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How Big Pharma Defines What is Sick and Healthy

David Healy’s Pharmageddon Adapted to the Risperdal Case


Text by Maria-Antonie Ellendorff (Freie Universität Berlin)


Art by Pablo Dohms



The American healthcare company Johnson & Johnson (J&J) is, with about 80 billion US dollars in revenue each year, currently the leading biomedical producer in the world. The latest achievement has been its 2021 covid19 vaccine, which additionally added to the company’s market value. The company usually makes 90% of its profits from medical devices and prescription drugs, the other 10% from selling consumer products[1]. In 1993, the atypical antipsychotic drug Risperdal[2], developed by Johnson & Johnson’s subsidiary Janssen Pharmaceuticals Inc., was approved for sale in the United States by the U.S. Food and Drug Administration (FDA). Risperdal is used to treat schizophrenia, bipolar disorder and autism, especially in children and adolescents. It was the company’s first antipsychotic drug since the 1960s, and in retrospect it has been a blockbuster drug ever since. In 2007, Risperdal was the most profitable drug in Germany and the WHO added it to their List of Essential Medicines. Nowadays, Johnson & Johnson find themselves confronted with more than 10.000 lawsuits concerning, amongst other things, the aggressive marketing of Risperdal for use in people with dementia; although the company knew that a treatment with Risperdal would increase the chance of heart attacks and other lethal conditions in elderly drastically. Furthermore, numerous civil lawsuits ensued on behalf of children who, as a side effect of the treatment, grew breasts (gynecomastia). Not to mention the most common, yet no less severe and depressing side effects such as motor impairments, dizziness, loss of libido, severe weight gain, skin disorders etc. Risperdal still sells for over 300 million USDs each year.[3]

In this essay, I want to argue that pharmaceutical companies like Johnson & Johnson can still sell harmful and potentially life-threatening drugs like Risperdal by changing the public perception of what is sick and what is healthy in their favor. Moreover, I want to question the paradigm of the ‘greater good’, which is often used by big pharma to justify their drugs’ considerable side effects. To underpin my considerations, I will take a closer look at the work of psychiatrist and psychopharmacologist David Healy, and especially his use of the term Pharmageddon (2012).

Healy dedicates his work to the history of psychopharmacology, clinical trials in psychopharmacology and the impact those trials and the use of psychoactive drugs have on modern healthcare. The title of his 2012 monograph Pharmageddon sounds like the pamphlet of conspiracy theorists or an apocalyptic action movie; in fact, Phramageddon is a quote of Great Britain’s then leading health care consumer advocate Charles Medawar. By using the term Pharmageddon, Healy and Medawar go beyond a mere pharmaceuticalization as they are emphasizing a paradox. Not just our pharmaceutical consumption changed, but the drugs themselves (Healy 2012, 4). Medical treatments that were invented to heal us are now damaging us. The reason for us staying with this system is that individually we profit from modern drugs. They make our everyday life easier, more comfortable, less pain- and stressful and more beautiful, while collectively we are losing sight of where these innovations lead us (ibid., see also Healy 2002, 2). Healy concentrated his work on northern American and western European settings. This can be seen as one of its main flaws, as he does not take into consideration the impact big pharma (which is so far mostly located in the global north[4]) has on other medical systems and the perception of health in other parts of the world. As for now, I will adapt Healy’s regional focus.

Here, I want to discuss three turns of events in the modern era of medical practice. Healy highlights as major stepping stones for what he calls Pharmageddon, using the aforementioned example of Johnson & Johnson’s Risperdal. I do not want to narrow down complex and long-lasting processes to an over-simple one-two-three-scheme. Rather, I want to distinguish how post-war globalism, capitalism, and an expanding pharmaceutical industry are intertwined and how these factors ultimately can shape, “[o]ur very ideas of ourselves” (Healy 2012, 237).

In the 1950s, the way drugs were patented changed. From then on drugs would only be patented for several years, and the pharmaceutical companies therefore had an increased interest in producing blockbuster drugs, which they could sell most profitably during that period. The new patent law also led to the aggressive marketing we still have, as companies could only exclusively sell their drugs within a limited period of time before significantly cheaper knock-offs would flood the market. In the case of Risperdal, Johnson & Johnson was in the urgent need of a new blockbuster drug to replace their original antipsychotic Haldol[5], which had been on sale since the 1960s and which ran out of patent in 1986. Although there are no mentionable differences in the effect of both drugs[6], Risperdal was meant to break all selling records the widely popular Haldol had established before. The first business plan scheduled over one billion USD in US-sales[7] a year until the turn of the century, which meant Risperdal had to be used by tens of millions of Americans. Considering the prevalence of psychotic disorders that Risperdal was accredited for at the time[8] lies at just around one percent. Johnson & Johnson had to therefore broaden their target groups to those, not included in the FDA approval.

I will let the Johnson & Johnson story rest for a moment and come back to Healy’s Pharmageddon. Besides modern patent laws, Healy identifies the, also in the 1950s established, prescription-only status of high potent drugs as another driving force of pharmaceuticalization (Healy 2012, 247 f.). By making drugs only available on prescription, doctors instead of patients have become the main consumers. Doctors can profit from collaborating with pharmaceutical companies and are, as medical professionals, typically not familiar with marketing strategies. Unlike patients’, their own wellbeing is also not at risk.

