Question:  Why are you so down on Luvox?  It has worked well for me in the past.  Also, I use 1200 of Lithium and my creatinine is 1.2.  I have used it 10 years.  At what creatinine level should Lithium be stopped?  I would try Abilify but am diabetic. - John

Prolonged use of Lithium can lead to some type of kidney impairment, probably inflammatory.  It’s more likely if serum levels are higher (1.0 and above) and may be more likely in individuals that have frequent urination and thirst.  It usually develops after years of use, and so far in my experience, it has not progressed to be a severe problem. But usually the Lithium itself was stopped.

I don’t routinely monitor creatinine levels.  They only start going up if kidney function is reduced by 75% or more.  If that occurs, the serum Lithium will go up without a change in dose or decrease in sodium intake or excess sodium loss (e.g. taking diuretics, vomiting, or diarrhea).

As with all meds, the decision comes down to benefit vs. risks, and in your case, Abilify might be a good option.

Question: I recently saw a special on deep tissue stimulation for OCD. It worked in this patient. How does deep tissue stimulation work? - Lea

Answer: I have not seen anything about that.  However, I recommend the Brain Lock technique to all my OCD patients - preferably to listen to the audio tape version of the book.
In the book Dr. Schwartz describes a cognitive behavioral technique used in a successful study done at UCLA.  The most important step in the technique is to shift your focus to something else.  At any given moment your focus is in your mind, in the environment, or in your body.  When stuck in obsessive thoughts or compulsive rituals, you need to shift focus.

• In your mind: thinking about something else or visualizing.
• To the environment: listening to music, watching a movie, playing a video game
• Into your body: exercising, yoga, etc. 

Deep tissue stimulation at the least would help shift focus to the body.  If combined with breathing or other relaxation techniques, it could also facilitate a shift into a more relaxed state of brain activity (alpha rhythm - slower and bigger waves than the usual beta activity of the awake state).  In the alpha state, the mind is more creative and not distressed which facilitates more positive thinking and imaging.  The same state can be achieved through long aerobic activity like running or meditation.

So, I can see where deep tissue stimulation could be useful for anyone with stress overload symptoms.  The problem that I would expect to see is that it works that day and the benefit lasts for awhile, but next week or next month, significant symptoms may return and deep tissue stimulation may not be available or feasible.

Brain Lock

I generally love to fly - it’s great for reading or doing the crossword puzzle with my wife. Thursday morning (08-10-2006) the news was dominated by the early morning arrest in London of over twenty Islamic terrorists who were in the final stages of plans to blow up ten jumbo jets enroute to the U.S. Although they were citizens of England, they had ties to training camps in Pakistan, most likely al Qaeda.

British security had managed to prevent a disaster with a loss of life equal to 9-11. The bombs were going to be assembled on the plane using innocuous looking liquids that could be easily gotten through security. I wondered if American security agencies are doing as well in monitoring extremist activity here.

Earlier in the week I watched news stories predicting a major escalation in terrorist activity of possibly cataclysmic proportions. Your life and mine and all our loved ones are intimately tied to an Islamic faction that sees us as evil. Our destruction is their way of glorifying God. How much do you know about Islamic history?

Unfortunately I had to fly to Tucson, Arizona Thursday afternoon to do a presentation and then fly back Friday morning. Fortunately I didn’t have to check a bag - and I knew there were new restrictions on what could be carried on - no liquids, gels, not even toothpaste. Getting through security and boarding was fairly routine except that every couple of minutes there would be an announcement "no drinks or liquids of any kind can be taken on the plane." So I was surprised that the woman boarding in front of me was carrying a "Big Gulp" soft drink. Surprisingly no one said anything to her as she walked past 3-4 agents and flight attendants and took her seat. I thought, "did I miss something?". So I asked a flight attendant in the back if they reversed the rule already. She said absolutely not and she went down and confiscated the lady’s drink. I felt like a snitch but I also wondered how close are they paying attention - not real reassuring.

