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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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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

Update: Science writing prize entry, version 2!

12 Nov

Here’s the edited piece I wrote for the 2012 Wellcome Trust/ Guardian Science Writing Competition. I was fortunate enough to be shortlisted, and I thank the Wellcome Blog for posting this edited version of the piece (which I have posted previously in unedited form) on their site- albeit along with the least flattering photograph I think I’ve ever had. I intend to do more writing of this type in the near future, so watch this space!

Wellcome Trust Blog

We’re publishing the shortlisted entries to the 2012 Wellcome Trust Science Writing Prize. Today, David Lawrence on the common forms of human enhancement.

I should warn you: I took a cognitive enhancement drug before I began to write this. A central nervous system stimulant, to be precise. I took it to increase my capacity to think clearly, and to keep me focused. 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 buys a dose too, anyway. It’s perfectly legal – in fact, there aren’t any specific regulations on it at all.

Okay, so I had a coffee. You probably had one too this morning, without considering that you were, in fact, enhancing yourself. Caffeine crosses your blood-brain barrier and inhibits your adenosine…

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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

In Depth: Enhanced and you don’t even know it

19 Oct
On Biojammer, I make a lot of mention of human enhancement and related technologies. But it’s kind of a vague term, and it can have a lot of different interpretations. Here’s my take on what’s meant by ‘enhancement’, along with all the academic articles I reference linked for your elucidative pleasure. Or not.
 

To understand why nobody can agree on what enhancements actually are,  you have to recognise that the term is in itself academically divisive. There is great variability in the literature as to what it may refer, ranging from the relatively narrow scope given by a European Parliament Science and Technology Options Assessment (EP STOA)-

“a modification aimed at improving individual human performance and brought about by [specifically] science-based or technology-based interventions in the human body… Excluded… are improvements of human performance which are realised by the use of devices which are not implanted or not robustly fixed to the body”

You’d probably know about this, in fairness.

-to the all-encompassing, as employed by Buchanan in his book Better than Human

 “an intervention- a human action of any kind- that improves some capacity (or characteristic) that normal human beings ordinarily have or, more radically, that produces a new one.”

Those seem pretty different!

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Image

Don’t worry, be happy.

5 Oct

Don't worry, be happy.

Stop worrying, and love the gene…

In Depth: Are we obliged to learn genetic information about ourselves?

4 Oct

A brief note of apology- I simply can’t get the superscript and reference links to appear on-site, even with the correct html. Until we come up with a solution in the Biojammer labs, I’m afraid it’s gotta be the old fashioned way.
 
 

The idea that there is a right to refuse to know relevant genetic information about ourselves is one which appears to be broadly recognised in law. The Council of Europe’s Oviedo Convention states that:

“Everyone is entitled to know any information collected about his or her health. However, the wishes of individuals not to be so informed shall be observed.”1

However, I would question whether this is consistent with the principle of autonomy. Given the growing relevance of the field, let’s focus on the idea of genetic information in predictive medicine.

First off, we’re going to need to explore what the concepts at hand actually mean in context.

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