List of problem prescription drugs is growing

NewsDay

01/21/2008 - An increasing number of prescription drugs - some that have been widely promoted through seductive advertising - are turning out to have problems long after they've reached the market.

With more than 40 percent of the U.S. population taking at least one prescription medication, the ever-growing list of medication concerns is drawing public attention and a sharp eye from consumer watchdogs.

Research within the past week has raised questions about Vytorin, a popular cholesterol-lowering drug, and an analysis published in the New England Journal of Medicine suggested doctors and patients may have been misled about the effectiveness of many antidepressants.

Even though Vytorin has been on the market for nearly four years, it was reported only last week that it does not prevent heart attacks and strokes. Older drugs in the statin class are far more effective, doctors say.

Vytorin isn't the only medication to come under a microscope years after it was approved. In November, Bayer Health Care voluntarily yanked from the market a drug called Trasylol, designed to prevent blood loss and the need for transfusions, after a Canadian analysis demonstrated that it increased the risk of death.

Last summer, studies revealed heart failure risks associated with two diabetes drugs, Avandia and Actos. Now, both drugs' labels carry a black box warning, the U.S. Food and Drug Administration's highest level of caution.

In 2005, medical investigators led by researchers at North Shore University Hospital in Manhasset found that Natrecor, a medication designed to rescue heart-failure patients from heart rhythm and respiratory crisis, may instead dramatically increase their risk of dying within 30 days of leaving the hospital.

Johnson & Johnson, parent company of Scios, Natrecor's maker, found flaws in the study and maintains that the medication is safe.

Arthur Levin, director of the Center for Medical Consumers in Manhattan, said medications are not always thoroughly vetted. "In recent history there has been increasing pressure to get new drugs to market," he said, "and that comes from a lot of sectors: patients and their organizations, the drug companies and, of course, from people in Congress who think the FDA gets in the way of drugs reaching the marketplace. There are a lot of players who emphasize speeding up the process."

As a result, the number of bad medications - some undisputed killer drugs - has grown in recent years.

"There's Rezulin, Bextra and Vioxx, and the list goes on and on," said Dr. Sidney Wolfe, director of the health research group of Public Citizen in Washington, D.C. The consumer watchdog organization maintains a hit list of medications it wants the government to recall.

Wolfe said a major issue that has drawn only faint concern centers on drugs that fall into the "me too" category. Even though older drugs, with known safety profiles, can effectively treat a medical disorder, new ones are approved. A new drug may merely offer a different chemical mechanism.

"People are too enamored with new biochemical mechanisms. Who cares what the mechanism is if it harms the patient?" Wolfe said.

"We have a flawed system for getting drugs to market," Levin said Friday. "What we have is a very, very narrow standard to determine what works. The threshold, the burden is very low. The drug can't be worse than what's out there - it just has to be more effective than a placebo."

Patients who rely on the medications often learn about problems inadvertently, sometimes discovering them before their doctors.

Eric Heifetz of Lake Grove, whose doctor had prescribed Vytorin, learned through the media about the study that thrust that drug into an adverse light. He knew about the Vytorin study before his doctor.

"It was on TV," he said, referring to a news report. Heifetz said his doctor switched him to Lipitor, a powerful statin drug that lowers cholesterol. "We'll see how this one works," he said.

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