While the lawsuit was not intended to change the rules regarding clinical trials generally, observers are wondering whether a recent case may indeed change them for patients who, drugmakers say, don't meet the criteria for the trials. In the decision, a judge ruled that 16-year-old Duchenne muscular dystrophy patient Jacob Gunvalson should be allowed to use an experimental drug treatment that his parents say could be the last hope to save his life. The drug developer, PTC Therapeutics, contends that Jacob doesn't meet the criteria for the drug's clinical trial, and expects to appeal the decision. Even if PTC Therapeutics loses its appeal, the family will need federal approval to use the drug.
Jacob's mother, Cheri Gunvalson, says the suit was not intended to expand clinical trial practices at pharmaceutical companies. In her suit, she said that the drug company led her to believe that her son would be included in the trial, and discouraged her from enrolling her son until he no longer met the criteria for the study. However, observers are already wondering whether the decision will influence how drugmakers design trials, and offer special access to trial drugs, given that the process of granting such exceptions has largely been discretionary until now.
To learn more about this decision:
- read this article [1] in The New York Times
Related Article:
Suit challenges biotech firm over last-chance drug [2]
Links:
[1] http://www.nytimes.com/2008/08/21/business/21dystrophy.html?_r=1&ref=health&oref=login
[2] http://www.fiercehealthcare.com/story/suit-challenges-biotech-firm-over-last-chance-drug/2008-07-17