Here we go again.
Remember how I frequently say that naturopaths are relentless, how, whenever they attempt to get a naturopathic licensing bill passed in a state and fail, they’re soon back to try again. Basically, they keep trying until they succeed, and once they succeed, it’s game over for keeping their quackery from having the imprimatur of the state. Perhaps my favorite metaphor for this is that of the killer in a 1980s slasher flick, like Jason or Michael Myers, who frequently "dies" ta the end of one movie, only to come back the next movie to mow down another bunch of hapless teens. The difference, of course, is that right-to-try bills rarely die; most of them pass.
It turns out that advocates of “right-to-try” laws are a lot like that. Right-to-try laws have been proliferating with kudzu throughout the US since 2014. It’s not surprising, as you will see. They give the illusion of helping terminally ill patients, and voting for them lets legislators feel good about themselves without actually confronting hard choices, not to mention to appear to be doing something helpful when they are not. So I wasn’t surprised to learn that, after Governor Jerry Brown did the right thing and vetoed a right-to-try bill in California last fall, a new bill appears on the verge of finding its way to his desk again, with its supporters hoping that this time will be different, that this time Gov. Brown will sign the bill. They might be right. The rationale Gov. Brown used when vetoing the bill was that he wanted to given the FDA an opportunity to reform its Compassionate Use program as it has been doing.
It’s been a while since I’ve written about “right-to-try.” In fact, the last post about it appears to be the one I wrote praising Gov. Brown’s veto (time flies!), noting that he was the only Governor thus far with the courage to veto this ill-advised bill. In any case, right-to-try is a a movement started a couple of years ago by the libertarian Goldwater Institute, ostensibly to let terminally ill patients try experimental treatments without interference from the FDA. In reality, right-to-try is a cruel sham. Such laws give the illusion of providing potential cures to desperately ill and dying patients in the form of experimental drugs when in reality it does nothing of the sort, raising the hopes of the patients rallying to persuade their lawmakers to pass these laws and then basically doing nothing for them.
There are several reasons why right-to-try laws are a cruel sham. The first thing you should know about them, though, is that they all follow the same basic template originated by the Goldwater Institute. Next, states do not have authority over drug approval. The FDA does, and federal law and regulations trump state law. It’s also incredibly rare that an experimental drug will make the difference between life and death in a terminally ill patients. Yet it is that hope that supporters of right-to-try laws, in particular the Goldwater Institute, have shamelessly exploited to persuade legislators to pass these laws all over the nation. Worse, the requirements are risibly low and betray a total lack of understanding of how drug development works in that they only require that the experimental drug (1) have passed phase I trials and (2) still be in clinical trials. Of course, phase I trials are not designed to test efficacy. Their purpose is to work out optimal dosage, identify the maximal tolerated dose, and identify major side effects. Worse, they usually only consist of a few tens of patients, often less than 30. To propose letting seriously ill patients drugs that have been tested in so few people and not demonstrated to be efficacious and safe is to invite disaster. Finally, consistent with their libertarian origin, right-to-try laws provide no financial support for patients, who are basically on their own when it comes to paying what can be the substantial financial charges. They also strip away patient protections, making it virtually impossible for a patient injured using such a drug to sue either the drug company or the physician administering the drug. Finally, given that the FDA, not the states, controls drug approval, drug companies will be highly reluctant to offer such drugs without the approval of the FDA, and the FDA already has programs for single patient INDs, also known as compassionate use, to allow patients access to experimental drugs.
I once challenged the Goldwater Institute and right-to-try supporters to produce a single example of a terminally ill patient who had benefitted from right-to try or who had even been granted access to an experimental drug, basing my challenge on the case of Bob Bardone, who had amyotrophic lateral sclerosis, a fatal degenerative neurological disease also known as Lou Gehrig’s disease. This was a man who moved to Missouri because of its right-to-try law, hoping to gain access to experimental therapies. He didn’t. I did a bit of Googling to see if in the interim there had been any patients who received experimental medication under right-to-try. I couldn’t find any. Maybe I’ll Tweet at the Goldwater Institute’s flacks again and see if they can provide me with an example. The last time I did that, the excuse was that the laws were new. They’re not so new any more. It’s been two and a half years since the first one was passed. There are now 30 of them or so. That excuse won’t fly any more. In reality, the purpose of right-to-try laws is to undermine the authority of the FDA, build pressure for a federal law weakening the FDA, and to provide a pretext for lawsuits designed to challenge the FDA’s authority to regulate drugs. Oh, and to stoke hostility directed at the FDA. That’s very important to the Goldwater Institute.
