It’s been two weeks since Donald Trump unexpectedly won the Presidential election despite losing the popular vote. Regular readers of my not-so-super-secret other blog know my opinion of this; so I won’t belabor it too much here. If you’re curious, I have written about Donald Trump’s antivaccine views here many times dating back to 2007, and, amusingly, I’ve even been at the receiving end of criticism from an “integrative medicine” activist in which my snark was compared to that of Donald Trump and my criticism labeled not just once, but twice. As you might imagine, I was not pleased.
Leaving all that aside, as an advocate of science-based medicine, naturally I wondered: What can we expect in terms of medical science under President Trump next year? Jann Bellamy already began the discussion by undertaking a fairly comprehensive overview of the disturbing anti-science positions Donald Trump and many now coming into his new administration espouse. I’m going to do a bit of the same, but I’m going to drill down and focus solely on medical science. While I agree that Trump’s position on human-caused climate change and his stated intent to pull out of important climate treaties and, in essence, cease any attempt to mitigate the effects of human activity on climate change is a looming disaster that our grandchildren and great-grandchildren and beyond will likely curse our generation for, my areas of expertise are medicine and biomedical science; so I’ll focus on issues related to them and leave the discussion of climate science to people like Phil Plait. Also, I’m not going to focus on issues that are more more political than scientific, like what will become of the Affordable Care Act (although I suspect that Trump will find dismantling it far more difficult than he thought it would be), but it’s impossible to avoid politics altogether when discussing federal science and medical policy.
There have been a few articles in the scientific press speculating what the election of Donald Trump means for science. Here is a sampling:
- Donald Trump's Presidential Election Win Stuns Scientists
- What scientists should focus on — and fear — under Trump
- Richard Dawkins and Other Prominent Scientists React to Trump’s Win
- The ultimate experiment: How Trump will handle science
- What does Donald Trump’s win mean for science and medicine?
- Here’s some advice for you, President Trump, from scientists
Not surprisingly, the two primary reactions that come through loud and clear in these articles are fear and uncertainty. This is not surprising, given the litany of antiscience positions that Trump articulated (if you can call it that) during the campaign. The uncertainty comes from the fact that on a lot of issues relevant to science, Trump hasn’t said much of anything and for the last 18 months the Trump team has has little interaction with the scientific community. This means, for a lot of medical science policy issues, we really have no idea what he’ll do. We can, however, make educated guesses based on past statements and the Republican Party platform.
A week ago, Nature published an article, What scientists should focus on — and fear — under Trump, that featured nine scientists expressing their fears and hopes. One issue that stood out to me (and is one I haven’t seen covered before) had to do with standards for drug approval.
Donald Trump, Mike Pence, and “right-to-try”
In a section of the article entitled Beware of plans to lower drug standards, Douglas Sipp of the Riken Center for Developmental Biology, Kobe, Japan writes:
Supporters of the idea that drugs should be tested for efficacy before being sold are in for a long four years. In recent years, Republican majorities in the Senate and in the House of Representatives have backed several bills that would drastically reduce the authority of the US Food and Drug Administration (FDA), and its ability to require that new medical products are demonstrated to be safe and effective before they are marketed.
One of the pillars of Republican belief these days is that nearly all regulation of industry is bad, that it holds back the power of the free market. As I’ve documented more times than I can remember, there is a strong Libertarian/right wing bent to large swaths of what is known as the “health freedom” movement. Basically, the “health freedom” movement loathes the FDA and views it as an impediment to innovation. If you believe the narrative, the reason we don’t have cures for cancer and many other diseases is the Draconian regulatory hurdle of the FDA. There is little doubt that Trump has imbibed deeply of this belief system, and with both chambers of Congress under Republican control, there will likely be a deregulation spree shortly after Trump is inaugurated.
In case you doubt me about how much many conservatives detest the FDA, let me remind you of something I came across last year when writing about the fear of Ebola that was rampant in the US because of the outbreaks in Africa. There I mentioned what is to me an iconic article articulating this point of view, Kill the FDA (before it kills again) by Nick Gillespie:
As my Reason colleague Ronald Bailey has written, this means the FDA’s caution “may be killing more people than it saves.” How’s that? “If it takes the FDA ten years to approve a drug that saves 20,000 lives per year that means that 200,000 people died in the meantime.”
Yes, there are some who quite literally (and mistakenly) believe that the FDA is killing patients. As I wrote at the time, completely missing from Bailey’s and Gillespie’s equation is the number of drugs that the FDA doesn’t approve because they don’t show efficacy and safety that could allow even more than those 20,000 people a year to die or even actively kill some of them. After all, it was the FDA that prevented, for example, approval of Thalidomide in the US and the rash of birth defects seen elsewhere in the world.
It’s this sort of attitude that leads to Sipp’s concerns:
Most concerning is the Republican push for a federal ‘right to try’ law, which would indemnify companies and individual physicians that sell experimental drugs to dying patients after only preliminary safety testing. Similar laws have been enacted in 32 states. But these have had little impact, being superseded by federal code. A federal right-to-try law would effectively make phase I clinical trials (which test safety) the threshold for marketing new products. This would have profound consequences — on how new drugs are brought to market, and for clinical-trial enrolment. The right-to-try movement is making overtures overseas too. In Canada, for example, all members of its parliament received a coordindated e-mail calling on them to endorse such a law.
Although I was unable to find any statement by Donald Trump about “right-to-try” laws, Mike Pence supported Indiana’s right-to-try law and in August responded to the question of a child whose father has amyotrophic lateral sclerosis (Lou Gehrig’s disease) about right-to-try thusly, “I'm very proud the state of Indiana signed 'Right to Try' legislation into law, and I promise you, I promise your dad, I promise Matt - we're going to take your incredibly powerful, courageous, inspirational example. We're going to take it to Washington, DC, and we're going to get it done.” Support for a federal right-to-try bill is also embedded in the Republican platform.
