Medical Device Scandal in UK: U.S. ?????

EDITOR'S CHOICE

The scandal of medical device regulation

BMJ 2012; 345 doi: http://dx.doi.org/10.1136/bmj.e7180 (Published 24 October 2012)

Cite this as: BMJ 2012;345:e7180    FiDA highlight

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1. Fiona Godlee, editor, BMJ

1. fgodlee@bmj.com

Try describing Europe’s system for regulating medical devices and, as Peter McCulloch says in his editorial this week, the response from your audience will be incredulous (doi:10.1136/bmj.e7126). Read his description and see if you too find yourself asking, “How could this have come about?” It’s a question that now demands urgent remedy. If this was not already clear from recent BMJ investigations (BMJ 2011;342:d2748, BMJ 2012;344:e1410), a new investigation makes it uncontrovertibly so. Working with undercover reporters from the Telegraphnewspaper, the BMJ’s Deborah Cohen has exposed a fragmented, poorly regulated, market driven system, with financial incentives to prioritise manufacturers’ interests over those of patients, and with no requirement for clinical evaluation of a device’s safety or effectiveness (doi:10.1136/bmj.e7090).

Armed with a fictitious hip implant modelled on one that was recalled on safety grounds in 2010, the reporters approached 14 of the 78 “notified bodies” to which the European Union delegates the job of certifying medical devices. The one to which they eventually submitted their glossy dossier was happy with the design and confirmed that it would approve the device subject to manufacturing documents and a factory visit.

Why did we decide to work with the Telegraph on this “secret shopping” exercise? Firstly, there was a clear and pressing public interest. Secondly, we took the view that the information could not have been obtained by other means. Thirdly, we were reassured by the fact that the BMJ has successfully used fake information to test various systems in the past. As part of a randomised trial published in 1998 (JAMA1998;280:237-40), we sent out for peer review hundreds of copies of a research paper into which we had inserted errors. The reviewers were not told that the paper was a fake. For this study, as with the fictitious hip implant, we obtained approval for our plans from the BMJ’s ethics committee.

More famously, in 1868, the BMJ’s then editor Ernest Hart placed a newspaper advertisement in which he posed as a father seeking a foster mother for his illegitimate child. His aim was to expose the notorious Victorian practice of baby farming, in which unwanted infants were taken in to be nursed in exchange for payment, but were instead neglected and often killed. The advertisement received 333 replies and sparked a series of articles calling for reform (BMJ 28 March 1868, 301-2). According to the historian Peter Bartrip, the journal’s influence was crucial in achieving legislation.

If the latest undercover operation has similar effect, we will consider the means worthy of the end. Because legislation is what is now urgently needed to protect patients. McCulloch says this must go beyond the tinkering reforms proposed by the EU. Instead, he calls for a system of provisional licensing in which devices could only be marketed if they were being used within clinical studies of their safety and effectiveness. Whatever new system is proposed, he is right to say that it must have patient safety, not trade, at its heart.

Notes

Cite this as: BMJ 2012;345:e7180

Footnotes

• Follow BMJ Editor Fiona Godlee on Twitter @fgodlee and the BMJ@bmj_latest

Found this in the mouse maze! Patient last to know.

 Being a patient advocate is like running in a maze designed to disorient and exclude.

Regina Holliday (patient advocate, artist) painted this while attending the PCORI patient-engagement workshop in DC today.  It is unreasonable of PCORI/FDA to expect any patient or advocate to demonstrate more tenacity or willingness to work productively.  This system is rigged.  I await my invitation to the December 4 PCORI meeting.

FDA PushesDevice Surveillance Plan That Could Involve PCORI; Off-Label, Data Access Debated

Posted: September 11, 2012  (FiDA highlight)

FDA device officials are pushing for a national postmarket surveillance monitoring system that emphasizes Unique Device Identifiers and their incorporation into electronic health records, device registries, modernized adverse event reporting and new methods to analyze postmarket information, laying out the plan in a paper released late last week and discussed at a public meeting Monday (Sept. 10). The head of the health law's comparative effectiveness institute expressed interest in participating in the initiative, which FDA hopes will extend beyond the agency.

Stakeholders also debated potential governance structures, eventually floating a public-private partnership. When pressed on the role the health law's Patient-Centered Outcomes Research Institute could play, PCORI Executive Director Joe Selby said he is particularly interested in involving patients and contributing analytic methods. “We’d be glad to be party to discussions like that,” he told and FDA official during the meeting. He said, however, there should be a business case made to each party, and it is more challenging to make the case for patients and health systems.

