a reform proposal that would preclude bias in clinical trials used to test drugs that is inherent in the current system where the pharmaceutical firms sponsoring the drug designs the clinical trial and selects the researchers who will conduct the research. Under the current approach manufacturers can frame the research in a way that biases the result. Moreover, organizations that perform the research depend on the pharmaceutical firm sponsor for their income, an arrangement that fosters dependency corruption. The reform proposal would remove all drug firm influence on the design and conduct of clinical trials used to decide whether to allow marketing of a drug. A federal agency would select the researchers to design and conduct the phase II and III clinical trial, or the clinical trial would be conducted by an independent government agency. The pharmaceutical firm that wished to market the drug would be required to finance the clinical trial. Between the late 1950s and 1980s, reformers and congressional leaders championed variations of this proposal, but pharmaceutical industry opposition blocked its enactment and so the federal government pursued alternative strategies, which have proved ineffective. By the mid-1990s, scandals prompted several leaders in drug policy and research to again advocate legislation to require independent drug testing. The paper concludes by the discussing difficulties that will arise in implementing this proposal and how these can be overcome.Looking further afield, last month we reached an unrecognised inflection point in the history of health ‘big data’.
US-based medical giant Merck announced an agreement with Israel’s Maccabi Healthcare to “leverage Unique Real-World Database to Inform Novel Health Approaches”.
Maccabi is a comprehensive health maintenance organisation, which operates pathology facilities, hospitals, nursing homes, pharmacies, pathology facilities and ‘wellness’ centres. It has invested heavily in information technology over the past two decades and now has electronic information about its over two million members. That membership accounts for around a quarter of Israel’s population. The Maccabi data encompasses records about medical conditions that are attributable to lifestyle, for example cancer and heart-lung disease associated with smoking or cancer associated with too much time in the sun. It also encompasses conditions that are associated with the genetic profile of particular demographics.
The announcement indicates that the two organisations will use their
technical and information research capabilities to draw insights from Maccabi’s data to support personalized health care delivery strategies across several therapeutic areas, including prevalent and costly chronic diseases ... the parties seek to enable better understanding of unmet patient needs, real-world outcomes achieved with medical treatments, and optimal approaches for improving patient adherence. That understanding will be based on analysis of Maccabi’s fully integrated, electronic, de-identified patient data.The sharing is expected to
support personalized health care delivery strategies across several therapeutic areas, including prevalent and costly chronic diseases ... enable better understanding of unmet patient needs, real-world outcomes achieved with medical treatments, and optimal approaches for improving patient adherence”.What is the significance of the partnership for Australian health researchers, insurers and regulators?
From a research perspective the announcement is exciting because it is the first time ‘Big Pharma’ has acquired access to comprehensive health data about 25% of a nation’s population, as distinct from the more limited DNA collection undertaken by deCODE (subsequently acquired by AMGEN) in Iceland, which reportedly covered around half of that nation's 320,000 population. The deidentified Maccabi data is not a one-off snapshot. Instead it reportedly covers a period of twenty years and will apparently be provided on an ongoing basis.
Merck indicates that the data will be deidentified – (pseudonymised or more comprehensively anonymised?) but the partners are likely to face questions about the potential for what's typically characterised as deanonymisation or reidentification.
From a competition policy perspective the announcement is interesting. Many researchers would presumably love to have access to the information but will be excluded, given that the data will apparently be restricted to Merck and that corporation’s partners. The increasing scholarly literature about a global ‘right to health’ has not yet engaged with notions of a right of access to fully or partly anonymised longitudinal health data. That data typically remains a commercial commodity, for sale to the highest bidder apart from restrictions under national privacy law.
Perceptions of the commercial value of large longitudinal health data sets will pose a challenge for Australian insurers and regulators, particularly amid talk about privatising Medicare, Australia Post and other icons. Would a major lifesciences enterprise want to buy privileged access to the anonymised data of most of the Australian population over the past decade through a deal with Medicare? What about buying a smaller dataset from one of the private sector health insurers? One pointer, as noted in a forthcoming article, was the partnership between insurer NIB and an offshore enterprise that offered direct to consumer genetic testing.
