Yesterday, 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 that basically said: You can have an increase in the NIH budget. You can have the Cancer Moonshot. You can have President Obama’s Precision Medicine Initiative and his brain mapping initiative. You can have additional funding to combat the opioid crisis. You can have all that, but only if you also accept a grab bag of longstanding pharmaceutical industry wishes, such as new pathways to approve drugs and devices with a lower standard of evidence. You must also accept a provision that makes approval of stem cell quackery based on smoke and mirrors easier. I also forgot yesterday to note that you must also accept a provision that basically protects chronic Lyme disease quackery by instructing the Secretary of Health and Human Services to “review all efforts within the Department of Health and Human Services concerning Lyme disease and other tick-borne diseases to ensure interagency coordination, minimize overlap, and examine research priorities.” Chronic lyme disease quacks recognized that provision immediately for what it is. Worse, that increased funding for biomedical research isn’t even guaranteed beyond the next couple of years; it will be subject to the whims of the budget process every year. The changes to the law with regards to the FDA, however, are forever.
Clearly, we’re in for some rough times at the FDA, whose ability to guarantee that approved drugs are safe and effective will be sorely tested. Unfortunately, the situation could well turn out to be be even worse than just what the passage of the 21st Century Cures Act will make it. While researching what’s new with that piece of legislation, I learned just whom President-Elect Donald Trump is considering for the role of FDA Commissioner:
As far as jobs enshrined at the top of our impenetrable bureaucracy go, the head of the Food and Drug Administration is pretty important. The chief of the FDA is responsible for setting the course of an organization that oversees the safety and efficacy of a huge array of products that Americans use everyday, from makeup and cell phones to food and drugs. In total, each year it oversees more than $1 trillion in consumer goods.
Which is why it is pretty freaking terrifying that President-elect Donald Trump is considering appointing staunch libertarian and Peter Thiel crony Jim O’Neill to head the FDA. In the past O’Neill has proposed FDA reforms that would dilute much of the agency’s regulatory authority. Among other things, he has advocated for the FDA to give up on vetting the efficacy of new drugs before they come to market. O’Neill, in other words, would like the FDA to stop performing one of its primary functions and let all of us act as lab mice. Such a move might allow drug makers to rake in tons of cash on untested medical treatments that might not ever work.
This is a scary position for anyone, much less the person being considered to take over the FDA, but it’s not a surprising or—among libertarians, anyway—even a particularly unusual one. I’ve discussed it before on multiple occasions although not in the context of the 21st Century Cures Act. This particular bill is based on a common libertarian delusion that, if only we’d slash those “onerous” FDA regulations and accelerate the approval process for drugs, thanks to the magic of the free market, the cures would come flowing out of industry and academia. As I discussed yesterday, though, this is a delusion, given that the FDA actually approves drugs at least as quickly as its European counterparts, and often more quickly. Basically, slow drug approval was a problem that was largely addressed and mostly overcome with the various expedited approval pathways developed in response to the AIDS epidemic and the political activism of those affected by HIV in the 1980s and 1990s.
Where we have encountered the libertarian delusion that the FDA should only be requiring evidence of safety before letting a drug company market its drug or a device manufacturer merket its device and let the evidence for efficacy be developed later was in the context of “right-to-try” laws. That’s where we encountered Nick Gillespie use the fear of Ebola as an excuse to peddle right-to-try, the placebo legislation that purports to allow patients access to “life-saving” experimental treatments even though it does no such thing. I don’t want to dwell on right-to-try now, as I’ve discussed it many times before and will probably have the opportunity to discuss it again because I fully expect a federal version of the law to be fast tracked next year the way the 21st Century Cures Act was fast tracked this year. However, an article by Gillespie from 2014 entitled Kill the FDA (Before It Kills Again) does give one an idea where people like Gillespie and O’Neill are coming from, as does an article by Ronald Bailey, What's to Blame for Fewer New Pharmaceuticals? The basic idea is that the FDA is so strict that people are dying in droves because it doesn’t approve new life-saving drugs fast enough. Of course, 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 people to die or even actively kill some of them. As conceded by even Bailey, it was the FDA, prompted by one woman who looked deeper into the safety data than anyone else, that prevented, for example, approval of Thalidomide in the US and the rash of birth defects seen elsewhere in the world. Also, the FDA had enough flexibility to allow an American infected with Ebola access to an experimental therapy that hadn't even been tested in humans yet. That's hardly consistent with the libertarian view of the FDA as hopelessly rigid.
But who is Jim O’Neill? First of all, let’s look at what he isn’t. He isn’t what the FDA commissioner has traditionally been, someone with a medical background, either as a physician or a scientist. He was, however, principal associate deputy secretary at the Department of Health and Human Services under George W. Bush, whatever that means. What he is is managing director at Mithril Capital Management, the firm founded by Paypal and Facebook backer Peter Thiel. (No conflicts of interest there with the pharmaceutical and medical device companies that the FDA regulates, right?)
Not surprisingly, O’Neill is a free market fundamentalist, seemingly believing that all that pesky FDA regulation is unnecessary and that the magic of the free market will deliver life-saving drugs and devices at low prices while weeding out the bad stuff:
In a talk at a 2009 conference, O’Neill touted the advantages of freer markets for a wide variety of health-care goods and services.
“Basically, because there’s not a free market in health care, people are suffering very significant health consequences that in a free market they would not suffer,” he said in a talk at the 2009 Seasteading Conference. Among other advantages, a free market in health care “would drive prices much lower and allow innovation in cheaper delivery of care, both in terms of drugs and devices and better forms of delivery,” he said.
As I like to say: This worked so well before the founding of the FDA in 1906. Anyone remember where the term “snake oil salesmen” came from?
He also appears to be into a fair amount of woo, in particular anti-aging woo. Now, if there’s one area where there’s a whole lot of quackery and dubious medicine, it’s anti-aging research. Remember, a lot of the stem cell clinics that use the hard sell to sell outright quackery to desperate patients claim that their stem cell treatments slow or reverse aging. Now, I’m no more looking forward to my own death than any other human being is, particularly now that I’m into later middle age, but if there’s one thing that’s struck me about “regenerative medicine” and anti-aging medicine, it’s how loaded with quackery it is.
