Rachel Siewert (WA, Australian Greens) Share this | Link to this | Hansard source

As Chair of the Community Affairs References Committee, I present the report on regulatory standards for the approval of medical devices, together with the Hansard record of proceedings and documents presented to the committee.

Ordered that the report be printed.

by leave—I move:

That the Senate take note of the report.

On 16 June 2011, the Senate referred the regulatory standards for the approval of medical devices in Australia to the Senate Community Affairs References Committee for inquiry. The committee received 34 submissions: 18 from industry and industry associations and peak bodies, three from government, two from consumer groups and 11 from affected patients and consumers. We held a public hearing on 27 September 2011.

The committee examined the regulation of medical devices in Australia. This is a complex and evolving area. The committee considered whether the current mechanisms for premarket assessment and postmarket surveillance of medical devices are appropriate for ensuring patient safety. The inquiry was conducted in a dynamic policy and legal environment. It was occurring in parallel with the ongoing implementation of the recommendations of the health technology assessment review and the consideration of the Therapeutic Goods Administration transparency review.

The inquiry also focused on the consumer experience of those approximately 5,500 Australians who have received the DePuy ASR metal-on-metal hip replacement, including total hip replacements and hip resurfacing systems. This was a matter brought to the public attention on 16 May 2011 by the Four Cornersprogram Joint Reaction. That followed other stories around this issue.

The committee heard shocking evidence of patients experiencing devastating health problems as a result of being implanted with either the DePuy ASR hip or the hip resurfacing system. Many witnesses spoke of their repeated surgeries, repeated and extended hospital stays, significant financial loss and major personal and family impacts. Health problems cited included severe pain, loss of mobility and a complex process of both physical and psychological effects due to the shedding of cobalt and chromium irons from the implanted devices. The excessive levels of chromium and cobalt in these patients' bodies have produced symptoms such as bone loss, extensive damage to bone and soft tissues, and hip dislocations. The Department of Health and Ageing notes that excessive levels of these metals can also produce other significant medical complications. One submitter's condition is in fact now terminal.

I will cite only a few quotes from the report, because other members of the committee also want to contribute:

The committee was shocked by the intolerable, and unacceptable, experiences of patients who received the DePuy hip and hip resurfacing system. These very personal experiences—

which we heard—

serve to underline the need for improved pre-market clinical testing and post-market surveillance systems for medical devices, as well as improved timeliness and decisiveness when acting upon the information that is available.

These experiences brought home to the committee that the TGA could have done more in response to the concerns with the device and that Johnson & Johnson Medical did not serve patients well.

The report further states:

It appears to the committee that ASR hip devices were in use after a higher than expected revision rate had been identified. The committee believes that insufficient information was provided to consumers regarding the concerns with the device. This is regrettable.

The committee has made 18 recommendations in the report and these go to improving the regulation of medical devices by the TGA and increasing the rigour of the regulatory assessment of the higher risk medical devices, both before the devices come to market as well as through monitoring and surveillance of these devices post market. The committee has recommended that the HTA review recommendations 8c, 13, 14 and 15 are fully implemented in a timely manner—in other words, the recommendations that have been made from ongoing processes need to be implemented. We recommend investigating whether the increasing number of medical devices on the Australian market is actually improving clinical outcomes and we make a range of other recommendations.

An issue I have not touched on in my comments relates to inducements, which came up during the inquiry. We recommend the need for further work to address the issue of inducements paid by pharmaceutical companies and medical device manufacturers to doctors and teaching hospitals. This issue has been addressed in the United States through the physician payment sunshine provisions of the Patient Protection and Affordable Cure Act of 2009. The definition of inducements should include a commercial interest in a company or device, any cash payments or discounts offered to medical practitioners and any other gifts provided to medical practitioners. As I said, these are just some of the recommendations we made. I believe there was a lot of compelling evidence provided to this inquiry of the trauma and physical impacts that consumers have suffered as a result of receiving some of these hip devices.

I commend the recommendations to the government. I thank committee members and particularly thank, once again, the staff of the Community Affairs References Committee staff and the staff that we borrowed from the Standing Committee on Finance and Public Administration, Christine McDonald and Bu Wilson, who served us extremely well in a both timely and professional manner.