I’ve written many times before about “right-to-try” laws. As of now, there are 32 states that have passed such laws, an astounding accomplishment for the proponents of these laws at the Libertarian think tank the Goldwater Institute, which began its promotion of these laws less than three years ago. Remember, the first right-to-try law passed in Colorado in May 2014.
This success should not be surprising, because right-to-try laws give the appearance of helping terminally ill patients. Passing right-to-try laws lets legislators feel good about themselves without actually confronting hard choices, not to mention to appear to be doing something helpful when they are not. On the surface, they are very, very appealing, to the point where I’ve grimly joked that opposing right-to-try appears akin to advocating disemboweling puppies or being against mom, apple pie, and the American flag, even though thus far, by any objective measure, right-to-try laws been a miserable failure thus far. I myself have experienced some of that vitriol, and know from various private conversations that university medical centers and pharma think these laws are a horrible idea. Yet, it is very rare for an official representative to state outright opposition to such laws. (Note: I do not represent my university or cancer center in any way on right-to-try. See? Even I feel obligated to point that out!)
In any case, right-to-try is a movement started by the libertarian Goldwater Institute, ostensibly to give terminally ill patients the “right to try” experimental treatments without interference from the FDA. Indeed, the Goldwater Institute provided the template for these laws, and all right-to-try laws that I’ve examined hew pretty closely to this template (many even use the exact language provided by the Goldwater Institute), with customizations intended to make individual laws fit into the legal and regulatory framework of the state passing them. In reality, right-to-try is a cruel sham.
There are several reasons why right-to-try laws are a cruel sham. First and foremost, states do not have authority over drug approval. The FDA does, and federal law trumps—if you’ll excuse the word—state law. Also, it’s incredibly rare that an experimental drug will make the difference between life and death in any given terminally ill patient. Yet it is that hope that supporters of right-to-try laws, in particular the Goldwater Institute, have shamelessly exploited to rally patient groups and to persuade legislators to pass these laws all over the nation. Basically, the Goldwater Institute has sold patients and legislators on a lie.
Unfortunately, that lie has power. Even though state right-to-try laws are toothless—or are, as I like to call them, placebo legislation—they exist to put pressure on Congress. This year a federal version of a “right-to-try” law, S.2912, The Trickett Wendler Right to Try Act of 2016, has been languishing in Congress, apparently meeting the same fate that its href="http://scienceblogs.com/insolence/2014/04/25/the-compassionate-freedom-of-choice-act-of-2014-pernicious-health-freedom-nonsense-that-degrades-human-research-subject-protections/">predecessor did in 2014. What S.2912 would do, if passed, would be: (1) to explicitly federalize each state’s right-to-try law, in the process eliminating the FDA’s ability to protect terminally ill patients from what could be dangerous or inappropriate drugs; (2) eliminate all federal liability from physicians and drug companies that offer a drug under right-to-try, meaning that if a patient suffers because of the inappropriate use of such a drug the patient (or, given that the patients under this bill have terminal illnesses, the family) will have no recourse to sue the manufacturer under federal law, in addition to having no recourse under state law; and (3) bar the FDA from using outcomes of patients using experimental drugs or devices under right-to-try in its deliberations over whether to approve them for sale. Basically, the Trickett Wendler Right to Try Act of 2016 would not help terminally patients. It would endanger them.
The Trickett Wendler Right to Try Act of 2016 is almost certainly dead in 2016. Not much is going to happen in a lame duck session outside of essential business, and President Obama would probably veto the bill anyway. However, I expect this bill, or something very similar (and perhaps more alarming) to be reintroduced next year in the new Congress. With Trump in office and Republican majorities in both chambers, who knows where it will go?
Sipp is utterly correct, though. If a federal right-to-try law like Trickett-Wendler passes, it would effectively make phase I clinical trials the threshold for marketing new products to terminally ill patients. Remember, phase I trials are safety trials in which a handful of patients (often less than three dozen) are given the drug at varying doses. They can only find the worst adverse events, and they are not designed to test efficacy. Basically, a federal right-to-try law would risk throwing us back to the pre-thalidomide FDA, at least with respect to terminally ill patients, who are most vulnerable. Once that door is unlocked, it’s also clear that right-to-try proponents will push for liberalizing right-to-try to the “seriously ill,” as some state laws already do and are likely to find a sympathetic ear in the White House.
Donald Trump and stem cell clinics
Then there’s the US REGROW Act. This seeks to lower standards for cell therapy products — such as stem-cell treatments — and has been stalled in a Senate committee since this spring. Major scientific groups have issued statements opposing the act, including the International Society for Stem Cell Research, the International Society for Cellular Therapy, and the Alliance for Regenerative Medicine. The bill’s prospects had seemed grim. Substantive amendments in recent months had, for instance, removed an alarming call for Congress to prohibit the FDA from requiring phase III clinical trials, typically the final hurdle for therapies to be approved for market for most investigational cell therapy products. Now, under a Republican-dominated government, its dim chances seem to have brightened.
I’ve discussed the dangers of unregulated stem cell clinics before on several occasions. Even under current FDA regulations, there is a large industry of stem cell clinics in the US making scientifically unsupportable claims and selling stem cell therapies as a panacea for aging, arthritis, chronic lung disease, chronic heart disease, cancer, eye disease, and even autism. In the US, the situation is not as bad as it is in overseas stem cell clinics, where literally almost anything goes, damn the consequences, even if it’s a tumor on a paralyzed man’s spinal cord made up of stem cells. It’s an industry that blatantly uses celebrities like Gordie Howe, in some cases even offering their $30,000 product for free, in order to promote their business. (Yes, I know that Gordie Howe was treated in Mexico, but the company that provided his stem cells and arranged for his treatment outside of the US is an American company based in San Diego.) Basically, such clinics engage in unethical for-profit human experimentation, except that they seem not to keep records adequate to determine if their treatments actually do any good.
