For those you following the Good Pharma – Bad Pharma debate may find last week’s BMJ Editorial by Fiona Godlee interesting:
Fiona Godlee. Clinical trial data for all drugs in current use. BMJ 2012;345:e7304.
‘Clinical trial data for all drugs in current use must be made available for independent scrutiny.’
‘…. The drug industry does many good things. It produces medicines that can improve health and save lives. It creates jobs and stimulates economic growth. Sadly it does bad things too. Persistently and systematically over decades it has withheld and misreported data from clinical trials. As a result, a whole range of widely used drugs across all fields of medicine have been represented as safer and more effective than they are, endangering people’s lives and wasting public money. Such wilful distortion is scientific misconduct…..’
‘…. Hats off then to GlaxoSmithKline, which announced last month that it would allow access to anonymised patient level data from its clinical trials.4 An independent panel will assess all requests, and the company’s chief executive officer, Andrew Witty, says access will be granted on the basis of a reasonable scientific question, a protocol, and a commitment from the researchers to publish their results….’
‘….. And amid the plaudits, a moment of doubt. Surely what this apparently brave and benevolent action really serves to highlight is the rank absurdity of the current situation. Why aren’t all clinical trial data routinely available for independent scrutiny once a regulatory decision has been made? How have commercial companies been allowed to evaluate their own products and then to keep large and unknown amounts of the data secret even from the regulators? Why should it be up to the companies to decide who looks at the data and for what purpose? ….’
“I have to agree with the principle of free access to trial data and at the level of individual trial subjects. At the end of the day the only way the Pharma industry is going to clean up its image is by being transparent and honest. If pharma don’t come to the party and help I suspect the EU and Governments will impose a freedom of information-type act giving stakeholders access to the data. If this was the norm lives may have been saved; Glaxo’s rosiglitazone scandal is the obvious example. Interestingly, I was a principal investigator at my old institution on the GSK-sponsored trial of rosiglitazone in MS.
“The following is the trial report provided by GSK. It is galling that somebody didn’t make the effort of writing up the trial results and publishing them. There are even journals of negative results for this sort of data. I should know I have published a paper in one of these journals in the past. It is unethical not to publish negative results. Could a trial report be construed as sufficient? In my opinion, no. The publication needs to be peer-reviewed to make sure it of sufficient quality, etc.”
Lim ET, Petzold A, Leary SM, Altmann DR, Keir G, Thompson EJ, Miller DH, Thompson AJ, Giovannoni G.Serum S100B in primary progressive multiple sclerosis patients treated with interferon-beta-1a. J Negat Results Biomed. 2004 Oct 13;3:4.
“The cynic in me suspects that Glaxo is doing this to prevent legal action or to try and prevent Governments’ from making this compulsory in the future. What do you think? Can the industry regulate itself? Deja vu?”