Download this page in PDF formatDear Misha Cohen and Chinese Herb Academy moderators,
I’m quite willing to have an open, active discussion of these issues. I request that my following letter be posted on Chinese Herb Academy, as that is where Misha responded. The moderator, Doug, has refused to publish this. I fail to see the benefit to this discussion or our profession in disallowing me to defend myself or explain my claims and criticisms. Certainly a one-sided attack of my tone, intent, and scholarship while avoiding direct discussion of the issues I’ve raised doesn’t put the Chinese Herb Academy in a higher moral or academic position.
Sincerely,
Kevin
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Misha Cohen has written a preliminary response which she posted on the Chinese Herb Academy. Without her “express written permission” I can’t directly reproduce it. I can, however, discuss it.
Misha begins by being perplexed at my criticism. She states that it does not work towards scholarly discussion. However, my posts clearly and directly reference her published abstracts and research data. In Health Concerns’ large Handbook and collection of promotional material they never have directly referenced, quoted, or linked to the abstracts or studies. My posts provide those direct references. I analyze quotes and data. My censored post directly requested criticism and corrections on the actual abstracts and studies I reference.
Misha states that she has not reviewed the studies in question, was not the author of the journal articles, and would need several hours to do a full literature review to remember the details. I found these via searching for her name as a co-author on Pubmed. She has had 3 published studies on HIV. Here is the Pubmed.com link which pulls up studies for “Cohen MR HIV Chinese”: http://www.ncbi.nlm.nih.gov/pubmed?term=Cohen%20MR%20HIV%20chinese
She says they never studied the anti-viral effects of the formulas, just general effects for symptomatic management. Both the abstract and the research data include HIV load counts and CD4 levels.
I very directly address the differing statements about HIV count data in my (censored) summary about this issue. So far, no one has discussed it directly. Here it is again, from my list of 8 points:
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4. The abstracts of their own research conclude:
“Patients taking Chinese herbs reported significantly more gastrointestinal disturbances (79% versus 38%; p = .003) than those receiving placebo… At completion of the study, no significant differences between the intervention and placebo groups were found regarding plasma viral loads, CD4 cell counts, symptoms, and psychometric parameters. HIV-1 RNA level was unchanged at study end…This standardized formulation of Chinese herbs for HIV-infected individuals did not improve quality of life, clinical manifestations, plasma virus loads, or CD4 cell counts. The data suggest that this formulation of Chinese herbs is not effective when administered in a Western medicine setting.”
5. If the abstract was correct, the situation would be bad enough, as it seems unethical to sell a formula to acupuncturists to recommend to AIDS patients if the only documented effect is gastrointestinal disturbance (both the herb and placebo group had worse CD4 counts, so it’s not like they both improved).
6. Unfortunately, the abstract is not correct, specifically when it says the “HIV-1 RNA level was unchanged at the end of the study.” Their own data (which they left out of their discussion) shows for all patients in the study, the Chinese herbs group’s HIV-1 RNA level went from 35,612 to 53,371 (149.86% of starting) and the placebo group’s HIV level went from 52,027 to 33,254 (63.9% of starting). That difference is 85.96% between herbs and placebo, in opposite directions! This opposite effect was magnified in the subgroup taking antiretrovirals.
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Misha also states that Enhance and Clear heat were “never designed as anti-viral for HIV or any other disease.” Here is a brief direct quote from the current Handbook for Enhance:
“A concentrated isatis (da qing ye and ban lan fen) extract is used in high doses for its strong antiviral activity, particularly in hepatitis, herpes simplex, herpes zoster, and viral warts. It has a broad range of safety. Additionally a high proportion of clear heat clean toxin herbs are used for the underlying heat inflammation/viral infection present in persons with HIV infection, Cytomegalovirus (CMV), and other chronic viral syndromes.”
Following that is one of the references to her double-blind research accompanied by the direct claim of antiviral effects:
“Clear Heat was designed to be used as the primary adjunct formula to Enhance. Enhance, along with Clear Heat, has been the subject of two double blind studies (see Professional Health Concerns Newsletter, Vol. 5, #3). Clear Heat is specifically used for its antiviral and antibacterial activities and is helpful for swollen lymph nodes.”
The subset of patients in the Switzerland study who took both the herbs and the antiretrovirals were not analyzed as their own group. After crunching the numbers to extract that data, the results were stunning. I’ve reported it clearly in my longer post, including the math I used to get to my results. While the number of patients was small, it is the best published data I found. It shows that Enhance and Clear Heat completely counteract the antiretrovirals. I have asked for more recent research data if it is available, but so far no one has even commented directly on the abstract, much less my data analysis.
Also in the Health Concerns description for Enhance is the statement: ”Similarly, it appears to be helpful to people with HIV for the side effects of drug therapy such as AZT anemia.” This is just three short paragraphs after “designed by Misha Cohen, OMD, L.Ac.” The general reader would take this as a recommendation and stamp of approval, though what little research there is shows the herbs to be far worse than placebo in combination with antiretrovirals.
The most basic premise of the scientific method is that when you test your hypothesis and don’t get the predicted results, you must modify your theory and try again.
The second premise of responsible scientific discourse is to encourage your peers to analyze and criticize your methods and data to look for weak holes so you may improve and refine your theories. I would still like to be convinced that my findings are incorrect and that my concerns for AIDS patients taking these formulas can be laid to rest by better, more current research.
Sincerely,
Kevin O’Neil
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Ancient Way Acupuncture & Herbs, Inc.
