Respectful Insolence

It’s always frightening when lawyers delve into the realm of medicine. It’s even worse when pre-law students and political science majors do the same.

Such was the thought running through my mind when I came across the most recent issue of the Yale Journal of Medicine & Law. The result is what I would most accurately characterize as–shall we say?–uneven. Even though the authors try to don the mantle of skepticism, for the most part they fail. Perhaps the best example of this failure is this particular article entitled Chiropractic Medicine: “Quackery’s” Struggle for Fair Practice. Rarely have I seen an article as chock full of misinformation about chiropractic written by an apparent non-chiropractor. I’ll show you what I mean. First, the author (Eduard Vangelder) begins with the classic logical fallacy of appealing to popularity:

Chiropractic medicine is a commonplace and popular form of medical treatment in today’s society. Classified as a form of Complementary and Alternative Medicine, chiropractic medicine primarily aims to improve body posture and treat such functional symptoms as neck and back pain. According to the 2007 National Health Interview Survey (NHIS), over 18 million Americans adults (8% of the general population) and more than 2 million children had received chiropractic or osteopathic spinal manipulations in the previous twelve months. Chiropractic medicine has not always been so widely accepted, however, and for nearly a century after its inception in 1895, it was frowned upon and labeled with terms such as “quackery” and “an unscientific cult” by the American Medical Association (AMA). Chiropractic medicine had to come a long way to be as widely accepted and recognized as it is today.

Note the narrative, common to many forms of “complementary and alternative medicine” (CAM). Chiropractic was once viewed as “quackery,” but now it’s become “mainstream.” It’s popular! Therefore there must be something to it! But no good CAM story would be complete without a nice, juicy conspiracy theory. So Vangelder parrots one, namely the conspiracy theory claiming that conventional medicine tried to suppress chiropractic not because it was rank quackery but because it was trying to suppress an effective, rival therapy.

Vangelder starts out by describing the origins of chiropractic, which, as all good skeptics should know, was created in 1895 by Daniel David Palmer. Of course, what Vangelder forgets to mention is that Palmer claimed that he had manipulated the spine of a man who was nearly deaf and thus cured him. He also forgets to point out that chiropractic, as created by Palmer, was based on vitalistic beliefs. In fact, in this chiropractic resembled acupuncture in that it postulated that disease was caused by interruptions in what chiropractors called the “innate intelligence,” which was a “nervous energy” or “life force” that flowed through the spine, blockages of which chiropractic could relieve by relieving subluxations. Not surprisingly, Palmer viewed the “innate intelligence” as representing God’s presence in man. Indeed, Palmer briefly considered branding chiropractic as a religion because he could then claim First Amendment protections for it, but decided against it only because of the confusion that would result between chiropractic and Christian Science.

Vangelder then discusses the efforts of the American Medical Association to limit chiropractic, portraying it as seemingly unreasonable and more for the purpose of protecting doctors’ turf than actually protecting patients from pseudoscience. He finishes by portraying the lawsuit against the AMA that prevented the AMA on antitrust grounds from acting against chiropractors:

Ever since Wilk, the AMA and other federally associated institutions have been obliged to recognize and treat chiropractic medicine as a legitimate practice in alternative medicine. Nevertheless, a subtle disrespect for chiropractic practitioners as “unscientific witch doctors” still, to some extent, pervades the AMA and the medical community today. Doctors should always question the scientific legitimacy of a particular method of treatment and the credentials of any person who calls themselves a healer. Historical development indicates, however, that misconceptions about chiropractic medicine are likely to continue to dissipate as it becomes more respected within the realm of “standard medicine” and as its safety protocol falls more and more under the auspices of federal regulation.

One notes that nowhere in Vangelder’s article does he actually concentrate on the science behind chiropractic (or, more appropriately, the lack thereof). Instead, he frames the story as that of brave maverick chiropractors, underdogs, battling an arrogant AMA and triumphing by achieving popular acceptance. Science doesn’t enter into the story anywhere.