Articles about O’Neill focus on a quote by him:
“We should reform FDA so there is approving drugs after their sponsors have demonstrated safety -- and let people start using them, at their own risk, but not much risk of safety,” O’Neill said in a speech at an August 2014 conference called Rejuvenation Biotechnology. “Let’s prove efficacy after they’ve been legalized.”
That’s right. O’Neill advocated approving drugs based on safety studies alone, and leaving those pesky efficacy studies for after approval. Of course, if a drug is approved based on safety studies alone, pharmaceutical companies would have much less incentive to actually do rigorous efficacy studies. This statement betrays an utter lack of understanding of how the drug approval process works. Matthew Herper explained how, and I see no reason not to quote him:
Most drugs are not safe. Instead, their benefits outweigh their risks. For instance, Iclusig, a drug used to treat a type of blood cancer, causes blockages in veins and arteries that can be deadly. But it is approved because the benefit, for cancer patients who have been failed by other drugs, is big enough that risk is worth taking.
Experts used to use a cartoon where early human studies were used to prove safety and later ones to prove effectiveness to explain how drugs get approved. But it was never really true. The first studies usually are tests to make sure there aren’t terrible side effects–patients drop dead–and that there are hints of efficacy. As they get bigger, a clearer picture emerges.
I note that the FDA approval process is a matter of law, specifically the 1962 Kefauver amendment that said drugs must be proved safe and effective before they can be sold. That law was passed in the wake of the thalidomide scandal. Fortunately, thanks to one stubborn woman, Frances Oldham Kelsey, an FDA scientist who insisted on more safety data and did not budge under pressure (and who, fortunately, was supported by her superiors even under intense pressure from the pharmaceutical company that wanted to market thalidomide in the US). For O’Neill to change the approval process would require a change in the law. There’s also a longstanding tradition of the FDA commissioner not commenting on or meddling in the approval process of any given drug and instead leaving it to the career scientists at the FDA. This is a good tradition that should be maintained, but one wonders if O’Neill would maintain it. Unfortunately, the law also gives the FDA commissioner fairly broad discretion about what evidence the FDA will consider sufficient evidence of efficacy, but fortunately much of that is codified into federal regulations, where there’s a process that has to be followed to change them.
I actually listened to the whole speech, which is still on YouTube:
One quote stood out: “The best science project is a profitable company.” WTF? No, a profitable company and good science are not necessarily the same thing. However, that one phrase does seem to distill the view point of libertarians with respect to drug and device development. I get it to some point, though. O’Neill is a venture capitalist. He funds startup companies, which is high risk and potentially high reward. Now, much of O’Neill’s talk is about business and not all that unreasonable. What drove me crazy was when he started getting into science and regulation. He’s also not entirely wrong when he points out that when someone says “industry wants this,” it’s usually big companies.
Be that as it may, what I also see in O’Neill’s talk is that he doesn’t understand why drug development is so hard compared to devices and platforms. He points out how software development is completely unregulated, while biotech is heavily regulated, which to him is why the pace of drug development has slowed down and biotech is very expensive compared to software. Seriously? The dude is comparing apples and oranges One reason why drug development is so hard these days is because the low hanging fruit has all been picked, leaving only progressively more difficult targets. Yes, we have all this genomic information, but one wonders if O’Neill understands the concept of a “druggable target.” Basically, that’s an enzyme or molecule that a drug can be designed to target. What we find in all this genomic medicine and systems biology is that druggable targets are increasingly harder to come by.
Another bit that tells me that O’Neill doesn’t understand medicine: He expresses astonishment that the FDA wanted to regulate in vitro diagnostic multivariate index assays, like 23andMe:
“In order to regulate in this space, FDA had to argue that an algorithm, a series of numbers that match up to things, is a medical device,” he said. “I found that really astonishing -- astonishing that someone could say it with a straight face, and astonishing that someone could claim the ability to shut down companies that were never touching a patient but only accurately matching algorithms.”
Um, when an algorithm is used to diagnose or treat medical diseases and conditions, hell yes that’s a diagnostic test. Whether you want to call it a medical device or not is besides the point. The algorithm is part and parcel of the medical test.
My jaw also dropped at this statement by O’Neill in the same talk:
As a libertarian, I was inclined to believe that the regulatory costs that the FDA impose kill a lot of people and provide a lot of harm to the economy, and I don’t deny that … but one thing that surprised me is that the actual human beings at the Food and Drug Administration like science; they like curing disease and they actually like approving drugs and devices and biologics.
This should tell you a lot about Jim O’Neill. He had the attitude that those FDA scientists enjoyed shutting down innovation, preventing drug approval, and in general preventing industry from profiting. Of course, nothing could be further from the truth. FDA scientists are dedicated to promoting the health of the people of the US; they view their role as watchdogs to prevent ineffective and unsafe medicines from being approved as integral to that role, but they like approving effective new drugs.
It’s also rather troubling that Peter Thiel would really, really like Jim O’Neill to have the job of FDA commissioner. Here’s one reason why:
More than anything, Peter Thiel, the billionaire technology investor and Donald Trump supporter, wants to find a way to escape death. He's channeled millions of dollars into startups working on anti-aging medicine, spends considerable time and money researching therapies for his personal use, and believes society ought to open its mind to life-extension methods that sound weird or unsavory.
Speaking of weird and unsavory, if there's one thing that really excites Thiel, it's the prospect of having younger people's blood transfused into his own veins.
That practice is known as parabiosis, and, according to Thiel, it's a potential biological Fountain of Youth--the closest thing science has discovered to an anti-aging panacea. Research into parabiosis began in the 1950s with crude experiments that involved cutting rats open and stitching their circulatory systems together. After decades languishing on the fringes, it's recently started getting attention from mainstream researchers, with multiple clinical trials underway in humans in the U.S. and even more advanced studies in China and Korea.
Parabiosis is, as Steve Novella described it, the next snake oil. Actually, I think Steve went a little too soft on it, and maybe I’ll do a post about it in the future. In the meantime, let’s just say that I don’t trust the scientific acumen of either Peter Thiel or his protege Jim O’Neill, and that’s not even considering O’Neill’s love of seasteading, setting up independent libertarian societies at sea.
