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Entries in Genentech (2)

Tuesday
Apr242012

Company Approves Drug for Dying Mother

Photodisc/​Thinkstock(TAMPA BAY, Florida) -- Social media proved to be one powerful tool for a mother dying of breast cancer and desperate to get a drug that has yet to be approved by the U.S. Food and Drug Administration.

In a self-made video, Darlene Gant lies in her bed, too weak to sit up. She holds up a letter to her son. Beside her are several other letters: one for her son's 12th birthday, two more for his high school and college graduations, another for his wedding day. Gant is writing these letters now, because she doesn't believe she'll be around for the milestones.

Gant, 46. from Tampa Bay, posted the video on YouTube as an attempt to plead with the FDA to allow her to use a trial drug known as pertuzumab under compassionate use. The FDA is expected to approve the drug, developed by Genentech, on June 8. But Gant doesn't expect to live that long.

"In the meantime, no one is eligible for compassionate use, including me, so, although I don't put everything into pertuzumab, it could stabilize me and help save my life and extend my time here on the earth with my 11-year-old son and my family," Gant said in the video.

Gant initially took aim at the FDA for prohibiting the medication, but she soon realized that FDA had given the green light. It was Genentech Inc. that initially refused her the drug.

Gant said she and family members sent in several requests to obtain the drug before the expected approval date, but the company refused. She implored viewers to write to Genentech to request the drug for compassionate use.

Days after posting the YouTube video, South San Francisco-based Genentech agreed to provide the unapproved drug to Darlene for compassionate use. A spokeswoman for the biotechnology corporation said it is now working with Gant's doctors to provide the drug to her.

"Genentech is committed to a fair and impartial evaluation of each request for access to our investigational medicines, and takes these requests very seriously," company spokeswoman Krysta Pellegrino said. "Appropriate decisions regarding potential access to investigational or unapproved medicines can only be made after in-depth discussions between Genentech clinical teams and the person's qualified treating doctor."

While treatments and medications, particularly for compassionate use, are highly individualized and decided on a case-by-case basis, Lisa Gualtieri, assistant professor of online consumer health and social media and health at Tufts Medical Center in Boston, said that social media is becoming a new way to communicate about health and medicine.

"Darlene Gant made a very emotional plea for herself 'and all the other mothers … passing on our final words,'" Gualtieri said. "There may have been other ways she could have gone about her appeal, but it worked. The drug company responded. Drug companies are themselves increasingly using social media, and I hope they use it as a mechanism for more open communication with patients and their families in much the same way many businesses have done: to listen, to respond, and to monitor sentiment."

Dr. Richard Pazdur, director of the FDA's Office of Oncology Drug Products, explained in a blog Friday that the FDA must work directly with the companies and patients' physicians to decide whether a person is an appropriate candidate for a drug under compassionate use. Costs, interference with drug development and company policy tend to be the reasons pharmaceutical companies deny a patient a drug for compassionate use.

"Drug companies ... don't want a death attributed to their new drug," said Art Caplan, professor of ethics at University of Pennsylvania. "They may not have any idea how much drug to use and they often have a very limited supply on hand, which they hope to use in testing the drug not for one person's last desperate gasp at a bit more life."

Patients must have an immediate need and a life-threatening disease or condition to gain access to unapproved trial drugs. If eligible, the manufacturer and the patient's doctor must make special arrangements to get the drug for the patient.

While Gant's way of obtaining the drug was unique, Caplan said it is unlikely that this will set a precedent in getting trial drugs.

"Every case is a huge maelstrom of hope, begging, corporate self-interest, slow bureaucratic due process, media spotlighting and public frustration," Caplan said. "It is simply very hard to solve access issues with a single policy given the many interests besides the patients that are in play in these cases. Each winds up being unique."

Gant said she is "excited" to obtain the drug for compassionate use, which she will begin taking in one to two weeks. But she also feels guilty that so many other women do not have the same opportunity.

"I really hope this opens up a dialogue about compassionate use for people with cancer," Gant said. "I'm not afraid to die, but I couldn't do it without one last fight. I'm a fighter and an advocate."

Copyright 2012 ABC News Radio

Tuesday
Jun282011

Avastin Pits Breast Cancer Patients Against FDA Experts

Comstock/Thinkstock(WASHINGTON) -- Priscilla Howard, who has metastatic breast cancer, has been taking the drug Avastin for a little more than two years and has seen a remarkable difference in the progression of her disease, she told a panel of experts at the U.S. Food and Drug Administration during the first day of a two-day hearing that pits the FDA's Center for Drug Evaluation and Research against Genentech, Avastin's manufacturer.

"I am progression-free but not cancer-free," said Howard, one of a handful of Avastin patients who gathered both inside and outside the FDA to fight for keeping Avastin on the market.

"I want every available weapon in my arsenal as I fight this devastating disease," Howard told the panel. The hearing will ultimately decide the fate of what some patients consider a life-saving drug.

Although a handful of breast cancer patients testified Tuesday that Avastin helped in treating their metastatic breast cancer, a review of studies conducted by the FDA's Center for Drug Evaluation and Research suggests the risks outweigh the benefits of Avastin for treating breast cancer, FDA officials said at the hearing.

The FDA granted an accelerated conditional approval for Avastin in February 2008 to treat late-stage breast cancer patients. It had been suggested that the drug slowed the progression of the disease and improved overall survival.

But results from four trials that enrolled more than 3,000 women found no significant reduction in progression of the disease or improvement of death rates among those who took Avastin and underwent chemotherapy.

"The decision must be based on the totality of evidence in all clinical trials," Dr. Richard Pazdur, director of the FDA's Office of Oncology Drug Products, said at the hearing Tuesday. "The totality of data submitted to FDA shows it's not safe and effective [for treating] breast cancer."

The hearing is the culmination of recommendations to begin regulatory withdrawal of the drug for use on breast cancer patients. Some cancer specialists said the decision could hold huge implications for the way their patients will be treated.

"This decision [could] remove an option for patients," said Dr. Edith Perez, clinical oncologist at the Mayo Clinic.

Doctors had previously reported seeing their patients benefit by taking Avastin, but it's not clear which patients it helps the most.

"We will be working hard to make sure that patients who are getting Avastin and seeing good control of their cancer will continue to get Avastin with their treatment," Dr. Gretchen Kimmick, medical oncologist at Duke University Medical Center, told ABC News in December.

Still, the FDA studies found no overall benefit from the drug, and even suggested that some patients increased their risk of death because Avastin is, in some ways, toxic.

Copyright 2011 ABC News Radio







ABC News Radio