KNOWLEDGE INC.: INTEGRITY FOR SALE IN PHARMACEUTICAL RESEARCH
Introduction
The last half of the 20th century has witnessed enormous breakthroughs in the life sciences. We have found a way to eradicate polio and smallpox, developed the means to transplant a fully-functional artificial heart, engineered CT scan technology that can peer into the human body, and sequenced the entire human genome (essentially the blueprint of life) just to name a few. These and countless other advancements, some would argue, are nothing short of miracles; miracles that have immensely transformed our quality of life as well as the society we live in. More and more people are beginning to believe that the potential capabilities of scientific research are boundless. This has led to a dangerously naïve faith in the work of doctors, researchers, and other “experts” in the field.
Inevitably, along with many of the key medical discoveries of our time has come the involvement of companies that profit from these discoveries. In the free-enterprise economy that has gained so much acceptance around the world, in order to take “the translational step from the lab to the clinic… you need to find money, and that process is driven by profit” (Mangan 2003). In fact, the pharmaceutical industry, one of the key components of modern health care, has become the single most profitable industry in the United States at the end of the 20th century (Conrad and Leiter 2004). But while companies look for profits, the researchers who are working for, sponsored by, or collaborating with these companies must maintain scientific integrity in their work. The inherent problems in this arrangement are not hard to see and issues of conflict-of-interest and research ethics have grown more prominent in recent years. These issues, combined with the intense (and often sly) marketing techniques used by corporations and the ever-growing public confidence in the feats of modern medicine, have resulted in harmful and sometimes deadly consequences. As potentially helpful as modern medical research can be, it is crucially important that steps are taken to educate consumers and regulate academia in order to prevent the interests of profit-seeking corporations from overshadowing the interests of health for the people.
The Medical “Market”
Like most other developed nations, Canada’s economy can be described as a market economy in which goods and services are traded according to their exchange values. Until the last decade, the delivery of health care was never really viewed as a market in the traditional sense. Patients with ailments would approach doctors who would then diagnose the problem and prescribe a treatment. However, with the expansion of direct-to-consumer advertising by pharmaceutical companies and the emergence of extended and private health care, a medical market of sorts has formed in recent years (Conrad and Leiter 2004). Yet while consumers are “supposed to be informed, appreciate differences in quality, and have bargaining power and free choice about buying… these assumptions are often violated in health care markets” (Conrad and Leiter 2004). In this sense, the disadvantages to patients are twofold: they usually do not have the means to attain a sufficient understanding of the drugs yet they are bombarded with marketing campaigns that urge viewers to approach their doctors for a prescription. The newly-evolved medical market has more autonomy to innovatively pursue profit-making opportunities and has consequently facilitated a trend known as medicalization.
The Rise of Medicalization: Paxil and the “Post-Prozac Era”
Medicalization is the process by which non-medical issues become transformed into medical problems in terms of illnesses and disorders. It is a lucrative trend that has become “one of the most potent transformations of the last half of the twentieth century in the West” (Conrad and Leiter 2004). One popular example of medicalization is shown in how male impotence, which was treated as a psychological problem for most of the 20th century, became a medical problem treatable by the now well-known Viagra and other similar drugs.
While male sexual dysfunction is a relatively definable disorder, profit-driven drug companies have also explored the medicalization and treatment of more ambiguous conditions. In 1996, Paxil (manufactured by a company now called GlaxoSmithKline) was approved by the Federal Drug Administration (FDA) to treat depression, a market that was already heavily saturated with a handful of drugs, which along with Paxil, were known as selective serotonin reuptake inhibitors (SSRI’s). Competition was fierce and GlaxoSmithKline responded by applying to the FDA to have the drug approved for treating anxiety disorders as well, specifically social anxiety disorder (SAD) and generalized anxiety disorder (GAD). These approvals were granted in 1999 for SAD and in 2001 for GAD. However, the two disorders were neither well-recognized by the public nor well-defined by the scientific community. SAD had only become a recognized disorder in the late 1960’s and estimates of its prevalence in the population were as low as 2.75% and as high as 13.3%, a discrepancy due to mere differences in the wording of criteria questions (Horwitz 2002). GlaxoSmithKline seized the opportunity created by such ambiguity and launched an aggressive marketing campaign that essentially uncovered a “hidden” mental health epidemic. Citing the 13.3% prevalence rate, the company claimed that one in eight people suffered from SAD and television advertisements showed everyday social scenarios that caused anxiety, portraying SAD as an extremely common condition (Horwitz 2002). GlaxoSmithKline also sponsored SAD public awareness campaigns that made no mention of the company’s involvement (Koerner 2002). Critics referred to the trend as the “medicalization of shyness” (Lianne 2005). Subsequently, with the approval of Paxil to treat GAD in 2001, a similar campaign was launched. This time, even local newscasts joined in on the hype by raising awareness of GAD, often using the very footage that was sent to them directly from GlaxoSmithKline’s public relations department (Koerner 2002). This footage included a segment featuring Dr. Jack Gorman, an esteemed psychiatrist at Columbia University who also happened to serve as a paid consultant to GlaxoSmithKline (Koerner 2002).
