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Regulation

Safety First? How the Current Drug Approval System Lets Some Patients Down

Andrew Culliford, whose story is featured in the Daily Mail, is one of the estimated 7 in 100,000 people living with Motor Neuron disease, a progressive degenerative disease which attacks muscles, leaving those affected eventually unable even to breathe unassisted. For Andrew, a young father who has a severe form of the disease, it means a two to five year life expectancy.

Like Les Halpin and Jenn McNary, the mother of twins afflicted with a similar rare disease, he has a simple request: earlier access to medicines that might help improve or extend his life.

The US introduced a mandatory pre-approval process for pharmaceutical drugs after over 100 people were killed by an untested drug formulation . Today, each drug must go through a series of strictly controlled trials, including Phase 1 tests on healthy volunteers, followed by Phases 2 and 3 which test the drug and dosages on smaller and then larger patient groups. The process is estimated to cost $500 million per drug and to take 8 – 12 years.

The process is designed to ensure the efficacy of drugs has been scientifically demonstrated to a very degree of confidence, and to ensure that patient safety is sufficiently protected. In many ways it has been a triumph of science and regulation.

But it has been a failure for one small group of patients: those with rare, imminently lethal diseases, for whom there are no existing good treatments. Those who will die in less than 8 years. It is these patients who are asking to have access to untested medicines, and to avoid placebo controlled trials, where half the participants are given no drug at all. Les has proposed innovative methods of patient recording data. I have discussed this proposal previously on this blog , and in a joint paper with Les Halpin and clinicians.

Read More »Safety First? How the Current Drug Approval System Lets Some Patients Down

Censorship, pornography and divine swan-on-human action

The Prime Minister has declared that Internet service providers should by default block access to pornography, and that some “horrific” internet search terms to be “blacklisted” on the major search engines, not bringing up any search results. The main motivation of the speech appears to be that access to pornography is “corroding childhood” by having children inadvertently seeing images or visiting websites their parents do not want them to see. There is no shortage of critics, both anti-censorship groups, anti surveillance groups, technology groups and people concerned with actual harm-reduction. There are two central problems: defining pornography, and finding its harms.Read More »Censorship, pornography and divine swan-on-human action

In the genetic supermarket, should parents be allowed to buy?

Imagine a world in which genetic interventions (for hair/eye colour, health, strength, happiness, morality…) were tested, safe, effective and accepted. In this genetic supermarket, who should be allowed to buy – to decide how children should be modified? Parents seem the obvious choice – but on reflection, there seem few reasons to allow this.

Why is it good for people to make their own choices? Firstly, out of liberty: everyone should have the right to do what they want with themselves. Secondly, because people know their own preferences much better than anyone else (one of the reasons that the communist command economies failed). And thirdly because people can experience the consequences of their choices, and become more skilled consumers, driving poor products out of business.

None of these applies to parents choosing their children’s genes. Here they are making the choice for other people, whose preferences they don’t know (because they don’t even exist yet!). And unless parents plan to have ten or twenty children, they have no relevant personal experience to draw on for comparing genetic interventions. And the main effects of these interventions are very long term, making the parents even less suited to making the choice in an informed way.Read More »In the genetic supermarket, should parents be allowed to buy?

How do you want to die?

How do you want to die? Quickly, painlessly, peacefully lying in your own bed?

Most people say that. But then, people seem to cling to their lives, even if that could mean a less peaceful end. When asked whether they would want physicians to perform certain interventions to prolong their lives like CPR (cardiopulmonary resuscitation) or mechanical ventilation (‘breathing machine’), people say ‘yes’.

Interestingly, a study discussed in a Radiolab podcast from earlier this year reveals that contrary to lay people, physicians do not want these life-saving interventions they perform on their patients performed on themselves.Read More »How do you want to die?

State versus parental authority: morality or efficiency?

In a previous post, I touched briefly upon the role of the state in child-rearing. The state takes on a very specific set of roles, while parents fulfil others. The rhetoric surrounding parental rights or government power seem to imply that we’ve reached this division after careful consideration of the rights of all parties, based on fundamental moral principles.

However, it seems suspicious to me that this principled division corresponds nearly perfectly to practical considerations. In other words, the government has all the rights in the areas they’re good at, while parents have all the rights in the remaining areas.

Consider, for instance, that the government is quite good a detecting blatant physical abuse. You just have to send someone to have a look, and in most places, the government can and does just that. Teachers are on the lookout for this, and social workers generally have the right to investigate and intervene.Read More »State versus parental authority: morality or efficiency?

Podcast: David Nutt, ‘The current laws on drugs and alcohol – ineffective, dishonest and unethical?’

