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Delays in adoption of statins on the Pharmaceutical Benefits Scheme: Reflections of a John Snow Scholar

This article is sponsored by the Royal Australasian College of Physicians

The evidence for using statins in diabetic patients with normal cholesterol levels to prevent myocardial infarction or stroke was firmly established in 2002 with the publication of the Heart Protection Study. This large, prospective controlled trial found a relative risk reduction attributable to statins of around 25% in this and other population groups. [1] Statins were not subsidised for this indication in Australia until 2006. [2] I conducted a research project that sought to quantify the effect of this delay in terms of the number of cardiovascular events that might otherwise have been prevented if the subsidy for statins had occurred in 2002, when the evidence for this indication became available.

Completion of the project provided me with a more complete understanding of the use of the breadth of data sources available to synthesise an answer to the research question: what was the impact of the delay in subsidising statin drugs for diabetics with normal cholesterol from 2002 to 2006, in terms of cardiovascular outcomes? It also gave me valuable insights into the public health implications of the decisions of Medicare Australia relating to the funding of drugs, such as those for lowering cholesterol for the primary or secondary prevention of cardiovascular disease.

As an unusual research question, for which I could find little precedent in the published literature, it posed a challenge in terms of designing some means of answering it and required a creative approach. I used baseline cardiovascular risk data from the United Kingdom Prospective Diabetes Study, [3] statin-related risk reduction data from the Heart Protection Study, [1] and epidemiological data from the Australian Bureau of Statistics’ National Health Survey. [4] For one part of the study I also referred to unpublished data from the Perth Risk Factor Survey.

In order to integrate these data to provide an answer to my research question, I had to learn statistical methods and familiarise myself with software that I had never previously used, which was also very challenging and at times frustrating, although good supervision helped to somewhat offset this! I have no doubt that the skills learned will be of use in the future. I then had to present my research methodology and findings in the format of a journal article.

The project allowed me to learn about access to pharmaceuticals in Australia and how the decision-making process is conducted for subsidising medicines for particular patient groups. I gained…

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So you think you can research?

I had always considered myself an exceptional dancer. In my mind, my dance moves were unparalleled. However, in reflection, I must admit that the majority of my moves were employed to impress the scrub-nurses by turning my gown in tune to the bopping background beat of the theatre iPod. However, my delusions of dancing grandeur were shattered after watching a number of the popular dance-based shows on television. I realised it took far more than genetic talent, which I still choose to believe I have in abundance, to make a dancer. It requires hours of practice combined with fitness, good music, choreography and originality to succeed. Research, it appears, is not too dissimilar.

I had never been the most proactive student and my CV was barer than a middle-aged German tourist holidaying in Thailand. I had reached a stage in my career where it was time to contribute to medical research. Those who partake in evidence-based medicine know how important research is to the field of medicine.

If you have ever considered undertaking some formal research yourself, here are a few lessons I learnt the hard way:

What do you need?

So, you want to research? Not sure where to begin?

In dance, you need to start with either good music or a good choreographer. In research, your music is your idea, question or inspiration, and your choreographer is your supervisor.

The music (idea)

The chances are that someone, somewhere, has already attempted to adapt “the sprinkler” to your chosen music. As in research, if you think you have a good idea, someone else may have had it before you. To find out, the next step is to conduct a literature review. Medline is a good place to start.

Don’t be disheartened if someone has already researched your hypothesis. In medicine, most people can only answer very specific questions. So, if your good idea has already been partially covered, then read a few articles and find a more specific, unanswered question similar to your original one.

For example, if your question was “How effective is heparin in preventing DVT?” then refine your question to “How effective is low molecular weigh heparin in preventing DVT in male patients aged between 80 and 81 with a past history of smoking 22 cigarettes a day who have just undergone a knee replacement and whose favourite colour is light blue, when compared to Aspirin?” and believe you me, it is unlikely anyone else has researched that topic! Also, if someone has attempted to answer your question, it is worthwhile reading their article. If you find that their methodology is lacking, then you may decide to investigate that topic regardless, albeit with more watertight…

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A very good iDEA: The inaugural gathering of the student division of Doctors for the Environment Australia

The result of one attendee’s bright iDEA.

