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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


Original Submission

Related Stories

Failure of Promising Alzheimer Drug Strikes a Blow to Theory 17 comments

The amyloid hypothesis is the theory that the accumulation of beta-amyloids in the brain leads to Alzheimer's Disease. These amyloids are "sticky" protein fragments, and the idea is that something in the body that normally regulates them fails and they accumulate in the brain. The idea was proposed in the early 1990s when it was observed that many Alzheimer's patients exhibited larger than normal amounts of amyloid plaques. This hypothesis has driven a very active area of research for drugs and treatments that address beta-amyloids.

In what some see as a fundamental blow to the hypothesis itself, it was recently announced that one of the leading drugs, solanezumab from Eli Lilly, has failed in a large trial of people with mild dementia. The clinical trial involved more than 2,100 people diagnosed with mild dementia due to Alzheimer’s disease, but the results showed only a small benefit of the drug. Eli Lilly has also been conducting prevention trials where the drug is given to people known genetically to be high-risk for the disease, and they said they will discuss with their clinical trial partners whether they will continue those studies.

Lilly’s result may say more about the characteristics of solanezumab than the accuracy of the underlying amyloid hypothesis, says Christian Haass, head of the Munich branch of the German Centre for Neurodegenerative Diseases. The antibody targets soluble forms of amyloid, he points out, so it “could be trapped in the blood without ever reaching the actual target in the brain in sufficient quantities”.

The appeal of the amyloid hypothesis is that it is a simple one. However, in the 25 years since it was proposed, it has led to essentially no progress in preventing or curing the disease. Criticism of the theory has grown with each failed result.

“We’re flogging a dead horse,” adds Peter Davies, an Alzheimer’s researcher at the Feinstein Institute for Medical Research in Manhasset, New York. “There’s no sign of anybody getting better, even for a short period, and that suggests to me that you have the wrong mechanism.”


Original Submission

Another Failed Alzheimer's Disease Therapy 10 comments

Dr. Derek Lowe, from In the Pipeline, writes about another disappointing failure to treat Alzheimer's Disease:

Merck announced last night that the first Phase III trial of their beta-secretase (BACE) inhibitor verubecestat was stopped because of futility. The monitoring committee, after looking over the data so far (the trial's been running since 2012) concluded that there was no real chance of seeing efficacy.

[...] The list of Alzheimer's clinical failures is impressive, but the list of failures to clinically validate the amyloid hypothesis is even more so.

[...] Beta-secretase inhibitors have failed in the clinic. Gamma-secretase inhibitors have failed in the clinic. Anti-amyloid antibodies have failed in the clinic. Everything has failed in the clinic. You can make excuses and find reasons – wrong patients, wrong compound, wrong pharmacokinetics, wrong dose, but after a while, you wonder if perhaps there might not be something a bit off with our understanding of the disease. Remember, every time one of these therapies comes around, it builds on the failures before it. Better and better attempts are made – I mean, verubecestat seems to be a pretty good compound, from the preclinical drug discovery perspective. It's surely the best swing anyone's taken at beta-secretase (and there have been many). But it just flat out did not work.

The good news about this study is that it adds to the evidence that the amyloid hypothesis of Alzheimer's Disease is a blind alley and that the presence of amyloid plaques is simply correlative and not causative. As more data comes in from the study, I hope that the evidence will be conclusive enough that more effort will be spent on pursuing other therapeutic targets.

See also: https://en.wikipedia.org/wiki/Alzheimer's_disease#Amyloid_hypothesis


Original Submission

Pfizer Halts Research Into Alzheimer's and Parkinson's; Axovant Sciences Abandons Intepirdine 11 comments

Pfizer has announced that it will halt efforts to find new treatments for Alzheimer's and Parkinson's diseases. Meanwhile, Axovant Sciences will halt its studies of intepirdine after it failed to show any improvement for dementia and Alzheimer's patients. The company's stock price has declined around 90% in 3 months:

Pfizer has announced plans to end its research efforts to discover new drugs for Alzheimer's and Parkinson's diseases. The pharmaceutical giant explained its decision, which will entail roughly 300 layoffs, as a move to better position itself "to bring new therapies to patients who need them."

