I’ve referred to so-called “right to try” laws as a cruel sham.on more than one occasion. Since 2014, these laws, all based on a template provided by the libertarian Goldwater Institute, have been proliferating at the state level with the help of lobbying by the aforementioned Goldwater Institute and a concept that makes it pitifully easy to caricature opposition to these laws as wanting to heartlessly snatch away from terminally ill patients the last chance at life while laughing and twirling one’s mustache like Snidely Whiplash. Not surprisingly, state legislatures all over the country have found such laws irresistible, leading to their passage in over 30 states in just two and a half years. Over the last week, right-to-try has had a major victory in that, contrary to what he did last year and contrary to the hope of science advocates, California Governor Jerry Brown signed the right-to-try bill (AB-1668) that was passed earlier this month. However, it has also suffered a major defeat in that a couple of days ago the federal right-to-try bill was blocked in the Senate.
The basic premise behind right-to-try laws is that people are dying in droves because the FDA is too slow and too hidebound to allow dying patients access to experimental drugs that are still undergoing clinical trials to be approved by the FDA. No, really, that’s the argument libertarians make, that the FDA is literally (yes, I mean literally—just ask Nick Gillespie and Ronald Bailey) “killing” people. Enter right-to-try, laws that purport to allow terminally ill patients (or, in some cases, patients with life-threatening but not necessarily terminal illnesses) to access experimental therapeutics in a desperate bid to save their lives. Sounds reasonable on the surface, right? What is assiduously not mentioned are other libertarian-based aspects of these laws. For instance, there is no mechanism in most right-to-try laws to help patients seeking to access experimental therapeutics financially. Indeed, pointedly, such bills go out of their way to state that health insurance companies do not have to pay for suc treatments and can be interpreted to state that they don’t have to pay for treating complications arising from the use of right-to-try drugs or devices. Given that such bills also allow pharmaceutical companies to charge for experimental therapeutics and such expenses can be very high, this effectively means that only the rich or those skilled (or whose families are skilled) at using social media to raise a lot of money fast could potentially access right-to-try.
These laws also explicitly remove patient protections in that most of them state that doctors recommending right-to-try can’t be sued for malpractice or disciplined by their state medical boards, seemingly no matter how inappropriate or incompetently executed such a request might be. Nor can drug manufacturers be sued. Basically, these laws tell terminally ill patients: Good luck. You’re on your own. And don’t sue if things go bad, no matter what. Given that right-to-try laws also only require that experimental therapeutics have passed phase I trials and still be in clinical trials to be eligible, there’s a high probability of adverse events and harm. Indeed, I not uncommonly laugh derisively and contemptuously whenever I hear a Goldwater Institute flack claim with a straight face that right-to-try only allows drugs that have been shown to be safe to be used, because phase I trials generally only have a few dozen patients followed briefly. Let’s just put it this way: No one who knows what he’s talking about views drugs that have passed phase I trials as having been shown to be safe. At best, such drugs have been shown not to have high levels of life-threatening toxicity.
Of course, the biggest flaw in these laws is that it is federal law, not state law, that controls drug approval. Right-to-try laws can say that terminally ill patients have the “right” to access experimental therapeutics, but it is the FDA that determines whether they, in fact, do. Companies are understandably reluctant to grant access to experimental therapeutics without the FDA’s prior approval because (1) the FDA will not look kindly upon it and they want FDA approval and (2) if there are any adverse events it could harm their chances of winning approval for their drugs. Also, the FDA does have what it calls its Expanded Access Program (sometimes referred to as Compassionate Use) already to allow terminally ill patients to access experimental therapeutics, and it does it without removing patient protections under Institutional Review Board (IRB) supervision. Moreover, the FDA already grants the overwhelming majority of Expanded Access requests. Indeed, as I pointed out, thus far, after two and a half years of existence, right-to-try has been a miserable failure. The Goldwater Institute can’t identify a single patient who has received an experimental drug under a state right-to-try law, although it claims to know of 40-60. Meanwhile a quack like Stanislaw Burzynski has abused right-to-try. Meanwhile, the only patient I’ve been able to find who actually used right-to-try died.
So it was that I was very disappointed to learn that Governor Jerry Brown had betrayed the citizens of the State of California by buckling under this time:
Terminally ill patients in California will be able to try potentially life-saving medication before it passes FDA final review thanks to a new piece of legislation inspired by the movie "Dallas Buyers Club."
