Two steps forward, one step back

Senator David Vitter had some things to say to the FDA yesterday, in response to their recommendation to revoke the approval of the drug Avastin as therapy for breast cancer:

Vitter, R-La., used emotional language in a news release announcing his request for a meeting with the head of the FDA’s Office of Oncology Drug Products, though he was more restrained in the letter itself.

“I shudder at the thought of a government panel assigning a value to a day of a person’s life,” Vitter said in the news release. “It is sickening to think that care would be withheld from a patient simply because their life is not deemed valuable enough. I fear this is the beginning of a slippery slope leading to more and more rationing under the government takeover of health care that is being forced on the American people.”

So much for progress.  We’re back to death panels.

Let’s review.  This was a recommendation made by the FDA’s independent advisory panel, which came out 12-1 last week to recommend the revocation.  They were only talking about breast cancer, not treatment of other cancers, for which the drug continues to enjoy approval:

The FDA in 2008 approved Avastin for breast cancer patients based on a trial showing it extended the amount of time until the disease worsened by more than five months. The decision was considered controversial by some cancer doctors because the drug had not been shown to extend patients’ lives.

As a condition of approval, Roche was required to conduct follow-up studies to demonstrate the benefits of adding Avastin to conventional chemotherapy.

But two follow-up studies recently submitted by the Swiss drugmaker did not show the same degree of delay in cancer progression as earlier studies. Additionally, patients taking Avastin did not show a significant improvement in lifespan, the gold standard of cancer treatment effectiveness.

Roche scientists argued Tuesday that patients taking Avastin experienced improved quality of life as tumor growth and other symptoms are delayed-but panelists were not convinced.

“The study shows there’s very little benefit to patients with significant toxicity risks and no clear survival benefit,” said Natalie Compagni Portis, the panel’s patient representative.

I think it’s worth nothing that as part of these panels, they always make sure the public is represented by a patient representative.  Ms. Portis is a breast cancer survivor, and a past board member of Breast Cancer Action.  Go back and read her comment.  Does Senator Vitter think she’s running the death panel for breast cancer patients?  Here are some more comments from the people Senator Vitter is attacking:

“Everybody wants to offer metastic breast cancer patients hope, but we shouldn’t offer them false hope,” panel member Natalie Compagni-Portis, a patient representative with Breast Cancer Action in San Francisco, said during the meeting, according to the AP. “We have to raise the bar in terms of safety.”

“These patients are terminal, and it’s our job to make their lives better, not to say that it’s OK to have a stroke or that it’s manageable,” Maha Hussain, an oncologist at the University of Michigan and the advisory panel’s chairwoman, said during the meeting. “You didn’t show that patients are living better or that they’re living longer.”

How did they come to this decision?

In trial results submitted to the FDA by the drug’s U.S. maker, Genentech Inc., use of Avastin (bevacizumab) did boost the progression-free survival of women with advanced breast cancer by an average of 5.5 months, when combined with the chemotherapy drug paclitaxel. Progression-free survival refers to survival without any advancement of the malignancy.

However, the same Genentech study of 722 patients showed that patients reaped no gain in terms of their overall survival after taking Avastin.

Another company-funded trial, this time including 462 patients with advanced breast cancer, showed similar results, with Avastin having no effect on overall survival.

At the same time, the FDA said, the drug has “major safety issues,” including hypertension, clotting events, left ventricular heart dysfunction, heart attack, gastrointestinal perforation and proteinuria (excess protein in urine). A special FDA staff review of the data found that rates of grades 3 to 5 toxicities rose by more than 20 percent when cancer patients received Avastin on top of regular chemotherapy.

Let’s be clear.  It’s proven that the drug has serious side effects.  It is uncertain that it’s doing any good.  So the independent advisory panel recommended that its previous approval – contingent on further results that did not occur – be revoked.  I’m curious what results would have to occur for Senator Vitter to oppose the drug.

Can we all agree that it’s not a good idea for us to take drugs that are known to hurt us and not known to help us?  Can we manage to do so without wheeling out death panels?

FYI, here is Breast Cancer Action’s letter supporting the panel’s decision.  I assume Senator Vitter will be attacking their motives as soon as possible.

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