Well, it’s done.

Today, the Senate passed the 21st Century Cures Act, a bill designed to weaken the FDA and empower pharmaceutical companies, sending it to President Obama’s desk. There’s no way Obama won’t sign it, as it contains provisions funding his Precision Medicine Initiative, and he supported it all along. For all its flaws, I knew the bill’s passage was inevitable since after the election, when Senate Majority Leader Mitch McConnell stated that the bill was a priority. I knew it even more when the Senate linked the bill to the “Cancer Moonshot” initiative spearheaded by Vice President Joe Biden in the wake of his son Beau’s death from brain cancer. After all, 21st Century Cures Act funds the “Cancer Moonshot” initiative.

The first time I wrote about the 21st Century Cures Act, I thought there were some good provisions in it, such as increasing funding for the NIH, but that it had a fatal flaw—several, actually. However, those fatal flaws derived from the idea that, if we only relax the “stifling” regulations of the FDA that, if you believe proponents of the bill that’s soon to become law, the magic of the free market would unleash the creativity of private industry and academia to open the spigot and let the cures to all sorts of diseases flow. The bill didn’t go very far in 2015, but by summer 2016 it was still around, still containing the same flaws, still being pushed by the same characters. I discussed both times how the central premise of the bill, that the FDA is too strict, that its “out of control” regulations are hampering medical innovation and slowing drug approval unduly while (of course) people are dying in droves waiting for the cures that government is keeping from the people, is simply not true.

Let’s recap before moving on, remembering that the bill that passed is actually in some ways than it was when I last wrote about it. The central premise of the bill is ideological nonsense. It turns out that radical reform involving weakening the FDA is not needed. The FDA already has the tools to do what the 21st Century Cures Act demands without weakening patient protections or scientific rigor. In fact, the FDA, despite being underfunded, is actually remarkably efficient at new drug approvals, evaluating nearly all new drug applications within 6 to 10 months, an impressive turnaround for such complex assessments. It’s been pointed out that the FDA actually acts more rapidly than most European regulatory agencies. Basically, there is no evidence that the FDA hampers overall medical innovation, nor is there evidence that the FDA’s current requirements lead to higher drug prices or cost lives. None of that stopped passage of the bill. Unfortunately, the argument fooled a lot of people, including, to its utter shame, the American Society of Clinical Oncology (ASCO), which urged passage.

The full bill is a massive 824 pages long; so reading the whole thing in a short period of time is not feasible. As I mentioned before, not all of it is bad. There are actually some provisions I can totally get behind, such as increasing the NIH budget, and, even though I’m more skeptical than most about the hype surrounding “precision medicine,” I can support funding President Obama’s Precision Medicine Initiative. I’m also less impressed with the promise of “high risk, high reward” research because much of the rhetoric touting examples of such research relies a lot on the 20/20 nature of hindsight. I like to refer to the example of Herceptin, a drug whose inventor, Dennis Slamon, often portrays as having been a hard sell to fund and whose development was a triumph of such “high risk” research. The truth is less dramatic, and in fact much of the research was federally funded. The problem, of course, is that there are really no hard data and science to support the belief that funding more risky projects will result in more dramatic advances or payoffs than a more conservative approach. Advocates of such an approach always have anecdotes of scientists whose ideas were later found to be validated and potentially game-changing who couldn’t get NIH funding, but how often does this really happen? No one knows, and often such anecdotes, when examined critically, are found to be—shall we say?—a bit embellished. Of course, the vast majority of “wild” ideas are considered “wild” precisely because they are new and there is no good evidence to support them. Once evidence accumulates for them, they are no longer considered quite so “wild.” More importantly, most advocates of funding much more risky projects are looking through what we doctors like to call the “retrospectoscope,” which, as we say, always provides 20-20 vision. We know today that the scientists whose anecdotes of woe describing the depradations of the NIH were indeed onto something. How many more proposed ideas that seemed innovative at the time but ultimately went nowhere?

That’s not to say it’s not worth funding some riskier projects, but it’s not necessarily productive earmark a lot of money for such projects, most of which will end up being wasted on projects that go nowhere because they are risky and a large proportion of them would be expected to fail. A far better approach would be to increase NIH funding in general. When funding is tight, the NIH becomes a lot more conservative in choosing which grant applications to fund. When funding is looser, study sections evaluating grants become more willing to take risks on good ideas that are more “out there.” This leads to a mix of “safer” projects expected to produce incremental advances along with some riskier projects. On the other hand, there isn’t anything wrong with one provision of the bill, which instructs the director to set up “Eureka Awards” to identify and fund areas of biomedical research that “could realize significant advancements through a prize competition.” Such a competition is probably not much more than a gimmick, unfortunately, but it probably won’t hurt anything either.

