Patterico's Pontifications

6/7/2019

The Washington Post and Pfizer

Filed under: General — DRJ @ 6:54 am



[Headlines from DRJ]

Washington PostPfizer had clues its blockbuster drug could prevent Alzheimer’s. Why didn’t it tell the world?:

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.

Science MagazineA Missed Alzheimer’s Opportunity? Not So Much:

The Washington Post made quite a splash with this story about Pfizer, Enbrel (etanercept), and Alzheimer’s disease. There’s already been a lot of comment about it yesterday on Twitter and insome other venues, but I thought it might be useful to try to sum things up in an easily accessible place.
***
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. There are a couple of therapies approved, but they don’t affect the disease progression at all – they help a few people, a bit, for a little while, and that’s it. That argues for a huge unmet need in the area (which no one disputes, God knows), but it also argues for caution. Many, many approaches have been tried already, from many angles, and every single one of them has gone down in flames.

Much more at the link.

— DRJ

20 Responses to “The Washington Post and Pfizer”

  1. Complicating Alzheimer’s trials is the fact that certain populations are statistically more likely to get Alzheimer’s than others. This makes double-blind trials for therapy quite difficult since an inadequate cross-section of certain populations (such as those Down Syndrome) means that the therapy can’t be approved for that population.

    Gryph (08c844)

  2. I’ll adopt one of the comments from the Science Magazine article, blue-penciled for accuracy:

    When discussing a topic as heart-wrenching as Alzheimer’s, to find the statement that Enbrel could reduce the risk of AD by 64% in the very first sentence of the WaPo article is beyond ignorance and has strayed precariously into negligence. This type of clickbait baloney is far below representative of the standards of WaPo.

    nk (dbc370)

  3. I agree, nk. The Post article is based on Pfizer’s review of insurance claims. That tells us about health insurance, not medicine.

    DRJ (15874d)

  4. DRJ, the author of the link, Derek Lowe is an exceedingly cautious scientist. I have long admired how he doesn’t go for the splashy clickbait statements. At a talk of his I attended some time ago, he actually said that his approach to this kind of thing has led to “a marked lack of invitations to cocktail parties.”

    So whether or not he is correct, I am glad he is still trying to explain things to the public, instead of giving them inflated hopes.

    Simon Jester (4357eb)

  5. That Science Magazine article is from Derek Lowe.

    I highly recommend reading his “Things I Won’t Work With” posts, especially the earlier ones.

    Xmas (eafb47)

  6. There is another concern here: drugs like Enbrel work by at least partially shutting down the immune system, meaning extra risk from infections and contagions. Given that Alzheimer’s occurs in among the age groups most at risk from such things in the first place, you want to think long and hard before speculatively testing them on the elderly.

    kishnevi (496414)

  7. A far cheaper approach for Pfizer, but one they would never countenance, would be to leak the results of their study so that patients would demand the drug from doctors, without having to go through all that pesky regulatory approval.

    Kevin M (21ca15)

  8. I think it’s very true that pharmaceutical companies avoid </b? promoting health benefit that are true. And they do that when they have hopes of getting regulatory approval.

    The more true and significant they are, the more they are likely to try to keep that under wraps,

    If it's not true, or they can't patent it, they don't really care if their salesmen say stuff because they'll never get FDa approval for saying that anyway.

    The drug approval system is that perverse.

    Sammy Finkelman (9974e8)

  9. And tobacco companies keep under wraps the health benefits of nicotine (especially for mental health) or ways in which harm can be mitigated by regularly taking certain extra vitamins.

    They would then be in the position of possibly being accused of arguing that cigaettes are anet benefit, and they don’t want to claim that.

    The legal system is that perverse.

    Sammy Finkelman (9974e8)

  10. 7. Kevin M (21ca15) — 6/7/2019 @ 9:56 am

    7.A far cheaper approach for Pfizer, but one they would never countenance, would be to leak the results of their study so that patients would demand the drug from doctors, without having to go through all that pesky regulatory approval.

    But then they could get caught, and would never get regulatory approval by the FDA, and it’s precisely because they think this might get it, that they keep that secret.

    Sammy Finkelman (9974e8)

  11. Among the cost v benefit factors that a pharma company might consider when evaluating whether to initiate very risky & costly trials, is how likely it might be that future government actions may restrict pharma product maximum pricing to some “expert” determined amount. Which would likely interfere with recovering R&D costs.
    …not saying that had any part in Pfizer’s decision, of course. It’s just a random thought.

