British drug trial goes wrong, two critically ill By Kate Holton
Wed Mar 15, 10:02 AM ET



Two men were critically ill in a British hospital on Wednesday and four others serious in intensive care after suffering violent reactions to a new drug they took as part of a clinical trial.

Police said they were working with the country's medicines watchdog to establish the circumstances.

The American company running the trial said they had operated within industry guidelines but a girlfriend of one of the volunteers said they had been told to pray for a miracle.

She said her boyfriend was swollen beyond recognition.

The drug, known as TGN 1412, was being developed for a German company to treat chronic inflammatory conditions and leukemia.

A spokeswoman for the Northwick Park Hospital in London where they are being treated said they were doing all they could to help the men, whom she described as young.

Myfanwy Marshal, whose boyfriend took part in the trial, said she had been told her partner could die at any time.

"They just all went down like flies, all six of them," she told the BBC.

"The (doctors) can't give us a cure, they're talking to experts. The doctors were on the phone to experts all night (asking) what they can do.

"They've said to us 'we're in the dark, we don't know what to do. We don't know this drug."'

She said her partner looked like the "Elephant Man" -- a freak show figure in Victorian Britain whose head ballooned outwards until his skull was wider than his waist.

All his internal organs had failed, she added.

Another man's head and neck had swollen to three times normal size, the Sun newspaper quoted a friend as saying.

EXHAUSTIVE INVESTIGATION

The Medicines and Healthcare products Regulatory Agency (MHRA) said eight healthy men took part in the trial, two of whom were given a placebo, or dummy drug. The six who took the real drug all fell ill.

"We will now undertake an exhaustive investigation to determine the cause and ensure all appropriate actions are taken," MHRA's Professor Kent Woods said in a statement, adding they were working with the Department of Health and London police.

A police spokeswoman said they were liaising with the watchdog to see how the investigation developed.

Richard Ley, spokesman for the Association of the British Pharmaceutical Industry (ABPI), said he had never heard of anything like it before.

"This is an absolutely exceptional occurrence. I cannot remember anything comparable," he added.

British media reported the men were paid 2,000 pounds ($3,500) to take part. The trial was in the first phase, when healthy humans test the drug.

It was set up by U.S. drug research company Parexel International Corp. on behalf of German pharmaceutical company TeGenero AG.

Parexel said it had operated within regulatory guidelines and that such adverse reactions were extremely rare.

"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," said Benedikte Hatz, Chief Executive Officer of TeGenero AG, in a statement.

The ABPI's Ley said it was now very common for clinical trials to be conducted in different parts of the world at the same time. He said "tens of thousands of people, if not more" took part in clinical trials in Britain each year.

As soon as the men fell ill, the MHRA suspended the trial and notified other European regulatory bodies about it.

(Additional reporting by Gideon Long)

http://news.yahoo.com/s/nm/20060315...0BHNlYwN 0bWE-

??? .. and this is low-carb and/or diet relevant news how???
If only they ate low-carb, they would've been spared ... how???




Doreen

.

Yes, I wondered what on earth this article had to do with low carbing/diet etc myself.

1. If pharma companies, and the agency watchdogs, would allow drugs this horrible to get to human trials ... imagine what gets through the approval process.

2. People need to be aware that just because something is approved by the FDA, AMA, (government watchdogs) etc -- does not mean that it is safe.

3. Put this story and other stories together, like this story

More Research Scandals in the News
http://forum.lowcarber.org/showthread.php?t=289402

4. The "health experts" wanted to start me on a hand full of prescription drugs. But I went low carb instead and now have no need for prescription drugs.

5. Imagine the problems, from the prescription drugs, I could have avoided.

6. And "health experts" say low carbing is unhealthy.

It's funny that people talk about how bad synthetic vitamins and supplements are -- but prescription drugs -- which have to be synthetic -- are okay?

I'm not saying that prescription drugs will kill everyone and cause a horrible death. But for something like this to happen with all of this testing and oversight has to make you wonder (1) how safe the current prescription drugs are and (2) what else can you do to avoid taking prescription drugs?

Hopefully it will scare more people that "wise up" and start taking better care of themselves.

I know that I am preaching to the choir here in low carb land ...

But IMHO at least 50%, perhaps as much as 80% of all prescription drugs could be eliminated if people simply ate a low carb diet, took thier supplements, and got a moderate amount of exercise.

Obviously most of the people hooked on prescription drugs do not understand the effects of doing so. I think that only 20% of the people that understand how bad something is for them -- would keep doing it.

People assume that prescription drugs are safe. Not so.

It cracks me up that doctors would actually tell patients -- don't worry about the side effects -- we have more prescription drugs for all those problems!

Why did they try out leukaemia drugs on a healthy person who does not have leukaemia, why not try it out on someone who actually has leukaemia, after all, they have nothing to lose but everything to gain if it works.

From Monsters and Critics.com

UK News
Doctors say British drugs trial scandal is \'unique\'
By DPA
Mar 16, 2006, 19:00 GMT

London - Doctors fighting to save the lives of six men who fell seriously ill after a clinical drugs trial in Britain said Thursday they were dealing with a \'unique\' set of symptoms.

Of the six volunteers, who were given the German-produced anti-inflammatory drug TGN1412, two remained in critical condition, a spokesman for Northwick Park Hospital in Harrow, north London, said Thursday.

\'The exact sequence of what\'s happening here is unique,\' said Dr Ganesh Suntharalingam, clinical director of the intensive care unit Thursday.

