Faulty implants, dodgy drugs and a toothless watchdog that's failing patients
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.
Health Secretary Andrew Lansley criticised clinics for providing 'poor quality' data
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.