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The “Gonzalez Trial” for Pancreatic Cancer: Outcome Revealed

A Review

Dr. Lipson’s “detoxification” post on Thanksgiving Day and Dr. Gorski’s recent post about “Gerson Therapy” were timely, because last weekend I noticed something that I should have noticed months ago. Before delivering the punch line, let me remind you, Dear Reader, of the nature of the topic. The regimen advocated by Nicholas Gonzalez is a variation of a “detoxification” treatment for cancer that has been around, in one form or another, for more than 50 years (“Gerson Therapy” is another example).† Here is the National Cancer Institute’s (NCI) description:

Patients receive pancreatic enzymes orally every 4 hours and at meals daily on days 1-16, followed by 5 days of rest. Patients receive magnesium citrate and Papaya Plus with the pancreatic enzymes. Additionally, patients receive nutritional supplementation with vitamins, minerals, trace elements, and animal glandular products 4 times per day on days 1-16, followed by 5 days of rest. Courses repeat every 21 days until death despite relapse. Patients consume a moderate vegetarian metabolizer diet during the course of therapy, which excludes red meat, poultry, and white sugar. Coffee enemas are performed twice a day, along with skin brushing daily, skin cleansing once a week with castor oil during the first 6 months of therapy, and a salt and soda bath each week. Patients also undergo a complete liver flush and a clean sweep and purge on a rotating basis each month during the 5 days of rest.

As unlikely as it may seem, in 1999 American taxpayers began paying for people with cancer of the pancreas to be subjected to that regimen, in a trial sponsored by the National Center for Complementary and Alternative Medicine (NCCAM) and the NCI, conducted under the auspices of Columbia University. Gonzalez provided the treatments. A few months ago I presented a multi-part treatise on the “Gonzalez regimen” and the trial. It demonstrated that all evidence, from basic science to clinical, including the case series that supposedly provided the justification for the trial, had failed to support any real promise (the case series had previously been considered by reader Dr. Peter Moran, who also found them wanting).

It showed that the impetus for the trial, as has been true for other regrettable trials of implausible health claims, can be traced not to science but to the reactionary politics of anti-intellectual populism: initially to Laetrile and to the “Harkinites,” and more recently to the Honorable Dan Burton (R-IN). It reported that there were major problems with the Gonzalez trial from the outset, and that for at least one subject the regimen was more torture than therapy. It reported that for unclear reasons the trial had come to a halt a couple of years ago, and that it appeared that there would never be a report of its findings.

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Posted in: Cancer, Clinical Trials, Medical Academia, Medical Ethics, Politics and Regulation

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Canadian Justice: Breast-Fondling Chiropractor Faces “Interpersonal Skills Training”

There is something unexpectedly sinister about this news report from my former home town in Canada. Apparently, a local chiropractor has been using his “medical training” to excuse his sexual misconduct. Here’s the story from the Halifax Chronicle Herald:

During a hearing in July, the woman said the chiropractor would frequently grip her around the ribs and hold tight, sometimes cupping her breasts, while speaking softly over her shoulder.

On other visits, she said, he would have her lie on a table and would undo one side of her johnny shirt, exposing her breast, place a thumb between her breasts and roll her onto her side by pressing the weight of his own body on her.

Dr. LaPierre testified he performed a technique called the Zindler manoeuvre. It involves applying precise, quick pressure to a restricted joint to restore movement. He said he would have explained the procedure to her the first time but not on subsequent treatments…

The second incident involved a woman who complained that in 2006 the chiropractor “massaged” her breast while trying to find the source of her back pain.

Dr. LaPierre said he was using a technique called “matrix repatterning” that required contact with the woman’s sternum. He said he didn’t recall where the rest of his hand was at the time. He determined the woman had a rib out of alignment.

What was the punishment for his behavior?

Dr. Phillip LaPierre must have a female observer present when he examines women for the next five years, must take training on interpersonal skills and must pay a fine and costs totaling $26,000 now that a panel of the Nova Scotia College of Chiropractors has found him guilty of sexual misconduct based on the two complaints.

It’s hard to imagine such a small fee in an American court of law. If a US physician were molesting his patients, I’m willing to bet that the fine would have an additional zero or two at the end.
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Posted in: Chiropractic, Medical Ethics

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“Integrative Medicine Experts”: Another Barrier to Effective Discipline

This is the final entry in the current series having to do with state regulation of physicians.† It is the final one merely because I’m tired of the topic, for now. There is plenty more to write about, including an event that occurred only yesterday right here at my own hospital. I’ll give a preview of that at the end of this post, but first we’ll look at another recent event.