These stem cell clinics use a hard sell technique, too, not unlike that of salesmen selling time shares, complete with extravagant claims, high pressure sales techniques, and “special” discounted prices that you can only get if you sign on the dotted line and provide a check or credit card number right then and there at the informational meeting. Basically, there’s a lot of shadiness and quackery in just the US stem cell industry, which is why the FDA has been taking a look at the plethora of dubious stem cell clinics in the US and preparing to propose new regulations that could shut down many of them.
It’s not clear if REGROW will now be passed, but given the anti-regulatory bent of the new administration, I wouldn’t be surprised if it, too, is reintroduced in the new Congress and has a much higher probability of passing than before, when even then it was viewed as too radical and dangerous, mainly because it was and still is. Even before the election, there were powerful Senators talking about reintroducing the bill or somehow folding it into a larger bill supporting the NIH. If that happens, stem cell quacks will be given essentially free rein to sell whatever snake oil they please.
Will Donald Trump loosen drug approval standards?
Of course, right-to-try, although horrifying in how it would dismantle safeguards to prevent drug companies from taking advantage of patients, is still a rather special case. It applies only to terminally ill or “seriously ill” (whatever that means) patients. Similarly, there are, at least now, relatively few patients seeking unapproved stem cell therapies, in part because they cost tens, if not hundreds, of thousands of dollars unreimbursed by insurance companies. Perhaps of more concern is this, again discussed by Sipp:
Other attempts at deregulation may also take advantage of the new, effectively one-party government. These include proposals to lower evidence standards for drug approval across the board, and to undermine FDA authority over the promotion of ‘off-label’ uses of approved drugs.
This is the threat that is more likely to harm more people. As I pointed out before, it is basically a religious tenet of Republican orthodoxy that the free market always does things better and that, if left to itself, the free market will sort out everything. You might think I exaggerate, but I don’t, at least not much.
I’ve already discussed the 21st Century Cures Act. It’s a bill that was proposed last year, seemed not to go anywhere much, but is still very much alive and still poised to endanger patients. Basically, it’s a bill that would substantially increase the NIH budget (good), but couples that necessary increase to some very bad ideas, such as doing exactly what Sipp warns against, letting the FDA approve off-label uses of drugs without a randomized clinical trial. It would also weaken patient protections in clinical trials, increase the number of things drug companies can pay doctors for without having to report it to the government.
The central assumption behind the bill is that, for greater medical innovation at a lower cost to let the medical advances flow to a grateful populace, the FDA needs to be reined in. Of course, what the best level of regulation is to balance cost and time to approval versus guaranteeing the safest, most efficacious devices and drugs. It’s such a seductive idea, and you don’t have to be a nutty government-hating libertarian to feel the attraction. The idea seems so…logical.
Here’s the problem. The premise is wrong. It turns out that such 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 pretty 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 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. Unfortunately, the 21st Century Cures Act is cynical politics played to increase pharmaceutical company profits. It is not, nor has it ever been, about protecting patients. Although its advocates genuinely believe that its purpose is to bring cures faster to patients who need them, the 21st Century Cures Act will do no such thing, and tying changes in the FDA regulatory framework to increasing NIH funding is the ultimate cynical political ploy to gut the FDA and turn back the clock on drug development at least 50 years.
I also look for the 21st Century Cures Act to be resurrected yet again in 2017. Yes, this is speculation, but educated speculation, I think, based on the general anti-regulatory bent of the Republican Congress and Trump himself. As for the NIH itself, last year Trump appeared on Michael Savage’s radio show, where in response to Savage suggesting that if Trump wins he’d like to be appointed head of the NIH (!) Trump said:
Well, you know you'd get common sense if that were the case, that I can tell you, because I hear so much about the NIH, and it's terrible.
Even though it’s fairly obvious that Trump was probably either just joking about appointing Savage as NIH director or just stroking his host’s ego, this is not the sort of statement that makes me, as a medical scientist, feel all warm and fuzzy. Remember, Michael Savage weathered a controversy in 2008 in which he blamed “99% of the cases of autism” on “lax parenting.” No wonder it’s unclear whether Francis Collins will stay on as the director of the NIH after January 20. (Personally, if I were him, I’d go back to my lab.)
Which brings us to vaccines.
Antivaccine activists petition Donald Trump
After the first Republican debate last year, I extensively documented Donald Trump’s long history of making antivaccine remarks in which he stated some variation of how it’s a “monster shot” that causes autism. Basically, I’ve been documenting Donald Trump’s antivaccine statements for close to a decade now, since I first encountered him making such statements in 2007. I’ve frequently said that, given how many times Trump has changed positions on so many issues, his antivaccine views represent arguably his most consistent belief, one that hasn’t changed since at least 2007.
