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Public Health

Not Just About Consent: The Ethical Dimensions of Research Methodology Knowledge in IRBs

15 Jun, 17 | by bearp

Guest Post: Sarah Wieten

The recent article, “Some Social Scientists Are Tired of Asking for Permission” in the New York Times inspired a great deal of debate about the role of institutional research ethics board (IRB) oversight in social science, which some argue is in most cases unlikely to involve significant harm to participants.

While the role IRBs play in sociological research is being re-examined, the importance of IRB oversight for medical research was not similarly called into question. But what exactly does IRB oversight in medical research involve? Should these groups be content with assuring that patients and participants in medical research have provided informed consent? Or do they have wider duties? What is the relationship between methodologically rigorous science and ethical science?

The approval of research projects by IRBs is an integral part of the conduct of research in universities. IRBs ensure that all research follows key ethical guidelines and is pursued for good reason, and in doing so, they aim to keep patients and participants out of harm’s way. IRBs are important gatekeepers of institutional research, and serve as a check on the work of scientists, physicians, and others who are pursuing new knowledge.

We would assume then, that people serving on IRBs have a clear understanding of relevant research design. That way, they can check the research for ethical issues stemming from the methodology. They can also make sure that methodologically poor studies do not proceed, as this would be an unethical waste of resources (and would put participants at risk without a reasonable prospect of gaining reliable knowledge in exchange).

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“NOW’s interest in pharmaceutical gender equity seems to have disappeared with its funding.”

15 Jun, 17 | by Iain Brassington

There’s a remarkable piece on the Hastings Center’s blog by Alycia Hogenmiller about a drug called Addyi.  Addyi is a drug that doesn’t work to treat a condition that doesn’t exist, pushed by campaigners who are actually industry shills.

Sprout Pharmaceuticals, run by Cindy and Robert Whitehead, was determined to obtain regulatory approval for flibanserin (Addyi), an antidepressant-turned-aphrodisiac that had already twice failed to gain approval by the FDA.  To create this fake feminist campaign, Sprout hired Blue Engine Media, a PR firm that created a sham organization called Even the Score. The campaign hired two feminists: a former director of the FDA Office of Women’s Health, and the former president of the Women’s Research and Education Institute – both well-known to women’s groups.  Even the Score recruited and paid consumer advocacy groups to pressure the FDA into approving flibanserin for Hypoactive Sexual Desire Disorder – a condition previously created by industry to sell another drug.

I want to know more about those people hired.  What were they thinking?  What did they think they were doing?  What weren’t they thinking?

It’s sad to see advocacy groups become mouthpieces for pharma.  It is even sadder when those mouthpieces are feminist groups that should be protecting the interest of women but instead are protecting a company’s bottom line.  Every single one of the advocacy groups that don’t take money from pharmaceutical companies opposed Addyi’s approval and use.  For example, the National Women’s Health Network, the Jacobs Institute for Women’s Health, the National Center for Health Research, the Reproductive Health Technologies Project, and the New View campaign all publicly opposed the drug before and after approval.  “This decision to approve flibanserin is a triumph of marketing over science,” said Cindy Pearson, head of the National Women’s Health Network.

[…]

Addyi was never a true symbol for gender equity.  The drug doesn’t work well and was never safe.

Just roll back a bit…

Every single one of the advocacy groups that don’t take money from pharmaceutical companies opposed Addyi’s approval and use.

Whoa.

Several lessons can be learned from the story of Even the Score.  First, don’t trust, support, or listen to purported consumer advocacy groups that take money from pharmaceutical companies.

D’ya reckon?

Go and read the whole thing.  It’s astonishing.

The conference in respect of which the post is written looks good, too.

Appealing to the Crowd: Ethical Justifications in Canadian Medical Crowdfunding Campaigns

8 Jun, 17 | by miriamwood

Guest Post: Jeremy Snyder
Paper:Appealing to the crowd: ethical justifications in Canadian medical crowdfunding campaigns

Medical crowdfunding is a practice where users take advantage of the power of social networks to raise funds related to medical needs from friends, family, and strangers by sharing fundraising appeals online. Popular venues include GiveForward, GoFundMe, and YouCaring, among others. This practice appears to be growing in terms of the number of active campaigns, the amount of money raised, and its visibility. An analysis of five crowdfunding sites found that in 2015 41% of all fundraising campaigns were for medical needs.

