How hard was it to get into the Compassionate Investigational New Drug Program?
It was very difficult getting into the federal program. It took me 10 years of trying to educate the government, the first five as a scientific project, which I put together making myself as the patient and my doctor as the researcher. FDA stonewalled me, said I hadn't been to this research center, I hadn't done this, I hadn't done that. So they had no intentions of giving it to me. Then when I met Robert Randall in 1977, he suggested instead of trying to do it as a scientific project, turn it around into a compassionate care protocol, which is what we did. But again, the government was stonewalling and they weren't going to do anything. I brought in my Congressman, didn't matter. Well, my cousin went to law school at the University of Virginia, and he brought it to the school as a project. And they agreed and they took me on as a project. So for three years while he was in law school, they were trying to work with FDA to try to get this thing approved. FDA had no intentions of approving it. So finally the University of Virginia Law School got upset and said, "That's it. We're going to court, we're suing. "FDA said, "Wait a second. We're going to grant Irvin hearings. He can come up to Rockville, Maryland and have 15 minutes to plead his case." So that was the next step. But UVA figured well, they're going to turn me down, so they started putting the lawsuit together. I went there, I had my time there. Robert Randall and Alice O'Leary had arranged by advertising to have the general public and/or other staff people and other doctors and nurses and everything at FDA come. So there were about 200 to 300 people in the audience at that time. I spoke for about 12 minutes, said everything I needed to say, and then I said I was opening for questions. A guy raised his hand, stood up in a white coat, and said, "I really don't have a question, I have a statement." And I said, "Fine, what's that statement?" Well, one of the things I'd said when I was speaking was that my doctor and I researched and that when I took Dilaudid -- synthetic morphine -- and I had marijuana or cannabis to go along with it, that the cannabis would enhance the Dilaudid to where I took less. And when I didn't have cannabis, I took more Dilaudid. And we had studied this for 10 years. So this guy stands up and said, "I'm a visiting oncologist from Venezuela. I'm here studying pain treatments for cancer patients. The best pain treatment you have in this country is Dilaudid, which is what we have in Venezuela. And if you and your doctor have studied for 10 years that using cannabis along with the Dilaudid makes the Dilaudid work better and you take less, this needs to be researched further," and sat down. The committee chairman and everybody, you could see their face and their whole demeanour, like "Oh, no." So I said, "Are there any other statements or questions?" No one had any other statement. I turned to the chairman and said, "Mr. Chairman, that concludes my presentation. "The guy is sitting in the middle of like nine doctors on each side of him, he turns like this and everybody kind of doesn't want to look at him. He turns like this, everybody turns this way. Nobody wanted to make eye contact with him. He turned to me and said, "Mr. Rosenthal, I think I can speak for the entire committee that you were very eloquent and very convincing, and that your protocol will be approved."