Now take a look at this photo:
Yes, that is our President-Elect. according to antivaccine blogger Levi Quackenboss (whom we’ve met before), in August, Donald Trump met with the most famous antivaccine zealot in the world, Andrew Wakefield. (I’d say that Donald Trump is the most famous antivaccinationist in the world, except that so few people seem to be aware of his antivaccine views.) It also slipped by under my radar when Wakefield posted this video to Facebook in August:
Yes, antivaccinationists—at least many of them—love Donald Trump. Love him. For example, our good buddy and antivaccine conspiracy theorist since at least 2009, Jake Crosby, whom I like to refer to as Young Master Crosby (or, if I’m on Twitter, The Gnat), has been posting Hillary for Prison graphics, urging people to donate to the Trump campaign, and generally worshiping the ground Donald Trump walks on. Before the election, he posted this Tweet about me:
Post-election @Gorskon and (S)Mellody Hensley. #MAGA pic.twitter.com/8akeCBZWNe
— Deplorable Jake, MPH (@JakeLCrosby) September 10, 2016
He then reposted it after the election:
@gorskon Over the wall you go. https://t.co/ZE5RXs22k8
— Deplorable Jake, MPH (@JakeLCrosby) November 10, 2016
He apparently didn’t realize that I had been in Mexico at the time on vacation. He also posted a gloating post, Deplorables prevail!!!. Elsewhere, a man every bit as deranged as The Gnat, Mike Adams, has been delivering a steady stream of pro-Trump propaganda, along with his other pseudoscience, quackery, and lies, for several months now. Since the election, he’s been practically giddy with glee over Trump’s victory.
You get the idea.
I’ve already discussed in detail how Donald Trump met with Andrew Wakefield in August. What I didn’t reveal is that apparently, according to our old antivaccine “friend” Kent Heckenlively, the person who set up this meeting was Gary Kompothecras, a wealthy, politically connected Florida chiropractor known for threatening public health officials on behalf of antivaccine quacks like Mark and David Geier. I’ve also documented how, frighteningly, antivaccinationists now actually think that Trump will deliver on his antivaccine rhetoric, now that he is President-Elect.
Antivaccine activists are even still flogging that conspiracy theory, the subject of a film by Del Bigtree and Andrew Wakefield, VAXXED, an antivaccine propaganda film disguised as a documentary, a film so unsubtle and over-the-top that that Leni Reifenstahl, were she alive, would likely say, “Genug!” or even “Mehr als genug!” (I know, I use that joke way too often, but, damn, it’s appropriate.)
Fortunately, I highly doubt that much, if any, of the demands I documented will come to fruition. The most important reason is priorities. President-Elect Trump and the Republican Congress have far bigger fish to fry, such as “repealing and replacing” Obamacare (which will turn out to be far more difficult than they think), slashing taxes and spending, gutting environmental regulations, and the like. Even if Trump wants to do anything in line with his antivaccine beliefs, it would be way, way down his list of priorities, so much so that he’d be unlikely to get to it in the first two years, if ever. Also, government bureaucracies, such as the CDC and HHS, are resistant to change. It would take a concerted and prolonged effort to change the CDC in the way that Quackenboss wants it changed. Again, fortunately, it’s highly unlikely that these issues are high enough on Trump’s radar that he would want to spend the political capital necessary to accomplish it. Finally, vaccine mandates are the purview of the states. No President can come into office and wave a magic wand to change them. Each state would have to do it on its own, which is highly unlikely to happen.
Still, it is disturbing that Trump holds these views and that he would meet with an utter crank like Andrew Wakefield.
There are lots of other health science related topics that could be impacted by Trump administration policies that I didn’t cover here, such as Mike Pence’s opposition to embryonic stem cell research, statement that smoking doesn’t kill, and lack of acceptance of the theory of evolution. Ditto the dire consequences of this election for women's reproductive health. Those have been covered here and elsewhere in detail. I intentionally focused on a handful of areas that I've discussed the most in the past and that I haven't seen discussed much elsewhere.
My key concerns about the Trump administration focus on the potential for neutering the FDA and leaving patients open to exploitation by drug companies and bogus stem cell clinics and on whether Trump’s oft-stated antivaccine beliefs will find their way into policy. My conclusions are, of course, educated guesses at best, speculation at worst, but even so they worry me. I definitely believe that we are in for a weakening of the FDA and a loosening of drug approval standards, both through the likely passage of a federal right-to-try law and the sorts of policy embodied in the worst passages of the 21st Century Cures Act. The only bright spot that I can see is that I doubt Trump cares enough about vaccine policy to put any sort of sustained effort into tampering with the CDC, although through his appointments to Secretary of HHS and the director of the CDC he could still do serious mischief. Fortunately, school vaccine mandates are state-level laws, and there is practically nothing he can do about them unless he wants to invest serious political capital into passing laws, for instance, tying federal funding to loosening of school vaccine mandates, laws that even many Republicans would oppose vigorously.
We can’t yet know for sure what form Trump’s medical science policies will take, but thus far they do not look good, and that’s even leaving aside what will become of the ACA. Unfortunately, Donald Trump will be our President for the next four years and will have a compliant Congress for at least the next two. Those who advocate for science and public health should be very, very afraid.
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Doesn't the FDA approve new vaccines? Wouldn't the upshot of this be that FDA lets new vaccines onto the market after less scrutiny?
Nice strawman Trouble. I don't recall anyone regularly commenting here ever complaining about FDA regulation delaying vaccine approval needlessly.
It's Trump's new reality show: America's Next Thalidomide.
And he has two if his pet groups pushing for this: vested interests, and the Birchers.
As the saying goes, those who do not learn from history are condemned to repeat it. The problem is, if Trump does weaken the FDA then it's hard to see how robustness could be reintroduced without a massive change in the legislature.
Like you said before, we certainly have our work cut for us. By weakening the FDA to the point of allowing the approval of new drugs without sufficient testing, Trump would effectively become the uber shill for big pharma.
I'm not sure how anti-vaxers reconcile Trump's position on regulations (meaning he supports basically no oversight for drug development or marketing) and their desire to go after vaccines.....he's probably the least likely person to support any additional oversight.
My hope is that the entire thing is so overwhelming to him that he leaves the CDC alone because he thinks it's not enough to bother with right now.
I would like to call this reverse-hindsight: IF the tested product turns out to be very efficient, then of course we could have started giving it to patients straightaway*.
Unfortunately, that's a very big "IF".
