It turns out that almost 50,000 patients on Lithium were invited to take part in a bipolar clinical trial, raising questions about how Medicare stores and uses personal health information. Medicare is Australia’s universal healthcare system.
It started when an Australian professor from University of New South Wales (UNSW), professor Gordon Parker, received an email from a former patient quite angry that her privacy was breached, reports Kate Aubusson of The Age.
Who Shared 50,000 Australian’s Intimate Lithium Prescription Information?
Well, it turns out, it was Australia’s Department of Health Services. And consequently, the patient had misdirected her anger at professor Parker. Apparently, reports Ms. Aubusson, the the Department of Health (DHS) sent the letter on behalf of the QIMR Berghofer Medical Research Institute research team. They sought to invite participants to consider a study exploring potential biomarkers for bipolar disorder.
The QIMR team sought to have prospective study participants answer an online questionnaire and, if eligible, potentially participate by supplying a saliva sample, which would be used by the QIMR team to extract DNA. It is part of a broader effort to find bipolar treatments. Other studies were calling for participants for DNA samples but they utilized news and social media—not a public health insurance beneficiary database.
Professor Parker was surely concerned, reported The Age. Such recruitment methods raise “serious ethical questions.” Professor Parker noted, “I had no idea [the DHS} kept such a database on people [who] dispensed Lithium, and I suspect many don’t know Medicare is holding this private, identifying data.”
Medical Negligence attorney Tom Ballantyne expressed the need for more rigorous informed consent and improved government transparency about data privacy and protection rules governing how health data is managed and shared.
On the other hand, Ballantyne was quick to note that some very important benefits could result from this kind of research.
The Research Sponsors Response
Professor Sarah Medland of QMIR did not intend for this kind of outcome. The Age reported that she sent an apology letter to recipients who were upset or uncomfortable about being on the mailing list. Medland noted, “We did not intend for there to be any upset or concern.” She continued, saying, “The aim of the study is to try and improve our knowledge of bipolar and find better ways that people can navigate the treatment journey. We were aiming to ensure our sample was as representative as possible so the results were meaningful to the largest number of people.”
The QMIR team sought to recruit 5,000 participants—6,000 people consented to participate and 4,500 actually participated.
Department of Health Services opt out
Now the DHS in Australia has an opt-out policy. Letter recipients can request to be excluded from future mailings.