The bill, dubbed the "Right to Try" law, makes California the 32nd state to allow patients with terminal illnesses to try drugs that have passed the FDA's Phase 1, but haven't been fully approved.
Phase 1 is the first stage of drug testing in human patients. Drugmakers earn approval to conduct clinical trials on people after presenting the results of successful trials on animals, according to the FDA. After presenting the data -- and a plan for human trials -- the FDA determines whether drug companies can go forward with additional testing.
Patients can try experimental treatments only after exhausting all other options, according to the libertarian think tank Goldwater Institute, and the patients' treatments with Phase 1 drugs cannot be included as data in ongoing clinical trials.
Of course, as I pointed out before when I discussed the California bill, this description is utter bollocks. In a way, the California bill (now law) is worse than the average state right-to-try law. It doesn’t actually require that the patient be terminally ill, only that he has an “immediately life-threatening disease or condition.” As I put it at the time, that’s incredibly broad. A severe case of pneumonia could be “immediately life-threatening.” A heart attack is definitely “immediately life-threatening.” A stroke is “immediately life-threatening.” “Immediately life-threatening” is not the same thing as “terminal.” Yet AB-1668 tries to have it both ways, as it defines “immediately life-threatening disease or condition” as “a stage of disease in which there is a reasonable likelihood that death will occur within a matter of months.” That implies something less acute, but “within a matter of months” encompasses more immediately life-threatening diseases as well.
You could ask, quite reasonably: Why does this matter? One reason is that it’s California, the most populous state in the country. Any law passed in California matters. California is always the biggest prize, and right-to-try advocates were bitterly disappointed when Gov. Brown vetoed a previous right-to-try bill last year.
Unfortunately, the Goldwater Institute has been very effective in co-opting terminally ill patients to use the considerable justified sympathy voters and legislators feel for them to lobby for right-to-try:
In a guest column for the Washington Post, 32-year-old Matthew Bellina says Right to Try laws are an improvement on the FDA's Expanded Access program because they stipulate that the FDA won't shut down or delay clinical trials if an experimental treatment goes wrong.
Because derailing clinical trials can deal a significant blow to drug companies that have poured millions of dollars into research and development, drug companies are less likely to sponsor terminally ill patients without guarantees that the FDA won't retaliate for failed treatment.
Bellina, a military veteran and father who has terminal ALS -- amyotrophic lateral sclerosis, also called Lou Gehrig's disease -- testified before the Senate on a federal version of Right to Try.
Turning down someone dying of Lou Gehrig’s disease is pretty much close to impossible for a politician, even if the legislation being proposed is profoundly anti-patient, as right-to-try is. Also, this is one of the most pernicious aspects of right-to-try, as you will see. So let’s segue to the federal right-to-try bill. Gov. Brown might have buckled and signed what I like to refer to as “placebo legislation,” which makes legislators feel good and believe that they’ve done something when in reality they’ve done nothing, but the federal bill is where the action is because that’s the real goal of the Goldwater Institute, to weaken and then ultimately neuter the FDA. The Goldwater Institute is politically savvy enough not to come right out and explicitly say this, but other libertarians are not.
A week ago, hearings were held on a federal right-to-try bill, S.2912, known as The Trickett Wendler Right to Try Act of 2016. This is a bill being pushed by Republican U.S. Sen. Ron Johnson. Interestingly, as the bill has been US Senate Committee on Health, Education, Labor, and Pensions, Johnson used his position as committee chair of the US Senate Committee on Homeland Security and Government Affairs to hold hearings on the bill, even though it has nothing to do with his committee’s purview. Sen. Johnson’s opening statement is basically a rehash of Goldwater Institute talking points, complete with the usual anecdotes about patients with terminal illnesses who might have been saved:
Despite the legal uncertainty there are doctors willing to jeopardize their practice to give patients needed, but unfortunately unapproved, treatments. One of them is Houston oncologist Dr. Ebrahim Delpassand. Even though the FDA has told him no, he bravely continues to treat patients under his state’s law. Now nearly 80 patients, whose chance of survival would be, as he puts it, “close to none,” are alive thanks to his treatment.
