Steve Irons (Swan, Liberal Party) Share this | Link to this | Hansard source

I am pleased to speak on the House of Representatives Standing Committee’s roundtable forum held on impotence medications in Australia. I thank the member for Hindmarsh, the chair of this committee, for his interest in the subject and of course the secretariat for their fantastic contribution on the organisation of the day and on the day. I was hoping to see the member for Kingston here but, as we chaired and held the roundtable together, I will wait until the member arrives and congratulate her on her contribution on the day.

I have touched on the need for men with erectile dysfunction to contact their GPs to ensure they seek assistance from their GPs, instead of from the commercial sector via telephone. The main reason for this is that erectile dysfunction can be an indicator for other health problems that a phone conversation might not pick up.

The second issue I want to discuss relates to a practice known as compounding, which is undertaken by the company AMI. I do not know of other companies in the industry, but AMI were the only company which were prepared to come forward and contribute to the forum and I do thank them for that. Under the Therapeutic Goods Act 1989 it is an offence to import, export, manufacture or supply a therapeutic good, unless it is included in the Australian Register of Therapeutic Goods. Medicines on the Australian Register of Therapeutic Goods are subject to clinical tests and controls. There are a number of exceptions relating to this law, including the production and sale of compounded medicines which are prescribed by AMI to treat erectile dysfunction.

The report describes compounded medicines as one-off products made for an individual patient from raw ingredients. Section 2.44 notes:

The committee questioned the Pharmaceutical Society of Australia (PSA) about the need for and practice of compounding within pharmacies. The PSA indicated that the original purpose of compounding was to allow doctor to prescribe and pharmacists to provide treatment to a patient when no suitable alternative existed.

AMI’s use of compounding prescriptions attracted some criticism during the roundtable. A number of witnesses questioned how effective AMI products are at treating erectile dysfunction. A review of compounding by the Therapeutic Goods Association in 2005 led to proposals to better regulate the use of compounding. The committee noted:

The committee supports the need for an exemption for compounding from the TG Act for truly unique preparations when no other suitable products are on the market. However, it appears to the committee that the volume of compounded drugs prescribed by AMI goes beyond the justification for exemption. The committee believes that the NCCTG proposed recommendations are a sensible approach to strengthening the regulations around compounding, and therefore supports their development and speedy implementation.

I agree with these sentiments and impress upon the House the need to keep a watchful eye on how this situation progresses.

This was an important roundtable which raised some very important questions about erectile dysfunction in Australia. Members should encourage their constituents to visit their GP before going to the commercial sector and we must all take some responsibility for better oversight of the industry.

We took some evidence after the roundtable—it was in camera—from a very brave man who spoke to us about his experience with the commercial sector, how he had moved on from that experience and how he had managed with the help and assistance of his family and friends to see a traditional GP. He was referred to an organisation that specialises in these problems and managed to get a proper physical. It was great that the outcome for this man, after his long and traumatic experience in the commercial sector, was a positive one. I would continue to encourage people—as the committee does in the report—who are experiencing these problems to see their traditional GP because erectile dysfunction is a definite indicator of other problems that could occur. It is well known that it can be a precursor to heart problems two years ahead. It is important that we encourage GPs as well to make sure that when men come to see them that there is something like a notice on the wall saying, ‘If you are experiencing ED problems, don’t be afraid to speak to me about it.’ We also talked about the possibility that a GP’s secretary—so as not to embarrass them in the clinic—could hand them a little note saying that if they are experiencing problems they should be forthcoming about those problems with their GP and get the full benefit of a proper consultation with their GP.

It is great to see the member for Kingston here. I would particularly like to applaud her for her part in the work that we did together as a team on the day of the roundtable. It was an enlightening experience working with her, and her, I could say, medical background was particularly helpful on the day. I look forward to working with the member for Kingston in the future on other health and ageing committee roundtables. I particularly look forward to the tabling of this report.

In conclusion, I would again remind all members to encourage their constituents to visit their GP before going to the commercial sector, and we must all take some responsibility for better oversight of the industry. I commend the report to the House and look forward to the contributions from the members for Kingston and Shortland.

Amanda Rishworth (Kingston, Australian Labor Party) Share this | Link to this | Hansard source

At the outset, I would like to commend the member for Swan. During the roundtable we had a number of witnesses. He was in the chair at the time and did a sterling job of keeping the meeting on track while still allowing everyone to have their say. It was a lengthy experience—I think the roundtable lasted around four to five hours—but it was critical to ensure that we got everyone’s views on a range of areas.

From the outset I would like to acknowledge that male impotence, erectile dysfunction and premature ejaculation are sensitive and inherently private issues. However, as sensitive as they may be, my experience as a psychologist before coming to this place and as part of the subcommittee that prepared the Treating impotence: roundtable forum on impotence medications in Australia report, informed my opinion that the secrecy and embarrassment associated with this mainstream health issue are in fact part of a wider problem that needs to be addressed.

