The 21st Century Cures Act: Still alive, and still poised to endanger patients

it was less than a year ago that I described a bill wending its way through Congress called the 21st Century Cures Act “old vinegary wine in a new bottle.” The reason I characterized the bill that way was because it really was nothing new and it rested on a very old fallacy, namely that the only way to speed up medical “innovation” is to weaken the FDA and its standards for drug and medical device approval, which is exactly what the 21st Century Cures Act would do if passed into law. It’s basically the American cousin to the British Saatchi Bill, which in essence proposed to do very similar things, but even more so, so much so that Andy Lewis referred to it as the “quack’s charter.” Fortunately for the British, the version of the bill that ultimately passed bears little resemblance to the original Saatchi bill and lacked the most onerous removals of patient protections. I’m not so optimistic that the American Saatchi bill will so watered down.

It turns out that the 21st Century Cures Act is back in the news again. Having been passed by the House of Representatives last year, the 21st Century Cures Act is now up for consideration in the Senate, as Ed Silverman tells us:

Legislation passed last year by the House would provide billions more dollars for medical research and encourage faster approval of prescription drugs and devices. The Senate, meanwhile, is currently working on a set of companion bills in hopes of crafting a compromise measure.

“If we succeed, this will be the most important bill signed into law this year,” Senate health committee chairman Lamar Alexander, a Tennessee Republican, said at a committee meeting last month.

This sounds promising. After all, adding $9 billion to the National Institutes of Health’s budget over the next five years to underwrite new cures is a good idea. And in an era when desperately ill patients are clamoring for new medicines, giving the Food and Drug Administration extra tools also makes sense.

But there’s a catch. By linking the extra funds to speedier approvals, Congress appears ready to undermine regulatory standards. And this is a misguided notion that, unfortunately, is more likely to help companies than patients.

When I wrote about this misbegotten bill, I pointed out just this aspect of it. What I perhaps didn’t emphasize enough, is that the bill is in essence a “grand bargain,” as Silverman puts it. The bargain is this: Congress will step up funding for the NIH in return for a loosening of regulatory standards at the FDA. Not surprisingly, Silverman thinks that this is a bargain the American people should turn down. Even less surprisingly, I agree even more strongly.

As I pointed out last year, the NIH budget could really use an increase. After the doubling of the budget that occurred between 1998 and 2003 under Presidents Clinton and Bush, the NIH budget has remained more or less flat when adjusted for inflation. In fact, it’s worse than that. As NIH director Francis Collins noted, the NIH budget was cut by $1.5 billion in 2013 during the budget sequester, a blow “"from which we have really not quite recovered,” pointing out that approval rates of NIH grant applications are at their lowest rate in history. That’s because, since 2003, there has been a 20% decline in NIH budget adjusted for inflation. In essence, what the 21st Century Cures Act does is to hold the FDA hostage. In return for changes in the FDA that align with industry desires and those of an ideological bent to believe that the primary, overwhelming reason why the pace of pharmaceutical and device discovery has declined and costs have gone up so much is because of an overweening state, says Lamar Alexander, the Senate sponsor of the 21st Century Cures Act, we’ll fund the FDA to a greater level.

Unfortunately, as I discussed last year, the NIH and by extension the American public don’t get very much for giving up a lot, as this is a bad deal. That’s not to say that there aren’t some good things. For example, the 21st Century Cures Act doesn’t add that much to the NIH budget, a 3% increase per year for three years plus $1.86 billion a year “innovation fund” to support precision medicine initiatives and young scientists. Given that the current budget of the NIH is approximately $32 billion, 3% per year is less than $1 billion a year, which means that nearly two thirds of the increase is spoken for, much of it for “precision medicine.” Having been around, I’m also cynical enough to doubt that the part of the funds allocated to “young investigators” will actually benefit young investigators as much as Mr. Alexander thinks it will. If Mr. Alexander is willing to pump $2.86 billion a year for three years into the NIH, it would do a lot more good if there were no strings attached to the budget increase.

Perhaps the worst part of this mostly execrable bill (I find it hard to call a bill that increases the NIH budget significantly totally execrable) is this:

For instance, the House bill, which is known as the 21st Century Cures Act, would allow the FDA to approve added uses for a drug without relying on a randomized clinical trial — the gold standard for determining whether a medicine can benefit patients and the extent to which there are serious side effects. Instead, the bill would permit the agency to base such decisions on “clinical experience,” a loosely defined term that means, essentially, anecdotal observations from physicians and patients.