So what aspects of this bill won ASCO’s backing? I will admit that these do include some good:

  • Increasing interoperability of Electronic Health Records and preventing the practice of intentional information blocking.
  • Providing much needed supplemental funding for the National Institutes of Health and the Food and Drug Administration.
  • Requiring transparency for expanded access programs.
  • Requiring use of centralized Institutional Review Boards when appropriate.
  • Encouraging data standardization, such as requirements for ClinicalTrials.gov.
  • Refining Sunshine Act provisions to ensure necessary access by physicians to Continuing Medical Education and peer-reviewed literature.
  • Allowing for patient-focused drug development.
  • Clarifying the definition of a “clinician-led clinical data registry.”
  • Providing funding to address the nation’s opioid crisis.

All of this sounds fairly innocuous. For instance, if there’s one thing I learned in writing about “right-to-try” laws is that transparency regarding companies’ requirements for expanded access programs is often lacking. Providing more transparency to this process was about the only aspect of the federal right-to-try law that I didn’t find objectionable. Also, who could object to increased funding to address the nation’s opioid addiction crisis? There’s a problem, though. There’s no guarantee that that increased funding will continue. The increased funding is not mandatory and would be subject to whatever Congress’ whims happen to be during appropriation battles every year.

As for some of the rest, it’s not exactly clear what “patient-focused” drug development tools will entail. All it states is that “Secretary 3 shall make public a brief statement regarding the pa4 tient experience data and related information, if any, submitted and reviewed as part of such application,” including “patient experience data” and “information on patient-focused drug development tools.”

Particularly disgusting to me is ASCO’s support for “refining Sunshine Act provisions,” which actually meant exempting companies from reporting payments made to doctors for receiving continuing medical education sessions, medical journals, or textbooks and thereby roll back requirements for reporting such payments to a federal database (OpenPayments) that tracks financial relationships between companies and physicians. Thankfully, that provision of the bill was so controversial that it was removed from the bill after Senator Chuck Grassley (R-Iowa) threatened to put a hold on the entire bill unless the language was removed.

Unfortunately, the now removed language exempting reporting payments to physicians for continuing medical education was just one example of how, to get the good stuff in this bill, one has to accept a whole lot of bad stuff. The very worst provisions of the bill are provisions that would significantly weaken the FDA in several ways. Yes, some of the worst parts of the bill have been expunged, but a lot of bad remains. For instance, in an earlier draft of the bill, there was a provision that would have farmed out the certification of safety of medical devices after modification by their manufacturers to third parties, circumventing the FDA altogether. That provision is gone. Another troubling provision would have allowed shorter or smaller clinical trials to get medical devices approved, also gone.

Other questionable provisions have simply mutated:

One of the most troubling provisions in the previous draft of the bill would’ve created a program for the use of “clinical experience” evidence in drug approvals. Rather than relying on the gold standard of randomized clinical trials, this provision “would[‘ve] require the Secretary to establish a draft framework for implementing” such evidence. The new draft keeps this provision but changes the term “clinical experience” to “real world evidence” (section 3022). To be sure, this provision gives enormous discretion to the Secretary to limit (and maybe even reject) the use of such evidence. But in light of recent high-profile clinical trial failures, most notably just two days ago, we ought to be concerned about claims that the FDA is too slow and imposes too stringent requirements on drug approvals.

I looked at exactly what the bill says about “real world evidence.” It’s not encouraging:

(1) IN GENERAL.—Not later than 2 years after the date of enactment of the 21st Century Cures Act, the Secretary shall establish a draft framework for implementation of the program under this section.

(2) CONTENTS OF FRAMEWORK.—The frame work shall include information describing—

(A) the sources of real world evidence, including ongoing safety surveillance, observational studies, registries, claims, and patient-centered outcomes research activities;

(B) the gaps in data collection activities;

(C) the standards and methodologies for 2 collection and analysis of real world evidence; and

(D) the priority areas, remaining chal5 lenges, and potential pilot opportunities that the program established under this section will address.

All of these are well and good. I’ve actually co-directed an effort to use observational studies and an outcomes database to improve patient safety and the quality of care. Such tools, however, are poor at demonstrating efficacy of a drug, although they can demonstrate safety.

Worse, the bill undermines informed consent, as I discussed before. The provision is still there that would add another category of research for which it is acceptable to forego informed consent. Normally, it is only acceptable to skip informed consent when it is not feasible or it is contrary to the best interests of the subject. Add to that now that it would be acceptable to forego informed consent when “the proposed clinical testing poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of the human subject.” As Merrill Goozner put it and I agreed, even if the risk is minimal, why would the authors of this legislation waive a central tenet of international agreements designed to protect the rights of human subjects in clinical trials? I didn’t understand either (and still don’t), particularly since the act doesn’t define “minimal risk” or specify who determines whether a study is minimal risk. Presumably it would be the Institutional Review Board, and I know that there are standards for what constitutes “minimal risk research” in the code governing human subjects protection (for instance, blood draws are generally considered “minimal risk” as is the use of archived clinical specimens, such as tissue), but the wording of this provision is a bit vague. Moreover, the number of studies that would be facilitated by such a change in the requirement for informed consent must be vanishingly small.

