Allergic to People?

Allergic to People? The Manipulation of Information by Pharmaceutical Companies Case Study: Paxil

Project Team

Alex Cumsky, Alex Wong, Marisela Chavez, Shuokai Chang

Description

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For our research project we considered the following question, “How have advances in information technology changed public awareness of pharmaceuticals and prescription medication?” In addition, we scrutinized the relaying of drug information between healthcare professionals and drug representatives in addition to the morally questionable tactics of direct-to-consumer advertisements, especially with the rise of sensational marketing via television and the internet.

In 1980 the Bayh-Dole Act essentially launched Big Pharma as a marketable industry when funding for R&D began to include, and quickly depend on, private funding – a role originally filled by the National Institute of Health. During the 1990s research begins to migrate from universities to private corporations and laboratories. In the midst of a wavering economy, clinical research became funded by Big Pharma because it is more cost efficient. The result was complete control of research to the drug companies themselves and what should have been an obvious compromise of impartial information and credibility. However, due to the awesome economic success of the newly invigorated pharmaceutical industry the government turned a blind eye to the questionable workings of Big Pharma.

GlaxoSmithKline’s 1998 direct-to-consumer advertising campaign for Paxil provides a startling example of how embedded advertising is in our culture and how deliberately misleading it can be. GKS and their advertising firm Cohn & Wolfe attempted to rebrand Paxil as not just and anti-depressant, but as the first and only pharmaceutical treatment for Social Anxiety Disorder. This entailed promoting public awareness of SAD, sometimes through insidious means—posters, ads and billboards that appeared to be educational (despite no mention of Paxil in the ads) and were actually created by C&W as part of a larger marketing plan. Paxil advertisements turned largely normal social situations (such as shyness and fear of public speaking) into causes for concern.

Consequently, GSK was able to create the publicly understood problem of SAD in order to market its pharmaceutical answer: Paxil. This made Paxil an incredibly successful product in the drug market, regardless of its debatable medical legitimacy.  This market pressure to sell as many drugs as possible comes at an increasing conflict of interest to proper patient healthcare, which is predicated on slow, careful, non-biased, commercially disinterested research.  The pressure to get drugs quickly on the market, and the increasing marketing power and economic might of the drug companies (provided by a hospitable legal framework), makes it much easier for drug companies to force their products through the normal checks and balances of non-biased review. Doctors and institutions are often paid consulting fees, or have financial stakes in the industry.  The research they are contracted to provide is often biased.  Furthermore, when drug companies cannot manipulate a study to yield positive results, negative results are simply not published or prematurely terminated.  Both biased research and the withholding of negative research studies artificially inflates and over-presents the efficacy and safety of drugs being developed.  As is often the case, only legal action can extract the true information of the effectiveness of these drugs.

In conclusion, commercialization of drugs has led to an increased informational disconnect between consumers, physicians, and the drug industry. This convoluted manipulation of information by the American pharmaceutical industry embodies the dangers of prioritizing monetary incentives over public welfare, all of which carries serious ethical ramifications.

Bibliography

Angell, Marcia, and Arnold S. Relman. “Patents, Profits & American Medicine: Conflicts of Interest in the Testing & Marketing of New Drugs.” Daedalus vol. 103 no. 2 (2002): 102-111.

This article discusses the commercialization of medicine. It mentions some of the contributing factors, the effects, and some possible solutions. The Bayh-Dole Act, passed in 1980, was one of the major factors behind commercialization. The collaboration with academic institutions and other drug testing companies gave control over drug trials to private drug companies. Their manipulation of these trials, along with lax regulation by the FDA, enabled them to put “me-too” drugs, drugs that are simply variations of existing products, on the market. However, these drugs require extensive marketing, often in unethical ways that create conflicts of interest. This information was used in the background portion of our presentation.

Bass, Alison. Side Effects: A Prosecutor, a Whistleblower, and a Best-Selling Antidepressant on Trial. New York: Workman Publishing, 2008.

