Many patients who suffer from a broad range of illnesses and medical conditions may explore multiple avenues for treatment without success. As researchers and developers look for better solutions, clinical trials are one way that scientists determine whether or not a future treatment is viable and the potential risks for use with humans. As the recent Juno Therapeutics clinical trial shows, however, these clinical trials may pose serious risks for patients.
Behind the Juno Clinical Trial for Cancer Treatment
Juno is a $4.3 billion company developing a treatment for adult leukemia patients referred to as chimeric antigen receptor T-cell, also known as CART. A patient’s own white blood cells are genetically engineered to attack the B cells that typically become malignant in many blood cancer situations.
Use of fludarabine, also called ROCKET by the company, was incorporated into the cancer treatment regime for nearly two dozen adult patients in the clinical trial. The combination of JCA015 cells and fludarabine, however, may be fatal for patients. Since the start of the clinical trial, five patients have developed brain swelling symptoms along a similar timeline.
The FDAs Role in Junos’ Clinical Trial
In any case involving an experimental treatment, the sponsor or manufacturer must prepared an investigational new drug authorization called an IND. The FDA then reviews the IND and also has the right to halt the trial during that period or at any time during the deployment of the trial in which question are raised. This leads to a clinical hold, a response that is very rare on the part of the FDA. Whereas thousands of drugs were being tested at any given time between 2008 and 2014 under the IND process, fewer than 30 clinical holds were administered by the FDA.
When three cancer patients initially died in the clinical trial earlier in 2016, the FDA placed a hold on the trial’s activity. The hold, however, was lifted after just a few days. Some experts in the field of healthcare analysis believe that the FDA’s removal of that hold so quickly did not give the trial managers enough time to investigate the issues involved. A few months later, two more patients in the trial were dead after dealing with nearly identical issues as the others.
The process by which the FDA stops and restarts trials happens behind closed doors, making it challenging to determine whether or not their actions in this capacity were out of line. The FDA may have its own systematic process for reviewing holds and determining when to lift them, but many companies consider this to involve revealing potential trade secrets about their developments, making the law very complex.
What does raise questions about the FDA’s role in this case, however, is the fact that a recent study of clinical trial holds by the FDA revealed that 29 separate situations involving a hold between 2008 and 2014 had a median length of eight months. The FDA did propose new databases to keep track of experimental CAR-T treatments last March in order to capitalize on the growing data in this field.
Was your loved one injured in the cancer treatment clinical trial managed by Juno Therapeutics? If so, there’s a good chance you have legal questions about your ability to move forward with a suit. Contact an experienced lawyer today to learn more.
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