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Archive for Herbs & Supplements

NCCAM is a victim of its own history

Let me begin with a story. An assistant professor submits a reasonable application to NCCAM to investigate the potential metabolic and pharmacodynamic interactions of St. Johns wort with conventional chemotherapy. This was the year or year-and-a-half before SJW was known to have significant CYP3A4 inductive activity due primarily to its component, hyperforin. Said investigator used this preliminary data, not explicitly required for theNIH funding mechanism (called an R21), to question whether St. John’s wort used by depressed cancer patients might interfere with chemotherapy. The original proposal earned a priority score of 228 (as with golf, the lower the better: the best is 100, the worst is 500.)

The major reviewer critique was that the assistant professor, Your Humble Pharmacologist, lacked, at the time, significant natural products chemistry expertise. YHP was then doing his sabbatical in the NC Research Triangle area and wisely sought the support and expertise of the now-late Dr. Monroe Wall and surviving Dr. Manuskh Wani. These gentlemen discovered and solved the structures of taxol from Taxus brevifolia and camptothecin from Camptotheca acuminata. Taxol itself became a blockbuster drug for Bristol-Myers Squibb while camptothecin required water-soluble modifications to foster topotecan (Hycamptin) and irinotecan (Camptosar) that collectively saved or prolonged the lives of thousands of men and women subjected to breast, ovarian, lung, and gastrointestinal tumors. In 2003, they received the designation of an American Chemical Society National Historic Chemical Landmark for their three decades of work in this area. (Sadly, they received none of the profits from these drugs as their discoveries pre-dated the Bayh-Dole Act that allowed NIH funded researchers to share in the revenues of intellectual property emerging from their work.).

Being a savvy young investigator, I sought and enlisted the assistance and support of Dr. Wall and colleagues to provide my team with world-class, natural products expertise. Stunningly, the subsequent application was awared a score of 345 (*much worse than the original) with the criticism from reviewers that all Dr. Wall did was to lend a drug development aspect to an otherwise “herbal” applicaton.

To this day, I cannot fathom who better I could have sought for natural products expertise on this grant application.

Since then, three of my colleagues and I have submitted 13 applications to NCCAM, including an application for a comprehensive Botanical Research Center grant. All 13 received unfundable scores. Among these was a 279-page application for a NCCAM Botanical Research Center – reviewed but not discussed by the evaluation panel.

Nonetheless, I have taken the approach that if NCCAM were to continue its existence, I would try to be part of the solution.  I have accepted several invitations to review research and training grants for NCCAM and I am pleased to say that one or two projects that I ranked highly ended up being very productive, specifically in the area of natural products and traditional herbal medicines.  I also have some friends and valued colleagues who contribute to the scientific integrity of NCCAM. However, my collective experiences lead me to believe that they are voices quenched by the vast wilderness of the promotion and advocacy of “integrative medicine” and CAM.
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Posted in: Basic Science, Herbs & Supplements, Politics and Regulation, Science and Medicine

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Bad Books

In the interests of fairness and intellectual honesty, I’ve forced myself to read a lot of really bad books. The True Believer tells me his guru’s book is the Real Stuff. He tells me I have a closed mind and won’t look at anything outside establishment dogma, and if I only read the book and understood Dr. Quack’s evidence and arguments, I would be a True Believer too. I have tried, really I have. I’ve given the Dr. Quacks every chance to convert me, and I’ve hoped to learn something new, but I’m always disappointed. I’ve come to the point that I feel like I’m reading the same book over and over: it is always a mixture of real science, pseudoscience, and speculation, based on cherry-picked evidence and argued with the same logical fallacies.

I recently got hooked into reading another one by a correspondent who had called me an “ignorant relic” for writing a “grossly ignorant article” about alternative medicine. I suggested he read R. Barker Bausell’s book Snake Oil Science and a couple of others, which he promised to do. Then he said, “If I am willing to buy three books that you have suggested and read them and you are not willing to read what I have suggested, then that pretty much says all that needs to be said.”

