Friday, June 25, 2004

Clinical trials of Drug Companies

Last week, the American Medical Association urged the US government to establish a national registry of clinical trials. This is to counter the growing problem of drug companies failing to publish the results of trials that don't show their drugs in a good light, either through demonstrating that they don't actually work very well or through uncovering side effects. Journals would refuse to publish the results of trials that were not registered, and it would be very obvious if results were not being reported.

The New Scientist reports this week that although the big companies are making noises of agreement, in practice what they are prepared to do falls far short of this. Merck, for example, supports the proposal in theory, but according to the New Scientist is only prepared to register smaller trials, but only "large, pivotal trials". And while GlaxoSmithKline (currently contesting legal action with regard to its failure to disclose information on the effectiveness of an antidepressant) planning to set up a website showing the results of their clinical trials, this would only apply to drugs that have already been released. Information on drugs which have yet to be approved would still be hidden. Which rather misses the point of it.

In the same issue, and on the same page, the New Scientist also reports that drug companies want to ban people who respond to placebos from clinical trials of antidepressants. This would make their results look better, for sure. But surely the whole point of a trial is to see how well the drug compares to the placebo? If we rule out the placebo-responders from the start, then how can we possibly tell how the drug will perform in a real-life situation? The drug companies have apparently forgotten what the purpose of a medicine is.

Thursday, June 17, 2004

A cure for autism?

Nature reports that promiscuous voles can be made faithful by the addition of more hormone receptors in the brain. The hormone in question, vasopressin, appears to be produced in large quantities during sex, and seems to encourage bonding. And though they caution that pair bonding in humans is vastly more complicated than in voles, the idea of transferring this to human relationships is definitely there.

The BBC report gives a slightly different take on it. Autists have difficulty bonding, so maybe through vasopressin we could find a possible cure for autism.

Both are tempting ideas. We could cure infidelity, or autism, through hormone treatments. But first we have to decide what is a disorder, and what is natural. It would be far too easy, once we have a cure, to define anything other than some theoretical ideal as the disease. What's the difference between an autist and someone who just doesn't like chatting much? How many partners do you have to have before you need treatment for promiscuity?

Some people say we're already in this situation with antidepressants such as Prozac (given, according to some, to anyone who might be a little unhappy), or Ritalin to treat attention deficit disorder (or, perhaps, any child that doesn't sit still). On the other hand, some people say that both these drugs are underprescribed, and many depressed people and hyperactive children are going untreated. (Both sides of the argument can be seen here.) Here already we see the problems of a fuzzy boundary. Where diagnosis is based mainly on personal judgement, health professionals need a lot of time spent with the patient to work out what's going on -- time which they rarely get. More importantly, we need alternatives to the drugs, for those people who need something other than a chemical fix. And this will also be true if we develop a drug to treat autism.

Wednesday, June 16, 2004

First UK Human Cloning?

The BBC reports that a research group headed by Dr Miodrag Stojkovic of Newcastle University have requested permission from the Human Fertilisation and Embryology Authority to clone human embryos. This is the first such request in the UK. The idea is to isolate stem cells from the cloned embryos which are genetically identical to the donor. These could be used to replace lost cells without any fear of tissue rejection.

Naturally, this raises the issue of "spare parts". Is it right to create a twin of yourself, even a fourteen-day-old ball of cells of one, to pull to bits to plug gaps in yourself? That may be a rather crude and emotive way of putting it, but perhaps that is what we would be doing. Of course, a permanent cure for conditions such as diabetes or Alzheimer's disease would be wonderful, but are we creating people in order to kill them to do so? Or are we just creating a specialised (and rather useful) cell structure from someone's donated cells?

Ideally, of course, we could find a way of creating stem cells without creating embryos. But only embryonic cells are pluripotent -- able to develop into all cell types of the body. If we did find some way that didn't involve cloning, to produce what would, in effect, be embryonic cells, perhaps this could still be called an embryo, even if it's not organised into an embryo shape. After all, it has the potential to become a whole human.

Actually, this ideal process, of creating pluripotent stem cells direct from adult cells, has already been done. By a commercial company, which has patented the technique, and plans to sell the stem cells thus produced. They claim that it is simple and quick. Well, they would. And nobody else can use it without paying the company. Hence, presumably, the continued exploration of therapeutic cloning. But even if they have patented their own method, it opens the possibility of other methods of doing the same thing. And surely then we should be concentrating on this avenue. Not only does it avoid the needless creation and destruction of embryos, it's also likely to be more reliable. Cloning has so far been only fitfully successful at best. Better than finding a cure for diabetes is finding a cure for diabetes that works well.

Tuesday, June 08, 2004

Fight over sunlight

On Radio 4's Today programme this morning there was a debate between a pair of scientists about the amount of sunlight we should be exposed to (audio clip here). Everyone knows that UV light can cause skin cancer, but apparently people are now avoiding sunlight so much that we are in danger of becoming Vitamin D deficient. Vitamin D is apparently good not only for fixing calcium in our bones, but also for helping our bodies' own defences against cancer.

The trouble was that neither of the scientists on the programme really got to grips with the other's argument. So instead of a constructive and instructive discussion, we had a situation where two people simply repeated, over and over, a single point. Both of them were exaggerating the other person's position in order to make theirs look like the only reasonable choice. This is not good argument, and it is certainly not good science.

The worst of it is that the two weren't actually all that far apart. One was saying that we need three to five minutes a day of direct exposure to sunlight to make enough Vitamin D. (He didn't make clear whether this was supposed to be whole body exposure or whether face and hands alone would do.) The other was saying that we need to be careful to avoid overexposure for fear of getting skin cancer. I don't really see how these two are at all contradictory. Assuming all you need to show is your face and hands, you'll get more than enough exposure just walking to the shops. I am so fair-skinned that I have been known to get sunburn on a cloudy day. So I tend to avoid the sun. Nevertheless I'm sure that on average I get more than three to five minutes a day. At least in the summer, anyway. I really don't think there's many people so scared of cancer that they run out to the car on a sunny day with a newspaper over their heads, nor so desperate for Vitamin D that they lie out in the sun all day long, risking sunburn and skin cancer, to make sure they get it.

But one scientist accused the other of wanting people to throw away their suncream, and the other accused him of expecting them to lock themselves away in the cellar. The problem is really the irresponsibility of this unwillingness to acknowledge the other. The enire basis of scientific enquiry surely falls down if we cannot bear to take account of the criticism of others. (Can anyone spell "peer review"?) Science is supposed to be a discipline of reason. Scientists must therefore behave in a reasonable manner, or how can we believe what they say?