The Government’s New Regulatory Science
Last Sunday the NYT’s cover page piece, Sunday January 23, A New Federal Research Center Will Help Develop Medicines praised the administration’s efforts to put one billion dollars into a federally funded scientific think tank and research center that will “do as much research as it needs to do so that it can attract drug company investment”. The article sited the failure of drug companies to invest their resources into new treatments for diseases such as Parkinson’s Disease and mental illness. The article claimed drug companies have “neither the will or resources to undertake the effort.”
It is interesting to note that the NYT does not dig deeper to ask why America is rapidly falling behind in the area of drug development – the number of new drugs approved by the FDA decreased dramatically in 2010. Loaded with hypocrisy the piece turns a blind eye to the antiquated system known as the Food and Drug Administration (FDA). Unfortunately, the NYT neglected to report that the pace of research has accelerated beyond the ability of the FDA to keep up with approvals in a timely manner. Even though funding for the FDA has increased in recent years, due to its bureaucratic hurdles and antiquated scientific methods for the review of promising new treatments, the Agency is steadily falling behind the scientific community. Out of the public’s frustration, FDA is being pressured by elected officials to move promising drugs to market faster in order to save lives. Yet the FDA seems to be working overtime to thwart the public’s interest in new drug development.
Current indictments of biotech and pharma executives are a clear example of FDA’s ham-handed effort to slow the progress of the scientific community and new drug development. The reason is that FDA and other government agencies want to increase their control over health care decision making. The FDA cannot regulate the practice of medicine, so, instead, they are increasing their ability to control which drugs get approved – and reimbursed – for diseases that the government approves of. It used to be up the doctor and the patient.
The NYT article misses this undercurrent completely. The article fails to mention that the FDA’s bizarre prosecutions, double standards, and the attempts to politicize the interpretation of medical results, through their own definitions of statistics, has had a chilling effect on our nation’s finest researchers. Ask any doctor why they are happy not to be in research these days. As the government infringes on scientific free speech, scientific organizations, and academic researchers will not be able to – nor will they want to for fear of prosecution – send out their interpretation of study results of a trial for peer review without first gaining approval of the FDA or other government agencies. In effect, FDA’s prosecution of study results is bringing research efforts and scientific free speech to a standstill.
In a recent case sitting before the Supreme Court (Matrixx Initiatives, Inc vs. Siracusano) the FDA and the Department of Justice (DOJ) wrote an amicus brief regarding the role of statistical inference testing is assessing the meaningful of clinical study results. Disturbingly, their arguments before the Supreme Court are completely opposite, a full 180 degrees opposite, of the government’s position in a case that is before a Federal Court in northern California (the US vs W. Scott Harkonen).
On the one hand, in the FDA’s arguments to the Supreme Court, they assert that bright-line statistical criteria, such as whether a study result in statistically significant or not, is unimportant. Statistics alone, they argue, do not in any determine the ‘practical’ or clinical significance of study results. In U.S. vs Harkonen, FDA argues just the opposite, declaring that statistical significance is the ‘gold standard,’ and study results that do not meet his arbitrary standard are ‘generally regarded as unreliable.’
Such capricious, arbitrary, and inconsistent legal actions continue to make one wonder if there is a larger political agenda regulating science – like government control of health care decision making – or if this is simply a case of ineptitude. Contemplating this, one almost has to hope it is the latter.
Debate over what we learn from clinical trials is the daily task of our nation’s best medical researchers. As American citizens we expect and demand that this kind of thoughtful exchange occurs in a free and open scientific forum where all of us are committed to achieving the best outcomes for the American public.
Let’s hope the rapid push for a one billion dollar federal drug development center is not a further attempt by the government to gain control over the development of promising new medicines and who will get access to them. And how can we expect that an already failing FDA will provide fair and unbiased oversight of a fellow government agency’s drug development programs? How is that going to work?
Americans need to be asking if the FDA should have take on the role of overseeing our government’s own drug development efforts. It’s the proverbial fox guarding the hen house – except, in this case, the ability of the fox to guard anything, in an unbiased fashion, is in question. Should FDA have control over the publication of factual scientific results? Should the FDA be able to enact into law a standardized methodology for the interpretation of research data? Unfortunately, much of this has already happened.
It is not that drug companies no longer have the will, they simply do not want to face the blatant and bizarre double standards of the FDA’s billion dollar prosecutions.
Stay true,
M