Can A Side Effect Of A ‘Life-Saving’ Drug Be Worse Than Possibly Facing Cancer?
Patients who are undergoing immunotherapy are developing a disease akin to type 1 diabetes. “If I knew then, when I opted for the clinical trial, what type 1 diabetes entailed, I would never have gone for the immunotherapy. Never. I would have taken the chance of the cancer coming back,” said Jaime Vidal, 79, a retired mailman from San Bruno, Calif. In other pharmaceutical news: accelerated approvals for cancer drugs, troubling manufacturing problems and the right-to-try bill.
Stat:
Powerful New Cancer Drugs Can Trigger Diabetes — And No One Knows Why
Roughly 1% of patients receiving immunotherapy drugs experience the same irreversible side effect. Making matters worse, oncologists have little clue why. ...On Wednesday, the Parker Institute for Cancer Immunotherapy, JDRF (formerly called the Juvenile Diabetes Research Foundation), and the Helmsley Charitable Trust announced they are joining forces to launch a $10 million, three-year research initiative designed to identify the root causes of drug-induced diabetes among cancer patients. (Dolgin, 5/29)
NPR:
FDA's Accelerated Approvals For Cancer Drugs At Odds With Many Later Studies
Cancer drugs that speed onto the market based on encouraging preliminary studies often don't show clear benefits when more careful follow-up trials are done, according to research published Tuesday. These cancer drugs are granted accelerated approval to give patients faster access to the treatments and to allow drug companies to reap the economic rewards sooner. As a condition of this process, the Food and Drug Administration requires drug companies to conduct more research, to confirm whether the medications actually work and are safe. (Harris, 5/28)
Stat:
Drug Maker Tells FDA A Dancing Holiday Was To Blame For Infractions
During an inspection of a Centurion Laboratories facility in India last October, a Food and Drug Administration investigator noticed a variety of troubling manufacturing problems. These included a failure to follow written procedures for cleaning and maintaining equipment. Specifically, the investigator noticed equipment in one room that was marked as cleaned actually had “visible product build-up” and an air filter was damaged with multiple holes. This mattered to the FDA because the equipment was used to make drugs shipped to the U.S. (Silverman, 5/28)
Cincinnati Enquirer:
A Year After Federal Right-To-Try Bill, Paul Rinderknecht Lives In Hope
Getting sick turned Paul Rinderknecht of Springfield Township into a political activist for terminal patients who want more access to experimental drugs. A year ago, President Donald Trump signed the right-to-try law, and Rinderknecht celebrated. Yet the law has not helped him or thousands of other Americans who hoped for relief from dire conditions such as brain cancer and, in Rinderknecht’s case, the progressive paralysis known as Lou Gehrig’s disease. (Saker, 5/27)