This caught my attention, as this is a potentially verifiable claim. There is a video of Dr. Delpassand giving a statement included in the testimony:
Whoa. He’s with Excel Diagnostics, the very same company that I discussed when I looked into the one patient in Texas whom I could find who had accessed right-to-try and who had not been saved. Contrary to Sen. Johnson’s claims, he is not an oncologist; he is a radiologist. Of course, nothing Dr. Delpassand claims in his video statement shows that 80 patients who would have died have been saved, thanks to his being a brave maverick doctor willing to buck the FDA. One notes a highly one-sided account designed to make Dr. Delpassand look as good as possible. In any case, the therapy discussed by Dr. Delpassand does have potential, as I mentioned before. However, one thing that stood out to me was how the Goldwater Institute reached out to Dr. Delpassand. So basically, right-to-try allowed Dr. Delpassand to charge for the use of his treatment, even though it is not FDA-approved. Not surprisingly, the Goldwater Institute is painting this example as the nefarious FDA preventing patients from saving their lives, even though this treatment is not curative, as I described. He’s also a flack for the Goldwater Institute, having participated in a promotional video touting right-to-try:
So his evidence is that “many of these patients were given three or six months to live” and are alive a year later? Seriously? Stanislaw Burzynski uses the same argument about the patients he treats.
In any case, as I pointed out three weeks ago, the federal right-to-try bill is even worse than state right-to-try bills because (1) it would actually do something and (2) what it would do would be very, very bad for patients indeed. For example, it would forbid the FDA from considering adverse events suffered by patients utilizing experimental drugs under right-to-try when considering a drug for approval. Seriously, it says that. A patient could die, clearly as a result of an experimental drug, and the FDA would be explicitly barred from considering that information when deciding whether to approve the drug or not.
Speaking of Stanislaw Burzynski, I couldn’t help but note the testimony of Peter Lurie, MD, MPH. He repeated the same points about how the FDA’s Expanded Access Program rarely rejects requests and then notes:
However, even patients with serious or life-threatening diseases and conditions require protection from unnecessary risks, particularly as, in general, the products they are seeking through expanded access are unapproved – and may never be approved. Moreover, FDA is concerned about the ability of unscrupulous individuals to exploit such desperate patients. Thus, with every request, FDA must determine that the potential patient benefit from the investigational drug justifies the potential risks and that the potential risks are not unreasonable in the context of the disease or condition to be treated.
“Unscrupulous individuals”? That would well describe Stanislaw Burzynski. It could also describe pharmaceutical companies willing to profit off of drugs that made it through phase I studies but are not approved yet.
Fortunately, for now at least, the federal right-to-try bill has been blocked:
Republican U.S. Sen. Ron Johnson's push for a right-to-try bill ran up against the reality of hardball politics Wednesday.
Johnson's measure to allow terminally ill patients to receive experimental drugs not approved by the Food and Drug Administration was blocked by Senate Minority Leader Harry Reid (D-Nev.).
Johnson sought to move the bill through unanimous consent, meaning one senator could halt its progress. And that's what Reid did, blunting a Johnson initiative for the second time in recent months. In July, Reid blocked Johnson's bill to protect federal whistleblowers from retaliation.
Johnson faces a tough re-election fight against Democrat Russ Feingold, so any move to get legislation through by a parliamentary maneuver was always going to be difficult.
And it's even harder since Democrats are still upset that Republicans have blocked President Barack Obama's nominee to the U.S. Supreme Court, Merrick Garland.
Reid said he understood the "seriousness" of the Johnson proposal and acknowledged "the urgency that patients and their families feel when they're desperate for new treatments."
In objecting to the measure, Reid said Johnson's bill didn't have bipartisan support — there were 40 Republican co-sponsors and two Democrats. He said the bill didn't go through the hearing process where all the major players on the issue have voice. The Johnson-chaired Homeland Security & Governmental Affairs panel held two hearings on the subject.
"I think we should have had a hearing on Merrick Garland," Reid said on the Senate floor.
This is what I would call doing the right thing for the wrong reason. Unfortunately, that’s what happens in politics a lot. I’ll take it, though. If state right-to-try bills are basically symbolic rants against the FDA, the passage of a federal right-to-try bill would be a disaster for patients and the clinical trial process.
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I would be interested in learning how many are simultaneous supporters of 1) Right to Try, because it's immoral to deny Hope to the Needy and 2) the Precautionary Principle, because we just don't know if this or that novel procedure might turn out to have some horrible side effect decades down the road.
