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posted by Fnord666 on Sunday March 12 2017, @03:05AM   Printer-friendly
from the time-to-market dept.

President Trump will likely nominate Dr. Scott Gottlieb as head of the FDA. Though he is presently a resident fellow at the conservative American Enterprise Institute and a partner at a large venture capital fund, he used to be an FDA deputy commissioner known for advocating dramatic reforms in the process to approve new medical products.

According to his statements as well as comments to people familiar with his thinking on the FDA, Gottlieb intends to shoot for the rapid approval of complex generics, ushering in a wave of less expensive rivals to some of the biggest blockbusters on the market. He's also likely to spur the FDA to follow the course laid out by agency cancer czar Richard Pazdur in speeding new approvals, possibly setting up a special unit aimed at orphan drugs to hasten OKs with smaller, better designed clinical trials. Other potential reforms include the possible quick adoption of new devices that could be used to improve the kind of medtech Apple, Verily and others have been working on.

Gottlieb is viewed very favorably within the pharmaceutical industry as a regulatory reformer but not destroyer. If nominated, he will have been chosen over another high-profile name on the short list: Jim O'Neill.

The close associate of Peter Thiel, O'Neill famously suggested that drugs should be approved based on safety alone, letting consumers sort out what works. That left many fearing that Trump intended to toss out the regulatory framework for new drug approvals, raising fears that his idea of competition would allow de facto placebos to compete for market share.


Original Submission

Related Stories

FDA to More Strictly Regulate Homeopathic Drugs 47 comments

The FDA is proposing a new, risk-based enforcement approach to homeopathic drug products (alternative medicine):

To protect consumers who choose to use homeopathic products, this proposed new approach would update the FDA's existing policy to better address situations where homeopathic treatments are being marketed for serious diseases and/or conditions but where the products have not been shown to offer clinical benefits. It also covers situations where products labeled as homeopathic contain potentially harmful ingredients or do not meet current good manufacturing practices.

Under the law, homeopathic drug products are subject to the same requirements related to approval, adulteration and misbranding as any other drug product. However, prescription and nonprescription drug products labeled as homeopathic have been manufactured and distributed without FDA approval under the agency's enforcement policies since 1988.

"In recent years, we've seen a large uptick in products labeled as homeopathic that are being marketed for a wide array of diseases and conditions, from the common cold to cancer. In many cases, people may be placing their trust and money in therapies that may bring little to no benefit in combating serious ailments, or worse – that may cause significant and even irreparable harm because the products are poorly manufactured, or contain active ingredients that aren't adequately tested or disclosed to patients," said FDA Commissioner Scott Gottlieb, M.D. "Our approach to regulating homeopathic drugs must evolve to reflect the current complexity of the market, by taking a more risk-based approach to enforcement. We respect that some individuals want to use alternative treatments, but the FDA has a responsibility to protect the public from products that may not deliver any benefit and have the potential to cause harm."

FDA draft guidance (8 pages).

Also at Ars Technica and STAT News.

Related: Probiotics Come with Bold Health Claims, but the Science is Shaky
What a Gottlieb-Led FDA Might Mean for the Pharmaceutical Industry
Supplement Maker on FDA Blacklist After Deadly Bacteria Found in Water System
FDA Designates MDMA as a "Breakthrough Therapy" for PTSD; Approves Phase 3 Trials
Homeopathic "Healing Bracelet" Poisons Baby With High Levels of Lead
FDA: Love is Not an Ingredient
FDA Cracking Down on Unsubstantiated Cannabidiol Health Claims
FDA Blocks More Imports of Kratom, Warns Against Use as a Treatment for Opioid Withdrawal
Biohackers Disregard FDA Warning on DIY Gene Therapy


Original Submission

Politics: Koch-Backed Groups Urge Congress to Pass "Right to Try" Legislation 56 comments

Groups funded by Charles and David Koch have launched ad campaigns aimed at urging Congress to pass legislation that would make it easier for terminally ill patients to try experimental treatments. The bill passed the Senate unanimously, but FDA Commissioner Scott Gottlieb told the House in October (archive) that the FDA already approves 99% of requests for expanded access/compassionate use, and that the primary roadblock is not the FDA, but drug supply constraints. He said that pharmaceutical companies do not continuously manufacture a drug undergoing clinical trials, but instead produce "discontinuous batches":

Several deep-pocketed political advocacy groups founded by Charles and David Koch are ramping up their advocacy before Congress on a niche issue: access to experimental drugs.