Medical crowdfunding has not received a great deal of scrutiny from ethicists or other academics. We are interested in a number of questions related to medical crowdfunding, including determining what reasons are given by campaigners for potential donors to contribute to their campaigns. In order to answer this question, we recorded and analyzed the language used in 80 medical crowdfunding campaigns, focusing on campaigns by Canadians.

We found that the reasons given for donating can be broken into three groups. First, campaigners used personal appeals to encourage giving, focusing their attention on friends and family members who already knew the recipient. This personal connection to the recipient was often framed as creating a reason to give, such as that “we should gather around them as one big family and help as much as possible.” These appeals can be linked to the ethics of care and relational ethics. Second, the depth of the recipient’s need and resulting positive impact of donations were framed as creating reasons to give. These arguments echo justifications found in the duty of beneficence and utilitarian thinking. Finally, campaigners argued that donors should contribute as a way of giving back to recipients who had helped others. These campaigns made the point that the recipient’s generosity created a community debt where “now it’s our turn to help.” In this way, the values of fairness and reciprocity were represented in these campaigns.

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How to Keep HIV Cure-Related Trials Ethical: The Benefit/Risk Ratio Challenge

20 Feb, 17 | by bearp

Guest Post by Nir Eyal

Re: Special Issue of the Journal of Medical Ethics on the ethics and challenges of an HIV cure

For most patients with HIV who have access to antiretroviral treatment and use it properly, that treatment works well. But the holy grail of HIV research remains finding a cure. Sometimes that means a literal, sterilizing cure that would remove HIV from the body. But increasingly the aim is to find a mere functional cure that would send HIV into sustained remission during which antiretrovirals would be unnecessary.

Early successes in cure-related research, most notably the apparent cure of ‘Berlin patient’ Timothy Brown, prompted the International AIDS Society and the US National Institutes of Health to declare cure-related research a high priority. Recent successes in animal models have re-kindled hopes, and cure-related research is ongoing.

But there is a catch. Many of the early-phase cure-related studies that are currently planned or under way carry risks that are either very high or hard to quantify. These risks come from toxicity (e.g., of stem cell transplantation in an immunocompromised population), necessary interruptions to antiretroviral treatment (either short ‘pauses’ or intentionally longer breaks), or invasive physical exams. They affect study subjects and, sometimes, third parties like sexual partners or foetuses.

While high or unknown risks are a mainstay of early-phase trials in areas like cancer research, cure study participants typically have a safe and efficacious alternative to those risks: remaining on antiretrovirals. Can we justify asking patients who are doing well on antiretrovirals to accept the risk and uncertainty of many HIV cure-related trials? If we cannot, we might need to give up on the hope of curing HIV, or of achieving controlled remission.

These ethical questions about HIV cure-related trials were first raised by an activist, then asked again and again. They also arise in human subject research beyond HIV cure-related studies: what should we do when it is hard to keep a socially-important study beneficial in prospect to study participants? Are we ever permitted to compromise the individual’s objective interests in the pursuit of collective goals? What are legitimate ways of pre-empting this dilemma? The entire February 2017 issue of Journal of Medical Ethics is dedicated to clarifying and trying to answer these questions.

After an introduction, the journal issue provides a background by leading HIV-cure related researchers Dan Kuritzkes and Kenneth Freedberg and Paul Sax, as well as myself, a philosopher. Articles by legally-trained bioethicists Rebecca Dresser and Seema Shah and philosopher Caspar Hare suggest ways to quantify and mitigate risks to participants of cure-related studies. Contributions by philosopher Lara Buchak, bioethicist and lawyer Emily Largent, and AIDS activist David Evans assess how much the potential benefits to study participants, ranging from the remote hope of being cured through financial incentives to the satisfaction of having helped others, can legitimately offset any remaining risks. Legally-trained bioethicist George Annas and philosopher Danielle Bromwich explore how much participants’ fully informed consent can count as ample protection in cure-related studies, and when that consent counts as full. Philosophers Dan Wikler, Nick Evans (with first author public health expert Regina Brown), Rahul Kumar, and Frances Kamm assess when, if ever, the potential public health benefits of research—e.g., finding a cure for HIV—can warrant placing individual study participants at high net risk. An afterword asks how these investigations should affect future directions in research ethics.