Unfortunately, these types of marketing campaigns are commonplace in what has become known as the “post-Prozac era” of drug marketing. In the post-Prozac era, pharmaceutical companies advertise a (often ambiguously defined) disease instead of directly promoting a new drug. GlaxoSmithKline, for example has been able to repeatedly infer that shyness and worrying may in fact be medical problems (Conrad and Leiter 2004). This technique has created a surge in the use of mind-enhancing medications: in 2004, “Canadians filled over 45 million prescriptions for psychotropic medications, a 40% increase over the figure in 2000” (Lianne 2005). The applications of Paxil and other SSRI’s have been referred to as “cosmetic psychopharmacology” and “cosmetic neurology” due to their widespread use as artificial enhancements (Conrad and Leiter 2004).
The fact that a pharmaceutical company can almost “create” a widespread epidemic using a disorder that possesses so vague a definition is shocking, but it would not have occurred without the participation of consumers, so-called “experts” and of course, the pharmaceutical industry itself. Year after year, the public seems to put more faith in science and technology to not only solve serious problems, but significantly enhance quality of life as well. This consumer confidence in the power of medicine is simultaneously encouraged and abused by researchers such as Dr. Jack Gorman, who help conduct advertising disguised as medical advice in newscasts (Koerner 2002). The use of such “experts” by pharmaceutical companies results in a heavily biased perspective of the drugs in question, leading to the widespread view that they are highly effective drugs that can eliminate anxiety without significant side-effects. Unfortunately, many of the symptoms targeted by SSRI’s are rooted in complex psychological imbalances that are still unclear (Horwitz 2002). The fact that we may feel nervous or anxious in certain situations is not because we need more pills, as many have regrettably come to believe.
Amid all the publicity about SAD, GAD and the drugs that alleviate these disorders, the seriousness of drug side-effects was brushed aside. In 2002, reports finally began to surface regarding the severity of withdrawal symptoms from Paxil. Many lawsuits were filed alleging that the GlaxoSmithKline and their researchers failed to make the public fully aware of negative clinical trials showing that Paxil had not only negligible effectiveness in adolescents but also managed to cause more suicidal thoughts than a placebo.
The Controversy over Drug Trials: Nancy Olivieri and the Ethical Dilemmas in Industry-Academia Collaboration
The fact that authorities approved Paxil yet missed serious side-effects that surfaced much later shares some similarities with the introduction of oestrogens. At first recommended for preventing cardiovascular disease in post-menopausal women, oestrogens were later found to do the exact opposite, increasing one’s risk for developing “myocardial infarction, stroke, thromboembolism and invasive breast cancer” (Meland 2003). Some have openly asserted that the ignorant, initial widespread recommendation for the use of oestrogens were due, in part, to “experts” who had commercial affiliations and profited from such recommendations (Meland 2003). Assumingly, these interests may have adversely affected the objectivity of researchers. Unfortunately, drug companies have also played more aggressive roles in the manipulation of research findings.
