I was torn about what to blog about today. There were lots of things floating around that caught my eye and appear worthy of of a little taste of Insolence, either Respectful or not-so-Respectful, so much so that I couldn't decide. None of them really stuck out. Then I saw this news story pop up in my Google Alerts, Houston-area doctor grateful for time spent with Pope John Paul II:
My first thought was that Stanislaw Burzynski must have one hell of a publicist. Either that, or he has a good buddy at KHOU in Houston. My second thought was of a bill that was recently introduced into the House of Representatives by Rep. Morgan Griffith (R-VA), known as the Compassionate Freedom of Choice Act of 2014, because it's a bill that's intimately related to Burzynski because basically it would free him from all the hassle of the FDA regulating his administration of antineoplastons to terminally ill patients. Before I get to the bill (HR 4475), I note that, not being from Houston, I had never heard of Jacqueline Crea, the reporter who did the story. I mean, I know that local news often has to do local human interest stories that are tied into big news events like the canonization of Pope John Paul II, to give them the "local angle," but holy hell, KHOU was scraping the bottom of the barrel on this one! I know that Burzynski met the Pope back in the 1990s, and there were rumors that he was being treated for colon cancer and wanted Burzynski's input. Those rumors turned out not to be true. Other rumors were that Burzynski had been summoned to treat a prominent Cardinal, but that’s probably not true, either. More likely, the Pope just liked Burzynski because he was (and remains) a prominent Polish Catholic, just like John Paul II.
In any case, surely there must have been someone else in the Houston area who had an audience with Pope John Paul II. It's not as though such audiences are "rare" (JP had lots of them). In any case, if Burzynski has a publicist who pitched this story, that's one awesome publicist. If it's a KHOU producer who happens to be a Burzynski supporter, for shame.
Then I saw this from our old friend, Stanislaw Burzynski's propagandist Eric Merola, Laura Hymas loses her battle with cancer; An Antineoplaston Phase 2 study is now published in the peer-reviewed literature (April 23, 2014). You'll remember that I noted Laura Hymas's death last week. Apparently it's finally hit the media in the UK in the form of a story in Kent Online, where we find out that Hymas's cancer had actually recurred in November, a mere three weeks after her fairy tale wedding to Ben Hymas after they had thought that her cancer was gone for good. Hymas, unfortunately, is a woman who was extensively used by Burzynski and his allies as a "success" story "proving" that he could cure brainstem cancers. Sadly, she turned out not to be. Not surprisingly, Merola is going to blame the FDA for Laura's death, because it placed a partial clinical hold on Burzynski's clinical trials due to the death of a child (Josia Cotto) in 2012 and numerous violations of FDA regulations with respect to clinical trials found in an inspection in 2013 and detailed in an FDA warning letter in December.
From the newspaper article:
Ben, 34, said: “When we found out the cancer had come back we asked for the same treatment [Antineoplastons] but Laura was denied it [by the FDA]. We were in contact with her doctor in America [Burzynski] and he applied for the legal right to treat her again but this was declined [by the FDA]. We could have fought it legally but we just didn’t have time.”
And from Merola:
It's impossible to know if Laura would have survived her cancer a second time, if she were allowed to have access to these medications again. It certainly doesn't change the fact that denying cancer patients the right to choose their own therapy when no other therapy has been proven safe or effective—is an act of violence upon a cancer patient.
That's going to be the spin placed on poor Laura's death by Burzynski and his allies. Poor Laura could have been saved if the nasty FDA hadn't prevented her from getting her antineoplastons. Look for it: The concept that there are all sorts of "cures" out there but that the FDA is keeping people from using them. It's coming up next. (Oh, and Burzynski met the Pope who will become a saint; so he must be good.)