The comments and findings of the Treating impotence report are connected with the issue of men’s interaction with the health system and the larger issue of men coming to terms with the health needs and vulnerabilities which are specific to them. On this note, it is encouraging to see that Australian men are in the process of facing up to these issues. This trend can be seen most visibly through the popularity of Movember. We have certainly seen a number of moes around this place—some of them are going better than others. This has increased the visibility of organisations such as beyondblue and really brought to the forefront some of the issues that men face. However, despite the important work done in raising awareness and decreasing the stigma associated with men’s health, as a society we clearly have a long way to go.

The Treating impotence report and the roundtable forum upon which it is based came about after several members of the Standing Committee on Health and Aging were approached by men in their electorates with complaints about the erectile dysfunction treatment they were receiving. The main grievance these men had related to the contracts they had entered into with commercial dysfunction clinics, which they allege could only be cancelled under specific conditions. Being aware of the interrelation between these grievances and the impact that commercial ED clinics are having on men’s health more generally, the committee decided to hold a public hearing in the form of a single round-table forum, gathering interested individuals and organisations to discuss issues and potential solutions.

The roundtable was held on 21 August 2009 and benefited significantly from the participation of representatives of Andrology Australia, the Freemasons Foundation Centre for Men’s Health, Impotence Australia, Medicines Australia, the Pharmaceutical Society of Australia, the Chapter of Sexual Health Medicine of the Royal Australasian College of Physicians, the Royal Australian College of General Practitioners, SHine SA, the Therapeutic Goods Administration and the Urological Society of Australia and New Zealand, as well as Patricia Weerakoon, coordinator of the graduate program in sexual health at the University of Sydney. In addition, the roundtable was enhanced by the participation of the Advanced Medical Institute, more commonly known as AMI, the largest and probably most prominent commercial provider of ED clinics in Australia. In particular I would like to thank them for their input into the committee. The committee received evidence from an additional 15 submissions and heard in-camera evidence from one patient of a commercial ED clinic.

Leaving the issues surrounding the contractual and advertising practices of commercial ED clinics to one side, the report is structured in four main themes and I would like to address each of them. First is the extent of men’s interaction with the health system. Second is the appropriateness of using telemedicine as a first option for prescribing. Third is the adequacy of regulations governing the sale of ED medications. Fourth is the interaction of commercial ED clinics with the proposed e-health records system.

As I have already indicated, the effective treatment of ED in Australia is closely linked with the interaction of Australian men with the health system. On a positive note, the committee did hear evidence that in 2003 the Men in Australia telephone survey run by Andrology Australia suggested that 90 per cent of men aged over 40 visited a GP once a year. This same survey also found that 80 per cent of men were concerned about developing ED. So the evidence does suggest that men are seeing doctors; however, they may not necessarily be talking about the common issue of ED. The committee also received evidence that, despite this increasing engagement with the health system and evidence that ED is an issue of concern, men do remain selective about what they discuss with their GP. It was suggested that reasons for this guarded attitude include both patient embarrassment as well as discomfort on the part of doctors who remained uncomfortable with discussing sexual health issues with their patients.

Whatever the exact cause, the demand for commercial ED clinics suggests that when it comes to issues of erectile dysfunction, men are not turning to their GPs as the first point of contact and as a consequence are not receiving the holistic advice and treatment that they need. Instead, they are taking advantage of the anonymous waiting rooms and telemedicine solutions offered by commercial ED clinics. In bypassing GPs these men are bypassing the gatekeepers of our health system. This bypassing of GPs is a major concern not only for individual patients but also for the health system more generally.

The report correctly notes that GPs are ideally placed to assess the totality of their patients’ needs and have the ability to refer patients to specialists where necessary. An important function of a general practitioner is also to encourage their patients to adopt preventive health strategies. The concern of the committee is that men accessing commercial ED clinics may not be getting the holistic health care advice that they need. Importantly, the committee heard recent evidence which indicates that ED is an early marker for underlying conditions such as cardiovascular disease and diabetes. The danger is that in bypassing the conventional gatekeepers and treating ED in isolation and secrecy, these men might be missing out on important health advice and treatment.

The report expresses the view that a targeted public health campaign is needed to better inform men about the underlying conditions for which ED may be an early marker. In light of my earlier comments about the current momentum towards men embracing their health vulnerabilities, a successful public campaign could be very important to meet this issue. As the government has recently set up the Australian National Preventive Health Agency, this could be one issue to be looked at.

I also wanted to talk about the appropriateness of using telemedicine as a first option for prescribing. This was the second theme around which the report is structured. Telemedicine refers to the practice of using technology such as telephones and videoconferencing, reflecting the demand for patients to remain anonymous to both doctors and pharmacists. The committee heard that 50 per cent of AMI’s current patient load is treated using telemedicine.

