Bastyr University's St. John's Wort Article in JAMA:

CAM Research Breakthrough Or Big Pharma Sell Out?

© Peter Barry Chowka

(June 15, 2008) The biggest health story in the United States media during the second week of June 2008 involved a major study published June 11, 2008 in the Journal of the American Medical Association – JAMA – one of the most prestigious mainstream medical journals in the world. The study was the subject of hundreds of print articles, television and radio broadcast reports, and Internet items. The title of the Washington Post's article published June 11, 2008 was typical: “St. John's Wort Doesn't Work for ADHD.”

It was a case of yet another study appearing to debunk the therapeutic use of a common – nontoxic and cost-effective – medicinal herb and, by extension, cast doubt on all of natural healing and alternative medicine. In this vein, Science News titled its story, “Ineffective Alternative.”

But wait a minute. . . The lead paragraphs of most of the news stories noted that the study was done by Bastyr University north of Seattle – supposedly the leading accredited institution of natural healing higher education in the United States. In fact, the study's lead author is a professor at Bastyr, Wendy Weber, ND, PhD, MPH.

On June 14, 2008, Bastyr's Internet home page highlighted the JAMA article and its “News & Information” page linked to a number of media stories about it. There was also a June 11 Bastyr news release, which included this excerpt:

“These study findings are very significant for consumers,” says Wendy Weber, ND, PhD, MPH, research associate professor at Bastyr University and principal investigator for the St. John's Wort study. “Our results indicate that one of the most common, self-prescribed treatments for ADHD in children and adolescents is not effective. We hope the results of our study will prevent potential drug interactions which can be associated with St. John's Wort by encouraging parents to not give it to their child to alleviate ADHD symptoms.”

The Bastyr administration expressed its pride at the appearance of the study and in the university's association with JAMA:

“This study is an excellent example of a first-rate scientist and clinician using rigorous scientific methods to explore a treatment commonly used by the public without much evidence to support its effectiveness,” says Timothy C. Callahan, PhD, Vice President for Research and Collaboration at Bastyr University in Kenmore, Washington. “The results of this research study will inform the public and stimulate further research to determine the effective, appropriate use of complementary and alternative medicine.”

What's Going On Here?

Short answer: A lot. On a first reading, it's possible to deconstruct the study as being significantly flawed – see below – on top of the supreme irony of an institution that has promoted itself as a (if not the) leading center of education in natural therapeutics falling all over itself to publish and then brag about what is little more than a hit piece on a leading alternative medicine modality.

As I often say at this point, a little history is in order – helping to expose what seems in this instance to be a case of “déjà vu all over again.”

In fact, history informs us that this is not the first time that North American naturopaths (that is, the “official” naturopaths, who call themselves “naturopathic physicians,” highlight their four-year accredited naturopathic education, advocate state licensing of their “profession” as primary health care providers, hold themselves in higher esteem than less formally educated naturopaths who they refer to as “unlicensables,”and so on) have been associated with a study that, to put it mildly, is at best questionable, and more likely antithetical, in terms of advancing the field of natural healing and alternative medicine.

A remarkably similar earlier case took place five years ago. On August 15, 2003 I wrote about it in an article titled “Are Naturopaths Targeting Health Food Stores?” In that instance, scores if not hundreds of mainstream media articles echoed ones published in the Los Angeles Times (“Clerks who sell supplements often recommend unproven treatments, research shows”) and the Toronto Globe and Mail (“Health food stores could do more harm than good: study”). The lead author of the vehemently anti-nutritional supplement “study” in that case, published on August 7, 2003 in the journal Breast Cancer Research, was Edward Mills, DPH, MSc (Cand.), the director of research at CCNM, the Canadian College of Naturopathic Medicine, roughly the Canadian equivalent of Bastyr University. When the 2003 study was published, CCNM, like Bastyr in 2008, made much of it, with Mills and other CCNM representatives appearing widely in the media to promote it and to call attention to their new found acceptance (as naturopaths) in a mainstream medical journal.

As I wrote at the time, the CCNM study, in my opinion, was extremely flawed. But its conclusions, I found, were not incompatible with a newly emerging anti-alt med party line taking hold within the elite leadership circles of U.S. and Canadian official naturopaths. This mindset was based on a growing arrogance among the official naturopaths that only they (among the large and growing field of alternative health care providers) knew what was best and that self-care on the part of informed consumers and patients could be dangerous and should be restricted. In 1997, a leading U.S. naturopath told me, “When I see a patient and I make a recommendation for a specific nutrient or botanical, I do not want to send them down the street to the local health food store, where they might get: A) a less-potent or potentially allergenic product, B) the wrong product, or C) talked out of my therapy and into another by someone who probably has no medical background or training.” (The same naturopath presumably expected his patients instead to buy the supplements in his own office.) This naturopath further insisted, echoing the new found arrogance of his peers, “[Official] Naturopaths are the only physicians who have primary skills in health/risk analysis and disease prevention.”

