Thalidomide is still casting dark shadows 50 years on

Thalidomide is still casting dark shadows 50 years on

November 22nd, 2011 // 2:33 pm @

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.

While there is no question that litigation is appropriate where there has been negligence, deceit, fraud or incompetence, in most cases litigation is based on statistical side effects, where taking a drug increases the chance of, say, having a heart attack by a few per cent. There is no way of telling whether a particular heart attack is due to the drug, so companies will compensate everyone with a heart attack who happens to have taken it. Many cases are settled out of court for hundreds of millions of pounds, again adding greatly to the cost of drugs. This is equivalent to paying off hostage takers; it only encourages more of the same.

Even worse, this litigation culture can cost not just money, but lives. Perhaps the most tragic example is the anti-rotavirus vaccine produced by the drug company Wyeth in 1998. Rotavirus is responsible for about 40 per cent of diarrhoea cases in small children, and is a major cause of child death in Africa. Because this vaccine caused a small increase (in about one in 10,000 cases) of a usually non-lethal bowel complication called intussusception, Wyeth withdrew the vaccine, not only in the United States but worldwide, even though the risk/benefit ratio in Africa was hugely different to that in the US. It was not until 2006 that similar vaccines with fewer side effects were introduced; in the interim, some three million children had died.

The basis of such decisions lies in the distinction that the law recognises between harm caused by doing something as opposed to doing nothing. If a vaccinated child suffers a complication, you will be sued. If a child dies of a disease that it could have been vaccinated against, you won’t be.

So what needs to be done? First, medical regulation must be made faster and cheaper, and the necessary changes in the Consumer Protection Act and the relevant European directive enacted. That may be the easier part. Much harder is to persuade the public that no drug can be entirely safe, and that there should be a requirement for proof of direct causality – not just a statistical association – before compensation is due.

Next, no-win-no-fee cases should be forbidden. Finally, the legal distinction between harm caused by omission and commission should be reconsidered.

These changes will need political courage. But if nothing is done, health care will become increasingly unaffordable, and the great advances in medical science that will make headlines in the coming decades will fail to be translated into medicines that your doctor can prescribe.


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