To be fair, the FDA would not have to consider such information. And the Senate has, so far, not adopted this notion. But this is hardly the sort of rigorous scientific data that should be used to establish whether a drug is safe and effective.

I remember what I said about this at the time about this provision. To paraphrase, I said that homeopaths would love this provision, and so would drug companies. I asked: Why bother with the time, bother, and expense of those pesky clinical trials to get your drug approved for additional indications, when you can rely on clinical experiences based on therapeutic use, uncontrolled observational studies, or registries instead?

Why indeed?

As I said before, if I were the CEO of a pharmaceutical or medical device company, I’d love this bill. Indeed, the one thing this provision most definitely does not do is to speed effective treatments to patients. Rather, it smacks of being a payoff to pharmaceutical companies.

I was happy to find someone who is even harsher in his assessment of this bill than I am, namely Harvard University political scientist Daniel Carpenter, who is quoted as saying:

“This is a harsh way of putting it, but this is why I call it the 19th Century Fraud Act,” said Harvard University political scientist Daniel Carpenter, who studies the FDA. “This is a part of the bill that threatens to take us back more than a century.”

Exactly, but it’s even worse than that. The House version of the bill explicitly weakens patient protections in clinical trials. It would accomplish this by creating another category of clinical investigation where it is acceptable to forego informed consent. It accomplishes this by saying informed consent is not necessary when “the proposed clinical testing poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of the human subject.” Informed consent is a central tenet of all clinical trials in all countries that do them. This might—might—be defensible if the act defined what constitutes “minimal risk” or states who would determine whether a study is “minimal risk.” A charitable interpretation is that an institutional review board (IRB) would determine this. Even so, it’s a disturbing provision, and the number of studies that would be facilitated by such a change in the requirements for informed consent is likely to be vanishingly small.

The bill goes beyond even this unfortunately. Basically, the 21st Century Cures Act is Christmas in May, with Santa Lamar bestowing all sorts of gifts on the usual suspects. For instance, there’s a provision that sidesteps the Sunshine Act, adding an exemption for reporting medical education payments, which has the effect of increasing the number of things drug companies can pay doctors for without having to report them to the physician payment Sunshine database. One wonders how such a provision contributes to “medical innovation.” Actually, one doesn’t, because this provision contributes nothing. It’s a sop to medical groups who don’t like transparency.

Let’s take the arguments of proponents of the 21st Century Cures Act at face value for a moment. 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 batshit 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.

Michael Hiltzik points out that the 21st Century Cures Act is not just bad for patients but bad for industry:

The risk from easing the FDA's regulatory standards will be borne not only by patients but also by the drug industry and medical profession. The "Cures" act would mean "not just going back to an era that was less safe, but an era that was less credible," Carpenter says.

There is no doubt that the NIH is criminally underfunded right now. That is a separate question from what the appropriate level of regulation is for the approval of drugs and devices. Linking the two is nothing more than a cynical ploy to make weakening of the FDA, or at the very least encouraging FDA administration to weaken drug approval standards, palatable. Silverman describes this cynical conflation well:

The Republicans in Congress know what they are doing. By bundling NIH funding with faster FDA approvals, the lawmakers are making it easier to win support from universities and small biotech companies, which rely on government research grants. (In a pointed blog post last fall, University of Pennsylvania President Amy Gutmann wrote that Congress can “change the course of history” by approving the measures.)

They are also appealing to many patients and their families — an increasingly large and vocal group of Americans — who want the FDA to approve more medicines for unmet medical needs.

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.

Categories

More like this

Well, it’s done. Today, the Senate passed the 21st Century Cures Act, a bill designed to weaken the FDA and empower pharmaceutical companies, sending it to President Obama’s desk. There’s no way Obama won’t sign it, as it contains provisions funding his Precision Medicine Initiative, and he…
The approval of new drugs and medical devices is a process fraught with scientific, political, and ethical landmines. Inherent in any such process is an unavoidable conflict between rigorous science and safety on the one side, which tend to slow the process down by requiring large randomized…
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…
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…

Ha. I'm still waiting for FDA to get its stuff together for 20th Century drugs like UFT.

The FDA rules exist for a reason. Like many other safety regulations, that reason is because many people died without those rules. Far too many libertarians choose not to realize this.

Leaving a term like "minimal risk" undefined is an open invitation to lawyers who will push the envelope on the definition. Maybe in some places the IRB will put a check on some of this rules lawyering. But it gives people like Stan Burzynski a green light to operate their "clinical trials" because they can assert that the risk is minimal.

As for the loosening of gift reporting requirements: That actually gives a factual foundation to people who play the "pharma shill" gambit. They'll still be exaggerating their claims, but they can rightly point to this provision to support those claims.

By Eric Lund (not verified) on 20 May 2016 #permalink

It would accomplish this by creating another category of clinical investigation where it is acceptable to forego informed consent.

Doesn't this directly contradict the Helsinki Protocol?

By Rich Woods (not verified) on 20 May 2016 #permalink

I suspect one reason that the Republicans are willing to support this is that they believe in the “free market” and clearly government regulation of any kind is anathema. Clearly we will get faster drug development and better innovation if we remove hampering government regulation.

There is no arguing with religious fanatics.

By jrkrideau (not verified) on 20 May 2016 #permalink

# 3 Rich Woods

/

Quite likely but most Republican Members of Congress and Senators probably could not find Helsinki on a map let alone have heard of the Helsinki Protocol.

And the USA is not noted for its adherence to international conventions.

By jrkrideau (not verified) on 20 May 2016 #permalink

It accomplishes this by saying informed consent is not necessary when “the proposed clinical testing poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of the human subject."

Wow, is that terrifying. IANAL but seems like this would violate international law.

This is the problem with small government libertarians. So anti big government; so pro big corporation.

You want to talk about corruption? In my eyes it's not the overreaching big government that is a problem as much as the deregulating business first, citizens second types that worry me. And I say that as a somewhat paranoid privacy advocate, not really a 100% Democrat fanboi.

By capnkrunch (not verified) on 20 May 2016 #permalink

jrkrideau@4

I suspect one reason that the Republicans are willing to support this is that they believe in the “free market” and clearly government regulation of any kind is anathema.

The cynic in me wonders if any of them actually believe that or if they're simply in the pocket of industry. To believe in unrestricted free market capitalism is to ignore history as it has always caused terrible problems. Either they're idiots or paid for; either way they should absolutely not hold positions of power.

By capnkrunch (not verified) on 20 May 2016 #permalink

“the proposed clinical testing poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of the human subject.”

Under such an umbrella, drawing blood of the children attending a birthday party would qualify as normal.
There is minimal risk and there are adults around to provide safeguards.

By Helianthus (not verified) on 20 May 2016 #permalink

I'm aghast. How can you not support this bill, given the compelling evidence of the beneficence of Big Pharma? Look at all the work they did to ensure people could still be prescribed SSRIs even though they didn't work.

And I am absolutely sure that charlatans would not dream of driving a truck through the loopholes the bill would provide. Perish the thought.

By Guy Chapman (not verified) on 20 May 2016 #permalink

So...drugs (cough - Thalidomide - cough) would go on the market much sooner?

Anytime a political office holder complains and argues for less government they should be invited to resign. They are, after all, part of the government. And usually not the most useful part.

The cynic in me wonders if any of them actually believe that or if they’re simply in the pocket of industry. To believe in unrestricted free market capitalism is to ignore history as it has always caused terrible problems.

Libertarianism is like communism in this regard: both ideologies are superficially appealing, but cannot be successfully implemented because they require counterfactual assumptions about human nature.

The evidence I have seen is that these people really do believe this stuff. They think that they would be the elite in a place like Galt's Gulch. In reality, almost all of them would be turned into objectivist beef jerky. Part of me wishes that these people would actually do that experiment in a place where innocent bystanders (i.e., those of us who don't agree that Ayn Rand's novels are the neatest thing since sliced bread) would not be harmed.

By Eric Lund (not verified) on 20 May 2016 #permalink

# 7 capnkrunch

Re “free market” vs “pocket of industry”

Both? If nothing else their paymasters are firm believers in the “free market” or at least private industry. From my rather cursory reading the US far-right are firm believers (fanatics) about the evils of government and this seems to translate into a belief in “free markets” or at least as little govenment interference as possible.

To believe in unrestricted free market capitalism is to ignore history

And?

Quite seriously, we're talking about fanatical religious belief here not reason. Besides they probably know little or no real history just a few national myths and fairy tales plus a soupçon of Ayn Rand. Or have learned much of their history from movies whose actual relationship to the truth is tenuous at best. (As an aside, I once read an historian's informal review of “Brave Heart”. She reported 107 errors in the movie and then mentioned that was in the first minute of the film.)

Almost surely they don't know that the USA had fairly high tariffs and deliberate policies to develop internal industries through much of the late 18th and 19th centuries. They will have no idea that the basis of the Internet was a US military development, and so on. I'd bet most of them don't realize the FDA was formed after a massive food poisoning episode.

By jrkrideau (not verified) on 20 May 2016 #permalink

Eric Lund@12

They think that they would be the elite in a place like Galt’s Gulch.

It's possible. Galt's Gulch was founded by a banker and its currency backed by a pirate who steals relief money. So a fair number of them might fit one or both of these archetypes. I always found those Midas Mulligan and Ragnar Danneskjöld hilariously and I assume unintentionally ironic as they are elite yet just as or more parasitic as any of the strawmen characters in Atlas Shrugged.

By capnkrunch (not verified) on 20 May 2016 #permalink

It would accomplish this by creating another category of clinical investigation where it is acceptable to forego informed consent.

What form would this take, Orac? The pharma rep handing the doctor a bunch of stuff and instructing him to just *try it*, testing on kids in orphanages, testing innoculations on children's lunches, testing on prisoners? Gone are the days of just spraying people in subways with Good Stuff™ and classifying the results, huu?

"All I saw before me were acres of skin" ... "It was like a farmer seeing a fertile field for the first time".

https://en.wikipedia.org/wiki/Acres_of_Skin

What form would this take, Orac? The pharma rep handing the doctor a bunch of stuff and instructing him to just *try it*, testing on kids in orphanages, testing innoculations on children’s lunches, testing on prisoners?

I don't think it would be quite that bad - I don't believe even Big Pharma aspires to the level of anarchy in the supplement industry, which is what you describe here.

By Guy Chapman (not verified) on 22 May 2016 #permalink

In reply to by Gilbert (not verified)

Unethical human experimentation in the United States describes numerous experiments performed on human test subjects in the United States that have been considered unethical, and were often performed illegally, without the knowledge, consent, or informed consent of the test subjects. Such tests have occurred throughout American history, but particularly in the 20th century.

The experiments include: the deliberate infection of people with deadly or debilitating diseases, exposure of people to biological and chemical weapons, human radiation experiments, injection of people with toxic and radioactive chemicals, surgical experiments, interrogation and torture experiments, tests involving mind-altering substances, and a wide variety of others. Many of these tests were performed on children, the sick, and mentally disabled individuals, often under the guise of "medical treatment". In many of the studies, a large portion of the subjects were poor, racial minorities, or prisoners...

...In one of the studies, for which Dow Chemical paid Kligman $10,000, Kligman injected dioxin — a highly toxic, carcinogenic compound found in Agent Orange, which Dow was manufacturing for use in Vietnam at the time — into 70 prisoners (most of them black). The prisoners developed severe lesions which went untreated for seven months. Dow Chemical wanted to study the health effects of dioxin and other herbicides, and how they affect human skin, because workers at their chemical plants were developing chloracne...
...In 1966, the United States National Institutes of Health (NIH) Office for Protection of Research Subjects (OPRR) was created. It issued its Policies for the Protection of Human Subjects, which recommended establishing independent review bodies to oversee experiments. These were later called institutional review boards.

https://en.wikipedia.org/wiki/Unethical_human_experimentation_in_the_Un…

Of course, such tests are still carried out because they can; But in secret. Am I reading it right that this bill would re-legitimize such ignominious inquires? I can't be reading you right, right?

Am I reading it right that this bill would re-legitimize such ignominious inquires? I can’t be reading you right, right?

It all depends on who gets to define "minimal risk". Which, since it's apparently not defined in the bill, some enterprising lawyers will get to try. And inevitably, it will come before a judge who may or may not have the expertise to decide the issue.

