Remember when green coffee bean extract was the next big thing in weight loss, a remedy with positive clinical findings touted as a breakthrough by Dr. Mehmet Oz and aggressively hawked online?
Last week, the 2012 study that started the hype and jump-started a coffee bean buying frenzy was retracted by Joe Vinson and his co-author, Bryan Burnham of the University of Scranton. Writing in the journal Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy, Vinson and Burham said they were retracting the study, published in the journal, because "the sponsors of the study cannot assure the validity of the data."
The retraction followed a $3.5 million settlement last month between Applied Food Sciences Inc. — a manufacturer of a green coffee bean product and sponsor of Vinson and Burnham’s study — and the Federal Trade Commission.
In a complaint leading to the settlement, the FTC called the study, conducted by researchers in India at AFS Inc.’s behest, "so hopelessly flawed that no reliable conclusions could be drawn from it."
The study’s lead investigator repeatedly altered the weights and other key measurements of the subjects, the FTC charged. He changed the length of the trial and misstated which subjects were taking the placebo, the agency said.
When the Indian investigators were unable to get the study published, the FTC said AFS hired Vinson and Burnham to rewrite the study for submission to journals.
"Despite receiving conflicting data, Vinson, Burnham and AFS never verified the authenticity of the information used in the study," the FTC said in a news release.
Vinson succeeded in getting a spot on the roster of the American Chemical Society’s spring meeting to present the study, and it was quickly accepted and published by Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy.
The study was said to have 16 participants, who cycled between a low-dose of green coffee bean extract, a high dose of the supplement and a placebo. Subjects taking the supplement were reported to have lost an average of 17.5 pounds in 22 weeks and reduced their overall body weight by 10.5 percent.
And those reported changes came despite the fact that participants’ average daily calorie consumption did not change, Vinson reported. The FTC complaint, however, contends that participants were told to restrict their calories and to exercise more.
Vinson told the Los Angeles Times that a larger trial was planned to further investigate the supplement’s safety and effectiveness in 60 participants.
News of the supplement’s alleged promise prompted Oz, on his show, to hail green coffee beans as a "miracle" aid to weight loss. In the weeks that followed, supplement manufacturers used video of Oz’s seeming endorsement to boost sales, the FTC inquiry found.
"Applied Food Sciences knew or should have known that this botched study didn’t prove anything," said Jessica Rich, director of the FTC’s Bureau of Consumer Protection. "In publicizing the results, it helped fuel the green coffee phenomenon."
This summer, Oz — appearing before a hearing of the Senate’s subcommittee on consumer protection, product safety and insurance — was chastised for appearing to endorse green coffee beans and other dietary supplements as safe and effective treatments.
"I don’t get why you need to say this stuff when you know it’s not true," subcommittee chairwoman Sen. Claire McCaskill, D-Mo., said to Oz. "With power comes a great deal of responsibility."
In addition to agreeing to settle the case for $3.5 million, Applied Science Inc. agreed "to have scientific substantiation for any future weight-loss claims it makes, including at least two adequate and well-controlled human clinical tests."