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4O Mr. JAFFE. Basically, that it was a subject of an ongoing criminal investigation for FDA violations and trying to dissuade people from undergoing his treatment. Mr, BURR. In the third Grand Jury case, was an Assistant U.S. Attorney presenting the case removed for abusive use of subpoe- nas? Mr, JAFFE. He was removed and he did abuse the subpoena proc- ess. The government said that it was part of a general shakeup, but they couldn't identify any other U.S. Attorney that was re- moved or anything else about the staffing issues. Mr, BARTON. The gentleman's time has expired. We will have an opportunity for a few additional questions, if the gentleman still has additional questions. Mr. BURR. I do, Mr. Chairman. Mr. BARTON. Okay. The Chair would recognize, for a second round of questions, the ranking minority member, Mr. Wyden. Mr, WYDEN. Thank you, Mr. Chairman. I'll be brief. Mr. Jaffe, to what extent, if at all, is your client barred from distributing peer-reviewed articles on their procedure? Mr, JAFFE. I'm not clear on your question. Mr. WYDEN. One of the things that we're concerned about is ac- cess to information, about innovative medical products and devices. I'm c~trious whether your client has been in any way barred from distributing promotional information about their product. Mr, JAFFE. There are two separate questions, promotional infor- mation and peer-reviewed articles. I would say, as a general mat- ter, as someone who represents many of these practitioners around the country, they do not have access to peer-reviewed publications in this country, as a general rule. In particular, Dr. Burzynski sub- mits his publications to some American journals. The technical articles, biochemistry, in some of the major arti- cles, his publications are just turned down. The criticisms leveled against Dr. Burzynsld are published in the peer-reviewed journals. His rebuttals, by and large, are not. But I would say that that is a problem which I have seen in many of these individuals, not just Dr, Burzynski, As to the promotional materials, which is a separate issue, I think there are issues of Federal and State law. Directing your at- tention to Federal law~ Mr. WYDEN. On this point, has he in any way been restricted in making presentations about his product by the FDA? Mr. JAFFE. By the FDA? Mr. WYDEN, Yes. Mr. JAFFE. No, sir. Mr. WYDEN. Well, I thank you. One of the things that we are looking at, again, in an effort to try to bring about reform, is to make it easier to get information out in credible journals. At the same time, we would like to give the Food and Drug Administra- tion the opportunity, if they have questions about the integrity of one of these journals, to, for example, submit an additional state- ment saying that they have reservations about the article. But I gather that was not a problem. 41 Mr. JAFFE. I would say, affirmatively, sir, I don't think that his problems with peer-reviewed journals are directly related or caused by the FDA. Mr. WYDEN. Okay. I thank you. Mr. BARTON. The Chair would recognize the distinguished mem- ber from New York and, before that, indicate that since there is only one Democrat presently attending the hearing, the Chair al- ternates back and forth between sides, that's why Mr. Wyden had a second set of questions. Mr, Frisa. Mr. FRISA. Thank you very much, Mr. Chairman. I'd like to ad- dress this to the entire panel. Is there any established procedure by which someone with a product or a treatment or a procedure that falls outside that which is approved and is established and is tried and true for an innovation for something, again, that falls outside the normal categories to be brought to the attention of the FDA, to say this is different, please listen to our innovation. Mr. JAFFE. Up until a few years ago, there was no vehicle what- soever, and I think that's one of the problems with the leDA regula- tions. They treat everyone the same. And it's well a~.d goo.d if you're a multi-zillion dollar drug company and have the $200, $300 or $400 that it takes to get a drug approved. But if you're a small company, it's very difficult. I know the Congress, through the auspices of Senators Harkin, Daschle and others, have enacted this bill relating to alternative medicine. That has some of its problems now, but you now have an Office of Alternative Medicine which somehow helps. By and large, that's one of the problems. They treat everyone the same. Throughout history, basically, many innovators have been people sitting in basements somewhere that come up with an idea and the problem that I see, just as a theoretical and legislative matter, is that there is no vehicle in the FDA to recognize these kinds of peo- ple, and I think there needs to be. Otherwise, what you're going to have is all research done in institutions. And that's why, after how many hundreds of billions of dollars in 30 years, we don't have a cure for most kinds of solid cancers, because they all get the money. It all gets channeled in there and you have to get through all these processes and there are all these people out there who have interesting ideas that aren't getting tested. So I think you have identified one of the major problems in the drug approval process, and I think it's structural and it needs to be changed. Mr. FR~SA. I think it's obvious that most organizations resist change. I guess it's apparent in this case that there are very seri- ous implications for the way they go about resisting change. It appears to me that the FDA seems to do it with a vengeance. In the case of the Michaels, had you allowed yourselves to be in- timidated by either the fact that this is not a traditional treatment or that there might be consequences for going forward, there might have only been one of you here today. That, I think, is the tragedy, for an Agency that's charged with ensuring the health and safety of Americans. I'd like to see a warning label that the FDA may be harmful to people's health and safety. I just think it's a sorry state of affairs. I'm brand new to the Congress and it just seems agency after agen-