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Emotion, anecdotes, politics and ugliness in Avastin aftermath

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This week’s vote by an FDA advisory committee to remove the breast cancer indication for the drug Avastin has spawned ugliness that is seen all too often not only in politics these days – but in health care – which often becomes political as this issue already has.

Alicia Mundy of the Wall Street Journal writes:

“Energy and Commerce Committee Chairman Fred Upton (R., Mich.) has “grave” concerns about the FDA’s handling of the Avastin issue, House aides said this week.

That science now faces politics. The FDA will testify before the House Energy and Commerce Committee on Thursday, July 7 regarding the important re-authorization of the 2007 prescription drug user fee act, which impacts the agency’s authority and indirectly affects the agency’s budget. People familiar with the issue say that when FDA drug division director Janet Woodcock appears before the committee, she should be prepared to answer tough questions about the FDA and Avastin.”

And one need not look far for rhetoric on the web – one post calling the work of the FDA advisory committee “Obama’s Death Panel Hard At Work.” Maggie Fox of The National Journal writes:

“Last July, Sen. David Vitter, R-La., wrote to the FDA to accuse the advisers of taking cost into consideration–something the agency denies.

Besides outspoken patient advocates, a giant drug company, and conservative columnists, Avastin has some other heavy hitters on its side. Billy Tauzin, the former representative from Louisiana who became head of the Pharmaceutical Research and Manufacturers of America, credits Avastin for saving his life when he had a gastrointestinal tumor. Tauzin, who now walks the Hill as a lobbyist for AT&T, rarely hesitates to tell his story about his battle with cancer, calling Avastin “a miracle drug.”

Of course, gastrointestinal cancers are not breast cancers and all cancers are not alike and not all respond equally to the same agents.

In a classic episode in 2009 – an episode now ironically sponsored online by Viagra – CBS’ 60 Minutes told the story of Tauzin’s role in ramrodding through the Medicare prescription drug benefit, and, again his Avastin story was cited.

“The treatment was successful, and as a result Tauzin says he felt he owed his life to the drug industry. After serving out his congressional term, he accepted a $2 million-a-year job as president of PhRMA — Pharmaceutical Research and Manufacturers of America.”

And Vitter played a key role as politics hijacked the recommendations of the US Preventive Services Task Force’s recommendations on mammography in November 2009.

So these are becoming familiar themes.

Emily Walker of MedPage Today covered the hearing and wrote this first-hand account of some of the ugliness that took place:

“Christine Brunswick, the vice president of the National Breast Cancer Coalition and breast cancer survivor, took the mike and urged the panel to vote to withdraw the breast cancer indication, saying the data don’t show that it extends the lives of breast cancer patients, but do show it increases risk of harm, especially risk of hemorrhages.

“This decision can’t be driven by anecdotes,” she said. “It must be driven by science.”

Next, a woman got up to give her public presentation and started by saying, “I am disgusted to have to speak after that woman.” Her statement was met with applause.

But perhaps the most biting comment said by one of the patients at the hearing came the next day after every member on the panel — including the patient representative — voted against Avastin keeping its breast cancer indication. By day two, only a handful of patients remained, and they all stood as the vote was read, arms linked.

After the vote was read, they cried silently for a bit, but then began telling the panel about how the drug had worked for them.

One women yelled, “What a patient representative! You better hope your breast cancer doesn’t come back. You’re an embarrassment to all cancer survivors. “

That was met by a sharp intake of breath, or maybe that was just me.

FDA hearings — and all government hearings for that matter — should be a chance for all sides to have their views heard. No well-intentioned person should be subjected to a public flogging, and in this case, have their status as a cancer survivor attacked.”

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Gregory D. Pawelski

July 1, 2011 at 1:26 pm

Merrill Goozner brought up that the Avastin situation maybe a drawback to the “Accelerated Approval” process. Perhaps this is a drawback to the clinical trial system, a scientifically bankrupt paradigm which has not fostered either efficient or humane progress in cancer chemotherapy.
The problem is not with using the prospective, randomized trial as a research instrument, the problem comes from applying this time and resource-consuming instrument to address hypotheses of trivial importance: do cancers prefer Coke or Pepsi?
It is recognized that the benefits of Avastin overall are modest for women with metastatic breast cancer, and that it is known that for some women, Avastin offers a greater than modest benefit. Just who are those who benefit?
The VEGF (vascular endothelial growth factor) system is a target for a number of anti-microvascular cancer drugs. Avastin (bevacizumab) can block VEGF and cause existing microcapillaries to die.
There are a number of new classes of drugs that target VEGF, at the protein level (Avastin), at the tyrosine kinase level (Nexavar, Sutent) and at the intracellular metabolic pathway mTOR (Afinitor, Torisel). However, responses to any individual mechanism occurs in the miniority of patients. It is unclear why some patients repond to these interventions while others fail.
This reinforces the need for cancer therapies to be individualized. It remines us that it is the good outcome of the patient not the therapy applied that constitute successful therapy. There is really nothing wrong with Avastin. It’s a wonderful drug that incorporates the brilliant insights originally articulated by Judah Folkman.
There are not perfect drugs. There are simply drugs that work for certain patients. But that’s not what pharmaceutical companys like to hear. They like to produce drugs that apply to a broad base of patients. To make the most out of a drug, not just some subsets of patients.