New York Times Book Review
Bitter Pills: Inside the Hazardous World of Legal Drugsby Stephen Fried
We take our medicines on faith. We assume our doctors are well-informed, our drug companies scrupulous, our FDA diligentand our medications safe. All too often we're wrong. Just how wrong is documented in this critically acclaimed portrait of the international pharmaceutical industry by one of our most highly respected investigative journalists.
According to the Journal of the American Medical Association (JAMA), adverse drug reactions are the fourth leading cause of death in America. Reactions to prescription and over-the-counter medications kill far more people annually than all illegal drug use combined.
Stephen Fried's wife took a pill for a minor infectionand ended up in the emergency room. Some drug reactions go away in a few hours or days. Diane's did not. This emotionally wrenching experience launched Fried into a five-year examination of the entire pharmaceutical industry, the most profitable legal business in the world. Rigorously documented, Bitter Pills is a full-scale portrait of pill making and pill taking in America today, presented through the powerful human drama of doctors, patients, drug companies, the FDA, and government regulators as they war for control of our medicine cabinets.
New York Times Book Review
- Bantam Books
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The ER doctors, however, were not through with us. They still wanted to run more tests. Even though Diane's symptoms, such as "acute delirium," were consistent with a reaction to the Floxin, they could also be caused by a brain tumor, a stroke or a big horrible infection with larger neurological implications, like spinal meningitis. They wanted to do a CT scan.
I got to sit in the CT control room and watch the machinery visually slice and dice. There is nothing quite so frightening as watching your loved one's brain being scanned for tumors, especially when you're not exactly sure what a normal brain looks like. But it is also very moving to peer directly into your wife's mind. What spouse hasn't at one time or another wished to be able to do that?
Back in the ER after a clean scan, we were then told the prevailing wisdom about all adverse drug reactions: that the effects would subside when the medication left her system. And we were sent home--with a supply of the milder, cheaper antibiotic she probably should have taken in the first place for her urinary tract infection (UTI)--to wait for that to happen. On our way out, we walked past the main ER desk. On the wall behind it was a light box for reading X-rays, which was still illuminating pictures from the inside of Diane's brain. To the left of the viewer was a shiny metal towel dispenser. It was adorned with Floxin advertising magnets that had been left by some enterprising drug sales rep.
At that moment I thought the Floxinalia would actually make a nice detail for our emergency room horror story, the recitation of which would commence as soon as Diane was fine, ostensibly in a couple of days. But hersymptoms did not disappear as promised. Some waned, but new ones developed. Besides the "melting" and the fixed pupils, she had really aggressive, buzzy insomnia, visual distortions that made the world seem six-dimensional and aphasia: she would get halfway through a sentence and just couldn't get the rest of the words out. For a woman with a high school trophy for "best negative debater" sitting on a shelf behind her desk, this was probably the scariest symptom of all.
Over the next two weeks, she endured an electroencephalogram (EEG), which tests electrical function in the brain; a magnetic resonance imaging (MRI) of her head, which offers more structural detail than the CT scan; and a spinal tap, to check the cerebrospinal fluid for infections, as well as some blood work. All these tests just to rule out any other possible explanation for her continuing symptoms than an adverse reaction to the drug--the same drug that was supposed to be long gone from her system. While the tests themselves were creepy, what they were testing for was absolutely horrifying. I found myself weighing which awful result would be most acceptable, watching the life we had planned to have pass before my eyes.
The tests all came back on a Thursday, one of the most harrowing days of our lives. As we were read the results over the phone by our internist, I found myself mentally checking off all the nightmares that had been eliminated by the process--"brain tumor, no; stroke, no; AIDS, no." But Diane still wasn't well. The doctors concluded that the drug reaction had triggered some genetic predisposition to neurological illness. Since her body hadn't been able to correct the situation naturally, she would need to take a combination of heavy-duty drugs, each with its own possible side effects, to do it. If, in fact, it could be done at all.
But at least that urinary tract infection had cleared up.
It has now been five years since Diane got Floxed. In that time, we have learned more than we thought we'd ever want to know about what has been called "the other drug problem." The one with legal drugs.
Since that day in the emergency room, I have been on a quest. An investigative journalist and exasperated husband, I am trying to find out if my wife was the victim of a pharmacological foul-up or just a statistically acceptable casualty of "friendly fire" in the war on disease. I am also trying to find meaning in our experience, a married couple searching for each other through a medical emergency that never seems to end, the siren never completely quieted.
Along the way, I have met the people behind the studies, the statistics, the press releases and the lawsuits: heroes, scoundrels, geniuses and idiots, victims and victimizers, the amorphous "less than one percent" of the population who have the adverse reactions you read about in the fine print on your drug labels and even the people who massage the numbers to get them under one percent. I have seen close up what happens at that moment when science officially becomes commerce, when exciting new drugs are handed over from the lab nerds to the marketing types. I have watched everyone in the pharmaceutical food chain describe everyone but themselves as unhealthily arrogant. I have seen the world's top drug cop, the head of the U.S. Food and Drug Administration (FDA), excoriated as a "thug," a "bully" and even a "killer" by an industry-friendly legislator. And I have listened to the head of one of America's largest drugstore chains turn to me and growl, "These drug companies always hide under the cloak of "We're these great research and development houses and without us there would be no medications.' I think they're full of shit."
The Europeans have a very elegant word for a certain type of drug safety research. The word is pharmacovigilance, and it refers to research that is supposed to be done after a drug has been approved and we're taking it. Because the people who do this work are the sole link between the pharmaceutical world and the real world and are often the bearers of unwelcome news, they sometimes seem like pharmacovigilantes. Over these years, I have been doing my own form of pharmacovigilantism. I use my press credentials to move effortlessly between the camps warring for control of your medicine cabinet.
My quest began with tracking down everything I could find about Floxin. But I realized that the only way to understand what had happened to Diane was to see beyond one pill and journey to the heart of the legal-drug culture: the international pharmaceutical industry, the government drug police in countries large and small, the physicians, the researchers, the pharmacists, the nurses, the consumer advocates--and the patients who unwittingly place their blind faith in this system. In college there was a book we had to read for political science class called The Dance of Legislation, about how a bill becomes law. Since Diane's drug reaction, I have been investigating politicized science and watching "the dance of medication"--how a pill becomes law.
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.
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