In 2010, Genentech and Roche released a drug designed to treat Rheumatoid Arthritis (RA) and other similar autoimmune diseases. The medication, known as Actemra, was approved by the FDA but was not required to carry a black box warning label as many of the more recent RA drugs have done. This has been cause for consternation, as Actemra has come to be known as a potentially deadly drug associated with various risks like stroke, heart attack and disease in the lung. Over 1,100 patients taking Actemra have reportedly died according to Stat News who analyzed the FDA’s data.
The Drug Defined
Actemra is a humanized interleukin-6 (IL-6) receptor antagonist and it is meant to be taken by adults suffering from RA. Rheumatoid Arthritis is an autoimmune condition whereby the body turns on itself by specifically attacking the joints. To quell the wear and tear of RA, Actemra blocks the protein-coding gene, interleukin-6.
The drug has been selling really well since its 2010 release, having been prescribed to nearly 760,000 people. And last year the drug brought in a whopping $1.7 billion to Genentech. The company pushed the drug as the first of its kind, “a unique mechanism of action” and “an important new option for RA patients.”
STAT analysts went through 500,000 reports of side-effects, finding that Actemra carries the same (if not more) risk than other similar drugs. They also discovered that there have been at least 13,500 adverse event reports. This is worrying because, as mentioned, other similar drugs come with black box warning labels. Thus, it would seem, patients aren’t given sufficient warning of the potentially fatal effects of Actemra.
According to STAT, the 1,128 reports of death associated with the medication are not conclusive, meaning it can’t be said for sure that Actemra definitely leads to death. However, STAT was able to uncover documents containing doctors’ testimonies saying things like: Actemra was the only possible cause of death in certain instances.
Experts have spoken up, suggesting that the FDA enforce labels on the dangerous medication. The FDA’s response? Silence. In fact, the FDA recently approved Actemra for the treatment of CAR T Cell-Induced Cytokine, a fact that supports the assertion that the agency has failed to implement an adequate method for monitoring medications after they are released to the market.
Dr. Vinay Prasad, a medical ethicist from Oregon Health and Science University, told STAT that there’s much to be done: “We’ve done a very good job of making it easier to approve drugs, often based on very preliminary evidence. But we haven’t ramped up the standards of post-marketing surveillance to make sure that what’s been out there for several years is safe and effective.”
But the problem isn’t just with the FDA. According to STAT, the issue is also a matter of the corporate-agency alliance behind the reproduction of studies slanted in favor of the drug’s release. Why else would the FDA allow Genentech to carry out studies of its own drug? The conflict of interest is more than apparent, and yet this practice is the norm. Of the 11 authors who conducted the initial Actemra study, five worked for Genentech and every single one of them openly stated that they had financial conflicts of interest. Other studies carried out by Genentech had similar problems.
The drug has been linked to cancer, nervous system issues, tears in the gastrointestinal system and Hepatitis B, to name a few side effects listed on the Actemra label. Other side-effects not listed on the label include Pancreatitis, heart attacks, heart failure, respiratory issues and strokes. In the name of profits, Actemra has failed to take the copious adverse events into account, effectively ignoring the negative consequences of their negligence.
If you have suffered due to the use of Actemra, you may want to consult an attorney with experience in product liability law. With the right help, you might be able to obtain compensation for injuries incurred at no fault of your own.