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[Correspondence] Clarification regarding ethical review of Paolo Macchiarini’s research

On Jan 1, 2004, a law came into force in Sweden concerning the ethical review of research conducted in human beings. This law covers research conducted in living human beings, on human cadavers, and on biological material from human beings, and the handling of sensitive personal information. The Swedish Research Council considers Paolo Macchiarini’s activities1 to be research conducted in human beings.

Tackling smoking, childhood obesity and back pain: it’s not for want of trying

Humans are complex beings, and few of even our simplest actions are entirely rational. The more of us there are, the more unpredictable things get. It’s not entirely unexpected then that evidence on how to tackle complex health conditions, particularly at the population level, has been limited and simple solutions elusive. A recent crop of Cochrane reviews shows mixed results.

Let’s start with good news. Reducing exposure to second-hand smoke through legislation banning smoking in public and work places has been commonplace in Australia for many years. It’s reassuring then that a review of 77 studies from 21 countries demonstrated consistent evidence of a positive impact of these laws, especially on improving cardiovascular health outcomes and reducing mortality from smoking-related illnesses. However, the evidence was less consistent for respiratory and perinatal health, and for smoking prevalence and tobacco consumption (doi: 10.1002/14651858.CD005992.pub3).

Tackling childhood obesity is a huge challenge, even more so when many parents struggle with their own weight. Might interventions directed at helping parents change their family’s diet and lifestyle have an impact on their children’s weight? The evidence from a review of 20 wide-ranging studies is not especially encouraging. Diet, physical activity and behavioural treatments delivered to parents only had similar effects compared with parent–child interventions and compared with minimal contact controls (doi: 10.1002/14651858.CD012008).

Chronic low back pain is a common condition for which exercise is a modestly effective treatment. A recent review sought to find out if motor control exercise, a popular form of exercise similar to core strength training, is superior to other forms of exercise in relieving pain and disability. Despite the inclusion of 29 studies, little or no difference was observed in any of the outcomes measured. The effects were the same when motor control exercise was compared with manual therapy (therapy associated with physiotherapists or physical therapists). Only when compared with a minimal intervention was a clinically important effect found, which at least confirms that doing something is better than nothing (doi: 10.1002/14651858.CD012004).

One less talked about consequence of higher antibiotic prescribing rates in children is the increasing likelihood of antibiotic-associated diarrhoea. At least here there is some reason to cheer. A new review of 23 studies involving nearly 4000 children found that probiotics were generally well tolerated and have a protective effect in preventing antibiotic-associated diarrhoea, with a respectable number needed to treat of 10 (doi: 10.1002/14651858.CD004827.pub4).

For more on these and other reviews, visit the Cochrane Library at www.cochranelibrary.com.

In brief…

How to spend $20bn

Eminent medical researcher Professor Ian Frazer will lead a board charged with advising the Federal Government on investing funds from the $20 billion Medical Research Future Fund.

Professor Frazer, who will be joined by seven other directors drawn from the private sector and academia, will develop the five-year Australian Medical Research and Innovation Strategy, and set priorities every two years.

“The Advisory Board will ensure that any expenditure from the MRFF will have a strong business case, ensuring that the financial assistance provided…delivers the greatest value for all Australians,” Health Minister Sussan Ley said.

E-health overseer

The Commonwealth and the states and territories have agreed to set up the Australian Digital Health Agency to oversee the provision of national electronic health records and other digital health services.

The agency, which will begin operations in July, will be responsible for management of the national digital health strategy, and the design and operation of systems including the Commonwealth’s My Health Record.

Greens target ‘wasteful’ rebate

The Australian Greens would scrap the private health insurance rebate and reinvest the funds in public hospitals.

As political parties sharpen their policies ahead of the Federal election, the Greens have pledged to axe the “wasteful” PHI rebate, freeing up $10 billion over four years which would be redirected to the public hospital system.

Greens leader and public health specialist Dr Richard Di Natale said his party would also reinstate the joint Federal-State hospital funding model scrapped by the Coalition so that the Commonwealth would match 50 per cent of the efficient growth in hospital costs, with the change enshrined in law.

Trial run

The nation’s health ministers have committed to making Australia more attractive for clinical trials to boost investment and improve access to new medicines.

The ministers said that more needed to be done to make Australia a preferred location for clinical trials, including reducing fragmentation and inefficiencies. They have asked the Australian Health Ministers’ Advisory Council to develop options to organise sites, increase administrative efficiencies, improve engagement with sponsors, and reduce trial start-up times.

All the same

The nation’s hospitals will save $270 million over the next decade with the introduction of single standardised chart for the supply and reimbursement of Pharmaceutical Benefit Scheme medicines.

Commonwealth, state and territory health ministers have agreed to harmonise legislation to allow for the use of the standardised chart, in a move that will ease the regulatory burden on prescribers, pharmacists and nurses, improve patient safety and cut hospital administration overheads by around $27 a year. The new charts will be available from July.

A joint approach

The Commonwealth and the states will look at opportunities to jointly commission mental health services, including through Primary Healthcare Networks, following an agreement struck at the COAG Health Council meeting.