Depending on whose ox is being gored, of course.
it would forbid the FDA from considering adverse events suffered by patients utilizing experimental drugs under right-to-try when considering a drug for approval.
Great idea. So much for the rest of the world trusting the FDA when the agency approves a drug. If that idiot law passes we don't even need to invoke a "conspircy" that the US govenment is hiding information on drugs. We just need to point to the law that requires it to ignore data.
Sen. Johnson, sponsor of this bill, is up for reelection this year, and polling suggests that he is likely to lose to former Sen. Russ Feingold. There are plenty of reasons already why I would rather have Feingold than Johnson in the Senate, and this is one more.
@jrkrideau: That's a feature, not a bug. Libertarians start from the premise that all government regulation is bad, so kneecapping the FDA is considered a good thing. Never mind that the FDA exists precisely because we have previously tried the libertarian approach to drug regulation and found that people tend to die needlessly as a result.
The worst thing about crap laws like this is that even when it becomes absolutely clear that they are merely a quacks' charter, it is virtually impossible to reverse them. Like licensing magical bullshit, once the genie is out of the bottle, you won't easily get it back in.
Thanks for the update on the California law change. We'll have to look into at checking it out for an unapproved cancer drug on a trip in month or two, for the California stop.
This post focuses on less tested, expensive new drugs that might be most profitably exploited by pharma.
A more useful area for patients concerns those materials that are already approved overseas and available for personal importation, often cheap or generic. Like some drugs in the Dallas Buyers Club example.
Drugs approved overseas with more than 1-5 years satisfactory experience should be available to desperate US patients with some kind of reasonable effort. If the FDA wants to be useful, it could maintain currently updated staff reviews online about particular unapproved drugs of concern. Sometimes there is nothing wrong at all with unapproved drugs, it's purely political.
# 3 Eric Lund
@jrkrideau: That’s a feature, not a bug.
I think you missed my point. If US libertarian idiots want to mess up US agencies, oh well….
I was of the impression that drug trials and testing in the many or most of the OECD countries would be considered in any country's decision to license a drug.
My point is that we (i.e. the rest of the world) would have to discount any FDA drug approvals as being possibly based on incomplete data. We are going to waste time and money duplicating research since we would no longer be able to trust information from the USA.
And we don't even need a conspiracy theory to suggest that the FDA may be suppressing information—it's the law. It might be fun watching the libertarians and the anti-vaxers fighting that one out.
I thought the whole way life was supposed to work in a libertarian paradise is that you get to sue if something goes wrong. (Success of suit is not considered.) But these laws would *take away* the right to sue, leaving a patient with nothing. That's all new kinds of evil.
On a separate note, if the condition to be treated with these "right to try" laws is rare enough, and FDA is not allowed to consider the outcome of patients who use a treatment under "right to try", then it's entirely possible that the real clinical trial for a treatment would never be able to enroll enough patients, and therefore never get approved at all. How does that improve anything?
Fuck the FDA, DEA, and any other 'government agencies' that have letters in their name.
Intercourse the FDA, DEA, and any other 'government agencies' that have letters in their name.
{what's with the new swear filter?????}
Fuckbags! Just testing.....
Ok. '*..kbags didn't even make it through -- Stay absofuc*in' classy, 'scienceblogs'.
https://www.youtube.com/watch?v=uSEXgQ58AoM
For all you Limey's out there, did you know why London Dry Gin is more intoxicating than American Gin? I do.
α-pinene exists in two stereo-optic configurations. (-)α-pinene is produced by English Juniper trees, and (+)α-pinene is produced by American Juniper trees. The two enantiomers differ in biological biological effects:
Only (-)α-pinene is fatal and causes CNS depression. This is why English Gin will put you under the table, while American Gin will make you feel fabulous!
Mechanisms of Acute Inhalation Effects of (+) and(−)-α-Pinene in BALB/c Mice
http://onlinelibrary.wiley.com/doi/10.1111/j.1742-7843.2005.pto_96604.x…
https://en.wikipedia.org/wiki/Alpha-Pinene
Gilbert does make a case for early adoption of new anti-psychotic drugs.
Someone hasn't figured out how to swear at RI.
Oh well.
In other news...
