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Regulation and Regulators

“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.

Individually-Randomized Controlled Trials of Vaccines Against the Next Outbreak

11 Apr, 17 | by miriamwood

Guest Post: Nir Eyal, Marc Lipsitch

Paper: Vaccine testing for emerging infections: the case for individual randomisation 

The humbling experience of international response to Ebola taught the world a thing or two on preparing for Zika and for other emerging infections.

Some of those lessons pertain to vaccine development against emerging infections. One lesson was that vigorous vaccine development should start long in advance of outbreaks. CEPI, the Coalition for Epidemic Preparedness Innovations, was recently launched with an initial investment of half a billion US dollars from the Gates Foundation, Britain’s Wellcome Trust and the governments of Japan, Norway and Germany. There is also growing recognition that best practices on vaccine testing should be developed prior to outbreaks, from a study methodology viewpoint.

By contrast, in Zika, ethical guidelines on response in general and on an aspect of vaccine testing were created only once the pandemic erupted. Shouldn’t ethical disputes, e.g. on trial design for vaccine candidates, be ironed out in advance of emerging infections?

One persistent ethical question in vaccine testing pertains to individually-randomized control in efficacy trials. At the height of the 2014-5 Ebola outbreak, individually-randomized controlled trials were much maligned. Our paper at the Journal of Medical Ethics sets out to defend that approach for vaccine efficacy testing in emerging infections, including highly fatal and untreatable ones in developing countries.

more…

The Deadly Business of an Unregulated Global Stem Cell Market

30 Mar, 17 | by miriamwood

Guest Post: The deadly business of an unregulated global stem cell industry

Tereza Hendl and Tamra Lysaght

In our paper, we report on the case of a 75-year old Australian woman who died in December 2013 from complications of an autologous stem cell procedure. This case was tragic and worth reporting to the medical ethics community because her death was entirely avoidable and the result of a pernicious global problem – doctors exploiting regulatory systems in order to sell unproven and unjustified stem cell interventions.

The patient at the centre of this case, Sheila Drysdale, underwent a liposuction procedure administered by cosmetic surgeon, Dr Ralph Bright, at his private Sydney clinic. Dr Bright did not perform this procedure for cosmetic reasons, but rather to ‘treat’ her advanced dementia with adipose (fat) derived stem cells. Mrs Drysdale died within ten hours of the surgery. Following an inquest into her death, the New South Wales Deputy Coroner stated that the utilisation of stem cells to ‘treat’ dementia was “highly questionable” and displayed “some of the hallmarks of ‘quack’ medicine,” particularly owing to the lack of scientific evidence supporting such ’therapy.’ The Coroner, thus, called for a more rigorous regulation of ‘innovative’ medical procedures in Australia that would protect vulnerable patients. Sadly, the relevant regulatory authorities have done very little to bring about any justice for Mrs Drysdale, or to address the systemic problems in Australia’s legislative framework that allows medical professionals to offer unproven stem cell-based interventions to patients without any accountability.

more…

Combating Doping in Sports: More of the Same or What?

7 Feb, 17 | by miriamwood

Guest Post: Bengt Kayser and Jan Tolleneer

Paper: Ethics of a relaxed antidoping rule accompanied by harm-reduction measures

Doping in sports continues to be prominently present in the media. Regularly ’scandals’ surface that then trigger flurries of articles, documentaries and reactions in the media. The general tone is one of moral opprobrium, dopers are considered deviant and bad. Frequently these episodes are accompanied by arguments for more means for repression of doping. These efforts, in principle coordinated by the World Anti Doping Agency (WADA), aim at eradicating doping from sports.

Doping is  considered cheating and dopers are bad. But despite increasing means doping remains rife, leading to what some call an arms race in a war on doping. Anti-doping still continues to cling to its essentialist objective, getting rid of this behaviour, even though it appears increasingly clear that this objective cannot be reached. Already today athletes have to comply with exceptional rules, such as the obligation to inform about their whereabouts 365 days a year in order to allow in and out of competition unannounced urine and blood sampling for anti-doping controls. But calls for more means and more repression resound. Increasingly countries, pressurized by the International Olympic Committee and WADA, introduce criminal law to repress doping, in several countries also applicable to non-athletes.

But repression of human behaviour comes with a cost. Prohibition of alcohol in the USA in the first part of the last century is good example, as is the so-called war on drugs. Like the latter, anti-doping also has unintended side-effects and it is possible that the overall societal cost of anti-doping may surpass the positive effects of anti-doping. The question then arises if there exist alternative approaches to dealing with doping. But so far the only two discourses on alternatives for dealing with doping focus on either repression or liberalisation.