All of which brings me back to yet another manifestation of the pernicious influence that is the "health freedom" movement, or, as I like to call it, the freedom of quacks to prey on desperate individuals unhindered by pesky things like consumer protection laws. (I need to think of a catchier phrase to boil that concept down to a term as pithy as "health freedom.") In any case, this brings us back to the Compassionate Freedom of Choice Act of 2014, a bill championed by the Alliance for Natural Health USA, a "health freedom" group that has yet to see a pro-quackery bill it doesn't like and that has defended Burzynski vigorously before, as well as attacked any attempt to regulate "alternative" therapies.
In any case, as the time I originally wrote about this bill, HR 4475, its text hadn't yet been published to the Congressional website. The bill has been floating around for a while in various forms (for instance, former Representative Ron Paul (R-TX) apparently introduced it.) Now it is, as Guy Chapman has noted. He calls it a "quack's charter," and he's only off by a bit. The bill doesn't go quite as far as he believes, but the bill is still plenty bad, man. If enacted, HR 4475 would amend the Food, Drug, and Cosmetic Act by inserting after section 561 (21 U.S.C. 360bbb) the text of HR 4475. This section of the Food, Drug, and Cosmetic Act is entitled Expanded Access to Unapproved Therapies and Diagnostics, and it's the section of the act that regulates exactly that. The interesting thing is that this particular section of existing law is the framework under which the whole system of single patient INDs (also known as "compassionate use exemptions") is already based. As I've described before, single patients can receive promising unapproved drugs under what's known as a single patient IND, which has to be approved by the Institutional Review Board and the FDA and allows single patients to receive unapproved drugs. You can (and many have) argued that the single patient IND process is too cumbersome and restrictive, but HR 4475 seeks to (mostly) nuke this requirement. You'll see what I mean in a minute.
First, the law states that:
Nothing in this Act or section 351 of the Public Health Service Act prevents or restricts, and the Food and Drug Administration shall not implement or enforce any provision of law preventing or restricting, the manufacture, importation, distribution, or sale of an investigational drug or device intended for use by a terminally ill patient in accordance with subsection (b).
Guy Chapman went a bit beyond what the law would actually permit it wrong in his analysis, I'm afraid. HR 4475 clearly does not authorize the use of quackery like Hoxsey therapy, Gerson therapy, or anything else like that in terminally ill patients, although I suppose it is theoretically possible that advocates could get an IND for one of these quackeries and then carry out a phase I clinical trial, after which the quackery would fall under the definition of an investigational drug or device according to HR 4475. (In this, perhaps the Gonzalez protocol would qualify, given that it's undergone two clinical trials, the last of which was disastrously negative, but it was a clinical trial.) HR 4475 does, however, basically allow unfettered access by "terminally ill" patients to any "investigational" drug or device, which is defined as a drug or device that "(1) has not yet been approved, licensed, or cleared for commercial distribution under section 505, 510(k), or 515 of this Act or section 351 of the Public Health Service Act, and cannot otherwise be lawfully marketed in the United States; and (2) is or has been the subject of one or more clinical trials." In other words, it's very much like one of those "right to try" laws that are such a horrible idea but nonetheless popping up like kudzu in state legislatures.
The difference is that "right to try" laws in states would have little or no effect, because the FDA would still rule supreme over drug approval, and federal law trumps state law. HR 4475 would in essence codify "right to try" in the federal law under which the FDA works, which would do many orders of magnitude more harm to cancer patients and terminally ill patients. Basically, this law would allow any "terminally ill" patient access to any investigational drug with an IND that's gone through at least phase I trials. I've explained before in great detail why that's such a horrible idea, but it's worth mentioning again briefly this. Most investigational drugs that make it past phase I trials still end up failing. The chances for doing harm far exceed any chance for benefit. Drugs with seemingly miraculous activity against cancer, like Gleevec, that show up in phase I clinical trials are exceedingly rare. Indeed, HR 4475 says nothing about whether the clinical trials the investigational drug or device being to be used in terminally ill patients has undergone even need to show promise or not. Under HR 4475, a drug that completely failed in phase I clinical trials by showing unacceptable toxicity (for example) could be distributed to a terminally ill patient as long as the patient is told that the drug failed phase I clinical trials.
