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.
Drug companies frequently have been pilloried for not fully disclosing negative side effects of their drugs. What happens when the opposite is the case? What obligation does a company have to spread potentially beneficial information about a drug, especially when the benefits in question could improve the outlook for treating Alzheimer’s, a disease that afflicts at least 500,000 new patients per year?
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.
Meanwhile, Enbrel has reached the end of its patent life. Profits are dwindling as generic competition emerges, diminishing financial incentives for further research into Enbrel and other drugs in its class.
“I’m frustrated myself really by the whole thing,’’ said Clive Holmes, a professor of biological psychiatry at the University of Southampton in Great Britain who has received past support from Pfizer for Enbrel research in Alzheimer’s, a separate 2015 trial in 41 patients that proved inconclusive.
Enbrel reduces inflammation by targeting a specific protein called TNF-a. The Pfizer claims data analysis added to a growing body of evidence that broadly targeting TNF-a in the body has the potential to prevent Alzheimer’s, said Holmes, the professor of biological psychiatry at the University of Southampton.
Holmes is among the few researchers who has gained access to the Pfizer data; he won the company’s permission to use it in a grant application for a small clinical trial he is undertaking in England.
Pfizer said it also was skeptical because Enbrel has only a limited effect on the brain. The Enbrel molecule is too large to pass through the “blood-brain barrier’’ and directly target TNF-a in brain tissue, the company said.
Yet Alzheimer’s researchers believe inflammation outside the brain — called peripheral inflammation — influences inflammation within the brain.
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