Pfizer Alzheimer’s drug, Why didn’t it do anything to prove it?.

Pfizer’s deliberations, which previously have not been disclosed, offer a rare window into the frustrating search for Alzheimer’s treatments inside one of the world’s largest drug companies. Despite billions spent on research, Alzheimer’s remains a stubbornly prevalent disease with no effective prevention or treatment.

The Red Tea Detox

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.

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“Enbrel could potentially safely prevent, treat and slow progression of Alzheimer’s disease,” said the document, a PowerPoint slide show that was prepared for review by an internal Pfizer committee in February 2018.

The company told The Post that it decided during its three years of internal reviews that Enbrel did not show promise for Alzheimer’s prevention because the drug does not directly reach brain tissue. It deemed the likelihood of a successful clinical trial to be low. A synopsis of its statistical findings prepared for outside publication, it says, did not meet its “rigorous scientific standards.”

Science was the sole determining factor against moving forward, company spokesman Ed Harnaga said.

Likewise, Pfizer said it opted against publication of its data because of its doubts about the results. It said publishing the information might have led outside scientists down an invalid pathway.

Pfizer’s deliberations, which previously have not been disclosed, offer a rare window into the frustrating search for Alzheimer’s treatments inside one of the world’s largest drug companies. Despite billions spent on research, Alzheimer’s remains a stubbornly prevalent disease with no effective prevention or treatment.

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Some outside scientists disagree with Pfizer’s assessment that studying Enbrel’s potential in Alzheimer’s prevention is a scientific dead end. Rather, they say, it could hold important clues to combating the disease and slowing cognitive decline in its earliest stages.

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 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.”

Internal discussions about possible new uses of drugs are common in pharmaceutical companies. In this case, Pfizer’s deliberations show how decisions made by industry executives – who are ultimately accountable to shareholders – can have an impact well beyond corporate board rooms.

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As its Enbrel deliberations ended early last year, Pfizer was getting out of Alzheimer’s research. It announced in January 2018 that it would be shutting down its neurology division, where Alzheimer’s treatments were explored, and laying off 300 employees.

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.

He said Pfizer and other companies do not want to invest heavily in further research only to have their markets undermined by generic competition.

“Someone can pop up and say, ‘Look, I’ve got a me-too drug here,’ ” Holmes said, referring to the advent of generic versions of Enbrel. “I think that is what this is all about.”

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