FDA holds discussion on cancer drug

by Frank DeLoache

The U.S. Food and Drug Administration has invited a south Charlotte woman, who has survived three years despite a diagnosis of stage-4 breast cancer, to testify June 28 in Washington, D.C., in support of Avastin, the drug she believes has prolonged her life.

Testifying with Shannon Morgan will be her husband, Pat, and Dr. John Powderly, the Huntersville oncologist who has treated Morgan and other women diagnosed with breast cancer that is both inoperable and incurable.

The Morgans and Powderly apparently are the only three people from Charlotte invited to speak at the two-hour hearing, Powderly said this week. Federal officials have scheduled 40 people from across the U.S. to speak for three to five minutes.

Avastin is one of a new type of cancer drugs that cuts off the blood supply to cancerous tumors, preventing the cancer from growing. So even in women who have breast cancer that can’t be cured or operated on, Avastin can essentially stop further growth of the tumor, according to Powderly, a board-certified oncologist who operates Carolina BioOncology Institute, which is affiliated with Presbyterian Hospital-Huntersville.

Despite Avastin’s miraculous work for Morgan and other cancer patients across the country, the U.S. Food and Drug Administration announced last year it would withdraw approval for Avastin for treatment of breast cancer. The federal agency, following a recommendation of one of its advisory groups, said, “The data indicate 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.”

If federal officials remove their endorsement of Avastin for breast cancer, the drug will remain available to women, but the Morgans and others fear that insurance companies will no longer pay for the drug. “Who can afford $90,000 for a drug?” Pat Morgan said.

The agency still endorses the use of Avastin to treat colon, lung and brain cancer, Powderly said, and he believes researchers just don’t have enough data to show Avastin’s long-term effectiveness on Stage IV breast cancer.

But at the hearing on June 28, Powderly said federal officials will receive more research work, and he hopes Margaret Hamburg, head of the Food and Drug Administration, will reverse her earlier ruling against Avastin for breast cancer.

“I would be very happy to speak as an oncologist who treats breast cancer patients every day with Avastin …” Powderly wrote in application to testify at the hearing. “Our patient Shannon (Morgan) is an outstanding example of someone who has benefited greatly from Avastin. So I, like most oncologists, feel strongly that Avastin should remain FDA approved for breast cancer patients. I am very familiar with the Avastin breast trials, as I also was a principal investigator for these studies.”

Powderly credits Pat Morgan, Shannon’s husband and a former U.S. Marine, with getting their invitations to testify. Federal officials apparently couldn’t ignore Morgan’s unrelenting, vocal advocacy for his wife and other breast-cancer patients who depend on Avastin, Powderly said.

“It’s nice that the public outcry has forced them to reconsider their decision,” Powderly said.

“I write the FDA almost every day,” Pat Morgan said this week. “Any time I read something, I send them an email: ‘Did you see this one?’ ”

Still he has been bitterly disappointed that federal officials seem to have no interest in hearing from dozens, if not hundreds, of women from across the country – as well as oncologists like Powderly – who believe Avastin is effective.

“It’s so demoralizing,” he said from his home in the SouthPark area. “I’m so mad at my country right now.”

Morgan said he has appealed to U.S. Sen. Kay Hagan and U.S. Rep. Sue Myrick for help. After six months, Hagan sent a polite thank-you note and nothing else. Myrick issued a statement voicing her concerns about the Food and Drug Administration’s decision and promised to raise the issue in House committee hearing.

But Myrick “has disappeared” since then, and Pat Morgan is still trying to get an appointment with U.S. Sen. Richard Burr.

At the hearing, Pat Morgan said his wife will try to personally convince federal officials of the difference Avastin has made in her life. She continues to work at Marsh USA, an international insurance brokerage, a job that she’s held more than 30 years. She cared for her parents, both of whom died within a short time this year, Pat Morgan said.

For his part at the hearing, “I’m going to be the bad cop,” Shannon’s husband said. “Why has this seemingly a miracle treatment in Europe? Why take it away from breast cancer patients but leave it for other cancers?”

The patient and her doctor should decide to use – or not use – Avastin, he said.

“This is not the America I grew up in.”