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Science in the Profit Interest

Another black eye for the so-called “ethical pharmaceutical” business. In what is being called “the biggest research fraud in medical history,” a member of Pfizer’s “speaker bureau” has pled guilty to fabricating dozens of drug studies. Dr. Scott Reuben, working on a $75,000 grant from Pfizer produced a research study on their drug Celebrex. Naturally, the drug was found to be remarkably effective against pain. Well, except there were no patients in the study. It was completely fabricated.

This isn’t a first for the good (for business) doctor. The peer-reviewed (and shame on the reviewers) journal Anesthesia and Analesia had to retract 10 papers authored by Reuben. Another 21 Reuben articles were apparently also fabricated according to London’s The Day. Reuben received nearly a half million from Pfizer, which I guess he has to give back, and possibly pay a $250,000 fine on top of that. Maybe even jail time.

But for Pfizer and the other companies that got rave reviews from “ethical research,” nothing. Bextra and Vioxx were also beneficiaries of Reuben’s fairy tale “research.” But these drug companies are not treated as conspirators. They’re “victims” of this fraud. Coverage in The Day fills in the details.

Reuben’s studies, five of which were funded by Pfizer, had bolstered claims about the post-surgery effectiveness of such painkillers as Pfizer’s Celebrex and Merck’s Vioxx.

Reuben’s attorneys said a bipolar disorder with “alternating periods of mania and depression fueled his misconduct.”

Oh poor guy. I’m sure we can all understand how depression could make someone want to fake dozens of scientific articles. No, we can’t. That’s a BS defense.

Meanwhile, these bogus “research studies” have been used to bolster claims of effectiveness for Celebrex and other drugs, as the public is fed the fiction that we have the best research in the world and the safest and most effective drugs. Yes, we have the best research results money can buy, and the best “approving for dollars” system too.

This corporate medical/scientific corruption hurts us all, and the media is only too happy to trot out the results of these “studies” while lapping up billions in pharma advertising.

And it’s not like this is new. Before this “biggest drug research fraud case in history,” there was the former biggest in 1989 when NJ physician Robert Fogari pled guilty to taking $2 million from drug companies for investigational new drug research that he never conducted. Fogari “investigated” new drugs for nine drug companies including Ciba-Geigy, Johnson & Johnson, Warner-Lambert, Pfizer, Upjohn, Syntex, and Merck, Sharp & Dohme. Fogari had his employees list persons who were not in the study and make up patients. He failed to do the urine, stool and blood tests and forged signatures of radiologists and others. The doctor also failed to report the deaths of two
patients in the “study” in order to “maintain a favorable impression” with the drug companies who hired him. At least the deaths were presumably not caused by the drugs they didn’t take as a part of the study they weren’t in that never took place.

Fogari admits he did not conduct any legitimate research during the whole eight year period.

A year earlier, Constantine Kostas admitted that of the 85 subjects in his clinical trial of Cipro, only 15 had actually been given Cipro. I suppose it hardly matters, since Kostas also faked the results of lab tests and examinations that never took place.

All of this is especially irksome to those of us who have endured Big Pharma’s war on herbs and supplements. How many of the so-called “research studies” on herbs funded by big pharma are also bogus? It’s easy to find such “studies” in which the patients chosen were inappropriate, or the protocol designed in ways that appear destined to fail. Indeed, “failure” of an alternative medicine is exactly what the drug companies want to see.

et tu Prince Charles? “Herbal medicine must be regulated”

In a recent BBC article (hat tip to Ed Smith of Herb Pharm for noting this) Prince Charles is quoted as saying “herbal medicine must be regulated.” Here in the United States, we often hear legislators and especially FDA officials calling for stricter regulation of herbal products and other dietary supplements. So my first reaction to the BBC article was “oh, no! The orthodox medical establishment has gotten to Prince Charles.” I even wondered if his opinion was colored by the fact that he is now in the herbal medicine business with his own herbal product line.

Prince Charles has been a consistent supporter of alternative medicine, and made a special appearance by video at the Columbia medical school course on botanical medicine. The Prince has been a consistent supporter of homeopathy and traditional herbal remedies. So this seemed like a bit of a betrayal of his former position.

On further thought, though, I had to reflect on the drama surrounding regulation of herbal products and nutritional products by the European Union. The “drama” featured a clash of different regulatory approaches employed by Great Britain and Germany. In Germany, nutritional and herbal products are regulated as drugs, and the German position has been adamantly in support of the entire world treating these products as such. Read more

Eleuthero for Diabetes

Eleuthero, the herb formerly known as Siberian Ginseng, is one of my favorites.

It always has been. This classic adaptogen has been researched historically for its effects in enhancing physical and mental performance, for reducing stress, for protecting the heart against ischemia, protecting against liver toxicity and stimulating the immune system. The latest research, however, is about its effects on diabetes, an effect that has apparently been linked to a natural constituents of the herb, syringin.

An article in Planta Medica explore the effect of syringin in diabetic rats. When syringin was ejected interventionists late, plasma glucose levels decreased in a dose dependent fashion. It also modulated the plasma glucose spike caused by glucose challenge testing. The authors conclude “The ability of syringin to enhance glucose utilization and lower plasma glucose level in rats suffering from insulin deficiency suggested that this chemical may be useful in the treatment of human diabetes.”

