Nobel Prize-winning researcher criticized for not disclosing business interests

December 09, 2004

Los Angeles, CA - When Dr Louis Ignarro (University of California, Los Angeles) published research earlier this year on a metabolic intervention with L-arginine and antioxidants to reduce atherosclerotic lesion formation, he failed to disclose his relationship with Herbalife International (Los Angeles, CA), Bloomberg News reported.[1]

The lack of disclosure is problematic because the company paid Ignarroa winner of the 1998 Nobel Prizeand his consulting firm at least $1 million between June 2003 and September 2004 for consulting, promotional, and endorsement activities.

However, there was no mention of the relationship in the June 8, 2004 Proceedings of the National Academy of Sciences article that highlighted the beneficial effects of metabolic treatment on atherosclerosis in hypercholesterolemic mice.[2] In their study, Ignarro and colleagues report that metabolic intervention with L-arginine and antioxidantstogether with graduated and moderate exercise trainingcould reduce atherosclerotic lesion formation.

When contacted by heart wire , Ignarro said the research published in the June 8 issue predates his relationship with Herbalife.

"Moreover, the research was conducted on ingredients and dosages that are different from the ingredients and dosages in the Herbalife product that I formulated," said Ignarro. "The Proceedings of the National Academy of Sciences article was an extension of the research that several other scientists had published on the effects of physical activity, arginine, and antioxidants on nitric-oxide production during the past 10 years."

Vitamins C and E, as well as L-arginine, are ingredients in NiteworksTM, a nutritional supplement that "supports energy, vascular, and circulatory health," manufactured by Herbalife. The product also contains folic acid, alpha lipoic acid, and L-citrulline. In the published study, L-arginine, vitamin C, and vitamin E were tested alone and in combination, but the study did not include testing on L-citrulline, folic acid, or alpha lipoic acid. The entire study, said Ignarro, was conducted before the development of Niteworks and before additional experiments with L-citrulline.

On the label, the company boasts that the product is based on the research of Ignarro and affects circulatory-vessel dilation and elasticity. The bottles sell for $90 for a month's supply and bear the signature of Ignarro and his Nobel Laureate status. Ignarro was the 1998 corecipient of the Nobel Prize for his discovery concerning nitric oxide as a signaling molecule in the cardiovascular system. He shared the award with Drs Robert Furchgott (State University of New York, Brooklyn) and Ferid Murad (University of Texas, Houston).

Firm receives percentage of sales

In a filing with the Securities and Exchange Commission, Herbalife has reported paying Ignarro's consulting firmHealthwell Ventures LLCa share of Niteworks revenue. Healthwell was formed in January 2003 with the intention of receiving royalties from Herbalife, and Bloomberg reports the consulting firm is paid 1% of Niteworks sales revenue and had received an advance against royalties in 2003.

A press release summarizing the June 8 article issued by UCLA, where Ignarro is a professor of pharmacology, also failed to disclose Ignarro's relationship with Herbalife. A spokesperson for UCLA Health Sciences said the university doesn't research potential conflicts and relies on faculty members to disclose potential conflicts of interest. Calls to Proceedings of the National Academy of Sciences managing editor Bridget Coughlin were not returned, but Ignarro told heart wire the National Academy of Science plans to run a statement in the next publication on his behalf in an effort to avoid the appearance of any impropriety.

No human studies yet

The Bloomberg article delved a little further than lack of disclosure, with some experts questioning statements made by Ignarro and Herbalife. Furchgott, who shared the 1998 Nobel Prize with Ignarro for his own, independent research on nitric oxide, called Ignarro's claims about Herbalife's effectiveness improperly founded."They jumped the gun,'' he said. "I haven't seen any properly controlled studies. It just seems to me a mouse model isn't transferable to humans.''

Former New England Journal of Medicine editor Dr Marcia Angell (Harvard Medical School, Boston, MA) told Bloomberg that human clinical trials are needed to validate Herbalife and Ignarro's claims. "Until you do the trial, you don't know. There's a lot more work to do. You can't assume it will work for people.''

Furchgott added that unproven claims shouldn't be used to sell health products to the public. "I'm worried that Lou has gone into making a big thing of it before it's been thoroughly shown by controlled studies,'' he said, adding that he regrets Ignarro has become a spokesperson for an unproven product.

Ignarro defended the claims by stating there have been numerous human studiessuch as those by Dr John Cooke (Stanford University, CA) and other European researchersthat tested L-arginine in combination with vitamin C and/or vitamin E. "The combination appears to be clinically effective in atherosclerosis and other vascular disorders because of its nitric-oxide-generating capacity," said Ignarro. Clinical testing has not included L-citrulline, but studies looking at the effectiveness of L-arginine, L-citrulline, and antioxidants to lower abnormally high systemic blood pressure are in the works, he added.

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