reduces inflammation by regulating the migration of leukocytes, or white blood cells, to inflamed tissues. Pathological accumulation of white blood cells in tissue is a common feature in many autoimmune diseases, such as rheumatoid arthritis, ulcerative colitis, and psoriasis.

Copyright Copyright Hugin AS 2008. All rights reserved.

SOURCE: Biotie Therapies Oyj

On July 1, Medicare payments to doctors will be cut by 10.6 percent. Hold that fact for a moment while we explore all the reasons so many doctors are forgoing family practice, refusing to accept Medicare patients, not bothering to see patients in hospitals and considering buying a convenience-store franchise instead of practicing medicine.

In a New York Times essay (“Eyes Bloodshot, Doctors Vent Their Discontent”), Dr Sandeep Jauhar, a New York-area cardiologist, describes the devastating toll managed care, mounds of paperwork and reduced reimbursements are taking on his fellow physicians.

Primary care doctors have it worst. One doctor tells of fighting insurance company clerks over prescriptions, tests and payment denials. The doctor sold his practice and went to work in a hospital, only to be further frustrated by – insurance company clerks. He’s thinking about quitting medicine altogether.

The word is getting around to medical schools, where only 1,096 family-practice doctors are graduating this year – the lowest in 20 years. Most medical school graduates are going into specialties such as cardiology, but there is no escape, even for specialists, from insurance company clerks who seemingly question their every move.

Some doctors are not making hospital visits. Dr. Jauhar tells of internists who say it is “prohibitively inefficient to drive to a hospital, find parking, walk to the wards, examine a patient, check laboratory tests and vital signs, talk to a nurse and write orders and a note – for just a handful of cases. They cannot afford to leave their offices long enough to do it.” Instead, their patients are being seen by “hospitalists,” who may not be familiar with the patient or his ailment.

The median salary for a family-practice doctor is about $153,000, which explains why most medical students are going into specialties that pay two to three times more.

But what is even more worrisome than the coming dearth of primary care doctors is the bleak outlook for their patients. In order to make ends meet, doctors will have to see more patients, who can expect shorter visits.

Then there is the upcoming 10.6 percent cut in Medicare reimbursements, a reaction, no doubt, to escalating health-care costs. But it’s hardly an incentive for already frustrated doctors to continue seeing an aging population that often needs their attention the most.

(c) 2008 Press-Telegram Long Beach, CA.. Provided by ProQuest Information and Learning. All rights Reserved.

By Jewell Cardwell, The Akron Beacon Journal, Ohio

Jun. 18–Melanie and Bill Edwards of Hartville know about miracles.

Sally Rohler, mother of Melanie and grandmother to the family’s real-life miracle, was kind enough to bring me up to speed.

Jakub Edwards, 6, who was featured in my June 4 column, was diagnosed with idiopathic dilated cardiomyopathy (congestive heart failure) May 18 and was on the heart transplant list at the Cleveland Clinic.

Jakub’s new heart arrived at 9:45 p.m. June 7 after being flown from North Carolina, Mrs. Rohler said.

As heart transplant surgeries go, “his went very well,” Mrs. Rohler said. “The surgery went fairly well. Except that it was long. About eight hours.”

Mrs. Rohler said her grandson was playing T-ball one minute and all seemed right with the world. That was May 15.

“He was hitting real good,” she said. “But was getting out of breath.”

His parents took him to a doctor, who diagnosed asthma, she said.

“But he kept getting worse. By Sunday morning, he had a terrible stomachache,” Mrs. Rohler said. “They got him to [Akron] Children’s Hospital, where he was diagnosed with congestive heart failure. And he and his Daddy were flown in a helicopter to the Cleveland Children’s Clinic, where they said his heart was four times as large as it was supposed to be.”

He and his family prayed and waited with very mixed emotions for a miracle.

The miracle, they knew, would come at a high cost to another family. It meant another child would have to die. And that child’s parents — in the midst of their worst nightmare — would have to make a quick decision to donate organs — to choose life for someone’s child.

They did.

“It takes special parents to do that,” Mrs. Rohler noted.

And the Edwardses, Jakub and the Rohlers will forever be in their debt.

“We had people from all over — South Carolina, North Carolina, Texas, Ohio — praying for Jakub,” Mrs. Rohler said.

The women in a Sunday School class at Akron Baptist Church even made a prayer quilt with a baseball theme for Jakub. The Rohlers have been attending services there since their recent move from Columbia, S.C., to Cuyahoga Falls.

“He still has a very long road ahead of him,” Mrs. Rohler said. “So, he still needs everybody’s prayers . . . But he’s already off life support . . . “

That means, among other things, that his parents — who have been at his side since May 18 — haven’t been at their jobs. And are unsure when they’ll be able to return.

So, a Jakub Edwards Benevolent Fund has been set up at FirstMerit Bank (any branch) to help with expenses.

Brave boy loses battle

Following the death of their 9-year-old son, Susan and Joe Lettieri of Hudson are committed to doing everything they can to help other children battling cancer. Anthony “Tony” Lettieri “passed away at 3:55 p.m. [Thursday, June 12] in my arms,” Susan Lettieri wrote. She delivered the sad news in a widely circulated e-mail.

Tony, who had been diagnosed with acute lymphoblastic leukemia and had received a bone marrow transplant at Cincinnati Children’s Hospital, suffered a number of setbacks but did not lose his faith.

“Tony received the sacraments of Confirmation and Last Rites before dying . . . “

The Mass of Christian Burial was Tuesday at St. Mary Catholic Church in Hudson.

In lieu of flowers, she wrote, donations may be made to the Tony M. Lettieri Benevolent Fund, FirstMerit Bank, 3027 Graham Road, Stow, OH 44224; or to the Cincinnati Children’s Hospital Medical Center’s Blood and Bone Marrow Transplant Program in memory of Anthony Lettieri, c/o 3333 Burnet Ave., Cincinnati, OH 45229-3039.

Please continue to keep the Lettieri family in your prayers.

Kids With Courage

Hats off to Calvin Boshela, 16, of Hudson, who was tapped to be part of the American Family Children’s Hospital’s “Kids With Courage” program next month.

The five-year reunion for pediatric patients at the former University of Wisconsin Children’s Hospital is being hosted by supermodel Cindy Crawford, whose brother Jeff was treated there for leukemia. He died before his fourth birthday.

Calvin — diagnosed with leukemia when he was 3 and treated at the children’s hospital in Madison — will be accompanied by his parents, Don and Brenda.

More than 1,000 people are expected to attend — surviving cancer patients and their families like the Boshelas, as well as bereaved families like Crawfords.

Project Linus blankets

Major-league thanks to eighth-graders at Akron’s Riedinger Middle School.

Work and family teacher Therese Chadbourne reports that “for the second year in a row, thanks to a grant from Omnova Solutions, the students were able to complete 21 blankets for Project Linus!

“The students worked in pairs to prepare, cut and tie a blanket for a [seriously ill] child who is in Children’s Hospital. They worked together great, having a little fun and doing something good for their community.”

Books donated

A huge tip of the hat to Rotary Club of Fairlawn for its trail-blazing literacy project.

See if you don’t agree.

“This spring, Rotary Club of Fairlawn member Tom Kelley initiated the Rotary Literacy Program to improve literacy in our region,” writes Rotary spokesman Kurt Kleidon.

“Our club’s major literacy project is to put as many books as we can into the hands of children whose families cannot afford to provide books for them,” Kelley said.

To that end, the Rotary Club — helped in its endeavor by the Revere and Copley-Fairlawn school system and Bath Elementary School — chose Akron’s Findley Academy as the recipient, placing more than 6,000 books in the hands of deserving students and school’s library. Findley School has nearly 350 students in kindergarten through fifth grade.

Artwork raises funds

Kudos to Kathy Welsh — who teaches first grade at Fort Island Primary School in the Copley- Fairlawn Schools — her students and their parents for their creativity and generosity.

“Throughout the year, I saved artwork from the students from my classroom as well as from their art classroom,” Welsh said.

That artwork was the subject of a silent auction — complete with a cookie reception (students’ mothers baked the cookies), raising $413 for the Haven of Rest homeless shelter. Jewell Cardwell can be reached at 330-996-3567 or [email protected].

—–

To see more of the Akron Beacon Journal, or to subscribe to the newspaper, go to http://www.ohio.com.

Copyright (c) 2008, The Akron Beacon Journal, Ohio

Distributed by McClatchy-Tribune Information Services.

For reprints, email [email protected], call 800-374-7985 or 847-635-6550, send a fax to 847-635-6968, or write to The Permissions Group Inc., 1247 Milwaukee Ave., Suite 303, Glenview, IL 60025, USA.

NYSE:OMN,

Research and Markets (http://www.researchandmarkets.com/research/46d237/indian_pharmaceuti) has announced the addition of the “Indian Pharmaceutical Industry” report to their offering.

The purpose of this study is to describe the specific segment of the pharmaceutical market sector called the Indian pharmaceutical industry. This sector includes all of the generally-accepted pharmaceutical manufacturing activities that are currently used today, including the bulk drug industry, formulations and major therapeutic segments. It examines these clinical supplies as utilized in hospitals, clinics and doctor’s offices.

The principal objectives of this analysis are to:

1) identify viable technology drivers through a comprehensive look at various platform technologies for the Indian pharmaceutical industry;

2) obtain a complete understanding of the Indian pharmaceutical industry practices from its basic principles to its applications;

3) discover feasible market opportunities via an identification of high-growth applications in different areas of the Indian pharmaceutical industry, with a focus on the biggest and expanding markets for the Indian pharmaceutical industry;

4) focus on global industry development through an in-depth analysis of the major world markets for pharmaceutical manufacturing, including forecasts for growth;

5) establish the essentials of the Indian pharmaceutical market including definitions, processes and trends.

Key Topics Covered:

— Overview

— Introduction

— The Indian Market

— Characteristics of the Indian Pharmaceutical Industry

— Key Players in the Indian Pharmaceutical Industry

— Strategic Groups

— Critical Success Factors (CSF) of the Industry

— Policies and Regulations

— Changing Scenario of Product Patent Regime

— Laws Pertaining to Manufacture and Sale of Drugs in India

— Marketing and Distribution in the Pharmaceutical Industry

— The Changing External Environment

— Porters Five Forces Model

— Future Outlook for the Indian Pharmaceutical Industry

— Emerging Trends

— India – The Clinical Trial Destination

— Risks-Weaknesses and Threats-Faced by Indian Industry

— Intellectual Property and Access to Medicines

— Evolving Indian Drug Research and Development

— Case of a Leading Indian Firm-Ranbaxy Laboratories

— Strategic Options for Pharmaceutical Firms

— How to Build Sustainable Competitive Advantage

Appendix

— Requirements and Guidelines for Permission to Import and/or Manufacture of New Drugs for Sale or to Undertake Clinical Trials Clinical Trial

Studies in Special Populations

— Data to be Submitted Along with the Application to Conduct Clinical Trials/Import/Manufacture of New Drugs for Marketing in India

— Data Required to be Submitted by an Applicant for Grant of Permission to Import and/or Manufacture a New Drug Already Approved in India

— Structure, Contents and Format for Clinical Study Reports

— Animal Toxicology (Non-Clinical Toxicity Studies)

— Non-Clinical Toxicity Testing and Safety Evaluation Data of an Ind Needed for the Conduct of Different Phases of Clinical Trials Animal Pharmacology

— Informed Consent

— Fixed Dose Combinations (FDCs)

— Undertaking by the Investigator

— Ethics Committee

— Stability Testing of New Drugs

— Stability Testing of New Drug Substances and Formulations

— Contents of the Proposed Protocol for Conducting Clinical Trials

— Data Elements for Reporting Serious Adverse Events Occurring in a Clinical Trial

For more information visit http://www.researchandmarkets.com/research/46d237/indian_pharmaceuti

Specialist nurse Alison Rudd is retiring after nearly four decades in the NHS.

