InSites: New FDA Guidance on Informed Consent

InSites is a recurring commentary dedicated to clinical trial sites – including hospitals and academic medical centers – and their interaction with industry.

On July 16th, FDA released its: Informed Consent Information Sheet: Guidance for IRBs, Clinical Investigators, and SponsorsWhen finalized it will replace the 14-year-old, A Guide to Informed Consent. At 42 pages, it is as long as some informed consent forms (ICFs). Continue reading

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Is There Room for Real Engagement Between Bioethicsts and the Pharmaceutical Industry?

There is currently a lot of tension between bioethicists and the pharmaceutical industry.

On the one hand, bioethicists have had much to say about the ways in which the pharmaceutical industry distorts biomedical research, publication, policymaking, and clinical practice. Bioethicists are also often critical of doctors and policymakers who engage with industry, with many critics viewing such interactions the source of unconscionable conflicts of interest[1].

Supporters of the pharmaceutical industry counter that many critics of the pharmaceutical industry are engaged in a “witch hunt”, based on a naïve, if not paranoid, idea about the complexities of commercial world and the motives of those who engage with it or work within it. It is also argued that bioethicists offer little in the way of meaningful remedies for the problems it they supposedly expose.[2]

To some degree, tensions of this kind are inevitable and healthy, producing the kinds of checks and balances that ultimately benefit everyone concerned. We would not want a world without whistleblowers—people who are prepared to put their own professional, and even personal, wellbeing on the line in order to expose what they perceive to be individual or systemic wrongdoing.

But it could also be argued that no one really benefits from sustained mistrust, suspicion, and reluctance or inability to engage in shared moral deliberation, and that more needs to be done to encourage collaboration between ethicists and industry.

This raises the question: how can bioethicists and the pharmaceutical industry engage in more fruitful debate about morally-charged issues?

One approach that has been increasingly championed in the United States is for companies to employ or contract with bioethicists, who can advise on the management of ethical dilemmas as they arise in practice. While there are good arguments for such arrangements, questions are inevitably raised about, for example, the objectivity of such ethicists, and their capacity to expose wrongdoing in the companies with which they are engaged[3].

Whether or not these perceptions are accurate, they exist, and they underscore the need for there to (also) be bioethicists who sit outside industry, but who understand the nuances of industry, and are able engage meaningfully with those who work within, or with, pharmaceutical companies.

This is not an easy position for a bioethicist to inhabit, but is one that an organisation such as DIA can facilitate*. As a bioethicist who wishes to occupy this “middle ground,” I invite DIA members to offer their ideas as to how we, as DIA members, might move beyond the “hostile interdependence” that characterizes many of the interactions between biomedicine, bioethics and the pharmaceutical industry and engage with one another in shared moral deliberation.

Please respond to this Blog with your ideas—skeptics are most welcome, but constructive suggestions would be much appreciated.

*With this in mind, DIA has established a new Community: “Ethics and the Medicines Lifecycle”

[1]See for example: Elliott C. (2010) White coat, black hat: Adventures on the dark side of medicine. Beacon Press.

[2] See for example: http://www.medscape.com/viewarticle/822145; http://www.sciencebasedmedicine.org/irbs-conflicts-of-interest-and-witch-hunts/; http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2813836/; http://online.wsj.com/news/articles/SB10001424052970204468004577166840760748000

[3] See for example: http://virtualmentor.ama-assn.org/2006/02/msoc1-0602.html

Author Wendy Lipworth is Section Editor for Ethics and Policy for Therapeutic Innovation & Regulatory Science. Dr. Lipworth is a medically trained bioethicist and qualitative social researcher from Sydney, Australia. She is based at the University of New South Wales (Australian Institute of Health Innovation) and Sydney University (Centre for Values, Ethics and the Law in Medicine). Over the course of her Masters degree, PhD and National Health and Medical Research Council (NH&MRC) Postdoctoral Fellowship, she has developed a program of research focused on the ethics of biomedical innovation, with a particular focus on the ethics of drug development, regulation, funding and prescribing. Methodologically, her work is best described as empirical bioethics in which empirical research (e.g. stakeholder analysis) is used in conjunction with theoretical analysis to address real-world problems. 

