I hadn’t expected to write about this topic again so soon, but then I didn’t expect a major newspaper to have written such a boneheaded editorial about it. In a way, I hate to write this post, because USA TODAY did great things once. There, Liz Szabo wrote the single best science-based report on cancer quack Stanislaw Burzynski. Still, even usually reliable news outlets make mistakes, and in this case the editorial board of USA TODAY made a huge one when it published an editorial entitled FDA vs. right to try: Our view. Seriously, if there’s a case to be made for right-to-try laws, this editorial sure doesn’t make it. Heck, I have a hard time telling whether whoever wrote this actually bothered to read the various right-to-try laws, so off-base are the arguments used.
If you don’t know what I’m talking about, now’s as good a time as any to review the various aspects of “right-to-try” laws in the form of some old posts of mine and one by Jann Bellamy:
- The illusions of right-to-try laws by Jann Bellamy
- Dallas Buyers Club-inspired “right to try” laws: Good movies don’t make good policy
- The cruel sham of “right to try” comes to Michigan
Now, on to the USA TODAY article. It starts out with a comparison that seems reasonable on the surface but is really comparing apples and oranges. I’m referring, of course, to the recent moves on the part of health officials in the US and Africa to try unapproved drugs to treat Ebola virus disease, citing this discussion by the WHO regarding the ethics of using unapproved treatments for Ebola. On the surface, comparing this to the sorts of patients who would be eligible for right-to-try laws seems like an appropriate comparison, but it’s not. First, there’s a big difference between Ebola virus disease and the sorts of diseases that will drive patients to seek experimental drugs under right-to-try. Ebola virus disease is not a terminal illness. As I’ve discussed before, nearly 50% of people infected with it, if they receive modern medical care, will survive. Indeed, it is for this very reason that I’m not entirely convinced that using the experimental drug ZMapp, the experimental drug consisting of three different monoclonal antibodies against proteins of the Ebola virus, is wise given a benefit-to-risk ratio that is virtually completely unknown. After all, it hasn’t even passed phase 1 trials yet, which, ironically, means that it wouldn’t be eligible for use under right-to-try, even in states where right-to-try has passed, Colorado, Missouri, and Louisiana. Also, ironically, this tells us that the FDA has broad power to grant compassionate use exemptions even more liberal than right-to-try, which more than bolsters the argument that if any reform to the compassionate use exemption/single patient IND process needs to happen at the federal level.
Another factor to be considered is that Ebola is an infectious disease that is rapidly fatal (as in days, not weeks or months), and Africa is in the middle of the largest Ebola outbreak in history. Certainly these are mitigating factors, particularly given that the sorts of drugs that would be used in right-to-try would be highly unlikely to save a life, because by the very definition of right-to-try, only patients with a terminal illness qualify. In a rapidly fatal infectious disease, the equation is different, with a higher likelihood of making a difference than in truly terminal illnesses. Again, even so, it’s not clear to me that releasing ZMapp to the two Americans was a good idea. Both got better, but we still have no idea if it was due to the ZMapp or if they were among the 45% or so who survive.
The USA TODAY editorial then regurgitates the same old talking points that right-to-try advocates have been pushing for ages:
The process for getting experimental drugs is so daunting that fewer than 1,000 people sought and got federal approval to take such drugs last year.
Food and Drug Administration rules require patients to clear a series of hurdles. First, they and their doctors must find a company to provide its drug. Many drug makers — worried that a patient's death will spur a lawsuit or harm their chances for final FDA approval — refuse.
Even then, patients still need a hospital review board to sign off, a contract between the hospital and the drug maker, and FDA approval. The FDA application process, according to its own estimates, can take up to 100 hours.
Now, the bureaucratic absurdity is generating a backlash.
Colorado, Louisiana and Missouri recently approved "right to try" laws, which seek to simplify the process. The Michigan Senate passed a bill last Wednesday; in Arizona, an initiative will appear on the November ballot.
These carefully crafted measures allow patients and their doctors to go directly to a pharmaceutical company to seek access to drugs, but only those that have cleared the first phase of clinical trials and remain in development. The laws protect drug makers from lawsuits. And, pointedly, they seek to cut out the FDA, which now has final say.
