Juno Therapeutics began making headlines in mid-2016 after three patients died in the midst of a trial for the company’s leading cancer therapy. As a result of the deaths, U.S. regulators stopped the project. The therapy in question is considered extremely aggressive, but new treatment options like this raise the question of the pros and cons of even testing such options. By the end of 2016, five patients in the clinical trial would lose their lives, raising a host of questions about the severity of the treatment as well as liability for injuries and deaths.
The therapy, referred to as JCAR015, incorporated a chemotherapy drug called fludarabine just before the two most recent deaths occurred. One other patient who had also already received the pre-conditioning treatment for fludarabine also passed away in May. The patients in the clinical trial were individuals diagnosed with B-cell acute lymphoblastic leukemia, a kind of cancer that impacts a patient’s immune system.
The Regulatory Process for Clinical Trials
When any sponsors of a new treatment or medication has completed preliminary testing in a lab, will have to submit an investigational new drug (IND) authorization to the U.S. FDA. Once that has been filed, the clinical trial could start as early as 30 days later. The FDA may need to get involved in a clinical trial after review of the IND or in any situation when a concern emerges in the trial itself, as happened with the Juno cancer treatment.
The process for approving clinical trials is not as comprehensive as the assessment of initial drug applications (which are evaluated before any marketing approval is awarded) conducted by the agency. In a clinical trial situation, if the FDA detects a problem, they can issue a clinical hold, but this is rare in practice. Between 2008 and 2014, fewer than 30 holds were issued on the part of the FDA. In that same period, thousands of drugs were tested under active INDs.
Acute Lymphocytic Leukemia Facts and Impacts
Acute lymphocytic leukemia is a serious blood cancer that will typically progress and kill a patient very quickly without any outside treatment. The cancer is extremely common among children, many of whom can be cured quickly when treatment is ordered and carried out effectively.
Adults, however, have much lower rates of success with treatment. Nearly 6,500 adults are diagnosed with this cancer in the U.S. each year, and more than 1400 of those patients die. Those patients included in the Juno clinical trial had failed to reap benefits from prior treatments. More than 20 patients were involved in the program overall, but less than half received the pre-conditioning treatment for fludarabine.
Juno’s Treatment and Clinical Trial
The treatment developed by Juno was one of the first of its type involving the removal of a patient’s immune system cells. The cells are then engineered to identify the cancer and reinfused into the patient’s system. The goal of Juno’s study was to enroll up to 90 individuals to determine the effectiveness of such a novel treatment.
The patients developed cerebral edema after being given the fludarabine treatment. Juno’s response to the incidents was that the edema was a “rare but potentially fatal complication” of the therapy designed to treat relapsed or refractory acute lymphoblastic leukemia. In 2016, five total patients were killed during the clinical trial, and they all developed similar symptoms on the same timeline, too. Just a few days after receiving the treatment in question, at least four of the patients who ultimately died developed a fever.
Liability Questions and Concerns for Patients in Juno’s Clinical Trial
Although any patient participating in a clinical trial understands that this is a test of a potential medication or treatment option, this does not absolve the creator or distributor of the drug of any responsibility. The developers should always conduct in-depth studies prior to testing on humans, the results of which should indicate that the drug is expected to be reasonably safe for humans. Managers of clinical trials typically will use informed consent forms, but this does not mean that injured patients or the loved ones of a patient who is killed in the clinical trial process never have any opportunity for legal recourse.
Much like any other company or healthcare professional, managers of clinical trials have a responsibility to their patients to ensure safety wherever possible. Many new treatments emerging, particularly those designed to treat cancer aggressively, are marketed as “breakthrough therapies”, but these treatment options may come at a price. This highlights the importance for all manufacturers to conduct thorough testing on all medications and treatment options.
What Victims and Family Members Should Know About Their Legal Rights
Even when clinical trial managers have used informed consent materials, injured patients or loved ones of patients who have been killed may have legal recourse. Adverse results in a clinical trial could lead to many negative outcomes for the company running the trial, including payment of medical expenses and other losses associated with the injuries or deaths. The trial could also be halted and in some cases, criminal indictments may follow, too.
If you or someone you know has participated in this or another clinical trial where injuries or deaths occurred, it’s important to know that you need to speak with an experienced personal injury lawyer as soon as possible. Victims do have rights, and pursuing legal recourse with an injury or wrongful death claim may help prevent others from suffering a similar fate. Getting help from an experienced lawyer in this situation is important. Do not wait to learn more about your rights when you believe that a drug manufacturer or testing company has put patients at higher risk of severe injuries or death. The right lawyer can evaluate your case and give you more information about your responsibilities and next steps involved should you decide to move forward with a legal case. Don’t wait to get the help you need after a clinical trial leads to injuries.
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