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…


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]

Diagnostic and Statistical Manual of Mental Disorders: DSM-V on its way… but how much can we trust it?

The American Psychiatric Association (APA) is a very powerful body that has, since 1952, produced various versions of the Diagnostic and Statistical Manual of Mental Disorders – and the fifth edition is on its way.

The DSM is published by the American Psychiatric Association and provides a common language and standard criteria for the classification of mental disorders. It is used in the United States of America and in varying degrees around the world, by clinicians, researchers, psychiatric drug regulation agencies, health insurance companies, pharmaceutical companies, and policy makers. There have been five revisions since it was first published in 1952, gradually including more mental disorders, although some have been removed and are no longer considered to be mental disorders, most notably homosexuality.

In 1952, the manual was 130 pages long and listed 106 mental disorders… by 1994, DSM-IV was listing 297 disorders in 886 pages.

It has been alleged that the way the categories of the DSM are structured, as well as the substantial expansion of the number of categories, are representative of an increasing medicalisation of human nature, which may be attributed to disease mongering by pharmaceutical companies and psychiatrists, whose influence has dramatically grown in recent decades. Of the authors who selected and defined the DSM-IV psychiatric disorders, roughly half had had financial relationships with the pharmaceutical industry at one time, raising the prospect of a direct conflict of interest.

In the past, I have written about the DSM and I’m not a fan of what I consider to be a deeply flawed publication, whose main reason to exist seems to be to enable drug companies to sell more drugs for newly diagnosed ‘disorders’. It’s just another part of the modern marketing mix.

But I had better be careful what I write, as the APA jealously guards its property – see here.

And the APA itself isn’t really whiter than white – In 2008 it became a focus of congressional investigations regarding the way that money from the pharmaceutical industry can shape the practices of nonprofit organizations that purport to be independent in their viewpoints and actions.

The drug industry accounted in 2006 for about 30 percent of the association’s $62.5 million in financing, half through drug advertisements in its journals and meeting exhibits, and the other half sponsoring fellowships, conferences and industry symposiums at its annual meeting.

A recent APA president, Alan Schatzberg, came under fire after it came to light that he was principal investigator on a federal study into a drug being developed by Corcept Therapeutics, a company Schatzberg had himself set up and in which he had several millions of dollars’ worth of stock.

It’s all just a little bit too cosy, I reckon.


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