Monday, March 18, 2013

Amazing Dr. Allen Frances Interview Exposing DSM5




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 terribly 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 available 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.

Labels: , , , , , , , , , , ,

Wednesday, January 9, 2013

Newtown, Psychiatric Drug Connection to Mass Murders not covered

World News Daily
NEWTOWN MASSACRE
The giant, gaping hole in Sandy Hook reporting
Exclusive: David Kupelian

January 6, 2013


Since last month’s horrifying and heartbreaking school massacre in Newtown, Conn., politicians and the press have, as everyone knows, been totally obsessed with firearms.

Indeed, President Obama has vowed to impose strong new gun-control measures on the nation – very soon, with or without Congress.

Other possible factors – from violent video games to the “failure of our mental-health system” to the unintended consequences of making schools “gun-free zones” – have taken a back seat to guns. Within hours of the gruesome mega-crime, the media had provided extensive, round-the-clock coverage of precisely which firearms, manufacturers and calibers the perpetrator had used, how he had obtained them from his mother, where they were originally purchased, and so on.

But where, I’d like to ask my colleagues in the media, is the reporting about the psychiatric medications the perpetrator – who had been under treatment for mental-health problems – may have been taking? After all, Mark and Louise Tambascio, family friends of the shooter and his mother, were interviewed on CBS’ “60 Minutes,” during which Louise Tambascio told correspondent Scott Pelley: “I know he was on medication and everything, but she homeschooled him at home cause he couldn’t deal with the school classes sometimes, so she just homeschooled Adam at home. And that was her life.” And here, Tambascio tells ABC News, “I knew he was on medication, but that’s all I know.”

It has been more than three weeks since the shooting. We know all about the guns he used, but what “medication” may he have used? (One brief mini-hoax emerged when the New York Daily News published a story claiming the shooter, according to his uncle, had been on the controversial antipsychotic drug Fanapt. That story was quickly withdrawn after the “uncle” turned out to be a fraudster with no relation to the murderer.)

So, what is the truth? Where is the journalistic curiosity? Where is the follow-up? Where is the police report, the medical examiner’s report, the interviews with his doctor and others?

Get autographed copies of both of David Kupelian’s classics: “The Marketing of Evil” and “How Evil Works.”

But let me back up. Perhaps you’re wondering why this issue of psychiatric medications should be so important.

As I documented in “How Evil Works,” it is simply indisputable that most perpetrators of school shootings and similar mass murders in our modern era were either on – or just recently coming off of – psychiatric medications:

    Columbine mass-killer Eric Harris was taking Luvox – like Prozac, Paxil, Zoloft, Effexor and many others, a modern and widely prescribed type of antidepressant drug called selective serotonin reuptake inhibitors, or SSRIs. Harris and fellow student Dylan Klebold went on a hellish school shooting rampage in 1999 during which they killed 12 students and a teacher and wounded 24 others before turning their guns on themselves.Luvox manufacturer Solvay Pharmaceuticals concedes that during short-term controlled clinical trials, 4 percent of children and youth taking Luvox – that’s 1 in 25 – developed mania, a dangerous and violence-prone mental derangement characterized by extreme excitement and delusion.

    Patrick Purdy went on a schoolyard shooting rampage in Stockton, Calif., in 1989, which became the catalyst for the original legislative frenzy to ban “semiautomatic assault weapons” in California and the nation. The 25-year-old Purdy, who murdered five children and wounded 30, had been on Amitriptyline, an antidepressant, as well as the antipsychotic drug Thorazine.

    Kip Kinkel, 15, murdered his parents in 1998 and the next day went to his school, Thurston High in Springfield, Ore., and opened fire on his classmates, killing two and wounding 22 others. He had been prescribed both Prozac and Ritalin.

    In 1988, 31-year-old Laurie Dann went on a shooting rampage in a second-grade classroom in Winnetka, Ill., killing one child and wounding six. She had been taking the antidepressant Anafranil as well as Lithium, long used to treat mania.

    In Paducah, Ky., in late 1997, 14-year-old Michael Carneal, son of a prominent attorney, traveled to Heath High School and started shooting students in a prayer meeting taking place in the school’s lobby, killing three and leaving another paralyzed. Carneal reportedly was on Ritalin.

