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Human Subjects as Political Pawns

When it comes to “alternative medicine” trials, it seems that the NIH is willing to experiment on people in ways that would be unthinkable for real biomedical research. The federal Office for Human Research Protections (OHRP) has posted a preliminary determination letter, dated May 27, 2009, addressing some of the charges we had made against the politics-driven NIH Trial to Assess Chelation Therapy (TACT).

It is a remarkably damning statement, particularly regarding an NIH study. That is, it found—or the recipients admitted—that each of several charges was valid. Among these are misleading statements and unstated risks in the consent form, and the embarrassing backgrounds of TACT investigators. According to the determination letter,

…investigations revealed multiple instances of substandard practices, insurance fraud, and felony activity on the part of investigators.”

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“Acupuncture Anesthesia”: a Proclamation from Chairman Mao (Part IV)

The Cultural Revolution

After investigating ‘acupuncture anesthesia’ in the People’s Republic of China in 1973, John Bonica wrote:

From the guarded comments made by several anesthesiologists, I concluded that this disuse [of 'acupuncture anesthesia,' after its introduction in 1958 until the

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“Acupuncture Anesthesia”: a Proclamation from Chairman Mao (Part III)

A Digression: The Politics of Chinese Medicine in the People’s Republic of China (The Early Years)

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A Partial Book Review: Chinese Medicine in Early Communist China, 1945-63: a Medicine of Revolution, by Kim Taylor

Mao’s was a complex personality. He was by nature a control freak, highly secretive, quickly suspicious, ruthless in revenge. These were all personal characteristics that were to determine the flow of politics in early Communist China. (Taylor, p. 4)

We have already seen that attempts to create ‘acupuncture anesthesia’ began in the People’s Republic of China (PRC) in 1958. As suggested by the title of this series, this resulted from neither rigorous research nor the serendipity that occasionally heralds important discoveries. Rather, the apparent prominence of acupuncture in health care in the PRC was a matter of governmental fiat. Even before the Communist victory in 1949, it was clear to Chairman Mao Zedong that there were not enough ‘Western’ trained physicians to handle the massive health problems of the country, which included an infant mortality rate of 1 in 5, an overall death rate of 30 per 1000 per year, and widespread disability. Most of this was due to malnutrition and infectious diseases, including many that sound exotic and ominous to the modern ear:

…schistosomiasis, filariasis, ancyclostomiasis, Kala-azar, encephalitis, plague, malaria, smallpox and venereal disease…measles, dysentery, typhoid, diphtheria, trachoma, tuberculosis, leprosy, goitre, Kaschin-Beck’s disease…(Taylor, p. 103)

Pre-scientific Chinese medicine, acupuncture in particular, was identified by Mao and other Communist leaders as worthy of cultivating:

Our nation’s health work teams are large. They have to concern themselves with over five hundred million people [including the] young, old, and ill. This is a huge enterprise, and one that is extremely important. Thus our responsibility weighs heavily…At present, doctors of Western medicine are few [10,000-20,000], and [thus] the broad masses of the people, and in particular the peasants, rely on Chinese medicine to treat illness. Therefore, we must strive for the complete unification of Chinese medicine. –Mao Zedong, 1950, quoted in Taylor (p. 33)

Taylor writes that there may have been 500,000 doctors of ‘Chinese Medicine’ at the time. It is tempting to conclude that Mao’s call for the ‘unification of Chinese medicine’ was a cynical way to make it appear that the Chinese Communist Party (CCP) could provide adequate health care in a much shorter time than would be required to train sufficient numbers of modern physicians and to build and equip modern facilities. This is undoubtedly true, but Taylor argues that there were additional considerations:

…Mao evidently saw the profession of Chinese medicine not so much as a therapeutic practice, but more as a large, and therefore significant, body of people. Mao’s support of Chinese medicine during this time can be linked to a concern for adequate health care manpower, and by extrapolation, to a concern for social stability. If the Chinese medical practitioners were ignored and not forcibly, as it were, integrated into the new Communist society, and if their medicine was not encouraged, it would mean hundreds of thousands of people would be without a livelihood. Including their dependents, this would mean that there would be hundreds of thousands of people without any means of support. It is likely that Mao interpreted the more serious problem to be one of economics, and the importance of keeping people usefully employed within society, rather than the dangers of supporting a potentially ineffective medicine. (Taylor, p. 35)

