This is a tale of two types of weight-loss products and how the Food and Drug Administration had different responses to similar problems with them. The separate, but not equivalent treatment raises questions about how the FDA operates.
On Aug. 24, the FDA issued a statement about an ongoing safety review of orlistat based on reports of liver injury in people taking the weight-loss drug. It is marketed as the prescription drug Xenical and the over-the-counter medication Alli.
The FDA said it had received 32 reports of serious liver injury in patients taking orlistat between 1999 and 2008. Of those cases, 27 required hospitalization and six resulted in liver failure.
Sound familiar? It should. On May 1, the FDA issued a warning about the danger of Hydroxycut based on 23 reported liver problems over seven years, including 16 hospitalizations. One person died in February 2007 after taking that weight-loss product.
That is where the stories diverge. For orlistat, the FDA is conducting a review because, “no definite association between liver injury and orlistat has been established at this time,” according to the release. “Consumers taking Xenical should continue to take it as prescribed, and those using over-the-counter Alli should continue to use the product as directed.”
In contrast, the FDA told consumers to stop immediately using Hydroxycut even though the agency acknowledged in a health hazard evaluation board report that “The Board does not know what ingredient(s) of Hydroxycut are responsible for producing liver toxicity. In addition, there is insufficient information to determine whether there is a dose-response effect between Hydroxycut ingestion and liver disease or whether its effects are cumulative over time.”
Despite a lack of direct evidence, the board concluded “that the ingestion of the dietary supplement, Hydroxycut, presents a severe potentially life-threatening hazard to some users.” The makers of Hydroxycut immediately ordered a recall.
What might the same health board members think about orlistat? It has caused liver injuries for a longer time period and has put more people in the hospital with similar ailments — jaundice and liver failure.
Does the FDA give greater weight to the patient death? If so, it seems to us that the product would have been recalled in 2007.
Is the difference the way the products are regulated? The FDA approved Xenical in 1999 and Alli in 2007. None of the ingredients in Hydroxycut were identified in the report as needing FDA review.
If the distinctions are not clear from a review of the facts, then what are we to expect the next time a weight-loss product is associated with health problems?
About Joel Rothman
Joel B. Rothman represents clients in intellectual property infringement litigation involving patents, trademarks, copyrights, trade secrets, defamation, trade libel, unfair competition, unfair and deceptive trade practices, and commercial matters. Joel’s litigation practice also includes significant focus on electronic discovery issues such as e-discovery management and motion practice relating to e-discovery.
It is clear that the FDA has a very selective pro-big pharma agenda when it comes to the “advisories” around unregulated supplements.
Until better controls are put in place to control the purity, efficacy, and long term effects of nutritional supplements, supplement makers will be the FDA’s scapegoats and their products will be viewed with skepticism and mistrust.
Why? Because there is alot of junk being peddled out there using deceptive marketing practices.
Evidence that the adverse event reporting system is flawed was proven when Bob Reynolds PhD, a leading vitamin B 6 researcher found that none of the 70 or so adverse avents on vitamin B 6 reported to the Center for Disease Control was clearly due to vitamin B 6. Leading researchers need to be involved in establishing a good adverse effent reporting problem.
The toxicity data not only needs information on dose response, but a mechanism to expalin the toxicity.
Elwood Richard, Founder Now Foods
This is an interesting comparison. I don’t have all the details for both situations, but would comment that the prime role of public health protection is paramount to the FDA, or indeed any health agency.
Xenical will be manufactured to established quality standards, and tox data & human exposure data available. This regulated situation allows a more scientific evaluation of the potential safety signals. In contrast hydroxycut products probably cannot be similarly evaluated. So therefore because of potential risk, FDA likely to take a more cautious approach as it is much harder to perform a risk-benefit analysis.
In the EU Alli remains as OTC Xenical (lower dose only), whereas hydoxycut products,regulated as foods, have in some countries removed from sale due to safety concerns.
I don’t have all the details for both situations, but would comment that the prime role of public health protection is paramount to the FDA, or indeed any health agency.
Xenical will be manufactured to established quality standards, and tox data & human exposure data available. This regulated situation allows a more scientific evaluation of the potential safety signals. In contrast hydroxycut products probably cannot be similarly evaluated. So therefore because of potential risk, FDA likely to take a more cautious approach as it is much harder to perform a risk-benefit analysis.
In the EU Alli remains as OTC Xenical (lower dose only), whereas hydoxycut products,regulated as foods, have in some countries removed from sale due to safety concerns