    In 2005, 16-year-old Native American Jeff Weise, living on Minnesota’s Red Lake Indian Reservation, shot and killed nine people and wounded five others before killing himself. Weise had been taking Prozac.
    In another famous case, 47-year-old Joseph T. Wesbecker, just a month after he began taking Prozac in 1989, shot 20 workers at Standard Gravure Corp. in Louisville, Ky., killing nine. Prozac-maker Eli Lilly later settled a lawsuit brought by survivors.

    Kurt Danysh, 18, shot his own father to death in 1996, a little more than two weeks after starting on Prozac. Danysh’s description of own his mental-emotional state at the time of the murder is chilling: “I didn’t realize I did it until after it was done,” Danysh said. “This might sound weird, but it felt like I had no control of what I was doing, like I was left there just holding a gun.”

    John Hinckley, age 25, took four Valium two hours before shooting and almost killing President Ronald Reagan in 1981. In the assassination attempt, Hinckley also wounded press secretary James Brady, Secret Service agent Timothy McCarthy and policeman Thomas Delahanty.

    Andrea Yates, in one of the most heartrending crimes in modern history, drowned all five of her children – aged 7 years down to 6 months – in a bathtub. Insisting inner voices commanded her to kill her children, she had become increasingly psychotic over the course of several years. At her 2006 murder re-trial (after a 2002 guilty verdict was overturned on appeal), Yates’ longtime friend Debbie Holmes testified: “She asked me if I thought Satan could read her mind and if I believed in demon possession.” And Dr. George Ringholz, after evaluating Yates for two days, recounted an experience she had after the birth of her first child: “What she described was feeling a presence … Satan … telling her to take a knife and stab her son Noah,” Ringholz said, adding that Yates’ delusion at the time of the bathtub murders was not only that she had to kill her children to save them, but that Satan had entered her and that she had to be executed in order to kill Satan.Yates had been taking the antidepressant Effexor. In November 2005, more than four years after Yates drowned her children, Effexor manufacturer Wyeth Pharmaceuticals quietly added “homicidal ideation” to the drug’s list of “rare adverse events.” The Medical Accountability Network, a private nonprofit focused on medical ethics issues, publicly criticized Wyeth, saying Effexor’s “homicidal ideation” risk wasn’t well-publicized and that Wyeth failed to send letters to doctors or issue warning labels announcing the change.And what exactly does “rare” mean in the phrase “rare adverse events”? The FDA defines it as occurring in less than one in 1,000 people. But since that same year 19.2 million prescriptions for Effexor were filled in the U.S., statistically that means thousands of Americans might experience “homicidal ideation” – murderous thoughts – as a result of taking just this one brand of antidepressant drug.Effexor is Wyeth’s best-selling drug, by the way, which in one recent year brought in over $3 billion in sales, accounting for almost a fifth of the company’s annual revenues.

    One more case is instructive, that of 12-year-old Christopher Pittman, who struggled in court to explain why he murdered his grandparents, who had provided the only love and stability he’d ever known in his turbulent life. “When I was lying in my bed that night,” he testified, “I couldn’t sleep because my voice in my head kept echoing through my mind telling me to kill them.” Christopher had been angry with his grandfather, who had disciplined him earlier that day for hurting another student during a fight on the school bus. So later that night, he shot both of his grandparents in the head with a .410 shotgun as they slept and then burned down their South Carolina home, where he had lived with them.”I got up, got the gun, and I went upstairs and I pulled the trigger,” he recalled. “Through the whole thing, it was like watching your favorite TV show. You know what is going to happen, but you can’t do anything to stop it.”Pittman’s lawyers would later argue that the boy had been a victim of “involuntary intoxication,” since his doctors had him taking the antidepressants Paxil and Zoloft just prior to the murders.Paxil’s known “adverse drug reactions” – according to the drug’s FDA-approved label – include “mania,” “insomnia,” “anxiety,” “agitation,” “confusion,” “amnesia,” “depression,” “paranoid reaction,” “psychosis,” “hostility,” “delirium,” “hallucinations,” “abnormal thinking,” “depersonalization” and “lack of emotion,” among others.The preceding examples are only a few of the best-known offenders who had been taking prescribed psychiatric drugs before committing their violent crimes – there are many others.Whether we like to admit it or not, it is undeniable that when certain people living on the edge of sanity take psychiatric medications, those drugs can – and occasionally do – push them over the edge into violent madness. Remember, every single SSRI antidepressant sold in the United States of America today, no matter what brand or manufacturer, bears a “black box” FDA warning label – the government’s most serious drug warning – of “increased risks of suicidal thinking and behavior, known as suicidality, in young adults ages 18 to 24.” Common sense tells us that where there are suicidal thoughts – especially in a very, very angry person – homicidal thoughts may not be far behind. Indeed, the mass shooters we are describing often take their own lives when the police show up, having planned their suicide ahead of time.

