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Thursday, December 12, 2002

Session 3: Prescription Stimulant Use in American Children: Ethical Issues

Lawrence H. Diller, M.D.,
Dept. of Pediatrics, University of California-San Francisco

CHAIRMAN KASS: Since this Council has taken a fair amount of flak for believing that great literature actually has something to offer the consideration of some of the large bioethical themes, I hope that you will appreciate this selection from literature. This is thanks to Josh Kleinfeld of our staff, who, in connection with this particular part of the meeting, put together for the staff a large collection of selections from literature -- meant to illuminate, in a way, the nature of childhood -- which included selections from "Secret Garden," and from "The Adventures of Tom Sawyer" and the like.

And if I read just one paragraph, maybe our colleagues will arrive. I see that my willingness to do so is producing them in droves. I don't have a Tinker Bell. Just one paragraph.

"Mrs. Darling first heard of Peter when she was tidying up her children's minds. It is the nightly custom of every good mother after her children are asleep to rummage in their minds and put things straight for the next morning, repacking into their proper places the many articles that have wandered during the day."

"If you could keep awake, but of course you can't, you would see your own mother doing this, and you would find it very interesting to watch her. It is quite like tidying up drawers. You would see her on her knees, I expect, lingering humorously over some of your contents, wondering where on earth you had picked this thing up, making discoveries sweet and not so sweet."

"And pressing this to her cheek as if it were as nice as a kitten, and hurriedly stowing that out of sight. When you awake in the morning, the naughtiness and evil passions with which you went to bed have been folded up small and placed at the bottom of your mind, and on the top beautifully aired are spread out your prettier thoughts, ready for you to put on."

I see that that little soft shoe has produced a quorum, and that we can move ahead.


Could I ask, are the briefing book materials available outside?

CHAIRMAN KASS: It should be in the package that you have.

This afternoon's session is on prescription stimulant use in America's children.

We have moved from the thoughts about the future to the present; from old age to things especially connected with childhood; from life span and genetic alterations, to brains, behavior, and drugs.

This for some people is already a topic already well worked over. It is old-hat arguments about Ritalin that have bubbled over several times in the last 15 years, including with Congressional hearings.

Yet, I would point out that this is not been the subject of any discussion as far as I know in any previous national bioethics council. Ritalin is a stimulant, useful in the treatment of attention deficit and hyperactivity disorders. It is according to the report, and not just in the briefing book, available and widely used off-prescription by snorting on college campuses.

And if one member of this council can be trusted to report accurately, is used on campuses not only by students, but by faculty members in lieu of afternoon naps.

That this, in addition to being used as treatment for clear disorders, has been used widely and in fact independent of any disorders, and is available for the enhancement of attention and performance. But also according to at least some critics, to produce compliance and pacification, with a sex ratio of use, some places numbering from 8 or 9, to 1 boys to girls.

In any case, we are going to concentrate primarily on this drug in its use in children, where the questions of the nature of childhood and the medication of our children is of some special interest.

And it is a special pleasure and privilege to welcome Dr. Lawrence Diller to the council this afternoon. In an area in which there have been zealots and radicals on all sides, this is a man who has occupied the sober middle voice of moderation, and of care, and of proper concern.

He is a practicing behavioral and developmental pediatrician for nearly 25 years in Walnut Creek, California, and he is also an Assistant Clinical Professor at the University of California at San Francisco, and the author of two very important books in this area, "Running on Ritalin" and "Should I Medicate My Child."

Dr. Diller, it is a great pleasure to haver you here and we are looking forward to the presentation.

DR. DILLER: I am delighted and honored to be here. I have been reading up on you, Dr. Kass. I got your book, and I am also very, very impressed with you and this panel.

But in particular what maybe distinguishes me from some other presenters here is that I am a clinician and on the front lines, and in here I think your essay on what is wrong with bioethics today, or something along that line, you were somewhat dissatisfied with the blah-blah nature of bioethics these days. And you were suggesting perhaps a more activist bioethics position. And I would say that I have no choice since I am there making decisions, clinical decisions, every day, in terms of who should or shouldn't get medication, and what are the treatments.

And that the ethical questions that I am facing have forced me to consider my role, and really my sitting here is just a very wonderful culmination of this personal attempt to address my own professional qualms in what I am doing.

And you will see at the end I think that it leads to a very activist position in bioethics. I am starting 10 minutes late, and I may have rip through some of this since I also noticed that --

CHAIRMAN KASS: You can take your time.

DR. DILLER: Okay. I have got 18 questions where otherwise everybody else got 12 or less, and I am not going to even try to do that. So here we go.

Overhead picture appears

If it was only this easy, (speaking in response to slide on screen) and in fact the demands on children and adults don't even allow for this kind of choice in the real world, especially school.

And on the other end the article in JAMA in 2000, which let the world know that 2, 3, and 4 year olds were taking Ritalin, provoke political cartoons like this one.

And what are we talking about here? (More slides shown.) We are talking primarily about two drugs. They are both classified as stimulants. Amphetamine, which is better known as dexadrine or adderall, and methylphenidate, which has many different names at this point.

And the most famous or infamous one is Ritalin, but actually Ritalin has been surpassed relatively by -- the Ritalin trade has been surpassed by Adderall, which is an amphetamine, and Concerti, which is a methylphenidate-based product.

You can see by this schematic that their structures are very similar and in large group studies, their actions and side effects are very similar. So if I say Ritalin from here on, I am referring pretty much to the whole class of stimulant drugs, unless I specifically say a trade name otherwise.

And here are the current ever-expanding list of stimulants available, and I say that with a little bit of synergism, since while this boom did not begin with the pharmaceutical industry, it has really been supplanted and taken over by what is seen as an ever-expanding world-wide market in the production and use of stimulants.

And there is a graph in your book that is a little bit more up to date, but I took the 10 years between 1990 and 2000 to show you what the DEA keeps track of here, since it is a controlled substance. On the left is amphetamine, and on the right is methylphenidate, a 2,500 percent increase in production and use in this count.

Granted, not all directed to children. This is important. The biggest growing market for stimulant use in America is not in children, ages 5 to 13. It is actually in the teens and adult market, and the adult market over 18 is the most rapidly growing use of stimulants.

And again this is a change. Again, you will see here the much greater increase in amphetamine has to do primarily with the introduction of Adderall and the marketing of Adderall to physicians.

I am trying to guess at how many kids are taking stimulants. This is guess-work. I am not going to go into the details of how these were arranged. The problem with most published samples is they are based on small districts collected nationwide at best, usually in just some localities.

And you will see in a moment the huge variability in the use of stimulants preclude being able to expand a national guesstimate on how many children and people are taking stimulants.

And I am not going to go into why my figure is different from, say, from et cetera. But the general guess is about -- at this point would be about 4 million children taking stimulants perhaps right now.

So the question that comes up, or the first question that comes up on NBC, or CNN, is, "Is Ritalin over-prescribed?" But then the adjoining question is Ritalin under-prescribed, and the answer is probably yes, depending on the locality. Meaning under-prescribed and over-prescribed, depending on the locality that you check, but I have changed my answer over the years to say is Ritalin over-prescribed? No longer, it is both, and it is basically, yes, even though there are pockets of under-use.

And what we are talking about here, the indication for stimulants in our country, narcolepsy is one of them. It is used occasionally as an augmenter for depression and Altzheimers, et cetera.

But by far and away, 99 percent of these drugs are used for the symptoms of attention-deficit and hyperactivity disorders. I am not going to spend a lot of time on the description and the problematic nature of the ADHD diagnosis today. I didn't feel that was really my mandate.

But just to remind you that the core symptoms are inattention, and hyperactivity, and impulsivity. However, a change in 1980 in the diagnostic criteria said that you could have ADHD without being hyperactive.

Just again, like all psychiatric diagnoses, there are no biological or psychological tests for ADHD, and more interesting to me is looking at the use of stimulants in America, and in the wide variation which points -- you don't know how many people have ADHD for sure, but you can be much more certain of who is using Ritalin, and we will find out in a short time why.

And there are wide variations based primarily on social, cultural, and economic factors in Ritalin use in our country and the world. And this is a DEA map of several years ago.

It does not show up all that well here, but green is under-use, and red is over-use, and it is interesting that Hawaii perennially has been the lowest per capita stimulant-using state in the country, generally using one-fifth per capita of what the highest using state does.

