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posted by martyb on Friday May 12 2017, @03:50AM   Printer-friendly
from the cheques-and-balances dept.

Dr. Lowe, from In the Pipeline, writes of how the efficacy requirements of the FDA save US taxpayers money:

Remember solanezumab? That was the amyloid-targeting antibody that Eli Lilly kept on investigating in trial after trial, looking for some effect on Alzheimer’s. Last November, the final, final word finally came down that it really, truly, does not work. To recap, mouse model results with a similar antibody were published in 2001. Phase I results of solanezumab itself were published in 2010, and Phase II results were published in 2012.

The authors of the NEJM [New England Journal of Medicine] paper would like to point out that under the current system, the cost of investigating all this was largely borne by the drug’s developers, not the patients and not the taxpayers

[...] Under a system designed to speed up drug approvals, people might have started taking it back in 2010-2012, when the Phase I and II results showed no adverse effects.

[...] We have a very tightly regulated and opaque market indeed in this country for prescription drugs and every other form of health care, and it’s not a very good place to discover prices or utilities. You could imagine a system where these things could be done better than we’re doing them, but such a system would be pretty far from what we have going now.

[...] The NEJM paper estimates, pretty conservatively, that had solanezumab been given conditional approval back in 2012 or so, that we – meaning Medicare, for the most part, which is to say all taxpayers, but also insurance companies and patients – would have spent at least ten billion dollars injecting Alzheimer’s patients with an expensive placebo. No one would have gotten the tiniest bit better. False hope all around, with no benefit, and billions of dollars down the tubes.

Note: Bold added by submitter.

http://blogs.sciencemag.org/pipeline/archives/2017/05/09/there-are-failures-you-know
http://www.nejm.org/doi/full/10.1056/NEJMp1701047
https://en.wikipedia.org/wiki/Solanezumab
https://en.wikipedia.org/wiki/Alzheimer%27s_disease
https://soylentnews.org/article.pl?sid=16/11/27/0147228
https://soylentnews.org/article.pl?sid=17/02/16/0116248


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  • (Score: 2) by frojack on Friday May 12 2017, @04:30AM (12 children)

    by frojack (1554) on Friday May 12 2017, @04:30AM (#508468) Journal

    At least two of those do masquerade as medicine for consumption.

    The FDA can impose efficacy requirements on medicine. Why not on watered down medicine? Why not herbs sold as medicine?

    Efficacy simply means they need to be proven to work above the level of a placebo.

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  • (Score: 1, Interesting) by Anonymous Coward on Friday May 12 2017, @04:57AM (6 children)

    by Anonymous Coward on Friday May 12 2017, @04:57AM (#508480)

    > Why not herbs sold as medicine?

    What have you got against herbs and traditional medicine? Some of it is very effective and certainly very cost effective.

    Personal anecdote -- I have a painful arthritic big toe, it was dislocated 45 years ago, started to swell and hurt ~30 years ago. If I drink a few ounces of tart cherry juice every day it mostly controls the pain. If I quit (get busy and forget) for a few days, it starts to hurt more. Get back on and within a day or two I'm back to walking with little pain. It's tasty and there are no side effects, except that sometimes I proselytize like this...

    Of course I don't claim that it works for everyone, but an older friend has a similar/worse problem and had tried everything short of surgery on his toe--now he thanks me whenever we get together. He travels frequently and has found that he can get an extract of tart cherry in capsule form, a little more convenient when away from home.

    Do you have a "touch of the 'tis" (arthritis)? It's cheap enough to give it a try -- has to be "tart cherry", not the more common sweet or normal cherry. There are several different brands sold in USA.

    Note--I have no investments in cherry orchards or juice pressing/bottling...!

    • (Score: 0) by Anonymous Coward on Friday May 12 2017, @05:22AM

      by Anonymous Coward on Friday May 12 2017, @05:22AM (#508492)

      Some of it is very effective and certainly very cost effective.

      Personal anecdote

      You know what I find very effective for arthritis? Cyanide, one big dose of cyanide! Super effective, no one has ever reported any bad results! Or, could I interest you in some Hemp Oil! Cures cancer, usually by making you forgo treatment so you die faster and we don't have to listen to all your moaning and complaining, when you stopped being a productive member of society years ago and now are just a drain on the Health Insurance TrumpNoCare pool, dragging the rest of us down to a similar doom. And I have no investments in cyanide production, or Hemp Oil, but you can be sure that Ely Lille does.

