Prescription Drugs: Danger Within the Cure
Imagine a war on crime in which nobody knew how many murders occurred, or a Federal Aviation Administration that was unaware of how many airplanes had crashed. Suppose we were so casual about fatal automobile accidents that it was not even necessary to report one.
This is how we monitor the risks of prescription drugs, though they account for more deaths each year than all murders, auto accidents and airplane crashes combined. It is estimated that more than 100,000 people die every year from the adverse effects of prescription drugs, and 1 million are injured so severely they require hospitalization. Many of these deaths and serious injuries could be prevented with better programs and policies to limit the dangers involved.
Many people take pills confident the Food and Drug Administration has ensured that only safe drugs reach consumers. While the FDA has a generally competent and dedicated staff, this is not what happens. The FDA’s job is to make sure each new drug is tested thoroughly enough to identify its risks, and provide substantial evidence that it has medical benefits.
This means approved drugs usually have their benefits celebrated in the growing flood of direct-to-consumer advertising. But they also have major risks that are inadequately monitored, often ignored by doctors and seldom understood by consumers. The leading painkillers frequently cause perforated ulcers, requiring emergency surgery and resulting in 70,000 hospitalizations a year. Digoxin, a best-selling heart drug, caused more than 200,000 hospitalizations over a seven-year period. Even the awesome power of antibiotics carries risks that must be managed. They can create conditions in which intractable intestinal infections flourish or trigger a life-threatening allergic reaction. Millions more are afflicted with moderate side effects, including rashes, insomnia, nausea, hair loss, depression and sexual dysfunction. Drugs are inherently risky, and from the FDA to the consumer’s medicine cabinet, we’re doing a poor job minimizing those dangers.
The problem begins at the FDA, and the priorities imposed by limited budget and congressional mandates. For years, the chief complaint was that the FDA was too slow to approve new drugs. When given additional funds collected from drug companies, the FDA responded impressively. With a 40% increase in the drug-review staff since 1993, the FDA now approves new drugs as fast or faster than in Europe.
Unfortunately, the narrow focus on new drugs has made worse the already inadequate safety monitoring of drugs being taken by millions of consumers. The FDA has more than 1,500 full-time employees with duties mainly related to evaluating new drugs. However, a full-time staff of just 54 is responsible for monitoring the safety of the 5,000 prescription and over-the-counter drugs already on the market. There are more full-time federal employees in the U.S. Naval Academy laundry (a total of 107), than assigned to monitor the risks of drugs taken by millions of consumers.
To detect drug-related injuries and deaths, the FDA relies mainly on a voluntary system so widely ignored by health professionals that 99% of all adverse effects are never reported. As a result, the FDA cannot say whether deaths and serious injuries from drugs are increasing or reliably identify which drugs require greater vigilance in their use. As the diet-drug debacle with fen-phen proved, without better monitoring, people may continue to be harmed for decades before the danger is identified.
We have even more serious problems in the doctor’s office than at the FDA. The medical journals are filled with research that documents in horrifying detail an error-plagued system. For example, studies show that one of five elderly are prescribed at least one drug that is inappropriate or dangerous in an older population. Another revealed that 21% of all prescriptions for antibiotics were inappropriately given to combat the common cold, a virus against which these drugs are risky and ineffective. Government surveys show that more than two of three doctors fail to tell patients anything about the risks of the drug they just prescribed, despite a legal and ethical obligation to do so.
Of equal concern are the alarming number of simple medication errors in hospitals, pharmacies and doctors’ offices. Common mistakes include confusing the drug name, getting the dose wrong or ignoring the results of a diagnostic test or a plainly documented drug allergy. Reported deaths from medication errors, now more than 7,000 a year, have nearly tripled in a decade’s time. Yet, many fatal medication blunders undoubtedly are never reported on death certificates.
While the nation’s hospitals are now paying more attention to the drug-safety breakdown, the doctor’s office remains dangerously error prone. Without new tools and a better system, even the most conscientious of doctors is likely to make an unacceptable number of errors.
In such a poorly managed, inherently dangerous system, consumers must pay far more attention to risks and benefits of the drugs they take. Can they recognize the adverse effects of the drugs they’re taking, especially the subtle ones like fatigue or mild depression? Is this one of the drugs where a small overdose is dangerous? Do consumers know when they take one of the many drugs with alarming withdrawal effects if discontinued suddenly? These are just a few of the many questions that must be answered to use drugs wisely.
While individuals can do much to reduce their risks, an effective solution requires action by a concerned nation that usually does not neglect important safety issues. For example, we spend $3 billion annually to install air bags in new automobiles, hoping to save about 300 lives a year. Responding to the fatal crash of a TWA airliner near New York, in which terrorism was not involved, the federal government launched a massive counter-terrorism effort with 200 new employees at the FAA and another 1,300 at the FBI.
Yet, with 1 million severely harmed each year by prescription drugs, the FDA monitoring program has a budget of about $7 million. You don’t have to an expert to grasp how many lives we could save, and injuries we might prevent, with even a modest investment in drug safety.
