Well, I couldn’t do it. I thought I could just log the last post and keep my mouth shut, but it didn’t work. I made the mistake of reading this article again. So with apologies, I have some more things to say: Toward Fairness in Data Sharing by The International Consortium of Investigators for Fairness […]
In 1980, Arnold Relman, then editor of the New England Journal of Medicine, gave us a dire warning. He saw what was coming and laid it out for all to see: The New Medical-Industrial Complex by Arnold S. Relman, M.D. New England Journal of Medicine1980; 303:963-970. October 23, 1980 While he underestimated the involvement of […]
On my trip, I was thinking about the years of the abuse of the clinical trial system – wondering what could be done to put a stop to it? What creative reform would finally save the day? There have been so many attempts, and yet it goes on and on, at least with the psychiatric […]
In spite of the way drug company advertisements are often written, FDA Approval is not meant to be a medical recommendation. It simply means that a compound is safe for human use and that it has statistically significant medicinal properties demonstrated in two well conducted Clinical Trials. The FDA certified document [package insert] included with […]
After being stationed together in the UK, five couples have been vacationing together for a week every summer all over North America. We got to be sort of a family back in those days, and that continues, honorary aunts and uncles, nieces and nephews – now over 40 years. Back then we were two internists, […]
blog to follow soon Maria A. Oquendo, M.D. President, American Psychiatric Association Columbia University Medical Center 300 West 72nd Street Suite 1F New York, NY 10023 RE: CIT-MD-18, Wagner et al., ‘A randomized, placebo-controlled trial of citalopram for the treatment of major depression in children and adolescents.’ Am J Psych 2004; 161 (6): 1079-1083. Dear […]
Here are a few versions describing the Prescription Drug User Fee Act [PDUFA] [1] Wikipedia [2] FDA [3] PhRMA. Essentially it’s a deal between PhRMA and the FDA. The drug manufacturers pay when they register an NDA [New Drug Application], and in return, the FDA uses the money to speed up the evaluation process. It […]
What Happens When Underperforming Big Ideas in Research Become Entrenched? by Michael J. Joyner, Nigel Paneth, and John P. A. Ioannidis JAMA. published online 07/28/2016. [full text on-line] For several decades now the biomedical research community has pursued a narrative positing that a combination of ever-deeper knowledge of subcellular biology, especially genetics, coupled with information technology will lead […]
"During this growing time of behavioral healthcare, the State of Recovery Conference will bring together treatment providers from the substance abuse, mental health and eating disorder community nationwide and provide a focus on the business side of the behavioral healthcare including treatment center startup, revenue growth and total treatment program efficency…" "The substance abuse treatment […]