Then there’s the giveaway to the stem cell industry. That’s right, the stem cell industry, which includes clinics that sell stem cell quackery by dubious companies using the hard sell technique.

Behold:

SEC. 3033. Accelerated Approval for Regenerative Advanced Therapies (page 179 et seq): Creates an expedited review pathway for “regenerative medicine” products that allows use of surrogate endpoints and post-approval studies. This was not in previous versions of Cures and should not be rushed through without adequate discussion.

This is basically warmed-over language from the REGROW Act (Reliable and Effective Growth for Regenerative Health Options that Improve Wellness), introduced by Sen. Mark Kirk (R-Ill.) and co-sponsored by Sens. Susan Collins (R-Maine) and Joe Manchin (D-W.Va.). The language is different, but the idea is the same: To speed up the delivery of adult stem cell therapies to patients by cutting back on testing and letting them go to market before they have been demonstrated to be efficacious and safe. REGROW is backed by a wealthy Texas entrepreneur, Ed Bosarge, who runs the stem-cell firm Bosarge Life Sciences and has been—shall we say?—quite generous with campaign contributions to key legislators. Bosarge didn’t get everything he wanted, but this provision will basically allow the approval of all sorts of dubious stem cell “therapies” at a much lower standard of evidence.

The bill also changes course compared to current law and allows pharmaceutical companies to promote “off-label” uses of their drugs:

SEC. 3037. Health Care Economic Information (page 188 et seq): Allows pharmaceutical companies to promote off-label uses to insurance providers, allowing them to dramatically expand their markets while evading the requirement of FDA approval for new indications.

As I said at the time (and have been quoted saying again), a homeopath would love this provision, and, I’m sure, so would drug companies. Why bother with the time, bother, and expense of those pesky clinical trials to get your drug approved for additional indications, when you can rely on clinical experiences based on therapeutic use, uncontrolled observational studies, or registries instead? If I were the CEO of a pharmaceutical company, I’d love it. Indeed, the one thing this provision most definitely does not do is to speed effective treatments to patients. Rather, it smacks of being a payoff to pharmaceutical companies.

No, strike that. It is a payoff to pharmaceutical companies:

But the debate surrounding the 21st Century Cures Act came to embody a larger dispute about how government can and should operate. Some 1,455 lobbyists, acting on behalf of more than 400 companies and other organizations, lobbied on the legislation, according to the Center for Responsive Politics. Over the past year and a half, companies known to have lobbied on the Cures Act spent half a billion dollars to influence Congress. The resulting bill was packed with politicians’ pet projects and sops to industry.

Basically, the way the antiregulatory pro-industry contingent got this bill passed was to offer “something for everyone.” There’s an increase in funding to the NIH, although, again, like the funding for opioid addiction programs, it’s not guaranteed for long. Basically, the bill represented a “Hobson’s choice”:

The bill would make billions of dollars available for medical research. It would fund lofty goals, such as precision medicine, a White House initiative to map the human brain and Vice President Joe Biden’s “Cancer Moonshot.” It would save lives. But it would also undermine regulations that patient advocacy groups say are essential for making sure medical and drug research is conducted ethically and safely — meaning it could cost lives, too.

There’s no “could” about it.

Basically, the pharmaceutical industry and its lackeys in Congress bought off biomedical research advocates with the promise of more funding to the NIH and to efforts to combat the opioid crisis in the US. The price was a hole host of industry-friendly provisions weakening the FDA and producing new expedited pathways for drug approval, as well as permission to promote off-label drug use. True, a few of the more onerous provisions were removed, but one truly pernicious provision (the watered down REGROW Act language) was added. It’s not as bad as REGROW, but you can be sure that Bosarge will be back for more.

Expect more Vioxx disasters, now that the 21st Century Cures Act threatens to turn the FDA into a puppet of the pharmaceutical and medical device industry and Donald Trump is considering a libertarian with zero medical or scientific background who thinks FDA regulations kill people to be FDA director. Also expect pharmaceutical company profits to soar. I hope ASCO and the other medical groups that pushed for this bill think it was worth it.

Comments

  1. #1 Costas
    London
    December 8, 2016

    Well, wonders will never cease. Considering the ‘revolving door’ that exists between pharma & the FDA, and the whistleblowing that is now a matter of record, the only remaining mystery is why you ever believed that the FDA was anything other than pharma’s tame poodle for several decades at least..

    Vioxx was not the only disaster resulting from that cosy relationship. Just look at the list of drugs that have been either withdrawn or ‘black-boxed’ over the last 5 decades. But credit where it’s due. At least you recognise that a ‘liberated’ pharma industry ain’t necessarily in our best interests. Kudos.