More recently you will see this cluster in New England. It used to be that Michigan and Indiana, and New England now has, you know, 4 or the top 5 States clustered over there. And one sees that it is in proximity to Boston.

Massachusetts is also now -- this is a map from 1998. It is how far away you are from Boston that determines the likelihood of how much Ritalin that you are going to get. And no specific institution is mentioned.

What we see documented is a half-to-one-quarter-eighth use in African-Americans with comparable socio-economic status compared to white Americans in the use of Ritalin.

Similarly, Asian-American children are conspicuously absent from this "epidemic," you might say, probably for other reasons. And then Hispanic-Americans fall somewhere between white American use and African-American use.

Just an example of how two localities contiguous to a body of water have very different Ritalin use rates. The reason why we use Canada here is that it is said that culturally when American sneezes, Canada catches pneumonia.

So there is a very similar phenomenon and controversy going on in Canada. The difference is that they have national public health. So every single Ritalin prescription is documented.

You can do this in Canada, and you can't do this in the United States. So what we have is then Victoria, a very homogenous, white, basically suburban community on the other side of Vancouver Bay or whatever from Vancouver, which is a polyglot, very Asian city, and you see the difference in -- and again we have National Health in Canada. And so access is not the issue here for the difference in Ritalin-use rates between those two communities. And so one concludes that in Canada and in the United States, while there are pockets of under-use, ADHD diagnosis and stimulant use is primarily a white middle and upper-middle class phenomenon.

Whether that is good or bad would remain to be seen. For example, African-American women had many fewer hysterectomies in the 1980s. That turned out ultimately to be a good thing. African-American men get very few or very much less coronary artery bypass surgery.

It remains to be seen whether that is a good thing or not, and we are still not sure about the Ritalin issue. What is the reason for this wide disparity?

Well, the diagnosis is part of it. There is no test, and ADHD, except in extreme situations, can be a diagnosis in the eye of the beholder. Just to complicate things, a psychiatric diagnosis may be challenged in adults, but it is a very challenging and questionable procedure in children to witness here the number of additional diagnoses basically as a way of describing children.

And it is not unusual in certain tertiary clinics for children to have 3 and 4 diagnoses, along with the ADHD. What does all this mean? I think the nomenclature in the neurological system has a lot to be desired.

I want to highlight learning disabilities and opposition defiant disorder. And I leave bipolar out because bipolar is the most controversial diagnosis in children these days, but in the Harvard Clinic, 23 percent of their ADHD kids had a bipolar disorder.

This is a very important study, because this is a study that tells you what is actually happening in the real world, and not in the university center where the children are highly screened and categorized perhaps appropriately.

Basically you are looking at a population of 4,500 community kids, and those are the ages. It turns out that the prevalence is about what people feel, 3 to 5 percent maybe is what is out there in the population.

They found that 7 percent of the children overall were receiving stimulants. Of those with diagnosed ADHD, about three-quarters were getting Ritalin. What that meant was that over half of the children getting Ritalin had no ADHD.

They may have had other problems, but they were -- the medicine in the real world is being used for a variety of problems, including those of impulsivity, and inattention, and hyperactivity.

They also found like I have told you before that within their study that the more affluent the family, the more likely the child was to get stimulants.

And just again to highlight here, there is a huge difference between university-screened children and what is happening in the real community. The response from organized medicine, academia, has been for diagnostic guidelines and to push diagnostic guidelines on to the community.

But if history is any guide, that previous guidelines have never, never changed doctors, and practicing behaviors, which are much more influenced by economics and threats of legal suits. And we will see in the short time why economics might push doctors towards using stimulants.

So there has been a thousand percent increase basically between methylphenidate and amphetamine in those years. Why? Well, guess what. I am not going to tell you.

It is in this book and it is 340 pages long, and it goes beyond what I can do in a 40 minute presentation. And again that is not my mandate. I may touch on it briefly at the end. Okay. But this is important. The United States uses 80 percent of the world's Ritalin.

Now, it used to be 90 percent, and so it is changing in other countries. Canada uses almost as much as we do per capita. Australia is catching up. The U.K. -- it is Western Europe where it is very different, of course. The under-developed countries don't have or don't use any stimulants at all.

But even though Western Europe is maybe catching up, physicians in the U.K. are still using one-tenth rates of Ritalin use than we are. In France and in Italy, it is practically not used at all. And in Germany, it is somewhere in between.

So that doesn't mean that they could be using a little bit more Ritalin. It could be why are we using so much Ritalin.

Now, a little bit on the drugs themselves. The way that these stimulants work, is that they block dopamine receptor sites, and therefore increase the neurotransmitter at the synapse, and tagged dopamine seems to show up more at the pre-frontal cortex and the local cerruleus in the brain.

However, there still is no coherent theory to entirely explain Ritalin's action in ADHD. In other words, dopaminergic theories have been thoroughly explored by attempts at getting dopamine levels in the brain, and trying to get PET scans.

You read about these things, and they are very tantalizing, and very interesting, and no doubt they are biological correlates. However, at this point -- you know, like the PET scans, and the MRI scans, and any biochemical testing, none of them are ready for prime time, except on television, in terms of clinical use.

Why? Because there are way too many false positives and way too many false negatives. Ritalin is -- this is basically what we know about Ritalin's effects. (Excuse me for the sound effects. This was for another, and it will get either louder or softer and we will find out in a moment.)

Well, it does increase concentration efforts, and effort compliance, and peer relations. It decreases motor activity and impulsivity, and defiance, and aggression.

It increases strength, and endurance, and speed, and we may have a chance to talk about Ritalin in sports in a moment or towards the end. And academic grades do improve in the short term.

We will talk about -- there is no paradoxical effect. Ritalin works the same on children, adults, ADHD or not. There is no change with complex skills.

Okay. The long term studies were done, and there were decent long term studies done in the 1960s and '70s. They have been criticized for non-randomization.

The children who were treated with Ritalin, let's say, just 6 to 13, there was no long term changes when looking at them post-adolescence. Neither good nor bad being treated with Ritalin, or not being treated with Ritalin.

The rejoinder is that these children should be treated through adolescence, and then we would see a difference, but at least childhood treatment of Ritalin resulted in no long term changes.

In these studies, they were broken up where also they received either family counseling or special education. Curiously, the families that did receive family counseling, and special education did show reductions in arrest rates and substance abuse at 18.

And Ritalin tended to be augmenting to that. The studies have been criticized for non-randomization. A way of interpreting those studies would be that those families that choose to get involved in counseling, and/or special education, or have access to it, may be a different kind of family than one that doesn't.

And overall only small effects on learning and achievement long term. So there is a disappointment long term even though short term results are very, very impressive.

Just quickly here on Bradley's initial report, he said "appears to become hyperactive kids." Well, that's not how it got understood. and for decades, and still this notion that somehow a response to Ritalin means that if you calm down, it means that you are hyperactive and ADHD. It happens to everyone.

And indeed stimulants were studied extensively by the military in the 1950s, and I like to say that people don't know this, but Rommel used amphetamine with the German Afrika Corps in World War II, and the GIs were given amphetamine in return, and many GIs came back addicted to amphetamine after the war.

The military ultimately decided not to use stimulants as routinely. Why? Because of episodes of erratic behavior, and the idea of giving someone a gun who acts erratically was not thought to be prudent.

Finally, this was nailed finally with Rapaport studies of normal boys and men, and again showed equal amounts of improvement, and this is important for people considering enhancement versus treatment.

Equal amounts of improvement in performance tests between ADHD boys and non-ADHD boys on continuous performance tests when given stimulants. What happens here is that if this is ADHD, and this is normal children, when you give them Ritalin, this is what happens. The normal children act super normal.

And I already made the point, the last one there. Side effects. What doctors would generally feel tolerable side effects, sometimes families feel differently.

Temporary appetite suppression, insomnia, more seen with the amphetamine class. And this phenomenon called rebound, where the behavior deteriorates after the child or the medication wears off, is reported to be a very common phenomenon, and is never studied yet in any formal study, and I find that pretty interesting.

Tics have been brought up, and it is controversial, and I would say that currently if someone has moderate to severe ADHD, you ought to give them stimulants in the face of tics, because the ADHD is generally a more disabling condition.

Euphoria will occur. It doesn't occur in children. I would say the only clear biological difference that I can see, and this is important when it comes to abuse, is children don't get euphoric when you give them -- and I am talking pre-teens here.

