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Pitfalls in Regulating Physicians. Part 2: The Games Scoundrels Play

A Few Things that No Doctor Should Do

When a physician is accused of DUI, “substance abuse,” being too loose with narcotic prescriptions, throwing scalpels in the OR, or diddling patients, the response of a state medical board† tends to be swift and definitive. Shoot first, ask questions later. After all, the first responsibility of the board is to the public’s safety, not to preserving the physician’s livelihood. One might therefore expect that a physician accused of using dangerous, substandard treatments would face a similar predicament. As you’ve undoubtedly guessed, such is not the case.

Here on Science-Based Medicine I’ve discussed at least 4 risky and implausible treatments: Laetrile, the “Gonzalez Regimen,” Na2EDTA “chelation therapy,” and intravenous hydrogen peroxide. Any medical board worth its salt ought to recognize each of those as dangerous and sub-standard, and therefore ought quickly to impose serious disciplinary measures upon any licensed physician found using them. Sometimes that is the case, but all too often it isn’t.

Rothstein Redux

We saw an example last week. Binyamin Rothstein, who accused me of “stopping” the NIH chelation trial (if only I had that much power!), was initially charged with substandard practice in July, 1995. In March, 1996, having documented numerous examples of such practices including failure to diagnose life-threatening conditions such as meningitis, pneumonia, and congestive heart failure, and using treatments such as intravenous hydrogen peroxide, Na2EDTA, and colchicine, the Maryland medical board suspended Rothstein’s license for 3 years—only to ”stay” the suspension after 90 days on the condition that he consent to remedial training, oversight of his practice, and 3 years’ probation. The board also ordered Rothstein to ”devise Board Approved Consent Forms apprising patients of the concept of alternative medicine and the risks thereof.”

Features of Rothstein’s case are common to many investigations of quacks: the board usually finds an arsenal of quack treatments rather than one or two; basic medical care is found to be substandard and poorly documented; the board, even after documenting such appalling practices, tends to be lenient at first; and the board often reveals a naiveté about misleading language, appearing unconcerned that quackery has somehow become “alternative medicine,” with its implication that an accommodation ought to be made (in Rothstein’s case, the language about informed consent) .

Another feature of Rothstein’s case common to others is that his consent order was ineffectual. Only 3 years later he was found to have been practicing in the same manner as before. The board determined that he had violated his probation, but granted him another reprieve: 3 more years of probation, now with the stipulation that he must “terminate his practice of ‘alternative’ or ‘complementary’ medicine and shall practice only ‘traditional,’ ‘conventional,’ or osteopathic medicine for the entire period of probation.”

‘Twas not to be. In 2005, again finding that nothing had changed, the Maryland board revoked Rothstein’s medical license. The revocation order expressed the board’s frustration at having bent over backward to help him keep his job:

The Board has attempted to work with Dr. Rothstein for a decade. In the first Consent Order, every effort was made to accommodate his desire to practice alternative medicine, as long as he provided his patients with informed consent, did his patients no harm and did not neglect their conditions that required traditional medical evaluation or treatment. The first Consent Order was not effective in protecting the public health, because he continued to neglect his patients’ serious medical symptoms and conditions. Despite this failure, the Board once more entered into a consent order, Consent Order II, with Dr. Rothstein. This second time, however, the Board attempted to alleviate any danger to the public by prohibiting him from practicing alternative medicine and requiring that he practice competent conventional medicine. He was also ordered to “cooperate fully with the Board at all times” in the Board’s oversight of his practice.

Dr. Rothstein did not cooperate with the Board…

Thus it took a full decade, once the Maryland board caught wind of Rothstein’s mischief, to get him off the streets. Even then, as mentioned last week, he continued to market his brand of pseudomedicine through a shady business and an even shadier claim of “clerical privilege.” 

And That was One of the Better Outcomes!

Dear Reader: before you begin making inevitable comparisons to repeat DUI offenders in the pre-MADD era, consider that the Maryland board, as medical boards go, did a pretty good job. There are numerous physician quacks (although they probably constitute a very small percentage of all MDs and DOs) who have either evaded regulatory scrutiny altogether or have faced it but managed to quack again and again. I invite you to peruse the many cases linked from the website of CIRCARE (Citizens for Responsible Care and Research), whose President, the classicist Liz Woeckner, is one of our co-authors on the TACT article; and linked from Casewatch (one of the affiliated sites of Quackwatch), operated by Stephen Barrett and another of our TACT co-authors, Robert Baratz.

