By Rob Kall
Rob: “Radio ID” My guest tonight is Allen Frances, M.D.  He was the chair of the DSM 4 Task Force and the chair of the department of psychiatry at Duke University School of Medicine, Durham, North Carolina.  He’s currently Professor Emeritus at Duke.  Welcome to the Show!
Allen: It’s good to be here.
Rob: Now, the reason I contacted you is you wrote an article titled “DSM 5 Field Trials Discredit the American Psychiatric Association.”  Why don’t you start off by explaining what DSM 4 and DSM 5 are and what they mean and why they are important?
Allen: This is the diagnostic manual in psychiatry.  Until 1980, no one much cared about it, but DSM 3, published in 1980, became a huge best seller.  There are hundreds of thousands of copies sold every year, and the reason it is so important is because lots of decisions depend on it– who gets treated and who doesn’t, who pays for the treatment, who gets disability, who gets to pilot a plane, who gets to adopt a kid, workman’s compensation.  All sorts of things are triggered — and school services in particular — on having a psychiatric diagnosis.  It essentially sets the boundary between who’s normal and who’s not.  So this has become an enormously important document.  The last version of it, which I was sort of the head person on, was published in 1994, and there is a revision that is about to appear next year; it’s called DSM 5, and that revision has been very controversial- I guess for reasons that we will discuss.  But the changes made there could determine how tens of millions of people regard themselves: whether they have a mental disorder or not, and it could determine who gets medication and lots of people in our society are getting medication they probably don’t need; so the stakes are pretty high. 
Rob:   As the Director of Development of DSM 4- I may not have that title exactly right; correct me if need be- you had to be pretty high in terms of being a trusted member of this psychiatric hierarchy.  How did that happen?  How did you get that position?
Allen:   I worked on DSM 3, and I was part of the group that prepared DSM 3R- that was a revision in 1987- and so I had some experience in the kinds of questions involved.  It’s a pretty tedious job; I’m not sure that many people in the world would have wanted to do it.  So, yes, I was involved very much in how psychiatric diagnosis would evolve, and I guess what has happened in the last three years is I have become a critic of that process.  So, I went from being the director of a program that was involved in preparing DSM 4 to being a very sort-of staunch critic of how DSM 5 is being prepared.  I don’t think that the process has been careful enough or open enough to produce a document that will be trustworthy. 
Rob:  You describe how it affects people’s lives, but it also affects business too- the pharmaceutical business.  How many billions of dollars will be relying on DSM 5?
Allen: It’s really weird- the degree to which Americans are taking psychotropic medications.  In any given year, 20 % of Americans will take a drug that is a psychiatric drug.  About 11 % of the population is on anti-depressants, and 20 % of women are on anti-depressants, 4% of kids are on a stimulant, 4% of teenagers are on an anti-depressant.  Perhaps most remarkably, anti-psychotic drugs are amongst the best selling drugs in America: 18 billion dollars a year in anti-psychotic drugs, anti-depressants about 12 billion dollars a year, stimulant drugs about 7 billion dollars a year.  So we’ve really become a pill popping culture and the drug companies have a huge stake in this.  We are the only country in the world now that allows drug companies to advertise directly to consumers.  So, you are constantly seeing ads on TV, trying to disease-monger; trying to suggest that you have one or another psychiatric disorder, that this is a chemical imbalance in your brain, that if you take a pill that will be the solution to all of life’s ills.  And the drug companies have essentially gone into the business of selling psychiatric diagnosis as a way of selling pills.  If they can convince enough people that they are sick, then if people ask their doctor for a pill, they are very likely to get it.  If you ask your doctor for a psychotropic medication, you’re 17 times more likely to walk out of the office with a pill.  The real problem here is that most of these pills are not being prescribed with psychiatrists and aren’t being done after careful diagnostic interviews with someone who knows something about psychiatric diagnosis.  About 80 % of psychotropic drugs in America are prescribed by primary care doctors who have — in most instances- very little time- the average visit is about 7 minutes- in many instances little or no training in psychiatry, some instances no interest in psychiatry.  And primary care doctors tend to be inordinately influenced by drug sales people.  They get their education in psychiatry from people who are selling drugs who have the story line that psychiatric diagnosis is often missed, is very easy to make,
and that there is a simple pill that will solve all the problems.  So the current situation is weird; we have 90% of anti-anxiety drugs like Xanex being prescribed by primary care doctors, and 80% of anti-depressants are prescribed by primary care doctors.  60% of stimulants and half of the anti-psychotics are being prescribed by primary care doctors, very often after these brief seven minute interviews, very often because the doctor has samples that he has been given by the drug salesman that he gives out.  This is a convenient way to get the patient out of the office quickly.  And, the result is a tremendous overdose, I think — societal overdose- of medication.  7% of the population is addicted to a prescription drug- 7%.
Rob:   How many?
