Cancer therapy raises questions about FDA's reviews

After a surgeon removed a cancerous lump from Karen Medlock's breast in November, he recommended radiation, a routine next step meant to keep cancer from recurring.

But he did not send her for the kind of radiation most women have received for decades.

Instead, he referred her to a center in Oakland, Calif., specializing in a newer treatment, radioactive "seeds" inserted in the tumor site. It could be completed in five days instead of the six weeks typical for conventional treatment, which irradiates the entire breast using external beams.

To Medlock, it seemed an obvious choice. The newer treatment - given through a system called MammoSite, which is marketed by Hologic Inc. of Bedford - has been performed on about 45,000 patients in this country since the Food and Drug Administration cleared it in 2002.

Only when Medlock, 49, sought a second opinion did she learn a startling truth: MammoSite is still highly experimental.

The MammoSite system is among the thousands of devices the FDA lets onto the market each year after only cursory review and with no clear evidence they help patients. Doctors are free to use those products as they see fit. And because the doctors are frequently paid more by Medicare as a way to compensate them for the extra time and expense of adopting new procedures, these unproven products can become widely adopted.

FDA officials defend the quick-review process as a way to promote innovation.

Demanding lengthy study of such devices would be "a waste of resources," said Dr. Daniel G. Schultz, director of the FDA's Center for Devices and Radiological Health.

The agency let MammoSite on the market on the basis of a study involving 25 women that did not answer the question of how effective it is against breast cancer. Six years later, many cancer specialists say there is still no conclusive proof it works as well as conventional radiation.

Dr. Valery Uhl, the oncologist who provided Medlock's second opinion, outlined the evidence behind the available treatments. Medlock chose conventional radiation because of its well-documented record of success.

Critics say the FDA's process for reviewing medical technology is often too lax. More devices, they say, should get the same scrutiny applied to new drugs. A new drug is typically studied in hundreds or even thousands of patients before the FDA will approve it as safe and effective.

But under the fast-track review for most devices, a product's effectiveness is never directly established. Regulators simply determine if the device does what its maker says it does - in MammoSite's case, that it delivers radiation - and whether it poses any undue safety risks.

"Nobody is looking to see whether they help patients," said Diane C. Robertson, of ECRI Institute, a nonprofit group in Plymouth Meeting, Pa., that evaluates devices for insurers.

In response to a congressional request to study the FDA's device-review process, the Government Accountability Office is expected to release a report next month.

Dr. Dennis R. Hill, who originally saw Medlock, scoffs at the notion MammoSite is in any way experimental. "It is a proven method," he said.

MammoSite proponents say most doctors simply recommend the treatments they know best.

"There is a natural bias for radiation oncologists to do what they have been doing," said David Harding, an executive at Hologic.

Many prominent specialists, though, say the gold standard remains conventional radiation.

Even a radiation oncologist who is a leading proponent of MammoSite, Dr. Frank A. Vicini, wants to know how it compares with traditional radiation. He is directing a national study of MammoSite's effectiveness, but cautions it could take decades to decide if it should be used in lieu of conventional radiation.