Will outcry sway federal official?
by Staff Writer
by Frank DeLoache
WASHINGTON, D.C. – Shannon Morgan went to the national’s capital to fight for her life.
Her husband, Pat, accompanied her for the chance to look federal administrators in the eye and tell them their system is broken and harming the breast-cancer patients they are supposed to protect.
Dr. John Powderly, Shannon Morgan’s physician-oncologist and a cancer researcher, tried telling members of the medical panel in terms they could understand that Avastin is the only drug working for Shannon and a large group of stage IV breast cancer patients.
The Morgans, from south Charlotte, and Powderly, from Huntersville, were apparently the only three people from North Carolina to testify at the June 28 hearing about continued federal approval of Avastin in treating breast cancer.
Shannon and Pat Morgan came away from the hearing angry, fighting mad. They said members of the U.S. Food and Drug Administration advisory panel paid little attention to the testimony of dozens of patients and doctors from across the country. And they were not surprised the panel reaffirmed its earlier recommendation to remove federal approval of Avastin for breast cancer.
“I’m fighting for my life,” Shannon Morgan said after returning to her south Charlotte job later in the week. “I felt like I should be up there and give it my all. I did, and I feel great about that. If they want to be a bunch of idiots, it’s on their consciences.”
“They acted like they were bored and just wanted to be somewhere else,” Pat Morgan added. “This is the same fox that was in charge of the hen house before. The hearing was just a show to act like they really cared. This was a sham.”
Powderly was not surprised by the panel vote either. He thinks guidelines federal officials use to judge drugs are flawed and should be changed.
But he hopes the appeal hearing accomplished something else. The president of Carolina BioOncology Institute hopes the national media coverage and outcry produced by the hearing will give Dr. Margaret Hamburg, commissioner of the Food and Drug Administration, the political ammunition she needs to overrule the panel’s vote. Or at least, Hamburg will have leverage to craft a compromise that will maintain federal approval of Avastin’s use for patients like Shannon Morgan.
Patients got some good news this week when Medicare officials announced they will continue covering Avastin treatments for breast cancer, even if the Food and Drug Administration withdraws its approval. But patients, like Shannon Morgan, who depend on private health insurance don’t have that reassurance.
Hamburg has the final say in federal endorsement of drugs like Avastin, and Avastin is one of the drugs most commonly used to fight brain, lung, kidney and colon cancer. Because of the drug’s success treating those cancers, federal officials gave “accelerated approval” for using Avastin to treat breast cancer in 2008.
Normally, the Food and Drug Administration waits on sufficient testing of a drug before granting approval for general use. Federal officials approved Avastin for breast cancer contingent on tests confirming its success. But federal officials say research gathered since 2008 has shown that Avastin does not significantly extend the life of most breast cancer patients – not enough to justify potentially severe side effects.
But Powderly and other oncologists, researchers and patient advocacy groups spoke repeatedly on June 28 of thousands of patients – like Shannon Morgan and Davidson’s Carol Fleming – whom they refer to as “super-responders.” These Stage IV breast cancer patients have tumors that are incurable and inoperable, and doctors had given many of them only a matter of months to live with traditional radiation and chemotherapy. But repeatedly on June 28, doctors and patients said Avastin has saved and extended super-responders’ lives for as long as six years.
In her five minutes Shannon Morgan spoke urgently to convey to the advisory panel the importance of Avastin to her.
In 1999 when she was 41, doctors first diagnosed her Stage II breast cancer. “I had a radical mastectomy and was treated with four rounds of chemo, six weeks of radiation and hormonal therapy,” she explained. She also had reconstructive surgery.
Two years later, the cancer came back on the opposite breast, and she underwent the same regimen: a radical mastectomy, four rounds of chemo, six weeks of radiation and hormonal therapy and reconstructive surgery.
About seven years later, around 2008, the cancer returned in her abdomen. This time the doctors told Morgan she had Stage IV metastasized breast cancer.
“I was given 12 to 24 months to live …” she told the panel. “I was told chemo nor any other drug was an option. I was told to come back in six months. For what? Nothing! I had just been given a death sentence!
“That wasn’t good enough for me or my husband. We researched and found a well known, respected and caring oncologist, Dr. John Powderly. … He gave us hope. Dr. Powderly treated me with a triple chemo cocktail and Avastin.
“After my last round of chemo, I have continued to be treated with Avastin as maintenance. I have virtually no side effects … My recent bone and body scans show that I remain in remission almost three years later because of Avastin. Dr. Powderly and his team continue to monitor me for any possible side effects. Avastin alone is working for me as well as the many thousands like me. … Avastin is my miracle drug!”
But in their comments before voting again to withdraw approval of Avastin, panel members did not seem to even acknowledge the testimony of “super-responders” like Morgan.
Powderly, who is an adjunct clinical assistant professor of medicine at Duke and the University of North Carolina at Chapel Hill, said he understands how the panel reached its decision. “The process is the best we have, but this was a good example of where the process was overly protective” of all breast cancer patients “by denying (Avastin) to any breast cancer patients.”
The Food and Drug Administration “can’t make individual exceptions. It can’t approve a drug only for those it’s working for. It can’t say, ‘Just go ahead and try it.’ It has a statutory obligation to approve drugs considered efficacious and safe for the breast-cancer aggregate population,” Powderly said.
The other flaw is the way federal officials study drugs and what they consider important. “The FDA prefers to have death as a primary end point,” Powderly said. “I know that sounds crude, but the gold standard for drug studies is to follow a patient to death.”
But to conduct those types of studies, some breast cancer patients would have to get placebo – or harmless – drugs while others got Avastin. Then doctors would then measure who lived longer and their quality of their lives.
But Powderly and others have a moral objection to following a woman until she dies, knowing Avastin might have given her time. Powderly said doctors must offer patients “dignity of treatment.”
Federal officials should allow researchers to re-design future Avastin trials, he said. If a woman is randomly selected for chemotherapy without Avastin, but the chemotherapy doesn’t work, the trial should offer the patient the chance to “cross over” to receive Avastin treatment.
That puts an “earlier end point to the research,” basing conclusions on response rates and whether the drug stabilizes the cancer, instead of waiting for a woman’s death without access to Avastin. Researchers have been arguing for years that federal officials should give equal weight to those studies.
Another factor – call it human nature – has “diluted” the Avastin trial results.
Researchers have followed breast cancer patients who enroll in studies of Avastin, Powderly said. If by random selection, they get the placebo while other patients get Avastin, those with the placebo often see their cancer is still growing. In that case, many drop out of the study and obtain Avastin themselves separate from the trial.
The result is that Avastin may be lengthening the lives of the general population of breast cancer patients, thus compromising any attempt to compare Avastin patients to the general population.
But Powderly hopes the voices of patients and doctors may sway federal officials. “My hope is that the public outcry might have allowed the FDA to save face,” he said. “I hope it gives the commissioner a little bit of cover” to throw a lifeline to Avastin “super-responders.”
If not, Pat Morgan said, he and his wife and thousands of others are discussing a class action suit against the federal health agency.