Snake Oil Salesmen, political results, part 1

The Nevada Institutional Review Board: A Royal Mess     Signing ceremony for the creation of the Nevada Institutional Review Board, 6/17/05   In addition to Governor Kenny Guinn (sitting), the people standing from left to right are: Dean Friesen, Pharm. D., F. Fuller Royal, M.D., H.M.D. , Daniel F. Royal, D.O., H.M.D., J.D. , Sen. Michael Schneider.

In 2005, thanks in large part to the failure of the Medical Board to speak out, the Homeopathic Board embarked on a remarkable scheme to promote medical tourism by streamlining the process of legalizing medical treatments and devices that are outlawed in other states.  Dan Royal, JD, HMD, DO, and, to a lesser extent, his father, Fuller Royal, MD, HMD, spearheaded the effort by focusing, not on the health benefits that might be derived from alternative medicines, but on the millions of dollars that could supposedly be made from marketing unconventional therapies, especially in the uncharted territory of stem-cell therapy.  Dan Royal, stung by the failure of his FDA-disapproved "research" at the now defunct Great Lakes College of Clinical Medicine, devised legislation to create the Nevada Institutional Review Board (NIRB), which would be the first state-controlled, rather than federally regulated, institutional review board in the country.  Under the plan, a select group of alternative physicians would be empowered to solicit research applications from their business partners and other like-minded profiteers.  Then, after collecting significant fees for processing these applications, NIRB  members would approve and help to sell medical devices and agents that are illegal elsewhere and thus would be uniquely accessible in Nevada. 

State legislators, along with then Governor Kenny Guinn, apparently fell for the notion that medical miracles can be marketed just as gambling and prostitution are promoted in Nevada.  Along these lines, State Senator Michael Schneider celebrated the Royals' efforts to "jumpstart" the medical and scientific communities, stressing that the state would be a perfect destination for medical tourists since "Las Vegas and Reno, with all their hotel rooms, are 24-hour towns."  Likewise, Dean Friesen, an unlicensed pharmacist who serves as Director of Dan Royal's clinic and who was then President of the NIRB, rhapsodized about the windfall that medical tourism would bring. "It opens the door for a huge economic impact. Las Vegas is No. 1 as a tourist destination, No. 1 as a shopping destination. The reality is we believe in two years we can make Las Vegas the No. 1 destination for alternative medicine," Friesen was quoted as saying in a highly positive article published in the business section of the Las Vegas Review-Journal in December 2005.

What nobody in Nevada seems to realize is that institutional review boards (IRBS) are not supposed to function as boosters for economic growth.  Instead, as defined by the FDA, "an IRB is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects."  Likewise, according to the National Institutes of Health, "The primary mandate of...IRBs is to protect the rights and welfare of humans who are the subjects of research."  In keeping with their apparent ignorance of this primary purpose, state officials created the Nevada Institutional Review Board even though nobody attached to the project had any expertise in protecting the rights of human subjects, which is hardly surprising since none of the  practitioners involved seems to believe in scientific investigation, and many have already gotten into trouble for injuring people with treatments that are not supported by scientific research.  Of course, this dangerous situation would never have developed if the Nevada State Board of Medical Examiners, or anyone from the University of Nevada School of Medicine, or any other officials or experts in medical ethics or science had testified before the legislature, but no one has bothered to provide lawmakers with basic information about IRB's.

The Nevadans' hopes for medical tourism were nearly dashed last year by infighting between the Nevada State Board of Homeopathic Medical Examiners and the Nevada Institutional Review Board, which both started out under the direct control of the Royals.  While the squabbles seem to spring partly from family tensions between Fuller Royal and his son, Dan, the disarray within and between the two Boards is mainly the predictable chaos that erupts when troubled people are forced to work together to maintain power.  In this case, the situation was brought to a head by mounting legal debts the group incurred by turning to the Attorney General's Office to defend themselves against each other.  It is impossible to glean from the incomplete meeting minutes posted on the web all the ins and outs of the homeopaths' legal and emotional problems.  Nonetheless, their cryptic references to an unexplained "restraining order," confiscated "love-letters,"  a "stolen computer," a "false police report," and "a whisper campaign" that threatened to undermine the NIRB soon after its inception suggest that irrationality is no bar to government service in Nevada.  