I’ve got to admit I don’t have a lot of faith in the security rules. Remember when you had bottled water or coke and you had to take a sip of it? I asked one time why we had to drink the cola but not the shampoo or conditioner. I was told, "I don’t make the rules, Mack." Another time they had me break the mini file off my fingernail clippers; then two agents debated as to whether the 1/8" stub was safe. I said "if you’re thinking that might be a weapon, my ballpoint pen would be better." I asked another time if anyone had ever answered yes to "are you carrying a bag that some stranger asked you to carry for them?" Why not be more direct and ask, "are you stupid?" My wife once remembered that she had a pocket knife in her purse after she got on the plane - it was missed when they searched her purse item by item. As we deplaned, I asked the pilot what is involved in reporting a security violation. I wasn’t interested in a lot of red tape and paper work. He said "don’t worry about it, they’re doing the best they can. But what I worry about is that they took my finger nail clippers, but they want me to carry a gun". I should mention that I always prefaced my comments/questions with "I’m not wanting to cause trouble." Do you get the feeling we don’t have our sharpest minds developing our security rules and then we don’t have the most attentive people enforcing them? It makes me nervous.

Since I wasn’t checking a bag I was able to get on an earlier flight coming back, 5:15 am. But then I started to worry. I have to admit I’m a little superstitious - I like to knock on wood when I comment about good luck. Because of this mild superstition disorder - when you are a psychiatrist you think of all your disorders as mild - I was a little concerned about changing planes. I thought what if I’m changing from a safe flight to one that gets "dry gulched?" I hated to call and wake my wife up so early but I didn’t want her to end up freaking out if on the news they reported a "problem" with my planned flight. I also considered the alternative - her feeling relieved if the news reported that the flight from Tucson that I had changed to was sabotaged. What a mess. Fortunately when I wrote this on the plane I wasn’t feeling anxious - it was more of a theoretical concern - thank God for medication that helps control focus because I have at least one of the worry genes.

An editorial in Saturday’s Dallas Morning News by Leonard Pitts of the Miami Herald identified a major problem in America. We don’t like to be inconvenienced. And the powers that be don’t want to offend us (since we vote and all). Security in England is supposedly tighter and the Israeli El Al airline is so unimpressed with the TSA screening in the U.S. that they screen passengers again before they allow them to board. How inconvenient would it be to be blown out of the sky?

I’m an optimist. Deep down I feel blessed and protected. I believe God will probably wait as long as possible to bring me home. I can be a real pain in the butt.

When my wife and I flew to Puerto Rico three days after 9-11-01 the plane was mostly empty. It felt a little spooky. The hotel where I was teaching a seminar on, ironically, stress and insomnia, was virtually deserted. It was mostly us and all the service people. But times have changed. My flights to and from Tucson were full. In this instance a terrorist disaster was averted so people weren’t in a panic.

I have quickly become addicted to the Glenn Beck show on CNN Headline News at 9:00 pm eastern time. I love this guy! He’s definately one of us. I believe God put ADD people on this earth to stir things up and challenge the system. Earlier this week he had some expert on his show that said there are 1.1 billion Muslims in the world, most of whom are "normal" people. But 100 million of them hate our guts and want to destroy us (non Muslim infidels), especially Americans, and they are willing to die in the process. I feel sorry for the Muslims, especially in America who don’t have this radical mindset. It’s a lot like being Japanese post December 1941. But I also feel that as a group the Muslims have been way too passive in confronting their extremist factions. Case in point is the Lebanese citizens who embrace Hezbollah even though they celebrate the murder of Israeli women and children.

One of the things I like about Glenn Beck is that he says a lot of the things that I feel - sometimes exaggerated to make a point. The other night he started with "I hate politics. No, I hate politicians". My response was, amen! He also talks about how useless the UN is, amen! He refers to the extremist Muslims as "nut jobs". I wish they were crazy - insanity can be treated. Theirs is a fundamental ideology more powerful than ours. Our soldiers risk their lives in defense of democracy. The extremist Muslims are willing, even excited about blowing themselves up in defense of their beliefs. How scary is that? Beck has said repeatedly that we are already in WWIII and the Iranians (and their partners, especially Syrians) are even worse than the Nazis - because among other things they don’t care about their own survival. In fact the most extreme group believes that the return of their Messiah will be preceded by a time of great chaos and destruction. I believe in the power of self-fulfilling prophecy, so that makes me nervous.