    • (Score: 3, Interesting) by WalksOnDirt on Friday May 12 2017, @05:23AM (1 child)

      by WalksOnDirt (5854) on Friday May 12 2017, @05:23AM (#508493) Journal

      I have no problem with you drinking cherry juice, or with you saying it help you with a condition, or even recommending others try it. I do have a problem with the cherry juice bottler, or the store that sells it, or anyone profiting from it in any way, saying the same without efficacy testing. Experience has shown that if a claim will increase sales and the law allows then the claim will be made.

      I suppose I also have nothing against selling homeopathic "remedies", but it should be made very clear that only water is being sold. Care should be taken to ensure that no "buyers club" shenanigans are being pulled, either.

      • (Score: 0) by Anonymous Coward on Friday May 12 2017, @02:16PM

        by Anonymous Coward on Friday May 12 2017, @02:16PM (#508613)

        > I do have a problem with the cherry juice bottler, or the store that sells it, or anyone profiting from it in any way, saying the same without efficacy testing.

        Sure, I'm all for that. I think I first tried it after reading a tip in the newspaper "People's Pharmacy" column (...don't know if they have invested in tart cherry production).

        {gets tart cherry juice bottle from fridge}
        Label says: "Organic Tart Cherry 100% Juice, fresh squeezed not from concentrate"
        A small note on the bottom of the label, "A good source of Melatonin and Potassium" and another, "Antioxident Rich!"

        Nope, no mention of arthritis or pain relief at all, anywhere on front or back of label.
        This product passes the WalksOnDirt test!

    • (Score: 3, Insightful) by TheRaven on Friday May 12 2017, @11:08AM

      by TheRaven (270) on Friday May 12 2017, @11:08AM (#508561) Journal
      To quote Tim Minchin:

      "By definition", I begin
      "Alternative Medicine", I continue
      "Has either not been proved to work,
      Or been proved not to work.
      You know what they call alternative medicine
      That’s been proved to work?
      Medicine

      --
      sudo mod me up
    • (Score: 2) by AthanasiusKircher on Friday May 12 2017, @02:40PM (1 child)

      by AthanasiusKircher (5291) on Friday May 12 2017, @02:40PM (#508628) Journal

      What have you got against herbs and traditional medicine? Some of it is very effective and certainly very cost effective.

      And a lot of it is using placebo effects. But hey -- placebo effects are often subjectively "real," especially for pain relief. So if it works for you, why not? (I'm not being sarcastic here; placebo effects can do a lot of good for people. And sometimes when it comes to milder forms of pain, they might be better for you than taking some sort of drug instead, which could have more side effects.)

      That said, some herbs and "traditional medicine" HAVE been shown to have measurable effects under rigorous studies. Many (probably most) have minimal or no effect at all, when done in double-blinded conditions. There's nothing wrong with using herbs when they actually have been proven to do something. (And no, "It worked for me and my one other friend" doesn't count as "science," because people are very good at fooling themselves.) The danger is that SOME herbs also do BAD things, and science can prove that they do in large doses. The other issue with unapproved "herb" medication is that there's no rigorous controls on dosage in OTC supplements, so herbs that might actually have effects might be okay, but a particular batch of supplements could be useless or so strong that they could be dangerous.

      As for tart cherries, evidence so far in rigorous studies is mixed [skeptoid.com], but there do appear to be small effects, particularly in some studies on runners and pain after running. (I actually think the link there is a bit overly cynical; but it provides info on a few actual studies. A more balanced perspective would say that we've had some preliminary results showing small effects.)

      It's cheap enough to give it a try -- has to be "tart cherry", not the more common sweet or normal cherry. There are several different brands sold in USA.

      Better yet, just buy tart cherries (also known sometimes as "sour cherries") and eat them or cook with them. They're amazing and in my opinion so much more interesting and tasty than "normal" sweet cherries. They're really popular in Eastern European cuisines, and a bowl of cold sour cherry soup on a hot day is an amazing thing. Or make a pie with sour cherries -- I grew up eating them occasionally, and to me the sweet cherry "pie filling" you generally see is pretty disgusting. Sour cherry pie is a completely different world.

