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.
Morality in pharmaceutical regulation
29 JanReview: Worst Case Bioethics- George Annas
10 Dec
George J. Annas, Worst Case Bioethics: Death, Disaster and Public Health, Oxford University Press, 2011, Paperback, 335 pp., £27.50 r.r.p.
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: The rational patient
31 OctIf 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?
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 readingDoes dignity matter in biotech?
25 OctThe idea that human dignity is an empty concept is not a new one. It has been suggested in academic works throughout the best part of the last two centuries that the use of the term is often nothing more than what Marx termed a “refuge (from history) in morality”. In 1837, Schopenhauer set precedent for this attitude in his analysis of Kant’s ‘Grounding for the Metaphysics of Morals’, wherein he described human dignity as the
” …shibboleth of all perplexed and empty-headed moralists. For behind that imposing formula they concealed their lack, not to say, of a real ethical basis, but of any basis at all which was possessed of an intelligible meaning…”
-from the tone of which we can perhaps infer that Schopenhauer, at least, saw how widespread and wide-ranging the term had become even then.
This is not to say, however, that merely because a view has been held by our intellectual forebears it must be so. I would argue that there are other moral concepts which we respect despite their being used conflicting rhetoric, ‘freedom’ being the most obvious, if slightly trite, example. Consider that while it would be generally agreed upon (in the West) to support the principle of freedom in terms of political agency, this freedom can be interpreted differently- for example, positive versus negative liberty. Regardless of your interpretation, having respect for this freedom is regarded as a solid, defined concept and a key feature in democracy.
The concept of respect for human dignity is different, and this is best illustrated by Schopenhauer’s assertion that the subject ‘…lack[s]… intelligible meaning…”.
So can we really respect a concept without a universally agreed definition? Academics of far greater provenance than I have attempted to work out of what might constitute human dignity, and many thousands of pages have been published in argument. That this debate continues is indicative of the scale of the difficulty that exists in validating the term, and it is worthy of note that possibly the most important- in that it was designed to guide future U.S. policy– review of the term, by the President’s Council on Bioethics in 2008, concluded that “…there is no universal agreement on the meaning of the term human dignity.” I’m not, therefore, going to try and give a definition myself; but it is of value to note that this meaning has gone from something defined and rather narrow in scope to Marx’s all encompassing moral shield, and to an undefined phrase at the core of various legislative documents today. Continue reading
In Depth: Enhanced and you don’t even know it
19 Oct
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”
-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!
In Depth: Are we obliged to learn genetic information about ourselves?
4 OctThe 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.