The Weber-headed study by Bastyr, using NCCAM money and featuring Harvard Pharma pimp Biederman used an ineffective product to treat a so-called condition for which no practitioner in their right mind would ever use the herb, based on a completely hokey survey by some pharmacists in Texas that found 5 kids had been prescribed SJW for depression or ADHD.

One of the phenomena of the mainstream misinformation machine regarding herbal medicine is that any study, especially one published in JAMA, is apparently endowed with an aura of truth as if it were directly received from above on tablets of stone. This completely worthless and near fraudulent study of course failed to detect anything of consequence. But as a result the PR machine of mainstream news generation went straight into action, internet and press headlines proclaiming that St John’s Wort does not work for ADHD.

Mike Adams, an investigative reporter for Natural News Magazine in his expose of the Bastyr/ADHD/Hypericum study compiled a list of such headlines.

St. John’s wort fails to help kids with ADHD
The Associated Press

St. John’s Wort Doesn’t Work for ADHD
Washington Post

St. John’s Wort No Help in ADHD
ABC News

St. John’s wort no better than placebo for ADHD, Bastyr study finds
Seattle Times

St. John’s Wort No Help for ADHD
TIME Magazine

Herb does not ease ADHD
ZDNet

St. John’s wort doesn’t help ADHD, study finds
Reuters

None of which should surprise regular readers of HERBLOG, and none of which should surprise Bastyr. Hopefully the Bastyr Board will look at this pile of stinking stuff and ask Weber at al some hard questions. Promoting an understanding of how to use of herbal medicine in the modern world requires a little more than brown-nosing Big Pharma, validating DSM IV, and collaborating with corrupt truth twisters with an agenda to promote chemical control of kids behavior. This study does all of this and more.

HERBLOG awards this appalling study the title of jackass trial of the year. Let us hope that the good people at Bastyr wake up and do some genuine soul-searching.
This kind of thing does them no good at all.

Time to move on.

Biederman’s career highlights include a series of clinical trials to “prove” the efficacy of the ADHD drug atomoxetine (Strattera). Unlike Ritalin, this is not a direct stimulant, but appears to function as a norepinephrine reuptake inhibitor. (indirect stimulant for FWIW) The drug is made by Ely Lilly, one of Biederman’s major undisclosed sponsors (see earlier HERBLOG post about his failure to truthfully disclose conflict of interest payments.)

As discussed in the last HERBLOG post, the author’s justification for this clinical trial included the absurd claim that because 5 kids in Texas might have taken SJW for ADHD or depression, that Hypericum is the most prescribed herb for this “condition” of ADHD in the whole of the USA. On the same topic - ( ie Why the F***? ) there is yet another preposterous claim in the paper. In the introduction to the study, the authors state that …“since the NE uptake inhibitor atomoxetine has been approved by the FDA for ADHD and because Hypericum is believed to act as a norepinephrine reuptake inhibitor, we hypothesized that it may be beneficial in the treatment of ADHD….”

This so-called hypothesis is unmitigated nonsense.

Hypericum is NOT a NE reuptake inhibitor. That term refers to the pharmacological action of a drug (such as atomoxetine). Hypericum is a mild herb. Mild herbs are not drugs. They do not display drug type magic bullet actions. Hallo - Bastyr…come in please…where are you???? Do we really have to go through the fact that SJW is not a NERI, not an MAOI, not an SSRI, not even all of the above….

But for Biederman and Ely Lilly to be able to say that the Hypericum or any herb for that matter, does not work for ADHD…is to say the least convenient, if somewhat marginal. Sounds like a bit of a set up? Sounds like Bastyr folk walked right into it too. Nothing like an Institution that teaches botanical medicine saying that a her b does not work..it really must mean it does not work. Maybe they did not see the headlines coming….what headlines?

What headlines?….See next post.