By Eric Lund (not verified) on 20 May 2016 #permalink

If you squint (though rose-colored-glasses) you can see a not-terrible application: Company A has cancer product B that is only labeled for patients with Stage III X cancer. The basic science says that product B would work just as well or better for patients who are only stage II, but company A can't afford the full clinical trial. Safety and efficacy at stage III are known (and good).

But that's not what this bill is about. And frankly, whenever anyone talks about not needing informed consent, they should be reminded *why* the Helsinki Protocol exists. It's really quite easy, just two names. Nazi, Tuskegee.
Are you an amoral arrogant monster? Then you f-ing get real, genuine informed consent!

By JustaTech (not verified) on 20 May 2016 #permalink

Let's just say what the act truly is a gift to; trial lawyers suing drug manufacturers.
If this passes, I anticipate many, many, many more television commercials to call the law firm of .

@capnkruch

The free marketeers actually believe it. Why read history when you can read Ayn Rand and Milton Friedman? I would be less cynical if i could think they were all taking payoffs from Lord Draconis, as that would suggest they have a residual sense of decency tucked away whispering that they're doing something wrong.

Still, I wouldn't call them 'idiots'. Laissez Faire is a powerful inherited ideology, in the marxist-critical-theory sense of the term. It's just the way a large group think things are, mutually self-reinforcing. Maintaining it provides a variety of rewards: psychological, social, economic. The 'leaders' do very well for themselves. When unregulated capital produces the inevitable financial crises, they just profit all the more. The 'followers' among the masses who get screwed in both boom and bust see no other option to improving their lot than rising into the entrepreneurial class somehow. You know, they're not willing to rein in the rich because they dream they'll join them someday. The odds of this may be less than hitting the Lotto, but they play for the same reason: it's hard for them to live without imagining they have a chance, however small, to cast of the shackles of economic dependence and answering to the boss.

Wzrd1:

You know the same folks backing this are all for "tort reform", right? In the absence of proper regulation, the civil courts are the only mechanism available to act against gross corporate misbehavior. It may not be a good one, but w/o it, we'd be in one hell of a worse mess.

So basically the US population would become unwitting test subjects of mass unregulated human experimentation without a way to take legal action if/when something went wrong (I suppose there's always a civil suit but I highly doubt an average citizen could make it through the wall of ablative bureaucracy a pharmeceutical company could erect). This is terrifying.

By Ryan A Rognas (not verified) on 21 May 2016 #permalink

@Ryan, with unscrupulous investors and attorneys being the only clear winners.
Just another example of the truth of, "The United States of America has the absolute best government that money can buy".

By Wzrd1 (not verified) on 21 May 2016 #permalink

In reply to by Ryan A Rognas (not verified)

justatech
In the kind of cancer I have, stage refers to how far the cancer has spread. You might be thinking of grades? Grade would refer to how indolent>aggressive the cancer is. The more indolent (borderline and grade 1) are sometimes not treated with chemotherapy. Grade 2's and 3's would be.

@Wzrd1 Isn't that the truth.

By Ryan A Rognas (not verified) on 22 May 2016 #permalink

You seem to acknowledge the issue of tradeoffs when saying "balance cost and time to approval versus guaranteeing the safest, most efficacious devices and drugs.". Then unfortunately you make the leap to "magical thinking" that *your* lack of knowledge of evidence of harm is the same thing as evidence of lack of harm.

You state: "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."

Your prior comment about tradeoffs seemed an acknowledgement of the obvious reality that any regulation does slow innovation with the intent of limiting the risk of new treatments. I find it difficult to believe any rational person could believe that the FDA doesn't cost lives due to the time it takes for drug approval since obviously a drug that is approved wasn't available beforehand. The issue presumably is the tradeoff of lives saved by keeping a flawed product off the market vs. lives saved by getting a product to market sooner. The lives lost due to a bad product are easier for people to be aware of than the lives lost due to a product not being available.

re: "It’s been pointed out that the FDA actually acts more rapidly than European regulatory agencies."

