A large-scale clinical trial comparing angioplasty in combination with clot-busting and arrhythmia drugs with the use of the drugs alone in heart-attack patients who had delayed seeking treatment came up with a startling result: There was absolutely no benefit to angioplastyaccompanied by the implanting of drug-eluting stentsin these patients. And there are signs that, over time, the risks of angioplasty only grow.
If performed within 12 hours after a heart attack, angioplasty and stents do work to preserve heart muscle and reduce deaths, researchers write in an article published online by the New England Journal of Medicine. Later, it actually may harm patients, despite costing upward of $15,000 per procedure vs. several hundred dollars for the drugs.
Its the second major hit for stents in the past year. Several studies have found they may cause killer blood clots and work only in the smallest sections of coronary arteries, while plaque develops elsewhere.
Its also the most recent indication of the value of head-to-head studies of the major treatments for the most common life-threatening conditions. The problem is that there are far too few of these expensive studies. One reason may be that the drug companies and devicemakers that typically fund clinical research dont want to see independent reports that call into question some of their most profitable products. Another is that the same companies have tremendous clout within the federal governmentspecifically the National Institutes of Health and the Food and Drug Administrationthrough political donations and lucrative consulting arrangements with clinical researchers. Still another may be that the CMS, the largest payer, is legally proscribed from making coverage determinations based on the results of studies of comparative efficacy.
About the same time as the angioplasty study was published, the policy journal Health Affairs posted several articles on its Web site about the need for an independent group to finance and oversee a drastic expansion of clinical trials, especially nonpharmaceutical trials. The lead study called for a quasi-governmental grouplikely under the aegis of the Agency for Healthcare Research and Qualityto take on the job. The center would fund prospective trials on key questions for which comparative effectiveness evidence was found missing, in addition to the systematic reviews of existing research currently performed by the AHRQ, the Blue Cross and Blue Shield Association and other private-sector groups.
The reasons that such an expansion of our knowledge base is needed are manifold and growing in importance. The proliferation of quality-of-care indicators and their use in public reporting and incentive payment programs for providers is based on the notion that they are meaningful. And yet it is shocking how little we know of which diagnostic tools, medical devices, pharmaceuticals and treatment procedures work best at saving lives and delivering cost-effective care. As David Eddy, a pioneer in evidence-based medicine at Kaiser Permanente puts it: We dont know what we are doing in medicine.
For example, after many months of controversy, the NIH announced last month that it will sponsor a clinical trial comparing the efficacy of two Genentech drugs to treat age-related macular degeneration. Many retina specialists believe that Avastin, a cancer drug, used off-label, works just as well as Lucentis, which has been approved for macular degeneration but costs at least 20 times as much. The difference to the Medicare program would be measured in the hundreds of millions of dollars if Avastin were approved for this condition.
A quasi-governmental organization might work to ensure comparative studies proliferate, but we submit that unless all payers and providers agree to use the new data to begin fine-tuning our system, it may be time for the federal government to step in and make them.