"As a result of a recent comprehensive review, we have made the decision to end our neuroscience discovery and early development efforts and re-allocate [spending] to those areas where we have strong scientific leadership and that will allow us to provide the greatest impact for patients," Pfizer said in a statement emailed to NPR.

[...] Despite heavily funding research efforts into potential treatments in the past, Pfizer has faced high-profile disappointment in recent years, as Reuters notes: "In 2012, Pfizer and partner Johnson & Johnson (JNJ.N) called off additional work on the drug bapineuzumab after it failed to help patients with mild to moderate Alzheimer's in its second round of clinical trials."

Another potential treatment for neurodegenerative disorders — this one developed by Axovant, another pharmaceutical company — also found itself recently abandoned. The company dropped its experimental drug intepirdine after it failed to improve motor function in patients with a certain form of dementia — just three months after it also failed to show positive effects in Alzheimer's patients.

Looks like GlaxoSmithKline got a good deal when they sold the rights to intepirdine to Axovant Sciences in 2014.

Also at Bloomberg.

Related: Can we Turn Back the Clock on Alzheimer's?
Possible Cure for Alzheimer's to be Tested Within the Next Three Years
Mefenamic Acid Might Cure Alzheimers - Generic Cost in US is Crazy
New Alzheimer's Treatment Fully Restores Memory Function in Mice
Power Outage in the Brain may be Source of Alzheimer's
Another Failed Alzheimer's Disease Therapy
The FDA Saved Taxpayers from Paying Billions for Ineffective Alzheimer's Therapy
Alzheimer's Disease: A "Whole Body" Problem?
Bill Gates Commits $100 Million to Alzheimer's Research
Evidence That Alzheimer's Protein Spreads Like an Infection


Original Submission

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  • (Score: 2, Insightful) by Whoever on Friday May 12 2017, @03:55AM (13 children)

    by Whoever (4524) on Friday May 12 2017, @03:55AM (#508454) Journal

    Don't worry, Trump and the Republicans won't let this happen again. They want the FDA to only ensure that drugs are not harmful. They don't want the FDA to concern itself with effectiveness.

    Somehow, according to the Republicans (and, no doubt Libertarians) the magic free market will stop people over paying for ineffective drugs, despite the lack of information available to consumers.

    • (Score: 2, Troll) by frojack on Friday May 12 2017, @03:59AM (9 children)

      by frojack (1554) on Friday May 12 2017, @03:59AM (#508457) Journal

      How did you manage to turn this into a political rant?

      Are you seeing a doctor about your rage-hate issue?

      --
      No, you are mistaken. I've always had this sig.
      • (Score: 3, Insightful) by Whoever on Friday May 12 2017, @04:02AM (5 children)

        by Whoever (4524) on Friday May 12 2017, @04:02AM (#508458) Journal

        So you are not concerned about Trump's stated desire to stop the FDA from reporting on the effectiveness of drugs?

        This is a great story abut the FDA saving Americans billions of dollars, yet we know that this administration wants to prevent the FDA from performing this type of assessment.

        You don't think that there is a political issue here?

        • (Score: 0, Troll) by frojack on Friday May 12 2017, @04:19AM (2 children)

          by frojack (1554) on Friday May 12 2017, @04:19AM (#508466) Journal

          yet we know that this administration wants to prevent the FDA from performing this type of assessment.

          You know exactly what the liberal press wants you to know.
          You really should see a doctor about that hate issue you have.

          --
          No, you are mistaken. I've always had this sig.
          • (Score: 2) by Whoever on Friday May 12 2017, @04:54AM

            by Whoever (4524) on Friday May 12 2017, @04:54AM (#508478) Journal

            So are you claiming that I am wrong?

            Or do you think that an snarky comment will further your point of view?

          • (Score: 3, Insightful) by aristarchus on Friday May 12 2017, @05:16AM

            by aristarchus (2645) on Friday May 12 2017, @05:16AM (#508490) Journal

            I don't know, frojack. I can't recall. Hmm.

