Yet more on Ian Hudson and the MHRA

Another old post here about Ian Hudson playing fast and loose with important public health matters – how that man is still in his job in 2012 is beyond me.

Interestingly, I’ve just found this old article from the BMJ, 29 January 2005

Select committee angry over absence of drug regulator from session

London – by Lynn Eaton

Members of the House of Commons select committee on health appeared angry that they were not able to question one of the employees of the United Kingdom’s drug regulatory authority at a session last week looking into the influence of the drug industry.

Although several senior figures from the Medicines and Healthcare Products Regulatory Agency attended the session, the committee said that it would also have liked to have heard evidence from Ian Hudson. Dr Hudson is a member of the agency’s executive board and was worldwide director of safety at SmithKline Beecham from 1999 to 2001, having worked for the company since 1989. Dr Hudson joined the agency’s predecessor, the Medicines Control Agency, in January 2001 as director of the licensing division.

MPs wanted to question Dr Hudson about the company’s drug paroxetine (marketed as Seroxat in Britain and as Paxil in the United States). They were particularly interested in evidence concerning the safety and efficacy of the drug in people under the age of 18. In June 2003 the agency advised doctors that patients aged under 18 should not be prescribed the drug.

Committee members were told that Dr Hudson could not attend the session because he was at a London meeting as a representative of the Committee for Medicinal Products for Human Use, a part of the European Medicines Evaluation Agency.

“It would have been useful if Dr Hudson had been here, as he was at SmithKline Beecham and his department was responsible [for drug safety],” said Mr John Austin (Labour MP for Erith and Thamesmead).

The agency’s chairman, Alasdair Breckenridge, told MPs he had been a member of the scientific committee of SmithKline Beecham from 1992 to 1997, when he resigned. He fiercely defended his involvement with the committee and denied any knowledge of the issue of the safety and efficacy of paroxetine.

The agency’s chief executive, Kent Woods, also giving evidence to the committee, said that Dr Hudson had assured him he had no direct personal involvement in this safety issue. “However, because of his role in the company [SmithKline Beecham] he doesn’t get involved [in discussions on Seroxat],” said Professor Woods.

Speaking after the meeting, the committee’s chairman, David Hinchliffe, who was clearly angry at the committee’s inability to question Dr Hudson, said his understanding was that Dr Hudson was invited to attend.

However, Professor Woods, also speaking afterwards, said that some discussion with the committee secretariat about who would attend had taken place and that the agency had received a clear statement from the committee about whom it wanted to see, which did not include Dr Hudson.

Professor Woods and Professor Breckenridge also sought to reassure the committee that measures were now being taken by the agency to monitor new drugs more closely. Both reiterated the views of earlier witnesses that the public needed a better understanding of the risks and benefits of all drugs.

Professor Breckenridge admitted that the agency had “suffered from not being professional enough” in its communications. “We are determined to change that,” he said, explaining that the agency has just appointed a communications director.
I hope you noticed the paragraph in bold – “Speaking after the meeting, the committee’s chairman, David Hinchliffe, who was clearly angry at the committee’s inability to question Dr Hudson, said his understanding was that Dr Hudson was invited to attend”.

But what I find strange is that if you want to download this PDF – Witnesses for Thursday.pdf – you’ll see that it appears that Lord Warner (then Health Minister) and David Hincliffe had a phone conversation on the Monday morning before the hearing and agreed exactly who was going to attend from the MHRA… and you will see that Ian Hudson is not mentioned as a witness.

I’m confused – who’s lying then – Lord Warner or David Hinchliffe? and why?

I have emailed my concerns to members of the Committee who were there, asking questions that day, but so far I have been ignored – more than once…

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The MHRA, Ian Hudson and the House of Commons

Just to follow on from yesterday’s post about the MHRA and its links to Big Pharma, I thought this might be of interest.

Below is an old post I wrote, specifically about Ian Hudson and the way he avoided giving evidence to the House of Commons select committee – he just didn’t bother to turn up – he said he had a ‘prior engagement’.

How very convenient.

