Photo by Darell Eager
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A Prescription for Trouble
By Jerry Avorn, M.D., March & April 2006
How dangerous drugs get past the FDA—and what you can do to protect yourself
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A striking change has occurred in the way Americans think about their medicines. Yes, there has been plenty of good news about drugs that lower the risk of breast-cancer recurrence, prevent hip fractures, or restore function in patients with severe rheumatoid arthritis. But in little more than a year the nation has also been astounded by nearly back-to-back bad news:
- Half the 2004-05 flu-vaccine supply turned out to be unusable because of contamination problems in the manufacturer's plant.
- The painkiller Vioxx, taken by about 20 million people, turned out to double the risk of heart attack and stroke when taken long-term.
- Strong tranquilizers such as Zyprexa and Risperdal turned out to double the risk of death in older patients who took them for confusion or agitation.
What's going on? Not long ago most of us were comfortable in assuming that someone in government was monitoring the safety of the prescription drugs we use. But that belief seems naive now; the series of crises has raised the worry that the nation's drug-regulation process just isn't working as well as most people thought it was. The problem was hammered home in November 2004, when David Graham, M.D., M.P.H., a senior scientist at the Food and Drug Administration (FDA), told a Senate committee he didn't think the FDA was capable of protecting the American public from unsafe drugs.
Not until the 1960s did Congress give the FDA the authority to demand proof that the products drug companies sold actually worked. Before that, the agency could make sure drugs were pure and free of contaminants, but no proof of effectiveness was required. Then came thalidomide. As many of us recall, that was an antinauseant and sedative widely used in Europe that ended up causing severe birth defects when taken by pregnant women. The drug was never approved in the United States because a vigilant FDA medical reviewer required better safety data, so most American families were spared those tragedies. The thalidomide issue galvanized the nation, and a bill granting the FDA broader oversight quickly became law. Soon the United States became the world standard for rigorous drug evaluation.
That authority has eroded during the past two decades. In 1992 Congress passed the Prescription Drug User Fee Act, which required drug companies to pay the FDA to review their products. The effect was a greatly expanded work force of reviewers. The average time it took for a drug to win approval was slashed. But some in the agency claim that relying on payments from drug companies tilted the balance of power so that the industry being regulated ended up calling the shots.
The new setup encouraged the approval of new drugs—but did nothing to support the ongoing evaluation of those drugs once they were approved. In fact, the law required that all user fees be spent on speeding up drug approvals and none on studying unexpected side effects later on.
Another problem lay in the way new drugs were tested. Although most patients (and many doctors) believe the FDA is staffed with hundreds of white-coated scientists who conduct drug studies, the reality is that the agency itself performs virtually no drug trials. Nearly all testing of new drugs is carried out by the companies that make them. This is usually done accurately, but critics have long noted that the subjects in the studies are often much younger and healthier than the patients who will eventually take the drugs. Moreover, the studies may last only a few months, even for drugs that may be taken for a lifetime.
In 2004 many of us wondered whether the revelations about Vioxx would prove to be this generation's "thalidomide moment"—the crisis that would galvanize the nation to reform its prescription-drug policy once again. But that's not likely. In the wake of Vioxx, the government proposed a new Drug Safety Oversight Board that would do pretty much what was being done already. It's looking less and less probable that the nation will be able to use the Vioxx crisis to catalyze reform of our policies for prescription-drug approval and safety surveillance.
Fortunately, there are several steps an alert consumer can take to guard against drug risks. Everything starts with a candid conversation with your doctor. The prescription should not be seen as a sacred gift bestowed by an omnipotent authority to a meek and grateful patient. Rather, it is an opportunity for you to educate yourself, with your doctor's help. Here are some questions to ask:
- Is this drug new to the market? If so, is there another product with a longer safety track record that would work just as well? (If that other drug is a generic, it could well be a lot less expensive, too—and every bit as effective.)
- What side effects should I watch out for, and which ones should I call about? Many adverse drug effects appear as new symptoms that a patient may not attribute to the medication.
- Is the doctor offering free samples? If so, beware of their seduction. Free samples are the products drug-company sales reps give out through physicians to get patients used to taking new, expensive drugs. The first few may be free, but if you end up on an unnecessarily higher-priced product for years to come, it's no bargain.
Keep investigating after you leave the doctor's office. Become an informed consumer. In addition to The AARP Guide to Pills (Sterling, 2006), a new guide to prescription medications, several Web-based resources can provide useful information about drug choices. One of the best is produced by the editors of Consumer Reports, the folks who publish all that useful comparative information about automobiles and refrigerators. Now they have turned their attention to prescription drugs, and at www.crbestbuydrugs.org you can find advice about how to choose the best medicines, too. The Medical Letter, long a staple source of no-nonsense drug reviews for doctors, also has a website (www.medicalletter.org) that offers free information for patients.
In addition, you can play an important role as a citizen. Critics contend that if the FDA is too quick to approve iffy drugs and too slow to spot safety problems, the reason is that the government is more swayed by pharmaceutical-industry lobbyists than by the arguments of public health advocates or the needs of patients. Let your senators and representatives know how you feel about the recent spate of drug-safety problems. In my opinion, they should be urged to strengthen the FDA's mandate. The agency needs to test drugs more rigorously before marketing and to follow their long-term effects more carefully afterward.
We are the beneficiaries of decades of medical research that brings unprecedented new medicines previous generations could only dream of. But, paradoxically, we also live at a time when the nation's capacity to properly evaluate and regulate those medicines is in serious doubt. The current turmoil may one day lead to more effective
systems for drug approval and safety surveillance. But for now, the best protection is to be an enlightened patient—and an engaged citizen.
Jerry Avorn, M.D., is a professor of medicine at Harvard Medical School and chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at the Brigham and Women's Hospital in Boston. He is the author of Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs (Vintage, 2005) and a contributor to The AARP Guide to Pills (Sterling, 2006).
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