In any event, I was surprised to note that I haven’t written a post that is primarily about “right to try” laws in 2016. It’s been almost a year since I discussed the issue. So now is as good a time as any, and the progress of the California law is as good an excuse as any to write about this scam again. So let’s circle back to what’s happening in California:
A bill that would allow terminally ill people to obtain experimental drugs appears headed to Governor Brown's desk for the second year in a row. Brown vetoed a similar measure last year, but supporters believe conditions are right for him to sign it this time around.
Brown said he vetoed last year’s "Right-to-Try" measure because he wanted time to see how changes to the FDA’s "Compassionate Use" program streamlined the process of getting experimental drugs to terminal patients.
Nearly a year later, the new bill’s supporters say it's time for California to step in with its own solution, because the modified federal initiative has not reduced the minimum 30-day wait for drugs.
"The process may have to start over if the FDA has even one question," said the bill's author, Assembly Majority Leader Ian Calderon (D-Whittier). "Terminally ill patients can still end up waiting weeks and months" for an approval.
Calderon's measure would allow drug manufacturers to give certain terminally ill people access to drugs not yet approved by the FDA.
Let’s take a look at the bill, AB-1668 Investigational drugs, biological products, and devices. Reading it over, I see that it’s the same old nonsense, except that it goes even further than a typical right-to-try law. For example, look at the definition of “eligible patient” for right-to-try in AB 1668:
(b) “Eligible patient” means a person who meets all of the following conditions:
(1) Has an immediately life-threatening disease or condition.
(2) Has considered all other treatment options currently approved by the United States Food and Drug Administration.
(3) Has not been accepted to participate in the nearest clinical trial to his or her home for the immediately life-threatening disease or condition identified in paragraph (1) within one week of completion of the clinical trial application process, or, in the treating physician’s medical judgment, it is unreasonable for the patient to participate in that clinical trial due to the patient’s current condition and stage of disease.
(4) Has received a recommendation from his or her primary physician and a consulting physician for an investigational drug, biological product, or device.
(5) Has given written informed consent for the use of the investigational drug, biological product, or device, or, if he or she lacks the capacity to consent, his or her legally authorized representative has given written informed consent on his or her behalf.
(6) Has documentation from his or her primary physician and a consulting physician attesting that the patient has met the requirements of this subdivision.
“Immediately life-threatening disease or condition”? That’s incredibly broad. A severe case of pneumonia could be “immediately life-threatening.” A heart attack is “immediately life-threatening.” A stroke is “immediately life-threatening.” “Immediately life-threatening” is not the same thing as a terminal illness. Yet this bill 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. Basically, the definition is the very definition of vague double talk that would likely result in court battles over interpretation if anyone ever actually tried to invoke it who didn’t have an undeniable terminal illness. Maybe that was the intention. In any case, this bill, if passed, would be far broader than most of the ones I’ve reviewed.
Consistent with the libertarian origins of the bill, AB 1688 doens’t do what we in the biz call jack shit to help terminally ill patients access experimental drugs. Check it out:
11548.2. (a) Notwithstanding Section 110280, 111520, or 111550, a manufacturer of an investigational drug, biological product, or device may make available the manufacturer’s investigational drug, biological product, or device to an eligible patient pursuant to this article. This article does not require that a manufacturer make available an investigational drug, biological product, or device to an eligible patient.
(b) A manufacturer may do both of the following:
(1) Provide an investigational drug, biological product, or device to an eligible patient without receiving compensation.
(2) Require an eligible patient to pay the costs of, or associated with, the manufacture of the investigational drug, biological product, or device.
