A little after 10 a.m., Sept. 11, during a coffee break, members of the FDA Oncologic Drugs Advisory Committee learned that airplanes had crashed into the World Trade Center and the Pentagon.

A fourth plane was thought to be heading toward the Washington area, employees were being evacuated from federal buildings, and the city was gridlocked.

Committee Chairman Stacy Nerenstone decided to go on with the meeting.

“I made the announcement that if we were to stop the meeting, then the terrorists have won, because routine business couldn’t get done,” said Nerenstone, an oncologist at the Hartford Hospital Gray Cancer Center.

IDEC Pharmaceutical Corp. was in the midst of presenting the data on Zevalin (ibritumomab tiuxetan), a therapy for non-Hodgkins lymphoma. FDA was yet to present its evaluation of the data. Suspending the meeting would have been unfair to the sponsor, FDA, and the patients.

“I made the decision that everybody was prepared, and everybody was there, Nerenstone said. “To suspend it and just to have people milling around was just a waste of people’s time.”

For more than three hours that followed, the committee members maintained their concentration on the New Drug Application as the sound of fighter jets rattled the oversized, garish crystal on the chandeliers at the Versailles Room of Bethesda Holiday Inn.

“We continued the meeting, and actually it went over the time, because it was a very complicated subject,” Nerenstone said.

IDEC was asking for approval for relapsed and refractory low grade, follicular or CD20+ transformed B cell non-Hodgkins lymphoma or Rituxan-refractory follicular NHL.

The data justified full approval for Rituxian-refractory disease, the committee decided. For patients untreated by monoclonals, the committee was concerned about excessive cytotoxicity, and recommended accelerated approval.

“Once we got to the point where the committee got to discussing and started getting different points of view, there was about a good hour there when what was going on outside was totally forgotten, because we had a very serious discussion and had to come to some sort of a conclusion,” said ODAC member Donna Przepiorka, associate director of the stem cell transplantation program at Baylor College of Medicine.

“I was pleased to see the committee members being vocal, and not being intimidated by what was going on outside the building,” Przepiorka said. “One of the main issues had to do with whether we knew enough about how to measure the radiation given off by the drug to allow it to be used in patients before it was a last hope.”

The committee decided that the therapy should be made available to physicians for both indications. However, accelerated approval would require the company to return to FDA with a trial designed to justify giving Zevalin to Rituxan-naïve patients, Nerenstone said.

The committee’s afternoon session was cancelled, because FDA offices had been closed, and some key people couldn’t get to the hotel where ODAC was meeting.

“I would have kept it going,” Nerenstone said.

After Hours Of Waiting, A Pleasant Flight

With air traffic at a standstill and rental cars scarce, ODAC members were stranded in Bethesda.

Donna Przepiorka remained in Bethesda, trying to get to Houston.

Her flights were rescheduled 11 times. She tried unsuccessfully to rent a car. Finally, on Friday afternoon, she found herself on a Dallas-bound flight, made it to San Antonio, rented a car, and drove to Houston.

“It was a very interesting experience for me,” Przepiorka said. “The best part of it is that everyone who was traveling was clearly courageous, and really wanted to travel, and we are not going to get stopped.

“Everyone was very pleasant. It was probably the most pleasant trip I’ve ever taken in my entire life. No one was bothered for anything, even people who sat there for five hours waiting for a flight and then had to change it because it was cancelled.

“No yelling, no screaming, no harsh words, pleasant smiles all around,” Przepiorka said.

“My hope is that it would not deter us from moving ahead, which is why I think so many people got back on the planes.

“As soon as the government said, OK, let’s do it, everyone got back on the planes. I hope that we would see that as something that we need to do. We can’t hide from perceived or potential problems, because they are not going to be there for everyone, and if the government does its job, and I believe it will, we should not have another major disaster.

“No one can prevent everything, but that shouldn’t stop us from doing what we need to get done,” Przepiorka said.

A Gorgeous Sunrise Over West Virginia

Unable to get back to the Midwest by air, ODAC members Kathy Albain and George Sledge chipped in with University of Iowa oncologist Larry Cripe and Northwestern University oncologist Leo Gordon and rented a limousine and a driver. Cripe and Gordon attended the session on behalf of IDEC.

This was one of the few cases when a limo was not a luxury, and the price was reasonable—about $550 per person. “The rental cars were gone,” said Albain, an oncologist at Loyola University Medical Center. “There were none to be had.”

The 12-hour trip was pleasant, Albain said.

“We went across I-70, and, despite everything, saw a gorgeous sunrise in the mountains of West Virginia,” Albain said.

This journey concluded at Chicago’s O’Hare Airport, where Albain had left her car. The airport was closed, the entrance blocked off with bulldozers. Travelers were walking in, wheeling their luggage, and exchanging stories of traversing great distances on the ground.

“Makes You Realize What’s Important In Life”

ODAC member Douglas Blayney was fortunate enough to find a rental car.

“The guy behind me at the Avis counter was going to drive to Atlanta, and the guy in front of me was going to drive to Houston,” said Blayney an oncologist with Wilshire Oncology Medical Group of Pasadena, CA.

On Wednesday, Blayney drove to Old Greenwich, CT, to spend a few days with his sister, whose husband works in Manhattan. On Saturday, after trying to get on four flights, he got on a flight from Philadelphia.

“The patients and the office staff knew I was in Washington, and they were relieved when they learned that I was not on the airplanes coming home,” Blayney said.

Had he left the meeting a day early, Blayney could well have been on the Los Angeles-bound plane that rammed into Pentagon.

“This should serve as an opportunity for all of us to rethink our priorities and recommit ourselves to what got us into medicine in the first place, and that’s to make life better for our fellow men and fellow citizens,” Blayney said. “It makes you realize what’s important in life, and that is family and friends and our commitment to make life better.”