The agreement was suggested by the Queensland Government, which emphasised the need to identify opportunities for the joint commissioning of services across the Commonwealth and state-funded health services “[to] support a more integrated approach to service delivery and reduce any potential duplication”.

The meeting agreed that mental health was one of the areas where opportunities for joint commissioning would be explored, and called on PHNs to work with Local Health Networks to “align mental health commissioning efforts” from July.

Adrian Rollins

 

Assisted dying laws spread as euthanasia debate intensifies

Canada and California are set to join several European countries and US states in legalising doctor-assisted deaths amid calls for Australia to follow suit.

Canada is on track to allow physician-assisted dying from 6 June after the Trudeau Government introduced legislation to the Canadian Parliament, while the practice is set to become law in California on 9 June, nine months after a Bill was passed by the State’s legislature.

The international developments have come as debate about euthanasia in Australia intensifies.

High profile entertainer Andrew Denton has become a passionate advocate for legalising euthanasia, and last week he was joined by former Prime Minister Bob Hawke, who said it was “absurd” that patients in pain could not ask their doctor to help end their life.

“I think it is absurd that we should say that it is illegal that a person who is suffering terribly, and is in an irremediable condition, should be forced to continue to suffer,” Mr Hawke said in an interview on Mr Denton’s Better Off Dead podcast series. “It doesn’t meet any requirements of morality or good sense.”

Euthanasia will be debated in a policy session at the annual AMA National Conference next month, and the AMA’s Ethics and Medico-legal Committee is conducting a survey of member views on the issue as part of a review of the peak medical organisation’s policy on assisted dying.

Under the Canadian legislation, only adults with serious and irreversible medical conditions may seek a doctor-assisted death. They must apply in writing, with two witnesses, and the request must be evaluated by two doctors or nurses. Even once a request is granted there is a mandatory 15-day waiting period.

To prevent an influx of people from other countries seeking to avail themselves of the new law, it only applies to those eligible for Canadian Government-funded health services.

Under the new Californian laws, a person seeking assisted death must first have undergone rigorous questioning to determine that they were of sound mind and understood what they were seeking, and two doctors must have agreed that they had less than six months to live.

Opponents often fret that such laws will trigger a rash of doctor-assisted suicides, but experience in areas where they are in place suggests this is unlikely. In almost 20 years since similar legislation came into effect in Oregon, The Economist reported fewer than 1000 people have used it to take their own lives. 

California’s Department of Health Care Services has estimated that in its first year, fewer than 450 seriously ill people will seek a prescription of lethal drugs through the Medicaid program, and even less will actually use them.

Adrian Rollins

News briefs

Gender differences in pre-hospital care

A Swedish study published in BMC Emergency Medicine has found that female trauma patients were less likely to be given the highest pre-hospital priority, the highest pre-hospital competence level, and direct transport to the designated trauma centre compared with male trauma patients. A retrospective observational study based on local trauma registries and hospital and ambulance records in Stockholm County, Sweden, was conducted. A total of 383 trauma patients (279 males and 104 females) over 15 years of age with an Injury Severity Score (ISS) of more than 15 transported to emergency care hospitals in the Stockholm area were included. Male patients had a 2.75 higher odds ratio (95 % CI, 1.2–6.2) for receiving the highest pre-hospital priority compared with females on controlling for injury mechanism and vital signs on scene. “We found differences in trauma mechanism between genders, namely, that the second most common trauma mechanism for females was a low-energy fall (26.9 %) … Perhaps this might be one of the reasons why females, despite severe injury, are not recognised at scene as potential severe trauma patients since the trauma mechanism is considered to be of low energy. Recognising gender differences with educational efforts and in pre-hospital trauma management protocols may expedite the trauma care of female patients.”

Bad hair day in space for some astronauts

Research published in PLOS One has found that spaceflight alters human hair follicle gene expression, leading to a possible “inhibition of hair growth in space”, particularly among male astronauts. “We found that FGF18 expression in the hair follicle changed during spaceflight. Hair follicle growth during anagen is strongly suppressed by the local delivery of FGF18 protein. Epithelial FGF18 signaling and reduction of expression in the milieu of hair stem cells are crucial for the maintenance of resting and growth phases,” the authors wrote. They also found that “FGF18 expression is known to decrease in growing hair follicles; the increase in FGF18 expression in several astronauts during flight potentially reflects a temporary arrest in the hair growth cycle; FGF18 expression appears to be very sensitive to whether an astronaut is in space or earth-bound; FGF18 easily recovered to baseline levels after returning to Earth”. Gender also has its effect, they found. “Although there are many differences such as hormone levels or functions between males and females, female astronauts appear to have a better response against the features of the space environment, as one example, FGF18 expression in females was more stable in space than in males.”