Mao also wrote:

Although we should have an all-round and correct understanding of Chinese medicine, Chinese medicine also has to transform itself. We must accept this slice of our old heritage critically. To look down upon Chinese medicine is not correct. To claim that everything about Chinese medicine is good, or too good, this is also not correct. Chinese and Western medicines must unite. (Mao Zedung, 1954, quoted in Taylor, p. 35)

Thus there was, according to Taylor, to be a ‘scientification’ of Chinese medicine. This did not mean ‘scientific’ in the familiar sense:

In Mao’s definition of this ‘new democratic culture’, he was to use three words which were to describe its development. These were ‘new’ (xin), ‘science’ (kexue), and ‘unity’ (tuanjie). The term ‘new’ implied free from superstition and the heavy links to a feudal past. Instead the components of the new culture would have to be forward moving and enterprising. Mao advocated that such a change would be possible through the use of ‘science’. By ‘science’ Mao was not so much referring to the science linked with the Western investigation of nature, but more to the Marxist ideal of science as the criteria for true knowledge. For Mao stated that ‘this type of new democratic culture is scientific. It is opposed to all feudal and superstitious ideas; it stands for seeking truth from facts, it stands for objective truth and for unity between theory and practice’. ‘Unity’ was the third criterion in the building up of a new China. Everybody had to join together and fight for the same cause, and this included all classes of Chinese society, from the upper bourgeoisie to the peasantry, so long as their beliefs were not against those of the Party. It also implied a unity of knowledge, and this had particular implications for the revolutionary intellectual. (Taylor, pp. 15-16)

In other words, as Mao later asserted,

In the future there will be only one medicine; that is to say a [single] medicine guided by the laws of dialectical materialism, and not two [separate] medicines. (Quoted in Taylor, p. 35)

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“Acupuncture Anesthesia”: A Proclamation from Chairman Mao (Part II)

An Anesthesiologist’s Perspective

The late John Bonica (1917-1994), one of the great anesthesiologists of the 20th century, has been called “The Founding Father of the Pain Field.” He developed this interest while treating wounded soldiers at Fort Lewis, Washington, during WW II. Shortly thereafter he became a pioneer of epidural analgesia and other forms of safe pain relief for labor and delivery. In 1947 he created the first multidisciplinary pain clinic, at Tacoma General Hospital, and in 1960 brought it to the University of Washington School of Medicine when he became the founder and first chairman of its Department of Anesthesiology. In 1953 he published the first comprehensive textbook on the subject of pain, the 1500 page Management of Pain. In 1973 he founded what is now the largest professional organization devoted to pain relief, the International Association for the Study of Pain (IASP).

Dr. Bonica was born in Italy. He came to New York City with his family when he was 11. His father died four years later and he became the major breadwinner for the family. He competed in wrestling while in high school and won both the New York City and state championships. Later he worked his way through college and medical school by wrestling professionally under the pseudonym ‘Johnny (Bull) Walker’, and according to several sources he was the “Light Heavyweight Wrestling Champion of the World.” He continued to wrestle while in the army but concealed his military identity by becoming, in the ring, the “Masked Marvel.”

At the time of the burgeoning Western interest in acupuncture in the early 1970s, Dr. Bonica became the Chairman of the Ad Hoc Committee on Acupuncture of the National Institutes of Health (NIH). In 1973 he was “selected by the Committee on Scholarly Communication with the People’s Republic of China of the National Academy of Sciences to be a member of the first official American medical delegation to visit the People’s Republic of China, and was given the responsibility of evaluating acupuncture and anesthesia as practiced in that country.”

