Belmont history added to OHRP web site
The Office for Human Research Protections of the U.S. Department of Health and Human Services has added a new page to its web site detailing the history of the Belmont Report.
Some of the features of the Belmont Report Historical Archive are:
— A short history of the Belmont report and a review of current human subjects protection regulations.
— Oral history interviews with those involved in the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974-1978). Video versions of these interviews will be added later.
— A nine-minute educational/training video on the Belmont Report.
— A video program of the November HHS commemorative ceremony.
The web page can be accessed at www.hhs.gov/ohrp/belmontArchive.html.
Recent stem cell bill forbids cloning
More stem cell legislation surfaced in April on Capitol Hill in yet another effort to sidestep President Bush’s almost 4-year-old restrictions, as the latest bill seeks to safeguard the use of nuclear transfer for research while banning human reproductive cloning.
Introduced in the Senate, it’s called the Human Cloning Ban and Stem Cell Research Protection Act of 2005. While the use of somatic cell nuclear transfer for creating stem cell lines is legal in the United States, no federal funds can support such work. The bill would reverse that.
The proposal was written by Sens. Orrin Hatch (R-UT), Arlen Specter (R-PA), Dianne Feinstein (D-CA), Ted Kennedy (D-MA), and Tom Harkin (D-IA).
Michael Werner, the Biotechnology Industry Organization’s chief of policy, said a similar bill is expected to soon come forth in the House of Representatives as well.
Such bipartisan unity is a common theme with several of the recently introduced bills, which seek to establish federal funding for embryonic stem cell research through grants from the NIH.
That’s certainly the case for one House bill, co-sponsored by Reps. Mike Castle (R-DE) and Diana DeGette (D-CO), which has nearly 200 other House members on board. It stipulates that embryos must have been produced at in vitro fertilization clinics and be in excess. It also says donors must have received proper informed consent and there must be no financial incentives to offer embryos.
For the most part, the myriad congressional bills aim to supplement funding efforts already under way in a number of states "to fill the vacuum," Werner said, created by the President’s limit on federal funding.
In contrast to efforts to ease stem cell research restrictions, two other bills on the legislative agenda have been introduced to prohibit all cloning, for research and reproduction. One was written by Sens. Sam Brownback (R-KS) and Mary Landrieu (D-LA), and the other is from Reps. Dave Weldon (R-FL) and Bart Stupak (D-MI). The former has 26 Senate backers, and the latter has 113 supporters in the House.
FDA head says better communication needed
Sounding a call for a more communicative culture at the FDA, its acting commissioner, Lester Crawford, addressed a lunchtime crowd gathered at the BIO-Windhover 2005 conference held April 25-27 in Washington, DC.
The public, Crawford said, is looking to the FDA as a reliable source of information. Safety, of course, is the chief issue that has raised consciousness about the FDA’s role, and he acknowledged that "there’s been a lot of public scrutiny over this issue."
That topic has gained attention during the past year, largely due to product recalls of the once-popular COX-2 painkiller drugs. More recently, the agency approved Biogen Idec Inc.’s Tysabri, only to see the company withdraw the drug months later due to the discovery of deaths linked to progressive multifocal leukoencephalopathy. As a result, drug safety was a central theme during a senate committee hearing on Crawford’s nomination to lead the FDA on a permanent basis.
At that hearing, and again at the conference, he defended the FDA.
"It is important that these concerns do not distort the fact that drugs are safer today than they ever have been before," Crawford said, "and that millions of Americans each day benefit from them."
Efforts to improve the agency’s product surveillance include the newly established Drug Safety Oversight Board as well as its soon-to-be-unveiled DrugWatch web page to better provide the public with emerging data and risk figures.
The Office for Human Research Protections of the U.S. Department of Health and Human Services has added a new page to its web site detailing the history of the Belmont Report.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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