Mikey A ( Natural News) displays his comprehension/ summation skill ineptitude again in a post about the END of Civilisation
( It's the End of Civil.. as we know it... and I FEEL FINE)**
At any rate, he opines that Syrians are lean, mean fighting machines and westerners are crybully, spoiled weaklings.
It's Darwinism, stupid.
Except for Country Folk like him.
Hardworking, physical, problem solving- trained by adversity to persevere.
Says the guy who has made his money by selling stuff on the internet and scaring readers into survivalism.
** I once met two of those dudes- on an escalator in a hotel.
Nice guys.
How to swear at RI
1. Swear and wait for You-know-who to do you-know-what
2. Creative spelling and/ or typing patterns for immediate relief
I know, I know I should have not revealed the secret and let him figure it out for himself for hey, I was trained to assist people communicate/ function et al.
Not to worry, there are plenty of ways to do it, such as this famous example.
If you have the time to come up with a creative way to swear you also have the time to come up with a way to express yourself without swearing.
@13
Cool story, bro.
As a Tanqueray fan, it pained me to say that. It's sad, but true.
What is you favourite Gin Gilbert? Say Broker's and I'll die.
Lewis; I've never tried Gin. Though, based on your post, I just might as it sounds like there is more to it than just ethanol.
Good Lord.
https://www.youtube.com/watch?v=gR3s8VUYT9g
Would there be any preventive value by adding words to the effect that the purveyor has to provide detailed descriptions and mechanisms for the treatment and may not charge any money for the treatment?
Hey, G--
Everyone and everything written in the latin alphabet "has letters in its name." What's your problem with people shortening the names of things that they talk about more often? What do you have against the NWS and its parent agency NOAA? Is the British Inland Revenue better than the American IRS because it's not called the IR?
There has effectively been a National Weather Service since 1890 when it was known as the United States Weather Bureau -- It was swallowed up by the creation of NOAA in 1970.
NOAA is under the Department of Commerce and, as such, is somewhat politicized. I guess my main beef with them would be taking the human subjective element out of the NexRad automated radar systems and knee-capping the instruments by consigning them to only do the full PPI scans and at only a fixed six elevations in a rigidly set time; This really trashes their spacial resolution -- and no more hi temporal and spacial resolution RHI scans focusing on a small area of interest.
That and *cough* 'global warming' data diddling *cough*.
@ rs;
Believe it or not, I do occasionally find the time to explore other avenues of expression and get paid for it.
But swearing on the internet is more fun.
re gin:
Tanqueray is great
.
One of my ancestors got rather rich selling his formulae to a larger company and funded other family business/ projects over the years from some of which I have personally benefitted
.
For unknown reasons I got extremely blasted last night from a SINGLE drink which incorporated gin and then spent two hours in a Japanese restaurant eating and earnestly discussing politics with guests who spoke barebones English whilst my Japanese is nearly as bad.
Not as bad though.
Gin is a magical essence of fluidity and lubrication.
And who doesn't want that?
You missed one. Please pardon me now while I watch the scoreboards on the last day of the regular baseball season.
@ Narad:
I know but I don't do that.
AND yes, it is all about me ( to me anyway)
"But swearing on the internet is more fun."
I wasn't trying to be a tone troll. IRL I swear an awful lot. It's just that in written expression it really isn't needed. Indeed it can be a lot more fun (and effective) to knock someone with wit alone. The kooks who visit typically have no wit (or facts) and thus quickly descend to gross insult and swearing. Let that be *their* signature.
@ rs:
You're right.
Unfortunately, RI has had a deficit of quality trolls : thus I am uninspired but I will try harder.
Still, we can hit them with facts or meaningful references as well as an arcane vocabulary or interesting sentience structure.
In other news...
AoA has been trumping up its autism conference featuring Jenny McCarthy and other stellar personae
BUT has kicked a reporter out. ( see AoA)
Seriously, they usually claim that they are the ones who are censored.
In other other news...
Mikey Adams claims that HRC has never done an honest day's work in her life
and that the NYT fails...
Wait, let me stop laughing so I can type.
I know how much Orac and company adore Mike's reportage and worldview.
I sometimes wonder if he is secretly laughing as well as he writes crap to stir up his rightie readers so that they'll support him and buy his dreck.
interesting sentience structure
I am intrigued and would like to learn more about the structure of Denice's sentience.
Wait, Cat Jameson's son is "unable to regulate his temperature"?
