Johnson & Johnson toxic metal-on-metal hips: trial 'discovery' exposes secrets of scandal

Hip implant maker was alerted to safety fears, as surgeon told them: ‘It borders on unethical to market’

• Edward Malnick Claire Newell Lexi Finnigan  FiDA Highlight

11 APRIL 2017 • 10:00PM  The Telegraph

British patients were fitted with controversial hip implants despite the company behind them being warned by experts that the type of device was unsafe, secret documents reveal.

A senior engineer working for DePuy reported in 1995 that metal-on-metal constructions were “unpredictable” and parts prone to “catastrophic breakdown” five years before DePuy’s hips began to be implanted in Britons.

More than 20,000 patients were later fitted with the implants, which experts say can deposit toxic ions into the bloodstream as they wear. Thousands  were left in agony and had to have costly operations to have them replaced with safer alternatives.

Andrew Selous, a Conservative MP on the Commons health committee,  described the disclosure as “appalling”, saying: “If the company was aware of problems, they should have acted on the precautionary principle.”

A Daily Telegraph investigation today exposes a series of previously unseen memos, reports and emails, obtained from DePuy, that raised questions about the safety of metal-on-metal devices.

Dr Graham Isaac, a senior engineer based in DePuy’s Yorkshire factory, warned in a 1995 report that testing showed metal implants were “working well for a period of time” before wearing down, prompting the “release of a large volume” of debris.

In the same year, a surgeon advising DePuy told the firm that “we need to be cautious of the legal/litigation issues, lawyers etc ... perception of metal debris and metal ion release.” 

More than two decades later, the firm faces thousands of legal claims by patients who say they have suffered as a result of the metal-on-metal joint subsequently produced by DePuy wearing away in their bodies.

The Telegraph’s investigation also reveals how: 

• Senior company figures were told in 2003 that one surgeon had already collected “a lot of bad data about metal-on-metal debris” in patients who had received DePuy implants; 
•  A 2005 report warned that risks to patients of metal-on-metal were “as yet undetermined” but “the risk to DePuy may be major in terms of product liability or business impact”; 
• An internal email in September 2008 acknowledged there were “growing concerns over metal-on-metal hips”. Surgeons needed “a high stability non-metal option”; 
• Tony Nargol, a surgeon based in North Tees, repeatedly told DePuy from around 2008 about problems with its implants but was labelled an “outlier” and told his patients may simply have high volumes of metal in their blood because of a local “water supply problem”; 
• A report commissioned by the company in 2008 about the use of one of DePuy’s first metal-on-metal implants found that tiny particles released from the devices “have killed the bone” and soft tissues around the hip and “resulted in the tendons ripping away”. 

The papers, filed in a US court, include an email from John Irving, a US orthopaedic surgeon, in 2010, forwarded internally to the company’s president, insisting that “it borders on unethical to continue to market” the Pinnacle type of metal-on-metal hips “until the issues are elucidated”. 

The metal ions released have killed the bone and soft tissues around the hip replacement resulting in:

a. Fluid retention often under high pressure causing pain

b. Tendon rupture causing hip dislocation

c. Bone death resulting in fractures around the implant

Excerpt from Investigation into the Performance of the Ultima Metal-on Metal Hip Replacement, East Norfolk and Waveney Research Consortium, 2008

He accused the firm of a “head-in-the-sand response to this problem” and warned that “the products are harming patients” – three years before the implant was eventually discontinued.

DePuy’s Pinnacle implant was first used in the UK in 2002, with the ASR, another metal-on-metal device, released two years later. They were promoted as offering better mobility than devices that used a metal ball and plastic socket.

In his 1995 memo, Dr Isaac, now “distinguished engineering fellow” at the firm, examined data on metal-on-metal hips produced by rival companies. He wrote: “It is clear from the literature the survivorship of cobalt chromium [the materials used in metal implants], metal-on-metal prostheses in the past have been far from satisfactory.

Paul Peters MD: We need to be cautious of the legal/litigation issues and lawyers etc… perception of metal debris and metal-ion release.

Minutes from the first Alternate Bearing Project designing surgeon meeting, May 1995

“Manufacturing methods have improved. However, simulator testing of such components suggests their performance is as unpredictable as ever, working well for a period of time before suffering a sudden catastrophic breakdown of the bearing surface accompanied by a release of a large volume of wear debris.”

He quoted an expert warning that the combination of metal with metal was “likely to give rise to toxic levels of metal under clinical conditions”.

