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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.

What’s the Point of Professional Ethical Codes?

13 Jun, 17 | by Iain Brassington

For a few reasons, I’ve been thinking a bit over the last few months about professionalism and professional codes.  In fact, that’s the topic that’s attracted most of my attention here since… oooh, ages ago.  I find the idea of a code of professional ethics troubling in many ways, but also fascinating.  And one of the fascinating questions has to do with what they’re for.

They can’t be meant as a particularly useful tool for solving deep moral dilemmas: they’re much too blunt for that, often presuppose too much, and tend to bend to suit the law.  To think that because the relevant professional code enjoins x it follows that x is permissible or right smacks of a simple appeal to authority, and this flies in the face of what it is to be a moral agent in the first place.  But what a professional code of ethics may do is to provide a certain kind of Bolamesque legal defence: if your having done φ attracts a claim that it’s negligent or unreasonable or something like that, being able to point out that your professional body endorses φ-ing will help you out.  But professional ethics, and what counts as professional discipline, stretches way beyond that.  For example, instances of workplace bullying can be matters of great professional and ethical import, but it’s not at all obvious that the law should be involved.

There’s a range of reasons why someone’s behaviour might be of professional ethical concern.  Perhaps the most obvious is a concern for public protection.  If someone has been found to have behaved in a way that endangers third parties, then the profession may well want to intervene.  For example: if an HCP knew herself to be a carrier of a transmissible disease but did nothing about it, this would quite plausibly be a matter for professional concern, irrespective of what the law says, or whether anyone had been harmed.  The same would apply if we discovered that a surgeon was unable to function without a large brandy to settle his nerves.  But we’d want to make sure that the professional concern was for the right thing.  It would be inappropriate to sanction someone merely for being a carrier, or for being alcohol dependent.  (Along these lines, it seems defensible to me not to have suspended Martin Royle, a surgeon who falsified prescriptions in order to satisfy his addiction to painkillers.  It’s better to treat an addiction than to punish it.)

A second reason is for the sake of collegiality.  For example, there’s nothing illegal about being  a racist, and there probably shouldn’t be; but it is at the very best distasteful.  Imagine you discover that your colleague is an abiding racist.  It is not hard to see how this knowledge might have implications for your professional interactions – especially (but not only) if you’re a member of one of the groups to which your colleague has a demeaning attitude.  (Indeed, the same might be true if he had used to be a racist, but had changed his attitudes.  I suspect that that’s the sort of thing that might have a fairly long half-life.)  Now imagine that your colleague is a frequent attendee at rallies, held in support of racist policies, that are often associated with threatening behaviour: he doesn’t just dislike some people, but is visibly hostile to them.  That, it seems to me, might be a matter of professional concern, because it will predictably make the working environment much more difficult.  It would be harder to trust this colleague (again, especially but not only if you happen to be a member of one of the groups he hates).  That might be sufficient to raise worries about whether he’s a fit person to do the job in question.  Again, though, there’d have to be a proviso: there is a difference between one’s professional abilities and one’s personal attitudes, and between how one behaves in and out of work.  A surgeon is a surgeon for all that.  So there is a genuine problem here concerning what to do.  But a genuine problem means that there is a cause for concern.

(Indirectly, this second concern might have something to do with public safety, too.  A surgical team in which people are uncomfortable working along side each other may be one in which patient outcomes are affected.  But that would be a further matter, and would not have to collapse into the safety point.  Imagine that the profession is accountancy: it might still be that members of the group would simply be intolerably uncomfortable working alongside their racist colleague, although the audit will still be done perfectly well.  The same will apply in any profession.)

But there’s another factor, which is the status of the profession.  To what extent are professional ethics codes and bodies that judge professionalism in the business of protecting themselves and their high social status?  A couple of recent cases raises that question. more…

No Pain, All Gain: The Case for Farming Organs in Brainless Humans

10 Jun, 17 | by Iain Brassington

Guest post by Ruth Stirton, University of Sussex (@RuthStirton) and David Lawrence, Newcastle University (@Biojammer)

It is widely acknowledged that there is a nationwide shortage of organs for transplantation purposes.  In 2016, 400 people died whilst on the organ waiting list.  Asking for donors is not working fast enough.  We should explore all avenues to alleviate this problem, which must include considering options that appear distasteful.  As the world gets safer, and fewer young people die in circumstances conducive to the donation of their organs, there is only so much that increased efficiency in collection (through improved procedures and storage) can do to increase the number of human organs available for transplantation. Xenotransplantation – the transplantation of animal organs into humans – gives us the possibility of saving lives that we would certainly lose otherwise.

