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Subject death halts clinical trial

A clinical trial for an investigational arthritis drug has been put on hold after a subject in the trial, a bodybuilding father of three with no history of heart problems, suffered two heart attacks and died, the company developing the drug linkurl:announced;http://www.medigene.de/englisch/index_e.php today (July 8). Peter Munro, 48, was participating in a Phase 1 trial for RhuDex, a compound that blocks T-cell activation to prevent inflammation in rheumatoid arthritis, at a clinic outside of

By | July 8, 2008

A clinical trial for an investigational arthritis drug has been put on hold after a subject in the trial, a bodybuilding father of three with no history of heart problems, suffered two heart attacks and died, the company developing the drug linkurl:announced;http://www.medigene.de/englisch/index_e.php today (July 8). Peter Munro, 48, was participating in a Phase 1 trial for RhuDex, a compound that blocks T-cell activation to prevent inflammation in rheumatoid arthritis, at a clinic outside of Edinburgh. After suffering cardiac arrest just over a week ago, Munro was recovering at home on Saturday when he had another attack and died. Munro was in good health, and "only linkurl:took part in the trials;http://www.the-scientist.com/2008/2/1/38/1/ to clear his debts," his sister told linkurl:The Times.;http://www.timesonline.co.uk/tol/news/uk/scotland/article4289877.ece The family is calling for the clinic to be closed. RhuDex has so far been tested in 80 individuals in both Phase 1 and Phase 2 trials, and no others have fallen ill, according to today's release by MediGene, the German biotech company developing the drug. The release states that "no signs of cardiac effects due to RhuDex" were observed in preclinical studies. The company's linkurl:website;http://www.medigene.com/englisch/ProjektRH.php hails RhuDex as a "blockbuster drug candidate" with an "estimated annual sales potential of more than 1 billion." An autopsy is being performed to determine the cause of Munro's death, but the event raises fresh concerns over the safety of clinical trials. linkurl:Last year,;http://www.the-scientist.com/news/display/53453/ a patient died in a phase I/II gene therapy trial for inflammatory arthritis, though an investigation attributed the death to a fungal infection and not the therapy. linkurl:A year earlier,;http://www.the-scientist.com/news/display/23275/ six healthy trial participants became seriously ill, including losing fingers and toes, after taking a monoclonal antibody designed to treat immune disease and leukemia. In that case, an investigation placed blame on an "unpredictable biological action" of the drug.
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Comments

Avatar of: GARY LEVIN

GARY LEVIN

Posts: 1

July 9, 2008

Devastating to this family. It points out that many drugs eventually have serious side effects.\nI am sure he signed many waivers in regard to liability for the clinical trial. I doubt whether they will hold up in court. No trial participant can truly evaluate the risks involved. Hopefully he will receive full compensation as part of the cost of drug development process by big Pharma. They stand to make a lot of money on this drug, and if it not approved or the trial cancelled, they ought to be able to write off a settlement as part of the cost of doing business.....Hopefully it will not have to go to trial.
Avatar of: Vinod Nikhra

Vinod Nikhra

Posts: 48

July 9, 2008

It is really sad that a participant for the Phase 1 trial for RhuDex, a compound that blocks T-cell activation to prevent inflammation in rheumatoid arthritis, with no history of heart problems, suffered with two heart attacks and died. The ?two heart attacks? should definitely point to a serious side effect of the drug especially in a person with no history of heart disease.\n\nWhat is more disturbing is that the person in question was in good health to participate in the drug trial and did so ?only to clear his debts?. This only means that his participation in the Trial was not fully voluntary. This may also mean that information about his health status before entering the Trial might not have been ?a good health?.\n\nWe should stop labeling the outcome to ?an unpredictable biological action? of the drug every time. Couldn?t there have been some neglect on the investigator? part?
Avatar of: anonymous poster

anonymous poster

Posts: 3

July 10, 2008

that's the main problem when something happens to one subject in clinical trial: pinpoint the cause.\nIn this case, everyone's reaction seems to blame the trial, but to me a cardiac attack on a seemingly healthy sportsman (bodybuilder)is not so surprising. \nIn the last years, soccer fans around the world have seen young and fit players fall dead during a game (I say soccer because that's what I know best). These men are under constant medical care, yet their underlying cardiac problems were undetected for years. Recently a checkup on French player Lilian Thuram detected the same cardiac risk that killed his brother years ago. This player is no beginner (as far as I remember he was among the 98 World Cup champions), and it was detected only days ago!\nIf you add the fact that bodybuilders are sadly famous for steroid use, I would say this case won't be easy to solve!\nIf it is really the drug, it could be falsely blamed on other factors, anf if not, the drug could be blamed for nothing... Good luck!\nBy the way I have absolutely no link to the Pharma industry ;-)

July 12, 2008

The reactions have been stereotypal. "Guinea Pigs" is perhaps most commonly used cliche.\nAdmittedly, "An autopsy is being performed to determine the cause of Munro's death" yet Megan Scudellari feels that "the event raises fresh concerns over the safety of clinical trials" conveniently overlooking "RhuDex has so far been tested in 80 individuals in both Phase 1 and Phase 2 trials, and no others have fallen ill".\n\nAny death is sad. Yet, in a clinical trial, it must be understood that there is an explained risk of Serious Adverse Event. Unless there is evidence to show that the consent given by the patient was legally and/or ethically invalid, the cry and the generalizations againsts clinical trials are premature and amateurish. \n\nFresh concerns would have been justified if there were a third party probe that had proven invalid consent and/or violation of ICH/GCP and other SOPs that are mandated by law.\n\nThis is a usual case where the comments are naive, judgemental and provocative befitting an activist than a scientist.\n\nI am sorry if I have hurt feelings; but I hold that Serious Adverse Events is the price to be paid for progress in Science to bring in newer and SAFER medicines. Those wary of it ought to abstain from being VOLUNTEERS in a drug trial.\n\nDr. S. M. Sapatnekar\nDean,\nClinical Research Education & Management Academy\nMumbai - India
Avatar of: Alicia Prater

Alicia Prater

Posts: 7

July 30, 2008

I'm a little late coming in to comment on this, but I agree with the good Dr from India. Only 1 person in all the trials exhibited heart problems. Though this may indicate what could occur in a larger treated population, or what could occur if healthy individuals are mistakenly treated with the drug, it is not an indictment of the drug itself. Not yet. Heart problems can go unseen for decades and strike out of the blue in otherwise healthy individuals. I agree with others that caution is needed in proceeding, but cannot condemn the drug, the company, or the testing facility without more information about the man's death (and I'm usually all for holding pharma accountable).\n\nAlso, this was voluntary. To clear his debts means he signed up for the cash, voluntarily. It was still his choice to pay his bills this way. Though there is some question as to the ethics of offering money to trial volunteers, and it is an ongoing discussion in the medical community, if they're healthy and taking a drug to help determine the side effects they deserve some sort of compensation for that effort.

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