In our recently published paper in the Journal of Medical Ethics we argue that there is an ethically acceptable alternative somewhere mid-stance. Our point of departure is a partial relaxation of the anti-doping rule, accompanied by harm reduction measures, in a dynamic setting, i.e. adaptable over time in reaction to what the effects would be. We develop our arguments on five levels: (1) What would it mean for the athlete (the self)? (2) How would it impact other athletes (the other)? (3) How would it affect the phenomenon of sport as a game and its fair play basis (the play)? (4) What would be the consequences for the spectator and the role of sports in society (the display)? and (5) What would it mean for what often is considered as essential to being human (humanity)? Our analysis suggests that a partial relaxation of the anti-doping rule accompanied by harm-reduction measures appears ethically defensible on all five levels. Our proposed alternative framework thus potentially provides an escape from the present spiralling towards criminalisation of doping and doping-like behaviour in society. It is time to start discussing the practical details of such a policy change and to start experimenting.

Professional Codes and Diagnosis at a Distance

6 Feb, 17 | by Iain Brassington

This is the second part of my response to Trish Greenhalgh’s post on the propriety of medics, psychiatrists in particular, offering diagnoses of Donald Trump’s mental health.  In the last post, I concentrated on some of the problems associated with making such a diagnosis (or, on reflection, what might be better called a “quasi-diagnosis”).  In this, I’m going to concentrate on the professional regulation aspect.

Greenhalgh notes that, as a UK medic, she is bound by the GMC’s Duties of a Doctor guidance,

which – to my surprise – does not explicitly cover the question of a doctor’s duty towards a public figure who is not his or her patient.

[…]

My reading of the GMC guidance is that in extreme circumstances, even acknowledging the expectation of how doctors should normally behave, it may occasionally be justified to raise concerns about a public figure (for example, when the individual is relentlessly pursuing a course of action that places many lives at risk). Expressing clinical concern in such circumstances seems to involve a comparable ethical trade-off to the public interest disclosure advice (Duties of a Doctor paragraphs 53-56) that breach of patient confidentiality may be justified in order “to prevent a serious risk of harm to others.”

Well, to be honest, it’s not that much of a surprise to me that the GMC guidelines doesn’t stretch to public figures – but that’s a minor point.

The more interesting thing for me is what the relationship is between the practitioner and the GMC.  Greenhalgh ends her post by saying that she “wrote this blog to promote further debate on the topic and invite the GMC to clarify its position on it”.  But why should the GMC’s position be all that important?

OK: I’m going to go off on a bit of a tangent here.  Stick with me. more…

Chappell on Midwives and Regulation

2 Feb, 17 | by Iain Brassington

Richard Yetter Chappell has drawn my attention to this – a blog post in which he bemoans the Nursing and Midwifery Council’s rules about indemnity insurance, and the effects that they’ll have on independent midwives.  (I’d never heard of independent midwives – but an IM – according to Independent Midwives UK – is “a fully qualified midwife who has chosen to work outside the NHS in a self-employed capacity”.)  In essence, what’s happened is that the NMC has ruled that the indemnity cover used by some IMs – around 80, nationwide, according to some reports – is inadequate; these 80 IMs (out of 41000!) are therefore barred from working.

I’ve got to admit that this seems like a bit of a storm in a teacup to me.  For sure, there may have been infelicities about the way that the NMC handled its decision.  That may well be unfortunate, but it may not be all that much to get excited about.  However, Chappell makes two particularly striking points.  The first is his opening claim, in which he refers to this as “a new low for harmful government over-regulation”.  Well, it’s not really government overregulation, is it?  It’s the NMC.  Governing bodies are not government.  And whether it’s overregulation at all is a moot point: we need more information about what the standard is by which we should assess any regulation.  That leads us to the second striking thing that Chappell says, to which I’ll return in a moment.  Whether it’s harmful is also a moot point.  I mean, it may be true – as he points out – that the decision will have an undesirable impact on the relationship between some women and their chosen midwife.  But that won’t tell us anything about whether the policy is desirable all told.  It’s certainly not enough to warrant calling it “unethical” – and to dub something unethical is not a moral argument.

The second striking thing is this: more…

Professionalism, or Prying?

3 Jan, 17 | by Iain Brassington

“Professionalism” is a funny thing.  About this time last year, I was struggling to get a new course written for the coming semester; it was on professional ethics for lawyers.  A colleague made a comment along the lines that I must be spending a lot of time looking at the professional codes; I replied that I’d be spending almost none doing that; she looked baffled and wandered off, presumably convinced that I was joking.