That something is happening, and I think it is partly physiological, and I think it is partly sociological, because in the Army studies more euphoria was reported when the GIs took the medication in groups than when they took it individually. Isn't that interesting?

I find that very interesting. Anyway, kids don't like higher doses. They complain. They say they feel wired. They feel weird. And teens and adults will say they feel grand. They feel powerful.

Long term growth was an issue raised in the 1960s and 1970s, and studies from the '80s and '90s seem to squash that concern. What remains? The notion that Ritalin is in your system and out of your system is something that we have always held to be able to tell parents.

Well, in fact, animal studies show single or two doses of Ritalin permanently affect receptor sites. They increase the number of receptor sites in the synopsis, okay?

DR. McHUGH: Can you tell us what it means?

DR. DILLER: I don't know what it means.

DR. McHUGH: Can you explain what that means to the audience?

DR. DILLER: Well, one stance is that giving one or two doses of Ritalin to rats -- and you have rats who are unexposed to Ritalin, and then you expose rats to Ritalin, because you have to kill them and section their brains.

And you label the dopaminergic sites, and that the dopaminergic sites increase in the exposed Ritalin rats after one or two treatments. What does that mean clinically? I don't have a clue.

I am talking fast, and I am going through things very quickly. If there are questions, please, I don't mind being interrupted. The use in toddlers as I already mentioned is highly controversial and touched a national nerve as you saw, and that resulted in two conferences on the subject, and there is a study going on at Columbia right now.

We will talk about this in a moment, and this is the big fear that parents have. The increase of subsequent drug use in pre-exposed children to Ritalin. And then the notion is that Ritalin actually is superior to non-drug treatments in the treatment of ADHD. And we will touch on illegal use in a moment.

Okay. And the presensitization effects in animals and humans: single doses of Ritalin to both animals and humans presensitize them to subsequent addiction.

I am not going to go into the details of the clinical studies. One says that Ritalin does sensitize children to cocaine and cigarette abuse as adolescents, and one study says it doesn't, especially if you give it to them as teens and adolescents.

In other words, if you take Ritalin from a doctor, you won't abuse the drug yourself. My opinions on this as a physician who continues to prescribe Ritalin to children is I think both the presensitization effects, and whatever effects clinically, treatment as a child has on subsequent adult or teenage substance abuse is small compared to effects of family and neighborhood. That allows me to continue to prescribe at this time.

It is a little bit beyond our -- I am doing pretty good in terms of time actually here, but I want to get to some of the moral-ethical issues, and that may take some time.

We will probably touch on this. I guess this is the hottest one here. I already said that the greatest expanding market is in the adult market for adult ADHD. There is also an illegal market going on here, and you can read what it says.

Now, the bottom bullet there, I already mentioned the GIs. Since World War II, in the United States, we have had three waves of doctor-prescribed stimulant abuse epidemics.

In 1945 to 1950 was the GIs. In the early '60s, it was the period of the Dr. Feelgoods, and that just came up again recently, where the Hollywood stars were being treated, and so was President Kennedy being treated with IV amphetamine, and in the late 1970s and early '80s was dexadrine for diet control, weight control.

In all those situations, there were indications, support indications, for doctor-prescribed stimulants, and in all those situations a core group of patients became addicted through their physicians. There is no doubt in my mind that we are going to have another wave of doctor-prescribed stimulant abuse. Again, the paradoxical thing here is that it is actually safer in children than it is in adults.

And the adult situation has only really just started in the last 3 or 4 years. And when you see family physicians in particular prescribing stimulants, you know that they just won't be able to follow their patients as closely.

I want to get into the issue here of ethics and values. Okay. First of all, the issue of ADHD as a neurobiological diagnosis, and what that means is that either when a child or an adult has this, and what it means politically very often is that it could be used in the service of saying-- "Well, we can't really do anything about this kid environmentally. He is really pretty much determined to have this problem. The only thing is to contain him and to give him drugs." It also again raises issues on a moral level that if indeed they are so determined this way, then in fact if they make wrong choices, they can't be held morally culpable.

I actually like what Russell Barkley says about this. He is the intellectual guru you might say of ADHD, and he says that ADHD might be considered an explanation, but not an excuse for behavior.

Here we see maladaptive behavior as disease, versus accountability and responsibility. This is a big issue in the schools, particularly over discipline. And that the disability movement has held schools accountable in the sense that unless they make adaptations to their children's diagnosis, the child can't be held responsible for acting out behavior. This whole issue really pits the rights of the individual versus the rights of the community in probably some of the most provocative ways.

Indeed, you know, 3 children out of 4 were expelled for I think bringing a weapon to school, and this was before Columbine, and the fourth one was not because he had an ADHD diagnosis, and the schools had not made an adaptation, in terms of a behavior plan.

I am not saying that there shouldn't be behavior plans for children. And don't get me wrong. Buthis can be used again politically in very interesting ways.

Similarly the ADHD defense has been raised repeatedly in criminal law. It has never gotten a criminal off because those are based more on the McNaghten Rule of knowing right from wrong, but it has mitigated sentences, and I would suspect that you will see wealthy clients using that defense more than poorer clients in criminal cases.

This notion here as more and more people use Ritalin with their children, will it cause parents who aren't ready to use Ritalin, to feel like they must? And this has happened absolutely, and especially in the arena of special education.

But it happens daily in the classroom. Probably the most famous or infamous case of this is Patricia Weathers' child in Upstate New York, who actually was reported -- she and another family were reported to their local Children's Protective Services because they decided to stop giving their children psychiatric drugs.

The school reported the parents to CPS for medical neglect. In both cases the cases were thrown out, and they were adjudicated in favor of the parents, but it does show the extent to which schools at least have come to believe that acting out children is a biological problem that needs to be addressed with a drug.

Parents repeatedly have come to me and their legislators complaining about pressure from the school to get a medical evaluation and medication. The response has been in 11 States, and in essence gag laws preventing teachers or school psychologists from mentioning ADHD or Ritalin to the families.

They can still talk in terms of a medical evaluation, but they must exhaust -- the general language of these laws is saying that they must exhaust educational and disciplinary techniques before they request a medical evaluation.

The impairment question is an interesting one. The notion of having a psychiatric disorder implies that you are impaired in some kind of way, but Ritalin is very -- ADHD is very interesting in here, in that the standard has been not necessarily impaired compared to others, but impaired in terms of your potential.

So therefore if your Wexler Intelligence Scale comes out at 120 or 130, and you are only getting B's and C's at school, and you are not attending, and meaning not paying attention, and maybe you are disinterested, or maybe you have ADHD inattentive type, this is a common reason for parents and/or teachers bringing children to my attention.

This notion of impairment was brought to the forefront socially in a case of medical students versus The National Board of Medical Examiners, where these medical students had twice failed the national credentialing exam, and claimed that they wanted unlimited time on the basis of their ADHD disability. The courts adjudicated against the medical students, and indeed, Russell Barkley, cited a -- a witness for the National Board of Medical Examiners, in that the court ruled that while the students may be impaired within their own potential, they certainly are not impaired compared to the rest of the population, in that they finished medical school.

And indeed that on the individual clinical level many -- I see very few -- I see very few felons in my practice. I see very many lawyers, doctors, accountants, coming in wondering whether they have adult ADHD.

And whether that anxiety or setting the bar too high for them, but certainly the degree of achievement that they have made that allows them to come to my office strongly suggests that they are not severely impaired.

And yet, "Driven To Distraction," the book by Edward Hallowell, opened the gates for the use, I think, of stimulant medication in the adult population, primarily for enhancement purposes. That's my personal opinion.

I will get flak from that in certain self-help group organizations. Again, that goes very nicely into the last two points, treatment versus enhancement, and where is the line. Where is the line? There is no line. There is no line.

Cosmetic Ritalin. You have Peter Kramer here, and so the notion of better than good. Well, in Prozac it is mood, but in Ritalin, it is much more so clearly performance, and it has been known for a hundred years.

And so the issues of Prozac are kind of still speculative. And Ritalin? We have known that for a century. Interestingly, Ritalin and amphetamines are banned in sports. Why? Because in sports, we consider not just the achievement itself, but the effort involved in the achievement.

And it is felt -- and Dr. Sandel raises this somewhat later on in enhancement, I believe, versus treatment, or the problems of enhancement. We take not just the achievement, but the effort involved.

