When last I discussed the cruel sham that is the tide of "right-to-try" laws that has been flowing through state legislatures to become law over the last year and a half. "Right-to-try" laws, as I pointed out when I first noted the earliest ones being promoted in Colorado, Louisiana, Arizona, and Missouri, referring to them as Dallas Buyers Club bills based on their seeming inspiration from that movie and pointing out how they are very, very bad policy that, contrary to the claims of its proponents, are far more likely to harm patients than help them. In every state in which such bills have been introduced they have passed with little opposition. I expected the same thing to happen with the right-to-try bill (AB 159) introduced in California, and it seemed to be happening, with the bill passing the legislature with relative ease.
Then Governor Jerry Brown did something unprecedented. He vetoed AB 159:
Gov. Jerry Brown vetoed a measure Sunday that would have allowed terminally ill patients easier access to experimental treatments that have not yet been approved by the federal government.The measure by Assemblyman Ian Calderon (D-Whittier), dubbed the "right-to-try" act by supporters, would have authorized drug manufacturers to let patients facing imminent death obtain drugs that are still undergoing review by the Food and Drug Administration.
The FDA does allow for such patients to apply for "compassionate use" access to medications that are still in clinical trials, but proponents of the "right-to-try" legislation say the application can take too long for the gravely ill.
Brown, in his veto message of AB 159, noted the FDA recently streamlined the "compassionate use" program.
"Before authorizing an alternative state pathway, we should give this federal expedited process a chance to work," Brown wrote.
I was amazed. I was awed. My respect for Gov. Brown, which had been rather low when he added an unnecessary signing statement to a law designed to make nonmedical exemptions to school vaccine mandates, thus neutering it, and recovered when he signed SB 277 into law, eliminating nonmedical exemptions altogether, took another tick upward. The reason is that his veto indicates an understanding of why right-to-try laws are a cruel sham, coupled with real political courage. The reason right-to-try laws have been passing so easily is that their proponents have successfully co-opted the terms of the debate, pitting suffering, terminally ill patients who believe that their only hope to live is an experimental drug against the cold, seemingly uncaring bureaucracy of the FDA. What politician wants to be portrayed as taking hope away from such patients? Not many. Indeed, California Bill AB 159 is even worse than most in at least one aspect: It doesn't limit access to terminally ill patients but rather to patients with an "immediately life-threatening disease or condition," defined as "a stage of disease in which there is a reasonable likelihood that death will occur within a matter of months."
Basically, right-to-try laws all follow the same template provided by a libertarian think tank, the Goldwater Institute. The idea is to make it easier for terminally ill patients to access experimental drugs and devices. 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. In addition, they provide no financial support for patients, who are basically on their own when it comes to paying what can be the substantial financial charges. In addition, right-to-try laws 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. That's even leaving aside the fact that drug approval is controlled by the federal government, and 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.
Over the last year and a half, state legislature after state legislature, believing, based on the dishonest propaganda of advocates who claim that the FDA is killing people and the Goldwater Institute cynically featuring the sympathetic stories of dying patients (particularly those with Lou Gehrig's disease) to advance its agenda, has fallen under the spell of right-to-try. It passed in Michigan last year, sneakily pushed through the legislature. Over the last year, state after state passed these ill-advised laws. Not surprisingly, several months ago and more than a year after the first of these laws passed, right-to-try advocates couldn't point to a single patient helped by these laws, and even patients were starting to realize that they've been sold a bill of goods in the name of an antiregulatory fervor to weaken the FDA, which was the real reason all along for these laws. The Goldwater Institute just used terminally ill patients to lobby state legislatures, that and the fact that most people don't understand drug development and think that the arguments for right-to-try sound reasonable because of it. It's no wonder that patients feel betrayed and disappointed. Right-to-try laws, by their very design, create false expectation and false hope.
Because of the widespread misunderstanding of drug approval (specifically the primacy of the FDA over any state law) and the lack of attention paid to the patient-hostile provisions of the Goldwater Institute template for right-to-try laws that strip away legal protections and greatly weaken the right to legal recourse in the case of harm, these laws have passed 24 states. California would have been the 25th. No one seems to realize that the true purpose of right-to-try laws is to build a political consensus to weaken the FDA (as libertarian Nick Gillespie basically admits). Indeed, the Tenth Amendment Center virtually explicitly says as much:
Back in 1996, California voters recognized that keeping medicine away from sick people was a federal policy they could no longer ignore, and they passed Prop. 215 to legalize medical marijuana. The Right to Try Act is based on the same principle. And when enough people and enough states say no to federal bans, there’s not much that Washington D.C. can do about it.
