Why Pfizer Ignored Data Suggesting Their Drug Could Affect Alzheimer's (sciencemag.org) 66
In a controversial pharmaceutical story, this week the Washington Post reported "that Pfizer had evidence that [their drug] Enbrel could be useful in Alzheimer's disease, and didn't do anything with it," according to a blog post from Science magazine:
This came from an analysis of insurance claim data: a set of about 127,000 patients with an Alzheimer's diagnosis and a set of 127,000 without. It turns out that more people in the second group had been treated with Enbrel (302 patients) versus the first (110 patients). The Post obtained internal Pfizer documents discussing this and whether it was worth further investigation, and the company had concluded it wasn't.
Why wouldn't they? Several reasons. The biggest, though, is that no one undertakes an Alzheimer's trial lightly. The clinical success rate for Alzheimer's trials is arguably zero per cent... The article does note that Pfizer was getting out of Alzheimer's in general at the time (2015), but it also explicitly makes clear that Enbrel was nearing the end of its patent lifetime and brings up the idea that Pfizer deliberately took a pass because they weren't going to reap as much profit. Well, you'll have to trust me on this, it's a little out there, but drug companies don't generally walk away from big profits if they can help it. I've had my problems with Pfizer over the years, but I have never called into question their ability to make money. If Pfizer really thought that this was a promising lead into an Alzheimer's therapy, they would have found a way to turn a profit off of it.
The blogger also argues that Pfizer's data represented "a noticeable-but-small signal, and by itself (I cannot state this strongly enough), it would not be enough for anyone to launch an Alzheimer's trial."
Why wouldn't they? Several reasons. The biggest, though, is that no one undertakes an Alzheimer's trial lightly. The clinical success rate for Alzheimer's trials is arguably zero per cent... The article does note that Pfizer was getting out of Alzheimer's in general at the time (2015), but it also explicitly makes clear that Enbrel was nearing the end of its patent lifetime and brings up the idea that Pfizer deliberately took a pass because they weren't going to reap as much profit. Well, you'll have to trust me on this, it's a little out there, but drug companies don't generally walk away from big profits if they can help it. I've had my problems with Pfizer over the years, but I have never called into question their ability to make money. If Pfizer really thought that this was a promising lead into an Alzheimer's therapy, they would have found a way to turn a profit off of it.
The blogger also argues that Pfizer's data represented "a noticeable-but-small signal, and by itself (I cannot state this strongly enough), it would not be enough for anyone to launch an Alzheimer's trial."
Informal trials (Score:2)
"The biggest, though, is that no one undertakes an Alzheimer's trial lightly."
Yes, but even an informal trial might provide some indication of whether this drug really has some potential or not. It would be worth doing to see if formal, controlled trials would be worth pursuing.
Cost (Score:5, Insightful)
Even an informal trial could cost a few million dollars. And, as the OP pointed out, the success rate of targeted Alzheimer's drugs is pretty close to zero, so the odds of some drug just happening to help out with Alzheimer's in a statistically significant manner is pretty low, especially when it's a drug that has no known interaction with any of the theorized mechanisms that may cause Alzheimer's (Enbrel treats autoimmune diseases.)
The original report is, most likely, coincidence.
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especially when it's a drug that has no known interaction with any of the theorized mechanisms that may cause Alzheimer's (Enbrel treats autoimmune diseases.)
The original report is, most likely, coincidence.
There are studies/articles [google.com] that theorize that Alzheimer's disease is immune system related. (The blood brain barrier has become compromised for example.) So it doesn't seem that far of a stretch that an autoimmune drug might help with that.
If I recall, the theory is that the immune system sees the plaques building up as bad and goes to work attacking.
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Even an informal trial could cost a few million dollars. And, as the OP pointed out, the success rate of targeted Alzheimer's drugs is pretty close to zero, so the odds of some drug just happening to help out with Alzheimer's in a statistically significant manner is pretty low, especially when it's a drug that has no known interaction with any of the theorized mechanisms that may cause Alzheimer's (Enbrel treats autoimmune diseases.)