  2. #2 Whalesnot
    Upstate NY
    December 8, 2016

    Isn’t there/wasn’t there some Lyme Disease woo in there as well? More research funding but a seat at the table for the CLD and coinfection stuff, more of the “no penalty for endless antibiotics” hooey…

  3. #3 MI Dawn
    December 8, 2016

    @Costas: if you can a)prove that the European regulatory industries have done any better and b)explain why the US ,b>didn’t have the thalidomide disasters that most of Europe and the UK did, then I’ll listen to you about the FDA. Until then, I will just believe you’re a balloon full of hot air.

  4. #4 MI Dawn
    December 8, 2016

    Oh, for a preview box…that was supposed to be didn’t

  5. #5 Orac
    December 8, 2016

    Actually, as I pointed out in previous posts, the FDA does a very good job approving drugs. Even if I agreed with Costas, weakening the FDA’s mandate is not the way to fix whatever problems there have been with the FDA. The 21st Century Cures Act will likely only make those problems worse, particularly given that Trump is considering someone without medical or scientific expertise to run the agency.

  6. #6 zach
    United States
    December 8, 2016

    The whistleblowing is not a matter of record. The whole point of this article was that it weakened the FDA, so I fail to see how Costas read this article and then found it an appropriate response to jab the FDA.

  7. #7 Costas
    United Kingdom
    December 8, 2016

    @ Dawn: I think you might be labouring under a misapprehension. I am no apologist for our regulatory bodies either. As far as I’m concerned, they’re all as bad as each other. Shame your ambitions for your own don’t go much beyond being a slight improvement on ours though. I’m sure you’re equally proud of the forcible testing of dangerous drugs on your prisoners. After all, at least you never get to hear about what consequences they suffered as a result, do you? Now, please pass me that helium cylinder.

    @ Orac: You misconstrue my point if you think I’m arguing for a weakening of the FDA’s mandate. Quite the contrary. I’m arguing for the elimination of all conflicts of interests, and if that’s not possible, then their marginalisation in any licensing decision.

  8. #8 Brian Deer
    December 8, 2016

    We can’t be saying things like this. Aren’t we supposed to be shills, receiving secret payments from industry?

  9. #9 Orac
    December 8, 2016

    I really can’t believe I’m on the same side of this issue as the Autism Action Network (except for all the antivaccine nonsense they packed into their action alert, of course):

    http://capwiz.com/a-champ/issues/alert/?alertid=74452626&queueid=%5Bcapwiz:queue_id%5D

  10. #10 Costas
    United Kingdom
    December 8, 2016

    @ Zach: How is the FDA whistleblowing not a matter of record?:

    http://articles.mercola.com/sites/articles/archive/2012/08/13/drug-safety-whistleblower.aspx

  11. #11 darwinslapdog
    At Sea
    December 8, 2016

    This… on top of the election–where will the anti-“elitism” and disregard for expertise end? I no longer recognize the world around me. As the Beagle sails away from the US, I wonder if it will be different enough anywhere else when I get there?

    Have all these free-market cultists never noticed how selfish and greedy humans can be when they are given the unfettered freedom to peddle their wares however they see fit? Oh, I forgot, they don’t need no elitist readin’ and learnin’.

  12. #12 Lawrence
    December 8, 2016

    Mercola? Really?

    And why should we take anything posted there seriously?

    We are well aware that the FDA has been under-funded and under-staffed for quite some time.

    In this case, loosening its regulatory authority, even at the same time giving it additional funding, does not give me a lot of comfort.

  13. #13 Costas
    United Kingdom
    December 8, 2016

    @ Lawrence: Coz Mercola always lies of course, whereas you only ever get the truth from the FDA & big pharma. Maybe the ‘liberal’ press is more to your liking then:

    https://www.washingtonpost.com/politics/lawmakers-report-fda-monitoring-of-staff-e-mails-may-have-violated-whistleblowing-law/2014/02/25/9d52c73e-9e3b-11e3-b8d8-94577ff66b28_story.html?utm_term=.4552a6c89682

  14. #14 L. E.
    December 8, 2016

    Thanks for posting this Orac. It really helps to articulate the problems with this bill/new law hidden beneath the legalese.

  15. #15 Lawrence
    December 8, 2016

    If you had led with that story, you would have maintained some shred of credibility….

  16. #16 Costas
    United Kingdom
    December 8, 2016

    My credibility was never uppermost in my mind. But I’m always game for citing alternative sources when your anti-woo sensibilities have been offended.

  17. #17 NJK
    United States
    December 8, 2016

    I’m curious, what’s an example where informed consent would be contrary to the best interests of the subject? The only scenarios I’m coming up with seem to fall under either “not feasible” or a situation where consent would come from a guardian or health care proxy.

  18. #18 Lawrence
    December 8, 2016

    I’d also be interested in hearing more about “eliminating” conflicts of interest – given that people need to gain their expertise somewhere……

  19. #19 Eric Lund
    December 8, 2016

    This… on top of the election–where will the anti-“elitism” and disregard for expertise end?