Allen:   7% of the population
Rob: 7%
Allen: 7, yes.  And it turns out that there are now more visits to the emergency room for overdoses with prescription drugs than visits with street drugs.  In some ways, we have turned a very bad corner where the drugs you get from the doctor can cause you more harm than the drugs you would get from a street corner pusher.  So, I think that there has been a kind of overdose of diagnosis and overdose of medication.  And part of my reaction to DSM 5 is that it will make this worse by introducing new diagnoses that will have many millions of people qualifying for a mental disorder who –the night before it is published- would not have been considered to have a psychiatric illness.  And it’s reducing some of the thresholds for existing disorders, which again will increase diagnostic inflation and make it more likely that people will get psychotropic medication that they don’t really need plus the stigma of having a diagnosis that you don’t really have.
Rob:   This is huge for big Pharma, right?
Allen:   Oh yeah.  And let me be clear; big Pharma has absolutely no influence on what’s happening.  So the people preparing DSM 5 are not doing this with the intention of helping the pharmaceutical industry.  They are not doing this because of financial conflict of interest.  They are doing this- I think they are making a lot of very bad decisions, but the decisions are being made for the purest of motives.  However, Pharma will be on the sidelines licking their chops and figuring out how to exploit it. 
Rob: Why do you think this is happening then, because obviously you believe that this is a terrible error or not maybe error because it is intentional?  They are making judgment calls that are really bad you are pretty much saying.
Allen:  Yeah, I think that they are making very bad decisions for the purest of reasons.  The conflict of interest is not financial; it’s more intellectual, and there are two parts to it.  One is, if you are an expert working in a field, you tend to develop a huge attachment to your field.  You always worry about the fact that you may miss a patient that has a diagnosis in the area of interest that you have.  So you worry very much about expanding the domain of your area of research and clinical interest.  Experts never think about the impact of people who are mislabeled; they always worry about the people who are missed.  And, they tend to overvalue their own research and their own area of interest.  I think that is a big part of it. 
Rob:  You’ve written about your concerns about the research and then the quality standards.  This is not about concerns is it?  Is that the same issue?
Allen:  I think that very often the experts are suggesting diagnoses that are based on their own research or research of colleagues that is very far inadequate of proving that the suggestion is safe and scientifically sound.  Normally, there will be a study that shows there are some people who have a problem that can’t be diagnosed using the current system, and this will be argued in support of evidence for adding a new diagnosis or reducing the threshold of the existing one.  But the thing that is always missing in these calculations is a thorough risk benefit analysis: thinking through all the things that can go wrong for the people who are mislabeled.  Every time you make it easier to get a diagnosis, you will pick up people who previously were missed, but you will also pick up a bunch of people who don’t really need the label.  And experts have a vested interest in worrying about the missed patients; they have much less concern about the mislabeled patient.  The other thing here is really interesting, and it goes to a much larger question in American medicine, not just psychiatry: there has been- in the past thirty years- a tendency to think that we can do a kind of preventive medicine with very early screening tests for a number of diseases.  And if we could get there early enough, if we could  make the diagnosis early enough and begin the treatment before the disease could develop and do its worst harm- that this would be in the long run what benefits the patient.  What’s happening now, just in the last couple of years, is the realization that we are doing way too much screening in medicine and way to much preventative medicine.  Very often, you will see that the effect of early diagnosis is to provide treatment and to do tests that are more dangerous than the disease itself would have been.  So this is really a kind of sudden shift away from the notion that we can screen for every illness and get there early to a realization that this early screening may not have improved outcomes and may have caused harm because the treatments and the tests can be so harmful.  So, recently, there is an initiative called Choosing Wisely, developed by eight of the different medical specialties saying, if effect, let’s pull back.  Prostate screening was all the rage; now the recommendation is don’t screen for prostate- that by and large it doesn’t save lives and it causes a tremendous amount of damage and unnecessary surgery- that the prostate cancers that were picked up very often wouldn’t kill the person, but the treatments can be very
harmful to them.  Breast cancer screening has turned out to be way overdone, and it is important to begin targeting it to particular age groups and to do it less frequently.  And, actually, they have identified about 46 different areas in medicine where there has been too much testing and treatment.  Well, psychiatry is getting into this act late in the day at just the wrong time and with the best of intentions but probably the worst of unintended consequences.  The idea in DSM 5 was, if the rest of medicine is screening early; why shouldn’t we?  And so a number of the different suggestions are for disorders that are much milder than the traditional psychiatric disorders-intending to pick up earlier in the course the sorts of problems that might develop into schizophrenia or dementia, and hoping that you could intervene early before the disease has fully announced itself and caused its damage.  But, in order to have a screening test-or a screening diagnosis that is useful- you have to prove three things.  One, that it is going to be accurate- if you are going to introduce a new diagnosis, you want it to be accurate.  The second is intervention that will be really effective for it.  It doesn’t make sense to be identifying something if you can’t do something about it.  And, the third is intervention will be healthful and not harmful- that it won’t cause more side effects and more complications than whatever benefit it will provide.  It turns out, for all of the suggestions being made in DSM 5, there is no way of making the diagnosis accurately for just the people who need it-that there will be what we call a huge false positive rate- that in order to pick out the person who might go on to have the problem, you’ll often be picking up maybe eight or nine people who wouldn’t.  And, the intervention for them and the stigma for them is unwarranted.  There is really no excuse for mislabeling someone and possibly giving him a treatment that is going to be harmful, or to a label itself that may be stigmatizing.  The second issue is that for none of the things being suggested in DSM 5 is there a proven effective intervention.  And, the third thing is-as we were discussing before- very often the reflex, especially in the United States, when there is a diagnosis of a mental disorder, is to go right ahead and provide a medication- particularly since so much of the diagnosis and treatment is being done by primary care doctors in the seven minute appointments influenced so much as they are by the drug company sales people.  So, for the new diagnoses being suggested in DSM 5, very often there is a risk –a high risk- that it is inappropriate.  There is no proof at all that the diagnosis will be helpful, because none of the diagnoses have an intervention that has been proven affective.  And, in many instances, a person may get medication that will be harmful as well as a harmful stigma.  So, my contention is that we shouldn’t be venturing into the area of preventive psychiatry just at a time when preventive medicine is coming under such criticism and scrutiny because it is premature.  In psychiatry, we certainly don’t have the tools for an accurate diagnosis before the illness has declared itself.  We don’t have interventions that have been proven to be helpful.  And, the interventions that are likely to occur might actually be quite harmful. 