(c) (1) This article does not expand the coverage provided under Sections 1370.4 and 1370.6 of this code, Sections 10145.3 and 10145.4 of the Insurance Code, or Sections 14087.11 and 14132.98 of the Welfare and Institutions Code.
(2) This article does not require a health benefit plan to provide coverage for the cost of any investigational drug, biological product, or device, or the costs of services related to the use of an investigational drug, biological product, or device under this article. A health benefit plan may provide coverage for an investigational drug, biological product, or device made available pursuant to this section.
So basically AB 1668 allows drug companies to charge whatever they want for a drug that’s only passed the most basic of basic clinical trials, Phase I. It doesn’t require health plans to cover the charges for these experimental drugs. It doesn’t require state government to cover the costs of right-to-try drugs. It also does this:
111548.3. (a) Notwithstanding any other law, a state regulatory board shall not revoke, fail to renew, or take any other disciplinary action against a physician’s license based on the physician’s recommendation to an eligible patient regarding, or prescription for or treatment with, an investigational drug, biological product, or device if the recommendation or prescription is consistent with protocol approved by the physician’s institutional review board or an accredited independent institutional review board.
111548.5. This article does not create a private cause of action, and actions taken pursuant to this article shall not serve as a basis for a civil, criminal, or disciplinary claim or cause of action, including, but not limited to, product liability, medical negligence, or wrongful death, against a manufacturer of an investigational drug, biological product, or device, or against any other person or entity involved in the care of an eligible patient for harm done to the eligible patient or his or her heirs resulting from the investigational drug, biological product, or device, or the use or nonuse thereof, if the manufacturer or other person or entity has complied with the terms of this article in relation to the eligible patient, unless there was a failure to exercise reasonable care.
In other words, a doctor who recommends an experimental drug under right-to-try can’t be sued or disciplined by the state medical board. Neither drug manufacturers nor doctors recommending right-to-try drugs can be sued for liability. Basically, this bill is a travesty for patients. Under the guise of providing them access to potentially life-saving drugs (which it doesn’t do), AB 1668 basically puts patients with life-threatening illnesses completely on their own. Not very patient-friendly at all. Basically, it tells patients, “You’re completely on your own.”
Perusing other websites about right-to-try, I found nothing to disabuse me of this conclusion. In fact, looking at the FAQ on the Right-to-Try website, I find the same misinformation and lies about right-to-try that I found two years ago. For example:
Q: SOME CRITICS SAY RIGHT TO TRY IS JUST “FEEL GOOD” LEGISLATION THAT WON’T ACTUALLY HELP ANYONE. IS THIS TRUE?
A: No. Right To Try laws give people with terminal illnesses the legal right to use investigational medications years before they might otherwise be available on the market. No one can guarantee that a particular treatment will be effective, but these laws return choice and control over treatment options to where it is most effective: with patients and their doctors.
Actually, it is true. Right-to-try is just “feel good legislation” that won’t help anyone, much less terminally ill patients. Same as it ever was.
Here’s hoping that Gov. Brown shows the same political courage now that he showed last year when the previous right-to-try bill came across his desk. Contrary to how they are portrayed, right-to-try laws are among the most cynical, patient-hostile laws there are. Under the guise of helping terminally ill patients pursue hope, they strip them of many legal protections, open them up to exploitation by drug companies, and sell them false hope.
And they’re enormously popular because everyone wants to help terminally ill patients and so few patients understand clinical trials and drug development. I don't know if Gov. Brown will have the courage to veto the bill a second time, and, even if he does, it'll be back next year, and the year after that, and eventually a future governor will likely sign it. The sham will continue to deceive patients with terminal illnesses and their families.
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I can envision a woo-prone doctor telling a cancer patient, "You can be cut, you can be poisoned, you can be burned, or you can try this experimental treatment." There. The patient has now "considered" the approved treatment options.
And IANAL. If the wording in the rest of the bill is similarly vague, it ought to be possible for a decent lawyer to find other ways to weasel out of whatever minimal protections remain if it passes.
If I were to run a Phase I trial involving a dozen healthy people and wave my hands* over them to ascertain how much hand-waving would cause them harm, would I then be free in a 'right to try' state to charge tens of thousands of dollars for waving my hands over terminally-ill, desperate and/or woo-credible patients, with no liability?
