FDA Applies Uneven Standards to New Drugs’ Safety and Efficacy


A study in the Journal of the American Medical Association finds that, although “many patients and physicians assume that the safety and effectiveness of newly approved therapeutic agents is well understood,” in reality the quality of evidence for new drugs’ safety and efficacy varies widely, with about a third of new drugs winning approval on the basis of a single clinical trial. “Not all FDA approvals are created equally,” explained the study’s lead author.

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Downing, N., Aminawung, J., Shah, N., Krumholz, H., Ross, J.; Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012. JAMA. Online January 22, 2014. 311(4):368-377. doi:10.1001/jama.2013.282034.

Of further interest:
FDA’s ‘Safe and Effective’ Drug Approvals Based on Widely Varied Data, Study Finds (Washington Post)
Cannabis Has Been Studied More Than Many FDA Approved Pharmaceuticals (High Times)

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Kermit Cole
Kermit Cole, MFT, founding editor of Mad in America, works in Santa Fe, New Mexico as a couples and family therapist. Inspired by Open Dialogue, he works as part of a team and consults with couples and families that have members identified as patients. His work in residential treatment — largely with severely traumatized and/or "psychotic" clients — led to an appreciation of the power and beauty of systemic philosophy and practice, as the alternative to the prevailing focus on individual pathology. A former film-maker, he has undergraduate and master's degrees in psychology from Harvard University, as well as an MFT degree from the Council for Relationships in Philadelphia. He is a doctoral candidate with the Taos Institute and the Free University of Brussels. You can reach him at [email protected].


  1. The first thing I thought of,

    “I realize that FDA approval of the drug I am about to take is based upon very short-term studies (usually 6 to 8 weeks) which are designed, paid for, and supervised by the drug’s manufacturer. I further realize that the FDA does not require or expect that a drug’s full range of adverse effects will be known prior to marketing and prior to lengthy exposure of ordinary patients to that drug.

    I am also aware that the FDA’s knowledge about the drug’s adverse effects after marketing comes mostly from spontaneous physician reports, the FDA itself recognizes that these reports are just “the tip of the iceberg” of the probable true frequency of adverse effects. I know that wording in the package insert and in the Physician’s Desk Reference is the outcome of a complex negotiation between the manufacturer and the FDA. I also realize that it sometimes occurs that the FDA belatedly learns that the manufacturer has not fully disclosed to the FDA what it actually knows about a drugs’s adverse effects. Finally, I understand that despite FDA approval for psychiatric drugs being granted on the basis of short-term studies, the longer-range consequences of continuing druf use are not systematically studied by any responsible organization or government agency.

    If I am consenting to take the drug as part of a research study, I understand that the researcher’s primary interest and loyalty is not to me as a patient and not to my personal interests or welfare. I understand that the “needs of the research project” come before and have priority over my own personal needs.

    I understand that the drug is likely to provoke various unpleasant effects when I stop taking it, especially if I stop too suddenly. I understand that although withdrawal reactions are systematically ignored in psychiatric drug treatment or research, they might represent the worst part of my whole drug-taking episode. I further understand that these reactions will often closely resemble the original symptoms for which the drug was prescribed to me, and are likely to be taken for a return of these symptoms (a “relapse”), rather than for withdrawal effects. I realize that my doctor or the researcher is likely to interpret these reactions as a sign that my “illness” is chronic and that my drug is “effective.” ”

    Read more : http://laingsociety.org/colloquia/polofdiagnosis/modelconsent.htm

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