Alison, a Macmillan clinical nurse specialist in palliative care, was originally inspired to go into nursing by her Christian faith.

A thanksgiving service for her career will be held in Stafford Hospital Chapel at 11.30am tomorrow.

Alison, who is an elder at Stafford’s United Reformed Church, said: “It’s quite unusual for a chapel service to be held when someone retires – but my Christian faith is very important to me and is central to what I do.”

Alison, aged 55, lives with her husband, Stuart, a retired nurse, in Baswich, Stafford.

Former patients or relatives who wish to attend the service should call 01785 230291.

(c) 2008 Sentinel, The (Stoke-on-Trent UK). Provided by ProQuest Information and Learning. All rights Reserved.

SAN DIMAS – A 2-year-old boy fell into a pool and nearly drowned Monday evening, sheriff’s deputies said.

Los Angeles County firefighters came to the home in the 800 block of Avenida Ladera at 8:26 p.m. after someone had pulled the child out of the pool.

The boy was not breathing, said Los Angeles County sheriff’s Lt. Roxanna Hart. Paramedics revived the child and took him to Pomona Valley Hospital Medical Center for treatment. His condition today was not known.

(c) 2008 San Gabriel Valley Tribune. Provided by ProQuest Information and Learning. All rights Reserved.

By THE CANADIAN PRESS

EDMONTON – An Edmonton dentist hasn’t been practising since February after he tested positive for hepatitis B.

Health authorities are now contacting the patients of Dr. Byron Wong, who has practised in Alberta since 2001. Dr. Gerry Predy with Capital Health says the chance the disease was transmitted to any of Wong’s 1,400 patients is very low – somewhere between one in 10,000 and one in 100,000.

He says Wong has been co-operative and made the decision to release his own name, which isn’t usually done in cases of infectious disease.

Dr. Jonathan Skuba with the Alberta Dental Association says the situation has never happened before in the province.

Predy says patients should wait to be notified – no later than by mid-September – but can contact Capital Health if they have questions about hepatitis B.

By SHANTEE WOODARDS Staff Writer

Toni Marshall remembers the days when it was easy to leave the house and go to work, but that was 15 years ago.

The Arnold resident once worked as a tax auditor, spending long hours going over invoices while staying involved in several social groups.

But her activity plunged after she developed a sinus infection. Even after it cleared up, she noticed she could get 12 to 15 hours of sleep and still wake up exhausted.

She was concerned and eventually reached a doctor who told her she was among the more than 4 million Americans with Chronic Fatigue Immune Dysfunction Syndrome. It is unclear how many state or county residents suffer from the syndrome.

Aside from exhaustion, sufferers have short-term memory loss, pain in the joints and unrefreshing sleep.

The illness has caused Ms. Marshall to retire. Now she gets around with the help of an aide and tries to be active in area support groups. There is no known cure and some patients recover on their own. However, Ms. Marshall is not one of them.

“I’m tall, I’m broad and I’m strong,” she said. “I just thought that whatever this is, I know I can lick it. I needed someone who had a clue, (who) would take it seriously and let me know I had something and whether it was easy to deal with.”

The condition is more common in women, who have 522 cases per 100,000 women, according to the Chronic Fatigue Immune Disorder Association of America. One of the problems with the disorder is that many more people may have it, but have not been diagnosed, officials said.

The association is coming to Baltimore at the end of the month as part of a national campaign to educate the public. From June 23 to June 29, the Maryland Science Center will display portraits and stories of families impacted by the illness.

It has been a challenge to bring attention to chronic fatigue, said Dr. Peter Rowe, director of the Chronic Fatigue Clinic at Johns Hopkins Children’s Center.

“It’s under-recognized and under-treated,” said Dr. Rowe, who is also a professor of pediatrics. “Studies have shown that people with this as their health status can be as bad as people with lupus, multiple sclerosis and congestive heart failure. It can really have a substantial impact on people’s lives.”

The problems started for Ms. Marshall in 1993. At that time, she was being treated for a sinus infection and doctors discovered she also had a deficiency in vitamin B12. She received shots and medication to recover from the deficiency and assumed everything would be fine.

Yet Ms. Marshall noticed a difference when she returned to work. She had trouble learning simple tasks and fell behind. She remembered coming home from work in the evenings only to put a meal in the microwave and rest in her chair until her food was finished. But she would fall into a deep sleep long before her 6-minute meals were ready and wouldn’t wake up until the middle of the night, still feeling exhausted.

“It was a scary, scary time,” Ms. Marshall said. “It is a comfort to talk to people who understand and experienced similarly. None of us have experienced the same things, (but) we suffer similarly. It is a comfort to talk to people who have a clue what that’s like.”

Her situation is not uncommon, since chronic fatigue develops out of other infectious illnesses. Even though there is no cure, there are ways to help patients cope, Dr. Rowe said. One thing that seems to help is to get the patient to gradually adapt to a non-strenuous exercise regimen.

“Inactivity is the enemy,” Dr. Rowe said. “You’ve got to keep on pushing.”

For more information about the photo exhibit, call the CFID Association at 704-365-2343 or visit http://www.cfids.org/sparkcfs/ photo.asp {Corrections:} {Status:}

CHRONIC FATIGUE AN ‘UNDER RECOGNIZED’ ILLNESS

(c) 2008 Capital (Annapolis). Provided by ProQuest Information and Learning. All rights Reserved.

VHA Inc., the national health care alliance, announced today that it has combined two of its regional offices, VHA Metro and VHA Empire State, to create a single entity, VHA Empire-Metro, which will serve hospitals in New York and four health care organizations in adjacent states whose markets include New York. Operating under a single governing, management, and financial structure, VHA Empire-Metro will maintain two offices, one in New York City and one in Syracuse.

Edward M. Dinan, FACHE, president and chief executive officer of Lawrence Hospital Center in Bronxville, N.Y., is the newly elected chairman of the board for VHA Empire-Metro. Dinan also has roots in upstate New York. The board consists of hospital CEOs and other senior executives from VHA member organizations in this geography.

“By combining staff resources and developing a common vision for how VHA works with hospitals in New York and several members in Connecticut, New Jersey and Pennsylvania, we’ll maximize opportunities to help these hospitals improve their supply chain efficiency and clinical performance,” said William Himmelsbach, FACHE, who is the executive officer for the newly combined VHA Empire-Metro Office. For those VHA members in New York State, this combination will create opportunities to participate in pilot studies aimed at finding ways to improve economic efficiency and clinical effectiveness.

“VHA is an essential partner for member hospitals across the VHA Empire-Metro region. Hospitals are under intense pressure to improve quality while conserving resources. VHA enables us to do both,” said Dinan.

VHA supports hospitals through its three core services: supply chain management, which includes contracting for products and services; clinical improvement services, which involves helping hospitals meet or exceed national standards for patient care and patient safety; and through the formation of networks that enable member hospitals to work together to develop solutions for common clinical or operational challenges.

VHA Empire-Metro serves the following health care organizations across New York State and adjacent states:

 --  Bassett Regional Healthcare, Cooperstown --  Binghamton General Hospital, Binghamton --  Cobleskill Regional Hospital, Cobleskill --  Canton-Potsdam Hospital, Potsdam --  Cayuga Medical Center at Ithaca, Ithaca --  Chenango Hospital, Norwich --  Claxton-Hepburn Medical Center, Ogdensburg --  Columbia Presbyterian Medical Center, New York --  Columbia University in the City of New York, New York --  Community General Hospital, Syracuse --  Community Memorial Hospital, Hamilton --  Corning Hospital, Corning --  Crouse Hospital, Syracuse --  Delaware Valley Hospital, Walton --  Erie County Medical Center, Buffalo --  Faxton-St. Luke's Healthcare, New Hartford --  Faxton-St. Luke's Healthcare, Utica --  Finger Lakes Health, Geneva --  Geneva General Hospital, Geneva --  Gracie Square Hospital, New York --  Guthrie Healthcare System, Sayre, PA --  Highland Hospital of Rochester, Rochester --  Lawrence Hospital Center, Bronxville --  Little Falls Hospital, Little Falls --  Mohawk Valley Network, Utica --  Morgan Stanley Children's Hospital of New York, New York --  New Milford Hospital, New Milford, Conn. --  NewYork-Presbyterian Healthcare System, New York --  NewYork-Presbyterian Hospital, New York --  NewYork-Presbyterian Hospital - Westchester Division, White Plains --  The Allen Pavilion, New York --  New York Methodist Hospital, Brooklyn --  New York Westchester Square Medical Center, Bronx --  Northern Westchester Hospital Center, Mount Kisco --  O'Connor Hospital, Delhi --  Payne Whitney Psychiatric Clinic, New York --  Phelps Memorial Hospital Center, Sleepy Hollow --  Robert Packer Hospital, Sayre, PA --  Roswell Park Cancer Institute, Buffalo --  Silvercrest Center for Nursing and Rehabilitation, Briarwood --  Soldiers & Sailors Hospital, Penn Yan --  Stamford Health System and Hospital, Stamford, Conn. --  Stellaris Health Network, Armonk --  Strong Memorial Hospital Rochester --  The Brooklyn Hospital Center, Brooklyn --  The Burke Rehabilitation Hospital, White Plains --  The Mary Imogene Bassett Hospital, Cooperstown --  The New York Community Hospital of Brooklyn, Brooklyn --  The New York Hospital Medical Center of Queens, Flushing --  The Rockefeller University Hospital, New York --  The Unity Hospital of Rochester, Rochester --  The Valley Hospital, Ridgewood, N.J. --  Tri-Town Regional Hospital, Sidney --  Troy Community Hospital, Troy, Pa. --  United Health Services, Binghamton --  Unity Health System, Rochester --  University of Rochester, Rochester --  Valley Health System, Ridgewood, N.J. --  WCA Hospital, Jamestown --  White Plains Hospital Center, White Plains --  Wilson Memorial Hospital, Johnson City --  Wyckoff Heights Medical Center, Brooklyn      

These organizations own or manage more than 60 hospitals, which saved $56.1 million through VHA’s supply chain management programs in 2007, purchasing $1.14 billion in supplies through VHA and its contracting services company, Novation. Each VHA member voluntarily participates in VHA programs that help them help save money on supplies and improve patient care. Hospitals that buy supplies through VHA and Novation, save between two percent and five percent per year on those purchases.

