Consumer Health Digest #05-45
Your Weekly Update of News and Reviews
November 22, 2005
Consumer Health Digest is a free weekly e-mail newsletter edited by Stephen Barrett, M.D., and cosponsored by NCAHF and Quackwatch. It summarizes scientific reports; legislative developments; enforcement actions; news reports; Web site evaluations; recommended and nonrecommended books; and other information relevant to consumer protection and consumer decision-making.
Documents in Aetna/Cavitat case suggest widespread fraud. Aetna has accused Cavitat Medical Technologies and buyers of its Cavitat ultrasound device of participating in an elaborate conspiracy to defraud patients, the FDA, and insurance companies. The Cavitat device is claimed to help dentists diagnose neuralgia-inducing cavitational osteonecrosis (NICO), a condition that lacks scientific recognition. In 2002, Aetna issued a Clinical Policy Bulletin which explained why Aetna would not cover use of the device and other NICO-related procedures. In 2004, Cavitat filed a lawsuit accusing Aetna of publishing injurious falsehoods, engaging in unlawful restraint of trade, and racketeering. These charges were unfounded. After the racketeering charge and nearly all of the others were dismissed, Aetna filed a counterclaim for malicious prosecution and other wrongdoing. Based on documents gathered during the discovery process, the counterclaim alleges:
- Cavitat began selling its device before it applied for FDA permission to market them.
- The FDA rejected the company's request to market its device as capable of diagnosing NICO or distinguishing between normal and diseased bone. Despite this, its promoters claimed the Cavitat had been approved as a diagnostic device.
- Cavitat promoters falsely represented that an Institutional Review Board had been established to oversee research on the device.
- Cavitat promotional literature promised that a practitioner could generate $115,200 in annual revenue from Cavitat scans for a 427% return on investment.
- Cavitat and members of its scientific advisory board taught dentists how to miscode their claims so insurance companies would not know that they were NICO-related.
- Twenty-two dentists submitted a total of 427 miscoded claims for which they received undeserved payment from Aetna. Of these, 185 were filed by Jerry Bouquot, D.D.S., who received surgical specimens sent to him from all over the United States.
- Almost without fail, Bouquot's reports confirmed or supported the clinical diagnosis of the Cavitat practitioner. Aetna's counterclaim accuses him and others of conspiring to commit insurance fraud.
- The racketeering lawsuit was generated and financed by Cavitat users and others who apparently hoped that it would intimidate Aetna and other insurance companies into paying for practices associated with use of the device.
- To fund the suit, Cavitat solicited funds from third parties who had invested in the company, some of whom had a monetary stake in its survival, as well as others whose livelihoods derived from the use of the Cavitat device. In exchange, each of these individuals was promised a share of the hoped-for recovery.
Bouquot is now a professor at the University of Texas. In May, the University of Texas announced that since Bouquot became director of its surgical pathology laboratory, the number of specimens the laboratory received had more than tripled. [Durham E. Surgical pathology team aces CLIA inspection. TYDB eflash, May 5, 2005] Aetna is seeking recovery of its legal costs plus punitive damages that could amount to millions of dollars. Quackwatch has additional information about "NICO."
Texas Attorney General stops alleged fake flu vaccine scheme. The Attorney General of Texas has accused Comfort & Caring Home Health Care Services, America Home Health Care Services, and three individuals with scheming to administer shots that they falsely promoted as flu vaccine. A nurse working with the companies had notified the FBI about the scheme in which approximately 1,600 Exxon Mobil employees were inoculated. Iyad Muhammad (Eddie) Abu El Hawa, Martha Denise Gonzales, and Hossan (Sammy) El Hallak have been charged with violating the Texas Deceptive Trade Practices Act, which carries penalties of up to $20,000 per violation plus relinquishment of money they collected through the scheme. A Texas court has frozen the alleged perpetrators' assets. [Attorney General Abbott gets court order freezing assets of company dispensing fake flu vaccine. News release, Oct 31, 2005] The complaint and temporary restraining order are posted on Casewatch.
James Shortt, M.D., facing multiple legal problems. James Michael Shortt, M.D., who practiced "longevity medicine" in Greenville, South Carolina, is now facing criminal charges that he improperly provided drugs on 42 occasions between about December 1998 through about September 21, 2005. Thirty instances involve prescribing the anabolic steroids testosterone, stanozolol, nandrolone, fluoxymesterone, and/or oxymetholone "not for a legitimate purpose" and "outside the usual course of professional practice." The other instances involve providing human growth hormone "for a use . . . other than the treatment of a disease or other recognized medical condition." Press reports indicate that three of the recipients were professional football players. In April, the South Carolina Board of Medical Examiners suspended his license. The suspension was based on allegations that he had (a) unjustifiably prescribed testosterone (a steroid drug) to four men; (b) infused patients with hydrogen peroxide; (c) helped a patient obtain laetrile (an illegal and bogus cancer drug); and (d) improperly diagnosed a patient with Lyme disease and failed to report the alleged case as required by law. The indictment is posted on Casewatch. Shortt is also being sued by survivors of a woman he treated with hydrogen peroxide for multiple sclerosis.
Questionable product claimed to "enhance" stem cell activity. Four former Cell Tech executives have launched a multilevel marketing company whose flagship product is an alleged "stem cell enhancer" extracted from blue-green algae. The company claims that (a) circulating stem cells repair body tissues as needed, (b) stem cell circulation tends to decrease as people get older, and (c) the product (which costs $60 to $120 per month) releases stem cells from from bone marrow, and (d) the cells then circulate where they are needed and replace dysfunctional cells. A few studies—most done in laboratory animals—have shown that circulating stem cells from bone marrow can develop into a few other types of mature cells. However, no study has demonstrated that increasing the number of circulating cells is safe or makes people healthier. MLM Watch has a skeptical report. [Barrett S. StemTech's dubious claims. MLM Watch, Nov 21, 2005]
This page was posted on November 23, 2005.