Elsewhere in the issue, Annie Wang produces an article entitled Eastern Medicine and Herbs: Treating the Individual. This is perhaps the worst of the lot, at least in terms of sheer credulity. Wang’s post is basically a paean to traditional Chinese medicine in which she quotes Ted Kaptchuk (one of the prime investigators “credited” with the recent acupuncture/placebo paper published in the New England Journal of Medicine). In the article, Wang falls for the false claim that somehow traditional Chinese medicine (or other forms of alternative medicine) is “individualized” medicine:

So what is the appeal of Eastern medicine? Why do its believers swear by its natural remedies, while others label it as money-wasting, spiritual mumbo-jumbo? Eastern medicine, in particular Chinese medicine, focuses on the individual, with physicians giving each patient unique herbal treatments based on their individual diagnoses. Patients enjoy the personal attention given to them by their doctors, who not only ask about their symptoms but also try to connect their illnesses with their mental states.

The main difference between Eastern and Western medicine lies in how physicians diagnose diseases. A Western physician separates the patient’s symptoms from the patient’s being as he searches for what is typically a commonly-diagnosed underlying disease. An Eastern physician, however, unifies a patient’s symptoms and soul, perceiving illnesses as disharmonies in the body.

This is, of course, utter nonsense, a fetid load of dingo’s kidneys. A better term for the “individualization” of treatment under various alternative medicine regimens is what I like to call, “Making shit up as you go along.” That’s how “Eastern” practitioners diagnose diseases. Wang also falls into the false dichotomy between “Eastern” and “Western” medicine, a false dichotomy that I consider to be profoundly racist. After all, the implication that “Western” medicine is scientific and ” Eastern” medicine is more “intuitive,” as though Asians aren’t capable of rigorous science or “Westerners” aren’t capable of empathy for their patients.

Be that as it may, Wang then spends several paragraphs trying to convince readers that Ginseng is some sort of wonder herb, claiming that it can “improve performance, boost energy levels, reduce fatigue, enhance memory, and stimulate the immune system.” She even claims that Ginseng can melt tumors away, concluding:

More evidence must be collected before integrating herbal remedies into Western medicine. However, Western physicians could benefit by incorporating some of the tenets of Eastern medicine. One of the major complaints about Western medicine is that patients do not feel like they get enough individual attention from their physicians. By following the Eastern traditions of giving patients more personal attention and seeing them as more than just a collection of symptoms, perhaps patients will become more satisfied with Western medicine. Indeed, as Dr. William Osler, one of the founding professors of Johns Hopkins Hospital, once said, “The good physician treats the disease; the great physician treats the patient who has the disease.”

I hate it when apologists for quackery start quoting Osler. It’s almost as bad as when they quote Hippocrates. In any case, this is just more of the same, including the same false dichotomy between “Western medicine” and the woo that Wang likes so much. As far as medicine goes, Wang’s article is a law article. Well, actually, it isn’t. It doesn’t really mention law at all, which makes me wonder why it was even included in this issue.

Unfortunately, Molly Anderson takes up the slack that Annie Wang leaves behind. Penning an article entitled Alternative Cancer Treatments: Can the Food and Drug Administration ever be too cautious?, Anderson pens her very own credulous treatment of quack cancer cures. She even uses the term “allopathic” to describe conventional medicine, which is about as big a warning flag for an apologist for quackery as there is, even in spite of Anderson’s citing insulin potentiation therapy as a dangerous form of cancer quackery. In other words, IPT is dangerous, but that other woo works, or, as I like to rephrase it, the woo I like works and all that other stuff is dangerous quackery.

Anderson’s article starts, as so many quack apologist articles do, with a testimonial. Because this is an article about quack cancer cures–excuse me, “alternative cancer treatments”–Anderson chooses a testimonial from a person with what appears to be advanced cancer, a hemangioendothelioma. So what we get from Molly is the typical “they sent me home to die” narrative–until, of course, the person giving the testimonial finds the woo du jour. However, there is a wide spectrum of behavior in this particular tumor type, from indolent, slow-growing hemangioma-like tumors to very aggressive tumors angiosarcoma-like tumors. That Anoush, the “testimonial” patient used to set up the story, survived two years after choosing quackery says very little about whether the quackery he chose worked or not. Regular readers know that I’ve explained this sort of thing time and time again since the very beginning of this blog; so I’ll try not to belabor the point (much).