      So, I support your advocacy of tart cherries, but mainly for their culinary value! :)

      • (Score: 0) by Anonymous Coward on Friday May 12 2017, @05:17PM

        by Anonymous Coward on Friday May 12 2017, @05:17PM (#508738)

        > They're really popular in Eastern European cuisines,

        Ah, that explains something -- the brand of tart cherry juice I use is from Turkey.

  • (Score: 2) by Soylentbob on Friday May 12 2017, @05:29AM

    by Soylentbob (6519) on Friday May 12 2017, @05:29AM (#508496)

    Wouldn't that dilute the term "medicine"? Consumers should be informed that "medicine" means FDA approved, and FDA approved means proven to be effective and reasonably safe (a cancer-drug is IMO reasonably safe if it really eradicates the cancer but causes a 10 percent chance of developing diabetes a decade later. A cough syrup with the same side-effect is not *reasonably* safe.

    If consumer want to buy Homeo-, Naturo- or Psychopathy-products, snake oil, ape excrement, sugar-water, powdered beetle or dried weeds, they can do that, if they are uncertain if it is a medical product or not, they learn to look for the term "medicine".

    Consumer protection laws just have to ensure that there are certain protected classifications. "Medicine" means well-tested, effective, relatively safe, FDA approved. "Food" means harmless to eat, not sure if in US any approval is required, but vendor is liable that the product is in reasonable amounts safe for consumption. Everything else means, put it in any orifice you want, swallow it if you want, but on your own risk, and if you do it to your child and put your child at risk, you go to jail.

  • (Score: 2) by c0lo on Friday May 12 2017, @06:41AM

    by c0lo (156) Subscriber Badge on Friday May 12 2017, @06:41AM (#508519) Journal

    At least two of those do masquerade as medicine for consumption.

    I have no problems with them existing on the market, as long as they are not advertised as medicine or prescribed by medicine doctors.

    Why not on watered down medicine? Why not herbs sold as medicine?

    As I said above, as long as it is not sold or prescribed as medicine or advertised as "clinically proven to...", I have no problem with them existing on the market without FDA having to spend a cent on their efficacy.
    They can even use the "may help in x/y/z" on their labels.

    You see, I'm OK to use baths with Epsom salts for (post-effort) muscular pain relief and hawthorn berries as a coronary and periphery vasodilator: true, they aren't certified for human treatment (only recommended for horses [horseandhound.co.uk]) but I found they work to the same effects on me (and I'm making no recommendations here for any other humans, YMMV).
    Banning them will make me unhappy!

    --
    https://www.youtube.com/watch?v=aoFiw2jMy-0 https://soylentnews.org/~MichaelDavidCrawford
  • (Score: 2) by Wootery on Friday May 12 2017, @08:22AM (1 child)

    by Wootery (2341) on Friday May 12 2017, @08:22AM (#508538)

    We have similar nonsense here in the UK. Shysters can pretend their secret herb cocktail will cure all ills, and the government just stays silent.

    See also the works of Ben Goldacre, author of Bad Science and Bad Pharma. An example. [badscience.net]

    • (Score: 1) by purple_cobra on Monday May 15 2017, @12:55PM

      by purple_cobra (1435) on Monday May 15 2017, @12:55PM (#509984)

      Two excellent books that I recommend to anyone with an interest in pharmaceutical research or even an interest in public healthcare spending, e.g. the whole Tamiflu farrago. One SoS for Health, possibly even the current one, refused to outright condemn homeopathy, something that should have made him ineligible for the job; it's magical thinking and we absolutely do not need that in the NHS.

  • (Score: 3, Insightful) by Immerman on Friday May 12 2017, @04:04PM

    by Immerman (3985) on Friday May 12 2017, @04:04PM (#508673)

    The obvious problem is regulatory capture - it is extremely expensive to test something for safety and efficacy and navigate the bureaucracy, and the pharmaceutical companies like it that way - keeps out competition. Herbal treatments are not especially profitable, nor do they get any patent protection so even if Company A undertook the time and expense of getting a treatment approved, there's nothing to stop Company B from taking advantage of that approval to sell the same thing without incurring the overhead.