On the CIRCARE website there is also a wealth of information about nearly 100 unfit TACT investigators, which we posted as a reference for the article. Of those, fewer than 20 have been subjected to state medical board actions, and a few more to federal or criminal actions (including 2 fraud convictions—good judgment by the NIH and IRBs to approve them as investigators, no?). Yet all of them peddle quack treatments.

Does It Take One to Know One?

Let’s look at another ploy common to such cases: quacks frequently claim that there is a solid scientific basis for their methods, but that “conventional” physicians are unaware of it. A corollary is that “conventional” physicians are held to be unqualified to judge quack methods (now called “CAM” or “integrative medicine”). In a case decided in 1998, the Iowa state medical board suspended the license of V. Thomas Riley, MD, a board-certified ENT surgeon who had been treating patients with “chelation therapy,” IV hydrogen peroxide, and IV vitamin C, and advising them that their dental amalgams were posing a risk of mercury poisoning. He told a patient who had had a root canal that the tooth in question was ” ‘like a dead fetus’ in her body and had to be removed.”

To support such drivel, Riley produced 3 “experts.” One was Charles H. Farr, the “father of oxidative medicine” discussed here 2 weeks ago. For Riley’s case, Farr claimed expertise in “chelation therapy” and IV hydrogen peroxide. Another was Roy E. Kerry, a fellow ear, nose, and throat surgeon who styled himself as an authority on “heavy metal toxicity,” especially from mercury. Kerry later became famous after injecting the chelating agent Na2EDTA (the same drug used in the TACT) into a 5-y.o. autistic boy in Pennsylvania, who died minutes later.

Riley also offered several chelation “studies” to support his case; we reviewed each of them for our recent article, and found them to be at best worthless, but more likely fraudulent.

Fortunately, the Iowa board was having none of it, thanks in part to the testimony of its own expert on quackery, the late John Renner. A federal case in 1993 provided a precedent for courts rejecting the assertion that “expert witnesses” must be limited to those who have used the methods in question. The US Court of Appeals, 7th Circuit, affirmed a district court’s finding that the manufacture and distribution of a hydrogen peroxide-containing “gel” for oral ingestion violated several articles of the federal Food, Drug, and Cosmetic Act.* The court rejected the defendants’ claim that the government’s expert testimony should be disqualified merely because its author, Gloria Troendle, MD, “had no formal training in hydrogen peroxide therapy.” The court observed: “Requiring a physician to be trained in the very field whose legitimacy he questions would be unreasonable.” Regarding the defendants’ response to Dr. Troendle’s affidavit, the court opined:

The defendants have not rebutted this affidavit with any competent testimony from their own experts, choosing instead to impeach Dr. Troendle’s methods and to rely upon articles written by proponents of hydrogen peroxide therapy. Dr. Troendle has admitted that she has not tested or observed the effects of hydrogen peroxide, has not published articles concerning the drugs at issue, and has not interviewed doctors or patients who have used hydrogen peroxide therapy. However, she had no responsibility to do these studies; she gave her opinion based upon the information made available to her.†

Together, the last two cited cases seem to argue for optimism, regarding the role of science and reason in disciplining quack physicians and other purveyors of dubious methods. There is cause for optimism, but there have been many exceptions and setbacks, some of which might be considered systematic or part of an unfortunate societal trend. I’ll discuss some of those in two weeks.

Is Quackery an Addiction?

Let’s revisit some of the statements made at the beginning of this post. A lawyer friend of mine describes substance abuse,  ‘boundary violations,’ and other infractions of the sort mentioned in the first paragraph as “low hanging fruit” for medical boards. They’re easy—not always easy to prove, but easy to despise. But what about the contradiction between the “shoot first” mentality of boards plucking low hanging fruit and the give’em another chance mentality of the same boards when faced with the like of Binyamin Rothstein? Is there a role for boards repeatedly giving “the benefit of the doubt” in the latter cases? I don’t think so. A good argument can be made that quacks are at least as dangerous to patients and at least as entrenched in their practices as are drug addicts.

