On September 30, 2004, in the biggest recall ever of a prescription drug in the United States, the blockbuster arthritis and pain medication rofecoxib (Vioxx) was removed from the market when evidence emerged that it doubled the risk for heart attack and stroke.

The recall comes on the heels of a barrage of negative news about prescription medications. First, there was the report from the Women's Health Initiative that hormone replacement therapy (HRT) increases the risk for stroke. (See Daily Health News, August 24, 2004.) This was quickly followed by an ugly controversy in which the US Food and Drug Administration (FDA) tried to silence one of its own scientists from exposing serious concerns about antidepressant use in young people. (See Daily Health News, June 29, 2004.)

And now there is Vioxx. To learn more about the Vioxx debacle and its broader implications for drug safety, I spoke with Eric J. Topol, MD, chairman of the department of cardiovascular medicine at the Cleveland Clinic. Dr. Topol served on the FDA advisory committee that originally approved Vioxx and other painkilling COX-2 inhibitor drugs. He told me that a congressional investigation already has been launched into the effectiveness of FDA drug-safety monitoring. This latest news is bound to intensify that effort.

In the meantime, when it comes to prescription drugs, there are steps that you can take to protect yourself and your family...

QUESTIONS ABOUT SAFETY MONITORING

This blizzard of bad drug news raises significant questions about the safety of our medications. Is the FDA doing its job? Can you trust the medicine your doctor prescribes? How much influence do the pharmaceutical companies really have? The history of Vioxx exposes a number of very big holes in the pharmaceutical safety system, such as...

A lack of follow-through. As I have said before, the research presented in support of new drugs does not necessarily tell the whole story. There was early evidence showing that COX-2 inhibitors could affect the heart. However, in spite of the FDA advisory committee's strong urging that the FDA require Vioxx manufacturer Merck to conduct more rigorous studies, there was no follow-through. To make matters worse, the most recent studies that confirmed the connection were actually testing Vioxx's impact on colon polyps -- and in that study, Merck deliberately excluded people who had heart disease. Meanwhile, the public assumes that this approved drug was rigorously tested in a scientifically pure way.

According to Dr. Topol, the FDA could have and should have taken further and more timely action, including demanding additional clinical studies of people with heart disease, as well as issuing earlier warnings to the public.

Silence was golden. It turns out that shortly before Merck voluntarily withdrew Vioxx, FDA higher-ups "muzzled" investigator David Graham, MD, associate director for science in the FDA Drug Center's Office of Drug Safety. Poised to report on the increased cardiovascular risks of Vioxx, he was told that his conclusions were too strongly worded.

"Dr. Graham described an environment where he was 'ostracized,' 'subjected to veiled threats' and 'intimidation,' " reported Senator Chuck Grassley (Republican-Iowa) in a statement issued by his office. The senator continued, "Instead of acting as a public watchdog, the Food and Drug Administration was busy challenging its own expert."

The power of advertising. While some doctors argue that direct-to-consumer advertising has helped educate patients, the fact of the matter is that since the FDA loosened the prohibitions against it in 1997, the dollars spent on marketing drugs directly to the public have skyrocketed. Vioxx became a best-selling drug largely due to the strength of TV, newspaper and magazine ads. Sales of Vioxx were definitely fueled and amplified by direct-to-consumer advertising, confirms Dr. Topol. He believes that there should be no direct-to-consumer advertising unless it is a question of survival -- for example, to prevent a heart attack or stroke. In his opinion, these ads should not be permitted for quality-of-life issues, such as relief of arthritis pain or erectile dysfunction.

On a related note, you must be on guard when your doctor writes a prescription for a new drug. (See Daily Health News, September 23, 2004.) Doctors have become increasingly reliant on the pharmaceutical companies to educate them about new drugs. Our sister publication, Bottom Line/Health, spoke with Marcia Angell, MD, former editor-in-chief of The New England Journal of Medicine and author of a very powerful new book entitled, The Truth About the Drug Companies: How They Deceive Us and What To Do About It. In her book, Dr. Angell details how deeply dependent doctors are on the pharmaceutical companies for education. In 2001, drug companies paid more than 60% of the costs for continuing medical education for doctors. In addition, there is roughly a 1:6 ratio of sales reps to practicing physicians in this country. These reps attend medical conferences and give doctors such "boondoggles" as fine dinners, tickets to sports events and family vacations.

When it comes to drugs, newer is not necessarily better. Ask your physician to prescribe medicines that are not only effective for your condition but that also have the longest track record for safety. When available, also request less expensive generic and over-the-counter alternatives.

THE FDA MUST DO MORE

Congress is looking more closely into the internal workings of the FDA, in an effort to ensure that the conclusions of its own safety experts receive proper consideration.

Additionally, scientists and doctors emphasize that the FDA must take steps to monitor the safety of a drug once it arrives on the market. Dr. Topol notes that Vioxx was approved after being used in a clinical trial that involved fewer than 1,000 patients. After its approval, millions of people suddenly were taking it, but the close surveillance was at an end. Once a drug hits the market, the FDA's monitoring is more reactive than proactive -- that is, it primarily responds to reports of adverse events.

In the future, Dr. Topol believes that we need a stronger regulatory agency that will more closely monitor and respond to possible health risks once a drug has been approved... compel drug companies to conduct appropriate clinical trials, even after the drugs are on the market... and permit direct-to-consumer advertising only when there are substantial health benefits and negligible risks.

On November 5, 2004, the FDA announced the intention to address mounting safety concerns and restore public confidence in its surveillance system. To that end, it is sponsoring an Institute of Medicine (IOM) study of the United States drug safety system, with an emphasis on the post-market phase. The FDA also is providing an improved decision-making process to make certain that the views of all scientific reviewers are heard, and conducting a national search to hire a new Director of the Office of Drug Safety (a position that has remained conspicuously vacant for more than a year).

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ALL IN THE FAMILY

A friend of mine has four children. Inevitably, when one child gets sick, they all do. With cold and flu season upon us, the question is, how do you keep the germ of the day from knocking out an entire family?

According to Michael Carlston, MD, assistant clinical professor of family and community medicine at the University of California San Francisco, School of Medicine, the best advice is age-old advice: Wash your hands. Wash your hands before eating, before leaving the bathroom and anytime they are dirty, he says. But, here's the fascinating part of his advice...

Don't wash with antibacterial soap!

Dr. Carlston's objections to using antibacterials is not that these products don't work, but that they work too well.

Dr. Carlston explains that antibacterials get rid of the "friendly" bacteria that humans need. What's left are the more virulent strains that can harm us, minus a lot of the "friendlies" that protect us from the dangerous ones. The use of antibacterial soap actually puts us at a disadvantage. In a study published earlier this year in Annals of Internal Medicine, researchers found that people who use antibacterial soap got just as many runny noses and upper respiratory illnesses as those who did not.