Saturday, March 17, 2007
Consumer Alert: Bogus Juice Plus Research Published by South Carolina Distributor
A deceptive study purporting to show positive effects of Juice Plus nutritional supplements on peripheral artery disease was recently posted on the website of Greenville, South Carolina Juice Plus distributor, Dr. Robert G. Schwartz. The widely criticized supplements are sold by National Safety Associates (NSA) through a multilevel-marketing network of mostly untrained and unqualified but very aggressive distributors.
The study, which has the appearance of being an official reprint of a peer-reviewed research article,[1] was actually never published in a real journal and did not undergo peer review. The article appears to have been published in the November 2006 issue of a journal called “Resolving Complex Pain” but, in reality, no such journal exists; rather it is the title of a book authored solely by Schwartz, which sells on his website for $120.
Schwartz, a Juice Plus distributor[2] who runs his own practice, Piedmont Physical Medicine & Rehabilitation,[3] also sells various other high-priced supplements of dubious value. Not surprisingly, Schwartz’s self-published study reported positive effects of Juice Plus.
Schwartz’ article, which bears the title “The Impact of Juice Plus on Early PAD: A Clinical Study”, describes a non-controlled, non-randomized retrospective trial so poorly designed that it would be incapable of generating meaningful, interpretible results.
The article alleges that Juice Plus had a small positive effect on blood circulation in the legs (pulse volume and post-exercise systolic pressure) in 13 case reports of patients with mild peripheral artery disease who had taken Juice Plus in addition to anti-platelet medications for an average of 22 months.
Unlike a reliable, randomized, blinded, controlled, prospective study, in which patients are blindly assigned to a test agent or placebo group and monitored blindly going forward in time, Schwartz’s article describes using a highly unreliable retrospective design, meaning that the study was initiated after the subjects had already completed treatment, and Schwartz later decided arbitrarily which patients’ medical files to include or omit. The retrospective design is unreliable because it does not eliminate the possibility of an investigator cherry-picking the best case histories and omitting case histories with negative outcomes to artificially generate a desired outcome.
The methodology reported in Schwartz’s study was scant and incomplete, no statistical analysis of the data was performed, the extent of data variability (e.g. standard error or standard deviation) was not listed, and most importantly, no numerical data for the results of the Doppler ultrasound were shown, just tracings from a few arbitrarily selected cases. In addition, the study's design and data analysis make it impossible to distinguish between the effects of Juice Plus and the effects of the antiplatelet medications that all subjects were taking concurrently. Furthermore, no attempt was made to monitor the subjects' intake of fruit and vegetables or concurrent supplement use during the study. Any of these factors could account for the effects reported.
Schwartz’s article also falsely claims that Juice Plus was previously shown to reduce plaque formation (a critical component of atherosclerosis). In support of the claim, Schwartz incorrectly cited 2 studies, one by Samman et al. (J Nutr. 2003;133:2188-93)[4] and the other by Plotnick et al. (J Am Coll Cardiol. 2003:41:1744-9).[5] In actuality, neither study included any data whatsoever on plaque formation; in fact, neither “plaque” nor any other words with remotely similar meaning were even mentioned in the articles.
The very premise of the study makes little sense. If the idea is that fruit and vegetables are beneficial for patients with mild peripheral arterial disease who are also taking antiplatelet drugs, then research should be examining the effect of real fruit and vegetables, and the real thing is what physicians should be recommending to their patients, not Juice Plus. The patients in Schwartz's study would have undoubtedly been better served by increasing their fruit and vegetable consumption rather than buying Juice Plus from Schwartz. The benefits of real fruit and vegetables outweigh any of the benefits of the scant amount of nutrient-depleted plant powder in Juice Plus, and an inexpensive multivitamin would provide more appropriate amounts of all the nutrients that Juice Plus contains (and several that are not in Juice Plus or are present at very low levels) for a fraction of the cost.
There are several other facts that make Schwartz’s study particularly disturbing. Chief among them is that the study did not undergo a university or hospital Institutional Research Board review, nor was it scrutinized by an ethics committee, as is required for all medical research involving human subjects, in accordance with the Declaration of Helsinki.[5] It is unethical for an individual to conduct unsupervised medical research on human subjects without oversight of any kind.
In addition, Schwartz describes in his article that he solicited patients in his practice to take Juice Plus.
In regard to the sale of health-related products by physicians, the AMAs Code of Ethics states that:
The study, which has the appearance of being an official reprint of a peer-reviewed research article,[1] was actually never published in a real journal and did not undergo peer review. The article appears to have been published in the November 2006 issue of a journal called “Resolving Complex Pain” but, in reality, no such journal exists; rather it is the title of a book authored solely by Schwartz, which sells on his website for $120.
Schwartz, a Juice Plus distributor[2] who runs his own practice, Piedmont Physical Medicine & Rehabilitation,[3] also sells various other high-priced supplements of dubious value. Not surprisingly, Schwartz’s self-published study reported positive effects of Juice Plus.
Schwartz’ article, which bears the title “The Impact of Juice Plus on Early PAD: A Clinical Study”, describes a non-controlled, non-randomized retrospective trial so poorly designed that it would be incapable of generating meaningful, interpretible results.
