Why Pfizer didn’t report that its rheumatoid arthritis medication might prevent Alzheimer’s - The Washington Post
peter.suber's bookmarks 2019-06-06
"A team of researchers inside Pfizer made a startling find in 2015: The company’s blockbuster rheumatoid arthritis therapy Enbrel, a powerful anti-inflammatory drug, appeared to reduce the risk of Alzheimer’s disease by 64 percent.
The results were from an analysis of hundreds of thousands of insurance claims. Verifying that the drug would actually have that effect in people would require a costly clinical trial — and after several years of internal discussion, Pfizer opted against further investigation and chose not to make the data public, the company confirmed.
Researchers in the company’s division of inflammation and immunology urged Pfizer to conduct a clinical trial on thousands of patients, which they estimated would cost $80 million, to see if the signal contained in the data was real, according to an internal company document obtained by The Washington Post....
Pfizer did share the data privately with at least one prominent scientist, but outside researchers contacted by The Post believe Pfizer also should at least have published its data, making the findings broadly available to researchers.
“Of course they should. Why not?’’ said Rudolph E. Tanzi, a leading Alzheimer’s researcher and professor at Harvard Medical School and Massachusetts General Hospital. “It would benefit the scientific community to have that data out there,’’ said Keenan Walker, an assistant professor of medicine at Johns Hopkins who is studying how inflammation contributes to Alzheimer’s. “Whether it was positive data or negative data, it gives us more information to make better informed decisions.’’ ...
The broader market forces that critics say discouraged Pfizer from investing in Alzheimer’s clinical trials are rooted in Enbrel’s “life cycle,’’ the 20-year period of patent exclusivity when a brand manufacturer reaps monopoly profits from a drug. By industry standards, Enbrel, an injectable biologic drug, is relatively old, with FDA approval for rheumatoid arthritis in 1998....
A medical ethics expert argued that Pfizer has a responsibility to publicize positive findings, although it is not as strong as an imperative to disclose negative findings.
“Having acquired the knowledge, refusing to disclose it to those who might act upon it hides a potential benefit, and thereby wrongs and probably harms those at risk of developing Alzheimer’s by impeding research,’’ said Bobbie Farsides, professor of clinical and biomedical ethics at Brighton and Sussex Medical School in the United Kingdom...."