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Selling Sickness: Pharma Industry Turning Us All Into Patients

Mon, 12 Sep 2005

Related Link:
Selling Sickness Prologue

Selling Sickness: How the World's Pharmaceutical Companies Are Turning Us All Into Patients, by Ray Moynihan, an international health journalist, and Alan Cassels, a pharmaceutical policy researcher, is likely to become a best seller because it is compelling, highly readable, and health care budgets are being bankrupted by this industry. By examining 10 disastrous drug-related cases that have jolted public trust in medicine and hugely tarnished the luster of a once admired industry, the authors lay bare this industry's ingenious marketing strategy. That strategy has succeeded in hugely increasing demand for drugs--mostly by healthy Americans. The book's prologue contains the germ that sprang into action validating the authors' premise: that the pharmaceutical industry (Pharma) is no longer focused on selling cures for disease, but rather on marketing drugs to the worried well. The authors recount the candid comments made by the retiring CEO of Merck:

"Thirty years ago...Merck's aggressive chief executive Henry Gadsden told Fortune magazine of his distress that the company's potential markets had been limited to sick people. Suggesting he'd rather Merck to be more like chewing gum maker Wrigleys, Gadsden said it had long been his dream to make drugs for healthy people. Because then, Merck would be able to "sell to everyone." Three decades on, the late Henry Gadsden's dream has come true."

Moynihan and Cassels show how Pharma has used "weapons of mass seduction" to gain public trust and decisive influence over the medical profession, medical practice guidelines, public health policies, and both scientific journals and mass media. It succeeded in gaining control over medical practice and public expenditure through strategic, systematic, and systemic corporate sponsorship. Indeed, this industry has succeeded in shaping our very perceptions of health and sickness to promote "lifestyle" medicines.

Pharma seems to have adopted the marketing strategy of the cosmetic industry, and is creating discontent and anxiety about perceived imperfections; using psychological weapons to prey on people's fear of sickness, aging, loneliness, death - all calculated to create a demand for its latest pill. This immoral sales strategy disregards the fact that--unlike moisturizers, rouge, and perfume - drugs have risks and adverse side effects that are often catastrophic. To overcome this problem, industry has turned medicine on its head. Instead of relying on evidence for the presence of a disease, and evidence of a favorable risk/ benefit ratio to justify a medical intervention, doctors are prescribing drugs based on corporate sponsored "public awareness" campaigns that create "illness."

"[Public] awareness campaigns are turning the worried well into the worried sick. Mild problems are painted as serious disease, so shyness becomes a sign of social anxiety disorder and premenstrual tension a mental illness called premenstrual dysphoric disorder. Everyday sexual difficulties are seen as sexual dysfunctions, the natural change of life is a disease of hormone deficiency called menopause, and distracted office workers now have adult ADD. Just being 'at risk' of an illness has become a 'disease' in its own right, so healthy middle aged women now have a silent bone disease called osteoporosis, and fit middle-aged men a lifelong condition called high cholesterol."

Pharma's unprecedented profit margins attest to the power of suggestion - especially when re-enforced repeatedly through direct-to-consumer advertising. The authors use ten case examples to illustrate how "the vast web of interrelationships between doctors and drug companies" and the absence of independent review, enables Pharma to achieve its goal of selling sickness to an ever widening circle of healthy people. This monolithic corporate influence has resulted in the perversion of the practice of medicine and the goal of the healing profession. Indeed, adverse drug effects are creating chronic diseases requiring additional drugs.

Among industry's tactics is selling to everyone; showering doctors with doughnuts and stock options; hiring celebrities to influence demand; bankrolling patient advocacy groups; and taming the watchdogs (FDA). The selling of sickness and the birth of a blockbuster drug follows a familiar pattern: the marketing division of a pharmaceutical company identifies a wedge condition, and a set of symptoms or "risk factors"; the company hires a PR firm to come up with a "disease" name, either something catchy (e.g., SAD) or something connoting a serious biochemical deficiency; the company either develops a drug, or recycles an existing one for this new condition; and begins massive marketing to physicians and the public. An advisory panel of experts defines the "disease" broadly enough to include as many previously healthy people as possible, and issues guesstimates about the prevalence of the "disease"; the media pick up the story, suggesting that the "new" disease is greatly "under-diagnosed and poses severe health hazards if left untreated; the stage is set for the birth of the next blockbuster. This is how evidence-based medicine is achieved.

