It's impossible to be too careful

When it comes to warnings given by the drug manufacturers, many patients have an optimistic view. They seem to think that the FDA would not have approved the drug if it was really dangerous so, within limits, they take it as they think fit. Except that the manufacturers have taken great care to agree the wording of these warnings with the FDA so that everyone has fair warning. Just to give you an example of the care the FDA does take, the iPledge system is designed to protect women of child-bearing age if they decide to take accutane to treat their acne. Many women object to the requirement that they should take two different precautions to prevent conception while taking accutane. Some have religious objections, others see the testing before the drug is administered as an invasion of their privacy. Every drug is a balancing of risk against expected benefit. No matter how long the research and development team may work on a drug's safety, there will always be a small percentage of people who experience adverse side-effects. In the case of accutane, there are two side-effects that people need to consider. The one relevant to most people is the clear evidence that it damages the fetus and a high percentage of babies are either still born or born with disabilities. So, for men, accutane is a highly effective drug that can be taken with relatively few risks. But women are only allowed to take the drug if routine tests before, during and after the course of treatment show them to be using oral contraceptives. The iPledge system only applies in the US. Other countries are not quite as draconian. So, with some regret, I report a case from Canada. A married woman had suffered severe acne for many years and, when all the other alternatives had been tried, her doctor came down to accutane. The doctor knew the family and so was aware that her husband had had a vasectomy. Unfortunately, the inevitable happened. She began to take accutane and they continued to have unprotected sex. In due course, she found herself pregnant. Their child is seriously disabled. So no matter how careful you may think you are, things can still go wrong. And, just in case you were wondering whether there was anything approaching a happy ending to the Canadian experience, the answer is no. The couple sued the doctor and lost so they also have a big bill of costs to pay as a losing plaintiff.

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