Ban on Mercury-Based Agent
May Hurt Efforts Against Bird Flu
State laws forbidding the use of a mercury-based vaccine preservative could threaten efforts to protect the population against an avian flu pandemic, health officials said yesterday.
They said more than 20 U.S. states have laws pending that would limit or forbid the use of thimerosal. Six states have enacted legislation that takes effect as soon as January.
Several speakers at a meeting of the National Vaccine Advisory Committee said the laws would be an impediment to efforts to speed delivery of vaccines should the H5N1 avian flu, or any other virus, mutate into a pandemic strain.
"The states that passed these laws have just introduced a huge barrier to influenza programs," said Mary Beth Koslap-Petraco, coordinator of child health for the Suffolk County Department of Health Services in New York.
Studies have shown there is no association between vaccines of any type and neurological diseases such as autism.
Abortion Pill Is Not Considered
Risky Enough to Revoke Approval
The deaths of four women who used Danco Laboratories' RU-486 abortion pill were caused by toxic shock from severe bacterial infections, the Centers for Disease Control and Prevention found in a study.
But the four deaths are too "rare" an event to lead regulators to revoke approval of the drug, sold as Mifeprex, according to an editorial in today's New England Journal of Medicine that accompanies the study.
Mifeprex has been used to induce at least 460,000 abortions since the Food and Drug Administration approved it five years ago, according to an estimate on Danco's Web site. The drug is approved to terminate pregnancies in the first 49 days.
"What these four cases show is that medical abortion has a potential risk of severe infection, which people already know about surgical abortion and have always known is a risk in childbirth," said Marc Fischer, a CDC researcher who was lead author of the study.
The CDC reviewed the cases at the FDA's request. The agency added warnings about the risk of infection to RU-486's label in November 2004, after the first two deaths were reported.
All Types of Antipsychotic Drugs
May Boost Seniors' Risk of Death
Older antipsychotic drugs are no safer and might even be worse for the elderly than newer ones that the government warned about earlier this year -- both types raise the risk of death, a study suggests.
The Food and Drug Administration asked drugmakers in April to add warnings to the labels of newer antipsychotics because studies showed the drugs nearly doubled the risk of death for older patients with dementia.
These drugs are widely used to treat the aggressive behavior, delusions and hallucinations sometimes experienced by those with dementia, including Alzheimer's disease.
Researchers at Brigham and Women's Hospital in Boston worried that doctors would switch elderly patients to older medications such as Thorazine and Haldol.
The researchers analyzed prescription and death records for nearly 23,000 older patients who took antipsychotics. They found that 18 percent of patients on the old drugs died in the first six months, compared with 15 percent on the new drugs.
"If confirmed, our results suggest that conventional anti-psychotic medications should be included in the FDA's public health advisory," the researchers said. Their findings appear in today's New England Journal of Medicine.
Temporary Medicare Drug Card
Prompts Flood of Complaints
Medicare has received thousands of complaints about its temporary drug discount card, according to a congressional report released yesterday as the agency grapples with new gripes about the card's replacement program.
The Government Accountability Office said the insurance program for the elderly and the disabled received 26,000 complaints and formal grievances about the temporary cards. It took 23 actions against 15 insurers and other card sponsors.
Mark B. McClellan, administrator of the Centers for Medicare and Medicaid Services, criticized the report, saying investigators did not take the agency's full enforcement abilities into account and focused "on a snapshot . . . rather than the process."
The center also said it has received about 100 complaints about the marketing of the new plans by insurance companies and agents.
-- From News Services