Safety and trust
At the heart of medicine lies trust. Patients’ trust in health professionals, institutions and therapies; health care professionals’ trust in their teachers, information sources, managers and systems of governance; and government and society’s trust that all the stakeholders will do their best to be worthy stewards of our finite health resources. But trust is fragile, as Dunbar et al discovered in the wake of the recent inquiries into health system failures affecting four Australian hospitals (→ In the wake of hospital inquiries: impact on staff and safety). From their experience of rebuilding shattered health care institutions, they have learned that “...above all else, there needs to be a way in which health professionals can be sure that their concerns about clinical standards will be openly and impartially investigated, and that where it turns out that the issue is poor professional performance, good policies exist to deal with it”.
Taking a therapeutic drug is an act of trust. So is prescribing one! As well as externally collected evidence of efficacy and safety, most doctors rely on the product information (PI) supplied by the drug companies and collected in publications such as MIMS (Monthly index of medical specialties) for accurate information about drugs and dosages. But when it comes to thyroid-related medications, this might not be so. Stockigt examined the PI for these specialised products in MIMS and found that, compared with current medical literature, many PIs provided “inadequate, inaccurate or outdated therapeutic directives” (→ Barriers in the quest for quality drug information: salutary lessons from TGA-approved sources for thyroid-related medications). Dowden is not surprised by this finding, but agrees that it is disturbing. “As the product information also underpins consumer medicines information and sets the boundaries for advertising, flaws could have far-reaching consequences.” He suggests that, like the drugs themselves, the product information should have a “use-by date” (→ Product information past perfect).
Part of the process of updating our knowledge about drugs is post-marketing surveillance for possible harms. Although far from proving a causal association, the seven cases observed by Walker et al of interstitial lung disease in patients taking statins are worth further investigation (→ Potential link between HMG-CoA reductase inhibitor (statin) use and interstitial lung disease).
Participating in medical research is another act of trust, and informed consent is the gold standard for ethical recruitment of subjects. So, did a research project in which tissue samples from patients with colorectal cancer were tested for a genetic marker of hereditary non-polyposis colorectal cancer (HNPCC), without the subjects’ permission, breach ethical standards? Zeps et al believe it can be justified. “If individual informed consent had been a fundamental requirement . . . this retrospective screening for HNPCC could not have proceeded . . . Newly identified patients . . . and their at-risk family members can now receive potentially life-saving surveillance that was not previously offered . . .” (→ Waiver of individual patient consent in research: when do potential benefits to the community outweigh private rights?)
Finally, though they may not follow them, most people trust the public health messages delivered through the media. However, Janda et al are concerned that the vitamin D publicity machine might undo decades of indoctrination about the dangers of sun exposure. In 2005, the bone, skin and cancer experts joined forces to produce a position statement that balances the two messages, but the best way of promoting this to the public is still being explored (→ Sun protection messages, vitamin D and skin cancer: out of the frying pan and into the fire?).
Mycobacterial infections: Australia and beyond
Mycobacterium ulcerans infection (Buruli ulcer) causes destructive skin and subcutaneous lesions, and is most often found in Africa, Latin America, Asia and the western Pacific region, but is also endemic in the Bairnsdale region of Victoria (where it is becoming increasingly common), and parts of Queensland and the Northern Territory. The traditional treatment has been wide excision and skin grafting but, as Asiedu (from the World Health Organization’s Department of Control of Neglected Tropical Diseases) and Wansbrough-Jones point out, this is not always practical in less developed settings (→ Mycobacterium ulcerans infection (Buruli or Bairnsdale ulcer): challenges in developing management strategies). Attention is now turning to the role of antibiotics in treatment, so the results of a Victorian study (O’Brien at al, “Outcomes for Mycobacterium ulcerans infection with combined surgery and antibiotic therapy: findings from a south-eastern Australian case series”) comparing the outcomes of excision with and without antibiotics are very welcome. A multidisciplinary Australian group, the Mycobacterium ulcerans Study Team has developed “Consensus recommendations for the diagnosis, treatment and control of Mycobacterium ulcerans infection (Bairnsdale or Buruli ulcer) in Victoria, Australia”. Other states may need to take note: there has now been a case acquired in New South Wales (Lavender et al, “First case of Mycobacterium ulcerans disease (Bairnsdale or Buruli ulcer) acquired in New South Wales”).
And a much better known mycobacterial infection, tuberculosis, is generating controversy for Australian medical schools. In our letters section several experts agree to disagree on whether all our medical students should have BCG vaccinations (→ Should medical students be routinely offered BCG vaccination?). What do you think?
Another time . . . another place
Trust has declined in all social institutions in recent decades . . . Trust in doctors has also diminished with the explosion of public information on betrayals of trust, failure to follow evidence based standards, and poor quality care, but patients remarkably retain much trust in their personal doctors.
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