A brief history of the rapid rise and fall of new drug therapies

Why do so many prescription drugs seem to undergo a head-spinning reversal of fortune — panacea one day, poison the next? Here's a helpful guide to drug therapies:

For starters, anyone who watches TV or reads consumer magazines knows that the pharmaceutical industry aggressively markets drugs today.

• Because prescription medications can be patented for only a limited number of years, pharmaceutical companies try to garner as much profit as possible from a new medication before other companies can use the formula and produce copycat drugs.
• When these imitators reach the market, they may be heavily hyped, too.
• Some critics charge that marketing drugs directly to consumers through advertising creates a huge demand for these medications that surpasses the actual need.

There's a bigger problem, though. When a pharmaceutical company wants to sell a new drug, it must show that the drug is effective and safe by conducting experiments known as clinical trials.

• In these trials, people in one group take the real drug, while volunteers in a comparison group take placebos. The trials reveal how well the drug works and how often it produces unwanted side effects, and we'd be in big trouble without them.
• They certainly weed out drugs that don't work or cause serious side effects in a lot of people. But they aren't perfect.
• The trials used to gain approval for a new drug usually include no more than a few thousand people and last several months or years. Often, patients chosen to participate in these trials have uncomplicated cases of the condition being treated.
• Once a drug gains approval, however, millions of people may begin taking it, many of them sicker than the people in the trials and battling more than one medical condition — and that's when problems with the drug may become apparent.
• Researchers at Harvard Medical School and Cambridge (Massachusetts) Hospital examined the safety record of the 548 new drugs approved by the US Food and Drug Administration between 1975 and 1999.
• One out of 10 of these drugs was eventually taken off the market due to safety concerns or was branded with a "black box" warning — a caution printed in a black box on the drug information sheet and stating that the drug may cause serious or life-threatening side effects.
• These included heart attacks, liver and kidney failure, a weakened immune system and the ultimate side effect, death.
• In some cases, drugs discovered to carry serious risks are quietly removed from the market.
• In other cases, the story leads the evening news for weeks.
• In one of the most infamous examples of this problem, research showed that the heavily advertised and widely used arthritis drug Vioxx increased the risk of heart attack.
• To make matters even more confusing, many drugs that have been pulled off the market actually had very small odds of causing serious side effects. For instance, taking Vioxx increased the risk of having a heart attack by only one in 10,000.

To sum it up, many of these pharmaceutical drugs and clinical trials are done in the name of profit, regardless of their actual effects on your body. To protect yourself, always read the information sheet that comes with the medication your doctor prescribes, and ask about the drug's risks and benefits.