The most annoying aspect of this article is that Anderson frames her whole article as the FDA versus alt-med believers:

Overall, these procedures seem to be effective. But until the FDA permits clinical trials of these alternative techniques, experimental findings indicate their success, and the techniques obtain FDA-approval, cancer patients will have to travel internationally to explore alternative treatment options. Still, the effectiveness of these therapies is under intense investigation and evidence at this point neither supports nor deters their implementation.

For now, those seeking alternative cancer treatment will have to take the same unendorsed risk Anoush took two years ago. Perhaps they will be as lucky as Anoush has been, perhaps not. If anything, those brave enough to try can at least find solace in the prospect of the alternative treatments while they wait for conventional methods to improve, or for the FDA to catch up.

Yes, Anderson’s implication is that the FDA is far behind the times, out of the loop, too hidebound, too unwilling to see the light with respect to “alternative therapies.” Her language is full of straw men, misunderstandings of how the FDA works, and spinning FDA regulations in the worst possible light, so much so that I recommend her for a writing gig at NaturalNews.com. In fact, in Anderson’s account, the FDA isn’t trying to prevent these “alternative” therapies out of a desire to protect the public but to suppress “alternatives,” while laying down this howler of a turd:

But alternative cancer treatments should certainly not be considered feeble attempts with low expectations; stunting cancer growth with alternative treatment has the amazing potential to induce cancer remission.

But if certain alternative cancer treatments sometimes lead to better results than mainstream methods, why does the FDA continue to deny attempts at their approval?

The alternative cancer treatment approval process is a cycle almost as vicious as the disease itself. The FDA will not allow testing of these alternative treatments on human subjects, which eliminates the opportunity to conduct research on their effectiveness. Then because there is no scientific evidence supporting the effectiveness of the treatment, endorsement is denied during the FDA approval process.

Wow. Can I see your tinfoil hat, Ms. Anderson? I bet it’s a nice, thick one.

Anderson reveals a shocking ignorance of how clinical trials are conducted and how human subjects protections work. The FDA doesn’t mandate human subjects protections; the Department of Health and Human Services does through the Common Rule. All the FDA does is to require that any clinical trials used in support of an application for FDA approval of a drug or device must conform to the Common Rule and have been approved by a properly constituted Institutional Review Board (IRB). IRB approval is what determines whether a clinical trial is considered legal and ethical with respect to U.S. law, at least as far as whether or not the trial includes adequate protections for the human subjects participating in it. In any case, anyone in academia who wants to can propose a clinical trial, and if it passes ethical muster after review by local IRB of the institution where the investigators work approves the trial, it can be performed if the investigator has the funding to do it. Let’s just put it this way. If you’re going to write an article about the FDA and how it regulates (or fails to regulate) alternative medicine, you should at least take a little time to learn about the FDA.

The reason that some alternative medical treatments “can’t be tested” (in Anderson’s framing) is not because of a conspiracy to suppress “alternative medicine” but rather because testing therapies with virtually no chance of working on patients with cancer is almost always unethical and violates laws and regulations designed to protect human research subjects. Yet Anderson portrays the situation as the evil FDA trying to suppress alternative medicine cancer cures. What’s even more depressing is that this little screed appeared in a law journal, and its author clearly has zero clue about the laws and regulations concerning human subjects research and FDA approval. In fact, it’s obvious that she didn’t even bother to do a bit of research into the relevant law and regulations, which is the sort of thing you’d think–oh, you know–writers for a law journal would do. You’d think that a Yale student publication such as the Yale Journal of Medicine & Law could attract better student authors, capable of less sloppy, ideologically motivated work. You’d think wrong, apparently. Even though the Yale Journal of Medicine & Law is an undergraduate journal, presumably its authors are interested in going into–oh, you know–medicine or law or related fields.

