Quickly Vetted, Treatment Is Offered to Patients

Better not to get sick in the first place.

"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...

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.'"

And maybe some of these approaches will work.

But that is not the point.

It is better not to enter the sick care system until absolutely necessary because once you have to, you have lost.

"Fitness is the only REAL preventive medicine." (tm)

The sooner you get it, the better off you will be.