Rob:   “Station ID” My guest tonight is Dr. Allen Francis.  He was the chair of the DSM 4 task force and the department of psychiatry at Duke University, and he has become a very strong critic DSM 5, which is soon to be released upon the public.  Just to sum up a bit: you said that the new DSM 5, which is the official diagnostic standard for all kinds of psychiatric problems, is going to create problems, because there are going to be a lot of people who are false positives-  Many, many times more who are false positives than are really diagnosable.  And, then you said that there is a medication response- specifically in the United States- where the tendency is if somebody meets the criteria that somebody reads in this, they are going to be put on psychiatric medications.  So, a couple of questions: What is the percentage of people who are currently diagnosed and medicated with psychiatric medications in the United States? How does that compare with other countries?  How do you think that will change with DSM 5? There you go- that is a couple for starters.
Allen: Good summary and good questions.  Currently, 20% of the population in any given year will have a psychiatric diagnosis-20%.  Of that 20%, only a quarter- so 5% of the whole population- have a severe psychiatric disorder.  15% would have a mild to moderate one.  Lifetime- the rate would be 50%.  And, the scary thing is that these may actually be underestimates, that if you carefully do prospective interviewing, it turns out that by age 32, half the population would qualify for an anxiety disorder, 40% for a mood disorder, 30% for a substance disorder.  So, we have a situation in which a very large proportion of the population would qualify for a psychiatric disorder.  Europe is catching up; there is a lifetime rate of about 43%.  And, a really scary study recently showed that if you evaluate kids carefully, by age twenty one 83% of kids would qualify for a mental disorder. 
Rob: 83% of kids would qualify for medication?
Allen: No, for a mental disorder.
Rob: Oh, for a mental disorder.
Allen: And, so in other words, if you do careful follow-ups — you start taking a population of kids, a general population of kids and you follow them- randomly selected- for eight years- age 12 until 21- and you do careful interviews, you get a tremendously high rate of disorder.  Now, I think these are exaggerated numbers.  I think that the way that the disorders are defined are too loose and the way the studies are done tends to have a biased toward reporting high numbers.  But, I think that the problem- by the way, Rob?
Rob: Yes?
Allen: I think the battery in my phone might go out.  If it does, I’ll recall on
another phone. 
Rob: I’ll hang in there and you call right back to the same number.
Allen:  Yes, that would be good.  I think that the issue here that we have a diagnostic system that encourages very high rates of diagnosis.  And, we have a capitalist system of medical care that encourages drug companies to take full advantage of these high rates of diagnosis: to encourage very loose and inappropriate diagnosis and the resulting excessive treatment with potentially very harmful medications.
Rob: Now, from what you’ve described at the beginning of the interview, where most of the psychiatric medications are prescribed by general practitioners and not psychiatrists, this can’t be very good for the field of psychiatry in terms of their making a living and the job being done properly.  What do you have to say about that?
