The Truth about the Drug Companies
The Truth About The Drug Companies:
How They Deceive Us And What To Do About It
Marcia Angell, MD,
Random House, New York 2004
336 pp. $24.95
ISBN 0375508465
As an MD and for many years editor-in-chief of the prestigious New England Journal of Medicine, Marcia Angell's work life has been uniquely positioned to build an overview of the pharmaceutical industry. Now, as a member of Harvard Medical School's Department of Medicine, she tells us her goals for medicine in America. It should first be a service to the public, but it is failing the public's needs, although it is a colossally successful industry, substantially helped by tax benefits, laws and public support. Angell challenges the industry's insistence that its extraordinarily high prices are caused by research and development costs. The industry in one year was more profitable than all the other Fortune 500 companies put together, about 35 billions worth. This does not include other billions of income that cannot be estimated because of over-the-counter drugs, middlemen, mail order purchases--the list goes on. Its true costs for research and development cannot be estimated because of the secrecy that surrounds the industry, but the numbers officially quoted are far less than any relationship to earnings would suggest, and these numbers are inflated by management and marketing expenses that are unacknowledged. How has a successful and respected industry in the 1970s turned into an overfed gorilla? This troubling situation began with well intentioned laws and a patent system designed to speed tax-supported basic research into useful new products. These laws and the patent system begun in the Reagan era, have resulted in the emergence of too many me-too drugs, and too few innovative new ones. Some of these drugs have become a gravy train for blockbuster distribution fed by heavy advertising. (Most recently, the anti arthritis drugs Vioxx, Celebrex and Bextra, me-too drugs, are the target of lawsuits because of concealed and life threatening side effects of heart disease). The bottom line of costs is always what arouses attention. Not surprisingly, seniors who take so many drugs are rebelling. They are aided by state governments who are footing pension costs. The absurdity of buying back FDA-approved drugs from Canada, that even with added transaction costs are still cheaper than US prices, makes a mockery of the idea that the market adjusts prices to quality and efficiency. The United States is the only one among all the other developed countries, that has no method for price control of drugs. All of this, from Angell's perspective, is totally predictable. She is particularly disturbed by a patenting system that promotes blockbuster drugs aimed at a huge population whether the drugs are really needed or not. New diseases are created by advertising. Heartburn becomes GERD, gastro-intestinal reflux disease, which requires the purple pill Nexium. Prozac, going off-patent, is tripled in price and packaged in pink and lavender for premenstrual syndrome, under an impressive new name. Angell is asking for reform of an industry that now more or less openly controls clinical testing of their own drugs. The requirements are almost absurd, since a drug is not tested against another reasonably effective drug, but against a placebo, which means it need not be better or even as good as another already on the market. In addition there are legally manipulated deterrents for lower priced but equally efficient generics. A the present moment both doctors and the FDA are substantially controlled by the pharmaceutical industry. This is for reasons which are indirect as well as obvious. The Accreditation Council of Continuing Medical Education which certifies the many continuing education courses which doctors take throughout their working lives, accredits hundreds of new firms to offer the programs. These are for-profit firms hired by the drug companies. Big pharma is paying over 60% of the cost of continuing medical education! What about the FDA? The Prescription Drug User Fee Act authorized drug companies to pay user fees to the FDA. This money was to be used only to expedite approval of drugs. Since the 2002 version of the Prescription Drug User Act, fees have almost doubled. Although a small fraction of that can be used for some limited safety monitoring, the lion’s share is still earmarked for speedy drug approvals. Yet the faster the approval process, the more likely it is that dangerous drugs will reach the market. It has happened. Thirteen drugs have been withdrawn from the market after causing hundreds of deaths. These are little known situations, not among the widely publicized stories about the arthritis painkillers. If the money goes to speeding drug approvals, what about monitoring drug safety, gathering data on long-term use, manufacturing standards, regulating marketing--all important tasks for an impartial FDA. If the money that big pharma makes is spent not on research and development, who is doing the research? It is the universities and the National Institute of Health. But therein lies an obvious moral quandary. From an ethics and values perspective the most disturbing augury for the future is the market bubble passion aroused in academic research, and the dependence on direct big pharma money, or money disguised through neutral agencies. Angell is very disturbed that the checks and balances created by government oversight and protections have been coopted by the legal permission given to universities to patent and license their discoveries and charge royalties. Angell wants drug trials to be conducted entirely in nonprofit academic settings with faculty freed from their own financial conflicts. Above all academic institutions should not have equity interest in the pharmaceutical industry. Researchers should have no financial ties to companies whose drugs they evaluate. Hopefully then unfavorable research results would be much less likely to be suppressed, and papers could not be manipulated to emphasize favorable findings. All clinical trials should be publicly registered, and their results available to everyone. Angell's basic suggestion for reform of the industry is in reform of the patent law that has encouraged the enormous profitability of me-too drugs."New discoveries should be useful, novel, and non-obvious." Angell's next recommendation is to strengthen the FDA as an independent agency . This requires public understanding and support. In the meantime she advises us to ask our doctors many questions. Is the new drug better than an old one, because the older the drug, the better the safety record is likely to be. How long has the drug been tested?. She also asks the patient to ask the doctor if he knows who has overseen the drug trials. Obviously this is placing an enormous responsibility for an individual to oversee his own health, when he really wants to trust a professional for advice in an area in which he is almost helpless. We are left with many good suggestions that present problems that are essentially as political as they are medical . But the present system is flawed, and the public is becoming increasingly wary. The prestige and authority which big pharma has enjoyed is fragmenting, and blurring the overall respect which American medicine has achieved. Change is coming but public understanding is needed to ensure that the future is an improvement.
Phyllis Ehrenfeld has received the Arnold Gingrich Award in prose for the most highly evaluated fellowship from the New Jersey State Council for the Arts. She has been Editor of the American Anorexia Bulima Associaton for many years. Several of her plays have been presented as staged readings in the Bergen County area. She is presently representative to the united Nations for the National Service Conference of the American Ethical Union.
The Truth About The Drug Companies:
How They Deceive Us And What To Do About It
Marcia Angell, MD,
Random House, New York 2004
336 pp. $24.95
ISBN 0375508465
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