Consider Rothstein’s view of his troubles with the Maryland board:

My penchant for healing has always gone beyond the confines of Western medicine and two things occurred: I had a very high success rate in treating patients, and I evoked the ire of the Maryland Board of Physicians. As a result of these two events, the Maryland Board of Physicians elected to revoke my license, not because anyone was injured, complained, or failed to respond to treatment but because my patients all did well. For full details of my case, please log onto www.binyaminrothstein.com. You be the judge.

The attitude that quackery works so well that it irks, or embarrasses, or threatens other physicians is another common feature of such cases and of quacks themselves. It’s hard to imagine that Rothstein didn’t already hold those views at the time of his first brush with the board.

I believe that opinions such as Rothstein’s are every bit as compelling to those who hold them as heroin is to a junkie or, more to the point, as the next bet is to a compulsive gambler. Imagine a gambler who doesn’t merely believe he’ll win his next bet, but who almost always does win it, and you’ll begin to sense how it must feel to be a quack physician. The unfortunate reality is that practicing pseudomedicine is not only far easier—intellectually, ethically, and in hours spent—than is practicing real primary care medicine, but it is also considerably more lucrative. Here is a passage from our chelation article (please refer to the original for references):

Chelation Goes Private: “A Big Cash Cow”

Nevertheless, a tiny group of advocates continued to practice “chelation therapy,” usually in the office. Then as now, it consisted of an initial series of IV infusions of disodium EDTA, magnesium, vitamins, and minerals, followed by monthly “maintenance” infusions. At first, chelationists called the treatment a “chemical Roto-Rooter” or a “chemical endarterectomy,” but eventually promoted it as a near-panacea for conditions as disparate as multiple sclerosis, schizophrenia, autism, cancer, peptic ulcer, back pain, and chronic obstructive pulmonary disease.[34,56,57] According to a recent article reprinted on the Web site of the ACAM, the most conspicuous organization of chelationists, “heart patients undergoing chelation typically receive 30 to 40 weekly treatments, then are scheduled for lifelong monthly sessions to keep the arteries free of plaque.[58]” The article quoted the price of a single chelation treatment – the ingredients of which cost a few dollars[59] – to be $120–$125. In addition, according to the Trial Chelation Consultant for the TACT,[4] there are “nutritional supplements in the range of $20 to $200 per month [and] diagnostic study costs and professional fees…ranging from a few hundred to several thousand dollars.[57]”

The article on the ACAM Web site reported that TACT co-investigator and “prominent expert[4]” Allan Magaziner “said his center [was] treating 400 to 500 heart patients with chelation.[58]” L. Terry Chappell, another “prominent expert” and co-investigator, told a government hearing in 1999 that he had treated “at least 2500 to 3000 patients with chelation therapy” over a period of about 18 years, but that this represented “only 20–25% of [his] medical practice.[41]” Former ACAM president and convicted extortionist Ted Rozema,[60] also a TACT co-investigator, testified at the same hearing that in 16 years he had treated “over 2000 patients [with] over 80,000 infusions of EDTA.[41]” The 2001 TACT protocol states that Trial Chelation Consultant, prominent expert, and TACT co-investigator Dr. Martin Dayton, who was convicted of conspiracy and mail fraud in 1986,[61] “has clinical experience with over 75,000 chelation infusions.[4]” The late H. Ray Evers, a convicted felon revered by chelationists as a “pioneer of chelation therapy,” reportedly claimed to treat, during the 1970s, 1000 patients per year at $3000 each.[62,63] According to a former practitioner, “chelation is a big cash cow.[59]”

Another TACT investigator, Rashid Buttar, has shown that cancer quackery is also a big cash cow. And so on.

Quack physicians are Con Men extraordinaires. They combine the psychology of religious fanaticism with the positive behavioral feedback of the norm of reciprocity and substantial monetary gain. They are successful because they have the imprimatur of the state and face little competition. They are members of a tiny, state-protected oligopoly, comprising individuals who combine a license to practice medicine with a compulsion to practice pseudomedicine.