In early December 2009, just prior to the much-hyped COP15 round of United Nations climate negotiations in Copenhagen, 40 medical students, representing six states and eleven medical schools, descended upon Melbourne for iDEA, the inaugural gathering for the student division of Doctors for the Environment (DEA). Attendees were encouraged to be mindful of their carbon footprints whilst travelling to the conference, with many students opting for train or coach rather than air travel. Most impressively, three Tasmanians cycled for three days from Hobart to Melbourne University (with the assistance of the Bass Strait ferry).

Education and networking were the focus of this three day gathering at Newman College within the University of Melbourne, where a plethora of distinguished speakers presented talks and interactive workshops to enlighten the receptive minds in attendance: academics, environmental activists, clinicians and all combinations of the three.

All present agreed that it was long overdue that medical students gathered to discuss environmental issues relevant to health; issues that for various reasons have been sidelined by the medical fraternity. These issues often traverse traditional subject boundaries, implying a perceived or real lack of academic expertise. Additionally, the lack of confidence in using one’s ‘authority’ as a medical professional plays a part. Climate change, for instance, is often seen as a political or economic concern rather than a threat to health. Being too busy, self-preservation, fear over allegations of hypocrisy, ignorance, inertia and ‘donor fatigue’ all contribute to the reluctance of doctors to speak up.

According to Costello et al., climate change “is the biggest global health threat of the 21st century” and the repercussions to health will be global in reach, but with a disproportionately large impact falling on the developing world. [1] Matthew Wright, co-founder of Beyond Zero Emissions, a Melbourne-based organisation promoting the rapid transition to a zero carbon future, raised the interesting point that planning for a zero-carbon future is different to planning for a low emissions future, which, in turn, is different to planning for a doubtful emission reduction trading scheme in which concessions are made to big polluters. Although it seems paradoxical, government inaction in the short term could thus be preferable to legislating a hurried, binding scheme, that is in fact ineffectual in preventing an unsafe average global warming of two or more degrees.

Richard Di Natale, a former GP and Public Health physician, provided insight into how one might make the transition from clinician to environmental activist and politician. His non-linear career trajectory has seen him transition through positions in primary care, HIV programme development, Government Health Department bureaucracy and community-building. Most recently, he is persuading Victorian voters to give him the job of a Greens Senator at the next Federal election…

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Applying the retrospectoscope to an elective: Reflecting on six weeks in Timor-Leste

Timorese girls from the Gleno Orphanage, located about 40km or a two hour drive from Dili in the Emera Mountains. The mobile clinic from Bairo Pite Medical Clinic visited the orphanage monthly.

The medical elective is notorious for being an excuse for taking a holiday in an exotic corner of the world. Like many of my colleagues, I also travelled to one such corner, Bairo Pite Clinic in Timor-Leste (the official name of East Timor), in search of an adventure with some medical experience thrown in. In retrospect, those six weeks were without doubt the steepest learning curve of my medical training. However, there are a number of things I wish I had known and a great number I would have done differently. Therefore please let me share some insights I have gained with use of the retrospectoscope – the device in medicine which enables the viewer to judge past events or actions with the aid of knowledge obtained since they occurred. This is in the hope of equipping you with some knowledge to make your elective experience the time of your life.

Language

I arrived in Dili, the hot, dusty capital of Timor-Leste after an almost sleepless night in Darwin airport and with a four-word vocabulary of Tetun, the local language. Nevertheless, I was almost immediately loaded onto the clinic’s four-wheel drive ambulance to embark on my first of many mobile clinics into the mountains. For such clinics the four-wheel drive is loaded up with a box of very basic medications, and a driver, a doctor or medical student and a medications dispenser drive up to six hours on a road resembling a goat track to a remote village. There, they see a queue of patients – some waiting, some materialising from the surrounding forest- and drive back, often with acutely ill patients. And thus was the experience from which stems my first insight – learn some of the language.

