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Selling Diseases

This article is part of Big Pharma, Bad Medicine, a forum on the impact of the pharmaceutical industry on medical training and science, and the responsibilities of physicians.

Marcia Angell notes that industry-funded continuing medical education (CME) is marketing masquerading as education. I will focus on this critique because, in fact, CME is the pharmaceutical industry’s most important marketing tool. Through a largely unnoticed process that plays out over a course of years, the pharmaceutical industry uses CME—which, unlike other forms of drug promotion, is not regulated by the Food and Drug Administration (FDA)—to prepare the market for new drugs, expand existing markets, position products against competitors, and promote unproven uses of treatments.

Here’s how it works. Pharmaceutical-company employees, or specialized vendor services, identify opinion leaders—influential (or up-and-coming) health-care professionals at academic medical centers. Physicians are the primary target, but as nurse-practitioners and physician assistants become increasingly important in primary care, these hidden prescribers are also being targeted. Industry’s influence on NPs and PAs has not received enough attention; for example, the recently passed Physician Payments Sunshine Act requires that pharmaceutical companies disclose payments made to physicians, but not those made to other prescribers.

Selected opinion leaders are wooed, perhaps over an expensive one-on-one meal with a company researcher or executive—not someone identified with marketing. In the course of discussing the opinion leader’s work, the industry representative will elicit his or her opinions on a variety of topics, including the “disease state” of interest. Opinion leaders whose perspectives align with a company’s marketing goals are then courted. A company may nurture relationships with targeted health-care professionals over many years and will pay them to educate their peers at CME events and other settings.

Industry-paid speakers frequently deny espousing marketing messages. I’ve heard many physicians justify their pharma-funded speaking gigs by saying, “I never emphasize their product” or, triumphantly, “I don’t even mention their drug!” But these comments only highlight their sales skills. Pharma doesn’t hire doctors to sell drugs; that’s a drug rep’s job. Pharma hires physicians to sell diseases.

The process of selling what industry calls a disease state begins many years before a drug is submitted to the FDA for approval. Specific marketing messages for a product may be developed seven to ten years before a drug goes on sale. Pre-approval marketing messages assigned to opinion leaders might emphasize the _under-diagnosis of a targeted condition, stress the serious consequences of delayed treatment, or trumpet the importance of a new receptor or novel mechanism of action.

A classic way to expand the market for a drug is to invent a disease state or exaggerate the importance or prevalence of an existing condition. Here’s a fictitious example of the latter.

The gurgles and rumbles of an empty stomach are called, in medical-speak, borborygmi (it is one of the few onomatopoeic medical words). Let’s imagine that a company is developing a drug that prevents borborygmi. The first step would be to encourage people to take the disease state seriously. Marketing messages developed while the drug is still undergoing testing might include:

• While the occasional growling stomach is not a cause for concern, regular episodes could indicate the presence of CLASS (Chronic Loud Atypical Stomach Sounds).

• CLASS is not always benign. The distinction between normal stomach rumbling and a symptom of a serious disease can only be made by a physician.

• CLASS sufferers may limit their travel, work, and recreational activities out of embarrassment; some may become reclusive, fearing social stigmatization.

• CLASS can lead to overeating and obesity because sufferers may eat constantly to prevent audible stomach rumbling.

A pharmaceutical company may then begin to recruit physicians to act as mouthpieces for specific marketing messages. A gastroenterologist may be recruited to explain to prescribers that every person with stomach rumbling should be examined to rule out a malabsorption disease. Another physician may be recruited to report that 12 percent of the population has undiagnosed CLASS, and that some patients have become homebound because of the condition. A third could announce that CLASS is a new risk factor for obesity and associated health problems.

Sets of physicians are then invited to medical meetings, including CME events, to educate health-care professionals around the country about CLASS: it is no laughing matter, but rather a common, under-diagnosed condition with potentially serious consequences. Because the disease-state blitz begins years before a product arrives on the market, audiences are unlikely to connect a drug to the sudden upsurge of presentations on the disease it is intended to cure.