Next up in HR 4475, there's this:
(b) Patient Requirements.--In order for an investigational drug
or device to be intended for use in accordance with this subsection,
such drug or device must be intended for use by a patient who has--
``(1) been diagnosed with a terminal illness by a licensed
physician;
``(2) been informed by a licensed physician that no drug or
device that is lawfully marketed in the United States is likely
to cure the illness; and
``(3) executed a written informed consent document that
states--
``(A) the known and potential risks and benefits of
such drug or device; and
``(B) any indications of the illness for which a
drug or device is lawfully marketed, or for which
treatment is otherwise available, in the United States.
``(c) Prohibition on Requiring the Disclosure, Collection, and
Reporting of Certain Information by Food and Drug Administration.--
``(1) In general.--The Commissioner of Food and Drugs may
not require the disclosure, collection, or reporting of--
``(A) any information related to the delivery,
administration, or use of an investigational drug or
device pursuant to this section; or
``(B) any information related to the clinical
outcomes experienced by a terminally ill patient
supplied an investigational drug or device pursuant to
this section.
``(2) Exception.--Nothing in this subsection prevents the
sponsor of a clinical trial from voluntarily disclosing,
collecting, or reporting information to the Food and Drug
Administration.
One notes that "terminal illness" is not defined. I could go all Orac-style snarky on you and point out that life itself is a terminal illness (one that's sexually transmitted, as well). We all die eventually. On the other hand, there are other diseases that are arguably terminal that can take a long time to kill. Even metastatic breast cancer is now potentially survivable for several years, even longer if it's an indolent type with a low volume of metastatic tumor. Where do you draw the line in defining "terminal"? Normally, for purposes of laws, "terminal illness" is defined according to a certain estimated prognosis for life expectancy, be it six months, a year, or whatever. Even Abraham's law did that. My guess is that this is to allow the widest number and variety of people with "terminal" illnesses access to unapproved treatments as possible. All you have to do is to find a doctor to say you're terminal and there are no approved drugs or devices that can save you, and you're good to go! Really? Any licensed physician, regardless of specialty? Moreover, under these circumstances, as described in this bill, "informed consent" is a joke, a cruel parody of real informed consent. In clinical trials, even in single patient INDs, the informed consent process is lengthy and detailed. In any event, the bill reads as though it were written specifically for Stanislaw Burzynski, as it would allow someone like him to abuse the IND process without even the threat of the FDA bothering him.
Now here's the kicker. One of the criticisms of "right to try" laws is that drug and device companies won't want to allow patients to have access to their investigational drugs or devices because adverse outcomes might affect their application for approval to the FDA. HR 4475 has that covered:
(c) Prohibition on Requiring the Disclosure, Collection, and
Reporting of Certain Information by Food and Drug Administration.--
(1) In general.--The Commissioner of Food and Drugs may
not require the disclosure, collection, or reporting of--
(A) any information related to the delivery,
administration, or use of an investigational drug or
device pursuant to this section; or
(B) any information related to the clinical
outcomes experienced by a terminally ill patient
supplied an investigational drug or device pursuant to
this section.
(2) Exception.--Nothing in this subsection prevents the
sponsor of a clinical trial from voluntarily disclosing,
collecting, or reporting information to the Food and Drug
Administration.