 Media contact: Lynn Gentry 972/830-0798 Email Contact

SOURCE: VHA

CapMed, a division of Bio-Imaging Technologies, Inc. (NASDAQ: BITI) and a leader in interactive personal health management solutions, announced today that it will be hosting two presentations at America’s Health Insurance Plans (AHIP) conference in San Francisco, CA. The presentations, led by Wendy Angst, General Manager of CapMed and Michael Staufacker, Director of Program Development for StayWell Health Management, are scheduled for June 19th at 1-2 and again at 3-4 p.m. With limited seating available, interested parties are encouraged to email CapMed at [email protected] to reserve a place.

As the demand for improved healthcare heightens, wellness programs are becoming increasingly popular throughout the country. According to Working Well: A Global Survey of Health Promotion and Workplace Wellness Strategies, released in October 2007, 86 percent of U.S. employers surveyed offer wellness programs. The top strategic objective for offering wellness programs is to drive down health care costs.

“CapMed’s partnership with StayWell Health Management is just one of the many ways we enable consumers to become stronger advocates for their own health,” Angst said. “Combining CapMed’s award winning PHR with StayWell’s health assessment and disease management programs, provide powerful means for health plans to work with their members to increase member involvement and ultimately to lower medical costs.”

Combining wellness programs with CapMed’s comprehensive and interoperable PHR is a natural partnership that brings great value to the consumer. Through CapMed’s PHR, users can track and manage all facets of personal health and wellness information from home and from work or while in transit at any time of the day or night. Consumers can link to individually-relevant patient education information and receive important alerts and reminders, supporting CapMed’s goal of making health information personal, understandable and actionable. Additionally, consumers as well as their family members can take advantage of multiple tools and features to manage their health information. For example, users can access a drug interaction checker, import data from remote healthcare monitoring devices, and even authorize providers, family members and caregivers to view all or part of the data within their PHR.

CapMed will showcase the integrated offering with StayWell during the AHIP conference in Room B on the exhibit floor.

About CapMed

CapMed, a division of Bio-Imaging Technologies, Inc., is the cornerstone of Bio-Imaging’s Personal Health Management Division. CapMed is the leading provider of personal health management solutions for hospitals and health systems, providers, managed care, employers and pharmaceutical companies, with more than 600,000 distributed to date. These solutions enable patients to monitor and manage their health and to improve communications with care providers, ultimately improving outcomes and reducing costs of care and are available in multiple formats: onlinePHR, icePHR, icePHR Mobile, desktopPHR, and the Personal HealthKey. CapMed offers custom development to organizations who want to add unique or proprietary capabilities to the platform. For more information on the CapMed Personal Health Management Solutions, please visit www.CapMed.com.

About Bio-Imaging Technologies, Inc.

Bio-Imaging Technologies, Inc. is a healthcare contract service organization providing services that support the product development process of the pharmaceutical, biotechnology and medical device industries. The Company has specialized in assisting its clients in the design and management of the medical-imaging component of clinical trials since 1990. Bio-Imaging serves its clients on a global basis through its Core Labs in Newtown, PA, and Leiden, The Netherlands, along with business offices in PA, MA, The Netherlands, Germany and France. Phoenix Data Systems, Inc., a subsidiary of Bio-Imaging Technologies, is a leading global clinical data services provider of electronic data capture (EDC) services and a comprehensive array of broadly interoperable eClinical data solutions to the pharmaceutical and biotechnology industries. Phoenix Data Systems delivers full service EDC, a unique combination of electronic data capture, interactive voice response, reporting, and data management solutions. Through its CapMed Personal Health Management Suite, Bio-Imaging provides its Personal HealthKey* technology, the Personal Health Record (PHR) software, and CapMed Patient Portal allowing patients to better monitor and manage their health care information. Additional information about Bio-Imaging is available at www.bioimaging.com.

Certain matters discussed in this press release are “forward-looking statements” intended to qualify for the safe harbors from liability established by the Private Securities Litigation Reform Act of 1995. In particular, the Company’s statements regarding trends in the marketplace and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the consummation and the successful integration of current and proposed acquisitions, the timing of projects due to the variability in size, scope and duration of projects, estimates and guidance made by management with respect to the Company’s financial results, backlog, critical accounting policies, regulatory delays, clinical study results which lead to reductions or cancellations of projects, and other factors, including general economic conditions and regulatory developments, not within the Company’s control. The factors discussed herein and expressed from time to time in the Company’s filings with the Securities and Exchange Commission could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstance. You should review the Company’s filings, especially risk factors contained in the Form 10-K and the recent form 10-Q.

Acadia Pharmaceuticals has announced results from its Phase IIb trial with ACP-104 for the treatment of schizophrenia. The study did not meet its primary endpoint of antipsychotic efficacy or any of the secondary endpoints.

Neither dose of ACP-104 demonstrated improved efficacy as compared to placebo. There was no clinically significant decrease in neutrophil counts in the study drug arms.

The ACP-104 trial was a multi-center, double-blind, placebo-controlled Phase II study designed to evaluate the safety and efficacy of ACP-104 in patients with schizophrenia who were experiencing an acute psychotic episode.

A total of 247 patients were enrolled at multiple sites in the US. Patients were randomized to one of three study arms, with patients receiving one of two doses of ACP-104 (100mg or 200mg, twice daily) or placebo for six weeks.

The primary endpoint of the trial was antipsychotic efficacy as measured by the mean change from baseline in the positive and negative syndrome scale (PANSS) total score for ACP-104 versus placebo. Secondary endpoints included the PANSS subscales and the clinical global impression severity scale.

Uli Hacksell, CEO of Acadia, said: “We clearly are disappointed in the results of this study. While we will thoroughly analyze the data to understand the outcome, we currently do not anticipate conducting further studies with ACP-104.”

By Megan Holland, Anchorage Daily News, Alaska

Jun. 17–A man who made a career of death is dead.

Franc Fallico, the state’s former chief medical examiner, died Saturday, said Ann Potempa, a spokeswoman with the state Department of Health and Social Services.

Fallico, 66, had cancer.

Fallico retired from his job as state medical examiner in April, a position he held since 2001. He had been on extended medical leave since October.

“He loved to discuss/debate an issue and would take the opposing side just to challenge an ideology and make you think out loud,” his wife, Hisa, wrote in an e-mail on Monday.

He died at home, watching the movie “The Bucket List” with his wife by his side. The movie is about two terminally ill men who escape from a cancer ward to do the things they always wanted to do before they die.

During Fallico’s tenure, he was a familiar figure in courtrooms, in the news and among law enforcement around the state. He performed 1,577 autopsies, including those for some of Alaska’s most gruesome crimes. He delivered his courtroom testimony about horrific deaths in plainspoken, matter-of-fact tones.

He performed postmortems on some of Alaska’s most famous murder victims. Recently those have included Mindy Schloss, Lauri Waterman and Delaney Zutz.

Schloss, a nurse, turned up dead and her neighbor, Joshua Wade, who had been previously acquitted of one murder conviction, has been charged with killing her. In the Waterman case, a Juneau jury hung on whether her teenage daughter Rachelle should be convicted of murder. And 13-year-old Zutz was killed by a neighborhood acquaintance now serving a life sentence.

Fallico attended medical school in Italy. In 1976, he moved to Anchorage and worked as a hospital pathologist for 20 years at Providence Alaska Medical Center before becoming a medical examiner.

In 2005, he appeared in the Werner Herzog documentary “Grizzly Man” about the bear mauling death of Timothy Treadwell. His brief on-screen interview telling the riveting details of what happened grabbed the attention of national film critics. A New York Times reviewer said he was a “character around whom an entire reality show could be built.”

A funeral service is planned for 5:30 p.m. Wednesday at St. Patrick’s Church, 2111 Muldoon Road. It is open to the public.

—–

To see more of the Anchorage Daily News, or to subscribe to the newspaper, go to http://www.adn.com.

Copyright (c) 2008, Anchorage Daily News, Alaska

Distributed by McClatchy-Tribune Information Services.

For reprints, email [email protected], call 800-374-7985 or 847-635-6550, send a fax to 847-635-6968, or write to The Permissions Group Inc., 1247 Milwaukee Ave., Suite 303, Glenview, IL 60025, USA.

NYT,

American Medical Response (AMR), a subsidiary of Emergency Medical Services Corporation, has won a Stevie Award for Best Corporate Social Responsibility Program in The 2008 American Business Awards, presented on June 12 in New York City. AMR won the Stevie Award for its “Sentimental Journey” program.

Stevie Awards were presented in over 40 categories including Best Overall Company, Best Executive, and Best Corporate Social Responsibility Program. More than 2,600 entries from companies of all sizes and in virtually every industry were submitted for consideration.

The “Sentimental Journey” program began in AMR’s Colorado Springs operation almost 15 years ago when an ambulance crew was transporting a man home for hospice care on an autumn day. He told the paramedic that he wished he could see the aspens turning color one more time. The crew pulled off the road and fulfilled his wish. This chance event grew into the “Sentimental Journey” program in which AMR donates the crew, ambulance and medical care to help fulfill a last wish for a hospice patient. Following its growth and success in Colorado Springs, the program subsequently has been implemented in many AMR operations across the county.

Mark Bruning, AMR’s Executive Vice President, said, “AMR is honored to have been selected from so many deserving companies that commit to the time-honored practice of social responsibility in the business world. We are very proud of our Colorado Springs employees and our Sentimental Journey program, which reflects the strong values and commitment of our caregivers in hundreds of communities across the nation. Along with providing quality emergency medical care and transportation, the opportunity to give back to our communities is the most important and gratifying thing we can do.”

About Emergency Medical Services Corporation

Emergency Medical Services Corporation (EMSC) (www.emsc.net) is a leading provider of emergency medical services in the United States. EMSC operates two business segments: American Medical Response Inc. (AMR), the Company’s healthcare transportation services segment, and EmCare Holdings, Inc. (EmCare), the Company’s emergency department and hospital-based management services segment. AMR is the leading provider of ambulance services in the United States. EmCare is the nation’s leading provider of outsourced emergency department staffing and related management services. In 2007, EMSC provided services to 10 million patients in more than 2,000 communities nationwide. EMSC is headquartered in Greenwood Village, Colorado.

About American Medical Response

American Medical Response Inc. (www.amr.net), America’s leading provider of medical transportation, is locally operated in 40 states and the District of Columbia. AMR’s 18,500 paramedics, EMTs and other professionals transport more than four million patients nationwide each year in critical, emergency and non-emergency situations. Operating a fleet of approximately 4,500 vehicles, AMR, a subsidiary of Emergency Medical Services Corporation, is headquartered in Greenwood Village, Colorado.

About The Stevie Awards

Stevie Awards are conferred in four programs: The American Business Awards, The International Business Awards, The Stevie Awards for Women in Business, and the Stevie Awards for Sales & Customer Service. Honoring companies of all types and sizes and the people behind them, the Stevies recognize outstanding performances in business worldwide. Learn more about The Stevie Awards at www.stevieawards.com.

Global Sponsor of the 2008 Stevie Awards is Dow Jones. Supporting sponsors of The 2008 American Business Awards include FIS Softpro, High Performance Technologies Inc., John Hancock, RCN Corporation, Richardson, and Ultimate Software. Media sponsors include the Business TalkRadio Network, CRM Advocate, and Human Resource Executive.