A short while ago, I wrote a post about Dr Ian Hudson. Hudson is currently the MHRA’s Director of Licensing – but the job he had before he joined the agency was at GlaxoSmithKline – he was their Worldwide Director of Safety and we know from his CV that one of the drugs he had “significant involvement with” was, in fact, Seroxat…

In my previous post I bemoaned the fact that Hudson had decided to go elsewhere on the day he was expected to be questioned by the House of Commons Health Select Committee about Seroxat safety and trial data.

The MHRA has been questioned about the secret data that Glaxo kept hidden for more than a decade.

The MHRA replied that they were “confident that neither Professor Breckenridge nor Dr Hudson had prior knowledge of the data discussed in Dr Breggin’s report.”

Does the MHRA really expect us to believe that Glaxo’s Worldwide Director of Safety, who had a “significant involvement in Paroxetine” (Seroxat), did not have full knowledge of ALL the trials and data that appertained to this particular drug?

Does Ian Hudson expect us to believe this?

He was their Worldwide Director of Safety and Seroxat is one of GSK’s biggest ever blockbuster drugs… hmmmm?

This stinks.

The MHRA – still useless after all these years…

For those of you late to the party, the MHRA is supposed to be here to protect patients by licencing and regulating medicines (and medical devices) to make sure they are safe.

Over the years I have followed the work of MHRA (collected posts are here) and I have to say the organisation is useless. It protects nothing but the interests of the pharmaceutical industry. That’s not surprising since the pharmaceutical industry completely funds the licencing and regulation work and many ex big pharma employees now work at the MHRA in very senior positions (Ian Hudson take a bow).

This recent story from the Daily Mail here in England sums up years of MHRA failures.

Faulty implants, dodgy drugs and a toothless watchdog that’s failing patients
By John Naish

Just over two years ago consultant plastic surgeon Azhar Aslam became deeply worried — he’d had to remove eight silicone breast implants from women within a few months of each other because they had ruptured prematurely.

It struck him as highly unusual.

‘If implants do rupture, it is normally after seven to ten years, and it is usually caused by an impact, such as the wearer falling over or having a car accident,’ he says.

 Last week, the Medicines and Healthcare products Regulatory Agency (MHRA) admitted the safety of breast implants was actually impossible for it to judge

‘But these implants had failed after only two to three years, and the patients had not been involved in any impact.’

All the implants were made by the French firm Poly Implant Prothese (PIP).

Mr Aslam, previously an adviser to the European Academy for Cosmetic Surgery, sent some of the ruptured implants back to the manufacturer but was not satisfied with their explanation.

So on July 9, 2010, he wrote to Britain’s medical safety watchdog, the Medicines and Healthcare products Regulatory Agency (MHRA) which regulates and had approved the use of PIP implants.

He alerted Dr Susanne Ludgate, the medical director of devices, to the problem, offering to supply samples of the faulty implants.

Five days later, he received an email saying she’d passed his warning to the agency’s Adverse Incident Centre and they would be in touch.

But he heard not a squeak. ‘No one from the Adverse Incident Centre has ever contacted me. Perhaps they were busy or something,’ he says.

Or perhaps the watchdog was asleep.

For as we now know, more than 40,000 British women have been given these faulty implants.

Behind the furore over whether they should now have their implants removed — and who should pay for it — there is disquiet about the MHRA’s role.

Officially the agency is ‘responsible for ensuring that medicines and medical devices work, and are acceptably safe’. It not only approves these devices and drugs, but regulates them.

The agency’s initial response to fears over the implants was to say the failure rate was only 1 per cent.

Then, last week, the MHRA admitted the safety of breast implants was actually impossible for it to judge, because an accurate record of the number of procedures has not been kept.

Clinics were blamed for this failing, with Health Secretary Andrew Lansley criticising them for providing ‘poor quality’ data.

Mr Aslam lays the blame elsewhere.

‘We rely on the regulatory authorities to ensure our implants are OK,’ he says.

‘And when we try to tell them that something is wrong with the safety-approved implants, these authorities do not seem to take any proper notice. It leaves me asking, “Who can I trust?” ’

Sadly, this is not the first time the agency has been criticised for acting slowly and ineffectually.