Despite having an ‘interpreter’ – she spoke as much English as I spoke Tetun – I was luckily armed with the Lonely Planet Tetun phrasebook, which I think saved more lives than I did that morning. Daily Tetun lessons, jotting phrases on the back of my hand and the phrasebook ensured I quickly picked up enough language to hold a reasonable medical consultation. Despite this, I wished countless times I knew some Tetun before I arrived in-country. If you are planning on travelling to a non-English speaking country, do try and learn some local language before you depart. Being able to communicate with your patients makes a world of difference.

Pre-Read

After my mobile clinic baptism of fire, I returned to the Bairo Pite clinic in Dili to be confronted with the afternoon ward round, and a lady in the final stages of labour. Prior to my elective I had seen one patient with tuberculosis (TB) and delivered five babies. Score at the end of the first ward round: 67 TB patients and eight babies delivered. I vividly recall returning to my room that night acutely aware of how much I did not know. I sincerely wished then that I had taken the time to read up on the common problems experienced in Timor: tuberculosis, malaria, labour and its common complications and gastroenteritis. A basic understanding of how to identify and manage these conditions in resource poor countries is essential to getting the most out of your elective. The World Health Organisation (WHO) has some great articles on managing these and other health issues specific to the developing world. [1-4] I thoroughly recommend utilising these prior to and during your elective. Along with the Lonely Planet phrasebook these articles saved a number of lives.

Change the World

Before travelling to Timor-Leste, a number of people warned me against thinking I could change the world in six short weeks. And, yes, I completely agree with them, it is not possible. However, do not allow anyone to convince you of the disillusion that you cannot make a difference, but, like chocolate cake, there is a delicate balance between too much and too little. During my time in Timor-Leste, I fluctuated between strategising how to revolutionise their health system and becoming exasperated with the staff, the patients and the system itself.

I only found this happy medium after many discussions with long-serving expatriates, my supervisor, the famous Dr Dan Murphy and a 24 hour flight using the almighty retrospectoscope. Be aware that revolutionising the local health care system includes ensuring nurses actually take observations rather than just filling in normal results; it is amazing how your patient can be saturating at 99% when the clinic does not have a working saturation probe! The work ethic in Timor is much more relaxed than the Australian system, and it is worth remembering that the way you are used to is not necessarily superior and you are the visitor, so embrace and work along with their system. And remember, change on a big scale, if you want it to last, takes time, dedication and education. So if you are planning a revolution, be prepared for your elective to go for six years rather than six weeks.

However, it is also worth noting that you can make a difference for…

Addendum

The arrow head was lodged in the young man’s right atrium. In order to remove it we did a transverse thoracotomy and made a pericardial window. After placing a purse-string around the arrow shaft we removed it, although we had to extend the entry site a small amount in order to remove the barb. Then, we pulled the purse sting taught and oversowed the pericardium (i.e. when repairing the pericardial window you overlap the edges to prevent tamponade in the event of leakage). He made a remarkable post-operative recovery. He was demanding food in an hour and asking when he could go home in two hours! Thankfully he didn’t develop any infections, and because we didn’t open the pleura at all, he didn’t require a post-operative chest-tube. All of this meant he was discharged home after three days. I saw him again about four weeks later and you never would have guessed he had been in hospital, let alone had an arrow pierce his chest!

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What’s wrong with the Nobel Prize?

Introduction

The Nobel Prize is the single greatest honour that can be bestowed upon a scientist, and yet it has received its fair share of criticism. Even Nobel Laureate, Max Dulbrück, has criticised the Prize stating “by some random selection procedure, you pick out a person and make them the object of a personality cult. After all, what does it amount to?” [1] Recently, there have been calls to reform the Nobel Prizes with ten scientists writing an open letter to the executive director of the Nobel Foundation. [2] This article presents a critical analysis of the Nobel Prize and its role in science, showing that whilst flawed the Prize is still valuable.