The rest of this issue is chock full of articles ranging from the questionable to the downright credulous. Titles include Tips from the Past: The ancient Oriental medical art of acupuncture and its emergence in modern day alternative medicine, which is almost as credulous as the article on the FDA; “Leaky Gut” or Suspect Science?, which cites Andrew Wakefield and Jenny McCarthy but is at least somewhat skeptical in parts; Ayurveda: Holistic Treatment from the Hindu Scriptures, which is slightly better in that it at least recognizes the problem with adulteration of Ayurvedic medicines; and Naturopathy’s Battle for Licensing, which is a lot like the article about chiropractic in that it buys into the propaganda of naturopaths trying to represent their quackery as scientific as they battle state legislatures for licensure. Sadly, the credulity in these articles far outweighs the skepticism, and in some cases, such as the ones I used for examples, the lack of skepticism and science with respect to alternative medicine is brain-fryingly irresponsible.

If this is what passes for critical analysis of the intersection of law and medicine by students at Yale, I fear for its students. Where were the faculty advisors for the editors of this journal? Asleep at the switch, apparently.

Comments

  1. #1 baravelli
    August 18, 2011

    I love Vangelders phrase “…legitimate practice in alternative medicine”. What could possibly be an illegitimate practice in alternative medicine? Something that actually works?

  2. #2 qetzal
    August 18, 2011

    Nice take-down of some pretty poor scholarship.

    I do want to comment on the FDA’s role in clinical trials, however. It’s not just the IRB that determines whether a trial is legal. If the trial involves an investigational (i.e. unapproved) drug, then an IND submission to FDA is typically required as well. That’s actually a much bigger hurdle than IRB approval. It requires detaild information on how the drug is made (including rigorous procedures and controls for drug quality), detailed information on safety testing in animals, and lots more. An IND submission typically represents several years of work.

    There are some situations where an IND isn’t needed. If the drug is already approved – e.g. if you want to test a drug that’s approved for disease X to see if it might work against disease Y, you don’t necessarily need an IND. (But if your goal is to ultimately get the drug approved for disease Y, I think you’ll need to submit an IND at some point.)

    Also, I think that technically, the law says you can’t transport unapproved drugs across state lines without an IND. So in principle, if you make an investigational drug and test it all within a single state, you may be able to bypass the IND. I’m not too sure about that though.

    All that said, this statement by Molly Patterson is BS:

    The FDA will not allow testing of these alternative treatments on human subjects, which eliminates the opportunity to conduct research on their effectiveness.

    The FDA will allow testing of alternative drug treatments on human subjects, if you follow the rules that apply to all new drugs.

  3. #3 Anonymous
    August 18, 2011

    It should be noted that the writers and editors of this “journal” are not lawyers or doctors, or even law or medical students. They are undergraduates, and the “Yale Journal of Medicine & Law” is just one of about a dozen student publications that hardly anyone here at Yale actually reads, or is even aware of.

    I agree that Yale can certainly do better, if this is the junk that Yale undergrads consider medicine, though.

  4. #4 Greg Fish
    August 18, 2011

    After this I’m not looking forward to the day when lawyers get involved in the AI world. Actually, I can see it now…

    “Your honor, I submit to you that reprogramming this system to use a switch statement instead of a function dictionary is a violation of the machine’s rights! After all, since the machine can learn and make decisions it must be sapient and thus entitled to all the rights we provide humans.”

  5. #5 Denice Walter
    August 18, 2011

    Through the encompassing translucent greyness, rain falls sporadically and drearily- I had thought that the monsoons were over but I was wrong. I am feeling morose. Reading about this doesn’t help.

    Vangelder recounts the AMA/Chiropractic suit in much the same fashion as does the *ne plus ultra* of woo-meisters, Gary Null, who informs us that he himself was instrumental in the case ( and many others challenging the powers-that-be). More suits against the AMA and FDA are in the works, I understand. Adams plans some tomfoolery of his own. Fight the power! Indeed.

    There is something odd – even perverse- about applying the idea of a monopoly to SBM, as though it were a type of business, product, or service and *nothing else*. Because pseudo-science can’t enter the room through meaningful results of its research it instead has to get its foot in the door through legal decisions and loop-holes in the law, like DSHEA.