Nick Xenophon (SA, Independent) Share this | Link to this | Hansard source

At the outset I join with the chair of the committee, Senator Siewert, in the remarks she made about the assistance of the secretariat and other support that the committee received. I heartily endorse those remarks on the professionalism of the secretariat in preparing this important report.

This report came to the committee as a result of a referral, a motion I put up in the Senate as a result of being contacted by a number of constituents who have suffered severe, some would say life-threatening, health problems as a result of DePuy hip replacements and joint resurfacing. These are issues that ought not to have occurred in the first place. That is why this report is important. I have added additional comments to this report where I agree with the committee's recommendations but say I believe there ought to be some further rigour in the recommendations in terms of time lines in dealing with these important issues.

Let us put into perspective what is at stake here. We have a watchdog, the Therapeutic Goods Administration, that is supposed to have appropriate processes to deal with medical devices such as this. I believe the watchdog has failed Australian consumers. I believe that the watchdog, the Therapeutic Goods Administration, could have and should have done much better. There was significant evidence given to the committee that points out a failure of process, a failure in dealing with these matters.

Let us put this into perspective in the context of what has occurred here. In the case of the DePuy hip replacements and the joint resurfacing devices, approximately 5,500 Australians have received such devices. Many people who have received these devices have had to undergo multiple revision surgeries. We know that the average surgical revision rate is in the order of 3.5 per cent but the current revision rate for these devices in Australia is 10.2 per cent after five years. We know that independent UK research indicates a failure rate for some of these DePuy devices to be in the order of 49 per cent.

This is made even more tragic by the fact that many of the people who are undergoing these revisions are having severe health effects relatively young. Many of them are in their 40s. The problems caused by these devices relate to the trauma of surgery, the risks inherent with surgery—particularly for older patients—and also cobalt and chromium leeching into patients' systems, into their bodies, from the devices. This has caused a wide range of problems—and the committee heard evidence in relation to this—from depression, memory loss, fatigue and tinnitus to bone necrosis in the affected joint. Many of the patients who gave evidence to the committee stated they were not aware that their health problems stemmed from their devices until they saw the issue raised in the media or they conducted their own research. That shows there is a failure of transparency, and the committee has made some good recommendations in respect of that.

Some also stated that they had problems getting their health practitioner to take them seriously, and I have also been contacted by people who have been faced with similar problems from metal-on-metal devices, indicating that the whole category of device may be problematic.

What is particularly significant is the evidence that the committee heard from the National Joint Replacement Registry. I am very grateful for the work of that registry and for the work of the head of the registry, Professor Stephen Graves, whom I think is eminently qualified and well respected nationally; indeed internationally, given his role internationally in setting up a register for these devices.

I have been questioning the TGA on these issues at estimates hearings for several years and it has been a valuable opportunity to explore this through this committee process. I must say, for those who are listening on NewsRadio and those who are following this, that I think one of the things the Senate does best is the way the committee process works—without political rancour, without any party political basis to it and where the committee as a whole is looking to get to the truth of matters.

While the committee focused on these devices, it is important to remember that they are not the only problem devices and there are systemic issues in the way we deal with these devices. And then there is whether we ought to go to the French system, where you need to show the efficacy, the benefit, of new devices before they are put onto the market and before they get, if you like, government assistance. I believe the TGA has failed in its role as regulator and it is vital that new systems and processes are put in place to adequately protect Australia's health consumers. I believe the TGA's response to the DePuy situation was very poor, as evidenced in the report. In one case, information on the failure of the devices provided by the National Joint Replacement Registry was not examined by the TGA adequately until over a year after it was provided. That is clearly unsatisfactory.

One of the recommendations is to introduce legislation to require medical practitioners to disclose any financial, commercial or other interests they have which are relevant to the treatment of the patient. I will be providing instructions for legislation to be drafted along these lines in the near future if the government declines to do so. We need to have that transparency legislation.

In relation to DePuy devices, it should be pointed out that Dr Roger Oakeshott, one of the orthopaedic surgeons who implanted a number of these devices, did not, according to patients I have spoken to, disclose his commercial interest as one of the co-designers of the device. I think that is clearly unsatisfactory.