And:
“The Right to Try Act is a no-brainer,” Maharrey said. “When someone is on their deathbed, the fact that FDA regulations would let them die rather than try, has got to be one of the most inhumane policies of the federal government. Every state should nullify the FDA like this.”
Actually, as compelling as this sounds, this argument is far more about appealing to emotion rather than reason. In actuality, given the small proportion of drugs that make it successfully through the whole regulatory process after phase I, patients with terminal illnesses are far more likely to be harmed then helped by releasing experimental drugs that have only passed phase I trials. The frequent retort is that these patients are terminally ill and things can't get worse, but there is something worse than being terminally ill. It's being terminally ill and exhausting the last of your finances and even going into debt. It's being terminally ill and harming yourself so that your are less able to do what you want to do in your short remaining time. It's being terminally ill and dying sooner than you have to.
Moreover, as Gov. Brown noted, the FDA already has a compassionate use program that it is modernizing to make the process less onerous. It's a process that is inherently superior than any state "right-to-try" process because patients who go through it do not give up any of their legal protections, must be monitored the same way clinical trial subjects receiving the experimental drug are, and remain under the regulation of an institutional review board (IRB), which protects human subjects and provides ethical oversight. Gov. Brown is correct; it is foolish for state legislatures to try to interfere with that process until it can be evaluated whether the changes the FDA has proposed in its draft guidance have had an effect. These guidelines even include a provision that, if the application process is still too slow for a particular patient, in an "emergency situation that requires the patient to be treated before a written submission can be made, the request to use the investigational drug for individual patient expanded access may be made by telephone (or other rapid means of communication) to the appropriate FDA review division, and authorization of the emergency use may be given by the FDA official over the telephone," provided the physician explains how the use of the experimental drug meets the statutory requirements and a written submission is sent to FDA within 15 working days of the authorization to use the drug.
I mentioned earlier that, as of several months ago, no one has yet been able to identify a patient whom a right-to-try law had helped to obtain an experimental drug:
However, more recently, a number of questions have been raised as to whether these bills have actually brought experimental treatments to the patients in need, and whether they're even necessary because of a more simplified FDA compassionate use program.
Dr. Arthur Caplan, director of the Division of Medical Ethics at New York University's Langone Medical Center, who's also part of the NYU Working Group on Compassionate Use and Pre-Approval Access, told reporters in late August: "It's fair to say we haven't yet found a case where right to try laws have facilitated access to anything."
Caplan and several others also previously wrote in Health Affairs that although the "laws have created an expectation that terminally ill patients will be able to quickly access potentially life-saving treatments by being exempted" from FDA rules, "this expectation is, quite simply, false.
"Putting aside the invalidity of RTT laws [because of federal law preempting state law] and the false hope they create, these laws also fail to address more fundamental health and safety issues. RTT laws seek to grant vulnerable patients access to unproven and potentially harmful drugs or other medical products without any expert safeguards, such as scientific or ethical review by an Institutional Review Board or similar body," Caplan and others wrote.
Exactly.
Right-to-try laws sound on the surface to be compassionate and reasonable. They are nothing of the sort. Unfortunately, it's not at all a given that Gov. Brown's veto will stand. The bill passed the California Senate by a vote of 40-0 (even the normally science-based Senator Arthur Pan, co-author of SB 277, voted for it) and the Assembly by a vote of 76-2. Not surprisingly, its supporters are already lobbying the legislature to override Gov. Brown's veto. It wouldn't surprise me if they succeed, but I hope that they don't. Either way, Gov. Brown has shown us that it is possible to say no to this onrushing madness.
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Precisely.
We are not talking about fast-tracking clinically tested drugs into general availability, but about drugs taken from a much earlier stage of the trial gauntlet.
(cherry on the cake: the provider may start wondering, why even bother completing the trial, if he is already allowed to sell his stuff)
A few failed drugs turned out to kill the patient along his cancer. That's not the sort of medicine one would like to facilitate access to.
Helping these terminally ill patients into joining existing clinical trials may be a more efficient approach, for all people concerned - these patients with an urgent need, the medical/scientific community, and all the future patients.
In short, the Tenth Amendment Center is making a big assumption in its approach:
Until they prove their effectiveness around phase III trials, drugs and protocols under scrutiny are not "medicine".
Circular reasoning and appeal to emotion all-in-one.
The Goldwater guy said:
The word "nullify" should create a big echo on people's wingnut radar.
