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Mr. LUNGREN. So you use that without any knowledge whatsoever of the toxicity?

Dr. GRINSPOON. No, I am not saying that. I am saying that the people in the real world who generally do this have a pretty good idea. They are sophisticated people. They know where this drug comes from. They know what similar drugs do, and so forth. They are not fools, and they are not going to take something they consider dangerous.

Mr. LUNGREN. What about those who took MDMA? I understand now we have some pretty good evidence that that has some rather substantial problems with it concerning toxicity.

Dr. GRINSPOON. Well, I think that those people took a certain degree of risk. Now as for the toxicity studies, I disagree with Dr. Ellinwood. As I mentioned to him on the side, there are some studies out of Arkansas which challenge the studies that have come out of the University of Chicago. But the point is, you are absolutely right, I mean, those studies have to be done. But nobody would be even interested in MDMA if some human beings hadn't said, hey, this is something that has some properties which we have to pay attention to as a possible therapeutic substance.

Mr. LUNGREN. But in the meantime, what about the people who were given it by psychiatrists out there who have been harmed thereby?

Dr. GRINSPOON. Well, first of all, there is no evidence that these people have been harmed. And I am not at all suggesting that that is the way it should be done. I am saying that in the course of events a drug company becomes interested in a psychoactive drug because there is some witness or some witnesses to the fact-

Mr. LUNGREN. I understand what you are saying. I also understand the other side of it in which we have got a lot of kids out there taking these mind-bending drugs who are ruined for life.

Dr. GRINSPOON. Oh, I do, too. I share your concern.

Mr. LUNGREN. And we have these criminal minds out there that are keeping one step ahead of the law. And I appreciate your concern. I am the son of a doctor. I did medical malpractice defense for 6 years before I got here. I cosponsored the Patent Term Restoration Act to go to the very problem you are talking about. But damn it, we have got to do something about it. Dr. GRINSPOON. Mr. Lungren-Mr. LUNGREN. And I am just trying to figure out-Dr. GRINSPOON. Right.

Mr. LUNGREN. You seem to suggest to me that-you say in the real world people do this. Now you

are suggesting to me that in the real world people do this whether or not they are following the FDA procedures. Is that true?

Dr. GRINSPOON. In the real world people-

Mr. LUNGREN. Are violating the FDA procedures, is that what you are telling me?

Dr. GRINSPOON. I don't know whether that is a violation. For a person to take it himself I do not believe is a violation of an FDA procedure. But as I say, I am not a lawyer. I do not believe that is a violation.

Mr. LUNGREN. Is that considered to be human experimentation? Dr. GRINSPOON. It is human experimentation.

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Mr. LUNGREN. Is that human experimentation?
Dr. GRINSPOON. Pardon?
Mr. LUNGREN. Is that human experimentation?
Dr. GRINSPOON. Yes.

Mr. LUNGREN. As I understand it, at FDA you have to go through animal studies and animal experimentation before you are allowed that?

Dr. GRINSPOON. You do before you can do it on other people.

Mr. LUNGREN. I see. In your statement you say, first of all, criminal penalties are imposed under the bill we are talking about, are imposed without a requirement for evidence that anyone has been injured by a new analog or even that anyone has abused it. Isn't that what we are trying

to get at? That right now it is an after-thefact thing? We have a chemical analog out there on the street that thousands of people are using. We don't know the dire consequences until we would be able to identify it. And at that point we stop whoever it is from doing it. In the meantime he goes on to another analog and puts it out on the street until we find that that has an abusive nature, and then he goes on to another. That is what is happening in California.

Dr. GRINSPOON. There is no question I share your concern about that.

Mr. LUNGREN. But you object to the bill because that is what it goes after.

Dr. GRINSPOON. Well, I object to the wording of the bill, not the idea of the bill. I object to the wording of the bill because I fear it will inhibit a very important area of research. I share your concern about youngsters, about people being exposed to substances which damage them. No question.

Mr. LUNGREN. I know you share my concern, but you have a specific complaint about the bill in which you say, first of all, criminal penalties are imposed without a requirement for evidence that anyone has been injured by a new analog or even that anyone has abused it.

