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Robert
medicine forum Guru
Joined: 28 Apr 2005
Posts: 1700
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 Posted: Thu Mar 16, 2006 11:03 pm Post subject:
Re: London Drug Trial Goes Horribly Wrong
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"Wordsmith" <wordsmith@rocketmail.com> wrote in message
news:1142549019.716234.296620@j52g2000cwj.googlegroups.com...
| Quote: |
sanant0n@yahoo.com wrote:
London Drug Trial Goes Horribly Wrong
Six Men Sickened; Doctors Unsure of Their Recovery
By Stephanie Sy / ABC News
March 16, 2006 - - A man who took part in the drug trial that landed
six other men in a London hospital recounted the harrowing moments when
the participants sitting by his side fell violently ill.
In an interview to the U.K.'s The Sun newspaper, Raste Khan, who was
one of two volunteers to be given a placebo instead of the trial drug,
said the other participants reacted within minutes of receiving the
injection.
"The test ward turned into a living hell minutes after we were
injected. The men went down like dominoes," Khan said.
Khan says he witnessed the men writhing in pain, vomiting
uncontrollably, fainting, and hyperventilating.
All six of the men remain in the intensive care unit of Northwick Park
Hospital in London. Two of the men are in critical condition, while
four men in serious condition have shown slight improvement. The
patients have suffered multiple organ failure, leaving them in a
precarious medical state.
The eight volunteers were the first human subjects to be administered
the drug, in a clinical trial run by the American drug research company
Parexel. The drug was being developed to treat arthritis and leukemia,
among other diseases.
A statement issued by Parexel said, "An initial review at the site to
date has shown that best practices were followed and all of the
appropriate police and procedures were adhered to. Furthermore, we
commend the staff for their swift reactions with the volunteers when
the adverse reaction occurred. This type of reaction is extremely rare,
and is a very unusual event."
Complications Rare, Companies Insist
The Medical and Healthcare Products Regulatory Agency, the British
industry watchdog group, is investigating what went wrong. Among
possible reasons for the violent reactions are that they were given the
wrong dosage, took contaminated drugs, or experienced an unexplained
reaction that wasn't seen in the earlier animal testing.
Although complications sometimes arise in clinical trials, it is rare
that they happen this seriously so early in the testing process, when
only a small group of healthy people are given a low dose of the drug.
The drug was administered to animals in earlier testing, and the chief
of the German drug company TeGenero said there "[had] been no issue on
the safety of the drug on animals."
The lack of explanation is only compounding the distress of the six
men's families, who have been holding vigil at the hospital.
In an interview with the BBC, the girlfriend of one of the critically
ill volunteers said through tears, "This is a drug they have never
tested on humans before so they don't know what they are dealing with.
It's completely messed up their vital organs."
"I walked in, and I nearly fainted. He's a young, gorgeous, hunky guy.
... And I walked out, and he was all puffed out like the 'Elephant
Man.' He looks like a 45-year-old man who's had a cardiac arrest,"
Myfanwy Marshall said.
Like tens of thousands of others, the men had volunteered for the
clinical test to make extra money. According to British press reports,
they were being paid up to $3,500 for the study.
These people, assuming they live (or their families if they die), will
be megarich after the lawsuit. No excuse for this.
W : (
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Not a given. Negligence must be proven first and simply because they
suffered is not enough to prove it. Pain and suffering is not proof and it
can only be taken into account for compensating the negligence. One could
argue assumed risk if no negligence is found and they would get nothing. |
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John
medicine forum beginner
Joined: 24 Jan 2006
Posts: 15
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| Posted: Fri Mar 17, 2006 12:53 am Post subject:
Re: London Drug Trial Goes Horribly Wrong
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No excuse for what?
Humans had never taken this drug before. The first time a human
ingests a chemical is an adventure with an unpredicable outcome. The
preclinical data must have satisfied the drug regulators so they gave
the OK to test in humans. We do that all the time.
But,- if the dose given to the volunteers was incorrectly prepared or
if the developing company was less than truthful in reporting the
results of animal testing, there will certainly be trouble and
rightfully so. |
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Dr. Wayne Simon
medicine forum Guru Wannabe
Joined: 30 Apr 2005
Posts: 111
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| Posted: Fri Mar 17, 2006 6:44 am Post subject:
Re: London Drug Trial Goes Horribly Wrong
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"John" <jmennear1@nc.rr.com> wrote in message
news:1142556804.578234.58180@u72g2000cwu.googlegroups.com...
| Quote: | No excuse for what?
Humans had never taken this drug before. The first time a human
ingests a chemical is an adventure with an unpredicable outcome. The
preclinical data must have satisfied the drug regulators so they gave
the OK to test in humans. We do that all the time.
But,- if the dose given to the volunteers was incorrectly prepared or
if the developing company was less than truthful in reporting the
results of animal testing, there will certainly be trouble and
rightfully so.