One of the original  questions posed about this whole fiasco of a study is why on earth would a progressive-thinking center of excellence in natural medicine even contemplate trialling any medicine for so called ADHD?  Labels such as ADHD are arguably fictive (or philosophically nominalist) descriptors that do not refer to a real entity at all.  The DSM manual which taxonomically lists these “psychiatric disorders” can be seen as an elaborate hoax to support Big Pharma and psychopharmaceutical behavior control. Let us not forget that this is the same “authority” that labelled homosexuality as a “psychiatric disease” only a few years back. The whole business of mass-medicating children with psychotropic drugs is objectionable, and If there is a genuine question around herbal/botanical  interventions for children expressing the kind of behavior labelled ADD/ADHD  then the question comes up why SJW or Hypericum in the first place? There seems to be no rationale in traditional herbal prescribing for using SJW to influence this kind of behavior. SJW is a woundwort or healing herb, a liver herb, with a recent “biomedical” reputation for efficacy in certains forms of depression, although the trial data for this indicationis varying in quality and quantity. However, it is very improbable that any  trained practitioner, let alone licensed ND would propose taking SJW for ADHD. EVen the popular/consumer level  “natural” remedies given for so called ADHD generally include  either “stimulants” such as caffeine, and calming herbs such as Valerian, Kava and Scutellaria. SJW? not really.The rationale given in the Bastyr/JAMA paper for performing this clinical trial is that SJW is the most common herbal treatment for children with ADHD in the US. (along with Echinacea and Ginkgo). And where does this strange piece of information come from? The answer in the text is the citing of a reference to a questionnaire by three pharmacists  which surveyed a small number of caregivers  or parents of children attending community mental health centerers in urban, suburban and rural Texas. We have obtained the full text of this tedious little paper (see link below) . While the authors of the survey were probably well-intentioned, the document’s import is laughable when compared to the claims made for its significance by the Bastyr study authors. Firstly the children were diagnosed with EITHER depression or ADHD. Of 117 total patients, 5 (five) out of  n=117 who had either depression or ADHD had been given some SJW. A couple more were given Echinacea and or Ginkgo. From this entirely irrelevant and meaningless exercise we somehow get from 5 kids in Texas with depressive/ADHD diagnoses being given SJW on a one time basis  to the absurd and ludicrous claim that Hypericum is the most common herbal treatment for pediatric ADHD in the United States. This is extrapolation is bogus science masquerading as authoritative information - gone compeletely beserk. I was goingto make a cultural comment about the iPod being invented in Cupertino not Waco, but this stuff is not even remotely funny.Cala S, Crismon ML, Baumgartner J.Pharmacotherapy. 2003 Feb;23(2):222-30. A survey of herbal use in children with attention-deficit-hyperactivity disorder or depression.This is not the end of the study’s flimsy self-justification however attempts; the next reason given for performing this study is based  on erroneous  statements about the psychopharmacology of Hypericum. Stay tuned. We have started so we will finish.

According to the full text The Bastyr Hypericum/ADHD trial used a SJW product supplied by Vital Nutrients Inc that is “marketed as standardized to 0.3% hypericin”. The text further relates this material was “independently” verified prior to the trial, and also suggests that the extract was not a high hyperforin ( 3-5%) type of product. This is part of the end discussion in the paper that suggested the effects being tested were a result of hypericin not hyperforin.

An interesting point emerges here: Vital Nutrients Inc is a reputable company run by Bastyr alum Dr Rik Liva. Liva has established a solid reputation in the natural products industry as a vigorous proponent of GMPs, quality assurance and the need for testing to ensure quality in dietary supplements. He has often gone on public record as saying that adherence to QA/GMPs is absolutely necessary to prevent the public from being duped. But when his owncompany’s extract was tested it was found to be 0.13% hypericin not 0.3% as labelled. This is a huge discrepancy. Perhaps the “independent” testing of the initial material was simply a wholesale suppliers “C of A (Certificate of Assurance) about the quality? A further puzzle is that Vital Nutrients do not actually market a “low hyperforin” SJW product. Their web site lists only a 3-5% hyperforin SJW item

SO it could be said that Liva’s Vital Inc producthad the potential for duping the consumer, it duped the triallists at any rate. The abstract could easily have read something like “egg on face as clinical trial fails to measure anything due to clusterfuck confusion over product administered to verum group” but then that would not have made the study authors or their Bastyr alum’s company look too clever.

Since Liva is pretty adept at publicity, perhaps we will be hearing from him about the apparent problems with the product used in the trial. Perhaps the “independent verification” of the supplied material could be revealed? The Bastyr paper itself suggests that the product probably became oxidized during the 8 week trial due to its being dispensed in 2- part capsules. One would hope for a longer than 8 week shelf life for most products….Perhaps Liva will shortly be reoutfitting the Vital Nutrients SJW in a “onezie” suit.