I do not feel DePuy is doing enough to understand the extent of Pinnacle MOM hip disease. I believe it borders on unethical to continue to market the product until the issues are elucidated. These products are harming patients. DePuy needs to contact physicians that have used the product and encourage them to contact their patients for an urgent follow-up. Many of our hips have asymptomatic osteolysis!

Excerpt of letter to DePuy head of US marketing, Paul Berman, from John F Irving MD

The document was part of papers read out in a Texas court, where patients are suing DePuy over the Pinnacle implant. They were passed to the Telegraph by their lawyers. 

Mark Lanier, a lawyer,  said: “These documents show that DePuy knew this hip would fail.”

DePuy’s lawyers have said in court that the company had “always warned about the potential for a tissue reaction in a metal-on-metal device”.

A spokesman said patient safety was its “first priority” and it “acted appropriately and responsibly in the design and testing” of the Pinnacle.

The implant was cleared for sale by national regulators and “is backed by a strong track record of clinical data showing reduced pain and restored mobility for patients suffering from chronic hip pain”.

The spokesman added that the plastic and ceramic alternatives also “wear and produce debris”, and “the body reacts to any foreign material”.

Boz Michalowska Howells, representing more than 300 UK claims, said  it “appeared to be commonly known in the 90s that metal-on-metal hips cause could adverse reactions and it should have rung alarm bells”. 

Metal implants put under scrutiny

• 2002
  
  
  Pinnacle hip implants, including metal-on-metal type, sold in UK by DePuy
  
  
  
  
  
• March 2004
  
  
  DePuy sells its ASR metal-on-metal implants in Britain
  
  
  
  
  
• 2008
  
  
  DePuy aware some metal-on-metal parts for Pinnacle Ultamet “were slightly outside our manufacturing specifications”. Internal investigation finds it would not cause “safety issues”
  
  
  
  
  
• August 2010
  
  
  DePuy recalls its ASR Hip System “after receiving new information from the UK National Joint Registry as part of the company’s ongoing surveillance of post-market data”
  
  
  
  
  
• June 2011
  
  
  US Food and Drug Administration report states that “production capabilities for the Pinnacle metal-on-metal liners and femoral heads at the Leeds facility should be reviewed”
  
  
  
  
  
• June 2012
  
  
  Medicines and Healthcare Products Regulatory Agency guidelines say larger metal-on-metal hip implants should be checked for “life”, not just five years, with tests for metal particles in patients’ blood
  
  
  
  
  
• March 2013
  
  
  DePuy announces “discontinuation” of Pinnacle Ultamet device “because of low clinician use”

NHS in England: Medical device "hospitality" may land doctors in jail.

Jeremy Hunt: NHS bosses face jail over links to drug firms

By Tim Ross,   @TimRossDT  Senior Political Correspondent

10:00PM BST 22 Aug 2015

Senior medical staff will be forced to declare all gifts and hospitality they receive from drug companies or face the sack and the threat of jail.

In a major crackdown on corruption in the NHS, all hospitals and GP groups will be required to keep a register of hospitality and gifts from pharmaceutical firms to health service staff.

Jeremy Hunt, the Health Secretary, says he was forced to act after the Telegraph uncovered “disturbing” evidence of senior NHS managers being paid thousands of pounds and taken on expensive trips by firms lobbying to get their drugs used.

The transparency, or “Sunshine rule”, will be mandatory from next year and any member of staff who fails to declare full details of perks they receive will face disciplinary action.

If they are found guilty of wrongdoing – such as for accepting gifts or luxury foreign trips in exchange for influencing the NHS to buy particular products – they could be prosecuted under the Bribery Act, which can result in unlimited fines and up to 10 years in jail.

The NHS in England buys £7 billion of drugs each year, meaning that the taxpayer-funded health service is a lucrative business opportunity for drug companies and manufacturers of medical devices and equipment.

However, a report from Lord Carter earlier this year found huge variations in the amounts different hospitals pay for particular items –such as latex gloves or syringes - and in the cost and effectiveness of certain treatments, including varieties of replacement hips. This prompted concerns that billions of pounds was being wasted on inefficient systems.

Last month, an undercover investigation by The Telegraph disclosed that senior health staff who help choose drugs for the NHS were paid to work as consultants to pharmaceutical firms keen for the health service to "switch" to their products.

Some NHS managers charged up to £15,000 to organise “advisory board” meetings for drugs companies – often in luxury hotels around the world, the investigation found.

Writing in The Telegraph today, Mr Hunt says it is "shocking" that thousands of sales reps are targeting the NHS. He says he has seen evidence that 65 reps were on site at one hospital at the same time.

