Six men are fighting for their lives suffering life-threatening multiple organ failure. The men were volunteers in clinical trials for a drug to treat conditions such as rheumatoid arthritis and leukaemia. The drug had already been tested on animals although it is unclear how many of those unwilling subjects had previously been killed by the drug.
The men were rushed to London's Northwick Park Hospital on Monday. The hospital's intensive care director Ganesh Suntharalingam said all were in a serious condition and receiving "close monitoring and appropriate treatment".
The Medicines and Healthcare products Regulatory Agency (MHRA) immediately withdrew authorisation for the trial. An international warning has also gone out, to prevent it being tested abroad.
Chief executive officer Professor Kent Woods said: "Our immediate priority has been to ensure that no further patients are harmed. We will now undertake an exhaustive investigation to determine the cause and ensure all appropriate actions are taken."
Parexel, which was running the trial, said it had followed guidelines and such cases were extremely rare.
Professor Herman Scholtz, from Parexel, said that the "clinical pharmacology medical team responded swiftly to stop the study procedures immediately." He added: "Such an adverse drug reaction occurs extremely rarely and this is an unfortunate and unusual situation.
"Since our unit is located within the hospital, we have immediate access to world-class medical care and we did everything possible to get the patients treated as quickly as possible."
The incident once again proves just how valuable the results from animal tests really are.
The Medicines and Healthcare products Regulatory Agency (MHRA) immediately withdrew authorisation for the trial. An international warning has also gone out, to prevent it being tested abroad.
Chief executive officer Professor Kent Woods said: "Our immediate priority has been to ensure that no further patients are harmed. We will now undertake an exhaustive investigation to determine the cause and ensure all appropriate actions are taken."
Parexel, which was running the trial, said it had followed guidelines and such cases were extremely rare.
Professor Herman Scholtz, from Parexel, said that the "clinical pharmacology medical team responded swiftly to stop the study procedures immediately." He added: "Such an adverse drug reaction occurs extremely rarely and this is an unfortunate and unusual situation.
"Since our unit is located within the hospital, we have immediate access to world-class medical care and we did everything possible to get the patients treated as quickly as possible."
The incident once again proves just how valuable the results from animal tests really are.
Comments
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Missing the point (negative and positive results)
15.03.2006 14:03
There are both positive and negative results from testing.
If a drug is tested on a few mammalian species and in every case the results are that the drug is toxic the process does not continue to find out if "toxic in humans also?" If it doesn't seem to work in any of those test the process does not proceed to confirm that it also does not work in humans. There is of course a chance that the results in humans WOULD be different but the probablity low.
If a drug is tested on a few mammalian species and is safe and effective, then it still has to be tried in humans. There is that small probablity that in humans it will be unsafe or ineffective -- but in this case since it is proposed to use the drug in humans that must be done. Remember, a 1% chance that a drug safe for other animal species is unsafe in humans is not begligible if we are talkign about 500 proposed new drugs.
Arguements against animal testing of drugs for humans are best made on moral grounds -- that even though this is a statisticly useful process it is wrong. Arguing that the reason we should not use aninal testing "because it doesn't work" are silly bwecuase that is contrary to fact >
Mike Novack
e-mail:
stepbystpefarm mtdata.com
1%?
15.03.2006 15:37
Myself
I think you misunderstood that
15.03.2006 23:08
But yes, unlike in the social sciences where results get published based upon ridiculously low confidence levels, that's about right for experiments in the biological sciences. In other words, the protocol of the experiment would be set up using enough subjects that there would be about a 99% confidence level.
People have some funny ideas about what conducting an experiment and noting the results means. It does NOT mean that the results aren't purely by chance. It means (depending upon how the experiment was set up) that there is a calculatable probablility of the results meaning what they appear to mean (and of course 1 minus that probability that it's chance). The "usual standards" differ in the various disciplines as I already alluded to.
The point I was trying to make, if we are ONLY 99% sure that the results of an experiment were not pure chance, then of 3,000 published reports, about 30 of them would be expected to be nonsense.
Mike Novack
e-mail:
stepbystpefarm mtdata,com
I think you misunderstood too
16.03.2006 12:51
Myself
I think you misunderstood your mum
29.03.2006 18:33
Sparky