A frequently found ornament in the homes of my family in my childhood was a brass figurine depicting the three wise monkeys. This was used as a warning and a homily – very effectively against wrongdoing and in particular lying – or as its more often known today – research.
If you never came across it, the little chaps sat side by side: the first with his hands over his ears, the second over his eyes and the third over his mouth. Originating in Japan, they warned against hearing, seeing or speaking evil and why are they relevant today? Apart from the fact that they apparently have become collectors items, they came to mind when reading a report of an investigation by the Washington Monthly and the British Medical Journal.
They found that at least four members of an advisory board which voted to approve a drug used in birth control pills had either done work for the drugs’ manufacturer or received research funds from the manufacturer. Though they did disclose their ties to the FDA, the FDA decided that the ties did not matter and did not make the disclosures public.
So what did they not hear, see or speak about? In this case the birth control pills Yaz and Yasmin which contain a drug called drospirenone, which the FDA advisory committee endorsed last December. But among those who did hear, see and speak were the Alliance for National Health (ANH) who pointed out that women who take drospirenone are nearly seven times more likely to develop a thromboembolism than women who do not take any contraceptive pill.
This is serious as it is the obstruction of a blood vessel by a blood clot that can cause deep vein thrombosis, pulmonary embolism, stroke, heart attack, and death. Even worse is that women who take drospirenone have twice the risk of developing thromboembolism than women who take widely prescribed contraceptive pills containing levonorgestrel.
How can you impartially advise on the efficiency or drawbacks of a drug when you are tied to the manufacturer of that drug? The real ‘monkey’ here is the FDA who allowed the four members with financial ties to vote on the drug but barred another member and former researcher, Sidney M. Wolfe, from voting on the grounds that he had “an intellectual conflict of interest”. He certainly did as, based on several years of data, he had advised his readers six years earlier not to take Yaz. So someone who points out the problems is barred but those who have profited financially from their association are not.
The FDA certainly do suffer from blindness when it comes to conflict of interest as they also failed to provide the panel with recently unsealed court documents which revealed that former FDA commissioner David Kessler had accused Bayer of hiding data on blood clot risks associated with the birth control pills. The court documents also revealed that Kessler reported that Bayer paid $450,000 to a high profile gynecologist to sponsor the pill, including off-label use of the drug, during her book tour.
I have previously taken issue with ‘sponsored’ research into such things as breakfast cereals that are high in sugar – and guess where their research funding comes from? But that does not have the potentially fatal impact that not speaking out about serious known associations between drugs and side effects that is the case here.
Maybe we need three new wise monkeys: hear, see and speak about ‘evil’ where you see it or just keep your own ears and eyes open so you can speak about it.
Read more from AnnA at www.creativecatalyst.co.uk