    I’m afraid it’s turtles all the way down. PEOTUS has nominated a climate change denier to head the EPA, a man who 30 years ago was considered too racist to be confirmed by a Republican Senate for a federal judgeship, and a conspiracy-mongering former general who was cashiered from his last command due to his incompetence as National Security Advisor. And that’s not the complete list of PEOTUS’s anti-competent nominees.

    In my darker moments I have been wondering what good is a Ph.D. in a country that doesn’t care about facts.

  20. #20 Orac
    December 8, 2016

    Get a load of who is being considered for FDA director: staunch libertarian and Peter Thiel crony Jim O’Neill.

    http://gizmodo.com/trump-is-considering-an-insane-silicon-valley-libertari-1789821233

    This is a guy who thinks that the FDA should only concern itself with safety and not efficacy (you know, because the free market will sort out efficacy) and that regulatory burdens by the FDA kill lots of people.

  21. #21 Eric Lund
    December 8, 2016

    NJK@17: There is nothing wrong per se with informed consent. The problem is the potential for that to be turned into misinformed consent–most patients, of necessity, rely on their doctors to give them the facts, and some doctors, especially the woo-prone, abuse that trust.

  22. #22 Mike
    December 8, 2016

    FDA employees have written an article for the New England Journal of Medicine on what their interpretation of “real-world evidence”. (Sci-hub has it here)

  23. #23 Lawrence
    December 8, 2016

    Ah crap…..

  24. #24 Costas
    United Kingdom
    December 8, 2016

    @ Lawrence: Isn’t that the same argument that put ex- Goldman Sachs staff in the Obama administration? That must have come as a huge surprise to you then when they decided the banks were too big to fail/prosecute, and their inflated bonuses should be funded by the taxpayer? Well, if you want to continue being a sucker to that ruse, who am I to intrude on private grief?

  25. #25 vinu arumugham
    December 8, 2016

    “Basically, the pharmaceutical industry and its lackeys in Congress bought off biomedical research advocates with the promise of more funding to the NIH and to efforts to combat the opioid crisis in the US. ”

    Wait, so you accept that the pharmaceutical industry is corrupt? You accept Congress is corrupt? But you think the vaccines and drugs the companies produce are safe? If you produce safe products that work, why would you waste money on corruption? The products would be flying off the shelves. You would not have to corrupt Congress into creating laws shoving your products down people’s throats.

  26. #26 Orac
    December 8, 2016

    You’re a very silly person. I accept the overwhelming science that concludes that vaccines are safe. The FDA is correct about this, whether you like it or not. The FDA also actually currently does a good job of assuring that medicines, devices, and vaccines are safe and effective. What worries me is whether it will still be able to do a good job of that after the implementation of 21st Century Cures, and, if O’Neill is made director, I know the FDA will be seriously compromised on that score.

    Basically, the FDA has problems, but the answer to those problems is not to weaken the FDA or put a libertarian wingnut in charge who doesn’t believe the FDA should be requiring evidence of efficacy before approving drugs and devices. What’s just happened with 21st Century Cures and what might happen with O’Neill will make things much worse.

    Of course, quacks will probably love it. As I said, a homeopath would love 21st Century Cures and love Jim O’Neill even more.

  27. #27 Calli Arcale
    http://fractalwonder.wordpress.com
    December 8, 2016

    Wait, so you accept that the pharmaceutical industry is corrupt?

    Well, duh. Why do you think Orac and the rest of us are arguing for a stronger FDA? And why do you think Pharma is lobbying for “patient freedom” laws that weaken it?

    A lot of drugs can be safe and effective when manufactured, prescribed, and administered properly. But that’s a conditional statement, and there are massive financial incentives at play that make it harder for a company to remain ethical. I mean, we’re talking billions of dollars here. And market forces aren’t enough to keep everybody honest — to sell well, a drug only has to be *perceived* as safe and effective. And perception is a great deal easier to manipulate than reality is.

    See, the thing is, Big Pharma and alt med aren’t really that much different from each other. In a lot of cases they *are* one another — all the big multinational pharmaceuticals also sell supplements, after all, because honestly they’d be fools not to. The only real difference is what barriers each product has to clear in order to legally be sold. I tend to be much more wary of the products that evade regulation; it makes me wonder what they’re hiding. Sure, the regulated products are likely hiding something as well, but the probability space in which they can hide things is a lot smaller than for the unregulated products.

    Yes, Big Pharma is corrupt. Because of *course* they are. They are run by humans, and there is a gigantic amount of money at stake. This is why we need strong regulation. The FDA is genuinely the best defense we currently have. That’s rather sobering, since it’s had so many teeth pulled already, but the answer is definitely not to weaken it further.

  28. #28 Eric Lund
    December 8, 2016

    Yes, Big Pharma is corrupt. Because of *course* they are. They are run by humans, and there is a gigantic amount of money at stake. This is why we need strong regulation.

    Preach it, sister!

