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Controversial Genetic Drug Trial Will Continue

Posted by Jane Akre
Monday, November 26, 2007 11:54 AM EST
Category: Major Medical, Protecting Your Family
Tags: Medical Malpractice, Wrongful Death

For more information about Targeted Genetics clinical trials, see the following link. 

Earlier FDA release of gene therapy clinical trial and adverse event notice.

The Food and Drug Administration has given Targeted Genetics Corporation permission to resume a controversial genetically engineered arthritis drug trial.  

The FDA stopped experimentation this summer after a 36-year-old participant died. 

Jolee Mohr of Taylorville, Illinois was a wife, a mother of a five-year-old and otherwise healthy.

She had rheumatoid arthritis in her right knee so her doctor encouraged her to enroll in the experimental gene therapy trial where trillions of genetically engineered viruses were injected into her right knee to produce an immune-suppressing protein.

Mohr received her second injection July 2. She began going downhill, was hospitalized and on a ventilator when her liver failed. By July 24th she was dead of a fungal infection and massive internal bleeding.

A final report on her death will be issued next week but the FDA has concluded it was not related to her treatment.

It was theorized that the gene-altered virus was identical to the arthritis drug Mohr was already taking which is known to increase the risk of fungal infections. 

Mohr's intensive-care physician, Dr. Kyle Hogarth, believes the trial does not exclude patients who take prescription medication, making it difficult to know exactly what caused her death.

Mohr's death raises a host of other questions about medical ethics, experimentation on otherwise healthy participants and the federal safety net that is supposed to protect people.

Her husband, Robb Mohr, says his wife did not receive adequate informed consent about the side effects.

"It was presented to her like this is going to make her knee better," Mohr said to the Washington Post in August.  “It was supposed to be just a simple thing."

Had Jolee Mohr read the fine print of the trial she would have understood the end result would not alter her pain, but the trial's purpose was to see whether the drug was safe

Also within the 15-page document warned the possibility of an unknown side effect including, “in rare circumstances, death.”

In her case, Mohr was signed up for the trial at her family physician’s office.    

And others point to the medical ethics and possible conflict of interest of her rheumatologist, Dr. Robert Trapp, who received payments from the drug company for recruiting participants into a drug trial.  

The FDA has faulted Targeted Genetics for this procedure and in its announcement, the company plans to make sure study participants are fully informed about side effects.

Targeted Genetics also failed to report the seriousness of Mohr’s condition to the FDA until four days before she died while other trial participants continued unaware.

"We are working closely with trial site physicians to ensure we resume development in the most efficient manner possible with patient safety, as always, of paramount importance," H. Stewart Parker, president and chief executive officer of Targeted Genetics says in the company statement.

And as a result of Mohr’s death, participants will no longer be allowed to receive shots if they have a fever as Jolee did the day she received her injection. 

The Washington Post contacted Mohr’s widower, Robb. He was unaware the trial would resume.

"It seems weird that they are allowing it to go ahead, especially on patients who are already taking immune-system drugs," Mohr said. "To me, it is reckless experimentation."

Mohr family attorney, Alan Milstein believes patients have the right to be made aware of all potential side effects of experimental therapy.

Milstein and Robb Mohr are awaiting the result of the National Institutes of Health investigation before having substantive talks with the company.

Milstein also represented Jesse Gelsinger, the 18-year old who died in 1999 from an immune reaction to a gene therapy adenovirus, used to transfer disease fighting genes into cells. That case against Penn State researchers settled out of court.

Many hopes have been pinned on genetic engineering to treat disease on a molecular level but a decade of trials has not shown much success.

As many as 35 patients are still eligible to take part in the trial of the experimental drug, though the company expects many may drop out. #



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