On Monday, several Koch-backed groups, including Freedom Partners and Americans for Prosperity, launched an ad campaign urging Congress to pass so-called "right-to-try" legislation, which aims to help terminally ill patients access experimental treatments that haven't yet been approved by the Food and Drug Administration. The Senate unanimously passed a right-to-try bill from Sen. Ron Johnson (R-Wis.) last August, but it has since stalled in the House. Supporters, including lawmakers on Capitol Hill and other off-the-Hill advocates, are focusing their efforts this month on the Energy and Commerce Committee, which would likely have to clear the legislation before the full House could vote on it.

The new ad campaign — also sponsored by Generation Opportunity and The LIBRE Initiative — directly addresses Congress, saying at the end of one commercial, "Congress, give patients a chance. Pass right to try." In addition to a series of digital ads focused on D.C. and key congressional districts, the campaign will include lobbying efforts by the groups, according to a press release. In a letter sent Monday to Committee Chairman Greg Walden (R-Ore.), executives wrote, "We strongly urge your committee to act expeditiously to approve Right to Try legislation and send the bill to the House Floor for a full vote."

Johnson told STAT he's doing everything he can this month to get the legislation passed, and suggested the vice president might become even more engaged. Vice President Mike Pence has supported right-to-try efforts since he signed a similar law as governor of Indiana.

S.204 - Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017

Related: What a Gottlieb-Led FDA Might Mean for the Pharmaceutical Industry
FDA Nominee is a Proponent of "Adaptive Trials"
Texas Sanctions FDA-Unapproved Stem Cell Therapies
University Could Lose Millions From "Unethical" Research Backed by Peter Thiel
"Black Hole" of Accountability for Drug Trials Flouting FDA Oversight?
Drug Approvals Sped Up in 2017


Original Submission

President Trump Signs "Right to Try" Bill 36 comments

Trump signs 'right to try' drug bill

President Trump signed a bill Wednesday allowing terminally ill patients access to experimental medical treatments not yet approved by the Food and Drug Administration (FDA). Dubbed "right to try," the law's passage was a major priority of Trump and Vice President Pence, as well as congressional Republicans.

"Thousands of terminally ill Americans will finally have hope, and the fighting chance, and I think it's going to better than a chance, that they will be cured, they will be helped, and be able to be with their families for a long time, or maybe just for a longer time," Trump said at a bill signing ceremony at the White House, surrounded by terminally ill patients and their families.

Trump thanked lawmakers sitting in the audience who sponsored the bill, including Sen. Joe Donnelly, a vulnerable Democrat up for reelection in Indiana.

Also at CNN.

Related: What a Gottlieb-Led FDA Might Mean for the Pharmaceutical Industry
Texas Sanctions FDA-Unapproved Stem Cell Therapies
Drug Approvals Sped Up in 2017

Also submitted by mrpg


Original Submission

Groundbreaking Ketamine-Derived Treatment for Depression Approved by the U.S. FDA 24 comments

Fast-Acting Depression Drug, Newly Approved, Could Help Millions

Of the 16 million American adults who live with depression, as many as one-quarter gain little or no benefit from available treatments, whether drugs or talk therapy. They represent perhaps the greatest unmet need in psychiatry. On Tuesday, the Food and Drug Administration approved a prescription treatment intended to help them, a fast-acting drug derived from an old and widely used anesthetic, ketamine.

The move heralds a shift from the Prozac era of antidepressant drugs. The newly approved treatment, called esketamine, is a nasal spray developed by Janssen Pharmaceuticals Inc., a branch of Johnson & Johnson, that will be marketed under the name Spravato. It contains an active portion of the ketamine molecule, whose antidepressant properties are not well understood yet. "Thank goodness we now have something with a different mechanism of action than previous antidepressants," said Dr. Erick Turner, a former F.D.A. reviewer and an associate professor of psychiatry at Oregon Health & Science University. "But I'm skeptical of the hype, because in this world it's like Lucy holding the football for Charlie Brown: Each time we get our hopes up, the football gets pulled away."

[...] Esketamine, like ketamine, has the potential for abuse, and both drugs can induce psychotic episodes in people who are at high risk for them. The safety monitoring will require doctors to find space for treated patients, which could present a logistical challenge, some psychiatrists said.

