The FDA and Hydroxycut: The watchdog gets some teeth
Tuesday, January 5, 2010
By Rick Schmitt
For years, the Food and Drug Administration has been the agency in Washington that consumer advocates love to hate, attacked and reviled for failing to protect the public against dangerous drugs and medical devices, and threats against the food supply.
But now, at least in the case of one of its most hotly debated responsibilities, the FDA may be in the early stages of shedding its paper tiger image. The cautious optimism among public health and consumer law experts, stems from a recall that the FDA triggered in May 2009 against the makers of a popular line of weight-loss products sold under the Hydroxycut brand.
The case was built in part on examples of side-effects and other health issues that the manufacturer, Iovate Health Sciences, had disclosed to the agency under a new federal reporting law, including the case of a 20-year-old man who died after taking the company’s pills. Iovate disclosed the death case to the agency earlier this year before the recall was official.
Relying on another section of the new law, the FDA was also able to conduct an inspection of company records that led to the discovery of hundreds of other cases of health problems associated with Hydroxycut that Iovate had not previously reported to the agency.
FDA officials declined to say how those findings influenced their decision to press for the recall. Iovate officials told the FDA that they did not believe those unreported cases — totaling more than 2,100 between December 2007 and March 2009 — were “serious.”
An Iovate spokesperson declined to comment. The company has previously said that it believed the concerns over its products were overblown, and that it agreed to the recall “out of an abundance of caution and because consumer safety is our top priority.”
Some legal and public health experts said the early action by the agency in the Hydroxycut case may have headed off the possibility of widespread public harm, unlike the case with ephedra, which took years to pull off the market even while it was contributing to more than 100 deaths, including the 2003 death of a top Baltimore Orioles pitching prospect.
Since January 2009, the agency has identified more than 70 supplement brands that have been illegally spiked with prescription drugs, including seizure medications and anti-depressants. In a related case, several officials with a Georgia-based supplement maker were sentenced to federal prison in January, for importing into the U.S. illegal knockoffs of several popular prescription drugs, from a warehouse in Belize.
“It seems to me they are making up for lost time,” says Paul D. Rheingold, a New York plaintiffs’ attorney who specializes in drug and medical device litigation.
Anne Andrews, an attorney in Irvine, who has litigated against supplement manufacturers for years, senses a political shift under the Obama Administration.
“They have acted very quickly on early data,” Andrews said. “My sense is that the FDA has looked at these products and just been agog.”
Obama is not new to the issue. As an Illinois state senator in 2003, he authored legislation banning ephedra. That effort came in the wake of the deaths of Northwestern University football player Rashidi Wheeler and a 16-year-old high school football player in Illinois.
The president has promised an increase in the FDA budget to address chronic staff shortages and other problems. While not addressing supplements directly, the agency’s new commissioner, Margaret Hamburg, has spoken of the need to make food safety generally a priority.
Susan Cruzan, an FDA spokesperson, said the agency was not singling out supplement makers but rather responding to public health threats as they arise. At the same time, some agency officials have acknowledged that they have benefited from new powers from Congress.
“I think given our new authority we’re able to collect information much more quickly and to act more quickly,” Vasilios Frankos, the director of the FDA division of dietary supplements, said at the time of the Hydroxycut recall.
Dietary supplements have long been a sore point for critics of the agency because, unlike prescription drugs, they can be marketed to the public without any showing of safety or efficacy. Boosters say the approach, embodied in the Dietary Supplement Health & Education Act of 1994, enhances consumer choice.
Critics say the approach has threatened public health by putting untested, and in some cases dangerous, products readily on the market. Making matters worse has been the fact that manufacturers of the supplements have had no duty to advise the FDA of cases in which their products have hurt people.
With millions of Americans taking weight-loss products, and polls showing most believing, incorrectly, that the government had found them safe, public health experts saw a recipe for disaster.
Finally, in December 2006, Congress acted in the wake of the decade-long battle over ephedra, during which the industry was found to have concealed deadly and widespread evidence that supplements containing the ingredient caused heart attacks and other cardiovascular problems.
The new law — the Dietary Supplement and Nonprescription Drug Consumer Protection Act — became effective in December 2007 and requires supplement companies to begin reporting “serious” health problems to regulators, within 15 days after becoming aware of them. The law also gives the FDA the authority to examine the records of supplement manufacturers. It mandates that companies maintain those records for six years.
The new rules have led to a tripling of the number of adverse health reports received by the agency, the Government Accountability Office found this January. For regulators, that is a potentially powerful weapon, although the GAO found that the agency still lacks the resources to adequately monitor the reports.
The GAO also found that the FDA continues to be hindered from effectively protecting the public from dangerous supplements in other ways. For one thing, supplement makers are not required to disclose all the ingredients in their products; they are deemed “proprietary,” like the closely held trade secret for Coca-Cola. But that makes it hard to isolate harms when regulators suspect supplements are causing medical problems.
In the Hydroxycut case, for example, the FDA was unable to pinpoint which ingredient was causing harm to the public, so it pressed for a recall of the whole line of products. But that has left the company free to reformulate the product, without having to tell the FDA about what new ingredients were put in or old ones taken out.