    The fatal flaw in libertarianism as a political philosophy is the same fatal flaw in Communism as a political philosophy: it depends on counterfactual assumptions about human nature. People will cut corners to make money as long as they think that cutting those corners won’t hurt them. That cutting those corners will hurt other people often doesn’t occur to them. The regulations exist because there have been documented instances where cutting particular corners has hurt, or even killed, other people. That’s true of regulation in general: most regulations are not enacted until after it can be shown that the regulations would have prevented some number of deaths. Case in point: secure cockpit doors on commercial aircraft. Airlines opposed it for years because it would have added dead weight to their aircraft. But if that regulation had been in place on 11 September 2001, the infamous events of that day would likely have been prevented, which is why the airlines subsequently agreed to that regulation.

    Of course, because we haven’t been seeing the deaths that the regulations have prevented, many people forget why the regulations were imposed in the first place. Which is why these libertarian ideas are able to gain traction. Sadly, it will take a bunch more unnecessary deaths for people to remember that the FDA rules are in place for a reason.

  29. #29 Rich Woods
    December 8, 2016

    @darwinslapdog #11:

    Have all these free-market cultists never noticed how selfish and greedy humans can be when they are given the unfettered freedom to peddle their wares however they see fit?

    Yes, and they expect to come out ahead by being more selfish and greedy than everyone else while — due to their innate brilliance and thoughtful insight — avoiding all the cons attempted on them by the other cultists.

  30. #30 Costas
    United Kingdom
    December 8, 2016

    @ Eric: Considering the notorious case of Andreas Lubitz and Germanwings Flight 4U9525, that was an unfortunate case in point. Finding the right balance between security and safety is a lot harder than you think.

  31. #31 mho
    December 8, 2016

    Is there even a shred of hope in the bill that some NCCIH money might get moved over to real NIH projects?

  32. #32 sadmar
    December 8, 2016

    in an earlier draft of the bill, there was a provision that would have farmed out the certification of safety of medical devices… to third parties, ,,, Another troubling provision would have allowed shorter or smaller clinical trials…

    Did the inclusion, and then removal, of these provisions have any connection to the Mad Dog Mattis / Theranos flap, where he tried and failed to get around the FDA to have Theranos blood-testing ‘fast-tracked’ into the field in Afghanistan?

    With Mattis slated to head DoD, and still sitting on the Theranos board, would you expect these measures to reappear in some other new legislation once the new Trumper Congress is seated and the prospect of an Obama veto is gone?

    If a Thiel crony heads FDA, do they even need legislation to bork approval processes in these ways?

    I was going to ask jokingly who was the more likely Trump pick for FDA from the short list of Elizabeth Holmes, Heather Bresch, and Martin Shkreli.

    Silly me, for not thinking about Peter Thiel.

  33. #33 Denice Walter
    December 8, 2016

    re # 20:

    I was wondering what Orac and Company would think of the FDA pick. Ha ha!
    Also see recent picks for energy, education, small business etc
    Next, Foxes in charge of Henhouses.

    -btw- I almost lost it yesterday when I heard a Mr Fisher talk about Trumpianism being against the ‘cult of the expert’!**

    Where of where had I heard that before ?

    ** Oh yeah right- we can just put anyone who is smart and hardworking and they can do as well… no… BETTER than people who are steeped in an area for 20 years or so and have accumulated degrees and resumes et al.

    It will work out SPLENDIDLY!

  34. #34 Denice Walter
    December 8, 2016

    Really and truly, my brothers ands sisters, I am laughing so hard in order to circumvent becoming morose.

    Seriously, I am quite upset at seeing my niche- the darkest dustiest corners of cyberspace habitually tarted up and paraded about as a species of reality for rubes- gone mainstream.

    This is not an enviable state of affairs.

    Interestingly, Mikey ( Natural News) can barely conceal his hatred of liberals, city dwellers and diversity in a recent post about why he likes the Electoral College.
    It is worth looking at.

  35. #35 Denice Walter
    December 8, 2016

    If you are not familiar of the ‘cult of the expert’, it’s what woo-meisters claim is keeping people from seeking out the assistance of brave, maverick, free thinking, paradigm shifters like themselves and INSTEAD enlist the services of doctors (( yeah, THEM!)) whenever they suffer an injury or illness.

    You see, these poor people have been psychologically conditioned by the establishment and media to believe that doctors are superior to just anyone who calls themselves a nutritionist. It is a system of smoke and mirrors that casts aspersions upon the real heroes of natural health and gives away their earned laurels to usurpers!
    To people like Orac who have degrees and stuff.

    If you listen to prn.fm or Mikey, you’ll learn the real ( post) truth.

    I am paid to kowtow to SBM but occasionally- like today- my thoughts break free!

    Hey man, I’m an internet journalista!

  36. #36 Eric Lund
    December 8, 2016

    Next, Foxes in charge of Henhouses.

    That is exactly what Trump and Bannon are doing.

    Interestingly, Mikey ( Natural News) can barely conceal his hatred of liberals, city dwellers and diversity in a recent post about why he likes the Electoral College.