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“Acupuncture Anesthesia”: A Proclamation from Chairman Mao (Part I)

James Reston’s Appendectomy

For many Americans, the current wave of public fascination with “complementary and alternative medicine (CAM)” can be traced to a single event: New York Times columnist James Reston’s appendectomy in China during the summer of 1971, which Reston reported in an interesting and amusing article on July 26 of that year. Many of those who noticed the publicity following this event erroneously concluded that Mr. Reston had undergone “acupuncture anesthesia.” A few years ago, a Google search for “acupuncture and Reston” revealed that approximately 50% of the numerous “hits” reported this, as though it were an uncontroversial fact. Other sources have suggested the same, but in veiled language. Here are examples of each: 

In the 1970s, interest in the procedure was sparked when New York Times editor James Reston wrote an article about his experience with acupuncture. Reston was covering Richard Nixon’s visit to China when Reston needed an emergency appendectomy, and acupuncture was used as an anesthetic.—UPenn News 1995 

In 1972 President Nixon opened the doors to China. A New York Times journalist James Reston was in China at the time and had an emergency appendectomy with acupuncture used as the anesthetic.—American Acupuncture 

[Acupuncture] made its official appearance in the U.S. in 1971 when an article by J. Reston was published in the New York Times describing his personal experience with acupuncture. While in Beijing reporting on a Ping-Pong tournament, he underwent an emergency appendectomy. Acupuncture was used as surgical anesthesia and to relieve post-operative pain. —Center for the Healing Arts, P.C.

The first US national media coverage concerning Acupuncture was in 1971 during President Nixon’s visit to China. There, visiting columnist James Reston told of his emergency appendectomy performed under Acupuncture anesthesia.— AZ Multicare

When New York Times columnist James Reston underwent an appendectomy while accompanying the Nixon entourage to Beijing in 1971, he wrote about a medical discovery called “acupuncture anesthesia.” Eisenberg, David, with Thomas Lee Wright: Encounters with Qi (p. 28) 

About a month after his appendectomy, Reston did write about acupuncture anesthesia—but not referring to his own operation.

Those who don’t report that Reston had acupuncture anesthesia are likely to write, also erroneously, that his “intense post-operative pain was relieved by acupuncture”:

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Posted in: Acupuncture, Medical Academia, Science and the Media, Surgical Procedures

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Harvard Medical School: Veritas for Sale (Part VI)

Loose Ends: Dr. Koh and More

After Dr. Federman’s letter and my reply, posted in Part V of this series,† there seemed little point in pursuing the matter further. Although Dr. Federman never answered my reply, he did send, at my request, a copy of Commissioner of Public Health Howard Koh‘s written “construction of the events in the Massachusetts Special Commission.” As you may recall, those events had occurred at meetings that Dr. Koh never attended:

July 29, 2002

Dear Dr. Federman:

I have had an opportunity to review Dr. Kimball Atwood’s characterizations of the role Dr. David Eisenberg played as an advisor and designee of the Department of Public Health (DPH) and I am writing to clarify several misrepresentations of that role. As you may know, I personally selected Dr. Eisenberg as my designee for the Massachusetts Special Commission on Complementary and Alternative Medical Practitioners based on his high level of scientific and clinical expertise in the field, as well as his international reputation for evidence-based research. I felt at that time, as I do now, that he was the appropriate choice to represent the Department and I am extremely grateful for his advice and his integrity during this most contentious process.

During the course of the Commission, Dr. Eisenberg brought to my attention some of the conflicts that had arisen among the members, despite his attempts to diffuse the hostility and to engage the members in collegial debate. In an effort to overcome these difficulties and deflect unwarranted criticism, Nancy Ridley, Assistant Commissioner for Health Quality Management, attended the meetings over the last six months as the DPH voting designee, with Dr. Eisenberg as an advisor. She also organized a DPH workgroup of the Commission in an attempt to bring consensus and closure to what had become a very polarized and highly personalized process.

I need to state emphatically that the approval of the final Commission report is my responsibility, and is largely a product of the DPH workgroup that Assistant Commissioner Ridley chaired. Dr. Eisenberg had actually not been supportive of either the “majority” or “minority” reports that were originally presented, and neither was Ms. Ridley. She attempted to address as many of Dr. Eisenberg’s concerns as possible but knew he still had issues with the final document. She feels very strongly that there needs to be regulatory oversight of non-physician practitioners of complementary and alternative naturopathic practice. Assistant Commissioner Ridley, on behalf of the Department and with my consent, signed the report that included a significant number of revisions which narrowed the scope of practice, ensured collaborative relationships between physician and non-physician practitioners, and broadened the scope of any proposed regulatory oversight required. Dr. Eisenberg’s advice to DPH was delivered in a fair and balanced manner based his outstanding experience as a clinician and scientist.

