A Dose of Reality (page 2 of 4)

Too Many Variables

Legato, who has a busy practice in internal medicine, continues, "All this hysteria is ridiculous. We're putting the pharmaceutical industry under a microscope in a completely inappropriate way. Americans have somehow come to believe they should get the best medical care with the latest remedies with no side effects. Well, guess what? There is no drug that doesn't have side effects."

Other experts say it's time for a major reality check. "With all due respect, I think the press has made this into a firestorm," says Peter Corr, PhD, head of worldwide research and development for drug manufacturer Pfizer. "As a society we expect medicine to be perfect. There is no such thing. There is always a risk."

Even when a side effect is suspected, it can be very difficult to prove that it was directly caused by the drug. "With some kinds of adverse reactions, like liver toxicity, it's fairly obvious that it's related to the drug," says Robert Temple, MD, director of the office of medical policy at the FDA's Center for Drug Evaluation and Research. "But it's much more difficult to link a heart attack or a stroke, because these are very common in the population. If someone has a heart attack, what would even make you imagine that the drug did it?"

There are so many variables, any one of which could cause an adverse reaction to a drug, from taking an incorrect dose to combining the drug with other medicines. A growing cause of concern is the trend toward self-medication with untested OTC supplements. If, for instance, a patient is taking an herbal remedy and also takes a painkiller or an antidepressant, what will the combined effect be?

Despite the risks, there's no need to panic about prescriptions, says Temple. "Of drugs that are approved, about one or two percent may be withdrawn eventually. It's rare." And if you have enough information to weigh the risks and benefits, you and your doctor can make an informed decision.

How Side Effects Emerge
How can dangerous side effects take years, or even decades, to become known? A new drug is first tested on animals. If the results indicate that it's likely to be both safe and effective, the company applies to the FDA for permission to begin testing it in humans. Human studies have three phases: to evaluate safety, to determine effectiveness, and to verify safety, dosage and effectiveness. Although a trial may extend as long as five years and often includes between 3,000 and 10,000 people, each participant may only receive the medication for a period of weeks or months. Statistically, rare and dangerous side effects may not emerge until millions of people have used the drug, after FDA approval.

So why don't we test drugs on more people and for longer periods of time? For one thing, quicker approvals may save lives, as with drugs for AIDS or a vaccine for a newly emerging flu pandemic. Another reason is cost. "It already costs a billion dollars to get a drug from an idea to the market," says Corr. "If we had to study a million patients before we took a drug to market, there would never be another drug."

Monitoring After Approval
After a drug is approved, it is subject to post-market surveillance. The FDA analyzes reports of "adverse events," or drug side effects, which come from the industry, from ongoing clinical trials and through its MedWatch program, to which consumers, physicians, pharmacists and other health professionals voluntarily report problems.

Negative reports about a drug that's on the market can yield crucial new information. "Clinical trials that are negative are, many times, just as important as the trials that show positive results," says Marvin Lipman, MD, chief medical adviser for Consumer Reports. Legislation was introduced in both the House and Senate in October 2004 to establish a registry of all clinical trials and their results (clinicaltrials.gov). "We are the most regulated industry in the world," says Corr. "And frankly, that's how it should be. If there is a problem with a drug, we want to know about it sooner rather than later."

Consumers may know sooner too. In February the FDA announced the creation of an independent Drug Safety Oversight Board to provide expanded and faster drug-safety information to doctors and patients. While there will always be risks, the public may be better equipped to judge and act on them.

"We still need to be willing to take personal responsibility for assessing the risk-benefit ratio of a medication," says Legato. "Yes, you have to be completely informed to do it. And, yes, it's complex. But if we don't do this, it's like going back to the Middle Ages when there were no risks, except of dying by the age of 26. We have nearly doubled life expectancy since the beginning of the 20th century. That did not happen by accident. Prescription drugs have played a huge role."

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• The Pill Peddlers
• Doctors with shady pasts turn to illegal online pharmacies.
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• Who Can You Trust?
• How to tell which online pharmacies are legitimate.
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• Deadly Medicine
• How one teenager lost his life buying drugs online.
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• What Medicare's New Prescription Drug Benefit Means
• The financial facts and figures...
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• Better Than a Pill?
• More and more medicines come in a patch. Are they right for you?
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