Although it is illegal for pharmaceutical companies to promote a drug before it is approved, nothing bars pharma-funded physicians from exaggerating the prevalence, severity, or importance of a disease state at a CME event in the name of education. By the time the new drug launches, the disease state is well-established; ideally, CLASS is accepted as a reimbursable diagnosis, and medical students are taught to treat what once was known to be a harmless manifestation of normal gastrointestinal function.

Other companies that want a piece of the CLASS market may create me-too drugs, and then hire opinion leaders to differentiate their new products from existing ones. When more than one treatment is available, opinion leaders might be assigned to highlight the deficiencies of competitive therapies; compare mechanisms of action (only drug X suppresses CLASS-associated disordered gastric rhythms); or invent diagnostic distinctions by, for example, dividing borborygmi into two subtypes, one of which is tailor-made for a new drug.

Opinion leaders are supported by industry only as long as what they say advances marketing goals. A prescriber who expresses doubts about an assigned product’s efficacy, concerns about its risks, or enthusiasm for a nonmarketable lifestyle change (say, exercise) as a superior therapy, will be dropped from a company’s speakers list.

Industry-paid speakers are pushing a product, even if they don’t realize it, and health-care professionals at industry-funded CME events are listening to marketing messages, even if they, too, are oblivious to this fact. As Angell points out, by paying for CME and other forms of “education,” companies are simply buying access to prescribers. Lawyers, accountants, and other professionals pay for their continuing education. It is time for doctors, nurses, and physician assistants to pick up their own tab.


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Comments

1 |
Mr
Aloha, thank you for your diligent work. may i encourage everyone to save pages like this, and also circulate them in a flier format of your choice! very important work to change our future! i appreciate in depth articles like this, yet simple enough to break down and understand for general public....aloha from Hawaii!
— posted 05/12/2010 at 18:57 by Mr Vincent Leaf
2 |
Your argument suffers from hyperbole.

Education (or marketing) about a disease state is not necessarily inappropriate. In my profession, psychiatry, some very important conditions have been widely underdiagnosed, mostly because of a dearth of specific, effective pharmacologic treatments. When a new drug offers substantially greater efficacy compared to previously available alternatives, accurate recognition of the condition becomes much more significant.

Obsessive compulsive disorder was such an example, when clomipramine (Anafranil) received approval. Recognition of treatment resistant psychosis became far more meaningful after clozapine (Clozaril) was approved. Diagnosis of opiate dependence became vastly more important when buprenorphine (Suboxone) brought a highly effective treatment into the hands of office-based physicians.

This is not to say that abuses don't occur, but promotion of disease awareness is not necessarily a bad thing.
— posted 05/13/2010 at 19:40 by Evan J
3 |
No data of any kind, not even anecdotal, exists to show industry sponsored CME has harmed a patients.

This is part of an insurance company campaign to deny brand name medication to dark skinned medicaid patients. These are not even left wing ideologues. These pharma bashers are insurance company running dogs.

I wonder if the doctor has ever watched the Super Bowl, a very expensive show offered for free. It is the same, an opportunity to advertise to those interested in the product.
— posted 05/14/2010 at 16:29 by David Behar, MD, EJD
4 |
Professional Therapists - one and all
I am 76 and was being treated with one of the newer medications. I almost died. Psychiatrists simply ought to go back to being medical doctors. Their "diagnoses" (DSM's) cause far greater harm than anything; being told that you will "never" recover and that you will have to take drugs for the rest of your life does not create a healthy alternative. Over 25 years of being "treated" by the mental health professionals and working for patients' rights, what has helped me is the support of other ex-patients, friend and family, and an incredibly understanding family doctor.
Irene Lynch
— posted 05/16/2010 at 17:19 by Irene Lynch
5 |
Interesting how an article exposing abuse is denigrated as bashing.

Get real. Frequent urination syndrome, GERD, the ever increasing number of psychaitric conditions, etc. These don't require prescription meds to treat. See the Annals of Internal Medicine on how excessive use of prescription drugs to treat mild conditions is harming patients.

