Health Headlines - June 1

Merck Admits Vioxx Data Error

Vioxx-maker Merck & Co. acknowledged Tuesday that it had erred when it reported early last year that a crucial statistical test showed the pain killer caused heart problems only after 18 months of continuous use.

The time issue is critical, because the company has taken the position in court that Vioxx can cause heart problems only if used continuously for more than 18 months, The New York Times reported. Merck had based the 18-month theory largely on data from a clinical trial, called Approve, in which the company tracked 2,600 patients to see whether Vioxx could prevent colon polyps. The company has now acknowledged that the statistical analysis of that test does not support the 18-month theory.

Nevertheless, Merck said it stood by the overall findings it reported in 2005 and published in The New England Journal of Medicine, including its conclusion that Vioxx's heart risks were not apparent if patients took the drug for less than 18 months. Outside scientists, however, said the company's admission, coupled with other clinical trials tracking real-world Vioxx use, supports critics' claims that Vioxx caused heart problems quickly.

An estimated 20 million Americans had taken Vioxx, which was withdrawn from the market in September 2004. Merck still faces more than 11,000 patient lawsuits.

U.N. Chief Chides World Leaders Over AIDS Fight

U.N. Secretary-General Kofi Annan warned leaders joining a three-day meeting in New York City Wednesday that the world has fallen far short of its promises five years ago to fight HIV/AIDS, and to find new ways to tackle the virus.

The United Nations hopes the high-level meeting on AIDS will bring a surge of new funding, after a report warned that the epidemic continues to spread, efforts to fight AIDS among women and children had failed and that young people still have little understanding of the disease, according to the Associated Press. The report also said that $20 billion will be needed each year to fight AIDS by 2008.

Several heads of state and dozens of government officials will seek to craft a document that charts a course to provide universal access for AIDS prevention and treatment by 2010, the AP reported.

The 25-year-old AIDS epidemic has claimed 25 million lives and shows no signs of slowing down, a United Nations agency reported earlier this week.

FDA Approves Growth Hormone

In a long-awaited decision, the U.S. Food and Drug Administration approved on Tuesday a new human growth product but stressed that its action doesn't set a precedent for other biological medicines.

Made using recombinant DNA technology, Omnitrope (somatropin) is used to treat growth disorders in children and adults. It is manufactured by Sandoz, a division of Novartis, which first applied for approval of the product in July 2003. The FDA had said it was unable to reach a decision sooner because of scientific and legal issues, and it later held public meetings to discuss the approval process for follow-on products, according to the Associated Press.

Omnitrope is considered a "follow-on" product because it is so similar to other products already approved that previous safety data could be considered in approving the new version. The drug has previously been approved for use in Australia and in Europe.

Patients Taking Blood Thinners Need Extra Help: Survey

Patients taking prescription blood thinners to prevent serious illness -- about 4 million Americans -- require more help managing these volatile medications and show a disconnect between knowledge of safe practices and use, according to survey data released Tuesday by the SOS Rx Coalition.

The results suggest that much more patient education is needed, as well as improved communication among health-care providers, caregivers and patients themselves. The drugs are often difficult to manage, require frequent monitoring, and can interact dangerously with other medications, herbal supplements, vitamins, and foods, the survey authors said.

SOS Rx is a collaborative coalition, put together by the National Consumers League, of more than 80 participating organizations dedicated to promoting outpatient medication safety. The patients' survey was just one of three online pollings within the United States conducted by Harris Interactive with patients, caregivers, and physicians about the use of oral anticoagulants on behalf of the NCL. Complete survey data, including caregivers' and physicians' perspectives, as well as focus group research and background, are available at http://www.mybloodthinner.org.

Indonesian Boy Latest Bird Flu Victim

Bird flu killed a 15-year-old Indonesian boy from the West Java town of Tasikmalaya, a health official confirmed Wednesday.

The latest victim, the third from the province, was rushed to a hospital in the city of Bandung on Monday and died a day later, Hariyadi Wibisono, director of communicable disease control at the Ministry of Health, told the Associated Press. Last week, a 10-year-old girl and her 18-year-old brother who lived in another village died of the disease. Sick and dead birds were reported near their home.

Still puzzled about how the disease spreads so quickly and how wild birds have helped disperse the H5N1 virus, more than 300 scientists and animal experts met in Rome Tuesday to examine these and other questions at a two-day conference organized by the U.N. Food and Agriculture Organization and the Paris-based World Organization for Aniabdo.

Lung Cancer's Gender Differences Under Study

Two new studies are exploring whether estrogen is a key player in how lung cancer acts differently in women than in men and might also be used to fight the No. 1 cancer killer.

One study at the University of Pittsburgh and the University of California, Los Angeles, will test whether women fare better given the anti-estrogen drug Faslodex on top of the lung cancer drug Tarceva. Their research indicates that estrogen may act as a fuel for lung tumors -- just like it does for many breast tumors -- and that blocking estrogen with the same drugs that breast cancer patients use might also work in the lungs, the Associated Press reported.

The other study, involving 600 women around the country, tests an experimental drug called Xyotax that, conversely, may need estrogen to work. Preliminary research shows that some 45 percent of women given Xyotax survived lung cancer for a year, compared with just 25 percent of women given standard drugs or men given either regimen. Women with the most estrogen in their blood fared best.

Expeerts estimate that lung cancer will claim more than 162,000 lives this year, 72,000 of them women -- more than are killed by breast, ovarian, uterine and cervical cancers combined.