Glaxo Escapes Prosecution Over Paxil In UK
15 CommentsBy Ed Silverman // March 6th, 2008 // 7:41 am
After a four-year investigation and examining 1 million pages of evidence, the UK’s Medicines and Healthcare products Regulatory Agency has decided not to pursue criminal charges against the drugmaker, although the agency did chastise Glaxo for failing to release more quickly clinical trial data about suicidal risk in youngsters.
The propsect of obtaining a criminal conviction wasn’t “realistic,” because the legislation in force in 2003 - when the investigation began - wasn’t clear enough, especially concerning the disclosure of data and off-label use, the MHRA said in a statement. Glaxo and individual Glaxo employees declined “invitations to attend interviews,” the MHRA says, but did provide three written witness statements - two on behalf of the drugmaker and one on behalf of an unnamed employee.
Glaxo provided the MHRA with data from clinical trials confirming that patients under 18 had a higher risk of suicidal behaviour if they were treated with Paxil, which is known as Seroxat in the UK, than if they received a placebo; and that Seroxat was ineffective in treating depression in kids. The probe began after disclosure that Glaxo withheld clinical trial info.
“I remain concerned that GSK could and should have reported this information earlier than they did. All companies have a responsibility to patients and should report any adverse data signals to us as soon as they discover them,” Kent Woods, MHRA’s ceo, says in the statement. “This investigation has revealed important weaknesses in the drug safety legislation in force at the time.”
Laws have subsequently been changed to require drugmakers to report adverse reactions in any clinical trial, though these rules don’t apply outside of Europe - and most of Glaxo’s Paxil trials were conducted in the US. The MHRA plans to press for change in law in the UK and eventually Europe to force drugmakers to report adverse clinical data no matter where trials are conducted.
“Such a course of action should be unnecessary in an industry which relies so heavily on public trust and aspires to high ethical standards. I would have thought it self-evident that such information should be made available promptly to the regulator in order that action can be taken to protect public health. However, that moral responsbility now needs to be insisted upon by the unambiguous force of law,” Woods wrote Glaxo ceo JP Garnier.
truthman
Thanks for highlighting this Ed.
It seems to me that what this sordid affair boils down to is..
The UK government and the MHRA found GSK guilty of suppressing Negative trial data about Seroxat (Paxil) causing suicide in teenagers..
But, they will not be prosecuting..
So effectively they are condoning corporate manslaughter (or in this case corporate child-slaughter)
It is no wonder the public have lost faith in the governments, the regulators and the drug companies? ..
Personally i think it is a perfect example of just how much influence and power big business multinationals have..
They are above the law..
GSK’s conduct in regard to Paxil disturbs me and disgusts me..
It is an abortion of justice , ethics and human rights..
And the scary thing is.. this is just the beginning..
Outside the Box
Truthman
Be very careful - your interpretation is quite wrong; it is very clear that the UK Government is deciding not to prosecute because the way the law is currently written does not give them the ability to gain a guilty verdict - and they are moving very rapidly to close this gap. What I believe we shall see coming out of the UK is a specific time period beyond the end of a trial that will be allowed before all results must be made known to the regulators. It is highly likely that the legislation will also include mandates to make public all aspects of trials prior to their start, comprehensive public access to results, and very large penalties for any company the infringes. In other words, they won’t make the same mistake and will, as a result, tighten controls on industry.
Unfortunately the multiple examples of pharmaceutical companies mismanaging adverse trial data will result in tighter regulations on the entire industry. We clearly cannot be trusted to act properly ourselves, and so government regulation will force it on us.
www.worldpharmanews.net
Pharmalot » Glaxo Escapes Prosecution Over Paxil In UK…
Glaxo provided the MHRA with data from clinical trials confirming that patients under 18 had a higher risk of suicidal behaviour if they were treated with Paxil, which is known as Seroxat in the UK, than if they received a placebo; and that Seroxat was…
truthman
I don’t see how my interpretation is wrong at all..
And Bob Fiddaman (a seroxat justice campaigner) seems to agree..
http://fiddaman.blogspot.com/
In fact I think if you read all the mainstream media reports, they have come to more or less the same conclusion..
A major tightening of the law governing the oversight of drugs companies will be announced today when the government says GlaxoSmithKline delayed informing the authorities that a controversial drug increased the likelihood of suicide among teenagers.
Primarolo will announce that GSK should have told the MHRA earlier than it did about the results. But GSK will not face criminal prosecutions, she will say, because the legislation in this area is insufficiently clear on whether and when drugs companies should inform the regulator.
truthman
http://www.guardian.co.uk/science/2008/mar/06/medicalresearch.drugspolicy
sorry link..
truthman
Bottom Line..