And it is felt that somehow taking a stimulant drug cheapens that effort. But there is another important reason that Dr. Sandel doesn't mention, I believe, in his paper, and that is free will under pressure.

If one athlete is permitted to take a stimulant drug, a performance enhancer, it puts pressure on all the other athletes to take the drug just to stay even.

For that reason, stimulants are banned in most professional sports, and they are banned in the U.S. Olympic Committee Sports. Interestingly, under legal pressure from self-help groups, the NCAA allows the use of stimulants in athletes who have a doctor's note that says that they have ADHD.

Now, the question is, isn't academics different from sports, you know? Sports is competitive, and sports is extracurricular. Well, I am not so sure how extracurricular it is to an inner-city child trying to get out of the ghetto. I would say that is a pretty life-meaning thing that he is engaged in.

But certainly things like the SAT test are competitive. That's why it is partly there. And reports are increasing of children -- and you will be hearing about this more, but children taking stimulants specifically for exams. It is already done on the college level, but being given stimulants by their doctors is something that we are facing. Will we be soon seeing drug urine testing for SAT exams?

And I think I am going to move quickly on this. This is the building I feel of anti-affirmative action swell that is going to occur in the disability rights movement. And the Bakke decision marked the line between the retreat from affirmative action.

And these kinds of things driven by the disability rights -- and I am not -- I mean, I think there are some very disabled people, and this is not my axe to grind. I am only saying that as disability becomes more and more nebulous, that these kinds of things are going to cause problems for the general community.

I am going to move quickly. Basically the MTA studies are the best government studies, and the headline that you saw earlier was "Drugs Work. Psycho-Social Treatments Add Nothing." Well, it turns out that it is not so cut and dry as that, and it turns out that the families preferred combining treatment with drugs.

But this is the important issue here. I am not worried that Ritalin doesn't work. I am worried that Ritalin works. It works quickly, and relatively cost effectively. But I don't see Ritalin as a moral equivalent to helping parents parent better, and helping teachers teach better.

And Joseph Biederman at Harvard said, "Well, we simply don't have enough money to provide all the psycho-social interventions." So with that I counter my own modest proposal.

With classroom size averaging 29 kids per class, and 4 million or so children taking Ritalin, I propose that we increase the number of children taking Ritalin to 7.5 million, and we could probably increase classroom size to 40 kids per class and save a lot of money.

Is anybody interested? Does the President potentially want to float that one? All right. There are those who said in fact that this is a conspiracy between academia and the pharmaceutical industry, and to some of the self-help groups that are funded by the pharmaceutical industry.

And I say that you don't need any conspiracy. You have the invisible hands of Adam Smith at work here. Market forces. But I do want to touch briefly on the pharmaceutical industry's influence.

There are market forces working on the physicians, too. Psychiatrists are paid much more for psycho-pharm follow-up visits than they are for one 45 minute visit with the child's family. Much more, three times more.

But with the drug industry here, this is how they influence what is going on in our thinking about children. There is money for the drug research, and there is absolutely as you know an incestuous relationship right now between researchers and the drug industry.

They claim a lack of conflict of interest. I don't see how that is possible long term. There is some talk about these studies published only promoting positive findings.

And advertising the doctor's work, and I am paid $500 to attend a dinner supposedly as a consultant for Atomoxetine, the new Strattera drug, and it was just a promotional event.

Okay. No stock dividends or equity to special education and family treatment here. And this is a picture of an ad in a women's magazine. I couldn't get in the title below in that. It says, "Homework is no longer a problem at the Williams' family because they have learned about ADHD. Call this 800 number."

What is my problem with this picture and that message? Well, to me, it reduces a fairly complex social developmental undertaking, homework, to one thing, the brain, to be solved by taking a pill.

Now, I may tell that to you, and occasionally I get on t.v. when they need a responsible dissenting voice in this otherwise media blitz, let's say, on Strattera, the new atomoxetine drug.

But relatively speaking, where is my voice compared to the power a million dollar corporation can bring to the introduction to a new drug? So the way that we think about children being so influenced by profit-making institutions deeply concerns me.

And ultimately what we have here, and I am almost done, is an intolerance in our country of temperamental and talent diversity. We have a great fear that our children will not make it, and this fear is passed on to the teachers, who put a lot of pressure on the kids.

Would Tom Sawyer and Huck Finn be on Ritalin today? No doubt in my mind that they would be if they lived in my community. I see Tom Sawyers weekly.

What have we got here? It's not going to change very fast. Basically, we have a culture whose state religion is corporate consumer fundamentalism, which says seeking emotional and spiritual satisfaction comes from material acquisition.

And so I have a lot of round peg and octagonal peg kids who aren't fitting into square educational holes, because the message there is if you don't get into college, buddy, you are sunk. Ritalin will lubricate that hole for that child.

I am not against Ritalin. I use it after we fully explore what we can do with the family and the school, and if the child is still struggling, it can make sense. I am against Ritalin as a first and only choice.

One guy said, "Well, Dr. Diller, would you withhold treatment for diarrhea until you were absolutely sure of the cause, or would you treat the diarrhea?" Well, no, I would treat the diarrhea.

But if I even suspected that a factory upstream was polluting a river that was causing the diarrhea, and if I just treated the river, or just treat the child without addressing the larger issue of the factory, then I am complicitious.

And this is a term that I have picked up as a physician, with values and factors that I think are bad for children. So my role as a doctor, yes, is to relieve suffering, and if we have explored the alternatives, and we have tried them, then I will give Ritalin.

But my role as a citizen compels me to speak out about the larger issues. So I think that this thousand percent rise is a canary in the mine shaft, and we should be looking at the demands on children, and think of Peter Pan stories and things like that.

And look at how we distribute resources to children, and their families, and to schools. Real quickly, I think our diagnostic system is a mess, and that one of the reasons why we diagnose someone with ADHD and give Ritalin is because it allows for services.

The doctors make more money also if they come up with a diagnosis. We should consider a needs- based system that they use in mental retardation already.

Early learning is great. The Sesame Street and Headstart works very well to make a difference for the inner-city poor, but it has repeatedly shown to make no difference for the middle and upper-middle class.

What it does create is a sense of inadequacy, and everyone involved in education will tell you what we are expecting from four year olds is what we expected from five year olds a mere 20 years ago.

Well, there is just too large a segment, especially of boys, who aren't getting it. And when they look distracted, and parents of 4 and 5 year olds are coming, and referred by the school teachers, saying, "Does this kid have a chemical imbalance?"

I think we need to reintroduce round and octagonal holes in school for round and octagonal pegs, who will do quite well, thank you, in a maybe non-high-tech, non-professional position.

I think it would be very boring by the way if everyone became either -- it used to be doctors or lawyers, or Bill Gates. What makes our culture rich is diversity. And yet we are training all the kids to do the same, and if they don't do it, we are giving them Ritalin.

I am just going to -- I can't read this, and I am just going to let you see it. This is more communication between doctors and teachers, a very big problem. This would be very helpful in reducing the amount of ADHD or Ritalin if we could get more powers to provide immediacy of reward and punishment in the classroom, which works very fine.

A similar thing. Parental counseling does work, especially for the younger kids, but getting access to it is difficult.

So this is the final thing, ADHD and Ritalin use in America, and I think it is a message not just for children with ADHD, but all the families with children in America.

It is time that we paid attention and that is the website where you can get a lot more information. Thank you.


CHAIRMAN KASS: Thank you very much for covering a lot of ground and raising a lot of terrific questions, and for the spirit of concern that animates this and all your work on this subject to date.

We are going to get the lights on so that you can see the whites of their eyes as the conversation starts. I wonder if -- well, other people volunteer, but I would certainly like to ask two of our colleagues who work either in neuroscience or in psychiatry to offer their thoughts on the phenomena.

I mean, I take it that this is -- that while this is a large matter with us now, what we know about -- we included in the briefing book this long review article out of Johns Hopkins by Riddle on pediatric psychopharmacology, and it is perfectly clear from the spirit of that, that the biological understanding of psychopathology has won and has emerged victorious.

DR. DILLER: In the medical model?

CHAIRMAN KASS: Yes, in the medical model, and that there are lots of opportunities for all kinds of disorders, some of them clearly defined, and some of them squishy.

And also lots of opportunities, and never mind the diagnosis, where there will be a considerable demand for the aid of pharmacology to produce either compliance or better attention, or other sorts of desirable things that parents with perfectly understandable reasons may want for their children.

