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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.

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Review: Worst Case Bioethics- George Annas

10 Dec
Thought I’d have a stab at doing a proper academic book review while another over-analytical post gestates. Thing is, I’m skint, so it’s not a new book- instead it is from last year. I should give a disclaimer before you read- I’ve tried to do this properly, for once. That means I’ve boiled out my own opinions of some of Annas’ positions. The man is a rampant bioconservative when it comes to issues such as human enhancement and all the other neat stuff we love at Biojammer, and so obviously that gets my goat. He has, by other people, been called a ‘human racist (which isn’t necessarily perjorative in the same way as plain old ‘racist’, but I’d always argue against it as being wrong for a number of reasons which deserve their own post in the future)- perhaps better labelled as ‘speciesism‘- as he opposes any technology or idea which endangers the primacy of the ‘normal human’, which is a concept I have belittled elsewhere on this site.
 
This being said, he can write rather well, and the book is well worth a read whatever your own views.

George J. Annas, Worst Case Bioethics: Death, Disaster and Public Health, Oxford University Press, 2011, Paperback, 335 pp., £27.50 r.r.p.

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  In Worst Case Bioethics, George Annas- a respected and well-known professor in health care, human rights and bioethics at Boston University- gives a broad account of the manner in which US public health policy has been and continues to be shaped over time by national responses to doomsday or worst-case scenarios, both real and posited. In doing so he aims to illustrate the manner in which ethically questionable practices and controversial decisions have been excused politically as defences against these often sensationalised eventualities. He also frames his discussion in the context of the American public’s fear of death as a concept, and their apparent unwillingness to accept it as an inexorable eventuality. Continue reading

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

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

How can we govern new life forms?

12 Nov

Synthetic biology’ is an emergent scientific field with enormous potential for development and technological advancement. However, it also carries an equal capacity for risk and for harmful results to derive from the advancement of the science. Consequently, it is widely recognised in academic papers, political documents, and public discourse as requiring regulation on national and global levels, on both an ethical plane and as a safeguard.

Synthetic biology as a realised or projected field of research has existed for at least a hundred years.[ii] Today, we could attempt to define the science as “focus[sing] on the design and synthesis of artificial genes and complete biological systems, and on changing existing organisms, aimed at acquiring useful functions.”[iii] The advent of the technologies of DNA sequencing in the latter part of the 20th century and more recently of DNA synthesis[iv] have thrown the field into the spotlight as a major and realistic growth area, and have highlighted the absence of a cohesive regulatory methodology to unite the various disciplines involved.[v] Also noted to be absent is an intellectual property model pertaining to organisms or technologies arising from the field.[vi] Continue reading