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05 June 2019

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Dave Schuler

Perhaps it's a little too conspiracy-minded of me to mention it but a hypothesis that occurred to for why Pfizer did not pursue it is that the patent renewal for etanercept does not expire until 2028. They may have wanted to keep it in their pocket until they had a way to extend patent protections beyond then.

Kyū Matsu

Col. Lange,
I think the reason for not proceeding with trials might be that Enbrel (etanercept), first patented in 1998, will be going off patent in few years. Therefore, from a cost benefit perspective, Pfizer would not make the big bucks they would have if they had done the trials back in the 00s. In addition, several biosimilar drugs have been recently marketed which have the same therapeutic effect. So deciding not to do the trials nor to inform the scientific community was just a business decision.

For the record: According to Wikipedia, a months supply of Enbrel costs $2,225 in the U.S and about half that in Switzerland. I checked the cost of a new biosimilar drug here in Japan and it costs about $160 for a one month supply. I do not know if this is the co-pay or the full price. Normally the national health system pays 70-80% of prescription costs.

The withholding of scientific data/discoveries to see if they can be monetized is not a healthy trend

akaPatience

Let the word be spread with the hope physicians will consider and practice off-label prescription of this drug for their patients suffering from Alzheimer's Disease. Even though biologics such as Enbrel come with risks of therapy-related cancers and other serious side effects (just listen to the very scary disclaimers mentioned in TV ads), since AD generally effects people who are in the last laps of life, I'd think the benefit would greatly outweigh that sort of risk.

Willy B

It seems to me that the public interest is such that Pfizer should either be forced by government mandate to carry out the necessary clinical trials or that the government itself, through NIH or other appropriate agency, do the research itself and deny Pfizer any financial benefit that may follow from positive results.

Fred

Having had a parent suffer with Alzheimers for the last decade of life I wouldn't wish that on anyone. If accurate this would be a great new application. If the testing cost is only $80 million then they could have recovered that in year one. There has to be more to the story and patent protection, which Dave Schuler mentions above, while having a certain logic to it doesn't seem right since a minor change in chemistry to facilitate better alzheimers protection would result in a new patent for the new formulation of the drug. In addition they would have had a lock on a huge number of potential customers too.

"Science was the sole determining factor against moving forward, company spokesman Ed Harnaga said."
Sounds like data analytics found something and some others quashed it because !science!.
"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."

I wonder who involved in those decisions has left Pfizer for a competitor at a much larger level of compensation? Regardless their competitors with drugs similar to Enbril will now be looking at thier data too, if they weren't already. Congrats scientists! I think this type of thinking fits right in line with your recent post on us being "skilled but uneducated".

paul rosenberg

Any one of the researchers could have made the information available to the public. I'm sure it would have been a violation of their contract with Pfizer. But there is no substitute for courage.

Harlan Easley

It appears the people who took this drug had a reduce risk of developing Alzheimer's than individuals who did not. I doubt it would help current Alzheimer's patients since the damage is already done.

Inflammation has been indicated in multiple chronic diseases. As Fred mention, my Stepfather developed Alzheimer's at 55 and had it for 17 years and it is a soul crushing experience.

blue peacock

This is an example of a huge issue with the current US health care system. US consumers are paying 10x to 1000x the price for the identical pharmaceutical or durable medical equipment compared to other western countries. This is one factor in why US per capita expenditures on health care is DOUBLE other western countries and growing at a 9% CAGR which means expenditures double every 8 years.

There is no free market in most health care products & services in the US. What we have instead is government sponsored or enabled monopolies & cartels.

Lot of people complain about the insidious influence of the MIC. But the health care lobby is even more powerful. Total healthcare expenditures in the 1960s were in the mid single digit ratio to GDP. Now its pushing 18% of GDP.

Factotum

Enbrel costs $1300 an injection dose and carries serious side-effects. Could Pfizer simply be trying to create public market demand for a very expensive and unproven product with this "press release"?

From drugs.com
Important information
Using Enbrel may increase your risk of developing certain types of cancer, including a rare type of lymphoma. Ask your doctor about your specific risk. This has occurred mainly in teenagers and young adults using Enbrel or similar medicines to treat Crohn's disease or ulcerative colitis. Call your doctor at once if you have any of the following symptoms: fever, night sweats, itching, loss of appetite, weight loss, tiredness, feeling full after eating only a small amount, pain in your upper stomach that may spread to your shoulder, nausea, easy bruising or bleeding, pale skin, feeling light-headed or short of breath, rapid heart rate, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Enbrel can weaken your immune system. Serious and sometimes fatal infections may occur. Call your doctor right away if you have signs of infection such as: fever, chills, cough, sweating, body aches, skin sores or redness, diarrhea, burning when you urinate, or feeling very tired or short of breath.

David Lentini

Having spent nearly 20 years working with pharma as a patent attorney, I'm not surprised. Moderately effective drugs are a cash cow. Cures kill cash-flow. The real goal is a pill that you take once or twice a day until you die.

Linda

Somewhere in the article it says that NSAIDs May be useful because, as anti inflammatories they could help with inflammation of the brain as well. Well we have plenty of those as over the counter medicines. Am I missing something or wouldn’t NSAIDS be the answer - cheap, limited side effects and easily available.

Factotum

Or until the pill itself kills you. A fine line between profit and loss. Best pills are the heavily marketed placebo ineffectual ones, which have never been proven to help, but in fact also do not kill. If America has an incurable disease, it is their unwavering addiction to "pills".

Factotum

UCSF recently linked dry skin to Alzheimers - just use more body lotion to reduce chronic dry skin irritation. Fighting dental plaque and periodontal gum inflammation was also highlighted a few years ago. Since no one yet knows what causes Alzheimers, any promised "cures" are specious at this point. Pay attention to epidemiology research to see what linkages may emerge, which may not even need a pill to cure.

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