Unfortunately, the Patient Protection and Affordable Care Act (ObamaCare) is not the first American State intervention into the medical microeconomic order.  The free exercise of oncology research, whether pursued in a laboratory or clinic, is a case in point.  In fact, the evolution of American State regulation of oncology research over the past decade is an excellent example of the initial phase of what economist Robert Higgs named the “ratchet effect,” the process whereby State power balloons during a “crisis” but does not fully deflate to its original size after the “crisis” dissipates.

 

The American oncology research “crisis” was publicly created in early 2004.  The initial paragraph of the Report of the Clinical Trials Working Group of the National Cancer Advisory Board nicely summarizes the initiating event: “In January 2004, Dr. Andrew von Eschenbach, Director of the National Cancer Institute (NCI),   established the Clinical Trials Working Group (CTWG) to advise the National Cancer Advisory Board (NCAB) on whether and in what ways the NCI-supported national clinical trials enterprise should be restructured to realize the promise of molecular medicine for advancing oncologic clinical practice in the 21st century.”

 

In June 2005, the CTWG presented to the NCAB specific initiatives designed to improve the NCI-supported national clinical trials system.  Many of the initiatives recommended, either directly or indirectly, increased State power in the oncology research arena.  The ten most egregious plans were as follows: “create a comprehensive database containing information on all NCI-funded clinical trials”, “increase cooperation between industry and the NCI, FDA, and industry”, “work with CMS to identify clinical studies … for which CMS may be able to reimburse some routine and investigational costs”, “develop a funding and prioritization process to ensure that critical correlative science and quality of life studies can be conducted”, “create … a national cancer clinical trials information technology infrastructure”, “build a credentialing system for investigators and sites recognized by NCI”, “develop commonly accepted clauses for clinical trial contracts”, “restructure the phase III funding model”, “create a Clinical Trials Oversight Subcommittee of the NCAB”, and “develop a coordinated NCI organizational structure to manage the entire clinical trials enterprise”.

 

The pace of American State intervention into the field of oncology research escalated in April 2010 when the Institute of Medicine (IOM) released a report entitled A National Cancer Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program.  The NCI commissioned this report, according to the NCI website, to obtain an “outside perspective to NCI’s ongoing efforts to improve the clinical trials system.”  Though the IOM report noted American State oversight had become extensive and complex, it recommended further consolidation of State power in the oncology research arena.  The five worst initiatives were as follows: “review and consolidate some front office operations of the Cooperative Groups”, “consolidate back office operations of the Cooperative Groups”, “streamline and harmonize government oversight”, “develop standards for new technologies”, and “increase funding for the Cooperative Group Program”.

 

Also in April 2010 (April 29 and 30), the American Society of Clinical Oncology (ASCO) and the NCI cosponsored the “Cancer Trial Accrual Symposium: Science and Solutions”.  A summary of and recommendations from the symposium were published in the November 2013 edition of The Journal of Oncology Practice.  “The symposium was designed to complement initiatives being carried out at the national level,” including the June 2005 CTWG and the April 2010 IOM proposals.  A plethora of clinical oncology research best practices and areas for future research were identified.  The most concerning idea was to “use the NCI’s Certified IRB (CIRB) for NCI Cooperative Group trials”.

 

Nearly simultaneously, a feature article entitled “Challenges to National Cancer Institute-Supported Cooperative Group Clinical Trial Participation: An ASCO Survey of Cooperative Group Sites” and a related editorial entitled “Timing is Everything” were published in the May 2010 edition of The Journal of Oncology Practice.  The article detailed multiple investigator complaints about the NCI clinical trials system and documented that many research sites were planning “to limit participation in NCI-funded cooperative group trials” primarily due to insufficient NCI reimbursement and staffing; the editorial predictably recommended centralizing reforms.