Allen:   I don’t think the living issue is really pertinent, because psychiatrists are busy enough.  I think that it’s not like they need more business.  I think it is a terrible problem in terms of shoddy diagnostic and loose prescription habits reigning so supreme over good diagnostic practice.  It takes a long time really knowing someone to make an accurate psychiatric diagnosis.  It requires someone who has substantial training; especially when the diagnosis is of a mild condition that is on the fuzzy boundary with normality.  If someone has a clear cut psychiatric problem, almost anyone can make the diagnosis, but the people being diagnosed in primary care often present at the boundary with normality.  Here diagnosis is extremely difficult.  It often requires great expertise on the part of the person doing it and often takes lots of time- both in the individual interview and following people over time- not jumping to a diagnosis.  We have another problem in America that [?unclear 21:26] you don’t necessarily have to have a diagnosis to get treatment.  But, our insurance systems were such that unless you get diagnosed early, the doctor won’t be paid for the treatment.  There is tremendous pressure, therefore, for people to be fit into categories well before anyone can be sure that they really need the diagnosis.  Most of life’s problems are not mental disorders and we have tremendous resilience as human beings.  Most people with a psychiatric symptom don’t have a psychiatric disorder: it is not severe enough, it is not prolonged enough.  But very often, there is a quick jump to making a diagnosis before one is needed.  And watchful waiting, for most people with mild problems, watchful waiting is certainly the best first step, because about half of them will get better just on their own spontaneously within a few weeks.  In our system, once a person gets to the doctor’s office, there is a quick trigger response to make the diagnosis and put them on medication that will [?unclear 22:26] it.  And then when the person gets better, we have what we call placebo response, and about half the people with mild problems have a placebo response.  They don’t know what caused them to get better, so they’ll often misattribute the gains to the medication taken not realizing the fact that they would have gotten better on their own.  So, I think, as a country, we would be a lot better off trusting to natural resiliency- not jumping to the diagnosis when the problem is mild.  And there is another flip side to this that is particularly tragic; while we are over-diagnosing and over-treating people with mild problems that probably very often don’t need it we’re ignoring people who have severe problems.  Only 1/3 of people with severe depression see a mental health clinician.  The budgets for treating severe psychiatric disorders have been slashed drastically in the last few years because of the economic difficulties in the states.  So, we’re terrifically undertreating people that have clear-cut severe psychiatric disorders who could benefit for sure from our efforts.  And, as a country, we are over-treating people who are probably- in many instances- might be much better off without psychiatric diagnosis and without psychiatric treatment. 
Rob:   So, what strikes me about what you just told me is this requirement for a diagnosis-for treatment.  That means that psychiatry is being driven by insurance company policies. 
Allen:  And even worse, primary care, because at least when the psychiatrist has made the diagnosis, he’s probably spent some time with the patient and he has some expertise in making the diagnosis.  The primary care doctor is basing the toughest diagnostic quandaries-because the people they see are on the boundary between normality and psychiatric disorder- and they are jumping to a diagnosis in a few minutes without the benefit of the time required, the watchful waiting period that is often useful, and the training.  So, many people get labeled with a diagnosis they don’t need, and some of the diagnoses stick on you in a haunting kind of way.  It’s a lot easier to make a diagnosis than to get rid of one if it’s wrong.  So, sometimes once it gets on the record, it takes on a life of its own; and, I’ve talked to any number of people who have been stigmatized terribly by getting a diagnosis-usually bipolar disorder- that didn’t apply to them, was made casually.  The doctor would say something like, “You have a little bipolar disorder.”  But, once it gets in the record, it lives on, and you may have trouble adopting a child, you may have trouble getting life insurance, because the diagnosis will haunt you even if it is incorrect. 
Rob:  So, the worst diagnoses in terms of stigmatizing people are bipolar disorders?  Any other ones?
Allen:  Well, I think Schizophrenia would carry the stigma, but it’s not mislabeled nearly as often as bipolar disorder.  It has been a kind of fad in diagnosing adults-actually kids- incorrectly with bipolar disorder during these last 15 or so years.  It is part of the success of anti-psychotics that they have gotten an indication for bipolar, and the advertising was able to convince many patients and also many doctors that bipolar disorder was being terrib
ly underdiagnosed and that lots of people had it.  And so, there is a tendency to take the slightest degree of mood liability and misdiagnose it as bipolar disorder.  And lots of people have the diagnosis of bipolar disorder that probably have been mislabeled.  Let me make a point here though, that I don’t want people to listen to this and just stop their medication.  The two bad things that can happen when you have a psychiatric disorder-one is being mislabeled and getting medication you don’t need, but equally bad would be assuming you have been mislabeled when you really need the medicine-when the diagnosis is accurate- and stopping it on your own.  And the worst result of this phone call would be someone who really needs the medicine with a diagnosis that really does make sense stopping the medicine thinking that I am being so critical of psychiatry and psychiatric medicine that their best bet would be to stop it.  For people who need psychiatric medicine, for people who have a true psychiatric diagnosis, the medicine is enormously helpful.  So, there are some anti-psychiatry folks who try to criticize the field at large –they’re dead wrong.  Psychiatry does a tremendous amount of good, and these medicines are sometimes essential- indeed lifesaving- for people.  So, no one should say it is a trivial decision to go off medication, because if you need it, you really do need it.  On the other hand, it is not a trivial decision to go on medication.  If you don’t need it, it’s not necessary to take it; it may be bad for you.  So, the trick is figuring out which category you are in, to sort of take a hard look at your symptoms, to discuss them in detail with your family and with physicians, to become a very informed and smart consumer, so that you are not going to fall into either trap of over diagnosis and over medication or under diagnosis and under medication.  Our country has both of these problems.  You have way too many people getting medicines they don’t need, and way too many people not getting medicines they desperately need.  And so I think the only way to try to work in this labyrinth if you are a consumer is to get lots of knowledge yourself, to share with your family so you get a second opinion from them, to ask questions of the doctor and get reasonable answers- if their answers don’t seem reasonable, to get second and sometimes even third opinions.  I think that the decision to be on or not be on a psychiatric medication is a major one in a person’s life.  It requires all the thought that you would put into a decision on who you are going to marry, what car you are going to buy, what house you are going to buy.  It should be done very carefully; it shouldn’t be done casually in a primary care doctor’s office after seven minutes.  And, it shouldn’t be done casually by the person themselves listening to this phone call deciding that they are going to go off their medicine.  It is a very serious decision one way or the other. 