In other words, the drug and device companies who allow "terminally ill" patients to use unapproved drugs and devices don't even have to collect data on the outcomes patients who take their unapproved drugs or use their unapproved devices under this law, and, if they choose to do so, don't have to report those outcomes to the FDA. It's all voluntary. It's hard to imagine a provision more irresponsible than this. Add to the parody of "informed consent" in this law the fact that the law basically makes any reporting of patient response or adverse events completely voluntary. Basically, if you're a terminally ill patient, this law strips away all the copious protections for human subjects in research that the law currently provides. You're completely on your own, and the drug company is not responsible for anything, so much so that the law even ends with this provision:
Except in the case of gross negligence or willful misconduct, any
person who manufactures, imports, distributes, prescribes, dispenses,
or administers an investigational drug or device in accordance with
section 561A shall not be liable in any action under Federal or State
law for any loss, damage, or injury arising out of, relating to, or
resulting from--
(1) the design, development, clinical testing and
investigation, manufacturing, labeling, distribution, sale,
purchase, donation, dispensing, prescription, administration,
or use of the drug or device; or
(2) the safety or effectiveness of the drug or device.
In other words, if something goes wrong, the terminally ill patient or his surviving relatives can't even sue, unless there's obvious gross negligence or willful misconduct, whatever that is, even if there turns out to be an obvious defect in the design of the drug or device. In other words, terminally ill patients, you're completely on your own. Masquerading as a "health freedom" law that will let terminally ill patients have access to experimental drugs under a process less difficult than currently existing IND procedures, HR 4475 is a stealth assault on the very heart of clinical trial ethics. Remember, one of the main principles of the Common Rule and other statements of principles regarding human research subject protection is that vulnerable groups need more, not less protection. Those particularly vulnerable groups are traditionally defined as children, prisoners, and students, the former of whom rely on parents to exercise judgment and the latter two of whom are subject to potential coercion. I would argue that terminally ill patients are a particularly vulnerable population in that they are desperate and prone to grasp at anything represented as having a chance of saving their lives. If anything, they need more, not less, protection.
Basically, HR 4475 is a solution in search of a problem. It's based on the assumption that there are just oodles and oodles of new investigational drugs out there that could save the lives of lots and lots of terminally ill patients, if only the government would get out of the way and let the people have access to them. This is libertarian magical thinking at its most pernicious; there's no compelling evidence for this assumption and plenty of evidence against it. (And, no, my characterization of this assumption underlying HR 4475 is not a straw man.) Even if you view the IND process as being in dire need of liberalization, it's still a "solution" that won't fix the process but will, in essence, destroy the process. It's also clearly one of a number of attempts by the health freedom movement to get a "foot in the door." If successful, then similar arguments will be made to expand the "right to try" principle and decrease regulation on investigational agents for larger and larger populations. Although HR 4475 is clearly not explicitly designed to aid quacks who peddle treatments like the Gerson therapy or the Gonzalez protocol, it would be a godsend to someone like Burzynski, and it could potentially be a boon to unethical drug and device companies, who would be free to peddle their investigational drugs and devices, both promising and even those that failed, to that most vulnerable of patient populations, patients with no hope of survival. Health freedom, indeed. Apparently "health freedom" means the freedom of pharmaceutical companies to provide treatments whose efficacy is unknown and that are unlikely to make a significant difference in outcome (or even might be toxic) without actually having to learn anything from the exercise.
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Would be really interesting if that law would overrule the drug schedule, especially the call 1 classification. Medical cocaine anybody?
Unfortunately, it seems there is more credence to the theory that someone at KHOU is in Burzynski's pocket. I did a search of the site and found a couple of videos from an appearance Burzynski made on their morning show, "Great Day Houston," featuring an unbalanced softball interview with Burzynski and two of his "researchers" from the Burzynski Clinic. There is a good reason Burzynski and his minions were the only people to appear: the segment was sponsored by the Burzynski Clinic. The links are here:
http://www.khou.com/great-day/gdh_051210_seg2-93591594.html
http://www.khou.com/great-day/gdh_051210_seg1-93591354.html
So Burzynski paid KHOU to give him a morning's worth of good publicity on their show, and refered their viewers to Burzynski's website and toll-free number. I get the idea that KHOU is doing these puff pieces on Burzynski he is a sponsor and they don't want to offend him.
It'd sure be nice if MD Anderson wold take out ads slamming Burzynski, but I'm sure there's a greater chance I'll win powerball tomorrow.