By stacking expert medical advisory panels, Pharma is able to lower the bar that defines disease. Thus, in a campaign to promote the idea that "high" cholesterol is a life-threatening health hazard, the diagnostic guidelines that define "high" cholesterol were lowered several times to broaden the population being targeted: from 13 million according to the 1990 guidelines; to 36 million according to the 2000 guidelines; to 40 million according to the 2004 guidelines. Pharma achieved this remarkable cholesterol "epidemic" with help from the expert advisory panels, the majority of who had financial ties to the manufacturers. Eight out of nine of the 2004 panel - including a high official at the National Institutes of Health - served as paid consultants for these drugs' manufacturers. Cholesterol-lowering drugs (statins) bring in revenues of more than $25 billion a year.

Drugs touted for many newly declared "diseases" do little, if any, good; worse, they have often caused much harm. The public has been jolted to learn that the clinical trial results used to gain FDA approval are most often biased, the drugs have been tested only for short duration, and the negative findings have often been concealed. Selling Sickness shows how the combined effort by industry funded medical opinion leaders, PR companies, celebrities, subservient regulatory agencies, an uncritical media, and a chorus of industry-supported patient "advocacy" groups, have helped promote the medicalization of "conditions" stemming from the human condition.

Four of the ten cases are exclusively directed at women. The case of hormone replacement therapy (HRT) as a "treatment" for menopause, encapsulates what is fatally wrong with the marriage of convenience between doctors and industry. Science writer, Barbara Seaman, co-founder of the National Women's Health Network, and author of The Greatest Experiment Ever Performed on Women, is recognized as "the first prophet of the women's health movement" because she was one of the first to recognize that HRT was dangerous, and for decades continued to challenge the promoters of HRT by pointing to evidence of its carcinogenicity. Somehow, Seaman was not mentioned in the book.

No sooner have we recovered from the HRT debacle than a new Pharma funded campaign is rolling full steam ahead to pathologize women's sexual problems - now labeled female sexual dysfunction (FSD). Already FSD promoters are declaring that 43% of women are "affected" by FSD. The treatments being promoted are Viagra patches and hormonal steroids, including testosterone. The market by year 2008 is projected at $1 billion.

Selling Sickness dovetails the release of the powerful film version of John le Carre's fictionalized book, The Constant Gardner (2000). At a minimum the film raises serious questions about the immoral dumping of lethal drugs on Third World populations, and the integrity of industry-sponsored clinical trials conducted in those underdeveloped countries. Both are aimed at general audiences, persuasively demonstrating how industry's control of medicine is perverting the healing profession from improving health to doing great harm.

In the Author's Note to The Constrant Gardner, le Carre states:
"As my journey through the pharmaceutical jungle progressed, I came to realize that, by comparison with the reality, my story was as tame as a holiday postcard."

He goes on, "In describing the tribulations of Lara...I drew on several cases, particularly in the North American continent, where highly qualified medical researchers have dared to disagree with their pharmaceutical paymasters and suffered vilification and persecution for their pains. The issue is not about whether their inconvenient findings were correct. It is about individual conscience in conflict with corporate greed. It is about the elementary right of doctors to express unbought medical opinions, and their duty to acquaint patients with the risks they believe to be inherent in the treatments they prescribe."

See: an international sample of uniformly glowing reviews of Selling Sickness at: www.sellingsickness.com Below review in JAMA and excerpt from Mother Jones.

Contact: Vera Hassner Sharav
212-595-8974

http://jama.ama-assn.org/cgi/content/extract/294/9/1114

BOOK Review JAMA, September 7, 2005 - Vol 294, No. 9
Selling Sickness: How the World's Pharmaceutical Companies Are Turning Us All IntoPatients,
by Ray Moynihan and Alan Cassels,
241pp, $26, ISBN 1-56025-697-4, New York, NY, Nation Books, 2005.
Selling Sickness, directed by Catherine Scott, produced by Pat Fiske, cowritten by Ray Moynihan, videocassette, 52 min, color, $390, rental $75, New York, NY, First Run/Icarus Films, 2004.

