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"Research" Associated with the Promotion of
Questionable Theories, Products, and Services

Stephen Barrett, M.D.

One way to make things look legitimate is to say that research supports them. This article discusses many of the ways this is done. Some are very simple; others are quite elaborate.

Unsubstantiated Advertising Claims

Because most people regard scientific evidence as a plus, promoters often claim to have it when they do not. In the simplest cases, ad-writers simply make up the claims. In some cases, the term "clinically proven" is applied to situations where an observer merely declares that users of the product were helped. The U.S. Federal Trade Commission has the right to demand substantiation and—if none is produced—can obtain a cease-and-desist order prohibiting future claims that are not backed by adequate research.

Claims can also be based on studies that were actually done but were poorly designed or improperly interpreted . In 1999, for example, Rexall Sundown claimed that its herbal concoction Cellasene could reduce "cellulite" by flushing it out of the body. During a television interview, the company's chief executive officer claimed that three clinical trials sponsored by the company had demonstrated a 90% success rate, but the results would not be submitted to scientific journals because Rexall did not want to reveal the amounts of each ingredient in its formula. Pressure from the media soon forced disclosure of the studies, which turned out to be poorly designed [1]. It didn't take long for class-action suits and FTC action to drive Cellasene from the marketplace [2].

Another strategy is to sponsor research that is legitimate but has little or no relevance to the claims. Juice Plus+, for example, has funded studies which show that Juice Plus+ capsules, which contain antioxidant vitamins, will increase the users' antioxidant blood levels. Some of the studies were done at prominent universities. Studies of this type can add to scientific knowledge of nutrient absorption, but they fail to determine whether the products will improve the users' health. Yet Juice Plus+ distributors use the existence of the research as a major selling point [3].

Many articles have been published about x-ray findings, blood components, or other measurable things that change in response to chiropractic procedures. Typically, however, such reports fail to address the basic question of whether patients actually benefit from these procedures.

Since most people regard scientific evidence as a plus, unscientific promoters claim to have it when in fact they do not. Their writings may list dozens or even hundreds of publications that supposedly support what they say. But the references they cite may be untraceable, misinterpreted, outdated, irrelevant, nonexistent, and/or based on poorly designed research.

A research basis can also be implied in other ways. Some marketers do business under a name that contains the word "Research." Others attribute supported findings to people who they say have done lots of research, a claim that can be tested by searching the National Library of Medicine (MEDLINE) database for publications authored by these people.

Research Enrollment as a Marketing Tool

Some marketers pretend that buyers of their products can join a research project to monitor whether the product works. The marketers may also pretend that participation will help others by pointing the way to effective treatment and/or increasing scientific knowledge. The most elaborate research scheme I have seen is the Juice Plus+ Children's Health Study, which is claimed to help determine whether Juice Plus+ can affect the health and well-being of children ages 6 to 15. The results are tabulated from questionnaires that participating families complete. completed by participating families. However, the questionnaire is poorly designed, no control groups have been used, and the resultant data have been meaningless [4]. As far as I can tell, the study is just a gimmick to promote sales.

In the late 1980s, the Vertebral Subluxation Research Institute (VSRI) taught chiropractors how to recruit "research volunteers" and convert them into lifetime chiropractic patients. Its chiropractor clients were instructed to use telemarketing and other approaches to ask people to volunteer for a nationwide study on spinal conditions. During the first office visit they would be examined and given a brochure—"The Silent Killer"—which explains how "subluxations" can be caused by physical, chemical, and emotional trauma. During the second visit, they would be advised to have their subluxations treated. The "research" was doomed from the start because the chiropractic "subluxations" are so nebulous and loosely defined that they are not measurable by research standards [5]. VSRI's program attracted criticism from several chiropractic sources as well as from Consumer Reports on Health [6]. It faded into obscurity and was concluded in 1991 [6].

In 2005, another subluxation-based program called Research & Clinical Science (RCS) announced that it would "seek to validate the profession and position chiropractic as a scientific, evidence-based wellness practice." One of its brochures states that its research will be geared to "pinpointing exactly what impact subluxations have on the body, and what benefits chiropractic might offer to people of various ages and health levels." Several chiropractic Web sites are now advertising for volunteers who will be offered a free evaluation and then invited—as paying patients—to "commit to a 24-visit cycle, and continue coming until they reach their maximum potential." RCS's offerings to chiropractors promise that its program will generate between 10 and 25 new patients a month and promote long-term wellness and compliance among existing patients. To join the program, chiropractors pay $7,384 in advance or up to $8,384 for an installment plan. In return, RCS provides the training, research technology, brochures, and other marketing materials needed to act as an "RCS Authorized Clinical Investigator." Because "subluxation" detection is not a valid health yardstick, most "research volunteers" are likely to be invited to waste time and money getting care they do not need. Moreover, it is not proper to promote long-term care (24 visits or more) before any data show that it actually results in a positive outcome [7].

In 2008, the British Advertising Stadards Authority (ASA) upheld a complaint against the Nutrition and Health Institute, a company that advertised that a dietary supplement might help reduce the occurrence of prostate cancer. The ad stated: "The Nutrition and Health Institute are conducting a FREE TRIAL of a new natural supplement that we believe in conjunction with changes to diet and lifestyle could reduce both getting up at night and the likelihood of getting Prostate Cancer." The ASA concluded that the ad was misleading because responders might think they would be part of a clinical trial to evaluate the product and not merely being offered a free sample [8].

