We're used to seeing advertisements for prescription drugs on TV followed by the "ask your doctor" tag. Many of us go to our doctors and demand a prescription, even telling them in no uncertain terms that we'll go to someone else if we don't get it. But if we knew more about how drug companies test their products, how the FDA approval process works, and what the side effects of prescription drugs are, we'd all be a lot more hesitant to demand a pill to solve our problems.

Before a drug company can apply to the FDA to approve a drug for sale, it must first test the drug for potency (to establish correct dosage), indications for usage (what illnesses the drug can be used to treat), and screen it for side effects and adverse reactions. These side effects may later be added to a special warning label that accompanies each prescription.

But the testing process is deeply flawed. There are no set standards for the minimum number of human subjects in each trial. There is no requirement for the company to test its drug in women, children, or the elderly--most volunteers are college-age men or, until recently, prisoners. And finally, there is little money or incentive for the FDA to check on the private laboratories where testing is done to make sure basic protocol has been followed.

As drug companies cut costs and try to improve profit margins, they've turned to contracting out the clinical trials of drugs to private laboratories. When volunteers at these labs complain of side effects from a drug, their complaints often never make it into the data collected on the drug. Private labs are continually under pressure to provide drug companies with the results they want and are paying for: no serious side-effects. This makes it easier for labs to dismiss any serious side effects as pre-existing conditions not related to the drug.

The whole clinical trial process has three distinct phases. Phase I includes the first human trials of a drug, where a small number of healthy people take the drug to screen it for side effects and establish a dosage (usually a maximum dosage, rather than a minimum). Most labs rely on healthy college-age male volunteers to establish dosages that later may be found to be too much for a smaller woman, child, or an elderly person with a slower metabolism to take.

Phase II is the testing of the drug on a small number of sick people. During this process, the dosage levels may be adjusted.

Phase III is supposed to be the first large-scale testing; it's done on sick people at the dose or dosages at which the drug will be sold. Increasingly, Phase III trials are being done on ever smaller numbers of people to save money. Also, the trials are often done in foreign countries, where the FDA can't send an agent to inspect the lab.

After Phase III, the drug company submits its application and data to the FDA. But the FDA's scope is severely limited; they can only review the data that drug companies give them. An FDA medical officer can't recommend changes in dosage or usages for the drug, and they can't make recommendations to doctors about which drugs are safer to use for a particular illness. The best that an FDA medical officer can do is approve the drug, wait for adverse reactions to show up in the general population, then either force the drug company to do more trials or withdraw the drug from the marketplace. By that time, the damage has been done.

To add to this problem, doctors are not required by law to prescribe drugs only for their FDA-approved indications. Off-label prescribing is a very common practice worldwide and, while it helps many people, it nevertheless is an enormous uncontrolled experiment.

So there's really a fourth phase to the clinical trials for any new drug: the daily, ongoing experiment that occurs once a drug comes to market and we begin taking it. This is truly the first, large-scale testing done on most drugs. Increasingly, drugs are being pulled off the market, only after a number of people have died or been irreparably damaged by them.

Take, for example, the drug Duract, a potent painkiller. It's one of a number of "me-too" drugs which are widely prescribed for pain relief, especially after surgery. Since it hit the market in July of 1997, it's been prescribed to more than 2.5 million people. But Duract has a big problem. If you take it for more than ten days, you risk a very high chance of death or liver damage. Most of the problems come from off-label prescribing by doctors who haven't read the label or who can't imagine that the FDA would approve such a dangerous drug. Indeed, when there are twenty other prescription painkillers already on the market, why would the FDA approve one that can so easily kill you?

Wyeth-Ayerst, a division of American Home Products, was forced to pull Duract from the market. But because of the faulty FDA approval process and sloppy drug company trials, there are other medicines on the market that are just now entering their Phase IV "trials." Viagra, the penis pill, has been so popular that it's been prescribed to almost 2 million men since it was released in March. Within three weeks of its release, Pfizer admitted to the FDA that about a dozen men had died while taking Viagra, but the company attributed the deaths to other health problems. In May, the press reported an estimated 24 deaths from Viagra. Now, according to Public Citizen Health Research Group, the death count is 31, with 174 men reporting severe side effects.

Furthermore, the rate of off-label prescribing is particularly high with this drug, which is commonly perceived as a "life-style enhancer." In reality, Viagra is a pill being used to treat the side effects of many other drugs. Anti-depressants and blood pressure medications are notorious for causing male impotence; adjusting the levels of those medications may eliminate the problems. More ominously, impotence is an early sign of untreated heart trouble in older men. Prescribing Viagra to those men is unconscionable, given that diet, exercise, and lowering stress levels would have a greater long-term, overall health effect for these men than a pill that gives an instant short cut to an erection.

But the worst news is this: when a person has an adverse drug reaction (as over 3.7 million Americans do every year), it may never be reported by his or her doctor to the FDA. Doctors are required to report drug reactions by phoning them in to the FDA on an 800 line, or by filling out a form to mail to the FDA's MedWatch program. But there's no enforcement of this requirement, and compliance is poor. In fact, it often takes a patient's family to threaten the hospital, doctor, or drug company with a lawsuit for the adverse drug reaction to ever be noticed by the FDA.

Things need to change. The FDA has been under attack from both drug companies (who have already seriously hobbled it) and conservative politicians who want to eliminate it entirely. But in countries where adverse drug reactions are few--such as The Netherlands--a strong government testing and monitoring system is a main priority for government spending. Of course, in The Netherlands, there's also a very strong and vocal consumer group called the Health Action International (HAI), which keeps the pressure on to police drug companies.

Here in the U.S., Ralph Nader's Public Citizen Health Research Group, based in Washington D.C., has long been working for more regulation of drug companies and drug testing. Other groups, from the American Association for Retired Persons (AARP) to the Gray Panthers, have also leapt into the fray.

Before you decide you need a pill to cure your problems, think twice about what that medicine might do to you. And consider volunteering to help fight for safer prescription drugs.