        • (Score: 2) by JoeMerchant on Friday May 12 2017, @02:30PM (1 child)

          by JoeMerchant (3937) on Friday May 12 2017, @02:30PM (#508624)

          The FDA just prevented Abbot labs from collecting ten billion dollars to offset the costs of their research on this drug over the past 16+ years. They prevented the release of a mostly harmless, potentially helpful agent into the market to allow the market to decide for itself whether or not it is worth tens of thousands of dollars to try to bring their senile partners, parents and friends back from Alzheimers.

          On the flip-side, yes, it probably has a success rate no better than sugar pills, and, if Abbot were permitted to market the sugar pills at the same price as the failed drug it would probably do more good than marketing the "mostly harmless" drug to a desperate public willing to try anything.

          So, the question is: should we allow big businesses like Abbot to risk billions trying to develop drugs like this, or are they "too big to fail" - should the taxpayers and/or public be placed in the position of bailing out big drug companies that go this far down the rabbit hole pursuing an ineffective drug?

          --
          🌻🌻 [google.com]
          • (Score: 0) by Anonymous Coward on Friday May 12 2017, @04:53PM

            by Anonymous Coward on Friday May 12 2017, @04:53PM (#508713)

            ...potentially helpful...

            Do you know how I know you didn't even read the headline, let alone the summary of the article?

            So, the question is: should we allow big businesses like Abbot to risk billions...

            Um, that's what business is.

            ...should the taxpayers and/or public be placed in the position of bailing out big drug companies...

            NO. (This needs to be in 72 point font, but sadly there's no way to do that on this site. Actually, this needs to be visible from space, and by visible from space I mean visible from the other side of the known universe with nothing more than a cheap toy telescope.) Taxpayers should NEVER be forced to bail out ANY company, bank, or any other organization for that matter. They made their bed, they get to sleep in it. If not bailing them out crashes the economy, it shows that the economy was defective and needed fixing or replacing anyway. When it gets rebuilt, perhaps people will learn from their mistakes (sadly it seems everyone has forgot the great depression already) and prevent these entities from getting so large in the future.

            "too big to fail"

            That's an idea created by the big business cock-suckers on capitol hill in order to justify their continued welfare payments to banks and corporations. (Republicans aren't anti-welfare, they're anti-people. Welfare is completely fine as long as it's going to a business and not a person.) It exists in the same realm as the easter bunny, the tooth fairy, and unicorns that shit rainbows and piss happiness.

      • (Score: 0) by Anonymous Coward on Friday May 12 2017, @04:15AM (2 children)

        by Anonymous Coward on Friday May 12 2017, @04:15AM (#508465)

        Are you seeing a doctor about your rage-hate issue?

        I was, but the doctor diagnosed an incurable personality disorder, and then gave up on me.

        • (Score: 0) by Anonymous Coward on Friday May 12 2017, @08:16AM

          by Anonymous Coward on Friday May 12 2017, @08:16AM (#508536)

          Don't worry. The next doctor will simply prescribe you an ineffective drug and keep you coming back for checkups until you or your insurance (if you still have it) will no longer pay.

        • (Score: 2) by JoeMerchant on Friday May 12 2017, @04:00PM

          by JoeMerchant (3937) on Friday May 12 2017, @04:00PM (#508670)

          >>Are you seeing a doctor about your rage-hate issue?

          >I was, but the doctor diagnosed an incurable personality disorder, and then gave up on me.

          Happens all the time, it's bad for drug sales - we need to teach these doctors to keep trying.

          --
          🌻🌻 [google.com]
    • (Score: 3, Insightful) by khallow on Friday May 12 2017, @05:46AM (2 children)

      by khallow (3766) Subscriber Badge on Friday May 12 2017, @05:46AM (#508504) Journal

      Somehow, according to the Republicans (and, no doubt Libertarians) the magic free market will stop people over paying for ineffective drugs, despite the lack of information available to consumers.

