Multiple Organ Failure? Me too!

When you're young you're going to live forever.  That's why young men drive too fast, join the army and play contact sports.  A tuthree days ago, I suggested that whatever you tell them, many young men, no matter how well-informed, are going to choose excitement now even it it involves potential damage later on.

Bio-medical researchers have developed an elaborate charade to deal with the ethics of carrying out risky, potentially beneficial, procedures on sick people.  It's called informed consent and requires that both the pro and con of the intervention are explained to each patient, who then signs a long form to show that they have understood the issues and absolve the doctor and the hospital of any blame if the result is more con than pro.  I call it an elaborate charade because doctors and scientist in general find it really difficult to explain without jargon what they do to ordinary people in order to elaborate all the assumptions involved in the proposed treatment.  If the patient is sick already, and many people in hospital are, the pain and discomfort may inhibit clear and rational thinking, and they're probably too tired to read the whole document carefully.  Not to mention the 20% chance that they are functionally illiterate.

Informed consent is also mobilised when a new therapy has been developed from idea, to petri-dish, to animal model and comes up for its first safety trials in human subjects.  Animal models (lab rats often, or mice) work on the assumption that, as mammals, our genes, biochemistry and physiology are essentially the same as most other mammals.  The Professor of Comparative Immunology at TCD has spend the last ten years or more teasing out the extent to which these assumptions are valid.  A little over eight years ago (13 March 2006), TeGenero Immuno Therapeutics TGIT brought their new mono-clonal antibody (MAb) to CD28 a step nearer to market. CD28 is a protein that props up and interacts with the T-cell receptor on the surface of the immune cells called T-lymphocytes. T-cells are what gets fritzed when HIV uses them to propagate itself, and the symptoms of HIV-AIDS are what results.  MAbs preferentially, directly and specifically bind to their target protein usually changing their function in so binding.  TGIT hoped that their CD28-MAb, code-named TGN1412, would be helpful against leukemia and rheumatoid arthritis. They were, on the basis of lab work with the model primate Macaca fascicularis, optimistic about the efficacy and safety of their new drug.

They sub-contracted an independent drugs-trials company called Parexel to carry out the first human trials, which took place in Northwick Park Hospital in NW London.  Parexel recruited 6 healthy male volunteers and two placebo-control guys to take £2000 and a dose of TGN1412 equivalent to 1/500th of what had been given to the crab-eating macaques.  From 8am, the lads lined up to get their injections at 10 minute intervals, and just after the last dose had been administered, the first chap complained of a headache, and started to blow up.  One after the other, the six men experienced a cytokine storm which led to multiple organ-failure and weeks in hospital.  They have all been discharged but their immune system is now severely compromised and they are almost as much at risk of cancers, infections and auto-immune disorders as people with HIV-AIDS.  The placebo guys only spent a few hours shaking in their boots waiting to collapse into the same state into which they had just seen their new friends degenerate.

But get this: when the news about this debacle reached the public, Parexel and other drug-trials companies were inundated with volunteers - young men who hadn't realised until then that you could get £2 grand in folding money just for putting your life-time health at risk.  Why, they did that every weekend for nothing.