It is important that patients are able to give informed consent with regard to these devices. It is important that we have a better system in place. It is important that we have increased regulation of devices, including postmarket monitoring, and overall increased transparency in the operation of the TGA from the health technology assessment review and the Therapeutic Goods Administration transparency review. The fact is that many Australians who have had these DePuy devices implanted are looking at a ticking time bomb in terms of the impacts it can have on their health. At the moment the revision rate is some 10 per cent. If we go anywhere near the UK revision rates, that will be a very significant issue. I commend this report and I look forward to the government acting seriously to deal with a number of fundamental issues of reform.

Claire Moore (Queensland, Australian Labor Party) Share this | Link to this | Hansard source

The TGA is a very important part of the health system in this country. It was developed as part of the Department of Health and Ageing:

… to protect public health and safety by regulating therapeutic goods that are manufactured or supplied in, or exported from, Australia—

as well as aiming—

… to ensure the Australian community has access, within reasonable timeframes, to therapeutic advances.

This is an important responsibility for the organisation and it is absolutely critical that we have in place effective processes to ensure there is genuine trust in the role the TGA plays. Through the process of this inquiry by the Senate Community Affairs References Committee, we have heard that things should be done better. There is no doubt about that. The committee has come up with 18 recommendations and they have a similar theme. As Senator Xenophon and Senator Siewert have said—and as I know Senator Boyce will say, because we were very much in agreement about the process, about the concerns that need to be addressed and about the reasons it is important that we address those concerns—during the evidence we heard that the TGA, by and large, does a very sound job. In fact the AMA said that it served Australia well. Dr Hammett, the head of the TGA, whom we know well through Senate estimates, said:

It is a constant matter of balancing the challenges of regulating the large number of products we regulate. One of the important foundations of how we approach this is that we have an understanding that it does not matter what amount of resources we have; it is not possible to create a completely safe medical device, medicine or medical procedure.

It is important to know that. There can never be absolute guarantees, but we must have a process where we know that the best possible communication, the best possible science and the best possible cooperation has taken place so that we can come up with a sound medical system.

Our committee was shocked and saddened by the information provided to us by people who, in good faith, had received advice from practitioners in this country about a new process for hip implants which, they were told, was going to serve them better. In fact one of the biggest ironies in all of this was that many people had this particular process—the DePuy implant, DePuy being a subsidiary of Johnson and Johnson—because it was going to be the new best process in the medical arena. This was going to be the best way they could be helped. That was based on practice—this particular process had been used and had worked overseas. However, what we have seen—and we have heard some of the figures—is that there are problems with this device. This has come out through information that is fed back through the system, information which tells us there has been too much revision—people having to go back and have more surgery. There have also been way too many other kinds of medical problems caused by this process.

We heard some very sad things and I think the whole committee sends its best wishes to the people and the families who came forward with stories about what was happening in their lives. As Senator Siewert said, one of those patients, whom Senator Xenophon had been working with in South Australia, has a terminal diagnosis. We can never stop that happening, but, when we can see that things can be done better, we as a government, we as a parliament and we as the Australian community must do better.

The 18 recommendations are aimed at trying to ensure that there is much better communication and much better understanding in the process. The community affairs committee had previously inquired into the National Joint Replacement Registry, so we had already heard about some of the issues in terms of the volume of transplantation and the volume of devices available in this country. What we need to have is an assurance that the process works as well it can—that knowledge is being shared and that people are getting the necessary information as quickly as possible so they can then take action quickly.

It must be remembered through all of this that the device in question was actually removed from the Australian market several months earlier than anywhere else in the world, simply because of the pressure that the TGA process had placed on the company. I think, within the overall discussion, that we need to see that. It was not good enough, but nonetheless this process was stopped in Australia a good nine months before it was stopped overseas and I think the Australian move led to the international decision to have this device, which is proven to be dangerous—I think I can go that far—removed from the market.

One of the things that I just wanted to mention briefly—I know Senator Boyce wishes to make a contribution as well—is an issue which came up in this committee's hearings as well as in previous ones: the importance of the relationship between the consumer and the practitioner in any kind of medical process. We found that consumers were not fully informed about the surgical process or about the type of implant they were going to have. We value the concept of informed choice in our medical system, but it did not occur. I think that we as a community need to keep that concept on the agenda—to make sure that every person in this country working with our health system understands as well as they can what is going to happen to them, the options they have and the probable consequences of their decisions. They should not be reliant on a doctor—of any kind, in any place—just telling them what is going to happen and no more. This had happened consistently to the patients who came before us in the committee.

