GAO on Katrina: Fed. grants helpful, not sufficient
A pair of Government Accountability Office reports evaluating the progress of ongoing post-Hurricane Katrina rebuilding efforts – one looking at mental health services for children (highlights, full report), the other at organizations providing primary health care (highlights, full report) – find that while federal grants have had an impact in both areas, there is still considerable work to be done.
Photo by AuthenticEccentric via Flickr
In terms of mental health services for children, the GAO reports that progress has been made in recruiting and funding providers — school-based programs have been particularly successful – and in providing the transportation needed by children and families hoping to take advantage of such services. Obstacles include a lack of stable housing for many children and funding shortage looming on the horizon as many hurricane-related grants will dry up in 2010.
In 2007, the Department of Health and Human Services awarded Louisiana a $100 million grant targeted to restore primary care services to low-income populations. The state passed that money on to 25 outpatient providers in the greater New Orleans area. Most of those organizations, the GAO found, used that money to hire additional staff. Many also expanded the services they offered and added new sites or improved existing ones. The report does not come to a conclusion as to the long-term sustainability of the project.
Both GAO reports should serve as reminders that efforts to rebuild the Gulf Coast in the wake of Katrina are ongoing. The reviews show that the GAO hasn’t taken its eye off the affected areas, and neither should journalists.
Reports: Clinical trial oversight lacking
Filed under: Conflicts of interest, Hot Health Headline
ProPublica’s Alexandra Andrews reviewed two recent reports on conflicts of interest in the institutional review boards tasked with overseeing clinical trials and found that these boards may not be as independent as the public might like.
Board members “frequently” had connections with drug companies that can cause conflicts of interest, and while IRB chairs said they’d never presided over a session in which a conflicted member had voted, only 65 percent of surveyed members said they recused themselves every time a conflict came up. One third of surveyed IRB’s don’t even require members to disclose conflicts of interest, Andrews reported.
Sen. Chuck Grassley (R-IA), who has been a prominent advocate for the disclosure of doctor-industry ties, told ProPublica, “People have to trust that decisions about clinical trials are unbiased, and this study calls that into question. Lack of disclosure of financial ties can damage confidence in important medical research. Disclosure policies ought to be established and enforced to safeguard the integrity of that research because of its tremendous influence on the practice of medicine and public health.”
Even more alarming was a recent GAO release detailing the lack of barriers to the creation of for-profit IRBs.
GAO investigators created phony IRBs [7] (PDF), which they were successfully able to register with HHS using no more than an online registration form. One such company listed its address as “1234 Phulovit Lane” in “Chetesville, AZ” with employees named “April Phuls, Timothy Wittless, (and) Alan Ruse.” (You can still find its deactivated listing [8] on HHS’s Web site.)
Subsequent oversight wasn’t any better.
HHS then approved an assurance [9] for a bogus medical device company, also created by GAO, which listed one of GAO’s fake IRBs on its application. An assurance basically promises that the company will adhere to federal standards and, once approved, paves the way for that company to request federal research funds. According to GAO, “By approving our assurance application, HHS essentially deemed our bogus IRB as adequate to oversee human subjects research.”
And it almost sounds like some actual IRB’s weren’t much better than the one run by April Phuls and Alan Ruse.
GAO’s pièce de résistance was a sting operation involving real IRBs. GAO’s medical device company sent out plans for a fake trial to three real IRBs. Two of them responded with cries of “awful,” “a piece of junk” and the “riskiest thing I’ve ever seen on this board.” But the third IRB, now identified as Colorado-based Coast IRB, found it “probably pretty safe” and voted unanimously to approve it.
In HHS’ defense, at a hearing, Jerry Menikoff, director of the Office for Human Research Protections, which oversees IRBs along with the Food and Drug Administration, said “by registering an IRB, the government, the federal government is in no way endorsing that IRB or in any way saying that that IRB meets any standards.”
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