Last Sunday the NYT’s cover page piece, A New Federal Research Center Will Help Develop Medicines praised the administrations 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 commercialize promising new treatments and 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 has so rapidly fallen behind in the area of drug development. 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. Due to the FDA’s lack of funding, bureaucratic hurdles, and an antiquated system of approval, the Agency is continually falling behind the scientific community, and they are being pressured by the public and elected officials to move promising drugs to market faster in order to save lives. Current indictments of biotech and pharma executives are a clear effort to slow the progress of the scientific community in order to avoid this criticism.
What the article fails to mention is that the FDA’s bizarre prosecutions, double standards, and the attempts to politicize 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 prevails private companies, scientific organizations, or academic researchers will not be able to send out information on a trial for peer review without first gaining approval of the FDA or fear prosecution. In effect, this will and is bringing research efforts to a standstill.
In a recent case sitting before the Supreme Court (Matrixx Initiatives, Inc vs. Siracusano) the Department of Justice (DOJ) wrote an amicus brief regarding the validity of statistical inference that is diabolically opposed to what they are stating in a case that is before a Federal Court in northern California (the US vs W. Scott Harkonen). Such capricious, arbitrary, and inconsistent legal actions continue to make one wonder if there is a larger political agenda regulating science or if this is simply a case of ineptitude.
Furthermore, the government does not adhere to their own actions-arbitrarily approving drugs that missed primary endpoints in clinical trials while choosing to prosecute others. The court’s ruling in northern California also makes it a criminal felony to omit information from a press release of preliminary test results that could have allowed the reader to more fully assess the importance of the information presented. Which now borders on issues of scientific free speech.
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 research center is an attempt to now regulate the failing FDA. Americans need to be asking if the FDA should have control over the publication of factual scientific results when they are clearly marked as clinical trials and if there should now be a standardized methodology for the interpretation of research data- if so who will be overseeing this?
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.