Royal Patronage: An Interstate Approach

That nobody has been minding this snake oil store is plain, not only in the fact that most of the officers and staff of both Boards were or are employed at the Royals' medical offices, but also in the fact that the NIRB has generally met at Dan Royal's New Hope Medical Clinic in Henderson.  Thus, to hold a meeting of the ostensibly independent NIRB, Dan Royal has simply called his colleagues together from other parts of his building.  In this context, it was a breeze for him to nominate his partners and employees for various board positions ranging from President (his partner, unlicensed pharmacist Dean Friesen) to Chief Financial Officer (Robert Gentry, CFO at New Hope Medical, who lists himself as a CPA, but who is not licensed in Nevada) to Financial Consultant (Tausha Larsen, one of his patients) to Executive Vice-President for Research and Development (Nancy Lucas, who was later terminated from New Hope Medical after she filed a restraining order against Dean Friesen).

Dan Royal did not stop with salting the NIRB with his business associates.  He also used his position at the Homeopathic Board to set up business partners from out of state as licensed homeopaths in Nevada.  This strategy was designed to permit them to file applications to conduct research under the auspices of the NIRB and thereby evade state and, at least as envisioned by the homeopaths, federal laws and regulations that normally control medical research and treatment in the United States. 

For instance, in early 2006, the Royals helped David Steenblock, a California osteopath whose Brain Therapeutics Medical Clinic in Mission Viejo serves as a gateway to stem cell therapy in Mexico, obtain a homeopathic license in Nevada.  Meanwhile, Dan Royal set Steenblock up to make a presentation to the NIRB on stem cell treatment.  Steenblock's qualifications to speak on this topic may be judged by his publication of Umbilical Cord Stem Cell Therapy, which he co-authored with his employee, "Dr." Anthony Payne, who lists himself as a "Ph.D.," but who has apparently never studied human biology or any other subject related to medicine at any institution of higher education recognized by or accredited in the U.S.  After describing how he had cured a patient's blindness by injecting stem cells into an unspecified artery, Steenblock informed Board members that the federal government hands out grants for this kind of applied research, but these grants "must be used offshore" because such clinical procedures are illegal in this country.  However, Steenblock assured the Board, it might be possible to use federal grants to conduct clinical treatments that are illegal in other states if the funded studies were supervised by the NIRB.  None of those present, including Ned  Reed, Deputy Attorney General, seems to have noticed anything amiss in Steenblock's pack of lies, and Dan Royal never bothered to mention that he had welcomed Steenblock into his practice at New Hope Medical, nor did he bring this up later when he was laboring to get NIRB approval for seven research proposals on umbilical cord blood stem-cell therapy that Steenblock had submitted (NIRB Minutes, 3/28/06).

Despite their family squabbles, both Royals have touted the potential of Steenblock's proposals, which he somehow filed before the NIRB had established any procedures to solicit, select, and review research applications.  In fact, since the NIRB collected $60,000 in application fees in 2006, and since Steenblock is the only applicant named in meeting minutes, Steenblock might have been the NIRB's largest source of income.  It is, however, impossible to tell where this money came from or where it went since neither the Homeopathic Board nor the NIRB kept proper financial records, and these funds were excluded from two state audits that were published late last year.  But whether he paid these fees or not, Steenblock may have trouble carrying on his projects because he is currently under investigation by the Medical Board of California in connection with his prescription of stem-cell treatment for a two-year-old girl who suffered an allergic reaction after receiving a $10,000 injection in Mexico.

--Nevada Institutional Review Board, Meeting Minutes, 3/28/06

Political results, part 2