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This should tell the peta people why it is so important to do research on
drugs in multiple species before we try the drugs in humans. Because the
drug hopefully was tested in multiple species, both herbivores, omnivores,
and carnivores, it was very surprising that such an intolerable reaction
occurred in humans. Imagine if we took all drugs directly from molecular
biology engineering, and tried them immediately in humans. This kind of
thing would happen more often. Luckily animal studies have prevented this
type of thing from occurring from various potential dugs. Of course peta
could say look what happenned despite animal testing? And what did all
those animals have to be experimented on, and even sacrificed for? But I
will say this I would not put a human on a drug trial unless that drug had
tested safely in multiple species.
> |
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Wordsmith
medicine forum beginner
Joined: 16 Jul 2005
Posts: 5
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| Posted: Fri Mar 17, 2006 8:58 pm Post subject:
Re: London Drug Trial Goes Horribly Wrong
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John wrote:
| Quote: | No excuse for what?
Humans had never taken this drug before. The first time a human
ingests a chemical is an adventure with an unpredicable outcome. The
preclinical data must have satisfied the drug regulators so they gave
the OK to test in humans. We do that all the time.
But,- if the dose given to the volunteers was incorrectly prepared or
if the developing company was less than truthful in reporting the
results of animal testing, there will certainly be trouble and
rightfully so.
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I meant the circumstances of your second paragraph, of course. Thanks.
W : ) |
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John
medicine forum beginner
Joined: 24 Jan 2006
Posts: 15
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| Posted: Sat Mar 18, 2006 1:53 am Post subject:
Re: London Drug Trial Goes Horribly Wrong
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| Quote: | I would not put a human on a drug trial unless that drug had
tested safely in multiple species.
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I spend my time doing preclinical studies and have watched numerous
"drugs" that possess a world of potential go down the tube because of
an unexpected toxicity in a rat, dog, or monkey. But even at that I,
like most other preclinical guys, worry about the toxicity we are not
yet smart enough to predict. Things like NSAID hypersensitivy or the
cardiovascular effects (in some people) of the COX-2 inhibitors.
But it won't be long and we'll know how to predict these adverse
events,-- then the next clinical surprise will be upon us. It's what
keeps me getting up in the morning! |
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andytyler
medicine forum beginner
Joined: 19 Mar 2006
Posts: 1
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| Posted: Sun Mar 19, 2006 3:49 pm Post subject:
Re: London Drug Trial Goes Horribly Wrong
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There was an interesting article in the English newspaper The Daily
Telegraph recently.
It mentions new technology that can make this kind of research safer.
It mentions a Boston based company called Osmetech that has developed a
couple of devices called esensor which can test dna reactions and
Optigene a piece of equipment slightly bigger than a laptop computer
which will help scientists in labs and doctors in hospitals find
information such as a person's metabolism. Such relatively simple
information can make a lot of difference in deciding on what dose to
give a patient and even whether the medicine will work at all.
http://www.telegraph.co.uk/money/main.jhtml?xml=/money/2006/03/18/ccm...
http://www.osmetech.com/products/esensor/
http://www.osmetech.com/products/optigene/ |
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Repeating Rifle
medicine forum Guru Wannabe
Joined: 04 May 2005
Posts: 141
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| Posted: Sun Mar 19, 2006 9:56 pm Post subject:
Re: London Drug Trial Goes Horribly Wrong
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I see many posts on this subject but little in the way of fact.
Where can I find a summary of what is KNOWN about this incident in terms of
the chemistry and biology involved?
Bill |
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John
medicine forum beginner
Joined: 24 Jan 2006
Posts: 15
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| Posted: Mon Mar 20, 2006 12:04 am Post subject:
Re: London Drug Trial Goes Horribly Wrong
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Salmon Egg wrote:
| Quote: | I see many posts on this subject but little in the way of fact.
Where can I find a summary of what is KNOWN about this incident in terms of
the chemistry and biology involved?
Bill
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I too would like to see a summary of facts about the specific incident
but I think it will be some time before it appears in either the lay or
scientific literature. I'm checking out a company called TeGenero and
looking for info on the drug - TGN1412 - which activates T lymphocytes.
But I suspect I may be telling you stuff you already know. |
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Repeating Rifle
medicine forum Guru Wannabe
Joined: 04 May 2005
Posts: 141
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| Posted: Mon Mar 20, 2006 12:25 am Post subject:
Re: London Drug Trial Goes Horribly Wrong
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On 3/19/06 4:04 PM, in article
1142813093.333443.96010@u72g2000cwu.googlegroups.com, "John"
<jmennear1@nc.rr.com> wrote:
| Quote: | I too would like to see a summary of facts about the specific incident
but I think it will be some time before it appears in either the lay or
scientific literature. I'm checking out a company called TeGenero and
looking for info on the drug - TGN1412 - which activates T lymphocytes.
But I suspect I may be telling you stuff you already know.
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I really know almost nothing about the incident other that it produced some
very sick people. I know nothing about the background either.
Bill
-- Ferme le Bush |
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hawki63
medicine forum addict
Joined: 24 May 2005
Posts: 57
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| Posted: Mon Mar 20, 2006 4:25 pm Post subject:
Re: London Drug Trial Goes Horribly Wrong
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"John" <jmennear1@nc.rr.com> wrote in message
news:1142813093.333443.96010@u72g2000cwu.googlegroups.com...
| Quote: | Salmon Egg wrote:
I see many posts on this subject but little in the way of fact.
