Tag Archives: law

Morality in pharmaceutical regulation

29 Jan
There’s been a lot of questions recently about NICE’s approval procedures for new drugs. My own familiarity with the process is only related to the ethics committees’ role, so I wouldn’t try to offer any kind of solution- let’s face it theres going to be enough of those thrown out half-cocked in the coming months. What I do want to talk about, though, is the morals which underly the process, or at least that should. Normally, I’d rail against the idea that societal morality makes sense, but here, it really serves a purpose.
 

Moral criticisms often get thrown at big pharma, for reasons I don’t really need to go through here. The same can be said for the regulatory procedures governing what drugs make it to market, and who gets them. Things aren’t necessarily so simple as is often made out, though- it just doesn’t come down to blindly following rules and disregarding compassion, as so many commenters blithely shout. So, what I’m gonna do is attempt to demonstrate that while both policy and morality are essential for regulating pharmaceuticals, the latter is determinative of the fundamental nature of regulation; and that without morals it would be impossible to interpret standards set to maintain successful governance of the industry. Big talk, for sure.

Continue reading →

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In Depth: Presuming Consent in Organ Donation- Part Two (Electric Boogaloo)

27 Nov
 
Here, at last, is the second part of this post. It was unavoidably delayed by a combination of sudden busyness and industry on my part, but I’m sure that wont be a problem in the future. This part carries directly on from the first, which can be found HERE. There, I looked at the normative ethics of presumed consent, and here, I’m going to look at the legal standpoints involved.
 

The last post brings me to address another contentious issue inherent to a policy of presumed consent for post-mortem organ donation, which is that to have any moral authority over the populace, legislation must assume that all those within its remit actively engage with it. Such a concept is enshrined in UK law through the Human Tissues Act (HTA) 2004, the “guidance [of which] is clear that consent is a positive rather than a passive process”. That is to say that in the milieu of the proposed system the term ‘presumed’ is perhaps inaccurate, and instead the system operates on the basis that “consent can be given implicitly, by one’s actions, so it is argued that the failure to register an objection (given certain background conditions) should itself be taken as sign of consent”, which maybe implies that inaction is itself a defined action. I’d venture, however, that this approach could be seen as objectionable and liable to meet with challenge by the public in the actual event of its invocation. Furthermore, in the instance of UK law, a proposal on this basis was thought to require definitive legislative change to elements of the then-recently passed HTA because:

[T]he change from opt in to opt out for transplant purposes could risk undermining the 2004 act’s consent provisions, which safeguard the rights of individuals or their families to be asked if tissue can be used for a variety of other purposes. Continue reading →

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In Depth: Presuming Consent in Organ Donation, Parte the Firste

20 Nov
 
This is the first part of some rambling considerations about presumed consent, which takes off from the recently popularised Welsh initiative. I’m not going to make much reference to the question of elective ventilation, because while it is a related question in many ways, I consider it to be all rather tied up with death. Death, obviously, is a big part of organ donation; but  in and of itself I’d rather consider it more fully elsewhere. Nathan Emmerich, however, has written a paper on elective ventilation and death and their tie to organ donation, and it’s rather interesting stuff if you’re of a mind. 
 

One of the most internationally recognisable issues in modern biomedical law is the question of organ procurement. No state can claim to have available a surfeit of transplantable organs, and all too often you see a shortfall which results in tragic loss of life. One widely-touted solution to this issue is that of presumed consent- a policy gaining support in many of the nations who do not yet practice it.

In developed nations, and those in which modern medical technology is becoming more widespread, organ shortfall can only become worse as time progresses. Patients in need of transplantation can increasingly be kept alive by techniques such as dialysis, cardiopulmonary bypass, or the use of other extracorporeal devices; but these are hardly permanent solutions. For the patient to leave hospital and regain an increased quality of life, it is necessary for a suitable donor organ to be available and a successful transplantation to take place. Even where this is possible, organs are frequently lost through various forms of immunological rejection or failure, both acute and chronic in nature. For instance, UK statistics published by the National Health Service’s Blood and Transplant Authority (NHSBT) currently hold that 16% of cardiological transplants fail within one year of surgery.

Where they survive, these patients return to the waiting list of hundreds who require an organ, and the supply is effectively reduced for no gain. Continue reading →

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In depth: The rational patient

31 Oct

If we are autonomous as people, then it follows that we’re going to make what we consider to be ‘good decisions’. We’re going to make those about our daily lives, our actions, and our healthcare. But does a good decision always have to be a rational one?

If you can’t illustrate a concept visually, use a monkey.