Rob: Wow! So, that’s pretty intense advice- going on a psychiatric medication should be considered as seriously as you consider the person you are going to marry.  So, what you’ve basically said here is there are a lot of people who are inappropriately prescribed medications, but there are a lot of people who need the medications and it will help them and maybe change their lives and maybe even save their lives.  And, I’ve seen that.  I totally agree with you.  How do people decide?  I mean, here you’ve got somebody obviously going through something in their life that is bringing them to their GP, and the GP says, “Well, it looks to me like you’re bipolar.  I’ve got some samples from the pharmaceutical company.  Why don’t you try these and see how you do; and then, here is a prescription that you can get filled.”  Now your response is that people need to be good consumers.  They are under all kinds of stress or something is going on in their lives that brought them to the doctor.  They are feeling really like they want help.  It’s not an easy time to just very calmly say, “Ok.  Let me be a good consumer.”  What would you suggest that they do when they are encountering this situation?  It sounds like the one where they are at the greatest risk for being inappropriately put on medication.
Allen:  You’re right on the money, and I think that bad decisions are made in situations where people are under stress and feel need for urgent relief.  And, those bad decisions sometimes hurt for a lifetime, because many times people will stay on medication for years, and maybe for life, that they wouldn’t have needed in the first place if they had just waited a couple of weeks and they would have gotten better on their own.  I really can’t emphasize enough that it is not a trivial decision; it has been made a trivial decision with the sort of propaganda that psychiatric disorder is everywhere and that the medications are the only way to correct chemical imbalance- that’s kind of a myth, because all problems in life are a chemical imbalance- and that the medicines are completely innocuous and you just pop a pill and you’ll feel better.  I think that’s dead wrong.  I think that this is a very, very serious decision that often has consequences that will go on for years, and that unless- I think if you have a clear-cut psychiatric disorder and it pops off the page that you are a classic case, and if it is urgent, then by all means treatment should be started right away: diagnosis should be made, effectively, quickly, immediately, and everything should be done to solve the problem as soon as it’s been clearly identified.  But for those mild problems that are in between normal and mental disorder- and this is the majority of people who are taking medicine who would be in that category; there are only 5% of the population who has a severe mental disorder.  Three times as many people are being diagnosed with mild problems.  For those problems, people should be aware of the fact that they often go away on their own, that in studies, 50% of people in that category will have a placebo response.  It gets better without the active medication.  And that unless there is something urgent, unless the problem is really clear cut, the best bet is watchful waiting at the beginning to see how time and natural healing affect things.  The second intervention after
watchful waiting should be counseling and education, not pills.  And, I would say that for this group, pills should be a third that is reserved when time and counseling haven’t worked.  Counseling works as well as pills for mild to moderate problems in psychiatry.  So, I think that the tendency because there is a huge drug industry and the drug industry in total spends something like 30 billion dollars a year on advertising- and just in the anti-psychotic drugs alone they are spending I think something like three billion dollars a year on advertising- there is no constituency, there is no propaganda campaign for watchful waiting.  There is no advertising for psychotherapy.  And, so this is an imbalance in the way consumers have come to understand psychiatric problems with a very strong commercial interest trumpeting the benefits of medication even in certain situations where it doesn’t make sense.  And that has led to the imbalance.  I think that if you are a consumer, you shouldn’t trust the commercials.  I mean, one thing for sure- don’t ask your doctor after seeing a commercial, because once you ask your doctor it is likely to trigger the reaction.  You have the diagnosis, you get the pill.  I would always be doing research first on my own.  I understand that people with psychiatric problems are under stress.  I understand that many of them may not have great insight as part of the problem or part of the stress.  But, what I am trying to emphasize is the importance of individuals and of families taking part in the decision making.  You can only do this if you learn as much as possible.  And, you have to be cautious of what you learn, because lots of the stuff on the internet itself has been influenced by drug companies, so that there is no one safe place to go where you’ll be absolutely sure that the information you get is reasonable.  But, I would always trust sights that are non-profit more than I would trust sights that have anything to do with profit.  If you are seeing advertisements on the side of the page, it is likely that the content may have been influenced by the companies involved.
Rob:   >From what I understand, the treatment of these acute problems, bipolar disorder and schizophrenia, can be very different in other countries so that drug intervention as the primary treatment is not always the case.  Often it is creating a therapeutic milieu or community and that, from what I understand, in those situations the recovery rate is much, much higher.    
Allen:  Well, I would put it a different way.  If someone has clear-cut bipolar disorder, if someone has severe depression, if someone has schizophrenia, severe OCD, very severe panic disorder- in these situations medication is almost always necessary along with psychotherapy, along with social retraining and other skill training.  I think that the more severe the problem and the more clear-cut the problem, the more medication will be part of the treatment plan.  The problem we have here is pills being used for problems that are very mild that would get better. 