This book discusses both the conflicts of interest and the scientific misconduct inherent in the drug company and its immediate ramifications on patient care and informed consent. The 2004 New York lawsuit against GlaxoSmithKline is described in detail. Specifically, the selective publication and management of research data by the pharmaceutical companies and its deceptive influence on doctor-patient care is discussed. The book investigates how any drug trial or study can be designed so as to bear positive results. The drug companies and their outsourced health-care resources (Universities, medical Schools, Doctors Associations) are engaged in a coincidental self-deception and patient deception. Everyone appears to be “looking the other way.”

Big Bucks, Big Pharma: Marketing Disease & Pushing Drugs. Prod. Ronit Ridberg. By Ronit  Ridberg, Loretta Alper, Jeremy Earp, and Sut Jhally. Media Education Foundation, 2006. DVD.

This documentary describes several aspects of the commercialization of the pharmaceutical industry and elaborates on several marketing techniques. Companies increasingly flood the market with new drugs. Of all the FDA approved drugs from 1998 to 2004, 78% lacked any actual innovation. Companies market these drugs, which are no better than existing products, by spending billions each year sponsoring programs for doctors. They also market drugs for diseases other than those originally intended, sometimes even inventing non-existent diseases to scare consumers into buying. This information was used in the background and marketing portions of our presentation.

Conrad, Peter, and Valerie Leiter. “Medicalization, Markets and Consumers.” Journal of Health and Social Behavior vol. 45 (2004): 158-76.
This journal article examines the reasons behind the increase in the medicalization of American society – primarily those dealing with relationship between pharmaceutical industries and the FDA, and the control of information and market forces. It focuses primarily of two distinct changes in the medical marketplace: the impact of direct-to-consumer advertising and the recent emergence of private medical markets. This article also uses the case of Paxil and GSK (among other drugs and treatments) to trace the marked increase of pharmaceutical marketing, profits, and consumption. In terms of the ad campaigns aimed at targeting the demand side of the market, the FDA Modernization Act of 1997 increased direct-to-consumer advertising when it allowed broadcast ads to name both the disorder and the drug as long as they contain limited risk and benefit information. GlaxoSmithKline used this to its advantage when launching Paxil into a saturated market for antidepressant SSRIs. With the help of public relations firm, Cohn and Wolfe, ads informing the public about a new diagnosis, social anxiety disorder along with its apparent prevalence in the American population, effectively created a niche in the market for Paxil. The article also goes into more depth on the marketing and advertising strategies, as well as legal deals pulled with the FDA to create what is arguably the most profitable industry today.
Harder, Ben. “Pushing Drugs.” Science News vol. 168 no. 5 (2005): 75-76.
This paper deals with the two-fold attack the pharmaceutical industry is implementing on the American public: on one side sales reps target physicians with samples, gifts, and educational information, while on the other side mass media advertisements urge people to “ask their doctors” about specific brand name medication. This paper is important for our presentation because it reflects the various ways the pharmaceutical industry can create a profitable market by pushing a system of asymmetrical information and incentives.  A marketing strategy used by the pharmaceutical industry most medical professionals refer to as the “free lunch,” is a marketing strategy used by the pharmaceutical industry and its drug reps to increase prescriptions and profits. Many fail to realize the exceptional amount of dollars worth of what are essentially bribes, spent on physicians every year in addition to the billions of dollars worth of drug samples given to doctors which effectively result in prescribing patterns. Finally, this paper gives evidence for the advertising success of the pharmaceutical industry and the resulting high number of prescriptions doctors yield to their oft self-diagnosed patients.

Lane, Christopher. Shyness: How Normal Behavior Became a Sickness. New Haven: Yale
University Press, 2007.