There are major scientific hurdles in the way of transplanting whole animal organs into humans, including significant potential problems with incompatibility and consequent rejection.  There is, however, useful similarity between human and pig cells, which means that using pigs as the source of organs is the most likely to be viable.  Assuming, for the moment, that we can solve the scientific challenges with doing so, the bigger issue is the question of whether we should engage in xenotransplantation.

A significant challenge to this practice is that it is probably unethical to use an animal in this way for the benefit of humans. more…

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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A Plutocratic Proposal: An Ethical Way for Rich Patients to Pay for a Place on a Clinical Trial

8 Jun, 17 | by miriamwood

Guest Post: Alexander Masters and Dominic Nutt
Paper: A Plutocratic Proposal: an ethical way for rich patients to pay for a place on a clinical trial

Is it ethically possible to fund a clinical trial by charging the participants?  We believe we have discovered a way to do it.  Our suggested method has, as far as we know, never been proposed before.

In A Plutocratic Proposal: an ethical way for rich patients to pay for a place on a clinical trial we show how the system could work and argue that all the usual and obvious objections to patient-funded clinical research do not apply in this case; indeed, in several respects the Plutocratic Proposal is more ethical than established methods of funding human experiments.  Furthermore, we believe the Plutocratic Proposal will provide new money for research, particularly for neglected research into rare diseases; it will not deplete the already limited resources of traditional funders.

The ‘usual ethical objections’ include such points as:

  • paying participants could be exploited by research teams desperate to run their trials;
  • research teams might bend their inclusion criteria to accommodate rich patients and so encourage bad science;
  • by enabling research groups to charge patients directly, they can bypass the peer review process and so promote quack ideas;
  • paying patients will attempt to buy their way off concurrent comparison wings, which is not only ethically but scientifically ruinous.

How can a patient-financed funding scheme overcome such fundamental and, until now, apparently insuperable ethical objections?  Read the paper to find out

Nudges in a Post-truth World.

22 May, 17 | by miriamwood

Guest Post: Neil Levy

Full Article: Nudges in  a Post-Truth World

Human beings are motivated reasoners. We find ways to believe what we want to believe, sometimes even in the face of strong evidence to the contrary. This fact helps to explain why so many political issues are intractable, and why so many of us reject the scientific consensus on urgent issues like GMOs, vaccination and climate change. Given the importance of these issues, any means of increasing our responsiveness to evidence deserves exploration.

Nudges – proposals, stemming from the behavioural sciences, for changing the way people act by changing their environments – may be one way of increasing responsiveness to evidence. In my paper, I briefly review evidence that suggests that people resist messages for (apparently) irrelevant reasons, and that by focusing on these reasons, we can make them more responsive to these messages. For instance, people tend to dismiss testimony that comes from those who do not share their political ideology, even when the issue is an empirical one (like climate change). There is evidence that ensuring that the ideology of the source matches the ideology of the audience makes the audience more receptive to the message.

But nudges are ethically controversial. There are a number of reasons why they are controversial, but the central reason is that many people see them as threatening the autonomy of the nudged. It is one thing to address people are reasoning beings, by giving them arguments. It is another to address them as mechanisms, bypassing their reasoning. The truth of claims about vaccines, say, do not depend on who says them, and if we make people more responsive to these claims by altering their source, we manipulate them. We give them causes for their beliefs, not reasons. Or so many people claim.

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How Different are Female, Male and Intersex Genital Cutting?

16 May, 17 | by bearp

By Brian D. Earp  (@briandavidearp), with Rebecca Steinfeld, Goldsmiths, University of London 

Three members of the Dawoodi Bohra sect of Islam were recently indicted on charges of “female genital mutilation” (FGM) in the US state of Michigan. In Norway, meanwhile, one of the major political parties has backed a measure to ban childhood male circumcision.

Fearing that objections to female forms of genital cutting will be applied to male forms, some commentators have rushed to draw a “clear distinction” between them. Others, however, have highlighted the similarities.

In fact, childhood genital cutting is usually divided not just into two, but three separate categories: “FGM” for females; “circumcision” for males; and “genital normalisation” surgery for intersex children – those born with ambiguous genitals or mixed sex characteristics.

In Western countries, popular attitudes towards these procedures differ sharply depending on the child’s sex. In females, any medically unnecessary genital cutting, no matter how minor or sterilised, is seen as an intolerable violation of her bodily integrity and human rights. Most Westerners believe that such cutting must be legally prohibited.

