Changing stroke rehab and research worldwide now.Time is Brain! trillions and trillions of neurons that DIE each day because there are NO effective hyperacute therapies besides tPA(only 12% effective). I have 523 posts on hyperacute therapy, enough for researchers to spend decades proving them out. These are my personal ideas and blog on stroke rehabilitation and stroke research. Do not attempt any of these without checking with your medical provider. Unless you join me in agitating, when you need these therapies they won't be there.

What this blog is for:

My blog is not to help survivors recover, it is to have the 10 million yearly stroke survivors light fires underneath their doctors, stroke hospitals and stroke researchers to get stroke solved. 100% recovery. The stroke medical world is completely failing at that goal, they don't even have it as a goal. Shortly after getting out of the hospital and getting NO information on the process or protocols of stroke rehabilitation and recovery I started searching on the internet and found that no other survivor received useful information. This is an attempt to cover all stroke rehabilitation information that should be readily available to survivors so they can talk with informed knowledge to their medical staff. It lays out what needs to be done to get stroke survivors closer to 100% recovery. It's quite disgusting that this information is not available from every stroke association and doctors group.

Saturday, June 8, 2019

Pfizer knew drug may prevent Alzheimer's. Why didn't it tell us?

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.

Alzheimer's cause plaques between nerve cells in the brain.
Alzheimer's cause plaques between nerve cells in the brain.

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.

Advertisement


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.
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.
"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.

The company says it was not worth pursuing the results.
The company says it was not worth pursuing the results.Credit:AP

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?
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.

No comments:

Post a Comment