    So, what ‘medication’ was Lanza on?

    The Sandy Hook school massacre, we are constantly reminded, was the “second-worst school shooting in U.S. history.” Let’s briefly revisit the worst, Virginia Tech, because it provides an important lesson for us. One would think, in light of the stunning correlation between psych meds and mass murders, that it would be considered critical to establish definitively whether the Virginia Tech murderer of 32 people, student Cho Seung-Hui, had been taking psychiatric drugs.

    Yet, more than five years later, the answer to that question remains a mystery.

    Even though initially the New York Times reported, “officials said prescription medications related to the treatment of psychological problems had been found among Mr. Cho’s effects,” and the killer’s roommate, Joseph Aust, had told the Richmond Times-Dispatch that Cho’s routine each morning had included taking prescription drugs, the state’s toxicology report released two months later said “no prescription drugs or toxic substances were found in Cho Seung-Hui.”

    Perhaps so, but one of the most notoriously unstable and unpredictable times for users of SSRI antidepressants is the period shortly after they’ve stopped taking them, during which time the substance may not be detectable in the body.

    What kind of meds might Cho have been taking – or recently have stopped taking? Curiously, despite an exhaustive investigation by the Commonwealth of Virginia which disclosed that Cho had taken Paxil for a year in 1999, specifics on what meds he was taking prior to the Virginia Tech massacre have remained elusive. The final 20,000-word report manages to omit any conclusive information about the all-important issue of Cho’s medications during the period of the mass shooting.

    To add to the drama, it wasn’t until two years after the state’s in-depth report was issued that, as disclosed in an Aug. 19, 2009, ABC News report, some of Cho’s long-missing mental health records were located:

        The records released today were discovered to be missing during a Virginia panel’s August 2007 investigation four-and-a-half months after the massacre.

        The notes were recovered last month from the home of Dr. Robert Miller, the former director of the counseling center, who says he inadvertently packed Cho’s file into boxes of personal belongings when he left the center in February 2006. Until the July 2009 discovery of the documents, Miller said he had no idea he had the records.

        Miller has since been let go from the university.

    Although Cho’s newly discovered mental-health files reportedly revealed nothing further about his medications, the issues raised by the initial accounts – including the “officials” cited by the New York Times and the Richmond paper’s eyewitness account of daily meds-taking – remain unaddressed to this day.

    Some critics suggest these official omissions are motivated by a desire to protect the drug companies from ruinous product liability claims. Indeed, pharmaceutical manufacturers are nervous about lawsuits over the “rare adverse effects” of their mood-altering medications. To avoid costly settlements and public relations catastrophes – such as when GlaxoSmithKline was ordered to pay $6.4 million to the family of 60-year-old Donald Schnell who murdered his wife, daughter and granddaughter in a fit of rage shortly after starting on Paxil – drug companies’ legal teams have quietly and skillfully settled hundreds of cases out-of-court, shelling out hundreds of millions of dollars to plaintiffs. Pharmaceutical giant Eli Lilly fought scores of legal claims against Prozac in this way, settling for cash before the complaint could go to court while stipulating that the settlement remain secret – and then claiming it had never lost a Prozac lawsuit.

    All of which is, once again, to respectfully but urgently ask the question: When on earth are we going to find out if the perpetrator of the Sandy Hook school massacre, like so many other mass shooters, had been taking psychiatric drugs?

    In the end, it may well turn out that knowing what kinds of guns he used isn’t nearly as important as what kind of drugs he used.

    That is, assuming we ever find out.