I was willing, even though the very title of the book suggested that its message was incompatible with the scientific evidence as I know it: How to Prevent and Treat Cancer with Natural Medicine. The authors are big names in naturopathic and herbal medicine: Michael Murray, Tim Birdsall, Joseph Pizzorno, and Paul Riley. It’s nowhere near as bad as some of the bad books I’ve read, but it is a good example of the genre and I’ll use it to illustrate why I call them bad.

It offers “an arsenal of disease-fighting tools for prevention, treatment, and coping with side effects” (Yes, it offers tools; but do those tools work?) And it promises to “change your internal environment so cancer can’t survive.” (Wow! If it could really do that, every oncologist in the world would enthusiastically adopt these methods and the authors would be eligible for a Nobel prize.)
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Posted in: Book & movie reviews, Herbs & Supplements, Science and Medicine

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Colorado is Nearer to Promoting Naturopathic Pseudomedicine—Aided by the Colorado Medical Society

This week we’ll take a break from lambasting the National Center for Complementary and Alternative Medicine, as worthy as that task is, in order to confront some of the latest events involving the pseudomedical cult that calls itself “naturopathic medicine.”* Intrepid nurse and anti-healthfraud activist Linda Rosa reports that Colorado is dangerously close to becoming the next state to endorse ”NDs” as health care practitioners, and Scott Gavura of Science-Based Pharmacy called my attention to a report that British Columbia is considering enlarging the scope of practice for NDs, who are already licensed there, and that Alberta is on the verge of licensing them. In each case, those whom the public trusts to make wise decisions have betrayed their ignorance of both pseudomedicine and the realities of governmental regulation.

To explain why, it will first be necessary to make a few assertions, which are linked to developed arguments where necessary:

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Posted in: Health Fraud, Herbs & Supplements, Medical Ethics, Nutrition, Politics and Regulation, Public Health, Science and Medicine

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The Anniversary

I received a surprising morning call several weeks ago

“Wally?”

“This is he.”

“This is Judy V…. I just wanted to call and thank you again for what you did for me. It’s the 35th anniversary of my cancer…“

Judy V. is a physician’s widow. Her husband, a surgical specialist died in his 40s, 20plus years ago.   She had a Stage II breast cancer; the surgeon had done a modified radical, and I was consulted for possible adjuvant chemotherapy.

Thirty-five years ago the standard was simpler. Same for our knowledge of staging and biological behavior. Genomics was not a word yet. Targeted therapy was not a concept. Tamoxifen was the ony estrogen agonist and had just been introduced.  The standard adjuvant therapy was single agent melphalan or its equivalent. But even then, patients had choices. The surgery had probably cured her, but then… Chemo or none.
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Posted in: Cancer, Health Fraud, Herbs & Supplements, Nutrition, Pharmaceuticals, Politics and Regulation

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Amish Home Burn Treatment: B&W Salve and Burdock Leaves

People in the Amish community have been using “The New Concept in Treating Burns” and their experience is recounted in a little booklet by that title. It is a compilation of articles, testimonials, and letters to the editor of a monthly newspaper Plain Interests, published in Millersburg PA.

The treatment, involving B&W ointment and dressings of scalded burdock leaves, was developed by John Keim, an Amish farmer and natural healer. The Amish have a tradition of taking care of their own, and they try to avoid hospitals whenever possible. In the booklet, they even recommend treating hip fractures at home without surgery. (Which, after all, is what we did before we had hospitals and surgery).

They claim that with the B&W burn treatment:

  • Painful burns are rendered non-painful.
  • Healing is faster.
  • Painful debridement is not necessary.
  • Skin grafting is not necessary.
  • Scarring seldom occurs.
  • Iatrogenic harm from hospitals is avoided.
  • Patients can be treated at home at much less expense. (more…)

Posted in: Herbs & Supplements

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Bee Venom Therapy – Grassroots Medicine

Pat Wagner (or “The Bee Lady,” as she likes to be called) treats herself for multiple sclerosis (MS) by allowing bees to sting her. She calls this bee-venom therapy (BVT) and believes it has saved her from MS.

