After the tragic death of a healthy volunteer in a clinical study in France in January 2016, every responsible drug developer should pause to think for a moment: Could this happen to us? Have we taken all possible measures to prevent a tragedy like this?
In most cases the true answer to both questions is: Yes.
At Herantis, we plan to start recruiting patients in two clinical studies in 2016: With Lymfactin® in secondary lymphedema, and CDNF in Parkinson’s disease. Both studies have been planned for years. During that time their overall design and details have been discussed several times with multiple regulatory authorities and clinical experts. Extensive preclinical safety testing by independent laboratories and studies by leading scientists have been completed and results reviewed by authorities. Everything is done in compliance with regulations, which exist for the very reason of patient safety in clinical research. So, safety has been taken most seriously.
On the other hand, basically all therapeutics have side effects. Anyone could react adversely to even a common drug that is generally considered safe. Clinical studies are needed to assess the safety and efficacy of new compounds. And our two currently planned studies would be ‘first-in-human’ studies, which means the compounds have never before been tried in humans. Risks of the unknown do remain even if minimized with all the hard preceding work.
So, what should one do?
In my opinion, the best approach is complete openness. Especially in our studies where instead of healthy volunteers we will recruit patients with an incurable disease. We need to remind those patients that though participation in the study may bring some hope, there is absolutely no guarantee of any clinical benefit – and at the same time a small, but not negligible, risk of unexpected side effects exists.
After the Rennes tragedy anyone considering participation in clinical studies will of course be more conscious about such risks, which might mean slower patient recruitment in any future studies.
Herantis has planned to conduct its next two studies in Finland and Sweden. These countries are among the least corrupt in the world and their authorities are very competent, strict, and trusted. Both countries have excellent, highly educated clinicians; great expertise in the relevant fields; and most importantly, very compliant and knowledgeable patients who have no pressure participating in a clinical trial. Thanks to comprehensive public health care they will get excellent treatment regardless. Patients still remain in these countries who will, after a careful review of materials and discussions with the investigator, decide to accept the risks for potential benefits for both themselves and – as they admirably often emphasize – for countless future patients.
Without the brave first patients many horrible diseases will remain unmet clinical needs. My sincerest hope is that we can in return provide those first patients, and many others to come with at least some badly needed relief to their symptoms.
Herantis considers its development risks unchanged from its listing prospectus dated 12 May 2014.