Dazing Arizona  

Arizona’s citizens, more than most, can expect to be bamboozled by pseudomedicine. We’ve seen that the Arizona Board of Homeopathic Medical Examiners has, for years, provided a regulatory safe haven for quacks with MD and DO degrees. Although I haven’t previously mentioned it in this series, which is about quack medical doctors, Arizona is also a haven for another group of quacks: “naturopathic doctors.” Like its homeopathy board, Arizona’s Naturopathic Physicians Board of Medical Examiners has been less than committed to protecting the public from its licensees. In each board’s case, the state Office of the Auditor General has suggested numerous fixes, but there has been little indication of improvements.

Nor would improvements be expected: in the words of Edzard Ernst,

Those who believe that regulation is a substitute for evidence will find that even the most meticulous regulation of nonsense must still result in nonsense.

Arizona is also the home of one of the first academic “integrative medicine” programs, begun by Andrew Weil at the University of Arizona. We have previously seen examples of misleading language emanating from that program. We’ve also seen the program’s inordinate effect on the Federation of State Medical Boards (FSMB). We’ve seen examples of the writings of Kenneth Pelletier, one of the U of Arizona program’s consultants to the FSMB. A recent disciplinary case in Arizona illustrates the potential danger of a state medical board seeking consultation from another “integrative medicine expert” from that program.

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

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Does alternative medicine have alternative ethics?

Kimball Atwood has an interesting series of posts on the ethics of alternative medicine which I strongly encourage you to read.  He does a great job examining the ethical implications of certain alternative medicine practices, and has a terrific dialog with Peter Moran, a frequent commenter here.   At my other online locale, I make frequent forays into the morass of medical ethics, with an emphasis on specific clinical scenarios.  Today, though, I’d like to take a step back and examine the nature of medical ethics as they apply to so-called alternative medicine.

First, and perhaps most important, I am not an ethicist.  I do not have the depth of reading, the knowledge of terminology, or the specific education to lead a formal discussion on ethics.  What I am is a practicing internist, who must make ethical decisions on a daily basis. Most of these decisions are of necessity made “from the heart”, but it is not infrequent that I must evaluate a situation more formally and fall back on some of the ethical principles of my profession.

Ethics are not static.  They are not a divine gift bestowed on each of us as we don our white coats.  They are a living part of our specific cultures, and of the profession we serve.  Some of the modern principles of medical ethics are newer than others.  Beneficence, non-maleficence, and confidentiality are ancient principles of medical ethics, which continue to be relevant today.  Patient autonomy is a more recent value, reflecting a shift in how society views the relationship between patient and physician.  These ethics must be mutable, as the profession itself is ever-changing.  Despite this fluidity, there is an identifiable line of “doctor-hood” that has existed for at least the last century, and the members of this guild have always tried to adhere to some type of code of behavior.

Alternative medicine poses real challenges to the principle of medical ethics.  First, we’ll discuss who, in fact, is bound by these principles, then the way in which alternative medicine is or is not compatible with medical ethics. (more…)

Posted in: Medical Ethics, Science and Medicine

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Circumcision: What Does Science Say?

Some people think circumcision is mutilation; others want one even if they don’t know what it is. When I was working in an Air Force hospital emergency room one night, a young airman came in requesting a circumcision. I asked him why he wanted one. He said a couple of his friends had had it done, and he’d heard it was a good idea, and he was going to be getting out of the Air Force pretty soon and wanted to have it done while Uncle Sam would still foot the bill. I examined him: he had a neatly circumcised penis without so much as a hint of any foreskin remnant. I’ve always wondered what he thought we were going to cut off.

The subject of circumcision evokes strong emotions. Some people think of neonatal circumcision as a religious duty or a valuable preventive health measure; others think it is the epitome of child abuse. I have no strong feelings either way. I’m not sure what I would have decided if I’d had sons; fortunately my children were both daughters so I didn’t have to decide. I’m going to try to stand back and look at the scientific evidence objectively. What are the medical benefits and risks of circumcision? (more…)

Posted in: Medical Ethics, Surgical Procedures

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How State Medical Boards Shoot Themselves (and You) in the Foot

This is almost the final entry (for now) in a series of posts about the pitfalls of regulating physicians who peddle quackery.† In previous entries we’ve seen how quacks have portrayed an illegal and pseudoscientific treatment, intravenous hydrogen peroxide, as legitimate; how a physician who practiced that and other dubious methods eluded definitive regulatory sanctions for years; examples of quacks banding together to form pseudomedical pseudoprofessional organizations (PPOs) and bogus board-certification schemes to establish the appearance of professional legitimacy, for protection from regulatory scrutiny, to garner political clout, to attract funds from interested businesses, to dupe the Accreditation Council for Continuing Medical Education into granting continuing medical education credits (CMEs) for pseudoscientific conferences, and more.

Now we’ll look at several examples of how state medical boards in the U.S. have abdicated their responsibility to protect the public from such practitioners. A few caveats: first, in most cases I can only guess why that has happened. Some of it has probably been due to naiveté, or to political or legal pressures. To some extent it has probably been due to faddism and its close relative, misleading language. Next, the examples given here are by no means exhaustive. Next, a state medical board can only be as effective as the language in the state’s medical practice act allows it to be, and that is determined by legislators (politics), not board members. Finally, state medical boards have not uniformly made the wrong choices regarding quack practices and practitioners.

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

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Massage for AIDS

ResearchBlogging.orgI recently learned of a study entitled “Dominican Children with HIV not Receiving Antiretrovirals: Massage Therapy Influences their Behavior and Development.” It disturbed me, and I couldn’t get it out of my head. They’re massaging these kids but letting them die of AIDS? I went back and read the complete article, and it left me even more disturbed.

They studied 48 Dominican children ages 2-8 with untreated HIV/AIDS, randomizing them to receive twice weekly sessions of either massage or play therapy for 12 weeks. The abstract said that those in the massage group improved in self-help abilities and communication, and that children over the age of 6 showed a decrease in depressive/anxious behaviors and negative thoughts. That’s what the abstract said. The text revealed a more complex story. (more…)

Posted in: Clinical Trials, Medical Ethics

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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.

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

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Update on the NIH “Trial to Assess Chelation Therapy”

A few days ago, while gathering information for last week’s post about intravenous hydrogen peroxide, I noticed this:

ACAM Supports NIH Decision to Suspend TACT Trial

September 3, 2008, Laguna Hills, Calif. — The American College for Advancement in Medicine, ACAM today announced its support for the National Institute for Health’s (NIH) decision to suspend patient accrual of the Trial to Assess Chelation Therapy (TACT) Trial until allegations of impropriety can be proven false.  ACAM believes that the TACT trial represents a important milestone in assessing the role of chelation therapy in modern healthcare and respects the decision of the NIH.

ACAM continue to work with Dr Tony Lamas to answer the unfounded allegations of impropriety.

“We believe that the Office of Human Research Protection (OHRP) will find that the allegations are of a political nature. To serve the best interests of participants enrolled in the TACT trial and all patients and their physicians who seek answers about chelation therapy, we call for a swift end to the moratorium and resumption of the trial,” said Jeanne Drisko, MD, President of ACAM.

I alerted a few others, including Stephen Barrett of Quackwatch, who queried the news room of the National Heart, Lung and Blood Institute (NHLBI: the joint sponsor, along with the NCCAM, of the trial) and got this reply:

The investigators and institutions performing the Trial to Assess Chelation Therapy (TACT), in conjunction with their Institutional Review Boards, have temporarily and voluntarily suspended enrollment of new participants in the study. NIH has not issued any announcement or press release about this action. To contact the Office for Human Research Protections’ (OHRP) press office, call Pat El-Hinnawy, (202) 253-0458.

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Posted in: Clinical Trials, Medical Ethics

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“Patient-Centered Care” and the Society for Integrative Oncology

Should Medical Journals Inform Readers if a Book Reviewer can’t be Objective?

At the end of last week’s post I suggested that book reviewer Donald Abrams and the New England Journal of Medicine had withheld information useful for evaluating Abrams’ review: that he is the Secretary/Treasurer of the Society for Integrative Oncology (SIO), the organization of which Lorenzo Cohen, the first editor of the book that Abrams reviewed,* is President. I also promised to look at material from the book and from the Society’s website in order to discover “data that will allow even the most conventional oncologists to appreciate [the value of 'integrative' methods].”

There is little question that Abrams and Cohen know each other, or at least that Abrams couldn’t have been expected to write an entirely objective review of Cohen’s book. Abrams is the Program Chair for the Society’s upcoming 5th International Conference, sponsored by the American Cancer Society. He and Cohen will be sharing the stage for the “Intro/Welcome.” Does it matter that most NEJM readers wouldn’t have learned of this association by reading the review? Probably not, in the case of readers who are well-versed in the misleading language of “CAM.”

I believe that most readers of medical journals are not so sophisticated. Otherwise, how could it have been so easy for “CAM” literature to seep through the usual evaluative filters, not only in medical schools and government but in the editorial boardrooms of prestigious journals? For anyone from the Journal who might be following this thread, Dr. Sampson’s satirical but deadly serious account of “how we did it” is obligatory reading.

Do “Integrative Oncology” Methods have Value?

Now let’s take a look at what Dr. Cohen’s book and the SIO are up to. The book’s introduction and table of contents are available on Amazon.com. The introduction contains the usual, misleading assertions and falsehoods that are ubiquitous in “CAM” promotions. I’ve added a few hyperlinks:

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Posted in: Book & movie reviews, Cancer, Energy Medicine, Medical Ethics

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