XIGRIS Case

In 2001, the FDA approved XIGRIS, rhAPC, for the treatment of sepsis on the basis of a single trial the PROWESS study.

Eli Lilly, the developer of the drug, finding resistance to its (expensive) utilization, hired a public relations firm to develop and implement a three-pronged plan to increase sales:

1. Market to involved physician groups.2. Spread the word that the drug was being rationed and physicians were

“systematically being forced” to decide who would live and who would die.3. They created the “Surviving Sepsis” campaign to raise awareness of severe

sepsis as a problem and push toward treatment guideline.

They spent $1.8 million on a group of ethicists and physicians for a “Values, Ethics, Rationing, and Critical Care” group to make the ethical argument for more therapy.

They promoted guideline development and essentially paid the entire cost.

They, through the use of physicians with conflicts of interest, managed to get XIGRIS to the top of a new guideline on the treatment of sepsis and managed to avoid mention of those studies that indicated that XIGRIS caused an increase in bleeding.

Not all scientific societies accepted the guidelines.

Interestingly, the utilization of XIGRIS did not increase between 2004—2006.

Questions:

1. Indicate what is unethical in this scenario?2. Drug companies with a strong economic motive can put a lot of money into a

campaign for their drug. What can be done to prevent them from completely dominating the drug evaluation process?

3. The process of utilizing experts to adjudicate FDA approval and the guideline development comes into conflict with the very widespread conflicts of interest seen among experts in the field. What approaches would you use to assure knowledgeable and objective evaluations?

4. What does the term “discounting” signify in research involving conflicts of interest.