Update: My plastic pal who’s fun to be with has pointed out that my predictions below are unnecessarily gloomy; as an addendum or amendment to the Federal Food & Drug Act, the definition of investigational drug would probably be a registered Investigational New Drug (IND) and therefore the more egregious forms of quackery would not be covered.
It is, however, probably fair to assume that laetrile would have been covered had this provision been in place when it was being investigated, and that this clause would then have prevented the FDA from shutting down the laetrile scam.
It is, however, completely accurate to characterise this as the Stanislaw Burzynski (Protection From Scrutiny And Oversight) Bill. As with the Saatchi Bill in the UK, the Burzynski test is the vital one. If a Bill would prevent action against Burzynski, or, worse, would actively protect him, then it is an inherently bad Bill.
You know when the Alliance for Natural Health is promoting something, that it’s likely to be a bad idea, and that it’s almost certainly intended to give an unfair advantage to quacks against the forces of evidence and science.
H.R. 4475 is a proposed Bill which really does meet that definition.
The bill claims:
To allow the manufacture, importation, distribution, and sale of investigational drugs and devices intended for use by terminally ill patients who execute an informed consent document, and for other purposes.
Why would you need a Bill to permit this? If an IND is approved and there’s an active trial with Institutional Review Board approval, this already happens.
The answer lies not in what the Bill would permit, but in what it forbids.
“SEC. 561A. DRUGS AND DEVICES FOR USE BY TERMINALLY ILL PATIENTS.
“(a) In General.–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).
There the agenda is laid bare for all to see. This is not a bill to permit terminal patients to gain compassionate use, because compassionate use exemptions and INDs are already available. This is a bill designed to prevent the responsible authority from taking any part at all in holding back the actions of anybody engaged in selling (yes, selling, not trialling) any “investigational drug or device” (which pretty much covers everything as it does not require and indeed seems to forbid the FDA from deciding what investigational drugs qualify). Note that this does not use the terminology of regulated Investigational New Drugs (INDs), it merely requires that the drug is classified as investigational, without giving the FDA the final say on that.
Now, that might be overly cynical, you might think. Surely the FDA would continue to exert that level of regulation? No. Not only is it clearly exploitable in the courts, the intent of the Bill is clear and unambiguous: the FDA is required to get out of the face of anyone selling an unproven cure for a terminal disease. Courts in the US tend to respect the obvious spirit of an Act as much as its letter. And as you’ll see below, the Bill really is quite explicit: the FDA may not act as gatekeeper to the sale of quack remedies to terminal patients.
In effect, this is the opposite of the UK and Australian Cancer Acts. It explicitly exempts terminal patients from the protection of regulators.
And the intent is absolutely clear in section B: note that the treatment only has to be intended, not proven, effective, plausible, approved for investigation or anything else.
“(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.
Clear on that? The treatment only has to be intended, as above. There is no requirement for it to be even remotely plausible. Energy medicine devices, quack cures like Gerson or Hoxsey regimes, all fine, because they are intended to be used by terminal patients, even though we know with confidence approaching certainty that they do not work.
But there’s more:
“(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.
Wow. Who wrote this? Eric Merola? The exemption in (c)(1) means that the FDA is not allowed to even look at whether the treatment works. It’s officially none of their business. The treatment can be 100% ineffective, even hasten the death of patients, there is no requirement to tell the FDA and the FDA would be legally prevented from even asking.
A quack’s charter.
“(d) Definition of Investigational Drug or Device.–In this section, the term `investigational drug or device’ means 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.”.
On the surface this looks as if the treatment has to be respectable. But consider for a moment.
This Bill looks very likely to be prompted by the Burzynski Clinic’s recent travails. Under this Bill, as defined above, the antineoplaston therapy would be covered, because it has been the subject of trials. Even if the FDA withdraws the IND approval, that’s no longer required because the Bill only requires the intent to treat.
It doesn’t matter that Burzynski’s “clinical trials” are a legal fiction, as admitted by his lawyer, or that the results, such as they are, give no indication that the treatment works. It’s been the subject of a trial, that’s all that the Bill requires.
It doesn’t specify Phase I, II or II, so this could be based on a two patient Phase I series or anything. All that’s required is that someone, somewhere, managed to run a trial, whatever the outcome.
Laetrile has been subject to trials. Laetrile is allowed under this bill. Ditto Gerson. Ditto Burzynski’s antineoplastons.
Will this benefit drug companies too?
Not in the least. Drug companies want approvced treatments. This is useless to them. This Bill only protects quacks and those offering disproven treatments or unproven treatments that they have absolutely no intention of ever getting approved. Like antineoplastons.
Could it get any worse?
SEC. 3. LIABILITY PROTECTION.
The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is amended by inserting after section 561A, as inserted by section 2 of this Act, the following:
“SEC. 561B. LIABILITY PROTECTION.
“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.”. <all>
You read that right. If enacted, this Bill would permit any charlatan to offer any treatment they believe is intended to treat terminal disease, even if that belief is only plausible in the crack-fuelled fantasies of a lunatic, the FDA would be forbidden from looking at the treatment, interfering with its sale, or even monitoring whether it works, and patients would have no redress whatsoever if and when they find that the Emperor has, in fact, no clothes at all, because they will have signed an informed consent document, in the desperation of their terminal diagnosis, that allows the quack to try pretty much anything he likes.