Don’t dismiss conflict-of-interest concerns in IVF, they have a basis

It’s estimated over 5 million children have been born worldwide as a result of assisted reproductive technology treatments. Assisted reproductive technology, an umbrella term that includes in vitro fertilisation (IVF), is a highly profitable global industry, and fertility clinics are increasingly regarded as an attractive investment option.

In 2014, two major IVF clinics – Virtus and Monash IVF — floated on the stock exchange. Excited financial analysts observed at the time that:

people will pay almost anything to have a baby.

Over the past 12 months, there have been numerous critical media analyses of the IVF industry in Australia, including Monday night’s ABC Four Corners program, The Baby Business. The episode suggested IVF doctors are recommending treatments that are expensive, unsafe and likely to be futile.

The following morning the Fertility Society of Australia rejected these assertions, saying:

Four Corners presented no evidence to support these claims.

One of the claims made in the program was that IVF doctors have a financial incentive to treat women with the more invasive practice of IVF. The program suggested this financial incentive conflicts with the doctor’s duty of care towards the patient.

Four Corners highlighted the conflicted nature of commercialised IVF, where some IVF doctors are more concerned about their own interests (making money for themselves or their clinics) than they are about their patients.

Not surprisingly, the Fertility Society of Australia strongly denied such conflicts of interest exist. It argued that the profession is both highly ethical and highly regulated.

Why might doctors be conflicted?

While it is certainly a big call to claim some IVF doctors may not be sufficiently committed to their patients, the possibility that practice is being shaped — at least in part — by conflict of interest cannot simply be dismissed. There are three key reasons individuals working in the IVF industry, and the industry more broadly, may be perceived to be conflicted.

First, every time a doctor advises patients to consider IVF treatment, he or she profits financially from the recommendation. While all Australian doctors receive fees for their services, many IVF doctors also own shares in assisted reproductive technology companies, so they receive passive income that reflects the amount of assisted reproductive technology the company sells.

It is also worth noting that, as employees of publicly listed companies, doctors at clinics such as Monash IVF, according to their code of conduct, must:

recognise that (their) primary responsibility is to the Company and its shareholders as a whole.

It is therefore not unreasonable for people to be concerned some clinicians may be motivated (perhaps unconsciously) by financial conflicts of interest to make decisions that may not be in the best interests of their patients.

Second, there appears to be a lack of transparency about IVF success rates. Success, as measured by a live birth, is very dependent on age and the reason for seeking assistance.

In the youngest age bracket in Australia and New Zealand in 2013, the live birth per cycle rate was 27%. In the oldest it was between 1% and 5%, depending on whether a fresh or frozen egg was used. It is more likely that a cycle will result in failure than not, and some argue there is a lack of transparency about the likelihood of a live birth.

Even in the youngest age bracket, in Australia and New Zealand in 2013 the live birth per cycle rate was just 27%

A striking example of this was seen on Four Corners when Dr Gab Kovacs, ex-medical director of Monash IVF, claimed:

I know that if you hang in there you get pregnant, because one of my patients got pregnant after 37 cycles. And, ah, so I encourage people to stay on.

While it is quite possible this woman made a fully informed decision to undergo this number of cycles, Dr Kovacs’ subsequent claim that he couldn’t say “no” and had no choice but to continue to offer the woman what she wanted inevitably makes one wonder what she knew about her real chances of success.

A third reason for concern about conflicts of interest, and one that might distinguish conflicts of interest in IVF from those in other medical settings, is the potential for exploitation of strong personal and social values associated with reproduction.

A strong discourse of hope runs through the IVF industry, and people seeking assisted reproductive technology are often very vulnerable. The profit motive of these companies has the potential to exploit these cultural norms and social pressures for ends that are not necessarily in the best interest of patients.

There are now two positions being taken: by those who consider some IVF practices are exploitative and unethical, and by those who consider that conflicts of interest are inherent in medical practice and are sufficiently well managed.