To be continued..

As Dr Yarnell rightly points out - one really cannot criticize a study without reading the full text. So now we have the study, and the story continues to unravel. Here is one little issue…..

The material used in the study contained, when tested at the end of the 8 week trial period, 0.13% hypericin. The abstract states that the material was 0.3% standardized. So the material was less than half the strength stated in the abstract. An explanation was given that hyperforin is unstable and may have oxidised. However, the hypericin was the critical ingredient here, not hyperforin. In fact the Vital Nutrients Inc material was not a high hyperforin extract in the first place. The plot thickens.

So the question is why does the abstract say one thing and the full text another? BS science as usual… Dr Yarnell is indeed correct.

Hypericum perforatum (St John’s Wort) for Attention-Deficit/Hyperactivity Disorder in Children and Adolescents: A Randomized Controlled Trial.

Dr Joseph Biederman is a nasty piece of work. He is a pediatric psychiatrist and a major advocate of medicating young children with psychiatric medications for DSM conditions such as ADHD and pediatric bipolar disorder. The diagnosis of peeds bipolar cases rose 4000% in the decade from 1994-2003, and sales of pharma drugs to “treat” or chemically control the so-called condition doubled from 2003 to 2006 according to Natural News Reporter Mike Adams who recently covered Senator Charles Grassey’s expose of Biederman’s funding lies following the revelations made by NYT reporters Harris and Carey last month.

As the NYT reported, Biederman failed to disclose at least $1.6 million consultancy fees from Big Pharma until investigated by Senator Grassley. Biederman and his colleagues Wilens and Spencer, all notorious advocates of child drugging, have “uprated” their conflict of interest estimated income following enquiries by Grassley. To protect research integrity, the NIH who funded Mass General Hospital to the tune of $287 million in 2005 for research requires researchers to report consultancy fees, and at that time HArvard forbade researchers from conducting clinical trials if they received more than $10,000 pa in such fees. The NYT gives a typical example - Biederman suggested that Johnson and Johnson paid him $3,500 in 2001, ie less than $10,000, but the company admitted the figure was in fact$58,000.

Failing to report income by researcher is a possible violation of Federal and University rules. Mass General theoretically could lose NIH funding as a result of this scandal, but it seems pretty unlikely - at this time, Biederman’s case has been referred to a Harvard “University Committee” for review.

Ironically, another well known right wing psychiatrist, Fuller Torrey of the Stanley Research Institute, rounded on the Biederman fiasco in public saying “In the area of child psychiatry in particular..we desperately need research that is not influenced by industry money. The price we pay for these kind of revelations is credibility, and we just can’t afford to lose anymore in this field” reports the NYT.

So what’s new about such sordid conflict of interest revelations? Just that the same Dr Joseph Biederman is an author of the Bastyr study on ADHD and Hypericum that found the herb did not work. Better just take the drugs heh?

Bastyr’s defenders would probably say something like well we needed an acknowledged “expert” in the field in which we were going to run a trial…we would say, you can tell a lot about someone by the company they keep.

Here we go. Edzard is at it again. What a complete and utter craphead this guy is. If you read the fine print (= full text) of this profound exercise in masturbatory metastudy fantasia you will find that this study’s male authors decided (in their infinite [lack of] wisdom, and very finite lack of practical clinical experience as well as complete and utter incomprehension of the real world outside of their warped academic wankdom) to exclude studies that related to menopause induced by chemotherapy or surgery. So, as anyone with half an ounce of clinical experience knows, menopause induced by sudden surgical or cytotoxic chemotherapeutic trauma precipitates the most extreme symptoms that are profoundly distressing for those experiencing them. Black cohosh works for these folk. It works every time. All the time. It works so well that I have had patients kicking down the door to replenish their supplies of BC tincture when they even suspect they might have run out over the weekend. So you have to take enough. If you take enough…it works. The typical trial doses are less than 100 mg qd. How did they figure that out? Try an order of magnitude more. Its a herb. It won’t kill you. And it works. The contrast between the simple beauty and elegance of the real world effectiveness of this herb for menopausal symptoms and the pronouncements of the self-appointed high priests of evidence based medicine about the same herb is, I suppose, in the end, an expression of how profoundly screwed things really are today. Further rigorous trials are indeed warranted. Preferably the accused will be Ernst and his ilk.

