The Medical Industrial Complex: Disease Mongering, and the Bottom Line
Previously, I discussed one example of "medicalizing," the official creation of new patients out of the healthy population by means of changing the definitions of normality for such common conditions as obesity, blood sugar, blood pressure, and blood cholesterol. This is only one of many approaches to transforming the healthy into the sick. In 1973, the historian-philosopher, Ivan Illich, argued that the medical establishment was "medicalising life itself, medical treatment is mistaken for health care." Just 5 years later in a remarkably candid Fortune article Henry Gadsden, CEO of Merck announced he would like to see his pharmaceutical giant "be more like chewing gum maker Wrigleys" since it had long been his dream to make drugs for healthy people, so Merck would then be able to "sell to everyone."
Disease Mongering: Re-definition and Invention of Diagnoses
In the 1990s Lynn Payer in a magisterial phrase, described widening the boundaries of illness as disease mongering, "the selling of sickness, and growing the markets for those who sell and deliver treatments," Payer accurately described a problem that is growing like a malignancy in our health-obsessed culture.
For the past twenty years we have witnessed Henry Gadsden's dream of selling drugs to everyone evolving into a frightening as well as expensive nightmare. We are deluged with redefinitions of such universal life experiences as personality quirks, now "social anxiety disorder," and minor gastrointestinal complaints, expanded into GI reflux and irritable bowel syndrome. Moreover, normal muscle aches and pains become "arthritis," and even risk factors such as high cholesterol, are being defined as disease. The very concepts of health and illness are being reframed, resulting in a spectrum of normal complaints and behavior routinely being advertised as widespread, severe, and treatable with medication.
We have learned, thanks to investigative journalists, "...how this reality is played out with informal alliances of pharmaceutical corporations, public relations companies, doctors' groups, and patient advocates who promote these ideas to the public and policymakers." Currently, these alliances are working with the media to popularize previously little-known conditions, such as restless leg syndrome. In some cases large diagnostic categories have been defined, for example, "female sexual dysfunction" where there has been a serious attempt to convince the American public that 43% of women live with this condition. There is the case of bigger and better erections and how Pfizer redefined erectile dysfunction to include men of virtually any age going out on a date. This, to the tune of $2 billion a year, and rising. Then there is the Eli Lilly–sponsored promotion of "premenstrual dysphoric disorder," regarded by many as a nonexistent condition, to help sell their-branded version of the antidepressant Prozac© (rebranded as Serafem©)
More on these and other redefined or expanded conditions can be seen at The Public Library of Science sub site.
Because many patients do suffer severe forms of a condition, naturally there will be a large number of individuals who can be helped by the publicity, promotion, and marketing devoted to both the disorder and its treatment. For example, industry-funded awareness campaigns about the treatment and prevention of HIV/AIDS have been invaluable. But in other cases, the same marketing/awareness-raising campaign will be viewed very differently. What an industry-linked professional group may consider to be appropriate, an activist group free from industry ties may regard as a crude attempt to build markets for potentially dangerous drugs.
The Impact of New Drugs for Old Conditions
The supine acceptance by the medical profession of the blood thinner, Plavix©, is a frightening example of the results of a pharmaceutical media blitz. Thanks to manipulative marketing and widespread corruption due to conflicts of interest, sales of the drug, made by Sanofi-Aventis, distributed here by Bristol-Myers Squibb, are up 60% in the past two years to over $6 billion worldwide, making Plavix second only to Lipitor© as the best selling drug in the world! But is it possible that Plavix is safe, and at the same time a therapeutic triumph that saves lives? Plavix interferes with blood coagulation by a mechanism different from aspirin and is routinely used to prevent clots developing after the placement of cardiac stents, though its effectiveness in this setting has been widely questioned.
Plavix alone or combined with aspirin, is also used for hundreds of thousands of patients who are assumed to be at increased risk for heart attacks and strokes. However, a study of 15,000 patients published this year found that adding Plavix ($4.00 a day) to low dose aspirin (2-3 pennies a day) was no more effective than aspirin alone for preventing heart attacks, strokes, and cardiovascular deaths. In fact, Plavix plus aspirin nearly doubled the heart disease death rate, and caused many patients severe bleeding problems, especially in elderly patients with minor head trauma.
This is only part of the story, since it involves the strange case of "aspirin resistance." This is a controversial condition, first described in 2002, which is being used to discredit aspirin, a drug first trademarked by Bayer in1899! Involved further is the rise of companies, such as Accumetrics and Dade Behring which develop, manufacture, and market tests for aspirin/platelet resistance. This is a new multibillion dollar growth industry backed by investors inspired by authorization of coverage by Medicare and private insurers.
