The global diabetes management market accounted for $41.9 billion in 2010, and is expected to rise to $114.3 billion by 2016. Even more staggering is the dramatic increase in those diagnosed; a figure that has risen by more than 373% over the last 30 years. Industry professionals and students in pharmaceutical courses have seen Big Pharma pursue innovative treatments for the disease, evolving from injections to inhalers and most recently, to new oral therapies. Johnson & Johnson and Bristol/AstraZeneca are the front runners in this race, having both recently released drugs that represent a brand new class of treatment for Type 2 diabetes. And while the new drugs offer hope to many, they also raise concerns over their associated side effects, specifically an increased risk of heart attack and cancer.
Johnson & Johnson: Invokana
Invokana came about as a result of years of clinical research and 9 clinical trials with over 10,000 participants. First in a new class of diabetes drugs, known as SGLT2s, Invokana works by blocking an integral membrane protein, stopping sugar removed by the kidneys from re-entering the blood stream. Controlling blood sugar is essential to preventing the side effects of diabetes, such as vision loss, nerve damage, kidney damage, heart attack and stroke. However, trials indicated an increased risk of heart attack and stroke during the early stages of taking Invokana. The FDA has required Johnson & Johnson to follow up with 5 additional long-term studies of the drug’s connection to cancer, cardiac problems, and pancreatic disease.
Forxiga, otherwise known by its generic name dapagliflozin, has had a troubled journey toward FDA approval. Invokana endured intense scrutiny partly because of the risky side effects Forxiga exhibited during trials – they both belong to the same class of SGLT2 drugs. Last year, Forxiga was rejected by the FDA because of its connection with liver damage, and cancers of the breast and bladder. However, the drug has recently won the recommendation of a special panel of US advisors who report directly to the FDA. In a 13-1 vote held on December 13, the panel decided that the health risks associated with Forxiga are out-weighed by its benefits to sufferers of Type 2 diabetes.
Cause for Concern
Worries over new diabetes drugs and risky side effects are nothing new. GlaxoSmithKline continues to contend with numerous class action lawsuits over its Type 2 diabetes drug Avandia. In an alleged breach of pharmaceutical quality assurance, the industry giant stands accused of failing to fully disclose the medicine’s association with stroke, heart failure and heart attack. Subsequent studies reveal that patients, who took Avandia, as compared to other drugs, increased their risk of heart attack by 43%.
Given the history of cardiac risk, do you think further testing is required for the newest diabetes drugs before they’re released onto the market?