By Bruce Japsen, Chicago Tribune

Jun. 17–Turning the tables on the health insurance industry’s rankings of doctors, the American Medical Association on Monday said it will begin rating business practices of health plans that it says can slow payments to doctors and often confuse consumers.

The national physicians group, in Chicago this week for its annual policymaking meeting, said it is for the first time providing a report card that examines the timeliness and accuracy of claims processing of seven national commercial insurance companies, as well as Medicare. Aetna Inc., Cigna Corp. Humana and UnitedHealth Group are among the insurers rated online at ama-assn.org/go/curefor claims.

While the report card is aimed at helping doctors negotiate contracts with insurers and reducing claims-related costs, the AMA said it also could lead to improvements in consumers’ understanding of their medical bills and how medical care is priced.

“The goal of the AMA campaign is to hold health insurance companies accountable for making claims processing more cost effective and transparent and to educate and empower physicians so they are no longer at the mercy of a chaotic payment system that takes countless hours away from patient care,” said Dr. William A. Dolan, an AMA board member.

Insurers say they are making strides to improve prompt and accurate payment of claims.

“We have ongoing dialogue with physicians to better understand and address their business needs,” said Scot Roskelley, a spokesman for Aetna Inc., one of the nation’s largest health plans. “We also continually enhance our suite of electronic options for health-care professionals to obtain information and transact business with us.

“We will review and consider the information shared in the AMA’s campaign in our ongoing work to make our processes even better for physicians.”

Susan Pisano, a spokeswoman for America’s Health Insurance Plans, said both insurers and doctors need to work together for claims to be processed accurately and promptly. She said while insurance companies that rate doctors generally share the information with doctors before they make it public, the AMA did not share its report with insurers before releasing it.

As health-care costs rise, insurance companies, employers and consumers are demanding quality information, and health-plan-led efforts are increasingly grading and ranking doctors on a variety of quality measures. Physicians and patients also are demanding more insurer transparency so they know the cost of a procedure and how the payment is allocated.

The larger issue of “inefficient and unpredictable” medical claims processing can add up to $210 billion in costs annually, the AMA said. Meanwhile, diverting such resources as clerical-staff time to correct and grapple with inaccurate claims can cost doctors up to 14 percent of their total revenue, the AMA said.

“The difficulty consumers have understanding their bill is no different than the doctor has understanding their payment,” said Mark Rieger, chief executive of National Healthcare Exchange Services, a Sacramento company hired to put together the report card.

The Associated Press contributed to this report.

—–

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Copyright (c) 2008, Chicago Tribune

Distributed by McClatchy-Tribune Information Services.

For reprints, email [email protected], call 800-374-7985 or 847-635-6550, send a fax to 847-635-6968, or write to The Permissions Group Inc., 1247 Milwaukee Ave., Suite 303, Glenview, IL 60025, USA.

AET, CI, HUM, UNH,

WARREN, N.J. and PORTAGE, Ind., June 17 /PRNewswire/ — MonoSol Rx, a drug delivery company specializing in dissolving thin film pharmaceutical products, and Strativa Pharmaceuticals, the proprietary products division of a wholly owned subsidiary of Par Pharmaceutical Companies, Inc. , announced today that they have entered into an exclusive licensing agreement under which Strativa has acquired the U.S. commercialization rights to the thin film formulation of ondansetron from MonoSol Rx. The ondansetron thin film formulation is a new oral formulation in development for the prevention of chemotherapy-induced nausea and vomiting, prevention of nausea and vomiting associated with radiotherapy, and post-operative nausea and vomiting.

Based on the results of a recently completed pilot bio-equivalency study, MonoSol Rx is initiating pivotal trials immediately to enable application for drug approval in the U.S. Subject to favorable results, it is anticipated that Strativa could file an NDA with the appropriate regulatory authorities within the next twelve months.

Under terms of the agreement, MonoSol Rx will receive milestone payments prior to commercial launch and sales-based milestones that could total $23.5 million as well as payments for purchase of product supply and royalties on net sales.

Anti-emetic therapies constitute one of the largest segments of the supportive care market in the U.S., with annual sales of over $1.6 billion in 2007. Ondansetron was the prescription leader in the category in 2007, with 2.7 million scripts written.

A. Mark Schobel, president and CEO of MonoSol Rx, stated, “We are very excited about the collaboration with Strativa. They are uniquely positioned to market and sell our ondansetron thin film product given their focus on marketing novel prescription drugs. Thin film is particularly well suited for this indication because patients who are prescribed ondansetron often have difficulty swallowing due to extreme nausea caused by chemotherapy and radiation treatments. Following approval, ondansetron would be one of the first prescription drugs to come to market utilizing thin film drug delivery technology.”

John A. MacPhee, president of Strativa, said, “We are delighted to collaborate with MonoSol Rx and expand our pipeline of supportive care products. With two unique, yet complementary delivery systems of ondansetron in our portfolio, Zensana(TM) oral spray and the oral thin film, we are able to offer patients a better opportunity to find a product that meets their individual needs.”

Keith J. Kendall, executive vice president and CFO of MonoSol Rx, stated, “The financial components of this relationship demonstrate the value of MonoSol Rx’s intellectual property, expertise in thin film development and manufacturing as well as our ability to partner for the commercialization of innovative thin film products.”

About MonoSol Rx

MonoSol Rx is a drug delivery company specializing in proprietary, dissolving thin film pharmaceutical products. The Company’s thin film technology, which is similar in size, shape and thickness to a postage stamp, dissolves rapidly and utilizes a novel process and proprietary encapsulation compositions to mask the taste of the drug contained within the film. The Company’s thin film formulations offer significant patient benefits, including convenience, taste, and potentially greater efficacy. MonoSol Rx’s strategy is to develop and partner innovative thin film strip products in the prescription, generic and OTC pharmaceutical markets and to establish a leadership position in thin film drug delivery technology through continued development of its drug delivery technology and intellectual property portfolio. For additional information, please visit http://www.monosolrx.com/.

About Strativa

Strativa Pharmaceuticals is the proprietary products division of Par Pharmaceutical, Inc. Supported by Par’s financial and organizational capabilities including substantial cash resources, Strativa Pharmaceuticals is committed to developing and marketing novel prescription drugs. Its initial focus is on supportive care therapeutics in HIV and oncology. Drawing on the specialty products expertise of its staff, Strativa possesses the resources to prepare products for introduction and to help ensure their success after launch. For additional information, please visit http://www.strativapharma.com/.

About Par Pharmaceutical

Par Pharmaceutical, Inc. develops, manufactures and markets generic drugs and innovative branded pharmaceuticals for specialty markets. For press release and other company information, visit http://www.parpharm.com/.

   Contacts:   For MonoSol Rx:   Jason Rando/Stephanie Carrington   The Ruth Group   646.536.7025/7017   [email protected]   [email protected]  

MonoSol Rx

CONTACT: Jason Rando, +1-646-536-7025, [email protected], orStephanie Carrington, +1-646-536-7017, [email protected], both ofThe Ruth Group for MonoSol Rx

Web site: http://www.monosolrx.com/http://www.strativapharma.com/http://www.parpharm.com/

Eli Lilly and Company has announced that the FDA has approved Cymbalta for the management of fibromyalgia, a chronic widespread pain disorder.

Eli Lilly’s Cymbalta is said to be the first serotonin-norepinephrine reuptake inhibitor with proven efficacy for reducing pain in patients with fibromyalgia. The fibromyalgia indication represents the second FDA-approved use for Cymbalta for a pain disorder, demonstrating the medication’s analgesic effect.

The approval marks the fourth disorder that the FDA has approved for Cymbalta. In addition to fibromyalgia, Cymbalta is approved for the management of diabetic peripheral neuropathic pain and the treatment of major depressive disorder and generalized anxiety disorder, all in adults of age 18 years and older.

Madelaine Wohlreich, medical advisor and research physician at Lilly, said: “The approval of Cymbalta is important because it provides physicians and patients with a new treatment option shown to help reduce pain and improve functioning in this difficult-to-treat disorder.”

By Kelly Wiese

A state appeals court has been asked to decide just how far privacy reaches with medical information.

A medical malpractice lawsuit is pending in St. Louis County Circuit Court, where a man alleges his doctor botched a colonoscopy at Des Peres Hospital and left him partially disabled.

As part of the discovery process, plaintiff’s attorney Paul Passanante sought various records regarding Dr. Michael Impey from the state Bureau of Narcotics and Dangerous Drugs, the Missouri Physicians Health Program and the Board of Registration for the Healing Arts. He wants details such as drug test results and medical reports shared among the agencies.

Circuit Judge Richard Bresnahan granted Passanante’s discovery requests, but Impey is seeking a writ of prohibition from the Missouri Court of Appeals Eastern District to overrule that decision and quash the subpoenas. Both sides have filed legal briefs.

A key claim in the underlying lawsuit is that Impey has a history of abusing and addiction to prescription drugs. The physician was disciplined by the Healing Arts board, which licenses doctors, and lost his authority to write certain prescriptions but continued to do so anyway.

The suit claims Impey was still a drug addict at the time of plaintiff John Campbell’s procedure and resulting complications.

Passanante argues the medical information is relevant to the case and is not protected by doctor-patient confidentiality. For one thing, Impey testified about his actions at a medical license probation revocation hearing, which was open to the public, Passanante’s brief said.

Also, according to the appeals court filing, he gave up that privacy by reaching settlement agreements with the board and the narcotics bureau, both of which are public records. Plus, he agreed to have information about his treatment shared between them and the Missouri Physicians Health Program, which helps doctors with substance abuse problems.

The attorney also argues that medical privilege does not apply to felonious conduct, and that Impey’s writing prescriptions after being barred from doing so and giving false information to his own doctor to obtain drugs violated the law.

“Since when is a wrongdoer entitled to claim that the revealing the facts of his wrongdoing will do him irreparable harm?” Passanante, of Simon Passanante, wrote in his brief.

Impey’s lawyers see it another way. They argue that so-called medical privilege cannot be waived by testimony not provided voluntarily. They say anything shared in the probation hearing was solely to save Impey’s medical career, and should not open him up to further legal action.

They also say Campbell is trying to reach beyond the facts of the alleged malpractice.

“Plaintiffs, through their discovery efforts, have attempted to make the disciplinary actions against Dr. Impey for his improper use of narcotics the central issue in this case. It is not,” said the brief filed by lead attorney Robert Rosenthal, of Brown & James. “The central issue is whether Dr. Impey breached the standard of care while performing Mr. Campbell’s colonoscopy.”

They also want to keep Campbell from using a transcript of the probation hearing in his medical malpractice case. Rosenthal’s brief points to a section of law saying proceedings to discipline medical licenses for excessive drug use are not to be used against a doctor in any other proceeding.

Passanante counters that the probation revocation hearing was conducted under another chapter of law, as the hearing transcript states, so that restriction does not apply.

The court has not yet taken action in the case.

Originally published by Kelly Wiese.