@Mu: That's an interesting emphasis on something I noticed: once a therapy has qualified as an experimental therapy, the only way to remove that status seems to be if it becomes a legally available therapy. IOW, thalidomide would also be legally available this way.
The portions of the law Orac quoted are also badly written. In order to qualify for such a treatment, the patient must simultaneously have "been informed by a licensed physician that no drug or
device that is lawfully marketed in the United States is likely
to cure the illness" [(b)(2)] and signed a consent agreement which discloses "any indications of the illness for which a
drug or device is lawfully marketed, or for which
treatment is otherwise available, in the United States." [(b)(3)(B)] How do you satisfy both of these points simultaneously?
I also find it strange that there is an exception allowing voluntary reporting to the FDA [( c)(2)], since section ( c)(1) merely prevents the FDA from requiring the collection or reporting of this data but places no restrictions on the purveyors of such treatments.
Kind of flies in the face of Griffiths' and Hanna's states' rights routine. (Although Griffiths apparently thinks the states should be able to "veto" federal laws, so perhaps it would be a wash in his ideal world.)
I looked at this a week or so ago, and it doesn't appear to. Definitely not with respect to importation, since its scope is entirely within the FDCA/Public Health Service Act.
Curiously I opened this post thinking I had already read about the bill, but no, it turns out the same legislation is being proposed in the UK:
http://www.quackometer.net/blog/2014/04/the-saatchi-bill-a-quacks-chart…
Considering you can't prove a negative, would there be any way to stop any experimental medical treatment, ever? In other words, there could be any number of trials with negative outcomes, but they would just fall under "unproven" and trials could continue (as long as the money was there, which of course could be provided by the patients, ethics be damned.)
@Lancelot:
There are significant differences between the Saatchi bill and HR 4475, and they don't actually favor HR 4475, which, unlike the Saatchi bill, doesn't require that there be opinions from experts in the field that it is reasonable to try the unapproved drug or device before the drug or device can be tried. In other words, if the Saatchi bill is a bad idea (and I believe it is), HR 4475 is by comparison even worse, a horrible idea.
"IOW, thalidomide would also be legally available this way."
Thalidomide is used to help control multiple myeloma - perfectly legitimate and science-based.
Very, very much OT, but I know there are commenters here with a lot of autism experience - any recommendations of supportive but science-based blogs/resources for parents of high-functioning autistics? I know Autismum, but would love some more.
I don't like this proposed law, and the prohibition on reporting outcomes is appalling, since it means patient after patient can be conned into submitting to an experimental treatment with no ability to find out what happened to previous users. But in terms of "health freedom", I have always found it peculiar that unproven, experimental surgical procedures that do not involve device implantation can be done and billed for freely (and devices can be approved with less testing than drugs - then used with little or no clinical evidence of net benefit, cf. vena cava filters). Unproven surgical techniques have been implemented by Burzynski-level quacks not just in terminal cases (bone marrow transplant for breast cancer) but in elective situations (a guy pushing his own type of extreme surgery for endometriosis that had complications I can't even write about before lunch). Right now there is a guy pushing a procedure for Alzheimer's that involves moving part of the omentum inside the skull (yes, really).
If you take a drug, approved for the relevant indication or not, and it makes you sicker, if you have enough backbone you can tell the prescribing quack where to stick it. If you undergo a surgery and it makes you worse, you can't reverse the damage yourself, but only with the consent and aid of the folks who did it to you, or more likely, not at all. This isn't necessarily to say that drug practice should be deregulated to match surgical practice - maybe the latter should be more regulated - but it's hard to see why a patient should be able to consent to have a major surgery that's never been shown in a randomized trial to do more good than harm, but should not be able to consent to swallow a pill that has the same status.
I want to get upset about this bill, but just can't do so. Sure beefing up the reporting requirements and informed consent sections would be good. But I just can't get worked up over allowing terminally ill patients with no available treatment options being allowed to try an experimental drug.