In September 2010, for instance, the diabetes drug Avandia was finally banned in Britain after the European Medicines Agency ruled there was a serious risk it could lead to heart attacks or stroke.

Evidence against Avandia had been building since 2007.

And, while denying it had failed to reveal the risks when they showed up, in July 2010 the drug’s maker, GlaxoSmithKline, reportedly paid out £304 million in damages to settle about 10,000 patient lawsuits in the U.S.

However, in the same month an advisory body to the MHRA warned it that the ‘risks (of Avandia) outweigh its benefits, that it no longer has a place on the UK market’ and called for prompt action.

The MHRA did not reveal this warning to the public; it simply passed its information on to European authorities.

A few years earlier, media pressure was required to force the MHRA to act over another prescribed-drug danger. Again, it was a GlaxoSmithKline medicine — the antidepressant Seroxat.

Specialists had been warning for years of the raised risk of suicide in children. But the MHRA, relying on evidence from the manufacturer, issued assurances that there was no suicide link.

 Vioxx was withdrawn from the market in the UK four years ago, but only after a 2004 U.S. study found it doubled the risk of heart disease

Then, in 2003, following two BBC Panorama programmes, the drug watchdog mounted its own investigation and discovered the manufacturer had hidden information about the suicide link.

After this, the MHRA said it wanted to require drug makers to share more information about clinical trials — but admitted that, without stronger legislation in place, there was no chance of prosecuting the company for what it called an ‘ethical lapse’.

The watchdog was not only asleep, it was toothless.

Similar problems arose with the arthritis painkiller Vioxx. This was withdrawn from the market in the UK four years ago, but only after a 2004 U.S. study found it doubled the risk of heart disease. Leading cardiologists had been flagging up the risks for years.

After Vioxx’s withdrawal it emerged that data from clinical trials had been ‘fudged’.

The MHRA launched an investigation into whether its maker, Merck, had correctly reported the side-effects of Vioxx to the authorities.

But government prosecutors decided that there was no realistic prospect of a conviction in this case.

The MHRA says the UK laws requiring disclosure of negative drug trial results have since been tightened. No companies have been prosecuted since then.

Yet it’s not just the agency’s supervision of drugs that raises concerns, but medical devices, too.

These include crucial items such as heart pacemakers.

Last May, the British Medical Journal (BMJ) said not enough was being done to check the safety of medical implants.

It says that in 2009 the MHRA received more than 9,000 reports of ‘adverse incidents’ involving medical devices.

More than 1,880 of these involved serious injury and 202 resulted in death. In one case, a patient’s combined pacemaker/defibrillator misfired more than 30 times in one day, delivering huge jolts of 750 volts direct to his heart.

The BMJ has said our regulators are not ‘fit for purpose’ because of their failure to act in patients’ interests.

It is these sorts of problems that have led experts such as Andrew Herxheimer to call for the MHRA to be subjected to ‘root and branch reform’.

Dr Herxheimer is an emeritus fellow of the UK Cochrane Centre and a world leader in examining clinical trials to see how well therapies work.

One problem, says Herxheimer, is that the agency’s role is shrouded in confusion.

‘Its job description has not been defined,’ he says.

‘In fact, it seems to be acting as a rather secretive negotiating agency between the government and the pharmaceutical industry.

‘It is certainly too close to the pharmaceutical industry,’ adds Herxheimer.

‘There appears to be a revolving door with people who have previously worked in the pharmaceutical industry coming to work inside the MHRA. ’

Accusations have long been made that the watchdog is too close to industrial interests, notably when Ian Hudson, who was worldwide safety director of GlaxoSmithKline until 2001, became director of licensing at the MHRA.

Nor have the agency’s actions helped assuage these kinds of concerns.

Six years ago it had to apologise for misleading the public over the results of a consultation exercise with the medical royal colleges.

It claimed they were in favour of letting a powerful heart drug be sold by High Street chemists without a prescription.

In fact, an investigation by medical journal Drugs and Therapeutics Bulletin found the drug, a statin which can help lower cholesterol, had effectively been rejected by two-thirds of the expert bodies consulted because of fears over side-effects. 

The MHRA apologised and said it had made an ‘administrative error’.

‘This has got to be the killer argument for a massive overhaul of the MHRA,’ said Dr Ike Iheanacho, the journal’s editor.

‘This latest episode totally undermines faith in their decision-making process.’

MPs have also been worried by the agency’s behaviour. In 2005, a highly critical report by the Commons health select committee objected to a lack of openness and the MHRA’s closeness to the pharmaceutical industry.

It warned that scandals on the scale of Vioxx would happen again because the regulators were not sufficiently independent.

In response, the agency said: ‘Since November 2005 all staff and immediate members of their families are not allowed to have any financial or other interests in the pharmaceutical industry.’

But for Paul Flynn, Labour MP for Newport West, this does not go far enough. The problem, he suggests, is that the MHRA is ‘an organisation whose activities are entirely financed by a levy from the pharmaceutical industry’.

A key figure on the health select committee, he remains adamant the MHRA must be reformed or replaced with a more robust body.

As the arguments rage over this issue, breast implant surgeons such as Azhar Aslam and their patients are left stuck in the middle — unsure of who to trust for independent advice.

‘I would like to see the regulations tightened up,’ he says. ‘Otherwise how can I guarantee to women that the implants I am giving them are safe?’

The MHRA says it did respond to Mr Aslam. Mr Aslam and his clinic, the Linia Cosmetic Surgery in London, are adamant that they never received any such response.

[Might I suggest the MHRA publishes a copy if its response to Mr Aslam]

MHRA – too little, too late: once again

I’ve just read the new SSRI Learning Module on the MHRA website – the MHRA says “it’s for medical, nursing and pharmaceutical professions, and is suitable for those nearing the end of their formal training or those who have recently completed such training. Also, health professionals will find the module a helpful refresher, for example, at the start of a posting in clinical psychiatry.”

I was looking forward to reading something that I thought would bring healthcare professionals up to date on the dangers of SSRIs and so position the MHRA firmly on the side of patients.

In reality the learning module reads like something a pharmaceutical company would write – you know, like a more detailed Patient Information Leaflet (the leaflet you get in the box with your tablets). Nothing wrong with that I suppose, except from my experience, the PIL really played down the many strange side effects and horrible withdrawal I endured for almost two years – and as it was written by a drug company – about one of its own products – you would hardly expect otherwise.

An interesting point about the Seroxat PIL, for example, is the way it has ‘developed’ over the years – as GSK has been unable to hide the truth from the public over the years, so it has had to rewrite the PIL – have a look at all the different versions here and compare the very first one with more recent versions.

Blockbuster drugs earn pharmaceutical companies billions and billions in pure profit and so the ‘reputation’ of a drug is carefully built and jealously protected.

The truth doesn’t get a look in.

This can also be true of the clinical trials that the drug companies use to get their licences in the first place – perhaps you didn’t know that the drug trials that don’t produce the ‘right’ results (ie positive) for a drug are simply hidden or the trial is abandoned.

Bad results are buried, as there is no law that says drug companies have to submit the data from ALL the trials they undertook. However some trials are needed to submit with licence applications, so sometimes, as in the case of study 329 for Seroxat, the trial is published but the results are misinterpreted in a way that show the drug, Seroxat in this case, to be safe and very effective, when the opposite was actually true.

Anyway, back to the learning module. As I said it reads like something a pharmaceutical company would have written… And then I noticed this line “…This learning module is derived largely from summaries of product characteristics (which, in turn, are based on rigorous evaluation of submitted evidence)….”

And you know who writes the “…summaries of product characteristics…” don’t you?

And you know who submits the evidence [always positive], don’t you?

And you know who undertakes the rigorous evaluation, don’t you?

I think you may have got there ahead of me – the summaries of product characteristics are written by the Marketing Authorisation Holders, who just happen to be… The drug companies… that make the drugs – that rig the trials – that write the PILs – that hide the negative data – that make the billions.

The truth doesn’t get a look in.

Five years on and the MHRA has made no changes

Below are extracts from The House of Commons Select Committee Report of March 2005 on the The Influence of the Pharmaceutical Industry…

March 2005 – that’s a long time ago and the UK drugs regulator, the MHRA, has made none of the changes recommended.

The Select Committee summed up:

“The MHRA, like many regulatory organisations, is entirely funded by fees from those it regulates. However, unlike many regulators, it competes with other European agencies for fee income… dangers of the present arrangements…. During this long inquiry we became aware of serious weaknesses in the MHRA. Worryingly, in both its written and oral evidence the Agency seemed oblivious to the critical views of outsiders and unable to accept that it had any obvious shortcomings, except those that could be remedied by more transparency. The Agency’s attitude to its public health responsibilities suggested some complacency and a lack of requisite competency, reducing our confidence in its ability to undertake the reforms needed to earn and deserve public trust.

The consequences of lax oversight is that the industry’s influence has expanded and a number of practices have developed which act against the public interest.”

Download the full report here, in the meantime here are a few choice extracts:

Page 4: The industry is by no means solely to blame for the difficulties we describe. The regulators and prescribers are also open to criticism.

Page 8: The industry is hugely influential ….Its influence in Parliament is extensive. The Annex lists the All-Party Groups the pharmaceutical industry supports.

Page 4: The regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), has failed to adequately scrutinise licensing data and its post-marketing surveillance is inadequate. The organisation has been too close to the industry, a closeness underpinned by common policy objectives, agreed processes, frequent contact, consultation and interchange of staff. We are concerned that a rather lax regime is exacerbated by the MHRA’s need to compete with other European regulators for licence application business.

Page 5: The Government, like the MHRA, has tended to assume that all is for the best… In view of the failings of the MHRA, we recommend a fundamental review of the organisation

Page 30: The MHRA is unusual in being one of few European agencies where the operation of the medicines regulatory system is funded entirely by fees derived from services to industry

Page 31: The MHRA relies on company data, presented as a series of detailed assessment reports, in its decision whether or not to licence a drug. Raw data is very rarely analysed.

Page 49: The consent forms do not inform patients that the raw data may be maintained by the industry, not made available to the general public or even reviewed by the regulatory authorities.Much of the criticism was essentially of the lack of transparency and the difficulties for doctors and others in assessing the research which is undertaken.

Page 52: The major impetus for greater transparency with medicines came from a lawsuit brought in August 2004 by the New York State Attorney General against GSK, alleging the company had concealed negative clinical trial results. As part of the settlement, GSK agreed to set up a public register of all clinical trials on all of its drugs.This breached a longstanding
convention, vigorously upheld by the regulators, whereby clinical trial results
were regarded as company property and commercially confidential.

Page 52: Too many problems appear to persist unnoticed or unacknowledged by the organisations that are central to the co-ordination, conduct and review of the clinical trials.

Page 78: The relationship between the industry and the MHRA is naturally close. There are regular interchanges of staff, common policy objectives, agreed processes, shared perspectives and routine contact and consultation. Many of the senior staff of the MHRA have previously worked with the industry …Overwhelmingly, the different parties appeared to speak the same language, with companies determined to observe the letter of the law and the regulators determined to uphold it.

Page 79: Such closeness provides the basis of the trust that the MHRA said it relied on as an integral part of the regulatory process.239 The MHRA Chairman suggested that trust underpinned the stance of the MHRA towards the companies they regulate. We inferred that this extended to the routine acceptance of companies’ summaries of the results of tests on their drugs as true reflections of the raw data on which they were based.

Page 79: Trust is critical in the relationship between regulators and industry. However, at the heart of this inquiry are the concerns of those who believe that the MHRA is too trusting. Trust should be based on robust evidence; …The evidence indicated that the MHRA examined primary (raw) data on drug effects only if it suspected some misrepresentation in the summary data supplied. It was argued that such trust in regulated companies goes too far: reliance on company summaries is neither sufficient nor appropriate, in the absence of effective audit and verification of data that companies provide. …Denial of access to information held by the [MHRA] puts the interests of pharmaceutical companies ahead of those of patients and prescribers. This is particularly indefensible in the light of evidence that regulatory agencies, supposedly established to protect the public, are acquiescing in biased later publication of the information they hold.