(c) 2008 Daily Record and the Kansas City Daily News-Press. Provided by ProQuest Information and Learning. All rights Reserved.

ikaSystems, a premier provider of enterprise-level Web-based technologies for healthcare payer organizations, has released a new offering for the Medicare market. Available through a unique partnership with Government Works, a contractor with the Centers for Medicare & Medicaid Services (CMS), ikaMedicareGateway allows payers to significantly expedite and increase the accuracy of Medicare application processing, eligibility verification, and enrollment, membership and payment reconciliation through online functionality and real-time access to information from CMS’ MARx database. With this offering, ikaSystems now offers the industry’s most comprehensive solution for Medicare process automation and intelligence management.

“Whether they are looking to offer new Medicare benefit plans, rapidly expand existing plans or reduce administrative costs for large plans, payers have not had a comprehensive, sophisticated technology to replace and improve upon time-consuming and error-prone manual processes,” said Ravi Ika, president of ikaSystems. “With ikaMedicareGateway, as with all of our Medicare offerings, we have minimized the burden of compliance — particularly important during high-volume enrollment periods — through process automation, allowing payers to capitalize on explosive growth in the Medicare market while lowering administrative costs.”

At UPMC Health Plan of Pittsburgh, ikaMedicare Gateway combined with ikaPortals allowed the organization to expand its Medicare membership from 33,000 to 80,000 in 18 months without adding staff. The organization also achieved a four-fold increase in enrollment efficiency while improving accuracy. According to CIO Ed McCallister, “We could not have met our aggressive growth goals for our Medicare business without the business solution provided by ikaSystems.”

A hosted (ASP) solution, ikaMedicareGateway automates Medicare application processing, eligibility verification, and enrollment, membership and payment reconciliation. The process begins with an online application portal, which members, brokers or administrative staff can use to start the enrollment cycle. Through ikaMedicareGateway, instant eligibility queries and beneficiary look-ups are performed against the MARx database. Responses are immediate, both ensuring the accuracy of the information supplied and pulling data from the database to populate the rest of the application, saving time for administrative staff.

The quality of these initial processes creates error-free membership accretion files, significantly reducing rework and increasing cash flow by ensuring timely payment. In addition, ikaMedicareGateway users have seen enrollment, membership and payment reconciliation times reduced by an estimated 70 percent due to greater automation and accuracy, speeding the discovery of discrepancies and missing dollars. Finally, comprehensive data warehousing, reporting and efficiency features (e.g., automatic triggers) keep organizations fully informed and further increase their efficiency.

ikaMedicareGateway is a key component of ikaSystems’ comprehensive ikaEnterprise product suite for Medicare, which includes tools that automate the full spectrum of Medicare administrative processes, including marketing and sales management, claims administration, customer service, billing and commissions payment. Administrative tools in turn blend seamlessly with ikaEnterprise medical management applications, creating a connected, shared information platform for real-time collaboration. Because all ikaEnterprise applications are Web based, functionality is easily extended outside the health plan via ikaPortals, allowing members, providers and employers to take control of their own processes and share information. ikaSystems also supports organizations seeking to outsource administrative processes through partnership with a leading service provider.

About ikaSystems Corp.

ikaSystems is healthcare payers’ premier provider of Web-based ERP technology for process automation and intelligence management. ikaEnterprise, the company’s flagship product, automates all key processes in the payer business cycle, supporting commercial, Medicare and Medicaid lines of business. The system consists of five stand-alone, self-service Web portals for sales/broker, administrative, employer, member and provider use, each of which are tightly integrated with business intelligence and transactional systems for core claims adjudication, care management and proactive quality measurement and reporting. Using our agile, modular technology, organizations can move quickly to lower administrative and medical care expenses through greater automation and highly intelligent decision-making. To learn more, please visit www.ikasystems.com.

The Indianapolis Coalition for Patient Safety (Coalition) has announced that Suburban Health Organization (SHO) has joined its efforts. SHO is an organization composed of eight central Indiana hospitals working together to promote quality, efficiency and patient access.

Suburban hospitals include St. Vincent Health, which is currently a Coalition member, Hancock Regional Hospital, Hendricks Regional Health, Henry County Hospital, Morgan Hospital & Medical Center, Riverview Hospital, Witham Health Services, and Westview Medical Campus.

“Suburban and our Hospitals have a long-standing commitment to improving patient safety, and this is an excellent opportunity for us to participate in regional efforts,” said Julie M. Carmichael, FACHE, President and Chief Executive Officer of Suburban.

“We understand that common protocols for the same procedures in different locations can cut down on mistakes. By pooling our expertise with the Indianapolis Coalition for Patient Safety, we are demonstrating our commitment to patient safety throughout central Indiana and accelerating improvement through a community-wide effort,” Carmichael continued.

In other news, Carol Birk, Director, PharmaTAP, Purdue University, has been named as the Coalition’s new Executive Director. In addition to her duties at Purdue, she will be responsible for the administration and overall direction of the Coalition. Birk replaces Kathy Rapala, who has accepted a new position as Director of Clinical Risk Management at Aurora Health in Wisconsin.

“Carol brings a solid background in catalyzing improvement in patient safety, clinical quality and efficiency in a multitude of settings,” said Dr. Glenn Bingle, chair of the Coalition and Community Health Network vice president for medical and academic affairs. “Her extensive experience assembling multi-disciplinary teams will support the existing work and structure of the Coalition and help to bring its knowledge to a broader set of healthcare providers.”

Birk received her B.S. in Pharmacy from Purdue University, an M.S. in Pharmacy Administration from University of Wisconsin, and completed a two year administrative residency at the University of Wisconsin. She has extensive experience in hospital pharmacy practice and healthcare performance improvement.

The Coalition is comprised of chief executive, medical, nursing and pharmacy officers from Indianapolis-area hospitals, including Clarian Health, Community Health Network, Richard L. Roudebush VA Medical Center, St. Francis Hospital and Health Services, St. Vincent Health and Wishard Health Services. In addition, there is participation by entities such as Eli Lilly and Company, WellPoint, Inc., Indiana University, Purdue University, the Regenstrief Center for Healthcare Engineering and the Regenstrief Institute, Inc.

Since being founded in 2003, the Coalition provides a forum for Indianapolis-area hospitals to share information about ‘best practices’ and work together to solve the most concerning patient safety issues in Indianapolis hospitals in a non-punitive setting.

The Coalition patient safety projects are:

— analyzing processes used to dispense high alert drugs;

— implementing a surgical site marking and time-out policy;

— root cause analysis review;

— patient safety round programs;

— implementing standardized abbreviations; and

— participating in the Institute for Healthcare Improvement Campaigns and other national initiatives.

About the Indianapolis Coalition for Patient Safety:

The Indianapolis Coalition for Patient Safety, formed in 2003, is a non-profit, public-private partnership of health care leaders committed to advancing patient safety efforts. Its membership includes Indianapolis-area hospital systems, as well as participants who purchase, insure, support or educate the health care community. Through their shared vision, the Indianapolis health care community has accelerated the pace of patient safety improvement in Indianapolis. www.indypatientsafety.org.

About Suburban Health Organization:

Suburban Health Organization (SHO) is a physician and hospital network serving central Indiana since 1994. Its eight central Indiana hospitals work together to promote quality, efficiency and patient access in the communities they serve. SHO’s Quality Management Council includes physician and quality management leaders who meet regularly to share information and collaborate on opportunities to improve clinical care, patient safety and patient satisfaction. www.suburbanhealth.com

Rationale: Interstitial lung disease (ILD) occurs in Japanese patients with non-small cell lung cancer (NSCLC) receiving gefitinib. Objectives: To elucidate risk factors for ILD in Japanese patients with NSCLC during treatment with gefitinib or chemotherapy.

Methods: In a prospective epidemiologic cohort, 3,166 Japanese patients with advanced/recurrent NSCLCwere followed for 12weeks on 250 mg gefitinib (n = 1,872 treatment periods) or chemotherapy (n = 2,551). Patients who developed acute ILD (n = 122) and randomly selected control subjects (n = 574) entered a case-control study. Adjusted incidence rate ratios were estimated from casecontrol data by odds ratios (ORs) with 95% confidence intervals (CIs) using logistic regression. Crude (observed) incidence rates and risks were calculated fromcohort data.

Measurements and Main Results: The observed (unadjusted) incidence rate over 12weekswas 2.8 (95%CI, 2.3-3.3) per 1,000 person- weeks, 4.5 (3.5-5.4) for gefitinib versus 1.7 (1.2-2.2) for chemotherapy; the corresponding observed naive cumulative incidence rates at the end of 12-week follow-up were 4.0% (3.0-5.1%) and 2.1% (1.5-2.9%), respectively. Adjusted for imbalances in risk factors between treatments, the overallOR for gefitinib versus chemotherapywas 3.2 (1.9-5.4), elevatedchieflyduringthe first4weeks (3.8 [1.9-7.7]).Other ILD risk factors in both groups included the following: older age, poor World Health Organization performance status, smoking, recent NSCLC diagnosis, reduced normal lung on computed tomography scan, preexisting chronic ILD, concurrent cardiac disease. ILD-related deaths in patients with ILD were 31.6% (gefitinib) versus 27.9% (chemotherapy); adjusted OR, 1.05 (95%CI, 0.3-3.2).

Conclusions: ILD was relatively common in these Japanese patients with NSCLC during therapy with gefitinib or chemotherapy, being higher in the older, smoking patient with preexisting ILD or poor performance status. The risk of developing ILD was higher with gefitinib than chemotherapy,mainly in the first 4 weeks.

Keywords: non-small cell lung cancer; interstitial lung disease; Japanese patients; gefitinib, chemotherapy

Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors are a well-established therapy for the treatment of non- small cell lung cancer (NSCLC) in many countries. They are generally well tolerated and not typically associated with the cytotoxic side effects commonly seen with chemotherapy.

The EGFR tyrosine kinase inhibitor gefitinib (IRESSA; Astra- Zeneca, London, U.K.) was first approved for the treatment of advanced NSCLC in Japan in July 2002. In clinical trials and in preapproval compassionate clinical use, some reports of interstitial lung disease (ILD)-type events had been observed. As the drugwas made more widely available in Japan after approval, however, an increasing number of spontaneous reports for ILD appeared.

ILD is a disease that affects the parenchyma or alveolar region of the lungs (1). When associated with drug use, it can present precipitously with acute diffuse alveolar damage, which is fatal in some patients (2). Chest imaging shows ground-glass density and patients present with severe breathlessness. There is no specific treatment, but supportive therapy including oxygen, corticosteroids, or assisted ventilation is indicated. Acute exacerbations of ILD have previously been considered relatively rare in many settings, with Japan as a notable exception (3), but recent studies of patients with idiopathic pulmonary fibrosis (IPF) have challenged this and underlined this important risk (4).

ILD, especially IPF, is a known comorbidity in patients with NSCLC and has also been associated with many other lung cancer therapies (5). Rates of acute ILD events up to and exceeding 10% have been reported in patients receiving chemotherapy and radiotherapy (6-11). It is recognized that ILD is more common in Japan than elsewhere (5, 6, 12, 13).