Rob:   I think I lost him.  Yes, we’ve lost him.  So, he’ll be back in a minute with a different phone.  What I got that information from is, I guess, two years ago, I attended a conference for psychologists for social responsibility, and there was a panel reporting that in countries where there is a better social safety net- now I’m not talking about Medicare or Social Security or anything like that; I’m talking about families and communities that are there to help people who are having problems- in that kind of milieu, from what I understand, people get better at a much higher rate: double the rate.  And, actually, the numbers for people who are only put on medication are not nearly as good.  So, that’s one piece of it.  Another piece is- and I’m going to be asking Dr. Frances about this- is this idea of people prescribing medications for bipolar disorder to children, and prescribing —- oh, you’re back!      
Allen:   I’m back. 
Rob:  Alright, so what I was saying while you were gone is that one of the problems that I understand exists, in terms of this over-diagnosing and over-prescribing, is with the kids with bipolar disorder.  Is there even a diagnosis for childhood bipolar disorder in DSM 4?
Allen:  No.  The criteria in DSM 4 is the same for adults.  It is that the kids would have to have cyclical episodes of clear-cut mania and depression.  The suggestion was made for DSM 4, going back twenty years, that there be a separate criteria for kids that would recognize that they are developmentally different and that children are in different cycles and that instead there are children who are irritable, who have temper tantrums, who are conduct problems, and that these may be precursors to bipolar disorder.  We shot down this idea, because we didn’t think that there was enough evidence for it and we realized that it might lead to wild over-diagnosis.  This didn’t discourage the drug companies, and in collaboration with a few thought leaders in the field of child psychology who promoted this idea very strongly, they were able to convince the field.  They were able to convince not just child psychiatrists, but pediatricians and family care doctors.  The rates of childhood bipolar disorder have jumped forty times in the last fifteen years, and the direct consumer advertising was a wonderful way of promoting this, because you could get the parents on board, teachers on board, with the idea that any kid who had a conduct problem was really bipolar, and that giving medication for that problem would be helpful.  The result has been an enormous overuse of drugs in kids, and the drugs are particularly harmful in kids, because they cause tremendous weight gain.  The average 11-12 year old who weighs 110 pounds will gain 12 pounds in 12 weeks on an anti-psychotic drug.  They’ll jump up from 110 pounds to 122 pounds in just three months.  We already have an epidemic of childhood obesity.  Obesity is a risk factor for diabetes and cardiovascular disease and for shortened life expectancy.  And so, does it make sense for us to be using what is essentially a fake diagnosis,
because childhood bipolar disorder has not been something that is well studied or concerned- to give kids medication that may cause them so much lifetime harm?  It just doesn’t, in my view, it is one of the worst fads- I think that there are a number of different fads in psychiatric diagnosis- this is, I think, probably the least justified and the most dangerous of the current fads in psychiatric diagnosis. 
Rob: Fads in psychiatric diagnosis; ok, I want to cover that, but first I want to pick up on one thing you said.  Being put on a psychiatric medication, like what would be used for bipolar disorder, reduces your life expectancy doesn’t it? 
Allen:   Ok, I don’t want you to exaggerate this too much.  I think that if you need the medicine, the medical risks of obesity, diabetes and cardiovascular disease are definitely worth it, because the risks of not being treated are greater.  These medicines are enormously useful, essential, for people who need them, and someone taking an anti-psychotic for a good reason should certainly stay on them.  But, taking these medicines casually, because there were samples on the shelf of your primary care doctor and he said after seven minutes you might benefit from them; I think that is what I am trying to fight against.  I’m almost as worried about the people who- I’m in some ways equally worried- about the people who aren’t getting medication they need as I am about the ones who are getting too much medicine.  So, we have a misallocation where lots of people absolutely definitely have a diagnosis or require medication that are not getting it, because we have insufficient funding, because sometimes they are hard to get into treatment, and at the same time people who don’t need it are being given it casually and taking on the risks without there being much benefit.  
Rob:   Ok, so there were two pieces: one, I know that if you need the medication and you go off it, it may not work if you go back on it.  Isn’t that true?
Allen:  Everyone is different; there is a variable, but it certainly is not a good idea if you’ve had a good response to medicine to go off it without great care and thought about the risks and benefits. 
Rob: If it is provisioned by a psychiatrist.
Allen:  I would say yeah, definitely.  I should state that the longer a persons’ brain has a psychiatric symptom, the more embedded it tends to be, so that if a person has mania and has lots of manic episodes, it may make it more likely to have manic episodes in the future and it may make it, as you suggest, more likely that they will have difficulty being treated for the next manic episode.  So it is a very good idea to get there early and to treat thoroughly real psychiatric symptoms.  But on the other hand, it is equally important that we not get there so early that we are treating fake psychiatric symptoms and giving medication that is not indicated.  And, what we’ve done is provide way too little money in treating the serious and obvious psychiatric symptoms and way too much money being wasted on treating situations that would do better on their own. 
Rob:   So, again it goes back to what you said- going on psychiatric medications like you would, selecting the person you are going to marry-take it very seriously, don’t just jump on it.  And so, I have a question.  What percentage of people who are put on these anti-psychotic medications don’t really need them?  Is there any research on that? 