In intersex children, while it is still common for doctors to surgically modify their genitals without a strict medical justification, there is growing opposition to non-essential “cosmetic” surgeries, designed to mould ambiguous genitalia into a “binary” male or female appearance.

Belgian model Hanne Gaby Odiele, for example, has spoken openly about the negative impact of the “irreversible, unconsented and unnecessary” intersex surgeries she was subjected to growing up.

In male children, by contrast, the dominant view is that boys are not significantly harmed by being circumcised, despite the loss of sensitive tissue. Some even point to potential health benefits, although most doctors agree that these benefits are not enough to outweigh the risks and harms. Even so, many people believe that parents should be allowed to choose circumcision for their sons, whether for cultural or religious reasons.

But these attitudes are starting to change. Over the past few decades, and even more strongly in recent years, scholars of genital cutting have argued that there is too much overlap in the physical effects, motivations, and symbolic meanings of these three practices – when their full range across societies is considered – for categorical distinctions based on sex or gender to hold up.

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The Unusual Case of Ian Paterson and Criminally Harmful Surgery

9 May, 17 | by Iain Brassington

Guest post by Alex Mullock, University of Manchester

On 28th April 2017 in the case of breast surgeon, Ian Paterson, the jury in Nottingham Crown Court agreed that in carrying out unnecessary and mutilating surgery the defendant had done what no reasonable surgeon would do.  Paterson was convicted of seventeen counts of wounding with intent to cause grievous bodily harm (GBH) and three counts of unlawful wounding (under, respectively, sections 18 and 20 of the Offences Against the Person Act 1861) against nine women and one man. These ten victims, however, have been reported to represent a tiny proportion of all Paterson’s alleged victims, a group that might amount to hundreds from his many years of practice in the NHS and private sector.

The “obscure motives” that compelled Paterson may forever remain a mystery but it is interesting that the charges against him relate only to patients he treated in his private practice.  This enabled the prosecution to create a narrative that suggested that financial gain could have been the motivating factor for Paterson’s crimes.  Without greed as a possible motive his actions are baffling, and the prosecution’s case, in alleging that surgery which Paterson argued was performed in the patient’s best interests actually constituted GBH or unlawful wounding, would be more challenging because of the medical context of the allegations.  Importantly, the medical exception to the criminal law – the principle that consensual surgery carried out by qualified professionals is legitimate (“proper medical treatment”) – means that there is an assumption that harm caused by surgery is not a matter for the criminal law because it is a risk that we accept in order to enjoy the benefits of surgical medicine.

Even when surgeons make terribly negligent mistakes, English criminal law, interpreted through legal principles established through the courts, means that even recklessly dangerous surgeons need not fear the criminal law.  (An exception may arise if the patient dies, in which case a charge of gross negligence manslaughter might follow.)  Paterson’s conviction is a landmark case, which might have implications for the prevailing assumption that non-fatal surgical violations are not a criminal matter. more…

Gene Editing For A Long Life – A No Brainer?

28 Apr, 17 | by miriamwood

Guest Post: Isabelle L Robertson
Paper: Student Essay- Designing Methuselah: an ethical argument against germline genetic modification to prolong human longevity

I am 16 years old. I am at the start of my life and looking towards my future, deciding on universities, career options and how I want my life to be. At the moment I can expect to perhaps live to 90 years of age. To me, this seems like a pretty good life. If I was offered more would I take it? I’m not sure; perhaps, if my health and independence can be guaranteed, then yes, I might.

Scientists have identified genes in mice that regulate lifespan. They have then edited these genes and have bred mice that have lived a full generation longer than their peers. These genes have their equivalents in the human genome too. Gene editing is becoming more refined by the day and it is predictable that it will one day be technically possible to edit the genome of human embryos to extend their lifespan. Again, extending from mice trials humans with these same genes altered could live to around 130 years old, the equivalent of a whole extra generation.

Gene editing technology brings with it many exciting opportunities such as the possibility of ridding some individuals of disease causing genetic variants. The possibilities extend beyond this though. It is not an unlikely prospect that in my lifetime I will be faced with the choice of deciding if I want my children to have any genetic alterations. These alterations might not just be limited to lifespan extension either; it is foreseeable that enhancements to traits as varied as intelligence, appearance and athletic capability may be potentially on offer. It’s clear that ethical discussion around each of these scenarios is needed. In my paper I have concentrated on whether genetically editing the human genome to extend lifespan is likely to enhance the quality of a person’s life.

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