*Assumes hand-waving counts as a device. If necessary, to fulfil the letter of the law, I'm willing to sellotape a healing crystal to each palm (in the correct orientation, obviously -- I'm not an idiot).
That's a lot of words to complain about something and not offer any suggestions for help.
So I'm puzzled: You don't like these laws because they provide hope to people and dying people shouldn't have hope? Or because that hope has YET to be anything but false hope?
Or is it because the bills are poorly worded?
Or is it because people should not have the opportunity to try alternative paths for their own healthcare?
This blog entry is a perfect example of what's wrong with the Internet. Instead of advocating for something that you truly think will help, you spent all those rambling words complaining about something, offering no solution. You know, like IDENTIFY the problem and then OFFER SOLUTION. Identifying problems is very easy to do, we don't need any more words floating around the Internet that simply identify problems.
Note: Like my comment to you. You won't like reading it, probably. But maybe you'll take it to heart the next time you're compelled to write 1,000 words complaining and save 200 of them for: here's how the bills WOULD help...
All of the above were reasons, plus more that I enumerated. Right-to-try bills won't help. There isn't a single good thing for patients in them that I can see, and I didn't even discuss how quacks could abuse such laws. That's why the solution is simple. Don't pass them.
If you don't like what I wrote, no one's forcing you read.
@Jason Deegan: Orac has written here many times about Right-to-try bills and what's wrong with them. There are also excellent posts at Science-Based Medicine about RTT bills that you might find interesting.
The biggest problem is that RTT bills remove all protections from a patient. Get injured by a treatment or die sooner? Tough toodles, dearie, the law forbids you (essentially) from suing. The company wants to charge you 1 million dollars per dose? That's fine, too. And even if it's effective for you, if they decide to up the cost, you get to pay for it if you want to stay on it.
And no, your insurance doesn't *have* to pay for any investigational/experimental services. In fact, most insurances have specific exclusions for such. And guess what? If that treatment injures you (causes bleeding, stroke, whatever) and you need treatment? Insurance won't cover THAT, either, because it was caused by a non-covered service. So that's MORE money out of the poor patient's pocket.
But all the stories don't go into that. They are all testamonial "SEE??? THIS WORKED FOR ME!" and no one asks them how much in debt they are. No one asks the families whose loved one died what horrible debts are left.
Orac isn't against clinical trials. He's against the RTT laws that strip all the protections that people currently have to save them.
And, the bills WON'T help. They'd need to be totally re-written, to help. That's part of the point...
But maybe you’ll take it to heart the next time you’re compelled to write 1,000 words complaining and save 200 of them for: here’s how the bills WOULD help…
The bills won't help. That's the point.
(Dawn, you beat me to it.)
Hope is important, but should not be masked by outrageous claims. The beauty of science based medicine is the search for evidence and the explanation of the meaning of that evidence. J.Groopman wrote neatly years ago. Now, some oncologists faced with a near terminal patient say to the patient we can try this even though no data support it helping.Offering choices as in the earlier statement is not involvement in decision making. That some choose to wager against the odds is different from saying odds not good I'll try something the man preaches with confidence will,help, though he has no data
In addition to the giant whopping loophole of item #1 (the non-defined "life-threatening disease or condition"), this is huge too. The patient has to have considered all other treatment options -- but no particular reason is required for why the patient decided not to use them. In theory, this could even encompass rejecting antibiotics for a child's pneumonia in favor of cupping because the parent doesn't believe in using drugs. Or, more bluntly, rejecting them because the doctor misled them in order to be able to sell them something with less oversight and more personal profit. Really, the ONLY protection this bill offers is the expertise and good will of the doctor, and if the California legislature thinks all doctors are perfectly beneficent and competent, then I have some oceanfront property in North Dakota to sell them.
Well, docs selling fake medical exemptions to SB 277 vaccine requirements shows that not all California docs are perfectly beneficent and competent. :-)
The bills help. They help drug companies exploit desperate patients. These are not "right to try." These are "right to charge."