Mr Hunt pays tribute to the Telegraph investigation for shedding further light onto the practice and uncovering “disturbing evidence of NHS staff and professionals, alleged to have received payment or hospitality from pharmaceutical firms and medical device manufacturers to influence NHS purchasing decisions.”

A government report by Lord Carter found some hospitals paid 2p for one particular medicine, while one hospital spent £150 on a slightly different variant.

“Even worse, the Telegraph’s investigation suggested that some NHS staff and professionals making these decisions may have been influenced by extravagant hospitality," Mr Hunt says. "It’s hard not to conclude that some sales reps have ben ripping the NHS off, and diverting taxpayers’ money away from patient care.”

The minister says he does not want to stop “sensible” collaboration between private firms and the health service “but we must not tolerate abuse”. Only a tiny minority of staff have been accused of wrongdoing “and the overwhelming majority would be horrified” that drugs and equipment were being bought for any reasons other than that they were best for patients and taxpayers, Mr Hunt says.

The Sunshine rule is based on a similar initiative that was introduced in 2013 in America. The Department of Health said corrupt health staff would face disciplinary action, including the sack, and potentially prosecution which could result in fines or even jail.

The Human Medical Regulations 2012 ban the offering of gifts in connection with the promotion of medicines to anyone who is qualified to supply or prescribe medicines. Convictions under these laws can result in a two year jail term. Acts of bribery or fraud are covered by the Bribery Act 2010 and the Fraud Act 2006. Convictions under the Bribery Act can lead to up to 10 years imprisonment and an unlimited fine.

The Sunshine rule registers will be maintained by NHS hospital trusts, and Clinical Commissioning Groups, which oversee GP services and are responsible for purchasing drugs and equipment.

http://www.telegraph.co.uk/news/health/11818749/Jeremy-Hunt-NHS-bosses-face-jail-over-links-to-drug-firms.html

Regulators favor implant manufacturers over patient safety.

Faulty medical implantsinvestigation: 'A system in disarray that favours manufacturers at the expenseof safety'

By Carl Heneghan     The Telegraph  (FiDA highlight added.

6:55AM BST 23 Oct 2012

 Carl Heneghan is director of the Centre for Evidence-Based Medicine, University of Oxford

In terms of regulation, the role of the European Union is to ensure the highest level of patient safety. But what has been found out by the Telegraph and the BMJ’s investigation now puts this claim in serious doubt.

To put it bluntly, device regulation is in disarray: the evidence requirements at the time of approval are woeful, the conduct of notified bodies is sub-standard, and individuals supposedly representing the regulatory system are conflicted and in many cases under-qualified.

This all means that the system now heavily favours manufacturers at the expense of patient safety.

Notified bodies are organisations authorised to grant a CE mark in the EU. A company is free to select any notified body it sees fit to undertake certification of a new device.

An application for a metal hip should raise significant alarm bells, particularly given the worldwide alerts that exist to its problems. A Google search immediately retrieves “compensation”, “implant failure” and “could cause cancer”. But, in this case it did not raise concerns among eight of the contacted notified bodies.

It gets worse. In the evidence document submitted for application, the device was based on two previous recalled devices and a number of deliberate errors were inserted into the document: tests for corrosion didn’t add up, the hip data showed it wore at a very high rate and the data implied the hip would literally “fall out”.

Basically, it couldn’t be any worse for the device. But some notified bodies seem to want a device to get through at any cost. One said that they would provide a “solution for certification, somehow”.

European regulations state that companies should submit clinical data at the time of device approval, yet this can be as little as an evaluation of the scientific literature. This data is supposed to relate to the “safety, performance, design characteristics and intended purpose of the device”.

The investigation informs us that submitted data can be wrong, refer to previous recalled devices and not demonstrate safety at all. To date, no one adequately knows the make-up of notified bodies, their qualification or their skills.

But in this investigation they were certainly not equipped to deal with this case. Indeed, they had never dealt with a hip implant.

There have been many unsubstantiated reports that companies shop around for the best deal. As the Telegraph/BMJ investigation shows, the notified body does not need to see the device, clinical data can be sub-standard and wrong, the organisation with oversight of the device approval process does not need to reside in Europe, and they certainly do not need relevant skills. And despite all this you can access the European market, for an implantable device, without a single patient ever having received it.

The current situation needs urgent remediable action. At a minimum, and as a quick fix, there should be a requirement for new devices to have published clinical data.

The investigation has revealed appalling loopholes in the current system that could allow defective devices onto the European market. What is needed is transparency.

