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Re: Statistical question on SSRIs - ADDENDUM » Squiggles

Posted by Squiggles on May 14, 2006, at 15:06:42

In reply to Re: Statistical question on SSRIs - ADDENDUM » linkadge, posted by Squiggles on May 14, 2006, at 9:42:48

Notes:

- I finished giving it a cursory read - it is
actually only 342 pages;

- at the end of the day, labelling is considered
a good thing by the committee, regardless of the
0 vote on the proposition that fluoxetine (and other ADs) can cause suicidality; what are we
to make of that? I would say, that labelling or not labelling is inconsequential and a token which the FDA can take and do with as it pleases. It will probably make little of a dent to Eli Lilly or any other big drug company. Furthermore, to relieve the drug company of any responsibilty of what is overtly agreed a dangerous side effect (i.e. suicidality), the committee proposes that patients and the FDA might write a "Dear Doctor" letter to the physicians discussing the resolutions. Dr. Mann thinks that even this is going too far.

- personal points of interest: the "roll-back phenomenon" - that has been my speculation about how an AD and in particular ADs that are ennervating or agitating, can precipiate severe anxiety in the midst of depression, after taking it. This condition might drive a depressed, and
stuporous melancholic to actually get the energy to finally end his misery through suicide.

Apparently, this scenario is known from clinical circles as the "roll-back phenomenon" and it is not unique to Prozac. But it is not something that is given great heed in this hearing. I think the most salient causal factor for most seems to be "depression" - that depression carries with it the risk of suicide. A comparison between "suicide from depression" and "suicide after, between, during, of the drug taking" is not compared to my knowledge.

- personal point of interest: the description of the headaches: their severity and back of the head splitting sensation, and severe illness following; that is familiar to me: with clonazepam withdrawal; i was sick for a month and I think i had a seizure, brain haemorrhage or stroke; like the person describing this on Prozac, it was very hard to even move your head, and it felt like dying -- is it possible that the plasma level fluctuated on account of not taking Prozac every day as prescribed? Was there withdrawal? Is hyperthermia something that can affect the brain in drug treatment? Medical questions are surprisingly few in comparison to statistical proofs.

The dr. monitoring or lack of it, is brought up and there is some talk of how appalling physician care is in some cases. I would say that in such cases, I would agree with Dr. Torrey -- we need more clinics and more care, not more labelling and "Dear Doctor letters" from drug companies. Also, if there is such dearth of monitoring, it may actually harm the "adverse event observations" of these suicidal cases given by relatives of the victims in the beginning of the hearings. And if that is harmed, one cannot speak of apalling physician care and the independence of suicide from the prescribed drug. It does seem like the pilot has washed his hand and sealed our fate.

I am sorry, I am not able to say more right now.
I intend to read it again. My first impression is that the pharmaceutical companies are very smug, as they have a statistical formula to back up any adverse situation with a drug. The FDA seems to be in the middle, doing the hard work, and the consultants, from whom I think the most sympathetic appreciation of individual suffering comes (for example to mention a few -- Dr. Casper, Dr. Hellander, and Dr. Teicher, Dr. Lieberman, Dr. Zifry), and the necessity for individual care, come last in how effective their objections are and what practical, real impact they have on public health care.

Later

Squiggles


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