Healthy Skepticism Library item: 3867
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: news
Severe drug reactions from British drug trial leave 2 in critical condition
CBC News Online 2006 Mar 15
http://www.cbc.ca/story/science/national/2006/03/15/drug-reaction060315.html
Keywords:
Parexel TeGenero
Notes:
Ralph Faggotter’s Comments:
“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,” TeGenero’s chief executive Dr. Benedikte Hatz said in a statement.
The implication of this statement is that humans are to be expected to respond to drugs in the same manner as rodents.
To deviate from this expectation is then to be regarded as a “completely unexpected” digression from the norm.
In future it may be difficult to persuade prospective human experimental volunteers to accept this presumption!
Full text:
Severe drug reactions from British drug trial leave 2 in critical condition
Last Updated Wed, 15 Mar 2006 17:59:25 EST
CBC News
A clinical trial to test a potential anti-inflammatory drug in Britain has gone seriously wrong, leaving two men in critical condition and four others in serious condition, doctors said Wednesday.
As one of the volunteers in the trial, Myfanwy Marshall’s 28-year-old boyfriend was paid about $4,000 for his time and expenses.
Myfanwy Marshall’s boyfriend was one of the paid volunteers
Doctors say he could die at any time, Marshall said.
“He’s young, gorgeous, hunky,” Marshall said to BBC News. “I walked in, and he’s looking puffed out like the Elephant Man.”
The “Elephant Man” was a figure from Victorian Britain who was paraded about for having a head wider than his waist.
REALITY CHECK: Remembering Vioxx
“Two patients remain critical and four patients are serious but showing some signs of improvement,” Ganesh Suntharalingam, clinical director of intensive care at Northwick Park Hospital, said in a statement Wednesday.
“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 trial was immediately suspended and Britain’s health watchdog and London police are investigating. European drug regulators have been alerted.
Parexel International, which supervised the trial, said they followed industry guidelines for the drug, known as TGN 1412.
A German company, TeGenero AG, was testing the drug to treat diseases such as multiple sclerosis, rheumatoid arthritis and leukemia.
“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,” TeGenero’s chief executive Dr. Benedikte Hatz said in a statement.
The candidate drug was in phase one testing, which is the first time it’s given to a small number of people to check if it is safe. Additional tests are done to show if a drug works.
There are several possibilities on what went wrong:
The volunteers could have been given the wrong dose.
The drug could have been contaminated, possibly during manufacturing.
The reactions could be unexplained, and unexpected.
The British cases are mystifying, said Lori Sheremeta, a researcher at the Health Law Institute at the University of Alberta.
“It seems completely out of the ordinary,” said Sheremeta. “With that many occurrences of serious adverse reactions it sounds like something is going on.”
FROM CBC ARCHIVES: Thalidomide
Although it would be unusual for a drug to show such toxic side-effects for the first time in humans but not in animals, there is a precedent. The drug thalidomide never caused birth defects when it was tested in mice.
