Tuesday, September 22, 2009

Those Black Box Warnings on Antidepressants

In both medical and legal circles, there is a constant question. How do you warn the general population of the possible dangers of taking medications. Recently, this question has become more pointed. Pressure groups now actively campaign to persuade regulatory authorities to clarify the warnings, while lawyers ask the courts to allow litigation against the manufacturers for their failures to disclose all their research information about the possible side effects.

At its heart lie two deceptively simple questions:
  • do we want patients to make an informed choice about their treatment?
  • if so, are they not entitled to complete information?
The answers, of course, are an equally simple "yes". But this is meaningless unless we identify what information is relevant. As an example, the risk of suicide has been associated with those who take antidepressants such as zoloft — the most prescribed antidepressant in the United States in 2007. The Food and Drug Administration requires zoloft to carry a black box warning. What should this warning say to the several million people who take it?

By its nature, zoloft is always going to have some association with suicide. Zoloft is, after all, used to treat clinical depression and some who are depressed think about death and ultimately commit suicide. Thus, we need to disentangle cause and effect. Simply saying Buy Zoloft is associated with suicide is unhelpful. We need answers to more simple questions. Let us assume that people who are depressed tend to think about suicide, so:
  • does zoloft contribute to this tendency?
  • does zoloft make it more likely that someone will commit suicide?
  • does zoloft affect one group of people more than others?
The answer to the third question seems to be that zoloft affects the young more than the old. But this needs explanation. Consider the research into suicide and the internet published in the April edition of the British Medical Journal. There is already clear evidence that when television news covers a suicide or a drama depicts suicide, there are copycat deaths. The BMJ research tested whether there is a link between the internet and real world deaths. The internet through the search engines and sites such as wikipedia is increasingly influential. Graphic descriptions of the most reliable methods of suicide are freely available. But it is the proactive role of forums and chat rooms that represents a more potent threat. Here suicide can be encouraged as a problem-solving method and suicide pacts are agreed. This produces peer pressure, particularly among the young, to consider or attempt suicide.

How could we get more evidence? When someone commits suicide, the police and coroners could systematically record the use of zoloft, the dosage, the method of suicide, the use of the internet, searches made, forums used, and so on. When we have the evidence, all the relevant causes and their effects would become clear. As it is, the FDA has warned young people not to use zoloft. But it is probably only coincidence that young people use the internet more often and are more easily manipulated by those met in chat rooms. Without proper research, the current warnings are vague and not a rational way of regulating the use of zoloft.

People should be given all relevant information so they can make an informed decision about whether to use zoloft. Suppose someone is already subject to peer pressure from internet use and Googles methods of suicide. Why not Take Zoloft? Zoloft is designed to reduce depression, so this should reduce the risk of suicide.

As it stands, the warning system does not work and there is no co-ordinated research program to collect information to help it work more efficiently. Obviously, such research does not suit the commercial interests of the pharmaceutical companies because it might prove their product is not safe. It is sad that governments seem to take the manufacturers’ side rather than protect the ordinary citizen.

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