Posted by detroitpistons on March 14, 2010, at 13:01:18
In reply to Re: My letter to the FDA » detroitpistons, posted by evenintherain on March 13, 2010, at 15:38:55
OK, so I sent Dr. Laughren my original email, and then I also sent him this (the formatting has been lost):
Hello again Dr. Laughren,
As a follow-up to my original message, Id like to give you some further thoughts and (rhetorical) questions regarding this issue. I was sitting at my computer and I just started typing this, with no particular audience in mind.Its sort of an open letter to anyone who will listen. This is just me thinking out loud (err, in print).
Thanks for reading
A comprehensive, systematic and strategic approach needs to be put into place in order to facilitate the process of discontinuation from antidepressant therapy. Have the pharmaceutical companies conducted any meaningful research on discontinuation? If so, have the data been shared with anyone and/or utilized in the field? I suspect not, and I also suspect that complications from discontinuation are underreported. Im an outsider, so Im just speculating here, but I do have my ear to the ground, so to speak. I would think that research is probably necessary in order to collect the sample data necessary for statistical analysis.
Because successful discontinuation is highly individualized and seems to be based on a variety of factors, we need to at least have a sense of the scope of the larger statistical picture. Even based solely on anecdotal accounts and information, is there really any doubt that the frequency of discontinuation complications is indeed statistically significant? So why dont we do something? Dont we need basic distribution ranges of data collected for some of the major variables involved in discontinuation? But do we even know which variables need to be studied? Some things that come to mind are patients dosage sizes, length of treatment prior to discontinuation, titration rates and quantities with corresponding responses and outcomes, largest possible dose size that will still facilitate comfortable discontinuation, etc. Obviously, these are just some things from the top of my head, and Im certainly no expert, but my gut feeling tells me that we dont even really know which variables to measure. Until we decide to measure anything at all, I guess its a moot point.
The current shot in the dark approach and the paucity of information available to practitioners results in haphazard discontinuation planning. The less than optimal discontinuation outcomes that are characterized by significant disruptions of patients daily lives and impairment of their daily functioning are not figments of the imagination. This is a clinical reality and it needs to be treated as such, even if its unprofitable. Research is conducted and data are collected on virtually all other aspects of antidepressant therapy. Why then, is discontinuation not studied, and seemingly, not taken very seriously (as a whole)? If it is studied, then where are the data and are they being utilized? How many million Google hits on (fill in antidepressant) withdrawal do we need to see in order to finally begin to take a scientific approach to this issue?
Its time that pharmaceutical companies are held accountable for what happens after consumers start purchasing their products. Sure, theyll make sure that you have what you need to titrate up, but youre on your own after that. Effectively, they have pawned this responsibility off on ill-prepared physicians and patients. At the very least, drug manufacturers should be made to provide more dose sizes for discontinuation. Again, in this regard, they have placed the onus on practitioners and patients to come up with their own ramshackle solutions. Often this means opening capsules to separate extended release beads into smaller quantities, turning everyday Americans into amateur pharmacists. Often, people end up taking Benadryl or Dramamine or benzodiazepines in order to ease withdrawal (why dont we just call it what it really is?).
Is compounding even possible with extended release formulations? Even in cases which compounding is possible (by real pharmacists, of course!), why should the patients have to bear the responsibility and cost to have this done? Would it really be such a burden to these companies to produce some smaller dosing units and/or oral suspensions/ solutions? I have a hard time believing that the act of manufacturing and distributing these products is a significant barrier. Additionally, depending upon the medication, it can be difficult to get the required combinations of dose sizes, especially when samples are not available, as in the case of Effexor XR. Wyeth has discontinued all samples of Effexor XR (venlafaxine HCl) in favor of the new and improved Pristiq/ desvenlafaxine HCl (gee, what a clever chemical name!). Therefore, doctors and patients have to somehow acquire various dose sizes, essentially on their own. Then of course, in the case of Effexor XR, its not necessarily easy to jump from that last 37.5 mg dose to zero. A huge number of people have reported not being able to make that transition. There seems to be no formal approach to dealing with this issue and in my opinion, physicians are ill equipped to deal with discontinuation challenges. They simply cant prescribe incrementally smaller doses for lack of availability. Something needs to be done.
Its no secret that some of the psychotropic pharmaceutical manufacturers have knowingly failed to inform physicians and patients of the possibility and severity of the so called discontinuation syndrome. The lawsuits and settlements have confirmed this reality. Until we begin to take a methodical approach to the process of discontinuation, all that we have is junk science incredibly irresponsible, unethical, and thoroughly embarrassing, junk science.