At the American Medical Association meeting in June 2005, six separate resolutions were introduced advocating for limitations or outright bans on direct-to-consumer marketing of prescription drugs.1 Marketing, an important if not critical preoccupation of the major pharmaceutical producers, is no longer aimed just at physicians. Since the 1990s, research has confirmed that drug company­sponsored research funding and gift giving could significantly affect clinical trial outcomes and individual physicians' prescribing patterns.2,3 Selling Sickness goes one step further, alleging that, in an effort to increase sales, drug manufacturers have begun to repackage medical conditions and advertise them directly to the general public as diseases in need of pharmaceutical treatment. Companies have benefited from the more permissive climate established in 1997 by Food and Drug Administration (FDA) relaxation of drug advertising regulations.

As a result, the authors argue, current advertisements provide little realistic information about the marginal benefits of drug treatment for most people, while leaving out potentially serious adverse effects. This provocative hypothesis comes at a time of tremendous turmoil in the pharmaceutical industry. In August 2004, GlaxoSmithKline (GSK) settled a lawsuit brought by the New York attorney general alleging concealment of data showing increased suicidal and violent impulses in children and adolescents taking Paxil. As part of the settlement, GSK agreed to establish an online registry of all sponsored clinical studies.

Congressional hearings were held on Paxil in September 2004, and in November 2004, hearings were called yet again on Vioxx, a top-selling antiarthritis drug. It was alleged that despite aggressive public advertising, Merck had not fully disclosed its own research showing increased risks of heart attack and stroke associated with the drug. Amid national headlines, in October 2004 companion proposals were introduced in the Senate and House for the establishment of a national clinical trials registry.4,5 The legislation was reintroduced as a bipartisan Senate bill in March 2005.6 The motivation for the registry is to provide a comprehensive, publicly available, and unbiased source of information about the safety and effectiveness of any drug, biological product, or medical device.

Selling Sickness and its accompanying documentary film claim that consumer- oriented advertising is designed not only to support drug sales, but also to create new markets for drugs by convincing people they need more medicine. Moynihan, an award winning Australian health care journalist, and Cassels, a researcher at the University of Victoria in Canada, bring an international perspective to bear on the United States, which with less than 5% of the population accounts for almost 50% of the global market in prescription drugs (p ix). While drug companies defend their advertising efforts as a means of educating the public and preventing undertreatment, Moynihan and Cassels make the rhetorical point that, in fact, most undertreatment is not located in the industrialized Western nations. On the other hand, the risks of overtreatment, a more probable state of affairs in the United States, are much less recognized and publicized. As a contrast, the authors cite Europe, where in 2003 the central drug regulatory agency put an abrupt stop to Eli Lilly's attempt to advertise Sarafem/Prozac because of "considerable concern that women with less severe pre-menstrual symptoms might erroneously receive a diagnosis of PMDD [pre-menstrual dysphoric disorder] resulting in widespread and inappropriate short and long-term use of fluoxetine" (p 116).

The book is organized as a series of case studies, each focused on a particular drug. Each chapter explores a different aspect of drug marketing, with evidence drawn from published editorials, news reports, academic journals, and, most interestingly, original interviews with physician-spokespersons and pharmaceutical sales experts. One sales executive describes "the art of branding a condition" (p 70) as the synergy created when pharmaceutical companies bring so-called physician thought-leaders, prescribing physicians, and patient advocacy groups together - usually through personal network development and funding for community outreach and scientific study. This same executive notes, "the area that has been most ripe for condition branding has been anxiety and mood disorders" (p 127). Indeed, while the book addresses a variety of medical conditions, including hypercholesterolemia, hypertension, and osteoporosis, the film focuses primarily on the treatment of depression, using the example of Paxil as a focal point. The film emphasizes interviews with patients and parents of former patients and concludes with dramatic excerpts from testimony taken at congressional hearings on the drug.