Rather than simply dismissing concerns about conflicts of interest, as the Fertility Society of Australia has just done, IVF specialists, ethicists and other stakeholders need to create a forum in which these concerns can be discussed openly and constructively.

The Conversation

Jane Williams, Doctoral student at the Centre for Values, Ethics and the Law in Medicine (VELiM), University of Sydney; Brette Blakely, Post-Doctoral Research Fellow; Christopher Mayes, Post-Doctoral Fellow in Bioethics, University of Sydney, and Wendy Lipworth, Senior Research Fellow, Bioethics, University of Sydney

This article was originally published on The Conversation. Read the original article.

What should we eat?

Answers to this simple question often appeal to science. Nutrition science, we are told, can tell us what we should or shouldn’t eat if we want to be healthy, fit and prevent disease. But are these appeals to nutrition science legitimate? We think in many cases the answer is “no”.

Some of the most egregious offenders misusing nutritional science are listicles – “10 Unbelievable Diet Rules Backed By Science,” the “14 Things You Should Never Eat,” or “10 Foods Science Says Are Healthier For Your Hair.” But even more legitimate sources of advice can be prone to misuse science and are guilty of what we label nutritional scientism.

In a recent article in the Journal of Bioethical Inquiry we critiqued three types of nutritional scientism: (1) the oversimplification of complex science (including suggesting causation from probabilistic conclusions from observational studies) to increase the persuasiveness of dietary guidance, (2) superficial and honorific references to science in order to justify cultural or ideological views about food and health, and (3) the presumption that nutritional value is the primary value of food. We discuss the first and third of these here.


Widespread concern over diet-related chronic diseases partly explains the appeal of nutritional scientism. We want to give and receive clear dietary guidance. We want to know how diets affect our health and use that knowledge to control and prevent disease. However, the relationship among food, health and chronic disease is complex.

Diet and Causality

While scientific knowledge about the relationship between diet and chronic disease is unclear, scientific knowledge of nutrition has led to improved health dramatically with respect to nutritional deficiency diseases. For example, the relationship between dietary vitamin C and scurvy is causatively simple.  Vitamin C is an essential nutrient for all humans. If someone eats a diet that does not contain sufficient amount of Vitamin C for long enough, they will contract the deficiency disease. For nutrient deficiency, cause has a direct, non-probabilistic meaning, in the sense that if I hit my hand with a hammer, I will cause it to hurt every time.

The success of nutritional science in addressing problems of nutrient-deficiency disease might be so impressive that the aura of scientific success is extended to nutrition and chronic diseases, which are far more complex phenomena.

Chronic diseases are considered to be multifactorial.  Unlike nutrient-deficiency diseases, the meaning of causation for chronic disease is harder to understand, and thus establishment of causation is a far trickier problem.  Factors are understood in the mathematical sense, not as causes but as elements in a mathematical model.  Not everyone for whom factors are in place will get the disease, and not everyone for whom none of the factors apply can be assured of not getting the disease.  The evidence is fundamentally probabilistic, concerned with differential risk (population-level incidence) associated with the factors in the model.

Oversimplified dietary guidance may suggest that the relationship between the food and health status is more simply deterministic, an oversimplification of a highly complex situation.  Black and white dietary advice, for example to “never eat sugar” or “always avoid a particular food,” is a gross oversimplification. Invoking the science to justify oversimplified recommendations is our first form of scientism.  There are times when oversimplified recommendations are couched as a moral responsibility of the individual.

Food and diet, more than nutritional value

A second problem with nutritional scientism is that it reduces the value of food to the way it contributes to a biomedical model of health. This excludes of other values, such as pleasure, identity or culture. If we think of health more broadly, as the World Health Organization does, nutritional scientism is exposed as having a limited  understanding of the relationship between food and health.  In contrast to a focus on the biomedical model, the WHO defines health as a ‘state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity’. If health is broadly considered as social wellbeing, rather than narrowly defined as biomedical, it can be argued that an inordinate reduction of food to nutritional value is likely to be undesirable as it leads to the exclusion of values that are significant for identity, belonging, and wellbeing.