First, as has been pointed out before, the FDA approves the vast majority of compassionate use exemptions. Granted, the paperwork burden can be excessive. In particular, it’s truly off-base to include the hospital review board signing of as part of the “bureaucratic absurdity” regarding compassionate use exemptions. Either that was an oversight, or the person writing the USA TODAY editorial is utterly clueless about clinical trials and drug approval. That “hospital review board” is called an institutional review board (IRB), and its task is to protect the rights of human subjects in research. If there’s one thing you don’t want to tinker with too much, it’s IRB approval. Similarly, in this argument we see the same wishful thinking and fantasy that are always at the heart of arguments by “right to try” advocates, who seem to think that there are all manner of drugs out there that can save the lives of patients with terminal cancer or diseases like amyotropic lateral sclerosis. As I’ve pointed out multiple times, the vast majority of drugs won’t make it through clinical trials to be approved because they won’t demonstrate efficacy and/or adequate safety to be approved. so the chances of prolonging life significantly taking unapproved drugs. The chances for causing harm are therefore much greater than that the drug will help. Just as bad, testing drugs like this outside of clinical trials, unless the drug being tested is the rarest of the rare “miracle” drug, is unlikely to provide usable information about efficacy, although such use can provide information about adverse effects.
USA TODAY is right about one thing. These bills are “carefully crafted,” but not to do what USA TODAY thinks. They’re usually portrayed as being a spontaneous movement among patients and patient advocates. To some extent that’s true, as right-to-try has roots in AIDS activism. There’s a reason why some of its advocates refer to it as the “Dallas Buyers Club law.” Several years ago, the Abigail Alliance promoted similar laws, efforts that resulted in a US Supreme Court ruling that patients do not have a Constitutional right to unapproved drugs. However, this latest round of right-to-try activism has the fingerprints of the libertarian Goldwater Institute all over it. Indeed, the Goldwater Institute is flying its flacks to states considering these laws. (I know it did so in Michigan last month.) If you look at the text of the right-to-try laws already passed and right-to-try bills under consideration, you will see that they are almost identical to the Goldwater Institute’s model legislation.
The intent of the Goldwater Institute can be gleaned in its policy paper, Everyone Deserves the Right to Try: Empowering the Terminally Ill to Take Control of their Treatment. Particularly obvious is the part where the Goldwater Institute bemoans the expansion of FDA authority in the 1960s by the Kefauver-Harris Amendments that required that the FDA not just to demonstrate safety but efficacy as well. This expansion of FDA power was in reaction to the thalidomide debacle, leading the Goldwater Institute to make the rather bizarre (OK, very bizarre) argument that because the issue with thalidomide was a safety problem, not an efficacy problem and because thalidomide was never approved in the US (mainly due to the FDA, let’s not forget), the expansion of FDA power in response to the thalidomide debacle was “unwarranted”? As I discussed before, the report itself is also loaded with emotionally charged language about the FDA and terminally ill patients and a whole boatload of highly dubious statements. Every experimental drug is apparently “potentially life-saving,” at least the ones that made it through phase I trials, which apparently is enough to be “deemed safe by the FDA” (at least if you are foolish enough to believe the Goldwater Institute’s talking points).
Reading the model legislation itself, one will see an extreme emphasis on protecting companies providing experimental drugs and physicians who recommend them from lawsuits. Moreover, it’s a very libertarian law. Patients are completely on their own. They have to pay for everything themselves, and that liability doesn’t end after they die. There’s a specific provision stating that the drug company can go after the patient’s estate. There’s another provision that states that “the patient's health plan or third party administrator and provider are not obligated to pay for any care or treatments consequent to the use of the investigational drug, biological product, or device,” the exception being if it’s in the contract that the health plan pay. In other words, if a patient uses an experimental drug under right-to-try and suffers a serious complication, the patient’s health insurance plan doesn’t have to pay for the medical expenses necessary to take care of that complication.
So what does this mean? Basically, it means that only the rich will be able to take advantage of the provisions of right-to-try; that is, assuming that the laws aren’t struck down as unconstitutional. Of course, what the Goldwater Institute is counting on is the same thing that’s happening in states that have legalized marijuana for recreational use: That the federal government (in this case, the FDA) will decide that it’s too much trouble to enforce the law. While it’s true that there are inequities in the clinical trial system, these tend to be based more on geography and difficulty traveling to medical centers offering clinical trials. For right-to-try, it’s a pure, free market paradise, where companies can charge as much as they want for drugs that have only passed phase I clinical trials. I could see unscrupulous pharmaceutical companies resurrecting drugs that have passed phase I but went no further, opening phase II trials to which they don’t plan on accruing very many patients. Step 3: Profit.
