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Health care reform law: Follow the money
Reporting pharma payments is biggest change
As sweeping as the 906-page health care reform bill is, it will have limited impact on human subjects research protection, experts say.
The Patient Protection and Affordable Care Act, signed March 23, 2010, by President Barack Obama, will put billions more dollars into research and pilot projects. Potentially this will increase volumes at some IRBs and research institutions.
Both the 2009 federal stimulus package and the new health care reform bill flood billions more into research, but the money has to be spent in the next few years, says John Lewis, vice president of public affairs for the Association of Clinical Research Organizations (ACRO) in Washington, DC.
Part of the new research money is designed to set up an infrastructure for the government to conduct the research, but the rest goes out in grants, Lewis says.
Much of this money is for comparative effectiveness research (CER), and while this will have a short-term bubble impact on boosting research projects nationwide, there are some long-term concerns, he says.
One of these concerns is whether the CER findings will result in choking off some of the research and development pipeline by creating a de facto higher standard for new drug approval by the Food and Drug Administration (FDA), Lewis explains.
"Or, what if you could bring a drug to approval, but it wouldn't be reimbursed by private insurers if there's research that says it won't be as good as what's on the market," he adds.
The bill's cuts in Medicare rates for specialists could have the positive repercussion of convincing more physicians to become researchers as a way to diversify their income and generate more revenue, suggests David Vulcano, LCSW, MBA, CIP, RAC, past-chair of the board of the Association of Clinical Research Professionals (ACRP) of Alexandria, VA. Vulcano is the assistant vice president for clinical research at the Hospital Corporation of America in Nashville, TN.
This could mean that research programs will need to train more new researchers in research ethics and human subjects protection, as well as good clinical practice guidelines.
'We didn't win that point'
Overall, it appears the biggest change from an IRB perspective is the bill's provision regarding financial relationships between physicians and pharmaceutical and device companies. This is section 1128G, Transparency reports and reporting of physician ownership or investment interests, in the bill.
"This is something where we had lobbied for a research exemption," Lewis says. "If a physician is paid for participating in a clinical trial, it should not be viewed as a conflict of interest. But we didn't win that point."
IRBs typically rely on investigators to disclose their own conflicts of interest and financial relationships with sponsors.
"We ask through the continuing review form about conflicts that would relate to the actual principal investigator or sub-investigators or coordinators directly participating in the research, and we include their spouse," says John Isidor, JD, chief executive officer of Schulman Associates IRB in Cincinnati, OH.
"We ask if they have received money outside of the trial in excess of $10,000, and that's where I see a potential impact with IRBs," Isidor says.
The federal government and IRBs seem to be more interested in these physician/investigator conflicts of interest (COIs) than are research participants, says Alan M. Sugar, MD, former chairman of the New England Institutional Review Board, and professor of medicine at Boston University School of Medicine in Boston, MA.
"There have been several studies that look at a subject's perception of these COIs," Sugar says. "The overall conclusion is that study participants really don't care at all whether there is a financial interest by the investigator or not."
IRBs need to determine what constitutes a significant COI and proceed accordingly, he adds.
"Of course, if the law requires specific disclosures then the IRB must comply," Sugar says.
Both burden and opportunity
The new bill's disclosure provision will create both an opportunity and a burden for IRBs, Isidor notes.
IRBs might move toward having a zero dollar threshold to be better aligned with the health care bill's very low threshold. The bill says any transfer of more than $10 or an aggregate of $100 in one calendar year will need to be reported.
If an investigator were to report receiving a certain amount of money from a sponsor, then the IRB could check the government's online information to see if what the PI reported to the IRB matches what the sponsor reported to the government, he adds.
"Either the institutional conflicts of interest (COI) committee and/or the IRB can say, 'Look, we reserve the right to cross-check your disclosures against publicly-available databases for researchers and physicians,'" Isidor says.
Basically, the new bill says that on March 31, 2013, any manufacturer who provides a payment to a physician or other provider must report this to the U.S. Department of Health and Human Services (HHS).
These payments could be for research work. Consulting fees, honoraria, gifts, entertainment, food, travel, education, charitable contribution, royalty, investment interest, direct compensation, grants, and other payments also have to be reported. The bill states that if the payment or other transfer of value is related to marketing, education, or research specific to a covered drug, device, biological, or medical supply, the name of that covered drug, device, biological, or medical supply have to be included in the report.
This type of public disclosure could create a disincentive for physicians to get involved in research, Lewis says.
"We understand the concern over conflicts of interest, and there are clear cases that everyone can agree are conflicts of interest," Lewis says. "But when a physician is paid for conducting a clinical trial and is gathering data or health outcomes, then that's not a conflict and should be encouraged."
A number of pharmaceutical companies voluntarily have released this information, although it hasn't been done in a comprehensive way, Lewis notes.
"Now it will be a requirement," he says.