Several major concerns relating to the practice of telemedicine are raised in the report. Most obvious is the reality that many patients receiving ED treatment using telemedicine will not have a face-to-face consultation with their medical practitioner. Without such consultations it is difficult for doctors to detect and manage lifestyle factors associated with ED. Other concerns include the fact that many patients are not aware of who their doctor actually is on the other end of the telephone, and the lack of continuity of care for a patient when follow-ups are not undertaken by the original doctor. The roundtable heard evidence that when a patient decides that this treatment has not worked and decides to visit a conventional medical practice, their doctor will be unable to gain access to the patient’s treatment or medical history directly by contacting the commercial ED clinics. In fact, the evidence presented, which was of great concern to me, is that if a doctor did want to find out the medication that their patient was actually being treated with they would need to write to the CEO in order to access this information. This is a concern because the ED clinics are not necessarily prescribing globally recognised first-line treatments for ED, so the GPs and some of the witnesses said it was very important for them to get that information considering that patients may not be receiving globally recognised first-line treatments.

There was also concern raised that the narrow approach taken by commercial ED clinics may not take into account mental health implications for patients. We did receive evidence that when these narrow ED clinic treatments had failed patients thought that they had been left with ED for the rest of their lives. This is a confronting and completely unnecessary state of affairs in a country with a highly advanced health system. This was also an issue of concern to the committee.

The third theme that was addressed in the report is the adequacy of regulations to govern the sale of ED medications. The Therapeutic Goods Act 1989 regulates therapeutic goods in Australia. This act makes it an offence to import, export, manufacture or supply therapeutic devices or medication unless it is included in the Australian Register of Therapeutic Goods. There remains an exception, however, whereby medical practitioners can prescribe compounded medications for their own patients. These compounded medications are designed to be one-off products made by a pharmacy for an individual, using ingredients that may or may not have already been assessed by the Therapeutic Goods Administration. The exemption is designed to allow doctors to prescribe medication to patients where no suitable alternative exists.

The committee heard evidence that ED clinics are using this compounding exemption to prescribe a significant number of patients with individual compounded treatments. They heard evidence that the Australian Custom Pharmaceuticals has created 15 million individually compounded medications for AMI alone. This is occurring despite the fact that clinically proven and registered drugs as the globally recognised first-time treatment already exist and are readily available. In light of this frequent use of the compounding exemption under the Therapeutic Goods Act, the committee supported the recommendation of the National Coordinating Committee on Therapeutic Goods that the compounding of both high volume and high risk medications should be brought under the regulation of the Therapeutic Goods Act. This amendment would mean that individual doctors could still benefit from the exemption and prescribe individually tailored medication to their patients in the spirit of the original exemption. However, it would regulate more when this exemption is used by operators or pharmaceutical companies that do supply large amounts or medicines that are of high risk. I think this is an important amendment and it should be made.

The fourth area is the integration of commercial ED clinics with the proposed e-record system. The government has commissioned an important piece of research, done by Dr Christine Bennett, in the National Health and Hospital Reform Commission, which is considering the use of an electronic records system. This would be a patient-controlled system that would have integrated records going to their doctor, specialist, psychologist or physio. Everyone could use this patient-controlled mechanism. Noting that the records and treatment of patients who attend ED clinics are isolated from the wider healthcare system, the report encourages the government to consult with commercial ED clinics when it develops and implements the proposed e-record system. As I mentioned before, this will be important to providing the holistic health care to those men who may be suffering ED.

In conclusion, this is an issue that needs addressing. I hope that the Treating impotence report will start an important national conversation to break the taboo around erectile dysfunction and ultimately improve the regulation of this sector.

Jill Hall (Shortland, Australian Labor Party) Share this | Link to this | Hansard source

I would like to congratulate the previous speaker for her contribution to the debate and for the role she played in the round table that was conducted. The member was very involved in the whole process and made an enormous contribution to the report that we have before us today in the parliament.

The committee became very concerned about some of the treatments that were being proposed and some of the advertisements that were being circulated. I think it was the member for Lyne who, one day in the committee, raised concerns about signs on the side of the road. We became very concerned about the fact that there were all these treatments and advertisements, but we were not too sure how effective they were. That was coupled with the fact that many members in this House had received complaints about some of the clinics that were providing these services. The New South Wales Health Care Complaints Commission have previously conducted an inquiry into some of the practices of these clinics. As such, it was felt that it was worthy of the committee’s time to take a look at them and see exactly how effective these clinics were in delivering what they promised.

