Because acknowledging it would have resulted in vast pressure to do the trial. It is much cheaper to not release the report. The company doesn't care about anyone's health, profit is the only concern.
Pfizer knew drug may prevent Alzheimer's. Why didn't it tell us?
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 per cent.
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.
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 $US80 million, to see if the signal contained in
the data was real, according to an internal company document obtained by
The Washington Post.
"Enbrel could potentially safely
prevent, treat and slow progression of Alzheimer's disease,'' said the
document, a PowerPoint slide show prepared for review by an internal
Pfizer committee in February 2018.
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The
company said 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.
Science was the sole determining factor against moving forward, company spokesman Ed Harnaga said.
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.
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 believe Pfizer also should at least have published its data, making the findings broadly available to researchers.
Pfizer did share the data privately with at least one prominent scientist, but outside researchers 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.
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.
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.
Drug
companies often are criticised for extending the patent life of a drug -
and winning new profits - by merely tweaking a drug's molecule or
changing the method of delivery into the body. But it is a "heavy lift''
for a company to win regulatory approval to use a drug for a completely
different disease, said Robert Field, a professor of law and health
care management at Drexel University.
"Our patent laws do not
provide the appropriate incentives,'' Field said. Drug therapy for early
Alzheimer's "would be a godsend for American patients, so we should be
doing everything we can as a country to encourage development of
treatments. It's frustrating that there may be a missed opportunity.''
As
Enbrel's life cycle winds down, Pfizer has introduced a new rheumatoid
arthritis drug, Xeljanz, that works differently from Enbrel. Pfizer is
putting its marketing muscle behind the new treatment. While Enbrel
revenue is shrinking, Xeljanz revenue is growing. The Xeljanz patent
expires in 2025 in the United States and 2028 in Europe, according to
Pfizer's public disclosures. The drug is on track to make Pfizer
billions more each year for the foreseeable future.
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 US patients per year?
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 US patients per year?
A
medical ethics expert argued that Pfizer has a responsibility to
publicise 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 London.
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