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FDA hearing on Avastin draws protestors — UPDATED

FDA.Protest.June2011.jpg

Scores of protestors, many of them women with breast cancer, demonstrated outside a pivotal meeting at the US Food and Drug Administration (FDA) earlier today.

They were demanding that the US drug regulator reverse a December decision to withdraw its approval for the use of Genentech’s Avastin (bevacizumab) in metastatic breast cancer – breast cancer which has spread to other parts of the body.

“We sent a message to the FDA today loud and clear: Keep your hands off our women and allow them to keep their Avastin,” said Terry Kalley, the founder and president of the group Freedom of Access to Medicines which organized the protest along with the Abigail Alliance for Better Access to Developmental Drugs. The protestors estimated their numbers at 75 to 100. (FDA challenged this figure: see the update below.)


The FDA currently approves Avastin for treating colon, kidney, brain, and lung cancers. If the agency does not reverse its December decision, Avastin will become an “off-label” drug for breast cancer – meaning that doctors can still prescribe it but insurance companies will stop covering the approximately $8000 per month cost of taking it, putting the drug financially out of reach of most women.

The FDA argues that Avastin has not been shown to be safe and effective in women with breast cancer that has spread. It had earlier granted an accelerated approval for the drug’s use in this situation, but a condition of such an approval is that the agency be able to revoke it if further studies don’t bear out a drug’s safety and efficacy for a particular use. The FDA set that revocation process in motion last December, as Nature‘s blog details here. Its stance was made the more controversial by the European Medicines Agency’s simultaneous decision that Avastin “remains a valuable treatment option for patients suffering from metastatic breast cancer.”

The FDA, by contrast, had decided that:

“the drug does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh the significant risk to patients. These risks include severe high blood pressure; bleeding and hemorrhage; the development of perforations (or “holes”) in the body, including in the nose, stomach, and intestines; and heart attack or heart failure.”

As part of the revocation process, the agency’s Oncologic Drugs Advisory Committee is meeting today and tomorrow at a hearing – the first of its kind – requested by Genentech, part of the Swiss pharmaceutical giant Roche.

After hearing from patients, FDA officials and the drugmaker, the committee will vote tomorrow on whether FDA should continue the process it started in December and finalize its reversal on Avastin for metastatic breast cancer. The committee’s non-binding recommendation will then be considered by agency commissioner Margaret Hamburg, who will make a final decision in the coming weeks or months.

(For chapter and verse on the process, see this opening statement from today’s meeting, from Karen Midthun, the FDA official who chaired the meeting. Midthun, the top agency official in charge of biologic drug approvals, added: “FDA understands the enormous challenges we face with respect to breast cancer, especially metastatic breast cancer, and how hard it is for patients and the families trying to cope with this devastating disease and the need for more effective treatments.”)

Along with citing compelling personal stories of breast cancer sufferers helped by Avastin, the protestors argued today that the FDA’s process is flawed because the advisory committee is weighted with experts whom they claim are biased against Avastin and removed from its importance for breast cancer patients. Steven Walker, the co-founder of the Abigail Alliance and one of the public speakers, called the process “procedurally corrupt” in these remarks. “None of the voting physicians on the panel,” he wrote, “appear to be engaged in treating breast cancer as a significant part of their clinical research or medical practice.”

You can survey a list of members of the crucial committee here.

Ten police cars and SUVs dispatched by the federal government stopped the protestors from entering FDA property. They were confiined instead to the sidewalk outside the agency.

“No one came here to get arrested,” said Bryan Wilkes of Freedom of Access to Medicines. “We just wanted breast cancer patients and their families to have half an hour of expressing their voices.”

Photo courtesy Abigail Alliance for Better Access to Developmental Drugs

UPDATE, June 29 11 pm: In an e-mail to Nature late today, FDA challenged the organizers’ estimate of the number of demonstrators. Spokeswoman Karen Riley wrote: “There were 30-40 protestors.”

Comments

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    FAMEDS said:

    Freedom of Access to Medicines (FAMEDS) is the advocacy group leading the effort in favor of Avastin for the 17,500 Metastatic Breast Cancer patients currently on the drug. Please visit FAMEDS Website for resources including the latest Avastin hearing news, a collection of articles, videos and photos, and the petition: http://fameds.org

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    jahan said:

    Interesting typo “hear” not here in a verbal quotation. although one can’t be sure what was herd. please notify editorial staff.

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