I'd like to bring attention to an article on CNN:
http://www.cnn.com/2014/03/10/health/cohen-josh/index.html?hpt=hp_c2
sad story and all... but then I'd like to point out the first top rated comment on the bottom:
Quote:
Liz in Seattle • 4 hours ago
I am in biotech developing new drugs, and this reporter should be ashamed of the oversimplifications in this story. It is not about profits, people. Really. It is about liability. I have worked in companies where we have had to deny compassionate use requests, sometimes from our own investors. The reason is because giving the drug to someone who is near death means that the person is highly likely to suffer all kinds of awful medical events while on the drug. Whether these events are related to the drug or not, the company developing the therapy must report those safety events to the FDA and they can jeopardize the ability of the drug to get approved eventually.
If this little boy takes the new drug but then has sudden organ failure due to his disease, it doesn't matter if it would have happened anyway-- Chimerix would have to report that a patient developed organ failure while on their drug. That might trip up the regulatory agencies and make them decide not to allow the drug to ever reach the market. If that happened, then all of the patients who would have had access to the drug will never get it.
Compassionate use patients need to be carefully chosen, and sadly the patients who are closest to dying are those who are usually denied. It is very sad and I feel for this little boy like everyone else but I totally understand the decision. They can't risk derailing their entire program for one patient.
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I found Liz's comments seemingly more informative than the article itself. It makes perfect sense, and was echoed by a friend I have in the biotech industry (a chemist). He feels, like Liz does here, that the author of the article didn't give this side of the story quite enough of the page (it was glossed over in a single vague paragraph how such things could prevent a company from giving such compassionate use drugs). Instead, the author sure played up the boy's sickness and his distraught family enough... and now surely there are tons of people yelling OUTRAGE! OUTRAGE! at the company like they are on my facebook page.
I'm not a fan of this new journalism... deeply researching all sides of the story doesn't matter. The only thing that matters is how many people you can get upset and yelling about your subject.