Clinical drug trial puts 6 in intensive care

LONDON (AP) — Six men participating in trials of a new drug to treat autoimmune diseases and leukemia were seriously ill in a London hospital after suffering adverse reactions, a hospital official said Wednesday. British regulators ordered an immediate suspension of the drug tests. Ganesh Suntharalingam, clinical director of intensive care at Northwick Park Hospital, said two of the men were in critical condition and four were in serious condition. All six fell ill on Tuesday night.

Waltham, Mass.-based research organization Parexel International, which supervised the trial, identified the drug as TGN1412, a monoclonal antibody developed by TeGenero AG of Wuerzburg, Germany to treat autoimmune and inflammatory diseases and leukemia. "The drug, which is untested and therefore unused by doctors, has caused an inflammatory response which affects some organs of the body," Suntharalingam said.

The names of the six men were not released. But one woman said her boyfriend, a 28-year-old London bar manager, was among them. "They just keep saying he's very, very sick and we are doing all we can," Myfanwy Marshall told the British Broadcasting Corp. "They are saying he could be lying there in six months. He needs a miracle, those were their words." Marshall told the BBC her boyfriend had decided to participate in the trial for the cash _ about $3,500 _ to pay bills.

The Medicines and Healthcare Products Regulatory Agency, which ordered the tests suspended, said the six were the only people given the drug in a small trial. Two other subjects received placebos...

http://www.chron.com/disp/story.mpl/ap/world/3726058.html

on edit:

Lucky them

Either you would randomly be assigned to either drug or placebo or, there would be a crossover treatment, where those who got drug would then get placebo and vice versa. There would be informed consent clearly describing what drug/placebo you might receive.

I think that the problem here is that this was a very reactive antibody, specific to humans, which would not give this reaction in animals. These types of treatments can be very non-specific, causing a lot of reactions when administered. A safer approach would have been to test one subject at a time to look for adverse reactions but that's normally not done.

and testing any drug is risky. The first trials are generally done with healthy volunteers, generally all male, drawn from prisons and colleges.

Healthy volunteers are the first group, since they are more likely to be able to survive unforeseen adverse reactions.

If heathy adults prove the drug to be safe, it goes into a double blind study with the sick people it's supposed to help. The numbers are crunched and if it is better than the placebo effect, it goes on to large scale trials in sick people. If nothing terrible turns up, it's licensed.

Sometimes adverse effects don't turn up until the drug has been in wide use for a long period of time. Thik Vioxx and the statin drugs.

Since these guys had tolerated one dose with no problem, this may be one of the drugs that sensitizes the body with the first dose so there is an allergic reaction to subsequent doses. Yhink Zomax, an arthritis drug that had a similar problem that didn't surface until doctors started to pop them for headaches and drop dead. If you took it for arthritis, got on it and stayed on it, you had no problem. If you stopped and started again, it was frequently fatal.

In any case, these guys knew they were taking a risk, and they're heroes for doing so, IMO. I seriously doubt this drug will ever make it to market, though.

Now THAT was a big drug trial...

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11/4/04 news item - The Food and Drug Administration (FDA) estimates that Vioxx may have contributed to 27,785 heart attacks and sudden cardiac deaths between 1999 and 2003.

After animal testing, a small number of patients with advanced disease are given the drug to determine dosage, discover any obvious side effects, etc. Some of these patients may be helped.

If the regimen seems promising or, at least, is not highly toxic, the next phases of testing follow.

B-CLL is apparently rare. The monoclonal antibody being tested is listed as an "orphan drug." Perhaps there was not a sufficient patient population for testing?

http://www.lifescience.de/portal/news_detail,6647,,57324,detail.html

First I wonder if this drug was tested on mice, chimps etc. No reactions or nothing like this happened I presume.
There were animal studies before this drug was given to humans yes?

The $3,500 gives me a sort of revulsive chill. Why such a big payola to participate in a drug study.
If the amount of money reflects the risk researchers felt was inherent in this drug and so offered money
to desperate people, well, and I emphasize IF this is the case then F*** YOU all to hell TeGenero!
If such is not the case, then, have a nice day.

Of course I'm going by the research steps here is the US, GB might be different. Unfortunately, it seems the only way to get young, healthy subjects involved in these necessary trials (and I believe they are necessary) is to pay them a lot of $$. Unethical? Maybe, but these participants had to sign an informed consent that detailed the risks involved, including death. Whether or not they read this document or took it seriously is unknown. They may have just been thinking about the money.