U.S. Sen. Marco Rubio looked to bolster his re-election bid ahead of his Florida primary win by highlighting how he helped procure life-extending medicine for an Orlando woman’s daughter.
In a campaign ad released Aug. 18, Blanquita Trabold recounted how Rubio came to her family’s aid as her grown child suffered from terminal breast cancer.
As Trabold described how her daughter’s condition worsened, the screen read, "Doctors recommended a drug that was still in FDA trials. Senator Rubio worked with the FDA to get it."
"I called Sen. Rubio. I said, ‘This drug has not been approved by the FDA. But if you can get it, perhaps we can save my daughter’s life.’ He got me the medication within a week," she continued. "Thanks to Marco, I had three more months of my daughter. Marco Rubio was there for me when I needed him the most."
We hadn’t heard this account of Rubio helping a constituent get an experimental drug before, and there were no news accounts of the case. We wanted to see whether Rubio did intervene, and how fast it happened.
We can’t put the ad on the Truth-O-Meter, however, because we can’t independently verify the story beyond what Trabold and Rubio say. It’s not as if Rubio himself single-handedly got a special medication from the FDA, but his office does appear to have performed a constituent service for the Trabolds.
Maria Theresa Trabold — or Terrie, as her mother called her — was diagnosed with breast cancer at age 35 on July 7, 1998.
A University of Central Florida business and pre-law graduate, Terrie had married Jorge Ancira in 1986. She lived in Mexico with Ancira for years, but later settled in San Antonio, Texas, to be near his family.
Her illness was discovered by doctors during a visit to her parents in Orlando. She was treated for 14 years before the prognosis became terminal. She developed blood clots in her legs and was unable to travel in May 2012, Blanquita Trabold told PolitiFact Florida.
She said Terrie’s doctor told the family there was a medication that could potentially help the woman, but it was still being tested for approval by the Food and Drug Administration.
The medication was called pertuzumab, a drug made by California-based Genentech, which gave the drug the brand name Perjeta. The drug targeted a specific protein to arrest the growth of malignant cells in patients with late-stage metastatic breast cancer.
"Her doctor told us, if we do not get this medication for your daughter, she will not survive," Blanquita Trabold said. She told us that she had previously met Rubio and decided to visit his Orlando office for help.
Rubio’s Senate office told us that they contacted the FDA on April 24, 2012, the same day as Blanquita Trabold’s visit, to see if the agency would grant the Trabolds what’s known as a compassionate use request. Also referred to as expanded access, the process allows licensed doctors to obtain a drug being investigated for approval if a physician thinks the medication would be helpful, or in emergencies.
The FDA provided Rubio’s office with some preliminary questions for the family, which the office then relayed. By May 10, Rubio’s office asked the FDA to contact Terrie’s doctor in San Antonio, which the agency did the next day.
The doctor, not the patient, must submit an application to the FDA to allow the unapproved drug to go to the patient. The company manufacturing the drug ultimately decides whether to provide the drug.
The length of the process depends on the case, an FDA spokeswoman told us, but the agency grants 99 percent of compassionate use requests. Approval can happen in just days, or even over the phone in emergency cases. The FDA said that in cases where patients aren’t able to get the drug they want, it’s because the manufacturer will not supply it.
A Genentech spokeswoman said the company is "not familiar with Maria Theresa Trabold's case or the claims made by Marco Rubio." Privacy laws would prevent them from sharing specifics even if they did, the company said, although it did confirm Genentech has a compassionate use program.
The FDA also would not comment on Terrie Trabold’s application, or any other specific case. But it’s also not unusual for patients, their families or even members of Congress to initiate contact with the FDA on behalf of constituents to obtain unapproved drugs for compassionate use purposes, an agency spokesperson said.
Trabold couldn’t immediately recall the name of her daughter’s doctor in San Antonio, who would have been the one who turned in the application to the FDA.
Rubio’s office said Trabold told them on May 22 that the compassionate use request had been approved.
She confirmed that she contacted Rubio’s office again on May 29 to say Terrie had not yet received the medication. Rubio’s office notified the FDA to notify them the manufacturer hadn’t sent the medication yet. The drug was delivered on June 4. This follow-up is the week to which Trabold’s referring in the ad, even though the overall process took about a month from when she first contacted Rubio’s office.
Four days later, on June 8, 2012, the FDA announced it had approved pertuzumab as a treatment for a certain kind of late-stage breast cancer, in combination with two other drugs. (It also was approved as a form of early treatment for another type of breast cancer on Sept. 30, 2013.)
Terrie Trabold lived another six months after getting pertuzumab. She died on Nov. 4, 2012, survived by her husband, two children, mother and other family members.
That’s twice as long as the three months cited by Blanquita Trabold, who told us she had difficulty remembering the exact timeline from four years ago.
The pertuzumab wasn’t the only factor in prolonging Terrie Trabold’s life, Blanquita Trabold said. But she gave it credit for helping.
"It was six months that I had with my Terrie, thanks to getting the drug," she said.
U.S. Sen. Marco Rubio, "Daughter," Aug. 18, 2016
Daily Mail, "New drug shrinks even the most severe breast cancer tumours," July 4, 2008
U.S. Food and Drug Administration, "FDA approves Perjeta for type of late-stage breast cancer," June 8, 2012
Orlando Sentinel, Maria Theresa (Terrie) Trabold obituary, Nov. 8, 2012
National Cancer Institute, "Neoadjuvant Treatment of HER2-positive Breast Cancer," Sept. 30, 2013
U.S. Sen. Marco Rubio, "Rubio Highlights More Than 30,000 Constituents Helped In New Constituent Service Report," Dec. 4, 2015
Miami Herald Naked Politics blog, "Marco Rubio launches new ad, ‘Daughter’," Aug. 18, 2016
Tampa Bay Times Buzz blog, "Patrick Murphy blasts Marco Rubio for 'terrible record on women's health'," Aug. 19, 2016
U.S. Food and Drug Administration, "Expanded Access: Information for Patients," accessed Aug. 29, 2016
U.S. Food and Drug Administration, "Instructions for Filling Out Form FDA 3926," accessed Aug. 29, 2016
U.S. Food and Drug Administration, "Expanded Access: Information for Physicians," accessed Aug. 29, 2016
"Individual Patient Expanded Access Applications: Form FDA 3926," accessed Aug. 29, 2016
Interview with Matt Wolking, Rubio spokesman, Aug. 29-31, 2016
Interview with Lauren Smith Dyer, FDA spokeswoman, Aug. 29-30, 2016
Interview with Holli Kolkey, Genentech spokeswoman, Aug. 30, 2016
Interview with Blanquita Trabold, Rubio constituent and patient’s mother, Aug. 30, 2016