Of course, O’Neill also doesn’t seem to realize that a lot of biotech entrepreneurs are actually a fan of a tough FDA, as Matt Herper points out:
Many biotech entrepreneurs are actually fans of a tough FDA. At the Forbes Healthcare Summit, pharmaceutical billionaire Leonard Schleifer, the founder and chief executive of Regeneron Pharmaceuticals, said that he was against “making it really easy to get your drug approved” at the Forbes Healthcare Summit last week, before news of that O’Neill was under consideration leaked.
Schleifer said that he couldn’t compete with companies like Pfizer or Eli Lilly, which have 10 to 100 times as many salespeople as Regeneron. But he can compete to get approved first, or to have a better drug that has more uses that the FDA allows it to advertise based on science.
“Having a high bar is a good thing, in my opinion, because it allows innovators to compete,” Schleifer said.
In reality, his claim to being a libertarian in favor of innovation and the little guy competing to come up with the next big thing in a little lab notwithstanding, O’Neill’s concept of the FDA would hugely favor big pharma.
Truly, these days, the lunatics are running the asylum. Sheila Kaplan reports that the appointment of Jim O’Neill as FDA commissioner is not a done deal yet and that Dr. Scott Gottlieb, a former FDA deputy commissioner, is also under consideration for the job. I’m not sure that he’d be all that much better, given his having echoed the same sorts of anti-regulation arguments as O’Neill and his current status as a Resident Fellow at the American Enterprise Institute and has been characterized as having “an orientation which belies the goal of the FDA” and appears to have turned into basically a pharmaceutical company shill—a real pharma shill, who helped sell Eli Lilly’s drug Evista.
First the 21st Century Cures Act passes, weakening the FDA. Next, we’ll very likely end up with either a batshit nutty libertarian who doesn’t believe the FDA should require evidence of efficacy before approving drugs or a real, honest-to-goodness pharma shill as the next commissioner of the FDA. It’s going to be a long four years.
What's next? Appointing Andrew Wakefield as the director of the CDC? No wonder I fear for science and medicine policy under Trump!
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I am surprised that Obama is surrounded by libertarians. I don't think that the blame has to be put on libertarians, but on "technicists". Technicists ignore the way science work, and unfortunately they have infiltrated the knowledge industry much more efficiently than traditional quacks.
Trump's new reality show: America's Next Thalidomide.
It strikes me that the new regime is basically a collection of old white dudes trying to pull up the drawbridge around themselves. There are so many Sci-Fi books on this theme, starting with the granddaddy of them all, Wells' The Time Machine. Trump and his cohorts want to build gated communities where they are not exposed tot he externalities their lifestyle creates. Pollution, poverty and violence are outside the wall so can be ignored.
In that scenario, removing health care from a sizeable proportion of the population while promoting life extension for the very rich, makes perfect sense.
So...basically, the idea is to have rich people live forever by becoming vampires?
He isn't. It's the people in Congress and around Trump who are libertarians. The Republican Party, which has a substantial libertarian wing, has majorities in both houses of Congress. Sausages and laws are two things that most people don't want to know how they are made.
From what I know of Peter Thiel, he sounds like a Bond villain. Among other things, he was the backer of the lawsuit that bankrupted Gawker, and he has been pursuing the concept of creating free-floating island "states" that would be libertarian paradises a la Galt's Gulch. (I personally think the world would be a better place if he were to implement the latter scheme, provided he were part of the first such community.) His minion O'Neill sounds like Otis to Lex Luthor.
On the other hand we will have the amusing prospect of watching Trump's other picks, many of whom are the very worst kind of homophobic fundamentalist whacknuts, having to work with the openly gay Thiel.
If O'neil wants to try and compare software development to drug approval, he needs to look at the software development that goes into aircraft. The certification process for every line of code easily ramps up into the hundreds of thousands of man-hours. It's not like comparing the crap that Microsoft and Apple put out that requires bug fixes for the bug fixes of the bug fixes. This is code that cannot fail or lives are lost. Sort of like what is required for teh production of a new drug treatment. I'd still say that the drug treatment is a slightly more fraught process, just because humans are involved in the "live" testing of the product, where as the certified software can be tested virtually.
In the end libertarians are only good at increasing their wealth at the expense of the common good, but it is the ultimate expression of capitalism.
Key to the kingdom: "Californian Ideology" and "Libertarian Transhumanism":
Also look up articles on related subjects by Corey Pein in _The Baffler_.
Bottom line is: Thiel is up to his eyeballs in quackadoodle nonsense having to do with immortality. Anyone he proposes for FDA head is almost certainly a True Believer in that crap.
OTOH at least they didn't propose Ray Kurzweil or someone from Alcor. BTW Kurzweil subscribes to the acid/alkaline woo as well as having founded The Singularity with its "upload" woo.
Does anyone else here get the feeling that we're about to plunge into a science fiction dystopia?
Um, no. President Barack Obama is not surrounded by libertarians, but President-Elect Donald Trump is. Both Jim O'Neill and Scott Gottlieb last had government positions in the George W. Bush Administration. This post is about Trump's potential pick to head the FDA, not about Obama.
Re. Ellie @ 3: Don't look now, but there was a science fiction dystopia on exactly that theme: _Bug Jack Barron_ by Norman Spinrad. It's kinda' over-the-top melodramatic, but it does make the point.
Watch the beginning of the video of Jim O'Neill. He references The Singularity.
"" Anyone remember where the term “snake oil salesmen” came from?""
Why, yes. Yes I do.
#2 Guy Chapman: Star Trek DS9 covered that very well with the Sanctuary Districts. The rich people even came to believe it was for the best anyway.
People who hate the mission statements of these agencies getting appointed to lead the agencies in order to dismantle them. Whoever takes over from the great orange meat ball is going to have a bit of a mess to clean up. Let's hope they do, for all our sakes.
Is Obama obliged to sign the 21st Century Cures Act?
No. He could veto it. But he won't. He supported it, and it contains funding for his Precision Medicine Initiative and Brain Mapping Initiative, as well as funding for Joe Biden's Cancer Moonshot. No way he vetoes it. In fact, I think he might have already signed it yesterday.
So basically, this is what I mean: the blame should be on technicists, not on libertarians.
"One reason why drug development is so hard these days is because the low hanging fruit has all been picked, leaving only progressively more difficult targets."
You really seem to be enamored with the traditional drug development model, which even people in industry always describe as inefficient and broken. I'm curious to hear what you think the top 5 or top 10 drugs are in the last 20 years, and to frame them in terms of their impact on patient outcomes and change in standard-of-care.
Also, isn't age the leading risk factor for almost every major disease? Finding out how to influence aspects of aging at the molecular/cellular level might not be a terrible way to discover new drugs... At least that's what leading researchers from the Mayo Clinic believe: https://techcrunch.com/2016/10/27/jeff-bezos-mayo-clinic-back-anti-agin… (not to mention many other researchers from Berkeley, Stanford, Harvard, etc.)
Looks to me like the Mayo Clinic did it in order to take the money and run. And why not? Biomedical research funding is a lot harder to come by these days than it was a couple of decades ago. Also, Mayo is susceptible to woo; it has one of the bigger "integrative medicine" programs in quackademic medicine.
Gee thanks, Orac, you just made my day. Yaaargh. I will admit I only listened to the first 1 minute 8 seconds of the video, but that was a sufficient dose for the moment. I'll get back to the rest of it later today, preferably before having a snack so it reduces my caloric intake by killing my appetite.
OK folks, this is a five-alarm fire of an emergency.
Y'all really do need to read those articles by Corey Pein:
Describes the wacko California libertarian ideology, including that democracy is obsolete and benign despotism controlled by the Silicon Valley elite is the future.
"The decades-old quack procedure, which involves freezing corpse parts for later resuscitation... ...has regained an entirely undue aura of respectability as the thought leaders of Silicon Valley have trained their enterprising, disruptive vision on the conquest of disease and death."
If you could freeze your corpse (or just your head) and be revived in an era when all diseases have been cured and nanotech robots can rebuild your body better than new, why not deregulate medicine today in order to speed up the progress?
In other words, we all get to become guinea pigs now, so that by the time these nuts expect their corpsicles to be revived, they will reap the benefits.
Do not underestimate the degree to which they are driven by their fear of death and their ideological fanaticism. They are classic "irrationalists," by which I mean, people who are primarily concerned with "the next world" rather than "this world."
Don't just "be very very scared": get on the phone with your Representative and Senators and urge them to do everything possible to block this guy and anyone having his wacko fringe ideology.
The only way it could be worse is if Trump had nominated Mikey Adams.
Isn't that how a good proportion of them gained their wealth in the first place?
For those who want to become truly depressed, there is a series of graphic novels (adult comic books, if you will) called Lazarus. Here is a brief summary from one of the reviews:
On parabiosis, Novella missed a point:
Regardless, I'm put in mind of the Wraith
Matt Taibbi, then at Rolling Stone, coined the term "Vampire Squid from Hell" to specifically refer to Goldman Sachs, a major Wall Street firm that was at the epicenter of a lot of the financial shenanigans that led to the collapse of the housing bubble in 2008. So that's a fair label for the ones who made their money in the financial world.
It might be reasonable to apply that label to Thiel and O'Neill as well. The word "mithril" in the name of Thiel's company sounded familiar, and a quick Google search turned up the reference:
Wikipedia goes on to explain that after the Balrog destroyed the kingdom of the Dwarves at Khazad-dûm, there was no longer any source of new mithril in Middle-earth. So Thiel named the company after a valuable material the only source of which was destroyed by a race allied with Morgoth. An apt analogy for the sort of capitalism Thiel and his ilk practice.
So DJT is assembling a group of billionaires, generals and libertarians...
To create jobs, stop wars and increase the general welfare of the populace.
Something seems wrong here.
"Black is white, up is down...we're through the looking glass people!"
Considerations like this are why I take - have always taken - such a hard line on requiring stringent scientific validation of both safety and effectiveness in a proposed treatment or device and on standing against the use of naked political considerations to blow up the FDA.
Which is how I can sigh in disgust over the naked hypocrisy of people who today express outrage over their political enemies using political considerations to attack the FDA, in light of their professed eagerness to suppress the FDA - and its science based procedures - when it comes to dubious substances of which they personally are fond.
I would disagree that comparing drug development to software development is like apples and oranges. It's more like comparing an H-bomb to an apple. As in, there really is very little comparison to be made.
As for all of the anti-regulation sentiment, it's almost like they don't know *why* the regulations were created in the first place. The 19th century was a libertarian paradise of almost no regulations. And people died! From tainted medicine, from tainted food, from shoddy construction and from no fire escapes. There are regulations because We The People demanded them!
Gah. I can't tell if this idea that we don't need regulation is ignorance (of history), naivete (of people and corporations), or arrogance (that *they* will not be negatively affected).
Robert L Bell, here is a couple of naked slugs bumping uglies
^^ not that that was relevant to anything but the FDA does overstep when people get SWATed for selling raw, unpasteurized milk: http://www.fda.gov/Food/ResourcesForYou/consumers/ucm079516.htm
There's a good reason why it's illegal to sell raw milk for human consumption. http://www.theage.com.au/victoria/toddler-dies-four-children-seriously-…
Someone has to save the confused from themselves.
Time to invest in snake oil futures.
Lawrence@24: I'll outsource my reply to Eric Blair:
Seriously, I think it's fair to call these people Orwellian when it's evident they are using 1984 as an operations manual.
"I also forgot yesterday to note that you must also accept a provision that basically protects chronic Lyme disease quackery"
Quackery that's supported by many peer-reviewed studies. But I guess that just doesn't neatly fit into the Orac agenda. I know of another much more prominent and skilled cancer doctor by the name of Dr Neil Spector who knows far more about cancer [b]and[/b] Lyme disease than Orac every will, about either disease. So I think I'll believe what Spector says about chronic Lyme disease rather than this vaccine salesman/blogger, who only knows what he read on the CDC webpage.
You mean this Dr. Spector?
Sorry, but he doesn't have the science behind his claims about chronic Lyme disease.
