Health Highlights: April 24, 2005
E-mails Suggest Merck May Have Known of Vioxx's Risks: Report Medicare to Restructure Appeals Hearings: Report Antibody Cures Mice Infected With West Nile Virus: Study Women's Groups Ask for Review of FDA Breast Implant Vote
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
E-mails Suggest Merck May Have Known of Vioxx's Risks: Report
Did Merck officials know about the heart risks posed by its now-defunct painkilling drug Vioxx as far back as five years ago?
The New York Times reported Sunday that in 2000, Merck overruled one of its own scientists after he suggested that a 73-year-old female patient in a Vioxx clinical trial had probably died of a heart attack.
In an e-mail exchange concerning Vioxx, a top Merck scientist repeatedly encouraged the researcher to change his views about the death "so that we don't raise concerns." In later reports to the U.S. Food and Drug Administration and in a paper published in 2003, the company labeled the cause of death as "unknown," the newspaper said.
The discussion of the woman's death appears in several previously undisclosed Merck records, including e-mails from Dr. Edward M. Scolnick, Merck's senior scientist from 1985 to 2002, and Dr. Alise S. Reicin, a vice president for clinical research. The messages point to Merck's concerns about data contradicting its view that Vioxx was safe, the Times said.
When Vioxx was pulled from the market last September, Merck officials said they had only recently learned that the drug posed a risk of heart attack and stroke. At least 4,600 people or their survivors are suing the drug company, saying Vioxx -- a member of a class of drugs called cox-2 inhibitors -- caused their heart attacks or strokes. The e-mails and other internal Merck documents, including the report of the woman's death, were given to the Times by an unnamed source working with plaintiffs, the newspaper said.
A lawyer for Merck told the Times that the company had disclosed all information from clinical trials about Vioxx to the FDA. And Scolnick's e-mails "merely reflected his concern that the FDA weigh Vioxx's benefits and risks fairly. The e-mail discussion between the Merck scientists reflected an honest scientific debate over the cause of the woman's death," the newspaper reported, paraphrasing the lawyer.
Earlier this month, another cox-2 drug, Bextra, was withdrawn from the market for the same cardiovascular concerns. A third cox-2, Celebrex, remains available to U.S. consumers, but the FDA has mandated that it carry a strong "black box" warning label indicating the potential for long-term heart risks.
Medicare to Restructure Appeals Hearings: Report
Medicare beneficiaries will find it harder to obtain hearings in person to appeal government denials of claims for home care, nursing-home services, prescription drugs and other treatments, The New York Times reported Sunday.
Traditionally, more than 140 Social Security offices around the country hosted the appeals hearings. In July, the U.S. Department of Health and Human Services will take over that role, and agency officials said all judges would be located in just four sites -- Cleveland; Miami; Arlington, Va.; and Irvine, Calif., the Times said.
To compensate for the fewer sites, most hearings will be held with videoconference equipment or by telephone, Medicare officials told the newspaper. A beneficiary who wants to appear in person before a judge must show that "special or extraordinary circumstances exist," the new rules state.
However, an individual who insists on a face-to-face hearing would lose the right to a decision within 90 days, as currently stipulated by law, the paper said.
The Department of Health and Human Services said the use of videoconference equipment would enable judges to "complete more cases" within the 90-day deadline, because they would not have to travel to remote locations, the newspaper said.
But lawmakers, judges, consumer groups and lawyers for beneficiaries said the four hearing offices weren't enough, the Times said.
Antibody Cures Mice Infected With West Nile Virus: Study
A newly developed antibody can cure mice infected with the West Nile virus, researchers at Washington University School of Medicine in St. Louis reported Sunday. If more studies confirm the effectiveness and safety of the antibody, it could become one of the first so-called monoclonal antibodies used as a treatment for an infectious disease, the scientists said.
In a strain of mice that normally has about a 10 percent survival rate after West Nile infection, the scientists found that single doses of the antibodies given soon after infection could boost survival rates to 90 percent or more, the researchers said.
"To our knowledge, these experiments are the first successful demonstration of the use of a humanized antibody as a post-exposure therapy against a viral disease," said senior investigator Dr. Michael Diamond, assistant professor of molecular microbiology, pathology and immunology and of medicine. "They also suggest antibody-based therapeutics may have a broader utility against other infectious diseases."
The findings appear in the May issue of Nature Medicine.
Women's Groups Ask for Review of FDA Breast Implant Vote
The National Organization for Women and five other women's groups have asked Congress to investigate the U.S. Food and Drug Administration's recent review of silicone-gel breast implants. The groups contend that an FDA e-mail suggests agency officials were under outside pressure to approve the controversial devices, the Associated Press reported.
Inamed Corp. and Mentor Corp. are seeking an end to a 13-year FDA ban on most uses of the implants, which many women blame for a variety of health problems caused by leaking silicone. Earlier this month, an FDA advisory panel recommended that Mentor's implants be allowed back on the market under the certain conditions, but Inamed's products required more review. The FDA is weighing that advice as it completes its own review, the AP said.
A month before the advisory panel met, an aide to FDA Acting Commissioner Lester Crawford e-mailed the agency's medical device chief an unsigned "Update on Silicone Gel Breast Implants" that contended the devices were safe and that criticism of them amounted to "junk science," the AP said.
Responding in e-mail to the aide, FDA medical device chief Dr. Daniel Schultz wrote, "The truth lies somewhere in between this very positive perspective and the totally negative viewpoint of the other side," the news service said.
The women's groups sent copies of the e-mail to members of Congress on Thursday, asking that it and other complaints about silicone implants be investigated. "This e-mail implies the FDA had a predetermined interest in approval even before the FDA advisory panel met," they wrote.
A Senate panel -- the Health, Education, Labor and Pensions Committee, which oversees the FDA -- is reviewing the groups' request, a spokesman said.
FDA spokeswoman Julie Zawisza told the AP that the e-mailed "update" was not an FDA document and did not represent the agency's position. "We receive a lot of input from a lot of parties," she said.