Chapter 12: The FDA as a Barrier to Research Innovation

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Chapter 12: The FDA as a Barrier to Research Innovation

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In this chapter Dr. Freireich stresses that cancer will only be cured by funding clinical research into cures for cancer and offers his personal belief that the population at large understands this. (He uses the example of AIDS activists, who were successfully organized and lobbied for effective treatments.) He talks about the role of the FDA, which he sees curtailing physicians' ability to make progress by restricting the use of experimental drugs in dying patients. He sums up the affect of what he sees as bureaucratic conservatism: "If there's no drug, there's no danger, and there's no progress."

Publication Date

10-11-2011

Publisher

The Historical Resources Center, The Research Medical Library, The University of Texas MD Anderson Cancer Center

City

Houston, Texas

Topics Covered

The Interview Subject's Story - Overview; Critical Perspectives; The Researcher; The Clinician; Understanding Cancer, the History of Science, Cancer Research; The History of Health Care, Patient Care; Politics and Cancer/Science/Care; Ethics; Professional Values, Ethics, Purpose; Patients

Disciplines

History of Science, Technology, and Medicine | Oncology | Oral History

Transcript

Tacey Ann Rosolowski, PhD:

What needs to be done to increase those numbers—the rates of success?

Emil J Freireich, MD:

We have to get funding for clinical research. That’s what APOR advocated. We said to the NIH, look, why don’t you have—? They have eighty-five study sections—biochemistry, physiology, etc. Why don’t you have one for clinical research that’s staffed by physician-scientists? Let’s fund the best clinical research. How about that? Forget it. They added two clinicians to one of their study sessions. They said, see? We got them there. They’re a minority. They don’t direct the flow of money. So it’s going to take legislation.

I work with the Abigail Alliance. There’s an outfit called the Abigail Alliance, which was founded by the father of a lady who was—I forgot how old Abigail was. She was very young—twenty-two or twenty-three. She got head and neck cancer. They treated her. Everything failed. She was ready to die. Dr. Mendelsohn had worked on the epithelial growth factor receptor antagonists. They were in clinical trial. She didn’t qualify for the clinical trial because she’d had this and that, so she couldn’t get the drug, so they appealed to the drug company to give her the drug, and the FDA said, no, you can’t do that. You can’t get the drug if you’re not eligible for the clinical trial because it will detract from the clinical—you know—it’s all this crazy reasoning. All of which is false. So she died. She never got the drug. Her father formed this organization called the Abigail Alliance. He recruited family members whose loved ones had died being denied treatments which would have saved their lives.

When we first were working with Gleevec, the very first trial, the FDA required us to do a randomized trial—Gleevec versus conventional therapy. I had a patient with CML who was on the board of directors of Novartis—rich, powerful guy. I wrote to Novartis, to the president, and said, “This man is not eligible for the clinical trial. If you give us Gleevec, we can save his life.” They wouldn’t do it. The whole drug development process now is run by the FDA. The FDA is manned by failed physicians. The guy who runs—[Dr. Richard] Pazdur was on our faculty here. He was a so-so, average guy. He’s been in the FDA for ten years. He doesn’t know anything about anything, and he decides what needs to be done.

What does industry do? They say, well, we’ll never get a drug approved unless Pazdur approves it. So when they get a drug and want it developed, they go to Pazdur. So they now have an organization where the regulators in industry, the regulators in FDA—I’ve written an editorial about it—it’s right there—are the ones who direct research, not the geniuses who discovered drugs, who developed drugs, who treat patients. They’re out of it. It’s all done by guys with pencils who are desperate, protecting their careers. That’s what the word bureaucrat means. Bureaucrats protect their job. They don’t want to cure cancer. It’s a horrible thing.