The article alleges that Juice Plus had a small positive effect on blood circulation in the legs (pulse volume and post-exercise systolic pressure) in 13 case reports of patients with mild peripheral artery disease who had taken Juice Plus in addition to anti-platelet medications for an average of 22 months.
Unlike a reliable, randomized, blinded, controlled, prospective study, in which patients are blindly assigned to a test agent or placebo group and monitored blindly going forward in time, Schwartz’s article describes using a highly unreliable retrospective design, meaning that the study was initiated after the subjects had already completed treatment, and Schwartz later decided arbitrarily which patients’ medical files to include or omit. The retrospective design is unreliable because it does not eliminate the possibility of an investigator cherry-picking the best case histories and omitting case histories with negative outcomes to artificially generate a desired outcome.
The methodology reported in Schwartz’s study was scant and incomplete, no statistical analysis of the data was performed, the extent of data variability (e.g. standard error or standard deviation) was not listed, and most importantly, no numerical data for the results of the Doppler ultrasound were shown, just tracings from a few arbitrarily selected cases. In addition, the study's design and data analysis make it impossible to distinguish between the effects of Juice Plus and the effects of the antiplatelet medications that all subjects were taking concurrently. Furthermore, no attempt was made to monitor the subjects' intake of fruit and vegetables or concurrent supplement use during the study. Any of these factors could account for the effects reported.
Schwartz’s article also falsely claims that Juice Plus was previously shown to reduce plaque formation (a critical component of atherosclerosis). In support of the claim, Schwartz incorrectly cited 2 studies, one by Samman et al. (J Nutr. 2003;133:2188-93)[4] and the other by Plotnick et al. (J Am Coll Cardiol. 2003:41:1744-9).[5] In actuality, neither study included any data whatsoever on plaque formation; in fact, neither “plaque” nor any other words with remotely similar meaning were even mentioned in the articles.
The very premise of the study makes little sense. If the idea is that fruit and vegetables are beneficial for patients with mild peripheral arterial disease who are also taking antiplatelet drugs, then research should be examining the effect of real fruit and vegetables, and the real thing is what physicians should be recommending to their patients, not Juice Plus. The patients in Schwartz's study would have undoubtedly been better served by increasing their fruit and vegetable consumption rather than buying Juice Plus from Schwartz. The benefits of real fruit and vegetables outweigh any of the benefits of the scant amount of nutrient-depleted plant powder in Juice Plus, and an inexpensive multivitamin would provide more appropriate amounts of all the nutrients that Juice Plus contains (and several that are not in Juice Plus or are present at very low levels) for a fraction of the cost.
There are several other facts that make Schwartz’s study particularly disturbing. Chief among them is that the study did not undergo a university or hospital Institutional Research Board review, nor was it scrutinized by an ethics committee, as is required for all medical research involving human subjects, in accordance with the Declaration of Helsinki.[5] It is unethical for an individual to conduct unsupervised medical research on human subjects without oversight of any kind.
In addition, Schwartz describes in his article that he solicited patients in his practice to take Juice Plus.
"Depending on the clinical situation, everyone was started on either Cilostazol or Clopidogrel. They were also offered the opportunity to begin Juice Plus, a phytonutrient product".Not only does Schwartz’s mere selling of Juice Plus conflict with Code of Ethics of the American Medical Association (AMA),[6] it would also be illegal for Schwartz, an agent of National Safety Associates, to promote the product to his patients as a treatment for peripheral artery disease because (a) doing so would contravene the 1994 Dietary Supplement Health & Education Act (DSHEA),[7] and (b) Juice Plus has not undergone reliable testing for effectiveness, safety, and content quality, as would be required by the FDA (21 CFR Part 101)[8] in order to meet minimum standards for use in human patients.
In regard to the sale of health-related products by physicians, the AMAs Code of Ethics states that:
"In-office sale of health-related products by physicians presents a financial conflict of interest, risks placing undue pressure on the patient, and threatens to erode patient trust and undermine the primary obligation of physicians to serve the interests of their patients before their own...When judging the efficacy of a product, physicians should rely on peer-reviewed literature and other unbiased scientific sources that review evidence in a sound, systematic, and reliable fashion...Because of the risk of patient exploitation and the potential to demean the profession of medicine, physicians who choose to sell health-related products from their offices must take steps to minimize their financial conflicts of interest. "A relevant section of the DSHEA indicates that Schwartz’s article alone constitutes a violation of DSHEA:
Schwartz’s misleading study and unprofessional conduct add to a growing list of flagrant violations and deceptive promtional claims made by those who sell Juice Plus supplements.The DSHEA provides that retail outlets may make available "third-party" materials to help inform consumers about any health-related benefits of dietary supplements. These materials include articles, book chapters, scientific abstracts, or other third-party publications. These provisions stipulate that the information must not be false or misleading; cannot promote a specific supplement brand; must be displayed with other similar materials to present a balanced view; must be displayed separate from supplements; and may not have other information attached (product promotional literature, for example).
# posted by The JPRB Team @ 12:15 AM 
