Two authors of a 2012 paper sponsored by a company that made grand claims about green coffee bean extract’s abilities to help people lose weight have retracted it. The study was cited by The Dr. Oz Show, and last month it cost the company a $3.5 million settlement with the Feds.
Here’s the notice for “Randomized, double-blind, placebo-controlled, linear dose, crossover study to evaluate the efficacy and safety of a green coffee bean extract in overweight subjects,” a paper originally published in Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy:
The sponsors of the study cannot assure the validity of the data so we, Joe Vinson and Bryan Burnham, are retracting the paper.
The Federal Trade Commission (FTC) explained in a September press release about the settlement that:
The FTC complaint alleges the study was so hopelessly flawed that no reliable conclusions could be drawn from it. The flawed study, which purported to show that the product causes “substantial weight and fat loss,” was later touted on The Dr. Oz Show.
The FTC’s settlement with Applied Food Sciences, Inc. (AFS), which sells a green coffee ingredient used in dietary supplements and foods, requires the company to pay $3.5 million, and to have scientific substantiation for any future weight-loss claims it makes, including at least two adequate and well-controlled human clinical tests.
“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.”
Here’s what the FTC said about the study:
According to the FTC’s complaint, in 2010, Austin, Texas-based AFS paid researchers in India to conduct a clinical trial on overweight adults to test whether Green Coffee Antioxidant (GCA), a dietary supplement containing green coffee extract, reduced body weight and body fat.
The FTC charges that the study’s lead investigator repeatedly altered the weights and other key measurements of the subjects, changed the length of the trial, and misstated which subjects were taking the placebo or GCA during the trial. When the lead investigator was unable to get the study published, the FTC says that AFS hired researchers Joe Vinson and Bryan Burnham at the University of Scranton to rewrite it. Despite receiving conflicting data, Vinson, Burnham, and AFS never verified the authenticity of the information used in the study, according to the complaint.
We’ve asked Vinson whether he and Burnham ever verified the data, and The Dr. Oz Show for comment, and will update with anything we learn.
As the FTC explains:
Despite the study’s flaws, AFS used it to falsely claim that GCA caused consumers to lose 17.7 pounds, 10.5 percent of body weight, and 16 percent of body fat with or without diet and exercise, in 22 weeks, the complaint alleges.
Although AFS played no part in featuring its study on The Dr. Oz Show, it took advantage of the publicity afterwards by issuing a press release highlighting the show. The release claimed that study subjects lost weight “without diet or exercise,” even though subjects in the study were instructed to restrict their diet and increase their exercise, the FTC contends.
Scott Gavura critiqued the study for Science-Based Medicine in 2012.
Please see an update on this post.
This is outrageous in so many ways… The worst aspect for me is the fact that Vinsom and Burnham — academics at what appears to be a real university — were “hired” (paid) to “rewrite” some bogus nonsense for a Quack Medicine seller.
Skimming through Vinson’s CV, I see that he has also published articles touting the benefits of “Selenium yeast”, green tea, figs, “MEGANATURAL® GOLD GRAPESEED EXTRACT”, etc. I have not checked each paper for sponsorship details.
Despite his Professorship in Chemistry, Vinson specialises in writing dietary puff pieces (Goggle reports 1,530,000 Ghits for “chocolate benefits Vinson”).
His 1998 paper, “Selenium yeast is an effective in vitro and in vivo antioxidant and hypolipemic agent in normal hamsters”, has no Acknowledgements and pre-dated the era of CoI disclaimers. It does note that “Re-Natured® Selenium yeast was a gift of Grow Co., (Hackensack, NJ)”.
His 2004 paper, “MegaNatural® Gold Grapeseed Extract: In Vitro Antioxidant and In Vivo Human Supplementation Studies”, was published in the Journal of Medicinal Food. This comes from Mary Ann Liebert publishers, which means that (1) the website is an eyesore of advertisements for “Superfoods to Support your Healing Journal”; (2) they still want readers to pay for access to advertorials; and (3) no university library thinks it’s worth paying for a subscription.
At that stage my curiosity into Vinson’s sponsorship deals was exhausted.
OK, the gentlemen are “scientists” at the University of Scranton, which is run by the Jesuits and offers “Education Rooted in Faith”. Let us not place any serious scientific standards then to a professorship granted by a religion-centred institution. Amen.
Amen Brother
I’m the founder of a company that fights against this. We’ve started with a manual review of scientific literature on autism, but we’re going to expand into machine learning algorithms that analyze the papers automatically, and into other verticals besides autism.
It’s really important that scientists are held accountable for fudging data. We think we can do that. http://www.truthlyapp.com
“The Official Green Coffee Bean Extract”?
They invented green coffee beans did they?
Nope, they were just the first to show us the wonderful benefits!
In all fairness, they said their study was “randomized, double-blind, placebo-controlled, linear dose, crossover”, but they never claimed it was NOT made-up.
But seriously, what can editor and referees do when the findings are bizarre, yet the authors keep boldly presenting experimental proof, which by all logic must be fake? Again, see STAP.
About time. The # of people who come asking us about green coffee bean’s efficacy is only exceeded by the # of people who still think that DAA will boost their testosterone.
Yergh.
