New data obtained by NPR on the painkiller Vioxx shows that all patients who took the drug were at increased risk for heart attack, stroke and other complications, even those who took it for short periods of time. Some 20 million Americans are estimated to have taken Vioxx before it was withdrawn in 2004.
The new data are contained in a confidential 107-page report on a four-year study of Vioxx patients. Merck gave the report to the Food and Drug Administration (FDA) last week.
Experts who have reviewed it for NPR say it shows that patients were at higher risk of heart problems and strokes almost as soon as they started taking Vioxx.
The company says only patients who took the drug for 18 months or more were at risk from Vioxx.
The experts also say the new information shows the risk from Vioxx persists for at least a year after patients stop taking Vioxx. Merck disagrees.
Merck faces thousands of product liability lawsuits from former Vioxx patients. — Snigdha Prakash
Bird Flu Deaths of Indonesian Family Raises Concern
May 18, 2006 — The World Health Organization (WHO) confirms that at least six members of an Indonesian family have died of bird flu. That's the largest cluster of cases so far.
The family cluster occurred on the island of Sumatra. On April 27, a 40-year-old woman developed flu symptoms. Two days later she attended a family gathering. She later died of presumed bird flu. Her two teenage sons, sister and daughter also died. The WHO says no tissue samples were available from the first case. But the other four deaths are now confirmed as bird flu cases. Tests are pending on several other family members.
It's not known how the virus was transmitted. All the infections could have been from a sick chicken or some environmental exposure. Or the virus could have passed from person to person. That's happened in only one or two other known instances so far.
WHO is reporting another Indonesian death from bird flu unconnected to the family cluster. — Richard Knox
FDA Panel Considers Cervical Cancer Vaccine
May 18, 2006 — An advisory committee to the Food and Drug Administration is considering whether to recommend that the FDA approve a vaccine against cervical cancer.
Cervical cancers are caused by a family of sexually transmitted microbes called human papilloma virus, or HPV. Pharmaceutical manufacturer Merck & Co. has developed a vaccine that protects against four of the most carcinogenic HPVs.
The FDA advisory committee will consider tests on more than 20,000 women that show the vaccine as being safe and effective. The committee will vote Thursday on whether to recommend the vaccine.
The FDA's decision is due by June 9. Then it's likely to be considered by another federal committee, the Advisory Committee on Immunization Practices, which meets at the end of June. That committee is likely to decide whether the vaccine should be given to children before they become sexually active. — Joanne Silberner
Vaccine Campaigns Recommended During Mumps Outbreaks
May 17, 2006 — A government panel recommends stepping up mumps vaccination during outbreaks like the one currently happening in the Midwest.
In a normal year, the Centers for Disease Control and Prevention (CDC) records fewer than 300 cases of mumps. But since November, more than 3,200 people have come down with mumps in a dozen Midwestern states. That's a sign many people aren't immune to mumps.
A CDC advisory panel says when future outbreaks occur, everybody in affected communities should get vaccinated against mumps unless lab tests show they're already immune.
The panel says health-care providers should strongly consider giving workers born after 1957 two doses of vaccine unless the workers can prove they're immune. People who work in colleges and universities should also get two shots.
People born before 1957 are generally immune to mumps because they were exposed to the virus in childhood. — Richard Knox
Medicare Drug-Plan Penalties May Be Waived
May 15, 2006 — Congress could act this week on legislation to waive penalties for those who missed Monday's deadline to enroll in a Medicare prescription drug plan.
Backers of the program, including President Bush, managed to hold back efforts to extend the May 15 deadline to sign up for drug benefits for 2006. But now many of those same backers want to waive the penalty for those who failed to sign up.
The law calls for higher premiums — one percent per month — for every month an eligible enrollee delays signing up. Legislation introduced in the House and Senate would cancel those penalties for this year only, giving several million people a clean slate when enrollment for 2007 starts this November. — Julie Rovner
Contact-Lens Solution Withdrawn Worldwide
May 15, 2006 — A contact lens solution associated with fungal eye infections in the United States and Asia has been pulled from the market worldwide.
Last month, Bausch & Lomb removed its MoistureLoc contact lens solution from store shelves in the United States. Now the company says it will permanently end sales of the product globally.
The move comes several days after Bausch & Lomb met with officials from the Food and Drug Administration (FDA) to discuss the association between MoistureLoc solution and eye infections caused by a fungus called Fusarium.
Federal agencies are investigating more than 100 Fusarium infections, which can cause blindness. FDA officials say there's no evidence that MoistureLoc products were contaminated with Fusarium. But they say the products can increase the risk that a Fusarium infection will occur. — Jon Hamilton
Millions of Seniors May Miss Medicare Rx Deadline
May 15, 2006 — Medicare beneficiaries have until midnight to sign up for drug coverage, and millions who are eligible have yet to sign up. Those who miss the deadline will have to wait until the next open enrollment period in November. Most will also have to pay a penalty if they join late, which will make their premiums higher for life.
Several groups of seniors and people with disabilities don't have to act today, however. They include those who have incomes below about $14,000 a year for individuals or $19,000 for a couple. They can continue to apply for extra financial help.
Those who have private coverage as good as Medicare's don't have to act, either. And seniors who are still employed will get to enroll whenever they retire, without penalty. — Julie Rovner