Many contributions agree that myriad ways exist to justify studies that, at least on the face of it, run counter to the best medical interests of candidate participants. Furthermore, one need not be a utilitarian to argue as much. Even so-called contractualist ethicists such as Rahul Kumar can justify such studies, provocative though they may be for current culture in clinical study oversight. That culture, these articles suggest, is hard to defend from a wide spectrum of ethical theories.

——–

NOTE: This post will be cross-published at BMJ Opinion.

Politicians, Delusional Managers and the Future of the NHS: Have NHS Leaders Failed to “Speak Truth unto Power”?

11 Jan, 17 | by Iain Brassington

Guest Post by David Lock QC

[NB: This is a slightly longer version of a post that appeared on the BMJ blog earlier today.]

Politicians, delusional managers and the future of the NHS:  have NHS leaders failed to “speak truth unto power”?

This blog is not a rant – well not too much of a rant.  It is an expression of serious frustration about the way the NHS is run and about the willingness of senior NHS managers to become complicit in dishonesty.  It also needs to acknowledge the brave role of some in the NHS – particularly in NHS Providers – who keep telling it as it is and being decried for doing so.

Everyone at the frontline knows the NHS is running on empty.  The more perceptive know that more money for the NHS alone will not improve services for patients.  But – and this is perhaps the unpopular “but” – NHS senior managers ought to accept their share of the responsibility for the present crisis.  The problem is the failure of NHS managers to “speak truth unto power” to those above them and to our political masters for too many years.  Long before Sir Ivan Rogers used the phrase, a 2015 FCO blog explained the centrality of this concept as part of public service as follows:

The UK Civil Service doesn’t have an official motto – but if it did, it would almost certainly be: “speak truth unto power”. It’s a maxim that’s in the blood of good civil servants, even if they know that it won’t make their lives any easier. The best politicians learn to cherish civil service advice which points out the flaws in their arguments. The worst surround themselves with sycophants who create a micro-climate which wraps a warm embrace around their worst tendencies.

But, this principle appears respected in the breach in the NHS.   The £22bn efficiency challenge came out of nowhere and yet became an article of faith.  Of course, it has not been delivered and was never going to be delivered, but the planning process has continued in a parallel universe where no one has the courage to say “Actually this is nonsense – a public service has never delivered these efficiency savings and the NHS will not do so”.  So the fiction is maintained that this is what the NHS has to do by 2020.  But, of course, we are now in 2017 and so there is precious little time to deliver the undeliverable.

Secondly, the fiction is that the present government is putting an extra £10bn into the NHS, as well as promising an extra £350m per week as a Brexit dividend.  The £10bn claim was never accurate.   No set of “true and fair” NHS accounts could ever include the £10bn claim.  The £350m a week claim was made for votes, not for spending.  And yet who in the NHS has held the government to account for either promise? more…

Sex and Other Sins: Public Morality, Public Health, and Funding PrEP

8 Oct, 16 | by bearp

Guest Post by Nathan Emmerich

In the UK, a recent high-court decision[1] has reignited the debate about whether or not Pre-exposure Prophylaxis (PrEP) should be provided to those who are deemed to be at high-risk of contracting HIV.[2] Despite the fact that NHS England is now appealing,[3] it was a fairly innocuous decision: having suggested that they were barred from funding PrEP, the court ruled that it would be legal for the NHS to fund PrEP and that they should therefore consider doing so.3

What is less innocuous are debates about whether or not access to PrEP should be publicly funded at all. Whilst individuals report being able to buy a month’s supply online for around £45,[4] the annual cost of the drug to the NHS could be more than £4,000 per patient. Although this may seem a relatively exorbitant expense, it makes economic sense to provide PrEP; doing so could prove to be cheaper than providing treatment[5] to those who would otherwise become HIV positive.

Despite this sound economic rationale, the media, or certain sections of it, have predictably focused on one particular group who are candidates for the drug as they are at higher risk of contracting HIV: homosexuals. In particular, the debate has centred on promiscuous gay men or, to use the academic term, men who have sex with men. This includes individuals who regularly have sex with new partners, as well as those who engage in protected and unprotected group sex.

Perhaps as a result of this focus, the view that public funds should not be used for PrEP[6] seems fairly widespread. But while public acceptance has not yet been fully achieved, the Equality Act (2010)[7] means that it is illegal to discriminate against individuals on the basis of protected characteristics[8] such as sexual orientation.[9] We should, therefore, be concerned that arguments against funding PrEP might be motivated by some degree of homophobia.[10] If this charge is to be answered then we need to consider the arguments for and against the funding of PrEP in more detail.

There are, of course, plenty of other social groups that could benefit from PrEP, including some who are stigmatised, such as sex workers, and others who tend not to be, such as monogamous sero-discordant couples (i.e., a monogamous couple, one of whom is HIV positive and one of whom is not). However, reading the commentary on this issue would seem to indicate that the disinclination to fund PrEP is not applied equally. Thus, providing PrEP to hetero- or homo-sexual couples seems to attract support, but this is not extended to those whose sexual practices involve promiscuity.

As such, it would seem the opprobrium at work in this matter is primarily directed at non-monogamous ‘lifestyles’ and with sexuality playing a secondary role.

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A World Without Bioethicists? On Sally Phillip’s “A World Without Down’s”

8 Oct, 16 | by bearp

Guest Post by Nathan Emmerich, Queen’s University Belfast

On Wednesday night, BBC2 broadcast a documentary entitled ‘A World Without Down’s Syndrome?’ Even if you did not see the programme itself, you may have heard about it on the radio, read some of the commentary published over the past week, or spotted it on Twitter under the hash tag #worldwithoutDown’s. In my case, it was the presenter Sally Phillips’s appearance on Frank Skinner’s On Demand, that first drew my attention to the programme. There, Phillips talks about Peter Singer’s appearance on HARDtalk (in which he discusses related issues) and – whilst she is hardly alone in doing so – I felt that she misunderstood what Singer has to say. As a result I intended to watch the documentary to see which bioethicists appeared and if their views were represented accurately.

Despite the programme consisting of Phillips speaking with various people involved with questions re: testing for Down’s Syndrome – including doctors, scientists, individuals with the syndrome and their parents, those who run support groups and one brave women who had terminated a pregnancy following a positive test for Down’s – she did not actually speak to a bioethicist or, indeed, explicitly discuss any bioethical ideas.* Thus, whilst one could think that this documentary was about a bioethical issue – prenatal testing and screening for Down’s Syndrome – there was not any real discussion of the matter from a bioethical perspective.

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Should Junior Doctors Still Strike?

20 Sep, 16 | by bearp

Guest Post by Adam James Roberts

In early July, the British Medical Association’s junior members voted by a 16-point margin to reject a new employment contract negotiated between the BMA’s leadership and the Government. The chair of the BMA’s junior doctors committee, Johann Malawana, stood down following the result, noting the “considerable anger and mistrust” doctors felt towards the Government and their concerns about what the contract would mean “for their working lives, their patients and the future delivery of care” in the National Health Service (the NHS).

The BMA pressed the Government to reopen negotiations and to reverse its decision to impose the contract unilaterally. Those appeals having been rebuffed, the BMA announced two months later a new programme of strikes, citing concerns about the impacts on part-time workers, “a majority of whom are women”; on those doctors who already work the greatest number of weekends, “typically in specialties where there is already a shortage” of staff; the contract’s implications for the ability of the NHS to “attract and keep enough doctors” into the future; and the lack of an answer as to how the Government would manage to staff and fund the extra weekend care which was so often drawn on to justify pushing that new contract through.

Earlier this year, Mark Toynbee and colleagues argued in the JME that the earlier rounds of strikes by British juniors were probably ethically permissible, noting that emergency care would continue to be available, that the maintenance of patient well-being was apparently a goal, and that the strikers felt they were treating industrial action as a last resort. In a later paper, I attempted to outline and apply an ethical framework drawing on Thomist ‘just war’ theories, reaching the same conclusion about the strikes as Toynbee did.