 

The NCI ultimately responded to the April 2010 IOM report in November 2010.  James Cox (a prominent non-libertarian radiation oncologist at the M.D. Anderson Cancer Center in Houston) provided fascinating details of the NCI’s scheme in a scathing editorial entitled “The Institute of Medicine, the National Cancer Institute, and Clinical Trials”, which was published in the International Journal of Radiation Oncology, Biology, and Physics Volume 79, Number 5, April 1 2011.  Professor Cox reported that the “chairs of the nine Cooperative Groups studying adult cancers … were summoned to a meeting in Rockville, Maryland on November 29, 2010, at which the NCI recommended integration of the nine groups into not more than four groups.  Other recommendations included consolidation of data management and operations and reconfiguration of the NCI review of clinical trials.”  Also, in this intriguing editorial, Dr. Cox predicted that, if the NCI’s proposal regarding consolidation of operations was adopted, medical progress would slow and the conduct of oncology clinical trials would become more costly.  Finally, he recognized that the goal of the NCI’s proposal was not to improve clinical trials; instead, the goal was power, for the “desire of the NCI staff for many years” has been to “direct, even to dictate, the activities of the cooperative groups, rather than to rely on the expertise of leaders in the groups.”  This final concern — the lust for power — is the radical libertarian insight regarding the true nature of the State.

 

On March 21, 2011, ASCO and the National Cancer Policy Forum (NCPF) of the IOM convened a workshop entitled “Implementing a National Cancer Clinical Trials System for the 21st Century”.  Sadly, as the name of the workshop expressed, the goal of the meeting was to devise means to achieve the recommendations of the April 2010 IOM report rather than challenge the IOM’s plan to further State healthcare power.  The participants discussed, among many disturbing ideas, ways to efficiently consolidate the nine existing adult Cooperative Groups and increase public-private collaboration in the oncology research arena.

 

Another front in the American State’s war to increase its healthcare power involves “enhancing the regulations overseeing research on human subjects.”  On July 22, 2011, the United States Department of Health and Human Services issued an Advanced Notice of Proposed Rule Making (ANPRM), which advised extensive changes to the Common Rule, the informal name for “The Federal Policy for the Protection of Human Research Subjects.”  The worst proposed changes (i.e. those most consistent with consolidation of Sate healthcare power) included the establishment of “mandatory data security and information protection standards for all studies involving identifiable or potentially identifiable data”, “extending federal regulatory protections to apply to all research conducted at U.S. institutions receiving funding from the Common Rule agencies”, and “providing uniform guidance on federal regulations”.

 

On February 11-12, 2013, ASCO and the NCPF of the IOM convened a second workshop entitled “Implementing a National Cancer Clinical Trials System for the 21st Century”.  The goals of this meeting were to report on progress implementing the means chosen at the March 2011 workshop (see above) AND choose further means to achieve the April 2010 IOM recommendations.  Options discussed at the worship that increase State healthcare power included expanding “collaborations among stakeholders (e.g. the National Clinical Trials Network, the pharmaceutical and diagnostics industries, federal agencies, and patients)”, reimbursement of “the costs of tumor profiling and rebiopsy if necessary”, and creation of “a centralized clearinghouse for annotated genetic profiles of patients’ tumors”.

 

In summary, since manufacturing a “crisis” in January 2004, the American State has been publicly engaged in a multi-faceted attack on the free exercise of clinical and laboratory oncology research.  Central control of the oncology research arena by the NCI has been effectively achieved in the intervening decade; extensive micromanagement via the implementation of new comprehensive State regulation is in process.  This historical episode is an example of Robert Higgs’s “ratchet effect”, though, unfortunately, the partial diminution of State power after the “crisis” disappears has not yet begun, most likely because there has been minimal resistance to increased State healthcare power by the public and the relevant medical professionals.  Corruption, deterioration, and abandonment of genuine oncology research are the inevitable outcomes of the current trend of escalating State power.  High-quality oncology research is free oncology research, which can only be achieved via separation of Medicine and State.

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