While industry, consumer and academic stakeholders lauded FDA’s effort, concerns emerged about off-label uses and access to the data, given issues with patient protections and company proprietary concerns. “The key is going to be implementation,” said Paul Brown, government relations manager with the National Research Center for Women and Families. He cited examples in the report that spurred concerns about the potential to incentivize off-label use as the data collected through postmarket surveillance could support new indications.

“Analysis of de-identified EHR data containing a unique device identifier demonstrates that within the practice of medicine, physicians have been treating patients with incontinence due to other causes -- and the data demonstrates the device is as effective as it is in patients with incontinence due to prostate surgery,” according to an example comparing potential future uses of the system to the current state where manufacturers must conduct clinical trials to expand labeled indications. “The company submits the analysis and (the Center for Devices and Radiological Health) approves an expansion of the labeled indication solely on the basis of the collected postmarket data.”

Brown warned that, depending on implementation, the system could provide an incentive for companies not to conduct clinical trials and potentially exacerbate problems with off-label promotion. Another device safety advocate, however, said using the postmarket data would allow for a real-world analysis of devices as many risks are unknown until products are available to a broader patient population.

Brown also took issue with FDA suggestions that postmarket data could be used in support of device down classifications, saying such information should also be used to support up classification if appropriate. Further, he said FDA should have access to information in registries to detect safety signals, an issue that also emerged as academic and industry stakeholders debated who would have access to the device data as it could affect hospitals and individual practitioners. Industry stakeholders also expressed concern that the system should not try to be “all things to all people.”

FDA device center director Jeffrey Shuren emphasized that the agency would leverage national and international registries, as opposed to creating a registry repository.

“Let me be clear, we don’t need registries for every type of medical device nor is it feasible or sustainable to do so,” he said. “And we don’t want to develop a central repository.” Individual repositories should remain such as it helps protect patient privacy, he said.

Thomas Gross, director of the device center’s office of surveillance and biometrics, said the agency has already facilitated the development of dozens of registries. With regard to modernizing adverse event reporting, Gross touted the use of triggers in electronic health records to automate the reporting and a medical app that is being piloted.

FDA device officials said they hope to release a finalized version of the plan by the end of the year. -- Alaina Busch (abusch@iwpnews.com)

PCORI webcast today & Sunday October 27,28

PCORI   Patient Centered Outcomes Research Institute

Watch a live webcast of the patient-engagement workshop plenary session “Transforming Patient-Centered Research: Building Partnerships and Promising Models”:


Saturday, October 27, 8:30 a.m.-11:00 a.m. ET


Sunday, October 28, 8:00 a.m.-12:30 p.m. ET
 

Join the conversation on Twitter by following @PCORI and using the #PCORI hashtag during the workshop.


Provide feedback to PCORI on the workshop topics by email to GetInvolved@pcori.org. Feedback received will be considered as PCORI develops a report on the workshop

I will be watching the webcast although I applied to participate in person.   It is important to our community of patients with failed implanted devices that we are represented and participate in the discussion.

Workshop participants will help PCORI establish procedures for identifying research questions, reviewing research proposals for funding, and ensuring patient participation throughout the research process. It is the first in a series of workshops aimed at bringing PCORI’s vision for patient and stakeholder engagement to life.

The workshop’s five topics:

1.             Identifying and Selecting Research Questions

2.            Reviewing Research Proposals for Funding

3.            Matching Patients and Stakeholders with Researchers

4.            Disseminating Research to the Community

5.             Evaluating PCORI’s Patient and Stakeholder Engagement Programs

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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What is torture? What is criminal? Australian women sue J&J.

ABC News 7.30 Australia
Click on the link and watch this short news video. It is essential to understanding the story below.

Johnson & Johnson facing massive class action

10/15/2012 By Matt Wordsworth   ABC News 7.30 Australia (FiDA highlight added.)

Medical giant Johnson & Johnson is facing its third class action in Australia in as many years.

The case filed in the Federal Court yesterday relates to a product called transvaginal mesh.

It has helped many women who have suffered prolapsed organs by assisting their muscles with support, but for a significant number it has caused life-changing harm.

Lawyers believe it could be the largest product class action in Australian legal history.

It has also cast fresh light on the system of approvals because the mesh was introduced without any pre-market testing, with surgeons leading the call for change.

When Julie Davis was younger she had a plan to travel the world, meet the man of her dreams and settle down to have a family.

She succeeded, but along the way she endured a traumatic birth and some terrible consequences.

"I'd had a very bad forceps delivery with my first child who's now 10 and I had to wait until all my children were born to fix a very significant bladder prolapse," Ms Davis said.

"From my understanding it was the worst kind of prolapse because the bladder was actually outside my body."

It is a common problem, but there was a relatively new product to Australia - transvaginal mesh - that could be stitched in near the top of the vagina to help the pelvic floor muscles support the internal organs, much like a sling.

