An investigation by Stat News has revealed that approximately 1,100 patients have died as a result of taking a commonly-prescribed medication known as Actemra (tocilizumab). Most of those deaths resulted from heart attacks and lung disease – which are only two of the many unreported side effects of a prescription drug that is primarily used to treat rheumatoid arthritis. As now suspected, the manufacturer of Actemra will be facing hundreds of lawsuits.
Based on an analysis of over a half million reports, Stat News discovered “clear evidence” of risks that, in addition to those mentioned above, include strokes, pancreatitis and cerebral hemorrhaging. Despite these reports, neither Roche nor the U.S. Food and Drug Administration have taken any action to include appropriate package warnings.
With the FDA now granting virtually unlimited clearance for the introduction of drugs without significant testing, this most recent issue should come as no surprise. In the first place, worldwide sales of Actemra totaled $1.7 billion in 2016 – making it one of Roche’s top-sellers. In addition to treating the symptoms of rheumatoid arthritis, physicians write “off-label” prescriptions for approximately three dozen other disorders. However, the efficacy and safety of these uses of Actemra have not been thoroughly tested.
That brings us to the subject of the FDA and the federal government, both of which have been falling down on the job in recent years. The recent ill-advised “21st Century Cures Act,” ostensibly written to make cutting edge treatments more quickly available to patients who need them, has wound up enabling Big Pharma to shove new products through the regulatory pipeline at a relative breakneck speed. Only after patients wind up injured and dead are they able to identify potentially fatal side-effects – and even then, there is a great deal of denial.
Not surprisingly, the FDA has no comment on the recent reports about Actemra. Dr. Jeff Siegel, a senior medical director at Roche subsidiary Genentech, said that the recent Stat News investigation raised “important questions that we think about all the time.” He added, “We try very hard not to be complacent, and to fully explore these issues.” However, he insists that Actemra does not raise the risk of heart attacks, citing a recently-published 5-year post-marketing study. (It should be noted that the study was sponsored by manufacturer Roche).
Other experts beg to differ. Back when FDA advisers were meeting to consider whether or not to recommend approval for Actemra, one attendee raised the issue of a similar drug, Vioxx, which was taken off the market after thousands of patients died from heart attacks – a risk that failed to show up during early clinical trials.
At the time, Boston University rheumatologist David Felson expressed his own concerns: “I can foresee the possibility that in five years there’s another hearing like the one on Vioxx, where the cardiologists say to us, what were you guys thinking when you approved this drug?” Significantly, Roche’s “ENTRACTE” study, while demonstrating “no significant increases” in strokes or cardiac events, was associated with an alarming rise in LDL cholesterol among patient – which in itself, is a major risk factor for stroke and heart disease.
Despite Dr. Felson’s concerns and those of his colleagues, the panel went ahead and recommended Actemra approval, contingent on Roche conducting ongoing monitoring for possible side effects. However, no warnings were required on the packaging. Dr. Felson describes the recent Stat News investigation as “noteworthy and concerning.” His comment on the ENTRACTE study: “[It] sounds like a drug company trying to defend themselves.”
Roche and Genentech will be doing a lot of that in court during the coming months and years.