Questions raised about UCLA cardiologist’s endorsement of nutritional supplement

Matthew Budoff, a well-respected UCLA cardiologist best known for his strong advocacy of coronary calcium screening, has endorsed a patented nutritional supplement, BioShield-Radiation R1, “designed to neutralize the damaging free radicals produced by medical x-rays,” according to a press release from the supplement’s manufacturer, Premier Micronutrient Corporation. The press release states that Budoff “has become the first cardiologist in California to offer patients” the new pill.

But Duke’s Bob Harrington tells CardioBrief that the claims of the company for the supplement are unsubstantiated: “The whole thing is smoke and mirrors. Show us some data!”

According to Harrington, the company makes “incredible claims without referencing actual data.” He adds that “unfortunately,” this is “typical of the nutraceutical world.”

Some information about the drug can be found on the company’s website. According to a FAQ on the website, the pill is not FDA approved, because “dietary supplements do NOT require FDA approval.” The FAQ also states that no trials in humans have been performed. According to the company:

It would be unethical to perform the gold standard of clinical testing, i.e., a randomized double-blind placebo-controlled trial, for the simple reason that such a study would require delivering a known carcinogen (ionizing radiation) to humans.  All studies to date have been performed in animals.

It is unclear, however, why the company could not have performed a clinical trial on people exposed to radiation for legitimate medical purposes.

CardioBrief readers may also be interested in the company’s claim about the development of the pill:

BioShield-Radiation is new to the medical community, having been introduced in June 2009.  For many years prior, the scientists at Premier Micronutrient Corporation have performed studies with scientists associated with the U.S. military, the Department of Defense, and NASA, but the results of these confidential studies were never released publicly or made available to physicians.

The pill’s package states that it contains “multiple antioxidant micronutrients to address radiation exposure” and is “for use by patients undergoing radiologic imaging procedures such as CT, nuclear, mammography, fluoroscopy and dental x-rays.” The company website says the pill is also intended for use “for a single commercial flight.” (Another product, BioShield-Radiation R2, contains additional ingredients and is intended “for continuous or repetitive low-dose exposure as typically experienced by x-ray technicians and commercial flight crews”)

Contacted by CardioBrief, Budoff explained his position regarding the product:

I have worked for many years with Dr. Jim Ehrlich regarding early detection of atherosclerosis and he educated me on this product.  The research done is impressive, and we are offering this product to our patients who have radiation concerns.   The simple answer is that if it acts as a significant anti-oxidant, it may prevent free radical formation and help with radiation induced toxicity.  I have asked the company to do more research with proof that RNA and  DNA fragments are reduced in patients who receive the product.

As you know, there is a big pushback lately (due to articles by Einstein) against radiation and the theoretical toxicity they may cause, so simple things we can do to allay the public fears when scanning is necessary is helpful. We just offer this product as a free opportunity to our patients who may want to reduce their radiation exposure or have specific concerns.

A spokesman for the company said that Budoff had absolutely no financial ties to the company. “He’s just a customer,” the company told CardioBrief.

Update:

In response to queries about his relationship to the company and the difficulties performing clinical trials with the drugs, Budoff sent the following statement to CardioBrief:

I have no financial connection or arrangement with the company.  I think trials can be performed, but I am not sure what the endpoint would be.  For example, would we look at cancer rates in 20 years?  We can’t really measure body absorbed dose of radiation.  The only good study would be to look at RNA or DNA Fractures, but I am not sure how reliable these measures are.

Second Update: Please see a subsequent post for a detailed response from James Ehrlich, along with a response to Ehrlich from Bob Harrington.

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