Labels: , , , , , , , , , , ,

Wednesday, July 27, 2011

In Shift, Feds Target Top Execs for Health Fraud

Associated Press
May 31, 2011

WASHINGTON (AP) — It’s getting personal now. In a shift still evolving, federal enforcers are targeting individual executives in health care fraud cases that used to be aimed at impersonal corporations.
The new tactic is raising the anxiety level — and risks — for corporate honchos at drug companies, medical device manufacturers, nursing home chains and other major health care enterprises that deal with Medicare and Medicaid.
Previously, if a company got caught, its lawyers in many cases would be able to negotiate a financial settlement. The company would write the government a check for a number followed by lots of zeroes and promise not to break the rules again. Often the cost would just get passed on to customers.
Now, on top of fines paid by a company, senior executives can face criminal charges even if they weren’t involved in the scheme but could have stopped it had they known. Furthermore, they can also be banned from doing business with government health programs, a career-ending consequence.
Many in industry see the more aggressive strategy as government overkill, meting out radical punishment to individuals whose guilt prosecutors would be hard pressed to prove to a jury.
The feds say they got frustrated with repeat violations and decided to start using enforcement tools that were already on the books but had been allowed to languish. By some estimates, health care fraud costs taxpayers $60 billion a year, galling when Medicare faces insolvency.
“When you look at the history of health care enforcement, we’ve seen a number of Fortune 500 companies that have been caught not once, not twice, but sometimes three times violating the trust of the American people, submitting false claims, paying kickbacks to doctors, marketing drugs which have not been tested for safety and efficacy,” said Lewis Morris, chief counsel for the inspector general of the Health and Human Services Department.
“To our way of thinking, the men and women in the corporate suite aren’t getting it,” Morris continued. “If writing a check for $200 million isn’t enough to have a company change its ways, then maybe we have got to have the individuals who are responsible for this held accountable. The behavior of a company starts at the top.”
Lawyers who represent drug companies say the change has definitely caused a stir, but the end result is far from certain.
“People are alarmed,” said Brien O’Connor, a partner in the Boston office of Ropes Gray. “They want to know what facts and circumstances would cause the Justice Department to indict someone who hadn’t even known about the misconduct. They are doing all they can to achieve compliance.”
Others say high-powered corporate targets won’t go meekly.
“If the government does continue to press its campaign against individuals, we will see the limits of the government’s theories tested,” said Paul Kalb, who heads the health care group at the law firm of Sidley Austin in Washington. “In my mind, there is a very important open question as to whether individuals can be held criminally culpable or lose their jobs simply by virtue of their status.”
Although the Obama administration has increased scrutiny of corporate America generally, this shift in health care enforcement seems to have come up from the ranks, government and corporate attorneys say.
Investigators and lawyers at the HHS inspector general’s office, the Justice Department and the Food and Drug Administration started moving more or less independently toward holding executives accountable. Morris outlined the inspector general’s position in congressional testimony this spring, saying his office will use its power judiciously.
A test case is playing out with an 83-year-old drug company chief executive, Howard Solomon of New York City-based Forest Laboratories. Forest makes antidepressants, blood pressure drugs and other medications. Last month, the inspector general’s office notified Forest that Solomon could potentially be banned from doing business with federal programs.
The power to ban or “exclude” an individual rests with the inspector general. It’s routinely applied to low-level violators, but rarely to people of Solomon’s rank. In the industry, they call it the “death penalty.”
Last year, a Forest subsidiary pleaded guilty to criminal charges as part of a settlement with the Justice Department in which the company also agreed to pay $313 million to resolve long-running investigations. Prosecutors charged that Forest deliberately ignored an FDA warning to stop distributing an unapproved thyroid drug, promoted the use of an antidepressant in treating children although it was only approved for adults and misled FDA inspectors making a quality check at a manufacturing plant.
The company said it had considered the case closed. But then came the inspector general’s letter.
“No one has ever alleged that Mr. Solomon has done anything wrong and excluding him would be completely unjustified,” Herschel Weinstein, Forest’s general counsel, said in a statement. “In prior cases where a senior executive has been excluded, that individual has been accused of wrongdoing and ultimately has either been convicted of or (pleaded) guilty to a crime.”
Forest is fighting the move to ban Solomon. The inspector general’s office refused to comment on the case, and no final decision has been made. In congressional testimony, Morris said that when there is evidence an executive knew or should have known about misconduct, the inspector general “will operate with a presumption in favor of exclusion of that executive.”
Separate from the inspector general’s power to ban, the FDA has resurrected something called the “Park Doctrine,” which makes it easier for prosecutors to bring criminal charges against an executive.
The doctrine, stemming from a 1970s Supreme Court case, allows the government to charge corporate officers in the chain of command with a criminal misdemeanor. They could face up to a year in prison and fines if they had the authority and responsibility to prevent, detect or resolve misconduct affecting the public welfare but failed to do so.
It’s making an entire industry nervous.
Read article here: http://www.google.com/hostednews/ap/article/ALeqM5jIGsUXYEAKspVXkeAdCDNumbbNFA?docId=d620a807289f47a6b01dfe728972a0b3

