Six men are in serious or critical condition today after suffering violent reactions on Monday while taking part in pharmaceutical drug research. They remain in the intensive care unit of Northwick Park Hospital in London, reports the BBC.
Drug-maker TeGenero AG yesterday told family members yesterday that a dog had died in preliminary tests, and today denied that report, says lawyer Ann Alexander, who represents one of the sickened men.
Ms Alexander added: "These are ordinary health people who have been involved in a clinical trial and unfortunately everything seems to have gone wrong. I think the most scary thing for the families... is that they don't know what the outcome is going to be."
TeGenero called the reactions to their drug TBN1412 "shocking developments." The drug is designed to treat rheumatoid arthritis and leukaemia. This is the first time it has been tested on humans.
All six volunteers had to be admitted to intensive care within hours of taking the drug. One patient was described as lifeless, unable to move, and puffed up "like the Elephant Man."
Dr. David Ross, ND, CNHP, AHG
The drug regulatory body (the MHRA) has some real answering to do, despite their fine press statements. They would have approved this Phase I trial, and the protocol. It is well known that the MHRA does not exactly have a scientific approach to evaluating information, and instead believes what it is told by it's pharmaceutical "clients". The House of Copmmons Select committee reports that the MHRA rarely looks at raw data, and does not act as a plausible independent entity. Now if only the buck could be places at all the points in the system that failed here, and some regulators could be placed behind bars we would see human beings being treated as more than just "so much meat".
ReplyDeleteMHRA - In whose Interests?
ReplyDeleteThe recent TeGenero drug trial debacle was an accident waiting to happen. As long as the Pharmaceutical Industry continues to suppress clinical trial data the MHRA (Medicines and Healthcare products Regulatory Agency) will walk blindly and feed the British public false information.
News this week that GlaxoSmithKline knowingly withheld clinical trial data from the MHRA regarding the top selling anti-depressant drug Seroxat will add further fuel to the fire and hopefully push for an independent review into how the MHRA could be duped into believing that a drug they have reviewed on numerous occasions was safe.
The MHRA are made up of medical experts, some of whom are former employees and shareholders of the pharmaceutical companies they grant licenses to. Surely this is wrong and at the very least there is the suspicion of a conflict of interest?
For too long now the MHRA have been hoodwinked by the Pharmaceutical Industry. Lawsuits for damages in respect of harm caused to patients are popping up all over the place, but avoid media and public scrutiny because they are usually settled out of court on the proviso that evidence is not made public.
A public enquiry is needed to examine how the MHRA is run and why former Pharmaceutical Industry directors are allowed onto the board. Would a convicted drink driver be allowed to adjudicate on a road safety panel?
The MHRA need to pull the plug NOW on their close associations with the Pharmaceutical Industry. The British public expects and naively assumes impartiality and not a regulatory authority whose main interest seems to be one of ‘delivering jobs for the boys.’
Mr Robert Fiddaman (Group Moderator of the Online Seroxat Support Group)
Birmingham, UK