Compassionate Use and the Hippocratic Oath

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Ryan
Posts: 84
Joined: Sat Jul 08, 2017 1:41 pm

Compassionate Use and the Hippocratic Oath

Post by Ryan » 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.

huntingonthebluffs
Posts: 154
Joined: Wed Feb 24, 2016 12:00 am

Re: Compassionate Use and the Hippocratic Oath

Post by huntingonthebluffs » Sat Sep 29, 2018 5:00 am

You are far from wearing rose colored glasses. Thanks for your post, it is factual and gives some clarity to a confused set of events.

biopearl123
Posts: 486
Joined: Fri Jul 20, 2018 5:13 pm

Re: Compassionate Use and the Hippocratic Oath

Post by biopearl123 » Sat Sep 29, 2018 7:13 pm

Ryan, you are not wrong. The compassionate use list indicated that drugs "pending approval" or something of that nature were included leading anyone to conclude the drug was exactly that. Also the European job posting certainly suggested a Janssen commitment. Why on earth would they mislead in such an egregious manner? bp

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