Drugs

Court Orders Cancer Trial Treatment Resumed

A Rhode Island federal judge has ordered FDA to allow experimental cancer trial treatments to resume for a 20-year-old man while a full hearing on the case is scheduled. The Providence Journal reports that FDA had shut down a clinical trial at the Burzynski Research Institute in Texas due to a 2015 agency inspection at the S.R. Burzynski manufacturing facility that found violations of law and regulations that raised questions about the safety of human subjects who received products manufactured at the facility.

The youth involved in the suit was diagnosed with diffuse intrinsic pontine glioma (DIPG), a brain stem tumor that is expected to lead to his death within months. He learned of a Burzynski clinical trial for DIPG patients who opted against radiation therapy and began receiving antineoplaston therapy 4/21. That same day the institute received a letter from FDA imposing a “full clinical hold.”

The court filing says it appears that FDA issued the hold due to a reclassification of drug ingredients and that the agency did not know that there was anyone enrolled. The youth was asked by the institute if he wanted to continue despite the FDA order, the newspaper says, and he signed a waiver for the trial to continue. After another 11 days of treatments, the suit says, the patient began to feel “subjectively better” and hoped that the treatment might lead to his survival. But FDA advised the institute that it had to stop 5/3.

The suit says the patient’s family repeatedly asked the agency to left its hold, but to no avail. They also turned to Sen. Jack Reed (D-RI), who reached out to FDA commissioner Robert Califf.

The suit says that the youth recognizes there may be very limited likelihood of a favorable outcome and has fully consented to the risks of treatment. It says the agency is depriving him of substantial due process rights by stopping him from resuming the treatment and is acting in an arbitrary and capricious manner that ignores his interests and could result in his death.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome