Parexel
Clinical drug trials are back in the news: readers may remember with horror the 2006 trial by U.S. giant Parexel in which six human guinea pigs were hospitalised following near-fatal reactions to the substances being tested. These were dubbed the ‘Elephant Man’ trials in the media, because of the extent of the swellings. Ryan Wilson, aged 21, ended up losing parts of his feet and fingers, and was lucky to survive.
This week’s Sunday Express (April 13) front page headline is Drug Test Scandal Returns, and the story tells of two more young people hospitalised after tests involving Nalmefine, a dangerous drug which can cause liver malfunction and allergic reactions. This drug is allegedly designed to “help people overcome addictions”.
Lawyers and victims of the earlier trial are angry that Parexel is still running trials in the UK, saying that the company “never apologised or accepted liability, although the case against them in terms of negligence is overwhelming”, (referring to the 2006 trial). Cash-strapped students are often attracted to such trials, which currently pay £1300 for a nine-day stay at Parexel’s clinical testing unit based at Northwick Park hospital in North London. (This hospital is also in the news right now, because it has just launched an inquiry into why 13 women have died in childbirth in its maternity unit since 2002.)
People who have addictions need therapy, not medication. And they certainly don’t need medications that cause stomach ulcers and pancreatitis, which is what happened this time. If that’s what Nalmefine does to healthy people, what would it do to someone ravaged by addictions? Yet more evidence that not only do the drugs not work, they can seriously damage you.
What kind of stupid mindset is it that will even entertain the idea that people with addiction problems will recover through the use of drugs?
*If you would like to know more about hypnotherapy for drug and alcohol problems, visit the Central Hypnotherapy website.
Filed under: Drugs on Trial by Chris
Hi
Just a few facts:
1. The incident regarding Nalmefine at parexel never happened. It was made up. I believe Parexel are pursuing the Sunday Express for damage claims. I would suggest you remove your statement on the incident.
2. With regard to the ‘elephant man’ incident there was NO evidence against PAREXEL, let alone ‘overwhelming’ in the final report issued by the Medicines and Healthcare products Regulatory Agency, who are the independent body responsible for monitoring and investigating clinical trials. There was no mention of ‘negligence’.
3. It’s very easy to use an isolated example to criticise an entire science. Thousands of medical products are used every day in hospitals, none of which would be available if clinical trials ceased to exist. Clinical trials are one of the most heavily regulated industries in the world and UK companies adhere to very strict rules.
4. Before you accuse me of working for or on behalf of Parexel International, I do not. I am a Molecular Biologist who has take part in clinical trials before. I am simply correcting your article by stating the TRUE facts and defending a company that did nothing wrong.
5. The development of pharmaceuticals for human use is a long and difficult path. 99% of research drugs never make it to phase 1 clinical trials, let alone the shelf in the pharmacy. The whole process costs a pharmaceutical company around $8bn for each drug.
As our understanding of human biology expands, so does the complexity of drugs designed to treat fatal diseases such as child leukaemia, motor neurone disease, cancer and alzheimers. Therefor the processes by which these drugs are developed need to evolve and be adapted to suit 21st century needs. The ‘elephant man’ trial highlighted the fact that Animal Toxicology tests (which are done prior to human test) are no longer sufficiently accurate enough to provide safe results, and more suffisticated in vitro methods will have to be developed.
I have never suggested that clinical trials should cease to exist, only that they should be properly conducted according to their original conception by independent parties, not the drug manufacturers themselves.
If it transpires that the Sunday Express made the whole thing up, then I will remove reference to the story. I am certainly not going to do that purely on the grounds that you “believe” Paraxel are taking action against the newspaper. I have not made any statements as to the truth or untruth of the story - how could I?
If newspapers make up stories like this then of course they should be prosecuted, but lots of reviewers will talk about those stories and comment upon them, often in print, as a matter of course. There is no point prosecuting all of them as well, only the people that “made it up” in the first place - if indeed they did.
So I’m not going to remove anything at this point, but I am happy to place your ‘correction’ alongside, unedited, only reiterating that the drug in this case was not intended to treat leukaemia, MND, cancer or Alzheimers. The last thing people with addiction problems need is drugs! Even if all that stuff about side effects does turn out to be untrue, drug treatments for drug habits is Alice in Wonderland healthcare.