Little-known FDA exemption enables high-tech cancer treatment

A small group of women, very ill with cervical cancer, benefitted from a $500,000 device that uses heat to combat cancer, approved by federal regulators, but not proven to be effective. 

Hospitals that have used the device--called the BSD-2000--never took part in a study that would have been part of the machine's approval, leaving some cancer experts to wonder how the machine was cleared by the U.S. Food and Drug Administration in the first place, according to a New York Times article. The reason why, according to the article, is that the women in need of the treatment--who were too sick to receive chemotherapy--is too small a group.

Instead, a little-known FDA regulation called the humanitarian device exemption--which requires producers for products only used by a small group of patients to only prove the product is safe and has a probable benefit, instead of having to prove its effectiveness--was used, according to the Times. Junzo P. Chino, M.D., a cancer expert from Duke University, told the Times he sees one patient like the women in the group only about once a year.

"The provision is a good one, but the structure to get good effectiveness data is weak," added Larry Kessler, a former FDA official who is now a professor at the University of Washington in Seattle.

The rule, according to the Times, is similar to the one that governs drugs for rare diseases. Critics say products approved under the exemption get sold for years, while some that could be lifesaving don't get the chance to prove their worth. Under this rule, these products also can be used by doctors in any way.

William Maisel, M.D., chief scientist at the FDA's defense unit, said there is "no requirement that the device ever show more than a probable benefit," and a new study on the BSD-2000 would capture its effects on more patients. According to the article, the device "uses microwave energy to raise the body's temperature to as high as 113 degrees Fahrenheit.

The treatment, according to the newspaper, is based on the belief that high temperatures can kill cancer cells with little injury to normal tissues.

In October it was reported that MIT researchers developed a "stealth" drug delivery system to attack a type of breast cancer that is highly resistant to current therapies. In an article at ACS Nano, Paula T. Hammond and colleagues at the Koch Institute of Integrative Cancer Research at MIT describe a way to sneak small particles into tumor cells, lower their defenses and attack them with drugs. Their work focuses on triple-negative breast cancer (TNBC), an aggressive disease that is difficult to treat with standard therapy.

To learn more:
- read the article in the New York Times

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