So I worked for the Abigail Alliance. We got a judgment against the government. We had a bill introduced in the legislature, and we almost got it through. The idea was that if a patient and his doctor want access to an investigational drug, they should provide it at cost so that nobody is harmed, there’s no danger to anyone who didn’t volunteer, there’s no public foray, there’s no danger to the manufacturers, no danger to the government. It’s just insane that we don’t do that, but today it’s true. People are dying every day with drugs that could be—could be—curative and they can’t get them because of this stupid law. So we have to get our heads screwed on right. The public has to awaken to the fact that the government, which created the NIH, which created the Cancer Institute—there wouldn’t be any cancer research if it wasn’t for the government—the representatives of the people.

We need to have, as everybody has said, legislative relief. The FDA has to get out of the way of drug development. Drug development is between the scientific community and the afflicted patients. If you have cancer of the lung and you come to MD Anderson and the world’s greatest lung cancer doctor says, “Here’s the drug I think is good for you,” what’s the government got to do with that? It’s insane. It’s what happened in Russia when they had Lysenko-ism. You know, Lysenko was a scientist who declared that there was no heredity, because the Communist manifesto was everything is environmental. We’re living in a country where the government makes science. They tell you what you can and can’t do. It’s ridiculous. And we talk about freedom? When you get leukemia or are dying of leukemia and come see the world’s greatest leukemia doctor who has cured more patients of leukemia than any living person, before I can give you the drug that I think is good for you, I have to get approval from Ricky Pazdur who has never treated a leukemia patient in his life and never will—insane. Why are we doing it? You know the answer?

These things always occur in times of panic. You see, the liberals believe that—all the intellectuals and professors believe that they know what’s good for everybody. Those stupid people out there— So it’s always a time of crisis. The FDA began when there was a manufacturer who sold sulfanilamide or something and fifty people died of toxicity, so the government said we have to have a law that says the products that are sold to the public have to be safe before you can market them. Great idea. So the FDA began on safety. Well, as usual, you get a government program and it escalates. Safety got worse and worse and worse.

Then there was the Thalidomide disaster. Here’s a drug that was completely safe. You could have studied it in a laboratory for fifty years and never predict that it did what it did. When you gave it to pregnant women, their children came out without arms and legs. Ten years after we knew it happened in the clinic, scientists in laboratory finally figured out how to reproduce it in a mouse. There was no way this could have been prevented by anybody. There was no knowledge base. It’s just one of the realities you have to face. But Congress had the solution. FDA now must approve any drug that is marketed to the public for safety. Okay. Well, I already explained to you how that works. If I’m in the FDA, and the manufacturer says here’s the drug that cures cancer, they say, “Well, is it safe?” Well, if you give it to mice in a lethal dose it would kill them. Well, maybe you ought to give it to horses and cows and rhinoceroses in Africa—anything to delay it because if it kills anybody it’s your ass in a sling.

The FDA has this award named for Frances Kelsey, who was the one who didn’t approve Thalidomide in the United States. It was approved inEurope. In theUnited States, she didn’t approve it, so no Americans had Thalidomide disease. So they made a medal for Frances Kelsey. Well, why didn’t she approve it? Well, it was sitting on her desk while she was on vacation. So that’s the best and FDA can do; you just don’t do anything. If there is no drug, there is no danger and there’s no progress.

So they were doing okay. We finally figured out how to kill enough mice and convince enough people that you could get some progress, and then another tragedy. What was the tragedy? I can’t remember. Another tragedy occurred, and Congress passed a bill that the FDA has to decide not only on safety but efficacy. So now you can’t market anything as effective until the government says it’s effective. Well, anyway, the whole thing is insane.

The medicine has to go back to the academic medical community. There’s no way the government can intrude on— There’s no other area of research where the government decides what research can be done—none—maybe atomic energy. But in medicine, the government decides everything, and the government people are all bureaucrats. Some of them are scientists. The scientists who work for the government do research. They don’t mess around with sitting around the desk, approving drugs. Well, anyway, how did we get onto that?

Tacey Ann Rosolowski, PhD:

I can’t remember.

