Reply #14: Read the article [View All]

[sangh0]

It goes into it a bit.

In order to get FDA approval, a procedure/drug/machine/etc, has to shown to be safe and effective at treating something. Once that's done, it's approved and once approved, doctors can use that procedure/drug/machine/etc for ANY purpose EVEN IF it hadn't been tested or approved for that particular purpose. It's called "off-label"

The use of these treatments have NOT BEEN TESTED to see if they effectively treat the condition. They have only BEEN TESTED to see if the effectively treat SOME OTHER CONDITION.

From the article:

The problem arises because while drugs and devices are tested and evaluated by the Food and Drug Administration before they come on the market, those tests often leave huge gaps in doctors' knowledge of how well they work, and for whom.

The tests to gain F.D.A. approval "leave an awful lot of ground uncovered," said Dr. Richard Platt, professor and chairman of the department of ambulatory care and prevention at Harvard Medical School.

They do not tell doctors or patients whether an older and cheaper drug is as good as or better than a newer one, for example. And they do not reveal whether older people, with many medical conditions, will fare as well as the generally younger and healthier people on whom the drugs or devices were tested.

"The best way to learn about practical problems and practical benefits," Dr. McClellan said, "is to evaluate how treatments do in real world settings."

Dr. Platt and other academic experts, as well as patient advocacy groups like the Center for Medical Consumers in New York, agree, and applaud the new Medicare initiative.

It is so compelling, said Dr. Robert Califf, director of the Clinical Research Institute at Duke University, that "almost regardless of your political philosophy, this makes sense."

"We have an increasingly powerful array of drugs and devices and a bewildering array of choices," he said. "And there is a broad agreement among people who make these choices that we don't have the information we need."

The dearth of information reached a crisis with cancer drugs, Dr. Tunis said, when new drugs, so-called biologics, began reaching the market.

With cancer drugs, he said, the tradition is to test new medications in situations that their makers think are most likely to show benefit. That leads to approval by the F.D.A. Then the drugs often come into widespread use off-label - doctors give them to patients with different cancers or in combination with other drugs, trying them out in new contexts. Medicare is required to pay for the original approved use and for uses listed in certain drug compendia. Other than that, Medicare payments for off-label uses are up to the discretion of local contractors to the agency. Some pay; others do not.