US doctors accuse company of influencing drug policy
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Eli Lilly and Co. may have improperly influenced guidelines on the treatment of a dangerous infection called sepsis in order to sell more of an expensive new drug, three federal researchers said on Thursday.
Lilly did not deny trying to influence the guidelines by hiring a marketing firm and by paying doctors and ethicists to launch a campaign about choosing which patients to treat in the emergency room.
But the company said its efforts were educational, and had the goal of making sure only the appropriate patients were treated with the drug, called Xigris.
The U.S. Food and Drug Administration’s approval of the drug in 2001 was controversial, and half of the members of the advisory committee that considered the new drug had voted against it.
But the need was great—sepsis is system-wide infection that elicits an overwhelming and often deadly immune response. As many as 750,000 people develop the condition every year in the United States alone and up to 30 percent of patients die of severe sepsis, while up to 70 percent die of septic shock.
Lilly developed Xigris, a genetically engineered human protein also known as recombinant human activated protein C, or rhAPC, as a way of trying to control the deadly immune response.
Antibiotics can cure sepsis, but they take time.
A single trial showed that Xigris reduced deaths by 13 percent, from 44 percent to 31 percent, in patients with the highest risk of dying.
Xigris was considered a potential blockbuster for Lilly, with some analysts forecasting sales of more than $1 billion a year. But its sales hit only $214.6 million in 2005.
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One of the advisers who voted against approval was Dr. Peter Eichacker of the National Institutes of Health. He and two other NIH staff, Dr. Charles Natanson and Dr. Robert Danner, accused Lilly of pushing for guidelines on sepsis that were “an extension of a pharmaceutical marketing campaign.”
A campaign was set up including targeted marketing to doctors and the trade press and spreading word “that the drug was being rationed and physicians were being ‘systematically forced’ to decide who would live and who would die,” they wrote in an unusual letter to The New England Journal of Medicine.
The company also issued a $1.8 million grant to a group of doctors and ethicists to set up a task force “purportedly to address ethical issues raised by rationing in the intensive care unit”, the three researchers wrote.
“Finally a Surviving Sepsis Campaign was established, in theory to raise awareness of severe sepsis and generate momentum toward the development of treatment guidelines.”
The campaign “appears to have usurped guideline development for commercial purposes, possibly compromising highly regarded, third-party arbiters of medical quality in the process,” they added.
Later testing showed Xigris in fact can cause bleeding, and the company has said it is looking for way to identify, which patients would benefit from it.
“Our educational grant support for critical care and severe sepsis came at a crucial time for the scientific and patient communities,” the company said in a statement.
“Not all patients with severe sepsis are candidates for Xigris, so it was essential to help physicians identify which patients would be at a high risk of death, the approved patient population for Xigris.”
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