The wholesale cost for a course of treatment will be between $2,360 and $3,540, said Janssen, and experts said it will give the company a foothold in the $12 billion global antidepressant market, where most drugs now are generic.

[...] One question that will need to be answered is how well esketamine performs in comparison to intravenous ketamine.

Also at STAT News, Reuters, and NPR.

Previously: Ketamine Reduces Suicidal Thoughts in Depressed Patients
Studies Identify How Ketamine Can Reverse Symptoms of Depression
Ketamine Shows Promise as a Fast-Acting Treatment for Depression

Related:


Original Submission

Former FDA Commissioner Scott Gottlieb Joins Pfizer Board of Directors 14 comments

Scott Gottlieb walks through the revolving door to the Pfizer board

The revolving door turns again. After a two-year stint running the Food and Drug Administration, Scott Gottlieb has joined the board of directors at Pfizer, giving the world's largest drug maker crucial insights into the inner workings of the Trump administration as it attempts to contain national angst over the rising cost of medicines.

And in doing so, Gottlieb is also picking up where he left before joining the agency, since he had been on the board of several smaller pharmaceutical companies and was also a partner at a venture capital firm that invests in life sciences companies.

"This is classic and it's not surprising," said Sidney Wolfe, a founder of Public Citizen Health Research Group and a long-time FDA watchdog, who had expressed concern about Gottlieb's ties to industry before joining the agency. "Philosophically, he's returning to the ecosystem where he's most comfortable. And he'll get paid very well for it, too."

Also at Financial Times.

Related: What a Gottlieb-Led FDA Might Mean for the Pharmaceutical Industry
FDA Nominee is a Proponent of "Adaptive Trials"
Drug Approvals Sped Up in 2017
Koch-Backed Groups Urge Congress to Pass "Right to Try" Legislation
FDA Labels Kratom an Opioid
FDA Has Named Names of Pharma Companies Blocking Cheaper Generics [Updated] (including Pfizer)
U.S. to Make More Drugs Easily Available, Cutting Role Docs Play


Original Submission

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  • (Score: 0) by Anonymous Coward on Sunday March 12 2017, @03:20AM

    by Anonymous Coward on Sunday March 12 2017, @03:20AM (#477917)

    What wavelength a Gottlieb LED emits?

  • (Score: 5, Informative) by stormwyrm on Sunday March 12 2017, @03:23AM (19 children)

    by stormwyrm (717) on Sunday March 12 2017, @03:23AM (#477918) Journal

    Here’s what Orac at Respectful Insolence has to say about him [scienceblogs.com]:

    The third candidate (Scott Gottlieb) is the closest thing I’ve ever seen to a bona fide, honest-to-goodness pharma shill, who called the early termination of a multiple sclerosis drug study “an overreaction,” even though three participants had died, defended the off-label marketing of Evista, and, when he was Deputy Commissioner of the FDA, harassed underlings when FDA scientists rejected Pfizer’s osteoporosis drug candidate Oporia, forecast to earn $1 billion a year.

    And in a bit more detail here [scienceblogs.com]:

    I briefly mentioned Scott Gottlieb in my last post about Trump’s plans for the FDA. Now seems a good time to discuss him a bit more, because the possibility of his becoming the next director of the FDA amuses me to no end. Don’t get me wrong. I am also highly alarmed, almost as much as I am by the prospect of Jim O’Neill becoming the director of the FDA. My amusement is more a “laughing to keep from crying” sort of reaction. Here’s why.

    Scott Gottleib (sic) is a bona fide, honest-to-goodness pharma shill. He works for pharma and has for a long time[…]

    After he left the FDA, Dr. Gottlieb went back to private practice but also worked for Eli Lilly on the side to market Evista, even after Eli Lilly had been shown to have marketed it for off-label indications. During his actual tenure at the FDA as deputy commissioner, he had so many financial conflicts of interest with pharma companies that he had to recuse himself from resource planning for a potential bird flu epidemic because of his financial ties to Sanofi-Aventis, as well as work related to Eli Lilly, Proctor & Gamble, and, yes, five—count ‘em, five!—other drug companies. And yes, he did show his pro-pharma bias in ways other than criticizing the halting of a trial in which three people died…

    So the choice is now between a rapacious fox to guard the hen-house (Gottlieb) or someone who doesn’t believe in the hen-house and will demolish it the first chance he gets (O’Neill).

