"Since the recent studies, patients have been terrified of treatment by stents. They are opting more and more for bypass surgery and I think that often this is the wrong choice. Stent safety is an issue, but many patients can benefit from treatment with them." So says Dr. Judah Weinberger, senior cardiologist at Columbia University Medical Center and consultant to the US Food and Drug Administration (FDA) Medical Desvices Advisory Committee.
Weinberg was one of the senior officials on the FDA committees that reviewed the use of coated stents, in light of studies on them after being on the market for years. These studies allege that it has been shown over the years that there is no difference in life expectancy between those patients who were treated with stents and those who weren't. The general public found this conclusion quite alarming.
Weinberger suggests that these findings should not be taken literally. "On our examination, it transpired that only 25-30% of the patients treated with stents and included in this research were actually similar to the original trial group for stent approval. The rest were treated with stents prescribed for off-label use, that is to say under the directions of the prescribing physician and not as directed by the manufacturer. For example, the manufacturers explained that no more than one stent should be used per artery. Not all doctors listened and went along with the restrictions.
"It is not clear what the cause of death was in those patients treated with stents, which led to their numbers being equal to those not treated with stents and who died from heart problems. What is clear from our examinations of those patients whose treatment with stents was according to instructions, is that the stent had a positive effect. It reduced the scarring and re-clogging of the artery, without significantly increasing the side effects."
"Israel has a management problem"
Weinberger was in Israel as a guest of Elutex Ltd. (TASE:ELTX), which is developing a new method for coating stents. We took the opportunity to try learn a bit more about how the FDA works.
Globes: What is your view on Israel's medical device industry, and Israel as a location for clinical trials?
Weinberger: "From the aspect of the medical device industry, Israel is known to be an excellent source of new ideas. The place where this industry falls short is the sale of products to outside parties too soon, and this leads me to conclude that something is not working right in management. Biosense was acquired by Johnson & Johnson, and its product was a runaway success - couldn't it have done it alone? I believe that the key to its independence was to develop several products simultaneously for several fields. This would have guaranteed its chances of survival as a company."
When the FDA recruits you, and experts like you, to an advisory panel on device approval, to what extent does that approval depend on your opinions?
“The FDA nearly always listens to the panel, which also has legal responsibility. We only look at the interesting cases, that is to say, only the products that go through the long regulatory approval process for medical devices, the PMA. We take into account a broad range of interests. Our tendency is not just to give warnings about products that could be dangerous, but also to ensure that products that could save lives are approved quickly.”
What do you like to see in clinical trials? How do you assess them?
“I look, obviously, for the random component in the division of patients into treatment and control groups. I would prefer that the trial be double blind - meaning that neither the doctor nor patients know who received which treatment until the envelopes are opened, but of course, that’s not always possible. I aim to find out to what extent the patients cooperated with the treatment - there’s a problem when a large number of patients drop out in the middle, or do not cooperate with the trial as they should. I look at who manufactures the product, even those who produce certain parts of it, to make sure it is top quality, and one of the most important factors in my eyes, is who is conducting the trial and at which medical institution.
“When it comes to looking at the results, I look for clean statistics. For example, I want to see the company setting a predetermined target and then reach it. Too many companies state secondary endpoints. Did the patient see his doctor less? Does he sleep better? These are not data that will lead to an approval, but rather, it is information that we view as tentative. In instances like these, we usually tell the company to conduct a further trial.”
Published by Globes [online], Israel business news - www.globes.co.il - on August 9, 2007
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