FDA clears experimental Zika blood test for use

The US Food and Drug Administration (FDA) has announced that it will allow the use of an experimental test to screen blood donations for contamination with the Zika virus, the New York Times reports. Puerto Rico, who had halted local blood donations and had imported almost 6000 units of blood from the US, will therefore be able to resume local collection. Zika poses a special challenge to blood banks, the report said, because roughly 80% of people who are infected do not have symptoms. “A handful of cases of Zika infection via blood transfusion have been reported in Brazil. During the 2013 French Polynesian outbreak, researchers found roughly 3% of asymptomatic blood donors actually tested positive for Zika infection, which they deemed unexpectedly high. It is not yet known how commonly recipients of Zika-contaminated blood end up infected, or how they fare.”

ASR hip replacement case settles for $250 million

Hundreds of Australians implanted with a defective hip device will be eligible for a share of $250 million in compensation following the conditional settlement of a long-running class action, the ABC reports. A worldwide recall of DePuy ASR devices in 2010 involved around 100 000 patients worldwide and 5500 in Australia, with approximately 1700 of those patients eligible for a share in the settlement. The settlement was negotiated after 17 weeks in court, but has yet to be approved by the Federal Court. A lawyer speaking on behalf of those bringing the class action said hundreds of Australian patients had yet to have revision surgery and they were welcome to join the class action which will remain open for a period. “There was no admission of liability by the makers of the ASR DePuy hip replacements as a part of the settlement.”

[Correspondence] Refusal to provide health care to people with HIV in France

Refusals to provide care to people with HIV have been reported in the USA,1 the UK,2 and elsewhere in Europe,3 but their frequency remains poorly documented. In 2015, the French parliament examined a law that includes an article on non-discrimination in access to health care and the possibility of doing tests to determine the extent and nature of the discrimination. During the legislative debates, AIDES did a situation testing survey4 to ascertain the frequency and nature of refusals to provide dental and gynaecological care to people with HIV.

Weight loss: beware of buying unregulated products online

Weight loss products that promise quick and easy results may seem like an attractive option, but buying unregulated products online from overseas can cause you to seriously risk your health, lose your money and possibly break the law.

[Comment] Offline: Why the UK must stay in Europe

“Should the United Kingdom remain a member of the European Union or leave the European Union?” The case for voting to leave in the referendum on June 23 has been fiercely made. Reclaim our freedom and sovereignty. Take back control of our laws and borders. Stop would-be terrorists from entering our country. Be more influential in the world by stepping out of Europe’s shadow. Save money wasted on European bureaucracy. Or, more viscerally, our country is Britain, not a United States of Europe. By comparison, the case for staying within a European Union of 28 member states (19 of whom share a currency, the Euro) has often been defensive, reactive, and more about promoting fear of leaving the Union than advocating a positive vision.

Watchdog wants to dob on doctors

Health Minister Sussan Ley has asked AHPRA to suggest changes to National Law

The medical workforce watchdog will have the power to inform employers and places of practice of any change in the registration status of doctors under legislative changes being sought by the Australian Health Practitioner Regulation Agency.

Responding to a report critical of its handling of a serious case involving the preventable deaths of several babies, the Agency will gather and share more information regarding doctors under investigation and has asked for changes to its legislation to enable it to disclose more details to employers.

The changes are part of a detailed set of measures intended to address serious shortcomings identified by an investigation into its handling of the Djerriwarrh Health Service scandal, in which 10 babies died in two years – including seven deaths considered to have been avoidable.

AHPRA commissioned consultancy KPMG to examine how its Victorian office handled the matter after it was revealed it took 28 months to investigate a complaint about one of the doctors working at the health service in Bacchus Marsh, Victoria.

The Victorian Health Minister said the case involved a “catastrophic failure” of clinical governance at the health service, and ordered sweeping changes to its management.

For its part, AHPRA admitted that it had “taken longer than it should have” to investigate the complaint made to it about on the health service’s doctors.

In its report, KPMG said the watchdog needed to exercise better risk assessment, to throw more resources at investigating high-risk complaints, to operate with greater transparency, to address perceptions of being “pro-practitioner” and to critically evaluate its performance.

AHPRA accepted all the recommendations, and said that although the review concentrated on the agency’s Victorian operations, many of the changes it was making would apply nationally.

Aside from improving its process to assess high risk cases and speed investigations, the watchdog has detailed measures that will mean greater disclosure of information about matters and people under investigation.

“We are using the National Law more flexibly to improve information sharing with key stakeholders, such as notifiers, employers, [and the] Department of Health and Human Services (DHHS),” AHPRA said.

It said it had adopted a broader definition of employer to improve the gathering and sharing of practitioner employment details where action is to be taken, and was working with DHHS on an agreement setting out what sensitive information can be shared between agencies, and under what circumstances.

In addition, Health Minister Sussan Ley has asked AHPRA to suggest any changes to its legislation it might consider necessary, and it has suggested requiring registered practitioners to inform AHPRA of their employers and places of practice, and to give the regulator the power to “advise employers and places of practice of any changes to their registration status”.

The latest development come after a meeting between AHPRA, the Medical Board of Australia and AMA officials including Vice President Dr Stephen Parnis which discussed more timely investigations, and the need for greater consultation with the medical profession on ways to improve the complaints process both for those making complaints and those subject of notifications.

Adrian Rollins