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“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.
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.
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 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.’’
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.
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.
He said Pfizer and other companies do not want to invest heavily in further research only to have their markets undermined by generic competition.
Drug companies often are criticized 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 I. 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.
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.’’
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. It also has been approved to treat psoriasis.
Pfizer got rights to market it internationally when it acquired drugmaker Wyeth in 2009. But Enbrel, which earned Pfizer $2.1 billion in 2018, now faces generic competition.
Wagering money on a clinical trial of Enbrel for an entirely different disease, especially when Pfizer had doubts about the validity of its internal analysis, made little business sense, said a former Pfizer executive who was aware of the internal debate and spoke on the condition of anonymity to discuss internal Pfizer matters.
“It probably was high risk, very costly, very long term drug development that was off-strategy,’’ the former executive said.
Another former executive, who also spoke on the condition of anonymity to discuss Pfizer operations, said Pfizer offered virtually no explanation internally for opting against further investigation in early 2018, when the internal debate ended.
“I think the financial case is they won’t be making any money off of it,’’ the second former executive said.
https://www.washingtonpost.com/busi...ory.html?noredirect=on&utm_term=.26c3201a3ebf
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.
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.
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 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.’’
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.
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.
He said Pfizer and other companies do not want to invest heavily in further research only to have their markets undermined by generic competition.
Drug companies often are criticized 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 I. 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.
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.’’
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. It also has been approved to treat psoriasis.
Pfizer got rights to market it internationally when it acquired drugmaker Wyeth in 2009. But Enbrel, which earned Pfizer $2.1 billion in 2018, now faces generic competition.
Wagering money on a clinical trial of Enbrel for an entirely different disease, especially when Pfizer had doubts about the validity of its internal analysis, made little business sense, said a former Pfizer executive who was aware of the internal debate and spoke on the condition of anonymity to discuss internal Pfizer matters.
“It probably was high risk, very costly, very long term drug development that was off-strategy,’’ the former executive said.
Another former executive, who also spoke on the condition of anonymity to discuss Pfizer operations, said Pfizer offered virtually no explanation internally for opting against further investigation in early 2018, when the internal debate ended.
“I think the financial case is they won’t be making any money off of it,’’ the second former executive said.
https://www.washingtonpost.com/busi...ory.html?noredirect=on&utm_term=.26c3201a3ebf
