May 31, 2010

Milwaukee Journal Sentinel, At It Again

The warping of facts continues.  The Milwaukee Journal Sentinel (MJS) published the latest piece in its "Side Effects: Money, Medicine, and Patients" series, this time turning attention to the role academic physicians play in clinical research.

In short, the author (sometimes referred to as a "journalist") is furthering activists' arguments that industry sponsored research is biased and cannot be trusted.  The article, entitled "Doctors' role in drug studies criticized" (HERE), casts aspersions on physicians that collaborate on such trials by highlighting that they are compensated for their expertise and work, and they may not review raw clinical trial data.

The compensation issue has been building for decades, mostly among a small group of academic physicians and advocates yelling to each in an echo chamber.  Despite lack of sound evidence to support any of their claims regarding the impact of compensation, or physician-industry collaboration more broadly, on patients, new regulations are being adopted at academic medical centers and in both the federal and state governments.  The echo chamber sprung a (toxic) leak.

The attack on industry-sponsored research is more recent and comes in a variety of forms.  The attack on research is the third stage of a larger plan to sever all relationships between industry and physicians.

Stage 1: Portray product marketing as bribery resulting in unconscious prescribing.

Stage 2: Fabricate claims regarding bias in medication education and eliminate industry grants for CME.

Stage 3: Transition from industry conducting research on their own products to a government agency conducting trials.

This article, which claims that failure to review raw data constitutes scientific misconduct (inferred), fits into the stage three strategy and is one of several argument emerging that industry scientists cannot be trusted to do sound work nor should they be able to collaborate with outside experts.  The other argument being developed is that placebo-controlled trials, the standard for FDA approval of medications, are insufficient to demonstrate efficacy (more to come on another post).

Take two minutes to read the article ... it's worth attempting to find a documented negative outcome of the activities described or any link to patients.

May 30, 2010

NIH: For Or Against Improving Health?

Health reform was prompted by, and designed to solve, two fundamental issues: Escalating healthcare costs and the lagging health of the US populace.  Stressing impacts on personal bank accounts and using the perpetual political wedge – taxes – cost became the singular focus.  However, without rising obesity rates and higher infant mortality rates than peer nations, few would be able to justify our reform efforts. Consequently, the question remains, are we supporting our scientific communities who are charged with solving our underlying health problems?  We need not look beyond the National Institutes of Health (NIH) to find the answer.

NIH, the major public source of funds for health-related research, just released a draft policy that bristles with extensive, and expensive, bureaucratic mandates for institutions whose members apply for research grants.  It is another example of a growing trend toward regulatory escalation in the scientific community.  The policy further diminishes incentive for public-private collaborations, which are broadly recognized as fundamental for scientific progress, particularly in this financially constrained environment.

Over two decades ago, strident criticism emerged of private industry's remuneration of academic researchers, despite evidence of profound benefit.  Since enactment of the Bayh-Dole act in 1980, public-private collaborations rapidly expanded with commensurate scientific advancements and improvements in health.  The slogan used to advance criticism is "financial conflict of interest” (FCOI). The FCOI epithet, and its “appearance of conflict” analog, have become commonplace, expressing a near-complete denial of the evidence for collaboration between industry, academic researchers and the medical profession. 

Attempting to quell the appearance of impropriety and FCOI-insinuated allegations, in 1995 the NIH began requiring academic researchers applying for research grants to disclose to their employers payments above a threshold amount from private companies. The expectation was that the academic institutions would somehow, non-arbitrarily, determine the legitimacy of such payments.  However, once FCOI was conceptually validated by NIH policy, a massive compliance industry mushroomed, overemphasizing risks versus benefits, thereby dictating that FCOIs be regulated or eliminated under their expertise.

In striking irony, concurrent with release of the proposed regulations, NIH Extramural Research Director Sally J Rockey and NIH Director Francis S Collins, published an opinion piece in the Journal of the American Medical Association (JAMA) entitled “Managing financial conflict of interest in biomedical research”, which paradoxically claims that diverting resources from conducting research to regulatory oversight will “accelerate the movement of discoveries from the laboratory to the clinic”.

Americans want better ways to fight disease and improve health – period.  However, regulations now in force have done nothing to promote more rigorous research, and the NIH proposal holds little promise for anything but obstruction to the advancement of our nation's health.