I'm not a doctor, or even in the medical profession, but how would a randomized trial for surgery work? Would it be something like 'Dr. Smith, your next operation will be with technique A, and Dr. Jones, you will use technique B'. Then, after a year, you add up.... what?
Has there ever been a randomized surgery study?
I don't think anyone would suggest 'placebo surgery', would they? Because that would be silly
Mike @ 12
That makes sense if you're defining "experimental drug" as something that 1. has a chance in hell of working and 2. doesn't cost the patient hundreds of thousands of dollars while making the doctor rich.
Johnny: FYI placebo surgeries do exist. Because of confirmation bias, patients may report surgeries as making them feel better, even if it doesn't do anything.
It's been done. There aren't a lot of surgical RCTs.
Quite a few. There have, however, been very few randomized clinical trials with sham/placebo surgery because of the dodgy ethics of cutting a patient open without doing anything therapeutic. In any case, it's not as though I haven't written about this topic multiple times before:
http://scienceblogs.com/insolence/2007/02/08/surgical-research-tinkerin…
http://scienceblogs.com/insolence/2008/05/08/when-popularity-outpaces-s…
http://scienceblogs.com/insolence/2009/08/10/vertebroplasty-for-compres…
You can also do a randomized trial without an indistinguishable placebo and measure total outcomes - e.g., the studies of stenting vs. bypass surgery or of optimal medical management of atherosclerosis vs. stenting.
Orac, you have written about fishy surgeries before - but where the legalities are concerned, do you think the present situation, whereby it's much easier to consent to those than to a trial of an unproven drug, can be sustained? Thanks.
Well, ignorance has been fought.
It was a good day.
It seems to me that for Burzynski to provide truly informed consent, he has to provide more accurate statistics to his prospective patients. For example, we saw Liza Cozad's husband and a CBS newscaster telling the viewing audience that the antineoplaston therapy had a 27 percent chance of saving her. As recent posts on this blog have shown, the true number for actual glioma is probably more like zero percent. That's after you subtract out the one patient who had something else in Burzynski's recent paper on his phase 2 trial.
Failure to provide informed consent and subjecting patients to painful and potentially lethal procedures is grounds for malpractice litigation in most places. Perhaps the more effective method of exposing Burzynski and providing some level of justice to wronged patients (and their heirs) is to deal with the matter through civil litigation for malpractice or wrongful death. A courtroom is a more controlled environment than a congressional hearing room chaired by an illiterate zealot.
Orac has criticized the Texas medical board for failing to protect patients from Burzynski. I would like to suggest that this is fairly common throughout the country, and that civil litigation more often than not is what has had an impact on incompetent surgeons and other physicians.
Of course the medical profession doesn't like to recognize this painful truth, but to the outsider, it tends to look like a failure by the profession to police its own ranks. Considering the large number of competent doctors in Texas, or even just in Houston, it's surprising to the outsider (ie: the rest of us) that the medical profession has not been more outspoken about regulating incompetent physicians.
There seem to be lots of people who had relatives who had the Burzynski therapy, and some enterprising attorney ought to collect a hundred or so of them and file a hundred or so lawsuits. Then all of the competent oncologists will have a chance to testify as expert witnesses, along with government agencies and pathologists.
It seems to me that for Burzynski to provide truly informed consent, he has to provide more accurate statistics to his prospective patients. For example, we saw Liza Cozad's husband and a CBS newscaster telling the viewing audience that the antineoplaston therapy had a 27 percent chance of saving her. As recent posts on this blog have shown, the true number for actual glioma is probably more like zero percent. That's after you subtract out the one patient who had something else in Burzynski's recent paper on his phase 2 trial.
Failure to provide informed consent and subjecting patients to painful and potentially lethal procedures is grounds for malpractice litigation in most places. Perhaps the more effective method of exposing Burzynski and providing some level of justice to wronged patients (and their heirs) is to deal with the matter through civil litigation for malpractice or wrongful death. A courtroom is a more controlled environment than a congressional hearing room chaired by an illiterate zealot.
