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The Double Blind Placebo Controlled Trial
The blind allegiance to what I call the “fool's gold standard” lives on. Anyone with even a passing interest in bioethics knows it is unethical to conduct a double blind placebo controlled trial where standard therapy exists, except under limited circumstances. The exceptions are where: 1) there is no risk of harm if the patient forgoes treatment during the placebo phase such as in a trial for a drug that seeks to cure hair loss or impotence; 2) the standard therapy carries such severe side effects that patients might choose to avoid it; or 3) the standard therapy is otherwise of questionable efficacy. See, eg, Emanuel EJ, MD, PhD, Miller, FG, PhD: The Ethics of Placebo-Controlled Clinical Trials — A Middle Ground. N Engl J Med Vol. 345:915-919, (September 20, 2001), at http.//content.nejm.org/ cgi/content/short/ 345/12/915?query= TOC; Hellman S: Of Mice But Not Men: Problems of the Randomized Clinical Trial. N Engl J Med, Vol 324 (May 30, 1991); Levine RJ: The Use of Placebos in Randomized Clinical Trials. IRB — A Review of Human Subject Research, Vol. 7, No.2, (March/April 1985); Bok S: The Ethics of Giving Placebos. Scientific American, Vol. 231, No. 5 (November 1974).
Still, sponsors and researches continue to design and conduct such trials, providing the familiar excuse: “The FDA made us do it.” Indeed, in at least one case I have brought on behalf of an injured subject, I have seen the minutes of a meeting with an FDA official who advised the drug company that only a placebo controlled trial would be acceptable even though the drug company advised the official that standard therapy existed and there might be a risk of harm to the subject during the placebo phase. Even more startling is the response I have received in depositions of physician/principal investigators who believe such trials are the gold standard and are perfectly acceptable in the context of medical research as long as the subject signs the informed consent.
The DOJ's Corporate Enforcement Policy: One Year Later
The DOJ's Criminal Division issued three declinations since the issuance of the revised CEP a year ago. Review of these cases gives insight into DOJ's implementation of the new policy in practice.
The DOJ's New Parameters for Evaluating Corporate Compliance Programs
The parameters set forth in the DOJ's memorandum have implications not only for the government's evaluation of compliance programs in the context of criminal charging decisions, but also for how defense counsel structure their conference-room advocacy seeking declinations or lesser sanctions in both criminal and civil investigations.
Use of Deferred Prosecution Agreements In White Collar Investigations
This article discusses the practical and policy reasons for the use of DPAs and NPAs in white-collar criminal investigations, and considers the NDAA's new reporting provision and its relationship with other efforts to enhance transparency in DOJ decision-making.
Bankruptcy Sales: Finding a Diamond In the Rough
There is no efficient market for the sale of bankruptcy assets. Inefficient markets yield a transactional drag, potentially dampening the ability of debtors and trustees to maximize value for creditors. This article identifies ways in which investors may more easily discover bankruptcy asset sales.
A Lawyer's System for Active Reading
Active reading comprises many daily tasks lawyers engage in, including highlighting, annotating, note taking, comparing and searching texts. It demands more than flipping or turning pages.