There are a host of new drugs coming to market for respiratory and skin problems. These include Brodalumab, aka Siliq, Apremilast, aka Otezla, and Daliresp. Prepare to hear a lot more about Phosphodiesterase antagonists and drugs acting on Interleukin 17 or 23.
These drugs can cause suicide. The companies have made strenuous efforts to hide the problem, resorting to clinical trial maneuvers pioneered by other companies marketing SSRIs. And of course bear in mind that psoriasis and asthma and osteoporosis all cause suicide. The published clinical trial evidence is ghost-written, and gives very little hint of the problem.
Siliq is one of these drugs. It has been just been approved for psoriasis. Originally it was going to be a blockbuster for Astra-Zeneca. Having a Mab on the end of a drug’s name is a license to print money – even if the drug is an Injectable like Siliq. But faced with the clinical trial data, AZ sold it to Valeant. FDA have published an account of the clinical trial program that gives some sense of what the data might be like.
But Siliq may come with a silvery lining. The data are so bad – rather like antidepressant and antipsychotic data – that FDA have felt forced to put in place or else decided to experiment with a Risk Evaluation and Mitigation Strategy (REMS).
Prepare to hear a lot more about REMS. In one sense this isn’t new. Blood tests on Clozapine to check white cell counts are an example of REMS. Consent forms agreeing not to get pregnant while taking Ro-Accutane is a REMS. The plan is to roll out a lot more risky drugs under the cover of REMS programs.
This isn’t all bad. It may offer earlier access to drugs that in some cases may be helpful. It may remind everyone that all drugs are poisons.
You have to wonder how things would have looked if we had a REMS program like the one below in place for the Antidepressants and Antipsychotics. The original document can be accessed here, and a lot more related material can be accessed here.
The goal of the SILIQ REMS Program is to mitigate the observed risk of suicidal ideation and behavior, including completed suicides, which occurred in subjects treated with SILIQ by: