Legal and Ethical Questions: What is Pharma’s Obligation to Pursue Development of a Promising but Non-Profitable Drug?

 

Dr. Craig Klugman, a bioethics professor at DePaul University, expresses his opinion in this recent article in Columbia University’s Bioethics.com.

Dr. Klugman begins with a discussion of Pfizer’s biological drug, Enbrel, that he describes as having an annual five billion dollar price tag. Enbrel was approved years ago to treat rheumatoid arthritis and was later FDA approved for several other disorders.

In 2015 the Washington Post reported that when reviewing insurance claims, Pfizer discovered that Enbrel may possibly prevent Alzheimer’s.

According to the Post article, Pfizer did not move forward with clinical tests which could have cost Pfizer as much as $80 million.

How Ethics May Be Involved

Also according to the Post, Pfizer did not publish the data it found in its insurance review. One factor that may or may not have affected Pfizer’s decision is that Enbrel’s patent expires in the very near future.

The expiration of its patent gives other companies an opportunity to run their own trials. If the drug proves to be successful, then the generic companies will benefit the most.

Note that last year Pfizer declared that it discontinued its Alzheimer’s studies.

Dr. Klugman Outlines Scientific and Ethical Questions

  • If there is even scant evidence that a drug may slow or halt a disease, is the manufacturer obligated to follow up with testing that drug?
  • What is a drug company’s obligation to society to work with a drug that shows promise if there is no promise of profitability?

Here Dr. Klugman appears to ask and then answer the question of whether companies can be compelled to hold clinical trials. He points out that in our society, companies and their board of directors are generally free to choose which products they wish to pursue.

The exception would be an emergency and where the product is funded with public money. Dr. Klugman points out however that shareholder votes or a major drop in share price would certainly have an influence on the company’s decision.

He makes the distinction between a good business decision and one that is beneficial to the public. Although Dr. Klugman indicates that “someone” should take responsibility and conduct this line of research, he admits that it is not clear who that should be.

  • Does a company have any obligation to give data that it no longer intends to use in a clinical trial to other companies, universities, or the government?
  • By law, a physician is no longer obligated to refer a patient that they do not wish to treat to someone who will attend to that patient. Nor is a company obligated to reveal their trade secrets. But in an ethical sense, Dr. Klugman says that they do have an obligation. He points out that when companies profit due to consumer purchases, that forms a reciprocal obligation.
  • Are there ethical concerns when conducting a double-blind placebo (inactive drug) study if a drug has evidenced that it can halt or slow down a disease? Placebo control trials have been the source of controversy. Both sides of the argument have merit, but as set forth in the Declaration of Geneva, the health of the patient must be the physician’s first consideration. In other words, the use of a placebo is not considered to be ethical if any one arm of the trial is not receiving the best standard of care.

About Enbrel and Alzheimer’s

Although there are some medications to alleviate certain symptoms of Alzheimer’s, to date there are no medications to prevent or even slow the disease. The lack of such medications indicates that the Declaration of Helsinki might allow the use of a placebo in a clinical trial.

In this type of trial, Enbrel would be given to half the subjects while the other half would receive a placebo. But then the question would be – why would anyone choose to be in line for a placebo when they can receive the actual “off label” drug from their doctor?

And Finally –

Dr. Klugman suggests that a larger insurance review of existing databases may be in order. If the findings still point to a possible benefit to the more than 13.8 million Alzheimer’s patients expected to be diagnosed with the disease by 2050, then there is a moral obligation to go forward with clinical trials.

 


Rose Duesterwald

Rose Duesterwald

Rose became acquainted with Patient Worthy after her husband was diagnosed with Acute Myeloid Leukemia four years ago. He was treated with a methylating agent While he was being treated with a hypomethylating agent, Rose researched investigational drugs being developed to treat relapsed/refractory AML.

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