      Medicare is not "people" nor a free market. You should be concerned about institutional programs that will overpay for snake oil whenever the regulatory process gets gamed enough. We're fortunate that this situation didn't turn into a two billion USD per year exploit. But we should also be asking what similar exploits are ongoing or will happen in the future?

      • (Score: 2) by aristarchus on Friday May 12 2017, @06:18AM (1 child)

        by aristarchus (2645) on Friday May 12 2017, @06:18AM (#508509) Journal

        You should be concerned about institutional programs that will overpay for snake oil whenever the regulatory process gets gamed enough. We're fortunate that this situation didn't turn into a two billion USD per year exploit.

        khallow, do you ever think you may be paying too much for car insurance? Just wondering. You seem to have that Scroogy Republican fear of being lead to pay too much, and funding someone else's PROFIT!

        • (Score: 1) by khallow on Friday May 12 2017, @06:34PM

          by khallow (3766) Subscriber Badge on Friday May 12 2017, @06:34PM (#508783) Journal
          Car insurance provides a service, even if it's merely "can drive on a road" access. Two billion USD per year for a placebo provides considerably less than that.

          To use a better car analogy here, it's like, after an accident, proclaiming that the effectiveness of the airbags shows that driving is safe, while ignoring the circumstances that led to a really drunk driver somehow wrapping their car around a tree in the first place. The point being that the driver is likely to hit more trees and other objects in the course of their extremely shaky, high speed night commutes. And maybe the airbags won't save them next time?
  • (Score: 2) by frojack on Friday May 12 2017, @03:57AM (16 children)

    by frojack (1554) on Friday May 12 2017, @03:57AM (#508456) Journal

    Naturopathy
    Homeopathy
    Chiropractic
     

    --
    No, you are mistaken. I've always had this sig.
    • (Score: 2) by c0lo on Friday May 12 2017, @04:10AM (13 children)

      by c0lo (156) Subscriber Badge on Friday May 12 2017, @04:10AM (#508462) Journal

      My guess: as those are not drugs nor food, they aren't a concern of FDA.
      Then... what you want to do about? Ban them?
      At most, a consumer protection agency could be interested, but in the worst case scenario, that agency should at most be interested in making sure they aren't advertised as "medicine" (isn't this already true in US)?

      BTW, I'd add to the list the "nutritionists" (yeah, right); and mind you, they are about food (thus potentially of interest to FDA).

      --
      https://www.youtube.com/watch?v=aoFiw2jMy-0 https://soylentnews.org/~MichaelDavidCrawford
      • (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.

        --
        No, you are mistaken. I've always had this sig.
        • (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.

    • (Score: 2) by sjames on Friday May 12 2017, @05:06AM

      by sjames (2882) on Friday May 12 2017, @05:06AM (#508487) Journal

      All dirt cheap compared to what would have been charged for solanezumab. Of course, so is a BMW. OTOH, some alternative cancer treatments are anything but dirt cheap and so should see some scrutiny.

    • (Score: 2) by HiThere on Friday May 12 2017, @05:04PM

      by HiThere (866) Subscriber Badge on Friday May 12 2017, @05:04PM (#508723) Journal

      Don't know about all of those, but Chiropracty does have some benefits in certain cases. This has been demonstrated in accepted research. It seems clear that the results *do* depend on a qualified practitioner, and on his correctly diagnosing when Chiropracty is the correct approach, and that seems to be poorly handled. (That it costs the Chiropractor profits couldn't possibly be the reason.)

      --
      Javascript is what you use to allow unknown third parties to run software you have no idea about on your computer.
  • (Score: 0, Troll) by jmorris on Friday May 12 2017, @04:29AM (8 children)

    by jmorris (4844) on Friday May 12 2017, @04:29AM (#508467)

    Now look at it from a viewpoint other than trying to make the failed FDA look like it did good for a change. Imagine the drug had been greenlit, It didn't work, even after a few years on the market and a lot of people taking it. We would have known that for certain years ago, the whole medical world would have had to face their entire theory of the disease being wrong years ago and would have had to start rethinking it years ago, Because from my, admitted layman's viewpoint, everything they thought they knew about Alzheimer's said this drug should have done something to treat what they believed was the root cause. This is one of those failures that often lead to a major advance in science, an "that should have worked... that is odd" moment. Sucks to be Lilly but if they wanted a certain profit they got into the wrong business.