The original report is, most likely, coincidence.
That was my first thought but buried fairly deep in the article:
They divided those anonymous patients into two equal groups of 127,000 each, one of patients with an Alzheimer's diagnosis and one of patients without. Then they checked for Enbrel treatment. There were more people, 302, treated with Enbrel in the group without Alzheimer's diagnosis. In the group with Alzheimer's, 110 had been treated with Enbrel.
The numbers may seem small, but they were mirrored in the same proportion when the researchers chec
Re: (Score:2)
Even an informal trial could cost a few million dollars.
And what is a few million dollars to a company like Pfizer? It's not even a rounding error.
For a drug that may such potential, it's idiotic not to investigate it. That's what research is for. Sometimes you spend money to find out that it doesn't work, but if it does then you've just found a way to help millions upon millions of people.
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The anecdotal evidence was ultimately about 300 people being treated with the drug where the parameters were unclear, that's statistically insignificant. Putting together a clinical trial costs a lot of money and you would have to see significant results in some pilot study for it to be considered.
Research doesn't just operate on hunches and informal uncorrelated data sets, research is generally targeted at something. If some private funder wants to do something like this, they could definitely do so, but m
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"Research doesn't just operate on hunches and informal uncorrelated data sets" - Yeah it does. You're not an expert on research obviously, lol. There are a LOT of broad, unfocused studies out there. You know nothing about this.
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Putting together a clinical trial costs a lot of money and you would have to see significant results in some pilot study for it to be considered.
A few million dollars to Pfizer is a pittance to see if this drug has potential or not.
Re: Informal trials (Score:1)
They concluded the numbers were false because Enbrel does not enter brain tissue or spinal fluid.
Alternative explanation, people with Alzheimerâ(TM)s do not get as aggressive treatment for their rheumatoid arthritis.
TNF-inhibitors as a class (Score:4, Informative)
They concluded the numbers were false because Enbrel does not enter brain tissue or spinal fluid.
Also, the other TNF-inhibitors on the market did not seem to exhibit a similar negative correlation with Alzheimer's. That's probably the most significant item, the lack of a class effect.
Post-hoc data-mining of insurance claim information generally yields very noisy data (putting it generously). This whole article might be worth a minor note in an a pharmaceutical journal -- most definitely not a hit-piece in the Washington Post.
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What's an "informal trial?"
If Enbrel has any effect on Alzheimer's it's almost certainly preventative. You'd have to enrol tens of thousands of people in your trial, formal or not. Most of them wouldn't get the disease, regardless of treatment.
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Ever heard of side-effects? Why don't you sign up as the first guinea pig?
https://www.enbrel.com/support... [enbrel.com]
Re: Informal trials (Score:2)
Iâ(TM)m not advocating a trial of Enbrel for Alzheimerâ(TM)s. Immunosuppressants arenâ(TM)t ever going to make good prophylactic drugs because they have so many bad side effects. The trial would be ridiculously expensive and thereâ(TM)s no way youâ(TM)d get it through an ethics committee anyway.
Pfizer could have published their result though, since itâ(TM)s possible it could lead to something useful from investigating the mechanism.
Re:Informal trials (Score:5, Insightful)
I'm all for lambasting pharmaceutical companies for behaving badly (like when they're the sole supplier of a medication and they raise the price 10000%, although I'd argue that suggests we need to loosen up FDA regulations so companies don't end up with regulatory monopolies so frequently). But in this case they're acting exactly the same as you or I would. If you really believe there may be something to this (and that it's not merely a coincidental correlation [tylervigen.com]), put your money where your mouth is - start or fund a kickstarter to help pay for an informal trial. If you don't think you should be the one to have to pay for it when you yourself will not benefit from it if by a long shot it happens to work, well then you're in complete agreement with Pfizer.
What about you?? (Score:4, Insightful)
You didnâ(TM)t bother to even go to college and study the necessary stuff to make a cure either. If you didn't feel compelled to find a cure, why should anyone else, including Pfizer?