It is important to know that the TGA has been subject to two reviews. The government is working through those. There is a confidence that things can be done better. The government acknowledges that. I again thank all the people who contributed to our committee and shared their lives and their expertise with us to allow the committee system and this process, of which I am very proud, to operate again in this day.

Sue Boyce (Queensland, Liberal Party) Share this | Link to this | Hansard source

I would like to add my thanks to the secretariat of the Senate Community Affairs References Committee, particularly the co-opted members of the secretariat, who were in the main responsible for the production of this report, The regulatory standards for the approval of medical devices in Australia. My thanks go also to the committee members for the amount of effort that went into coming up with a consensus report. I think it is a great feature of the community affairs committee that we very often produce reports that are consensual, because we are looking at issues that we believe affect everyone.

The biggest issue that came out of this report was the complete disconnect between the idea of a hip implant, a hip replacement device, and the needs of health consumers in Australia. The TGA, as Senator Moore has said, dealt perhaps not so promptly but certainly reasonably when they discovered the problems with the DePuy ASR hip replacement devices, but I do not think there was any consideration in that of the effect on patients. It is quite easy to talk about the 'revision' of a hip replacement as though it is something like a piece of paper where you might revise the words that have been written before, but we know in this case that the revision of a hip involves surgery, hospital stays and very large problems for patients.

I would just like to talk about some of the evidence that came out of the submissions of people who have been affected by these hip replacements. Amongst the problems that developed were the need for revision and for other surgery, the need for repeated and extended hospital stays, multiple and extended courses of antibiotics, major personal and family impacts and—in many, many cases—significant financial loss caused by their health problems and the need for other members of the family to care for them. Health problems that were cited by submitters include severe pain, loss of mobility and a complex mix of physical and psychological effects that were due to the shedding of cobalt and chromium ions from the DePuy implanted device. We had evidence from submitters saying that the excessive amounts of cobalt and chromium in their bodies had produced symptoms such as bone loss, extensive damage to bone and soft tissues, hip dislocation, pus coloured fluid and pseudotumours, and depression. And, as has been mentioned by a number of speakers, one person who received a DePuy hip replacement in fact is now in a terminal condition as a result of complications that have developed from that hip replacement. But let us just talk about the straight revision surgery. The symptoms for patients who get to the stage of needing a replacement of the replacement are pain, swelling and problems with walking, which can be on a recurrent or a continuing basis. That is enough of an issue, enough of a productivity problem, surely, and enough of a human problem for us to do better than we do here.

Wearing another hat, I happen to know that for at least 15 years the place and time of manufacture and the path to its final resting place of a septic tank in Australia has been very, very carefully monitored. You can look at any septic tank installed in Australia in the last 15 years and know exactly who made it and when. If we can do that well with a product like that—which I admit could be very unpleasant if it fails as a product and may cause some local environmental damage—surely we can do much better with products that are being put inside patients, not just in terms of the fact that having the revision done causes pain but also in terms of the fact that it is leading to a poisoning of their system.

The other topic I want to very briefly cover whilst I am here is recommendation 18 of our report, which looks at the conflict-of-interest issues regarding surgeons and others involved in perhaps recommending these products without suggesting that there are alternatives and certainly without giving patients the ability to make an informed decision about which implant to have. I think we also need to notice that Johnson and Johnson Medical have agreed to pay $21.4 million as a criminal penalty as part of a deferred prosecution agreement for improper payments by Johnson and Johnson subsidiaries to public healthcare providers in Greece, Poland and Romania, in violation of the Foreign Corrupt Practices Act. This is a US decision. Similarly, the UK Serious Fraud Office obtained a civil recovery order against DePuy International Ltd in recognition of unlawful conduct relating to marketing and the sale of orthopaedic products in Greece between 1998 and 2006.

I find it difficult to believe that, if that sort of behaviour had been going on in Europe, there is not at least the potential that that had also been happening in Australia. We have no direct evidence of that, but there are suggestions by people who have been affected by these hip replacement devices that they certainly were not aware of options and they were not aware that the recommendations to them about having these hip replacements were being made by people who had a direct or indirect financial interest in their accepting that hip replacement. So I think it is important that particularly recommendation 18 be taken up quickly by the government. I seek leave to continue my remarks later.

Leave granted; debate adjourned.

Sitting suspended from 18:30 to 19:30