Nevertheless, the MHRA could hardly avoid acknowledging many of the scientific manipulations that took place within their report. Many others are not discussed. These include the apparent "recoding" of clinical records in randomized trials, and the counting of events in the washout phase of trials as events on placebo. There seems very little doubt as to what happened, and the fakery is not denied.
Many children and adults are likely to have died as a result of this fakery.
The upshot of this report is that scientific misconduct is acceptable in the United Kingdom. It is acceptable for doctors and patients to be misled.
The problem is that the MHRA is only concerned about information supplied to themselves by GSK. They are not concerned about the veracity and numeric accuracy of the information supplied by themselves to the public and to doctors. They regard the provision of false or incomplete information to themselves as legal so long as that information does not directly concern licensing. They ignore the fact that doctors and patients make decisions based on information in the scientific literature, and that this literature may be faked. They ignore the fact that they themselves rely on the "peer reviewed" scientific literature to make decisions. Despite this, the MHRA have previously declared that they have no remit to be concerned about the integrity of the scientific literature involving drugs, except where it is related to a licensing procedure. They maintain that the scientific literature is "exploratory" and that fraud in this literature is therefore not relevant.
It took the MHRA four years of "investigating" to reaffirm that fakery involving drugs no longer matters.
It is time for the honest members of the medical profession to say that they disagree.
This is a day of shame for science in this country, for our profession, and for the supine leadership of our profession.
No amount of legal tweaking over issues of data-supply to regulators is going to solve this problem. There are no right answers to the wrong questions.
The government might start by reassessing their failure to respond properly to the issues raised by the Commons select committee report of 2004/5. They might start by examining their refusal to address any of the critical issues raised by that report. They might make a clear statement that honest science matters. They might make it clear that in this country we expect the usual rules of science to be obeyed, and that raw and complete data should be made available both to regulators, authors of scientific publications and to concerned scientists. They might admit that the regulator has failed to scrutinize or retain actual raw data in the past, and has simply accepted the summary claims of industry with blind faith. They might think a little about the conclusions of the select committee concerning the honesty, integrity and independence of the MHRA. They might stop their cozy meetings with industry CEO's.
It was also most unusual that Gordon Brown should have invited the CEO of a company undergoing criminal investigation over the deaths of vulnerable patients to join his International Business Advisory Council.
No, I tell you. No, sir. Corruption charges! Corruption? Corruption is government intrusion into market efficiencies in the form of regulations......We have laws against it precisely so we can get away with it. Corruption is our protection. Corruption keeps us safe and warm. Corruption is why you and I are prancing around in here instead of fighting over scraps of meat out in the streets. Corruption is why we win.
(From the Movie Syriana)