Currently, drugmaker Daiichi-Sankyo is facing in excess of 1700 lawsuits over the hypertension prescription drug Benicar, which has been linked to sprue-like enteropathy. The link to this condition, which mimics the symptoms of celiac disease or gluten intolerance, was discovered by a physician at the Mayo Clinic in 2012. The Food and Drug Administration issued a warning the following year.
The physician who discovered the link, gastroenterologist Dr. Joseph Murray, subsequently took to YouTube, posting a video about the risks of taking Benicar. In his video presentation, he advises those taking Benicar who have suddenly developed gluten sensitivity to consult with their own doctors. That video subsequently went “viral,” and has doubtless saved the health and lives of thousands of people. It begs a question, however: why was manufacturer Daiichi-Sankyo not more forthcoming about the potential side effects? Why didn’t the company post its own video?
As today’s lawsuits against the Japanese drugmaker move forward, there are serious questions about the clinical trial that resulted in FDA approval in 2002. While Sankyo (as it was known before the merger) had been working on development of the drug for several years, the actual clinical trial lasted only three months. Keep in mind that management of hypertension is usually a lifetime proposition.
The trial consisted of 7 placebo-controlled studies, in which nearly 3300 subjects were administered doses in amounts of between 2.5 and 80 milligrams. At that time, the only side effect listed was dizziness (with a caveat that there may be more). Significantly, the approval letter stated “Under ADVERSE REACTIONS, the listing of ‘other (potentially important) adverse events…in controlled or open-label trials” should be changed to intestinal pain, dyspepsia, gastroenteritis [and] nausea’” in addition to several other side effects.
Those symptoms aren’t necessarily associated with sprue-like enteropathy, but intestinal pain and nausea certainly point in that direction. Plaintiffs in Benicar lawsuits allege that the risk of sprue-like enteropathy was not adequately evaluated during the clinical trial, because insufficient time was given. Further, plaintiffs point out that Daiichi-Sankyo spent far more money on marketing and advertising that focused on the drug’s benefits and minimized concerns about serious side-effects. Between 2002, when the drug first arrived on pharmacy shelves, and 2008, when symptoms began showing up in Benicar patients, the company spent an average of over $166 million a year on advertising and marketing.
In 2006, the FDA sent Daiichi-Sankyo a warning letter about “numerous claims…that suggest that Benicar and Benicar HCT are more effective than other angiotensin II receptor antagonists,” adding that “references provided in support of these claims…do not constitute substantial evidence or substantial clinical experience to support these claims.” It should be noted that Benicar is the only drug in its class known to cause sprue-like enteropathy. In 2013, the drugmaker received another warning letter from the FDA, stating that “promotional material [for Benicar] is misleading because it makes unsubstantiated efficacy claims.”
What is patently obvious is that, regardless of whether or not Daiichi-Sankyo actually knew about the risks of its flagship product (although it certainly should have), their focus was on maximizing sales and profits at any cost rather than any concern for patient safety.