This weekend Governor Brown also signed SB792 into law, requiring that daycare workers get MMR, TDaP and the influenza vaccine.
Good run of protecting people's health.
The Yellow Water Institute for Flappy Paddle Babies will not be happy about this.
Good.
Let these mendacious shitheels volunteer as the Phase I test subjects if they want research to move faster. That way the seriously ill patients they are so concerned about can go on the safer Phase II trials instead, once the worst toxic effects have been figured out on truly deserving cases.
I'm sorry, I'm finding this needlessly paternalistic and seemingly motivated by a distaste for who's pushing the law than its merits. How is this substantively different from the FDA's compassionate use program? Why do you object so strongly to having two different pathways to that?
@ Hal_10000
How so? Be specific.
I believe Orac was very clear on that.
In no particular order, this proposed second "pathway"
- is providing mostly false hope, by giving the illusion of access to effective treatments, whereas most of these treatments are most likely non-effective, if the usual pattern of 1 drug out of 10 getting approved is any indicator
- is being set on a lower threshold of acceptance than the FDA's; thus, more risky/unproven drugs getting in
- is circumventing the FDA compassionate use's pathway; and thus, weakening or neutering the FDA actions
- is allowing untested treatments to jump ahead of rigorous scientific/medical scrutiny (a scattering of unsupervised individual patients is not providing as much and good information as a full-fledged clinical trial).
Thus, in the long-term, Right-to-try is actually detrimental to patients because it will take longer to distinguish between a truly efficient drug and a oddball one with hidden flaws (imagine Vioxx provided as RTT).
HAL10000 -- Orac already said it well:
In other words, even if these patients are dying, it's not true that they have "nothing to lose".
The failure of RTT laws to provide these protections really betrays the health freedom beliefs underlying them. If it were actually about the patients they could easily incorporate these protections into the state laws. But it's all part of the libertarian agenda to weaken any kind of government regulation.
@HAL10k: Orac explained the difference between the FDA compassionate use program and right to try:
A drug that has not passed clinical trials is still an experimental drug, so by definition any treatment program that uses such a drug is a medical experiment. There is a reason medical experiments are strictly regulated (e.g., the Tuskeegee syphilis experiment, not to mention you-know-who across the pond). These "right-to-try" laws encourage, and in some cases require, doctors to perform unethical medical experiments.
Eric -- Nice dodge of a Godwin there! [golf clap]
Because one (right to try) is a sham that gives patients false hope and strips basic ethical and legal protections away from patients. The other (compassionate use) does not.
And in other news, our equivalent over here (the Saatchi Bill) is re-appearing in yet another form as a private member's bill soon...
I am so looking forward to a new set of misinformation about what this bill proposes, rather than what it is, i.e. a Trojan Horse for untested and very likely ineffective treatments and outright quackery...
A link, should anyone be interested:
http://www.stopthesaatchibill.co.uk/
Huh. I see that the initiative campaign against sb277 decided to crash and burn.
http://www.latimes.com/local/political/la-me-pc-vaccine-law-foes-fall-s…
I would think that any state that passes a RTT law would be opening the state up to a large liability law suit. Regulating drugs, I believe, is well within the police powers of the federal government and does not reside in the states.
Scenario: Someone with cancer finds a company that is testing laetrile and lives in a state with a RTT law. We know laetrile is a wooist drug and the FDA would never approve it. The person takes laetrile (under the RTT) and dies. The state has given tacit approval to a drug that is known to be a fraud. Would the state then be liable for this death?
IANAL, but no because:
- Sovereign immunity, as codified in the 11th amendment to the Constitution.
- Not forbidding you access to a treatment does not equal approval, even tacit. Otherwise, any death caused by something that's legal - even if it is regulated - would be the subject of a lawsuit. Likewise, any libel suit would include the state as a defendant, since the state allows people to publish things without prior approval.
Not to mention that the RTT laws could be the death knell for small biotech and pharma companies. Usually you only make enough of a new treatment/drug to run your clinical trials. You calculate *exactly* how many people you need in a trial to show safety and efficacy, and no more.
Because making treatments/drugs is expensive, especially if you don't know if it is going to work. So to be told "you must give the drug to so-and-so who can't be part of your clinical trial because they don't meet the inclusion criteria" could mean "you can't complete this trial properly, and therefore can't get approval, you're all laid off".
IANAL either, but as MO'B says, the state is probably immune.