Food is central to bodily survival and nutritional health, but it is also essential for human flourishing through communal relations, religious rites, personal milestones, cultural festivals and a wide variety of everyday interactions that contribute to human well-being. When scientific understandings of food, diet, and cuisine become the dominant or exclusive mode of understanding of food and diet, the label of nutritional scientism is again warranted.

Nutrition science properly contributes to answering the question—“What should we eat?”—but its contribution should be placed in the larger context of a plurality of values that include culture, ethics, pleasure, and well-being.

By Christopher Mayes and Donald Thompson

Why I always get an ISBN for my research reports

Julie Mooney-Somers

Mooney-Somers, J, Erick, W, Brockman, D, Scott, R. & Maher, L (2008). Indigenous Resiliency Project Participatory Action Research Component: A report on the Research Training and Development Workshop, Townsville, February 2008. National Centre in HIV Epidemiology and Clinical Research, The University of New South Wales, Sydney, NSW. ISBN: 978 0 7334 2647 6.

See that bit at the end, that’s my first ISBN. I can’t recall where I got the notion from, and I wonder now at my presumptuousness. I don’t think it was standard practice in my research centre to get ISBNs for research reports. But I had just come out of a horrid job that I’d stayed put in to get publications (it didn’t really work). I was in a new job and determined to get as much on my CV as I could. The first output was a report on a training workshop. I was thoroughly engrossed…

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Regulations have improved since thalidomide but drug scares are still possible

Wendy Lipworth, University of Sydney

The thalidomide tragedy, which resulted in thousands of deaths and disabilities in the late 1950s and early 1960s, changed medicine forever. One of its outcomes was the establishment of more robust mechanisms for the regulation of medicines and medical devices.

Regulatory bodies – including the Therapeutic Goods Administration (TGA) in Australia, the Food and Drug Administration (FDA) in the United States and the Medicines and Health care products Regulatory Agency (MHRA) in the United Kingdom – now decide which products pharmaceutical and medical device companies can market. They also monitor the safety of medicines and devices once they are on the market.

There is no doubt that the tightening of regulation has prevented countless deaths and disabilities, and saved many lives. But regulation cannot always protect us from harm and events disturbingly similar to the thalidomide tragedy continue to occur. Let’s look at two recent examples.

Vioxx pain drugs

In the 1990s, a new class of anti-inflammatory medicines emerged – the “COX 2 inhibitors”. These pain drugs were touted as being less likely to cause gastric ulceration than existing treatments.

One of these, rofecoxib (Vioxx), manufactured by Merck, was later withdrawn from the market, when it emerged that it increased the risk of myocardial infarction (heart attacks).

Vioxx increased the risk of heart attacks.
Reuters/Mike Segar

It emerged that the company had deliberately misinterpreted and concealed some of the information it had about these risks, thus delaying the withdrawal of Vioxx from the market.

Questions were also raised about conflicts of interest – on the part of academic researchers who collaborated with Merck in running trials of Vioxx, members of the data safety monitoring board whose job it was to monitor trials of Vioxx, and members of FDA committees who assessed Vioxx.

A number of class action lawsuits have followed, including one in Australia in 2010, which ruled against Merck. This decision was subsequently reversed, but this was because the judges decided it was not possible to causally link the particular claimant’s heart attack to his use of Vioxx.

Merck has subsequently come to a settlement agreement with Australian patients.

DePuy hip replacements

Yet another class action lawsuit concluded in Australia this June. The action was brought against DePuy International Ltd and Johnson & Johnson Medical Pty Ltd, which were accused of being negligent in their design, manufacture and supply of a particular kind of hip implant.

The story leading up to this will sound familiar: a promising new medical device – the DePuy ASR hip implant – was developed and marketed in the mid-2000s. The company claimed these implants would would reduce friction and wear, and improve patients’ mobility.