But are the radical Muslim terrorists and suicide bombers, etc. really crazy? Unfortunately, mostly no. How can we understand their mind set? How can we be empathic - i.e., able to see things from their point of view? We are admittedly only beginning to understand the science of mind. Notice I didn’t say the mind because it’s not one thing - it is the most complex entity that we have yet found in the universe. If you’re not caught up in the outdated pseudo dichotomy of, science or religion you know that living things have been adapting, evolving for millions of years. Most people accept that there is competition in nature, especially when resources are scarce - the survival of the fittest and all that. But there is an equally powerful adaptive force in nature, cooperation.

Years ago a psychology teacher wanted to demonstrate how prejudice develops. He divided his class into two groups and they were to role play either being a prisoner or a guard over the next few days. He had to stop the experiment early because of the cruelty shown by the guards and mental distress that was rapidly developing in the prisoners. It turns out that part of our genetic hard wiring is the capacity, force that pressures us to identify with our peer group. It’s easy to say "but I would never do that" - be like a Nazi soldier or a Ku Klux Klan member or suicide bomber. But the forces of nature are powerful. I feel confident that I wouldn’t - but I’m also one of the ADD people put in this world to challenge the system.

For years I’ve been telling my patients "we weren’t made for this world." We were made for a world where we were outside all day, physically active. Life was hard but simple. Hundreds of years ago they thought the world was flat. Now according to one of my favorite writers and political analysts, Thomas Friedman, the world is flat again. We are all intimately connected. My security while flying from Tucson to Dallas was tied to the faith and feeling of well being of Muslim terrorists all over the world. I, we are hated and our destruction is their loftiest aspiration and connected to their "nirvana". It’s scary.

But I don’t think the world will end yet. If God is ADD and we’re all entertainment (a theory I’ve had for years that’s never been effectively challenged) then why would everything stop now? It’s just getting interesting. Besides there’s no way the world can end before the Cubs win a world series, and there’s no chance this year. God has to be a Cub’s fan.

You may notice I’m talking a lot about God. When we feel in danger and especially when we feel helpless that’s the time more than any other that our faith can get us through. Unfortunately our enemies feel righteously the same way.

Let me know how you feel.

What do we know about the cause of postpartum psychosis?

Hormones, especially estrogen, have a significant effect on mood. Estrogen raises serotonin. When estrogen drops precipitously, as it does premenstrually, postpartum, and at the onset of menopause - the brain serotonin levels drop. In women who are sensitive to low serotonin (because of genetics or previous episodes of significant depression) dropping the level will bring on symptoms of depression.

This principle can be demonstrated experimentally. By giving someone a drink of amino acid (from which tryptophan has been removed) the level of brain serotonin will temporarily go down. This is because tryptophan is the amino acid the brain uses to make serotonin. Only people with a vulnerability to becoming clinically depressed will show a depressive response to the serotonin level drop. This phenomenon contributes to premenstrual depression and menopausal (especially perimenopausal) depression.

Think about how dramatically hormone levels drop after child birth. This is why postpartum blues (brief symptoms of mild depression) is extremely common. The postpartum period is the highest risk period for full blown clinical depression.

Post partum psychosis is an extreme form of mood disorder in which underlying genetic vulnerability causes not only depression but a psychotic state. This fortunately only occurs in 1 out of 1000 births.

Psychosis is often confused with delirium. Delirium is a state of severe confusion and disorientation that can be brought on by toxins, severe infections, and many other causes. Every area of functioning is impaired. Psychosis means there is a distortion between conscious reality and external reality.

The most common symptoms of psychosis are hallucinations (seeing things or hearing things that aren’t there) or delusions (beliefs that aren’t true). A person can have one serious delusion that can affect their behavior but can be totally normal in other areas of functioning.

A woman who has had one postpartum psychosis is at a very high risk in any future pregnancies. It was for this reason that Andrea Yates was advised not to have any more children. So why did she and her husband ignore this? I don’t presume to know all the factors that they took into account. But I know she was never diagnosed as bipolar.  And they were never adequately educated about the physiology and medical science that we do have about what causes postpartum depression and psychosis.

