Seeding, Misleading, Switching, and Stealing: The Vocabulary of Competition in Today’s Pharmaceutical Industry

* Disclaimers:  The image for this post was found on the internet in the public domain and it is in no way identified or affiliated with any entity or particular drug manufacturer.  While the article references specific companies in relation to a Wall Street Journal publication, it is in no way implying those companies, or any other specific companies, have engaged in the practices identified by Dr. Kessler, former Commissioner of the FDA, which are described in this article.

** This article was published in the editorial sections of the Columbia Missourian on July 12, 1995 and in the Columbia Daily Tribune on July 18, 1995.  Please see my Daily Musings post called “Detours” for an introduction to this flash from the past.

Recently, the Wall Street Journal reported that several pharmaceutical companies increased their donations to the GOP to influence legislation that ultimately saved them $1 billion dollars.  It seems Abbott Laboratories, Bristol-Meyers Squibb and American Home Products donated more “soft-money” to the Republicans this past year than the previous six years combined in an effort to eliminate rebates to the government from the sale of infant formula to the Women, Infants and Children program.  Paying off legislators, however, is just one method of dominating the pharmaceutical market, and these corporations go to great lengths to promote products that are much more lethal than infant formula.

More than $58 billion a year is reaped by the U.S. pharmaceutical companies, but each individual company commands only a small share of this monetary battlefield.  Merck and Co., for example, controls the largest market share, dominating only 6.2 percent of the industry.  The fact that each drug manufacturer controls such a small portion or total pharmaceutical revenues fuels fierce competition to influence your physician to prescribe, or misprescribe, medications.  David Kessler of the Food and Drug Administration’s Center for Drug Evaluation and Research cites increasing evidence of illicit drug marketing practices that mislead or literally buy physicians’ prescribing practices.

One such technique is called a “seeding trial.”  The company identifies physicians, not based on qualifications, but by their habits of prescribing competitors’ products.  These doctors are then enticed to prescribe a given medication by signing them on for a drug trial of no scientific value.  Already FDA-licensed, these drugs require no additional studies.  The only criteria for participation is the physician’s willingness to write prescriptions.  Little to no data is collected, and no control groups are used to compare effects of medications.  The physician is paid a flat fee for each patient enrolled, which usually varies from $85 to $500 a head.  Essentially, these false studies are designed to change a doctor’s prescribing habits to a medication with no appreciable benefits to the patients involved.  In a marketing memo intercepted by the FDA, one company highlighted the importance of one such trial in this manner: “If at least 20,000 of the 25,000 patients enrolled remain in the study, it could mean up to a $10,000,000 boost in sales.”

This type of payment for questionable research has resulted in other problems.  In his article “Institutional Conflicts of Interest,” Ezekiel Emanuel documented that institutions and physicians receiving royalties and payments associated with drug research were more likely to fail to provide informed consent; to ignore adverse reactions and complications endangering their subjects; and to introduce bias into the collection and interpretation of data.  If drug companies are eliciting false drug trials and physicians are altering results based on payment for these studies, how can any patient trust that [they are] being prescribed the correct product for [their] ailment?

If physicians cannot be coerced into false studies to change their prescribing habits, then drug companies simply misrepresent the benefits of their products.  Unsubstantiated claims of superiority, minimizing or failing to mention risk and adverse reactions or presenting pharmacokinetic distinctions with dubious relevance are all part of a well-orchestrated false advertising campaign.  A study conducted at the University of San Diego School of Medicine demonstrated that, at best, pharmaceutical representatives were only 89 percent accurate in their advertising statements.  This 11 percent falsification of data could be all it takes for your physician to prescribe a lethal combination of medications.

If “seeding and misleading” can’t get your physician into the manufacturer’s camp, then how about the “switch campaign?”  Insurance companies encourage the use of cheaper generic drugs to hold down health-care costs.  To avoid this loss of revenue, however, pharmaceutical corporations offer direct payments to physicians to “switch” to another dosage form of the same product or to another product in the same therapeutic class.  No real benefit surfaces for the patient, but now there is no generic substitute for the switched classification and no loss of profits for the manufacturer.

If all of this doesn’t make you reach for your antacid, then consider the newest trend in the pharmaceutical industry: stealing.  Drug companies are trying to create alliances with insurers that will allow them to guide the patients’ care, provide their medications and bypass the physician altogether.  A nurse would monitor the patient by phone while hospital and physician visits are discouraged.  The drug company would provide only its products, eliminating the physician’s option to decide form a wide range of medications.  I guess “stealing” prescriptive authority is certainly one way to eliminate the competition, but then again just who is practicing medicine here, and whose interest do you think these companies are representing?

In the Nov. 15 issue of Hospital Practice, Robert Schrier documented a drug-dosing crisis in America that accounts for 60,000 to 140,000 unnecessary death each year.  Adverse reactions resulted in 10.8 percent of all hospitalizations and 14 percent of all in-patient hospital days, and once hospitalized there was an additional 18 to 30 percent chance of experiencing and adverse drug event.  Medication producing dizziness and sedation in the elderly population caused 32,000 hip fractures last year, and potentially life-threatening mixtures of medications were found in 88 percent of all elderly patients prescribed three or more medications.  Prescription medications, taken the way they are ordered, account for more deaths each year than guns (35,000), than high risk sexual behavior (30,000) or even motor vehicle accidents (25,000).  In fact, each year prescription medications kill more people than the entire 16 years of the Vietnam War, during which we lost 57,147 Americans.  With these types of statistics, it is not very comforting to know that our drug manufacturers are illicitly influence the way our doctors treat our ailments.

***

Kessler, D. A., et. al. (1994).  Therapeutic Class Wars – Drug Promotion in a Competitive                        Marketplace.  The New England Journal of Medicine, 331(20), 1350- 1353.

 

Photo:  This photo was found on the Internet in the public domain.  No other attribution could be found.

Update June 3, 2018: It looks like nothing has changed since 1994, except there are probably more zeros after the profit margins of Big Pharma.  Check it out: “Why Prescription Drugs Cost So Much.”  All links are subject to link rot.

 

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