Health Highlights: Dec. 19, 2004
Pfizer Insists Celebrex Will Stay on Market Pentagon Wants to Resume Anthrax Shots FDA Criticized Over Lack of Leadership Possible Bird Flu Cases in Japan Lung Cancer Drug Disappoints EPA: One-Third of Americans Breathe Dirty Air
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
Pfizer Insists Celebrex Will Stay on Market
The head of Pfizer, Inc., said Sunday that the company was committed to keeping its popular painkiller Celebrex on the market despite a new study finding that, in high doses, the drug increases the risk of heart problems in cancer patients.
Similar study results prompted Merck & Co., Inc., to remove Vioxx, a similar and competing drug, from the market in September.
But Hank McKinnell, Pfizer's chairman and chief executive officer, said on ABC's This Week that the company has no plans to withdraw Celebrex in light of the new findings. "For millions of patients, Celebrex is the best option -- or, in some cases, the last option -- to live a normal life with the pain and inflammation of arthritis," he said.
Both drugs belong to a class of stomach-friendly painkillers called cox-2 inhibitors, which became popular because they relieve pain without causing gastrointestinal distress. The FDA's acting commissioner, Dr. Lester Crawford, expressed "great concern" about the safety of cox-2 inhibitors in light of the latest studies.
Pentagon Wants to Resume Anthrax Shots
The Department of Defense, insisting that servicemen are still at great risk of becoming exposed to anthrax in the Mideast and South Korea, wants to resume inoculating them against the bacteria.
The New York Times reports that Deputy Defense Secretary Paul D. Wolfowitz wrote a letter to U.S. Health and Human Services Secretary Tommy G. Thompson requesting that military officials have access to the vaccine.
In October, a federal judge ordered the military to stop requiring troops to be vaccinated without their consent. The judge, Emmet G. Sullivan, found that in approving the vaccine, the U.S. Food and Drug Administration didn't follow procedures requiring it to seek public comment on the safety and effectiveness of shots before approving them, the Times reports.
Wolfowitz, citing a classified intelligence assessment, said in his letter that "there is a significant potential for a military emergency involving a heightened risk to United States military forces of attack with anthrax."
The health agency has the authority to respond to a terrorist attack or other emergency by allowing the military to use some drugs, and a spokesman said the department will consider the Pentagon request, according to the Times account.
FDA Criticized Over Lack of Leadership
The U.S. Food and Drug Administration, under fire for its alleged failure to monitor the safety of drugs after they have been approved, is now facing criticism over its lack of leadership during the Bush administration.
The Washington Post reports that the agency, which regulates products covering about one-fourth of the U.S. economy, has been without a permanent leader for nearly two-thirds of the time Bush has been in office. As a result, the FDA is less able to respond quickly to emerging problems and has been weakened in the face of pressures to stray from the agency's science-based public health mandate.
"Recent events [especially the heart troubles caused by popular arthritis drugs] make it obvious there's no time to waste in securing stronger leadership at the Food and Drug Administration," Sen. Charles Grassley (R-Iowa) told the Post. "Permanent people need to be appointed to these jobs posthaste."
The agency has never gone so long without a chief in modern times. In Bush's first term, Mark McClellan's 17-month tenure was the only period during which the post was permanently filled. The White House told the newspaper that it had full confidence in the FDA's acting chief, Dr. Lester Crawford.
Paul Light, a member of the Brookings Institution's presidential appointments initiative, told the Post that the White House may intentionally prefer having no permanent leader to a pro-active one who might "slow down the industry."
Possible Bird Flu Cases in Japan
Health officials in Japan are investigating what may be the first human cases of avian influenza in the island nation.
Agence France-Presse reports that five people may have been infected with bird flu following an outbreak of the virus among poultry in February. None was seriously ill.
Four of the people were employees of an infected poultry farm, and the fifth worked for a crew that was disinfecting the farm, reported AFP. Health officials in Kyoto found bird flu antibodies in them, though no cases have yet been confirmed.
During the outbreak at the Asada Nosan Co., poultry farm, 240,000 chickens and 20 million eggs were destroyed to keep the virus under control, according to the wire service. In August, the company's president was jailed for a year for failing to report the outbreak.
Bird flu has gained a foothold in some Asian countries. In the last year, it has killed 12 people in Thailand and 20 in Vietnam, according to AFP.
Lung Cancer Drug Disappoints
A drug approved last year as a last-ditch hope for some lung cancer patients who didn't find relief from other forms of therapy has come up short in a large clinical trial.
The U.S. Food and Drug Administration reported Friday that patients with non-small cell lung cancer taking the drug, AstraZeneca's Iressa (gefitinib), after failing other cancer treatment showed no survival benefit.
The FDA approved Iressa under an accelerated process that allows some drugs to be used when patients failed two other forms of therapy. Iressa was cleared because data from clinical trials showed that it caused significant shrinkage in tumors in about 10 percent of patients -- mostly women -- and this was thought likely to increase patients' overall survival time. Also under this process, drugmakers must continue testing the drug.
An FDA statement said that AstraZeneca studied whether 1,700 patients would survive longer compared with patients taking placebo, and they did not. The agency has yet to decide whether to remove Iressa from the market.
EPA: One-Third of Americans Breathe Dirty Air
About one in three Americans live in areas with dangerous levels of soot pollution in the air, the Environmental Protection Agency announced Friday.
EPA administrator Mike Leavitt said the designations, which will require 20 states and the District of Columbia to devise strategies within three years to reduce the level of tiny air particles linked to respiratory illness and premature death, are actually a sign of progress.
"Today's cleaner air represents more than four decades of progress since the signing of the first Clean Air Act in 1963, followed by the Clean Air Act of 1970 and the amendments in 1990. This is a clean air relay that gets better with each generation, and we are making more progress than ever before," Leavitt said in a statement.
According to the Washington Post, Leavitt said that, as of 2003, the average concentration of fine particles in the air nationwide had declined 10 percent since 1999, when the EPA began monitoring it. America's air, he said, is "cleaner than any time in memory, but we're not done yet."