Here is the link //archinte.ama-assn.org/cgi/content/full/170/9/749

Thanks Adriane for speaking out.

— posted 05/18/2010 at 20:50 by Joseph P Arpaia, MD
6 |
marketing-based medicine dominates industry sponsored CME and much of the research literature too
Excellent article.

In response to Dr Behar - the smoking gun backing up Prof Fugh-Berman's viewpoint is in the increasing number of internal Pharma documents released from litigation. For some of these from my own specialty of psychiatry - see http://blogs.crikey.com.au/croakey/2010/03/01/evidence-based-medicine-or-marketing-based-medicine/

Note at the end of my article the link to the strong position of the Indian Medical Council. Despite the many problems in India, their position is far advanced compared to those of medical organisations in more economically developed nations, nations where the links between Pharma and many KOL's and medical organisations are well entrenched.
— posted 05/19/2010 at 10:30 by Dr Peter Parry, psychiatrist, Australia
7 |
My Experience Confirms This Account
I can confirm at least one instance in which what Fugh-Berman reports is true. A large product liability suit against the maker of a blockbuster pharmaceutical product caused another pharma to pre-emptively review the records of its own, competing blockbuster, sales of which provided a considerable portion of the company's worldwide revenues; I assisted in that review. The records examined, which spanned more than a decade, ranged from the earliest lab notebooks in which the product's formula was first sketched out to the latest marketing reports. They included detailed discussions at the highest levels about how to tailor the "disease state" to potential demographic needs (here and abroad) and what marketing messages would best support it. Those messages then guided the design of clinical trials and the preparation and roll-out of the literature campaign that followed, which included work nominally "authored" by thought-leaders but ghosted by outside firms. Many and mercenary were the corporate discussions on how to bring this apparatus relentlessly to bear on the FDA during its review-for-approval of the drug. However, while such behavior may seem questionable from a policy standpoint, it is perfectly rational, some would say required, in a competitive, corporatized market economy. If so, then the problem seems to be how to re-structure these competing incentives.
— posted 05/19/2010 at 16:32 by Anonymous
8 |
An excellent post! This is exactly how psychiatric "diagnoses" have been fabricated.

Philip Hickey, PhD
http://behaviorismandmentalhealth.com/
— posted 05/20/2010 at 16:31 by Philip Hickey, PhD
9 |
Evan J.’s comment is noteworthy in that it appears so reasonable and correct. Who can argue with the notion of reaching out to undiagnosed sufferers? The problem arising with psychiatry, however, is that the so-called illnesses are invented by the APA. This contrasts with general medicine, where illnesses are discovered in nature.

The APA’s definition of a mental disorder is:

“…a clinically significant behavioral or psychological syndrome or pattern that occurs in an individual and that is associated with present distress… or disability… or with a significantly increased risk of suffering death, pain, disability or an important loss of freedom.” (DSM-IV-TR, p. xxxi)

Now if you examine this definition carefully, what it says is: any significant problem of human living. That’s what it means. And successive expansionist revisions of the DSM make it clear that that is exactly how the APA interpret their mission: to bring as wide a range of human problems under the psychiatric umbrella as public opinion will permit.

The problem is particularly pressing in that psychiatry routinely engages the support of law enforcement to promote universal acceptance of its philosophy and the involuntary drugging of increasing numbers of people.

Philip Hickey, PhD
http://behaviorismandmentalhealth.com/
— posted 06/02/2010 at 20:46 by Philip Hickey, PhD
10 |
Solid
Nice article, Adriane. It's also nice to see a fellow Hoya writing for the BR.

Two observations here:

1 - Cash rules everything around me.

2 - It's impressive how many commenters have doctorates here - good readership!
— posted 07/01/2010 at 00:24 by Taylor
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About the Author

Adriane Fugh-Berman, Associate Professor of Physiology and Family Medicine at Georgetown University Medical Center, directs Pharmedout.org, which will be hosting a conference on industry funding of continuing medical education on June 25, 2010.

Part of Big Pharma, Bad Medicine, with
Marcia Angell, Dan W. Brock, Suzanne Gordon, and others.


   



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