When safety reports of acute ILD-type events in gefitinibtreated patients appeared in Japan, there was limited knowledge about ILD in patients with NSCLC. There was a need to better understand baseline incidence on different treatments, risk factors for developing ILD, and whether gefitinib might be associated with increased risk of ILD, or if patient selection or other aspects were involved. A pharmacoepidemiologic study was designed and conducted by an independent academic team together with scientists from AstraZeneca to define the risk and increase understanding of ILD in Japanese patients with NSCLC. Some of the results of this study have been previously reported in the form of conference abstracts (14, 15).

METHODS

See also the online supplement for further details on methods.

Overall Study Design

A nonrandomized cohort study with a nested case-control study component was conducted between November 12, 2003, and February 22, 2006, in 50 centers across Japan. Patients with advanced or recurring NSCLC who had received at least one chemotherapy regimen were eligible for cohort entry. Patients and their physicians selected the most appropriate treatment (gefitinib 250 mg or chemotherapy) and the patients were followed for up to 12 weeks after treatment initiation. Basic data were collected at the start of follow-up and included sex, age, World Health Organization (WHO) performance status (PS), and tumor histology. If a patient switched to a new treatment, he or she could be re-enrolled for a new treatment period of 12 weeks, provided he or she was still eligible.

Patients who developed acute ILD events during the follow-up were registered to the case-control study nested within the cohort as clinically diagnosed potential cases. For each potential case, four patients who had not yet developed ILD were randomly selected as appropriate control subjects from patients registered to the cohort at that time, and extensive clinical and demographic risk factor data were collected on cases and control subjects (see Figure E1 in the online supplement).

The study followed Good Clinical Practice procedures. An independent external epidemiology advisory board provided advice on design, conduct, and analysis of the study.

Diagnosis of ILD

To ensure an accurate diagnosis of ILD, several study design components were implemented: (1) an information card to all cohort patients, alerting them to the symptoms of ILD; (2) internationally agreed criteria for the diagnosis of ILD and a diagnostic algorithm (see Figure E2) developed from the American Thoracic Society/ European Respiratory Society consensus statement (1); and (3) a blinded diagnostic review of all clinically diagnosed potential ILD cases registered to the study by an independent case review board (CRB) of radiologists and clinicians.

Evaluation of Preexisting Lung Conditions

The CRB also blindly evaluated pretreatment computed tomography (CT) scans for the presence of a number of pulmonary conditions: preexisting (chronic) ILD (mainly IPF), drug-induced lung disease, pulmonary emphysema, radiation pneumonitis, lymphangitis carcinomatosis, and healed tuberculosis, and evaluated the extent of normal lung, as well as the extent of areas adherent to pleura.

Detailed Data Collection

For cases and control subjects, detailed data on NSCLC treatment, demography, cancer histology, clinical stage and the presence of metastases, WHO PS, smoking, previous cancer treatments, past and current medical history, surgical history, and concomitant medication and therapy were collected. Data on serious adverse events (SAEs) and hence all-cause mortality were collected for the gefitinib-treated patients in the cohort only; thus, information on mortality from causes other than ILD in chemotherapy-treated patients is not available from this study.

Statistical Analysis

From cohort data, we estimated observed person-time incidence rates as well as two measures of the observed “risk” of acute ILD to a patient; a naive estimate of observed cumulative incidence (incidence proportion, “frequency”), and risk up to 84 days by the Kaplan-Meier method.

Control subjects for the nested case-control study were sampled using incidence density sampling, and consequently the odds ratio (OR) obtained from the case-control analysis estimates the study incidence rate ratio (and approximately estimates the risk ratio) (16).

For the case-control statistical analysis, it was initially verified that the convenience matching for calendar time implicit in the risk set control sampling could be disregarded. In tabular analyses, we then identified potential confounders and risk factors, using as selection criteria a 10% change in the OR estimate for gefitinib versus chemotherapy treatment when stratifying for each factor separately, and a risk factor crude OR of less than 0.5 or more than 2.0, respectively. We also identified potential interactions between treatment and other risk factors, or between two potential risk factors. Modeling using logistic regression then proceeded in the corresponding four steps. Few previous data were available on risk factors for ILD in patients with NSCLC and so a hypothesis-free stepwise process with loose P value criteria (P

ILD-related mortality among the patients who developed acute ILD on gefitinib or chemotherapy treatment was obtained. Modeling of risk factors for ILD-related mortality followed a similar process to the ILD risk factor modeling. For gefitinib-treated patients, two additional data items were available: total all-cause mortality, which was analyzed by the Kaplan-Meier method, and SAEs, for which frequencies and possible consequences in terms of treatment discontinuation and death were calculated.

RESULTS

Cohort Subjects and Treatments

Cohort participation rates were high. In 10 sampled study centers, 89.6% of eligible patients were enrolled to the cohort. The number of treatment periods and subjects are summarized in Table 1. In total, 4,423 treatment periods in 3,159 subjects were available for analysis. In the cohort, 70.8% of patients had only one treatment period, 21.5% had two periods, and the remaining 7.8% of patients had three or more treatment periods registered (Table 1). Chemotherapy included a wide range of treatments, the most common being taxane monotherapy, followed by taxane+platinum and gemcitabine1vinorelbine combinations.

Cases and Control Subjects

In the overall cohort data of all treatment periods, clinicians reported 155 suspected cases of acute ILD during the follow-up, of which 122 were confirmed by the CRB after blinded review of CT and clinical data-79 of 103 gefitinib-treated (76.7%) and 43 of 52 chemotherapy-treated (82.7%) subjects. A total of 574 eligible control subjects were sampled from the person-time of the cohort. Almost all ILD cases and selected control subjects consented to participate in the nested case-control study, with final participation rates of 98.1 and 92.0%, respectively. Valid data from the CRB review of CT scans were available for 115 cases and 520 control subjects.

Descriptive Data

On data items available for the full cohort (sex, age, WHO PS, and tumor histology), the control subjects were quite representative of the overall cohort (details not shown). Comparisons of the gefitinib- and chemotherapy-treated control groups as representative of the cohort indicated that the former included more women, never- smokers, adenocarcinoma tumors, and poorer PS, as well as less preexisting ILD and pulmonary emphysema on CT scan (Tables 2 and 3). ILD cases, regardless of treatment, were more likely than cohort control subjects to be older, male, smokers, with squamous cell carcinoma histology, and have poor PS (Tables 2 and 3). The frequency of preexisting ILD and pulmonary emphysema was higher in cases, reflected also in a lower extent of normal lung on CT scan.

Cohort Analysis of ILD Occurrence

The observed incidence rate of acute ILD over the entire 12-week follow-up in the overall cohort was 2.8 per 1,000 personweeks-4.5 in the gefitinib-treated and 1.7 in the chemotherapy subcohort (Table 4). The observed incidence in the gefitinibtreated subcohort was highest in the first 4 weeks after starting treatment, greater than in the chemotherapy-treated subcohort. In the following two 4-week periods, the incidence was lower with no clear difference (Table 4, Figure 1A). The naive cumulative incidence of ILD at 84 days (i.e., observed frequency or proportion of the original cohort that developed ILD in the study) for patients in their first study treatment period was 4.0 and 2.1% for gefitinib- and chemotherapy- treated patients, respectively (Table 4), whereas the estimated theoretical 12-week risk of ILD (i.e., taking competing causes of death and loss to follow-up into consideration; Kaplan-Meier method) was 4.5 and 2.4%, respectively (Table 4, Figure 1B). Thus, the observed cohort rates and risks suggested an association of increased ILD occurrence with gefitinib treatment mainly in the first 4 weeks after treatment initiation. All cohort estimates are unadjusted for imbalances between treatments in other risk factors. Detailed comparisons between the treatments therefore used the adjusted case-control OR (as an estimate of the adjusted incidence rate ratio) to achieve comparability.

Case-Control Analysis of ILD Occurrence and Risk Factors

Major results. The OR of developing acute ILD with gefitinib treatment versus chemotherapy, adjusted for the full predictor model of major confounders together with additional identified important risk factors and interactions, was 3.2 (95% confidence interval [CI], 1.9-5.4) (Table 5). Several risk factors aside from treatment also had strong effects, including WHO PS, as well as smoking status and preexisting ILD together with the extent of normal lung on CT scan, which interacted in a complex way in the model (Table 5, Figure 2). Preexisting ILD was confirmed as a strong risk factor, with OR point estimates ranging from 4.8 to 25.3 depending on the extent of remaining normal lung on CT scan, in comparison with patients without preexisting ILD and high extent of normal lung on CT scan (Table 5). The full set of ILD risk factors in both groups from the final model thus included older age (>/=55 yr), WHO PS (>/ =2), smoking, short duration since NSCLC diagnosis (

When the case-control analyses focused on the first 4 weeks after treatment initiation (because the unadjusted cohort analyses above indicated that the bulk of the association with gefitinib appeared to be for this time interval) the estimated OR adjusted for a full predictor model developed on this period’s data was 3.8 (95% CI, 1.9- 7.7). The same model produced an OR for Weeks 5-8 of 1.6 (95% CI, 0.5-4.8), whereas the final 4-week period had too few cases for an adequate estimate. The estimate for Weeks 5-12 combined, using this same model, was 2.5 (95%CI, 1.1-5.8). The important covariates and predictors were the same in this model as in the model for the full 12-week data, with the exception of age, preexisting cardiac disease, and preexisting pulmonary emphysema, which were not included. Due to sparse data beyond 4 weeks, independent models for Weeks 5-8, 9-12, and 5-12 could not be developed.

Confounding and sensitivity analysis. In the overall 12-week basic analysis, moderately strong confounding by other risk factors was found. The crude OR of developing ILD with gefitinib treatment versus chemotherapy was 2.3 (95% CI, 1.5-3.6). When adjusted for some of the most important potential confounders one at a time, the adjusted OR point estimate for the association of treatment with ILD occurrence ranged from 2.1 to 3.1 (see Table E1 for details). The most important confounder was severity of preexisting ILD with strong negative confounding, and the only one that resulted in a lower adjusted OR than 2.3 (positive confounding) was WHO PS.

The propensity score analysis approach identified the following variables as the most important predictors of selecting gefitinib treatment in this study: female sex; nonsmoking status; non- squamous tumor histology; poor PS; preexisting lymphangitis carcinomatosis; no previous gefitinib treatment; and no preexisting ILD, emphysema, or radiation pneumonitis. The estimated OR of developing ILD for gefitinib treatment when stratifying by the propensity score was 3.3 (95% CI, 1.9-5.5), very similar to the primary result, suggesting that the primary regression modeling approach well captured the confounding in the data.

If some misclassification of ILD diagnosis remains despite the design features aimed to minimize it, the adjusted OR point estimate of 3.2 may apart from random variation be subject to systematic bias. A sensitivity analysis to evaluate the possible magnitude of such bias due to misclassification of ILD diagnosis suggested that the true study point estimate for the adjusted OR would be expected to lie between 2.6 and 4.8, assuming diagnostic sensitivity of more than 80% for both gefitinib- and chemotherapy-treated patients, and specificity of more than 99.0% for gefitinib and more than 99.5% for chemotherapy. Lower values for sensitivity/specificity were considered very unlikely for this serious condition in a cancer patient population, in this study setting.

