A psychiatrist, pharmacologist and medical historian who trained in Dublin and Cambridge, David Healy invokes Armageddon, the final battle between good and evil, to portray the current--hopefully not permanent--domination of medicine by a huge for-profit industry. Until the 1970s, medical tests and pharmaceuticals mainly targeted life-threatening diseases. Since then chronic disease management has been the growing focus. Drugs modify risk and lifestyle factors because that's where the money is, not because the results are good. A century ago "patent medicine" was not a term of respect; the science of pharmacy is tainted by selective reporting of research, advertising to consumers, and coddling physicians.
The ten top-selling drugs do relatively little good but account for $60 billion in annual sales. These "blockbusters" rose from 6% of the market in 1991 to 45% in 2006: "the big money now lies in marketing chronic diseases for which the current best selling drugs in medicine offer little benefit." (10) Consider the recent invention of "Low-T." Levels of testosterone normally decline with age and there is no evidence that raising them will do more good than harm. Television advertising of prescription drugs enriches our media; for good reason, direct-to-consumer ads of pharmaceuticals are illegal everywhere except the U.S. and New Zealand.
On-patent drugs greatly increase the cost of health care but doctors spend even more on remedying problems caused by drugs! (p. 11) Our concerns with lowering cholesterol, blood pressure, etc., lead Americans to spend far more on chronic prevention, as it were, than people in other countries who are healthier without it. Pharmaceutical companies learned their ad approach from purveyors of turn-of-the century patent medicines--quacks. Nowadays the same techniques persuade millions to buy bottled water and treatments for invented conditions like "Low-T" and "overactive bladder." In the 1960s, "magic bullets" like Penicillin, anti-hypertension and antipsychotic drugs did not need advertising, but the scene was set because they were available by prescription only and profits mounted with "the emergence of blockbuster branding in the 1980s." (26)
Doctors want to practice evidence-based medicine, which the pharmaceutical industry also advocates. The problem comes from the way those companies tweak the evidence. The Food and Drug Administration (FDA) is permissive judge. Only two statistically significant trials of a new drug will pass muster with the FDA, though there may be 98 misses! Healy's critique concerns the lack of access to basic data in drug trials. The FDA accepts findings that appear positive, but allow the drug company to list deaths as dropouts rather than as victims of the experiment. Negative results with new drugs need not be published, while many favorable ghost-written reports appear in respected journals under the names of researchers. Small differences between placebo and a medication on trial can become statistically significant without being clinically significant. Beating the placebo is not difficult; in clinical trials SSRIs were no better than older antidepressants but that comparison is not published. Journals hesitate to carry critical articles about new drugs because they may be sued. New drugs without real merit have repeatedly been made into best-sellers by physicians who don't understand how the system really works. As a result we pay twice as much for medical care that is only half as good as that of dozens of other nations, while untoward side effects of "successful" drugs decrease life expectancy here compared with other developed nations.
Ambiguities in psychiatric classification invite promotion of a single drug for both anxiety and depression. After the tranquilizers Valium and Librium came the SSRIs--selective serotonin reuptake inhibitors--in the 1990s. Some earlier antidepressants had an effect on the neurotransmitter serotonin and the SSRIs were no more selective than some older drugs! Depakote was approved by the FDA for the manic pole of manic-depressive illness. Abbott, its maker, could not legally say it prevented mood swings, so the term "mood stabilizer," which has no precise meaning, served as an advertising term (like tranquilizer and SSRI). Meanwhile manic-depressive illness, a rare and serious ailment affecting ten people per million, was renamed "bipolar disorder," a milder illness treatable in outpatients that affected 50,000 per million. Many doctors were persuaded that these patients were better served with prescriptions for costly mood stabilizers (Zyprexa, Seroquel) rather than equally effective and cheaper tranquilizers and antidepressants.
It takes a keen historian with expert knowledge of pharmacy and finance to explain the drugging of America so clearly, as Erectile Disfunction replaced impotence, boisterousness was labelled Attention Deficit Hyperactivity Disorder, and anxiety morphed into panic. "Disorders that were once defined by patients' needs for medical services and doctors' perceptions of their pathology are now increasingly defined by the goals of marketeers." (38). Bipolar disorder and osteoporosis, formerly rare, became common. Medicine changed "from a profession deeply hostile to marketing into a marketer's dream." (39) Healy analyzes marketing practices, fine-tuned instruments used on consumers at one level and doctors at another. "The normal elevations of blood lipids and thinning bones that go with age are transformed into diseases...subject to fashion with the main determinant of the fashion cycle being the patent life of the drug." (60)
Cholesterol has created a huge market; Lipitor made $12 billion in sales in 2008. Ads say it reduces the threat of heart attack by 36 percent. Typically this can be supported by a study in which three percent of men at risk and on placebo have a heart attack compared with two percent on the drug. This is a 50 percent reduction in relative (not absolute) risk. Patients and doctors alike may know this and still not appreciate that the reduction does not apply to people without a history of heart disease. Healy states that using pills to reduce cholesterol appears to increase mortality. Osteoporosis, another vogue, began in 1988, proclaiming normal bone thinning in women as treatable disease. (172) The "health products market" seems to have replaced the practice of medicine. "No pharmaceutical company is ever likely to provide a scanner, meter, or rating scale for medical care that focuses on the person rather than a disease." (191)
Healy has a broad historical perspective on the tools and ethics of medicine. French psychiatrist Phillipe Pinel (1745-1826), who opposed the growth of polypharmacy in his time, wins praise as a pioneer in diagnosis, humane treatment and prognosis. Also lauded is Frances Kelsey, whose FDA review in 1960 kept thalidomide from damaging countless fetuses. She noted inadequate testing and resisted corporate pressure. "When it came to drugs, the management of pregnancy became the one area of medicine that most closely conform to Pinel's hope for all medicine--that doctors in knowing when not to prescribe would demonstrate the highest medical art. Many think this still is the case but today's reality is quite different" (43)
I am not alone in the opinion that if you have to ask your doctor for an advertised drug, you need a new doctor. When I was in medical school it was unethical for doctors and hospitals to advertise. Newer often is worse, not better. One should wait until a drug has been on the market for several years before assuming it is safe: side effects emerge as time goes on. FDA approval is less a green light than a flashing yellow. First users of new prescription drugs are part of a very large unofficial experiment. We owe respect to David Healy for his knowledge, diligence and idealism. This and his other writings require expertise and courage. He knows he is an underdog in this battle and fights on for the benefit of patients and the medical profession itself. More power to you, Doctor Healy!
© 2014 E. James Lieberman
E. James Lieberman is Clinical Professor of Psychiatry emeritus, George Washington University, and co-editor of The Letters of Sigmund Freud and Otto Rank: Inside Psychoanalysis (2012).