They came to bury proton therapy, not to praise it

By Greg Freiherr, Diagnostic Imaging, Oct. 09

Using logic that could just as easily be applied when considering a toddler, the federal government damned proton therapy on Sept. 14 with a report that brands the cancer treatment as lacking evidence of effectiveness and safety.

"Particle beam radiation therapy can target the radiation with a high degree of precision, but its potential advantages over other radiotherapy alternatives have not been verified in long-term outcome studies," according to a technical brief from the Department of Health and Human Services' Agency for Healthcare Research and Quality (AHRQ).

Some clinicians consider proton therapy to be better than traditional cancer radiation treatments, the agency said in its brief, "but there is limited evidence about its safety compared with other types of radiation therapy."

This should come as no surprise, particularly to AHRQ. The agency notes that there are only seven centers in the U.S. at which proton therapy is available.

The advocates of proton therapy are ambitious, however, and that may have something to do with the report's appearance now. A company called ProCure has plans to build more such centers; one is expected to open next year. And the AHRQ report states that several other hospitals are considering developing smaller treatment facilities "based on technologies that have not yet been cleared by the Food and Drug Administration."

Rather than greet these developments with enthusiasm, the agency seemed determined in its technical brief to put as negative a slant as possible on what is known about proton therapy. The technical brief specifically stated that there is no indication that this type of radiation therapy is riskier than conventional radiation therapy, but then said "most studies were conducted on small numbers of patients and did not compare the safety of particle beam radiation therapy against other therapies."

In short, the technical brief concludes that there's really not much to say about proton therapy. Why then publish such a report? The reason, according to the agency, is to "highlight where more research is needed and where research may be sufficient to warrant a full systematic review."

If one goal is to highlight where more research is needed, wouldn't it have made more sense to send the report findings specifically to the handful of centers providing proton therapy? Similarly, if identifying where research may be sufficient to warrant a full systematic review were the other goal, wouldn't that be an internal matter better suited to an intra-agency memo? In fact, AHRQ is currently reviewing scientific studies on radiation therapies for head and neck cancers and proton therapy made the cut. The agency will evaluate its clinical effectiveness in this context. So, if this purpose is already satisfied, again, why publish the report?

I can think of no more effective way to keep a lid on a medical technology than to discourage investment early in its development. How better to do this than to come out with a report that labels the therapy as unproven and notes that hospitals are considering the use of technologies that have not been cleared by regulators.

Rather than meeting its stated goals of promoting knowledge about proton therapy, the report appears to be a thinly veiled attack on this form of cancer therapy, one that fits an evolving pattern within the DHHS. Time and again this department, acting through one or another of its agencies, has taken whacks at high technology.

This pattern of attack will intensify as long as technology bears the blame for spiraling healthcare costs. Inefficiency is the real culprit. Flogging technological scapegoats is doomed to fail, as it allows the real problems to persist. But bureaucrats responsible for healthcare in this country can't seem to grasp that.

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