Part 3

Bitter Pills: Inside the Hazardous World of Legal Drugs
by Stephen Fried

(Page 3 of 3)

Much to my surprise, I found that the world of legal drugs is actually far more fascinating than its illicit counterpart, where we journalists generally focus our attention. It can also be more dangerous. While pharmaceutical science has made some medical miracles almost routine, the sheer size of the legal-drug world means that its problem areas are bigger than the entire illegal-drug problem.

For example, far more people die each year from adverse reactions to prescription and over-the-counter medications than succumb to all illegal drug use. Illicit drugs kill anywhere from 5,000 to 10,000 Americans a year. The estimates for U.S. deaths from legal drugs have ranged from 45,000 to over 200,000 per year, which represents 2 to 9 percent of the 2.3 million people who die annually, thereby qualifying as at least the sixth leading cause of death in America, and possibly as high as the third - behind only heart disease and cancer. Of course, many people take many medications without experiencing such problems, which are referred to as "adverse drug reactions" in the United States, "medication misadventures" in the U.K. and "drug-induced sufferings" in Japan. But according to studies in the Journal of the American Medical Association (JAMA), as many as 11 percent of all hospital admissions are the result of adverse drug reactions, or ADRs, as they are often called. More than one-quarter of all inpatients have adverse reactions to the drugs they are given in the hospital - many the result of preventable medication errors - which makes ADRs the leading cause of in-hospital injury.

In America more people die each year from reactions to the drugs they get in the hospital than are killed in automobile accidents. (Some 10 percent of all auto accidents involve drivers impaired by medications.) Outpatients are victimized in greater numbers in another way by drug reactions: they stop taking their pills after being spooked by annoying side effects, neglect to tell their doctors, and are then hurt or killed by the untreated illness.

Before Diane got Floxed, I thought of medicines as pretty much idiot-proof. You take them assuming that the worst that can happen is that they won't work. It turns out the worst that can happen is that you drop dead. The next worse is that your body is permanently damaged. Less worse, but still not very good, is that you suffer for hours, days or weeks with something your doctor may or may not recognize as a drug reaction - anything from a skin rash to heart failure to a sudden inability to have an orgasm. The symptom may or may not go away by itself, but until it does, your doctor may mistake it for another illness and give you more drugs for that, leading to a cascade of prescribing. And your drug experience may affect how the next medication you take works in your body - or how well your body is able to fight infection in the future.

Adverse drug reactions are clearly a huge international health problem. A few enlightened pharmacologists also see them as an enormous learning opportunity, a "gift" that accidentally offers a chance to deepen understanding of drugs and the human body. For me, they have been both. Understanding drug reactions has been a way to explore what is wrong with the entire international pharmaceutical business - a $250 billion enterprise ($700 billion if you count all the other products sold by drug companies) that has managed to repel scrutiny more effectively than almost any other major industry, while remaining the world's most profitable business through many changes in economic climate.

Asking questions about what government regulators were doing about the drug reaction problem also became my way of infiltrating the FDA, an agency so misunderstood that it is easy to overlook its omnipresence in our lives. The FDA is responsible for regulating 25 percent of America's entire gross national product and its policies are the benchmark for world regulation of drugs and medical devices.

The work done by understaffed national agencies like the FDA has never been more important, because in all too many cases, the new economics of health care have transformed drugs from one possible treatment into the only possible treatment - or at least the only reimbursable treatment. In the past five years, drug sales in U.S. pharmacies and outpatient clinics have risen more than 50 percent and the total number of prescriptions dispensed, more than 2 billion a year, has risen over 25 percent. The vast majority of those increases are attributable to managed care's growing use of drugs to avoid hospitalization.

Drugs have become not only the tail that wags the dog but the tail that feeds the dog, trains the dog and makes the dog do tricks. And the growing power of the pharmaceutical industry is being controlled by a shrinking base of owners. Not only are the huge "drug houses" merging with each other and streamlining, but they are buying the firms that decide which drugs will be made available to patients in HMOs and other managed health care organizations. The companies also control the flow of information about medicines. The drug industry now funds, directly or indirectly, almost all the research done on drug products and almost all the drug education doctors get after medical school. Most of the destigmatizing public-awareness advertising campaigns about illnesses are paid for by the companies whose drugs are used to treat or in some cases define those illnesses. And more than ever, drug companies are end-running physicians' authority by advertising directly to consumers, which is why your magazines and n ewspapers are overflowing with pharmaceutical ads, your favorite TV shows are interrupted by pleas to "ask your doctor" about drugs and your doctor is quietly wincing every time he or she is "asked."

It's a situation that can easily turn unhealthy and too often does. Companies can't always be counted on to do "the right thing" when they're faced with a tough choice between profit and public safety. Experts in the field are growing worried about where the in-house "conscience" of these companies will be found, especially when firms with sterling reputations merge with their less high-minded competitors.

While drug therapies grow stronger and more profitable every day, the system that is supposed to assure the safety of those drugs is getting relatively weaker, an economic and bureaucratic liability easily targeted for downsizing. Even as computers and easier international communication make more drug safety efforts possible, the chasm between what can be done and what is being done to keep us safe grows constantly larger.

Ten years ago, the bottom-line business practices of the pharmaceutical companies were considered by many to be the dark underside of health care. Today, all of health care is being run like a drug company.

It's no wonder that, more than ever, patients and their doctors feel - well, pillaged.

© 1999 by Stephen Fried.

About the Author

Stephen Fried, an award-winning investigative journalist and essayist, is the author of Thing of Beauty: The Tragedy of Supermodel Gia and Bitter Pills: Inside the Hazardous World of Legal Drugs. His work has appeared frequently in Vanity Fair, The Washington Post Magazine, Glamour, GQ, and Philadelphia magazine. He lives in Philadelphia with his wife, author Diane Ayres.