* leaving aside matters of finding proper doses, recording side effect patterns and anything else I may be overlooking (I am not a pharmacologist).
Oh my, America is going to collapse into a vast landscape of death and degeneration with the election of this guy. I'm willing to bet that Trump will have about as much effect on the US as every other President has had.. Not much.
Remember when Obama was elected and the US was going to enter a golden age of enlightenment. Everyone was going to be equal, you'd finally get over the racist past to enter the equality driven future, the LGBTQ would become full partners in society, the corporations would be broken in favour of saving the environment.
Remember when Bush version 2.0 was elected and the environment was going to be despoiled en-mass, the National Parks sold off to the highest bidder, the EPA and planned parent-hood de-funded, and evolution replaced by creationism in school.
And the same can be said of Clinton, Bush Version 1.0, and Reagan. They were all going to fundamentally change the USA. In minor ways, they have put their finger-print on the nation, but none of them did anything truly great or truly horrible. All of them with a little perspective accomplished little change. Even when their side controlled the legislative as well as the executive, they were self-limited by everyone's self-interest.
So please, can we at least wait for the new guys first 100 days to happen before proclaiming that this is the end of the fucking world. The idiot hasn't even been sworn in yet.
Democracies all seem to be pretty good at minimizing the damage caused by our leaders. Just be glad you don't have an elected dictator-ship like Canada. A majority PM can do what-ever (s)he wants and the only barrier is the Supreme Court, if they deign to hear the case.
Yet people never say that the FDA saves lives if they reject drugs that would cripple or kill 20.000 people per year. Funny how that works... if they don't approve a drug they're murdering people because they're lazy, if they do approve a drug that later turns out to have higher than expected negative effects, they're murdering people because they're shills for Big Pharma (despite recalling the drug for safety concerns). Either way, you lose.
I'm not sure, but I think LouV missed the implication of Trouble's question. My guess is it's along the same lines as Lighthorse's "Trump would effectively become the uber shill for big pharma" and Lawrence's comment as well.
In sum, then, the idea might go like this: The anti-vaxers dream Trump will "drain the swamp" at the CDC and install a new regime that would essentially eradicate use of childhood vaccines -- which would be Big Guvment regulation, and thus will not happen. Instead, Jake and his posse will only find more and more vaccines fast-tracked and added to the schedule. Hah. Gotcha, Jake.
But things are more nuanced than that, which folks here know, so it's just an over-dramatized narrative to smack at the AVs.
Pharma stocks went up immediately after the election, even when other stocks were dropping. So the Street thinks a Trump administration will be good for pharma profits. However, that may not be anything to do with Trump himself, but just a reflection of the fact that with the GOP controlling both houses of Congress and the executive, new initiatives from conservative legislators will be passed into law for the first time after after many, many years of divided government.
AFAIK, Trump is not beholden to the pharmas, but a virtual who's who of conservative legislators are, as they have received substantial support from ALEC, which counts the pharmas as one of its major sources of funding.
But as Orac points out in the OP, it doesn't take the FDA ten years to approve a drug. It may be ten years from the time a prospective drug is initially synthesized to when it gets approval, but the overwhelming majority of that time is spent determining whether that drug is (1) safe and (2) effective. Somewhere in the neighborhood of 90% of prospective drugs fail one or both of those tests.
Even if a federal "right-to-try" law passes, will it have much effect on the ability of doctors to prescribe these experimental drugs? Manufacturing a drug in the small quantities appropriate for clinical trials is quite expensive, so they tend not to make any more than they need at any given stage of the process. It certainly does not help a patient if his doctor prescribes unobtainium.
The end of the world already happened, dumb-ass, under Reagan, Poppy Bush, Clinton and especially Shrub Bush, when fossil-fuel company profit-driven energy policy trumped environmental science and we helped pump enough carbon into the air to make a climate disaster apocalypse all but inevitable by 2100 (give or take a generation, I suppose.)
Do you see what Anonymous Pseudonym's game is here? Now, why would a Canadian try to convince us everything is fine in the USA (with Steve Bannon as the chief policy advisor to the POTUS etc. etc.), at the same time he's trying to sell us on the premise that Justin Trudeau is a scary elected dictator? He's scared there will be a mass immigration North from the remaining sane parts of 'Muhrica, and we'll over-run the Great White North, forcing football teams to get the 12 man off the field and shorten the end-zones, raze curling rinks for basketball courts, turn all the Tim Duncan's into Dunkin Donuts, and generally destroy all that is unique and special about Canadian culture. He knows they can't build a wall, and we'd just fly over it anyway, so he's going for Big Lie propaganda. Hah! Nice try, dude, but no dice. We're coming.
Heheh. I promise to leave Tim Hortons alone. There are lots of Tim Hortons in southeast Michigan; so since moving back I've come to appreciate a trip to Timmy's for some of its awesome coffee and a breakfast sandwich. :-)
@8 AP - Elected dictatorships, LOL. But it is true in a way that our (Canadian parliamentary) system does allow a majority gov't a lot of power to change things. Even though the US system has more checks and balances on the President, things like appointments to the Supreme Court can have ripple effects that last longer than the administration and can be significant. So while the sky may not be falling, our American neighbors may need to dust off their umbrellas. Stormy ways, my friends, stormy ways.
Does the name Stephen Harper ring a bell?
Canada had a close brush with the sort of disaster the US is now facing during the years they had a Conservative majority government. Harper actually took steps to stifle dissent from scientists who (unlike Harper) thought global warming was happening, and Harper was every bit as anti-science as Trump. I don't know what his positions were on medical research--perhaps one of the Canadian commentariat might enlighten me--but he was certainly bad news for anyone in atmospheric science and other environmental fields. And he was very much in thrall to the tar sands interests in northern Alberta.