To get an idea of what I mean about the libertarian bent of these laws, take a look at what Christina Sandefur of the Goldwater Institute says after being challenged with an observation that what right-to-try is all about is not helping terminally ill patients but rather letting those who can afford it (i.e., the rich) have unfettered access to experimental drugs:
— Christina Sandefur (@cmsandefur) August 13, 2014
Note the false dichotomy and how she ignores the likelihood that right-to-try laws will harm far more people than they are likely to help.
Bioethicist Art Caplan hammers the financial inequity in his response, FDA is not the main problem. There, he identifies this key problem with right-to-try laws, namely that they leave patients completely on their own far more than even the most lurid nightmares about our current clinical trial system promulgated by the Goldwater Institute to portray it as the worst injustice to patients known to humans. That’s the dirty little secret of “right-to-try.” What disappoints me about Caplan’s response, is that that’s the only aspect of these bills he concentrates on. Nothing about the dangers. Nothing about the exaggerations of the potential benefits and minimization of the risks. I realize he only had around 500 words, if that, but I’m not sure that financial issues were the ones to focus on, although I do give him props for this:
Right-to-try laws are basically "right to beg" laws. Begging is not what the dying and desperately ill should be asked to do. Legislators should stop enacting feel-good laws and show they care by finding the money to pay for experimental drugs and the travel and expenses involved in getting to them.
ADDENDUM: Looking at it again, I just noticed something about the Goldwater Institute model legislation. Remember how I was puzzled about how the Michigan right-to-try legislation had changed its wording about the disease to which it applies from “terminal illness” to “advanced illness”? Take a look at the model legislation. What does it say? Yep. “Advanced illness.” Now I know why the Senate bill in Michigan was changed. It was changed to match the new Goldwater Institute template. Does anyone wonder why this might be? I don’t. Clearly, this change in wording opens the way for such laws to apply to more than just terminal illness. Unfortunately, it was also passed by the Senate last week. True, the Michigan version states that "advanced illness" means the same thing as "terminal illness" for purposes of the bill, but that would be easy to change, and the Goldwater Institute template says no such thing now.
Does anyone still doubt that the intention of these laws is to open up right-to-try to everyone and thereby gut the FDA’s authority, bringing us back to the libertarian paradise of the days before the FDA, when wandering snake oil salesman wandered from town to town, selling their nostrums? We’re told that we don’t need the FDA because the “market” will protect us. Remember how well that worked out last time.
It's even worse than last time, since at least back in the days of Nostrums you could sue in court over this, drawing attention to it even if you didn't win anything (or had to settle). Now, the special legal protections for providers of the "right-to-try" experiments almost seem unnecessary since any such provider in the US is almost certainly going to require the patient to sign an agreement agreeing to mandatory arbitration over any malpractice issues (along with an NDA).
I was a little sympathetic to "right to try" laws at first, too, for terminal patients. If they're trying these treatments out, they've already decided they don't want to simply wait for death on palliative care - they'd rather risk it and shorter life remaining on experimental care. But the FDA already has a "compassionate use" program, if you can wing it.
Does anyone still doubt that the intention of these laws is to open up right-to-try to everyone and thereby gut the FDA’s authority, bringing us back to the libertarian paradise of the days before the FDA, when wandering snake oil salesman wandered from town to town, selling their nostrums?
Also worse than last time. At least with the Snake Oil Nostrums, all you had was some con-man huckster's word on it. Want to be every single one of the treatments that shows up if Right-to-Try becomes a reality on the ground will tout about how they're "FDA approved" because they passed a Phase I trial? It's worse than mere sham and ignorance.
By law, the FDA is not allowed to regulate "Homeopathic drugs" (aka water and sugar pills) with regards to efficacy and safety. That's why every day I see parents telling me that brand so-and-so's homeopathic teething pills don't seem to help much with their infant's teething pain. When I explain the quackery that is homeopathy, a majority of parents will then ask why are homeopathic medicines allowed to be sold in pharmacies. I will then inform them it is legal thanks to the passage in the 1930's of federal legislation (sponsored by a homeopathic US senator). A lot of parents will then inquire as to why someone in Washington doesn't repeal that law so parents don't waste their money on medicines that don't work. It's a good question.
