A recent article written by Craig Klugman debates the ethical obligations pharmaceutical companies have to conduct clinical trials for drugs which have a likely potential to benefit a patient population with an unmet need.
Enbrel
The drug Enbrel currently has FDA approval for plaque psoriasis, polyarticular juvenile idiopathic arthritis, ankylosing spondylitis (AS), and rheumatoid arthritis (RA). The treatment costs 5 billion dollars per year.
In 2015, Pfizer, the developers of the drug, alluded to the fact that it may also be efficacious for preventing Alzheimer’s disease after a review of insurance claims. But, they decided not to pursue a clinical trial. Such an investigation would have cost approximately 80 million dollars. Additionally, they decided not to publicize their findings and the data from their insurance claims still remains unpublished. Without this data, no other company can easily conduct a trial either.
Pfizer’s 20 year patent for Enbrel is now nearing the end. It wouldn’t have been a great business choice for Pfizer to conduct an 80 million dollar trial for a drug whose patent was expiring. If it did prove efficacious, generic manufacturers would reap all of the benefits of this expensive trial.
Coincidently, in 2018 Pfizer said they would be stopping their investigation of Alzheimer’s treatments.
No one knows if Enbrel would be effective for Azlheimer’s, but there certainly is a possibility. Although people taking Enbrel have had lower rates of diagnosis of the disease, this cannot be used as proof. In other words, a clinical trial is literally a necessity in order to understand whether or not this drug would truly be efficacious.
If no one sponsors this clinical trial, the world will never know.
There are two main topics of debate here.
- Did Pfizer have an ethical obligation to conduct a clinical trial examining the effects of Enbrel for Alzheimer’s disease?
- Did Pfizer have an ethical obligation to share the information they knew about Enbrel and it’s possibilities in Alzheimer’s disease with another company if they chose to not move forward with such a trial?
Conducting the Trial
The fact of the matter is, we live in a capitalist society. If businesses do not choose the option that makes most sense from a business standpoint, it is likely that they won’t last long. On the other hand, if they don’t consider the needs of the population they are serving, they are likely to experience extreme pushback.
“A smart business decision is not necessarily a smart decision for the society or the public.”
In this case, literal lives are at stake.
The first step to learning more about this potential correlation between Enbrel and the prevention of Alzheimer’s would be a larger investigation of insurance databases. If this investigation continues to show the drug’s potential, there is even more evidence that a trial is needed. Klugman suggests a patent extension of Enbrel for Pfizer, dependent on the conduction of such a trial. Another option would be a federal grant provided to researchers at a university who could complete the study.
For the latter to take place, the information would have to be disseminated.
Sharing the Information
If Pfizer doesn’t want to fund the trial themselves, do they have an obligation to at least share the knowledge of this drugs potential capability with another company? It might not be the best business decision yet again, but is it the ethical one?
“While they may not have broken any laws, they certainly violated an ethics of transparency, responsibility, and working toward the better health of all.”
Under the DHHS Conscience and Religious Freedom Division, health care providers were required to provide patients a referral to a doctor who would prescribe them the desired treatment if they chose not to administer it themselves. But now there’s a new Division, and this legal obligation no longer exists. It is now is solely an ethical choice. The issue is that not everyone has the same perception of an ethical decision.
As Kungman explains though, Pfizer would reap PR benefits by exchanging data with a university or company willing to conduct the trial. Yes, they would likely experience an economic hit the next quarter, but PR benefits are not trivial.
Concluding Thoughts
Perhaps, by now disseminating this plausible causation, Pfizer is secretly hoping that their drug will be continued to be prescribed off label, extending their longterm sales to the estimated (by 2050) future 13.8 million Alzheimer’s disease patients.
Perhaps, another company will be able to pursue this trial in the future.
Perhaps, this trial will be conducted and it will be uncovered that Enbrel is not efficacious for preventing Alzheimer’s like researchers currently suspect.
The moral of this story is we will never know until this trial is conducted by someone, somewhere in the world. Without the transparent exchange of findings between researchers, the initiation of this trial, and trials for other potential treatments for other diseases, could never see the light of day.
You can read more about this take on Pfizer’s decision not to pursue the Enbrel Alzheimer’s trial here.
