Tag: Effectiveness

HHIP: Friday, November 8: Peter Singer – Effective Altruism

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Harvard High Impact Philanthropy presents:

Peter Singer on Effective Altruism

Effective altruism is a new movement consisting of many individuals and several independent organizations, all focused on the deceptively simple idea that we should try to do as much good as we can. The existence of this movement raises many interesting questions, both practical and philosophical, which this talk will discuss.

Friday, November 8th; 4 – 5 PM, in Science Center D

RSVP to the event

Peter Singer is the Ira W. DeCamp Professor of Bioethics at the Princeton University Center for Human Values and Laureate Professor at the Center for Applied Philosophy and Public Ethics at the University of Melbourne. He is well known for his philosophical work, as well as for his books – most recently including The Life You Can Save.
This event is co-sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, with support from the Oswald DeN. Cammann Fund, as well as Harvard’s Departments of Economics and Philosophy.

Prof. Singer will also speak on “Ethics and Animals: Where Are We Now?” at 12 PM in Austin 200 (Ames Courtroom), 1515 Massachusetts Ave.

 

Regulatory Concepts in the News, Part I: FDA Efficacy Standards for Old Drugs

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By Patrick O’Leary

While reading some of the great articles from the health section of the New York Times over the holidays it struck me that such articles, in their need to be concise and accessible, often give only passing treatment to regulatory concepts that can be fundamental to the story. Accordingly, I thought it might be useful to write a series of posts digging down a bit deeper into some of the regulatory foundations of health stories that percolate up to public attention through the news. In this post I’ll begin by looking at an interesting point relating to drug efficacy standards raised by an article about a newly expensive (but decades-old) drug.

In Andrew Pollack’s “Questcor Finds Profits, at $28,000 a Vial” we read that a drug called Acthar, first approved by the FDA in 1952 and used primarily to treat rare infantile spasms, has in recent years become a very expensive and (for it’s maker) lucrative treatment for conditions ranging from multiple sclerosis to rheumatologic conditions. The article is worth a read for its thoughtful discussion of drug pricing, but it also makes passing reference to a some important regulatory concepts that bear further examination. One issue that particularly stood out to me was Pollack’s statement that Questcor, Acthar’s manufacturer, has been able to market the drug for a variety of uses “without being required to prove that the drug actually works” because it was “essentially grandfathered” into an anachronistic efficacy standard by being “approved for use in 1952, before the [FDA] required clinical trials . . . .” On first read, that sounds fairly alarming, so I thought it might be worthwhile to unpack the law around such “grandfathered” drugs a little. While it is true that FDA did not require proof of effectiveness for new drugs until lawmakers included this requirement in the Drug Amendments of 1962, it isn’t the case that pre-1962 drugs simply get a free pass on proving effectiveness. The truth, as one might expect, is somewhat more complicated. Read More