Another sideshow is also in progress, the result of a recent decision of the makers of Plavix. In order to avoid a possible infringement suit and loss of its patent rights Bristol-Myers Squibb and Sanofi-Aventis paid Apotex generics $60 million to delay launch of their products. This strategy backfired when the cash payment became the subject of a criminal investigation by the Justice Department. Apotex immediately began marketing the drug while the patent was still in force. As a result, the cost of Plavix is already dropping and may decline by 30% or more.
For further revelations and detailed documentation of these and numerous other conflicts of interest and widespread corruption in industry, medical centers, and the medical profession see the June, 2006 issue of Dr. Paul Rosch's The American Institute of Stress Newsletter.
Lamisil©, a drug for onychomycosis or toenail fungus is a $1.2 billion winner for Novartis which has spent over $236 million in advertising the drug in the past three years. 10 million Americans have taken the drug at a cost of $400 for three months although Lamisil cures only 38% of patients, and then only if they stay on the drug. A dermatologist advised one of my patients that the drug was too toxic for long term use, and she would be better advised to use nail polish. Meanwhile the FDA has linked the drug to 16 cases of liver failure. and 11 deaths as a result of treating this generally benign nail condition.
Another condition, Irritable Bowel Syndrome (IBS) has been cleverly redefined by Novartis to suggest that many with common bowel complaints that are neither persistent nor disabling, such as mild bloating, cramps, and diarrhea, have true IBS. Novartis has thus blown out of proportion these almost universal symptoms to promote their drug Zelnorm© (tegeserod), which received FDA approval in 2002. Thanks in large part to a stunning marketing campaign, millions of TV viewers gaze on naked bulging bellies-mostly female- adorned with Magic Markers displaying the words Abdominal Pain, Bloating, and Constipation, the marketer's "ABC's of IBS." The result: Sales of Zelnorm skyrocketed to $280 million in 2004. Because of 20 reports of life-threatening colitis and related conditions, 21 reports of severe diarrhea with dehydration resulting in hospitalizations, and at least 4 deaths, the FDA considered it a serious health risk and ordered significant changes in its warning label. Yet only recently the FDA approved Zelnorm for the treatment of constipation in patients under 65,"IBS-C,"an approval denied in the EU. Parenthetically since only about 10% of all serious drug reactions are reported, we can assume the numbers of both Lamisil and Zelnorm represent only the tip of the iceberg. Again, I am indebted to Dr. Rosch's Newsletter no. 6.
Medical Advertising and the Public
Prescription drug marketing directly to the consumer, can include virtually any class of prescription drugs, and is routinely permitted under U.S. law. Notable, is the profoundly different regulatory environment in the European Union (EU), Australia, and Canada where pharmaceutical manufacturers are forbidden to advertise prescription drugs directly to the public.
Summary and Comment
While the overall profits of Fortune 500 companies has declined by 53 percent in recent years, the top 10 U.S. drug makers increased profits by 33 percent. These companies had the greatest return on revenues, reporting a profit of 18.5 cents for every $1 of sales, which was eight times higher than the median for all Fortune 500 industries, making pharmaceutical companies easily the most profitable industry on earth.
Around the world, there are tentative steps to identify and combat the threat to human health from the corporate-sponsored selling of sickness. At a consumer level, Health Action International, the activist group working for a more rational use of medicines globally, has for a long time been concerned about what it has described as the blurring of boundaries between ordinary life and medical illness.
The appalling situation of medicalization and disease mongering, has been driven, not only by deliberate strategy of the pharmaceutical and medical equipment industries, but by the resulting deception, and sellout of official bodies, including, but not limited to the "health care professions"-mostly physicians, medical journals, the academic world, advocacy groups, the clinical research archipelago, and most shocking of all, U.S. Government Agencies, and even The World Health Organization!
In short, the American public, increasingly being classified as Patients, is being victimized by a kind of worldwide health conspiracy, what was called by Dr. Relman as long ago as 1980, "The Medical-Industrial Complex," consisting of a mosaic of witting and unwitting accomplices. Not to worry, long before the expense of health insurance goes through the roof, the cost of being Really or Not Really Sick, will finally become unsustainable.
Finally, one out of eight patients in several series requested advertised drugs. In many cases physicians prescribed requested medicines, but were ambivalent about the choice of treatment medicines almost half the time! This suggests that beyond making the public into patients, we are witnessing another striking phenomenon, but one hardly given serious attention: Making the public into doctors.
A friend whose husband with Alzheimer's, currently on Aricept©, told my wife she also wants to be on Aricept. "Why," she was asked, "you don't have Alzheimer's." "Yes, but I have some trouble remembering names and things." "Well, how are you going to get the drug?" "Don't worry. If my doctor won't prescribe it, I'll find someone who does."
Martin F. Sturman, MD, FACP
Copyright 2006, Mathemedics, Inc.
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