So I would be interested to know either from the side of the neuroscience or from the side of psychiatric practice -- well, there is a question raised about how we are taking this subject up, not only for itself, but what it might be a token for a whole area of similar things.

And whether I could ask Mike Gazzaniga and Paul McHugh to start in the conversation if you wouldn't mind.

DR. GAZZANIGA: Sure. Thank you. We are in a situation where the National Institutes of Mental Health, I think, endorses the use of Ritalin and says it is safe. It is the most studied of all the drugs administered to children.

And so we do have one of our major health/government agencies saying that this is an effective way to treat. And I am neutral on it. I am just reporting that is the fact of the case.

But I would be interested in knowing that given your conservatism on it and caution for it, when you actually get into the clinic and you see the next hundred kids that are referred to you, where does it land? How many of them do wind up having Ritalin prescribed?

DR. DILLER: I think on the ones who are -- well, first of all, I am in private practice, which is different, and I do see a relatively middle-affluent population, and I think that is to be considered.

But to answer your question, I would guess relatively about a third of the children who come in to see me, about a third to about a half wind up ultimately taking Ritalin. It is often a step-wise procedure in my situation.

I actually don't get to see the most flagrant cases of ADHD, because they are generally referred, or they are being addressed by the pediatrician and primary care doctor, okay? I am seeing the complicated cases of ADHD, or I am seeing lots of borderline stuff, the Tom Sawyers and the Huck Finns.

The case is made by the pro-medication side of the morbidity involved in untreated ADHD. The notion that many of these children do very poorly in school and ultimately become prey to both the juvenile justice system and in substance abuse.

And there is no doubt that impulsivity is an important factor as a temperament trait to those kinds of problems. The question is whether ADHD is the best marker of that, or are there other better markers, temperament markers, of intensity or adaptability especially being one of them.

In any case, they said there is usually morbidity of not treating, not treating children with Ritalin, and I don't know -- again, no one has long term data to say if Ritalin really is effective long term.

But I don't feel that we can just wait until we get finally, quote, "a good study," and in fact that good study will never happen in the United States anymore, because it is standard medical practice to give Ritalin.

But again that doesn't deny the issue that I am raising, which is that there is a core group of disabled children who wouldn't need a physician to say that there is something terribly wrong.

But that I suspect is along the lines of one-eighth -- and I am guessing -- of who gets Ritalin now. But there is a much larger group of a gray zone as you saw in that Rocky Mountain study, and that is a demonstration of real life practice there.

And there the notion of morbidity and using Ritalin to address morbidity raises for me serious ethical questions. Again, for me, the idea that Ritalin works is not at issue. The question is as a substitute or as an equivalent for helping parents, and/or teachers, simply because it either works faster or costs less money.

Now, studies again that say it works better than helping parents, or helping teachers, I think they are looking at a very narrow definition of what the problem is.

And I think that these studies look at the ADHD symptom list, and in that sense you could say that Ritalin is very specific. It is almost as if the disorder has become tailored to meet the effects of the drug.

At least ADHD has evolved over the last 30 years, and I have that feeling very much so. And by the way that is not unique to ADHD diagnosis. The rates of depression soared after the introduction of Prozac.

So the way that we conceptualize things very often are influenced by what treatments or how they are promoted. Anyway, I have got a little meandering there. I want to be clear here again that the answer to your question is, I would say, one-third of the kids.

But it usually is a step-wise process, particularly for the younger ones and the borderline ones, where we give behavioral interventions and make sure that the learning issues are addressed for a good 2 to 3 month period. It isn't very long.

But really -- and you can see what the family is capable of, and what the school system is possibly able to mobilize. But that is with a physician who acts as a strong advocate for those other things happening.

And typically the way that the economic system has worked out, and ideologically also, but it is very much driven by economics, again the notion that the child psychiatrist or the behavioral developmental pediatrician, is much more rewarded by a 15 minute psychopharmacology follow-up visit than a 45 minute visit.

So if your only tool is a hammer, all solutions are nails, and what has happened to our profession, I'm afraid, is that the person potentially with the most experience, and the most social clout, in terms of getting things to happen and change, has been relegated to giving one pill or another, and I think that is a damn shame for the sake of the children and the families.

CHAIRMAN KASS: Dr. McHugh, Paul McHugh.

DR. McHUGH: Yes. Well, that was a wonderful presentation, and for my colleagues, I would like to only underline a few things that you said that I think that they need to know in order to judge how this situation came about.

We have talked before, but I want to talk further about the present diagnostic system in American psychiatry, the DSM measure. It is a very peculiar classificatory system because it fundamentally is a symptom checklist for almost everything.

It doesn't organize things according to their natures, and even according to their causes and their development. So it has encouraged psychiatrists to use a top down approach to diagnosis. Instead of taking a history from the beginning of the developing person, and seeing aspects of that person's life played out in the themes that all of us face, such as schooling, family, occupations, marriage, and the like.

And it goes in and it says do you satisfy these five criteria here, and three of the other criteria. The result of that is that since there aren't a whole huge number of symptoms that anyone can show mentally, is that there is a huge expansion in the people who satisfy checklists.

You mentioned ADHD and that is our subject, but depression, and PTSD, social phobia. People say 1 in 8 people suffer from social phobia. All of this is top-down, and encouraged by both the classificatory system and by the fact that drugs seem to make a difference.

What happens as you have said in this approach is that drugs do make a difference, but no one thinks about the consequences in the social network of the person. No one thinks about the character of the child, and no one thinks about the character of the family.

No one gives advice on parenting and to a person about how they might overcome certain matters. And they do expose them to, after all, drugs that have serious consequences, including addiction.

DR. DILLER: But I don't want to leave on the record, let's say, this notion that children are becoming addicted by being treated through Ritalin. There is no evidence of that. The drug is misused.

DR. McHUGH: I was saying that some of the drugs -- for example, adults now, with adult ADHD, they have become addicted.

DR. DILLER: Yes, that is an issue.

DR. McHUGH: And they get a checklist, and they get a pill, and they get addicted. So the younger child does not become addicted presumably for the reasons that you said. That he doesn't like the drug because of his neurobiology. But your point about this issue is a general issue, and is a specific example of a general issue in American psychiatry today.

DR. DILLER: You know, we had lunch, and we agreed a lot about problems with the DSM, but being entirely realistic, the DSM is not only an ideological document, but it is a legal and financial document.

And it is particularly in its accessing services and money that the DSM is powerful, and the DSM for nature will not change until we are able to offer services and/or rights to people in another way.

Again, the drive towards disability, and the drive towards pathologization comes, and people are in genuine need much of the time, and they are looking for help and the way that they can access that help either in terms of services or money is by obtaining a diagnosis.

This economic push, and then there is a service industry built around that, in terms of the physicians and the mental health industry. Until that changes, and again I think that more and more people are asking about that, but there is a very entrenched bureaucracy here that sees it working well.

DR. McHUGH: A bureaucracy built by the psychiatric choice of a DSM-based approach, and the linkage that they could have with powerful drug companies.

It took only a few years to build that bureaucracy, and a coherent attack on it could I think bring it down, especially if you could show -- and we can show -- that an approach to patients -- that it takes a little more time, but it is bottom up rather than top down -- will not only do better for the patients, but do better for research. Ultimately right now our research on depression is incoherent.

DR. DILLER: It is delightful to have this kind of conversation, but you tend to have these at bioethics meetings, and not at industry-sponsored technical meetings.

DR. McHUGH: Well, that's because I don't take any money from drug companies, Dr. Diller.

CHAIRMAN KASS: He is also not afraid of anybody.

DR. McHUGH: Yes, right. But to just press on a little bit further in what you are saying. I do think that the other point that I wanted to emphasize that you made very good is this pressure to choose this, and you mentioned that athletic endeavors have struggled to fit that out.

You and I mentioned that at lunch, but my colleagues might well remember that a very distinguished American psychiatrist, Arnold Mandel, a person that I know, and a delightful man, was the psychiatric consultant to the San Diego Chargers, who were all on amphetamines, and he went down to try to stop them, and the defensemen said, "Now, listen, Dr. Mandel, can you imagine what it is going to be like for me to get out there with these other 300 pound guards dripping with amphetamine? I have got to do it." And in the process of trying to help them with this, Arnold Mandel got into a considerable amount of trouble with the FDA over it.