Another factor in the Yate’s decision to continue to have children was their faith. They relied more on spiritual experience and counseling with their minister than medical advice. Unfortunately they had come under the influence of an extremist minister, and their medical advice was inadequate and not convincing.

Can they be faulted for not realizing all of this?  I think not. It is not unusual for a person of strong faith to at times feel caught between science on the one side and their faith on the other.

Many centuries ago St. Augustine showed more wisdom in this matter than many of our current experts. He said in effect science and religion aren’t in opposition. They are both ways of looking at and understanding one truth. When science and religion don’t agree we need to discourse and study so that the disagreement can be resolved - without feeling like you have to choose one or the other. Of course not all supposed science is valid and not all ministerial counsel can be trusted. Extremism of any type is dangerous.

“They found Andrea Yates not guilty,” my receptionist said to me Wednesday afternoon. I was delighted and surprised. I felt proud to be a Texan. Twelve jurors were able to do the right thing in spite of an almost impossible legal standard complicated by obstacles and hurdles imposed by a system that has the intellectual sophistication of the dark ages. The political powers changed the rules after Hinckley was found not guilty by reason of insanity for shooting President Reagan. Politicians and ultimately judicial officials pander to the vote - that’s the system.

Wednesday night the backlash began. I like Nancy Grace – the popular CNN Headline News Channel’s attorney/program hostess. She is tough but I usually agree with her. She is willing to take on any issue or individual and challenge the system in desperate need of repair. But on her Wednesday night show she was in la la land. She acted like a trial lawyer with their client (in this case the five murdered children) but dehumanized the opposing side, in this case Andrea Yates. Her position was that Andrea Yates was stressed out by taking care of five small kids and being trapped at home all day so she murdered them to make her life easier. Give me a break. Yates immediately called the police, told them what she did, she knew she was going to prison; she probably even thought she would be put to death - this is making your life easier?

On Thursday night I was speaking to a group of physicians and pharmaceutical reps in Lubbock, Texas. I asked, “How many of you are happy with the Andrea Yates verdict?” Only one doctor raised his hand. The overwhelming majority thought she is guilty and should spend the rest of her life in prison.

Then, on Prime Time Thursday night on ABC, they showed one of the prosecution’s “expert witness” psychiatrists interviewing (badgering) Yates on video tape having her retell detail by detail the horrible scenes that will forever torture her mind. He was splitting hairs in an apparent attempt to trap her into telling what he thought was the truth - that she planned and carried out a cold blooded murder of her children because she was tired of the strain of motherhood. What an idiot. He impressed me not as an insightful, empathic physician but as a member of the oldest profession.

On the brighter side, The Dallas Morning News editorial on Thursday morning supported the verdict and noted that they were reversing their position from their earlier support of the guilty verdict. Friday morning the USA Today editorial headline read, “Yates verdict reflects a healthy evolution.” They applaud the new verdict and conclude that “society has come a long way since the acquittal of Hinckley…” They also added that the law needs to come a bit further. I’m afraid it’s going to take more than a bit.

Why is there so much confusion? How can intelligent caring people be so polarized?

I am totally convinced that nothing is going to change until the majority of voting citizens clearly understand the issues and support a separate handling of individuals like Andrea Yates who is in almost every way the opposite of a criminal.

Only when public opinion changes will politicians change the rules. Is it possible to change people’s minds? Yes, most people want to do the right thing.

We need to start with the word guilt. When most of us ask ourselves “is she guilty?”, we mean “did she do it and did she do it on purpose?” Included in that is “did she know what she was doing?” The law defines guilt more strictly in terms of “being responsible for her act.” This use to mean knowing it is wrong and being in control of your behavior - but post Hinckley it was changed to just knowing it was wrong.

Some states have already changed the language to the more appropriate option of “guilty and insane.” We need to have a national standard that reflects this more accurate and comprehensible description of severe mental illness and legal accountability. A verdict of guilty and insane should not be “you’re free to go, have a nice life.” It should mean you go to a locked psychiatric treatment facility where you are treated as long as necessary, perhaps for life. It should mean that if you are released it is under the close monitoring of the judicial system for as long as necessary, commensurate with the crime. Whatever enforcement monitoring is necessary to assure protection for all concerned is feasible and should be a mandatory component.

