After All, Look How Well it Worked Out for Retin-A
Who doesn't want to enroll more inmates in drug trials? The record is great. Safety, risk analysis, compassion:Until the early 1970’s, about 90 percent of all pharmaceutical products were tested on prison inmates, federal officials say. But such research diminished sharply in 1974 after revelations of abuse at prisons like Holmesburg here, where inmates were paid hundreds of dollars a month to test items as varied as dandruff treatments and dioxin, and where they were exposed to radioactive, hallucinogenic and carcinogenic chemicals.It will be interesting to hear more from Larry Gostin, who chaired the panel:
In addition to addressing the abuses at Holmesburg, the regulations were a reaction to revelations in 1972 surrounding what the government called the Tuskegee Study of Untreated Syphilis in the Negro Male, which was begun in the 1930’s and lasted 40 years. In it, several hundred mostly illiterate men with syphilis in rural Alabama were left untreated, even after a cure was discovered, so that researchers could study the disease.
The report also expressed worry about the absence of regulation over experiments that do not receive federal money. Lawrence O. Gostin, the chairman of the panel that conducted the study and a professor of law and public health at Georgetown University, said he hoped to change that.
Even with current regulations, oversight of such research has been difficult. In 2000, several universities were reprimanded for using federal money and conducting several hundred projects on prisoners without fully reporting the projects to the appropriate authorities.
Professor Gostin said the report called for tightening some existing regulations by advising that all research involving prisoners be subject to uniform federal oversight, even if no federal funds are involved. The report also said protections should extend not just to prisoners behind bars but also to those on parole or on probation.
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I agree that stringent oversight is necessary if prisonsers are to serve as volunteer research subjects. And I agree that in the 70s regulations were developed, at least in part, in reaction to the Tuskegee study. While much has been made of the availability of penecillin after WWII, it's efficacy for the treatment of late-stage syphilis was not established until much later.
- by bob koepp on Aug 15, 2006 at 1:41 AM | link
An article in the NY Times has a bit different opinion about what is really going on with the report from the IOM. And what is trying to be accomplished by this committee. I read the report which seemed innocuous enough, but in this article some very disturbing quotes were printed. If these are incorrect I would hope that those who were misquoted should try to rectify that...but I have a feeling these quotes may be accurate. One is from Dr. Kligman who ran the Holmesburg studies. He seems to be of the opinion that the trials at Holmesburg should not have been stopped! I read some of the declassified transcripts that were probing who was at fault...Dow Chemical or Dr. Kligman...and what I read stood the hair up on the back of my neck! Is he hoping we will all conveniently forget about what happened at Holmesburg!???
We all condemn the medical experiments of the Nazi's. But let's not forget that the US legitimized Eugenics as a discipline. The Nazi's only took it one step further by putting into practice those theories. We, as a country, should be held to a higher standard than seems to be the case in this situation. I would hope that the bioethics community will not support the inclusion of inmates in any sort of clinical trials. This is an absolute corruption of what the Nuremberg Code and Belmont Report stands for, if we can not protect those who can not protect themselves.
- by Karen Dwyer on Aug 28, 2006 at 5:39 PM | link