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by refurb 2500 days ago
Considering QT prolongation has resulted in several drugs being pulled off the market, I’m not sure I blame the Pharma company for being cautious.

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.
2 comments
nimz 2500 days ago
True that they're being cautious to protect their investment in the drug. In the case of TB, it's taken seriously enough that the drugs used to treat MDR/XDR TB are taken under close medical supervision, especially brand new drugs like Bedaquiline and Delamanid. They are usually administered under DOT (directly observed therapy) where a patient is required by law to take the drugs daily in front of a witness, or with lower-risk patients they use VDOT (Video Directly Observed Therapy) where patients can use an app to video record themselves taking the medicine daily and submit the evidence to the local Department of Health. In cases where patients don't comply to treatment, they can be arrested and isolated due to the public health risk.
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refurb 2500 days ago
Protecting their investment sure, but it can extend beyond that to impact clinical perceptions of the drug such that it limits use unnecessarily (regardless of whether Otsuka markets it).

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.

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sschueller 2500 days ago
So QT should be paying for the hospital stay and the drug if they are using this data. Drug trials aren't free either.
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