    Orac points out a very important trope used by woo advocates to argue their case: “SBM ( or the AMA or FDA) will not allow us to do the _real_ trial of alt med vs medicine. They’re scared of the results”. They then usually propose the vax/ unvax study or spurious cancer treatments against real ones. While the rules protect the patient from treatments that have virtually no chance of working ( see Gonzalez), the woos conveniently leave this part of the equation out and blithely label the rules as *harm* and *keeping valuable treatments away from the public*. Again, “Oh what a tangled web we weave…”

    It seems that our (un)worthy opponents use language and law to re-structure reality to fit their own distinctly whimsical notions ( and business plans): perhaps SBM ( or the AMA) can turn the tables on them by copy-righting the terms “doctor”, “medicine”,”treatment”, and “science” and suing anyone who uses them inappropriately (sarcasm)

    On a lighter note ( don’t we all need a laugh?):

    Mike Adams is embarking on a new pathway of helping others ( see NaturalNews): he is re-inventing his musical persona with a new name and new message. He will be encouraging people “to keep on keeping on”** in these harsh times of economic and political turmoil ( fires in London, bi-polar markets, dogs and cats living together, et al). He is truly a “wonder of creation”***! What *can’t* this boy do?( Mathematics, I imagine. Science. Writing. Walk and chew gum at the same time)

    ** my apologies to Mr Dylan
    *** my apologies to Ms Merchant

  6. #6 Dan
    August 18, 2011

    I can honestly see how chiropractors suck people in. I had one tell me that not only could he cure everything that ailed me, but that if I didn’t have chiropractic treatment I’d have arthritis in my spine by the time I was 40. I deny anyone to not feel a little worried at that sort of news when they don’t know any better.

    Thankfully I was worried enough to get an appointment with an orthopaedic surgeon. Who proceeded to save me $2500 and a year’s worth of schlepping across town. Score one for science.

  7. #7 hoary puccoon
    August 18, 2011

    Well, yeah, lots of people go to chiropractors.

    After my husband hurt his back raising a battened mainsail without the winch– while I was screaming at him “use the (expletive deleted) winch!” [a Point of Conflict in our marriage]– we must have heard, “I know this great chiropractor…” from at least 10 different people.

    Even after he had visited an orthopedic surgeon, was assured that his back pain did not require surgery, and had made an appointment with the physical therapist the surgeon recommended, one friend tried to get my husband to cancel the appointment and go to her preferred chiropractor. “She’s so much cheaper and she also does herbal and aroma therapy.”

    After a series of visits to the physician-approved physical therapist, my husband’s condition improved dramatically. And then we heard, “it would have gotten better anyway. Those things always go away with time.”

    So, of course, when people are hearing that chiropractors are cheaper and just as good, and when back pains do frequently improve on their own, a lot of people are going to go to chiropractors. A lot of people play the slot machines in Las Vegas, too. It doesn’t make them a prudent investment.

  8. #8 bioephemera
    August 18, 2011

    The only thing I’d quibble with is this, Orac:

    “It’s always frightening when lawyers delve into the realm of medicine.”

    That may be your opinion, but it has negligible relevance to the content of the post. This journal isn’t by lawyers, it’s not a law school journal, and it isn’t even dominated by pre-lawyers, so far as I can tell. The five editors in chief, managing editors, and senior editors of this journal are undergraduates majoring/focusing in:

    Political Science with a focus in Health Politics and Policy
    molecular, cellular, and developmental biology and economics
    health economics and health policy
    biology
    Political Science
    Mathematics and Philosophy

    I’d go on, but it’s a long masthead, and I think the point is made. None of these editors has announced an intent to study law, though several would like to be physicians. So perhaps we should make sweeping generalities about physicians, not lawyers. . . ? ;)

  9. #9 Dangerous Bacon
    August 18, 2011

    “Ever since Wilk, the AMA and other federally associated institutions have been obliged to recognize and treat chiropractic medicine as a legitimate practice in alternative medicine. Nevertheless, a subtle disrespect for chiropractic practitioners as “unscientific witch doctors” still, to some extent, pervades the AMA and the medical community today.”