GSK failed stalled on information on negative seroxat trials indicating Seroxat increased suicidal thoughts ..
The outcome was thousands of kids were damaged, some died..
What other word is there to describe a corporation committing manslaughter than the phrase :”corporate manslaughter” ?
If Ford sold cars with dodgy brakes and people were being killed because of this, and then they were found to have known but not warned, would they get away with it?..
truthman
Glaxo Dodges Prosecution over Seroxat Risk Data
GlaxoSmithKline will not be prosecuted for not informing UK regulators about safety issues concerning its drug Seroxat. The British Medicines and Healthcare products Regulatory Agency has announced that the decision was taken because there was “no realistic prospect of a conviction in this case,” as the legislation at the time, in 2003, was not comprehensive enough to force companies to disclose all of their clinical data to regulators.
http://www.enews20.com/news_Glaxo_Dodges_Prosecution_over_Seroxat_Risk_Data_06348.html
No mater what way you look at it, its corporate manslaughter …
The UK powers are claiming there was was insufficient laws to prosecute, not insufficient evidence..
Personally i feel for the families of the dead children..
I know of one personally..
Please read the story of Sharise Gatchell..
http://www.gevil.netopti.net/
Matthew Holford
Ed wrote:
“…Laws have subsequently been changed to require drugmakers to report adverse reactions in any clinical trial, though these rules don’t apply outside of Europe…”
I’m not sure about that. Any SAEs occuring in trials authorized in the EU must be reported on the European dbase. Also (and this may only apply to EU companies), under Regulation 34 of the Medicines for Human Use (Clinical Trial) Regulations, where a trial is held in the UK, but there are trials of the same drug elsewhere (including the US, presumably - it’s difficult to tell from the wording of the Regulations), then any adverse reactions occurring in the “foreign” trials must also be reported on the European dbase.
Matt
Matthew Holford
Anyway, it’s all very well tightening up the Law, but there’s no trust left in this relationship. None at all. The regulator has refused to answer the most straight forward of questions from campaigners. Its communications have been evasive and it resorts to official stonewalling all too easily.
Speaking personally, I wouldn’t trust the MHRA to police and enforce any new legislation, irrespective of whether it was the best, most tightly drawn ever passed.
Matt
truthman
This talk of implementing new laws is purely for PR purposes..
A prosecution of GSK would have been the only way to restore faith in the MHRA but the UK government knows better than to bite the hand which it feeds off ..
Justice in Michigan
“Such a course of action should be unnecessary in an industry which relies so heavily on public trust and aspires to high ethical standards. I would have thought it self-evident that such information should be made available promptly to the regulator in order that action can be taken to protect public health. However, that moral responsbility now needs to be insisted upon by the unambiguous force of law,”
This comment from Woods to Garnier says it all as far as I am concerned. There are plenty of people in the industry who would fully agree, and who act accordingly. So do many companies. But the bad actors cause bad consequences - for patients and for the industry.
The letter remains naive, however. The “unambiguous force of law” sounds impressive. But it has rarely worked alone as a way to ensure moral responsibility. For those inclined, it will just be another game with which to play cat and mouse. And if the mouse wins, it will be the ‘cost of doing business.’
My own core efforts have involved insuring legal accountability. But I am aware that, in the end, much more is needed.
Aubrey
This is a bad day for science.
Effectively this is government saying that scientific misconduct does not matter.
The MHRA investigation (for what it is worth) also neatly sidesteps many of the most blatant examples of fakery, as well as the corruption of the scientific literature upon which doctors reply.
This is why mandatory reporting (even if it were possible to enforce in this Alice in Wonderland envoronment) is almost meaningless if the literature remains corrupted and corruptible.
In the words of the author Thomas Pynchon:
“If they can get you asking the wrong questions, they don’t have to worry about the answers.”
We play their game when we debate the questions they’re asking. He who sets the ground rules, is bound to win, and winning in this instance means killing people and getting away with it. That way we don’t start asking the wrong questions. Questions about ourselves and about my profession of medicine.
Aubrey
Matthew Holford
Yes, Aubrey: it’s a powerful position to be in, when one gets to say what is true. However, when one begins to ask the “right” questions, one is either stonewalled, or discredited/intimidated (dependent, presumably, upon one’s profile).
You may feel aggrieved for Medicine. I’m not exactly cock-a-hoop for the Law, either. We’ve all contributed, I think.
Matt
Lisa Van S
Nathan,
Looky Here,.. I rest my case!
truthman
Why am i not suprised that Nathan, Bob and Brian from the Pro-pharma disney parade haven’t dared to touch this topic?..
Any comments on GSK Killing kids for profit guys?..