Labels: , , , , , , ,

Monday, July 25, 2011

Patients who use anti-depressants are more likely to suffer relapse, researcher finds

Science Daily
July 19, 2011


Patients who use anti-depressants are much more likely to suffer relapses of major depression than those who use no medication at all, concludes a McMaster researcher.

In a paper that is likely to ignite new controversy in the hotly debated field of depression and medication, evolutionary psychologist Paul Andrews concludes that patients who have used anti-depressant medications can be nearly twice as susceptible to future episodes of major depression.

Andrews, an assistant professor in the Department of Psychology, Neuroscience & Behaviour, is the lead author of a new paper in the journal Frontiers of Psychology.

The meta-analysis suggests that people who have not been taking any medication are at a 25 per cent risk of relapse, compared to 42 per cent or higher for those who have taken and gone off an anti-depressant.

Andrews and his colleagues studied dozens of previously published studies to compare outcomes for patients who used anti-depressants compared to those who used placebos.

They analyzed research on subjects who started on medications and were switched to placebos, subjects who were administered placebos throughout their treatment, and subjects who continued to take medication throughout their course of treatment.

Andrews says anti-depressants interfere with the brain's natural self-regulation of serotonin and other neurotransmitters, and that the brain can overcorrect once medication is suspended, triggering new depression.

Though there are several forms of anti-depressants, all of them disturb the brain's natural regulatory mechanisms, which he compares to putting a weight on a spring. The brain, like the spring, pushes back against the weight. Going off antidepressant drugs is like removing the weight from the spring, leaving the person at increased risk of depression when the brain, like the compressed spring, shoots out before retracting to its resting state.

"We found that the more these drugs affect serotonin and other neurotransmitters in your brain -- and that's what they're supposed to do -- the greater your risk of relapse once you stop taking them," Andrews says. "All these drugs do reduce symptoms, probably to some degree, in the short-term. The trick is what happens in the long term. Our results suggest that when you try to go off the drugs, depression will bounce back. This can leave people stuck in a cycle where they need to keep taking anti-depressants to prevent a return of symptoms."

Andrews believes depression may actually be a natural and beneficial -- though painful -- state in which the brain is working to cope with stress.

"There's a lot of debate about whether or not depression is truly a disorder, as most clinicians and the majority of the psychiatric establishment believe, or whether it's an evolved adaptation that does something useful," he says.

Longitudinal studies cited in the paper show that more than 40 per cent of the population may experience major depression at some point in their lives.

Most depressive episodes are triggered by traumatic events such as the death of a loved one, the end of a relationship or the loss of a job. Andrews says the brain may blunt other functions such as appetite, sex drive, sleep and social connectivity, to focus its effort on coping with the traumatic event.

Just as the body uses fever to fight infection, he believes the brain may also be using depression to fight unusual stress.

Not every case is the same, and severe cases can reach the point where they are clearly not beneficial, he emphasizes.
###

McMaster University, one of four Canadian universities listed among the Top 100 universities in the world, is renowned for its innovation in both learning and discovery. It has a student population of 23,000, and more than 145,000 alumni in 128 countries.

For more information, please contact:

Wade Hemsworth
Media Relations Manager
McMaster University
905-525-9140 ext. 27988
hemswor@mcmaster.ca

Michelle Donovan
Media Relations Manager
McMaster University
905-525-9140 ext. 22869
donovam@mcmaster.ca

Labels: , , , , , ,