Dr. GRINSPOON. Right. That means

Mr. LUNGREN. That is a statement of what the current situation is. What happens now is—I mean, let's look at what happens. You have a chemist out there. Now he is not going through FDA procedures because he is concerned about human experimentation or anything else. He is trying to make an analog of an already existing controlled substance so he can sell it, perhaps on the street as the controlled substance or something that is close to it so that there will be a market for it. But it is not currently on the controlled substances list, so he is not violating the law.

You know the money-you have heard the testimony about the money involved. So if the guy produces something for 3 months on the street he may make himself a multimillionaire during that period of time. We come in, even under emergency scheduling, and we say that is illegal from now on. We can't prosecute him for what he has done up to that point in time. He goes on to the next

one.

My question is, yes, it is right that we would impose criminal penalties in the manner in which you suggested, but I don't know any other way of doing it. And with the tremendous financial benefit out there at the end of the line, all you are telling the guy is you are going to have to stop doing that one, but the next month you will come up with another one, and the month after you will come up with another one. With computer simulation and everything else we have in terms of chemical composition, we will never catch up with these

Dr. GRINSPOON. Well, as I say, I think the law can be developed with language that does protect our concerns about research.

Mr. LUNGREN. Are you mostly concerned about self-experimentation? I mean, is that a hang-up in this bill that you have? ?

Dr. GRINSPOON. No. No, not particularly. No.

Mr. LUNGREN. Well, if we make reference to what the FDA currently, I mean, if we make specific reference, we say that as long as you are following FDA procedures that have been established, and even the suggestion we might have of having an advocate within FDA to say if you are going to put these things on an emergency schedule as you intensify the investigation and accelerate the investigation, because some think there is something good about it. If we do that, we limit the extent of the law to those things that are not within the parameters of the FDA-recognized procedure. Would you object to that?

Dr. GRINSPOON. If by that you say we limit the law to protect people who are involved in legitimate medical and scientific research, I certainly do agree with that.

Mr. LUNGREN. As established under the FDA, which is the authority that we have.

Dr. GRINSPOON. Well, that gets a little more complicated because I certainly, I have a lot of problems with the way the FDA law is now. It is exceedingly difficult to do research on a schedule I drug.

Mr. LUNGREN. I know. I have heard complaints.

Dr. GRINSPOON. Right. And that is what you said you don't want to get into.

Mr. LUNGREN. I know. We have complaints about it.

Dr. GRINSPOON. But in order to answer that question I have to say it. I can't give you an unqualified yes.

Mr. LUNGREN. No, I understand. I have got an orthopedic specialist at home who is a close friend of mine. He has even received an award from the Soviet Academy of Physicians for the work he did with chymopapin injections. And he happened to do one on an athlete who was playing for the Chicago White Sox. He hurt his back so badly he couldn't play anymore. He had an operation, but it didn't do him any good. The doctor gave him two injections, one at one level and one at another. The fellow was able to become Comeback Player of the Year the next year. He hit 33 homeruns an played third base. And this doctor was called on the carpet by the FDA because they had only given permission for one injection. And what he said was I gave one injection at one level, I gave it at the other and that was the level at which the protruding disc was a problem.

So I understand we have got some problems with the FDA, just like I am sure there may be somebody out there who has got problems with Congress occasionally. They are human institutions. I don't believe in infallibility except in limited circumstances.

But if you have a problem with the FDA I can understand that. I am trying to say whatever the structure is, whatever problem we can work out with the FDA, I want a bill that dovetails into that.

Dr. Ellinwood, would you comment on where you think we are with respect to the FDA procedures and how encompassing this should be as it abuts the FDA procedures?

Dr. ELLINWOOD. I would like to see more specificity either in the law itself or the congressional background for interpretation that sometimes goes along with the law. We do have a problem of getting from a point where you manufacture or you synthesize a drug, and there is a long period in between before you go to the FDA. Now during that period someone could lose it or it could be stolen from their laboratories, etc. At that point in time that we could have spawned a whole series of State laws and interpretation of laws. That individual could be in a lot of trouble if we did not have an IND. We could set up procedures where if the scientist is going to manufacture a drug that he thinks may be an analog, et cetera, he will notify the FDĂ, or DEA, the appropriate Federal group, so that they know he is on record. He would need to slate how much he produced. He would put the agency on notice that you guys can come look at my records. I think we need some different loophole or other avenue to protect that individual. I think we are going to spawn a whole series of State laws. Those laws may be not so

Dr. GRINSPOON. Some are already beginning.