* United States v. Vital Health Products, 786 F.Supp. 761 (E.D. Wis. 1992); affirmed as U.S. v. LeBeau, 985 F.2d 563 (7th Cir. 1993)

……………………

The State Regulation Series:

  1. Pitfalls in Regulating Physicians. Part 1
  2. Pitfalls in Regulating Physicians. Part 2: The Games Scoundrels Play
  3. The Pseudomedical Pseudoprofessional Organization (PPO*)
  4. A New Twist for Autism: A Bogus “Biomedical” Board
  5. How State Medical Boards Shoot Themselves (and You) in the Foot
  6. “Integrative Medicine Experts”: Another Barrier to Effective Discipline
  7. Bogus Diagnostic Tests 

  ………………………..

Addendum: This just in from last night’s 2008 Ig Nobel Award Ceremony!

MEDICINE PRIZE. Dan Ariely of Duke University, USA, for demonstrating that high-priced fake medicine is more effective than low-priced fake medicine.
REFERENCE: “Commercial Features of Placebo and Therapeutic Efficacy,” Rebecca L. Waber; Baba Shiv; Ziv Carmon; Dan Ariely, Journal of the American Medical Association, March 5, 2008; 299: 1016-1017.
WHO ATTENDED THE CEREMONY: Dan Ariely

Posted in: Health Fraud, Medical Ethics, Politics and Regulation, Science and Medicine

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7 thoughts on “Pitfalls in Regulating Physicians. Part 2: The Games Scoundrels Play

  1. As I mentioned in my post about Dr. Rashid Buttar, I think the reason that medical boards act fairly swiftly when it comes to substance abuse, the sexual abuse of patients, or doctors who are prescription mills is because it’s easy. There’s no value judgment necessary on treatments or the actual medical competence of the physicians. The medical board can tell itself that these would be otherwise good doctors if they had been able to control their urges or hadn’t given in to temptation to make a buck selling prescriptions for controlled substances and because they have fallen off the straight and narrow path they have to be stopped because clearly patients are being endangered. In contrast, n the case of quackery medical boards have to decide whether what the doc is doing is so far out of the standard of care as to be a serious danger, and docs tend to have a “there for the grace of God go I” attitude in terms of giving each other leeway in terms of what treatments they pick.

  2. David,

    Right you are, and I must admit to being a little embarrassed that I hadn’t realized that you’d written those things. In the spring I had looked at Buttar’s activities myself for the TACT article, and thus I smiled when I later saw your post, without actually reading it. :-(

    That said, the other points that you made are also good ones, eg, that “Most medical boards are overburdened and underfunded. Consequently, until complaints are made and there is actual evidence of patient harm, they are often slow to act,” and that each of the 50 boards (even more, as we’ll soon see) have different laws and standards. In the next installment I’ll discuss a bit about those differences.

    We also agree, I’m sure, that although the line between acceptable and unacceptable practices isn’t always clear, in some cases it ought to be utterly clear. For example, almost all state medical board statutes and regs include a requirement that licensees must obey federal and state laws. Of the four “risky and implausible” treatments that I listed above–Laetrile, IV hydrogen peroxide, IV Na2EDTA, and the “Gonzalez regimen”–all but possibly the last are illegal according to the federal food and drug act, because they are not approved for any indication and thus cannot be used even “off-label.”

    What that means, as I understand it, is that if a practitioner has purchased them from a source outside of his own state (the commerce clause figures here) for the purpose of administering them to patients, he has broken federal law. He has also broken federal law if he makes specific therapeutic claims for the substances, at least in writing (eg, the patient brochures for hydrogen peroxide that I quoted in Part 1 of this series, which constitute “misbranding”). I base those assertions on at least two opinions, one cited above (United States v. Vital Health Products) and the other involving ACAM member Jack Slinguff, who sold Laetrile during the time that he was a TACT investigator: http://med.ohio.gov/formala/34001265.pdf

    I’m not a lawyer, so I may not be perfectly correct in my legal discussion, but it seems to me that I’m close enough (any lawyers out there?). What seems clear is that it should be just as easy for state medical boards to discipline quacks who have broken federal drug laws as it is to discipline drunks or pervs, and that as asserted above, the former group is at least as dangerous TO PATIENTS as is the latter.

    BTW, even Gonzo’s regimen is probably illegal, although it’s not so cut and dry as the others. His touting of specific effects for “it” (really 150 “its”) is probably misbranding, since none of the ingredients has ever been approved for the “indications” that he claims. Hence for those purposes they are considered “new drugs” (not “supplements”) and at least some of them must have crossed state lines to get to him. Unless Colonel Folger also brought a mountain to New York, that is.

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