Allen:   It is hard to say.  I think we know a little bit more about depression.  11% of the population is taking an anti-depressant.  In the surveys, only 3% of the 11%- a little less than one fourth- have actual depression symptoms at the moment they are taking the medication.  So, 3% have depression symptoms, 8% don’t but they are still taking the medications.  Now, some of those 8% should be on medicine, because it serves a preventive purpose.  If someone has had loss or depression symptoms in the past and they responded to medication, you don’t want to stop the medication.  If someone has chronic depression and they respond to medication, even though they don’t have symptoms at that moment, the medication is serving a useful purpose.  But, lots of people go on the medication during a time when they were going to get better anyway, that have a 50% placebo response rate.  And, of the 8%, no one knows for sure, but it is a safe bet that at least half would be people who don’t really need to be on the medication.  So, my guess is- and it is a very rough guess, there is no right answer to this- if we have 11% of the population taking anti-depressants, maybe two thirds of those people really need them and maybe one third don’t.  I think that with anti-psychotics, the ratio is probably even worse, because they have been so heavily publicized for off-label use.  Twenty percent of people with anxiety disorders now are getting an anti-psychotic on top.  They are being given out like sugar water, and they are really not sugar water.  So, again, if someone has a clear-cut bipolar disorder or schizophrenia, they should stay on their medicine.  I don’t want anyone to be discouraged from hearing this.  On the other hand, if you are getting an anti-psychotic for another indication, maybe you need it, but I would do a lot of research on it and I would discuss it with a doctor; and it has to be a good reason.  If a doctor can’t explain something in ways you understand, it is a good time to get a second opinion. 
Rob: If somebody is put on a medication and they don’t really need it; what are the adverse side-effects, the iatrogenic effects of it?
Allen:  It varies medication by mediation, it varies by dose, it varies with time, and some of these are just unknown.  We don’t know what the effect would be of putting people at the age of six on medication; what affect that will have fifty or sixty years later, because there just hasn’t been time to study it.  So I think it’s very specific to the individual medicine.  Amongst the drugs avail
able on the market now, by far the most problematic are the long term effects of anti-psychotics.  This weight gain issue is enormous even though the medicines themselves are initially well tolerated in the short run.  For people who gain weight on them, that is a huge issue that has to factored in.  I think that there is way too much anti-anxiety medicine being spread out.  Xanax is a very popular drug in primary care for anxiety.  The dose that is effective is very close to an addictive dose, so that once on a heavy dose of Xanax it is very hard to get off of it.  The withdrawal symptoms mimic anxiety or are worse than the anxiety you had when you started, so that if you try to stop the pill you think you are having a relapse and you have to stay on it.  So there are real addictive problems with the anti-anxiety agents, particularly Xanax, and they are way over-used in primary care.  And then there is the real elephant in the room, and those are narcotic prescription medications that have taken off and in many instances are replacing street narcotics.  They are often responsible- in conjunction with many anti-anxiety elements or alcohol- with drug overdoses and with prescription addiction.  It is a huge problem in the military: 110,000 of our soldiers are on psychotropic drugs, 110,000- I think about 8% of the active duty.  And many of them are receiving more than one drug.  There are instances where soldiers actually die because of the prescription medicines that they have received; they have overdoses of prescription medication, and they are often also used in suicide attempts.  So, I think that if I had to pick the most dangerous drugs that are being prescribed, I’d probably put the narcotic pain medicines up there first, the anti-anxiety agents for their addiction problems, and the anti-psychotic medications because of the weight gain. 
Rob:  And what about these kids being put on stimulant medications: Adderall and Ritalin and what have you under the diagnosis of Attention Deficit Hyperactivity Disorder?
Allen:  Thank you; I think that there are some kids for whom these medicines are absolutely helpful and even essential in their getting a decent education and being able to function in school and with family.  The problem is that the rates of ADHD have tripled and the rates of medication use have sky-rocketed, so that they are currently being used for kids who are probably essentially showing individual difference or developmental lags but don’t really have a mental disorder.  A really chilling study comes from Canada: they found- this is a large sample, about ten thousand kids- that one of the best predictors of getting a diagnosis of ADHD and getting medication was when you were born.  If you were born in December, you had a tremendously lower rate- about 70% in boys- of ADHD than if you were born in January.  And, the reasons are simple; that that was the cut-off for school.  The youngest kid in school is most likely to be developmentally immature and most likely to get the diagnosis of ADHD, most likely to be put on medication.  We have this strange, weird situation where we are medicalizing immaturity; we’re medicalizing the youngest kid in the class.  Each of the diagnoses and each of the treatments make a lot of sense if it is done appropriately where the symptoms are severe and enduring.  The trouble is, when you have fads, and it’s like any kind of fashion- there is a huge overshoot.  And so kids that don’t really need the diagnosis, who would be better left alone or better monitoring, or watchful waiting, or parent training, or maybe school systems could pay more attention to individual kids; a lot of this- of what gets diagnosed as ADHD- may have to do with a school system that is under trained and the easiest way of dealing with it is to medicate each kid. 
Rob:   Now, when you medicate a kid with ADHD that has its own risks as well.  What are the risks when you put a child on stimulant medication?  Isn’t it true that sometimes that can actually precipitate other more severe problems as well?