    --
    Numquam ponenda est pluralitas sine necessitate.
    • (Score: 2) by c0lo on Sunday March 12 2017, @03:55AM

      by c0lo (156) on Sunday March 12 2017, @03:55AM (#477921) Journal

      Just don't get seriously ill.
      If you do... well, you are going to sell your house anyway; so probably it will be better for you to take the money and go Cuba [nytimes.com].

      --
      https://www.youtube.com/watch?v=aoFiw2jMy-0
    • (Score: 3, Informative) by Anonymous Coward on Sunday March 12 2017, @03:56AM (3 children)

      by Anonymous Coward on Sunday March 12 2017, @03:56AM (#477922)

      So the choice is now between a rapacious fox to guard the hen-house (Gottlieb) or someone who doesn’t believe in the hen-house and will demolish it the first chance he gets (O’Neill).

      So, the same choices that we got for all the heads of other agencies in the trump administration.

      • (Score: 2) by digitalaudiorock on Sunday March 12 2017, @07:26PM (2 children)

        by digitalaudiorock (688) on Sunday March 12 2017, @07:26PM (#478173)

        So, the same choices that we got for all the heads of other agencies in the trump administration.

        This...+10000. Who else has been waiting for a single pick by Trump that doesn't seem as though a lot of work went into finding the worst possibly candidate? It's getting to where you can only assume that the underlying motive is sabotage, plain and simple. How is anyone still defending this fucking guy?

        • (Score: 2) by Justin Case on Monday March 13 2017, @03:52AM (1 child)

          by Justin Case (4239) on Monday March 13 2017, @03:52AM (#478304) Journal

          I think this is called draining the swamp.

          What makes people more furious than anything else is that he is keeping his promises.

          • (Score: 0) by Anonymous Coward on Monday March 13 2017, @04:27PM

            by Anonymous Coward on Monday March 13 2017, @04:27PM (#478480)

            > I think this is called draining the swamp.

            Indeed. Sane people thought "draining the swamp" meant removing lobbyists working on behalf of the rich.
            What he really meant was removing all the barriers that the lobbyists were hired to war with, so now the people who previously fertilized the swamp are directly in control. Swamp drained!

    • (Score: 1, Disagree) by khallow on Sunday March 12 2017, @05:19AM (13 children)

      by khallow (3766) Subscriber Badge on Sunday March 12 2017, @05:19AM (#477937) Journal

      Here’s what Orac at Respectful Insolence has to say about him:

      The third candidate (Scott Gottlieb) is the closest thing I’ve ever seen to a bona fide, honest-to-goodness pharma shill, who called the early termination of a multiple sclerosis drug study “an overreaction,” even though three participants had died, defended the off-label marketing of Evista, and, when he was Deputy Commissioner of the FDA, harassed underlings when FDA scientists rejected Pfizer’s osteoporosis drug candidate Oporia, forecast to earn $1 billion a year.

      That's a pretty huge point in favor of Gottlieb actually. Slowing medical treatments that the whole of humanity can benefit from just to save a few people in experimental treatment projects has to be one of the greatest evils of regulation ever just by body count. And if he does reduce the cost of bringing drugs to market via regulatory reduction, he will lower the barrier to entry for new pharmaceutical businesses, which will reduce the power of the current Big Pharma cartel. And current cost of drug development in the US is outright insane [tufts.edu] (what small start up can afford that kind of cost?) and needs to be curbed.

      So the choice is now between a rapacious fox to guard the hen-house (Gottlieb) or someone who doesn’t believe in the hen-house and will demolish it the first chance he gets (O’Neill).

      Kind of sad when Trump is the closest thing to a grown up in the house here with the first attempt in a while to curb the cost of approving new drugs. The point of drug regulation (and medical research regulation as a whole) isn't to protect a few people in a risky experimental program from serious injury or death. Nor is it to protect the Big Pharma cartel from competition. Sure, Gottlieb probably won't be a panacea. But we need to remember the big picture. Sure, we'll all die of something eventually, but there's no reason we can't extend our lives a great deal at a reasonable cost. Sane regulatory and competitive business environments should be part of that.

