Health Highlights: Dec. 16, 2004
FDA Issues Warning on Pesticides Found in Ginseng Woman Reportedly Died From AIDS Drug During Government Testing FDA Scientists Felt Pressure to Approve Drugs: Report Money Earmarked for Kids' Vaccines Being Used for Adults Sleeping Pill Approved for Longer-Term Use
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
FDA Issues Warning on Pesticides Found in Ginseng
The U.S. Food and Drug Administration has issued a nationwide warning after having discovered residue of untested pesticides in ginseng imported by a New Jersey firm
The FDA says U.S. marshals seized a quantity of ginseng from FCC Products Inc. of Livingston, N.J., and found residue from the chemicals procymidone and quintozene. And while the agency says the distribution was probably small, it issued the nationwide alert for anyone who may have bought the ginseng from the New Jersey company because the chemicals haven't been officially tested for how well they're tolerated by humans.
"A raw agricultural commodity or a processed food or feed is deemed to be unsafe and adulterated, and subject to FDA enforcement action, if a pesticide chemical residue for which no tolerance has been set is present in food," the FDA said in a statement.
Ginseng is an herbal root, usually from Asia, that is often used to increase energy levels. It is classified as a food supplement and not usually subject to FDA regulations.
Woman Reportedly Died From AIDS Drug During Government Testing
A pregnant woman enrolled in government-run clinical trials died last year when doctors continued to give her an experimental AIDS regimen despite signs of liver failure, the Associated Press reported Thursday.
The therapy tested on 33-year-old Joyce Ann Hafford of Memphis, Tenn. included the antiretroviral drug nevirapine. Used since the early 1990s, the drug could cause lethal liver problems over time, which the government had warned about over the last four years, the AP reported.
Hafford was taking the drug in an attempt to protect her soon-to-be-born son, Sterling, from acquiring the HIV virus at birth.
NIH officials now acknowledge that the drug most likely caused her death, but told the wire service that disclosure of this information to family members is usually left to the doctors who treat such patients. Family memmbers claim they were never told the reason for her death.
The NIH says Hafford should have signed a 15-page consent form that specifically warned of the possibility of liver failure. Her family says she didn't know of any such warning, while the AP said the disclosure document contained page after page of complex medical terms like "hypersensitivity reactions."
The AP this week has released several reports on nevirapine, alleging that the government continued to push for the drug's use both in the United States and abroad, despite experts' growing concerns that it might be unsafe.
FDA Scientists Felt Pressure to Approve Drugs: Report
Nearly 20 percent of U.S. Food and Drug Administration scientists polled two years ago said they had been pressured to approve new drugs, despite concerns about the medications' safety, the Washington Post reported Thursday.
The 2002 survey of almost 400 FDA scientists also found that more than one-third of respondents weren't confident about the agency's ability to adequately assess the safety of drugs pending approval, the newspaper said.
And once drugs were already on the market, just 34 percent of those polled were completely or mostly confident of the agency's ability to monitor the medication's safety, the survey found.
The survey was conducted by the inspector general of the FDA's parent agency, the U.S. Department of Health and Human Services. It appeared to support the allegations of FDA drug reviewer Dr. David Graham, who in testifying about the recent withdrawal of the painkiller Vioxx told Congress that the FDA wasn't able to keep some drugs that appeared to be unsafe from the market. Graham also alleged that FDA reviewers were intimidated into voicing approval for medications, despite their reservations, the Post said.
Only a portion of the survey was made public last year. The entire survey was to be released Thursday by two public interest groups that obtained it under the Freedom of Information Act, the newspaper said.
Money Earmarked for Kids' Vaccines Being Used for Adults
The U.S. government is diverting money budgeted for vaccinating children to pay for experimental flu vaccines for adults, The New York Times reported Thursday.
Given this year's flu vaccine shortage, outgoing Secretary of Health and Human Services Tommy Thompson announced last week that the federal government had secured up to 4 million emergency doses from the British pharmaceutical giant GlaxoSmithKline. But the inoculations, produced at a plant in Germany, are not approved for use in the United States and thus must be treated as experimental.
To pay for testing of these experimental doses, the government is dipping into a $220 million grant program to provide routine vaccines for children who are just above the Medicaid threshold to receive vaccines for free, the Times said.
While federal officials cited by the newspaper said the experimental vaccines were a necessary precaution against a possible flu outbreak, some state officials decried the practice of protecting older Americans at the expense of youngsters.
"We should not be pitting vaccines for children against vaccines for adults," Washington state Secretary of Health Mary Selecky told the Times.
Sleeping Pill Approved for Longer-Term Use
Current sleeping pills shouldn't be used for more than seven to 10 days, the U.S. Food and Drug Administration recommends, citing the possibility that their effects could wear off or that the drugs could become addictive.
But the agency's approval Wednesday of the Sepracor drug Lunesta could change that. Patients who took the drug for six months during clinical trials reported no loss of effectiveness and few signs of addictive side effects, The New York Times reported.
The exact wording of the product's label hadn't been made public at press time, the newspaper said, so it was unclear how far the agency would go in relaxing the usual seven-to-10-day recommendation.
In other action, the FDA also approved the Schering-Plough nasal spray Nasonex to treat nasal polyps. The company said it was the first inhaled steroid approved for this use in the United States. Nasal polyps, affecting up to 4 percent of the population, are non-cancerous growths that can obstruct breathing. Nasonex was first approved in 1997 to treat seasonal allergy symptoms.
The agency said it also approved the Amgen intravenous drug Kepivance (palifermin) to prevent mucositis, a common side effect among blood cancer patients undergoing chemotherapy before bone marrow transplants. Patients with mucositis, characterized by painful sores and ulcers in the lining of the mouth, often have trouble eating, drinking, and swallowing.