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Originally published Saturday, March 8, 2014 at 6:06 AM

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Death by supplement shows cracks in federal oversight

DMAA, a powerful stimulant in supplements aimed at weight loss and better workouts, was cited as the cause of one young man’s death in 2013. But the FDA didn’t hear of him. The system that is supposed to warn the public about such dangers is not only flawed, it’s abysmal, says one


The Atlanta Journal-Constitution

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ATLANTA — When 23-year-old Andrew Mabry was found dead in his Atlanta apartment in February 2013, answers were hard to come by.

There were no signs of foul play or suicide, and family members feared that Mabry, living alone and spending most of his time training for a tryout with a local minor-league football team, had died from the effects of alcohol or drugs.

Then the Fulton County medical examiner reached a surprising conclusion.

Mabry died “as a result of using a supplement similar to amphetamines,” wrote Dr. Michele Stauffenberg, the deputy chief medical examiner.

The ruling was significant, attributing a death directly to Dimethylamylamine, or DMAA, a powerful stimulant in supplements aimed at weight loss and better workouts.

And, to this day, the U.S. Food and Drug Administration knows nothing about it.

Mabry’s death slipped through the cracks of a system that’s supposed to warn the federal government — and the public — about serious health issues related to supplements. Yet all too often that system fails.

“With supplements, what you often have are silent killers,” said Dr. Pieter Cohen, an assistant professor at Harvard Medical School who has studied DMAA and its effects.

For more than 20 years, the FDA has learned about serious health issues related to drugs and supplements through its MedWatch system. It’s a largely voluntary process in which anyone can report an adverse event but only product manufacturers and distributors are required to do so.

Adverse event reports are particularly important for supplements because, unlike drugs, supplements can legally be sold without companies providing proof they are safe and effective.

But reporting has been spotty, even among the medical community, creating an environment that many believe doesn’t properly monitor products used by nearly 70 percent of Americans.

“The FDA can’t police this stuff,” said Lee Balefsky, a Philadelphia attorney who has filed lawsuits against supplement-makers. Supplement companies “don’t need FDA approval to put this stuff on the market, so it’s very difficult to get it off. (The FDA) gets these anecdotal reports, and that’s the only way they can really figure out what’s going on.”

The FDA has been trying to stop companies from selling DMAA for more than a year. The effort has been based in part on dozens of adverse event reports indicating the stimulant has led to heart attacks, strokes and other serious medical conditions.

But The Atlanta Journal-Constitution found that the toxic effect may be even more serious than what has been reported to the FDA.

Court records and other documents reviewed by the newspaper show that at least 10 deaths in the last three years have been linked to DMAA. However, only five were reported to the FDA, according to agency records obtained by the newspaper.

Cohen said the number of unreported deaths is further evidence of a system he calls “abysmal ... in fact, practically nonexistent.” That Mabry’s death was never reported is particularly troubling, he said, because it’s the first he’s seen in which DMAA was listed as the cause and not merely an underlying factor.

“This is incredibly important information that the FDA would have wanted to have,” Cohen said.

Dan Fabricant, the FDA’s top supplement official, said any system that relies largely on volunteer participation presents “challenges.” For that reason, the FDA is always trying to educate the public and health-care providers that reporting is essential, he said.

“It’s a marketplace of 85,000 (products), and if we’re not getting reporting from all walks of life, we can’t do our job,” Fabricant said. “Manufacturers may not always do what they’re supposed to do. That’s why the public and the medical community are so crucial (to the process).”

Almost from its inception, the MedWatch system has been characterized as ineffective in flagging the dangers lurking in the $32 billion supplement industry.

During the uproar over ephedra a decade ago, lawmakers and watchdog groups claimed that deaths and other health issues linked to the stimulant should have been known to the FDA long before the agency banned it in 2004.

A 1999 report by the Government Accountability Office described the system as incomplete and inadequate. Subsequent GAO reports have also found it lacking.

In its latest report, released last March, the GAO detailed how between 2008 and 2010 the FDA received roughly 1,000 fewer adverse event reports for supplements than the nation’s 57 poison-control centers. It recommended that the poison-control cases, normally confidential, be made available to the FDA, but, to date, that hasn’t happened.

Dr. Marsha Ford, president of the American Association of Poison Control Centers, said the material has yet to be turned over to the FDA because the agency hasn’t signed off on documents requested by the association relating to patient privacy.

“Poison-control centers have been around for 60 years, and we do get calls that the FDA is just not going to get,” she said. “So I think it would probably strengthen things all around if we could work together as we have proposed.”

Fabricant, of the FDA, declined to comment, saying he can’t discuss an ongoing negotiation.

The GAO also noted that the FDA provides less information online about safety concerns stemming from supplement adverse event reports than it does for drugs.

Making that information readily available to the public would “improve consumer awareness and understanding of potential health problems associated with supplements,” the report said.

Legislation in Congress would provide another means of monitoring.

Under the Dietary Supplement Labeling Act of 2013, introduced by Democratic Sens. Dick Durbin of Illinois and Richard Blumenthal of Connecticut, supplement companies would be required to register new products with the FDA within 30 days of putting them on the market.

Cohen calls the Durbin-Blumenthal measure, which faces opposition from industry groups, and the FDA’s potential agreement with the poison-control centers “small steps in the right direction.”

“If we’re going to live in a world where basically anything goes and anything can be introduced in a supplement, we’re going to need to track these things better,” he said.

For many, the biggest problem with the MedWatch system is doctors and their lack of reporting. The American Medical Association says it “strongly” encourages physicians to report adverse events related to supplements, but the policy is frequently ignored.



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