Another problem that unnecessarily made the Yates jury’s decision more difficult is that they were not allowed to know what would happen to her if they found her not guilty. For all they knew she could have walked out the front door. This is ostensibly so that they make their decision based strictly on the law (with all its nebulous and abstract concepts). They should not be deciding based on the practical element of “what difference does it make what we decide?” Why not? Because despite the iconic balanced scales, the law is not about logic or fairness, it’s about “what are the facts and what is the law?”

In fairness, Andrea Yates did not meet the Texas law’s standard for criminal insanity. She knew what she was doing was against the law, and she knew she would be punished. She also knew it was against God’s law and the commandments. She believed that by killing her children she was sacrificing her life and her soul to save theirs. She felt responsible for them being bad kids (misbehaved) on the wrong path. In fact, Pastor Michael Woroniecki often quoted from the gospel of Mark, “whoever causes one of these little ones to stumble, it would be better for him if, with a heavy millstone hung around his neck, he had been cast into the sea.” She had attempted suicide twice because in her mind that would be protecting her children from her bad mothering. How ironic that it was the ultimate sacrifice of a mother for her beloved children.

Basically the jury decided - we don’t care what the law says, this woman was (and still is) crazy, psychotic. She is not a criminal - what she needs is help not punishment.

It’s hard to put yourself in someone else’s shoes. One of the best definitions of empathy that I’ve heard is: can you tell the other person’s story from their point of view? (which does not mean you agree with their thinking or that you approve of their behavior.) How can you imagine being insane? The closest I think you can get is to think about how your mind works when you are dreaming - random, weird, sometimes scary. That’s how a psychotic person’s mind works when they are awake. They cannot control their mind - it controls them.

What kind of a person is Andrea Yates? She is the opposite of a criminal. She was an R.N. She has been described by people who know her well as one of the most selfless and giving people they know. When her father was sick and dying, she’s the one who was taking care of him in addition to taking care of her own five kids. When someone in the neighborhood was sick, she’s the one that prepared meals for them. Her ex-husband, who also lost his five kids, has never wavered in his support for her. He knows that she killed the children out of love and psychosis. What possible criminal motive could she have had? She didn’t try to get away with anything - she immediately called the police.

To really understand the ordeal that she and her whole family went through you should read the excellent book, Are You There Alone?: The Unspeakable Crime of Andrea Yates, by Suzanne O’Malley. They went through years of suffering and medical mismanagement. It has been known for at least 10 years that postpartum psychosis is a rare complication of childbirth and that it is almost always a form of bipolar disorder (the old term is manic depressive).

For centuries throughout the world, new mothers in a state of insanity have murdered their babies. The U.S., to my knowledge, may be the only industrialized advanced country that considers it murder.

We have known for years that patients with bipolar disorder are made worse by antidepressants - unless they are on adequate doses of mood stabilizers or at least on an antipsychotic. Yates had been on Haldol (an older harsher antipsychotic - but more acceptable to insurance companies because it’s in generic), but even that had been stopped. When she killed her children she was on just antidepressants. Whose fault is that?

Yates had been hospitalized on several occasions, but kicked out early due to insurance company pressure. The hospital unit she was last treated on was for drug addicts, where she was forced to go to group therapy and lectures about addiction. How useful was that? Whose fault was that?

Ironically again, she was a devout Christian who was unduly influenced by a lunatic minister who repeatedly burdened her with guilt and impossible standards by which she was to judge the mental/spiritual health of her children. The thread of extreme fundamentalism seems to appear too often in cases where mothers kill their babies.

Could the influence of extreme “spirituality” on someone with the genetics of bipolar disorder contribute to the loss of control by the rational part of the mind?

There is no question that five children tragically lost their lives, but who/what is really to blame? Is it the system, the minister, the insurance companies, the hospitals, the doctors? Some people blame the ex-husband. When I review all the facts I see him as one of the victims. Maybe he relied too much on faith. Maybe he didn’t scream loud enough when her treatment wasn’t working. But I believe he did everything he knew to do.

