Are You Ready For Nanomedicine?

Well, it seems that the Federal Drug Administration is willing to admit when it has short comings. But it is going to regulate the latest entry – nanotechnology. Noting the “critical need to learn more” about the impact of nanotechnology on medicines and medical devices, the FDA has asked for help.

Speaking out in support of this action by FDA, is Gang Bao, director of the Center for Pediatric Nanomedicine, a joint project of the Georgia Institute of Technology, Emory University, and Children's Healthcare of Atlanta.

Jamey Marth, PhD, director of the Sanford Burnham Center for Nanomedicine at the University of California, Santa Barbara said that the application of this technology is truly revolutionary.

In nanomedicine it is difficult, but important, to understand the scale of the nano. A nanometer (nm) is a billionth of a meter. For example a single sugar molecule in 1 nm in diameter, the DNA helix is 2 nm in diameter, a typical virus in 75 nm in size and a red blood cell is 7000 nm.

According to Jamey Marth, we have not been able to answer all question about a lot of diseases. These diseases, diabetes, cardiovascular disease, disease of aging, and cancer have some genetic bearing, but this is only part of the answer. With nanomedicine we will be able to identify and discover those processes that are outside our genetic makeup. Nanomedicine give us new tools to treat disease.

The FDA has already approved two cancer drugs based on nanotechnology. Besides better treatment with few side effects, the second generation drugs of this type will carry nanoparticles on their surfaces that not only target the drugs to cancer cells, but also allow them to penetrate deep into tumors.

Marth says that nanomedicine will speed the discovery of biomarkers that identify diseased cells. Once these biomarkers are found, they can be used to bind therapeutic nanoparticles only to the cells that need them, leaving normal cells alone.  Bao's team is pioneering another approach: using nanoparticles to repair genetic mutations. Their first target will be the mutation that causes sickle cell disease.

The major task ahead for the FDA will be to set guidelines for demonstrating that new nanomedicines are safe. But Marth says there are both toxic and nontoxic approaches to nanomedicine. Even so, Bao says the FDA guidance will be important, as materials that behave one way on a normal scale can behave quite differently at a nanoscale.

"There might be some unique features of nanoparticles that induce some toxic effects," Bao suggests. "If they could get into the body, stay in the cells, not be cleared, there might be some harmful effects down the road, and we need to understand that. We do not think the particles we use have any intrinsic toxicity, but we need to know this for sure."

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