"Capitalist oligarchs, meanwhile, hoard huge sums of wealth—$18 trillion stashed in overseas tax havens—exacted as tribute from those they dominate, indebt and impoverish. Capitalism would, in the end, Marx said, turn on the so-called free market, along with the values and traditions it claims to defend. It would in its final stages pillage the systems and structures that made capitalism possible. It would resort, as it caused widespread suffering, to harsher forms of repression. It would attempt in a frantic last stand to maintain its profits by looting and pillaging state institutions, contradicting its stated nature. "
I thought I would never see the day when the integration of Capitalism with the Government would get to the point where the Capitalist actually instead of proxy governing through the selected party and its chosen representatives directly takes on the duties of governance. Strange times indeed.
So DJT is assembling a group of billionaires, generals and libertarians…
Speaking of which, somebody hasn't updated his "blog" in quite some time.
^ Argh, blockquote fail. I'm improvising with a larger found-somewhere monitor, which just makes everything bigger and harder to parse.
So…basically, the idea is to have rich people live forever by becoming vampires?
And everyone else is lining up for the role of Renfield.
On parabiosis, Novella missed a point:
You can hardly criticise Novella for missing (in August) a study published in November.
Yeah, Amy Wagers' initial claims about the benefits of parabiosis (and in particular about GDF-11) turned out to be unreplicable artefacts a load of fetid dingos' kidneys almost immediately. And it doesn't help that Thiel is especially besotted with Karmazin's "Ambrosia" company, and Karmazin has prior form as an out-and-out unequivocal scammer.
The FDA has already made major changes like breakthrough therapy designations and approval of drugs on striking phase 2 data (at least in oncology.) I understand that people facing terminal illnesses want solutions now, but letting anything through the system doesnt give you more answers, it just gives you more garbage and even steers resources (marketing will be a huge expense when you dont actually have DATA to back up your claims) away from finding those actual solutions.
If people want access to drugs quicker then more money needs to be put in to clinical trials so that drugs that do show signs of being extremely efficacious can have their label expanded as fast as possible (when the data warrants it).
Olaparib in OvCa is a prime example. The label is fairly restrictive considering the benefit it has shown in numerous trials, and my understanding is that it is widely prescribed off label. So the FDA says...."ok this is fine in this one particular setting," and insurance says...."nahhh we are good with it in alot more than that."
That is a curious interplay that exists between insurance and the FDA. Sure lets say you gut the FDA and they start approving all sorts of cancer meds because they have low grade 3/4 AE rates, but little evidence of efficacy. Does anything think insurance will cover that? 100k a year for a drug that hasnt demonstrated efficacy.....insurance companies will all say no, in which case the FDA saying yes isnt that relevant. Even if they were much cheaper, insurance isnt in the business of paying for treatments that dont do anything.
Medicine is a scientific endeavor, not a marketing endeavor.
Oh? So the esteemed Dr Spector, 100x the cancer doctor you'll ever be, is just another ignorant victim of quackery, purveyor of woo? Has he also read too much interwebs? Perhaps you should contact him, doctor to doctor, and let him know he didn't need that heart transplant, it couldn't have been Lyme disease that caused his illness, he didn't need the weeks of IV antibiotics, because you know so much more about these things, having quickly scanned the CDC webpage once. Perhaps you can recommend LYMErix to him as well?
Please let us all know how you know so much more about Dr Spector's disease than does Dr Spector. I love watching you make a fool of yourself. Standby for standard CDC webpage quote in 3...2....1
Be very careful what you ask for. I might just start reading what Dr. Spector has written to see if it holds up...
Far smarter and more accomplished people than Dr. Spector have been taken in by pseudoscience; e.g., Linus Pauling.
insurance isnt in the business of paying for treatments that dont do anything.
I suspect that health insurance companies will happily include worthless though expensive treatments as part of their coverage as long as it gives them an excuse to charge higher premiums.
The best story about what we're in for is "The Iron Heel", by Jack London.
The best song about the near future of the First Amendment is "Should I See", by Frozen Ghost.
The best succinct takedown of libertarianism comes from Prof. Steven Dutch: https://tinyurl.com/Why-I-Am-Not-a-Libertarian
Incidentally, Dutch (who I think is always worth reading even when I disagree with him) has a lot to say about pseudoscience, conservatives, liberals, bad movie science, and lots more; digging into his pages is worth the time spent.
So…basically, the idea is to have rich people live forever by becoming vampires?
Vampires were a 'proof of concept” experiment. Once they figure out the Sunlight side effects it's full speed ahead. I'm putting my money into sunscreen research in the near term
# 26 Justatech
it’s almost like they don’t know *why* the regulations were created in the first place
A. They don't. Most are completely ignorant of history with the exception of some hagiography about Carnegie or Ford or Mellon.
B. The very few who do know a little history know they are much smarter than those rub.
C. They worship Friedman and the Fresh Water crowd while also sacrificing at the alter of the Austrians.
Gah. I can’t tell if this idea that we don’t need regulation is ignorance (of history), naivete (of people and corporations), or arrogance (that *they* will not be negatively affected).
All of the above plus pure greed.
@Guy Chapman #28
Some people care about their dairy products and are clean and careful with it's collection, handling, and distribution -- Industrial milk is full of puss, exacerbated by growth hormone use, so it does need Pasteurization.
Certainly, a private buyer's club should be allowed foods of their choice. The record of raw milk is far more clean than vegetables, meats, and condoments which are only recalled after a problem occurs and then mostly with the beleaguered 'good faith' and descretions of the producers.
And, as demonstrated by the Cargill recalls, that safety is mererly illusory.
During the Rawsome raid:
I'm afraid I file "food freedom" with "health freedom": it's a brand used by people who want to make unjustified claims for their product.
In other news...
( and speaking of vampires)
Trump will nominate an oil honcho who hangs with Vladimir for Secretary of State
I suppose that he * looks the part" ( why he liked Romney)
Oh. I see that ORAC has addressed raw milk. Never mind.
The world is a complicated place. As with any recently discovered public health issue, there might be some issues still to work out.
That said, an entire industry of cranks and quacks and crackpot frauds has grown up around the growth opportunity of separating desperate and fearful people from their money.
Both of these statements are true, at one and the same time.