Also in 1997, as I wrote last month, one of the most prominent and influential U.S. naturopaths – in fact, a co-founder, the long time president, and currently the president emeritus of Bastyr University, Joseph Pizzorno, ND – publicly endorsed toxic antiretroviral chemotherapy drugs as the best treatments for HIV/AIDS. A critical excerpt from that article is: “One of the first grants the original OAM [NIH Office of Alternative Medicine] gave re: HIV/AIDS in 1994 was to Bastyr University in Washington state. Bastyr, growing rapidly at the time, was founded as a school to turn out naturopathic doctors – doctors of natural medicine. With the infusion of unprecedented levels of new funding at the behest of the government and as a result of other factors, the naturopaths were going from essentially North America's barefoot doctors of natural healing to white coat- and stethoscope-wearing, drug-prescribing crypto allopaths longing for mainstream acceptance and rewards as they raced towards practicing in 'integrative' medicine environments – ones mostly dominated by orthodox allopathic clinicians.”

There was also the case in recent years of another leading naturopath, Gannady Raskin, MD, ND (currently, the dean of naturopathic medicine at Bastyr, in fact) and his service on the Washington state Vaccine Advisory Committee including during the period when the committee (which has the force of state law behind it) met to push (“maximize uptake” and “enthusiastically endorse”) the questionable new vaccine Gardasil for adolescent girls supposedly to prevent them from getting the HPV virus. This same naturopath-dean was the co-author (it's a small world – the aforementioned Edward Mills was another co-author) of a 2003 study, published in BMC Clinical Pharmacology, about the safety of the over-the-counter nutritional supplement niacin.

As I wrote in an article about this situation on March 15, 2007,

Curiously, considering Raskin's profession as a doctor of natural medicine, the study bashes over the counter (OTC) nutritional supplements. The niacin study’s conclusions by Raskin et al: “In summary, this study (1) demonstrates the need for randomized trials to inform policy and patient choice about the safety of OTCs; (2) underscores the adverse public health impact of OTCs; and (3) likely underestimates the impact of adverse effects of OTCs in patients with comorbidities.”

Raskin appears to be a firm believer in integrated – as opposed to alternative – medicine. He co-authored a 2002 study in the University of Toronto Medical Journal, “Characteristics of Patients Attending a Naturopathic Medicine Teaching Clinic.” Raskin et al express concern about alternative therapies: “Considering the wide variety of CAM therapies available, a patient may be at risk of misinformation and treatment leading to harm.” Raskin and his co-authors also wrote: “The medical education of Naturopaths is structured on the conventional medical education. . . With increasing amounts [sic] of CAM therapies available and the training of practitioners varying widely, it is likely best to suggest that highly trained [naturopathic] practitioners integrate services within conventional healthcare settings.”

In a further insight into his thinking, Raskin, in an April 1, 2005 article published in the Puget Sound Business Journal (Seattle), wrote: “In Washington, the state Legislature is currently considering a bill that would expand the naturopathic doctor's scope of practice. Naturopathic doctors are asking permission to perform certain procedures and prescribe certain pharmaceuticals that are basic to primary care medicine and for which they have been trained. They do not want to be medical doctors. They simply want to practice their medicine (which has always included some pharmaceuticals and for which they have an excellent track record).”

It is not insignificant that, according to an endnote, the research led by Bastyr that resulted in the June 2008 JAMA study was funded by the National Center for Complementary and Alternative Medicine (NCCAM) at the National Institutes of Health.

The Plot Thickens: A Big Pharma Smoking Gun?

At this point, the story takes a bizarre turn. Or, it could be said that “You ain't seen nothin' yet.”

One of the co-authors of the JAMA Bastyr-directed St. John's wort/ADHD study is Joseph Biederman, MD, Professor of Psychiatry at Harvard University and Chief, Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD at Massachusetts General Hospital. According to the “author information” published with the Bastyr-run JAMA study, “Dr Biederman reports that he currently receives research support from the following sources: Alza, AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Janssen Pharmaceuticals, McNeil, Merck, Organon, Otsuka, Shire, the National Institute of Mental Health, and the National Institute of Child Health and Human Development; that he is currently a consultant/advisory board member for the following pharmaceutical companies: Janssen, McNeil, Novartis, and Shire; that he is currently a speaker for the following speaker's bureaus: Janssen, McNeil, Novartis, Shire, and UCB Pharma; and that in previous years, he received research support, consultation fees, or speaker's fees for/from the following additional sources: Abbott, AstraZeneca, Celltech, Cephalon, Eli Lilly, Esai, Forest, Glaxo, Gliatech, the National Alliance for Research on Schizophrenia and Depression, the National Institute on Drug Abuse, New River, Novartis, Noven, Neurosearch, Pfizer, Pharmacia, the Prechter Foundation, the Stanley Foundation, and Wyeth. No other disclosures were reported.”

