The Parexel View

The lady in the blue sweater . . .

Having just submitted my piece for Word magazine defending Question Time against facile charges of dumbing-down, it was heartening to see another lively and intelligent debate last night. I also got the chance to shake my fist at the screen, which is a useful defence against developing cancer. In decending order of party-affiliated vacuity, we had Margaret Hodge MP, the condescending, eye-narrowing, head-shaking work and pensions minister; David Willetts MP, shadow education secretary and a great favourite of the programme, on account of his unusual number of brains; Jenny Tonge, sacked Liberal front-bencher (something to do with suicide bombers) now outspoken Liberal peer with newly-dyed hair, which looks much better; Simon Jenkins, floor-crossing Guardian columnist whose words I find regularly compelling and fair (not bad for a former editor of the Standard and the Times); and Kwame Kwei-Armah, who I would describe as “most famous for appearing on Casualty” if I was trying to make a snooty point, but since I’m not, the playwright and actor.

From Gateshead, the audience were as tuned in, passionate and vocal as we’ve come to expect, not least a teacher from Sunderland who attempted to cut through the party bullshit about Blair’s education bill (which squeezed through its second reading thanks to life-saving support from the Tories – how proud he will be of his legacy). I was particularly interested in the panel’s reaction to this Parexel story: six human guinea pigs fighting for their lives after a drugs trial that went wrong. My first reaction, and you might not like it, is, hey, they volunteered to take part in this trial. It’s a risk you sign on the dotted line for. Drugs-testing is a well-known method for topping up grants or paying for a skiing holiday (you can get up to two thousand pounds a trial – two thousand, three hundred and thirty in this case – and you only have to leave three months before you can do another one); those that sign up do so with plenty of small print to protect the drugs company and, I daresay, in a spirit of “what could possibly go wrong? There are people with white coats here”. I respect the volunteers’ right to do this, and I wish no harm upon any of them. But when it goes wrong, as it has done with this trial for TGN1412, an anti-inflammatory, it’s difficult to get worked up. The QT panel indulged in a display of kneejerk sympathy which, for me, skirted the issue, which is twofold.

1) Why are we testing drugs on animals (in this case rats and monkeys), if the drug can still have catastrophic effects on humans? Doesn’t this blow the pro-animal-testing argument out of the water? It’s a waste of time. I don’t recall a media feeding frenzy the last time six monkeys swelled up and had to fight for their life. Is the life of a mouse so cheap? How many mice must die to make the papers? (It’s ironic, because if a pet dies, we go nuts, and if a pet dies in a horrible way, it will make the papers, but these creatures are being bred as convenient drug-dustbins just so that we can relieve joint pain. And worse ailments, I know, but there’s still something wrong, to me, about the set-up.)

2) The bit that nobody seems to be picking up on: when are we going to stop treating genetic modification as A Good Thing? This drug is a “humanised monoclonal antibody”, a genetically engineered protein that is part mouse but mostly human. These drugs usually aim to suppress an immune system reaction – but this does the opposite. Either way, it’s part-mouse! Who wants the genetic makeup of a mouse sticking in them? This is unholy.

I don’t wish to get into a crowing debate about the pharmaceutical companies, but, like all other companies, especially ones that make billions of dollars a year, they need to make more money. And to make more money, they must invent new drugs in the hope that one will be a “blockbuster”. and to get these on the market, they must test them. Fair enough. But let’s not be surprised when one puts six fit young men in hospital, or when one, like the painkiler Vioxx, turns out after about four years on the market to cause heart attacks and strokes.

We are all guinea pigs, not just those poor blokes on organ support machines.

Check out Parexel’s website (I’m not doing a link, you’ll find it) – they’re an American company who are very keen to promote drugs trials in Latin America, where there’s a large untapped market described in the blurb as “naive subjects”. I’m sure this is a medically-recognised term, but the big buzz-phrase at Paraxel of “shortening time-to-market”. Good idea. Let’s speed things up.

Be careful out there.

20 thoughts on “The Parexel View

  1. Very good comment on this story and I wholeheartedly agree on all your points. The media is as usual blowing this all out of proportion – “evil drug company” sounds better than, “well they signed away their rights, so it’s just a case of bad luck”… I naturally feel sorry for them, but I’ve taken part in a clinical trial myself and the fact that they offer so much money emphasises the risks involved!I liked your points about how animal testing has obviously not worked here and the genetic modification points. Maybe the media should be focussing on these angles instead… but that would not sell as well to people who like their stories on the more simple side.