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So do propose something that hasn't proven itself to ultimately collapse. Most research in the US is government funded, more funding than runners-up France, Germany, China and the UK put together, but that doesn't mean said research just aimlessly throws things at the wall that may not pay off. In the end the motive is always profit of some sort, regardless of how altruistic the source is.
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has any pharmaceutical company had on this mission statement regarding their research such a word?
No. But it would make a great trade name for their new jock-itch drug.
Re: (Score:2)
> by AndrewFlagg ( 753349 )
> has anyone ever looked at the word benevolence? has any
> pharmaceutical company had on this mission statement (?)
We have organizations that focus on benevolence. They're called non-profits. You don't get to become a Pfizer by focusing on benevolence. This is not a criticism of them. The company is a tool for making money by selling medical items. Just that, nothing more.
Anybody who has 80 Million $ (US) to spare is free to fund their own study. Pfizer knows the de
I Don't Have a Problem With This Business Decision (Score:1)
When faced with a decision to take on a high risk research project for a low return benefit, I too would likely take the risk averse route and forgo a study. I see no issue here.
For the hand wringers, the good news is that with Enbrel becoming patent free, you can all do your own studies and not have to worry about evil big pharma blocking you.
It reminds me of the cannabis fanatics. Promises, promises, but no studies and no clinical proof of anything. Now the barrier to entry fro performing a real scientifi
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"It reminds me of the cannabis fanatics. Promises, promises, but no studies and no clinical proof of anything. Now the barrier to entry fro performing a real scientific study is very negligible and yet we still have no real clinical studies."
Very negligible. Except for that thing about the Feds and their annoying little schedule 1 classification.
Oh, and this: 978 Studies on Cannabis for 184 Conditions https://www.cannabisreports.co... [cannabisreports.com].
Perhaps leverage to extend exclusivity (Score:1)
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I read years ago Pfizer was trying to find new uses for Viagra to extend the patents to prevent generics. Couldn't they have done the same with Enbrel?
They already did so. The original patent on Viagra expired in April, 2012.
several reasons.... (Score:1)
Why wouldn't they? Several reasons.
#1 - money; #2 - money; #3 - money.
Math (Score:2)
It sounds like Pfizer actually understood the statistical evidence in their possession and made an informed, rational decision.
That does not at all sound like something a drug company would do.
barely a signal (Score:4, Insightful)
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Could be completely spurious, like the correlation between IE usage and murder rate.
Also, people diagnosed with Alzheimer's range between fairly mild to very severe cases. People with moderate to severe Alzheimer's may not talk to their doctor about their arthritis. If they don't, they won't get Enbrel.
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"Could be completely spurious, like the correlation between IE usage and murder rate."
I believe it is causative as I found that my murder rate went down when I adopted Firefox. I know, I know, this is merely anecdotal, but I believe there are enough examples out there that a study should be done.
Ugh. (Score:1)
> 127,000 patients with an Alzheimer's diagnosis and... 127,000
> without. It turns out that more people in the second group had
> been treated with Enbrel (302 patients) versus the first (110 patients).
Ok, I've only had two semesters of prob and stat, and it's been a
couple of decades, so I'm pretty rusty; but I'm fairly sure that's
so close to meaningless as makes no nevermind. Especially if it
wasn't controlled for other factors, such as age.
Also, Alzheimer's is pretty much the holy grail of drug re
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>curing ...
>have to keep taking it
Read the WaPo Article (Score:2)
I read Alzheimer articles frequently because of genetic history of it in my family...grandmother, aunt, and uncle all affected, and mom is showing signs.
Both Pfizer and Amgen decided that the results were not conclusive enough to warrant further research. Pfizer is getting out of the Alzheimer research business anyway, so it makes no business sense for them to continue.
Hopefully, other research will turn up something. Vitamin D is currently of interest.
https://www.mayoclinic.org/dis... [mayoclinic.org]
Alzheimer Trials (Score:2)
Missing the Point (Score:1)
The issue is not the only issue. Pfizer chose not to publish the information.
"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 did share the data privately with at least one prominent scientist, but outside researchers contacted by The Post belie