Parents Says Drugmaker Reneged On Clinical Trial

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duschenneAttorneys for a Minnesota family suing to gain access to an experimental muscular dystrophy drug for their 16-year-old son argued yesterday that PTC Therapeutics led them to believe they could participate in a clinical trial but then went back on its word, the Associated Press reports.

Jacob Gunvalson and his parents want the New Jersey drugmaker to provide him with the drug, PTC124. The teenager suffers from Duchenne muscular dystrophy, a rare and deadly condition that mainly strikes young boys and causes steady deterioration of muscle tissue. Typically, those who suffer from it die in their 20s because of weakness in their heart and lung muscles, the AP notes.

The dispute centers hinges on a clinical trial of PTC124 that included a 28-day preliminary phase in 2005 and a 96-week phase that is about to begin. Gunvalson’s parents claim PTC employees - including a woman who once hosted them at her house overnight - assured them Jacob would have access to the drug even though the med he was taking at the time excluded him from participating in the preliminary trial, according to the AP.

Later, they discovered that Jacob could not participate in the 96-week trial because he hadn’t participated in the preliminary trial. “There is not a shred of evidence that he doesn’t qualify” for the second trial other than the fact he didn’t take part in the first trial, attorney Marc Wolin told U.S. District Judge James Martini, the AP writes.

PTC lawyers contend that no promises were made to the Gunvalsons and that their son was excluded from the initial trial for medical reasons, and not due to any statements made by PTC employees. In a statement, PTC says giving the Gunvalsons access to the clinical trial “would harm all companies developing experimental drugs by providing a precedent for using the courts to gain special treatment instead of participating in controlled clinical trials.”

Martini pressed PTC attorneys on the relationship between the Gunvalsons and Claudia Hirawat, a senior vice president at PTC who hosted the family at her home last year. “It suggests to me a pretty close relationship,” Martini said in court. “It could have given them some reason to believe that when the time came, she would be able to get them into a program.”

Martini is expected to rule today.

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  1. Nice. Stock prices first, a dying child second. Another sick american business with all the wrong values.

  2. Hi… I am Kelsey Gunvalson Jacob’s 13 year old sister I live with Jacob and I thought it was cool that he was on google so I was looking around on google and i think that it is great that you give out this information so people know what is happening… he is not here right know they are in Philadelphia right know… so that is awsome what you are doing and thanks, and ya…

    Kelsey Gunvalson

  3. Kelsey,
    You are one brave teenager,.. I applaud you…

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