  2. Very good comment on this story and I wholeheartedly agree on all your points. The media is as usual blowing this all out of proportion – “evil drug company” sounds better than, “well they signed away their rights, so it’s just a case of bad luck”… I naturally feel sorry for them, but I’ve taken part in a clinical trial myself and the fact that they offer so much money emphasises the risks involved!I liked your points about how animal testing has obviously not worked here and the genetic modification points. Maybe the media should be focussing on these angles instead… but that would not sell as well to people who like their stories on the more simple side.

  3. I don’t know if I agree or disagree with animal testing, I haven’t read both sides of the argument in depth. However, you say that it hasn’t worked in this case, but what about all the other cases where it has worked? It’s easy to pick out one or two instances to suit your argument – either way.Can someone tell me the alternatives to animal testing?By the way, Andrew, how come your blog just seems to be reviews of the tv programmes or films you have watched? It wasn’t like that before.

  4. I don’t know if I agree or disagree with animal testing, I haven’t read both sides of the argument in depth. However, you say that it hasn’t worked in this case, but what about all the other cases where it has worked? It’s easy to pick out one or two instances to suit your argument – either way.Can someone tell me the alternatives to animal testing?By the way, Andrew, how come your blog just seems to be reviews of the tv programmes or films you have watched? It wasn’t like that before.

  5. Worries about new technologies are a normal human response but people need to retain perspective. There are plenty of effective antibody drugs (same technology as the current case) in the clinic, all of which have by law to have been tested on animals. Look at Herceptin for example – a drug so effective against breast cancer there’s (rightly) a raging demand to make it more widely available. This current case is distressing but a rarity. Scaremongering helps no-one – there’s a risk in any activity in life but the risk needs to be balanced with the benefit. I could get knocked down on my way home tonight, but I’m still going to go.

  6. Worries about new technologies are a normal human response but people need to retain perspective. There are plenty of effective antibody drugs (same technology as the current case) in the clinic, all of which have by law to have been tested on animals. Look at Herceptin for example – a drug so effective against breast cancer there’s (rightly) a raging demand to make it more widely available. This current case is distressing but a rarity. Scaremongering helps no-one – there’s a risk in any activity in life but the risk needs to be balanced with the benefit. I could get knocked down on my way home tonight, but I’m still going to go.

  7. I must admit, my first thought upon hearing this story was indeed, “oh dear…but that’s why they pay you so much.” I am sympathetic to the men, and their friends and relatives, but it’s depressing how the media feels it has to simplify these stories to the extent where people feel the only appropriate response is to be pissed off at someone. On the animal testing front, I concur with those above who point out the colossal benefits it has brought. How many human lives have already been extended.

  8. I must admit, my first thought upon hearing this story was indeed, “oh dear…but that’s why they pay you so much.” I am sympathetic to the men, and their friends and relatives, but it’s depressing how the media feels it has to simplify these stories to the extent where people feel the only appropriate response is to be pissed off at someone. On the animal testing front, I concur with those above who point out the colossal benefits it has brought. How many human lives have already been extended.

  9. I totally agree with Andrew on all points, especially animal testing; the fact is, we are physiologically different to other animals and this case just proves to me that animal testing is pointless. There are plenty of examples of drugs which have generated completely different effects in human beings than was expected from the animal testing, and as Andrew points out, not all of these effects come to light at the human testing stage. I would argue that testing on animals is a wholly unscientific practise and alternatives are available and being employed by some scientists*, so why aren’t they all doing it? Profit and “shortening time-to-market” I guess is the answer. cj.* eg the Dr. Hadwen Trust

  10. I totally agree with Andrew on all points, especially animal testing; the fact is, we are physiologically different to other animals and this case just proves to me that animal testing is pointless. There are plenty of examples of drugs which have generated completely different effects in human beings than was expected from the animal testing, and as Andrew points out, not all of these effects come to light at the human testing stage. I would argue that testing on animals is a wholly unscientific practise and alternatives are available and being employed by some scientists*, so why aren’t they all doing it? Profit and “shortening time-to-market” I guess is the answer. cj.* eg the Dr. Hadwen Trust

  11. The projects described on the Hadwen trust website are NOT currently available alternatives to animal testing, they are ongoing research projects to establish if the non-animal experiments are viable alternatives. Roll on the day when there ARE real alternatives to animal testing, and fair play on the Hadwen people for putting resource into that, but they aren’t going to be developed overnight (and the government would have to change its drug licensing legislation which requires testing in animals). Until that time, animal experimentation is the best we can do. I’m a pet owner and animal lover and don’t like the idea of animal testing any more than most people but it’s an inescapable truth that barely anyone alive has not benefitted in some way from a drug developed with the aid of animal testing. The number of cases of unexpected side effects needs to be assessed against the number of people still alive or with an improved quality of life thanks to drugs that do work.