Right-to-Try effectively does the same (albeit at a state and not federal level) for drugs just entering the FDA approval process. Will people soon be asking the same questions about Right-to-Try drugs with regards to a loved one who was hurt, killed, or didn't live long on a Right-to-Try drug? Worse yet, will we start to see fewer new drugs entering the FDA pipeline due to this misguided legislation?
We are all "terminal". None of us gets out of this gig alive. But popular opinion in the US prefers to avoid the reality of unavoidable death. Popular opinion--based on clear increases in CAM and Right-to-Try laws--also wants the "quick fix" (aka the "Easy Button") when it comes to medicine and medical treatments. There is no "Easy Button". Modern science-based medicine didn't get to where it is overnight or through anecdotal drug "trials". This will be a step backwards for science-based medicine--and much more importantly patient care-- if these "Right-to-Try laws are passed.
Another downside of right-to-try: If the experience of those who acquire therapy under right-to-try laws suggests that the treatment might be effective, it becomes nearly impossible to do a real clinical trial. Who would want to be randomized to placebo? So the right-to-try laws threaten our ability ever to establish safety and effectiveness reliably.
This news is troubling to me. Yes, once in a blue moon some treatment may appear that seems to be a cure for some heretofore untreatable illness. But the risks simply don't outweigh the benefits. Add to that the very real potential of the FDA being short-circuited by these laws and it could get really dangerous. This is also the big danger to Rand-style laissez faire libertarianism -- the most ruthless are not checked by anything but the civil courts, and few of their victims will be in a position to sue.
(PS: I just noticed . . . there's a "Expose Orac" Facebook page ? you're famous! )
"(PS: I just noticed . . . there’s a “Expose Orac” Facebook page ? you’re famous! )"
Oo, and a blog too.The blogger (who really really loves Jake Crosby) attacking Orac's "anonymity" has an "about me" section featuring a blank where a photo should go, and absolutely no personal information.
The irony, it amuses.
I notice that the blog has four posts on it, the last from 2012. The Facebook page is similarly lame.
The other day, Jake broke the so-called big news ( via Focus Autism) that CDC malfeasance has been exposed by Brian Hooker with the assistance of a whistleblower: it seems the agency covered-up an MMR-autism "link" ( African-American boys given the MMR later had less autism).NOW AoA and TMR have jumped on the bandwagon as they finally have the PROOF they require.
-btw- there's even a video from Andy compariing the CDC's malfeasance to the Tuskegee syphilis experiments.
A sceptic can only ask: them Are you serious?
there’s a “Expose Orac” Facebook page
Orac hasn't exactly gone to great lengths to keep his identity a secret, so such a page (or blog) wouldn't be telling us anything we didn't already have the option to know, if we chose. As he has mentioned here before, Orac has another blog on which he uses his real name. I once followed a link to the latter blog and immediately recognized his writing style. I'm sure others, critics as well as fans, have done so, too.
As for the topic at hand: Yes, it's obvious that the goal is to neuter the FDA, because an effective FDA is Evil Government Regulation. In Libertarian World, there is no other kind of government regulation. They forget why it was necessary to create the FDA (and dozens of other alphabet soup agencies) in the first place.
Libertarianism, like Communism, is an attractive political theory as long as you don't stop to consider how you would successfully implement it in a society consisting of actual human beings.
there’s even a video from Andy compariing the CDC’s malfeasance to the Tuskegee syphilis experiments
As for the topic at hand: Yes, it’s obvious that the goal is to neuter the FDA, because an effective FDA is Evil Government Regulation. In Libertarian World, there is no other kind of government regulation. They forget why it was necessary to create the FDA (and dozens of other alphabet soup agencies) in the first place.
Indeed. The people supporting these right-to-try bills and laws genuinely think that they are making things better for terminally ill patients when really what they are being co-opted to do is to help the Goldwater Institute weaken the FDA to the point that it is an ineffective shell, barely able to guarantee the safety, much less the efficacy, of drugs and medical devices. This will make things much worse, not just for terminally ill patients, but for all patients; i.e., all of us.
Chris Hickie @2:
a homeopathic US senator
Would that be an ugly bag of even more mostly water than usual?
"Would that be an ugly bag of even more mostly water than usual?"
