Compassionate Use and the Hippocratic Oath
Posted: Fri Sep 28, 2018 11:04 pm
I have to add ~ the Compassionate Use for Imetelstat *was* online. I saw it, it was an official site, and it was there. Then it was down.
Follow me here ~ for Imet to wind up available for Compassionate Use, even for a micro-second, it would have to pass through Doctors / Experts / Clinicians involved in the trial. There would be many layers of legal and sign-offs to move that forward. The Hippocratic Oath would stop a Doctor from recommending Imet for Compassionate Use if they did not feel it was safe and effective for their patients.
This does lend credence to the supposition that it was not the effectiveness drug or the data from the trials that led to the end of CA, but a business decision. I honestly believe this thesis. Now, this could be for many reasons:
- Breakdown in negotiations for some reason
- Expected revenue from Imet (although they listed as $1B/year drug up until 2 weeks ago)
- The additional patient cohort in MDS was a sicker population with higher transfusion needs, maybe Janssen picked this cohort to see if Imet was a true blockbuster blockbuster slam dunk and that is what they want in partnership
- As noted in another post, just focus on their other MDS offering
- Potential cost of to manufacture therapy
That is a nuance that we may never know. But effectiveness, sorry to be wearing the rose-colored glasses but I still think there is potential to help many blood cancer patients.
Follow me here ~ for Imet to wind up available for Compassionate Use, even for a micro-second, it would have to pass through Doctors / Experts / Clinicians involved in the trial. There would be many layers of legal and sign-offs to move that forward. The Hippocratic Oath would stop a Doctor from recommending Imet for Compassionate Use if they did not feel it was safe and effective for their patients.
This does lend credence to the supposition that it was not the effectiveness drug or the data from the trials that led to the end of CA, but a business decision. I honestly believe this thesis. Now, this could be for many reasons:
- Breakdown in negotiations for some reason
- Expected revenue from Imet (although they listed as $1B/year drug up until 2 weeks ago)
- The additional patient cohort in MDS was a sicker population with higher transfusion needs, maybe Janssen picked this cohort to see if Imet was a true blockbuster blockbuster slam dunk and that is what they want in partnership
- As noted in another post, just focus on their other MDS offering
- Potential cost of to manufacture therapy
That is a nuance that we may never know. But effectiveness, sorry to be wearing the rose-colored glasses but I still think there is potential to help many blood cancer patients.