Industry defends CAMs against “biased, poorly written” study

Industry has slammed a study in the Journal of the American College of Cardiology that highlighted dangers of cardiovascular disease patients using herbal products and called for drug-like laws to apply to the herbal sector.

“The principles and standards of evidence for safety and efficacy of drugs used in conventional medicine should also apply to herbal and other CAM products, with decisions about their use based on the results of scientific inquiry rather than on long-held but untested belief systems or traditions,” the report authors concluded.

But industry groups like the Council for Responsible Nutrition (CRN) were highly critical of what they called the study’s flawed and misunderstanding of the current regulatory climate for complementary and alternative medicines (CAMs).

CRN vice president of scientific and regulatory affairs, Douglas MacKay, said the report was so misinformed he was surprised an academic journal saw fit to publish it.

"We question how a peer-reviewed publication would even accept an article such as this, given the fact that the authors make conclusions about 'herbal remedies' based on their own uninformed, inaccurate, and outdated interpretation of the law which covers dietary supplements, including herbal supplements,” he said.

“The article contains sweeping generalizations, often not backed by relevant citations, and copious factual errors, including a reference to products -- some of which are not actually herbal supplements -- that produce adverse effects on the cardiovascular system.”

Measures taken

Dan Fabricant, the scientific and regulatory director at the Natural Products Association (NPA) said the authors, led by Ara Tachjian, MD, had betrayed a dangerous and damaging ignorance of the regulations that govern botanical products.

“DSHEA measures like good manufacturing processes (GMPs) and adverse event reporting (AER) address many of the issues raised by the researchers who don’t seem to realize that these measures have already been implemented,” he told NutraIngredients-USA.com. “It’s like this paper was written five years ago.”

He said there was potential for interaction with drugs as the paper suggested, but there was nothing new in this, and at any rate the greater hazard lay on the pharma side.

Mark Blumenthal, the founder and executive director of the American Botanical Council, said such articles often appeared that purported to protect consumer interest but possessed little knowledge of the area.

“The article has so many flaws and errors it is difficult to know where to begin to critically review it,” he said, noting an absence of Latin names for the 16 herbals highlighted as one important omission.

He said herbs like Oleander, chan su and Uzara root were not commonly used in the US as implied in the paper and ginseng was referenced without clarifying its species.

MacKay added: “If consumers are buying from reputable companies, they can feel confident in the quality and safety of these products. Herbal supplements should not replace medications or the need for smart lifestyle choices like healthy diet and regular exercise, but instead should be integrated as part of a total health regimen."

Blumenthal called on the Journal of the American College of Cardiology to retract the article.

Source: Journal of the American College of Cardiology

February 2010, Volume 55, Number 6, Pages 515-525, doi:10.1016/j.jacc.2009.07.074

Use of Herbal Products and Potential Interactions in Patients With Cardiovascular Diseases”

Authors Ara Tachjian, MD, Viqar Maria, MBBS and Arshad Jahangir, MD