    These statements reflect a common gripe among chiropractors, many of whom believe that the Wilk decision somehow legitimized chiropractic (in reality it was a narrow ruling that made clear that the AMA could not sanction physicians for association with chiros, and was not in any way a ruling on the efficacy of chiropractic), and that continued skepticism about chiropractic is, if not actually illegal, at least immoral in the light of the Wilk decision.

    The medical community can and does frown on the sleazy and dangerous aspects of chiropractic (including its being touted for internal complaints, its reliance on unproven gadgetry and association with antivax sentiments and many sorts of useless woo). That has nothing to do with antitrust issues, and everything to do with the right of patients to receive effective and safe treatment.

  10. #10 Phoenix Woman
    August 18, 2011

    Lemme guess: None of the people writing about chiropractic ever mentioned all the people injured or outright killed as a result of chiropractic “treatments” like neck cracking.

    You’re better off with a licensed massage therapist. Much better off.

  11. #11 MikeMa
    August 18, 2011

    PW:

    You’re better off with a licensed massage therapist.

    And richer, very likely.

  12. #12 BraselC5048
    August 18, 2011

    Once again, slightly off topic, but right new just might be the best chance we’re going to get to get rid of the National Center for Complementary and Altertinave Medicine. Currently there is a panel of 12 congress members tasked with comming up with budget cuts, followed by an up or down vote. If we can convence members of the pannel to zero out the NCCAM’s budget, the angency’s supporters in congress won’t get much of a chance to do anything about it. This would be an excellent oppertunity for a letter writing campaign. Convincing them that it’s a waste of money, which it actually is, for once, might be our best chance to get rid of it we’ll ever get. Pointing out if you’re a docter or scientist, which many of us are, could make out letters even more persuasive. Oran Hatch won’t get a chance to do anything about it.

    Any thoughts? Are we going to go ahead with it?

    (Don’t let altertinave medicine supporters find out about it- competing letter writing compaigns would likly achieve nothing.)

  13. #13 Beamup
    August 18, 2011

    Frankly I don’t want them to waste their time on such small potatoes. Getting some sort of agreement on the big issues (i.e. taxes and Medicare) will be nigh-impossible to begin with, and such distractions seem counterproductive.

  14. #14 herr doktor bimler
    August 18, 2011

    A better term for the “individualization” of treatment under various alternative medicine regimens is what I like to call, “Making shit up as you go along.”

    Alternative term: “Avoiding any possibility of performance tests”.

  15. #15 LindaRosaRN
    August 18, 2011

    Eduard Vangelder is a Classics (Greek & Latin) major.

    The “Yale Journal of Medicine and Law” apparently has no relationship with the Yale Law or Medical Schools…or Yale. It is not recognized as a real law journal.

    But this pro-CAM publication — with its impressive name — is certainly something the quacks will point to the next time they want something from legislators. 

  16. #16 Rogo5
    August 18, 2011

    Another alternative term: “Making you feel special when I (the alt med practitioner) have recommended the same thing to every one who has ever walked into the building.”

  17. #17 lilady
    August 18, 2011

    @BraselC5048: You proposed this letter writing campaign a few days ago, and in any other year I might agree with you; NCCAM should go. But I have to agree with Beamup here that state of the economy and the deliberate prolonged negotiations to raise the debt limit as well as the unsuccessful attempt to balance the budget by raising taxes for the wealthy (progressive taxation…not regressive taxation), are of much greater concern. We are dealing with runaways costs associated with Medicare and Medicaid, which need remediation. Of course our role as international cop with an unlimited, unsustainable defense budget adds measurably to the fiscal fiasco we find ourselves in.

    BTW, those “interests” such as alternative medicine practitioners and supplements manufacturers as well as their audience of “believers” have very powerful lobbyists in Washington…as well as legislators who are “in their pocket”.

  18. #18 meg
    August 18, 2011

    This bit confused me:
    “Eastern medicine, in particular Chinese medicine, focuses on the individual, with physicians giving each patient unique herbal treatments based on their individual diagnoses. Patients enjoy the personal attention given to them by their doctors, who not only ask about their symptoms but also try to connect their illnesses with their mental states.”