      • (Score: 0) by Anonymous Coward on Sunday March 12 2017, @09:27AM (11 children)

        by Anonymous Coward on Sunday March 12 2017, @09:27AM (#477984)
        Someone who has a hankering for a return to the days of the FDA before 1938 looks like. Enjoy your elixir sulfanilamide.
        • (Score: 1) by khallow on Sunday March 12 2017, @01:45PM (10 children)

          by khallow (3766) Subscriber Badge on Sunday March 12 2017, @01:45PM (#478038) Journal

          Someone who has a hankering for a return to the days of the FDA before 1938 looks like.

          Just like rolling back some of the insane regulation on minimum wage laws and short work weeks is a roll-back to the days of sweat shops? This is a typical conservative argument. Change is a bad thing, even when the system is obviously broken.

          • (Score: 3, Informative) by c0lo on Sunday March 12 2017, @01:59PM (9 children)

            by c0lo (156) on Sunday March 12 2017, @01:59PM (#478042) Journal

            FYI - the relevant Elixir sulfanilamide [wikipedia.org]

            Elixir sulfanilamide was an improperly prepared sulfanilamide medicine that caused mass poisoning in the United States in 1937. It caused the deaths of more than 100 people. The public outcry caused by this incident and other similar disasters led to the passing of the 1938 Federal Food, Drug, and Cosmetic Act.
            ...
            In 1937, S. E. Massengill Company, a pharmaceutical manufacturer, created a preparation of sulfanilamide using diethylene glycol (DEG) as a solvent, and called the preparation "Elixir Sulfanilamide".[3] DEG is poisonous to humans and other mammals, but Harold Watkins, the company's chief pharmacist and chemist, was not aware of this... Animal testing was not required by law, and Massengill performed none; there were no regulations requiring premarket safety testing of new drugs.
            ...
            The owner of the company, when pressed to admit some measure of culpability, infamously answered, "We have been supplying a legitimate professional demand and not once could have foreseen the unlooked-for results. I do not feel that there was any responsibility on our part."[6] Watkins, the chemist, committed suicide while awaiting trial.
            ...
            Congress responded to public outrage by passing the 1938 Food, Drug, and Cosmetic Act, which required companies to perform animal safety tests on their proposed new drugs and submit the data to the FDA before being allowed to market their products. The Massengill Company paid a minimum fine under provisions of the 1906 Pure Food and Drugs Act, which prohibited labeling the preparation an "elixir" if it had no alcohol in it.

            If that's a pretty huge point in favor of Gottlieb actually (who called the early termination of a multiple sclerosis drug study “an overreaction,” even though three participants had died), I think I understand a scared-shitless reaction whenever Gottlieb is mentioned.

            --
            https://www.youtube.com/watch?v=aoFiw2jMy-0
            • (Score: 1) by khallow on Sunday March 12 2017, @02:50PM (8 children)

              by khallow (3766) Subscriber Badge on Sunday March 12 2017, @02:50PM (#478054) Journal
              Your insinuation is an exercise of the false dilemma fallacy. Just because someone wants to roll-back some regulation, doesn't mean that they wish to roll it back to complete absence of regulation.
              • (Score: 2) by c0lo on Sunday March 12 2017, @04:28PM (7 children)

                by c0lo (156) on Sunday March 12 2017, @04:28PM (#478087) Journal

                So, Gottlieb says "stopping some trial after 3 deaths is an overreaction" and you ask me to trust him he'll rollback only some regulation which, presumably, are unnecessary, right?

                Just what regulation do you think can be safely rolled-back?

                ---

                In constructing your answer, on top of "elixir sulfanilamide", consider:
                - homeopathy - pure non-toxic water. You don't die because of it, you die because the original illness is not addressed. In the same category, snake-oil from various snakes pushed by noisy markedroids, swamping out the signal of a good cure;
                - Thalidomide [wikipedia.org] - non-toxic on short time span, on medium-long term causes malformed children with 40-50% chances of survival. After studies of efficacy/safety, it still have (FDA-)approved uses [wikipedia.org].

                --
                https://www.youtube.com/watch?v=aoFiw2jMy-0
                • (Score: 1) by khallow on Sunday March 12 2017, @04:50PM (6 children)

                  by khallow (3766) Subscriber Badge on Sunday March 12 2017, @04:50PM (#478096) Journal

                  So, Gottlieb says "stopping some trial after 3 deaths is an overreaction" and you ask me to trust him he'll rollback only some regulation which, presumably, are unnecessary, right?

                  Just what regulation do you think can be safely rolled-back?