    That white robe looks good on him. But why is he ticking off his potential customer base? City dwellers are more likely than most to have spare cash to buy what Mikey is selling. They aren’t the ones who are paying off hefty loans to buy trucks that are bigger and more luxurious than they need[1], as well as the other toys suburban and exurban people are expected to have, and the HVAC bills for detached houses that are far bigger than they need.

    [1]Says the guy who hasn’t made a car payment in more than 20 years, when he paid cash for his current vehicle. Living within walking distance of work and everyday shopping helps.

  37. #37 Denice Walter
    December 8, 2016

    OH, Eric!
    We have to stop meeting like this!

    But what you say is true- both he and the other idiot, by attacking the left,, dems and liberals, throw away a potential source of revenue. I think that prior to the runup to the election they might have been more liable to toss a bone (broth) or two to the crunchy contingent.

    Mikey has got worse with his anti-urban screeds in the past year or two.
    Must be the gun love.

  38. #38 Rich Bly
    Ocean Shores
    December 8, 2016

    Totally off topic: rest in peace John Glenn; one of my first childhood hero’s.

  39. #39 Mark Thorson
    December 8, 2016

    Obama is about to sign the bill which recognizes chronic Lyme disease as a real thing.

    http://outbreaknewstoday.com/lyme-disease-bill-heads-presidents-desk-senator-gillibrand-18211/

    “This bipartisan, constituent-driven legislation will bring about effective ways to treat, detect, and prevent these conditions, including chronic Lyme.”

    • #40 Orac
      December 8, 2016

      Oh, I knew Obama would sign it. It contains funding for his Precision Medicine Initiative and Biden’s Cancer Moonshot, and it’s the last piece of legislation he’ll ever get passed, not to mention one of the rare pieces of legislation with bipartisan support he’s signed into law.

  40. #41 Gilbert
    December 8, 2016

    Obama is about to sign the bill which recognizes chronic Lyme disease as a real thing.

    Is it only a matter of semantics that undiagnosed and untreated lyme which persists and manifests for many years holds the label *chronic*?

    Do you think I’ll do better playing dominoes on cheeze than on pasta? I’d really like a pizza for about an hour. There is this hanky here with a map on it that seems pizza related — Is it yours? In no way does ‘walnut’ == Hatian…Doh! who am I diddling? Of course, it does.

  41. #42 JustaTech
    December 8, 2016

    NJK @17: Sometimes having a record of informed consent can itself be a risk because of the potential outcomes for the research participant if their participation in the study became known due to wrongful release of records.
    For example: If you are surveying people about their illegal drug use, even if all you do is ask them questions, and you get their full name in order to get informed consent, and then the informed consent records get released (accidentally or maliciously), then everyone on that list has been outed as a drug user and could face very serious consequences.

    Thus it would be *more* ethical to totally protect their anonymity than to have a record of their consent. And that could be true of any socially sensitive subject.

  42. #43 JustaTech
    December 8, 2016

    Rich @38: John Glenn? Damnit, 2016!

    Gilbert @41: Usually with “chronic” Lyme the bacteria is never detected, nor does the patient have a history of the classic rash, nor travel to places with Lyme disease. It is distinct from untreated Lyme disease and lingering affects of Lyme disease.

  43. #44 JustaTech
    December 8, 2016

    I’m torn between wanting to write Senator Warren a nice letter thanking her for standing against this bill, a grumpy letter to my senator for voting for this bill, or looking at the latest cabinet/director appointments and curling up in the fetal position.

    I’m reminded of a Sublime song from the album 40oz to Freedom (which turns out to be a cover of a Bad Religion song) called “We’re Only Gonna Die From Our Own Arrogance”. It talks about humanity’s less than nice drives and end with the line “We’re only gonna die from our own arrogance, that’s why we might as well take our time”.

    I don’t know what it says that a ska-punk album from 1992, that I discovered in 2003, has really helped me process/ not freak out about the past two months.

  44. #45 sadmar
    December 8, 2016

    Sorry, JustaTech, the fetal curl won’t do unless we drawl back into the womb. That’s the only place we can be safe in Trump-world. Unless our moms or poor or non-white.

    Today’s announcement is Hardee’s/Carl’s Jr. CEO Andy Puzder will be the new Labor Sectretary. He’s against raising minimum wage, opposed to expanding overtime pay, an aggressive union buster, and, says Robert Reich, “doesn’t believe in regulating companies to ensure the safety and security of workers.”

    Picks like these don’t bear directlty on science, but they’re going to have an effect on public health. My first though to that was all the injured workers with no or poor post-ACA healthcare putting a burden on emergency care. But, duh, sadmar, the guy is anti-regulation and he owns a big chain of fast food restaurants. Food safety health inspections? Nah. Caveat emptor.

    As i typed, a quote from Puzder appeared on my TV screen. He’s apparently into replacing his employees with machines.