Which is why we have this little saying, that a rash of mechanical issues in one make of airliner does not constitute proof that your magic carpet flies.
# 45 Gilbert
Industrial milk is full of puss
I will give you the benefit of the doubt and just assume you are totally ignorant of things like cows. Do you know what a cow looks like?
I don't see any real problem with unpasteurized milk consumed at home on the farm where I'm from—Canada. I survived 18 years of it. But this was with well-tested herds in an advanced society. Gee, all those tests were government mandated. Almost like the FDA mandating standards.
Once in an industrial milk distribution system I'd be very, very wary and if I was in most African countries I'd switch to total paranoia.
Since I've spent 30 years working with hay, water, range cubes, fencing, innoculating, and bottle-feeding 'cows' for a man with a picture of a cow in the back of a Dodge to prove they're only pets, I know that cows look like this:
Bullshit. That is what a cow looks like:
I see the FDA in terms of its failures.
Extraordinary prices (e.g. 10,000x) on simple, 40-70+ year old drugs.
Too slow to remove some clearly injurious drugs (poor post marketing followup), too slow by 2-3 decades to allow foreign drugs with good track records that are long generic and were/are even best in class.
The never ending attacks on legitimate supplements.
Do you know what a cow looks like?
They are spherical and usually found in vacuum conditions.
Since the FDA lacks oversight on supplements because of Congress, you're tilting at a windmill there, PRN.
LoL, peter; It looks like cartons of 'lactoplasm' (synthetic milk) from the movie Hardware (1990).
And spherical cows are a special breed most easily modeled as a point mass at its center of mass in ... um ... vacuum.
You do realize, don't you, that the FDA is not in charge of price controls? You seem to want less FDA regulation -- yet at the same time, you blame it for not regulating price?
Which are *never* ever overpriced, huh? (*cough*Airborne*cough*)
LoL, peter; It looks like cartons of ‘lactoplasm’ (synthetic milk) from the movie Hardware (1990).
Now I'm hungry for some of those radiation-free reindeer steaks.
Mmm, Reno's; And then Major Good Vibes cigaretts afterwards.
Gilbert, I have to say I both am and am not surprised that you're into raw milk.
If I were to have a serious conversation it would start with a discussion of the issues of educating the purchaser of raw milk that it must be handled very differently from pasteurized milk, which is all most people have ever used.
Or I could quote my outbreak investigation professor, who described milk as "fecal matter in a growth medium".
Or we could talk about the very serious risks from tuberculosis and listeria.
But you're not into public health, so I'm not sure you'd be interested.
Actually, JustaTech, I drink the Publix rBGH free milk. It doesn't taste like rot as so much milk from Kroger does (I used to select by not only date but location code -- it was that bad). The bad taste of 'standard' milk is most attributed to the amount of puss from mastitis which the growth hormone exacerbates -- This also includes an extra load of antibiotics to deal with the problem. Pasteurization has been the crutch for extra nasty milk collection for the corporate carelessness and financial considerations inherant to the factory-farm.
So, though I don't go seeking raw milk, I think people who choose to use it should have an avenue to do so. Cheezes made from raw milk are purported to taste better. Naturally, it takes extra precaution to prevent contamination such as cleaning the teats with iodine first.
Of course, the collection and handling matter; but are they gonna have mommy pasteurize her breast milk before piping it back to baby? It may cut down on instances of 'thrush' which can be aquired from a dirty titty, but the kids might hate them for it later in life.
The FDA has a long, long history attacking supplements, at least since the 1960s. DSHEA did reduce these attacks, but has not totally eliminated them. Even now, since 1994, some supplements have disappeared, like pyridoxamine, a once common form of vitamin B6.
The FDA eliminates competition and competitive accesses. This creates the situation that allows price gouging to thrive and expannon-competitved.
Oh. 'tuberculosis and listeria? You forgot campylobacter which has been associated with Guillain-Barré Syndrome.
...This creates the non competitve situation that allows such price gouging to thrive and expand.
It appears that the FDA was merely following the law:
And given the numerous avenues for procuring just about any supplement you might want, including the corner grocery store, I continue to find your harping on this line to be disingenuous at best.
It appears that the FDA was merely following the law:
...or making up arbitrary rules up as they go along. I personally know, from reading labels myself, pyridoxamine was on the shelf since the 1960s, albeit in mixed form -al, -ine, -amine. So I don't find the FDA "interpretation" satisfying.
And given the numerous avenues for procuring just about any supplement you might want, including the corner grocery store, I continue to find your harping on this line to be disingenuous at best.
This B6-FDA scam personally costs me time and money while limiting options as a cog in dealing with life threatening situations that no doctor engaged said that they knew a better result...
Justatech: There are regulations because We The People demanded them!
And now we don't want those regulations anymore, just like we don't want progress anymore or vaccines. We the people are irredeemably stupid.
And if you have a problem with supplement pricing, perhaps you should take it up with the manufacturers, since they don't have nearly the overhead of pharmaceutical companies....
""It appears that the FDA was merely following the law
Well. Isn't that special. Just another example of the FDA taking something that works away from the people and handing it to pharma. In this case, the 'drug' has not made it to the market; Almost, as if, it works a little too well. Almost, as if, it were being sat on like so many patents bought up and shelved to protect Big Petroleum.
Gilbert @61: "are they gonna have mommy pasteurize her breast milk before piping it back to baby?" Actually the issues around sanitary handling of breast milk for non-immediate use is a big topic for a lot of people, as is the related topic of safe handling of breast milk for use by others.
Basically, if you aren't using it this second, you heat-treat (much lower temps than dairy) and freeze.
Now that is a fascinating topic, and was great fun to discuss in school.
Love to see that match up. A world renowned cancer doctor with patents in breast cancer medications who actually lived through chronic Lyme disease and survived a heart transplant versus a mealy-mouthed hack surgeon with delusions of grandeur from a cut-rate hospital who blogs more than he treats patients, and whose total understanding of Lyme disease comes from a CDC pamphlet written in 1980. Looking forward to it.
Please post when you decide to make a fool of yourself by quoting frauds like Allan Steere, Barbara Johnson, and the other gov't parasites vs Spector's medical brain, research and first hand experience with chronic Lyme disease.
