Health Highlights: May 5, 2003

Here are some of the latest health and medical news developments, compiled by editors of The HealthScout News Service:

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FDA Approves Controversial Lung Cancer Drug

The U.S. Food and Drug Administration gave accelerated approval Monday to AstraZeneca’s drug to treat advanced cases of non-small cell lung cancer (NSCLC).

Approval of Iressa came only a few days after the consumer group Public Citizen urged the FDA not to OK the drug, saying it had shown serious side effects and caused a number of deaths in Japan. The Japanese results caused a delay in the approval, but the FDA said they weren’t reason enough to bar the drug’s use as a third-line cancer treatment. That means eligible patients must not have responded to two previous chemotherapy regimens.

Last fall, AstraZeneca revealed that Iressa had been taken by more than 10,000 people in Japan, but that the medication had been implicated in 39 deaths and caused serious cases of lung disease in 125 others. At the same time, in U.S. clinical trials, more than 13 percent of the 216 patients taking Iressa saw their tumors shrink by at least 50 percent, the company says. Nonsmoking women tended to respond to the therapy better than smokers or men.

The FDA’s accelerated approval process allows a drug to be prescribed before its safety and effectiveness are fully understood. The program is implemented when the drug may be used to treat a life-threatening condition that has no proven cure.

Iressa is among a new class of drugs that target only cancer cells and are meant to leave healthy tissue alone. It prevents cancer from sending a signal that spurs healthy cells into over-reproducing, a typical marker of cancer. The drug’s side effects include diarrhea, rash, and acne.

Lung cancer, of which NSCLC accounts for 80 percent of cases, is the leading cause of cancer death in the United States. It’s expected to claim 157,000 lives this year.

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Babies of Obese Women at Risk of Birth Defects: CDC

Women who are obese or significantly overweight are at significantly greater risk of having babies with birth defects, according to government researchers at the U.S. Centers for Disease Control and Prevention.

Babies born to obese mothers are much more likely to suffer from congenital heart problems and neural tube defects like spinal bifida, the scientists say. And the infants’ risk is more than triple the norm of being born with a defect called omphalocele, in which the intestines and other abdominal organs stick out through the navel, reports the Associated Press analysis of the study.

The reasons for the connection are unclear, but the experts speculate nutritional imbalances or a higher incidence of diabetes among the obese women may play a role.

The study appears in Monday’s editions of the journal Pediatrics.

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FDA to Track Diet Aid Reactions

The U.S. Food and Drug Administration will soon launch a new system to track adverse reactions to dietary supplements, The Hartford Courant reports.

But the new rules stop short of requiring supplement manufacturers to report these reactions to the FDA, as other federal health officials and some experts had recommended, the newspaper reports.

The FDA, for its part, says Congress hasn’t given it the authority to require supplement producers to report such reactions. Such legislation is pending on Capitol Hill, the Courant says.

While prescription drugs must be tested for safety and effectiveness before they get the FDA’s blessing, dietary supplements and alternative medicines are much less tightly scrutinized before they are released. That’s what makes the new system of tracking reactions once the products are released so important, FDA officials tell the newspaper.

The diet aid industry has come under fire since February, following the death of a Major League Baseball player who used the diet aid ephedra. The coroner who performed the autopsy on the player said the herbal supplement played a role in his death. The FDA reportedly has more than 100 similar reports in its files.

Supplement sales among Americans nearly doubled from 1994 to 2000 to about $17 billion a year, the Courant reports.

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Boston is the Latest to Go Smokeless

Following the lead of larger cities in California and New York, Boston on Monday became the latest metropolis to declare its indoor workplaces off limits to those who light up. The smoking ban, which imposes fines of up to $1,000, includes the city’s 700 bars, restaurants, and nightclubs, reports the Boston Globe.

Joining Boston on Monday were the Massachusetts communities of Watertown, Saugus and Framingham. And state lawmakers are set begin debate this week on a proposal to ban smoking statewide.

“In the past, being surrounded by smoke was the norm. Now the opposite is true,” John Auerbach, executive director of the Boston Public Health Commission, tells the newspaper.

Not so delighted are many of the city’s bar owners, who say that business is already hurt by the weak economy and that the ban’s timing isn’t exactly opportune. Laments one, “We’re in the hospitality business, and we’re supposed to make the customers happy. Now we have to ask them to do something they won’t enjoy.”

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Mountain Climber Cuts Off Arm to Free Himself

An expert outdoorsman from Colorado was to undergo surgery Monday after he was forced to use a pocketknife to cut off his arm, which had become trapped by a boulder while he was climbing in Utah.

Aron Ralston, 27, of Aspen, became trapped April 26 while mountain climbing in Canyonlands National Park and the boulder shifted onto his arm. After spending days trying to budge the boulder and running out of water, Ralston used his pocketknife Thursday to cut off his arm, the Associated Press reports.

He remains hospitalized in fair condition. Surgeons say they hope to fit him with a prosthetic arm, the AP says.

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Separated Twin has Successful Follow-Up Surgery

Surgeons in Guatemala have inserted a valve to ease pressure on the brain of a nearly 2-year-old girl who was born conjoined and then successfully separated from her twin sister.

The three-hour surgery on Maria de Teresa was termed a success by her doctors; the valve was inserted to replace another one that had become infected, the Associated Press reports.

The girls were born July 25, 2001, to a poor family in rural Guatemala. Charitable groups in that country and the United States were able to bring the conjoined girls to Mattel Children’s Hospital at the University of California, Los Angeles, where they were successfully separated last August in a 23-hour operation, the AP says.

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