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FDA Should Require Long-Term Drug Studies September 20, 2007

Posted by Dreamhealer in Research.

By Diana Zuckerman

If your Dad took Vioxx for his arthritis and became disabled from a stroke, you may be wondering if the Vioxx is to blame. If your Mom took hormone replacement therapy, and ended up with breast cancer, or perhaps Alzheimers, you might be quite upset about the advertisements that persuaded your Mom that hormones would keep her looking and feeling young. And if your child took anti-depressants, and tried to kill himself, you might be feeling more than a little hostile.

These scenarios are all too common among families across the country this holiday season. It’s hard to give thanks and go shopping when you feel worried and betrayed. You know things are out of hand when even the most pro-business Republican Congressmen are holding hearings criticizing drug companies for greed and the FDA for not protecting consumers.

The problem is bigger than greed, laziness, or FDA getting too cozy with industry. The problem is that the FDA system is based on an outdated view of the purpose of medical products.

When the law creating the FDA was passed in 1938, the goal was to prevent people from dying from dangerous concoctions, such as the elixir that killed more than 100 people during a 4-week period in 1937, 34 of them children. In those days, most medications were taken for a short time – for colds, flu, pain, or diseases that would kill you before too long. So it was easy to test them: you studied people who took the drugs for the prescribed period of one week, and determined if they got better, and what the side effects were.

Now, most blockbuster drugs are taken for chronic conditions – not necessarily illnesses – that are likely to last for the rest of your life. The big money is in drugs that lower cholesterol, reduce the pain or other symptoms of chronic diseases, or help prevent us from developing a disease – pills you need to take day after day, year after year. But most of these drugs are approved by the FDA after being studied for just a few weeks – just as they always have been.

Unfortunately, drugs that are studied on a few hundred people for a few weeks are then taken by millions of people for many years. The FDA, and sometimes even the company, doesn’t really know what the long-term risks are. If problems start to show up, the company prefers to hope that the diseases are unrelated to the pills – just a coincidence.

So if a middle aged man took Vioxx and then had a heart attack, it was hard to know if the heart attack was caused by the Vioxx, or by the man’s aging body. The company needed to study many more people taking the drug for more than a year before that became obvious. And now, there is reason to think that other drugs that are similar to Vioxx might have the same potentially fatal “side effects.” But we won’t know unless the companies do the studies to find out – and let’s face it, the companies don’t have much incentive to do those studies.

In recent years, Congress has been pushing the FDA to review drugs more quickly. The cost to consumers is enormous. We spending billions of dollars to buy the latest miracle drug at prices much higher than similar, older drugs that often work as well or better – and we also run the risk of permanent damage or even death. The risks come from using a new medical product for a long time, when its safety record is based on short-term use.

The list of blockbuster drugs removed from the market is getting longer, and it’s not just pills: jaw implants, heart valves, bladder slings, and silicone implants are just a few of the medical devices that were studied for short periods of time and did harm after being implanted for longer periods of time. Like the drug companies, many implant companies have continued to claim that their products were generally safe when “used as directed.”

Of course, sometimes the company knew about risks but someone covered them up. In the case of anti-depressants for children, numerous company studies showed that the drugs were not effective, and data suggested an increase in suicide attempts. The companies didn’t care to share that information with the FDA. And, when the FDA finally analyzed that information, they did not quickly share it with parents who desperately needed that information.

The FDA is feeling embarrassed, and their solution is as old as Washington: ask a group of experts to write a report about how the FDA approval process can be improved. Even more outrageous, the report will not consider the implanted medical devices that are the spare parts our parents and grandparents, and even some of our children, depend on. Apparently, the recent horror stories about drugs and vaccines has caused amnesia about previous horror stories about implants.

In the Code Orange world we live in, we have security check-points in government buildings, airports, and train stations. Those protections are important, but with potentially thousands of Americans likely to die from dangerous prescription drugs, the lack of flu vaccines, and defective implants this year, some of the greatest dangers we face are in our own bodies. The solution is simple: the FDA should be requiring and carefully monitoring long-term studies of medical products that patients will rely on for a long time. Our government needs to strengthen the FDA and other security check-points designed to protect us from those very real dangers.
Diana Zuckerman is president of the National Research Center for Women & Families in Washington, DC.

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