There are now thousands of people who administer BVT to themselves or others, mostly in private homes by unlicensed practitioners. BVT is not prescribed by a doctor, yet it is used like any other drug, given in regular doses at regular intervals. There is no scientific evidence to support its use, and yet thousands of multiple sclerosis sufferers and others tout its effectiveness.

BVT, which is one modality within Apitherapy, or the use of various bee products as a medical treatment, is still a relatively small phenomenon. It is largely an unrecognized grassroots or folk medicine treatment – but like all such phenomena has been given a huge boost recently by the easy spread of information via the internet. It has also been adopted by many so-called alternative medicine (CAM) practitioners, and has been increasingly wrapped in the typical marketing jargon of CAM. So, in a way, this grassroots treatment has been corporatized by the CAM industry.

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Posted in: Herbs & Supplements, Neuroscience/Mental Health, Science and Medicine

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Vitamin Cocktail with a Meme Twist (Supplement my gimlet with a dash of dissonance)

A trail of recent reports is trying to tell us something. But are we listening, and are “they” listening? If so, does it mean the same to “them” as it does to us?

The report trail is telling us that multiple vitamins fail as preventatives against cardiovascular disease, cancer, or even for anything other than for dietary vitamin deficiency. And that is what we were saying in the first place – forty and more years ago.

Here is a partial list of these recent reports –  followed by an odd turn

Vitamins E and C were ineffective in preventing `cardiovascular disease in men. Sesso HD, Buring JE, Christen WG et al. JAMA, 2008;300 (Physicians’ Health Study II, mong 14,641 male physicians. [...] The study participants were randomized to receive 400 IU of vitamin E every other day or a placebo and 500 mg of vitamin C daily or a placebo.

B Vitamins (B12, B6, folate) May Not Reduce Cardiovascular Events For Coronary Artery Disease Patients Ebbing M, et al, JAMA 2008, Aug 20 — In a large clinical trial involving patients with coronary artery disease, use of B vitamins B6, B12, folate was not effective for preventing death or cardiovascular events. Patients were randomly assigned to one of four groups receiving a daily oral dose of one of the following treatments: folic acid, 0.8mg, plus vitamin B12 , 0.4mg, plus vitamin B6 , 40mg (n= 772); folic acid plus vitamin B12 (n = 772); vitamin B6 alone (n = 772); or placebo (n = 780).The study was stopped early because of concerns among the participants about preliminary results from another similar Norwegian study suggesting no benefits from the treatment and an increased risk of cancer from the B vitamins. Daily supplementation combination that included folic acid and vitamin B6 and B12 had no significant effect on the overall risk of cancer, including breast cancer, among women at high risk of cardiovascular disease. Zhang M et al, JAMA 2008 Nov. 5.

Certain Vitamin Supplements May Increase Lung Cancer Risk, Especially In Smokers. November 11, 2008, from American Thoracic Society. March of the American Thoracic Society’s American Journal of Respiratory and Critical Care Medicine.

Selenium and vitamin E supplements, taken either alone or together, did not prevent prostate cancer; these results came from initial, independent review of study data from the Selenium and Vitamin E Cancer Prevention Trial (SELECT), funded by the National Cancer Institute. (publication  Feb. 1 in the Journal of Clinical Oncology.)

These reports, along with those showing inefficacy of vitamin E in CV prevention and others, all in recent months, dovetail on more reported over the past decade. Now for the dissonance. A popular Web portal posted a brief questionnaire following one of last week’s reports. It asked readers to answer if they took vitamins regularly, infrequently, or not at all.
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Posted in: Cancer, Clinical Trials, Health Fraud, Herbs & Supplements, Nutrition, Politics and Regulation

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Bad Science: Four Things I Learned From Dr. Ben Goldacre

“You cannot reason people out of positions they didn’t reason themselves into.”

– Ben Goldacre, MD

Dr. Ben Goldacre is the author of the popular Guardian column, Bad Science. He has recently published a book by the same name. Bad Science received a very favorable review from the British Medical Journal and although I was tempted to write my own review for Science Based Medicine, I decided to cherry pick some concepts from the book instead. I hope you’ll enjoy the cherries.

