Rogue One: A Drug Wars Story. What Can History Tell Us About Pharmacy?

How should we regulate pharmaceutical innovation?

This blog will have a series of posts which seek to explain why a medical student ought to care about the history of medicine.

In the distant past, James Payne, MD candidate 2021, wrote a compelling article arguing that the current pipeline for producing new medications may be overregulated. Contemporary drug development is loaded with checks for safety, efficacy, even just plain bureaucracy. James raises the possibility that regulation results in worse medicines.

In particular, the FDA has legal authority to approve or deny new medications on the basis of safety and efficacy. If clinical trials are unavailable or unconvincing, the drug cannot make it to market. Presumably, this is to protect the public health– how could it possibly be to anybody else’s benefit?

The world of pharmaceuticals is a complex swirl of economics, policy, organic chemistry, and medicine. What could a historian add to our understanding?

I argue that there are unique insights that the study of the history of medicine can contribute to this medical problem.

HIV medications, ACT UP.

In the early 1980s there was an unprecedented health crisis brewing in the US. In 1981, it was noticed that a population of homosexual men were suffering from diseases previously only associated with severely immunocompromised patients: Pneumocystis jirovecii pneumonia, esophageal candidiasis, Kaposi sarcoma. By the end of 1981, 270 of such cases were documented by the Centre for Disease Control. In 1992 alone, 33,590 were estimated to die of HIV related illnesses.

Amongst the outbreak, organizations advocating for faster drug development materialized.

Anti-retroviral were being developed but had not yet found use in the clinic. ACT UP was an activist organization whose goal was to take down the FDA. The main argument was that medications were a health care commodity, and that patients then had a right to access to those medications, even if through a research study. The specific research methodology of double-blind placebo was called into question as unethical. The slogan was simply “drugs in people”.

It was effective. HIV is, of course, still with us today. It has been tamed from a devastating epidemic into a chronic condition. In large part, this was due to the activists which called for the dismantling of FDA bureaucracy in a time of crisis.

One part of history of medicine is a collection of facts. Remembering the fact that thousands of HIV positive people died of AIDS in the absence of treatment can be an important consideration when thinking about the troubles associated with studying the safety of medication. It’s not simply an academic concern, but a lesson people have had to suffer through.

Psychiatry and FDA from 1950-1970s

The FDA was first established to regulate the safety of medications. On the face of it, they act as an agency to prevent the powerful pharmaceutical companies from taking advantage of the general population by producing unsafe or ineffective medications.

As ACT UP has argued, the outcomes of FDA regulation did not serve the general public in the case of patients dying from HIV. As opposed to outcomes, exploring the intent of the FDA, however also reveals that the priority may not have been for public good.

Dr. Edward Shorter, historian of psychiatry, explored unpublished and archival internal communications of the FDA from 1950s-1970s. In this time, the FDA was gaining new legal authority (through the Kefauver-Harris amendment in 1962), and was exercising this political will not in service of the public, nor in service of pharmaceuticals, but for itself! A number of previously safe and efficacious medications for mood disorders were banned from the market, for example meprobamate. Dr. Shorter describes this as the agency going “rogue”. The FDA decided first that meprobamate was to be regulated, and actively suppressed expert testimony to the contrary, as per internal documents.

The second part of the history of medicine is the process by which new facts are discovered. These new insights into the pharmaceutical industry could only be discovered by interrogating the archive.

One of the reasons I love studying history of medicine is that it allows us to seriously reconsider our presumptions. If we start by assuming pharmaceutical regulation is a positive, history gives us examples of the contrary. It’s our duty as future physicians to learn lessons from the suffering in the past.

 

Author: Ariel Gershon

Ariel Gershon (Meds 2019) completed a BSc at the University of Toronto in pathobiology before starting at Schulich. He was a president of Schulich’s Osler Society from 2016-2017, a group of medical students who meet to talk about the history of medicine over lunch. He‘s interested broadly in the medical sciences, medical humanities, and indoor gardening. Tweet at me @GershonMD2019