Kevin O’Neil, Licensed Acupuncturist
kevin@ancientway.com
www.ancientway.com
541-884-6377
http://www.facebook.com/pages/Ancient-Way-Acupuncture-Herbs-Inc/113170805389474
@ancientwaykevin
I am unaware of the totality of this issue, any subjective and even controversial writings have my support when freedom of speech ( Writing ) is involved.
I do not support any writing on any subject though where the writer has not actually carried out any personal research. Personally no matter how unimpressed I am by a product or claims about a product I will test it before I comment. If I find a product works in spite of what some say then I say bollocks to them. I am happy with any success a product I achieves. My patients come first not points of view
Recently I have been involved in quite a lot of research and have found a couple to be very very good one of them is Virapress.
In the near future I will be invoked in research on some products that currently great claims are being made about.
I am also currently testing TBL-12 . I have interviewed quite a few people who have had miraculous benefits from the product. I understand than only in the last week or so TBL-12 was classed as a drug in America. Mt Sinai have been involved in researching TBL-12 too.
So go for it Buddy write what you like ,staying of course away from anything that could be construed as libel that can burn your ass. Even speaking and writing the truth can be taken as libel in most countries.
Alastair
Alastair, thank you for your support of free speech. We have disagreed vehemently in the recent past via my blog. While it started with you attacking me, I didn’t censor what you had to say, and I think we have both learned from butting heads. Sometimes it takes a good head butting to shake some thoughts loose. When you get presentable research on your products, drop me a line, I’ll be glad to check it out.
There are some very complex issues, here, so let me take my best shot. The abstract says “HIV-1 RNA level was unchanged at study end.” From what I can tell, they were talking about the differences in HIV-1 RNA between the two groups, herbs and placebo. There is no statistical difference between the two, as can be seen in Table 4. There is no statistical difference between the baseline scores of the two groups (p=.688) and no difference between the scores at the end of the study (p=.806). This may seem counter-intuitive given the differences in median values within each group. But statistical differences are calculated from the full range of values, and here the ranges are enormous: 171-501,838 for herbs and 146-2,017,770 for placebo at the beginning of the study and 131-412,684 for herbs and 86-4,086,230 for placebo at the end of the study. So although there seems to be an increase in viral load in the herb group and a decrease in the placebo group, when you compare the two statistically it’s all a wash. The same seems to be true for the CD4 counts. While there are statistically significant changes within each arm, these become insignificant when one arm is compared with the other.
If there had been evidence that the herbs were increasing viral load or lowering CD4 counts, then international ethical guidelines would have required that the study be aborted before completion. But while there is no clear evidence that the herb patients’ CD4 counts or viral loads were being worsened by the study formula, such an outcome can’t be completely ruled out. The number of subjects in the study, n=68, fell far short of the n=200 that the authors had originally planned for. If there had been more participants and more statistical power, we might have had a clearer sense of whether the herbs were in fact negating the antiretrovirals, as you suggest. At this point we’ll never know, since the results of this study, which show an increased risk and no benefit, would make future human trials on this formula unethical (alas, such rules do not seem to apply to the free market).
There are a number of unanswered questions. For example, the trial kept track of compliance with the herb regimen, but did not appear to track compliance with the subjects’ Western medical regimens. It seems plausible that the 28 herb pills the subjects had to swallow daily could have displaced any prescribed antiretrovirals. It is also possible that the increased GI symptoms caused a decreased compliance with the Western drugs. The study did not attempt to monitor plasma levels of the antiretrovirals. We know St. John’s Wort can lower plasma levels of Indinavir; we can’t rule out such an interaction in this study, given the large number of herbs in the formula, most of which have never been tested for their impact on the P450 system. In short, we cannot rule out the possibility that the herb patients took less of the prescribed drugs and got less out of them.
Misha Cohen’s role in the study is not clear. There is no competing-interest statement saying that she owned royalties to the formula. We don’t know if she now receives any compensation from Health Concerns for the sale of her formulas, or whether there is any financial connection between her and the company at all.
My guess is that Health Concerns would argue that the continued sale of the formula is legitimate given the caveats contained in the study discussion, where it is suggested that the herbs may have worked better in a non-Western setting where the herb prescription could be “tailored to each patient.” But this formula is really designed as a shotgun treatment, containing a wide range of tonics, heat clearing agents, and blood stasis movers and so it is clearly designed to address a very wide range of TCM diagnostic possibilities and to treat the widest possible range of patients. Furthermore, some of the herbs appear to have been selected based on Western research and not TCM guidelines per se. For example, Ji Xue Teng was selected “to stimulate bone marrow function,” (clearly *not* a reference to the “TCM” concept of bone marrow). And since the formulas are in pill form, they cannot be modified like a decoction and thus cannot be “tailored to each patient.” Finally, unless Health Concerns restricts their sales to licensed acupuncturists (and from what I can tell they do not), we would not expect Chiropractors, Osteopaths, Naturopaths or other non-TCM trained professionals to realize when these formulas should or should not be used. For all intents and purposes, the formulas are being sold as AIDS treatments and should be judged as such.
In that regard, the conclusion of the authors speaks for itself: this formula “did not improve quality of life, clinical manifestations, plasma virus loads, or CD4 cell counts.” Furthermore it caused “significantly more gastrointestinal symptoms.” Why would anyone want to prescribe this formula to their AIDS patients?
Thanks for the detailed notes, I’ll look more into the way p values are calculated.