DuPuy was accused of not properly testing the product.
terekhov igor/Shutterstock

Complication rates soon proved to be much higher than expected. Around 2,000 of the 5,500 Australians who received the device have required, or are expected to require, revision surgery.

The device was finally withdrawn in Australia in 2009 and worldwide in 2010.

The company has subsequently been accused of not testing the implant adequately, and of knowing – and denying – that its device did not meet manufacturing specifications.

As with the Vioxx case, concerns have been raised about possible conflicts of interest on the part of some of the surgeons who recommended the implant to their patients, and the regulators who evaluated it.

Is there more to come?

These two eerily similar events raise the question: can we do anything to reduce the likelihood of similar occurrences in future?

There is certainly scope to tighten our governance of the pharmaceutical and medical device industries, and the behaviour of those who interact with them. We can also make our regulation of new medicines – and devices and surveillance of existing products – more robust.

There are, however, several important limits to our capacity to prevent harms from medicines and medical devices – all of which help to explain why history keeps repeating itself.

First, pharmaceutical and medical device companies are commercial entities which invest billions of dollars in developing new medicines and devices. Tight regulations are in place and outright fraud is fortunately very rare.

The commercial imperative is, however, powerful. As a result, there is always the possibility that studies of new medicines and devices will be designed, and their results interpreted and disseminated, in a manner that overstates their benefits, and underplays their risks.

Conflicts of interests may affect the reporting of scientific data.

Second, most patients who are injured by medicines and medical devices sustain these injuries in the course of routine medical or surgical therapy – either because of unpredictable adverse events, such as allergic reactions to antibiotics, or because of unintended medical errors.

The adage that “all medicines are poisons” is, unfortunately, true, and we need to accept that even the best physicians and surgeons are only human and will inevitably make mistakes.

Third, we need to balance our desire for innovation and access to new technologies against our desire for safety and control. While there is definitely room to improve regulation and surveillance, we don’t want our clinicians and regulators to be so risk-averse that health technologies cannot make it onto the market or survive once they get there.

Finally, while we might like to think that academic researchers, clinicians and regulators are committed solely to their the pursuit of knowledge, patients and the general public, the reality is they all need to earn money, and attract funding for their work. This inevitably creates a situation in which their “primary commitments” compete or conflict with other loyalties or with self-interest.

We need to accept that “conflicts of interest” are part and parcel of all social roles. Therefore, there will never be a group of people whose only commitment is to protect patients.

When this sobering fact of human nature is combined with the dangers of the commercial imperative, the inevitability of unpredictable side-effects and medical errors, and the need to balance our desires for safety against our desire for innovation, the future looks uncertain.

The best we can hope for is that our systems of checks and balances will continue to be refined so that the “thalidomides of the future” will be caught and addressed as early as possible.

Stay tuned for other instalments in the thalidomide series this week.

The Conversation

Wendy Lipworth, Senior Research Fellow, Bioethics, University of Sydney

This article was originally published on The Conversation. Read the original article.

Speaking with: Aric Bendorf on how to increase organ donation rates in Australia

William Isdale, The University of Queensland

Roughly 1,600 people are currently on waiting lists to receive an organ transplant in Australia. But for many, the wait will be unsuccessful due to the low number of donors.

Australia was once a world leader in organ donations, but today its organ donation rate is lower than much of the developed world. The country ranks 20th in the world for donations, despite having a higher than average rate of potential donors, and sits below world leaders such as Spain, Belgium, France and the USA.

Australia’s approach has been to focus on signing up more people to be donors and on encouraging families to consent to donation after the death of a relative. But if Australia wants to be world-leading, that’s not enough.

William Isdale spoke with Aric Bendorf about what needs to change if Australia is to, once again, become a leader in organ donation.

Subscribe to The Conversation’s Speaking With podcasts on iTunes, or follow on Tunein Radio.

