Medical Tourism in Nevada:

Legislative Update, 4/07

 

 

Summary by Susan E. Gallagher, Associate Professor

Political Science Department, UMass Lowell

Dr. Dan Royal and Dr. Dean Friesen, New Hope Medical Clinic

Nevada Institutional Review Board featured on the "Tops in Town Awards"

(Click on boxes to see full texts of bills.)

 

In 2005, with the help of Nevada State Senator Michael Schneider, Dr. Daniel Royal, a lawyer, lobbyist, registered insurance agent, and osteopath who served as President of the Nevada State Board of Homeopathic Medical Examiners, and his business partner, unlicensed pharmacist Dean Friesen, set up the Nevada Institutional Review Board, which was the first state-sponsored and controlled institutional review board in the country. 

Institutional review boards (IRBS) are, by definition, supposed to make certain that medical research studies protect the safety and dignity of human subjects, mainly by ensuring that researchers possess genuine credentials, adhere to federal regulations, avoid conflicts of interest, and follow proper procedures in collecting and reporting results.  In line with this primary purpose, IRBS are usually attached to research universities, which maintain offices to monitor compliance, or they are administered by separate institutions that are independent from government and corporate sponsors so that the quality of research will not be compromised by personal, commercial or political interests. 1

In a sharp departure from this ethical landscape, Royal and Friesen devised the Nevada Institutional Review Board (NIRB) so that they could solicit medical research proposals from business associates, collect exorbitant fees for processing applications, deposit funds in accounts that would be exempt from state audits, and then profit further by helping to market medical devices and treatments that are illegal elsewhere and thus would be available only in Nevada. 2

Along with Royal, who served as Secretary-Treasurer, and Friesen, who was elected President, NIRB personnel included Robert Gentry, CFO and Executive Director, who lists himself as a CPA, but is not licensed in Nevada, along with Tausha Larson, Financial Advisor, a patient at Royal's New Hope Medical Clinic who was supposed to provide "accounting services," but who is also not licensed as a CPA.  The NIRB never seems to have gotten around to actually forming various subcommittees, but the nominees included Robert Wempen, who was disciplined by the Medical Board of California for gross negligence and incompetence in 1999, and Michael Gerber, head of the Nevada Homeopathic Integrative Medical Association, whose California medical license was revoked in 1984. 3

 Royal and Friesen's scheme began to crumble almost as soon as it got underway.  In January 2006, amid bickering between Dan Royal and his father, Fuller Royal, another member of the Homeopathic Board, Nancy Lucas, then Executive Director of the NIRB and also employed at Dan Royal's medical clinic, filed a restraining order against Friesen for reasons that have never been publicly explained.  After Governor Kenny Guinn demanded Friesen's resignation on March 6, 2006, Friesen was reportedly freed from an undefined "cloud of suspicion" by the Attorney's General's Office.  Then, he and Robert Gentry, who also worked at New Hope Medical Clinic, were both removed from the NIRB. 4

The rash of personnel changes that ensued at both Boards during 2006 is not fully documented in meeting minutes.  It is, consequently, hard to tell if mysterious issues involving "a burglary," "a fraudulent police report," "a stolen computer," and "love letters" that somehow ended up at the Attorney General's Office were to blame for the shake-up.  It could be that Friesen's departure was connected to the misconduct that forced him to give up his California pharmacy license in 1995.  Similarly, Gentry's removal might have been due to his misrepresentation of himself as a CPA.  It it is not certain if Dan Royal retained his position as Secretary-Treasurer of the NIRB after he was apparently "deposed" as President of the Homeopathic Board.  However, he continued to participate in meetings of both Boards throughout these confusions, racking up debts to the Attorney General's Office to carry on disputes with his father.  5

Meanwhile, in line with the stipulation that the Homeopathic Board was required to oversee the NIRB, the Nevada Legislative Counsel Bureau (LCB) held in February 2006 that the NIRB was not authorized to create the NIRB Medical Foundation, a 501(c)(3) that Royal, in his capacity as Secretary-Treasurer of the NIRB, had established sometime earlier without properly consulting other members of the Homeopathic Board.  The NIRB Medical Foundation, which listed Dan Royal, Dean Friesen, and Robert Gentry as trustees, was devised to solicit gifts and donations for the NIRB, but, according to the LCB, this aspect of the scheme directly violated the requirements of the legislation that Royal himself had crafted in 2005. 6

