Intellectual Property vs. Medical Progress

Here is a Wall Street Journal article that describes how an important medical treatment for brain injuries got no support, in part because it depended on a naturally occurring chemical rather than a potentially patented blockbuster drug.Burton, Thomas M. 2007. “One Doctor’s Lonely Quest to Heal Brain Injury: After 40 Years, Skeptics Back Hormone Therapy.” Wall Street Journal (26 September): p. A 1.

“Decades of research — often conducted in his spare time and with piecemeal funding — led him to a surprising hypothesis: that progesterone, a natural female hormone that protects fetuses in the womb, may actually protect and heal injured brains. His work slowly helped overturn medical orthodoxy that states that brain tissue, once injured, stays that way. Now he and colleagues plan a large-scale human trial over the next several years. While the outcome is far from assured, the effort could produce a new treatment for the estimated 10 million people world-wide who suffer traumatic brain injuries each year.”

“Dr. Stein’s journey shows just how difficult it is to challenge the medical establishment, which often begrudges ideas outside the mainstream. It also underscores how difficult it is for a lone researcher to persevere without drug-company or other major financial support: For many years, Dr. Stein held administrative jobs and had to moonlight to continue his research. Drug companies tend to focus more on blockbuster drugs they design than on naturally occurring ones with minimal profit potential.”


After decades of neglect, his work was finally subjected to experimental trials.  Here is what happened:

“Over the next three years, the study focused on 100 head-injured patients who had been brought into the emergency room at Grady Memorial Hospital in downtown Atlanta.  Some patients received standard treatment to control bleeding and fevers along with state-of-the-art head-injury treatment.  Others were also given intravenous progesterone, at triple the highest natural levels at the end of pregnancy.  One Saturday morning in 2005, Dr. Stein was driving north of Atlanta on a shopping trip with his wife when a stern-sounding Dr. Kellermann called him. Dr. Kellermann said he had just learned the study’s findings, adding, “Pull over to the side of the road.”

“Dr. Stein froze, fearing that decades of research with animals would prove useless, that progesterone might have turned out to raise the death rate in humans for some unforeseen reason.  His heart was thumping as Dr. Kellermann told him the results: Patients on progesterone had a death rate of just 13% from their head injuries, less than half the 30% death rate of those on standard treatment.  And progesterone showed no negative side effects.  The 100-subject study was too small to prove that progesterone caused the lowered death rate, but the findings were consistent with animal research. Don Stein was so elated that he had to ask his wife to take over the driving.”

“In the respected journal “Annals of Emergency Medicine” this past April, Dr. Stein and his researchers summarized the study: “Moderate traumatic brain injury survivors who received progesterone were more likely to have a moderate to good outcome than those randomized to placebo.”



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