Comparing two government monopolies doesn't say anything about how fast in theory the approval process should go. I don't see an ungated version of this paper so I hadn't delved into the credibility of its analysis:

http://www.sciencedirect.com/science/article/pii/S1062976909000805
"An exploratory study of FDA new drug review times, prescription drug user fee acts, and R&D spending

Controlling for other factors such as pharmaceutical profitability and cash flows, we estimate that a 10% decrease (increase) in FDA approval times leads to an increase (decrease) in R&D spending from between 1.4% and 2.0%. "

The process takes many years, merely looking at the times it takes for the final FDA approval of the final filing to be approved rather simplistic and not too useful. A prominent GMU economics professor noted a few months ago (and included is a bit from a comment on it):

http://marginalrevolution.com/marginalrevolution/2015/12/the-fda-and-ma…
"The Vox piece had some howlers. Most notably this:
'There’s no evidence the FDA blocks innovation or makes innovation harder or makes it more costly,' said Kesselheim.
Frankly, that would be laughable were it not coming from a professor of medicine at Harvard Medical School
...We live in a world of tradeoffs. Let’s debate the tradeoffs. But let’s not engage in magical thinking where there are no tradeoffs and “no evidence” that the FDA makes drug development more costly.
comments
The fact that Priority Review Vouchers can be sold for hundreds of millions of dollars each is prima facie evidence that the FDA retards innovation. "

The cost of drug development has risen drastically over the years, as Tufts has documented:

http://csdd.tufts.edu/news/complete_story/tufts_csdd_rd_cost_study_now_…
"The most recent analysis by the Tufts Center for the Study of Drug Development of the average cost to develop and gain marketing approval for a new drug—pegged at $2.558 billion—has been published in the Journal of Health Economics, it was announced today."

The current effort to reform the process may be flawed, but that doesn't mean there isn't anything wrong with the process. Those who actually bother studying how governments operate in the real world, e.g. public choice economists, grasp that it doesn't make any sense to assume a government agency is doing the best job possible. It seems merely a leap of faith since you wish to believe it, since it isn't supported by logic or evidence.

Unfortunately those who study regulatory capture economics explain that it is to be expected that industries will capture the regulatory process. After the efforts naturopaths and other quacks have made to get licensed around the country and get other government seals of approval, it shouldn't be a surprise to anyone that other quacks will try to have influence over the approval process.

Unfortunately some people seem to have trouble abandoning their religious-like faith that government *must* be responsible for the approval process, rather than for instance private competing certification companies where doctors and insurers can decide who to trust. If a company gives in to quacks, then another science focused approval company will point that out to get people to value their ratings more highly. Competition works better than monopolies, even government monopolies, despite wishful thinking on the part of those who don't bother learning much about theories of government failure.

By Common Sense Boulder (not verified) on 22 May 2016 #permalink

Common Sense Boulder@26

Unfortunately some people seem to have trouble abandoning their religious-like faith that government *must* be responsible for the approval process, rather than for instance private competing certification companies where doctors and insurers can decide who to trust.

This is exactly the unrealistic libertarian bullsh!t I mentioned upthread. It's a nice thought but history tells us that an unrestricted free market never regulates itself in the public's best interest. That's why we created the rules and regulations in the first place. You want to talk about"religious-like faith"? Examine yours in the free market.

By capnkrunch (not verified) on 22 May 2016 #permalink

@capnkrunch, quite spot on. Ignoring history because it is inconvenient is foolish in the extreme.
Some seem to honestly want a return to the era of radium and thorium water sales!

By Wzrd1 (not verified) on 22 May 2016 #permalink

In reply to by capnkrunch (not verified)

I had to share this from everyone's favorite "cutting- edge" scientist" Mike Adams. This is from an article he wrote today on Natural News. I don't know whether to laugh or throw my shoe the the window.... and I quote:

"The other thing we need, quite frankly, is independent scientists like myself who are conducting cutting edge, truly independent science, without any financial ties to governments, corporations or academia. My science lab, which has now passed our ISO 17025 accreditation audit, is free to pursue precisely the kind of scientific analysis of food and medicine that is blackballed or censored in the government-funded scientific community. Other scientists would lose their jobs if they pursued the kind of science I'm pursuing on a daily basis with absolute freedom.

Notably, this makes me a rare practitioner of real, independent science and a protector of the very kind of independent skepticism and scientific analysis that should be embraced by any system of knowledge that's based on legitimate science. Yet the science I'm conducting is widely considered a threat to the scientific establishment, precisely because I'm willing to analyze vaccines for heavy metals and organic chemicals, for example. Such research is simply not allowed by the cult of scientism (the vaccine zealots) because they depend on widespread ignorance of vaccine composition to continue parlaying their fraudulent lies about vaccine safety."