  12. The projects described on the Hadwen trust website are NOT currently available alternatives to animal testing, they are ongoing research projects to establish if the non-animal experiments are viable alternatives. Roll on the day when there ARE real alternatives to animal testing, and fair play on the Hadwen people for putting resource into that, but they aren’t going to be developed overnight (and the government would have to change its drug licensing legislation which requires testing in animals). Until that time, animal experimentation is the best we can do. I’m a pet owner and animal lover and don’t like the idea of animal testing any more than most people but it’s an inescapable truth that barely anyone alive has not benefitted in some way from a drug developed with the aid of animal testing. The number of cases of unexpected side effects needs to be assessed against the number of people still alive or with an improved quality of life thanks to drugs that do work.

  13. Bits of my passion have come back to me.A close family member used to work (in a medical capacity) at a Dublin facility that ran these Phase1 trials. Before her time someone had died – it went to court – basically he had substances in his body that he shouldn’t have had… didn’t tell them… soon as they injected the trial drug into him he died – didn’t even get as far as the hospital.The current news story only illustrates what a sham news reporting is. Every day of the week around the world people are being made ill as a result of being willing participants in phase1 trials. Why don’t we hear about the participants who are bought off ? One situation I’m aware of: several men were given a particular drug. The company found out that in animal tests that it caused cancer in every animal tested on. They got these men to sign a waiver and gave them 2 grand each. They’re probably dead now. Where they come from nobody gave a shit – show me the money… where do I sign?We were hoodwinked by “the man” during the cold war… they’re trying to hoodwink us again about non-Christian societies… drugs and why we need them… I’m not convinced.Now. Where’s my inhaler ?

  14. Bits of my passion have come back to me.A close family member used to work (in a medical capacity) at a Dublin facility that ran these Phase1 trials. Before her time someone had died – it went to court – basically he had substances in his body that he shouldn’t have had… didn’t tell them… soon as they injected the trial drug into him he died – didn’t even get as far as the hospital.The current news story only illustrates what a sham news reporting is. Every day of the week around the world people are being made ill as a result of being willing participants in phase1 trials. Why don’t we hear about the participants who are bought off ? One situation I’m aware of: several men were given a particular drug. The company found out that in animal tests that it caused cancer in every animal tested on. They got these men to sign a waiver and gave them 2 grand each. They’re probably dead now. Where they come from nobody gave a shit – show me the money… where do I sign?We were hoodwinked by “the man” during the cold war… they’re trying to hoodwink us again about non-Christian societies… drugs and why we need them… I’m not convinced.Now. Where’s my inhaler ?

  15. I’ve just discovered your blog so excuse the tardiness.I have multiple sclerosis, one of the disorders this drug was being developed to alleviate.If it wasn’t for guys like these, and the drug companies who employ them, trying to discover new medications for my incurable disease I face a future of gradual decline and loss of physical capability. It is ironic – because of the MS – I wouldn’t be allowed to be a human guinea pig until phase 3 trials, whereas it’s okay to risk the health of already healthy volunteers!I feel that the payment offered these testers was derisory, compared to the profits the company stood to make. The current therapy for MS – which is not a cure, and which is offered to fewer patients than Herceptin, although no one fights about that (sorry, different rant!) – costs the NHS £10 000 per patient, per year. I have to agree with the comments about where this leaves the validity of animal testing. I think it’s fairly obvious that animal testing is increasingly irrelevant. It is a source of distress to me that anything designed to alleviate my symptoms has caused suffering or death in another creature. At least the men in the trials had a choice – the monkeys and rats did not.

  16. I’ve just discovered your blog so excuse the tardiness.I have multiple sclerosis, one of the disorders this drug was being developed to alleviate.If it wasn’t for guys like these, and the drug companies who employ them, trying to discover new medications for my incurable disease I face a future of gradual decline and loss of physical capability. It is ironic – because of the MS – I wouldn’t be allowed to be a human guinea pig until phase 3 trials, whereas it’s okay to risk the health of already healthy volunteers!I feel that the payment offered these testers was derisory, compared to the profits the company stood to make. The current therapy for MS – which is not a cure, and which is offered to fewer patients than Herceptin, although no one fights about that (sorry, different rant!) – costs the NHS £10 000 per patient, per year. I have to agree with the comments about where this leaves the validity of animal testing. I think it’s fairly obvious that animal testing is increasingly irrelevant. It is a source of distress to me that anything designed to alleviate my symptoms has caused suffering or death in another creature. At least the men in the trials had a choice – the monkeys and rats did not.

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