The origin of the Nobel Prize

The Nobel Prize is named after Alfred Nobel, who made a fortune in the munitions industry after inventing dynamite. When he died in 1896, Nobel’s estate was worth more than 33 million kronor with one year’s interest from the fortune equal to the annual budget of Sweden’s greatest university. [1] Nobel’s will, written in 1895, dedicated the majority of this estate to prizes for those who had “conferred the greatest benefit on mankind” by making “the most important discovery or invention” in the fields of physics, chemistry and physiology or medicine. In just one short paragraph, Nobel directed how the Prizes should be awarded: the Swedish Academy of Sciences was appointed to award the Physics and Chemistry Prizes and the Karolinska Institute was given responsibility for the Prize for Physiology or Medicine. [3] Nobel also included Prizes in Literature and Peace, but these will not be discussed in detail in this article. For various reasons, Nobel’s will remained in legal peril until 1898 when the Nobel Foundation was finally established as the legal legatee. [4] In 1901, five years after Nobel’s death, the first Nobel Prizes were awarded.

The role of the Nobel Prize in recognising and rewarding great discoveries

The purpose which Alfred Nobel intended his Prizes to serve remains their primary role: to recognise and reward great scientific discoveries. [5] Indeed, one of the reasons that the Nobel Science Prizes now demand so much respect is that their histories give testimony to many of science’s most significant discoveries. Only on a few occasions has a Nobel Prize in Science been awarded for an undeserving discovery. Most notably, Johannes Fibiger won the 1926 Nobel Prize for Medicine for discovering that parasites caused cancer, a discovery which later turned out to be completely unfounded. [1,6] There have also been instances in which outstanding advances in scientific thinking have gone unrecognised by the Nobel Prize. Albert Einstein, although awarded a Nobel Prize for the discovery of the photoelectric effect, received no recognition for his most important achievement, the theory of special relativity. On the whole however, the Nobel Prizes for Science have been awarded for great scientific discoveries. The prizes have found their value in the calibre of their recipients. [5]

The Nobel Prizes for Peace, and in particular Literature, have not fared as well. [1,4] In the early years the Nobel Committee for Literature favoured conventional authors and failed to recognise greats such as Tolstoy. Consequently, the reputation of the Literature Prize was damaged and still suffers. Some suggest that the Science Prizes have enjoyed more success because science is objective, and the selection of Prize winners is less arbitrary than in the subjective fields of literature and peace. This is not the case. The selection process for the science awards is also subjective and may be influenced by the bias of the decision-makers.

Is the decision-making process arbitrary?

The statutes of the Nobel Foundation dictate rules for selecting Prize winners, adding several criteria to those stipulated by Nobel. These can be summarised as follows: [7]

  • Prizes may only be awarded for work that “by expert scrutiny has been found to be of … outstanding importance” and of great benefit to mankind.
  • “The awards shall be made for the most recent achievements in the fields of culture referred to in the will and only for older works if their significance has not become apparent until recently.”
  • “To be eligible to be considered for a Prize, a written work shall have been issued in print or have been published in another form.”
  • Prizes may not be awarded posthumously but a Prize may still be presented if the Prize winner dies before the presentation ceremony.
  • Prizes may be shared between two or three co-workers or between two discoveries but not between more than three people.

The Foundation’s statutes also provide guidelines for nominations and adjudication of the awards. Nominations are not open to the public and to be considered for an award, a written nomination must be received from “a person competent to make such a nomination.” This includes all Nobel Laureates, members of the Prize-awarding bodies (the Swedish Academy of Sciences and the Karolinska Institute) and those invited to submit nominations. [6] Each Prize-awarding body sends out thousands of invitations every year to scientists world-wide, and a rotation system is used to include as many people as possible. Nominations for an award are then considered by a subset of the Prize-awarding body, the Nobel Committee, which consists of three to five persons appointed by the Prize-awarding body. After careful deliberation, the Nobel Committee votes to determine which candidate should be recommended for the award. Although the final…