MIWatch.org calls for real disclosure reform
Filed under: Conflicts of interest, Pharmaceuticals, Studies
Phyllis Vine at MIWatch.org, a site that follows news about mental illness, asks whether drug company disclosures about payments made to doctors go far enough and whether anyone actually pays attention to such disclosures.
Vine raises the question of doctors taking part in “educational settings, including grand rounds, courses at professional conferences, or continuing education programs that pharma spends billions of dollars underwriting.”
She addresses the disproportionate number of psychiatrists who represent pharmaceutical companies and dominate the upper bracket of paid speakers. Vine also notes that, while many schools have drafted or are drafting policies about faculty-industry relations, enforcement of those policies is questionable.
Read the whole post on MIWatch.org.
Report focuses on researchers’ conflicts of interest
Filed under: Conflicts of interest, Government, Studies
There are vulnerabilities in how financial conflicts of interest are handled by NIH-funded researchers, according to a report (PDF, 46 pages) released today by the Department of Health and Human Services’ Office of the Inspector General. Among the findings:
- 90 percent of the grantee institutions rely solely on the researchers’ discretion to determine which financial interests are required to be reported
- because nearly half of the grantee institutions do not require researchers to provide specific amounts of equity or compensation on their financial disclosure forms, specific financial interests of NIH-funded researchers are often unknown
- grantee institutions do not routinely verify the information submitted by researchers about their financial interests
- some grantee institutions lack documentation to support their oversight of financial conflicts of interest
- the majority of grantee institutions do not have policies and procedures that address subgrantee compliance with federal regulations regarding financial conflicts of interest
- conflicts were not reported by grantee institutions to NIH in a consistent format
- grantee institutions are not required to report to NIH any financial interests that they have with outside companies
The inspector general’s review focused on the 41 grantee institutions that submitted financial conflict-of-interest reports to NIH in fiscal year 2006.
The review found that the most common financial conflict of interest is equity ownership (including stock and stock options) in companies in which the researchers’ financial interests could significantly affect the grant research.
Other financial conflicts of interest among researchers involved inventing technology, consulting, or holding positions with outside companies. To manage financial conflicts of interest, grantee institutions often require researchers to disclose conflicts in research publications; however, grantee institutions rarely reduce or eliminate financial conflicts of interest.
The report includes a number of recommendations – that it has previously recommended – to improve the reporting of financial conflicts of interest.
Grassley compares ghostwriting, plagiarism
Filed under: Conflicts of interest, Government, Pharmaceuticals, Studies
Sen/ Charles Grassley (R-Iowa) continues his investigation of “medical ghostwriting” with a letter to 10 medical schools asking “what they are doing about professors who put their names on ghostwritten articles in medical journals — and why that practice was any different from plagiarism by students.”
Sen. Charles Grassley
At issue is the practice in which a writer — sometimes paid by a pharmaceutical or other involved company — works on an article intended for publication without being named while a less-involved researcher receives credit.
Journals, medical associations and even pharmaceutical companies have called for an end to the practice but medical schools have been slower to respond.
Grassley has asked the medical schools to explain their policies on ghostwriting and plagiarism, to list complaints and describe investigations into both practices.
NY stem cell researchers can pay egg donors
The ethical thicket that is stem cell research just got a little more complex. New York became the first state to allow taxpayer-funded researchers to pay women to donate eggs specifically for stem cell experiments.
"Stripped" human oocyte; granulosa cells that had surrounded this oocyte have been removed. Courtesy: RWJMS IVF Laboratory via Wikimedia Commons
The compensation could run as high as $10,000. Supporters argue it will spur better, quicker research results. Opponents say paying for eggs crosses an ethical line.
The state board that made the new policy says it’s just like compensating women for donating eggs for reproductive purposes. But the National Academy of Sciences doesn’t see it that way, saying in its guidelines for stem cell research that payment to donors for eggs is a no-no.
Some scientists in the field say the main source now — eggs left over from in vitro fertilization procedures — hasn’t been adequate. (New York won’t pay for those eggs under the new policy anyway.)
Scientists outside New York are already envious. Harvard stem cell researcher George Q. Daley, told The New York Times, the payment policy “will mean a tremendous advantage” for labs in New York.
Seven Texas schools seek tier-one status
Holly K. Hacker of The Dallas Morning News has a story about Texas universities seeking to be “tier-one” institutions. As Hacker explains, “tier-one” universities are “where researchers make the next big breakthroughs in science or engineering and where top scholars teach the next generation of leaders and problem-solvers.”
Tier-one universities help the economy, attract students and researchers from out of state and encourage students to stay in state for their education.
They also receive “hundreds of millions of dollars in research grants from groups like the National Institutes of Health.”
Hacker is having a live chat at 11:30 central time today (Monday).
Covering Obama’s stance on stem cell research
President Barack Obama is expected today to overturn the Bush-era policy that restricted federal funding of embryonic stem cell research. In his official agenda that lays out his positions on issues, Obama said he would “support increased stem cell research. Allow greater federal government funding on a wider array of stem cell lines.”
When stem cells like these human embryonic stem cells divide, each new cell has the potential to remain a stem cell or become a cell with a more specialized function, such as a muscle cell or a red blood cell.
Photo: National Institutes of Health
Terri Somers of The San Diego Union-Tribune wrote an article for AHCJ about covering stem cells that includes background on the science, politics and global competition of stem cell research. AHCJ also has a presentation from Zach W. Hall, former president of the California Institute for Regenerative Medicine, that looks at stem cell research in that state. And Al Tompkins at the Poynter Institute provides some background and links on stem cells.
According to Chris Cillizza of The Washington Post, Obama will sign an executive order that will allow study of a broader group of stem cell lines. Cillizza looks at some of the politics surrounding the issue, as well as polls that attempt to measure Americans’ position on stem cell research. The New York Times reports that Obama is leaving some of the more difficult questions about stem cell research to Congress to resolve, such as “whether taxpayer dollars should be used to experiment on embryos.”
Arthur Caplan, Ph.D., director of the Center for Bioethics at the University of Pennsylvania, writes that “This reversal of former President George W. Bush’s ban on such funding is good news for the science needed to find treatments for currently incurable conditions and for the ethics at stake in the issue.”
Stimulus funds study of effectiveness of treatments
Filed under: Government, Health care reform, Health policy, Hot Health Headline, Pharmaceuticals
Robert Pear reports in The New York Times that $1.1 billion of the $787 billion federal economic stimulus package will fund research into the relative effectiveness of drugs and other forms of medical treatment.
A council of federal employees will advise President Obama and Congress on the funding of studies that proponents hope will help bring down the soaring cost of health care. Advocates say the research will be used for reference purposes, and not to mandate certain treatments.
“The money will be immediately available to the Health and Human Services Department but can be spent over several years. Some money will be used for systematic reviews of published scientific studies, and some will be used for clinical trials making head-to-head comparisons of different treatments.”
In Calif. lab, researchers put innovations to the test
Sandy Kleffman of the Contra Costa Times visited Kaiser Permanente’s Sidney R. Garfield Center for Health Care Innovation, where researchers from Kaiser and other organizations come together to test their innovations in real-world situations.
The 37,000-square-foot warehouse in San Leandro, south of Oakland, was built in 2006 and contains mock living rooms, operating rooms and more.
“The goal is to discover unforeseen problems before health care firms spend large sums of money on innovations that sound great in the laboratory but don’t work in the real world,” Kleffman reported.
When Kleffman and other reporters visited, researchers were testing everything from a remote video diagnostic tool to the Nintendo Wii and its use in rehabilitation.
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