China’s pharma scandal and the ethics of the global drug market

China is in the midst of conducting a series of corruption investigations of pharmaceutical companies that have been operating in the country. It all started with the investigation of officials from pharmaceutical company GlaxoSmithKline, who were reportedly engaged in “bribery and corruption” in China. The officials apparently used travel agencies to funnel illegal payments to doctors and government officials. That was in July. In August, Associated Press reported French drug company Sanofi was being investigated for bribing Chinese doctors in 2007. And late last week, South China Morning Post reported that German pharmaceutical conglomerate Bayer had joined the ranks of companies being investigated by the Chinese. That report mentioned pharmaceutical companies Eli Lilly, Novo Nordisk, H Lundbeck, AstraZeneca and UCB had also been contacted by Chinese investigators. This wide-ranging, ongoing scandal highlights the many regulatory and ethical challenges of globalised drug developmen

Giving up the ghost: exorcising biomedical research articles

In 2009, medical editors from around the world gathered at a Peer Review Congress in Vancouver, Canada, to discuss, among other things, “ghost authorship” of medical research articles. Ghost authorship of such articles involves deliberate suppression of the fact that it’s been written by someone other than the named author or authors. In most cases of academic ghost authorship, (not to be confused with ghost authorship of sporting “autobiographies"), an article is written by a professional medical writer who is commissioned or employed by a pharmaceutical company. The name of this ghost author is suppressed and the only names that appear on the article are those of researchers. These “authors” (sometimes referred to as “guest authors”) are often prominent academics who might have been involved in conducting the research, but not in writing the article itself. Evidence presented at the Vancouver conference suggested approximately one in ten research articles submitted to major medical journals has a ghost author

Shifting power relations and the ethics of journal peer review

Background: Peer-review of manuscripts has recently become a subject of academic research and ethical debate. Critics of the review process argue that it is a means by which powerful members of the scientific community maintain their power, and achieve their personal and communal aspirations, often at others’ expense. This qualitative study aimed to generate a rich, empirically-grounded understanding of the process of manuscript review, with a view to informing strategies to improve the review process. Method: Open-ended interviews were carried out with 35 journal editors and peer reviewers in the UK, USA and Australia. Results: It is clear from this research that relations of power and epistemic authority in manuscript review are complex and dynamic, may have positive and negative features and that even where power is experienced as controlling, restrictive and illegitimate, it can also be resisted. Conclusions: The manuscript review process is best thought of not in terms of simple dominance of reviewers and editors over authors, but rather as a shifting ‘net’ of power relations. These complex power relations need to be understood if reviewers are to be encouraged to participate in the process and to do so in the the most ethical and effective manner

Academics on the payroll: the advertising you don’t see

In the endless drive to get people’s attention, advertising is going ‘native’, creeping in to places formerly reserved for editorial content. In this Native Advertising series we find out what it looks like, if readers can tell the difference, and more importantly, whether they care. Academic medical researchers are hot property for companies marketing pharmaceuticals, complementary medicines, medical devices, fitness equipment, weight loss products, “health foods” and other health-related goods and services. Their opinions are highly respected by the general public, and their endorsement in the media of a product can help to ensure consumers and patients purchase it, or at least discuss it with their “health care provider”. But this raises a question: why would an academic researcher choose to endorse a health-related product in the general media? The most worrying explanation is that the academic is being employed by the company to speak favourably about its product. Such commercial relationships are rarely made transparent and rely on a public perception that academics are objective observers and commentators. For the most part, however, this is unlikely to be the case. A far more likely explanation is that any academic endorsement occurs in the context of a long and mutually productive relationship with the company concerned. Academics are frequently targeted by companies on the grounds that they provide authority and act as “key opinion leaders” who are able to influence the opinions, beliefs and behaviours of others in both professional and public arenas. This relationship with industry is frequently one of many. Academics who comment on products have frequently partnered with the company in its clinical trials of the product; put his or her name to the resulting academic publications; provided strategic advice on how to have the product regulated and perhaps subsidised by the government; or given talks to other academics and clinicians about the research (if not the product itself).NHMR

Forget tea and biscuits, why should doctors get any gifts from pharma companies?