If all the discussion and TV specials (that attract a lot of viewers and make the networks a lot of money) ultimately lead to greater understanding, then a change in public attitudes and a change in laws might happen. Then the death of five children will not have been in vain. The best outcome would be for a greater awareness to lead to early diagnosis and effective treatment for postpartum psychosis so that future babies aren’t the victims of Dark Age mentality in the 21st century.

Guilt is feeling bad because you hurt someone else. Shame is feeling bad because you don’t live up to your own standards and values. Shame is what the system should feel for not protecting the five children of Andrea Yates. Shame is what the system should feel for letting her sink deeper and deeper into the depths and torture of psychotic hell. Shame is what the system should feel for rubbing her nose in it over and over and parading her around like a freak show exhibit.

Shame on everyone who contributed to the problem or exploited it for personal or financial gain.

Andrea Yates, her ex-husband Rusty, and all their family and friends will suffer the rest of their lives because babies of mothers with postpartum psychosis don’t have a lobby group and can’t vote. Let’s change the system!

Let me know what you think by adding your comments.

Question:

Answer:

Strictly speaking, there is no standard treatment for Fibromyalgia. I’m not aware of any treatment having formal FDA approval. Cymbalta does have some positive controlled studies and Eli Lilly may be applying for approval.

Low thyroid is a common problem associated with fibromyalgia (see Thyroid Facts and Myths).

Stimulants are frequently used for chronic fatigue although they are not FDA approved for this. You are on a good combination of meds. If you are taking Cymbalta early in the day, switching to bedtime might help.

There are multiple options that could help motivation and energy levels:

• Increasing Concerta
• Increasing Cymbalta
• Adding Wellbutrin XL

Of course, you would need to discuss options with your doctor. It’s usually best to make only one change at a time.

Good luck!

Dr. Jones

The Supreme Court this week turned their back on patients with severe psychiatric illness – as in “we ain’t lettin’ no crazy people off the hook.” They also turned back toward the dark ages where psychosis was thought of as totally mysterious, or demonic possession.

After reviewing a case where a 17 year old paranoid schizophrenic boy fatally shot a police officer in Flagstaff, Arizona, the Supreme Court let stand the guilty verdict of the Arizona court. In 1993, Arizona passed a new insanity defense law that made it virtually impossible to qualify as insane. The judge in Arizona refused to allow testimony from psychiatric experts about the characteristics of mental illness.

The Supreme Court by a 6-3 vote ruled that Arizona has the right to restrict the insanity defense as long as they don’t deny him or her due process – say what? They also defended the courts right to not allow psychiatric testimony because “there is considerable disagreement within the profession, and experts often disagree in court testimony.” Excuse me, but if court testimony is not allowed when there is disagreement in the area and experts disagree, we should just board up all the court houses.

The most disappointing thing to me is that the highest legal authorities in the land had an opportunity to move us in the direction of being not only more scientific but more humane, and they just didn’t get it.

Many of the more advanced countries in the world have gradually changed their laws to incorporate the advances in the understanding of the “broken brain.” The U.S. on the other hand, changed the laws to severely restrict the insanity defense. This was another example of a knee-jerk response to an event - in this case, John Hinckley being found not guilty for reason of insanity after he shot President Reagan. Rather than educate the public about mental illness we change the laws so that they will keep the congressmen in office.

A new jury is currently being subjected to the horrifying details of Andrea Yates’ murder of her five children. They will have a difficult decision because although her motivation was totally insane, she knew it was against the law. In Texas, as in many other states since the Hinckley ordeal, this makes her guilty of capital murder – only an overzealous prosecution expert witness kept her from the death penalty.

More on Andrea Yates next week…….

God put ADHD personalities on this earth for a purpose. Or if you prefer, genetic variability (polymorphism) enhances survival by increasing adaptive options to an ever changing environment. Case in point, last week while attending the annual meeting of the American Psychiatric Association, I felt compelled to go up to the microphone and say to around 1,200 people (of the 20,000 attendees) in effect “this is b… s…!”