Planta Med. 2008 Feb;74(2):109-13. Epub 2008 Jan 17.
Hypoglycemic effect of syringin from Eleutherococcus senticosus in streptozotocin-induced diabetic rats. Niu HS, Liu IM, Cheng JT, Lin CL, Hsu FL. Graduate Institute of Pharmacognosy, College of Pharmacy, Taipei Medical University, Taipei, Taiwan

To further elucidate the action of this compound, and of this plant, the same authors published another article showing one mechanism of action, “enhancing the secretion of beta endorphins from adrenal medulla to stimulate peripheral micro-opioid receptors resulting in a decrease of plasma glucose in diabetic rats lacking insulin.”

Horm Metab Res. 2007 Dec;39(12):894-8. Increase of beta-endorphin secretion by syringin, an active principle of Eleutherococcus senticosus, to produce antihyperglycemic action in type 1-like diabetic rats. Niu HS, Hsu FL, Liu IM, Cheng JT.

Soldiering on With Herbs

A new book based on research funded by the National Institutes of Health explores the use of dietary supplements by military personnel. One of the best things about this book? It’s available online in its entirety, HERE. It reports on research conducted by a committee chosen to “identify those that may be of benefit or might pose serious hazards.” the committee selected supplements to review “based on their frequency of use, potential for adverse events, and interest for the military.” The supplements considered in the book are caffeine, chromium, creatine, dehydroepiandrosterone (DHEA), Ephedra, garlic, Ginkgo biloba, ginseng, β-hydroxy-β-methylbutyrate (HMB), melatonin, quercetin, sports bars, sports drinks, tyrosine, and valerian. Overall, the book takes a skeptical view of these supplements, mostly because of insufficient high quality research. Here are some highlights: Read more

Antioxidants at Every Meal

An article in Agricultural Research, a US government publication, points out the importance of consuming antioxidants with every meal.

In the process of breaking down and metabolizing food, our bodies generate a lot of free radicals. “And without any antioxidants present, like those from colorful fruits and vegetables, for instance, there’s nothing to counteract this detrimental effect,” says Ronald Prior, a chemist at USDA’s Arkansas Children’s Nutrition Center in Little Rock.

Antioxidants can almost be viewed as an antidote to the body’s problematic, not-100-percent-effective, energy-processing system.

Peabody, Erin. “A daily dose of antioxidants?(Providing the Foundation for Healthy Food Choices).” Agricultural Research. U.S. Government Printing Office. 2008.

Selections Coming Soon

The HerbSelect program is brand new (no pun intended). We’re reviewing product recommendations now and will be posting them in the near future. Thanks for your interest in this first-ever program from the Herb Research Foundation.

Tiger Woods and Theanine to the Next level

Tiger Woods says his experience with the “calming” alkaloid l-theanine in the form of Gatorade Tiger Focus, “is taking me someplace I never imagined.” An article in The Gazette, May 24, 2009 details some of the research on theanine and the “tea paradox” of how a caffeinated beverage can be described as “calming.”

A relaxed, awake state is associated with Alpha waves, and an awake and excited brain will emit high frequency Beta waves. Caffeine can be shown to suppress theta and alpha waves, while promoting the beta waves that are linked with stress and anxiety. So, what does theanine do?

A number of studies have confirmed that within 30 minutes of ingesting theanine, there is a measurable enhancement of alpha wave activity, implying an alert but relaxed state.

And while clinical studies to date don’t show an improvement in memory or mental function in humans, rodent studies show some promise. The dose of theanine in the Gatorade product, 25 mg per serving, is below the levels used in studies, but tea itself does fall within the range of use that affects alpha brain waves.

Green Tea Research

Green Tea is one of the most extensively, and successfully, researched herbs in the world today. It was first noticed several decades ago, that people involved in presenting the green tea ceremonies had remarkably low incidence of cancer. Hundreds of studies later, we now know that green tea, and in fact all tea (Camellia sinensis) as a wide range of beneficial properties for reducing risks of cancer, heart disease and liver disease, plus antioxidant properties, benefits for the skin and much more. We hear present some of the recent research on tea and its antioxidant polyphenols.

For all the latest news on tea, click Tea under Categories to the right.

Tea Antiinflammatory
Green tea polyphenols such as EGCG have potent anti-inflammatory properties. Prior research had shown that EGCG inhibits tumor necrosis factor through a mechanism that was thought to have implications for inflammation generally. Epidemiological studies link regular consumption of tea with decreased cancer risk and a reduction in mortality during the 12 month period following a heart attack. “Considerably less is known regarding the mechanisms by which tea confers these health benefits.” The present research demonstrates one important mechanism Read more

Green Tea And Thermogenesis

The thermogenic effect of tea is generally attributed to its caffeine content. An article in Alternative Medicine Review reports that green tea extract stimulates brown adipose tissue thermogenesis to an extent which is much greater than can be attributed to its caffeine content alone. Read more

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