Tag Archives: drug

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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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

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.