Professor David Nutt argues in this podcast of his lecture, that whilst the use of the law to control drug use is long established, it remains unproven in efficacy. Although seemingly obvious that legal interdictions should work there is little evidence to support this assertion. So for example cannabis though illegal is at some time used by nearly half of the population. Similarly drugs like ecstasy and amfetamine are widely used by up to a million young people each weekend. This use is underpinned by a demand for the pleasurable experiences that the drugs produce, and also by a paradoxical desire by some people to break the law.

As well as being ineffective for many users prohibition of drugs often leads to perverse magnification of harms and drug use. When the “English” approach to heroin use i.e. prescription to addicts was abolished in the 1970s on moral grounds heroin use increased tenfold in a few years as addicts were forced to become dealers so getting more people addicted to fuel their income. The banning of alcohol in the 1920s in the USA lead to huge criminal expansion of alcohol sales the perpetrators of which turned to other drugs once prohibition was repealed: a legacy that we still experience today.

Moreover the un-scientific and arbitrary distinct between legal drugs particularly alcohol and tobacco and “illegal” drugs also has perverse negative consequences. As well as bringing the scientific foundation of the drug laws into disrepute it also precludes the use of possibly life-changing drugs for those who might benefit from them as treatments: examples of these include cannabis for Multiple sclerosis, MDMA [ecstasy] for PTSD and psilocybin for cluster headaches.

For these reasons Nutt argues that there are serious ethical implications for a simplistic prohibitionist approach to drugs and suggest alternative strategies that might be used.

Read More »Podcast: David Nutt, ‘The current laws on drugs and alcohol – ineffective, dishonest and unethical?’

Enhancement: Rat Race or Supermarket? (Podcasts)

In this special Enhancement seminar, visiting speakers Rob Sparrow and Chris Gyngell discussed two aspects of enhancement. You can hear the podcast here (mp3). Rob Sparrow on ‘Enhancement and Obsolescence: Avoiding An “Enhanced Rat Race”‘: A claim about continuing technological progress plays an essential, if unacknowledged, role in the philosophical literature on “human enhancement”. Advocates for… Read More »Enhancement: Rat Race or Supermarket? (Podcasts)

Why are we not much, much, much better at parenting?

We’ve come a long way, as a species. And we’re better at many things than we ever were before – not just slightly better, but unimaginably, ridiculously better. We’re better at transporting people and objects, we’re better a killing, we’re better at preventing infectious diseases, we’re better at industrial production, agricultural and economic output, we’re better at communications and sharing of information.

But in some areas, we haven’t made such dramatic improvements. And one of those areas is parenting. We’re certainly better parents than our own great-great-grandparents, if we measure by outcomes, but the difference is of degree, not kind. Why is that?Read More »Why are we not much, much, much better at parenting?

Phones 4 U, Ke$ha and becoming offensive

Channel 4 was censured by Ofcom this week for cutting to a light-hearted sponsorship advert just after viewers had watched the particularly graphic and disturbing rape scene in the film The Girl with the Dragon Tattoo. The Phones 4 U sponsorship ad was thought to be especially inappropriate for that moment as it features a couple apparently having sex, during which the woman pauses and asks to the camera ‘I’m faking it, can I upgrade’? Ofcom received 17 complaints about the timing of the advert and this week concluded that ‘the juxtaposition of a light-hearted sponsorship credit featuring a woman during sex with a disturbing and distressing rape scene in a film was clearly unsuitable… In Ofcom’s view this clearly had the potential to be offensive to viewers’.

The timing was clearly unfortunate, but to say that the juxtaposition was offensive is a stronger claim.  Of course, the psychological effect of being immersed in a violent scene at one moment and then confronted with the same(ish) subject matter presented trivially will not do much for the viewer’s aesthetic experience. But the regulator’s suggestion seemed not only to be that the juxtaposition detracted from the viewer’s enjoyment, but also that it was in some way wrong.Read More »Phones 4 U, Ke$ha and becoming offensive

Popular Opinion and Gun Rights

Advocates of even the mildest gun control reform in the US were dealt a serious blow yesterday, as the Senate failed to enact an expansion of background checks for gun purchases online and at gun shows.   Some have been quick to gloat over the result, while others were taken aback that the Senate could so blatantly ignore the will of the American people.  A number of polls have indeed shown massive support for background checks on gun purchases (upwards of 90%) – according to one survey, the proposal is even more popular than kittens.  This level of support predates the Sandy Hook massacre.  Political analysts will go to great lengths to explain how such a popular measure was voted down (the strength of the National Rifle Association’s lobbying efforts play a large part, no doubt), but we can also ask whether it should have been – in particular, independent of the merits of the bill, whether politicians should not have flaunted the will of the people.  Read More »Popular Opinion and Gun Rights