The book provides a more methodical examination of the specific mechanisms of marketing a drug. These are laid out as a broad survey of a landscape dominated by industry efforts to increase drug sales: advocacy for expanded medical testing and stricter definitions of risk levels to expand the range of use, gifts and research grants as well as cultivation of leading academic physicians as spokespersons, advertisements and publicity appearances featuring celebrities without disclosure of their paid status, funding of promotional activities and materials distributed by patient advocacy groups, publicizing of misleading statistics and downplaying of negative or inconclusive research, lobbying of the FDA for rapid approval or approval of marginally beneficial drugs, and, finally, promotion of drugs as a means of functional enhancement for an otherwise healthy individual. Some of these promotional activities are notable for their subtlety; they pose as educational efforts to increase the public's health. A former sales representative writes that the best "product champions" were physicians who delivered a seemingly balanced message, who were not crude, and who could "sell without selling" (p 39). The running theme of these individual analyses is that marketing drugs is, for the most part, based on a misconception of actual risk-benefit ratios.

While many patients are aptly treated for what may be life-threatening conditions, a great number are not and are instead taking drugs under what amounts to a false premise of great benefit or greatly decreased risk. Selling Sickness is a bracing condemnation of contemporary pharmaceutical marketing techniques. It suffers perhaps from an overly broad brush, and the authors at times seem to apply the general premise of overtreatment with excessive liberality to all drugs. Nonetheless, this book is a welcome, bitter tonic to the surfeit of glossy advertising and lucrative enticements that surround any practicing physician today. It provides substance and legitimacy to the rationale behind emerging efforts to counteract the pervasive influence of the pharmaceutical industry: minimizing conflicts of interest in medical practice and research, publishing the work of authors who are free of excessive industry ties, specifying and clarifying the indications for drug therapy, and providing balanced and dependable sources of information about the risks and benefits of medication use to patients. In our current climate, these are aims with which any ethical physician would agree.

Sue Sun Yom, MD, PhD
M. D. Anderson Cancer Center, Houston, Tex

1. American Medical Association. Resolutions 507, 519, 532, 533, 534, 536 (Reference Committee E). In: Delegates' Handbook. June 2005. Chicago, Ill: American Medical Association, 2005.

2. Als-Nielsen B, Chen W, Gluud C, Kjaergard LL. Association of funding and conclusions in randomized drug trials: a reflection of treatment effect or adverse events? JAMA. 2003;290:921-928.

3. Wazana A. Physicians and the pharmaceutical industry: is a gift ever just a gift? JAMA. 2000;283:373- 380.

4. Fair Access to Clinical Trials Act of 2004 (FACT Act), S 2933, 108th Cong, 2nd Sess (2004).

5. Fair Access to Clinical Trials Act of 2004 (FACT Act), HR 5252, 108th Cong, 2nd Sess (2004).

6. Fair Access to Clinical Trials Act of 2005 (FACT Act), S 470, 109th Cong, 1st Sess (2005).

http://www.motherjones.com/commentary/columns/2005/07/selling_sickness.html

Mother Jones: Licensed to Ill
By Bradford Plumer --- July 25, 2005

One of the biggest concerns in the United States today is that health care costs keep accelerating upwards, growing faster than inflation, faster than our paychecks. But no one seems to be able to agree on why, exactly, costs are climbing so rapidly. About a decade ago Paul Krugman argued, quite convincingly, that health care keeps getting more expensive simply because Americans keep demanding the latest and most expensive treatments, and are prepared to pay good money to get it - well, some of them, at least. As such, rising health care costs per se are nothing to fret over: modern medicine keeps getting better and we should expect to pay more for it.

Fair enough, but here's an alternate theory: health costs are zooming upwards in part because millions of more-or-less healthy Americans are being misled into thinking that they actually have diseases and disorders that require expensive medical treatment. No? Too outlandish? Consider this story. In 1998, Lilly, one of the world's largest pharmaceutical companies, was on the verge of losing its patent on fluoxetine (more commonly known as Prozac) worth over $2 billion annually. However, if Lilly could find a new use for the drug, the patent could be extended. That year, Lilly helped fund a "roundtable" of researchers to gather in Washington D.C., along with staff from the Food and Drug Administration to discuss a scientifically controversial condition called "premenstrual dysphoric disorder" (PMDD), which had only recently, and after much controversy, been included in the appendix of the Diagnostic and Statistical Manual - the bible of psychiatric disorders - as a disorder "under evaluation." But the Lilly-funded researchers soon published an article in a small medical journal suggesting, falsely, that the debate was over and that PMDD could now be considered a "distinct clinical entity," distinct from the stress and tension that can accompany ordinary PMS.....cut...

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