Analysis of ILD Mortality

Mortality due to ILD among gefitinib- or chemotherapy-treated patients. The mortality due to ILD for the patients who developed acute ILD was 31.6% (95% CI, 21.6-43.1) among gefitinib-treated patients and 27.9% (95% CI, 15.3-43.7) among those with other treatments; the OR was 1.05 (95% CI, 0.3-3.2) for gefitinib versus chemotherapy, adjusted for relevant risk factors. Several other factors were strong predictors of a fatal outcome for patients with ILD, including age of 65 years or older, smoking history, preexisting ILD, CT scan evidence of reduced normal lung (=50%), and/or extensive areas adherent to pleura (>/=50%), with ORs ranging from 2.4 to 11.7 (see Table E2).

Overall mortality among gefitinib-treated patients. In the gefitinib-treated cohort in whom such data were available, an analysis of mortality from all causes by the Kaplan-Meier method showed that cumulative mortality at 12 weeks among the patients who did develop ILD was 58.7%, compared with 14.6% (95% CI, 12.8-16.3) among the large majority who did not develop ILD (Figure 3). For the entire gefitinib cohort, including the subjects who developed ILD, the observed cumulative mortality was 16.0% (95% CI, 14.3-17.8), so that the increased mortality in ILD cases impacted the total survival rate at 12 weeks in the overall gefitinib-treated cohort only to a limited extent, reducing survival from 85.4 to 84.0%. SAEs among Gefitinib-treated Patients

SAEs were only collected for gefitinib-treated patients in the cohort, and a total of 198 patient registrations reported SAEs (10.5%), of which 38 (2.0%) reported SAEs resulting in a fatal outcome. Within this group, there were 142 patient registrations with drug-related (as reported by the physicians) SAEs (7.5%), of which 30 (1.6%) resulted in a fatal outcome. The majority of these (25 out of 30) were due to ILD-type events. There were 122 patient registrations where study treatment was discontinued due to the reported SAEs (6.5%). SAEs seen in the gefitinib-treated patients were generally consistent with the known safety profile of gefitinib and/or the patient’s underlying disease and comorbidities.

DISCUSSION

This study provides important information on ILD in an advanced/ recurrent NSCLC setting in Japanese patients in Japan, and it is the largest prospective study of this condition to date. For the first time, the risk of acute ILD events for a large and relatively unselected chemotherapy-treated NSCLC patient cohort in Japan was determined in clinical practice. The study also quantified the greater risk of developing acute ILD associated with gefitinib treatment than with conventional chemotherapy, mainly in the first 4 weeks after treatment initiation. The study confirmed and further defined risk factors for developing ILD with gefitinib or chemotherapy. The factors included older age, poor WHO PS, smoking, short duration since diagnosis of NSCLC, reduced normal lung on CT scan, preexisting ILD, and concurrent cardiac disease. Several of these factors, or related factors, had been reported previously in bivariate or multivariate analyses from other studies (8, 18, 19). These risk factors were the same for patients treated with gefitinib or chemotherapy in the study, and no treatment-specific risk factors were identified. In particular, patients with CT evidence of preexisting ILD (chronic) were at considerably elevated risk of developing acute ILD during treatment, but there were relatively few subjects with preexisting ILD and the data did not indicate a statistically significant difference in treatment-related risk depending on the preexisting ILD status. Of clinical relevance, some of these risk factors were just as strong as, or stronger than, gefitinib treatment, for example having a poor WHO PS (=2) rather than a good PS (OR, 4.0; 95% CI, 1.85-8.75), implying that they can be used to identify patients at particular risk of ILD in clinical practice. The relationship between ILD and pharmacokinetic characteristics of gefitinib, as well as genetic polymorphisms and proteomics determined in study subjects, were also investigated as secondary and exploratory objectives in this study. These analyses are ongoing and results will be submitted for publication in due course.

Over the whole study follow-up, the average incidence rate for acute ILD events in patients treated with gefitinib was 3.2-fold higher relative to that seen with other chemotherapy treatments, adjusted for imbalances in other risk factors between treatments. The increased risk of ILD associated with gefitinib treatment was seen most clearly in the first 4 weeks after treatment initiation. Thus, increased physician awareness of risk factors and careful surveillance of Japanese patients during this period are indicated to manage risk. Such an approach is in line with current recommendations in Japan (20, 21). Beyond 4 weeks after treatment initiation, the risk of ILD associated with gefitinib treatment appears to fall.

ILD risk factors were found to be the same for both types of NSCLC therapy. Gefitinib is, however, a molecularly targeted agent. There is a significant body of evidence to indicate that gefitinib is a valid treatment option for some patients with NSCLC. In the IRESSA Survival Evaluation in Lung cancer (ISEL) study, a large phase III, placebo-controlled trial (n = 1,692), gefitinib was associated with some improvement in overall survival versus placebo, although this failed to reach statistical significance in the primary analysis of the overall population (22). Preplanned subgroup analyses from the study showed statistically significant differences in survival in favor of gefitinib in patients of Asian origin and those who had never smoked. Furthermore, tumor biomarker data suggest that patients with a high EGFR gene copy number, or an EGFR mutation, may be more likely to benefit (23, 24).

Therefore, the consideration of those patients more likely to benefit from the drug balanced with the better identification of these risk factors associated with ILD enables the physician to make careful judgment of the most appropriate therapy for the individual patient. Patients with several risk factors will generally be at more risk, and patients with risk factors may be at higher risk if gefitinib is used. This approach is facilitated by the fact that evidence to date suggests that subgroups less at risk of ILD tend to be those that respond well to gefitinib treatment (8).

A fatal outcome is the major concern with ILD as an SAE of drug treatment. In other large studies, fatality rates due to ILD in gefitinib-treated subjects of approximately 30% have been seen (8, 25), and a similar mortality was observed in this study in both gefitinib-treated and chemotherapy-treated ILD cases. The main predictors of a fatal outcome were older age (>/=65 yr), smoking history, and preexisting ILD, as well as CT scan evidence of reduced normal lung (=50%) or extensive areas adherent to pleura (>/ =50%). Because mortality is high among patients with NSCLC and the frequency of ILD in Japanese patients with NSCLC is low in comparison, ILD-related mortality impacted the overall survival at 12 weeks, for the cohort of gefitinib-treated patients, only to a limited extent (85.4 to 84%). Accordingly, there needs to be an appropriate individualized risk-benefit evaluation for patients also considering other treatments, many of which have their own problems with treatmentrelated mortality due to SAEs other than ILD.

Some methodologic issues may have influenced the study results and deserve comment. This kind of observational pharmacoepidemiologic study is generally considered sensitive to confounding by indication. Most often, it is assumed that more “sick” or “susceptible” patients will receive a new treatment, leading to possibly more adverse effects in this group, even in the absence of a true relationship to treatment. Attempts to adjust for confounding using collected data would then push the adjusted estimate of effect closer to the null, but if sufficiently precise information on strong confounders cannot be collected, it may be impossible to remove all of the confounding. In conducting this study, the suspected adverse effect of ILD was recognized, and in the clinical setting, recommendations were in place to proceed with caution when treating some patients with suspected elevated baseline risk of ILD. This kind of selection would tend to produce the type of data pattern that was in fact observed in this study, a pattern of negative confounding that produces a more elevated OR when adjustment for confounders is performed. Thus, the results are well in line with what might be expected.

Misdiagnosis of ILD (outcome misclassification) is another concern, but it is expected that the stringent design features have minimized this problem in the present study (see online supplement for details). The diagnostic CRB review is a key feature, but it was still CT based, and biopsies-generally considered the gold standard for ILD diagnosis-were in most cases not taken. Overall, a sensitivity analysis suggested that, under reasonable assumptions about possible misclassification of ILD, the main result would remain similar and the conclusions from the study would not be greatly changed.

Random error is another consideration. However, although random error may be responsible for some bias in the point estimate, the confidence interval is reasonably narrow. The results are also consistent with other recent data. For example, as of January 2006, the estimated reporting rate of ILD-type events in Japan from the AstraZeneca Global Drug Safety Database of patients receiving gefitinib treatment was approximately 3.1% (26); from a retrospective study by the West Japan Thoracic Oncology Group (WJTOG), which studied 1,719 patients receiving gefitinib of whom 69 developed ILD, the frequency was 3.5% (95% CI, 2.8-4.5%) (8); from a postmarketing surveillance (PMS) study conducted by AstraZeneca KK Japan, which included 3,322 gefitinib-treated patients, it was 5.8% (25); whereas from the present study, the cumulative incidence at 12 weeks was 4.0% (95% CI, 3.0-5.1%).

These estimates are quite similar, even recognizing that the populations and selection of patients differ between these samples, and duration of follow-up, although similar, varies. In the present study, for the first time, an estimate of cumulative incidence of ILD after 12 weeks of treatment was obtained also from a chemotherapy-treated patient group; this frequency was 2.1% (95% CI, 1.5-2.9%), providing an estimate of this problem unrelated to gefitinib in patients with NSCLC in Japan. The prognosis for gefitinib-treated patients who were diagnosed with ILD was also quite consistent with other studies. In the PMS study, ILD-related death among patients diagnosed with ILD was 38.6% (25); in theWJTOGstudy it was 44.3% (8); in the AstraZeneca Global Drug Safety Database as of January 2006, the proportion of ILD-type events with a fatal outcome in patients receiving treatment with gefitinib in Japan was 37.3% (AstraZeneca, data on file); and in the present study it was 31.6%. This proportion was quite similar to the chemotherapy-treated group, 27.9% (adjusted OR, 1.05; 95% CI, 0.4- 3.2).

The factors associated with risk of acute ILD observed in this Japanese NSCLC population are largely different or even complementary to factors that predict better response to gefitinib. This would seem to support a hypothesis that the mechanism by which ILD occurs is distinct from the successful cancer response mechanism, offering a potential path toward selecting patients with optimal risk-benefit balance for gefitinib treatment.

Interestingly, the issue of ILD in patients with NSCLC, after gefitinib or other treatments, appears to be a problem largely limited to Japan. From the AstraZeneca Global Drug Safety Database, the reporting rate of ILD-type events in patients receiving treatment with gefitinib was only 0.23% in the rest of the world excluding Japan, based on more than 215,000 patients worldwide estimated to have been exposed to gefitinib (26). Even for neighboring countries, the pattern differs from Japan: the rate for East Asian countries, including Korea and Taiwan but excluding Japan, was 0.17% (26). The proportion of ILDtype events with a fatal outcome was similar, however: 37% in Japan and 31% in the rest of the world. The reasons for this difference in incidence of ILD between Japan and other countries remain unclear, but may relate to both constitutional and environmental factors specific to Japan or Japanese patients. For other drug treatments, too, a higher incidence of ILD has been noted in Japan than elsewhere (12, 13).

Within the study, some exploratory analyses are still ongoing related to genetic and proteomic predictors for ILD in patients with NSCLC, to search for biomarkers for early recognition of ILD and hopefully individualized risk assessment. This may help to shed light on why ILD appears to be a particular issue for Japanese patients and the possible underlying mechanisms.