    Last time I went to the doctor, he spent a good 15 minutes with me, going through my symptoms, and working out possible diagnosis. He then concluded I should best see a specialist, referred me to one that through other contacts I have discovered is one of the best here in Sydney, and made sure that I would come back to him if things flared up in the meantime. I found his ‘personal attention’ fantastic.

    Oh, and given we have a good public health care system here, I didn’t pay for it.

  19. #19 Ophelia Benson
    August 18, 2011

    Eduard Vangelder is a Classics (Greek & Latin) major.

    The “Yale Journal of Medicine and Law” apparently has no relationship with the Yale Law or Medical Schools…or Yale. It is not recognized as a real law journal.

    So what you’re saying is, this rag that calls itself a journal of medicine and law is actually just a “journal” about medicine and law written by undergraduates in the humanities?

    That’s pathetic!

    It’s blatantly deceptive, at the very least. That’s not what reasonable people understand “journal of” to mean, especially when “Yale” is at the front.

  20. #20 qetzal
    August 18, 2011

    I commented this morning, but apparently got lost in the moderation black hole, so I’ll try again.

    Good takedown of some pretty bad scholarship. However, I wanted to comment on the FDA and clinical trials. In most cases, these “alternative cancer treatments” would be considered investigational drugs by FDA. That means that before they can be tested in humans, one would need to submit an IND to FDA. The IND has to describe how the drug is made, all the QC tests used to confirm identity, purity, potency, etc. It also has to describe all the safety testing, which typically includes in vitro tests (on cell lines) and animal tests. That’s in addition to describing the proposed clinical trial, the informed consent, etc. The amount of work involved is MUCH more substantial than what an IRB approval requires. Doing the work and submitting the IND can easily consume several years (speaking from personal experience).

    The exception would be if one wants to test a drug that’s already approved, e.g. for Disease X, to see if it might work for Disease Y. In that case, I don’t think an IND is required. (Unless you’re hoping to get formal approval to label the drug for use in Disease Y.)

    So it’s true that getting FDA’s blessing can be a major effort. But it’s not true, as Molly Patterson claims, that

    The FDA will not allow testing of these alternative treatments on human subjects.

    The FDA WILL allow testing of these alternative treatments on human subjects, IF the people who want to do the testing just conform to the same rules that apply to every other unproven drug. Of course, they think that their “treatments” are special, and shouldn’t have to play by the same rules as all those evil ‘allopathic’ drugs.

  21. #21 Lawrence
    August 18, 2011

    Of course, the woo-meisters have no problem trying untested treatments on their patients, but if a pharma company tried the same thing, imagine the hell they’d raise.

    It is a double-standard of the worst kind.

  22. #22 Orac
    August 18, 2011

    @bioephemera

    Hit a nerve, did I?

    Let’s just put it this way: If you were a regular reader of this blog, you’d know that I don’t spare medical students when appropriate. Search for “AMSA” if you don’t believe me.

  23. #23 Jesse Weinstein
    August 18, 2011

    It appears that the publication may be bending the rules governing student organizations at Yale. These rules include the following phrasing: “Any undergraduate organization wishing to incorporate the name of Yale into its title must secure permission to do so … In order to obtain approval by the Yale College Dean’s Office, the organization should be certain (1) that the nature and purpose of the organization are clearly evident from its title, and (2) that its proposed name does not imply University endorsement of the activities, services, or products offered by the group. Therefore, the words “Undergraduate” or “Yale College” must appear in the organization’s title or subtitle, and must be prominently displayed. … Permission to continue to use the Yale name is contingent upon maintaining these requirements and conforming to the regulations applicable to the organization.” (quoted from http://yalecollege.yale.edu/content/manual-undergraduate-organizations#g (archived: http://www.webcitation.org/612ilKO5G ), linked from http://yalecollege.yale.edu/content/publications-and-masthead-disclaimer )

    The official name of the publication in question is “Journal of Medicine and Law, Yale: An Undergraduate Organization” (according to https://apps.students.yale.edu/uor/RegisteredOrganizations ; archived: http://www.webcitation.org/612ii19FD ) which satisfies the letter of the regulations; however, the “undergraduate” part is not included in the title or subtitle of the publication on their website ( http://www.yalemedlaw.com/ archived: http://www.webcitation.org/612ih24mq ), nor is it “prominently displayed”. This appears to be a violation.