Page 79: Regulatory inertia was clearly illustrated through publication of the findings of the UK’s first ever public investigation into a drug safety problem:

Page 82: In setting up the review of SSRI antidepressants, the MHRA/CSM responded to another long-standing concern about regulatory activity: the possible conflicts of interest of regulators.

Page 83: user reports of often serious problems had been systematically discounted or ignored.

Page 85: In evidence to this Committee, Mr Brook expressed concerns about the influence of the industry on drug regulation, specifically the perceived threat by MHRA staff of legal entanglement resulting from regulatory action: …every time we made difficult decisions there was always this issue of: ‘We have got to be very careful because the pharmaceutical companies will sue us if we get this wrong; they will take us to court and take us through legal processes’; and it was very clear that the MRHA officials were very mindful the whole time of that dimension, to my view, more than the dimension of public health and public responsibility of the public.

Page 87: Further concerns, relating to the MHRA’s reliance on company summaries of data, rather than raw data are discussed elsewhere.

Page 96: A statement to the effect that heart problems were associated with Celebrex was issued by the MHRA in December 2004. In the statement, the Agency made it clear that it had not seen the actual data from the drug company but that its advice was based on information from Pfizer’s website.

Page 98: The regulatory authority, which is responsible for controlling much of the behaviour of the industry has significant failings. Lack of transparency has played a major part in allowing failings to continue. The traditional secrecy in the drug regulatory process has insulated regulators from the feedback that would otherwise check, test and stimulate their policies and performance. Failure can be measured by the MHRA’s poor history in recognising drug risks, poor communication and lack of public trust. Regulatory secrecy also underpins publication bias, and other unacceptable practices. The closeness that has developed between regulators and companies has deprived the industry of rigorous quality control and audit.

Page 102: Thirdly, procedures for investigating complaints about breaches of regulations are too slow, poorly enforced and weakly sanctioned.

Page 103: The MHRA does not routinely examine raw data submitted with the licence application but is dependent on summaries provided by the applicant. The Expert Working Group on SSRI’s report of December 2004 showed that summaries of information may not provide the detail required to assess drug risks adequately.

Page 106: The publication of misleading promotional material is a criminal offence and the punishment should befit such a status.

Page 106: The MHRA, like many regulatory organisations, is entirely funded by fees from those it regulates. However, unlike many regulators, it competes with other European agencies for fee income… dangers of the present arrangements….During this long inquiry we became aware of serious weaknesses in the MHRA. Worryingly, in both its written and oral evidence the Agency seemed oblivious to the critical views of outsiders and unable to accept that it had any obvious shortcomings, except those that could be remedied by more transparency. The Agency’s attitude to its public health responsibilities suggested some complacency and a lack of requisite
competency, reducing our confidence in its ability to undertake the reforms needed to earn and deserve public trust.

Page 117: The MHRA should put in place systematic procedures to randomly audit raw data.

BMJ says Avandia should never have been licensed in Britain and should now be withdrawn

Is Glaxo going to get away with it… again?

After the scandal of Seroxat – an unsafe drug with dangerous side effects, that made billions in profit and gained a licence using dodgy data supplied by GlaxoSmithKline, we now have the Avandia scandal: the story of an unsafe drug with dangerous side effects, that made billions in profit and gained a licence using dodgy data supplied by GlaxoSmithKline.

See a pattern forming?

Two days ago, the British Medical Journal (BMJ) said Avandia should never have been licensed in Britain and should now be withdrawn, after medical experts advised that its risks “outweigh its benefits”.

The drug – also known as Rosiglitazone – was approved by the European Medicines Agency ten years ago to help lower blood sugar levels in patients with type two diabetes. However, the BMJ’s investigations editor, Dr Deborah Cohen, said the European drug approval process was not rigorous enough and raised concerns about the quality of data used by Glaxo SmithKline.

The journal said that no new patients should start taking the drug, while those already taking it should consult their GP. It said that those at a higher risk of heart disease should be advised to stop taking it.

