Source: The Chronicle of Higher Education, December 12, 2003. Report on fibromyalgia research taking place at Dartmouth College.
What it is: A way to treat the muscle pain, chronic fatigue, and other symptoms of fibromyalgia syndrome using hormones administered through a gel.
The market: Fibromyalgia, a musculoskeletal pain disorder, affects three million to six million people in the United States, 95 percent of whom are women. There is no known [single] treatment for the disease, the cause of which is unknown.
The spark: For Hillary D. White, it was all very personal. An associate professor of microbiology and immunology at Dartmouth Medical School, Dr. White was dealing with the stress of applying for a big federal grant when she began to realize how much her back and legs were hurting, and how tired she was feeling.
She soon recognized that her symptoms were those of fibromyalgia. Because of her interest in reproductive immunology, she knew that hormones like estrogen and testosterone are thought to limit pain. She also knew that male hormones are anabolic – “they build muscle.”
Then one day she let her mind wander. The symptoms of fibromyalgia, she realized were “eerily similar” to those for low testosterone: chronic fatigue, sleeplessness, and muscle wasting. “I was lying down at home feeling pain all over and feeling miserable,” she says, when a simple thought popped into her head. “Maybe this is a problem with testosterone.”
Developing the invention: A blood test gave strength to her theory. While most healthy women have low levels of testosterone, Dr. White’s were extremely low. “Undetectable,” she says.
Under treatment from a fellow Dartmouth physician, she began investigating testosterone. The results “were immediate and enormous,” she says. Soon after, she applied for a patent.
Invention’s status: Dartmouth received a patent on Dr. White’s idea in August 1999, just five months after applying for it. The university licensed the invention to a New Hampshire company, Bentley Pharmaceuticals, in October 2000.
Dartmouth chose Bentley because the company had already developed a technique for administering testosterone through the skin by use of a gel, but the company hadn’t firmly settled on the kinds of ailments it hoped to treat. “We had the symptoms; they had the product,” says Dr. White.
Bentley subsequently helped pay for a 12-patient clinical trial to test the testosterone gel for treating fibromyalgia, with some additional financial support coming from a state program designed to help promote the development of local companies.
The company is now planning a larger follow-up trial. Bentley and Dartmouth have also jointly applied for a patent specifically on the use of the gel form of testosterone to treat fibromyalgia.
Because the product is not yet on the market, Bentley is not paying royalties to Dartmouth, but the company has made some initial “milestone” payments as it moves to develop the product.
Meanwhile, Dr. White continues her research. She suspects that other hormones might work as well or better in treating fibromyalgia. “I don’t think testosterone is the entire story.”
The website of the Dartmouth Medical School is http://www.dartmouth.edu/dms/index.shtml.