The Revolving Door Between the Pharmaceutical Industry and the FDA
The recent approval of the controversial Alzheimer’s drug Aduhelm raises serious concerns about the impartiality of the drug review process in the United States. It also highlights potential conflicts of interest between the Food and Drug Administration (FDA) and the pharmaceutical industry.
One of the key jobs of the FDA is the approval of new medications for treating disease. This process can and does make and break companies. If a new type of drug is approved for a common medical condition, it can result in billions of dollars of profits for the pharmaceutical company. If the drug is not approved, it can result in millions of dollars in losses.
With so much money and the health and well being of thousands or millions of patients on the line, you would think there would be strict laws about FDA employees leaving their job and joining the pharmaceutical industry. Unfortunately, the laws are quite lax. Estimates suggest that around 60% of drug reviewers at the FDA do just that (Bien 2016). This raises obvious concerns.
If an individual wants a particularly lucrative job with a drug company, pushing approval of one or more of their products through the FDA would likely help. And ex-FDA employees have contacts at the administration that could be utilized inappropriately for pushing drug approvals. Not to mention that they also have an understanding of weaknesses in the drug review process and how to potentially exploit them.
Examples of Concern
Aduhelm and Alzheimer’s Disease
Aduhelm is a drug that is designed to clear plaques from the brain that are implicated in dementia. The drug is an antibody that sticks to these plaques marking them for clearance by the immune system.
In clinical trials, however, Aduhelm has shown negligible effects on dementia. Improvements in cognitive function are quite small (Avgerinos 2021). In addition, it has significant risks, causing changes identifiable on brain imaging that are associated with brain inflammation and swelling. Thirty-five percent of patients on Aduhelm experienced these changes, often reporting headache, confusion, dizziness and nausea (Salloway 2022). Due to the poor research results, a panel of experts recommended against its approval. Typically, the FDA follows expert recommendations. However, for Aduhelm, the FDA reversed precedent and approved the drug for clinical use in patients.
With the pharmaceutical company initially pricing the drug at $56,000 for a course of treatment, numerous concerns were raised. The FDA inspector general and other congressional committees are investigating Aduhelm’s approval, and with good reason (HHA 2022, Maloney 2021). Why a drug associated with such a serious level of adverse side effects that provides only negligible improvement won approval raises the possibility of collusion between the drug maker and the FDA, especially considering the billions of dollars in profits available from selling such an expensive drug.
Oxycontin as a Treatment for Chronic Pain
Probably the most notorious example of the revolving door between the FDA and the pharmaceutical industry was the approval of OxyContin. OxyContin is a highly addictive opiate pain medication. Its approval heralded the beginning of the opioid epidemic.
Developed by Purdue Pharmaceuticals, OxyContin was claimed to be mostly immune to abuse due to having an extended-release mechanism. However, Curtis Wright, MD the key FDA examiner for OxyContin noted numerous problems (Koch 2019):
- Crushing the tablets led to immediate release if ingested, easily bypassing the time-release mechanism
- Even with the time-release formula, withdrawal symptoms had clearly been documented in several patients in clinical trials indicating concerns for addiction
- Tablets could be liquified and injected as a simple approach for abuse
Even with the aforementioned concerns, Wright backed OxyContin for approval. After approval was secured and the beginning of the opiate epidemic sealed, Wright left his position at the FDA and shortly thereafter landed a lucrative job with Purdue Pharmaceuticals, a likely reward for gaining the medication’s approval (New Yorker 2017).
The FDA is tasked with approving safe and effective medications. However, the fact that a large percentage of employees at the FDA eventually leave their positions for higher paying jobs in the pharmaceutical industry is of obvious concern. We need to trust the FDA and their drug approval decisions. Paying FDA regulators better and barring them from working in the pharmaceutical industry for five or ten years would go a long way to eliminate the revolving door between the FDA and the industry that they oversee, although other reforms are likely necessary.