THAN THE OLD?
The new Cancer Drugs MUST be better than older ones right?
British Medical Journal, Efficacy, safety, and cost of new anticancer drugs, 2002; VOLUME 325: pages 269–271. By: Dr. Silvio Garattini, M. D., Director of the Mario Negri Institute for Pharmacological Research and Dr. Vittorio Bertele’, M. D., Director of the Drug Regulatory Policies’ Lab at the Mario Negri Institute for Pharmacological Research.
The two eminent Italian pharmacologists pored over the results of trials of the 12 new anticancer drugs that had been approved for the European market from 1995 to 2000, and compared them with standard treatments for their respective diseases. They could find no substantial advantages–no improved survival, no better quality of life, no added safety–with any of the new agents. All of them, though, were significantly more expensive than the old drugs. In one case, the price was 350 times higher.
“In spite of not improving survival, quality of life, or safety, these new drugs cost much more than the standard treatments…From these results over the past six years there is little to justify some of the promises made to the public…It is widely expected that the general population of cancer patients not involved in clinical trials will gain no benefit from new anticancer drugs.”
Pseudo-Evidence Based Medicine: When Biomedical Research Becomes an Adjunct of Pharmaceutical Marketing.
In Free Knowledge¸ editors: Patricia W. Elliott and Daryl Hepting, University of Regina Press, 2015, pp. 26-42
By: Professor Arthur Schafer, University of Manitoba
“Corporate funding of university research has instead led us to a point where many of the new drugs coming to market are nothing more than “me-too” drugs—invariably more expensive than their predecessors (which have come off patent) but no more efficacious and often more dangerous.”
Deutsches Ärzteblatt International, 2010; 107(17): 295–301
The Financing of Drug Trials by Pharmaceutical Companies and Its Consequences. By: Schott et al.
“…it should be obligatory to prove that a new drug provides additional benefit compared with existing pharmacological and non-pharmacological forms of treatment.”
Journal of Clinical Oncology, 2003 Vol 21, No 7 (April 1): pp 1404-1411
End Points and United States Food and Drug Administration Approval of Oncology Drugs
By: Johnson et al
“There is a common misperception that the United States Food and Drug Administration (FDA) requires a survival improvement for approval of oncology drug marketing applications…Non-survival end points were the basis for 75% (53 of 71) of oncology drug approvals from January 1, 1990 to November 1, 2002.”
You might think drugs only get on the market if they’ve been shown to be useful. But “useful” can mean many different things: for FDA approval, for example, you may only need trials to show your drug is better than a placebo…
Journal of the American Medical Association, 2011;305(17):1786-1789.
Availability of Comparative Efficacy Data at the Time of Drug Approval in the United States
By: Goldberg et al. Out of all the 197 new drugs approved in the past decade, only 70% had data to show they were better than other treatments.
United States Congress. Advertising, marketing and promotional practices of the pharmaceutical industry: Hearing before the committee on labor and human resources. 101st Congress, 2nd Session. Washington, DC: U.S. Government Printing Office; 1991.
Testimony of Dr. Arthur M. Zoloth, PharmD., Virginia Mason Medical Center
p-143 “It is my understanding the FDA classifies the majority of the drugs that are submitted for approval. In the past eight to 10 years, something like 80-90 percent of those drugs have been classified as “C,” having questionable therapeutic advantage. I think one has to question…all of this education and funding if they are nothing more than for “me, too” drugs, which by the way usually come out costing more than the original product.”
U.K. House of Commons, Session 2004-05
Health – Minutes of Evidence- Fourth Report, December 16, 2004
Dr. Richard Horton, M.D., FRCP, FMedSci, present editor-in-chief of The Lancet.
“…the classic case example that we talk about a lot is the way AstraZeneca very successfully took omeprazole to Nexium which had a little bit of fiddling with its formulation but was essentially the same drug, got marketing approval for what was a new branded drug—supposedly—and kept the patent life for that supposedly new drug when in fact it had no competitive advantage on now what was a generic medicine.”