The final report into a catastrophic drug safety trial that left six men fighting for their lives in the UK in March 2006 has severely criticised Parexel, the firm that carried out the trial.
Parexel’s catalogue of errors, listed in the report issued by the Medicines and Healthcare products Regulatory Agency, include failing to complete proper patient medical records and not providing 24-hour medical cover.
However, the report concludes that the serious adverse reactions experienced by the healthy volunteers were the result of an “unpredicted biological action of the drug in humans” — echoing an interim report issued in April 2006.
Why, for all it’s flaws, the FDA (or some sort of regulatory agency) is a good idea. Granted, it does sound like it was simply a problem with the drug itself – which is why we do clinical trials – but there were enough flaws within Parexel’s protocol that it highlights why we need oversight agencies.
This is becoming an even worse problem in the third world countries, or upcoming ones such as India, where drug companies are fleeing at alarming rates to do their trials – no FDA, no regulatory agency, no institional review boards, nothing. Just free reign and the money to buy people who’re desperate enough for the cash that they’ll do just about anything – especially with trials, where you have a chance of placebo and walking away with money and no side effects.
Of course, this British disaster shows the problem with that logic – it’s a Big Pharma version of Russian roulette.
Gabon has taken the unusual step of bringing in bioethics experts to educate their government about drug trials, and to insist that all trials done in their country follow US FDA protocols and procedures. This insures greater safety for their citizens, and Big Pharma still goes there, cuz it’s still cheaper. It’s almost a win-win situation; I wonder, and should dig, on just what FDA rules are for accepting clinical trials run outside the USA. And I think I have just the book to do it,…