I wasn’t joking.  I did look a little at the professional codes, but only as a jumping-off point.  My schtick was more like, “Here’s what the SRA says about client confidentiality; now let’s spend the remaining 98% of this lecture looking at why it might say that, and whether it ought to say something different”.

Yet, as I wrote the lectures, professionalism – not professional codes, but professionalism – did keep cropping up.  After all, if you’re going to talk about lawyers’ ethics, or doctors’ ethics, or engineers’ ethics, the implication has to be that there’s something quite specific that applies to each of those professions, otherwise it just collapses into… well, ethics; and it might be that there is a clear way to define who belongs to the profession, and a clear hierarchy, and that it is proper (or, at least, it may be proper) that there is some sort of pressure exerted by that hierarchy that shapes behaviour in a way that neither the law nor standard social norms do.  There are some things that are regulated by professional ethics that aren’t regulated by bog-standard ethics.  To return to the lawyers’ example, there might be certain things that are acceptable or even required from a lawyer that wouldn’t be in other cases, and other things that are unacceptable that are trivial outside the profession; and the same might apply to medics.  (In passing, I think that that might be one of the fault lines in academic medical ethics: those of us that come from a philosophical background understand “ethics” to mean one thing, and those of us who come from a medical or, in at least some cases, a social science background understand it to mean another.  We normally rub along fine, but sometimes we are talking at cross-purposes.)

A range of problems arises from that, though.  For example, though codes of ethics might attempt to codify what it is that’s demanded by professionals, they’re often rather vague, or presuppose a heck of a lot that’s actually rather important.  That can lead to situations in which it’s impossible to tell what’s required on the ground.  “Maintaining the reputation of the profession” is a concern of some of the professional codes I’ve seen, though quite what that means is anyone’s guess, since it might collapse to “doing whatever keeps the public on side, no matter how senseless”; and while that might maintain esteem in one sense, it does so only by undermining the concept of professional integrity.

A second problem comes from the need to know what things are properly within the “professional” remit, and what professional bodies have any business talking about.  The difficulty here is that “professionalism” implies living a kind of life; being a professional involves being a certain kind of person.  One doesn’t stop being a professional when the end-of-shift klaxon goes.  And yet there’re certain things that do have nothing to do with professional regulation: whether or not to be teetotal is not a professional matter, and a professional body that tried to involve itself in such decisions would be stepping over the line.  Still, where the line should be drawn may not be obvious.

All of this brings me to this blog post over on the BMJ blog, in which Niro Kumar considers doctors and dating apps. more…

Trump’s Anti-Regulator

12 Dec, 16 | by Iain Brassington

In the latest edition of “Dude, really?” news to come from the post-election US…

Wait: let me start that again.  In the latest edition-that-I’ve-had-time-to-digest-because-I-really-can’t-keep-up-with-this-stuff edition of “Dude, really?” news to come from the post-election US, it would appear that a strong candidate to head the Food and Drug Administration under Donald Trump is one Jim O’Neill.  According to the Scientific American,

O’Neill would be an unusual choice. He is not a physician, and lacks the strong science background that nearly all former commissioners have had in recent years.

A graduate of Yale University, with a master’s degree from the University of Chicago, O’Neill went to work at the Department of Health and Human Services in 2002, after a stint as speechwriter at the Department of Education. He worked his way up to principal associate deputy secretary, where he advised the HHS Secretary on all areas of policy, according to his LinkedIn page.

Now, so far, that is probably not too big a deal.  Since the head of the FDA is not actually involved in doing any bench science, the fact that he lacks a strong science or medical background needn’t matter too much.  What does matter is that the person in charge of the agency should be able to to consult the right kind of person and so on: in other words, to be broadly scientifically literate, and to have access to specialists.  That sets a much lower bar.  Medical or pharmacological expertise, after all, is much more likely to mean expertise in one comparatively narrow area within each subject than it is to mean a thoroughgoing expertise in the whole field; therefore even someone with a strong science background would have to rely on advice from others when it comes to things outside the postholder’s particular area of study.  Indeed, by the time you’ve worked up the administrative experience to lead an agency, it’s probably a while since you cleaned your last test-tube – so even your notional expertise may not be quite as cutting edge as you’d like to think.  And, working the other way, being a whizz-bang scientist is perfectly compatible with being terrible at what is essentially a senior civil-service gig.

So… not a medic, not a scientist?  Not necessarily a problem.  You just have to know which people to ask what questions – and that’s what you’d be doing anyway.*

But, of course, there’s a “but”.  Actually, there’s several “but”s.

Like, for example, it’s one thing not to have a strong scientific background; but it’s quite another to reveal that more…

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