But now it has emerged that the Commission on Human Medicines advised the Medicines and Healthcare products Regulatory Agency (MHRA) in July that Avandia “no longer has a place on the UK market” and should be withdrawn, as its risks outweighed its benefits.

The Commission’s advice has been revealed following an investigation by the BMJ in collaboration with the BBC Panorama programme. Dr Yoon Loke, a clinical pharmacologist based at the University of East Anglia, told Panorama that the drug could have caused an extra 1,000 heart attacks and about 600 extra cases of heart failure in the UK last year.

However Professor Donald Singer of the British Pharmacological Society said that patients should not be concerned in the short term. In what appears to be a confused statement he says “These are not acceptable risks in the long term and you scale up in the country, clearly that could lead to many hundreds of people being affected. But from day to day, the actual risk to a given patient is quite small.”

Thanks for clearing that up Donald… ?

Glaxo shares down as agency warns against Avandia

The story below from the London Evening Standard.

It is amazing that this story has the spin that it does… talking about an “…embarrassing blow to [Glaxo’s] reputation…” and explaining how the MHRA “…warned that the heart risks associated with Avandia…”

Hmmm?

What about the patients who have DIED because they took Avandia?

What about the way the MHRA dragged its feet over issuing the warning?

That’s where the real story is. I suggest that you all watch Panorama tonight (Monday 6 September) at 8.30pm BBC1.

Anyway – here’s the story:

GlaxoSmithKline was hit by an embarrassing blow to its reputation today when Britain’s drug regulator said its diabetes medicine Avandia should be pulled from sale because of concerns about its risk to the heart.

The Medicines and Healthcare products Regulatory Agency warned that the heart risks associated with Avandia – which was once Glaxo’s best-selling product and is still used by tens of thousands of Britons meant “it no longer has a place on the UK market”.

Avandia sales peaked at £1.4 billion in 2006, but fell to £771 million last year amid safety fears. Its value would drop off much more rapidly if the MHRA’s warning influences a special meeting the European Medicines Agency – which decides whether drugs should be used by patients in the EU – called to investigate the drug.

The MHRA said it would “robustly” put forward its position on Avandia at the meeting on Wednesday.
The latest concerns came to light after the British Medical Journal found that the Commission on Human Medicines – a group that advises Government ministers – had recommended the withdrawal of Avandia in July. At the time, the British watchdog reacted only by writing to doctors advising them to “consider alternative treatments where appropriate”.

But today fresh fears arose that the drug could be recalled from the market, sending Glaxo shares down 7.5p to 1254p. Analysts had hoped that the Brentford-based drugmaker’s Avandia headaches were over after Glaxo took a record legal charge of £1.57 billion in July, with a significant part going to settling patients’ lawsuits against Avandia.

Panorama, the MHRA, GlaxoSmithKline and… Avandia

Regular readers of this blog will know all about Glaxo, the MHRA and Seroxat.

But Glaxo, bless ’em, clearly don’t feel any shame about the Seroxat scandal, because they went and did it all again with Avandia, their killer diabetes drug… details here

This coming Monday, 6 September at 8.30 pm (in the UK), Panorama is airing its latest programme – all about Avandia:

We’re in the grip of a diabetes epidemic. The NHS spent more than half a billion pounds on medication for it in 2009. Patients trust that these drugs are safe, but does one come with a hidden cost to health? Shelley Jofre investigates the rise and fall of Avandia, until recently one of the UK’s best-selling diabetes drugs, and asks whether the medicine’s regulator is putting the interests of the drugs industry before patients.

You can read ALL about Avandia on this link

Glaxo and the MHRA – a marriage made in heaven? Read more here.

The MHRA and Glaxo’s solicitiors – just how close are they?

There’s some very interesting news at Seroxat Sufferers. Bob Fiddaman has been writing a series of posts about the identities of the expert witnesses that Glaxo are using to defend themselves against the High Court action.

It’s all a bit too cosy and I defy anyone to describe Glaxo’s experts as independent (which they should be under English law).

