Tuesday, August 18, 2009

Obama's pills

PINK PILL vs BLUE PILL

It is interesting that President Obama implied in his national media address on health care that the only difference between a costlier pill and a less expensive one is color. Why take a blue pill when a pink might be less costly? The White House is now proposing that one factor in keeping drug costs too high is the patent laws.

In making these arguments it is shocking for me to see these politicians who have degrees in History ignoring the historic role that color and patent law had in saving the life of FDR,Jr in 1936 and then in turn creating the public clamor in favor of the creation of the Food and Drug Administration. In one of the most compelling cases in patent law history it turned out that it was the color red that saved the life of the son of the President and millions of other people world wide to this day.

In 1932 the German Pharma giant Bayer concluded a five year research project on a red colored pill they named, Prontosil. The researchers noted that lab mice had been cured of bacterial infections when treated by the new drug. Prontosil was the first antibiotic and by showing the scientific community that bacterial infections could be treated it helped save many millions of lives throughout the world. Its developers received the Nobel Prize for Medicine.

But now the TWIST comes. It turns out that the color made all of difference in the effectiveness of the drug. And it was the patent for the medicines that helped scientists discover the true value of the color of the pill.

In 1936, the French Pharma group at the Louis Pasteur Institute realized that they could not compete with Bayer and other companies spending the equivalent of billions of dollars in today's economy on drug and patent development. So they took to researching how to create new drugs that were patent knock offs. That is, drugs that performed the same but were different enough to get around the patent laws.

The husband and wife research team, Jacques and Therese Trefouel, discovered that the red dye used by the Germans had a drying agent that made the color consistent. The drying agent's patent was old and in the public domain. But the real discovery was that the drying agent, SULFA, was the real antibacterial in the pill.

So color and patent law teamed up to create the world's first miracle drug. It is a twist that we should all be made aware of when looking to radically overhaul our pharmaceutical system.

The final twist in this story is the role SULFA then played in helping to form the FDA. Because the drug was off patent it was being manufactured by anyone who could mix the chemicals together to make the color red. There were no dosing regulations and no controls over the process. Eventually a small manufacturer unknowingly produced a sulfa drug with a mixture that was deadly for young children. The resulting outcry by the public helped in the creation of the FDA to regulate the manufacture and sale of medicines here in the USA.

It should be noted that the US is now the home to almost all of the top developers of new drugs and treatments. If we change our system how is it going to change the development of medicine? Or, is the White House simply saying that there is nothing new to be developed...especially if it costs too much.