Consumers got a detailed glimpse of the nasty ways in which drug companies actively withhold negative results when Nancy Olivieri’s story fell under the public eye. As a researcher at the Hospital for Sick Children of the University of Toronto, Olivieri had collaborated with a Canadian pharmaceutical company called Apotex to conduct clinical trials on an experimental hemoglobin treatment. When she found that the treatment was not only ineffective but also showed toxic effects on the liver, Apotex aborted the trials and threatened Olivieri with legal claims, saying that she could not share her findings due to a non-disclosure clause (Baird et al. 2002). On the contrary, Olivieri felt that she was legally and morally obligated to report the results and subsequently forced a controversy that began to involve her hospital and the University. The University of Toronto failed to back up her position, but instead removed her title as director of the department of haemoglobinopathy at the hospital. Some suggest that the University was influenced by an expected upcoming $20-million donation from Apotex (Blumenstyk 1999). Although Olivieri was given back her job and commended for her integrity in the face of immense pressure, the incident made headlines across the country and raised awareness of the shocking problems that faced industry-academia collaboration.
Olivieri stood steadfast to her own morals and values as a researcher despite threats from her sponsors and disciplinary action from the very university that should have protected her (Schafer 2004). It is not hard to imagine however, that there are quite a few in the scientific community who would be far more complacent to such pressure. Here lies the real issue: researchers in labs around the world who experience situations similar to that publicized by Olivieri may instead choose to keep quiet, or even alter their findings to better satisfy the interests of companies.
Regulations: Discouraging Conflict-of-Interest and Reducing the Influences of the Market
One obvious question remains after realizing the perils of industry-academia collaborations and the capabilities of corporations to pursue profits at the cost of consumer safety: How do we prevent or at least reduce such incidents in the future? While some point the finger at corporate practices, many maintain that it is the institution’s responsibility to uphold scientific integrity through regulations (Blumenstyk 1999). Still others argue that most Universities already have well-established conflict-of-interest regulations and that it is the enforcement of these regulations that needs to be stepped up (Mangan 2003). In some nations, national governments have established scientific ethics watchdogs to specifically look for dishonest practices, flawed protocols, and inappropriate use of statistical theory among other issues (Meland 2003).
Conclusion
Scientific research is now more powerful than ever as a tool for discovering our world, a fact that is well-exemplified by recent advancements in the field of medicine. However, with the emergence of the medical “market”, health care delivery has also become increasingly complex. Large corporations such as those in the lucrative pharmaceutical industry have a paradoxical relationship with the scientific community: they are encouraged to integrate seamlessly with medical research in order to deliver new, potentially life-saving drugs as quickly as possible yet still maintain a sufficient distance to prevent over-involvement with and influence over research findings. To make matters worse, these same companies are using marketing schemes that have intensified the medicalization of mild and ambiguously defined disorders. While pessimists may see these trends as indicators of an unavoidable reality in which profits come before health, the strict regulation of industry influences and constant vigilance over the ethical implications of corporate actions will effectively ensure that this medical “market” is more beneficial than it is harmful.
Works Cited
Baird, Patricia et al. “Clinical Trials and Industry.” Science 297.5590 (2002): 2211.
Blumenstyk, Goldie. “Universities Urged to Protect Scholars Whose Findings Anger Companies.” Chronicle of Higher Education 45.31 (1999): A44.
Conrad, Peter and Valerie Leiter. “Medicalization, Markets, and Consumers.” Journal of Health and Social Behavior 45 (2004): 158-176.
Horwitz, Allan. Creating Mental Illness. Chicago: University of Chicago Press, 2002.
Koerner, Brendan. “Disorders Made to Order.” Mother Jones 27.4 (2002): 58-65.
Lianne, George. “Are You Ready for Your Mental Makeover?” Maclean’s 118.25 (2005): 32-37.
Mangan, Katherine S. “Medical Research Ethics under the Microscope” Chronicle of Higher Education 49.46 (2003): A22.
Meland, Eivind. “Research Ethics Revisited.” Scandinavian Journal of Primary Health Care 21 (2003): 130-131.
Schafer, A. “Biomedical Conflicts of Interest: A Defence of the Sequestration Thesis – Learning from the Cases of Nancy Olivieri and David Healy.” Journal of Medical Ethics 8 (2004): 8-24.
Work Consulted
Chatterjee, Anjan. “Cosmetic Neurology: The Controversy Over Enhancing Movement, Mentation, and Mood.” Neurology 63 (2004): 968-974.
(Image by Jane Wang)