Yes but I would say with more alcohol than usual and a lot less sugar.
"It’s obvious that the goal is to neuter the FDA, because an effective FDA is Evil Government Regulation. In Libertarian World, there is no other kind of government regulation. They forget why it was necessary to create the FDA (and dozens of other alphabet soup agencies) in the first place."
This is not just Ron-Paul-marginal Liber-nuttery, it's been mainstream Republican doctrine since Reagan, which is to say it's neo-Coolidge, which is to say it's the ideology of pure unfettered capitalism. When conservatives blather about how we'd all be so much better off with all that regulatory interference with the supposedly self-correcting market, my brain answers with a four-letter word: TRIS. But the eleven letters of 'thalidomide' will do just as well. Even if the old Invisible Hand would 'work' sooner or later (which it doesn't; because monopoly, unequal power distribution, yada, yada) how's that supposed to comfort parents whose kids were burned to cinders by their 'flame retardant' jammies?
"The people supporting these right-to-try bills think they are making things better for terminally ill patients when really they are being co-opted to help the Goldwater Institute weaken the FDA." Damn straight! But even exposing that specific bit of bait-and-switch isn't going to address the more fundamental problem: the 'over-determined' claim of free-market ideological Kool-Aid on the American mind.
(Jargon explained: 'over-determined' is Louis Althusser's term for the the idea that prevailing ideologies have no single source, but assemble out of whole bunch of small instances, like individual thought molecules, each innocuous enough by itself evaporating into the air and gathering to form a cloud over the public mind. The term is often mis-used or misunderstood by the perception 'over' means "excessive, extra," when in fact it just means "occupying a certain space above" like a cloud...)
Still, even usually reliable news outlets make mistakes
But it's really very distressing to see a major national newspaper with -- no doubt -- its heart in the right place failing to grasp that when you see a state-level bill with "right to" in the title that's being flogged by a think tank, the first thing you should do is look for funding from the Koch brothers.
Because the odds are very high that it's their work and should be treated accordingly -- ie, examined closely with an eye to answering the question: "What filthy lies does this piece of legislation tell in order to disguise its ugly and soulless true purpose?"
Thoughtful consideration of the bill on its merits without reference to the Kochs would be better, of course. But that's not always possible. .
Are any of you terminal? Chronic? Perhaps not, but I won't make that assumption. I'm an MS patient, dxd 10 years ago who's been treated with my own mesenchymal stem cells. I, along with hundreds of patients, have received quality of life benefits from being treated with our own cells. This treatment is not allowed in the USA even though there are 100's of study on Pub Med that speak to it's safety and efficacy. This type of treatment is NOT a cure, but it offers improvements that no FDA approved drug on the market even comes close to. Maybe "Right to Try" legislation isn't perfect, but hey it's bringing attention to the important issue at hand! Take Alzheimer's for instance. "As our population ages, the disease impacts a greater percentage of Americans. The number of people age 65 and older will more than double between 2010 and 2050 to 88.5 million or 20 percent of the population; likewise, those 85 and older will rise three-fold, to 19 million, according to the U.S. Census Bureau." http://www.alzfdn.org/AboutAlzheimers/statistics.html
Getting a neurological condition yourself, or someone you hold dear, is a fact of life. It will literally touch EVERY American family. Another fact is there is NO cure for most neuro diseases, and time is literally running out for millions! This is really a civil rights issue. I contacted the FDA for 2 of my friends who were critical, and was told emphatically NO! They would not be considered for "compassionate care." One was being placed in a nursing home at the age of 48 for MS and the other became suicidal as she knew being treated with her own stem cells was her last hope. She was also looking at being place in a nursing home at the age of 28. Both had little time left to live. My 28 yr old friend has since traveled to Germany and received treatment. My other friend traveled to Mexico. They are both improving, but no thanks to our FDA. Medical Tourism is alive and thriving thanks to the lack of compassion for chronic, no option patients here in the USA. It's a real problem and one that's easy for most of you to talk about 2nd or 3rd hand. None of the patients I know are willing to sit back and let cruel diseases take them from their homes, family and friends. These people aren't rich. So the theory that only rich people will have access to this is entirely false. Friends and families have raised the money for them to receive these stem cell treatments. Unfortunately who will have the control over the cells from my own body and who will get to make the money on it seems to be taking medical innovation back tories! Bureaucratic agencies in Washington, making health care decisions for me is ludicrous! It should never have been their right to treat my cells like a mass produced drug! I am educated, informed and can make an extremely intelligent decision right along side my very capable physician. Outside paternalistic attitudes are extremely unnecessary and unwarranted. the dark ages. Let doctors innovate like they've been doing for cies! Bureaucratic agencies in Washington, making health care decisions for me is ludicrous! It should never have been their right to treat my cells like a mass produced drug! I am educated, informed and can make an extremely intelligent decision right along side my very capable physician. Outside paternalistic attitudes are extremely unnecessary and unwarranted.
