"They knew it could help" is a gross misrepresentation and oversimplification of the facts.
The insurance data had a noticeable-but-small signal that, by itself, is not by any stretch of the imagination sufficient for anyone to launch an Alzheimer’s trial.
When was the last time a drug company walked away from big profits? Pfizer knows how to make money and if Pfizer really believed that their drug was a promising lead into treating Alzheimer’s, they would have found some way to turn a profit off of it.
Enbrel doesn’t penetrate the brain; therefore, what is the mechanism of action? The question of whether or not there was something real in the data that was worth pursuing was ultimately answered by both Pfizer and Amgen with a resounding "no".
So far, every single amyloid-antibody trial has ended in abysmal failure. Targeting beta-amyloid is not the pathway to success for which people had hoped.
That Enbrel’s patent is about to expire is being debated in the courts right now.
Enbrel was never an Alzheimer's drug but rather it targeted rheumatoid arthritis and psoriasis. Therefore, any generic/biosimilars would have to demonstrate their own efficacy against Alzheimer’s.
We know that the brains of Alzheimer’s patients show persistent inflammation. It's a chicken/egg problem: does Alzheimer’s lead to inflammation or does inflammation lead to Alzheimer’s. And every single anti-inflammatory therapy - aspirin included - has been looked at for its potential in treating Alzheimer’s and, so far, nothing affects the disease progression.
Has anyone seen the precautionary warnings on this drug? As a preventative drug, maybe the downside vs. the benefit ratio was too huge to get the FDA involved. Announcing a possible benefit, still unproven, would have the FDA crawling all over your physician's files looking to shut you down, imo.
Allowing the patent (that word it PATENT, not patient) to expire and physicians willing to use the medication off label can become a less expensive way to get the already approved drug to patients.
I have observed the FDA get involved in clinical trials, with findings that the drug had too many side effects and was not only taken off the market in the U.S., but the smaller study shut down, the researcher put out of business, involved in years of lawsuits, in spite of the temporary benefit to the Alzheimer's patient. Not a cure, but a return of cognition. Too bad.
In Re: William K. Summers, M.D., is an independent neuroscientist and was the inventor of Tacrine (Cognex) as a treatment for Alzheimer's disease {US Patent No. 4,816,456}. Tacrine was the first FDA approved anti-dementia drug.
My experience as a nurse for 40 years is that pills given to our elders often make worse problems than no pills, and in fact often enough kill them. They enter MD office with anxiety and high BP, are given pills, and fall in the night because of the pills. The pills for all kinds of late in life dementias often make them worse. You will have a patient with parkinson's given a medication to help with balance and it increases hallucinations; you give them pills for hallucinations and it makes their balance go bad. And there is honestly no pill out there yet that is proven to work, yet our MDs with the 6% back on each prescription (so few know about this) keep prescribing medications with no idea the costs of them to patients and families. I would just say, there are time we need pills (Congestive Heart Failure is death without them). And there are more times we do NOT. Research on forums regarding medication. Read ALL the side effects before accepting prescriptions. Know that for the pharmaceutical companies, and often for the doctors we so trust, the elderly are cash cows. I understand that as a nurse I saw more often those who suffer side effects than those who were helped and stayed home. I am simply advising to be very very careful with medications.
my nephew is a physician and told me that he wouldn't give my mom any kind of sedatives or sleeping pills for her episodic insomnia because of that very reason--he's afraid she would fall during the night while on her way to the bathroom.
"The other question that arises: Did Pfizer choose not to pursue a clinical trial due to the fact that Enbrel’s patent would soon be expiring? Enbrel’s 20-year patent has since ended, making way for generic versions of the drug. This means there was no financial incentive for Pfizer to pursue a long, costly clinical trial when profits from the drug would soon shrink to a trickle."
No. When one patent expires, you tweak the formula, change the name, resubmit for approval, take out a new patent and Bob's your uncle - ker-ching again until the next time. It's such a standard strategy, and so easy to align with a radical change of use, that this couldn't possibly have been a significant disincentive.
ETA. there was a 2008 post on here about Enbrel. It is an interesting read.
The insurance data had a noticeable-but-small signal that, by itself, is not by any stretch of the imagination sufficient for anyone to launch an Alzheimer’s trial.
When was the last time a drug company walked away from big profits? Pfizer knows how to make money and if Pfizer really believed that their drug was a promising lead into treating Alzheimer’s, they would have found some way to turn a profit off of it.
Enbrel doesn’t penetrate the brain; therefore, what is the mechanism of action? The question of whether or not there was something real in the data that was worth pursuing was ultimately answered by both Pfizer and Amgen with a resounding "no".
So far, every single amyloid-antibody trial has ended in abysmal failure. Targeting beta-amyloid is not the pathway to success for which people had hoped.
That Enbrel’s patent is about to expire is being debated in the courts right now.
Enbrel was never an Alzheimer's drug but rather it targeted rheumatoid arthritis and psoriasis. Therefore, any generic/biosimilars would have to demonstrate their own efficacy against Alzheimer’s.
We know that the brains of Alzheimer’s patients show persistent inflammation. It's a chicken/egg problem: does Alzheimer’s lead to inflammation or does inflammation lead to Alzheimer’s. And every single anti-inflammatory therapy - aspirin included - has been looked at for its potential in treating Alzheimer’s and, so far, nothing affects the disease progression.
As a preventative drug, maybe the downside vs. the benefit ratio was too huge to get the FDA involved. Announcing a possible benefit, still unproven, would have the FDA crawling all over your physician's files looking to shut you down, imo.
Allowing the patent (that word it PATENT, not patient) to expire and physicians willing to use the medication off label can become a less expensive way to get the already approved drug to patients.
I have observed the FDA get involved in clinical trials, with findings that the drug had too many side effects and was not only taken off the market in the U.S., but the smaller study shut down, the researcher put out of business, involved in years of lawsuits, in spite of the temporary benefit to the Alzheimer's patient. Not a cure, but a return of cognition. Too bad.
In Re:
William K. Summers, M.D., is an independent neuroscientist and was the inventor of Tacrine (Cognex) as a treatment for Alzheimer's disease {US Patent No. 4,816,456}. Tacrine was the first FDA approved anti-dementia drug.
"The other question that arises: Did Pfizer choose not to pursue a clinical trial due to the fact that Enbrel’s patent would soon be expiring? Enbrel’s 20-year patent has since ended, making way for generic versions of the drug. This means there was no financial incentive for Pfizer to pursue a long, costly clinical trial when profits from the drug would soon shrink to a trickle."
No. When one patent expires, you tweak the formula, change the name, resubmit for approval, take out a new patent and Bob's your uncle - ker-ching again until the next time. It's such a standard strategy, and so easy to align with a radical change of use, that this couldn't possibly have been a significant disincentive.