In icon’s Cancer Watch we have told you that Big Pharma were making a case in the USA that if their drugs were approved by the FDA, yet subsequently went on ten years later to damage and even kill those patients who had taken them, then Big Pharma had no responsibility for the consequences. That responsibility had passed to the FDA who had approved the drug.
I suspect most people with an IQ of double digits can see that this lays open the Government body to huge dangers. Since clinical trials rarely last for more than 5 years and fail to quantify the side-effects, there could be many drugs where patients or their families subsequently felt aggrieved. And if they take their unhappiness to court, the financial penalty then lies with the FDA, and ultimately the tax payer, not the executive board and profits of the pharmaceutical company. Also (and perish the thought that they would ever do this) it might encourage some unscrupulous companies to be less open about the side-effects, as once the drug was officially approved they no longer had to worry about them.
As we all know, what happens in the USA tends to happen in the UK just a short while later.
Despite all this obvious dodgy thinking, the FDA were in the process of granting the immunity to Big Pharma. That was until the Diana Levine case happened in the US Supreme Court early in 2009. By a 6-3 ruling, the court has ended the immunity from prosecution for Big Pharma before it started!
This case concerned Wyeth, but now no Pharma drug or company will have immunity from prosecution, and this case opens the doors to literally hundreds or even thousands of claims in the USA.
Hopefully now this will make Pharmaceutical companies more conscious of the need to spell out the dangers and side-effects, and be more open about them at times of Government Health body approval. Frankly, that openness seems in everyone’s interests.
Other articles of Interest: So can you trust a Clinical Trial?