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Vioxx, Bextra, Accutane, Crestor, Meridia, Serevent ... Congress Investigates Drug Safety and The FDA

Posted on: Wednesday, 24 November 2004, 06:00 CST

NEW YORK, Nov. 24 /PRNewswire/ -- The headline of the New York Times on November 14, 2004 perhaps said it best. "Despite Warnings, Drug Giant Took Long Path to Vioxx Recall." The article describes Merck's decision in May of 2000 to directly test "a disturbing possibility that Vioxx, a painkiller, might pose a heart risk." The study was rejected by executives at the company.

With the blockbuster drug Vioxx being pulled from the market, and now, with several other widely-written prescription drugs coming under closer scrutiny by the government, drug safety has become -- and rightly so -- a major focus for all of us.

Scott Hendler of HendlerLaw in Austin, Texas and New York, New York (http://www.hendlerlaw.com/ ) practices pharmaceutical litigation and closely monitors the pharmaceutical and over-the-counter drug industries. And now with what may become the largest investigations of drug company and FDA testing methods in US history, Hendler passes along what he tells his friends, his own family members and his clients.

For more than a decade, HendlerLaw, an international plaintiff's trial firm, has devoted its practice to helping people who have been victimized by corporate misconduct, specializing in toxic injury and pharmaceutical drug litigation. With offices in Austin, TX and New York, NY, the firm provides professional legal representation and offers a range of support services to clients and their families as they seek accountability for their injuries and cope with their illnesses. For more information, please visit http://www.hendlerlaw.com/ .

10 Things You Need to Know About Prescription Drugs

and the Pharmaceutical Industry

From Scott Handler of Hendler Law

1. Most of them do much more good than harm. They save millions of

people everyday, substantially improve quality of life and help

prolong life expectancy.

2. No drug is completely safe. All have potential side effects.

Doctors prescribe a medication when they ascertain that the benefits

of its use will exceed the potential risks. And doctors understand

much less about the risks than people tend to think -- their primary

sources of information about drugs are the drug companies themselves!

3. The FDA does not actually test any drugs. They only review the

results of clinical trials conducted and submitted by the

pharmaceutical company seeking approval for the drug.

4. The FDA's drug approval process is funded in large part by the drug

companies themselves. User fees were introduced in the early 1990s

to help expedite the drug approval process (reducing it from an

average of 30 to 15 months). However it raises the question of who

the FDA is truly serving -- the people of the United States or the

pharmaceutical companies?

5. The long-term safety of drugs is not established before they are put

on the market. And this is true despite the fact that so many drugs

are used daily to treat chronic conditions such as high cholesterol,

diabetes and Alzheimer's.

6. Drugs are frequently marketed and prescribed for medical problems

they were not approved for and have never been proven to be effective

(or safe) in treating. This practice is called "off-label"

prescribing.

7. "Natural" products and herbal remedies are not always safe

alternatives to prescription drugs. This industry is not regulated

by the FDA; therefore while many of these products may be beneficial,

few have been clinically tested for efficacy or safety, and drug

interactions are unknown. Reports of adverse events from these

products are now appearing regularly in the medical journals.

8. Only a small fraction of drugs represent any improvement over

products already on the market -- although they are marketed as

"breakthrough" drugs. The substantial premium being charged for

these products is not a function of higher quality, but represents

an attempt to maximize profits while patents are still in effect.

9. The pharmaceutical industry has the most powerful lobby in

Washington. There are more drug industry lobbyists in Washington

than there are elected representatives in Congress.

10. Although the pharmaceutical industry leads the public to believe that

high prices are necessary to support research and development

efforts, they actually spend more on marketing than on researching

drugs. The truth is that the pharmaceutical industry is more

profitable than any other industry -- by a considerable margin.

Tips for Drug Safety

From Scott Hendler of HendlerLaw

DOS DON'TS

Ask your doctor. Always ask your If it ain't broke, don't fix it.

doctor if the drug he is prescribing If you're on an established

is new on the market. If so, ask if medication that's working

there are older (5 years+) products for you, don't switch to the

available (they will likely be less latest "breakthrough" product.

expensive too!). Ask if he is aware Remember, drugs are not tested

of any potential safety issues and for long-term safety before

side effects. Also find out if he or they're put on the market.

she accepts gifts or payment from any Also remember that very few new

of the pharmaceutical companies. drugs represent any improvement

over what's already out there.

Be a tough customer. If you're not Don't be a guinea pig. Not only

satisfied with the answers you're are drugs put on the market

getting from your doctor, find a after limited testing, they are

new one. Ask friends for commonly prescribed for

recommendations, check the doctor's conditions they have never been

credentials and ask for references. approved or tested for at all!

During the interview, find out how This practice, called "off-

they research new drugs and their label" prescribing, is used by

general approach to prescribing drugs. drug companies to create bigger

Also ask whether or not they accept markets for their products.

gifts or money from any of the drug Make sure any drug you take has

companies. Don't be afraid to ask been "indicated" or approved

tough questions -- your health is by the FDA for the specific

at issue and you need to be your ailment in question (read the

own best advocate! prescription information, go to

http://www.fda.gov/ or visit the drug's

website to find approved uses).

Be a good patient. Make sure your Don't expect a pill for

doctor is aware of all the everything. Americans are

prescription drugs and herbal heavily over-prescribed drugs.

remedies you're taking. Also make Because of all the drug

sure he or she knows about you and advertising on TV we think

your family's medical history. Take there is a quick fix for

your medicine exactly as prescribed everything and doctors feel

and don't hesitate to call your under pressure to send us away

doctor if you begin to experience with a prescription. But the

side effects. best remedy for a cold virus is

still to drink lots of fluids

and get plenty of rest!

Do your homework. There are many Don't play doctor. Never share

resources for researching drugs: your prescriptions with others

- The FDA http://www.fda.gov/ or accept a pharmaceutical drug

- Public Citizen's from someone. This happens more

http://www.publiccitizen.org/ - than you think especially with

(check the Health Resource Group) painkillers; however giving

- http://www.worstpills.org/ someone a narcotic for their

For more, just do a search on headache is a whole different

your favorite search engine (if a ballgame than giving them

bunch of law firms appear, you'll a couple of aspirin.

know there are problems!)

Focus on prevention. Of course, Don't be careless. It goes

the best way to avoid unsafe without saying -- but we're

drugs is to stay healthy so you saying it anyway -- keep

won't need them. You know the your medications safely

drill -- exercise, eat well, get out of reach of young children

plenty of rest and try to avoid and protected from your

stress. teenagers, and discard any

unused portions immediately.

For more information, please call Amy Krakow 212.699.9024.

HendlerLaw

CONTACT: Amy Krakow, +1-212-699-9024, for HendlerLaw

Web site: http://www.hendlerlaw.com/http://www.fda.gov/http://www.publiccitizen.org/http://www.worstpills.org/

Source: PRNewswire

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