The prescribing physician, OTOH, is likely to be in a world of trouble. As I said upthread, he would arguably have conducted an unethical medical experiment. So unless the state law specifically excludes it, he could be sued for that. Alternatively, he--and the hospital or institute with which he is affiliated--could find themselves subject to a federal investigation. With penalties up to and including suspension and debarment. That's potentially bad news if the doctor is affiliated with a medical school--at almost every university with a medical school, the medical school is the leading procurer of external research funds, and the overhead that comes with those funds. If an institution were debarred, that would blow a big hole in their budget.
@JustaTech: Again, IANAL, but my guess is that Little Pharma would have recourse if a state tries to coerce them into providing an experimental drug under RTT. Federal law trumps state law, so if they cannot comply with both, they must comply with federal law. Unlike the next-of-kin in Rich Bly's scenario, the company would have grounds and standing to sue the state.
So to be told “you must give the drug to so-and-so who can’t be part of your clinical trial because they don’t meet the inclusion criteria” could mean “you can’t complete this trial properly, and therefore can’t get approval, you’re all laid off”.
Right to Try doesn't require the drug company actually provide the drug. It just permits the drug company to do so.
Nick Gillespie make it quite clear in his writing that he wants the FDA completely gone. He insists that market forces will do better to protect patients than regulation, apparently completely unconcerned of the realities of the US drug market before the FDA, or the current reality in nations with lax regulatory oversight.
I don't know if he simply hates regulation more than he cares about patients, or if he really is this bad at critical thinking. But I'd trust his opinion on patient safety about as much as I'd trust a fox arguing in favor of free-range chickens.
Yes, until fairly recently I never seriously believed that there were people who actually thought that there should be, in essence, no regulation of drugs and that the free market would protect patients. Normally, the argument is made in the form of something like this: Without the FDA, private companies or organizations would take over the function of assuring drug safety, the way UL does for electrical products. It's an utterly nonsensical argument, of course, given history and what drug development was like before the FDA, but people like Nick Gillespie really believe it.
Orac,
I do seriously believe such irrational peoples can and do exist. For years. Of course, they are at the 6th sigma of the bellcurve or irrationality but then, it's the extreme end of the population's behavior for which, the extreme subject, I've been studying because they give a really good example of the population's behavior because they are extremely overt about what the rest of the population may want to hide. I hate to use that context to pitch in my blog but I just wrote about it:
http://www.securivm.ca/2015/10/social-engineering-using-scientific.html
More often than not, I am in error and I do think about my hypothesis of the population having the same belief at a far lower level as compared to extremists but I am always working on my mistakes and learning. You can see why in my blog post.
Alain
I am thrilled to read this--someone in Brown's office either read the bill, or listened to someone who had.
"He insists that market forces will do better to protect patients than regulation, apparently completely unconcerned of the realities of the US drug market before the FDA, or the current reality in nations with lax regulatory oversight."
Ah yes, what I like to call the market fairy. The magical market fairy solves all problems, no matter how complex.
Imagine my surprise to discover that the same libertarians pushing for the abolition of the FDA are also pushing for "tort reform", to make it harder for customers claiming to have been injured by products to sue the suppliers thereof, as apparently such abusive lawsuits are holding back innovation.
If a free-market medication kills you, or just lets you die from ineffectiveness, the approved libertarian response is not to sue, but simply not to buy that product again.
@ hdb
Eh, it's so logical, my grandma can do it, why can't you commie/liberals/sheeple do it and you insist on being a slave of the government?
The FDA (or similar European organizations) may be slow to react, but I'm afraid the invisible hand of the market is even slower and less effective.
To start with, the market doesn't care about effectiveness, just about sales figures.
As long as you keep changing your snake oil name to keep selling it, and/or blame the harmed customers for not having followed the protocol scrupulously enough (plus, this little matter of the cheeseburger you ate 10 years ago, or your granddad having been vaccinated), you will stay in business.
That's actually something Big Pharma is doing, if one wants to be honest, at least in the cosmetic/vitamin fields. Let's add some vit E to our anti-aging cream, glue a new fancy name on the box, and voila. A whole new product, totally not like our previous brand.
I have also seen the theory that there is no need for the FDA or the option of tort law, because no-one company would sell a product that kills customers (or even lets them die) -- to do so would lower the company's future income. Market forces will prevail!
Sometimes it is even the same people as subscribe to conspiracy theories in which the pharm companies are suppressing the real cure for cancer, to maximise their income, because of those evil market forces.
@ hdb
Well, it's true it's gratifying for one's ego to produce something which is working, and having customers staying alive so they can come back is not a bad business model, either.