Allen:   Well, as far as a tendency toward bipolar disorder, there is a risk that it is going to stimulate that.  There is sleeplessness, there is lack of/difficult with appetite, not gaining weight, not growing as you might expect, there are very rare instances where you get behavioral problems exacerbated, but they are real, and very, very occasional cardiovascular problems.  And also, there is a huge secondary market; 30% of college kids and 10% of high school kids will have used someone else’s stimulant medication.  There is a secondary market with kids either selling or giving away their medicines to their friends, and the medicine is being used more and more for performance enhancement or recreation by people who have either faked a diagnosis or have gotten the diagnosis too casually and are in some instances handing it around to the market or to their buddies.  I think that if someone has a substance abuse risk, one of the great ways of getting supplies is to go to your doctor and say that you have these symptoms.  They are very easy to describe, and if your doctor is a very loose prescriber-and they are- there is a very quick prescription of a stimulant medication that may actually be addicting for that person or exacerbate psychiatric problems.  I don’t think we should have the assumption that every person who has distractibility or hyperactivity needs medication.  And one of the problems in DSM 5 is that it will make it much easier for adults to get a diagnosis of ADHD and adult distractibility can be caused by any number of psychiatric problems as well as just a part of life.  If we make it easy for adults to get ADHD, I think that will be the next fad.  The next diagnosis d’jour would be that lots of people are going to think they have ADD and they’ll be getting medication they don’t need often for recreational purposes or for performance enhancement.  I don’t think that we should be handling medical diagnosis this way; I think it should be carefully done and the medication step should be equally thoughtful.  There should be a clear reason every time someone takes a medication.
Rob: “Station ID” I’m speaking with Dr. Allen Frances.
Allen:   I think I’m going to have to go soon. 
Rob:   Ok.  Just wrapping it up; Dr. Frances was the chair of DSM 4 task force and the department of psychiatry at Duke University.  I wanted to take a kind of bigger picture look at this.  With DSM 5, it is going to change America; it is going to change the percentage of people who are diagnosed, the percentage of children who are diagnosed and labeled.  It is going to change the numbers by the millions of people who are put on psychiatric medications.  Isn’t that so?
Allen: Well, it’s hard to know what the impact will be.  Not everyone who will qualify for a diagnosis will get one, so that these [? 53: 42] studies, which show that tens of millions of people might be diagnosed who would have been diagnosed before if they went to the doctor and asked for the diagnosis- but not all of them will do that.  I think it could have a substantial negative effect, and that’s why I’m so concerned about it. 
Rob:   What I’m concerned about is this is no small change.  Because of how influential the DSM has become, it could change our American culture, and I’m curious if you have had any thoughts on that really big picture?  DSM 4 really took off, and DSM 5 is going to drastically expand the percentage of people who are diagnosed or medicated.  How do you see that changing the American culture as compared to other places where they don’t do it this way?
Allen:  I think that a lot of the damage has already been done.  I think we have a situation where we are using way too many medications for way too many fake diagnoses.  I think that DSM 5 will make that worse; DSM 5 will turn the temper tantrums of children into something called a Disruptive Mood Disregulation Disorder.  It’ll turn the normal forgetting of old age into something called Minor Neurocognitive Disorder.  It’ll turn gluttony into Binge Eating Disorder.  It’ll make grief into major depression.  So these are some serious problems, but I wouldn’t underestimate the problems we already have before DSM 5.  It may help to turn what is already a severe diagnostic inflation into something of a diagnostic hyper-inflation, but we already have the problem.  It’s not just DSM 5’s fault; it’s something that we are living with now, and I think the major hope that this can be reversed is the tobacco industry.  Thirty years ago the tobacco industry was all-powerful, and who would have thought that at this point smoking would have been reduced from 60% to 20% or less in the population.  It went from a sexy habit to a dirty secret in the lives of the people who continue doing it.  The odds were against this ever happening because of the huge financial power of the tobacco industry, but it did happen.  And, I think the pharmaceutical industry has tremendously overstepped, and that even though it has enormous resources and tremendous political pull, that people may come to their senses and realize that we have to pull back and try to use the medications more thoughtfully where they belong.  The companies are constantly being fined.  There have been- over the last ten years- more than a dozen very large fines: the biggest is three billion dollars, another 1.5 billion dollars for off-label illegal marketing, in some cases criminally illegal, of their products- anti-psychotics and anti-depressants particularly.  So, there has been a government push-back against illegal drug company practice, but the fines- even the three billion dollar fine- is just the cost of doing business when the profits are so large.  I think that if some of the company directors wound up being hit more with personal fines or going to jail, if patents were shortened or illuminated for drugs where there had been illegal marketing, if the penalties were greater I think the companies would be under better control.  I think the idea that companies are allowed to market to consumers is outrageous, not done anywhere else in the world; that should be stopped.  It’s better now than it was years ago, so there have been efforts to monitor the pharmaceutical industry, and think that they are successful to some degree but a lot more needs to be done.  I have to go.
Rob:  Ok. Thank you so much!  You have been a great interview, and keep up writing about this.  We need people warning us what is going on here.

Allen:  Thank you; and you ask good questions.  You’re a smart guy.  Thanks very much.