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Preference: Statistics, epidemiology and research design

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Too much gluten a disease risk

High consumption of gluten is emerging as a risk factor in the development of coeliac disease.

While much attention to now has been focused on when gluten in introduced into a child’s diet, a Swedish study suggests researchers should instead turn their attention to how much gluten they eat.

Sweden is considered a high-risk country for the development of coeliac disease – a gluten intolerance for which there is no known cure. The only effective treatment is to follow a gluten-free diet.

Lund University researcher Carin Andren Aronsson was keen to investigate why such gluten intolerance occurs, and examined the records of 8700 children across four countries (Sweden, Finland, Germany and the United States) who are part of The Environmental Determinants of Diabetes in the Young project.

“Our findings indicate that the amount of gluten triggers the disease,” Ms Aronsson reported, adding that differences in dietary habits between children from different countries should also be examined.

She found that Swedish children up to two years of age with a high gluten intake of more than five grams a day had twice the risk of developing coeliac disease compared with those who ate less.

Further, she discovered that Swedish children had a higher risk of developing the auto-immunity that gives rise to coeliac disease than children in other countries studied, including Finland, Germany and the United States.

But the researcher dismissed the idea that breast feeding, frequently a point of speculation, had a role to play.

“There was no apparent connection between the duration of the period of breast feeding and the risk of developing coeliac disease,” Ms Aronsson said.

She were equally unequivocal that when gluten was introduced into a child’s diet was not significant.

“The timing alone of the introduction of gluten in the diet is not an independent risk factor for subsequent development of gluten intolerance,” she said.

Ms Aronsson said she intended to expand her study to include children from more countries, with data retrieved over a longer time span.

Adrian Rollins

News briefs

Morning sickness may be good news for pregnancy

A new study published online by JAMA Internal Medicine suggests the “morning sickness” symptoms of nausea and vomiting may be associated with reduced risk of pregnancy loss. As many as 80% of pregnant women report nausea or vomiting or both. Researchers from the Eunice Kennedy Shriver National Institute of Child Health and Human Development in the US examined the relationship between nausea and vomiting and pregnancy loss in a secondary analysis of women with one or two prior pregnancy losses enrolled in a clinical trial. The study included 797 women who had urine test-confirmed pregnancies and nausea symptoms that were tracked in pregnancy diaries and questionnaires. Among 797 women, 188 pregnancies (23.6%) ended in loss. At week 2 of gestation, nearly 18% of women (73 of 409) reported nausea without vomiting and 2.7% of women (11 of 409) reported nausea with vomiting. Those proportions grew to 57.3% of women (254 of 443) and 26.6% of women (118 of 443), respectively, by gestational week 8, the study reported. Nausea and nausea with vomiting were associated with a 50–75% reduction in the risk of pregnancy loss in women with one or two prior pregnancy losses, according to the authors. A number of theories have been proposed regarding the potential mechanism of this association. “Our study confirms prior research that nausea and vomiting appear to be more than a sign of still being pregnant and instead may be associated with a lower risk for pregnancy loss,” the authors concluded.