But how people would know, if no-one is looking at the product's effects?
Libertarians seem to ascribe the god-like power of omniscience to the customers.
Under this libertarian model, Vioxx and the thalidomide racemic would still be happily sold to an unsuspecting audience.
Something something Dan Savage something.
Bob@22:
The invisible hand of the free market promised to give me a reach-around, but all I got was my pocket picked and a lot of bloody stool.
The continued existence of companies that sell tobacco products is disproof of this proposition. The US Surgeon General has been warning for more than 50 years that cigarette smoking causes lung cancer. You can still buy cigarettes in the US, as long as you are at least 18 years old. And in some countries, the fraction of the population that smokes is still increasing--China and Indonesia in particular.
As for the "invisible hand of the market": I am reminded of an old New Yorker cartoon with the caption, "There it is again--the invisible hand is giving us the finger."
On the same line, an old joke:
Q: How many Chicago School economists does it take to change a light bulb?
A: None. If the light bulb needed changing the market would have already done it.
" no-one company would sell a product that kills ( or even lets them die)"
And YET we have Burzynski, Clement, Gonzalez, Gerson and various entrepreneurial woo-meisters** who promise cancer/ other cures without SBM
** one of whom is opening a spa/ health resort/ medical counselling service in Texas
@ perodatrent:
Ha ha!
We got my son indo a medical device study under Compassionate use.
It did not seem to me an onerous process. Although I know I was shielded very well by his Docs.
Said device is now approved so he actually did help advance medical science. Yay!
It took a couple of months, but since we saw this coming from way out, it was well planned
I would hesitate to sign him up for another device that was in a much earlier stage.
So many questions so many risks. I understand the allure, and as compared to a drug, his device is pretty simple. But there has be deliberate debate and understanding of benefits and risks.
Under this libertarian model, Vioxx and the thalidomide racemic would still be happily sold to an unsuspecting audience.
Don't be silly - once all the women who had horribly deformed babies wrote terrible reviews of thalidomide on Yelp, potential customers would read them and stop buying it - the perfect market-based solution! Except for the thousands of lives that have to be sacrificed before-hand, of course.
The thing with the invisible hand is that it’s, well...invisible.
Big thumbs up to Jerry Brown!
Sarah A: Won't work. Flappy paddle babies are obviously their OWN fault for not believing hard enough.
(Hey, it works for sCAM.)
This is the thing so many of the libertarian persuasion ignore. Most regulations exist because they were designed to prevent a recurrence of practices that resulted in death or substantial harm to a bunch of people. It's not just the pharmaceutical industry, either. Lawnmowers nowadays have a dead-man switch which shuts them off when the operator lets go; when I was a kid, that switch wasn't universally present. Seat belts and airbags in cars are another example. Their purpose is to prevent needless death and injury.
Furthermore, in the case of health care, we did the experiment in this country--that was the situation before PPACA came into effect. The system was so obviously broken that even the Heritage Foundation was advocating a fix--PPACA was based on a system originally designed by the Heritage Foundation. A necessary (but not sufficient) condition for free markets to work is that buyers and sellers have all available information and can take it into account. For many medical conditions, that isn't true: you need treatment, and you need it now, even if the immediately available provider isn't the best.
The lack of any kind of regulation for consumer goods, particularly food, was the reason behind the boom in Home Economics education from the turn of the century through WWI. In addition to everything else they had to do (reading about housework prior to the invention of the vacuum cleaner and washing machine makes me shudder), women were encouraged by magazines like the Ladies' Home Journal and Modern Priscilla to become testers/researchers of canned goods, etc to protect their families.
It was considered a suitably lady-like application of the study of chemistry and the reason two generations of female undergrads interested in science were steered towards the Home Ec department.
@has (#32):
Maybe you should keep your wallet somewhere else..?
Under this libertarian model, Vioxx and the thalidomide racemic would still be happily sold to an unsuspecting audience.