    • (Score: 3, Insightful) by Azuma Hazuki on Friday May 12 2017, @04:54AM

      by Azuma Hazuki (5086) on Friday May 12 2017, @04:54AM (#508476) Journal

      Here, have some more radium toothpaste, dipshit. "Failing FDA." Christ.

      --
      I am "that girl" your mother warned you about...
    • (Score: 5, Insightful) by Whoever on Friday May 12 2017, @04:57AM

      by Whoever (4524) on Friday May 12 2017, @04:57AM (#508481) Journal

      If the efficacy standard is removed, most new medicines simply won't work. The drug companies will concentrate on new and exciting ways to market placebos.

    • (Score: 1, Funny) by Anonymous Coward on Friday May 12 2017, @05:29AM

      by Anonymous Coward on Friday May 12 2017, @05:29AM (#508495)

      [Begin coded Massage] Special SJW Action Group, jmorris Squad, Lt. Boner reporting. New development. Target seems to have acquired delusions of medical competence. We have not seen this before. Evidently thinks that entire disease theory is in error. Checking right-wing nut-job conspiracy database. . . Could be "demonic possession" , or "Commies putting stuff in the drinking water" , hard to distinguish. Also, jmorris is claiming to be a "lay-man": is this some kind of same-sex code? Please advise. Target seems to be deteriorating quickly. Boner, out. [end coded Massague]

    • (Score: 4, Interesting) by sjames on Friday May 12 2017, @06:15AM (4 children)

      by sjames (2882) on Friday May 12 2017, @06:15AM (#508508) Journal

      The failed clinical trials have done the job of forcing the re-think just fine. Even interested laymen have known for a while now that Lilly's trial was just a desperate attempt to find any tiny shred of efficacy to rescue their expensive dud.

      Given that other drugs also aimed at amyloid plaques have also failed, the whole hypothesis is already under question.

      • (Score: 0) by Anonymous Coward on Friday May 12 2017, @07:41AM (3 children)

        by Anonymous Coward on Friday May 12 2017, @07:41AM (#508526)

        That's the problem with scientists - they claim things and then we find out they were lying and it ends up costing American business a lot of money. LOCK THEM UP LOCK THEM UP

        • (Score: 2) by c0lo on Friday May 12 2017, @10:35AM (2 children)

          by c0lo (156) Subscriber Badge on Friday May 12 2017, @10:35AM (#508558) Journal

          LOCK THEM UP LOCK THEM UP

          Last I looked, it's still impossible to lock up a business. Or... was it the money you wanted to lock up?

          (grin)

          --
          https://www.youtube.com/watch?v=aoFiw2jMy-0 https://soylentnews.org/~MichaelDavidCrawford
          • (Score: 2) by number11 on Friday May 12 2017, @06:03PM

            by number11 (1170) on Friday May 12 2017, @06:03PM (#508767)

            it's still impossible to lock up a business.

            Nah. Don't need to waste public money on private prisons. House arrest would be easy. Freeze their bank accounts and padlock their premises for the length of the sentence.

            Wouldn't it be nice to see JPMorganChase get 30 days?

          • (Score: 2) by sjames on Wednesday May 17 2017, @07:02AM

            by sjames (2882) on Wednesday May 17 2017, @07:02AM (#510950) Journal

            We can simulate some aspects of jail for corporations. Years in prison becomes years of operating as a non-profit. Stock valued at zero while 'in prison'. Parole equals open books with the slightest impropriety returning them to non-profit status for the remainder of their sentence.

  • (Score: 0) by Anonymous Coward on Friday May 12 2017, @09:40AM (7 children)

    by Anonymous Coward on Friday May 12 2017, @09:40AM (#508554)

    Another antibody towards amyloids, waste of time. It is so obvious that is a symptom or protective measure*, but I'm a crackpot who gave up on NIH dominated research.