    ColoComment (f7fbd5)

  12. A far cheaper approach for Pfizer, but one they would never countenance, would be to leak the results of their study so that patients would demand the drug from doctors, without having to go through all that pesky regulatory approval.

    But without the approval insurance companies are not likely to pay for it. And drugs like Enbrel are not cheap. According to this page from the official website, the list price is almost $1300 per week.
    https://www.enbrel.com/support/financial-support

    kishnevi (496414)

  13. I know a bit about the pharma business, but not this part. Could Pfizer publish a Note about an interesting correlation with the idea that someone else might study it? Or would the FDA call this off-label advertising and start laying fines?

    matt d (b5cbe0)

  14. Off-label use is tricky and susceptible to pressure from patients and even doctors. And as kishnevi said:

    For example, Alexander’s research showed that nearly one in five doctors questioned who prescribed the drug quetiapine (Seroquel) for dementia with agitation mistakenly believed it was approved for such use. But the medicine carries a “black box” warning — the FDA’s sternest warning — stating that the use of antipsychotic drugs was associated with an increased death risk in elderly patients with dementia.

    However, as described at the link, off-label prescribing is common and there are several good reason it occurs.

    DRJ (15874d)

  15. Defending phizer? what b.s. hap many time times did thomas edison fail in inventing the light bulb before he succeeded. you got stock in phizer?

    lany (7b782c)

  16. That sounds personal, lany. Who are you talking to?

    DRJ (15874d)

  17. the FDA’s sternest warning — stating that the use of antipsychotic drugs was associated with an increased death risk in elderly patients with dementia.

    It’s asssociated woth increased death risk for anyone!

    It is just that they got a statistically significant result with that subgroup of patients. And elderly are more likely to die.

    You’ve got to learn how to read these things.

    Sammy Finkelman (102c75)

  18. By the way, cigarettes are only half as dangerous.

    https://jamanetwork.com/journals/jamapsychiatry/fullarticle/481866

    Thus is not the right link. It doesn’t compare it to smoking. I saw it in a book.

    Vaping would on;y have the risk of cardiac death.

    Sammy Finkelman (102c75)

  19. Even though they know it’s wrong (or should know) they still persist in telling people to consume very little salt.

    https://www.wsj.com/articles/are-you-getting-too-much-salt-in-your-diet-probably-not-11559507235

    Dietary guidelines often change, but “restrict your salt intake” has resisted the advances of science. The National Academy of Medicine recently reiterated its advice to limit daily sodium intake to 2,300 milligrams (a little over a teaspoon of salt), or 1,500 milligrams for those at risk of cardiovascular disease. An article last week in the New England Journal of Medicine endorsed that view and called for the Food and Drug Administration to impose voluntary sodium limits on 150 food categories.

    These recommendations ignore scientific developments and may be harmful to your health. In March we published an article in the Lancet summarizing six decades of research on sodium intake in more than a million people world-wide. We found the sodium “sweet spot”—the intake range associated with the lowest risk of disease and the longest life expectancy—to be between 3,000 and 5,000 milligrams a day, considerably higher than the usual recommendations. Once daily sodium consumption falls below 3,200 milligrams, all-cause mortality increases and life expectancy decreases dramatically.

    …Understanding the stark contrast between the National Academy of Medicine’s recommendation and what science has identified as sodium’s healthy range is critical to the nation’s health. Minimal decreases in serum sodium predict increased mortality in healthy people. Although this is not fully understood, we know that risk increases when sodium intake breeches the lower limits of the brain’s ability to maintain serum sodium within its narrow range—especially in healthy middle-aged men, for whom it nearly doubles the risks. Comparable increases in risk exist for the ill and the elderly. Low serum sodium at hospital admission is associated with increased length of stay, in-hospital death, and discharge to a care facility. If, contrary to the British experience, the prospective FDA restrictions on sodium in food prove successful in reducing intake, that could magnify the risk for Americans.

    Related Lancet artivleZ:

    https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)30232-6/fulltext?mod=article_inline

    Sammy Finkelman (102c75)

  20. Rush Limbaugh on changing, often wrong health, nutritoion or dietrary advice:

    https://www.rushlimbaugh.com/daily/2019/06/07/busting-the-conventional-wisdom-on-health-fads/

    Sammy Finkelman (102c75)


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