Two months later, in April 2006, a state audit of the Homeopathic Board found that during Dan Royal's tenure as President, the Board ran up a debt of over $83,000 to the Attorney General's Office, overcharged for various reimbursements, and failed to follow any proper procedures regarding virtually all of its official responsibilities.  For example, the audit found that one Board member had improperly charged the Board $5,500 for travel expenses related to lobbying activities without gaining Board approval, without furnishing sufficient documentation, and without justifying expenses incurred by a non-board member.  Dan Royal is not named as the culprit, but he is the only Board member who was registered as a paid lobbyist. 7

Although Royal and Friesen collected $60,000 in NIRB research application fees during this period, presumably from their business associate, David Steenblock, who is the only applicant named in meeting minutes, these funds were excluded from the state audit.  The only discernable explanation for this exclusion is that Dan Royal had transferred these funds to the NIRB Medical Foundation, which had already been deemed illegal. However, it's not clear how the NIRB could have acquired these fees since mechanisms to solicit, select, and review research applications had yet to be put into place. Apparently, the only excuse available for Royal's incompetence in handling his duties at both the Homeopathic Board and the NIRB is that even though he is a lawyer, paid lobbyist, and physician, he failed to fulfill his official obligations because he was not aware of the requirements of state law. 8

In March 2007, without explicitly addressing any of these improprieties, Schneider introduced a series of bills that were designed to revive Royal and Friesen's original plan by vastly expanding their control over medical research and treatment in Nevada.  In this round, Schneider attempted to resolve his friends' problems by creating a Board of Complementary and Integrative Medical Examiners (BCIME) to replace the Homeopathic Board.  This entirely new government bureaucracy would enable Royal and his colleagues, not merely to profit from approving proposals submitted by business associates, but to invent a whole new field of medicine.  Along with the authority to regulate insurance coverage,  Schneider's bills would give the BCIME the power to approve or deny licenses to various types of health care providers without regard to accepted medical standards, federal regulations, or any other rules established to protect public health and safety in the United States. In order to give its licensing authority clout within Nevada, the BCIME will also be empowered to slap felony charges on health care providers who fail to obey whatever regulations that its bureaucrats choose to impose.

When Schneider brought Royal's raft of bills up for discussion before the Senate Committee on Commerce and Labor on March 28, 2007, the Senator opted not to delve into specifics.  And Senator Ralph Townsend, Chair of the Committee, went out of his way to silence all remarks about Dan Royal's wrangles with his dad.  As a result, no one explained exactly why Schneider and his colleagues were trying to help Royal remove the NIRB from under the supervision of the Homeopathic Board.  However, Senate Bill 414 itself leads off with a surprising rationale:

 

There are no "temporary" conditions included in the NIRB legislation that Royal wrote, Schneider sponsored, and the Committee approved unanimously after what appears to be under three minutes of discussion in 2005.  But what is even more striking about  this description of the insolvency of the Homeopathic Board is that it uses the results of Royal's own misconduct and incompetence as Homeopathic Board President—detailed in last year's state audit—to justify awarding him more authority.  At the same time, in asserting that the NIRB "has shown that it can maintain financial solvency while independent of the Board of Homeopathic Medical Examiners," the text underscores that the NIRB had been operating illegally, both by refusing the supervision of the Homeopathic Board and by violating the mandates of state law in respect to its financial affairs. 9

 

Whether the Commerce and Labor Committee will stay mum about Royal's past performance as a government official, as all members did on March 28, is hard to predict at this point.  However, claiming ignorance may prove difficult since Committee member Warren B. Hardy, Jr. happens to be the son of W. Brent Hardy, the Director of Pharmaceutical Associates, Inc., who served as Vice-President of the Homeopathic Board during Royal's troubled tenure as President.  Senator Hardy seems to have concluded that it was not necessary to highlight this potential conflict of interest since his father, who was the only Board member who opposed the otherwise unanimous vote to depose Royal as President, either resigned or was removed from his position sometime last year.  Thus, just as Royal's recent record as Homeopathic Board President appears to be irrelevant to the Committee, Senator Hardy apparently believes that he is perfectly free to vote on the abolition of the Homeopathic Board without regard to his father's recent role in its tortured history,  10   

A Word on Royal and Schneider's Foray into Stem Cell Legislation

In 2006, according to its own budget review, the Homeopathic Board somehow ran up a $10,000 debt for stem cell research to the Attorney General's Office. 11  Without mentioning this previous undertaking, Schneider brought a stem cell bill up for discussion on March 28.  At first glance, Schneider's bill may seem to have much in common with legislation introduced or passed in other states that is designed to ward off potential expansion of stem cell research by limiting this research to the utilization of non-embryonic sources such as umbilical cord blood. 

