There's Method to Our Madness

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.