Canada is likely to end up with a substantially larger fraction of the world's population than it has now. The country will be less severely affected than many others--most of Canada will still be inhabitable even as places like Florida drown.
@11 Eric Lund & @9 sadmar
My wife was on an experimental interferon medication which was wickedly expensive because it was in limited production for the trial period, or so the excuse went. When it went into full scale production, it got more expensive. So much for economies of scale. Maybe this is a reason for Pharma stock enthusiasm, a bunch of expensive, maybe-they-work meds can start pumping up the revenue stream earlier. Woohoo.
BTW, after many years and many bucks, the interferon treatment was found to be not as effective as initially it appeared for MS, bummer.
On the not-so-supersecret-other blog, I have had inquiries as to Canada's immigration policies. Hey, we benefited from the Loyalists some 200 years ago, we'll take an influx of Rationalists any day. It may get cold, but Tim's is always warm! I feel for the Florida problem though, large parts of our population will have to find a new southern haven to escape winter.
In a more serious vein, I was working in a science-based federal department in the Harper years and it was miserable.
Ahem. Windows Vista.
To market, to market to ... (there's a post-ellipsis pig in there)
I haven't followed the whole issue of drug introduction lag time much, so perhaps this has been discussed before.
Have the proponents of shortening the discovery-to-market time interval, be it because of right-to-try, doing away with the FDA, or anything else, compiled lists of drugs for which significant benefits can be clearly shown to have been likely, had those drugs been released earlier? How many drugs really can be shown to save 20 thousand extra lives per year, in comparison with drugs already for sale? How far back the analysis goes clearly is very significant - if penicillin had been on the market in the 19th century, it certainly would have made a huge difference. But how about the drugs that were released in 2015: what difference would having released them in 2010 made? Surely those who want the regulations relaxed can tell us.
My impression is that the vast majority of drugs, excluding vaccines, introduced in the past couple of decades have been incremental improvements (in revenue for shareholders, if nothing else) over existing drugs, rather than products that offered treatment for something previously untreatable. New vaccines and, if discovered, new antibiotics I view as being products where rapid introduction could have real benefits, but I suspect they are far from the thoughts of those who want to have new drugs available at Walmart before the dead mice have gone cold.
I'd also like to see some numbers for how many additional lives could be saved if the vast greed of the executives and shareholders of pharmaceutical companies were dialed down so more people could afford the drugs.
@12 : The environmental disaster in the making won't destroy the world, just our current civilization. And by the time that happens, most of us will likely be long dead. But that is a death by a thousand cuts.. Basically going back to the start of the industrial revolution. Or if you want to be really fair, going back to when humanity started farming instead of hunting/gathering.
You can have our extra man from our football league, if you give us a chance at winning the Stanley Cup one of these years. Canada's game my ass. And please take Timmies. I like it almost as much as I like Celine Dionne and Bieber.
@ 14 : Justin is no scarier then Jean Chretian, Stephen Harper, or Brian Mulroney. All of them did things with their majority that I agreed with, and things I disagreed with. Problem is, a majority here means that there is no real recourse to change the decision until the next election. Since Canadians historically have no long term political memory, that doesn't accomplish anything. I do hope Justin follows through with changing our electoral style to something more representative, but why change what benefits his party.
@ 15 : I disagree with the reasoning for Harper forcing all members of the GoC to sing off the same song sheet. He tried to run the nation like a corporation, and that isn't a very popular way to do things. We can argue how effective it was at ensuring the party line was consistent... Sort of what Justin has been doing to date. We learned that bit of politicking from our Southern cousins.
In the end time will tell which political promises Trump made will actually be kept. The US federal bureaucracy will tone some of his silliness down, as will political in-fighting and give-and-take. His VP actually scares me more, being a Christian fundamentalist is never good for public policy. A political opportunist like Trump is far less dangerous. But that is just my 2 cents worth. That and a toonie will get you a cup of coffee.
There are places in Canada that fit the bill even today--you may have to put up with a fair amount of winter precipitation, but at least at the lower elevations you rarely have to shovel it. I refer of course to the southwestern part of British Columbia, particularly Vancouver Island, the Lower Mainland, and the Sunshine Coast. A few degrees of warming will make Vancouver Island's climate resemble what coastal northern California has today, and if you have a 50-year time horizon, investing in real estate in the Okanagan wine country might be a good choice.
I fear for medical science, general science, the rule of law, mental health, international markets etc etc etc.
Months ago, I described Trumpism as an alternate reality....
welllll.... welcome aboard!
We're there now!
Watching his current process of screening candidates for his cabinet, I feel he is turning reality-based, fact checking reporters and political commenters into advert writers for his latest reality show,
Who will be selected? Who will be tossed aside? Who can look away?
Which poor young reporter will freeze in the Jerseyan wilds because she wore her most photogenic - but unquilted- coat?
Which veteran reporter- remembering the halcyon days of George W - will start pulling out what little remains of his receding hairline as the endless parade of unlikely secretaries of state continues pitilessly?
Whom among his choices are there for show and who is really there as a serious possibility?
It is a very bad narrative - and a train wreck on public display you can't look away from.
I won't even go into the medley of possible COIs he faces by choosing not to put his interests into a blind trust.
And a new hotel just perfectly situated for foreign diplomats and business people.
Will press conferences deteriorate into fashion shows for the latest Trump logo couture/ joallerie? ( It's already happened)
Or ads for the latest new hotel?
Canada is not far away enough...
Why do none of these Trumpsters discuss hate speech and white power meetups ( Washington DC) in response to his victory?
Why use their symbols ( Pepe the frog) ?
Are only *Hamilton* cast members critiqued?
I must stop before I totally lose my cool and have to calm down before I work at my project..
