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.
âAfter 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,â reporter Gardiner Harris wrote. âThe new rules represent one of the most profound changes of the past 16 years to regulations concerning drug development.â
Harris acknowledged manufacturers were âkeenly awareâ of the change, which the FDA hasnât announced publicly. But he didnât 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 groupâs health research arm; and a researcher at Columbia Universityâs department of psychiatry. There was no evidence that Harris sought input from drug manufacturers or industry associations.
He cited âcritics,â like Public Citizenâs Dr. Sidney Wolfe, who say the measure is âlong overdue.â He didnât cite anyone questioning the need or potential cost of the move, although the FDAâs Dr. Eric Colman noted that âthe whole spectrum of suicidal thoughts, ideation and attempts is much more difficult to studyâ 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. âIndeed, the agencyâs initial review of the effects of antidepressants in children was plagued by inconsistent and erroneous observations,â he wrote, telling of a suicidal boy who was listed as having âpersonality disorderâ and a girl who slapped herself in the face listed as having attempted suicide.