WSJ editorial about Avastin: "The Race Against the Cure"

I'm so glad the Journal has been on this issue. I posted about it a few days ago here Breast cancer and the drug Avastin, as well as a few othertmes in the past couple of years.

The FDA hearing is today. The link text is from the middle of the editorial and refers to a prior reveiw by the FDA.

In that episode, Dr. Pazdur rigged the review process against Avastin. Genentech was supposed to show that Avastin improved "progression-free survival," the time women live without their disease spreading or worsening. Over three rigorous clinical trials, and in combination with chemotherapy, it did so, even if the results were less statistically robust in the follow-up studies. But Dr. Pazdur and his staff reviewers unilaterally revised the approval "endpoints" that Avastin was supposed to hit, to undermine the drug.

What Genentech is really challenging is the FDA's statistical purism that blinds it to the benefits that accrue to some patients amid the averages of randomized controlled trials. Avastin offers some terminally ill women months or years of life. For others, it delays the onset of symptoms, improves their quality of life and gives their doctors another tool to better control disease. No treatment in late-stage oncology is perfect, but a good definition of insanity is denying all patients an option because it may only help some of them.

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More broadly, the Avastin fight is about the FDA and its desire to more tightly control the development of cancer drugs. Avastin was initially approved under the FDA's "accelerated approval" process that is supposed to speed treatments for terminal illnesses and unmet medical needs. Dr. Pazdur, the New England Journal of Medicine and the rest of the medical-political establishment have decided that accelerated approval's flexibility is too friendly to commercial drug developers, and in Avastin they've found a pretext to gut it.

The FDA's anti-Avastin campaign is enforcing a culture of research and development that will discourage the innovation, investment and risk-taking that will be necessary to produce the next generation of cancer treatments. More imminently, thousands of women may die more quickly and live with more pain because government regulators substitute their own opinions about clinical meaningfulness for those of oncologists and their patients.

At considerable political risk, Genentech is doing patients and medical science a service with its Avastin appeal. Dr. Hamburg will not make a more important decision during her FDA tenure.

Note the "politiacl risk" to Genentcech - they have 20 drugs in the pipeline, most for cancer treatment. The FDA could sit on approval for those drugs. It's happened before!

Comments

[Antoinette Cosentino MD]

I'm sure it all comes down to $$$.
Too many people with the disease and the drug becomes very expensive. And in this culture of death, why prolong the suffering of these terminally ill women? They should just willingly choose to end it now, and spare, us, the living, their suffering and save us money too!
( For those who don't get it, I'm being sarcastic!)
This is about government power, under the guise of "regulation of a drug." Expect a lot more of this under Obamacare and for common but costly illnesses.

[maria]

Sadly Antoinette, I am in complete agreement.