Two important reports Wednesday offer early hints of the potential impact of a $1.1 billion federal program to compare the medical benefit and the cost-effectiveness of surgeries, medicines and medical devices. The reports — by the Institute of Medicine and the Federal Coordinating Council for Comparative Effectiveness Research – suggest priorities for spending $700 million of the research funds set aside under the American Recovery and Reinvestment Act of 2009.
The reports don’t name particular products or companies, but many of the suggested projects would scrutinize expensive products and services sold by identifiable companies, to wit: biologics for treating auto-immune such diseases as arthritis, now sold by the likes of Abbott Laboratories (ABT), Johnson & Johnson (NYSE:JNJ) and Bristol-Myers Squibb (NYSE:BMY); home health programs to prevent falls by older adults, now promoted by the likes of Amedisys (NASDAQ:AMED); heart arrhythmia treatments marketed by Medtronic (NYSE:MDT) and St. Jude Medical (NYSE:STJ); tests for drug-resitant staph germs, as sold by Cepheid (NASDAQ:CPHD); prostate cancer treatment with the Intuitive Surgical (ISRG) robot; drug treatments for attention deficit hyperactivity disorder, as sold by Shire (SHPGY).
The Institute of Medicine’s report also endorses comparing costs of treatments, along with their effectiveness. “The overall value of a strategy can be understood best by considering costs and benefits together,” suggested the institute. The medical products industry bridles at cost-effectiveness scrutiny.
Comparative-effectiveness research has been rare. Companies that sponsor research on new treatments tend to avoid study designs that compare their product to rival products. Scientific journals, meanwhile, have traditionally preferred studies that succeeded, leaving useful information on failed studies unpublicised. The government effort will try to plug holes that aren’t typically addressed by industry-sponsored treatment studies, said an editorial today at the website of The New England Journal of Medicine, written by Drs. Patrick H. Conway and Carolyn Clancy. They are trying to orchestrate the sundry federal research efforts under the Recovery Act, as executives of the Federal Coordinating Council for Comparative Effectiveness Research.
”The goal of randomized efficacy trials is often to prove that a treatment is superior to placebo,” say Conway and Clancy. “But more important questions may be whether the intervention is better than other available interventions for specific populations…”
The Institute of Medicine is part of the National Academy of Science, and is a non-profit group assigned to give the nation independent advice on the big questions in medicine. Before issuing today’s list of 100 suggested priorities for the effectiveness program, the Institute took testimony in March from medical groups, patients and industry. Much of the industry input was predictable.
The association of contract clinical researchers — such as Covance (NYSE:CVD) — insisted that its members should get a piece of the action, in carrying out the $700 million research program.
In their March testimony, health insurers decried the overprescribing of the anti-clotting drug Plavix from Bristol-Myers for preventing the recurrance of a stroke. Plavix costs $1,500 per year, noted one health insurance trade group, but is only sightly more effective than $15-a-year aspirin. Proton-beam treatment for prostate cancer, as sold by Varian Medical Systems (NYSE:VAR), costs four times as much as radioactive seed implants, with little evidence for its comparative superiority, said the insurers. New biotech treatments for cancer — the big business at Genentech (DNA) — cost more than $50,000 a year, but only deliver marginal improvements to sick patients. The Blue Cross and Blue Shield Association, meanwhile, urged studies comparing heart disease treatment with drugs as against stents (as sold by Boston Scientific (NYSE:BSX), J&J and Medtronic) and as against bypass surgery.
The biotech industry’s trade group, in its March comments, warned government researchers of the shortcomings of comparative effectiveness studies. Studies shouldn’t zero in on drugs and biologics, warned the group, and should give them credit for hard to measure benefits like “increased worker productivity” or “reduced caregiver burden.”
Ironically, for a science-based industry, the biotech group seemed to set up an argument against “evidence-based medicine” — the trend in effective medical practice, whereby a doctor chooses treatments based on good scientific studies rather than his isolated hunches about an individual patient. “Imposing rigid practice guidelines,” warned the biotech group, “can interfere with the ability of providers to deliver the most appropriate care for each patient.”
The biotech lobby sounded more concerned, I dare say, about interference with the influence of their sales reps on doctors, when promoting the latest, expensive treatment. The lack of private sector studies of comparative effectiveness is a classic example of “market failure” and a terrific opportunity to muster scientific knowledge in helping the country avoid getting crushed by its medical bills. – by Bill Alpert