The purpose of the clinics that we were looking at was to look at erectile dysfunction, and the committee was looking at the treatment and the management of erectile dysfunction in Australia. In recent times, as I have already mentioned, a number of erectile dysfunction clinics have been established. These clinics have caused concern to some of the people that have visited. The first concern I would like to place on the table is that when people contact one of these ED clinics they do not receive a holistic approach. If a man is suffering from erectile dysfunction, the first thing he should do is visit his doctor, because it can be a symptom of a much more serious illness. It can be an early marker for chronic lifestyle and other diseases, such as cardiovascular, diabetes, depression, excessive use of alcohol, smoking, prostate problems, neurological disorders, hormone imbalance and the side effects of other medications and stress. That is just a few of the diseases that it could be an indicator of. I feel that when you are looking at treatment options for erectile dysfunction the first thing a man should do is visit his local GP and talk to them about his problems.

There are many treatments available. There is the non-invasive treatment such as oral medication—Viagra is the most commonly known one; there are injectable treatments like Carverject, which has also been a long-term marketed product; and there are surgical treatments such as penile prostheses and vascular surgery, which goes back to the linkage between chronic disease and ED. Most of these commercial ED clinics prescribe treatments that are different to those above: nose sprays, gels, applications, lozenges or penile injections.

There have been mixed reports about the success of these treatments, and that is what concerned the committee. There does not seem to be the amount of transparency that there should be around these treatments. Whilst the committee felt that we did not have the expertise to make a judgement about the competing treatments, we all felt very strongly that the first port of call should be a qualified medical practitioner and that a full health check was needed prior to actually making a decision about whether or not the appropriate treatment was the spray or the gel, or trying one of the more traditional treatments—or whether it was a mark of some more serious health problem.

One of the issues that were discussed during this roundtable that we had was the fact that men are not proactive about maintaining their good health. They tend to neglect their health. They feel that there is some stigma attached to visiting their doctor. They think that they are invincible. One of the best messages that can come out of this is the message that I started with: the need for men to have good ongoing health checks. We were given considerable anecdotal advice about men not being likely to visit GPs. But those over 40 years of age, in actual fact, do listen to their GPs and are happy to consult. I feel that it has to be put that this is not something that they need to be embarrassed about. This is just another health problem.

There has been a telephone survey of men in Australia called ‘Mates.’ It found that men did visit their GPs. The survey asked questions mainly focusing on reproductive health but there were also a broad range of questions about lifestyle, sexual behaviour and general health. The answers suggested that almost 90 per cent of men aged over 40 visited a GP once a year. But it found that men were also very concerned about developing reproductive health problems. Around 80 per cent were concerned about developing erectile dysfunction. The survey identified that men are selective—and this is the point that I was trying to make—about which topics they choose to raise with their GP. Embarrassment alone should not deter men from discussing all of their health problems with their GPs. The most important message out of this is that you need to get treatment for erectile dysfunction from your GP. Mention it to your GP. Talk about it with your GP. Do not be selective in the topics that you raise with your GP.

One of the things that were discussed at our roundtable was whether or not telemedicine was appropriate. Given what I said about men being selective about the issues that they will raise with their GP, telemedicine gives men some sort of anonymity. They can do things in a way such that they do not have to disclose their identity to the same extent. I would like to emphasise that this is a problem, because men are not getting this holistic treatment that I referred to previously.

The committee believed that the health system needs to better identify erectile dysfunction as an early warning sign of more serious conditions; it is, as I have already stated, an underlying symptom of cardiovascular problems and diabetes. This cannot be done if men are not visiting their GPs. The committee felt that we needed to implement a targeted health program to better inform men about underlying conditions associated with ED. There have been a lot more health promotions directed at men. The prostate cancer group—in particular the one that exists in my area—ran a program called ‘A little prick’, which encouraged men to have a PSA test. Men are becoming more aware of and more familiar with discussions and issues to do with men’s reproductive health.

The downside of telemedicine that is operated through these ED clinics is that they tend to treat erectile dysfunction in isolation and they do not target it as primary health linked in a holistic health way. I feel—as does the committee—that the Minister for Health and Ageing should ask the state and territory medical boards to review the adequacy of the national policy in relation to technology based consultations. I am a very strong supporter of telemedicine but I think it has to be done in conjunction with a holistic approach to medicine, particularly in this area.

The inquiry conducted by the committee—and the committee’s report—raised a number of questions. I am not convinced that the ED clinics that operate in Australia are properly regulated. The commercial ED clinics treat men in isolation. We looked at the e-records system, and I think that there are some concerns about that. There are also some concerns about the compounds and the fact that they can be exempt from the TGA.

Whilst we did not make any recommendations, this report raises a lot of questions. I think that it is worth the minister and the parliament having a considered evaluation of the ED treatments and ED clinics that are provided around Australia. We need to be mindful that any medical treatment that is provided should be holistic and that all aspects of a person’s health should be considered when looking at prescribing a treatment for a person who is suffering from erectile dysfunction.

Debate (on motion by Mr Melham) adjourned.