Earlier that morning I had attended a series of lectures about the latest research findings in the treatment of bipolar depression. One of the speakers was Dr. Fred Goodwin, author of the textbook Manic Depressive Illness, and arguably the preeminent world authority on bipolar disorder. After the session I talked with Dr. Goodwin and asked him why they used a particular symptom scale in assessing severity of illness and treatment response. He agreed that the scale (called the MADRS) was inadequate, but he said it’s better than the scale that is most often used for recurring Major Depression (the HamD). I asked why not use the scale developed by Dr. Rush (the QIDS-C). Dr. Rush is the director of research at UT Southwestern Medical School in Dallas and one of the leading experts in mood disorders. Dr. Goodwin admitted that the QIDS-C would be better – since it includes excess sleep not just lack of sleep as a symptom and since it better assesses the more typical symptoms of bipolar depression like lack of energy and motivation. He said the problem is that the FDA likes the HamD scale. They compromise to allow the MADRS. I then asked “so why not use overall clinical improvement as the primary outcome instead?” Well the FDA prefers the HamD or the MADRS.

I left feeling frustrated and wondering why the “tail wags the dog”. The FDA is not the expert on bipolar disorder (or any other disorder for that matter). They are administrators, government employees. Why do they decide how research is done? It was during the next symposium that I lost it. The next session was called, “Advances in Mood Disorders”. There were three speakers – each presenting one of the selected chapters from a just published textbook of the same title. Dr. Rush was one of the presenters. Dr. Kupfer’s presentation was the one that pushed me over the edge. He presented a comprehensive model for how to improve our assessments and treatments. One of the many components of the treatment model was to have an assistant function as a team coordinator making sure the patient’s family and primary care doctor were all contributing to and aware of the current status of treatment.

A big part of the treatment process is using the best medications – usually in combinations. But what are the best meds? Well, we don’t know because our studies are handicapped by the FDA. Who cares? What difference does it make? Ask the patients and families whose lives are at stake. I still believe bipolar disorder is the hardest condition we treat in psychiatry. Something had to be said. I had to do it. I started with, “Dr Kupfer, you and Dr. Rush have a habit of taking us to a higher plane and raising our expectations for more effective treatment.” (The audience applauded). One problem that we all have is that we are limited by the data that we get from well controlled research. I then recounted my conversation with Dr. Goodwin earlier that morning. When are we going to step up and be more proactive with the FDA? Pharmaceutical companies are running scared. They are acting increasingly paranoid in light of recent multi-million dollar fines levied against companies who were for example promoting medications for indications not formally approved by the FDA.

I am personally sick of hearing literally 10 to 15 repetitions of possible side-effects from medications – especially when they are for a patient population we don’t even use the medication for. We clinicians and researchers are the ones in the best position to help our patients – the FDA definitely has a role but right now they’re acting like a big bully keeping everybody intimidated. We need a change. We need it now. (The audience applauded again). The main stream follows the rules. The ADHD group says this isn’t working – let’s change the rules.

I just read an article on Oprah.com entitled Chill Pills about the use of medication for stress symptoms. I am struck by the sharp contrast between the article and the talks I gave yesterday in College Station, Texas (home of the Aggies).

The biggest problem I see is our “experts” are frequently those who are entrepreneurial enough to write a book OR who have climbed the ladder of academia and achieved professor status in the department of psychiatry at one of our medical schools.

They may be gifted writers but they may not be perceptive/engaged clinicians. Do they have the strong curiosity and discipline required to keep current with our rapidly growing understanding of the science of the mind? Are they empathic, i.e., can they tell their stories from their patient’s point of view? Do they listen and learn from each of their patients - what is it like to have a panic attack, be depressed, or not be able to pay attention? Do they learn the nuances of each of our treatments by doing one thing at a time? Do they work in a joint effort with their patients who they have empowered to actively participate in the treatment process? Maybe, but maybe not.

Some of our highest ranked professors are so busy they hardly have time to see real patients. If they do it’s often a one time consultation where they pronounce a diagnosis and make recommendations for treatment (many times they sound really good). The only problem is the recommendations often don’t work, but the expert never actually sees the outcome of their sage counsel.

A great example of the problem:

The treatment guidelines for managing panic disorder represent the consensus of our leading organization’s experts (American Psychiatric Association). As noted on Oprah.com, they recommend SSRI’s (selective serotonin reuptake inhibitors) like Paxil, Zoloft, Lexapro, Prozac, be used first line. Benzodiazepines (Xanax, Niravam, Klonopin, and Ativan) can be used in acute or pressing situations but must be used with great caution, especially because of sedation and addictive potential.