Music: Free Music Archive/Kai Engel – The Idea

Additional audio: Sunrise (Channel 7), Organ and Tissue Authority, The World Today (ABC Radio National)

The Conversation

William Isdale, Research Assistant, T.C. Beirne School of Law, The University of Queensland

This article was originally published on The Conversation. Read the original article.

Fear and Hypocrisy in Australia: Immigration Detention and Free Speech

It was not long ago that the Abbott government vowed to champion free speech, pledging to amend Section 18C of the Racial Discrimination Act, a section of the act that made almost completely useless speech illegal. This commitment was re-affirmed a number of times, including again in early 2015 after the Charlie Hebdo massacre. It seems however the government’s commitment to free speech is largely selective, actively working to keep the marginalised and powerless out of the debate, happy to gag and attack those who dissent.

The recently introduced Border Force Act has raised the ire of a number of individuals and professional bodies, gaining significant media attention with a possible two year prison sentence for speaking about the conditions in immigration detention. Much has been said about how this will impact on the ability of health professionals to report abuse and advocate for patients, however less has been said about how this will only further silence those who are genuinely voiceless.

Silencing the Silenced

The stories we hear from within detention centres are often told through third parties, with many former employees feeling compelled to speak on behalf of those who could not. For all the noise surrounding immigration detention policies, how many of those voices are refugees or asylum seekers?
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Hannah Arendt explored this powerlessness in The Origins of Totalitarianism, she argued that even though human rights are proclaimed to be universal, asylum seekers and stateless persons were left with nothing to protect their rights, effectively in limbo, no longer a member of a community where their rights could be enforced. This precarious situation has often been referred to as “the right to have rights”.

“… but it turned out that the moment human beings lacked their own government and had to fall back upon their minimum rights, no authority was left to protect them and no institution was willing to guarantee them.”

She emphasised how this stripped away the right to make oneself heard and opinions matter.

“The fundamental deprivation of human rights is manifested first and above all in the deprivation of a place in the world which makes opinions significant and actions effective… They are deprived, not of the right to freedom, but of the right to action; not of the right to think whatever they please, but of the right to have an opinion”

Managing and processing the powerless

Immigration detention in Australia compounds this powerlessness by further limiting asylum seekers ability to control their own lives and speak candidly about their circumstances. Andre Dao reminds us that this powerlessness can manifest in asylum seekers gambling on their bodies, a symbolic way to regain some control, to be heard. As Dao puts it “you are no longer a human being with free will. Instead, you’re a problem to be managed, an object to be processed.” Few better statements sum this up than these words recalled by an ex-detainee on a hunger strike who was being spoken to by a department employee.

“You understand that your life is in our hands. Your death is also in our hands because we won’t let you die.”

Although a number of asylum seekers have spoken out over the years, their voices rarely make it to the mainstream. Furthermore there remains the expectation of silence both during and after detention, it is not until permanent residency has been gained and families reunited that many feel safe to speak about their experiences.

Silenced subjects and misinformation

Maintaining this silence is key to maintaining our current approach to asylum seekers. The system has been built around rhetoric and misinformation, from children overboard to the present day. Most people can bark back three word slogans, but fewer could tell you what percentage of the world’s asylum seekers arrive on our shores or begin to explain the trauma and torture many have faced before finding safety.

The voices we most need in our debates around asylum seeker policy in Australia are absent, not only that, they are actively excluded. So as well as threatening professionals with gaol time, the Border Force Act only further ensures that that we never get to hear these stories, it ensures that we don’t know who we are locking up or for what reason.

It’s not obvious how the Border Force Act serves to “stop the boats” or “smash the people smugglers business model”, taking into account the boats stopped a long time ago. In attempting to justify this legislation however, the rhetoric has boiled down to a very familiar means justifying the ends rationale, something we should all be careful of and something where it seems appropriate to leave the last words with Hannah Arendt.

“The crimes against human rights, which have become a speciality of totalitarian regimes, can always be justified by the pretext that right is equivalent to being good or useful for the whole in distinction to its parts.”

Ryan Essex

PhD Candidate, The University of Sydney.