Australian research points to new lymphoma treatment

An international trial led by Peter MacCallum Cancer Centre radiation oncologist, Professor Michael MacManus, has found that patients with early stage low-grade lymphoma live longer without a relapse with immuno-chemotherapy plus radiotherapy treatment rather than radiotherapy alone. The results of the international phase III TROG 99.03 clinical trial were presented last month during a Plenary Session at the 2016 American Society for Radiation Oncology (ASTRO) Annual Meeting in Boston. The primary aim of the trial was to see if, by adding immuno-chemotherapy to the standard treatment of radiotherapy alone, outcomes could be improved for patients with stage I-II low-grade follicular lymphoma. Patients (150 participants from across Australia, New Zealand and Canada) were randomised to one of two arms; radiotherapy alone or radiotherapy followed by six cycles of cyclophosphamide, vincristine, prednisolone (CVP) or in the later part of the trial, rituximab and CVP (R-CVP). “This is a slow-growing lymphoma and in the short term, the prognosis is good,” Professor MacManus said. “Radiotherapy can cure around half of these patients. However, more than half of the patients will eventually relapse after radiotherapy alone, generally outside the area of the body treated with radiotherapy. Although the disease may then respond well to further therapy, most patients will eventually die from lymphoma after their relapses. It is clear from the trial results that radiotherapy plus R-CVP is associated with a much better chance that patients will survive to 10 years without a relapse. It is likely to mean that the cure rate will be much higher. The long natural history of the disease makes it very difficult to perform randomised trials in these patients, because it takes many years to know if their treatment has been effective. Few trials groups can sustain a trial over the more than 15 years that would be required to answer the question. Our trial has run for 16 years. The results of this trial will immediately inform every discussion of treatment strategy for every patient with stage I-II follicular lymphoma in the developed world.”

Device reforms may be too late to prevent premium pain

The Federal Government is coming under pressure to speed up its review of prosthetic prices if consumers are to avoid another painful hike in private health insurance premiums.

Health funds have warned that unless the cost of medical devices on the Prostheses List falls into line with the much lower prices paid by public hospital in the next few weeks, policyholders will continue to pay an extra $150 to $300 on their premiums.

The warning is the latest shot in a tussle underway between insurers, medical device manufacturers and private hospitals other over the cost of prostheses, as documented in a series of articles in The Australian newspaper.

The health funds, increasingly worried about the backlash from consumers over rapidly rising premiums and complex and confusing insurance products, have set their sights on prostheses prices as a key way to contain costs.

They claim that existing pricing arrangements are woefully out of date and force insurers to pay grossly inflated prices for medical devices compared with public hospitals. According to insurers, they are being charged up to $3450 for a coronary stent that costs $1200 in the public system, while a defibrillator costing them $52,000 costs a WA public hospital just $22,555.

Altogether, the funds estimate they could save $800 million by bringing public and private prostheses prices into line, savings they say would be passed on in cheaper premiums for consumers.

But the Medical Technology Association of Australia, which represents medical device manufacturers, has defended the sector against what it considers to be false and misleading claims.

MTAA co-lead Andrea Kunca said the industry rejected accusations of inflated pricing and fully supported the work of a Government working group brought together earlier this year to work through “meaningful solutions” for reform of the Prostheses List.

The Australian has published claims that the MTAA, in concert with private hospital operators, has so far been successful in frustrating attempts by Health Minster Sussan Ley to reform the Prostheses List, and any changes are unlikely to come in time to head off another sharp increase in the health fund premiums next year.

According to The Australian, fierce lobbying by well-connected outfit CapitalHill Advisory on behalf of the MTAA derailed an early attempt by Ms Ley to cut implant prices.

Influential Senator Nick Xenophon has announced he will push for a Senate inquiry into private health insurance and the pricing of medical devices on the Prostheses List, a move welcomed by the MTAA.

“There have been a number of misleading and false claims put in the public arena in regards to the medical device industry,” Ms Kunca said. “A Senate inquiry will allow these false claims to be answered once and for all. From the MTAA’s perspective we look forward to presenting the facts rather than anecdotal misinformation put forward by some.”

Premium crunch time

The health funds have to submit proposals for their 2017 premiums, which have to be approved by the Health Minister and are announced in April, by early November.

Doctors, insurers and the Government fret that another 6.5 per cent premium increase could accelerate the shift among policyholders toward cheaper policies with multiple exclusions and less coverage, or even convince many to ditch private health cover altogether – the insurance industry has cited research that at least 20 per cent of current members would find premiums unaffordable in the next six years.

Ms Ley recently overhauled the membership of the Prostheses Listing Advisory Committee, appointing University of New South Wales Professor of Medicine Terry Campbell as Chair. Professor Campbell’s appointment was a belated replacement of long-serving Chair Professor John Horvath, who left last December to become a strategic adviser at Ramsay Health Care.