I believe that one of the contributing factors for the polarization within the Commission had little to do with Dr. Eisenberg’s participation rather than that of his staffperson, Michael Cohen, who attended Commission meetings in his absence. Mr. Cohen was repeatedly characterized as the alternate DPH designee, which he was not.

In summary, Dr. Eisenberg’s expertise and professionalism throughout this difficult process have been greatly appreciated by the Department. DPH was truly fortunate to be represented and advised by a person of Dr. Eisenberg’s stature and character. I would be more that pleased to speak to you or Dean Martin on his behalf. Please feel free to contact me at xxx.xxx.xxxx if you need any additional information.

Sincerely,

Howard K. Koh, MD, MPH

The range of self-serving misrepresentations in that letter is wide, and is worrisome in someone who will be “responsible for the major health agencies, including the CDC, FDA and NIH, and [will be] the leading health advisor to the Secretary of HHS.” I have already discussed some of the facts here and here, and will add more now.

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Harvard Medical School: Veritas for Sale (Part V)

September 26, 2002

Kimball Atwood, M.D.
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Dear Kim,

I have now had time to look into the allegations in your letter of June 14th which, incidentally, I shared with Dr. David Eisenberg and he with several others. I have sought consultation about our exchanges and the gist of my response follows.

Some of your concerns and allegations are very helpful and constructive. Perceptions are particularly important in controversial fields where there is limited objective proof. Your cautions and interpretations in this area have been very useful to us.

Some of what you said is just plain wrong. This includes the allegation the Harvard has “a stake” in the area and therefore would not look into your allegations objectively. Relatedly, Dr. Howard Koh has written us a construction of the events in the Massachusetts Special Commission that is strikingly different from yours. And Dr. Anthony Komoroff has pointed out that many of your comments about the InteliHealth treatment of CAM are now grossly out of date as the material inherited from another provider has been reviewed by HMS faculty and modified. [Indeed, you have referred in other correspondence to modifications you have noticed.] Dr. Komaroff also commented on the misleading way your citation the treatment of homeopathy was disconnected from the rest of the paragraph.

Some of what you said is a matter of taste or interpretation, where even well intentioned people may disagree. In this particular area I have weighed your arguments carefully and, in places, learned from them.

But I think the biggest difference may be in a misperception about what our purposes are. The Council of Academic Deans of Harvard Medical School approved beginning a Division of Research and Education in Complementary and Alternative Therapies with exactly the focus described. Our goal is to do peer-reviewed basic and clinical research on the claimed, but unproven, efficacies of complementary and alternative approaches to therapeutics. The recent scientific sessions and requests for proposal held by the Division are clear testament to this intent. In addition, in common with the Association of American Medical Colleges and most of the allopathic schools of medicine, we intend to teach our students something about CAM and in particular how to assess its claims rigorously. We do not, repeat NOT, have any intention of making our students CAM practitioners. They have enough to do learning what we have always focused on.

Sincerely,

Daniel D. Federman, M.D.

cc: David M. Eisenberg, M.D.

………………………….

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The Dull-Man Law

Kimball Atwood is obviously trying to throw mud at Harvard and at homeopathy, but when you throw mud, you get dirty…

(Sigh) So little time, so much misinformation. Hence the Dull-Man Law:

In any discussion involving science or medicine, being Dana Ullman loses you the argument immediately…and gets you laughed out of the room.

This will be the last time that I don’t invoke that law, because it is the perfect opportunity to explain why it is such a useful shortcut. The occasion is the current series about my alma mater, Harvard Medical School (HMS), and its regrettable dalliances with quackery.† The series consists mostly of correspondence that occurred between Dean Daniel Federman and me in 2002. Some of it refers to homeopathy.*

Mr. Ullman, a self-styled expert on homeopathy who lacks any medical training, is a darling of the ‘integrative medicine’ movement, as explained here. He has posted several comments objecting to my assertions in the HMS series. Other commenters have skillfully refuted some of his arguments. Some have been left unchallenged, however, and a naive reader might therefore assume that they are valid. They are not, but explaining why takes time and a modest acquaintance with the topic. Other than to clarify the issues for the uninitiated, then, such time would be wasted. Henceforth, let it not be so: From now on, this post can be cited by anyone wanting to avoid the drudgery of refuting Mr. Ullman’s claims. (more…)