None of the regulators has a register of approved devices and none of them get to see the submitted data for the device. This can’t be right.

http://www.telegraph.co.uk/health/9626921/Faulty-medical-implants-investigation-A-system-in-disarray-that-favours-manufacturers-at-the-expense-of-safety.html

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Safety or Secrecy: Implanted Medical Devices

New rules to end secrecy oversafety of medical implants

By Laura Donnelly, Health Correspondent, The Telegraph

7:50AM BST 09 Sep 2012  (FiDA blog highlight added)

The changes will mean that for the first time the public will be able to access details of the clinical research behind the products, and their safety record since coming on to the market.

The rules are being drawn up by the European Commission in the wake of the PIP breast implant fiasco and the scandal of metal-on-metal hips, which were found to poison the body and suffer failure rates of up to 50 per cent.

Under the current system, the clinical evidence to support devices, and the records of adverse incidents linked with them are kept behind closed doors.

Manufacturers must share some information with a "nominated body" of their choice, which authorises their products for use, yet it cannot be seen by the public, nor by independent scientists because of draconian European Union regulations.

British regulators run a voluntary system so surgeons can report concerns about medical devices, yet the EU confidentiality rules mean their data is not published, with patients and doctors told nothing - unless the situation deteriorates so badly that a safety alert is issued.

Last December it emerged that more than 40,000 British women received substandard breast implants, made by Poly Implants Protheses (PIP), with some made from industrial silicone, instead of the medical substance which had been authorised.

In January, The Sunday Telegraph disclosed that thousands of Britons had been given metal-on-metal hip implants which were found to poison the body, with some devices having failure rates of up to 50 per cent.

Weeks later, regulators the Medicines and Healthcare products Regulatory Agency (MHRA) issued a warning that 49,000 people with the implants should undergo checks throughout their lifetime and undergo further operations to replace the devices if problems were found.

The new proposals from the European Commission, due to be published within weeks, are expected to recommend that three directives on medical devices, passed during the 1990s, are rewritten.

Under the plans, a duty of confidentiality which is currently placed on all organisations which handle clinical data would be erased, in a bid to make the system more transparent.

The current rules were intended to protect the commercial interests of manufacturing companies, but safety campaigners and regulators believe they have gone too far in putting the interests of business ahead of patient safety.

Professor Sir Kent Woods, chief executive of the MHRA, which has called for the change, said: "The evidence should be out there – so that scientists can look at it, so that patients can look at it and so the public can look at it."

He said it had now become "widely accepted" in the pharmaceutical industry that companies had to make the data from their clinical trials public after drugs were licensed, and that reports of adverse reactions to drugs were documented and published.

Medical devices and implants should follow the same direction, he said.

Because of the single European market, devices used in this country can be manufactured elsewhere, then authorised by a "notified body" in any of the 27 EU member states.

That meant that in the case of the PIP implants, a company in Germany was responsible for the quality of devices produced in France and imported for use in 300,000 women around the world, including Britain.

British regulators the MHRA accredit the six notified bodies which operate in this country and can audit them to check their processes – but have little control over the quality of checks done abroad.

The MHRA has urged the European Commission to change the system, so that accreditation is done by representatives from several countries, in order to ensure that all countries are working to the same standards.

Prof Woods said he felt confident about the expertise of the organisations it inspects but said: "I can't be confident that notified bodies in every one of the 27 countries are working the same way".

He said the rules of a single market in Europe meant it was not possible for British regulators to check all the devices used in this country.

The MHRA is also calling for more rigorous standards to ensure that the clinical evidence to support the application for a licence is more consistently and robustly scrutinised.

The commission is considering how information should be better shared across EU member states, which Prof Woods said could have helped regulators to detect the PIP scandal sooner.

"If we had been able to easily share adverse incident data across Europe I think we would have picked up an increased signal about rupture rates – though not that the filler was fraudulent," he said.

The Commission is also considering whether an "implant card" should be given to all patients who receive an implant, with details of the date, name of device, batch, lot and serial number.

The MHRA said it became clear when problems arose over breast implants and metal-on-metal hip replacements that most patients given implants were not aware what type of device they had.

Sir Bruce Keogh, the Department of Health medical director, is leading a review of cosmetic surgery which is considering whether details of all operations should be held on a central register, to help detect problems with particular types of implants.

FiDA blog comment: 

Tomorrow 9/10/12 the US FDA is conducting a webinar/public meeting on the issue of unique device identifiers UDI's for implanted medical devices.  The US government is liberating a substantial amount of 'big data' from Medicare for research.  Patient harm will be reduced and safe and effective implanted medical devices will be identified so that consumers can make informed decisions.  "Proprietary" information that endangers public health will be exposed.