                  First of all, why should the trial have been halted? Gottlieb made an important point [time.com] at the time that the deaths could have been due to MS complications rather than the drug:

                  "Just seems like an overreaction to place a clinical hold" on the trial, he wrote. An FDA scientist rejected his analysis and replied that the complication "seems very clearly a drug-related event."

                  Even if the latter was true, that still means that the medication could be adjusted to attempt to reduce such drug-related events.

                  Second, a significant part of the problem is that pre-clinical trials (testing before testing on humans occurs) are notoriously ineffective at weeding out drugs that have problems in clinical (human) trials. We need some serious innovation in coming with with better pre-clinical trials. FDA is a solid roadblock to that.

                  • (Score: 2) by c0lo on Sunday March 12 2017, @05:00PM (5 children)

                    by c0lo (156) on Sunday March 12 2017, @05:00PM (#478101) Journal

                    We need some serious innovation in coming with with better pre-clinical trials. FDA is a solid roadblock to that.

                    Exactly how FDA roadblocks pre-clinical trials?

                    --
                    https://www.youtube.com/watch?v=aoFiw2jMy-0
                    • (Score: 1) by khallow on Sunday March 12 2017, @06:24PM (4 children)

                      by khallow (3766) Subscriber Badge on Sunday March 12 2017, @06:24PM (#478129) Journal

                      Exactly how FDA roadblocks pre-clinical trials?

                      Let me first demonstrate that this is a huge problem [sciencemag.org] (speaking of :

                      So how is everyone doing in the clinic? Sheesh, you had to ask. The overall Likelihood of Approval” (LOA) from Phase I is 9.6 per cent. So no, if you were hoping for an upturn in the more recent numbers, it doesn’t seem to be there. Somewhere around ten per cent success has been the estimate for some time now [sciencemag.org], and here it is again [sciencemag.org]. The worst therapeutic area is oncology, with a 5.6% LOA. That reflects some of its traditional features: lower barrier to entry, which brings in a lot of marginal ideas, difficult diseases to target once you’re in the clinic, and a corresponding willingness to try some fairly out-there stuff.

                      These numbers shouldn’t be too surprising to folks in the industry itself. What I’ve found while writing this blog, though, is that people who don’t know drug discovery tend to be very surprised indeed. It bears repeating: ninety per cent of all drugs that go into the clinic fail. And ninety-five per cent of all cancer drugs. That’s the central problem of the whole industry, right there. If you can make those numbers look better, hundreds of millions of grateful patients (and untold billions of dollars in revenue) are waiting for you.

                      The point here is that approval of pharmaceuticals, medical technologies, and other treatments is a sort of inverted pyramid system where expense increases substantially with each step forward. When you get to the point of FDA rejection (one of the very last steps before marketing), it tends to be a huge financial disaster at present. It should be a huge warning sign to us that we're seeing a 90% failure rate (which gets worse as one goes into certain areas like cancer treatments with particularly bad animal models) from human testing (with apparently still a 40% failure rate going into the last and by far most expensive phase of testing before FDA consideration). So right here, the formal testing regime currently approved by the FDA has a huge, rear-loaded failure mechanism and introduces considerable delay in the system.

                      It appears that final stages of human testing are for the foreseeable future unavoidable [sciencemag.org], due to human biology being ridiculously hard and conflicts of interest often being less than ideal, meaning we will have considerable regulation, delay, and expense even under the best of circumstances. But what we have is this lengthy, expensive, risky, remarkably unreliable process for doing anything to improve peoples' lives and health. That needs to change. The FDA has shown little interest in doing so.

                      • (Score: 2) by c0lo on Sunday March 12 2017, @10:56PM (3 children)

                        by c0lo (156) on Sunday March 12 2017, @10:56PM (#478238) Journal

                        Ok, I got the numbers. What I don't get is: what you see as "FDA roadblocks pre-clinical trials" which need to be removed?
                        The only way that I see the higher chances of a new drug to be proven effective and safe with reduced costs is to have the drugs failing the process as soon as possible thus removing extra cost in advanced steps.
                        Do you see some other way here?