For many years it was a refrain among libertarians that by keeping thalidomide off the market, the nanny-state FDA was denying people access to a wonder drug, when a simple warning about contraindications would have sufficed
@HDB #44
I might actually be sympathetic to that argument - with the MAJOR caveat that you can't warn people about contraindications that you don't know about because you haven't tested for them yet because you're in a rush to get a drug onto the market. I remember when I worked briefly as a pharmacy tech there was a prescription acne drug that women of childbearing age had to fill out and sign a form stating that they understood that the drug caused severe birth defects and that they were on two forms of birth control before they could get it. So obviously it is possible to sell a drug that causes birth defects if the proper precautions are taken. The problem with thalidomide, as I understand it, was that it was being marketed to pregnant women before adequate testing had been done in pregnant animals. Similarly, many people argue that Vioxx is worth the relatively small increased risk of a heart attack for a patient who is in chronic pain that doesn't respond to other drugs. The problem wasn't with the drug per se, but with the fact that Merck tried to hide the evidence that it increased heart attack risk - which is another counterexample to the claim that pharmaceutical companies can be trusted to police themselves because its in their own best interests not to sell defective products.
^Tag closing fail - only the phrase per se should be italicized
Bob @21
Probably both since Gibbertarain implies a lack of both empathy and critical thinking.
@ Militant Agnostic:
But libertarian Mike Adams ( Natural News today) insists that lefties are the ones lacking higher mental functions, religion and skill with mathematics and economics. Indeed, if you de-activate a part of righties' brains, they become liberals! ( He uses the words MR amongst others).
Mike exemplifies cognition itself or so he tells us. He studied that stuff.
IOW, he's still projecting like a multiplex movie theater. Which I find about as surprising as news that the Pope is Catholic.
I've actually read Das Kapital. I don't see any major issues with Marx's economic analysis: he correctly identified a major trap to which capitalism is prone, and into which it did routinely fall up to and including the 1930s (and arguably during the 2008 financial crisis as well). His political analysis is another story entirely. It's unfortunate that the latter proved so much more influential than the former. I'd rather deal with Marxists of the Groucho type than the Karl type.
I'd say that communism and libertarianism are alike in two key respects: (1) They are superficially appealing political theories. (2) Successful implementation of either one requires several counterfactual assumptions about human nature.
Given that terminally ill patients would not be around long enough for Vioxx to manifest a heart condition, nor that they are likely to be pregnant, I don't understand the vehement opposition here. No one is going to ask for a random drug in testing out of the blue. There has to be some basis wherein they think there will be some benefit (like it has been approved in Europe and used off-label for a condition with some success).
This post is poorly reasoned and reactionary, using the libertarian bogey man and the specter of thalidomide to squelch an otherwise reasonable proposal. If they have months to live, and are paying for their medicine themselves, really, at that point, why not let people try?
Read the links to my previous posts on Right To Try. That's why they're there; so that I don't have to repeat my arguments in detail again. Here they are, in case you can't find them in the text:
http://scienceblogs.com/insolence/2014/03/06/right-to-try-laws-are-meta…
http://scienceblogs.com/insolence/2014/08/14/the-cruel-sham-of-right-to…
http://scienceblogs.com/insolence/2014/08/19/usa-today-flubs-it-big-tim…
http://scienceblogs.com/insolence/2014/10/28/ebola-right-to-try-laws-an…
http://scienceblogs.com/insolence/2015/05/25/the-cruel-sham-that-is-rig…
http://scienceblogs.com/insolence/2015/05/26/the-cruel-sham-that-is-rig…
Bottom line: Right to try laws are a sham. They give the illusion that the state is doing something without actually doing anything. Worse, if they were to succeed in doing anything, it would be to screw terminally ill patients by letting companies suck the last bit of their cash from them or forcing them to go on Internet fund raising drives for the short remaining rest of their lives, while stripping the protections provided by the FDA and Office for Human Research Protections provide by requiring that single-patient INDs be approved and overseen by an IRB to protect the patients' rights and interests. Even the libertarians supporting them admit now that they don't do anything. Their fallback is to actually admit what was the real purpose of these laws as if it were new and not the idea all along: To put pressure on the FDA and weaken it.
@ rogue
My apologies, the conversation drifted. I wanted to use examples of drugs which everybody know as having heavy side-effects in a subset of the population.
However, "terminally ill" doesn't mean you are going to die within two weeks. It's a catch-all sentence used for patients with a few weeks left as well as for people with up to 6 months left, or more.
I daresay that, for those on the higher end of the time frame, medium- to long-term effects will have time to manifest. That's not a trivial risk.
Nitpicking, but a few unfortunate women do find themselves with an advanced cancer - or other life-threatening illness, like AIDS - and pregnant at the same time.
Granted, in their cases, it's more about choosing between the fetus' or the mother's life, because the treatment will affect the fetus in a deleterious way, rather than the lack of access to efficient medication.
OTOH, RTT laws could grant these women access to barely tested drugs, and I'm not thrilled discovering the hard way that these drugs are inefficient AND teratogenic.