NY Times Touts New FDA Regulations, Ignores Industry

     Prescription drugs are more expensive in the United States than other countries for a number of reasons, arguably the biggest of which is that other governments artificially control prices so that Americans are left with the burden of funding research and development of new drugs.


     The Pharmaceutical Research and Manufacturers of American (PhRMA) says its members spent an estimated $38.8 billion to discover and develop new medicines in 2004. The industry association says the cost of developing a new drug is around $802 million and takes 10 to 15 years.


     The bureaucratic restrictions set on drug manufacturers contribute to those research and development costs, and a new requirement from the Food and Drug Administration could add to the burden. PhRMA reports that only one of 250 compounds that enter preclinical testing end up approved by the FDA.


     But in tripping over itself to report more FDA regulation as a benefit for consumers, The New York Times on January 24 failed to examine how a new mandate will affect drug prices and availability of potentially life-saving medications.


     “After decades of inattention to the possible psychiatric side effects of experimental medicines, the Food and Drug Administration is now requiring drug makers to study closely whether patients become suicidal during clinical trials,” reporter Gardiner Harris wrote. “The new rules represent one of the most profound changes of the past 16 years to regulations concerning drug development.”


     Harris acknowledged manufacturers were “keenly aware” of the change, which the FDA hasn’t announced publicly. But he didn’t include anyone from the pharmaceutical industry in his story.


     Harris interviewed two FDA division directors; the director of the National Institute of Mental Health; the director of the anti-business Public Citizen group’s health research arm; and a researcher at Columbia University’s department of psychiatry. There was no evidence that Harris sought input from drug manufacturers or industry associations.


     He cited “critics,” like Public Citizen’s Dr. Sidney Wolfe, who say the measure is “long overdue.” He didn’t cite anyone questioning the need or potential cost of the move, although the FDA’s Dr. Eric Colman noted that “the whole spectrum of suicidal thoughts, ideation and attempts is much more difficult to study” than other side effects. That problem is compounded by the fact that many who are treated with antidepressant drugs may already experience suicidal thoughts due to their illnesses.


     Harris also inadvertently illustrated how government bureaucracies fail to fulfill their stated duties effectively. “Indeed, the agency’s initial review of the effects of antidepressants in children was plagued by inconsistent and erroneous observations,” he wrote, telling of a suicidal boy who was listed as having “personality disorder” and a girl who slapped herself in the face listed as having attempted suicide.