Friday, September 5, 2014

As Antidepressant Lawsuits Wind Down

Here is some food for thought about drug companies, perspective and economic understanding.

The first story is a summary of the on-going battle between the drug companies and the families of youths who committed suicide after taking antidepressants.  The drug companies were targets of hundreds of lawsuits until “a decision made by the Food and Drug Administration 10 years ago this fall that required drug makers to include a ‘black box’ warning that says that antidepressants can cause suicidal behavior in adolescents. In 2007, the warning was broadened to include young adults.”  Interestingly, of those many lawsuits, most were settled out of court, but of the ones that went to trial the drug companies lost only one.  It’s a reasonable conclusion that depressed people would have a tendency to commit suicide with or without the drugs, so it’s a little hard to blame the drugs.  That didn’t stop a few lawyers from making a career out of this type of litigation and collecting many settlements from companies who are rightly leery to leave the decision up to a jury and to spend countless hours and dollars on trials and appeals.  Still there is considerable controversy over whether the side effects of antidepressant drugs are safe and may possibly be to blame for suicides.

On the other side of the coin, one expert witness at the FDA hearings feared that such a strong warning would scare adolescents away from drugs they really needed.  Since then a medical journal from London, FMJ, has published some highly criticized research showing a reduction in usage of the drugs and an increase in suicides.  (Remember correlation does not prove causation.)  Meanwhile the University of Maryland joins the discussion with a paper stating:  "Lithium used as a drug treatment for major mental disorders such as bipolar disorder and depression is effective in reducing the risk of both attempted and completed suicide.”  Although the black box warning greatly reduced the inclination to sue, the disagreements over this issue continue.

I thought these were interesting reports alone, but coincidentally, it came to my attention on the same day that there is a proposal in Congress to loosen restrictions on buying drugs on line from Canada and other foreign countries, allowing people to buy them for less.  

Now I am no fan of the drug companies, especially as they interrupt every other TV program to remind me to ask my doctor about the latest prescription pill; but I can sympathize a bit with their position.  They must invest heavily in research and development, running into many dead ends and jumping through regulatory hoops, to develop and get FDA approval for the drugs we need, while facing pressure from the government to keep prices down and a long line of potentially costly lawsuits.  But the minute we hear of an epidemic like Ebola, the first question everyone asks is:  “Why isn’t there a drug or vaccine for that?”

Put yourself in their shoes just for a minute.  You work really hard to produce a drug that’s 99% effective with the prospect of having 99 cured customers who resent you because they think they paid too much and one other customer hiring a lawyer to punish you for not being perfect.  I think it would be a little disheartening.

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