                        --
                        https://www.youtube.com/watch?v=aoFiw2jMy-0
                        • (Score: 1) by khallow on Monday March 13 2017, @06:42AM (2 children)

                          by khallow (3766) Subscriber Badge on Monday March 13 2017, @06:42AM (#478322) Journal
                          Reading around, I think there's two effects. First, a certain amount of hoop jumping before a drug is allowed to be exposed to humans. Second, I think FDA would be reluctant to embrace particularly aggressive testing such as using human-like clones (eg, cloned human organ clusters or human bodies born without brains). And there's always the risk adverse nature of the FDA job. Nobody gets fired for playing it safe.
                          • (Score: 2) by c0lo on Monday March 13 2017, @07:26AM (1 child)

                            by c0lo (156) on Monday March 13 2017, @07:26AM (#478332) Journal

                            First, a certain amount of hoop jumping before a drug is allowed to be exposed to humans.

                            Those hoops, added or removed?
                            If removed: how this is going to drive down the costs if the drug turns out to be toxic? Given that human testing is much expensive than testing on model animals, I believe its their interest of doing the best the pharmas can in pre-clinical trials, when the costs are lower.

                            If added: how's this removing roadblocks from pre-clinical trials?

                            using human-like clones (eg, cloned human organ clusters or human bodies born without brains).

                            I'll let aside we are barely at the level of cloning organs (from stem cells), much less at the level of cloning humans without brains.
                            What stops them from using any line of immortal cells [wikipedia.org]? At least the toxicity can be (partially) evaluated on a cell closer to human than any model animal.

                            --
                            https://www.youtube.com/watch?v=aoFiw2jMy-0
                            • (Score: 1) by khallow on Monday March 13 2017, @02:59PM

                              by khallow (3766) Subscriber Badge on Monday March 13 2017, @02:59PM (#478422) Journal

                              If removed: how this is going to drive down the costs if the drug turns out to be toxic?

                              It allows the drug company to solve that problem as they see fit before it gets to human testing.

                              What stops them from using any line of immortal cells?

                              As I recall, for a time, certain lines were banned from federal funding by the Bush administration. And the higher level Department of Health and Human Resources was for a time the means by which a ban on the funding of anything derived from human fetuses was enforced. There is a history of interference here.

      • (Score: 2) by sjames on Sunday March 12 2017, @03:30PM

        by sjames (2882) on Sunday March 12 2017, @03:30PM (#478063) Journal

        The part you're missing is that the drug in testing was killing the research subjects, and would have continued doing that on a much larger scale if it was approved for marketing.

        The trial wasn't halted just to save a few research subjects, it was halted because it had become clear that the new drug was unacceptable. That is, it failed.

  • (Score: 4, Interesting) by Azuma Hazuki on Sunday March 12 2017, @04:06AM (8 children)

    by Azuma Hazuki (5086) on Sunday March 12 2017, @04:06AM (#477926) Journal

    Well, not "we" as in all of us as individuals, but God *damn* it, maybe all the historically-illiterate know-nothing RWNJs need to suffer (and perhaps die in large numbers) because of their choices so this doesn't happen again. Then again, things are *so* bad that there might not BE a next time. So thanks for that, R voters. Yeah Hillary sucked nuts, but not like this.

    --
    I am "that girl" your mother warned you about...
    • (Score: 2) by c0lo on Sunday March 12 2017, @04:30AM (3 children)

      by c0lo (156) on Sunday March 12 2017, @04:30AM (#477930) Journal

      Yeah Hillary sucked nuts, but not like this.

      Remember that "We came we saw he died?"
      I'm afraid she'd be sucking more than nuts.
      Something like the marrow bones of those killed in escalating wars that controlling, authoritarian bitch would think she will win.

      (is it agent orange better? nope, tough luck, he's as bad but in other ways)

      --
      https://www.youtube.com/watch?v=aoFiw2jMy-0
      • (Score: 3, Insightful) by Anonymous Coward on Sunday March 12 2017, @05:25AM

        by Anonymous Coward on Sunday March 12 2017, @05:25AM (#477940)

        escalating wars that controlling, authoritarian bitch would think she will win.

        Also perfectly describes Trump, only turned up to 11 :/

        (is it agent orange better? nope, tough luck, he's as bad but also in other ways)

        FTFY

      • (Score: 0) by Anonymous Coward on Sunday March 12 2017, @11:48AM (1 child)

        by Anonymous Coward on Sunday March 12 2017, @11:48AM (#478013)

        When North Korea nukes Tokyo you'll still be going on about how Trump saved lives.

