Harvard Medical School professor Jerry Avorn, a critic of drug industry marketing, hired five faculty members in the past nine months to study whether prescription medicines are as good as advertised.
Avorn says a $3 billion injection of funds from President Barack Obama’s health overhaul bill is certain to accelerate research that compares the effectiveness of drugs and other medical therapies, producing guides for doctors that pharmaceutical companies rarely do. In the past, lawmakers sometimes viewed comparative effectiveness analysis — the process of determining whether one treatment works better than others — like a “Coke vs Pepsi” taste test, Avorn said in an interview. “It was held to be not high science, and not about the molecular basis of disease.” That may change with Obama’s health bill, signed into law March 23.
The legislation builds on $1.1 billion designated for this research in the stimulus bill and creates an institute specializing in comparative studies, with at least $500 million in annual funding starting in 2013. Doctors such as Avorn and insurance companies led by UnitedHealth Group Inc are racing to take advantage of the influx of money and increased focus.
The research pits multiple treatments against one other to determine the best outcome for patients — such as figuring out whether a particular drug is better at addressing high blood pressure than other medicines or lifestyle changes. Such studies can also indicate which therapies give the most benefit for their cost, said John Sullivan, an analyst with Leerink Swann & Co, a Boston investment bank that focuses on health care.
‘Better job’
“We have to do a better job of being able to say to doctors and their patients what constitutes effective care, both cost effective and clinically effective,” Sullivan said. “That’s what comparative effectiveness research can do.”
Avorn, 62, cited a federally funded study called ALLHAT as an important exception to the government’s former disdain for this research. The study concluded that Pfizer Inc’s Norvasc blood-pressure drug didn’t ward off heart disease as well as cheaper medicines known as diuretics. Funded by the National Institutes of Health in Bethesda, Maryland, the study’s results were reported in 2002.
Avorn has written more than 200 papers on drugs and which offer the most benefits, and he appeared in a five-minute spoof report about pharmaceuticals on the “The Daily Show With Jon Stewart” in 2006. He said the flow of government money has enabled his researchers to conduct studies of antidepressants and links with suicide, the safety of unborn babies whose mothers are undergoing HIV-AIDS treatment, and the side effects of drugs that treat the bone-thinning disorder osteoporosis.
Avorn’s mission
His division at Brigham and Women’s Hospital, a Boston teaching affiliate of Harvard Medical School, focuses on the effectiveness and economics of treatments. His team received $14 million from the stimulus package, other government grants and companies such as CVS Caremark Corp since July, he said. Some awards were for multiple years. That compares with the division’s annual budget of about $5 million.
The new funding and focus are also luring companies. Ingenix, an Eden Prairie, Minnesota-based unit of UnitedHealth, said last month that it acquired QualityMetric Inc, a company that measures how patients rate the effectiveness of care. The insurer cited federal funding for comparative studies as one reason for the purchase.
UnitedHealth, Aetna
UnitedHealth, based in Minnetonka, Minnesota, declined 10 cents to $32.16 yesterday in New York Stock Exchange composite trading. The shares have gained 5.5 per cent in 2010.
Competitors are also expanding in comparative research as a way to reduce costs and make better medical decisions. Aetna Inc, a Hartford, Connecticut-based insurer, bought ActiveHealth Management, a provider of programs to analyse patient data, in 2005. Aetna said that the purchase would improve patient safety and treatment quality, while lowering expenses.
More acquisitions and partnerships probably will follow, said Paul Keckley, executive director for the Deloitte Center for Health Solutions, a Washington-based research arm of Deloitte LLP.
“There are several little players in this space that are under $30 million in revenue,” Keckley said, declining to name specific companies. “You’ll see those being acquired.”
Drugmakers may also look at companies that do comparative studies, or hire more workers in the field, Keckley said. Such research may help them defend their products against potential negative results from government-funded studies and gear up for more requests for information from regulators, he said.
Hospital networks
Large hospital networks, with their extensive databases of medical records, will be important when it comes to comparing treatment outcomes, Keckley said. While some research will involve large clinical trials, other studies will pick out trends from existing data. Researchers typically will have to look at data sets with more than 10 million records, he said.
The new funding “is bringing in more players,” said Clifford Goodman, vice president at the Lewin Group, a Falls Church, Virginia-based consulting company owned by UnitedHealth. “But it is also deepening the commitment of some of the existing ones.”
After last year’s stimulus bill, the government enlisted the National Academy of Science’s Institute of Medicine in June to come up with 100 initial priorities for the research.
Heart rhythm
At the top of the list were comparisons of treatments for atrial fibrillation, which is the most-common form of abnormal heart rhythm and affects 2.2 million Americans, according to the Dallas-based American Heart Association. The plan called for assessments of the outcomes of surgery, a procedure using a catheter and treatment with drugs.
The institute created under the health bill will be funded with $10 million this year and may reach $500 million or more annually in 2013, according to an estimate from the Brookings Institution, a Washington-based nonprofit research center. The budget may increase if insurance rolls grow, Brookings estimates. The health bill covers the period through 2019.
The legislation bars Medicare, the US government insurer for the elderly, from using the research as the sole basis for reimbursement decisions for medical products or procedures.
Studies that compare treatments don’t always yield a clear winner or loser, said Don Moran, president of Moran Co, a health policy research and consulting company in Arlington, Virginia.
Ambiguous results
“The evidence is probably going to be ambiguous 70 or 80 per cent of the time,” Moran said. “A slam-dunk conclusion that a specific technology is superior to another is not a common thing.”
Comparative studies did change the treatment of breast cancer, spurring doctors to end the routine removal of entire breasts after research found less drastic operations worked just as well, said Robert Rosenheck, a psychiatry professor at Yale University School of Medicine in New Haven, Connecticut.
Research showing one treatment clearly works better doesn’t always affect sales of other treatments, Rosenheck said.
A 2005 study of antipsychotic medications found that a 50-year-old drug that cost about $2.50 a day worked as well as newer medicines priced eight times higher, he said. Even so, sales of the next-generation antipsychotics, led by AstraZeneca Plc’s Seroquel, Eli Lilly & Co’s Zyprexa and Johnson & Johnson’s Risperdal, jumped 43 per cent in four years to $14.75 billion by 2009, according to IMS Health Inc, a collector of prescription-drug data based in Norwalk, Connecticut.
Research bias
Edmund Haislmaier, a senior research fellow at the Washington-based Heritage Foundation, said he worries that the government funding will crowd out other research, and may encourage a bias toward looking at the “collective over the individual.”
“From a policy perspective, it’s better to have competing private entities than one single entity, and certainly one single government entity,” Haislmaier said. His foundation says it provides conservative public policy research based on principles led by limited government.
For Harvard’s Avorn, government attention and funding provided a “shot in the arm” for his research. Comparative research will let doctors and health-care companies focus their efforts, he said.
“Finally the health-care system has begun to ask questions companies all over the world have been asking for generations,” Avorn said.