Orac has criticized the Texas medical board for failing to protect patients from Burzynski. I would like to suggest that this is fairly common throughout the country, and that civil litigation more often than not is what has had an impact on incompetent surgeons and other physicians.
Of course the medical profession doesn't like to recognize this painful truth, but to the outsider, it tends to look like a failure by the profession to police its own ranks. Considering the large number of competent doctors in Texas, or even just in Houston, it's surprising to the outsider (ie: the rest of us) that the medical profession has not been more outspoken about regulating incompetent physicians.
There seem to be lots of people who had relatives who had the Burzynski therapy, and some enterprising attorney ought to collect a hundred or so of them and file a hundred or so lawsuits. Then all of the competent oncologists will have a chance to testify as expert witnesses, along with government agencies and pathologists.
Something's amiss. I only hit the submit comment button one time, and my comment immediately went up double. If this one also goes up double, we'll know for sure.
I know that nobody is likely to get an IND for Laetrile, but to my reading the Bill does not reference INDs. It only talks about an investigational drug, though of course as an act amending the FFDA it may be that investigational drug is defined by inheritance, a point I'd neglected.
So:
This bill allows a drug manufacturer or provider to throw anything some fool will buy into a corner of the marketplace populated by the desperate +/or arrogantly stupid
It's supported by the crowd who considers drug manufactures, anyone board-certified as an MD and apparently anyone who is in bio research to be part of a giant weevil reptilian conspiracy feeding off the unknowing sheeple.
Sure it does, albeit admittedly indirectly, when it instructs that the text of HR 4475 be inserted after the specific section in the Food, Drug, and Cosmetics Act that covers expanded access to INDs. HR 4475 also references the part of the Food and Drug Act that defines an investigational drug or device. That section defines INDs them thusly:
That section of the law gives the FDA the regulatory power to definite what an IND is, and the use of the same language ("investigational drug") means the same thing as in the currently existing Food, Drug, and Cosmetics Act.
Ironically, if HR 4475 were made law, it would basically convert that section of the Food, Drug, and Cosmetics Act on expanded access to investigational drugs to a rather confusing mess. First, the original part of the law would still say that the FDA director may grant compassionate use exemptions for an IND intended for serious diseases, and then, right after that section, the text of HR 4475 would say that the director can't deny any such compassionate use exemption for terminally ill patients without defining "terminal illness" according to the usual ways it's defined. Good times for lawyers. Not so good times for patients or the poor FDA officials who have to figure out how to apply such a badly conceived law. Hopefully it will never pass.
How do we stop this bill?
How can we defeat this bill? A poison pill would be to make it illegal for drug suppliers, clinics, doctors etc. to receive any compensation in these cases. If only we had that much power.
The FDA kills people by distraint. The problem with the bill is that it protects the quack physician's interest. It should protect the motivated patient and their family from the FDA. Say you have refractory aids or cancer.
Proposition 1
The terminal patient should have the direct right to import foreign approved drugs and devices upon executing some affadavit that shows an informed status. Whether a drugs or device has a domestic or overseas IND might be worthy of more restriction, a later secondary discussion.
Proposition 2
Whether the patient has the right to self manufacture. Grind, encapsulate, sterilize peach pits or items of commerce, or use their enhanced Gilbert science kit if they had organic chemistry.
Here, the physician is the advisor, or incidentally, the administrator of the drug the patient acquires personally, independent of the MLM or MD. The first issue is the patient's rights in extremis, not the doctor's or the drug company's privileges under license or registration.
Does one have to be valedictorian, National Merit or a CalTech PhD to have a full set of personal rights?
By keeping it from getting out of committee. The members are here. I've got Bobby Rush, who would likely be sympathetic to spiking it. The Republicans are probably open to observations of the infringement of state's rights.
