Posted by Larry Hoover on July 30, 2007, at 9:45:45
In reply to Re: lithium » Larry Hoover, posted by Squiggles on July 30, 2007, at 8:08:13
> > Let's recap the sequence of debated issues.
> >
> > You initially questioned the sociological value of patented drugs, arguing that generics would be of greater value to society.
>
> Actually, i questioned the motive of the manufacture of generics. The sociological value could easily be got by making all drugs cheaper.Whatever.
> > I then entered the discussion, suggesting that doing away with drug patents would destroy drug research and development as it is presently conducted. Furthermore, I declared that lithium would never be approved under current drug testing guidelines. Although a minor point in what I had written, you chose to focus on that one issue.
>
> Two different issues here:Thanks for picking that up.
> i don't know if it's true that patent protection has in any way delivered great strides in medication, in comparison to the old days.
There are no old days or new days, vis a vis patent protection. The only new difference is the requirement for stringent clinical trials.
> Second issue: could you tell me why you think that lithium would never pass testing guidelines today?
Okay. I feel like you didn't read anything I posted, but.....Animal testing shows that lithium impedes iodine uptake at the thyroid, and impairs both thyroid hormone and reproductive hormone status. Thus, lithium would fail at Phase 1. However, if it got past that hurdle, lithium shows immediate adverse effects on kidney function in a substantial proportion of healthy subjects. It thus could not get past Phase 2, even if the thyroid function effect was not judged to be an issue. There would be no Phase 3 efficacy trials, so the putative superiority of lithium in bipolar disorder would never be known.
> >
> > I won't re-argue the presentation of evidence, but I believe that the null hypothesis is inconsistent with the body of evidence. I reserve my conclusions until after studying the data, to avoid confirmation bias. (However, I also accept that to believe that might also demonstrate bias. I am reminded of Escher, but I digress....)
>
>
> Yeah, you digress-- i don't understand what your point is here.http://en.wikipedia.org/wiki/Confirmation_bias
Recursion of bias. Escher.> >
> > What is most interesting to me is that, despite your protestations that lithium is safe to the thyroid and the kidney, your own doctor routinely tests these functions. You seem to derive some comfort from this. I suggest that you have simply been lucky, both in having the doctor you have (only about 1/3 of lithium-treated patients even get routine thyroid testing), and in the negative results therefrom.
>
> There are many drugs given today (e.g. some heart drugs, diebets drugs, which require regular monitoring.For efficacy. Or for uncontrolled sequelae of the underlying disorder. Seldom for toxic effects. And those disorders are literally life threatening, which puts them in a different light.
> This should not be an argument against the efficacy or safety of a drug, except perhaps for economic reasons to the hospital.
The issue *is* the safety of the drug. And, as I have repeatedly stated, the change in perception of risk over time. Lithium is in use today because it was grandfathered into the current regulatory regime. Not because it is safe, according to current guidleines.
> > Generalizing from your experience, one might conclude that lithium is safe. However, the experience of others is also relevant to the issue of safety.
> >
>
> The experience of others?Yes, all those other people who take lithium and get thyroid and kidney problems. Or other problems, which I've simply not bothered to mention. Consider that you yourself raise the issue of neurotoxicity: "Dr. Schou had pointed out that a lithium holiday would be appropriate for chronic users because of the accumulation of lithium in the brain. "
If you shop around long enough, you can always find an authority whose opinion you like. You name drop all the time (such as the infamous Thomas Szazs, author of The Myth of Mental Illness). It's a logical fallacy, though: argumentum ad verecundiam, an appeal to authority. Which goes back to confirmation bias. If you're not going to look at the evidence, then there is no point in discussing this further.
Lar
poster:Larry Hoover
thread:772306
URL: http://www.dr-bob.org/babble/20070730/msgs/772853.html