Steve Bannon is much scarier than Mike Pence, as is Chris Kobach, NSA Director Mike "Islam Is Like a Cancer” Flynn, Attorney General Jeff Sessions, and the prospect of Secretary of State Rudy Giuliani. This isn't Harper or Mulroney. This is UKIP in England or the National Front in France taking control of the government with fellow-traveller Tories tossing in with them to elect Jean-Marie Le Pen PM (forget Marie's cleaned up version...)
Orac: As a Michigander, have you ever crossed the Blue Water bridge between Port Huron and Sarnia? At least into the late 1980's there was an independent donut shop near the base of the bridge in Port Huron that had The Best Donuts ever known to humankind. Raspberry-filled was the specialty, IIRC, and they were so good that even if raspberry-filled was a flavor you'd never order or even maybe eat from any other source, one bite of the one they had, and you'd say, 'Damn, That's the best donut I've ever had!' Seriously, if you ever go up that way, check the web to see if it's still there, and don't miss it if it is.
The End of The World:
You meant it figuratively, so don't get cute by going totally literal. Yes, there will still be insects. Especially beetles. Lots and lots of beetles. Oh, there will be a few humans wandering around in the dark for awhile, humming selections from the collected works of Devo. Until trhe bugs get them. Where did it start? Farming? Too early... Industrial revolution, a bit too late. The finger started to hit the reset button with the Age of Reason, Newtonian 'Natural Philosophy' and the transition from feudalism to capitalism. It was only 'science' as we know it that allowed humans to transform their environment at a pace that far outstripped the pace of evolutionary adaptation.... But an asteroid might have taken us pout anyway, so there's no need to burn the members of The Royal Society in effigy or anything. As Gerry from Devo would say, they were just following their genetic imperative, like any good Spuds.
At 2:13 in this video from 1980, Gerry eats a donut:
They made a big entry into CT when I was living there, couldn't get enough of the market away from Dunkin and Starbucks, and ran back North with their cups -- spilling to hot coffee -- between their legs. I don't drink coffee, and can't eat donuts after the bariatric surgery, so I never tried them out, and barely noticed their coming and going. Dunkin had a decent breakfast sandwich that almost made up for the totally in competent service at the drive-through.
@ Denice Walter
Have a donut!
You'll feel better, and we should all enjoy the Old Ways while we still can...
@Sadmar : My bad. I assumed that you were taking end of the world literally with your climate change comment from Reagan on down.
Trumps selections for cabinet positions is concerning, but I maintain that their ability to cause drastic changes will be limited by the bureaucrats.
I am hoping that science will win out over mythology and magical thinking, but I do expect it to get worse. Forcing Homeopathic remedy producers to prove the purity of their magic water is a step in the right direction. Maybe reality will win out and the Right-to-try horse-shit will be exposed and become political poison. Unfortunately this would require the populace to understand the issue and express their will to their elected politicians. Will that happen? I doubt it, but expect the worst and anything else is a bonus.
Check the crawl added to the head of this Devo live clip.
For a Before The Scientific Revolution theory of where things went wrong, from Tonio K. (1978)
@Sadmar - You can't get away from me that easily. I will hunt you to the ends of the internet until you explain the meaning of the phrase "putting the pittance more into the kitty." I MUST KNOW!
sadmar@23: It's hard to name somebody in Trump's inner circle who isn't scary, one way or another. Pence, for instance, is a True Believer with a track record. It may not look so scary if you are a white "Christian" hetero cis male. It looks somewhat scary if you are missing one of those attributes (I'm in that category, as I can't pretend to check off the "Christian" box as Pence and his ilk define it). If you are missing more than one, then you should be very afraid. As Governor of Indiana Pence supported one of the most stringent "religious freedom" (read: "right to impose my 'Christian' religion on you") laws, as well as a law requiring funerals for miscarriages. Bannon, Kobach, Sessions, and Flynn are also terrifying in different ways.
The one saving grace is that sooner or later, some of those people are going to be on the outs with Trump. We have already seen this with Chris Christie. The explanation for that one is straightforward. The father of Trump's son-in-law was convicted on Federal charges during the aughts and spent a year in prison. Who was the prosecutor responsible for indicting him? Hint: That prosecutor subsequently became Governor of New Jersey.
The trouble is, long before we start to hear screams from the Topkapi Palace, this crowd will have done a lot of damage.
It's interesting that almost any kind of mutilation can legally be invented by surgeons in the U.S. and marketed with no trials whatsoever, yet you have fits at the thought that the size of mandated trials for stem cell therapies might be reduced. Stem cell therapy for spinal cord injury is plausible based on reports from animal studies and a number of small human trials in which a significant minority of patients in treatment groups did see improvement. Suggesting that a person facing catastrophic disabilities should not be allowed to choose an experimental treatment anywhere in the world is pretty nervy. Though the research groups are generally in non-Anglophone countries, much of the research is published in English and you fail to acknowledge it as small-s science at your peril.
I am all for knowledge, so I'm happy to run toward you and oblige regarding: “putting the pittance more into the kitty.”
The "kitty" is the grant money. The "pittance more" is the (relatively) small amount (compared to the cost of the project as a whole) that has to be added to the kitty to pay MI Dawn for writing up a report of the findings at 8th grade comprehension level. (We coax her with a less taxing work situation than she has now, you see), and the "putting" into her checking account of the "pittance more" over and above the (no-Dawn-to-explain-this-sh*t) budget -- compared to the budget status quo -- is done by whatever arm of the military/corporate complex is sponsoring the research.
I think we'd have work for you too, in addition to Dawn, if you were available. “Giving mice HPV vaccine and pertussis toxin at the same time destroys part of the brain and causes cells that line the blood vessels to commit suicide” absolutely rocks.