@Terrie: One of the many issues with RTT bills is that companies with a drug in clinical trials usually won't have extra supplies available to patients who are not enrolled in the trials. The drugs are relatively expensive to manufacture because they are not mass-produced, so they make what they expect to need for the next phase of clinical trials, and little if any extra. There is also a massive amount of R&D at risk here: if somebody outside of a clinical trial has a bad reaction, the company is likely to get a large amount of bad publicity, if not a federal lawsuit (remember, the laws tend to protect the doctor from lawsuits, so the manufacturer is the only party the patient can sue). Whereas if a bad result happens in a clinical trial, they can quietly stop the trial--these things happen, and the patients were informed of the risks.
The real bottom line is that people with highly fatal illnesses are unable to access beneficial generic drugs and even nutrients, long available in other advanced jurisdictions.
People die sooner, they die broke, in great pain because simple molecule or old generics aren't available in the US. Many things that are available in the US are priced 100x or more higher than in a competitive market. Even with \high abilities and advantages, getting basic life and QOL supporting drugs and nutrients can be extremely difficult or prohibitively expensive. It seems like we always have 1-2 supply crises going at any given time. Mostly I blame the FDA type laws.
This specific proposal may not exactly address all these problems, but people are sick of being smothered to death by the FDA and the corrupt cartelization that has occurred. Alter it (favorably) or abolish it...
@prn: go away and infest your usual haunts. You lie there, you're lying here. Your supplements, IV vitamin C, homeopathic crap is out of the question.
You can't treat everything with your freakin' supplements that you sell for way-over-their worth, and have no proof that they actually contain what they are supposed to contain, thanks to Big Supplement tying the FDA's hands over testing.
Yes, the US FDA tests things that may be available in other countries more carefully because of the thalidomide debacle. I know you are WAY too young (or lacking in intelligence) to remember such a thing.
"favorably" to whom?
The FDA has very little actual oversight of supplements & you can pretty much get anything you might want, off the shelf or online, at just about any price for that matter.
Lawrence, several examples.
The FDA specifically "disappeared" pyridoxamine, a cheap B6 vitamin. some years ago by reclassification as an expensive orphan drug with a startup company that financially failed. Injectable vitamin C has ongoing harrassment problems with both the FDA and many of the states. Leucovorin is a form of vitamin B9, where a tablet might be $25 when there isn't a spot shortage, instead of 10 cents and plentiful.
DSHEA did not "free all the prisoners".
MI Dawn, lots of errors and wrong assumptions. I am not selling supplements. The FDA sucks balls at testing in many ways. Testing for many simple molecules simply can't account the cost increases but cartelization effects can. I don't think even Orac would accuse me of being "homeopathic" since you all look so homeopathic to me. It is ***your*** aggressive, arrogant ignorance that is the problem here. Otherwise I wouldn't even be here.
@prn: The FDA isn't ALLOWED to monitor supplements, remember. Because the FDA is mean and all governmenty, and wants guarantees that a pill actually contains the chemicals claimed on the side of the bottle (which most Big Supp doesn't want to list anyway) AND that they are in the amounts listed AND that they actually do what the seller CLAIMS they do.
What's wrong with that? If I buy a bottle of aspirin, that says each pill has 325 mg of aspirian, then I expect each pill will contain that dose. The FDA tests it, so it can guarantee that. I know that aspirin has been tested, is useful for certain illnesses/problems, and is not useful for others. It has risks and side effects, all of which are documented. It warns me what to do if I take too much.
If I buy a bottle of Vitamin D, I have no such guarantees. I could be paying for expensive sawdust. I could be paying for 1/2 or 4 times the dose listed. There are no listings of the risks and side effects. There are no warnings about overdoses. I can't be sure that what I'm using it for is appropriate.
If Vitamins and other supplements were as monitored as a simple drug known as aspirin, people who care about science and medicine might feel happier about their use.
I pains me to say it; but I have a certain sympathy for what prn is saying.
This side of the Pond Big Pharma would never get away with charging such outrageous prices. If a script is written, it's usually for the generic drug.
