News in brief - Oct. 18, 2004

Manufacturer voluntarily withdraws popular arthritis drug - Studies find more community-acquired drug-resistant infections - Dietary supplements yield health benefits and cost savings - Firm gets grant for avian flu vaccine

Manufacturer voluntarily withdraws popular arthritis drug

Merck & Co. Inc, announced last month that rofecoxib (Vioxx) would be withdrawn voluntarily from the market because of studies linking the pain reliever to an increased risk of heart attack and other cardiovascular events.

"We are taking this action because we believe it best serves the interests of patients," said Raymond V. Gilmartin, chief executive officer of the company.

Merck's decision was based on the results of the Adenomatous Polyp Prevention on Vioxx trial, which found no increased risk in the first 18 months of the study but did at the three-year point. This discovery also ended the study early.

The drug has long been dogged by questions of cardiovascular safety. In its phase III studies before approval, no problems emerged, but other studies suggested otherwise. Most recently, a retrospective analysis of Kaiser Permanente's records presented in August at the International Society for Pharmacoepidemiology Conference in Bordeaux, France, found that the drug could triple the risk of heart attack.

The Food and Drug Administration advised patients to consult with physicians about other medications.

Studies find more community-acquired drug-resistant infections

Physicians are seeing more infections acquired outside of the hospital setting that are impervious to antibiotics, according to two studies presented at this month's annual meeting of the Infectious Diseases Society of America in Boston.

"This crisis has the potential to touch us all because drug-resistant infections can strike anyone -- young or old, healthy or chronically ill," said Joseph R. Dalovisio, MD, IDSA president.

One study found that the number of methicillin-resistant Staphylococcus aureus infections caught by children in the community and treated at one hospital in Corpus Christi, Texas increased from nine in 1999 to 459 in 2003. Another study out of Los Angeles found that 14 cases of necrotizing fascitis could be blamed on the bug, and this was a new clinical entity.

"This is about as serious an infectious disease emergency as you can get," said Loren G. Miller, MD, MPH, lead author of the Los Angeles study and assistant professor at the David Geffen School of Medicine at the University of California, Los Angeles.

Dietary supplements yield health benefits and cost savings

Five dietary supplements, calcium, folic acid, omega-3-fatty acids, glucosamine and saw palmetto, showed health benefits and cost savings in a study commissioned by the Dietary Supplement Education Alliance and done by The Lewin Group, a national health care consulting firm.

A review of the available literature revealed that there would be a savings of nearly $14 billion in health care costs because of a reduced number of hip fractures among those older than 65 if that group consumed 1,200 mg of calcium with vitamin D each day for five years. Approximately 734,000 hip fractures could be avoided over the five-year period studied, 2004-09, according to the report. The group also found that if 10.5 million women of childbearing age began taking 400 micrograms of folic acid daily, approximately 600 fewer babies would be born with neural tube defects per year, saving as much as $1.3 billion in medical costs over the next five years.

The Lewin review also found evidence that omega-3 fatty acids can help reduce deaths from cardiovascular disease; that glucosamine has an anti-inflammatory effect and is believed to help in the repair and maintenance of cartilage; and that saw palmetto might alleviate the symptoms of benign prostatic hyperplasia.

Firm gets grant for avian flu vaccine

Taking the potential threat of avian flu very seriously, the Dept. of Health and Human Services awarded a $13 million contract to Aventis Pasteur Inc. to manufacture and store 2 million doses of avian influenza vaccine.

The vaccine will match the H5N1 influenza virus that has killed 29 people in Thailand and Vietnam this year, said HHS. If a pandemic of avian influenza of the same strain should occur in humans, the vaccine would be used to protect laboratory workers, public health personnel and, if necessary, the general public.

HHS also awarded a contract to Chiron Corp. to produce an investigational vaccine based on the H9N2 strain of avian influenza virus that has also infected humans. Both strains have the potential to trigger a modern-day pandemic.

Meanwhile, public health authorities were closely monitoring developments in Thailand where there was a suspected case of human-to-human transmission of the virus. Such a transmission, as opposed to bird-to-human, is thought to be the first step necessary to spark a flu pandemic.