Despite Patient Deaths Associated with Actemra, Drugmaker Genentech Continues to Seek Approval for Additional Indications
In Big Pharma's quest to increase sales and profits, it will continually seek new uses and markets for its products – even when those products have proven harmful to patients.
Genentech and its corporate parent, Roche, makers of the rheumatoid arthritis medication Actemra, are already facing litigation over hundreds of deaths linked to the product. Nonetheless, they have been busy exploring new purposes for Actemra, for which they are hoping to receive FDA approval.
Last month, Genentech announced completion of patient enrollment for a Phase 3 trial of Actemra as a treatment for scleroderma (also known as systemic sclerosis). Earlier this summer, the FDA granted “Breakthrough Therapy Designation” for Actemra as a treatment for the scleroderma, which is a serious and often fatal auto-immune disease that attacks the connective tissues.
Granted, there is no cure nor any FDA-approved treatments for this relatively rare disease, which affects approximately 300,000 people in the U.S., although there are medications that treat some of the symptoms. Scleroderma, which primarily affects women between the ages of 25 and 55, causes thickening and hardening of the skin and the build-up of scar tissue in the joints and internal organs.
These symptoms are the result of an overproduction of collagen, the structural protein making up the body's connective tissues. In addition to joint and muscle pain, scleroderma can affect the kidneys as well as the cardiovascular and respiratory systems. Most current treatments involve the use of immunosuppressant drugs, which can slow the progress of the disease – but also leaves the patient more vulnerable to infections.
Because of the FDA's “breakthrough treatment” designation, there will be expedited development and review for Actrema as a treatment for this debilitating condition. So far, preliminary studies suggest that the medication may offer greater benefits for scleroderma patients than currently available therapies. The recently-completed Phase 2 study showed a significant reduction in skin thickening in patients who took the medication for a 48-week period.
Now, Genentech will be working quickly to gather the clinical evidence required in order to gain FDA approval for scleroderma. Specifically, company researchers want to determine if the medication can relieve the symptoms of the disease without affecting respiratory function.
The problem is that Actemra can still cause serious side effects, not the least of which include allergic reactions, stomach tears, elevated risk of some types of cancers, hepatitis B, and other infections. According to a recent report from StatNews, patients have also suffered strokes, pancreatitis, and cerebral hemorrhaging due to taking Actemra. Furthermore, evidence suggests that the manufacturers were aware of these risks and said nothing to consumers or the medical community.
Dr. Jeffery Siegel, head of Genentech's rheumatology and rare diseases division, says the company will “continue to push forward with the determination that we can potentially deliver a therapeutic option to a patient population that has serious unmet need.” However, their primary objective is to increase sales, regardless of the potential risks to patients.
We can hope that, for those suffering from scleroderma, those risks will be outweighed by the benefits.