So that pressure which we saw in the sports is not present for families for all kinds of things.

And what is missing fundamentally is an understanding of the person and the distinctions amongst disorders that could express themselves in similar ways, but would take quite different treatments.

And that is both a technical, professional, and deeply moral problem right now in our field.

CHAIRMAN KASS: Michael Sandel.

PROF. SANDEL: This is a question that I would like to direct initially to you, Paul, and then to Dr. Diller. Taking the critique of the DSM and the overuse and so on that you have educated us about really over a number of these sessions, and hearing the stories about Huck Finn and Tom Sawyer, which you often hear in the popular discussion -- and, well, they would have had if only ADHD had been around, they would have been diagnosed and so on.

DR. DILLER: Or worse.

PROF. SANDEL: Here is the thing that as a non-medical expert that one is led to wonder, and I wondered what your answer would be. Is ADHD really a disorder or a disease?

DR. McHUGH: In my opinion, when I first was introduced to ADHD in my training, it existed, but it existed in a very few children, and it was associated with the most remarkable forms of hyperactivity, in which -- and usually with a touch of brain damage and mental retardation.

These were children that would run around and tear up the household, fall asleep in the laundry basket, and then wake up and buzz around further. Those were the cases that Bradley was talking about back in 1937 when he introduced the idea that amphetamine might seem to improve.

It was these kids, and there has been an insidious spread of that to the point where a sizeable proportion of people temperamentally on the active side are encompassed by the term, since the drug will slow all people down who are, let's say, 10 years old. It will slow -- and if you can imagine a dimension in which kids with a Bell-shaped curve related to their activity, you can see that there would be a group out here on the right, and there might be a disease group that was also pushed further out to the right.

If you could move them all to the left, you would if you were strict in your criteria get few of the temperament and all of the people with the disease.

But if you were loose in your criteria, you would move down close to the mean, so that anybody that spoke back to Mrs. Murphy in the third grade like I did would be on it, you know, right off the bat. And those are serious issues that should be of concern to us.

DR. DILLER: Well, when you asked the question, I kind of like internally moaned because it is a fighting words kind of question, especially to those families that have made a commitment towards treating their children with medication, because the implication then is, well, you know, you are just making all of this up, mom and dad, and it is used in that kind of rhetorical kind of way. I know that you didn't mean it that way.

DR. McHUGH: Nor did I by the way.

DR. DILLER: I know. I know. And so my answer is similar to Dr. McHugh's, and maybe a little bit different, in that there are -- well, first of all, the construct has lots of problems to it.

The construct meaning as defined in the DSM-3< "often fidgets -- you know, often acts up," -- well, what is often? You know, the construct, even though two psychiatrists can agree -- and we will get to in a moment about this Bell-shaped curve that he was talking about -- is very different in the community.

So that study, and how it is willy-nilly diagnosed, and prescribed in the community. There is a core group of children, and I don't care what environment they are in, or how they were raised, or whatever, who would be troubled by problems of inattention and impulsivity, and hyperactivity.

And again if Dr. McHugh is referring to that group, this whole panel would probably agree on that. Again, I was guesstimating one-eighth to one-tenth of what we treat.

In fact, WHO criteria in Europe tend toward that criteria, and that is what you get, one-eighth to one-tenth. That Bell-shaped curve that Dr. McHugh mentioned, attention and the ability to focus, let's say, is dimensional.

It is not categorical. You suddenly don't have ADHD if you have 5 of 11 symptoms, and if you have 6, then you do. I mean, that's crazy. Pardon the pun.

But let's say you have -- or I have to make a graph like this, and you have a Bell-shaped curve, and over here is really good attention, and that can be a problem, too. Sometimes that is called obsessive-compulsive type stuff.

And here is really poor attention, and unlike intelligence, for example, trisomy, and Downs syndrome, where you have that Bell-shaped curve, and then you have a space, and then you have another curve, clearly identifiable. That's not true with these symptoms, okay?

The real interesting thing is where that line -- let's say that if this is bad, where that line of deviance is decided, and that is clearly culturally, socially, family, economically determined. So, you know, Hawaiians are way over here. African-Americans are over here, and it looks like Victoria is almost like in the middle, where they start to worry about it.

And the diagnosis has become broader and broader, and again, speaking of -- and I am laughing at Dr. McHugh, and his feistiness, okay, which might have been construed as a non-compliant ADHD.

Very often the weaknesses that we have as children are the very things that we learn to work off of and develop our strengths on. And again I think it would be a very -- and you have got to remind parents about that, because they are so afraid that their kids are going to get hurt and fall behind.

But in terms of how we become full people is often working off of our weaknesses. And Dr. Kass' kind of work and in looking at enhancements, and the thing is that as we choose to focus on things that are good, and attention. And what is the Wexler Intelligence Scale anyway?

It just checks out how good you are going to do in school. It says nothing about creativity, or other important things, such as how well you relate to people. It says nothing about that, because I would tell you that emotional intelligence is the best predictor of how happy you are going to be as a person, rather than anything that you do on the Wexler Intelligence Scale.

My point is that by over-valuing certain characteristics that we can do something about, we wind up diminishing other important characteristics, and how often will I have to tell a family of a very sweet -- you know, a 10 or 11 year old girl. You know, she does have a learning problem, and she isn't going to do as well in school, but she has a great heart, you know what I mean? And that is going to serve her so well. How can we protect her through this educational process that will otherwise diminish her because it is a square educational hole?

DR. McHUGH: If I could just finish off then. I did want to ask you a question, Dr. Diller, that you would know and I don't. But I remember that about a decade and a half or so ago that Dr. Stevenson looked at the schooling systems in mainland China, where they apparently had this understanding that boys were wrestlers.

And that they organized the school day where instead of having a kid come in at eight o'clock and sit at a desk until noon, that they had frequent recess breaks, especially for the boys, for some 25 minutes after every 45 minutes, and brought them back in for courses.

Now, do you know anything more about how other cultures and other places that don't have access to drugs, have approached the issue of hyperactive boys, and the tendency of boys all would be a bit more of that sort.

DR. DILLER: Well, my quip was that they are probably beaten more regularly, you know.

DR. McHUGH: It didn't do me any harm.

DR. DILLER: And that is a concern again. I mean, there is a legitimate concern that in the past that these children were simply labeled as bad, lazy, or whatever. Again, the line here between emotional moral things like motivation and caring -- you know, Barkley at one point considered ADHD a neurological disorder of motivation, but he realized that he was moving into such a philosophical mine field that he quickly focused more on impulsivity being the core feature of ADHD.

And to answer your question, in every culture, and in every society, and again the pro-medication biological camp will trot this out, there are kids who meet criteria for ADHD. It is a -- and as you would expect, in any Bell-shaped curve.

If you are tight enough in your criteria, you will select the group that has this problem. How different cultures handle it I think is of interest. I would say in general, if I can make a comment there, we have looked at the notion of the presto-tempo, or the notion of why America and that question there.

One of them is the presto-tempo theory of ADHD that are fast-paced; you know, computers, video games, t.v., cell phones, pagers, et cetera, which lead to an over-stimulation of children, and therefore they have more ADHD.

I have trouble with that, because I think that children in Milan, and Tokyo, and London, are pretty well exposed to similar things, and yet their use of Ritalin is non-existent in Tokyo, and actually non-existent in Rome, because the Italians have not legalized Ritalin yet. They are going to shortly.

More compelling to me is this notion of consistent and inconsistent cultures, and a consistent culture is one that demands group conformity and making the self secondary to the group in general, okay?

An inconsistent culture prides its independence, spontaneity of expression, and ideas of self, but then demands conformity at school. The best examples of a consistent culture are the Westernized Asian cultures, where again Ritalin use is virtually non-existent.

There is probably this core group of children who are being beaten. The best example of an inconsistent culture is ours, where again all these notions of self-expression are valued, but then we demand conformity at school, and Western Europe is somewhere in between.

So I am not answering your question there, but I think parenting and discipline is a very important aspect. You know, 50 years ago or 60 years ago when there was more authoritarian type families, we were seeing a different kind of problem in children. We were seeing much more psychosomatic disorders in children. Now with the liberalization of parenting, whether it is to the authoritative model, or permissive model, or just our confusions about discipline in raising children, parents are very mixed.

They get this mixed message, and teachers do, too, about what is the right thing to do. We are seeing a different kind of problem, and a much more acting out kind of problem.

