A 16-year-old patient, terminally ill with a rare form of muscular dystrophy, should be allowed to use an experimental drug treatment despite objections from the drug’s developer, a federal judge in Newark ruled recently. The case, which touches on major ethical issues, is being closely watched by the pharmaceutical industry. Under the ruling, Jacob Gunvalson, of Gonvick, Minn., would be able to start taking a drug intended to treat Duchenne muscular dystrophy, a rare and fatal disease that strikes boys and young men. The developer, PTC Therapeutics of South Plainfield, N.J., contends that Jacob does not meet the criteria to be a part of the drug’s clinical trial, and is planning to appeal. Federal regulators must also approve his application to use the drug. It was not immediately clear what implications the ruling would have for other patients seeking access to clinical trials of experimental treatments. Drug developers tightly enforce parameters on who can participate in these trials, citing concerns about safety and the validity of the research.
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