The EGFR is expressed on a number of constituent cells of the lungs including epithelium, smooth muscle cells, fibroblasts, and endothelium (27). There have been a number of animal studies using bleomycin- and vanadium pentoxide-induced lung injury with EGFR- tyrosine kinase inhibitors to determine the role of EGFR in lung fibrosis. Gefitinib and AG1478 have been used in such studies of mice and, when administered in a range of therapeutic doses, show clear attenuation of both bleomycin- (28) and vanadium pentoxide- induced (29) lung fibrosis, although one study (30) has shown augmentation of bleomycininduced fibrosis (when using a subtoxic dose of gefitinib). The similarity of study design and choice of animal strain in the bleomycin studies make it difficult to explain the discrepant results other than by the excessive dosing. This leaves uncertainty as to the underlying mechanism of lung fibrosis in patients with NSCLC receiving gefitinib.

In summary, the study appears to be of adequate validity to avoid serious systematic biases, random error does not seem to be the most likely explanation for the results, and the observed increased risk of ILD with gefitinib treatment relative to chemotherapy treatment in Japanese patients is consistent with previous studies. Although preexisting ILD was confirmed as an important determinant of developing acute ILD symptoms after treatment with gefitinib or chemotherapy, the results also suggested that risk of ILD may be generally affected by a variety of other factors that decrease the amount of normally functioning lung tissue or affect the capability of tissue repair and recovery. The study thus identified several risk factors apart from treatment, which included preexisting ILD, which were not treatment specific, and which were partly similar to risk factors for idiopathic or rheumatic pulmonary lung fibrosis. These findings taken together suggest that there may be a common etiology that gives some patients a greater susceptibility both to idiopathic or rheumatic pulmonary fibrosis and to acute drug- induced lung injury after various treatments.

Conflict of Interest Statement: S.K. does not have a financial relationship with a commercial entity that has an interest in the subject of this manuscript. H.K. does not have a financial relationship with a commercial entity that has an interest in the subject of this manuscript. Y.N. does not have a financial relationship with a commercial entity that has an interest in the subject of this manuscript. M.F. does not have a financial relationship with a commercial entity that has an interest in the subject of this manuscript. K.N. does not have a financial relationship with a commercial entity that has an interest in the subject of this manuscript. Y.I. does not have a financial relationship with a commercial entity that has an interest in the subject of this manuscript. M.T. does not have a financial relationship with a commercial entity that has an interest in the subject of this manuscript. S.Y. does not have a financial relationship with a commercial entity that has an interest in the subject of this manuscript. K.N. does not have a financial relationship with a commercial entity that has an interest in the subject of thismanuscript. M.S. does not have a financial relationship with a commercial entity that has an interest in the subject of this manuscript. The Japan Thoracic Radiology Group does not have a financial relationship with a commercial entity that has an interest in the subject of this manuscript. H.J. has been an AstraZeneca employee since 2001. Y.I. has been an AstraZeneca employee since 2000. A.A. is a full-time employee of AstraZeneca. C.W. has been a full-time employee at AstraZeneca since 2001 until present and owns shares in the company. T.H. is a full-time R&D scientist at AstraZeneca, UK, and received stock options. F.N. is a full-time employee of AstraZeneca and owns shares in the company.

Acknowledgment: The authors thank the study monitors, nurses, data managers, other support staff, and the patients participating in the study; the external epidemiology advisory board (Kenneth J. Rothman, Jonathan M. Samet, Toshiro Takezaki, Kotaro Ozasa, Masahiko Ando) for their advice and scientific review of study design, conduct, and analysis; Professor Nestor Muller for his expert input into radiologic aspects of ILD diagnosis; all case review board members (including Japan Thoracic Radiology Group members [with *]) individually (Moritaka Suga, Takeshi Johkoh*, Masashi Takahashi*, Yoshiharu Ohno*, Sonoko Nagai, Yoshio Taguchi, Yoshikazu Inoue, Takashi Yana, Masahiko Kusumoto*, Hiroaki Arakawa*, Akinobu Yoshimura, Makoto Nishio, Yuichiro Ohe, Kunihiko Yoshimura, Hiroki Takahashi, Yukihiko Sugiyama, Masahito Ebina, and Fumikazu Sakai*) for their valuable work in blindly reviewing ILD diagnoses, as well as prestudy CT scans for preexisting comorbidities; and all hospitals and clinical investigators who contributed to the data collection in the study (see below). The authors thank Sarah Charlesworth, from Complete Medical Communications, who provided editing assistance funded by AstraZeneca.

Hospitals and principal investigators contributing to the study: National Hospital Organization Hokkaido Cancer Centre (Hiroshi Isobe), Hokkaido University Hospital (Koichi Yamazaki), National Hospital Organization Dohoku National Hospital (Yuka Fujita), Tohoku University Hospital (Akira Inoue), Sendai Kousei Hospital (Shunichi Sugawara), National Cancer Centre Hospital East (Yutaka Nishiwaki), Nippon Medical School Chiba Hokusoh Hospital (Yasushi Ono), Tokyo Medical University Hospital (Masahiro Tsuboi), Nippon Medical School Hospital (Tetsuya Okano), Toho University Omori Medical Centre (Nobuyuki Hamanaka), Toranomon Hospital (Kunihiko Yoshimura), National Hospital Organization Tokyo Hospital (Atsuhisa Tamura), Juntendo University Hospital (Kazuhisa Takahashi), Kyorin University Hospital (Tomoyuki Goya), Tokai University Hospital (Kenji Eguchi), Kitasato University School of Medicine (Noriyuki Masuda), Kanagawa Cardiovascular and Respiratory Centre (Takashi Ogura), Niigata Cancer Centre Hospital (Akira Yokoyama), National Nishi-Niigata Central Hospital (Hiromi Miyao), Toyama University Hospital (Muneharu Maruyama), Kanazawa University Hospital (Kazuo Kasahara), Aichi Hospital, Aichi Cancer Centre (Hiroshi Saito), National Hospital Organization NagoyaMedical Centre (Hideo Saka), Fujita Health University Hospital (Hiroki Sakakibara), Nagoya Ekisaikai Hospital (Masashi Yamamoto), Shiga University of Medical Science Hospital (Noriaki Tezuka), Kyoto Katsura Hospital (Takeshi Hanawa), National Hospital Organization Kyoto Medical Centre (Yoshiyuki Sasaki), Rinku General Medical Centre Municipal Izumisano Hospital (Hisao Uejima), Kinki University, School of Medicine (Kazuhiko Nakagawa), National Hospital Organization Kinki-chuo Chest Medical Centre (Masaaki Kawahara), Osaka City General Hospital (Koji Takeda), Osaka City General Hospital (Hirohito Tada), Osaka City University Hospital (Shinzoh Kudoh), Osaka Prefectural Medical Centre for Respiratory and Allergic Diseases (Kaoru Matsui), Osaka Police Hospital (Kiyoshi Komuta), Toneyama National Hospital (Soichiro Yokota), Kobe City General Hospital (Keisuke Tomii), Hyogo Medical Centre for Adults (Shunichi Negoro), Kobe University Hospital (Yoshihiro Nishimura), Institute of Biomedical Research and Innovation (Nobuyuki Katakami), Tenri Hospital (Yoshio Taguchi), Okayama University Medical and Dental School Hospital (Katsuyuki Kiura), Hiroshima City Hospital (Hidetaka Sumiyoshi), Hiroshima City Hospital (Noritomo Senoo), National Hospital Organization Shikoku Cancer Centre (Tetsu Shinkai), National Hospital Organization Kyushu Cancer Centre (Yukito Ichinose), Fukuoka National Hospital (Akira Motohiro), University of Occupational and Environmental Health (Masamitsu Kido), University of Occupational and Environmental Health (Kenji Sugio), National Hospital Organization Nagasaki Medical Centre (Akitoshi Kinoshita), Kumamoto University Hospital (Mitsuhiro Matsumoto), Kumamoto-Chuo Hospital (Sunao Ushijima), Okinawa National Hospital (Mutsuo Kuba). AT A GLANCE COMMENTARY

Scientific Knowledge on the Subject

Acute interstitial lung disease (ILD) occurs in Japanese patients with non-small cell lung cancer (NSCLC) receiving gefitinib. There is, however, limited knowledge about risk factors for ILD and the incidence of ILD in patients with NSCLC receiving other treatments.

What This Study Adds to the Field

Acute ILD was common in Japanese patients with NSCLC receiving chemotherapy or gefitinib, with higher risk for gefitinib. Age, performance status, smoking, and preexisting chronic ILD were also important risk factors, aiding clinicians in treatment selection.

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Shoji Kudoh1, Harubumi Kato2, Yutaka Nishiwaki3, Masahiro Fukuoka4, Kouichiro Nakata5, Yukito Ichinose6, Masahiro Tsuboi2, Soichiro Yokota7, Kazuhiko Nakagawa4, Moritaka Suga8, Japan Thoracic Radiology Group9*, Haiyi Jiang10, Yohji Itoh10, Alison Armour11, Claire Watkins11, Tim Higenbottam12,13, and Fredrik Nyberg14,15

1Nippon Medical School, Tokyo, Japan; 2Tokyo Medical University Hospital, Tokyo, Japan; 3National Cancer Center Hospital East, Chiba, Japan; 4Kinki University School of Medicine, Osaka, Japan; 5Nakata Clinic, Tokyo, Japan; 6National Kyushu Cancer Center, Fukuoka, Japan; 7Toneyama National Hospital, Osaka, Japan; 8Saiseikai Kumamoto Hospital, Kumamoto, Japan; 9Japan Thoracic Radiology Group, Shiga, Japan; 10AstraZeneca KK, Osaka, Japan; 11AstraZeneca, Macclesfield, Cheshire, United Kingdom; 12AstraZeneca R&D Charnwood, Loughborough, United Kingdom; 13Sheffield University, Sheffield, United Kingdom; 14Epidemiology, AstraZeneca R&D Molndal, Molndal, Sweden; and 15Institute of Environmental Medicine, Karolinska Institute, Stockholm, Sweden

(Received in original form October 11, 2007; accepted in final form March 12, 2008)

Supported by AstraZeneca.

*A list of Japan Thoracic Radiology Group members may be found in the ACKNOWLEDGMENT.

Correspondence and requests for reprints should be addressed to Fredrik Nyberg, M.P.H., M.D., Ph.D., Epidemiology, AstraZeneca R&D Molndal, SE-413 83 Molndal, Sweden. E-mail: [email protected]

This article has an online supplement, which is accessible from this issue’s table of contents at www.atsjournals.org

Am J Respir Crit Care Med Vol 177. pp 1348-1357, 2008

Originally Published in Press as DOI: 10.1164/rccm.200710-1501OC on March 12, 2008

Internet address: www.atsjournals.org

Copyright American Thoracic Society Jun 15, 2008

Originally published by Kudoh, Shoji Kato, Harubumi; Nishiwaki, Yutaka; Fukuoka, Masahiro; Nakata, Kouichiro; Ichinose, Yukito; Tsuboi, Masahiro; Yokota, Soichiro; Nakagawa, Kazuhiko; Suga, Moritaka; Jiang, Haiyi; Itoh, Yohji; Armour, Alison; Watkins, Claire; Higenbottam, Tim; Nyberg, Fredrik.

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