I was always a big fan of "Doctors without Borders", but this gnarly group of "Doctors without Brains" here is just a little too dismal for me.
Lester @31: You refer to cancer as a single disease. Is this a bit of linguistic flair, or do you think that "cancer" is a single disease?
I am asking because your answer is relevant to other questions I would like to ask you.
"Worked" for whom and why?
Because supplements aren't required to actually go through any sort of real testing for efficacy, PRN's claims are spurious at best.
At least the pharmaceutical company is attempting to help people afflicted with serious problems - and the R&D costs would be prohibitive otherwise.
We happen to live in a capitalist system & while it has its faults, the profit motive has actually provided us with substantial benefits....
These "chronic Lyme" fanatics are just as bad as anti-vaxers.
I can say, legitimately, that I suffered through three separate bouts of Lyme disease - each one could be traced back to a separate tick bite, in separate geographic locations, in the correct temporal timeframe.
Each time, a hefty dose of antibiotics was more than sufficient to get me back to full health.
I, legitimately, call BS on you. Your story doesn't add up. You can't see the tick when it bites because its tiny and half embedded in your skin, usually in an inconvenient location not easily seen. Most often they feed, fall off and you never even know they were there. There is no way to "trace back to a separate tick bite". Lol... Even if your obvious fairy tale was true, I guess an N of 1 is proof enough for you huh?
More fake news from RI.
Your question is moronic, but you probably know that. Cancer is a large group of diverse afflictions, but is a term used to refer to them in general. Why be such a pedant? Have you no skill, insight or knowledge with which to show intelligence other than sheer pedantry?
Is Lyme disease a "single" disease? Don't worry, I already know what you 2nd year med students are going to say.
Well, of course I could. Perhaps where you live, you just leave ticks embedded in your skin...I, on the other hand, do not.
Getting the ring rash on each occasion was just a bonus, though the last time we thought it was Mono, until I got tested for Lyme.
Lester:You can’t see the tick when it bites because its tiny and half embedded in your skin, usually in an inconvenient location not easily seen. Most often they feed, fall off and you never even know they were there.
You might want to stop calling Lawrence names, since you spew plenty of BS yourself. Anyone who's lived or goes for walks in areas ticks might be knows to check themselves and their pets thoroughly for ticks, and that ticks will happily feed for hours, which increases the chance of finding and removing them. And while they do embed in inconvenient areas, that problem is easily solved by having someone else look you over for ticks. I can only assume you've never actually encountered a tick yourself.
Vitamin D; it's not just for rickets anymore:
Lester @76: I was trying to clarify that you understand that there are many, many different diseases that are grouped under the umbrella of "cancer" with many different causes and treatments. I didn't want to explain that if you already knew it, because that might be considered rude. Instead I was hoping we could have a discussion of which specific cancers you wanted to talk about.
But that doesn't seem to be what you want to talk about, so I won't bother.
Lyme disease is well described and meets Koch's postulates.
I am not nor have I ever been a medical student. I am a scientist. Right now I make cancer treatments. Not that any of that matters to you.
Lawrence's fairy tale is obvious. You are extremely credulous for believing it. His story follows the bogus CDC info to the letter, which tells me his is making this all up to support the BS in the above article. The "ring rash" as Lawrence called it, is actually a rarity, as the rash most often doesn't have central clearing looking like a target. To have that occur 3 times, is extremely far-fetched. So I simply think its BS, or fake news.
I see the same thing here about vaccines all the time. "My cousin got mumps and now he's deaf! See???", etc, etc. Its so transparent, its actually funny. I guess "The plural of anecdote is not data" unless its a RI commenter's story. Then it's absolutely hard data, right? The hypocrisy in this blog and its commenters is suffocating.
JustaTech, it seems Lester has devolved into something we usually find under a bridge. Ignore.
Aww, Chris, but I was going to tell the troll all about the lovely little lizards that prevent Lyme disease!
Oh well, you're right. And there's good evidence that it *is* a troll because trolls have such thick skin that no tick would ever bite them, so they have no *actual* understanding of a tick bite.
You know, UV light is a pretty good disinfectant, and had the added benefit of turning trolls to stone. Let me gown up and grab some glasses and we can turn on the UV lamp, eh?
Go ahead, I'll get some popcorn.
Oh yeah, I forgot. None of you have enough brains to even put together a cogent argument, so therefore I'm a troll. Lol... "I can't be wrong, my fragile ego won't allow it, so you must be a troll". What a pathetic joke. You give real skeptics a bad name.
Where did you get the idea that erythema migrans is a rarity? Is this from your own experience as an ID clinician?
Ben: " Is this from your own experience as an ID clinician?"
ID = Insult Dude? It seems his main form of communication are a series of insults. Nothing to see here. I am not even going to ask him why he considers insults to be a valid form of scientific evidence.
My bad, ID = infectious diseases.
Ben, I know it was. My response was sarcasm and an accurate description of his form of commenting. Perhaps you were trying to be serious and get an actual factual answer with supporting answer.
Let me tell you, it is not going to happen. Just get some popcorn and see what kind of fanatic caterwauling of insults he will hurl next from under his bridge.
So, is he calling into question that Lyme exists or calling into question that it's possible to get infected multiple times?
I did misspeak, the last time I was infected with Lyme, we got the tick, but there was no associated rash....so when my lymph nodes enlarged several weeks later, the doctor thought it was Mono.
It was only because my wife reminded me of the tick bite that he had me tested for Lyme, which came back positive.
I happen to do quite a bit of outdoor activities in the deep woods...ticks are just a fact of life.
Tick Score: Troll 1, PGP 0
I lived in Lyme CT for 12 years. When you get there, they staple a Lyme disease fact sheet to your forehead. The malady is spread by deer ticks, which are indeed as the troll described; about the size of poppy seed, painless bite, fall off once they're full. The way you know you've been bitten is – duh – you get the distinctive symptoms of real bacterial Lyme disease: ring rash, fever, chills, headache, fatigue, muscle and joint aches, and swollen lymph nodes.