A good decision is the making of a value judgement- the Oxford English Dictionary defines a value judgement to be “an assessment of something as good or bad in terms of one’s standards or priorities”. It stands to reason that the inherent goodness of something can only be judged subjectively, reliant upon what the evaluator considers goodness to be. I would posit that any collective or societal understanding of goodness must be based in generally accepted social mores and principles of behaviour (yeah, it’s one of those posts). For instance, in a medical and health science environment I think I’m safe in suggesting that it would be considered ‘good’, or at least desirable, to follow the principle of beneficence and to work in favour of restoring or improving a patient’s health (unless it has been determined that this is contra to the patient’s best interests, but that’s a  very different discussion). However, where you are making a decision for yourself, the subjective nature of goodness dictates that you can only make a truly good decision within your own self-perceived parameters- which is where the concept of rationality becomes vitally important to the equation. Continue reading →

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Wellcome Trust/ Guardian Science Writing Prize 2012 entry

2 Oct

I was fortunate enough to be shortlisted in the above competition this year, with a day of workshops at the Guardian followed by a champagne and schmoozing shindig at the Wellcome Collection in the evening. What follows is my entry in its original form- I have been sent an edited version for approval which is going to be posted here soon (with links!), along with the other shortlistees and the winner. I’ll link directly to it once it goes up, the edits being mostly issues of style. I was very pleased to be shortlisted- indeed, advice from Rebekah Higget, a blogger for Guardian Science among other things, was what led me to start biojammer.com.

Is it time to secure our future?

I should warn you: I took a cognitive enhancement drug before I began to write this article.

A central nervous system stimulant, to be precise. I took it to increase my capacity to think clearly, and to keep me focussed. It gives me an advantage over the girl at the table next to mine- I’m going to be able to keep working longer and more productively with my enhanced brain than she is. Until she goes and buys a dose too, anyway. It’s perfectly legal- in fact, there aren’t any specific regulations on human enhancement at all.

Okay, so I only had a coffee. Well, that’s fine, right? You probably had one too this morning, without considering that you were enhancing yourself. Caffeine crosses your blood-brain barrier and inhibits your adenosine receptors from reducing your synaptic activity- so that morning brew has artificially altered your brain chemistry to your advantage. Until those molecules are rendered pharmacologically inactive, you’re something more than a normal human. Right now, I’m Superman, though I might avoid the tights.

Admittedly, there’s a world of difference between my mildly increased alertness and such potential as exists in the field of biomedical enhancement. Leaving the hyperbole behind, biotechnologies are promising us abilities beyond those of mortal man. Prosthetics, developing at a rapid rate to serve the needs of military amputees, can in some cases now be grafted directly to a patient’s own nerves. Maybe not today, but in time it will be perfectly feasible technically to endow one of these robotic limbs with a strength beyond that of flesh and blood. Nootropic drugs- cognitive enhancers, akin to that coursing through my nervous system- offer improved memory, increased metabolism, augmented thought processing, and potentially an extended lifespan. More controversially, perhaps, there are the genetic manipulation techniques which could render us immune to diseases, specify our attributes, or even grant us those we could never have inherited from our parents.

These are much more than just theories. For instance, Melissa officinalis, the herb ‘lemon balm’, has produced a “significant increase in the speed of mathematical processing, with no reduction in accuracy” in human tests performed by the University of Northumbria. We hear stories, too, of star athletes banned from competition for ‘doping’. Unsporting, yes- but ultimately another form of human enhancement. On the same theme, take Oscar Pistorius, the famed ‘blade runner’ whose transtibial prostheses have generated controversy over his perceived advantage as a sprinter.

In academia, there has been arcane discussion for decades over the ethics of using such technologies. Scientists and philosophers on both sides of the issue have sparred without resolution in the pages of journals, both praising the prospective benefits and admonishing us against the theorised risks to our health and humanity. If I alter my natural state, am I playing God, or subverting nature? In my effort to break the limits of humanity, might I lose my inherent dignity? And how could I possibly predict any side effects, in years ahead?

They’re valid questions, and debate could rage unabated for years to come. Some of them might never be answered, at least not to everyone’s satisfaction. Look at embryonic stem cells- a field of research with wonderful therapeutic possibilities, but fraught with argument over morality, the right to life and what constitutes a human. Cloning, too, is a hotbed of contention, as are developments in the creation of synthetic life. All these biotechnologies offer us much, but has their maturation stalled to some degree by the questions that are rightly asked.

There is one important difference which sets human enhancements apart: it is not that these questions and fears are not warranted, but that we can address them in advance. Prior to the resounding success of Dolly, cloning was largely science fiction in the public consciousness. Before the birth of Louise Brown, IVF treatment simply wasn’t something the general population had sufficient awareness of in order to enter reasoned debate. Discussion and dispute came after the fact, along with reactive legislation like the 1990 Human Fertilisation and Embryology Act, which instituted regulations on in vitro work long after the practice had become widespread. Now, though, we’re in a different position.

Technologies and pharmaceuticals which augment our capabilities are already here, and we use them every day. Their burgeoning development into the ‘pill to make you perfect’ isn’t coming as any surprise, if you consider the wealth of advancements announced in the media every day. So really, we’re in the perfect position to make our decisions and conceive our laws ahead of time, instead of playing catch-up with science. Given the potential touted by enhancement techniques, can we afford to allow progress to run aground?

To decide my position, though, I might need to enhance my cognition. This time with foam, and sprinkles.

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