In this guest post, I attempt to update or supplement that literature, considering some of the more recent and popular arguments against the current rounds of strikes and whether any of them might be morally compelling. In particular, I look at the fact that the BMA’s junior leadership had described the rejected offer as “a good deal”; the argument that strikes are a disproportionate response to the remaining issues; the concerns voiced about the strikes by Britain’s General Medical Council; and the allegation that striking doctors are “playing politics”.

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Gouging

26 Aug, 16 | by Iain Brassington

Jumping to the defence of pharmaceutical companies over their pricing policies isn’t fashionable – and a lot of the time, it’s not going to end prettily.  But it’s perfectly coherent to think that the profit motive is one of the motors of innovation, and that it’s part of the quid pro quo for spending money on drugs that may do nothing; in fine, that the profit motive may actually be a necessary part of getting the good stuff we want.  To an economist, the phrase “normal profit” means the minimum profit necessary to keep a firm going – where average revenue equals average total cost.  But if that was all that was on offer, there’d be no incentive to enter a market in the first place: if you’re (on average) in the same place as you were before entering the market, why bother?  So it’s reasonable to think that there ought to be some level of supernormal profits.  They help ensure we get a world that’s better tomorrow than it was yesterday.

On this account, the problem is not with making a supernormal profit – oh, all right then: what in everyday English we’d simply call a profit – but with gouging and/ or profiteering.  The question that needs to be addressed is one of what level of profit, and what kind of return on investment, is reasonable.  In some sectors of the economy, it may be quite high.  For example, if I can manufacture a luxury good for which people are willing to pay through the nose, and make a stonking great profit from it… well, all hail me.  In other sectors, this will not be the case.

The determinants of the level of acceptability will depend on all kinds of factor.  It’s a complicated question, and it may defy satisfactory answers from time to time.  All the same: one doesn’t have to be able to say that or why x is good in order to be able to say that y stinks.  The story about EpiPen pricing that’s emerged over the last week or so is one such case.

Here’s the story: EpiPens deliver a dose of adrenaline, and are therefore very useful in cases of allergic reaction.  Adrenaline is not expensive, but delivering it via a syringe is cumbersome; EpiPens make it much simpler.  Mylan Pharmaceuticals obtained the rights to the device in 2007; since then, the price has risen by somewhere between 400 and 500% in the US (different sources offer different amounts; but a pack of two EpiPens costs about $415 in the US, and about $85 in France).  That’s bad enough on the face of it, though Mylan CEO Heather Bresch does apparently have a defence, as Fortune explains: more…

What is a Moral Epigenetic Responsibility?

23 Aug, 16 | by miriamwood

Guest Post by Charles Dupras & Vardit Ravitsky

Re: The ambiguous nature of epigenetic responsibility

Epigenetics is a recent yet promising field of scientific research. It explores the influence of the biochemical environment (food, toxic pollutants) and the social environment (stress, child abuse, socio-economic status) on the expression of genes, i.e. on whether and how they will switch ‘on’ or ‘off’. Epigenetic modifications can have a significant impact on health and disease later in life. Most surprisingly, it was suggested that some epigenetic variants (or ‘epi-mutations’) acquired during one’s life could be transmitted to offspring, thus having long-term effects on the health of future generations.

Epigenetics is increasingly capturing the attention of social scientists and ethicists, because it brings attention to the importance of environmental exposure for the developing foetus and child as a risk factor for common diseases such as cardiovascular, diabetes, obesity, allergies and cancers. Scholars such as Hannah Landecker, Mark Rothstein and Maurizio Meloni have argued that epigenetics may be used to promote various arguments in ongoing debates on environmental and social justice, as well as intergenerational equity. Some even suggested that epigenetics could lead to novel ways of thinking about moral responsibilities for health.

Is it fair that disadvantaged populations are exposed to an inequitable share of harmful environments – such as polluted areas – that are epigenetically-detrimental to their health? Who should be held responsible for protecting children and future generations from epigenetic harm induced by their environments? Should we hold the parents accountable for detrimental epigenetic impact of their behavior on their children? And how should we manage the possible risks of stigmatization and discrimination of people that we consider blameworthy of inflicting epigenetic harm on others? These sensitive questions call for a nuanced investigation of the impact epigenetics can have on our understanding of moral responsibility.

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