Hah! I say again, hah! A thousand words you say? Hugely have you failed in even a scant examination of our kind host's other posts, even on the same subject. Why, our Machine Mind Master could toss off a veritable torrent of words fourfold greater than that while polishing his perspex case in the morning.
Re-reading this blog post and determining what was actually said or strongly implied is left as and exercise for the student.
You have it backwards. The US is the competitive market, which means the manufacturers can charge whatever the market will bear. Countries where prices are kept lower are those with government price fixing and/or single payer health insurance (which has far superior negotiating powers than the mottled patchwork that we have here).
Just a quick word to say that I'm alive, sort off well but currently, this is my first migraine ever to land me at the hospital ever (50+ migraines back in 2007-2008, none landed me at the hospital).
Currently in rehab in Sherbrooke city for the next 22 weeks, will have intertoob access in the next 3 weeks.
Yikes, Alain! Was it a complex migraine? That is what landed my son into the hospital. They are truly scary.
Hope all goes well.
Yes, it was a complex one but I guess the cause is a sunburn of the head
Wow. We have no idea what caused son's complex migraine. Best wishes for a full recovery, and not a repeat of that experience.
For lurkers: it is a migraine that is so bad it mimics a stroke. It even causes severely slurred speech, or no speech (the 911 dispatcher heard my son trying to speak in the background, which caused her to make sure paramedics were called immediately). Plus, which was an issue since my son has a heart condition, it effects motor control, etc. My son's left arm went numb.
In short: not "just a headache." While I had learned quite a bit about migraines from hubby's family and having a kid with them, none of us ever knew a "complex migraine" existed until son spent a day in the hospital (his speech was still quite slurred for a while, he even got a few weeks of insurance paid speech therapy).
Hi Alain, missed you. So sorry that sounds dreadful and hope you recover soon.
Calli, competition takes place under many conditions. In the US, the FDA effectively eliminates most of the prescription competitors and competitive alternatives. International prices for the same Chinese/Indian API based generic with adequate QC can be quite different.
I think we have different definitions of adequate quality control, prn. There have been an awful lot of horror stories about Chinese and Indian generic medications.
I'm not going to deny there are problems. There are. But the FDA is little more than a convenient fall guy for these problems, and eliminating regulation will not be the panacea you think it will be. If we want real competition with generics, we need to start seriously publicly funding medical research, I think. Not just the pittance we already spend. We should be spending as much public money on clinical trials as we currently spend on NASA. NASA spending has paid off handsomely in the form of advances in our aerospace industry and technological capacity; why not apply that public investment model to medicine as well?
The only reason more generics aren't able to get into the market is they can't afford to run the trials themselves. So they piggyback off of the trials run by the original manufacturers. But manufacturers are very clever, and they know how to game this, so that this will not always be feasible. Take Ritalin XR. Methylphenidate's been available generic for ages . . . but Ciba was shrewd enough to wait until their patent protection was about to run out before introducing an extended-release version. This happens all the time, where a clearly superior version just so happens to come out right when they're about to lose patent protection. Generic manufacturers may decide it's not worth the bother and expense to chase the old generic.
When it comes to things with devices, they have even more games they can play to elbow generic manufacturers out of the way. Inhaler manufacturers waited until the last possible minute to get approval of their non-CFC inhalers. The law was forcing the switch, but it gave them an opportunity to shut out all the generic manufacturers, who would not yet be able to make the HFA inhalers due to patent protection. Of course the one most in the news right now is the damn EpiPen. There are only two auto-injector manufacturers in the US, and the EpiPen has a clear market dominance as theirs is easier to use. The medication in it is easily eligible for generic status, but the device itself is another matter. Things get muddled when the drug is both a drug and a device, and the rules are different for devices, which as manufacturers of everything have known for a long time, can be controlled by many means, including branding the hell out of them so that you can even use trademark protection to control your competition.
Looks like the only person this might help is Burzynski
Who exactly is a manufacturer under this proposed law? Could I cook up a concoction , call myself a manufacturer of a drug, and offer to sell it to very sick people as an experimental treatment?
(Though it sounds like you're away from the Internet for a few weeks):
Good to hear from you!