Friday, March 07, 2008

A Day of Shame for Science in the United Kingdom

This is the report of the so called "criminal" investigation of GlaxoSmithKline (GSK) by the UK Medicines and Healthcare Regulatory Authority (MHRA). It concerns fakery and misrepresentations of science involving the drug Seroxat/Paxil. Given the close links between the MHRA and GSK this can hardly be regarded as an independent or relevant investigation.

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)

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Radagast said...

I don't care how any of this shite has been justified - inadequate legislation in force, at the time, indeed! What of corporate manslaughter? Or fraud? Withholding data wasn't the only option available.

The fact of the matter is that the outcome is wrong. And if the outcome is absurd, then something went wrong, within the process. "If the outcome is absurd, then "maybe" there was something wrong with the rule, to start with". So said my Criminal Law professor, Dr Matthew Weait. That's why we have deconstruction, in the Law.

This outcome is absurd. It's so absurd, and yet it's normal. That's how absurd the system is. Will a change in the Law achieve anything? Not if Alistair Benbow's statement is anything to go by: he fully expects the industry to be involved in the discussion of new legislation. This is an industry that had the disclosure of trade secrets made a criminal offence, back in 1968. It seems very likely that any new provisions will be so distorted by the needs of the Worshipful Company, that in the end they fit round its business model, rather than disturbing it.

The outcome is wrong. And nobody cares who should.


Anonymous said...

Can't win. Might as well give up really. Whats the point?

Anonymous said...

Never give up. The MHRA have clearly been looking for a loop hole within the law to get out of this disgraceful criminal investigation. They have made themselves apparent that they work hand in hand with drug companies. I believe in justice and truth and one day it will happen. The goverment and the MHRA are guilty as hell. Someone out there will find another loop hole that they will never get out of. That could be a whistle blower, the Law or an Goverment official. It will happen, never Give UP.

Fid said...

The investigation was more of a way to find a way to let GSK off the hook rather than find them guilty of any wrong.

The evidence has been publically available for years. The MHRA were merely 'investigating' the blindingly obvious.

What sickens me is there has been no apology - not from GSK, not from the MHRA nor the DoH.

An apology would be a start and maybe helpful to the parents who have lost children because of Seroxat.

The MHRA need to meet with patients, they need to be shown the real evidence. After all, the patients have nothing to hide, nothing to gain.

Woods letter to Garnier is nothing but a token gesture for us critics. I'm sure there was correspondence between the two before that letter was actually drafted.

Bad day for science... calamitous day for justice.

Anonymous said...

Written by Charles Medawar (Social Audit) on 5th March, the day before the MHRA's announcement of non-prosecution.

"The reality is that any prosecution of the Company would put the Agency itself - and Chairman Breckenridge in particular - too squarely in the frame. What was it he told Panorama for the second of their four splendid programmes? (11 May 2003) - "What you can say with great firmness is that these drugs do not increase the risk of suicidal thought and they do not increase the risk of suicide". If that's the Agency's best assessment after more than a decade of drug investigation, personally spearheaded by the blunt tool, Breckenridge, why should the law expect GSK to do any better? I'd sooner argue that GlaxoSmithKline was fit for purpose (serving shareholders), than the MHRA (safeguarding public health)."

Anonymous said...

No good at politics, but the following seems to suggest we need to get to the EU lawmakers?

Jetzt Sueddeutsche

"...On Thursday, for instance, there was much excitement over the discovery that the manufacturers of an anti-depressant drug, Seroxat, could not be taken to court for concealing evidence that it might drive people to suicide, thanks to a glaring loophole in the law. But the reason this law was so ill-drafted was that it emanated from the EU bureaucracy, as health minister Dawn Primarolo tacitly admitted. Thus the British Parliament no longer has the power to amend it. The only way it can be changed is for Ms Primarolo to plead her case with our real government in Brussels.

This was only one of thousands of new laws each year which have supposedly been "scrutinised" by MPs. Why should they notice the loopholes when they no longer have any power to change the laws? If Mr Miliband argues that this is what MPs are paid for, his own logic suggests that they should no longer be paid for a job they cannot do.

MPs conceded as much themselves on Thursday, when Bill Cash moved an amendment to reverse the provision of the treaty which gives EU law primacy in every respect over the will of Parliament. Only 50 MPs supported it, including 41 Tories - against the wishes of their party's leadership. The rest were happy to accept that the Parliament to which they belong should no longer rule this country.

Sunday Herald

"...Posted by: Prof. Dixie Dean, Highlands Scotland on 5:08am today

Even GSK does not claim to 'post all research on its drugs on the internet', so please provide your evidence Strathturret.

Big Pharma is notorious for concealing adverse results from drug trials. Not only but perhaps most of all GSK, currently negotiating settlement of tens of thousands of legal claims in the U.S.A. and elsewhere.

Furthermore pharmaceutical industry accounting practices are at best questionable since serendipitous play in laboratories is recorded as 'research' and/or 'product development' expense. Such costs should properly be regarded as investor liability, not borne by taxpayers.

I have lobbied the 7 Scots MEPs to press the European Pharmacovigilance Committee in support of the M.H.R.A.'s letter calling for change in current E.U. Law which is a barrier to UK regulation of the pharmaceutical industry.

People in England, Ireland, Wales, please ask your own MEPs to liaise with the Scots and help bring Big Pharma under adequate control

dixie dean (Prof. Em.)"

Anonymous said...

"This was only one of thousands of new laws each year which have supposedly been "scrutinised" by MPs".

So this VIDEO, "The Real Face of the European Union", may very well depict what we're up against, very near the beginning it describes the depth of 'scrutiny' of laws.