Developments in Diabetes Treatment Reflect the Best and Worst of Big Pharma

Januvia and Janumet lawyers at Pintas & Mullins Law Firm report of some troubling new studies recently published linking the diabetes medications with an increased risk of pancreatitis and pancreatic cancer. As two of the nation’s largest drug companies, Merck and Pfizer, team up to develop a new type 2 diabetes medication, other treatments are further sickening patients already ridden with diabetes.

There are nearly 26 million people in the United States currently battling diabetes, making it one of the leading causes of death in the country, and responsible for about $170 million in health care costs. Nearly every major pharmaceutical company has a hand in diabetes treatment, although some treatments are coming with their own life-threatening side effects.

This is clearly a very competitive field of research, and Merck and Pfizer’s new drug, an oral sodium glucose cotransporter (SGLT2) inhibitor is about to begin phase III studies, ushering in a new class of antidiabetic drugs. Johnson & Johnson also just introduced a new SGLT2 inhibitor, and Lilly/Boehringer and Bristol-Meyers have something on the horizon as well. This news is particularly welcomed because the older classes of antidiabetic drugs are causing serious and life-altering side effects in many patients.

There has recently been uproar among patients and healthcare professionals over the very real risks associated with diabetic drugs in the incretin mimetic class. These drugs, which include the wildly popularJanumet, Januvia, Byetta, and Victoza, among others, are now associated with a significant risk of pancreatitis and pancreatic cancer. Between October 2006 and February 2009, the FDA received 88 reports of patients taking these drugs developing pancreatitis (although it should be noted that this number is a significant under-representation, as all cases reported to the FDA are voluntary.)

Other diabetes drugs, such as the former blockbuster Avandia, later proved to have an increased risk of heart attack in patients, and is now restricted only to those who have tried and failed to respond to other treatments. Avandia is also now banned in Europe.

As a result of these problems, the FDA is requiring Johnson & Johnson to conduct five long-term studies, in addition to those already required of new drugs, for its SGLT2 inhibitor, Invokana. The agency is requiring Johnson & Johnson to look in into the long-term effects on patient’s cardiac, liver, and pancreatic health, along with any potential carcinogenic properties. This will cost the company hundreds of millions of dollars, however, Reuters is projecting Invokana to have potential sales of $416 billion by 2016.

Meanwhile, Merck’s only significant commitment to the billion-dollar diabetic industry is with Januvia. With its new partnership with Pfizer, and their joint-development of a SGLT2 (called ertugliflozin), the companies are hoping to reestablish the trust diabetes patients lost in Merck with Januvia and Janumet.

In early 2012 the FDA sent Merck a warning letter for failing to conduct post-market studies for Januvia and Janumet, which was required of them if the FDA was going to approve any new supplemental drugs. For some reason, Merck failed, or was unable, to meet the deadlines for these submissions, raising suspicion in the medical community.

Despite this, in 2011, Januvia and Janumet totaled nearly $5 billion in sales even as the drugs put thousands of patients at risk of pancreatic problems. In the warning letter, the FDA told Merck that it had not provided adequate explanation for the extensive delay, and that it faces up to $250,000 in fines for each violation. Forbes reported that the agency was genuinely angry, and that it was considering fines of up to $10 million.

With this act of negligence, Merck demonstrated that it cannot be expected to seriously assess the safety risks its drugs have on patients – and that its bottom line, is, exclusively, profits. If a drug manufacturer cannot be counted on to conduct studies detailing patient safety, it must thus be held accountable for any injuries, diseases, and adverse side effects its drugs do cause.

Januvia and Janumet lawyers at Pintas & Mullins Law Firm urge any diabetic patient who developed pancreatic problems from these drugs to contact a skilled attorney as soon as possible. You have important legal rights, and may be entitled to significant compensation against Merck for its negligence and heedless pursuit of profits.