Honesty & Placebos

As you can imagine, any good book about bad science must devote at least one chapter to the concept of placebos. We are all quite familiar with placebos, and how squarely the vast majority (and some would argue all) of complementary and alternative medicines fit into that category.  Ben surprised me with a couple of points that I hadn’t considered previously. Firstly, that alerting patients to the fact that you’re planning to prescribe them a placebo does not necessarily negate its effects, and secondly that no matter how skeptical or intelligent you are – all humans are subject to placebo effects.

Ben references a 1965 study from Johns Hopkins [Park et al., Archives of General Psychiatry] in which patients were explicitly told that they were going to receive a sugar pill (with no medicine in it at all) as treatment for their neuroses. The researchers reported substantial improvements in many of the study subjects’ symptoms.

This is the script that the physicians were to use to explain the placebos to the study subjects:

Mr. Doe… we have a week between now and your next appointment, and we would like to do something to give you some relief from your symptoms. Many different kinds of tranquilizers and similar pills have been used for conditions such as yours, and many of them have helped. Many people with your kind of condition have also been helped by what are sometimes called ‘sugar pills,’ and we feel that a so-called sugar pill may help you too. Do you know what a sugar pill is? A sugar pill is a pill with no medicine in it at all. I think this pill will help you as it has helped so many others. Are you willing to try this pill?

Wow. I was under the impression that the efficacy of the placebo was in the person’s belief that it was a legitimate medicine/therapy. Perhaps it only matters that the prescribing physician believes it might help? Perhaps snake oil salesmen are wasting their time on linguistic and pseudoscientific mental gymnastics?

Of course, the “gymnastics” do help. Other research has shown that the more complex the associated placebo ritual, the more potent its effects (such as piercing the skin with fine needles in many different locations). Nonetheless, I was surprised that an honest and accurate description of a placebo does not necessarily negate its effects.
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Posted in: Book & movie reviews, Herbs & Supplements, Science and the Media

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Why we don’t prescribe bark for cancer

My valued colleague, Dr. Antonio Baines, recently invited me to speak for his graduate course in Toxicology.  Dr. Baines’ course is one of the most highly-regarded graduate classes at North Carolina Central University for M.S. students in Biology and Pharmaceutical Sciences.  Antonio asked that I discuss the pharmacology and toxicology of herbal and non-botanical dietary supplements but pretty much gave me free reign as to the mechanism by which I would do so.

In the past, I have often introduced herbal supplements to students who already know a bit about drug and toxicant action by taking the example of the anticancer drug, taxol (Note: Little “t” taxol was the name originally given to this chemical by its co-discovers but the corporate sponsor used it as a registered trademark for the brand name, big “t” Taxol, and the USAN proposed the use of the cumbersome paclitaxel as the generic name.).  As I noted in my previous post, taxol is an anticancer drug isolated from the bark of the Pacific yew tree, Taxus brevifolia, and was the first compound shown to kill cancer cells by promoting microtubule polymerization (and preventing depolymerization).

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Posted in: Herbs & Supplements, Science and Medicine

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Fake Treatments for Fake Illnesses

I wrote previously on NeuroLogica blog about Morgellons disease. Both Peter Lipson and Wallace Sampson have also covered this interesting syndrome here on SBM. Briefly, sufferers of this dubious syndrome believe they have foreign material exuding from their skin, causing chronic itching and sores. The evidence suggests that in truth they suffer from something akin to delusional parasitosis – the false belief of foreign parasites in their skin, leading to chronic itching which causes the sores and also works clothing fibers into the skin, which are later exuded.

Morgellons, in short, is a fake disease, a false and somewhat far-fetched explanation for symptoms that have a much more prosaic, if undesired, explanation.

Those who believe they have Morgellons, however, are legitimately ill and are an extremely vulnerable population. They feel they have a serious and mysterious illness, and worse the medical profession does not understand their illness and so denies that it exists. This is a perfect setup for snake oil-peddling con-artists.

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