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Family’s tragedy shows cracks in safety oversight system

Lack of reporting downplays risk to public of dietary supplements

By Danny Robbins - The Atlanta Journal-Constitution

When 23-year-old Andrew Mabry was found dead in his midtown Atlanta apartment last February, 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 county’s deputy chief medical examiner.

The ruling was significant, attributing a death directly to DMAA, a powerful stimulant in supplements aimed at weight loss and improving 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 that 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 that are 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 that the stimulant has led to heart attacks, strokes and other serious medical conditions.

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

Court records and other documents reviewed by the AJC 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 consumers 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).”

Decades of criticism

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 charged 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 U.S. 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 declined 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 currently pending in Congress would provide another means of monitoring.

Under the Dietary Supplement Labeling Act of 2013, introduced by Senators 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 fron 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.

Policy ignored

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.

Stauffenberg said her office didn’t report Mabry’s death because that’s simply not something the Fulton ME’s office does, even for deaths attributed to prescription drugs.

“I don’t think it really falls under any category we would report,” she said. “I don’t know if we’ve ever reported anything to the FDA because we get people who overdose on prescription drugs, but we don’t report all those as adverse drug reactions to the FDA.”

Mabry’s grandfather, Dr. Thorne Winter, also didn’t report the death to the FDA even though he considered it. Winter, a physician in Atlanta for nearly 50 years, said making a report “was basically just on the `to do’ list and never got done.”

In 2007, researchers at Johns Hopkins University studied a group of 335 physicians and found that 60 percent were unclear what to do when learning of a potential adverse event involving a supplement. The study also found that 37 percent didn’t even know that supplements aren’t subject to FDA approval before being sold.

James Glisson, a Mississippi physician who holds a doctorate degree in pharmacy and has extensively studied supplements, said some doctors have little knowledge of supplements, while others simply don’t care. Still others are fearful that reporting an adverse event may increase the likelihood they’ll be sued, he said.

“The value of whether somebody’s taking St. John’s wart is not very high on the list of things to keep up with,” Glisson said.

Steve Mister, president of the Council for Responsible Nutrition, a trade group for the supplement industry, said he thinks the MedWatch system is largely effective in dealing with supplements, although the FDA could do a better job of promoting it within the medical community.

“I don’t know if there’s a flaw in the law,” he said. “It’s just an area where the FDA should be doing more to make sure, whether it’s through medical organizations or whatever, that people know this is out there and that they should be using it.”

Mister said the system has improved since Congress passed a law in 2006 requiring supplement manufacturers to report serious adverse events involving their products within 15 days.

However, evidence suggests that companies aren’t always filing the reports.

The AJC found that the death of a 24-year-old Texas woman, Jessica Davila, in November 2011 hasn’t been reported even though it was tied to DMAA in a lawsuit filed a year later against a Dallas company, USPLabs.

Mark Zamora, an Atlanta attorney who is representing Davila’s family, said the medical examiner in Austin, where the young woman died, did not reference DMAA specifically. But USPlabs has known of its product’s link to the death for a year and half as a result of legal filings, he said.

“This is another example of a hole in the system, yes, no question,” Zamora said.

Repeated calls to the company and its spokesman were not returned.

Autopsy finding

The AJC learned of Mabry’s death from Winter, who contacted the newspaper in December. He said he decided to publicize his grandson’s death after reading the AJC’s reporting on how a Norcross company, Hi-Tech Pharmaceuticals, had continued to sell DMAA products in spite of the FDA’s efforts to stop it.

“I saw those articles and thought, `OK, this is what’s going on,’ ” Winter said.

At the time of his death, Mabry was training for a tryout with the Georgia Blaze, a team being organized for the start-up National Spring Football League.

A graduate of Whitefield Academy in Mableton, Mabry was back in Atlanta after a year at Valdosta State and looking to find his path in life. Football, even at the lowest professional level, was his latest plan.

“Andrew went through stages where he’d be very into something,” his sister, Melissa Cline, recalled. “At one point, it was trying to get into law enforcement. At one point, it was trying to get into the military. And then it was this football thing.”

Worried that Mabry had died of a drug overdose, family members waited anxiously for the autopsy report. When it arrived, they were both relieved and confused, unsure as to what DMAA meant.

“Completely unknown, yeah,” Cline said.

At the time of Mabry’s death, more than a dozen supplements were found in his apartment _ products with names like N.O.-Xplode, Amplified Wheybolic Extreme 60 and GNC Beyond Raw Ravage _ but none listed DMAA on their labels.

A zip-lock bag containing a white, granular substance also was discovered in the apartment, but the material, which resembled DMAA in raw form, was never tested.

Stauffenberg said she was unclear herself on what DMAA was when the toxicology test came back. The test was conducted by NMS Labs of Willow Grove, Pa., which added DMAA to its testing protocol in 2012.

“They said, `On this testing, we found this substance called DMAA,’” she said. “I’m like, `DMAA? I’ve never heard of that.’”

Stauffenberg’s report found that the level of DMAA in Mabry’s blood coupled with “likely” hypertension led to a fatal dysrhythmia, a condition where the heart beat becomes either too fast or too slow.

Asked recently what went into her thinking, Stauffenberg said Mabry’s heart showed signs of enlargement, making him vulnerable to DMAA.

“I don’t know how much (DMAA) it takes to cause death,” she said. “I don’t think anybody does. All I know is it’s there. It was measured. It was confirmed. And one of the effects is it makes the heart beat harder and faster and stresses it.”

Winter, who still sees patients at 81, also said he had no idea what to make of DMAA until he went to the Internet and learned about it.

Now fully educated, he hopes making others aware of his grandson’s death will save another young person from a similar fate.

“The bottom line is, if this helps somebody else or gets the (substance) off the market, it’s worthwhile,” he said.

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