Comments on: The Problem with Phase III Clinical Trials

By: Carl Anderson

Carl Anderson — Fri, 15 May 2009 04:43:19 +0000

This is an interesting article. As a former FDA field investigator conducting inspections of clinical trials I can assure you that inclusion/exclusion criteria in the protocol are considered to be important to review and many Warning Letters reference these inclusion/exclusion criteria. I have attached a link to this article on my blog, Carl’s Blog on FDA Stuff and a few comments of my own. I think we really need to take a hard, scientific look at study design in this country. I’m not sure I entirely agree but there is a lot of food for thought.

By: Maiken Scott

Maiken Scott — Thu, 07 May 2009 17:55:43 +0000

Take a listen to WHYY’s coverage on this issue – here is a link
http://whyy.org/cms/news/health-science/behavioral-health-health-science/2009/04/30/majority-of-people-who-take-anti-depressants-not-represented-in-clinical-trials/7620

By: Marlene

Marlene — Thu, 07 May 2009 17:38:32 +0000

Can’t say I understand what I am to understand from all of this.
Anyway, just saying that I have been offered to be in two different Clinical Trials. After a couple visits each I ended up no longer qualified. I wasn’t ill enough….

By: Akhristin

Akhristin — Wed, 06 May 2009 16:13:08 +0000

I was diagnosed with paranoid schizophrenia. I suffered episodes of depresion in high school after my grades started to drop or I earned lowere grades. Prior to this happening I was an honor student and so I took it hard. In occurance I began to suffer from depresion trying to OD on medication. After seeing a theripist my demensia decreased and due to the medication I began to get back on track on daily routines. I was pacing myself and wearing clothes backwards to class, talking out loud screaming under pressure even. I have an understanding family that gave me lots of moral support to get through the dementia. I feel somehow I lost my memory about my past and still have delusional thoughts about the past. Now I am able to sustain a normal life under medication that I will have to take for the rest of my life. I continued with my education and I am determined to graduate with a BS from the university. I realy needed a psychiatrist and theripist to help me with my condition. The paranoia was worse with hearing voices inside my head under stress. Life is god scent.

By: therapyfirst

therapyfirst — Wed, 06 May 2009 14:52:06 +0000

Another nice post. Makes me wonder why the ‘usual suspects’ at Furious Seasons attack you as being pro-medication when you put posts like this out every few weeks at least.

By the way, an observation I find none of my colleagues have really understood or even considered in the first place, in my opinion, is that the examiners of Star*D cut off Celexa at 60mg, which is equivalent to about 15 to 20 mg max for Lexapro, a cousin of Celexa. And yet, I continue to interact with patients who have been prescribed 20, 30, even one at 40mg of Lexapro. A study like this would have at least maximized the dose of the initial medication, so if they felt 60mg Celexa was a max dose, what the hell are psychiatrists thinking in prescribing the doses of Lexapro these days? Makes you wonder who is defining ceiling limits, because I find the Forest Reps (who make Lexapro, and Celexa prior to it being generic) struggling for a reply when I mention these prescription doses with Lexapro. Is 20mg a ceiling or not?! If you the reader find this a matter of interest, ask questions!!!

By the way, Furious Seasons with a nice group of posts today about the cluelessness of pharma. Sad stuff going on, especially if his comments about the inappropriate role between NAMI and pharma has legitimacy.

“the road to hell is paved with good intentions”. Every Doctor should have that quote above his/her door at the office.

In reply to Dr Laura Smith above, watch out for any literature that promotes meds for Axis II disorders. Reinforces the wrong message, as the only meds value is for co-existing Axis I disorders, and you have to wonder with the mood lability and inflexible thought patterns in cluster B disorders especially, if there is a true Axis I in the first place. Personally, I think medicating Axis II runs more a risk of increasing dysfunction before improving function. Especially with antipsychotics and benzodiazepines!

Just an opininon, of a psych doc.

By: Dr. Laura Smith

Dr. Laura Smith — Wed, 06 May 2009 14:05:13 +0000

Hello John,
Chuck and I recently reviewed the literature on medication efficacy for Borderline Personality Disorder. One recent article showed some success in treating symptoms of BPD with medication. However, the studies for the most part excluded people who had substance abuse or recent suicide attempts–two symptoms that are usually present in people with BPD. So, what you are reporting is going on in many different areas of psychopathology.