Another chance to bash the Pharma industry
The pharmaceutical industry hasn't had much luck in recent years really. The latest incident of six young healthy volunteers ended up in intensive care unit at Northwick Park Hospital in London (which, incidentally, is my local hospital) after being injected with a single dose of a new experimental drug, just gave some sectors of the public more ammunications against the industry. I've been following the stories and various comments on the net in the last 24 hours, and it's quite interesting to read how some people mix in the argument against animal testing into this unfortunate incident - basically their argument is that there is no relationship between animal studies and human studies, because the species are different. But so far I have not seen any alternative solutions put forward by these people. Do they really think that drug companies enjoy spending money on animal studies if they are unnecessary? Also without animal studies, and the drugs go straight from the lab to human studies, there would be a lot more such incidents.
One of the books that I am reading at the moment is called Big Pharma by Jackie Law. This book is a collection of revelations of how pharmaceutical industry operates. Quite an interesting read and includes in-depth analyses on some of the recent problems the industry has faced such as the Vioxx case and the SSRI anti-depressants. Certainly got me thinking a bit..... In a way, have people in the western world become too reliant on medicines for any of their health issues, without looking into possible lifestyle changes. eg why do some people want a slimming pill to lose some weight when they can't even cut down or change their diets?
I've learnt that recently there's a film called Side Effects released in the States. It's a story about a sales rep working in the pharma industry. I haven't seen the film yet but would love to see it - just to see how much of it is true, and whether I'll cringe (just like how people cringe when they watch The Office - that's what made that comedy so successful).
Finally, just hope that the six men in the intensive care unit in Northwick Park Hospital will pull through and make a full recovery. Miracles do happen sometimes and I certainly hope that they will happen this time.
posted by Albert Chau @ 11:03 pm
2 comments
2 Comments:
Not just the industry that deserves bashing. What about the discredited regulators who would have been involved here.
The drug regulatory body (the MHRA) has some real answering to do, despite their fine press statements. They would have approved this Phase I trial, and the protocol. It is well known that the MHRA does not exactly have a scientific approach to evaluating information, and instead believes what it is told by it's pharmaceutical "clients". The House of Copmmons Select committee reports that the MHRA rarely looks at raw data, and does not act as a plausible independent entity. Now if only the buck could be places at all the points in the system that failed here, and some regulators could be placed behind bars we would see human beings being treated as more than just "so much meat". Perhaps we could include those wise government ministers who chose to ignore most of the House of Commons SC report on the pharmaceutical industry and the regulators.
The MHRA gave the Clinical Trial Authorisation (CTA) based on the pre-clinical data submitted, but they were not the one approving the protocol for this phase I trial - as far as I understand, the protocol was reviewed and approved by the ethics committee (I can't remember which region, but I have a feeling it's Brent). Whether MHRA has failed to notice any warning signs from the pre-clinical data and thus gave the CTA inadvertantly, I have no idea.
Don't want to play armchair doctor / detective here to speculate what has gone wrong (it could be contamination, it could be human errors such as overdosing, or it could be the drug releasing the cytokines in the body triggering all the cells to attack the organs), but one thing that baffles me is why they would risk testing on 8 subjects at the same time? Is there no limit in the protocol that says the max number of patients to be treated at the start?
Too many questions to be answered, so wait and see the whole thing unfolds!
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