Two fight for lives after drug trial poisoning!

[RedOnce]

Britain
Times Online - March 15, 2006

The distraught girlfriend of one of two men fighting for their lives in a London hospital after being poisoned in a drug trial today said she had barely recognised him because his head was so swollen. Myfanwy Marshall, 35, said that her boyfriend looked "like the Elephant Man" after being given a dose of the drug, TGN 1412. Her boyfriend is a 28-year-old British man who had taken part in drug trials before without adverse side effects, but is now in the intensive care unit at Northwick Park hospital, Harrow, north-west London....Ms Marshall said that her boyfriend felt ill 80 or 90 minutes after being given an oral or injected dose of the drug.

Five other men were also admitted to the intensive care unit at Northwick Park from an independent medical research unit on the hospital campus after taking part in the trial. The six, all paid volunteers, had reacted badly to the drug, which is formulated to treat chronic inflammatory conditions and leukaemia. The hospital said today that two of the young men were in a critical condition today while four others, still in intensive care, were in a serious state but showing signs of improvement.

Dr Thomas Hanke, the company’s chief scientific officer, added "The drug was developed in accordance with all regulatory and clinical guidelines and standards. In pre-clinical studies, TGN1412 has been shown to be safe and the reactions which occurred in these volunteers were completely unexpected."


http://www.timesonline.co.uk/article/0,,2-2087234,00.html

[jilln]

1. regulatory and clinical guidelines and standards

ie, they tested it on animals, continuing until they found a species it didn't kill, so they are legally absolved of any responsibility, and then when they tried it in humans they found - SURPRISE - humans are different from whatever species it didn't kill.

[benburch]

4. Now, that was uncalled for.

Sounds to me like they had a bad batch. All of these people come down with poisoning at once. Some had taken the experimental drug before. This does not sound like they were given the right stuff.

And what would you rather? That we continue to develop and test drugs, or that we stop now and only use the ones we know about?

[jilln]

8. no, that we modernize

and stop using medieval methods

on edit: Not sure why you think this was a bad batch. The article clearly says that the guy had participated in trials before, but it does NOT say for this drug. The article says

"Has there been some manufacturing problem? Has there been some issue of contamination? Has there been a dosing error or is this indeed some completely unanticipated side effect of the drug in humans, which is specific to humans?"


so obviously they realize it could be an unanticipated side effect, and the article also says this was the first time they'd tried this drug on humans.

Furthermore, it says:

"These events were completely unexpected and do not reflect the results we obtained from initial laboratory studies which enabled us to progress investigations into human volunteers.


So obviously the animal trials DID NOT APPLY.

As for the article's claim that adverse drug reactions are rare, see this:

http://www.vaccinationnews.com/DailyNews/November2001/AdvDrugReact4thCauseDeath.htm

PISON, TN -- (INTERNET WIRE) -- 11/26/2001 -- The Journal of the American Medical Assoc* reported adverse drug reactions as “the 4th and 6th leading cause of death.” 4-15-98. This was in hospitals under monitored conditions and with “drugs that were properly prescribed and administered.” If we included all drugs prescribed by doctors for patients at home with no monitoring, and all drugs that people buy over-the-counter, , drugs would rival improper diet as a leading cause of death, says Richard Ruhling, MD.

[benburch]

9. What would you suggest as a replacement? nt

[jilln]

10. here's some info

some alternatives:

http://www.humaneseal.org/research.html

and a FAQ on the subject:

http://www.pcrm.org/resch/anexp/faq.html#2

[benburch]

11. So, the very first time a drug is actually tested...

...you want that to be in a Human Being?

That is what those two site advocate. None of the other testing they suggest rises to the bar of knowing what a drug will do in a living system.

[jilln]

13. not true

And as the original article shows, the first time a drug is REALLY tested, it's on a human being anyway.

[soothsayer]

2. ugh, you have to really be desperate do drug testing

tho my dad was a scientist and did it sometimes (but I think he prolly needed the extra dough)

[benburch]

5. Some do it through altruism.

To try to help others.

[pansypoo53219]

3. i was a guinee pig for a med

but i got he placebo. which turned out to be the best option. the drug didn't work.
they were pretty damned careful. no food. blood pressure,temp and other checks before let go the first dose.
(i cheated, i had to have some sugar, i think i had some gum or a mint)

[Spinzonner]

6. Has she actually seen THE Elephant Man ?

DOubt he looked like that. THat was structural bone malformations, not uniform swelling.

[Warpy]

7. Uh, this is why they TEST THEM

First the drug has to be proven safe in several different species, not just one. Second, they test healthy vounteers to make sure it's safe (this one apparently isn't) because healthy volunteers are more likely to recover from an unanticipated reaction. Then they do double blind studies using the sick people it's supposed to help and compare morbidity and mortality statistics to see if they've got a benefit over and above the placebo effect. If the numbers are good, then they may get to patent it.

Testing a drug is risky at any stage of the process. Volunteers have to be told that. Many healthy volunteers are prisoners hoping to earn money for the prison canteen. Others are college students strapped for cash. Some are the scientists, themselves.

Sometimes adverse effects are so rare or only occur after a very long time that only when the drug goes to the general population does a problem appear.

Drugs have to be looked at as selective poisons at any step of the process. These cash poor college students who put themselves on the line to test a promising but disastrous cancer drug are heroes, as is anyone who sticks his neck out to help other people. Demonizing the researchers doesn't do anyone any good at all.

[Avalux]

12. Phase I trials -

The people who participate in them are young and healthy; they are given the drug to assess if it'll be safe, not efficacious. They are monitored round the clock in an overnight facility while receiving the drug.

The volunteer (and I stress that word) has to sign an informed consent with the knowledge that the new drug may cause serious side effects and possibly death. Of course they are paid to volunteer, which is the motivating factor for participation in most cases.

Phase I trials are a necessary component of drug development; unfortuntately, sometimes the promising new drug can do more harm than good. Those participating knew the risks involved.