Anyway, last Friday afternoon Bob noticed some visits to his blog – at 16.37hrs the MHRA looked in and started read the posts about Glaxo’s ‘independent’ witnesses – then 41 seconds later, in what could only be a coincidence of the most massive proportions, you can see Glaxo’s solicitors Addleshaw Goddard, reading the exact same post.

I wonder what the chances are of that happening?

Millions to one, I’d imagine. Or maybe even billions to one….

Unless, of course, there is a connection between the two organisations and they share common interests.

I’d like Addleshaw Goddard to explain this one to me.

The posts are here, here, here and here.

Enjoy.

Glaxo & the MHRA; the MHRA & Glaxo…

I’ve always questioned exactly where big pharma ends and the regulators begin.

Certainly the MHRA (the UK’s medicines watchdog) has always had VERY close ties to the drug industry, and I mean VERY close.

The revolving door that connects the MHRA and GlaxoSmithKline (in particular) has always been well used.

The Chairman of the MHRA, Alasdair Breckenridge, is a former employee of GSK (then known as SmithKline Beecham), as is the Head of Licensing at the MHRA, Dr. Ian Hudson.

Breckenridge has a track record of publically supporting Seroxat (but not really very well!)… Hudson is much more interesting – he worked at SmithKline Beecham for 11 years (Glaxo 2 weeks) as Worldwide Director of Safety. He then joined the MHRA as its Head of Drug Licensing.

During his time at SmithKline Beecham and Glaxo he had “significant involvement” with a number of drugs, especially Paroxetine (Seroxat) and two others. We know this because of this document – Ian Hudson Interests – which he filled in before joined the European Medicines Agency.

I’ve mentioned it before, but Hudson is such an authority on Seroxat that Glaxo actually used him as one of their defence witnesses in the famous Tobin/Schell case (he gave evidence for Glaxo alongside David Wheadon). And to this day we still don’t know if Wheadon was guilty of perjury in that court.

However by 2005, Hudson was not so keen on talking…

A House of Commons Health Select Committee wanted to hear evidence from the MHRA specifically about Seroxat trial data and safety, Professor Alaisdair Breckenridge (MHRA Chairman), Professor Kent Woods (MHRA CEO) and June Raine (MHRA Director of Vigilence and Risk Management) all managed to attend the hearing.

MPs had expected to be able to question Ian Hudson as well… unfortunately Dr Hudson could not attend as he had… a prior engagement.

A prior engagement!? Hudson is the one man who knows more about Seroxat’s secrets than anyone outside of GlaxoSmithKline.

A prior engagement? – don’t make me laugh, Ian.

Now, in 2010 we see more evidence of the revolving door between the MHRA and Glaxo in the company’s choice of expert witnesses to appear in the High Court.

The tireless Bob Fiddaman at Seroxat Sufferers has discovered some very interesting facts about Glaxo’s expert witnesses.

One is Dr. Rashmi Shah is the owner of Rashmi Shah Consultancy Ltd. Shah was employed by the MHRA between 1987 and 2004. Positions held were: Senior Medical Officer, Senior Clinical Assessor and Senior Medical Assessor.

I would be very interested to know 1): who are the current clients of Rashmi Shah Consultancy Ltd and 2): which company was its first client back in 2004…

I’d put money on the answers being – 1): GlaxoSmithKline and 2): GlaxoSmithKline

But this is only the start – Bob Fiddaman is promising revalations about other Glaxo ‘expert witnesses’ in the near future – keep on checking back at Seroxat Sufferers.

You want more evidence of the cosy relationship between the MHRA and Glaxo?

What happened when the MHRA found that Glaxo had hidden negative trial data?… The MHRA announced, in March 2008, that GlaxoSmithKline would not face prosecution for deliberately withholding trial data, which revealed not only that Seroxat was ineffective at treating childhood depression but also that it increased the risk of suicidal behaviour in this patient group. The decision not to prosecute followed a four and a half year investigation and was taken on the grounds that the law at the relevant time was insufficiently clear.”

You want more evidence of the cosy relationship between the MHRA and Glaxo?

How about MHRA staff co-operate with Glaxo to monitor critical comment on the internet..