The Risks of Prescription Drugs

The primary thesis of this book is that greedy drug companies, along with government and professional bodies who have grown dependent on industry funding, have colluded for many years to rip off the American public and expose patients to the unnecessary risks of new drugs that by and large are no better than existing products but are more dangerous and expensive. The book suggests that in the case of psychiatry and some other fields, new illnesses are created or inappropriately expanded by manufacturers looking to create new markets for these drugs, often with the help of physicians and investigators who are paid to support this effort.

The editor and all but one contributor, who is a family physician, are sociologists, and the book has a sociological and, at times, polemical orientation. For example, it is argued that attention deficit hyperactivity disorder has been diagnosed more frequently recently because drug companies have developed new treatments for it, the promotion of which has led to more new “patients.” The book also includes a discussion on how social anxiety disorder, which was once vanishingly rare, is now common because manufacturers have gotten an indication for existing products, such as paroxetine, or have developed new medications that are no better. There is a section devoted to the assertion that manufacturers minimized the finding of the Women's Health Initiative that hormone replacement therapy was more dangerous and less helpful than previously believed, and the Food and Drug Administration (FDA) dragged its feet in letting physicians know about the important implications of this finding. There is also a section on how only a single crusading FDA employee battling the FDA-industrial complex saved the United States from the epidemic of teratogenicity resulting from the unnecessary use of thalidomide in other countries for minor sleeping problems. Nevertheless, medications are released into this country without adequate data on adverse effects, and this is getting worse because the FDA has sped up the approval process to help manufacturers extend the working patent life of their products.

The solutions to these political and economic issues are also political and economic: public funding of new drug testing, which must demonstrate superiority to existing products in the same category; elimination of the effects of marketing on practitioners and patients; prohibition of off-label use of medications; and following guidelines of the American Medical Student Association that are endorsed by Senator Grassley. These guidelines, by the way, include, among other things, banning pharmaceutical representatives from all academic sites, providing unrestricted educational and research grants from big Pharma to institutions rather than to departments or individuals, and limiting compensation from and ongoing relationships with industry.

The book is very well edited, if repetitive at times, and it contains some very useful facts and references. However, anyone expecting a balanced discussion of interactions of medicine with industry with realistic and novel ideas for change will be frustrated by incessant reminders of the avarice of industry, the weakness of physicians, the lack of scientific rigor of researchers, and the flimsy regulation by government of medication use. Many of the points that are made are important and valid, but without adequate consideration of scientific and clinical issues in pharmacotherapy, they only evoke a negative reaction toward the entire field. For example, the reason why all negative effects of new treatments are not apparent at the time the treatments are released is not just that manufacturers conceal or minimize negative results: it takes three times as many patients to find important adverse events as it does to find a therapeutic effect, and it takes much longer to find rare but serious adverse effects. A new treatment may not be better than existing ones for a majority of patients with a particular disorder, but it may present considerable benefit for a subgroup for which the cost is justified by the benefit, as occurred with gefitinib, an epidermal growth factor receptor antagonist that was not statistically superior to existing treatment for refractory lung cancer but turned out to be highly effective in a small percentage of patients with a particular genotype. The benefit of a new treatment may be more apparent in combination with another medication than by itself. Overall, I had hoped for more suggestions about teaching clinicians how to interpret scientific data in the context of marketing, rather than another book about the pharmaceutical “evil empire.”