    * Hint: Amyloids are the most thermodynamically state for many peptides/proteins to form. Rather than an abberation it requires eternal and effective vigilance to prevent.

    • (Score: 0) by Anonymous Coward on Friday May 12 2017, @09:44AM (1 child)

      by Anonymous Coward on Friday May 12 2017, @09:44AM (#508555)

      * Hint: Amyloids are the most thermodynamically stable state for many peptides/proteins to form. Rather than an aberation it requires eternal and effective vigilance to prevent.

      • (Score: 0) by Anonymous Coward on Friday May 12 2017, @09:53AM

        by Anonymous Coward on Friday May 12 2017, @09:53AM (#508556)

        aberration

    • (Score: 0) by Anonymous Coward on Friday May 12 2017, @12:00PM (4 children)

      by Anonymous Coward on Friday May 12 2017, @12:00PM (#508570)

      It is not fucking obvious.

      Prions also form amyloids and their formation directly induces disease. How is it obvious that the amyloids in Alzheimer's are benign?

      Populations with genetic determinants that specifically predispose them to producing amyloid beta in the brain develop early onset Alzheimer's at a much higher rate than non-carriers. How is it obvious that all these cases are simply a coincidence?

      Populations with genetic determinants that predispose them to have inefficient clearance of amyloid beta in the brain have increased Alzheimer's risk than non-carriers. How is it obvious that these cases are a coincidence?

      • (Score: 0) by Anonymous Coward on Friday May 12 2017, @04:36PM

        by Anonymous Coward on Friday May 12 2017, @04:36PM (#508699)

        I honestly can't tell if you are trolling. "How can two things be correlated if one doesn't cause the other?" Is that what you want me to explain?

      • (Score: 0) by Anonymous Coward on Friday May 12 2017, @04:40PM (2 children)

        by Anonymous Coward on Friday May 12 2017, @04:40PM (#508704)

        Actually, I see that this is NHST-disease again. You are concerned with determining whether correlations are "real" vs "coincidence", so you can commit a slew of logical fallacies you were taught in school; eventually leading to acceptance of your favorite explanation. "Real" vs "coincidence" is not at all an important issue.

        • (Score: 2) by HiThere on Friday May 12 2017, @05:11PM (1 child)

          by HiThere (866) Subscriber Badge on Friday May 12 2017, @05:11PM (#508730) Journal

          Even that's not correct. There is obviously *some* causal connection between the presence of amyloids and Alzheimer's disease. But it's not at all obvious what the connection is. One might directly cause the other, one might be a (protective?) reaction to the other. They might both be caused (either directly or indirectly) by something else. Or one might cause the other to be noticeable. Coincidence, however, is an unreasonable hypothesis.

          --
          Javascript is what you use to allow unknown third parties to run software you have no idea about on your computer.
          • (Score: 0) by Anonymous Coward on Friday May 12 2017, @05:16PM

            by Anonymous Coward on Friday May 12 2017, @05:16PM (#508737)

            I bet if you look up any top 20 list of diseases (just to use as a proxy for the amount of study they have gotten) and then check the literature, you will find the presence of amyloids associated with every one. I mean that 100% of disease states are going to be associated with the presence of amyloids.

  • (Score: 0) by Anonymous Coward on Friday May 12 2017, @11:28AM (2 children)

    by Anonymous Coward on Friday May 12 2017, @11:28AM (#508563)

    Isn't all government meddling bad? Free market, all drugs should be allowed until proven guilty by consumers not buying the stuff.

    • (Score: 0) by Anonymous Coward on Friday May 12 2017, @02:03PM

      by Anonymous Coward on Friday May 12 2017, @02:03PM (#508609)

      Hmmm, were there some snake oil sales-people back in your family tree?

    • (Score: 0) by Anonymous Coward on Friday May 12 2017, @04:42PM

      by Anonymous Coward on Friday May 12 2017, @04:42PM (#508705)

      I agree with the absurdity, but I think there's another side you might not be considering.