Tonio K. (1978)
Life in the Food Chain! I have that album.
I see that Jane's usual citation standards are holding firm.
Narad, isn't it fascinating that jane chooses to call surgical procedures under aseptic conditions "mutilation", but thinks that a few small trials that had at best a "minority" see some improvement gives the non-rigorous stem-cell sellers carte blanche to inject sick people with something they claim are stem cells?
It's almost like a double standard of evidence!
Jake isn't exactly the best at photoshop. Points for him depicting Orac as a nerdy feels guy, though.
If only he spent as much time studying epi as he did making that meme...
"I fear for medical science under Trump."
From what I've read so far, the next four years will bring the most damaging Respectful Insolence Orac has to offer.
Respectful Insolence the Science blog will devour the first T in Trump to make rump.
Respectful Insolence the Science blog will devour the first T in Twit to make wit.
Respectful Insolence the Science blog will satiate itself on the letter T for the next four years.
A bit off topic, wasn't Lilady a Republican?
MJD, I don't see how lilady's political beliefs would be relevant even on a thread specifically about her.
Do you seriously entertain the notion that I eat donuts?
HOWEVER I do enjoy various French**, Italian, Syrian and Japanese cakes whenever I see them for sale.
AND yes, I do frequently starve myself all day so I can eat both dinner and desserts.
** two francais opened up a shop nearby.
Maybe Sadmar is missing some Texas oriental food. On my drive down to Dallas, I passed a restaurant featuring donuts and fried rice!
To my surprise, CIDRAP picked up the story of the Wakefraud–Trump meeting, citing a Science item that I had previously missed.
I just wanted to comment on the quality of the cartoons of our host and the other vaccine supporter-
they illustrate his particularly juvenile bent. I don't think it looks at all like Orac ( I don't know the other person) except for the glasses. It displays association of physical unattractiveness with socially undesirable characteristics ( to the person who puts forth such dreck).
Small children do that. The 'ugly' person is 'bad' The 'pretty
person is 'good' ( see Disney characters). Remember the study wherein kids say the black doll is the 'bad' one reflecting prejudicial societal attitudes that they've already learned? Similar.
Unfortunately, I also looked at Jake's most recent posts. I think that his future as an MPH / PhD is now officially over.
Could someone with better eyesight check whether this photo indicates that the President-Elect might be a consumer of the deadly neurotoxin aspartame?
I'm not familiar with the can labeling these days. Perhaps the NYT editorial board was trying to poison him.
@ Narad #41
The Donald is known for his love of Diet Coke, so no credit to the NYT. 'Original' Diet Coke is sweetened with aspartame. There's also a version sweetened with Slenda, which has a yellow ring around the top of the can, and yellow highlights on the labels of the bottles. The can in your pic is 'original' with aspartame, as is the bottle in this pic: http://tinyurl.com/jjwavuq
According to the Coke website, both varieties of Diet Coke include " ingredients sourced from genetically engineered (GE) crops, commonly known as GMOs..."
@ Denice #37
"Do you seriously entertain the notion that I eat donuts?"
No. 'Have a donut!" is a joke premised on the assumption you're type of person who does not eat donuts. The ideas being:
A. On the eve of the apocalypse discarding whatever concerns for the future that figure into donut-avoidance to just ENJOY would be salubrious to your humours;
B. Especially if you wash down the donut with a quart of (non-diet) Coke Classic, the resulting sugar coma would provide respite from the realities troubling your cool and calm.
It’s almost like a double standard of evidence!
Based on her hit-and-run sniping, I suspect that Jane's ideation is confined to a spectrum with "Scientism" on the bad end and "Truthiness" on the other, yummy one.
^ Blockquote error, I hope, is obvious.
Suspecting jane's ideation spectrum has 'Truthiness' at the yummy end may be giving her too much credit.
Speaking of Truthiness, while the Science Insider item on When Andy Met Donald kills any speculation the photo on Quackenboss's site was faked, it suggests her account lacked certain aspects of genuine veritas. She presents the story as Andy being invited by Trump to a confab specifically for the purpose of discussing vaccines.
Translation, Trump was hitting up a whole bunch of Florida swells for money, and his buddy Gary Kompothecras gave him a nice donation up front in return for giving his clique some of that time with Andy tagging along, and the promise that Trump could score additional donations from him, Mark Blaxill and Jennifer Larson on the back end, the posed photo being a part of the deal. That could explain why only Quackenboss had the photo. The Vaxxed crew would likely have plastered it all over the web if they'd had it, but it was likely the exclusive property of Kompothecras, and he was holding tight to it for some reason, except for maybe rewarding Quackenboss in return for some sort of favor.
It wasn't immediately, but I have never known you to use exclamation points.
been here a couple times ... obviously you are a smart guy ... no idea how you are able to write so much :)
three quick thoughts:
(a) re trump, i honestly was not surprised and never believed polls/etc for even a second. the narrative has been obvious for a long time ... but what stuck out and made it obvious ... though everyone said 'outsider', criticized, etc. -- he was always in the light & focus of discussion. it seems like kabuki theatre to me ... but to extent that he is truly opposition, it seems that is how he gains status/position (by being opposed, hated on, etc).
(b) props for enthusiasm re science, and definitely need shepherds to look after knowledge in present day. but wonder why not just speak to it and act on it vs carry around as a cause. respect/adherence to science/reason does not require constant explicit reference, it will be obvious. kinda like a person who keeps saying s/he is honest ... might even start to doubt.
(c) related to above. taking on trump/public figure/politician is one thing. however, Dr. Wakefield is a fellow scientist. though ideas may be different, and obvious got onto wrong side of a dispute, it seems petty and disrespectful to attack another intellectual in shared arena of interest. undercuts scientific pursuit as a whole, in my view.