As usual, his cutting edge article references his own website predominantly. Good Grief.

By jazzlives62 (not verified) on 22 May 2016 #permalink

@ jazzlives62:

Mikey ( HWSNBN) whilst disparaging Drs Barrett, Tyson and DG, vaccines, psychiatric meds and most reality-based material,
plugs his ( so-called) lab, his book ( AVAILABLE @ Amazon) the paranormal and religiosity.

Altho' it's hard to see much of value in his activities, remember that while he IS selling his merits as well as his products to his enraptured thralls, he is also trying to convince himself how brilliant and talented he is.
I venture that it's no accident that he and the other alt med poseur chose to pretend to be scientists rather than other professions-
I guess that their childish dreams of glory were quashed
by non-acceptance and/ or inability when applying or studying at universities.
Notice that his degree is in Technical Writing. The other's is in Business . Why was that? Does science cost more?
Both of them are from the US and attended higher education during eras when financial aid was plentiful, public education prevalent and brilliance rewarded. Both have to explain this too much.

Heh.

By Denice Walter (not verified) on 22 May 2016 #permalink

Orac,

Common sense boulder =~= the libertarian dental student of a few years ago??

Alain

Other scientists would lose their jobs if they pursued the kind of science I’m pursuing on a daily basis with absolute freedom.

A moment of unintentional honesty from Natural News.

By herr doktor bimler (not verified) on 22 May 2016 #permalink

Wzrd1@29

Ignoring history because it is inconvenient is foolish in the extreme.

Hilariously, Common Sense Boulder recognizes that monopolies are bad while ignoring that free markets have historically coalesced into monopolies or oligopolies but for government intervention. Notably pretty much every major industry prior to the early 1900s or any new industry in the last century: telephone providers (Bell), PCs (Microsoft), internet service providers (Comcast, AT&T, Time Warner).

But the commercial regulatory agencies is even more absurd. Their customers, and therefore the ones who exert market pressure, would be the pharma companies, not end consumers. This means the cheapest, fastest and easiest regulatory processes would win out, not the safest or must honest.

The historic example, while not quite regulatory agencies but similar enough, is the credit rating agencies involvement in the subprime crisis. They were forced, by market pressure, to fraudulently rate securities lest their customers simply go to the other agencies. This lowest common denominator bad faith acting is the real result of unrestricted capitalism and it is an experiment that had played out over and over with the same results yet refuses to die. Libertarianism is the vaccines cause autism of economics.

Thinking more on it I agree with sadmar@21 when he says they actually believe it, with one caveat. The faithful masses are sold a narrative but I think the leadership knows full well what they are doing and are acting entirely out of self interest to protect profits.

I would also add that being sold a story is no excuse for ignorance. Especially one so easily corrected. This is high school level American history.

Also, lol at Mikey being unbeholden to corporate interests. Certainly we all recall when he used his mass spectrometer to show how unsafe competitors' supplements were. That's the kind of testing and regulation we could expect under Common Sense Boulder's brilliant scheme.

By capnkrunch (not verified) on 22 May 2016 #permalink

@capnkrunch; the ratings agencies were bad for not for the reason you gave, but for a different reason, namely that the "free" market they operated in gave two companies, S&P and Moody's an ability to dominate the market with over 97% share, as there were no regulations against cartelisaton or monopolisation. The lack of rules also ensured that the agencies could charge for a good rating, essentially the banks paid for CDOs to be given AAA status not the agencies gave them because they were low risk.

This had the effect (which also continues to this day) of restricting funding options for small companies in many industries even if they are really low risk, because they cannot afford to pay five and six figure sums to the ratings agencies for a high score, preserving big company advantage.

Thus the problem with free market systems. Yes government agencies tend to be monopolies, but they are tightly regulated with many layers of oversight.

@ capnkrunch:

"lol at Mikey being unbeholden to corporate interests"

Like the other loon @ prn.fm, he has so many corporate interests of HIS OWN to promote that he scarcely has time to promote those of others. He's had/ has a bunch of companies from Arial ( which he supposedly sold to fund NN) to Truth Publishing and various websites that sell products and/ or adverts. He's had an MLM superfood company ( Green Lipped mussels) and interest in selling real estate in Ecuador, he's led nature tours and given lectures- there's now a lab and his 'charity' ( Consumer Wellness) as well. The more you look, the more you find.

