Democrats Seek Bill to Kill American Poor

A guest Editorial in the WSJ uses the less provocative headline "Uncle Sam, M.D." (Paid link)

But never, never forget that increased government in the regulation of pharmaceuticals costs lives. Dr. Scott Gottlieb opens his article with an important story of expanding the use of a compound outside of its approval aegis.

Almost 13 years after the drug Bexxar was first used in cancer patients, the Food and Drug Administration cleared it for marketing in June 2003 to treat a particularly deadly form of non-Hodgkin's lymphoma. Bexxar represents a leading edge of cancer innovation, attaching a radioactive payload to a protein that is designed to hone in on cancer cells and unload its toxic cargo. The drug isn't a certain cure but has clearly prolonged many lives in its four years on the market, and might have already benefited twice as many patients if it didn't spend an equal number of years awaiting FDA approval.

The same thing happened to Erbitux. While Dr. Waksal and Martha Stewart were in court, prison, or house arrest, and imClone was performing two years additional testing for a use the company did not recommend, people were dying of colon cancer at the rate of 15,000 per year.

After it was approved, it was found effective in treating other forms of cancer -- upping the death toll from keeping it off the market for two years and stifling innovation.

No bad deed goes unrewarded in government. A new, Democratic led 110th Congress is seeking broader powers for the FDA:

The new drug safety legislation, which is attached to a larger bill that renews the FDA's principal funding stream called the Prescription Drug User Fee Act, will change the way drugs are used by patients through provisions that give the FDA more control of medicines after they are approved. One central measure would put the FDA squarely in the role of regulating medical decisions in order to "manage" drug risks -- by giving the agency unprecedented new authority to control the way drugs are distributed by pharmacies and prescribed by physicians. It's a watershed measure, one that will grant the FDA some of the same responsibility for regulating medical practice that has been traditionally left to the states and professional medical bodies.

Please call your representatives. Tell them not to allow the Democrats to keep new drug innovations away from our nation's poor. It's just not right.

Pharmaceuticals Pharmaceuticals Posted by jk at June 18, 2007 9:54 AM