Where can I find a summary of what is KNOWN about this incident in terms
of
the chemistry and biology involved?
Bill
I too would like to see a summary of facts about the specific incident
but I think it will be some time before it appears in either the lay or
scientific literature. I'm checking out a company called TeGenero and
looking for info on the drug - TGN1412 - which activates T lymphocytes.
But I suspect I may be telling you stuff you already know.
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funny...it made the front page of the LATIMES....a very long and detailed
article... |
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Wordsmith
medicine forum beginner
Joined: 16 Jul 2005
Posts: 5
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| Posted: Mon Mar 20, 2006 9:46 pm Post subject:
Re: London Drug Trial Goes Horribly Wrong
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hawki63 wrote:
| Quote: | "John" <jmennear1@nc.rr.com> wrote in message
news:1142813093.333443.96010@u72g2000cwu.googlegroups.com...
Salmon Egg wrote:
I see many posts on this subject but little in the way of fact.
Where can I find a summary of what is KNOWN about this incident in terms
of
the chemistry and biology involved?
Bill
I too would like to see a summary of facts about the specific incident
but I think it will be some time before it appears in either the lay or
scientific literature. I'm checking out a company called TeGenero and
looking for info on the drug - TGN1412 - which activates T lymphocytes.
But I suspect I may be telling you stuff you already know.
funny...it made the front page of the LATIMES....a very long and detailed
article...
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Drudge had it on his site...but he didn't leave it up very long.
W : ) |
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Herman Rubin
medicine forum Guru Wannabe
Joined: 24 May 2005
Posts: 114
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| Posted: Tue Mar 21, 2006 6:04 pm Post subject:
Re: London Drug Trial Goes Horribly Wrong
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In article <1142813093.333443.96010@u72g2000cwu.googlegroups.com>,
John <jmennear1@nc.rr.com> wrote:
| Quote: | Salmon Egg wrote:
I see many posts on this subject but little in the way of fact.
Where can I find a summary of what is KNOWN about this incident in terms of
the chemistry and biology involved?
|
| Quote: | I too would like to see a summary of facts about the specific incident
but I think it will be some time before it appears in either the lay or
scientific literature. I'm checking out a company called TeGenero and
looking for info on the drug - TGN1412 - which activates T lymphocytes.
But I suspect I may be telling you stuff you already know.
|
There is an article about it in the online publication of
the British journal _Nature_. It seems that the drug binds
to a receptor on the surface of the infection-fighting
T cells, and causes them to go off at the slightest provocation.
For details, I suggest you read the article; I have made a
summary which omits the technical details.
--
This address is for information only. I do not claim that these views
are those of the Statistics Department or of Purdue University.
Herman Rubin, Department of Statistics, Purdue University
hrubin@stat.purdue.edu Phone: (765)494-6054 FAX: (765)494-0558 |
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Pumbaa
medicine forum Guru Wannabe
Joined: 05 May 2005
Posts: 107
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| Posted: Sun Apr 09, 2006 2:47 pm Post subject:
Re: Anybody know where I can buy syringe, I don't have a prescription thanks
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If you lived in rural Mississippi you could go to a farm feed store and find
all kinds of injectable medications for horses, cows, goats, sheep, so
forth. The needles and syringes are also there so you can inject your
livestock.
I take it that you don't live in a 'free' State but some place like
California where they try to regulate everything but wine. |
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Monkey
medicine forum beginner
Joined: 07 Feb 2006
Posts: 2
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| Posted: Sun Apr 09, 2006 7:47 pm Post subject:
Re: Anybody know where I can buy syringe, I don't have a prescription thanks
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On Sun, 9 Apr 2006 09:47:48 -0500, "Pumbaa"
<pinkertonjames@hotmail.com> wrote:
| Quote: | If you lived in rural Mississippi you could go to a farm feed store and find
all kinds of injectable medications for horses, cows, goats, sheep, so
forth. The needles and syringes are also there so you can inject your
livestock.
I take it that you don't live in a 'free' State but some place like
California where they try to regulate everything but wine.
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Thanks for the info, in fact I was thinking more about a website, I
found some website who sell medicine without prescription but none of
them sell syringe... I f somebody have one please tell me thanks! |
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Eru Ilúvatar
medicine forum beginner
Joined: 15 May 2006
Posts: 1
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| Posted: Mon May 15, 2006 6:12 am Post subject:
hydroxyzine
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memerider <poodlebreeze@netscape.net> wrote:
| Quote: | As an allergy sufferer, to my knowledge, Vistaril has traditionally
been indicated to treat symptoms similar to some of those treated by
drugs such as benadryl--to dry up mucus due to allergic rhinitis and as
a light sleeping aid. Are there other common off-label uses you are
aware of?
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It's just an antihistamine with a sedation side effect. There's
nothing special about hydroxyzine. |
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