 

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InSites: Insurance Coverage Analysis in Clinical Trials

InSites is a recurring commentary dedicated to clinical trial sites – including hospitals and academic medical centers – and their interaction with industry.

As we approach the fourteenth anniversary of the effective day of the final rule for Medicare coverage of routine costs in qualified clinical trials (click here for more information),  it is useful to reflect at how little we have progressed toward a rational and efficient system of taking insurance coverage into account in budgets.

Although the stated purpose of the rule was to address under-enrollment of Medicare beneficiaries in clinical trials, it has evolved into a complex set of processes designed to avoid the legal and financial risks of inappropriately billing government  and commercial insurance payers. The process begins with an analysis of the protocol to determine which items and services can legitimately be billed to the payer. Medicare is the typical billing standard. At this first step – the so-called Coverage Analysis – inefficiency and inconsistency reign supreme. Continue reading

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Encouraging Adherence in Treatment

Adherence to medications is key to good outcomes in chronic illness.  Yet studies indicate no real breakthroughs in achieving better adherence.  In all the major conditions where adherence is critical, e.g. control of blood pressure in diabetics, prevention of asthma attacks, anti-platelet and hypolipidemic therapy post myocardial infarction, and adherence rates are dismal.   Continue reading

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First-ever FDA guidance on transferring research oversight from one IRB to another

On May 23, the US Food and Drug Agency (FDA) released its Guidance for IRBs, Clinical Investigators and Sponsors: Considerations When Transferring Clinical Investigation Oversight to Another IRB (http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM398613.pdf). Despite newsworthy events involving transfer of IRB oversight based on research subject deaths and institutional decisions to outsource IRB review dating as far back as 1996, it seems that the highly-publicized shutdown of a commercial IRB in 2009 (http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149565.htm), has driven this first such guidance. Note that FDA Guidance consists of suggestions on what should be done (but isn’t required). Continue reading

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5 Ways to Increase Usage and Citation of your Article

Did you know that more than 85% of traffic to published journal articles comes from Google and Google Scholar searches? If you’ve been published in TIRS, here are some ways that you can help make your article more visible and retrievable for other researchers in your field. Continue reading

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Statin Down the Hatches: OTC Statins- More Questions than Answers

OTC statins. Not a new conversation, but certainly a timely one as we continue to face not just Hyperlipidemia – but medication adherence (and particularly for chronic, asymptomatic conditions).

Are statins “safe enough” to be available without a prescription? Well, with the appropriate caveat that no drug is 100% safe, it’s pretty fair to say that their safety profile is excellent – for Rx products. But is the same true if they were available OTC?

Can a patient self-diagnose and self-dose?  Do symptoms hide another, potentially more serious, underlying condition?  And what of safety concerns?  Continue reading

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What Lies Ahead 2014: Trends to Watch

Have you seen DIA’s What Lies Ahead 2014 report yet? The second annual report was released last month, providing experts’ insights into the year ahead for pharmaceuticals, biotechnology and medical devices.  To read the full report on DIA’s website, click here.

The report identified the top trends in therapeutic innovation and regulatory science, with a three-way tie for the top spot between Patient/Consumer Engagement; Utilizing Big Data; and Regulatory Support of Innovation.

Continue reading

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Statistics in Therapeutic Innovation and Regulatory Decision Making- A Podcast

What is the current role of statistics in medical product development, and what trends will we see in statistics moving forward? The January issue of Therapeutic Innovation & Regulatory Science featured a forward-looking collection of manuscripts to provide insight into these questions. Continue reading

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Patient Power!…Patient Power?

One of the most intriguing aspects of translational science and medicine is the rapid emergence of patient reported outcomes as a priority in biomedical research.  Of course, the most striking efforts are those underway by Patient-Centered Outcomes Research Institute (PCORI) that are fast out of the gate with truly impressive goals and budgets.   Continue reading

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