Steve April 19, 2011 at 8:17 am

These cases of HSTCL need context. How many people take these drugs? What is the baseline rate of HSTCL in the general population? How about in the subpopulation of people who have IBD? All statistical, population-based based questions which really aren’t a very scientific way of understanding risk to individuals – but it is how FDA usually evaluates risk. FDA seems to acknowledges that people with IBD may develop this disease at a higher rate because of their IBD – but they don’t say hy they think that, or what they know about it. They also don’t present any scientific information. How well is the potential mechanistic connection between these drugs and HSTCL understood? Is development of the disease a probable effect of the drugs based on what we know about the drug mechanisms of action and what we know about the causes of the disease? In other words, is it reasonable to assume that an increased incidence of HSTCL would result from use of these drugs? Some cases of gastrointestinal disease (IBD) and other diseases treated with these drugs are quite serious and can even be fatal. It is not the article author’s fault that these facts are missing from the article. They are also missing from the FDA’s safety alert. So without context, how does the FDA’s safety alert helps patients and physicians decide to use, or not use, these drugs? If the risk of developing one case of HSTCL that would have occurred absent use of the drug, is one in 100, it’s very relevant to patient/physician decision making, but what if it is only one in 10,000 for all people taking these drugs? If one or more of these drugs is the only way a person can control his/her disease (and that is the case by the way), then a better sense of the relative risk is needed, so patients and physicians can weigh for themselves how to manage that risk against the risk of their disease. Come on FDA – what else do you know? If this is a small risk in the context of patient/physician decision making – tell us. If you only suspect there might be an increased risk, your alert should clearly explain that uncertainty. If you are sure there is an increased risk – your alert should explain that. This alert is about as helpful as telling us – 30 months from now lightning may strike the ground in some places. Is this a defensive knee jerk because you are getting reports without context – or is it an alert about a real risk. I think the FDA doesn’t know. So what should FDA do in a case like this? I think they should clearly state what they do, and don’t, know. If this is just a case of getting some adverse event reports so they are throwing an alert out there telling me they are getting adverse event reports, they are looking into it, they will let us know when they actually know if it is important, and they thought the public should know, that is what the alert should say, and it should be called something else – like an advisory. If they are really concerned, based on some level of usable data, that there is an increased risk from using this class of drugs – it should be called a safety alert, and they should tell us why they are concerned. This alert will cause some patients and physicians to stop using these drugs. For patients who need them – and won’t ever develop HSTCL (which is probably the large majority of them) is that a good public health outcome? Did FDA think about that? If they did, there is nothing in the safety alert about it. Bottom line FDA. It seems you are just covering your tail with this alert. How is this information useful for medical decision-making? That is your mission – protecting and promoting the public health – not just lobbing uncertainty into the mix so you can say later on you were on top of something, just in case it eventually turns out to be significant.