I know someone critically ill who was petitioning Otsuka for access to Delamanid under compassionate use, but Otsuka would only agree to give access if the patient stayed in a hospital for 4-6 months. This is just a crafty way for pharma companies to refuse access since they know the cost of months of hospital stay is not affordable or practical. Luckily in this instance, TB Alliance and others fought with Otsuka to get this patient access to the drug.
In many high-need countries (India/Africa/China etc), desperate doctors frequently just lie to Otsuka about the patient staying in the hospital in order to get access to the drug.
Opening access to Pretomanid is a great advancement!
For brand new drugs that cure critical illnesses, the FDA has a compassionate use program (officially called Expanded Access) which allows drugs that are not fully approved yet to be used immediately by very ill patients. Otsuka requiring months of hospitalization to monitor for a rare side effect was just wrong and against the spirit of compassionate use access IMO. This side-effect is easily and cheaply monitored by regular EKGs at a local primary care doctor or urgent care clinic.
They are putting the use of the drug entirely in the hands of people who might not have the resources or training needed. If the use of the drug resulted in several deaths, it could significantly delay approval or kill the program entirely.
I was tangentially involved in a clinical development program that offered access through compassionate use. The folks who received the drug were truly out of options. As a result several died. Investigation determine the drug was not the cause. That didn’t stop the rumors from swirling and several physicians pulling out of the clinical trials and actively discouraging patients from taking part. Probably extended the development by at least 2 years (it was eventually approved) and as a result many people who could of benefited from it had to wait, which likely resulted in a number of deaths that could have been avoided.
I think they're unethical and morally bankrupt.