Today I Learn… I make a point of learning something new everyday. This is what I learn each day

1, Jul 14, 2010

Tragedy Arising from Therapeutic Misconception About Clinical Trials

Filed under: Clinical Research — admin @ 12:15 am

The 36-year-old Jolee Mohr, mother of a 5-year-old, was a rheumatoid arthritis patient. She was otherwise young and healthy at the time of her death in 2007. She died three weeks after her participation in a clinical trial with trillions of genetically engineered viruses to ease the pain of rheumatoid arthritis.

To say she died of this clinical trial is like blaming others for our failure. I would rather say two major factors are equally responsible: 1) the therapeutic misconception about clinical trials, that is, the belief that the trial will help her get better without fully understanding that it was only a Phase I study designed to assess toxicity; 2) patient’s failure to read important documents and the risk factors before signing.

When her doctor, Dr. Robert Trapp of the Arthritis Center in Springfield, Illinois told her about the gene therapy study, she had faith in her doctor of seven years. “You trust your physician. He’s your doctor. You trust him like you do your minister,” her husband said. It is your life and you should trust no one but your own research and instinct.

Even worse is the fact that Jolee Mohr signed a 15-page informed consent form (ICF) most probably without reading it and knowing all the risks involved. As her husband put it, “Knowing her, she probably didn’t read through it.”

The ICF warns subjects of “some scary possibilities” of the study. It said that the genetically altered viruses in the study — called tgAAC94 “could spread to other parts of your body. The risks of this are not known at this time… We have seen this type of spread in animal studies when tgAAC94 has been given by injection into the joint,” the form said.

More scary facts include — altered viruses can “damage the DNA in the cells of your body by inserting itself into your genes,” it went on. “If this happens, it could put you at risk for developing cancer in the future.”

And on page 9, it is clearly written that unknown side effects could result in “pain, discomfort, disability or, in rare circumstances, death.”

This informed consent form is an extremely important legal document. By signing on it, you agree to take full responsibility for whatever consequences it forewarns you and thus relieves any duty or responsibility of the other party in case something unexpected happens.

This “rare circumstance” in the form of the tragic death of a young mother is posted here, hoping readers can be wiser than Mohr when they face a similar situation.

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