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Health care reform and clinical research: Gold rush or drug bust?
Millions available, but long-term impact questioned
The new health care reform bill provides another big influx of federal research funding, and research organizations will need to prepare and apply as quickly as they can, experts say.
Last year's stimulus package provided a billion-dollar incentive to research organizations and resulted in thousands of new health care-related grants and studies.
"It was supposed to be spent in 18 months, but that's not going to happen," Lewis says. "The new bill would provide several hundred million dollars each year, so it's larger in scale than the stimulus bill."
Clearly there will be more money available for doing CER, but the ramifications of this type of research on drug development are unknown, Lewis notes.
"A few hundred million more funding means there's potential business for us," he explains. "But if, on the other hand, the research that's done eventually is used in a way that will stymie future innovation in research and development, then that's not a good thing."
The pharmaceutical industry can handle CER results that show one particular drug is superior to another. But the bigger concern is what the effect will be on drugs in the development pipeline, Lewis says.
"If you're creating a de facto higher standard for approval than what we currently have, or if you bring a drug to approval, but it won't be reimbursed by private insurers because the research says it won't be as good as what's on the market, then there could be problems for the industry," he explains.
The health care reform bill overall has some positive and negative features for the research industry, says David Vulcano, LCSW, MBA, CIP, RAC, past-chair of the Association of Clinical Research Professionals (ACRP) board and an assistant vice president for clinical research at Hospital Corporation of America in Nashville, TN.
A clinical research bubble
The influx of new research money is creating a bubble, he says.
"They've had a real estate bubble and a tech stock bubble, and this is a clinical research bubble of government-sponsored research," Vulcano says. "They've put $10 billion toward research to spend in the next few years."
The initial bill, and not the reconciliation bill, had categories for mandating funding for certain kinds of research, he says.
"So there will be an injection of funds for research involving postpartum depression, pain, comparative effectiveness research, emergency medicine, and health care delivery," Vulcano says. "So for clinical trials in those areas, in and of itself, there are some good positives for the research industry."
The health care reform bill changes the oversight of CER funding from the Federal Coordinating Council of Comparative Effectiveness Research to a new organization called the Patient-Centered Outcomes Research Institute, Vulcano says.
"They didn't want a completely government entity, so they replaced that organization with a public-private partnership," he explains.
However, the new oversight organization likely will rely on the Institute of Medicine's list of 100 initial priorities when funding CER projects. The institute had developed the list of priorities with $1.5 million in funding from the stimulus package's CER funding, he adds.
"If sites want to try for grants then they'll have to get involved with the government grant process because all grants will follow the government-funding process," Vulcano says. "We'll learn more about which priorities they'll want to fund first as it comes along."
CR sites should read the research provisions in the new bill and watch as more details emerge because the federal research grants will be highly competitive, he predicts.
"There were so many applicants for the stimulus package money that they had over 6,100 projects done as of last year, and they still have more to go because it is supposed to be spent by September, 2010," Vulcano says.
Biotech gets 'number one priority'
Biotech companies received a small but important change from the health care reform bill.
The bill cleared up ambiguity about how long biosimilar products could have patent protection, Lewis says.
"There is now a 12-year data protection period for the biotech innovator, so they have 12 years of patent protection or marketability to recoup their investment," he adds. "That was a
number one priority of the biotech industry, and so it was a big win for the industry, and we supported that."
The other important piece of this was a patient safety issue with very strong requirements for clinical testing or clinical trials for biosimilars and high standards to demonstrate
similarity and interchangeability with innovator drugs, Lewis explains.
The ACRO was concerned about having this piece included and worded correctly in the final legislation, he adds.
"Some earlier versions of the bill would have made clinical trials optional and given the FDA
more discretion, and we thought it was important to make it clear that to ensure efficacy and safety you would need the same data you would on an innovator drug," Lewis says. "This would be something that would give patients and prescribers confidence that the generic would have the same efficacy and be at least as safe as the innovator drug for that patient."
The health care reform bill might also have a positive impact on research sponsors since more people in the country will be insured, and some costs that are picked up by sponsors now could be paid by private insurers, he says.
"The more people who are insured, the less sponsors will have to offer compensation for services insurance doesn't cover," Vulcano says.
In particular, cancer research sites will see some changes that likely will have a positive impact on their patient study participants.
For example, the new bill mandates that private insurers will have to pay for routine care for patients who are involved in clinical trials. Previously, some states had this mandate, but now it's universal, Vulcano says.
"If I'm getting chemotherapy and getting an investigational drug, then private insurers might say they wouldn't pay for anything since I'm in a clinical trial," he explains. "Now it's a global mandate, and insurers have to pay for this routine care."
This change could have a big impact on recruitment in oncology trials, he adds.
The bill also provides funding for pilot research projects involving patient-centered medical home (PCMH) models, says Cecil Wilson, MD, an internist in Winter Park, FL, and the president-elect of the Chicago-based American Medical Association (AMA).
The PCMH model involves having patients work with a primary care team to cover their chronic illnesses and other health issues, Wilson explains.
Pilot studies in North Carolina and Iowa have shown positive health outcomes and cost-savings outcomes, and the bill will provide funding for similar pilot projects.
Controversial provision intact
An unpopular aspect of the law in the research community is the Physician Payment Sunshine Provision, which requires sponsors to report payments made to physicians.
"This requires physicians to disclose any payments they receive from pharmaceutical or biotech companies," he says. "This is something where we'd lobbied for a research exemption."
However, the provision was included and now will require companies to begin tracking payments for reporting purposes as of Jan. 1, 2012.
This is a disclosure requirement, and it will fall on the pharmaceutical and biotech companies to disclose any payment over $100 that is made to a physician or pharmacist or other health care professional," Lewis says.
"We are concerned this will be another disincentive to physicians to get involved in research," he adds. "We understand the concern over conflicts of interest, and there are clear cases where everyone can agree there have been conflicts of interest."
But physicians who are paid to conduct clinical trials and gathering health data and outcomes are generally not in conflict of interest, and they should be encouraged to do this work, Lewis says.
"By forcing disclosure of their income, you are discouraging people from participating in research at a time when we need more physicians doing research," he adds.
"Nobody wants their income or a portion of their income hanging out there in public," he says. "So you could eliminate some talented people from getting involved in research, and that ultimately could delay development of drugs."
The ACRO is surveying investigators and non-investigators, and that is one of the questions they'll ask, Lewis says.