Meanwhile, the British government moved to reassure the public, saying in a statement that the events that had occurred during the drugs trials were \'wholly unexpected.\'

The German company TeGenero, manufacturer of TGN1412, has offered an apology to the families of the six victims, which include a man from New Zealand.

But a spokeswoman for TeGenero has insisted that the developments did \'not reflect\' results from initial laboratory studies and animal tests with TGN1412.

The six trial volunteers, aged between 18 and 40, fell ill within hours of being injected with the drug Monday.

One of the trial participants, who was given a placebo, Thursday described what happened.

\'They went down like dominoes,\' 23-year-old Raste Khan told the Sun newspaper.

\'They began tearing their shirts off complaining of fever, then some screamed out that their heads felt like they were going to explode,\' said Khan.

Parexel, the US clinical research company which conducted the trials at Northwick Park Hospital, said it had followed all regulatory guidelines.

But Ann Alexander, British lawyer for the families, said Tursday there had been a \'lack of consistency and some misinformation\' in what her clients were told ahead of participation in the trials.

She referred to information that an animal had died in tests with the drug, used to treat rheumatoid arthritis, leukaemia and multiple sclerosis.

TGN1412 is described as a new-generation drug aimed at activating the body\'s own immune system.

Britain\'s health watchdog MHRA has launched an investigation into the scandal, while an international warning has gone out to prevent trials being carried out in other countries.

Professor David Eisenberg, from University College London, said Thursday the trials had prompted the \'most unusual and unique consequences.\'

Speaking at Northwick Park Hospital, Dr Suntharalingam said Thursday he had never had to deal with a case quite like this before.

The men suffered inflammation which had subsequently affected other parts of their body, including their internal organs. \'We do not know exactly what triggered the reaction\', he said.

The patients were being treated with anti-inflammatory drugs such as steroids.

\'Some of the features such as the need for a large amount of fluid and unstable organs are things that happen with other disorders but the exact sequence of what\'s happening here is unique,\' said the doctor.

\'There is an inflammatory process going on that seems to have been triggered by something. That process started to affect other parts of the body so we have two jobs to do, one is to try to treat the inflammation and the other is to deal with the consequences of it,\' he said.

Dr Suntharalingam refused to comment on reports that one patient\'s head had swollen to three times its normal size but said: \'This sort of condition does require fluid and that does cause swelling.

\'That swelling does go away on recovery but it\'s very distressing for the families to see. It is one aspect of intensive care that gets better as the patients get better,\' he added.

But he said it was far too early to say whether that would be the case.

© 2006 dpa - Deutsche Presse-Agentur

© Copyright 2003 - 2005 by monstersandcritics.com.
This notice cannot be removed without permission.

http://news.monstersandcritics.com/...ter_1138831.php

It is good to remember that clinical trials can be dangerous. Sometimes it might be worth the risk but other times, not so sure.

"But a spokeswoman for TeGenero has insisted that the developments did \'not reflect\' results from initial laboratory studies and animal tests with TGN1412."

It goes to show that once again our bodies are substantially different from animals even though we share the vast majority of our genes with them. Does that mean we might not fare well on the high fruit diet of some fellow primates?....hmmmmm

You are right.

If I was in an emergency situation and they said "you are going to die -- but this experimental drug may save your life" then I might try it.

If I was in a bad situation and they had prescription drugs with a long history then I would take them.

If I simply had a health problem -- I would try to solve it naturally with diet, supplements, exercise first.

What is funny is that I was in a bad situation and simply changed my nutrition and am now prescription free.

I hate to sound like an idiot (it's easy for me) and I feel sorry for these 6 guys and their families, but this is the kind of situation where we may actually learn something new, and important. Apparently this new compound did something very powerful to their immune systems. It may lead to new knowledge about how the immune system works, and lots of implications of that. Of course drug companies will hope it leads to some new profitable drug.

This is low carb news in the following sense. Medical practice is going through a paradigm shift from the disease management to metabolic pathway maintenance. The disease management paradigm looks at the symptoms of metabolic syndrome, for instance, and considers them separate diseases requiring separate treatments. Treatment almost always consists of some designer molecule, which may alleviate the symptom but cause a host of other problems because symptoms do not exist in a vacuum. The disease management paradigm is characterized by the lipid hypothesis and supported by the medical-pharmaceutical-health insurance complex. It is driven by the search for designer molecules because the profits from them are enormous.

The metabolic pathway maintenance idea says that we remain healthy because complex metabolic pathways including the interactions of hormones, enzymes, proteins, and fats, are working properly and telling out cells to cooperate in appropriate ways. Disease states are caused by changes in these metabolic pathways caused by some kind of stimulus that distorts them. Often, the distortion is caused by high levels of insulin caused by ingesting too many carbohydrates, so carbohydrate restriction is the first step in metabolic pathway maintenance.

The tragedy unfolding in the UK is a sign that the search for the designer molecule is driven by a level of greed that goes way beyond safety.

I didn't understand much of what you said before this -- but I did understand this. I agree 100%.

And people (most of us already know this) need to wake up and realize this before it is too late!

ceberezin: Brilliantly stated! I wish I could have said that as clearly.


I'd add that this system has been finely honed over 2 million years of evolution, just in our direct ancestors.

I think I'd disagree with this though:



I haven't seen any definite signs of it yet. And I think the war could easily be lost. The guys with the most money usually win.

I was thinking the same thing (and also wondering if it made me a bad person since I felt more curiosity than compassion :/ ).
My first thought was how this is likely going to lead to a profound discovery.