Iovate pulled 14 products, marketed with such names as “Hydroxycut Hardcore” and “Hydroxycut Max Aqua Shed.” But since the recall it has come out with another line based on “new” and “advanced” formulas. Like other weight-loss products, they promise to boost your metabolism, and like others, often include caffeine as a key ingredient.
Some experts say consumers could still be at risk.
“The recall was a good first step, but it is product specific rather than ingredient specific,” said Ano Lobb, a public health consultant in Barre, Vt. “The fear I have is that it sends the message that this harm has now been resolved and taken care of.”
The FDA told Iovate in April that it should conduct a “rigorous safety review” if it intended to use any of the old ingredients in the new products, and to share the evaluation with the FDA. The company declined to say whether it had given the requested information to the regulator.
Indeed, while saying the FDA has made progress, some say it is way too early to conclude whether any changes are anything but incremental, at best. Without some sort of pre-market approval process, they say, the current system covering diet supplements makes guinea pigs out of unwitting consumers.
“Given the scant resources they have, and given the scant legal authority they have, I am not sure doing something once every three or four years raises any evidence they are being more aggressive,” said Sidney M. Wolfe, the founder and director of the Health Research Group arm of the Washington advocacy group Public Citizen and a long-time FDA critic. “They are picking their way at it, very slowly and minimally.”
Hydroxycut made a name for itself, and its corporate owners, during the heyday of ephedra.
A profile of Iovate in the National Post of Ottawa, Ont., in 2006 said it grossed as much as $350 million a year, and made a multi-millionaire out of its 30-something owner, Paul Gardiner, a body building enthusiast who used to pose in company ads. A 2005 Los Angeles Times article reported that the firm spent $10 million a year on advertising and marketing, including TV spots and placement with such retailers as Wal-Mart and GNC.
Anne Andrews said the firm was one of the few companies that aggressively sold ephedra-based products right up until the FDA banned the substance in 2004. Then known as MuscleTech Research and Development, the company sought bankruptcy-law protection after it was hit with a number of personal injury lawsuits by people who had gotten sick taking its pills.
According to the National Post, MuscleTech reformulated itself, transferring most of its assets to Iovate Health Sciences, which is now based in Ontario, Can., and which continues to use the MuscleTech brand on some of its products as well as the MuscleTech name for its web site.
Today, Iovate, which is privately owned, distributes 750 different weight-loss and muscle-building products and operates in 70 countries, according to company officials. It touts Hydroxycut as “America’s No. 1 weight-loss supplement.” It sold about nine million packages in 2008.
In announcing the recall, the FDA cited a risk of severe liver injury associated with the pills, based on evidence it found in reports to the agency, medical journals and discussions with leading liver specialists. Besides the one death, the pills were associated with at least one liver transplant, and other acute liver injuries. Several of the injured were members of the U.S. military, including a soldier deployed to Iraq.
Officials said they identified other conditions associated with the supplements, including seizures and cardiovascular disorders. And an otherwise healthy woman contracted hepatitis while taking six Hydroxycut pills a day in preparation for a body-building competition.
A Wisconsin man has sued Iovate claiming that he developed necrosis of the liver after taking Hydroxycut for three weeks. Andrews says she has been retained by a former Army sergeant in Germany who had an acute form of heat stroke and was subsequently discharged after taking Hydroxycut.
Several lawsuits seeking class action status have also been filed, including one in Los Angeles accusing Iovate and Hydroxycut of fraud and misrepresenting the safety and effectiveness of their products.
“My whole body was cramping,” says Tony Noyola, 23, who took Hydroxycut for a few days and ended up in the hospital for a week. “It started in my legs and then started gradually moving up into my upper body.” His urine turned brown. Eventually, Noyola says he was diagnosed with rhabdomyolysis, a condition that involves the breakdown of muscles, more often found in victims of earthquakes and bombings.
But the relatively early intervention by the FDA suggests Hydroxycut may not turn out to be the public health catastrophe that some had originally foreseen. Lawyers said many people who took Hydroxycut and got sick appear to have recovered once they stopped taking the supplements. That stands in sharp contrast to the situation with ephedra, where lawsuits and injuries proliferated while the industry and government battled over whether the stimulant was truly dangerous.
This new dynamic could be good for public health.
“This time around, the FDA acted obviously much quicker than the former FDA did in the days of ephedra,” says Tom Anapol, a plaintiffs’ attorney in Philadelphia. “They wanted to eliminate the risk sooner rather than later. We have a different administration now. My speculation would be that they are out in front of this.”
Mark Zamora, an attorney in Atlanta, says only a small percentage of the calls he has been getting from Hydroxycut users involve people who may have been seriously injured. The majority mainly are interested in getting their money refunded, he says.
“Honestly, I think that is good,” Zamora said. “It shows that people were not severely hurt.” Zamora said he has been no fan of the FDA over the years, but he senses a change may be afoot. “Maybe that is a function of a new day at the FDA,” he said.