The Australian Medical Association (AMA) and medical specialist groups are currently debating public disclosure of gifts received by doctors from pharmaceutical companies. The bone of contention is how valuable the freebies need to be before the doctor has to declare them. The debate has arisen in the context of a review of Medicines Australia’s Code of Conduct – a document produced collectively on behalf of the Australian pharmaceutical industry to guide the behaviour of member companies. In keeping with similar moves overseas, Medicines Australia is proposing to mandate disclosure of gifts and payments to doctors, starting in 2015, and is currently seeking stakeholder input into the technicalities of such a move.NHMR

Why drug shortages are an ethical issue

Drug shortages are a growing problem in developed countries. To some extent they are the result of technical and organisational failures, but to view drug shortages simply as technical and economic phenomena is to miss the fact that they are also ethical and political issues. This observation is important because it highlights both the moral and political imperative to respond to drug shortages as vigorously as possible, and the need for those addressing shortages to do so in ethically and politically sophisticated ways. This brief article outlines the ethical issues that need to be considered by anyone attempting to understand or address drug shortages

Consent to Biobank Research: Facing Up to the Challenge of Globalisation

There is broad agreement that open-ended consent to research involving banked specimens and associated data is morally justifiable. Importantly, this approach is justifiable if, and only if, clear mechanisms are in place for 1.ethical and scientific oversight, and 2. ongoing communication with tissue donors. The problem for those in favour of open-ended consent for research is that biobanks have the greatest potential as resources for translational research if they are networked - both nationally and internationally. And as networks, by definition, require that custodianship of samples be relinquished at some point, this makes it difficult, if not impossible, to guarantee sound ethical and scientific oversight and to promise ongoing communication with donors. Unless the reality of globalisation is addressed head on, even the most thoughtful ethical proposals, such as that put forward in this article, will soon be obsolete.NHMR

Do consumer groups really advocate for the public interest?

The Guardian recently claimed to have exposed an attempt by a number of pharmaceutical companies to thwart efforts by the European drug regulator (the European Medicines Agency) to have all clinical trial data made available to the public. The tactic is apparently being used by industry, and coordinated by the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA). The idea is to mobilise patient advocacy groups to campaign against greater transparency on the grounds that information might be misinterpreted and cause health scares. Several companies have denied using such a strategy, while others have refused to comment

Where to now for health-related journal peer review?

Peer review of health-related manuscripts has enormous power in determining what is published in health-related journals, and what makes its way into health policy and clinical practice. However, peer review is at times ethically problematic and not always effective in achieving its goals. Over the past 25 years, a large number of debates about, and studies of, the peer review process has been published. Despite this, there is limited agreement about the strengths and weaknesses of peer review, and limited evidence about whether peer review achieves its goals and whether interventions to improve it have been successful. The authors argue that this state of affairs is not acceptable and that there is a need to systematise efforts to understand and improve the review process

There’s more to Pradaxa’s problems than meets the eye

Pharmaceutical companies don’t have a particularly good reputation, for some very good reasons. But we can’t let suspicions about the motives of such companies cloud our assessments of drug safety because patients may also suffer. People with abnormal heart rhythms and other diseases that cause blood clots (thromboses) often require blood-thinning (anticoagulation) medications. For many decades, warfarin has been the most widely used such drug but it’s associated with a risk of bleeding (including fatal haemorrhage) and requires regular blood tests to monitor safety and efficacy. So the advent of new oral anticoagulant drugs was heralded as a major advance by both patients and clinicians – principally on the grounds that they appeared as effective as warfarin, may be associated with a lower risk of serious bleeding, and are cost-effective because patients don’t need ongoing blood monitoring. For these reasons, a number of these new drugs, including dabigatran (Pradaxa) and rivaroxaban (Xarelto) were fast-tracked through the regulatory approval processes in the United States and in New Zealand. Emerging problems But reports now suggest Pradaxa might be less safe than it appeared to be in clinical trials. Specifically, it’s claimed the drug may be responsible for higher-than-expected levels of abnormal bleeding, including hemorrhagic strokes, and that it may, in fact, be less safe than warfarin