F.D.A. defends the quick-review process as a way to promote innovation
27 10 08 - 12:25
Quickly Vetted, Treatment Is Offered to Patients
By REED ABELSON
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, the surgeon referred her to a center in Oakland, Calif., specializing in a newer form of treatment where radioactive “seeds” are inserted in the tumor site. It could be completed in only five days instead of the six weeks typically required for conventional treatment, which irradiates the entire breast using external beams.
To Ms. Medlock, it seemed an obvious choice. The newer treatment — given through a system called MammoSite — has been performed on about 45,000 breast cancer patients in this country since the Food and Drug Administration cleared it for use in 2002.
Only when Ms. 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 F.D.A. lets onto the market each year after only cursory review and with no clear evidence that they help patients. Doctors are free to use those products as they see fit, without telling patients that the devices are not proved. 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.
F.D.A. officials defend the quick-review process as a way to promote innovation. Because most new products are simply an improvement on an existing device, they say, there is rarely need for a full review.
Demanding lengthy study of such devices would be “very, very inappropriate and a waste of resources,” said Dr. Daniel G. Schultz, the director of the F.D.A.’s Center for Devices and Radiological Health.
The agency let MammoSite on the market on the basis of a study involving only 25 women that did not answer the fundamental question of how effective it is against breast cancer. Six years later, many cancer specialists say there is still no conclusive proof that it works as well as conventional radiation. The F.D.A. says it did require a label warning that the system had not been shown to be a substitute for conventional radiation.
Dr. Valery Uhl, the radiation oncologist who provided Ms. Medlock’s second opinion, outlined the evidence behind the available treatments. Ms. Medlock chose conventional external-beam radiation because of its well-documented record of success in preventing the return of cancer. To use an unproven therapy like MammoSite, Dr. Uhl said, “makes me really nervous.”
Critics say the F.D.A.’s process for reviewing medical technology, under which medical devices have become a $75 billion-a-year industry in this country, is often too lax. More devices, they say, should get the same scrutiny applied to new drugs. While that process is not perfect, a new drug is typically studied in hundreds or even thousands of patients before the F.D.A. 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, an executive with the ECRI Institute, a nonprofit group in Plymouth Meeting, Pa., that evaluates new devices for insurers and hospitals. “We’re never going to wisely allocate resources in health care unless we start to focus on what’s best for patients.”
In response to a Congressional request to study the effectiveness of the F.D.A.’s device-review process, the nonpartisan Government Accountability Office is expected to release a report next month.
Critics say that when the F.D.A. clears a device, the public may wrongly assume that the government has proof it is medically effective. F.D.A. approval has been “widely misinterpreted,” said Dr. Jay R. Harris, the chairman of radiation oncology at the Dana-Farber Cancer Institute and Brigham and Women’s Hospital in Boston.
Differing Opinions
Dr. Dennis R. Hill, the doctor who originally saw Ms. Medlock, scoffs at the notion that MammoSite is in any way experimental. “It is a proven method,” he said. He said the oncologist who told Ms. Medlock it was experimental was skeptical because she provides only traditional radiation.
But the oncologist in question, Dr. Uhl, says she has performed many radioactive-seed treatments but wants to make sure patients are fully informed about the range of options.
Of the 250,000 women in this country who are found to have breast cancer each year, around 200,000 are candidates for radiation treatment if they choose to undergo a lumpectomy or partial removal of a breast. Most still get conventional radiation.
MammoSite proponents say that is because 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 Inc., the company in Bedford, Mass., that markets MammoSite.
Many prominent specialists, though, say the gold standard remains conventional radiation, for which breast cancer local recurrence rates are 3 percent or less at five years. Success in preventing cancer recurrence is measured in long intervals of 5 or 10 years or more, and there has been little long-term study of MammoSite.
Even a radiation oncologist who is a leading proponent of the MammoSite treatment, Dr. Frank A. Vicini, wants to know how it compares with traditional radiation. He is directing a national study of MammoSite’s effectiveness, but he cautions that it could take decades to conclude whether it should be used in lieu of conventional radiation.