        • (Score: 2) by c0lo on Sunday March 12 2017, @12:43PM

          by c0lo (156) on Sunday March 12 2017, @12:43PM (#478022) Journal

          you'll still be going on about how Trump saved lives.

          Idiot, mate, you're an idiot if you think I like Trump better than Hillary.
          I'm not, and is also true I don't like the russian Agent Orange better than that bitch. Both of them are made from shit, except that one is donkey shit, the other is elephant dung.

          IMHO, you should have elected anybody else but those two.
          Being non-USian as I am though, I'll respect your right to shoot yourself in both feet with a weapon the calibre you think will inflict the maximum damage.

          --
          https://www.youtube.com/watch?v=aoFiw2jMy-0
    • (Score: 0) by Anonymous Coward on Sunday March 12 2017, @06:57AM (3 children)

      by Anonymous Coward on Sunday March 12 2017, @06:57AM (#477963)

      Shortening the approval process for new drugs will save lives in the long run.

      You're welcome.

      • (Score: 2) by aristarchus on Sunday March 12 2017, @09:20AM (1 child)

        by aristarchus (2645) on Sunday March 12 2017, @09:20AM (#477982) Journal

        Shortening the approval process for new drugs will save lives in the long run.

        Unless they kill more people in the short run to the extent that they also kill more people in the long run. Do you not remember the 1950's? https://helix.northwestern.edu/article/thalidomide-tragedy-lessons-drug-safety-and-regulation [northwestern.edu] Yeah. And why is Peter Thiel, that vampire, involved in health care at all? Why should government be involved in safety, as opposed to effectiveness? Unless we have some proven drug, in double-blind objective studies, and can cure Republican Libertarian Really Creepy Gay Billionaire syndrome. (Do we, yet? What? No funding? OMG!) I say let the market decide. If a company sells drugs the kills their customers, they will just go out of business when the mechanism of the market kicks in! Right, khallow! That is why you just cannot by street heroin these days. Just can't do it. Can't buy Epi-pens, or AIDS medication, either, but that is a different issue.

        • (Score: 0) by Anonymous Coward on Sunday March 12 2017, @01:15PM

          by Anonymous Coward on Sunday March 12 2017, @01:15PM (#478028)

          Hero-in.

          If a company sells drugs the kills their customers, they will just go out of business when the mechanism of the market kicks in!

          I'm afraid the kills customers will go out of business before the mechanism of the market kicks in.

          Ah, I see now, you were taking about a (as in "one") company going out of business.
          Sorry, this singulars and those plural pronoun is making my non-native english head spin.
          I'd better go to sleep now.

          That is why you just cannot by street heroin these days.

          See you to morrow, buy-bye. Hero-out!

      • (Score: 4, Informative) by Thexalon on Sunday March 12 2017, @01:40PM

        by Thexalon (636) Subscriber Badge on Sunday March 12 2017, @01:40PM (#478035)

        Shortening the approval process for new drugs will save lives in the long run.

        ... unless they don't work, or they kill more people than they help, or they work but have crippling side effects, or they work but not as well as competing products.

        Which, in order to determine, we'd have to do extensive trials of the drug on humans who have whatever the drug is supposed to cure, and wait long enough after the subjects got the pills in order to check on longer-term effects.

        --
        The only thing that stops a bad guy with a compiler is a good guy with a compiler.
  • (Score: 2) by gringer on Sunday March 12 2017, @08:19AM (2 children)

    by gringer (962) on Sunday March 12 2017, @08:19AM (#477971)

    O'Neill famously suggested that drugs should be approved based on safety alone, letting consumers sort out what works

    And how is this different from the current situation?

    • (Score: 0) by Anonymous Coward on Sunday March 12 2017, @01:46PM (1 child)

      by Anonymous Coward on Sunday March 12 2017, @01:46PM (#478039)

      I have a hunch currently the drugs need to be both safe and effective.
      May have something to do with the harm on the pocket of vulnerable people caused by plain water marketed as a cancer cure.

      • (Score: 2) by Immerman on Sunday March 12 2017, @03:49PM

        by Immerman (3985) on Sunday March 12 2017, @03:49PM (#478068)

        In theory, but sadly only just barely in practice. There's fair number of drugs on the market that have been shown to be roughly as effective as placebos in independent testing. But so long as the manufacture can also manufacture tests showing how effective they are, they tend to get approved.

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