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Weighing Risks, Benefits of Prescription Drugs

Patients should have more say in treatment decisions, some experts say

THURSDAY, April 28, 2005 (HealthDay News) -- The U.S. Food and Drug Administration (FDA) has been faulted by some critics for waiting too long to take drugs off the market that carry potentially dangerous side effects.

A recent example: Vioxx and Bextra, part of the controversial class of cox-2 painkillers. Both have been linked to an increased risk of cardiovascular problems.

But during a panel discussion this week, the agency was singled out for just the opposite reason. By banning certain drugs, the experts claimed, the FDA fails to adequately weigh the benefits that some medications -- including cox-2s -- provide for people who are dependent upon them for improved quality of life.

And, the agency is also denying consumers the right to decide for themselves -- in tandem with their doctor -- whether to take a drug or not, speakers said.

"There is informed consent, and if there is adequate educational information, patients can analyze the risks and benefits of taking a drug," said Dr. Irvin Modlin, a professor at Yale University School of Medicine.

He was one of several speakers present for the panel discussion titled Strong Medicine: What's Next for Drug Development? It was part of a pharmaceutical conference and exhibition in New York City that concludes Thursday.

"The FDA, in its balancing benefit versus risk, gives risk the greatest weight. Benefits get scant attention," claimed panelist Peter Barton Hutt, a Washington, D.C., lawyer who specializes in food and drug law. He was chief counsel for the FDA from 1971 to 1975.

The other panelists were Sarah W. Fuller, president of Decision Resources, a Massachusetts-based research and advisory firm that focuses on the drug industry, and John Swen, executive director of science policy and public affairs for the pharmaceutical company Pfizer Inc.

Because of its intent to lower risk to consumers, the FDA has become tougher on companies seeking approval for drugs, calling for longer clinical trials and more of them. This scrutiny is one reason behind the rising cost of prescription medicines, Hutt contended.

"In eight years, the cost of bringing a drug to market has gone from $804 million to $1.7 billion," he said.

Fuller said the future of drug research is promising. She cited the work of smaller biotech companies, as well as innovations in manufacturing and advances in technology and science, that have improved diagnostics and drug delivery.

"The pipeline of new drugs is robust, with 1,300 drugs in research and development, and 300 in late-stage development," Fuller said. Without going into specifics, she said they include drugs to treat so-called "pre-disease" conditions, including vaccines. And there's much research into drug therapies for people over 65, who will make up 20 percent of the U.S. population by 2010, she said.

Swen acknowledged that the drug companies need to do a better job of explaining to consumers how they research and develop medicines.

"We need to promote greater transparency. People don't understand the ethics of clinical research," he said.

Swen would not comment on Pfizer's decision earlier this month -- based on an FDA request -- to remove Bextra from the market.

Cox-2 inhibitors have been embroiled in controversy since Merck & Co. withdrew Vioxx last September after research showed users were at increased risk of heart attack and stroke. Only one cox-2 inhibitor, Celebrex, also manufactured by Pfizer, remains on the market, and the FDA has asked that the drug carry a heightened black box warning of possible side effects.

More information

For more on drugs, visit the U.S. Food and Drug Administration.

SOURCES: John Swen, executive director, science policy and public affairs, Pfizer Inc., Groton, Conn.; Sarah W. Fuller, president, Decision Resources, Waltham, Mass.; Irvin Modlin, M.D., Ph.D., professor, Yale University School of Medicine, New Haven, Conn.; Peter Barton Hutt, senior counsel, Covington & Burling, Washington, D.C.; April 26, 2005, panel discussion, Interphex2005 conference, New York City
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