In this book, Lane charts the history of Social Anxiety Disorder (also known as Social Phobia). He describes the key studies that lead to the disorder’s inclusion in the DMS III in 1980, and how the definition of the SAD has evolved over time. Most significant for this project is Lane’s research into and analysis of GlaxoSmithKline and their advertising firm Cohn & Wolfe’s 1998 campaign for Paxil. Lane begins with a brief history of the advertising of anti-depressants (focusing on ads from the 1960s and ‘70s), before segueing into a specific discussion of Paxil. Lane details the groundwork laid by Cohn & Wolfe, which included “educational” ads designed to raise people’s awareness of SAD (with mentioning Paxil) and press releases intended to generate news stories about this overlooked yet severe disorder. This set the stage for a reintroduction of Paxil (which, in 1999, became the first FDA approved drug to treat SAD) to consumers. Lane provide many reprinted examples to Paxil advertising, and he argues that their main goal is to redefine normal behaviors (self-consciousness, nervousness) as symptoms of SAD. For Lane, GKS’s ads for Paxil were not so such about selling the drug, but about selling SAD as a disease that required pharmaceutical treatment.

Moynihan, Roy and Alan Cassels. Selling Sickness: How the World’s Biggest Pharmaceutical
Companies are Turning Us All into Patients. New York: Nation Books, 2005.

Throughout their book, Moynihan and Cassels discuss different diseases and disorders (high cholesterol, Osteoporosis) that they believe have received disproportionate amounts of marketing and medicalization relative to such diseases’ actual prevalence in the world. For the purposes of this project, the sections dealing with depression and Social Anxiety Disorder (SAD) were most helpful. In the depression chapter, the authors detail what they see as the ethically challenged relationship between doctors and pharmaceutical corporations—specifically how pharmaceutical corporations and their (usually not medically trained) representatives sponsor conferences and provide incentives (from pens to luxurious trips) in the hopes of persuading doctors to prescribe specific drugs. This, Moynihan and Cassel argue, leads to many misdiagnosed patients—people who are diagnosed with diseases they don’t have and prescribe medication they don’t need. Even more significant for this project is the chapter on SAD. In it the authors describe GlaxoSmithKline’s advertising campaign for Paxil, going into great detail about the company’s use of skewed statistics (GSK once suggested approximately one out of eight people suffered from SAD (129)) and celebrity interviews to make the disorder seem increasingly common. Moynihan and Cassels conclude that GSK was most interested in creating an expanded market for their product—not in helping those people actually suffering.
The People of the State of New York by Elliot Spitzer v. SmithKline Beecham Corporation and
GlaxoSmithKline. Supreme Court of the State of New York County of New York. June-
July 2004. Print.

This court case outlines how GSK withheld information that its Paxil drug caused negative side effects in children (suicidal thinking and behavior) out of concerns that this information, if disclosed, would have a negative commercial impact. Paxil was not approved for pediatric use, but by FDA rules doctors can prescribe drugs for problems that the drug was not initially approved for, provided that positive research data points to its efficacy and safety. This is considered “off-label” use. This case clearly shows how; in addition to withholding important information, drug companies also deliberately manipulate facts by changing verbiage and wording. Suicidal thinking becomes “emotional liability” etc.
Goode, Erica. “Old as Society, Social Anxiety Disorder is Yielding its Secrets.” New York Times
20 Oct. 1998. New York Times. 21 Jul. 2009 <http://www.nytimes.com/1998/10/20/science/old-as-society-social-anxiety-is-yielding-its-secrets.html?scp=5&sq=social%20anxiety%20disorder&st=cse>

Money Talks: Profits Before Patient Safety. Dir. John W. Ennis. Prod. Kathleen Slattery-
Moschkau and Holly Mosher. Hummingbird Pictures, 2006. DVD.
Stevenson, Seth. “Extroverted Like Me: How a Month and a Half on Paxil Taught me to Love
Being Shy.” Slate Magazine 2 Jan. 2001. Slate Magazine 15 Jul. 2009 <http://www.slate.com/id/2143243/>

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