    The people to contact about this would seem to include: Denise Castellano (email is: her name, separated by dots, at yale.edu) at the Yale University Licensing Program (although that seems to focus on clothing licensing) (name found here: http://www.yale.edu/licensing/trademark.html ) John Meeske (email is same form), the Associate Dean for Student Organizations and Physical Resources (name found here: http://yalecollege.yale.edu/content/office?tid=39 ) and the publication itself: editor@yalemedlaw.com .

    Hopefully this will be useful!

  24. #24 Shane in Aus
    August 18, 2011

    Just as an aside.
    We had a very sick patient into my hospital today.

    it turned out he had serious bleeding from torn intercostal arteries as the result of chirpractic manipulation.

    We saved his life by that wonderful aspect of applied human biology called medicine otherwise known as shit that works.

  25. #25 Ophelia Benson
    August 19, 2011

    I don’t call that an aside, I call that bang smack central.

  26. #26 Dan
    August 19, 2011

    If personalized medicine is so important, why aren’t there any eastern medicine practitioners in emergency departments? “Ah, Mr. Smith, the Western treatment for a shattered femur generally starts with morphine, but your aura is different. I think we’ll start with a poultice of spider webs and unicorn spit.”

  27. #27 Vicki
    August 19, 2011

    Email sent: I identified myself as a graduate of Yale College (and gave the year), mentioned my elective courses in logic, and said that while of course those were electives, I hoped every Yale student would learn the basics of reasoning correctly, including that “some people agree with me” is not a valid argument.

  28. #28 qetzal
    August 19, 2011

    I really hate it when authors write their conclusions as if the study proved them, rather than merely supporting them. In the results part of the abstract, these authors state:

    Cortisol slope significantly decreased for biofield healing versus both mock healing and control (P < .04 in both cases; Cohen's d = 0.58).

    A straightforward statement of what was observed in the study. Perfectly fine. But then in the conclusions part of the abstract, they claim:

    Biofield therapies increase cortisol variability independent of belief and other nonspecific factors.

    No, no, no. The evidence from the study may suggest this, but it is wrong and unscientific to state it as a fact!

    Bad authors! Bad!!

  29. #29 qetzal
    August 19, 2011

    Sorry, my last comment was supposed to go on this thread.

  30. #30 Mojo
    August 19, 2011

    In other words, IPT is dangerous, but that other woo works, or, as I like to rephrase it, the woo I like works and all that other stuff is dangerous quackery.

    I suspect that there may be one of Bernard’s “irregular verbs” lurking here.

  31. #31 herr doktor bimler
    August 19, 2011

    one of Bernard’s “irregular verbs”
    Must also credit Bertrand Russell.

  32. #32 Jesse Weinstein
    August 20, 2011

    @Viki — That’s great to hear; let us know what response (if any) you get!

  33. #33 DLC
    August 21, 2011

    Yale Journal of Medicine and Law?
    Sounds like I’d be better served by spending my money on a new Yale lock. A more useful item than what appears to be a vanity journal.
    Just remember, when you see Alternative Medicine, that someone forgot to put the “to” in between Alternative and Medicine.
    because sCAM is an alternative to medicine. It’s only long-term effect is on the weight of your wallet.

  34. #34 Vicki
    August 22, 2011

    I got email from John Meeske (the relevant dean at Yale) this morning. It sounds promising:

    Dear Vicki,

    Thank you very much for bringing this to our attention. This sounds like a major violation of Yale policies and we will definitely pursue it and make sure it doesn’t happen again.

    Best,
    John Meeske (’74)

  35. #35 Ophelia Benson
    August 22, 2011

    Vicki rocks!