      The FDA often approves drugs that end up ineffective or even dangerous. I think a lot of our protections tend to result in people, over time, gradually ceasing to think for themselves. This is dangerous since it can lead people who would otherwise behave responsibly to engage in unsafe behavior. The opiate 'epidemic' is probably the most clear of this. There are some people that might not be willing to smoke a joint, but feel safe and secure chugging down opioids after a minor injury because of the guise of safety around the whole show. Or people popping back xanax at the mildest mental discomfort again because of the same charade of safety around it all. 'It's legal so it must be safe.' And doctors have a huge conflict of interest here since they're supposed to inform patients to the best of their ability, but there's big bucks to be made pedaling these drugs.

      People are seriously messing up their lives because they think because something is legal and regulated that it can't be so bad for you. I think we have the worst sort of regulation in that it seems, on the surface, to be effective yet we simultaneously have regulated organizations handing out opiates, drugs like xanax, and even antibiotics like they're candy. So people feel very secure, yet they're not.

  • (Score: 0) by Anonymous Coward on Friday May 12 2017, @03:21PM (1 child)

    by Anonymous Coward on Friday May 12 2017, @03:21PM (#508652)

    Who do you think funds the company's to do research? Customers do. Losses are pass down as higher future prices. Nothing happens in a vacuum.

    • (Score: 0) by Anonymous Coward on Friday May 12 2017, @04:27PM

      by Anonymous Coward on Friday May 12 2017, @04:27PM (#508692)

      Hardly. These companies are protected from competition due to patents. They set their price to as high as the market will bear. Their actual costs are, at best, tangentially related. Put another way if you could somehow magically cut all their expenses by 50% tomorrow, drugs would be just as expensive. They'd just pocket the extra.

  • (Score: 0) by Anonymous Coward on Friday May 12 2017, @04:24PM (3 children)

    by Anonymous Coward on Friday May 12 2017, @04:24PM (#508689)

    When a regulatory agency actually doing their job is newsworthy we have some problems. Remember when the DoJ used to enforce antitrust laws, or when the FTC would prohibit mergers that would substantially compromise competition or harm consumers?

    Reminds me of another recent great result from the FDA - one for which those suffering from spinal muscular atrophy are surely also rejoicing over. The FDA approved a life saving medicine for this often fatal condition. And they're fine with the very reasonable pricing of just [$125,000](http://www.reuters.com/article/us-pharmaceuticals-approvals-idUSKBN14M08R) a dose - protected from any competition due to their patent. I mean it seems perfectly reasonable for a government to approve a company setting the price of life saving drugs at 5 times the median personal yearly income... per dose. That's true progress.

    • (Score: 0) by Anonymous Coward on Friday May 12 2017, @04:51PM (1 child)

      by Anonymous Coward on Friday May 12 2017, @04:51PM (#508709)

      I don't think the FDA has any regulatory power to approve/influence the price of drugs. Do you have evidence that they do?

      • (Score: 2) by HiThere on Friday May 12 2017, @05:15PM

        by HiThere (866) Subscriber Badge on Friday May 12 2017, @05:15PM (#508735) Journal

        Yes. By removing the generic form of Colchicine from the market they caused the price to rise from around $0.05/pill to around $5/pill. They didn't set the exact price, but they sure influenced the price.

        --
        Javascript is what you use to allow unknown third parties to run software you have no idea about on your computer.
    • (Score: 2) by krishnoid on Friday May 12 2017, @07:49PM

      by krishnoid (1156) on Friday May 12 2017, @07:49PM (#508820)

      Remember solanezumab?
      ...
      Remember when the DoJ used to enforce antitrust laws, or when the FTC would prohibit mergers that would substantially compromise competition or harm consumers?

      This is just cruel in an article about Alzheimer's sufferers.

      And they're fine with the very reasonable pricing of just [$125,000](http://www.reuters.com/article/us-pharmaceuticals-approvals-idUSKBN14M08R) a dose - protected from any competition due to their patent.

      Does the FDA have control over that? Seems like it should be more an FTC kind of thing, or something Medicare would have leverage in negotiating down.

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