A recent analysis of prescribing habits of over 7,000 physicians, including primary care physicians, psychiatrists and other specialties, found alprazolam (Xanax, Niravam) to be by far the most prescribed medication for stress disorders. Could it be because these medications work well and have few side-effects?

A 12 year study (at Harvard) in 11 specialty clinics of real patients with panic disorder looked at how they were actually being treated and with what success. One of the good things about the study is these patients weren’t excluded if they also had other problems like depression. Studies the FDA requires for approval of medication are limited to those with only one disorder and many times this selects for patients with lesser degrees of difficulty. How did the clinicians do relative to the APA’s recommendation? Not very well.

• 10% were treated just with SSRI’s
• Combining SSRI’s with benzodiazepines gradually increased from 10% to 20%
• Benzodiazepines alone continued as the common treatment at 50%

Unfortunately, the treatment success outcomes were shamefully low with only about 25% getting well and staying well. The same was basically true for social anxiety and generalized anxiety disorder. The biggest problem I could see was the low doses of benzos that were used. I suspect the cognitive behavioral component of treatment was also very inadequate. The main point is the “in the trenches” the wisdom of the APA’s experts doesn’t represent the real world.

What’s the solution?

Unfortunately, I don’t see light at the end of the tunnel. Entrepreneurial doctors will keep writing books, professors of psychiatry will be looked to as the “experts,” and clinicians will continue seeing patients and studying to keep current.

The clinicians may say to themselves I should write a book, especially when they read or hear things through the media that do not reflect the reality they live everyday. But who has time to write a book? I can barely find the time to write 1-2 blogs a month.

Give me something to fix my problem. Don’t give me anything that could ever cause any side-effects …

Fortunately most people are fair and reasonable. They know anything strong enough to significantly change brain functioning, put you to sleep, stop panic attacks or anxiety, relieve depression, or improve focus and motivation has to be strong enough to sometimes cause side-effects. The infinite variety of genetics that helps make each of us unique can cause a myriad of idiosyncratic reactions to medication.

Case in point. “Perchance To … Eat? A few Ambien users find themselves at the fridge” was an article in Newsweek, March 27, 2006. The story is about a woman who was sleepwalking and bingeing during the night. She found out online that other people taking Ambien were having this problem. A New York attorney has filed a class action suit on behalf of 300 patients who complain of similar problems or of doing things while sleepwalking that are dangerous, like driving a car. Most or all of these people apparently have a history of sleepwalking.

Sleepwalking occurs during deep, stage 4 sleep. Ambien (and other sleep medications Lunesta, Sonata) help restore normal sleep, which includes deep sleep. Twenty-six million prescriptions were written in the U.S. last year for Ambien. Since this case was reported 2-3 weeks ago, prescriptions have been falling off.

In our litigious society, there is a history of overreaction where the benefits of the many are lost because of the misfortune or idiocy of the few (or sometimes the one).

For any given medication, there are literally hundreds of possible side-effects, including those that are rare (defined as less than 1 per 1,000). The massive amount of information makes it difficult to find the important, relevant information.

Common side-effects are usually due to

• over-shooting the blood level in search of the “right dose”
• common genetic variants
• combining different medications
• or many other possibilities

In making a joint decision to try a medication, a doctor and patient consider potential benefit vs. potential risk. It’s not fair or reasonable to say after a rare side-effect “this medication shouldn’t have been prescribed.”

If we use the principle, “don’t prescribe any medication that can ever cause a potentially serious side-effect,” we might as well close the pharmacies. Anaphylactic reactions to penicillin are a case in point. While we’re at it, let’s also get rid of shell fish, peanuts, and strawberries.

There has to be a reasonable balance. On the one hand, the Hippocratic Oath is, “first do no harm.” On the other hand, surgeons are told if you never remove a normal appendix you are being too careful – dangerously cautious. Waiting until an appendix ruptures while waiting to be certain will jeopardize a life. The best mantra is, “benefit vs. risk.”