The stoush comes against the backdrop of rising dissatisfaction among doctors and consumers with the quality and value for money of private health insurance.

The AMA has been a vocal critic of the proliferation of complex and confusing policies, many with multiple exclusions that leave unsuspecting patients with inadequate cover.

AMA President Dr Michael Gannon has declared the medical profession’s support for Government reforms to improve the value of private health insurance by banning junk public hospital-only policies, standardising terms, mandating minimum levels of cover and preserving community rating.

Dr Gannon said doctors were doing the right thing, with 86 per cent of privately insured medical services charged on a no gap basis, and a further 6.4 per cent involving a known gap.

“This means that less than 8 per cent of privately insured patients are charged fees that exceed that paid by their private health insurance,” the AMA President told the National Press Club in August. “Put simply, the majority of doctors and hospitals understand the impact of gaps on patients and are doing the right thing by them.”

He said that because of these, doctors were deeply unimpressed with the behaviour of some insurers, “particularly the biggest and most profitable ones”, in putting profits ahead of the interests of patients.

Dr Gannon said that if such actions, including aggressive negotiations with private hospitals and attacks on the professionalism of doctors, continued unchecked “we will inevitably see US-style managed care arrangements in place in Australia”.

Adrian Rollins

Medicare data breach prompts law change

The Federal Government has moved to tighten privacy laws after doctor provider numbers were disclosed in a breach of security around Medicare and Pharmaceutical Benefit Scheme data.

Attorney-General George Brandis has announced plans to amend the Privacy Act to make it a criminal offence to re-identify de-identified Government data following a discovery that encrypted MBS and PBS data published by the Health Department had been compromised.

The Department was alerted to the worrying security lapse by Melbourne University Department of Computing and Information researcher Dr Vanessa Teague, who found she was able to decrypt some service provider ID numbers in a dataset being used by her and several of her colleagues. She immediately alerted the Department.

In a statement, the Department said no patient information had been compromised in the incident.

“The dataset does not include names and addresses of service providers, and no patient information was identified,” the Department said. “However, as a result of the potential to extract some doctor and other service provider ID numbers, the Department of Health immediately removed the dataset from the website to ensure the security and integrity of the data is maintained.”

The security breach has come as a Senate inquiry hears concerns about data security surrounding the decision to award Telstra Health $220 million contract to design and operate the National Cancer Screening Registry, and follows the collapse of Australian Bureau of Statistics systems on census night.

The AMA said that although the data security breach was concerning, it should not result in governments withholding data.

The Association said that although it was paramount that personal information be properly secured and protected, it was important that de-identified and encrypted data be made available by Government to help inform research and the analysis of health information.

Senator Brandis reassured that the Government remained committed to making valuable data publicly available.

“The publication of major datasets is an important part of twenty-first century government providing a great benefit to the community,” the Attorney-General said. “It enables…policymakers, researchers and other interested persons to take full advantage of the opportunities that new technology creates to improve research and policy outcomes.”

But Senator Brandis said that advances in technology had meant that methods used in the past to de-identify data “may become susceptible to re-identification in the future”.

Under his proposed changes to the Privacy Act, it would be a criminal offence to re-identify de-identified Government data, encourage someone else to do it, or to publish or communicate such data.

The Health Department said it was conducting a “full, independent audit” of the process followed in compiling, reviewing and publishing the data, and promised that “this dataset will only be restored when concerns about its potential vulnerabilities are resolved”.

The Office of the Australian Information Commission is undertaking a separate investigation.

