The January 20, 2014 edition of the Journal of Clinical Oncology contained a special article by Richard Schilsky, M.D. entitled "Wither the Cooperative Groups?"  In this article the author provides a risk-benefit analysis of the recent decision by the National Cancer Institute (NCI) to fund "up to only four adult cooperative groups", which quickly led to consolidation of the nine major oncology clinical trials groups into four centralized organizations.  I previously commented on this controversy in an 08/02/12 blog post.  

Schilsky covers no new ground in his article.  He dutifully showers praise on the cooperative group system, which he describes as a "publicly funded standing infrastructure to conduct cancer clinical trials". He then lists the positives and negatives (though he is clearly sympathetic to the positive claims) of the NCI's plan "to create a network, the National Clinical Trials Network (NCTN), that would comprise the four remaining adult cooperative groups".  The author delivers a thoroughly "objective", noncontroversial, and mainstream evaluation.  Thus, it is useless.

The LIBERTARIAN BIOETHICS BLOGger's ultimate view of this "special article" is as follows: Sadly, it just doesn't occur to Schilskly (and other statist physicians of his ilk) that a privately funded oncology clinical trials system is possible or justified or ideal.  

Martijn Lolkema et al published an intriguing review article in the May 20, 2013 edition of the Journal of Clinical Oncology entitled "Ethical, Legal, and Counseling Challenges Surrounding the Return of Genetic Results in Oncology". 

The following section of the article piqued the interest of the LIBERTARIAN BIOETHICS BLOGger: "The debate on whether to reveal genetic research results to study participants has been dynamic, and various opposing viewpoints have been expressed … .  However, the extreme positions from nondisclosure to full disclosure are seldom defended.  At one end of the spectrum, full disclosure is considered by the majority of commentators to be undesirable and nonsensical at best, because it suggests disclosure of all raw sequencing data … ."  So, the authors claim that full disclosure of patient information to … wait for it … patients is an "extreme" position.  Wut?  They then commit the logical fallacy of appeal to authority by referring to the opinions of "the majority of commentators".  They finally provide an opinion rather than an actual argument, claiming that full disclosure is absurd because patients would receive raw sequencing data.  Wut?  I assume they mean patients will be unable to interpret the raw sequencing data so it is silly to provide such information; using this logic, however, the typical patient should never be given any raw data (blood test results, discs containing radiologic images, etc.) because the typical patient also is unable to interpret those results. 

This article is not a complete loss, though, for the authors ultimately recommend a "tiered consent" process, whereby physician-investigators ask … wait for it … the patient about which genetic information, if any, the patient wants "returned".  

A June 20, 2013 Journal of Clinical Oncology editorial by David H. Johnson entitled "Financial Disclosure, Industry Sponsorship, and Integrity in Cancer Research Reporting" caught my eye for a couple reasons.  First, I met Dr. Johnson, a true Southern gentleman, when I was a radiation oncology resident and he was a medical oncology attending physician at Vanderbilt University Medical Center.  Second, the essay questions the rarely examined belief that pharmaceutical company funding of academic oncology experts necessarily leads to pro-industry bias in the evaluation of the results of oncology trials.

Dr. Johnson's editorial evaluates an article by Giovanni Bariani et al, published in the same JCO issue, entitled "Self-Reported Conflicts of Interest of Authors, Trial Sponsorship, and the Interpretation of Editorials and Related Phase III Trials in Oncology".  The authors of this study tested the association between authors's conclusions and self-reported conflicts of interest (COI) or trial sponsorship in oncology studies.  They concluded that the "interpretation of recently published phase III cancer trials by their authors or by editorialists was not influenced by financial relationships or industry sponsorship" and speculated that enhanced "awareness of COI policies may have led to more integrity in cancer research reporting."  

The authors's conclusion must be startling to those who automatically assume that pharmaceutical company funding of academic oncology experts is evil because it necessarily causes pro-industry bias in the evaluation of oncology trial results.  Per usual, empirical research is superior to unfounded intuitions. Dr. Johnson helpfully editorializes that "the skepticism that now accompanies industry sponsorship may cause physicians to unfairly discount findings derived from industry-sponsored trials independent of the study's methodologic quality", such "unwarranted discounting of meaningful trial results regardless of methodologic quality suggests that physicians may not use potential advances in patient care in a timely manner", and "our attitudes toward industry-sponsored trials may have swung too far in a negative direction."

I think, however, that the speculation by the authors that the integrity found in their study may be due to the recent introduction of COI policies is questionable at best.  They do not cite identical studies that were performed prior to the introduction of COI policies, so they frankly do not have a baseline to which they can compare their data.  It is conceivable, therefore, that COI polices had no impact whatsoever and that oncology authors and editorialists have always demonstrated professional integrity.

As a final note, neither Dr. Johnson nor Bariana et al mention the true problem with pharmaceutical company funding of academic oncology experts: modern pharmaceutical companies are fascist organizations that collude with States in an attempt to exclude alternatives to the products sold by the pharmaceutical companies from the market, so self-respecting academicians who wish to avoid the appearance of any bias (pro-pharmaceutical company and/or pro-State) should never accept such funding.  Apparently pointing out this obvious fact is the libertarian duty of the LIBERTARIAN BIOETHICS BLOGger.  Hopefully I perform this duty well.   

An August 20, 2013 Journal of Clinical Oncology article by Nguyen et al entitled "Public Availability of Results of Trials Assessing Cancer Drugs in the United States" analyzed to what extent the results of completed studies of oncology drugs performed in the United States were publicly available, as required by the Food and Drug Administration Amendments Act (FDAAA), at clinicaltrials.gov or were published in medical journals.  This paper was accompanied by an editorial by Prasad et al entitled "Finishing the Picture: Problems With Public Reporting of Clinical Trials", which reviewed the paper in detail.  A close reading of these articles by a libertarian reveals an interesting statist bias.

Intriguing findings of the Nguyen et al study were as follows: (1) "Compliance with the FDAAA was higher for trials funded by industry only than those with mixed or academic funding … (20% v 11% and 6%; p < .001 …"; (2) "On multivariate analysis, industry funding only was associated with compliance with the FDAAA compared with academic funding only (adjusted odds ratio, 3.6; 95% CI, 1.8 to 6.9; p < .001) …"; and (3) "The source of funding was independently associated with compliance: trials having industry primary funding were more compliant than those with academic primary funding."

How does the editorial present these results?  "Contrary to the notion that the pharmaceutical industry might have the most to lose from clinical studies which did report negative results, compliance with the FDAAA legislation was highest in trials with industry primary funding.  This parallels the unexpected finding reported previously; namely, that pharmocoeconomic findings reported in pharmaceutical industry-funded reports were of higher quality than those findings reported by researchers who lacked pharmaceutical industry support. … It is not known if the selective incomplete reporting reflected differentials in studies with statistically nonsignificant primary or secondary outcomes or if the delayed studies were those where US Food and Drug Administration registration was being pursued and corporate interests mitigated against early dissemination."  It is difficult to interpret the editorial commentary in any other way than as a pro-State, anti-market bias.

Of course, libertarian readers recognize that the giant American pharmaceutical corporations are anything but "free market" entitles.  Rather, they are fascist organizations.  Their superior compliance with FDAAA regulations, as compared to non-commercial academic researchers, is no surprise when one considers the fact that such fascist corporations have a greater incentive (survival based on profit vs. loss) than purely State-funded academic organizations, which survive regardless of how much money they lose.

The article and editorial authors predictably recommend increased American Imperial State regulation of clinical trials reporting.  Sigh.  A libertarian's work is never done.