EVERYBODY in Lyme knows to look for the rash if they start feeling a little ill, because it's distinctive and early, so when you spot it a few days after a sojourn in the woods, you head right of the doctor for the anti-biotics before your knees stiffen up, your nodes swell and you start to get palsy drooping one side of your face. The rash doesn't always develop into the bulls-eye pattern, but it's still called "ring rash" because it's usually, you know, circular. And it is true some Lyme infectees don't show a rash at all, but the infected will still notice soon enough, as the bacteria involved are particularly vicious little critters. In addition to your facial palsy, you got your heart palpitations, inflammation of the brain. shooting pains in the hands or feet, short-term memory loss...
The 'troll logic' here appears to be:
a. Not all Lyme patients get the rash.
b. Therefore the rash isn't caused by the Lyme.
c. Therefore, if you had the rash, you didn't have Lyme.
d. Therefore, when Lawrence says he can trace his rashes back to tick bites, he must be part of a great CDC coverup.
Apparently the CDC is rounding up hordes of those weensy teensy ticks, cleaning all the Lyme bacteria out of them, injecting them with some secret rash producing formula, and releasing them in the Connecticut woods as a False Flag operation to confuse everyone and hide the truth.
[Fun fact: the other thing they staple to your forehead if you live in or near Lyme is a little envelope of Iodide pills for when the nuclear power plant melts down.]
Fun Fact of the Day - my first bout of Lyme was contracted just down the road from Lyme, CT (in Mystic, actually).
When I got sick at home (in Tennessee), the pediatrician was a little proud of the fact that he was the first doctor in the state to have diagnosed a case of Lyme (even if it wasn't contracted in the State).
There are a number of individuals I know who suffered from chronic health conditions, caused by untreated Lyme - because thirty years ago or longer, no one knew the disease existed.
The only "chronic Lyme" condition that exists is when you don't treat it & it progresses from stage 1 to stage 2 to stage 3 (regular sick, to joints, to the organs). This isn't rocket science, but it is immunology.
I had a deer tick (Ixodes scapularis) on me in 1992. I got the bullseye rash but I never went for treatment -- Is that wrong?
Not to tread on any "fragile egos" here, but 1) erythema migrans is very common in Lyme disease (estimated to occur in over 80% of cases according to the following site), and 2) central clearing of the rash is said to happen less than 40% of the time, which is certainly not "rare".
(I would have cited a CDC page except CDC bad because whistleblower scandal, just like vaccines bad because Vioxx).
Yes, that was wrong. You got lucky in the infection not developing the typical complication. If you see the rash, you go get the anti-biotics. Period.
(OT, just makin' conversation)
What were you doing in Mystic? Were you there for any length of time? When?
I lived in Mystic for a number of years, early 90's. My Mom still lives there, so I get back from time to time - especially during the Summer so the kids can enjoy the beach.
Sadmar: My aunt owned dogs and some very ticky woods. We mostly had wood ticks but believe me, my parents had tick checks down to an art.
Among other things, he has advocated for the FDA to give up on vetting the efficacy of new drugs before they come to market.
How do you even do that? Drug safety is a matter of evaluating risk versus benefit. How can you approve a drug as safe if you don't know how effective it is? For example, no one would approve the PD-1 drugs if all they looked at was safety because the drugs sometimes cause the immune system to reach out and eat a random organ--but that risk is worth it in some cases because they actually move the needle on metastatic melanoma. If that benefit weren't proven, they would surely not be approved based on safety. So the immediate effect of removing efficacy evaluation from the FDA's mandate would be fewer approved drugs. At least in hematology/oncology.
Lawrence: "I did misspeak, the last time I was infected with Lyme, we got the tick, but there was no associated rash….so when my lymph nodes enlarged several weeks later, the doctor thought it was Mono."
As I suspected. Clearly my finely tuned BS sensor is working just fine. And lymph nodes aren't typically swollen with the vast majority of Lyme disease patients, or if so, only very briefly and its usually gone by the time you get to the doctor's office, just like the rash.
The bacteria actually target the lymph nodes and once there, cleverly deactivate the immune system. So you have an initial immune system response but that quickly goes away once the immune system is deactivated, long before the swelling of lymph nodes and other typical signs of inflammation. Even the rash, if you are lucky enough to get it doesn't hurt or itch, and goes away very quickly on its own leaving the patient thinking they are fine.
You might see inflammation of the knee if you are of the 15% of the population that has an allergy to OSP A, but typically, Lyme doesn't cause inflammation like other infectious diseases do. So when I read comments like the above, I can tell they are constructed from the typical narrative of an infectious disease, not from actual experience or knowledge of this particular disease, and in this case, its likely a "support comment" to help align with the blog article.
Lawrence: "The only “chronic Lyme” condition that exists is when you don’t treat it & it progresses from stage 1 to stage 2 to stage 3 (regular sick, to joints, to the organs). This isn’t rocket science, but it is immunology."
Looks like I was right again, no scare quotes needed. Apparently its much more difficult than rocket science judging by the 300,000 of new cases every year. Pretty much anyone that was bitten by an infected tick prior to 1994 didn't realize what had happened to them, and never got treated because it was never diagnosed, and like you mention, years of untreated Lyme disease will leave you in a very bad place. Even after 1994, thanks to articles like this one, doctors poo-poo Lyme disease patients, leading to far more expensive treatments. Ask Dr Neil Spector for details about this. If a primo cancer doc working at Duke can't get properly diagnosed, how do you think it works for the vast majority? They go undiagnosed and untreated, thanks to BS blog posts like the above. Its articles like these that send your average doctor down the wrong path. Misdiagnosed Lyme patients are very, very expensive to deal with. Again, ask Dr Neil Spector for details who required hundreds of thousands of dollars including a heart transplant to treat. All because an idiot doctor couldn't diagnose him properly and cure him with $50 worth of doxycycline. And people wonder what keeps driving up health costs....
My apologies if these inconvenient truths don't align with your 2nd year medical textbook. It is just a textbook after all, so half of it is wrong by definition.
It doesn't seem to work at all in the outbound direction, e.g.,
Please look up HLA-DR4 specificity and Osp reactivity. I very much doubt its in your 2nd year medical textbook. Sorry that tick borne illness isn't so easy to understand. You'll just have to deal with it. Or go into denial, which is always easy.