As stated before, Johnson & Johnson found themselves in quite a dilemma in 1993 as they could not meet the selling target they had established for Risperdal by only selling it to the FDA-approved target group. The off-label[9] prescription of drugs by doctors is possible, even common, but for companies it is prohibited to advertise the use of their drugs for non-FDA-approved conditions. Johnson & Johnson had to find a way around the law to access broader consumer groups. Instead of recruiting thousands of doctors and running the risk of calling the FDA’s attention, Johnson & Johnson would silently promote Risperdal to institutions, like state-run Medicaid programs, nursing-homes, mental health facilities, etc.. Omnicare, a company which provides nursing-homes with pharmacy services is one example of how Johnson & Johnson avoided the FDA’s restrictions. In 1997, Omnicare and Johnson & Johnson signed a contract, which assured Omnicare tens of millions of dollars to sell Risperdal to patients to calm restlessness and other minor health conditions.[10] At that point, the FDA as well as Johnson & Johnson knew about a high risk of strokes and other potentially life-threatening heart-related diseases in the elderly induced by Risperdal use.

Coming back to Healy’s Pharmageddon and the idea of evidence-based medicine, the term evidence-based medicine was first introduced in 1990 and simply means that the effectiveness of medical treatments has to be proven in empirical trials before their approval by the FDA. That way, the influence, the pharmaceutical industry has on the development and distribution of drugs was meant to be contained. The opposite happened. The pharmaceutical companies, in cooperation with doctors they pay, design and run the tests themselves. Side effects, however crucial they might be, are not taken into consideration as long as they are not statistically relevant. The statistics, presented to the FDA or the patient in the end, seem value neutral but are in fact highly biased (Healy 2012, 241, see also Petryna 2011, 314). As I mentioned in the first passage, many young boys as a side effect of taking Risperdal struggled from hormonal imbalance, which caused them to grow female breasts. Risperdal was tested on 592 children, 489 of them were boys, 22 of the boys suffered from gynecomastia, which makes a chance of 4.5 percent for boys to develop gynecomastia when using Risperdal. Johnson & Johnson knew that rate was way too high for Risperdal to ever get approved by the FDA, so a team of three Johnson & Johnson employees and two doctors, who were paid by them as well, did a ‘re-analysis’ of the data. They cut out the boys over the age of ten (as they are not children anymore) with gynecomastia and instead brought the girls, who are less likely to be affected, back in and got to a 0.8 percent risk of children developing gynecomastia in connection with taking Risperdal. In 2006, the FDA approved Risperdal for the use in children and adolescents.

There are two main observations I made while dealing with Healy’s work and the Risperdal case I particularly want to stress: Using the example of Risperdal, I was able to demonstrate how a pharmaceutical company, in collaboration with medicine, and under benefitting political circumstances, can produce an artificial medical demand. In doing so, conditions which were formerly understood as somehow normal were then marked as worth treating (see also Maris 2015, 158). Insofar the growing pharmaceutical industry does not just produce drugs, but diseases as well (Healy 2003, 4, see also Davies 2021,12). Secondly, Johnson & Johnson employees repeatedly defended Risperdal despite the well-known side effects as beneficial for the majority of the patients. While that is true, it can in conclusion be stated that this also matches the paradox Healy calls Pharmageddon. A majority of the population personally benefits from modern pharmaceuticals. They seem to make us happier, healthier and more productive. And as long as that majority still finds it appropriate to use highly potent drugs on ill-behaved children and clouded elderly, the pharmaceutical course is not likely to change.

In 2013, Johnson & Johnson agreed to pay 2.2 billion USD in criminal and civil fines for promoting Risperdal to children, elderly, and people with developmental disabilities. That is the largest settlement for the illegal marketing of a drug in US history and still, Johnson & Johnson without much doubt still financially profited from their crimes.



Notes

[1] J&J includes popular drugstore brands, like Listerine or Neutrogena. [2] All information on Risperdal is from a 15 chapter story the journalist and lawyer Steven Brill published in the Huffington Post and from original documents, that were published in the course of a lawsuit against J&J in 2013. All references are cross-checked with other media as well. [3] J&J’s patent expired in 2003, which opened the market for no-name or low-price brands, who adapted the chemical composition of Risperdal. Therefore, Risperidon (the active substance in Risperdal) is even more widespread, than the J&J statistics can illustrate. [4] On test recruitments in Brazil and Poland see: Pertyna 2011. [5] Haldol is considered a first-generation antipsychotic drug. [6] That is the conclusion stated by the then FDA doctor Paul Leber in a statement from 1993. The corresponding document is published within the Steven Brill article. [7] The US-sales make about two thirds of all sales. [8] Originally, Risperdal was only approved for treating schizophrenia. Only in 2003 the short-term use on other disorders and later the treatment of children and adolescents was approved. [9] Off-label means the medication of conditions, which are not indicated on the FDA approval label. [10] The most prescribed psychiatric drugs in the US are for anxiety and depression, not schizophrenia or bipolar disorders (Maris 2015, 160). Therefore, it made sense for J&J to broaden their range of application.



References


Brill, Steven. 2016. “America’s Most Admired Lawbreaker.” Accessed July 16, 2021. https://highline.huffingtonpost.com/miracleindustry/americas-most-admired-lawbreaker/


Davies, James. 2021: Sedated. How Modern Capitalism Created our Mental Health Crisis. London: Atlantic Books.


Healy, David. 2002. The Creation of Psychopharmacology. Cambridge: Harvard University Press.


Healy, David. 2003. The Antidepressant Era. Cambridge: Harvard University Press.


Healy, David. 2012. Pharmageddon. Berkley: University of California Press.


Maris, Donald. 2015. Pillaged: Psychiatric Medications and Suicide Risk. Columbia: The University of South Carolina Press.


Petryna, Adriana. 2011. “Pharmaceuticals and the Right to Health: Reclaiming Patients and the Evidence Based of New Drugs.” Anthropological Quarterly 84, no. 2: 305-329.

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