I'm especially intrigued how Mike and Gary establish charities- I've sure that there's something skeevey afoot.
Doesn't the US have laws?

By Denice Walter (not verified) on 23 May 2016 #permalink

mho @25: No, I did mean stage. There are drugs and treatments that are only approved for metastatic X cancer (breast, prostate, lung).
It can have to do with the mechanism of action of the treatment, or the population of patients who took part in the Phase III clinical trial that was used to support approval.
But like I said, it's a pretty niche area.

By JustaTech (not verified) on 23 May 2016 #permalink

Wzrd1: Some seem to honestly want a return to the era of radium and thorium water sales!

Yup. I used to think that most conservatives wanted to return to the 1950s. I was off by about a century.

By Politicalguineapig (not verified) on 23 May 2016 #permalink

The credit rating agencies, S&P and Moodies, ostensibly exist because they have the highest credibility. In a true capitalistic free market economy even a minor blemish to that credibility could/should be catastrophic to such a company. They still exist and are still dominate. Do we need any other evidence that our free market capitalistic system is NOT?

By Robert Miller (not verified) on 30 May 2016 #permalink

I have been fighting Stage IV Colon Cancer for 9 years and 7 months. I was initially given 6 months to a year to live. The statistical life expectancy is 2 years 4 months. The reason I m still alive is because I ignored from day one the FDA approved first line therapy, did my own due diligence and used common sense. I went off the reservation and used things that were outright banned by the FDA. I also used chemo that was not approved for my cancer and not covered by medicare. Later and off and on I also used Folfiri and Avastin but not as recommended by my oncologist or the FDA. For example at the moment I am in good health though not having had chemo for a year. CT scans in March and April show that I am in better shape in the latter probably because of a virus I infected myself with two years ago massively and later injected intermittently. Wednesday I will have a bronchoscopy to debulk tumor material in my bronchia and right upper lobe. It will be irradiated but not killed and infected with the same virus. I will inject that (vaccine) and inject the virus alone also. I may also inhale the live virus since the bronchoscopy will leave damaged tumor that may be more open to direct infection. A full court press. I would like to combine this with at least one checkpoint inhibitor. I have tried to get into trials of same but been denied because my last use of chemo still worked. It seems you have to be closer to death for admittance though a healthier non-risk adverse patient might show better results both for themselves and the trial.
I have never had a course in biology. I think that for every patient saved by a risk adverse FDA 100 die. I would call it the thalidomide syndrome.

It takes the FDA longer to approve a virus that has minimal side affects than a chemo that competes with your cancer in killing you.

I would like to see the FDA approving drugs much sooner and while trials are ongoing. I would like to see a patient bill of rights that says they can try anything they want if terminal.

9 years 7 months, I feel fine at 72 yoa and I'm going sailing!

By Robert Miller (not verified) on 30 May 2016 #permalink

BTW the first thing I used, banned by FDA, before any chemo reduced my tumor by 65% in four months and then kept it stable for 14 more months. And I had very good quality of life during that time mixing it with my orange juice each morning. Still think it is a possible cancer cure if more research is done on it. Researchers can't get funding for it.

By Robert Miller (not verified) on 30 May 2016 #permalink

That's very interesting. You see, I once went over to a Korean War vet, after lunch and having seen his hat, to say thanks for saving Mother in Law from being killed by the Norks back in '51.

He started telling me about his daughter who had been fighting Stage X [something something] Cancer for Y years and Z months after she was initially given A months to a year to live. None of the fancy doctors in Cleveland could explain it but the reason she is still alive is because her dad (the guy with the hat) looked up cancer on the internet and treated her with hydrogen peroxide.

At that point I backed away and broke for the door but he followed me out into the parking lot and wouldn't shut up until I put it into reverse and drove away.

So my question is, do they hand out some kind script generator at crackpot school? So many cancers, and so many miracle stories, but it's always the Same Damned Thing. Can't you be original in your dumb stories, like once a decade or so?

By Robert L Bell (not verified) on 30 May 2016 #permalink