Questionable Clinical Trials

Quackery promoters often claim that clinical trials are underway to test their methods. If that is true, they imply that if their method were not effective, reputable researchers would not spend time and money to study it. If a genuine study fails, the quacks invariably claim that it was not properly designed. In many cases, of course, the research claim is a complete fabrication.

Chelation therapy provides two examples of mischief associated with clinical trials. Its proponents claim—falsely that intravenous infusions of EDTA and other substances are effective against cardiovascular disease and many other conditions. In 1989, an article in FDA Consumer listed chelation therapy as one of "The Top Ten Health Frauds." [9] Three issues later, the magazine published a complaint that the listing was inappropriate because an FDA-approved clinical trial was underway. The complaint was followed by "an apology for the error," which stated that the editor had not been aware that chelation therapy had been approved for a study. The editor's note also quoted an FDA official who said that the study should "unequivocally answer at least several questions related to the utility of chelation therapy in . . . intermittent claudication." The FDA should not have backed down, because mere approval for a clinical trial is not proof that method works. Nevertheless, for several years, proponents continued to trumpet the existence of the study as evidence that their claims were justified. The study, however, was never completed. Proponents claimed that a drug company that was funding the study has withdrawn, leaving them without the resources to complete it.

Another clinical trial of chelation therapy began in 2003. The study—called the Trial to Assess Chelation Therapy (TACT)—is funded by the National Institutes of Health with an estimated completion date of July 2009. The chelation is supposed to be administered at more than 100 facilities, many of whose operators have been in serious trouble and should not be regarded as trustworthy. In September 2007, the Government's clinical trial Web site indicated that most sites had not finished recruiting patients, so it is not clear whether this study will be completed. Meanwhile, of course, it is trumpeted as evidence that chelation works and that participating doctors are competent researchers.

IRB Mischief

Some research-related schemes involve networks of practitioners, manufacturers, and others who hope that "research" claims will enable them to ward off government regulatory action and protect them from suits by dissatisfied customers. Some even set up (or pretend to set up) institutional review boards (IRBs) to oversee what they do. Such schemes can be difficult to investigate because IRBs are not usually required to publicly disclose their membership or activities. However, court cases and Internet postings sometimes bring their wrongdoing to light. A few years ago, for example, the American Association of Acupuncture and Bioenergetic Medicine told prospective members:

Ready access for the medical health care provider to AAABEM's Institutional Review Board (IRB), which can oversee each doctor's research protocol, thereby reducing the risks of adopting protocols which would be contrary to FDA regulation. The IRB can provide some protection for members from medical boards as well [10].

Over the years, I have encountered schemes in which IRBs (a) did not hold meetings, (b) did not properly review studies, (c) violated conflict-of-interest rules, (d) did not ensure that patients gave informed consent, and/or (e) were associated with illegally marketed medical devices. I have seen no evidence that IRB-related schemes actually protect the providers who participate. However, their consent forms and other trappings could persuade patients that bogus offerings are legitimate.

The consent forms used in IRB-related schemes typically include a liability waiver. Such waivers would not hold up in court because public policy does not permit people to sign away their right to be protected from fraud and negligence. In addition, federal regulations prohibit exculpatory language through which the subject or representative waives any legal rights or releases the investigator, the sponsor, the institution, or its agents from liability for negligence [11]. However, people who sign these waivers might fail to seek damages or report wrongdoing because they believe that they have signed away their right to do so.

The most notorious IRB was operated by the Great Lakes College of Clinical Medicine (GLCCM), which, in 2001, changed its name to the International College of Integrative Medicine. Documents posted to the Citizens for Responsible Care and Research (CIRCARE) Web site chronicle how at least 17 doctors associated with GLCCM have faced regulatory action [12] and that GLCCM's IRB shut down in 2001 after the FDA demanded compliance with its patient-protection rules [13]. AAABEM received a warning letter citing multiple violations in 2008 [14]

Additional Information

References

  1. Barrett S. "Cellulite" removers. Quackwatch, Oct 9, 2000.
  2. Rexall Sundown to pay up to $12 million to settle charges regarding cellulite treatment product: Company allegedly made false and unsubstantiated claims for "Cellasene." FTC news release,
    March 11, 2003.
  3. Barrett S. Juice Plus: A critical look. MLM Watch, Jan 29, 2006.
  4. Barrett S. Questionable research by the Juice Plus Children's Research Foundation, MLM Watch, Jan 27, 2008.
  5. Barrett S. Subluxation: Chiropractic's elusive buzzword. Chirobase, May 21, 2006.
  6. How to win patients and influence people. Consumer Reports on Health 3:11, 1991.
  7. Barrett S. Chiropractic "research" project is a marketing tool. Chirobase, Jan 28, 2008.
  8. Adjudication: The Nutrition and Health Institute, ASA, April 9, 2008.
  9. Top 10 health frauds. FDA Consumer 23(8):28-31, 1989.
  10. Benefits of joining the American Association of Acupuncture and Bioenergetic Medicine. Health World Web site, archived Dec 3, 2002.
  11. General requirements for informed consent. Code of Federal Regulations§46.116. effective June 25, 2005.
  12. Medical Board Orders for Physicians Associated with the Great Lakes College of Clinical Medicine. CIRCARE Web site, accessed Jan 31, 2008.
  13. Great Lakes College of Clinical Medicine IRB document index. CIRCARE Web site, accessed Jan 31, 2008.
  14. Ulatowski T. Warning letter to Fred Lam, M.D., Nov 13, 2008.

This article was revised on November 26, 2008.

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