"The surgery itself was way more traumatic and devastating than I had imagined," Ms Davis said.

"I just felt unwell all the time, I was in pain, a lot pain, discomfort down below. I also had this feeling - lack of energy, like my body was fighting something all the time."

While her husband shouldered the load of earning an income and running the household, Julie, who was only in her 40s, was forced to use a mobility scooter.

For her, walking was painful, so too was sex, and the emotional toll was almost too much.

"It did get to the point where I just actually was chronically depressed and I had to go to see a GP and go on antidepressants," she said.

"There was one point [when] I was driving my car and I was just thinking, 'jeez, it would be easy just to turn the wheel at Curl Curl headland and just go off' because I felt that desperate."

'Adverse events'

It was after this that Ms Davis sought out a new surgeon, urogynaecologist Richard Reid.

He says the mesh was acting like a cheese grater in her body and had literally rubbed a hole in the wall of her vagina.

"When the mesh is put underneath the bladder, the bladder moves back and forth as it fills and it moves back and forth during intercourse," Dr Reid said.

"Because mesh scar is fundamentally quite fibrous and the bladder is very soft, we call this compliance mismatch, which means the same as rubbing a piece of cheese over a metal grater; the metal grater is obviously harder than the cheese."

Research published last May in the New England Journal of Medicine found mesh kits had "higher short-term rates of successful treatment" but also "higher rates of surgical complications and post-operative adverse events".

Two months later, in July 2011, the Food and Drug Administration (FDA) in the United States issued a formal warning saying they were a "greater risk" with "no evidence of greater clinical benefit".

Johnson & Johnson removed its product from sale earlier this year and class actions are already underway in America and Canada, and now Australia.

Rebecca Jancauskas, who is representing Ms Davis as the lead plaintiff in the class action, estimates as many as 20,000 Australian women may have had transvaginal mesh implanted, and that is despite the product having undergone no clinical trials.

"This prolapse mesh class action that we've commenced in the Federal Court today has the potential to be the biggest product class action that Australia has ever seen," Ms Jancauskas said.

Certain classes of medical devices may be sold without adequate testing if they are going to be used in a similar way to existing products.

Mesh kits had already been very successful in treating urinary incontinence, an area where there is not the same friction from internal organs.

"So the system was set up and the device companies have used the system," Dr Reid said.

"I think that with the wisdom of hindsight, it would have been more prudent for them to have done more testing before it was released, but in many I see the primary fault is the system didn't think out what was going to happen."

Previous class action

It is not the first legal trouble for Johnson & Johnson in Australia.

Last year a class action was launched over its DePuy hip replacement device which left hundreds of patients poisoned and seriously disabled.

In 2010 the company faced similar legal proceedings over its knee replacement products.

Just like the mesh kits, neither product had undergone pre-market clinical trials.

"Given that this is now the third product class action that Johnson & Johnson has faced in three years, it should raise some serious concerns about their product safety standards," Ms Jancauskas said.

The company has issued a statement saying:

Johnson & Johnson Medical continues to have confidence in the safety and efficacy of these products.

The decision to discontinue these products was based on their commercial viability in light of changing market dynamics, and is not related to safety or efficacy.

This is not a product recall, and based on this notification it is not necessary for women who have received one of these products to take any action.

For more than a decade, our organisation has invested in the research, development and clinical study of products to treat a wide range of pelvic disorders.

We remain committed to advancing the standard of care for women's health and will continue to offer safe and effective treatment options for women.

Some are angry at the Australian regulator, the Therapeutic Goods Administration (TGA).

Senator Nick Xenophon, who was part of a parliamentary inquiry into the hip devices, says he is concerned that similar problems are still happening.

"Well this is another instance of regulatory failure. The TGA is meant to be a watchdog of these devices but it's failed time and time again," Senator Xenophon said.

"This is the third serious instance in the last 12 months. After the problems with hip replacements, breast implants and now this, [it] indicates there are some serious systemic problems with the TGA."

And while America's FDA issued its warning to consumers last year, there has been no such move from the TGA.

In a statement, it explained that it held a detailed review in 2010 and found the complication rate was low and depended on the skill of the surgeon, but that it would continue to monitor the situation.

Ms Davis says "it's been a tough road" and she has now had her mesh surgically removed.

She and husband Tim are desperately hoping that after four years and five surgeries, there is something to look forward to.

"I hope that we're over the hill now and start rebuilding our lives again in the way that we planned to begin with," Mr Davis said.

"We had great plans and great ideas of how we wanted to build our life, with the children et cetera, and I feel that life has been running away from us and we haven't been able to sit back and enjoy some of it."

Statement from the TGA in response to  ABC News 7.30 (Australia) - go to link above, please.