DR. McHUGH: I agree that the parent problem is a major issue in the culture. I just wanted us to also remember that there are different schooling patterns that produce a different environment for a young child, and as I said, I thought that Stevenson had reported these quite distinct classroom periods for boys, young boys, in mainland China.

DR. DILLER: The model in our country is really Pelham's work out of the University of Buffalo, where they do use token reinforcement and time out in the classroom.

And they operate with that and can generally operate without medication with very hyperactive children, and/or in a more generalized classroom, reducing the frequency and total amount of medication for the day in these kinds of classrooms.

CHAIRMAN KASS: Gil Meilaender and then Frank.

PROF. MEILAENDER: This is a different kind of question from what we have been talking about. One of the sort of trickier difficult things about the kind of questions that you are dealing with is that you have got a drug that might have any number of uses that most everybody would regard as legitimate and appropriate.

But then would also have uses that might seem at least questionable, and there might be many cases when you would say, "Well, I don't know if that was so wise, or maybe even a virtuous judgment about the use of it."

You might be reluctant to just say it is wrong. What I am interested to know though is whether you can give me some examples where you would say it is wrong.

Physicians, after all, hold one another accountable for their practice. So, for instance, if I see my doctor and I say, you know, I lag mid-afternoon every day, and my doctor gives me one of these drugs to help, is that unwise, or is that wrong, and if it is not wrong, then what would be wrong? I am looking for -- I would like a few examples of a place where you would want to hold another physician accountable.

DR. DILLER: Well, it is not an easy question. I can think of situations where --

PROF. MEILAENDER: I would not have asked it if I thought that it was.

DR. DILLER: Well, I can give you situations on the extreme, where I think the doctor is wrong, not just morally, but legally, okay? But I think the notion of being wrong morally is so much more interesting and problematic than the extreme examples that I am about to give you that I know have happened.

For example, it was reported to me that in a managed care health care system that a mother went to the doctor for an initial interview about her child and problems at school and ADHD.

And the child psychiatrist gave the mom the checklists that are used typically to get or to define the diagnosis as best as possible, either symptom checklists that Dr. McHugh was referring to. You know, how much does he fidget, and how inattentive is he, et cetera.

She had the forms filled out by her, and her husband, and the teacher, and she mailed them in and received a Ritalin prescription in the mail for her son without the doctor ever seeing the child.

I would say that that is wrong, and I think that the doctor would be morally or legally culpable because he never saw the child. Mind you that our leading researchers say that really seeing and interviewing the child for the diagnosis of ADHD is rather not an important part of the diagnosis.

Why? Because children really can't report accurately what they do, and they can sit there very nicely like this in our office and still have problems outside.

So leading researchers in fact do not see children under 11 or 12. It is very interesting. They simply conduct an interview with the mothers over the telephone, and are being able to extrapolate statistically what they have done in the past, and that is how they conclude that the child is ADHD at home.

I have gone a little bit off, I know, but this is just an example.

PROF. MEILAENDER: If I may, the example that you gave, it sounded sort of like a bad practice.


PROF. MEILAENDER: But if the child had met with the doctor, and the doctor determined that the child really met these symptoms, it would not have been bad to prescribe it.

What I am looking for is an instance where it would just be wrong to prescribe it. I mean, for instance, if you don't like my example that I gave about lagging in the afternoon, occasionally where somebody might do all the right steps, in terms of meeting, that you would just think that it was a mistaken idea?

DR. DILLER: Well, it is really tricky. Again, it really depends on the doctor, and the doctor involved, and the patient involved. It is really tricky because the medicine has ubiquitous performance enhancing effects.

Who is to sit in judgment and say that this is not a bad enough problem? I would be more concerned, let's say, with an adult who has a history of alcohol or stimulant abuse, or is currently abusing alcohol. I think that would be a very bad idea to give them stimulants.

You have to be a pretty responsible person, and you have to be a pretty responsible person or have a pretty responsible family to use stimulants appropriately and safely.

So one of those factors would be how responsible is that person, and I think alcohol abuse makes me think very likely that he is a bad candidate and could get into trouble.

The example that I think of is a 28 month old who I never saw, but I saw the mother. This is for me very -- the kind of example that comes up to a lesser extreme. I saw the mother, who called me up and said would you be willing to medicate my 28 month old with psychiatric medication.

And I thought -- and this was before the Zito study in 2000. This was about 4 years ago. I thought, well, that's interesting. What could a 28 month old possibly be doing that the mother would want me to medicate that child with psychiatric drugs. So I met the mother.

The mother to me was a health professional. She clearly had problems herself and was under a great deal of stress. I subsequently -- and so I said, "Well, I would like to meet your child one time." She didn't come back because of the insurance that didn't pay for subsequent visits.

But I did have to call her about something about 3 or 4 months later, and she told me that she had gone to see a very big name in the Bay Area in child psychiatry, and this 28 month old was taking Zoloft, Adderall, and Neurontin.

I called the physician up. I knew him once, and I said, "Joe, what was this kid doing that he could be on three psychiatric drugs?" The mom had a lot of problems, and he said, "Well, Larry, we have the best diagnostic facility in the Bay Area, and this kid had depression, a bipolar disorder, and ADHD."

Now, I was telling Dr. McHugh back in the bad old days, some 35 years ago, I used to talk to psychoanalysts and have the same kind of disconnect. Actually, some psychoanalysts are now my best friends.

I said -- and the mom was ready to jump off the Golden Gate Bridge -- she told me. So I said, "Well, why didn't you treat the mom, you know?" Did I think that doctor did wrong? Yes. I actually wrote an article about it. I never mentioned his name.

But on a lesser level that is happening across this country, you know. Smaller degrees of wrong, and I gave you that one as one that I feel was clearly wrong, you know. That is the best that I can answer that one.

CHAIRMAN KASS: Could I follow on this, because I am looking for certain generic things out of this conversation as well. Frank, would you forgive me for butting in on this? You yourself indicated that the line between therapy and enhancement is fuzzy.

In a way it doesn't -- it may not finally matter whether there really is a disease or not if there are conceivable benefits to be had from a medication. But I will stipulate that the medication is relatively safe, and as these things go, this one is at least as far as we know, at least in children.

So if one wanted to say what really is the problem here, part of the problem seems to be that this is an easy way around getting to the heart of much more difficult problems, and that would take a lot more time, and maybe do a lot more good, and that this is a kind of cheap and quick way to avoid really grappling with difficulties that are there.

But when Gil pressed you -- and the problem is then complicated because the decisions are now made by parents with the collusion and collaboration of some physicians for children who have no say in this, and so that is the special case.

But if one would move for the moment to the adults, and ask, yes, you might not give stimulants to someone who is an alcoholic or other sorts of things, but are there uses -- assuming that someone would say, look, this will help me.

It will help me be less drowsy. And it will help me be more alert. It is not actually cheating as Charles would say, and it is not like having steroids in body building to make me simply more alert, because when I am more alert, I can actually work harder and accomplish the things that I really want to do.

So the question is, is some sort of skeptic sitting here and saying, well, why should we be worried about these things in their extra medical use, assuming that we stipulate their safety?

DR. DILLER: They are not safe in adults. That is an important factor. You are talking about a hypothetical -- well, first of all, I think the hypothetical is worth considering, because the search for the Holy Grail is on.

You know. Lilly just introduced Strattera, and it is not Ritalin. The Holy Grail in ADHD pharmaseuticals is finding something that works as well as Ritalin, and doesn't have abuse potential.

Why? The implications as you say are major. If there was a substance that could do that, it would be a universal market potentially. The thing that was interesting to me, and I had not considered it until I did that Hastings Center conference 6 years ago is this notion of the idea of valuing certain attributes and qualities over other attributes and qualities.

And you have got to remember that if there ever was a substance like this, there would be a corporate entity strongly, strongly, selling that, in terms of making money. And I think it is a -- in the hypothetical it is an interesting question, of what would be bad about it.

And I think there is potentially something bad about it, in that it devalues other human qualities that are actually rather important, simply because we can improve one.

So that is how I would answer it in the hypothetical, but I want to be very clear that -- well, I feel like Cassandra in America here. You know, this thing that is going on in the adult side in my opinion is doomed to bite us again.

And it will take probably the deaths of certain individuals, and probably celebrities, traced back to doctor-prescribed stimulants that will once again get the country -- well, and the threat of legal suits to the doctors.