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Harvard Medical School: Veritas for Sale (Part IV)

HMS Puts the Messenger in its Crosshairs

When, during the fall and winter of 2001-02 I first approached Dean Daniel Federman of the Harvard Medical School (HMS) with evidence that the HMS “CAM” program was promoting pseudomedicine, I gave him some materials that I thought would be adequate to make the case: ‘CAM’ Director David Eisenberg’s dubious funding sources and his failure to disclose them to the Massachusetts Special Commission; the website of the Caregroup/Harvard Medical School Center for Alternative Medicine Research and Education (CAMRE), which urged anonymous websurfers to “consult your local telephone yellow pages” for ‘naturopathic physicians’ and other quacks; the presence on the ultra-PPO American Association for Health Freedom (AAHF) Advisory Board of attorney Michael H. Cohen, the Harvard CAMRE’s “Director of Legal Programs” (at the time, Dr. Federman agreed with me that the mere existence of such a position was curious, if the CAMRE’s purpose was ”research and education”); that Dr. Eisenberg and Atty Cohen had contributed to a report to the Massachusetts State Legislature recommending a formal state imprimatur for the practice of pseudomedicine; and other embarrassing findings. A bit later, in March 2002, I sent him a draft of the essay that I posted in Parts I and II of this series.

That material proved not to be adequate, for on March 20, 2002, Dr. Federman sent me the following letter:

Dear Kim,

I ready to undertake a formal review of the Harvard Medical School’s Division of Research and Education in Complementary and Alternative Medicine, and of its leadership to investigate the charges outlined in your letter of November 4, 2001, subsequent emails, and our meeting of January 22, 2002 in my office. I have read almost all of the voluminous literature you sent me and am writing to ask you to assist our efforts. Specifically, I am asking you to prepare a one to three page summary of the specific portions of the material you sent me that you consider erroneous, duplicitous, misleading, or fraudulent.* I do not feel I should summarize your views. Please be specific and give sources, where you can, in support of your statements.

I am committed to achieving a careful and balanced review of the issues you raise.

Sincerely,

Daniel E. Federman, M.D.

* [These are terms that I had used in my communications with Dr. Federman; the only one from which I backed away, after he reacted with considerable alarm, was "fraudulent."]

That was the first real suggestion that the fix was in. The pertinent literature that I’d sent Dr. Federman did not consist of “my views” or even my words. It consisted of statements copied from CAMRE publications and other public sources. Why did Dr. Federman now seem to be framing the issue as a matter of (my) opinion? Why weren’t the points that I’d already presented and documented (they were specific and I gave sources) sufficient to trigger an independent, formal review? What about the summary that I’d already written in the form of a letter to Harvard Magazine, which Dr. Federman had also read? No matter: I was still confident that he would do the right thing when he saw the totality of the evidence, abundantly and overwhelmingly supporting my contention that the CAMRE and other HMS affiliates were promoting pseudomedicine—dangerously, unethically, and in contrast to their stated purpose.

It was then that I resolved to write the essays that I posted in Parts I, II and III of this series.‡ I also prepared the summary that Dr. Federman had requested, which is reprinted below. In June, 2002, I sent these together with this letter:

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Harvard Medical School: Veritas for Sale (Part III)

In Parts I and II of this series* we saw that from 2000 to 2002, key members of the Harvard Medical School “CAM” program, including the Director, had promoted quackery to the legislature of the Commonwealth of Massachusetts. We also saw other explicit or tacit promotions by Harvard institutions and professors, and embarrassing examples of such promotions on InteliHealth, a consumer health website ostensibly committed to “providing credible information from the most trusted sources, including Harvard Medical School….”

Those points were made in an essay that I sent in the spring of 2002 to Daniel Federman, the Senior Dean for Alumni Relations and Clinical Teaching at Harvard Medical School (HMS). I also sent Dr. Federman a treatise on homeopathy, including several examples of credulous Harvard professors and misrepresentations aimed at students, patients, and the public. Much of the content of that treatise has been covered by the series on homeopathy† with which I began my stint here on SBM, so here I’ll post only the parts relevant to promotions by academic physicians, including those at Harvard. There is a bit of redundancy involving InteliHealth, but please bear with me if you’ve made it this far; the discussion will be meatier than the short summary in Part II.

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