Saturday, February 23, 2013

UK Drug Regulator [MHRA] Cosy Up to Sir Andrew Witty




be in bed with

Definition - to work with a person or organization, or to be involved with them, in a way which causes other people not to trust you

If further evidence were needed to highlight the British drug regulator's close ties to the pharmaceutical industry, in particular, GlaxoSmithKline, then one needs to look no further than this years MHRA's annual Lecture.



I must confess, I had to do a double-take when I heard and read about this [hat tip to Pharmagossip]

The MHRA are usually good at hiding their sycophantic allegiance to Glaxo but this time they are actually broadcasting the fact. This from the MHRA website:

"The MHRA Annual Lecture is an opportunity to hear from international experts on important themes in the regulation of medicines and medical devices and advances in science and research.

"This year’s lecture, on Monday 11 March 2013, will be given by Sir Andrew Witty, Chief Executive Officer of GlaxoSmithKline and member of the Prime Minister’s Business Advisory Group, who will be offering his industry perspective on the strengths, challenges and opportunities facing the UK life sciences industry."

The message to the general public is clear, at least it is to me.

Glaxo recently were handed down a huge $3 billion fine. They agreed to plead guilty to a whole host of fraudulent charges that was laid against them.

Glaxo admitted guilt for promoting two drugs for unapproved uses and failing to report safety data about a diabetes drug to the Food and Drug Administration, the American version of the MHRA. No safety data was reported to the MHRA either.

The settlement covered criminal fines as well as civil settlements with the federal and state governments.

The case concerns 10 drugs, including Paxil, known in the UK as Seroxat.

Now, this is how perverse the relationship is between Glaxo and the MHRA.

Who better to give a talk to the MHRA than the head honcho of the very same company that admitted guilt to fraud?

I'm actually laughing out loud as I type this.

Let's just look at how the MHRA dealt with the fact that Glaxo, for years, had been lying to them regarding the safety of Seroxat in children.

Here's a recap - Glaxo had sat on information that showed how kids taking Seroxat were at a higher risk of suicidal acts. They also sat on information that showed, in fact, that Seroxat was not effective for treating depression in children and adolescents.

Once the MHRA became aware that they had been kept in the dark about this they decided to investigate Glaxo, an investigation that lasted 4 years - the result of which saw the MHRA publicly tell Glaxo off. "You've been naughty, now don't do it again".

No criminal charges were brought against GSK. Any child that had carried out suicide during this period of suppression from Glaxo was, in my opinion, shown two fingers by the MHRA.

The MHRA let Glaxo off the hook, so much so that the then CEO of Glaxo, JP Garnier, said publicly that Glaxo had done nothing wrong. To hold back information about a drug that can kill children and adolescents is, once again in my opinion, the work of a psychopath.

For years many advocates have been disappointed that Glaxo and other pharmaceutical companies have been allowed to throw money in the direction of plaintiffs in the US. What advocates want is jail time for the top executives at GlaxoSmithKline.

The MHRA, in their investigation, had a golden opportunity to root out the main players in the Seroxat cover-up. They failed on a miserable scale.

After 4 years of trawling through one million documents the MHRA had at their disposal they, through their CEO, Kent Woods, announced, "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."

Thanks for your own personal concern Kent, that really reassure's me and, I guess, the likes of Stephanie Gatchell whose daughter, Sharise, hanged herself just weeks before the MHRA announced Seroxat wasn't safe for kids.

Here's where it gets even more perverse. During the 4 year investigation the MHRA did not interview one single employee of GlaxoSmithKline. What kind of investigation was it?

The MHRA relied solely on the fact that they had never granted a licence for the use of Seroxat in children and adolescents. Job done, they slept better in their beds at night.

However, Seroxat was being prescribed to children and the MHRA knew it. Their answer to this?  Well, the usual cop out. Dr's can prescribe drugs off-label [for unauthorized uses] if they so wish. A few deaths here and there means nothing.

You see, the MHRA have their hands tied. They know drugs are prescribed off-label to children yet they claim they cannot do anything about it. In other words, "It's up to the doctor".

Excuse me?

Let's take a scenario, it may be far fetched but it shows how utterly useless the drug regulatory authority is, furthermore it puts holes in their argument about not being able to intervene with doctor's who wish to prescribe off-label.

If the MHRA granted licence to a drug for adults and indicated that it was not for use in children or adolescents then that's fine. They are, for all intents and purposes, doing their job correctly.

WHAT IF?

Here's the flaw in their argument.

It's 2015 and ThumblyBarmy, a relatively new pharmaceutical company, apply for a licence from the MHRA for a new antidepressant they have produced. They show the MHRA how safe and effective this drug is, let's call it Draxon for the sake of this argument.

Draxon is granted a licence for use in adults.

It's now 2017 and the MHRA, via their adverse reporting system, are aware that Draxon is being prescribed to kids, in fact over 6,000 prescriptions have been dispensed for children since Draxon's release in 2015.

No worries though because the MHRA have already said it's for adults only.

2018 now and the MHRA are inundated with reports of suicide in children and adolescents, so many reports that the public are strongly voicing their opinions about the safety of this drug.

Do the MHRA just shrug their shoulders and say there is nothing they can do, the responsibility is with the prescribing doctor?

In 2019 100 children taking Draxon kill themselves over the period of one weekend. The link to Draxon inducing suicide is proven. Are we expected to believe that the MHRA wouldn't find it in their power to ban the use of this drug?

There's a myth in the UK that Seroxat is banned for use in children, in fact there's a myth that all other SSRi's are banned for use in kids. Truth is, they are not.

The MHRA have issued warnings to doctor's that state that these types of drugs are "not recommended for children and adolescents"

One gain the MHRA will use the get out clause of responsibility that it's the doctor's decision and not their's.

So, Draxon has just saw 100 deaths in one weekend. ThumblyBarmy deny any links to its drug and suicide in children. Are we to believe that a drug regulator would just shrug their shoulders and do nothing? Of course not. The MHRA would immediately act and ban the drug.

In other words, it would take a mass suicide [related to a product] that would make the MHRA act. Do we really need a regulator in place that is of the opinion that isolated suicides related to SSRi use is really, a; of no significance and/or b; not really a concern of theirs?

So, it's 2013. The MHRA, after it's 4 year investigation of Glaxo's suppression of information that could have saved children's lives and after hearing of GlaxoSmithKline's recent admittance that they committed fraud decide to invite the head man at Glaxo, Andrew Witty, to give a lecture.

Sorry Kent but this is akin to the Battered Wives Association inviting Peter Sutcliffe to address an audience.

The MHRA's Chairman, Alasdair Breckenridge, who is apparently resigning this year, was a former employee of GlaxoSmithKline [then SmithKline Beecham]. The MHRA's Head of Licensing, Dr Ian Hudson, is the former World Safety Officer at GlaxoSmithKline.

By the way, neither Breckenridge or Hudson were interviewed during the MHRA's four year investigation into Glaxo.

BBC Panorama have investigated both GlaxoSmithKline and the MHRA. If you haven't watched it yet then I urge you to do so.

The UK needs to call for the MHRA to be disbanded. I, for one, cannot believe that such a band of limp-wristed ignorami are still regulating drugs that UK children take.

Want a better regulator? Rxisk.org is a good place to start.

Andrew Witty will be lecturing for the MHRA on Monday 11 March 2013. Meantime, here's the BBC Panorama documentary, "Taken On Trust". At the time of filming, the MHRA were two years into their investigation of Glaxo. Nothing has changed.










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