Avastin: Emotion or science ?

The FDA hears some very emotional testimony from breast cancer patients yesterday as they pleaded with the FDA to allow Avastin to be used for the treatment of breast cancer.   However an agency medical official described women who suffered fatal hemorrhages or other side effects from the drug and argued that it didn’t deserve approval in breast cancer. Which direction will the FDA go ?  That is going to be decided later but the decision has to be based on science not emotion because medicine is based on science.

“The women who didn’t do well taking this drug can’t testify today,” said Helen Schiff, who came to speak on behalf of a coalition of breast and ovarian cancer survivors. A member of her group who took Avastin suffered a hemorrhage and “was bleeding from every orifice in her body,” said Ms. Schiff. The woman died about a month later, she said.  In a rare move, the FDA offered accounts of side-effect victims to support its case. Agency official Patricia Keegan talked at length about a 53-year-old patient who suffered an “Avastin-related gastrointestinal perforation” after receiving four doses of the drug. “Women are dying,” she said.

Emotion or science ? What happens when a drug can kill patients and can possible extend life ? Does leaving the label give a sense of "false hope" and can our healthcare system afford drugs that may not be supported by science ?

The National Breast Cancer Coalition’s representative, Christine Brunswick, drew boos when she said the FDA’s decision should be based on science, “not on any individual story, no matter how compelling.”

A number of pro-Avastin patients and family members said they were afraid that if the breast cancer approval is taken off the drug’s label, their insurers or Medicare will stop paying for the drug, which costs about $88,000 a year.
But some doctors and government officials said that was unlikely because the drug will continue to be listed as a breast-cancer treatment in compendiums that Medicare and private insurers use as references.

“Most of the major insurance companies have said they will continue to pay for Avastin for breast cancer because they follow NCCN standards,” said Len Lichtenfeld, the deputy chief medical officer for the American Cancer Society, in an interview. “I’m not certain an insurer would want to fight this coverage battle in the current environment.

However this problem goes to the root of how the FDA approves drugs and what for what indications.  If further studies are needed than the FDA must work with Roche to implement these studies.  The FDA could also recommend Avastin as a last line treatment but the FDA has to look at the data and set the direction based on the science not emotion.  They key question that is going to have to be answered is “should a label be changed when a drug can hurt a lot of patients while helping a few?”