Emil J Freireich, MD:

I can’t either. APOR—so APOR is advocating for the public to recognize that cancer is a major healthcare problem. They have to put funding in the hand of physician scientists who are working on humans with cancer. We have this MD/PhD program that I told you we can’t get by the dean. Dr. Kurzrock has this slogan. If you can get a PhD working on mice, why can’t you get a PhD working on people? What’s the answer? The answer is that if you’re working on people, it belongs to the government—bad situation. We’ve got to rectify it, and it’s got to be done like the AIDS people. We’ve got to get the cancer population marching in the streets and saying let’s make progress and stop kidding ourselves that safety is—

Oh, the efficacy situation. What was the efficacy one? I forgot what the crisis was, but we have a number of examples where we have drugs that are very effective for five percent of people with a given disease—CLL. They go to the FDA and they say it’s not effective enough. So the five percent can’t get the drug because it doesn’t work in more than five percent. That’s legislation, and it’s actually a guideline that the FDA adheres to. It’s insane.

Tacey Ann Rosolowski, PhD:

I think I’ve gotten a good picture.

Emil J Freireich, MD:

That’s why APOR is important. We have to lobby. The guy who sponsored the legislation for the Abigail Alliance—and I was one of the litigants—was the senator from Kansas. Do you remember his name? But he didn’t run for re-election. He ran for the presidency, and he didn’t win. So that legislation is floundering. It never got through the rules committee so it never got voted on, but it certainly would have passed. And the idea was that—well, investigational drugs should be made available to patients and academic physicians. I’ll give you a reprint.

Tacey Ann Rosolowski, PhD:

Yeah, I’d like to see it.

Emil J Freireich, MD:

It’s right here. I keep my latest diatribes on my table in case people will read them.

Tacey Ann Rosolowski, PhD:

I may even have read that when I went online. I think I saw something to that effect online.

Emil J Freireich, MD:

It’s an editorial. It’s not citable.

Tacey Ann Rosolowski, PhD:

Okay. So I think I’ve gotten a good picture of that whole cultural and political dilemma.

Emil J Freireich, MD:

From my perspective.

Tacey Ann Rosolowski, PhD:

Yeah. In terms of the areas of research—I mean—I know you feel that clinical research needs to be done—but in terms of the community of clinical researchers that you know, what are the most promising, exciting areas of research that can be undertaken or followed up on right now to help with the leukemia problem?

Emil J Freireich, MD:

I’m not sure what you want me to say.

Tacey Ann Rosolowski, PhD:

Well, I’m asking kind of a state-of-the-field.

Emil J Freireich, MD:

Anyone who has—you know—one of the greatest experiences that a human being can have, after you satisfy all your physical needs—you know—sex, food, music, whatever—the greatest personal human satisfaction comes from discovery. If you work out something that no one ever has done before you, that is an exhilarating event, and once you’ve discovered something, you become a new person because you now believe that you can discover anything. If I discover a little, teeny thing, I’m willing to tackle something bigger and bigger and bigger, and first thing you know, you want to cure cancer. So it’s been studied systematically, scientifically, that young people who make discoveries early in life are the ones who make discoveries later in life, because it builds confidence and a curiosity that allows you to discover things.

So my personal view about transferring things from the academia to the public is a trivial problem. That occurs instantaneously. When the first clinical trial of Gleevec was done, Novartis couldn’t make enough Gleevec. When the first polio vaccine was proven effective in a randomized trial, they couldn’t make enough polio vaccines. So the transfer to the community is a trivial problem. That occurs immediately because the public and the caring physicians want the best for their patients. Regardless of what the skeptical community believes, when a patient comes to a doctor, he really wants to help you. With the exception of some rogues, that’s an ethic. What we need is an environment where people can investigate. What makes humans human is freedom. If a person is free to investigate what he thinks needs to be investigated, things will happen. If people have to get federal approval before they can do research, they’re dead in the water.

Chapter 12: The FDA as a Barrier to Research Innovation

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