This Dachelbot entry is more hilarious than you let on (boldface added):
"While Marc Ramirez at the Dallas Morning Sun tried to portray Rye Druzin as a legitimate reporter for the San Antonio Express-News interested in covering a controversial subject presented at the Dallas Autism Education Summit, the truth shows the really sinister side of the mainstream media."
What, you may ask, is "the truth"?
"Druzin wasn't really 'prepared to cover remarks by Bexar County District Attorney Nico LaHood....' I’m sure Druzin’s assignment at the Autism Education Summit was to smear everyone daring to speak out about vaccines and the link to autism and say nothing about the charge of scientific fraud at the CDC.
"I'm sure Marc Ramirez was told present Druzin as a cusading reporter wronged by anti-vaccine advocates.
"How do I know this?
"First of all,[*] none of these people EVER want to genuinely and extensively interview Andrew Wakefield, Del Bigtree or any of the other people involved in this controversy."
That's right, "the truth" is "because," full stop.
* There's no corresponding "second of all," but she does start babbling about Hearst newspapers.
“unable to regulate his temperature”?
The Lizard People walk among us!!
@ herr doktor bimler:
Ha ha! I didn't intend that but it might actually be true.
it should be.....
SENTENCE.
In other news... **
I had the great pleasure ( amidst other gleefulness of late due to a recent NYT report and having interesting work on my 'desk' ) to hear a new 'expose' of Dr Barrett courtesy of hoary, old woo-meister, Gary Null, which was read aloud today on his noontime woo-fest ( prn.fm) - starting at 18 minutes in until the end- called " Who You Gonna Call?
Quackbusters!"***
It should be posted as an article soon at prn.fm- or some other sinkhole of unreason on the internet- and I refer to it because it uses every trick in the book to 'splain why SBM is not to be trusted and hoary, old woo-meisters are.
In short, it's hilarious.
When I hear him talk about the Quackbusters ( sic), I always wonder when he will go into detail about our fearless ( and peerless ) leader, Orac, who is as perspicacious as he is perspicuous (tm). At any rate, he's been mentioned briefly a few times.
** I do this because someone has to do it. Seriously.
Fortunately, no weather and traffic.
*** not really
That's a Patty Bolen coinage, isn't it?
Anyway, I'm reminded that it's a new quarter, so I have 15 PACERbuxx ready to burn a hole in my pocket if there are any requests for docket updates (assuming that I can get RECAP to start working again).
In response a recent tweet by You-know-who...
Why is commenting way down on recent posts?
I am certainly not an expert but I imagine that these posts do not appear to incite trolls and the minions to stomp upon them.They are concise and do not lean themselves as material for riffing on by the minions.
Also, they do not easily lend themselves to various minions' expressions of their finer tastes** involving bacon and chocolate combinations.
Everyone is still reeling from revelations in the NYT?
Actually, I think it is all about bacon and chocolate.
** in memory of lilady
@ Narad, anything new on the Merck mumps thingy?
@ Narad:
Well, yes it is!
Truly, his hoariness' article went into detail about why Barrett lost court cases by not being an 'expert' in woo. Also crap about the chiros' ancient case anti-AMA.
There was something I hadn't heard before about Barrett's CEU and other education being out of date by a judge. I expect the craptastic article will be posted somewhere soon.
I was doing other work at the time so I didn't take copious notes.
Brave Sir Patty refused to post a comment recently that pointed out a Barrett victory (as well as overtly mocking Patsy). I should see whether I kept a screen shot, but I'm dog-tired today.
Hah!
Bolen's 'new and improved' website is certainly laughable.
It features posts by such luminaries as himself, Estave and Heckenlively..
Like I said previously, I've been in a rather gleeful state of mind and looking at sites like the Bolen Report increases my merriment.
Minions might want to take a peek.
I want to lift spirits. It's my job.
It's likely to be mostly procedural, but I'll update that docket once I make sure that the infrastructure is working.
Considering how important you think fact-based science is, you should be sure to get your facts straight. You wrote:
"So basically, right-to-try allowed Dr. Delpassand to charge for the use of his treatment, even though it is not FDA-approved."
The Texas Right To Try law does not allow patients to be charged at all for treatments. And do you know what treatment he is giving? A treatment that has been available in Europe for over a decade that is totally safe and completely effective. Facts. Stubborn things.