Roadstergal OT @ #10: Some possible start points for you might be Emily Willingham's writings, The Thinking Person's Guide to Autism and lbrb (http://leftbrainrightbrain.co.uk/). Hope these are useful.
reader, how exactly does one arrive at informed consent if there is no data to inform? If a patient has no ability to determine whether or how much a medicine will make him suffer, he or she is at the mercy of any poison salesman in the world.
Are all foreign approvals equal? If they're not, who decides which ones meet an acceptable standard.
Either we have oversight for everyone or the whole damn thing falls apart.
Commercial goods seldom exist in a data vacuum, albeit data often different than FDA approved summaries. This proposition would protect the buyer's access to normal commercial sources without US medical claims, not advertisers with claims or doctors with financial interests in the treatment. Advertisers still have their regulatory burdens and liabilities.
who decides - those with the most to gain or lose. Such a user necessarily takes a larger responsibility including to consult with knowledgeable sources or take the added risk.
Either we have oversight for everyone or the whole damn thing falls apart.
The patient work and knowledge requirements without the highly advertised providers tend to keep the idle away. Traditionally, Americans repudiated officious oversight for everyone.
Commercial goods seldom exist in a data vacuum
I infer that you are unfamiliar with the history of Florida real estate. Quite a few sellers of commercial goods don't want prospective buyers to know what they're buying--not all, mind you, but a large enough fraction that we've had to pass laws against that sort of thing. Caveat emptor may work in small communities with a limited variety of goods, but it doesn't scale well. And in an economy as large as the US, there are more buyers than sellers of any particular kind of goods. The sellers might consider it "officious oversight", but the buyers are more likely to regard it as making sure that the product works and is not harmful. Galt's Gulch is fantasy.
this isn't a rhetorical question: Do physicians normally discuss financial risks of treatments in anything but broad strokes? Do informed consent documents go into any financial details about various treatment outcomes?
@#10 Roadstergal: "Thalidomide is used to help control multiple myeloma – perfectly legitimate and science-based."
ummm…yes, it is legitimate and science-based, but there were a lot of controls associated with this drug when I took it. Do we want powerful, dangerous drugs freely circulating without oversight? I had to attend monthly briefing sessions regarding birth-control and proper storage of the drug in my home when I took it in a a clinical trial. I was post-menopausal at the time but HAD to attend the session if I wanted to stay in the trial. I wonder if patients who aren't in clinical trials, who get it through a prescription, have to follow those rules? I thought it all made sense - thalidomide is dangerous stuff- I respected the seriousness of the situation. I didn't carry it around in my purse. It isn't something you want everyone to have access to.
reader -- I believe Proposition 2 in your post already exists. The law doesn't regulate what you can manufacture and consume yourself (with a few notable exceptions -- it's illegal to manufacture banned substances like meth, and you can also get in trouble for making things that are dangerous to your neighbors, like fireworks or nuclear reactors). But I believe it is entirely legal to mess with peach pits in your own home. Just don't sell them or administer them to other people; that's when you'd get in trouble.
Eric, my Prop 1 didn't even legitimize the Dallas Buyers Club activity, patients and family only allowed. When you effectively remove the promoter in the middle, and involve personal patient effort, abuse is far less lkely.
Eric, Galt’s Gulch is fantasy - 1776, 1789 and 1791 were not
Marie, dangerous drugs freely circulating with individual patients only, direct purchases with affadavits don't necessarily imply freely circulating large quantities of drugs.
Calli, Prop2...post already exists in many cases that's right. In other cases, politics will strike on mere possession or manufacture without extensive slow paper approvals for substances that are nutrients or break down to natural human substances. A one-two year batch of quantities for home consumption might conflict with others' presumptive ideas of sale and use.
Narad @30: Does it make sense to write to the representative from my state who's on the committee if they aren't "my" representative, and are going to be able to guess that I have very different and opposing views from them? I'd hate to push them towards it just because I'm against it.
Beats me. I think the objection can be constructed to appeal to either side of the aisle, though.