Company Approves Drug for Dying Mother
(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