At least one patient thinks so. And he writes about it today in the Wall Street Journal's Opinion Journal under the title "The FDA Is Killing Crohn's Patients."
Do patients have a moral right to know their treatment group at the end of the study?
Do patients (in particular those from a placebo arm) have a moral right to access the experimental therapy when the study ends?
If such a moral obligation exists, does an informed consent absolve a sponsor?
In each of the stories that have come to the mainstream media over the past few months (including the case of Fred Baron seeking off-label Tysabri), there is seems the assumption that the experimental therapy is not only known to be safe but assumed to be effective.
As argued in the WSJ, the constitution should be interpreted to allow "a crtitically ill patient...access to a potentially lifesaving drug that has been deemed safe for human consumption, if the patient agrees to bear the risks involved."
But an IND to initiate human trials is based only on preclinical/animal testing -- a barometer few would interpret as a stamp of being deemed safe for human consumption. In fact, it's the very clinical trial being conducted that is meant to demonstrate safety during the drug's life as an experimental medicine.
And is a patient's signature on a consent going to be adequate to demonstrate that the "patient agrees to bear the risks involved"? In fact, didn't the patient sign a very similar consent agreeing to risks involved when signing on to the clinical trial (including those of placebo use)?
Patient rights are a moral obligation. But so too is patient safety, which much be the priority. Finding a common ground in the coming year will be important for ensuring patients feel both safe and not-abandoned in clinical trials.
Now Washington is stepping forward with the "Access, Compassion, Care and Ethics for Seriously Ill Patients Act." Is Washington best suited to solve matters of morality and ethics?