Black cohosh (Cimicifuga racemosa) for menopausal symptoms: A systematic review of its efficacy.

Pharmacol Res. 2008 Jun 8;

Authors: Borrelli F, Ernst E

Since conventional hormone replacement therapy has fallen out of favour, alternatives are being sought by many women. These therapies include herbal preparations such as black cohosh (Cimicifuga racemosa). The purpose of this update of a previous systematic review is to evaluate the clinical evidence for or against the efficacy of black cohosh in alleviating menopausal symptoms. Five computerized databases (Medline, Embase, Amed, Phytobase and Cochrane Library) were searched to identify all clinical data that provided evidence on the efficacy of C. racemosa. Bibliographies of the articles thus located were scanned for further relevant publications. Only double blind, randomized, clinical trials (RCTs) were included in the evaluation of efficacy. No language restrictions were imposed. Trials were excluded if they did not focus on menopausal problems, they included women suffering medically induced menopause, they did not use black cohosh monopreparations, or they did not use placebo or a standard drug treatment for the control group. Six studies with a total of 1112 peri- and post-menopausal women met our inclusion criteria. The evidence from these RCTs does not consistently demonstrate an effect of black cohosh on menopausal symptoms; a beneficial effect of black cohosh on peri-menopausal women cannot be excluded. The efficacy of black cohosh as a treatment for menopausal symptoms is uncertain and further rigorous trials seem warranted.

PMID: 18585461 [PubMed - as supplied by publisher]

(Via Herbal Science Research aggregator.)

In this cutting and articulate letter to the editor of Homeopathy regarding a NYT article by the infamous Dan Hurley the author of the letter points out the fundamental paradox of mainstream views of homeopathy (and herbs) which is simply that they are claimed to be BOTH dangerous yet ineffective at the same time. Since no abstract is available, we will quote extensively from this letter Paralogisms of scientific journalism : Rosenbaum P, Homeopathy. 2007 Oct;96(4):285-6, which concludes that such articles imply the need for a serious examination of what he calls the “sociology of scientific journalism”.

But some sections of the media, including important
medical journals, have published claims that infinitesimal
substances are suspected, not of toxicity, but of
the opposite: of not possessing any detectable biological
effect in vitro or in vivo. It is here we find the
paralogism.

Of course these are partial conclusions, therefore,
challengeable. Experimentation in human beings,
observational studies and studies of health-related
quality of life quality of line in health, for instance,
strongly contradict these conclusions of inaction. If the
Food and Drug Administration finds empirically that
adverse effects are associated with homeopathic
medicines, and that they are significant, how is it that
they are accused of being pharmacologically inert?.
The notorious question: ‘‘does it work or not?’’ carries
an unbearable ambiguity: it work, but only to
intoxicate. But infinitesimal dilutions are not even
‘‘substances’’ strictu sensu. If there is not even a trace
of active drug, nor any other validated evidence, how
can one determine such actions? We are face—and this
article in the New York Times is just a single
example—with a superficial analysis of data which
impact on both society at large and the community
of users.

The surprise here is the size of paralogism. An
influential newspaper reports that homeopathic medications
may be poisonous. However, until recently
they considered they were nothing but water. Any
apparent effects are only mirages placebo-effects. So,
either we are witnessing a remarkable epidemic of
placebo effects in the poison monitoring centers or a
phenomenon that, if verified, should be a top priority
list, with public support of research. Are homeopathic
medicine fake? Or are there active poisons in infinitesimal
doses? If there are, everything has to be
reassessed.

But there is a more radical alternative: to evaluate
sociologically what is happening in scientific journalism.
We know that logic alone is insufficient to meet all
the demands and possibilities of validity. As shown by
Thomas Kuhn, it is supported by the values and needs
of a certain culture, at a certain moment. In his classic
book ‘‘The Structure of Scientific Revolutions’’ he
warns that there is a pressing need for the analysis of
development of theories and scientific verifications: the
psycho-sociology of science, understanding of its
motivations and meanings of its discourse. This means
that it is important to recognize the non-universality of
regulatory standards. In this case, the need is urgent.

Precisely Paulo, well put.

More on ginkgo and coagulation: trial evidence that finally knocks out the myth that ginkgo is likely to cause additive interaction of over-anticoagulation when combined with aspirin. Of especial interest is that the study population was OLDER adults, the higher risk group that are often on an rx of aspirin as well as ginkgo users.
Effect of Ginkgo biloba (EGb 761) and aspirin on platelet aggregation and platelet function analysis among older adults at risk of cardiovascular disease: a randomized clinical trial: Gardner CD, Zehnder JL, Rigby AJ, Nicholus JR, Farquhar JW, Blood Coagul Fibrinolysis. 2007 Dec;18(8):787-93

Several case reports have implicated Ginkgo biloba in clinically adverse bleeding disorders. Ginkgo biloba has been reported to increase pain-free walking distance among patients with peripheral artery disease (PAD). Standard PAD therapy includes 325 mg/day aspirin. The objective of this study was to examine potential adverse effects of concomitant aspirin and Ginkgo biloba on platelet function. Ginkgo biloba (EGb 761, 300 mg/day) was compared with placebo for effects on measures of platelet aggregation among adults consuming 325 mg/day aspirin in a randomized, double-blind, placebo-controlled, parallel design trial of 4-week duration. Participants were adults, age 69 +/- 10 years, with PAD or risk factors for cardiovascular disease. Outcome measures included platelet function analysis (PFA-100 analyzer) using ADP as an agonist (n = 26 placebo; n = 29 ginkgo), and platelet aggregation using ADP, epinephrine, collagen and ristocetin as agonists (n = 21 placebo; n = 23 ginkgo). Participants kept daily logs of bleeding or bruising episodes. There were no clinically or statistically significant differences between treatment groups for any agonists, for either PFA-100 analysis or platelet aggregation. Reports of bleeding or bruising were infrequent and similar for both study groups. In conclusion, in older adults with PAD or cardiovascular disease risk, a relatively high dose of Ginkgo biloba combined with 325 mg/day daily aspirin did not have a clinically or statistically detectable impact on indices of coagulation examined over 4 weeks, compared with the effect of aspirin alone. No adverse bleeding events were observed, although the trial was limited to a small sample size.

PMID: 17982321 [PubMed - indexed for MEDLINE]

One of the biggest mainstream misinformation myths takes a dent from…. the mainstream: ginko, garlic, ginseng and other herbs experimentally associated with antiplatelet activity therefore cause dangerous interactions in vivo because they will affect hemostasis etc etc etc NOT. More details to follow after getting the full text of this one...

The effect of herbal medicines on platelet function: an in vivo experiment and review of the literature
Beckert BW, Concannon MJ, Henry SL, Smith DS, Puckett CLPlast. Reconstr Surg. 2007 Dec;120(7):2044-50

BACKGROUND:: Herbal medicines are used by a considerable number of surgical patients. An increased risk of bleeding, substantiated by anecdotal reports, has been attributed to the use of certain herbs, and numerous in vitro experiments have identified some herbal extracts as platelet inhibitors. The purpose of this investigation was to determine whether standard commercial preparations of commonly used herbal medicines have an effect on platelet function in vivo and, by extension, to provide clinical scientific evidence of the safety of their use in the perioperative period. METHODS:: Five commercially available herbal agents were investigated, including Ginkgo biloba, garlic, Asian ginseng, St. John’s wort, and saw palmetto. In a blinded fashion, one of the agents was administered to 10 adult volunteers at the manufacturer’s recommended dose for 2 weeks. At the end of the 2-week period, in vivo platelet function was quantified using the PFA-100 assay. After a 2-week “washout” period, the protocol was repeated using a different agent. This 4-week cycle was repeated for each of the five herbal agents, as well as the control agent aspirin. RESULTS:: In vivo platelet function was not affected by the administration of any herbal agent and was markedly inhibited with the administration of aspirin. CONCLUSIONS:: The herbal medicines investigated in this study do not affect platelet function in vivo. Neither this experiment nor a review of the literature supports the concern of perioperative bleeding in users of these herbal medicines.

PMID: 18090773 [PubMed - in process]