But the truly distinguishing features of SB 361 are that it is expressly concocted to boost the "health tourism industry"---which is usually associated with travel to other countries--and that it places stem cell research in the hands of investigators who would not be regarded as qualified in any other state.  Since respectable medical researchers are understandably reluctant to carry on studies that violate federal guidelines, it will be interesting to see if Royal digs up any supportive experts or if he will be forced to rely on his business associate, David Steenblock, to testify before the legislature.  Steenblock's competence to expound on this topic may be judged by his publication of Umbilical Cord Stem Cell Therapy, which he co-authored with "Dr." Anthony Payne, a.k.a., "the Wizard Who Came from the Sky," who has apparently never studied medicine or human biology at any accredited institution of higher education, but who has been awarded an "honorary MD" by the Open International University for Alternative Medicines in Calcutta. 12

Note: In an effort to pull the NIRB out of the fire that had been set by his son, Fuller Royal introduced AB234, a competing bill in the Assembly that would similarly expand the power of homeopaths to prescribe whatever they please, and also keep the NIRB in the hands of homeopaths and other believers in alternative healthcare. Writing in support of this plan in his 2006 Report to the Legislature, Royal Sr. stressed the great strides that the NIRB would make in crucial areas of medical research and treatment, but failed to mention that the NIRB had yet to include any members with any knowledge of the primary purpose of institutional review boards, which is protect the safety and dignity of human subjects.  Royal did mention that "researchers who have submitted requests from the NIRB to conduct research in stem cell therapy" were awaiting approval.  However, David Steenblock, who is the only research applicant named in meeting minutes, may have trouble pursuing his proposals because he is currently under investigation by the Medical Board of California in connection with his $10,000 prescription of a stem cell injection for a two-year-old girl that was administered in Mexico. 13

You can find independent documentation of all quotes and claims at Snake Oil Salesmen Hit Jackpot in Nevada, which draws from public meeting minutes, government web sites, and other reliable sources of public information.

Learn more about the cast of characters involved with the Nevada State Board of Homeopathic Medical Examiners and the Nevada Institutional Review Board.

Find out why it's no use complaining to the Nevada State Board of Medical Examiners: Public Citizen survey of state medical boards, 2003-2005.  Note: Nevada ranked 47th in this survey despite a surplus of $3.35 million that it has been trying to spend down since 2003. 

Read the FDA/AMA position on ABC coding, a primary focus of Royal's healthcare legislation

Read an undated internal performance audit of the NIRB in which CFO and Executive Director Robert Gentry attributes the NIRB's dysfunctionality to the deterioration of the Homeopathic Board during Dan Royal's tenure as President.

An interesting sidelight: The same legislation that created the NIRB established new rules requiring criminal background checks for licensed physicians and osteopaths.  However, the legislation failed to apply to the Board of Homeopathic Medical Examiners requirements imposed on the Board of Medical Examiners and the Board of Osteopathic Medicine. 

 

This budget appears on p. 15 of a pdf of the meeting minutes for 4/1/2006.  The debt owed to the AG's office has increased considerably since last year, thanks in part to Harvey Bigelsen's ongoing lawsuit, which apparently ensued after the Board approved him to practice as an Advanced Practitioner of Homeopathy (APH), but denied his application for a license to practice as a homeopathic medical doctor (HMD).  While  Board members expressed sympathy with Bigelson, they regretfully concluded that they could not permit him to practice as an HMD because his medical license had been revoked in New York, and he could not obtain a medical license in any other state.  Also note that the Homeopathic Board somehow incurred a $10,000 debt to the AG's office for stem cell research, a figure that defies comprehension even under these circumstances.

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