“Texas-based AFS paid researchers in India to conduct a clinical trial…” If so, then why is there only ONE Indian co-author, the last, MV Nagendran? This is the first problem. Secondly, “Joe Vinson and Bryan Burnham at the University of Scranton [were hired] to rewrite it.” They did not verify the data, simply rewrite the paper. This is the second problem. The third problem lies with AFS. If they knew a priori before the badly written paper was sent to Vinson and Burnham that there had been experimental tampering, then why did they pursue the publication of the paper anyway? That sounds like reckless and irresponsible behavior to me, and not within corporate responsibility models. Will the Indian researchers who were paid to do the research, but who manipulated several aspects of the paper, be requested to reimburse their salaries received? Finally, why did the authors choose a fairly unknown publisher, Dove Press? How lenient was the peer review and could Dove Press release the peer reports?
Interestingly, under the retraction notice, the following list of EOCs, errata and retractions at Dove Press appears:
“Expression of Concern
A cross-sectional study on perception of stigma by Chinese schizophrenia patients [Expression of concern]
Ren ZB, Wang HQ, Feng B, Gu CY, Ma YC, Chen H, Li BL, Liu LY
Neuropsychiatric Disease and Treatment 2014, 10:1333-1334
Published Date: 18 July 2014
Retraction
Impact of an educational program on nursing students’ caring and self-perception in intensive clinical training in Jordan [Retraction]
Khouri R
Advances in Medical Education and Practice 2014, 5:157-158
Published Date: 22 May 2014
Retraction
Biologic targeting in the treatment of inflammatory bowel diseases [Retraction]
Bosani M, Ardizzone S, Porro GB
Biologics: Targets and Therapy 2014, 8:39-40
Published Date: 31 January 2014
Corrigendum
Interaction of recombinant and native Cav2.3 E-/R-type voltage-gated Ca2+ channels with the molecular chaperone Hsp70 [Corrigendum]
Radhakrishnan K, Krieger A, Tevoufouet EE, Dietz GP, Nagel F, Bähr M, Hescheler J, Schneider T
Journal of Receptor, Ligand and Channel Research 2014, 7:1-2
Published Date: 17 January 2014
Retraction
Female stalking: a systematic review [Retraction]
Carabellese F, La Tegola D, Alfarano E, Tamma M, Candelli C, Catanesi R
Research and Reports in Forensic Medical Science 2014, 4:1-2
Published Date: 31 December 2013
Retraction
Drugs in development for treatment of patients with cancer-related anorexia and cachexia syndrome [Retraction]
Mantovani G, Madeddu C, Macciò A
Drug Design, Development and Therapy 2013, 7:1385-1386
Published Date: 21 November 2013
Expression of Concern
Sexual behaviors among men who have sex with men: a quantitative cross sectional study in Kathmandu Valley, Nepal [Expression of concern]
Mishra SR, Khanal V
HIV/AIDS – Research and Palliative Care 2013, 5:163-164
Published Date: 18 July 2013
Erratum
Parizek M, Douglas TEL, Novotna K, Kromka A, Brady MA, Renzing A, Voss E, Jarosova M, Palatinus L, Tesarek P, Ryparova P, Lisa V, dos Santos AM, Bacakova L
International Journal of Nanomedicine 2012, 7:5873-5874
Published Date: 26 November 2012
Retraction
Cárdenas WH, Mamani JB, Sibov TT, Caous CA, Amaro E Jr, Gamarra LF
International Journal of Nanomedicine 2012, 7:5107-5108
Published Date: 21 September 2012”
Finally, why did the authors choose a fairly unknown publisher, Dove Press?
Dove is not that unknown and its reputation might have had a bearing on why it was chosen.
How lenient was the peer review and could Dove Press release the peer reports?
More to the point, have they been written yet?
” The sponsors of the study cannot assure the validity of the data so we, Joe Vinson and Bryan Burnham, are retracting the paper.”
Surely it’s the authors / investigators that are responsible for assuring the validity of the data, and not the sponsors? Or am I misunderstanding what the word sponsor means in this context?
Quite right – this is reminiscent of Gerald Schatten, who was asked to help Woo-Suk Hwang c.s. with writing their fraudulent Science paper and later tried to ‘retract’ his co-authorship.
It is my understanding that the only person accountable for the content of the paper is the author. Since when have sponsors been dictating the content?And then, why do universities give that much weight to publications, if researchers can hire others to write the papers?How do publications written by other academics verify the scholarly work claimed by a researcher?
So many words written about this! The notion that a chemical can lead to substantial weight loss without altering diet, exercise, etc., defies basic science and basic logic. “If it sounds too good to be true…..” I mean, seriously, what else can be said? It’s hard to imagine any scientifically savvy individual buying this in the first place.
Dr. Oz has let his viewers down by not critically evaluating what he touts on his show. His credibility is gone and his job should be too.
Dr. Oz is a cardiologist by trade, not a chemist. What, exactly, do you think he should have done to “critically evaluate” what he touts on the show? Run his own random blind tests? Look, at some point you have to rely on others’ scientific research because there is usually no way to verify the actual results without running some kind of test yourself. I’m hopeful and expect that he would retract his support for this supplement based on this new data, but to slam him for relying on others’ research is a little far, in my opinion.
Dr. Oz is not a cardiologist. He is a surgeon. Most recently he has become a TV personality who markets a variety of very questionable products to naive consumers; that’s how he ended up in front of a congressional subcommittee. The claim that debunking fraud requires one to set up his own lab is not correct. The authors of the fraudulent research, like Oz before the subcommittee, tried their best to pretend that their role was passive. Neither they, nor he, are believable.