Why the FDA Moves Slowly and How it Affects You

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When the Food and Drug Administration approves a drug there is often a substantial amount of media attention. Rarely, however, do the stories discuss how many years it took for that drug to be brought to the market and made available to the public. It is a complex balance the FDA must achieve – patient safety versus timely drug availability for sick patients. Joining host Andrew Schorr on this Patient Power program is Sam Kazman from the General Council for the Competitive Enterprise Institute in Washington, D.C. to present a cost/benefit analysis of what happens when the FDA moves too slowly and what you can do about it.

During the program, host Andrew Schorr speaks to his personal experience with the FDA approving a drug for his illness, Chronic Lymphocytic Leukemia. Although the drug was endorsed by many world thought leaders in this particular leukemia, it was not approved and was therefore unavailable to many patients. The drug was eventually approved, but it begs the question: Could more patients have been saved if the drug was available earlier? Was the extra time taken by the FDA worth it?

Learn about the role politics play in getting drugs approved by the FDA. What elements does a drug company have to weigh in deciding to research and develop a drug? Does the FDA moving slowly make the public any safer? What is the threshold a drug company should have to meet for a drug to be approved? None of these questions have clear answers, but all of them need to be answered.

Mr. Kazman contends the big issue with drug innovation is that because drugs are tested in the developmental stage on a relatively small number of people, it is simply impossible to find out every side effect that might appear once a drug is approved and used by a wider population. Listen to this Patient Power program and find out where you stand.

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Andrew Schorr:

Hello and welcome again to Patient Power live on HealthRadio. I’m Andrew Schorr delighted to be here. Today’s a big day here in the Schorr household. My “was” nine-year-old is now ten, Eitan. So we gave him a new nickname when he woke up this morning. I said, ‘Your nickname is now “Double Digit,”’ and he’s acting ten already. So he is at the skateboard park to celebrate his birthday. We have spring break out here.

Hopefully it’s a good day for you. The weather has been crazy hasn’t it? I know it has been very changeable in Seattle and certain places back East and the Midwest, craziness in April. My Seattle Mariners and the Cleveland Indians didn’t get to play any games because of snow. They’re supposed to have a four-game series. How are those guys going to make that up later in the season? Goodness. Well the Mariners are headed to Boston, and so am I. So I’m delighted that I’m going to go with the family to Fenway Park. Don’t ask how much we paid for the tickets, it’s ridiculous, but that’s Thursday afternoon. Anyway we’re excited around here.

So I’ve been back East a few times in my life, and one of the times I was back last fall was for a new experience, and that was to go to an FDA advisory committee hearing. As my regular listeners know, 11 years ago now almost exactly I was diagnosed with a leukemia, chronic lymphocytic leukemia; I didn’t know what it was, never heard about it, and thought when I heard the word leukemia that I was dead. Now fortunately a few years later after connecting with a leading expert in the field at M.D. Anderson down in Houston, M.D. Anderson Cancer Center, I was in a clinical trial, and there were approved drugs for other illnesses, one for mine CLL but with other drugs approved for other things, used together in combination in a clinical trial experimentally, and it worked. So here I am today, seven years post-treatment and, knock on wood, there is no sign of the leukemia, and now most people get that combination of medicines for their leukemia if they have my flavor of leukemia, and in many cases it works well. Not all cases but many cases.

Now one of the drugs, a monoclonal antibody, kind of targeted therapy made by Genentech, Rituxan, is not yet approved for the leukemia, but it is used what they call “off-label,” and we’ll talk about that, but there is clinical evidence that it works and certainly I’m living proof. Okay.

Well why did I go back to Maryland and D.C. area and sit in a big hotel ballroom as there was sort of a trial almost if you will, an FDA kind of hearing, for a drug? It was a new proposed drug for my leukemia, and I know that my leukemia could come back so I want there to be more drugs available should I need it and certainly to help my peer leukemia patients if what I got doesn’t work, maybe there is something else that will.

So there was a drug called Genasense from a small biotech company Genta, but a public company, and it had presented all its years of data and it had world famous leukemia specialists there. This was what they call a I think an oncologic drug advisory committee hearing, and there where various cancer specialists there who were sitting almost like a jury, and they would recommend to the FDA whether they think this drug Genasense should be approved for chronic lymphocytic leukemia. Well I had never been to a hearing like this, and here’s what happened briefly, and then we’ll meet a guest, and he may have some comments on it and others about the FDA, but what happened was is that the first thing was there were no experts in that leukemia as advisors to the FDA on the panel. That struck me as really weird.

There were solid tumor experts and pediatric leukemia experts, but none of the people I knew were world famous who were on the panel except for one doctor who was a non-voting member, who was what they call an “industry representative,” and they even kind of discounted him later on and wouldn’t let him talk before the vote, which was very disrespectful.

The other thing that struck me was the FDA was gunning for Genasense right from the start with a preamble that just sort of basically dissed the drug, and we can talk more about it, but right now that is on appeal with a higher authority at the FDA, unusual, and whether it works and gets that drug approved we’ll see, but the committee voted it down mostly. The people who were most knowledgeable in that leukemia voted “yes,” but the ones that weren’t voted “no.” I think it was seven to three, and the FDA officials continued even after that in subsequent meetings to be very down on the drug. I don’t like that. I didn’t think it was fair as a taxpayer.

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