Physicians Committee for Responsible

It is not uncommon for activists to proceed on both fronts with respect to issues of interest. For example, challenges to the voluntary High Production Volume (HPV) Challenge Program were initiated under both 20 and 21. On December 27, 1999, People for the Ethical Treatment of Animals (PET A) on its own behalf and on behalf of four other organizations, including Physicians Committee for Responsible Medicine, filed a citizens petition... 

Pharmaceutical companies frequently establish a committee of senior management to authorise the first study of a NME in humans, the review and approval generally being a prerequisite for submission to the external lEC. However, as stated in Section 4.3.4, the clinician responsible for the first study in humans must be personally satisfied that the preclinical data, relating to efficacy and safety, justify administration to man. A useful test is for the physician and other responsible personnel to ask themselves Would 1 be prepared to volunteer for this study and would 1 be happy for a loved-one to do so ... 

Another common practice model for hospital-based pharmacists is a one-on-one collaboration between an infectious diseases pharmacist and an infectious diseases physician. Under this model, the infectious diseases physician is generally responsible for standard infectious diseases consults. The pharmacist acts as an extension of the infectious diseases physician s clinical practice clinical practice, rather than competition or duplication. The pharmacist identifies patients in whom antimicrobial therapy is suboptimal (i.e., wrong drug, wrong dose, questionable indication, potential for IV-to-oral conversion). After conferral with the infectious diseases physician, an intervention is recommended or implemented. These interventions usually follow predefined criteria established by the Pharmacy and Therapeutics Committee. 

This activity often described as The Medical and Social Conscience of a company largely resides in the Medical Affairs department. In most large -and medium-sized pharmaceutical companies this responsibility lies with Medical Affairs. The review of all materials, whether detail pieces provided in person to physicians in practice, slide sets for speakers on behalf of the company, general promotional material that is disseminated via print, radio, TV or web must be reviewed and approved by internal committees comprised of Medical Affairs staff, regulatory and legal personnel. In addition to the company review, this material must be sent to FDA at least by the first day of use. Review by FDA s DDMAC should be sought for TV advertisements. 

The Committee on Atomic Casualties also instructed me to visit the dean of the new medical school at ucla. Dr. Stafford Warren. All 1 knew then was that Dr. Warren had been among the first American physicians to visit both Hiroshima and Nagasaki after the bombs. Only later did I learn that he had been responsible for radiation safety for the entire Manhattan Project, which had developed those first bombs. He had also been a witness at the dawn of the atomic age when the world s first atomic blast lit the skies at Alamogordo, New Mexico, on July 16,1945—less than a month before the bombs were deployed against Japan. 

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