Adrian Rollins 

News briefs

Snail venom key to better diabetes treatment

An international team of researchers led by scientists from the Walter and Eliza Hall Institute of Medical Research, Flinders University, the University of Melbourne and Monash University has found that venom from certain fish-hunting cone snails could hold the key to developing “ultra-fast-acting” insulins, leading to more efficient therapies for diabetes management. “One such insulin, Conus geographus G1 (Con-Ins G1), is the smallest known insulin found in nature and lacks the C-terminal segment of the B chain that, in human insulin, mediates engagement of the insulin receptor … We found that Con-Ins G1 … strongly binds the human insulin receptor and activates receptor signaling. Con-Ins G1 thus is a naturally occurring mimetic of human insulin … These structural findings provide a platform for the design of a novel class of therapeutic human insulin analogs that are intrinsically monomeric and rapid acting.” The study was published in Nature Structural and Molecular Biology on 13 September.

Sugar industry sponsored anti-fat research

A report published online by JAMA Internal Medicine examined the sugar industry’s role in coronary heart disease research and suggested the industry sponsored research in the 1960s and 1970s designed to influence the scientific debate to cast doubt on the hazards of sugar and to promote dietary fat as the culprit in heart disease. Researchers from the University of California used archival documents from the Sugar Research Foundation (SRF), which later evolved into the Sugar Association, historical reports and other material to create a chronological case study. The SRF initiated coronary heart disease research in 1965 and its first project was a literature review published in the New England Journal of Medicine in 1967. The review focused on fat and cholesterol as the dietary causes of coronary heart disease and downplayed sugar consumption as also a risk factor. SRF set the review’s objective, contributed articles to be included and received drafts, while the SRF’s funding and role were not disclosed, according to the article. “This historical account of industry efforts demonstrates the importance of having reviews written by people without conflicts of interest and the need for financial disclosure,” the authors wrote, who point out the NEJM has required authors to disclose all conflicts of interest since 1984. There also is no direct evidence that the sugar industry wrote or changed the NEJM review manuscript and evidence that that the industry shaped its conclusions is circumstantial, the authors acknowledged.

[Series] HIV and tuberculosis in prisons in sub-Saharan Africa

Given the dual epidemics of HIV and tuberculosis in sub-Saharan Africa and evidence suggesting a disproportionate burden of these diseases among detainees in the region, we aimed to investigate the epidemiology of HIV and tuberculosis in prison populations, describe services available and challenges to service delivery, and identify priority areas for programmatically relevant research in sub-Saharan African prisons. To this end, we reviewed literature on HIV and tuberculosis in sub-Saharan African prisons published between 2011 and 2015, and identified data from only 24 of the 49 countries in the region.

[Perspectives] Ellen Wiebe: pro-choice doctor providing peaceful deaths

Ellen Wiebe is not what you would expect from a physician who has spent her career ensuring women’s right to choose abortion and now, in her renaissance, providing medical assistance for people who are dying. Having faced down death threats, endured claims that she is a murderer, and provided 40 years of service to Canadian family medicine and research, you would think she would call herself a fighter, an activist, certainly a trailblazer. But, no. Wiebe rejects those labels and instead describes herself as just doing what is best for her patients.

Australian Burden of Disease Study 2011: methods and supplementary material

This document provides a detailed description of the methods used to derive the fatal and non-fatal burden of disease (using the disability-adjusted life years, years lived with disability and years of life lost measures) for the Australian and Aboriginal and Torres Strait Islander populations for 2011 and 2003, as well as estimates of how much of the burden can be attributed to various risk factors . The report is targeted at researchers and epidemiologists, and those seeking to further understand results provided in the Australian Burden of Disease Study 2011.

[Perspectives] Infective endocarditis

Sir William Osler—fearsomely learned, immaculately dressed, perhaps the most famous physician of his day—was not a man given to public confessions of inadequacy. In his 1885 Gulstonian Lecture he gave a bravura performance, drawing on two decades of experimental research to construct a new framework for understanding different forms of endocarditis. In his conclusion, however, he emphasised “the outlines of our ignorance” in understanding this protean disease. As Osler knew all too well, few diseases have been transformed so drastically by shifts in medical theory and practice, and few have proved so endlessly resistant to stable classification.