    They’re always polite, they always upsell, they never take a vacation, they never show up late, there’s never a slip-and-fall, or an age, sex, or race discrimination case.

    They do, however, apparently vote Republican. 😉

  45. #46 Gilbert
    December 8, 2016

    He’s apparently into replacing his employees with machines.

    LoL. You just wanna have people to not have sex with robots:

  46. […] week, Congress readied the weakening of the FDA for DT by passing the 21st Century Cures Act. On the surface—and from the mainstream media—the public may believe that it should embrace the […]

  47. #48 Mark Thorson
    December 9, 2016

    Gilbert meets the ILADS criteria for diagnosing dementia subsequent to chronic Lyme disease.

  48. #49 herr doktor bimler
    December 9, 2016

    Rich @38: John Glenn? Damnit, 2016!

    This is exactly why we’re keeping Buzz Aldrin in protective custody in NZ until it’s no longer 2016.

    Cherry 2000 is a fine movie (and a major influence on ‘Mad Max: Fury Road’).

  49. […] I noted the passage of the 21st Century Cures Act, a Hobson’s choice of a bill for those of us who support increased biomedical research funding […]

  50. #51 jrkrideau
    At the bottom of the lake (the bottom end that is)
    December 9, 2016

    Denice Walter

    Oh yeah right- we can just put anyone who is smart and hardworking and they can do as well… no… BETTER than people who are steeped in an area for 20 years or so and have accumulated degrees and resumes et al.

    Strangely enough the Federal government went to that model for appointing deputy ministers about 20 or 25 years ago. A manager does not need any subject matter knowledge he or she just needs to know how to manage. The Phoenix pay system program seems to show what a good idea that was.

  51. […] I noted the passage of the 21st Century Cures Act, a Hobson’s choice of a bill for those of us who support increased biomedical research funding […]

  52. […] Orac has already done a great job of summarizing the problems with the bill. He writes: […]

  53. #54 Denice Walter
    December 9, 2016

    @ sadmar:

    There are other places to be safe in (( shudder)) Trumpworld:

    WE can seek out the company of sceptics and thinking people ( but not Thinking Moms)

    We can learn how to meditate and elevate ourselves above the travails of this vale of tears. It’s an illusion anyway.

    We can create an oasis of culture like the transplanted Japanese do here with their riverside shopping mall and restaurant hub as a home away from home and much cheaper than airfare.

    Punks do similarly elsewhere.

    We can foment a rebellion against the status quo- although that’s what got us here, isn’t it? ( not by us, though)

    What is your present take on two cultures revolving around their love or hate for the Trumpster?

  54. #55 Denice Walter
    December 9, 2016

    @ jrkrideau:

    You know, our web woo-meisters have been following that model and getting rich off of it.

    They pretend to be health experts and more recently….

    JOURNALISTS!

    Having their own media empires!
    Earning money off of adverts and selling products that answer the needs created by their fraudulent fear mongering!

    Today, Mike Adams addresses the REAL fake news!
    I.e. the MAINSTREAM!

    Natural News yesterday and today.
    ( an especially disgusting article which helps spread the myth about the Sandy Hook Massacre being staged/ not real)

  55. #56 JustaTech
    December 9, 2016

    sadmar @45: Man, I remember when Hardee’s was a fried chicken chain, not a burger chain.
    And if Puzder thinks it’s trivial to replace all fast-food workers with robots, well, has he got another thing coming.
    Several things, in fact.
    1) It is really hard to automate within a space/process designed for humans. Is he going to completely re-build the kitchens of all of his stores?
    2) Robots break down. A lot. Who’s going to fix them?
    3) Robots don’t do well with humans (customers) who are drunk, confused, have an accent, mumble, want something from 10 years ago, etc etc etc.

  56. […] OR WIN FOR PROGRESSIVES? On one hand The 21st Century Cures Act passes, potentially turning the FDA into a puppet of the pharmaceutical i…, on the other hand Senate Passes Sweeping 21st Century Cures Act Funding Medicine, on the other […]

  57. #58 Bob
    December 13, 2016

    @NJK #17

    I’m late to this party, but I don’t think your question was answered. A certain scenario has been proposed before to illuminate a very narrow set of circumstances where informed consent would not be in the patient’s best interest.

    A patient arrives at an ER suffering from massive blood loss. He is dying, and will certainly die without a transfusion. There is no blood available to the ER staff of the appropriate type, but they do have access to an experimental blood replacement fluid.

    The patient is unconscious. The patient’s next of kin cannot be contacted. Death is certain without treatment, as assessed by multiple physicians.

    So, do you proceed with a surprise and non-consensual medical experiment?

    Situations like this could (and should) be extremely rare, but you can sort of enrich for them if you are specifically developing novel interventions for emergency medicine, especially if it’s intended for war zones or humanitarian disaster relief.

  58. #59 Dianne
    United States
    December 17, 2016

    The 21st century cures act was a spectacular piece of sausage. But it’s nothing compared to what Trump’s going to do.

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