Dr. ELLINWOOD [continuing]. Neatly interpreted as we would have at the Federal level. I am concerned that there is a nevernever land that might have a series of legal minefields.

a Mr. LUNGREN. I understand what you are saying. In fact, we drafted the law so that we have two standards which I think are as tough as standards we have in the criminal law. One is that you knowingly do this, and the other is that you intentionally do it. So that if someone was working on an analog as you suggest and it was stolen from him and someone used it for human consumption, the researcher would not meet the knowing or intentional standards whatsoever. You know, we could go to a standard of negligence or we could go to a “should know" standard. But we didn't. We went to the toughest standards you have.

Dr. ELLINWOOD. And I think if I had a great lawyer he could handle that beautifully. But I would have a lot of legal hassles before it got to that stage.

Mr. LUNGREN. Well, except that it is fairly well accepted what knowing standard is and what intentional standard is in criminal law. They are the toughest standards that you have got.

The other thing is, and, you know, I will be happy to put any language in that would even make it more evident what we are talking about. This problem that some have suggested at the panel that somehow some chemist or some scientist comes up with

a particular formula and almost before he or she can get to the FDA to fill out the application they are in violation of the law. And therefore somehow you are stopping this research, I really think is a little farfetched because that is what happens now.

The idea about a pharmaceutical company bringing in a drug from another country for human consumption, when they bring it in and before they can actually get the application form filled out

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they are found in violation of the law. I mean, let's be realistic. Pharmaceutical companies do that every single day. They bring in stuff from other companies. You know that as well as I do. We have complaints that we are a little slower than foreign countries are. Maybe in some cases that is why we didn't have much trouble with thalidomide and some of the other things that happened in West Germany, and maybe we ought to be thankful that we are a little slower on that.

But I really don't think that is a complaint because it happens right now. The FDA handles that problem. I mean, you must really think these folks are on mind-bending drugs if you think they are standing at the border, as soon as someone brings something in from a foreign country to go to a major manufacturer of pharmaceuticals to get to the FDA headquarters that they are going to arrest them. At least I find them a little better than that.

Dr. ELLINWOOD. Mr. Chairman, I really think that this could be solved by providing the background intent of the law.

Mr. LUNGREN. That is fine. Yes, I agree with that.

Dr. ELLINWOOD. I think that if that was provided and known, then I see no problem.

Mr. LUNGREN. We create legislative history by a report.
Dr. ELLINWOOD. Right.

Mr. LUNGREN. We can have clear language. We can, in addition, in the report, contain clear examples of what it is we are talking about and clear examples of what we are not talking about. And I am not adverse to that because having been one who has been operated on a number of times, some of these drugs that have been discovered in recent years have helped me get through pain, so I understand it like everybody else does. I don't want to stop the quest toward more science.

Mr. ANGAROLA. If I could just interject. I think it is element, and I know the Senate also tried to get language in the legislative history that attempted to clarify the statute as it was passed. I am always concerned, however, that the statute is there and perhaps a prosecutor doesn't look at the legislative history as closely as they might.

I was intrigued by your comment, Mr. Chairman, about this, perhaps, and again you would have to play with the language, would distribute for sale for nonmedical purposes. I think we are all clear that we don't want to impede research. It is quite evident that a lot of time and effort has gone in that route. And if you could get some language in the statute itself, I think that would be very, very beneficial.

And in addition, I think a point was made, and a very good one, about the proliferation of State laws, which I think could be really disastrous. If we can get a good Federal law, we are going to be a lot better off.

Mr. HUGHES. I think we all agree with that.
Has the gentleman finished his questions?

Mr. LUNGREN. The only thing I would say on that is I understand where you are going and I would like to go there. However, I wouldn't want to say that just because someone has an M.D. behind his or her name therefore they can give untested drugs to humans when someone else cannot. And as I say, my father is a

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