e-drug: R&D costs for drugs (2)
-------------------------------
The Lancet Commentary by T. Lynn Riggs raises the question of
whether the overall value of some of our new drugs is worth the cost of R
& D by the pharmaceutical industry and suggested that research to confirm
the stated costs and the social costs and benefits is needed. I suggest
one also should look at the costs of specific parts of the R & D
activities to see if the value from them is worth the cost. For example.
most of phase III is concerned with safety, yet rare serious adverse
effects can require larger numbers of patients exposed to the drug than
can be entered into phase III trials. A systematic study of phase III
trials to find out what useful information has been gained and at what
cost in money and time prior to approval would determine if this
component of drug development is worthwhile or if it should be modified.
A suggestion to decrease phase III and have better postmarketing
surveilance with easier drug withdrawals if safety is shown to be
inadequate has been opposed because by some in industry because of the
cost of preparing manufacturing facilities for marketing and the cost of
the launch. Yet, unless we change what we are doing, the cost of new
drugs will continue to climb and the promise of molecular biology and
better individualization of drug therapy will be unfulfilled.
regards
Marcus M. Reidenberg, MD, FACP
Professor of Pharmacology, Medicine, and Public Health
Head, Division of Clinical Pharmacology
Weill Medical College of Cornell University
Attending Physician, New York Presbyterian Hospital
Editor Emeritus, Clinical Pharmacology and Therapeutics
1300 York Ave., Box 70
New York, NY 10021
e-mail mmreid@med.cornell.edu
phone (212) 746-6227
fax (212) 746-8835
--
To send a message to E-Drug, write to: e-drug@healthnet.org
To subscribe or unsubscribe, write to: majordomo@healthnet.org
in the body of the message type: subscribe e-drug OR unsubscribe e-drug
To contact a person, send a message to: e-drug-help@healthnet.org
Information and archives: http://www.essentialdrugs.org/edrug