This laundry list of Big Pharma financial affiliations by a principal author of an herbal nutritional supplement study should raise major alarms by itself. But even more revealing is the embarrassing news about Biederman that began to be reported in a variety of media on June 8, 2008 – exactly two days before the news media embargo on the JAMA Bastyr study that Biederman was a co-author of was lifted.

One article, “Harvard medics 'concealed drug firm cash,'” was published (June 9) in The Independent (London).

Harvard University is at the centre of an academic and political scandal after three prominent members of its psychiatry department were accused of breaking conflict-of-interest rules by failing to declare millions of dollars in consulting fees from drugs manufacturers.

An investigation by Senator Charles E Grassley [R-IA] uncovered evidence that Dr Joseph Biederman, a world-renowned child psychiatrist who helped fuel an explosion in the use of powerful antipsychotic medicines, neglected to tell university officials that he had earned at least $1.6m from pharmaceutical companies that make them. . .

In one example, Dr Biederman, whose work is held responsible for a 40-fold increase in the diagnosis of bipolar disorder, claimed in an annual report to the university that he received no income from Johnson & Johnson in 2001. When Senator Grassley queried this figure, he confessed to receiving $3,500. The company says Dr Biederman was paid $58,169 that year, a discrepancy that remained unexplained last night.

The relationship between the Harvard academics and drug companies is highly controversial because their research has advocated the use of previously unapproved psychiatric medicines in children. The university began a formal investigation yesterday into their outside earnings.

The New York Times broke the story about Biederman on June 8, and the Times article has still more details about the evolving drama. (In its article, the Times published an excerpt from an e-mail by Biederman defending himself, in which he wrote “My interests are solely in the advancement of medical treatment through rigorous and objective study,.”) A June 10 article about the JAMA study by Reuters made a brief note of the new revelations about Biederman, but otherwise Biederman's problems have not been mentioned in other media reporting and Bastyr's hand outs have continued to highlight the association between its researchers and the Establishment elite presumably represented by Biederman.

Its rhetoric aside, a lengthy article dated June 13 on the ADHD JAMA study at the health section of Fox News, by Mike Adams, is essentially on the mark:

A Disturbing Trend: Bastyr Naturopaths Partner with Dr. Biederman to Discredit Herbs. . .

The St. John's wort study was led by Wendy Weber, ND, a graduate of Bastyr University. Bastyr is an “integrative medicine” med school that teaches drug-based medicine combined with more natural modalities. It's one of the top three naturopathic schools in the U.S., and yet to learn that one of its graduates is now collaborating with a psychiatric drug pusher who has been paid $1.6 million by drug companies is more than a bit disturbing.

It indicates that this Bastyr graduate either has no idea about the true agenda of the people she's working with or that she doesn't mind that agenda. Either way, she sort of ends up looking rather silly with her name positioned above the scandalous Dr. Joseph Biederman. . .

In the world of naturopathy, by the way, there is quite a chasm between the more “conventional” N.D.s (like Bastyr graduates) and the holistic, natural, salt-of-the-Earth kind of naturopathic healers who have no sponsoring institution. The Bastyrs of the world are working hard to get naturopathic medical practice legalized in many states, but they're also disliked by the non-accredited naturopaths who end up being labeled criminals for practicing their own brand of natural medicine in those same states.

Many non-accredited naturopaths insist that Bastyr is just a “green” replacement for organized medicine's tyranny. Without a doubt, when people see Bastyr graduates collaborating with top psychiatric drug pushers on a study that clearly seeks to discredit a valuable herb, it just fans the flames of dissent against Bastyr among more holistic practitioners.

What's my take on the issue? I think Wendy Weber must be a complete fool to lend her name to such a study. . .

It should be noted that Adams, the article's author, has previously heaped praise on Bastyr and its principals, including Pizzorno. Adams' June 13 article notes: “For a Bastyr graduate [Weber] to even take part in [the JAMA study] study. . . really makes me wonder what's happening in the classrooms over there these days. I've interviewed both Joseph Pizzorno and Michael T. Murray on several occasions, and I've found them to be extremely well-informed, high-integrity individuals who were highly instrumental in the founding and the success of Bastyr University.”

Perhaps Adams is unaware of facts like Pizzorno's enthusiastic promotion of toxic chemotherapy for HIV/AIDS as early as 1997, and Raskin's associations with pharmaceutical drugs and vaccines, both cited above.

