This year marks the 50th anniversary of the withdrawal of thalidomide from the market. Launched as a drug for treating morning sickness, it unexpectedly gave rise to severe abnormalities, including the absence of limbs in several thousand children around the world.
The episode was, undoubtedly, a profound tragedy. Yet its lasting consequence has been to endanger not thousands, but millions of lives, by creating a system of licensing for drugs so rigorous that it urgently needs to be rethought.
It has reached the point where the harm to human health, due to the extra time and expense to get regulatory approval, probably outweighs any increase in safety. It can now cost roughly $1?billion, and take more than 10 years, for a newly discovered drug to become available to patients. During that period, many patients who could have benefited may have died.
One solution would be to allow patients to have access to drugs much earlier if, having been given full information about effectiveness and side effects, they sign a legally binding indemnity that they will not sue if things accidentally go wrong. Yet British and European law will not permit this: it enforces a regime of strict liability with regard to drugs, which does not allow the balance between risk and benefit to be taken into account, or permit enforceable indemnities.
The law here is really being an ass, since assessing risk versus benefit is central to all medical decision-making. Medical regulation is itself driven less by the facts and more by the dread fear of litigation. Such litigation often takes the form of class action suits where lawyers solicit people who feel they may have been harmed by a drug and promise to get them compensation without financial risk, using no-win, no-fee arrangements. Yet the public fail to appreciate that it is they, as consumers, who really pay for any compensation, since it is passed on in higher drug prices.
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