As I said, that is what changes doctors' opinions. So there is no medicine like that yet for adults.

CHAIRMAN KASS: Frank, and then we should probably move forward to the break. We are running -- we started late, and we will run a little over. So, Frank, Bill, and Charles.

DR. FUKUYAMA: Well, you began the question that I was going to raise. I mean, I think that Jim Wilson in the discussion on Prozac said, well, why is this interesting or important. And actually I think that Dr. Diller answered it in a couple of ways.

I mean, the last one, I take that answer to be that it is an agent of social control, and it is a way of forcing or making people conform to certain models of behavior that may not be the ones that the child naturally chooses, or they may actually be the way by which society does a certain kind of social engineering, which we may not like.

But the other one I think was implicit in what you said, which is that it reduces our understanding of moral agency. That it biologizes or medicalizies a whole range of behaviors that traditionally were thought of as moral behavior that somehow came from within each individual, and had to be socialized, and taught, and so forth.

And now because we understand that there is a biological basis for some of this behavior, you then take the next step and say that it is all biological, and it is simply the result of not having taken the pill.

So I think that is kind of a key to why this is a problem, and I think that it is not a hypothetical problem. It is a problem in the present. It is part of a much larger phenomenon of denying individual responsibility for a whole range of activities that we thought of as under individual control.

Now, my question is if we agree that ADHD is over-diagnosed, and Ritalin is over-prescribed, what is the public policy measure that would fix that problem. I mean, you suggested -- I mean, you kind of stated that you didn't think there was much you could do short of celebrity deaths.

But there are a couple of ways that you could imagine. I mean, there is a demand side, and there is a supply side. On the demand side, I would imagine that that is probably the case; that there is so much interest on the part of the self-help groups and the parents, and the school systems, that it is hard to imagine a cultural revolution occurring short of the celebrity death to change that.

On the supply side, however, it is already the case that the fact that this is a Schedule II drug dramatically limits. I mean, if the movement to get it reclassified --

DR. DILLER: To get it decontrolled.

DR. FUKUYAMA: To get it decontrolled a few years ago had succeeded, I presume that the numbers of people taking this would be in the 10s of millions.

DR. DILLER: The use of triplicate forms in various States, for example, greatly diminish the -- New York and California are being low on that thing, they both use triplicate forms.

You know, when you are writing the prescription, it is like for a narcotic, and that also very much decreases it. But go on with your question.

DR. FUKUYAMA: Okay. So, for example, it seems to me that one of the powerful economic incentives since the designation of something as a disorder is such a squishy matter, it seems to me that the drug companies are actually inventing their own disorders for which their drugs are used.


DR. FUKUYAMA: And that this is all fed now by the ability of them to market directly to consumers. So I had noticed after Prozac went off patent, all of a sudden you saw it reappearing as treatment for menstrual -- I mean, there was a new menstrual disorder that no one had ever heard of and so forth.

DR. DILLER: Right.

DR. FUKUYAMA: I mean, would it be possible to -- I mean, one way of getting at the supply side is simply to ban this kind of advertising, which a lot of other developed countries do not permit, because that would kill -- I mean, that would get at some of the economic self-interests on the part of the pharmaceutical companies to create new diseases for which their drugs are solutions.

DR. DILLER: Well, I attended a litigation conference on Ritalin and class actions, and I became very respectful of how corporate bodies are incorporated, or have the rights of individuals, and how there is an obscure law, or where the Supreme Court ruled in 1884 that gave them this right.

And unlike individuals, they live forever, and have enormous ability to exploit free speech. So I think in fact the trend is still in the opposite direction.

For example, it had been illegal to -- because the U.S. is a signatory to a 1972 U.N. treaty on narcotics that prohibits the direct advertising of potential substance abuse drugs to patients. The reasons seem obvious. You get hooked on this stuff.

And until about a year or two ago, that was either respected or not challenged by the pharmaceutical industry, and now under free speech, they are actually pushing that agenda, and they have been successful on the State Court level.

I am much more pessimistic that those things will make that big a difference. If my wish list would begin with a serious reconsideration of the -- and it is going to tie into so many things, that the disability diagnosis, or the diagnosis as the key to accessing services and dollars.

And again this is such a strong drive to get this diagnosis. The pressure is not just on the parents. The pressure is on me. I want to help this kid. How many principals or teachers have come to me and said can't you find some diagnosis to give this kid so we can give him some help.

It is hypocritical. There is a model, and I already mentioned it, and the mental retardation wing of mental health, or service for the mentally retarded, has long ago given up trying to classify all the things that they do, and it is called a needs-based system of providing services.

I think that when I was in medical school that there was a lot of crazy things going on then, too. They used to -- because of the insurance system, we used to hospitalize someone to remove a hang nail because the insurance system would pay for it as an in-patient, and they wouldn't pay for it as an out-patient.

And that was a legacy of 40 years ago when surgery was the main reason for insurance. Well, it took a while, but about 20 or 30 years later, they finally said, you know, this is cheaper to do as an in-patient.

I think -- and I don't know how long it is going to take, but this disability-driven diagnostic driven system, everyone on the outside is pretty much agreeing that it is crazy, but no one seems to be able to stop it.

I would like if we can reach some impressionable Congressional or Executive minds with that kind of solution, and begin to work on it, because DSM-V is coming, and it is not going to be very different.

It's can we subvert -- you know, the DSM-V may have some value, but there is some real pernicious aspects to the DSM-V, which is mostly driven by service and dollar values.

If we can alter the need for that kind of diagnosis, then let them have their DSM-V for research purposes. It may be a useful document on some level for those purposes, but not for clinical decision making.

CHAIRMAN KASS: Let's do the last two briefly if we could. Bill and Charles, and then we will break.

DR. HURLBUT: Obviously we all are sensitive to the meaning of putting chemical compounds into the neurologic system, the whole systems of young children, and especially troubling is these early cases of very early use of these drugs.

But if you think of this as the equivalent of replacement therapy for a real deficit, you can kind of justify it maybe, and hoping that something like dextroamphetamine spansule won't be lingering out there in the future horizon.

But you referred quite a few times to the meaning of human diversity, and of course a profound fundamental question is does diversity include medical deficits. Do you know what I mean?

Just like it no doubt includes genetic differences that some of which have a downside to them. So here is my question. We have had really just a few generations of standardized education. It is kind of an experiment long term, but it is still there.

But it seems clear in our society that heading on through the educational track is your ticket to success, and you have brought this out. So prescending for the moment from the medical concerns, go back to Leon's question about what do you say to somebody who says, look, it is perfectly obvious that education is the way to the future.

And I want my kids to have a good future, and they say -- and back to you -- that it is not about materialism. But just a basic standing in the society and open opportunities.

And you said that there is a canary in the mine shaft from this. How many other things are going to be like this, where you might be able to make a real difference in the outcome using a drug. Isn't that just looming out there?

DR. DILLER: I think that in our -- well, I would just say it as our performance obsessed society. I don't see it as benignly. I think what has been trotted out over and over again is the difference between what you can earn with a high school diploma versus a college diploma.

And this is waved at parents and such, and I think it is going to be a tremendous cost to our culture and society if we insist that everyone go through 4-year college.

That doesn't mean that children on an individual basis shouldn't get help and even take drugs. But I think it would be helpful -- well, first of all, because there is lots of successful people who didn't go to college.

Yes, statistically, you know, this is the best guarantor of financial success. As I told you, emotional intelligence seems to be a better predictor of happiness.

So I do think the issues of Ritalin go to the core of values here, and whether values are such that -- and again, is everyone hitting or in the square peg. Is everyone in the square peg. We can maybe alter them to be pretty square, and we may get better at it.

But I would still question that, and I guess it is a fundamental values question there, and that is good for this group to take on.


DR. KRAUTHAMMER: It's late and I will pass. I have been -- my issue has been covered. Thank you.

CHAIRMAN KASS: Well, Dr. Diller, thank you very much for a very stimulating and very forthcoming, and thoughtful, and serious presentation. Council Members, we have a session to discuss Michael Sandel's working paper.

If you didn't get it beforehand, it was provided at your places. Let's make the break a little shorter so that we have a little time between the end of the day and dinner. Why don't we take 10 minutes and return in 10 minutes for Michael's session.

(Whereupon, at 3:41 p.m., the meeting was recessed and was resumed at 3:58 p.m.)

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