(The natural products industry site Nutra Ingredients USA dot com ran an article on June 13, 2008 “Industry junks St John's wort ADHD study.” It does not mention anything about Biederman's role.)

A little more history and a brief review of the JAMA ADHD study

Unlike some other mainstream medical journals, such as the New England Journal of Medicine, the Journal of the American Medical Association has demonstrated a pattern of publishing only negative studies on alternative medicine. To cite a few recent examples: The February 28, 2007 issue of JAMA featured an article trashing antioxidants, “Mortality in Randomized Trials of Antioxidant Supplements for Primary and Secondary Prevention.” The first 2006 issue of JAMA contained a study on L-arginine supplementation in people who had recently had a myocardial infarction. The conclusion: L-arginine doesn’t help and may increase the risk of death. In the February 8th, 2006, issue of JAMA, three lead articles proposed that low-fat diets don’t help to prevent breast cancer, colon cancer, and heart disease. All of these articles, thanks to the American Medical Association's (which publishes JAMA) world class PR spin machine, received major media attention around the world.

Why in the world Bastyr – if it is truly interested in advancing natural therapeutics – would want to be associated with a publication that limits itself to essentially quackbusting alternative therapies is almost beyond comprehension.

In addition to the corrupting anti-alt med influences of Big Pharma money and the potential anti-alt med bias of JAMA, the Bastyr-ADHD study in terms of the science itself is seriously flawed. Based on comments from several knowledgeable sources who are not conflicted by drug industry or institutional ties, the following points can be made.

The concept of using one herb (in this case, St. John's wort) to replace a drug for the treatment of ADHD is highly questionable. In the first place, the exact etiology of ADHD is unknown. In addition to a genetic factor, it has been reported that major etiologic contributors include intolerances to foods, adverse responses to food additives, sensitivities to environmental chemicals and molds, and exposures to

neurodevelopmental toxins such as heavy metals and other pollutants. Thyroid hypofunction may be a common denominator linking toxic insults with ADHD symptoms. There also may be low functioning of dopaminergic pathways in the brain.

Testing an antidepressant botanical for the possibility that it will have the same effects as antidepressant medications that are being used for ADHD is also flawed. For one thing, the standard antidepressant drugs that are being used for ADHD are most often used when there is a concomitant mood disorder – like depression – along with the conventional clinical diagnosis of ADHD.

Considering the complex and varied, if not unproven, etiology of ADHD, and the fact that the exact mechanisms of action of St. John’s wort have yet to be fully understood and elucidated, as well, the idea of using St. John’s wort as a sole treatment for a complex clinical matrix labeled “ADHD” seems like a shot in the dark, at best.

Almost as if it was an afterthought, the study authors reported that the levels of the active ingredients in the St. John's wort product used in the clinical trial were sub par because the supplement apparently degraded during the eight weeks of the study. While it contained 0.3-percent of the active ingredient hypericin at the beginning of the study, there was only 0.13-percent hypericin (approximately 60 percent less) at the end. In addition, the authors subsequently decided that hyperforin might be the more important ingredient – an ingredient that, by their own admission, apparently was not present in adequate amounts in the particular extract that was used. But rather than discard the results of the study, they were published in a prestigious journal and the authors definitively declared St. John’s wort to be no better than placebo for the treatment of ADHD!

In sum, this study proves nothing.

In light of these and other factors, considerations, and the history at hand, one wonders if the researchers were actually expecting or even hoping for a negative outcome. After all, if the study had been positive, showing that St. John's wort benefited ADHD, JAMA would probably never have published it no matter who the researchers were.

Not surprisingly, JAMA has made a big splash with this article; to ensure maximum distribution, the full text version is available free at JAMA's Web site along with video and other supplemental materials prepared for the media. A copy of the study, a news release, and supporting material were sent to select mainstream media outlets several days before the journal's publication, to facilitate maximum media reporting timed to the appearance of the study. Meanwhile, Bastyr is trying to use its associations with JAMA, and with the Harvard researchers (Biederman's high profile problems notwithstanding), for its own ends.

Postscript

I have previously cited comments by Robert Broadwell, ND, a veteran California naturopath with decades of clinical experience who has managed to maintain his commitmernt to holistic healing principles. Although they were made in the context of an interview almost five years ago, Broadwell's observations were prescient and – unfortunately – seem more applicable as time goes on.

Robert Broadwell, ND: “Someone was asking me the other day what we could do to keep naturopathy alive. And I said, from my own perspective, you're talking about something that's already dead.”

Peter Barry Chowka is a widely published writer and investigative journalist who writes about politics, health care, and the media. Between 1992 and 1994, he was an advisor to the National Institutes of Health. His Web site is: http://chowka.com