Paternalism is alive and well. obviously. Why all the hand wringing and speculation? What do all here who are physically well really fear? How many of you have taken care of a loved one who is terminally or chronically ill? How many of you would say NO to hope if you were terminally ill? How many of you believe that you should be making decisions for others? Please, just stay well and quit preaching.
I will offer up a scenario of why "right to try" is a bad idea that might well pull promising treatments off the market.
Imagine a patient with disease X. There is currently a clinical trial of treatment Y for disease X, but the patient was not enrolled. The patient uses the "right to try" laws to get treatment Y. The patient dies horribly from effects of treatment Y (which was why the patient was not enrolled in the clinical trial in the first place). The patient's death makes the news. Even if the clinical trial is not canceled, the stock price of the company that makes treatment Y tanks. The company goes under and treatment Y is never made again.
But what if treatment Y really did work for disease X, just not in people like the patient, who had a counter-indication? What about all the other people with disease X who could have tolerated treatment Y and had years added to their lives? Because of "right to try", that would never happen.
That is actually not an likely scenario. All it takes is one really bad adverse reaction to an experimental drug under right-to-try to tank the drug. Add to that news reports of the patient spending, say tens of thousands of dollars for treatment Y under right-to-try and the pharmaceutical company going after his estate to recover its debt (which is explicitly allowed for in the Goldwater Institute template and therefore every right-to-try bill or law), and you have a disaster in the making.
Right-to-try proponents tend to argue that right-to-try will encourage innovation. I see it the opposite way. It will make pharmaceutical companies more risk-averse and therefore less likely to innovate. It will place burdens on smaller biotech firms, incubators of innovation, most of which struggle to raise the capital needed to get their products through the regulatory process, such that they will be less likely to take risks.
"How many of you have taken care of a loved one who is terminally or chronically ill?"
Many of comment here have, and if you have read this blog you will have learned that Orac's wife also has.
We just prefer to not treat our loved ones like guinea pigs. And one reason we read this blog and the not so secret other one is to learn about the issues, and how to not become a gullible mark to the latest scam.
To Barbara: I have watched my husband's grandmother and grandfather both pass (Alzheimer's and osteosarcoma respectively) and was involved in their care. So yes most everyone has been touched in some way by terminal illness. what I remember most was when my hubby's grandfather (who had been battling cancer for some time) was told it had spread to the bones of his face and skull he opted to forego any additional treatment. The family was deeply shocked, including my husband. I sat him down and explained to him as gently as possible that the doctor's had told his grandfather his illness was terminal. He had already endured radiation and chemotherapy before (with side effects) and since cure was not possible he chose to live out the remainder of his life surrounded by his family with palliative care. It was a decision I deeply respected. what we have been pointing out here is that it is cruel to dangle hope like a carrot in front of the terminally ill and get them to sacrifice their remaining health, dignity, and goods on something that almost certainly will not help them. Destroying the power of the FDA and promoting anyone with any drug that has passed a phase I trial to offer that medicine to any patient who wants it is a recipe for disaster. It will cause way more harm than good.
To Jennifer: Some of us are in good health, but by no means all. I have great sympathy for your struggle with a diagnosis like MS and wish you nothing but the best. I can't find much in my first cursory search for stem cell treatment in MS only that it is under study. I think what is probably happening as with so many other things is that some people are just opening clinics outside of the US to give a therapy that hasn't been proven to work. That is dangerous in many ways, offering false hope if it doesn't work, draining your bank account (and those of your family and friends), as well as risking unsafe or unsanitary treatment in a country where the laws may not be set up to help you. You may believe the treatment is good, you may believe you are being helped, but unfortunately as humans we are easy to fool. This is obviously something that needs more study.