"You have Type 2 diabetes."
In 2012, 1.7 million Americans heard their doctors utter these five words while sitting in a cold, bleak white medical room. By the beginning of 2013, more than 26 million people in the United States were living with diabetes. With another 86 million showing symptoms of prediabetes, the pharmaceutical industry raced to find a way to keep patients together.
Johnson & Johnson pharmaceutical company was the first to cross the finish line. They were crowned innovators of the year for developing Invokana -- the drug of the future, a major medical advancement for Type 2 diabetes. Most of the medical community rang out in support.
"It's not hype to say that this is a new class of drug that could provide patients with a lot of beneficial results," Dr. Zachary Bloomgarden, clinical professor at Mount Sinai School of Medicine and nationally renowned diabetes educator, said in an interview with "A Sweet Life."
Invokana works independent of insulin, unlike previous diabetes medications. Belonging to the SGLT2 inhibitor drug family, Invokana allows excess sugar in the body to pass through urine after the kidneys filter it from the blood, rather than the sugar re-entering the bloodstream.
"The bottom line with this drug is that it controlled blood sugar levels without causing weight gain and caused almost no hypoglycemia," Dr. Bloomgarden said. "This drug could be the backbone of new treatments for Type 2 diabetes."
The doctor wasn't alone in his optimism for Invokana's future. Wall Street analysts predicted money would be flowing to J&J for years to come. Lawrence Biegelsen, of Wells Fargo, predicted sales would hit $667 million in 2016, according to the New York Times.
It's possible, however, these profitable projections were not just a reflection of Invokana's effectiveness, but of J&J's beastly marketing budget. Pharmaceutical companies may stand out from Fortune 500 companies for their life saving products, but when it comes to advertising their strategies parallel.
In six months, J&J paid $7 million to doctors for speaking fees and "related spending" supporting Invokana and another $17 million for medical journal placements, according to ProPublica. Invokana ranked in the top four for most money spent on a new drug -- but it was money well spent, as it became the top Type 2 diabetes drug.
But did the million dollar marketing plan help J&J beyond profits? Sitting behind the lavish curtain of commercials, magazine ads, and doctor reviews sat five members of the FDA advisory committee who were never sold on Invokana. In fact, several advised strongly against its approval. The pharmaceutical company's trial reports showed Invokana did lower blood sugar but also increased risk for kidney impairments and fungal infections. But because J&J did not complete any long-term studies, they weren't sure all the side effects came to light.
Despite this uncertainty, five objections is not enough to stop approval. But the FDA did require five post-marketing studies: a cardiovascular outcomes trial; an enhanced pharmacovigilance program to monitor for malignancies, serious cases of pancreatitis, severe hypersensitivity reactions, photosensitivity reactions, liver abnormalities, and adverse pregnancy outcomes; a bone safety study; and two pediatric studies.
Can Treatment Be Scarier Than Disease?
Doctors scribbled out prescriptions, patients swallowed the once-daily pills, and the FDA began to follow-up on those required postmarket studies in 2014.
After one year on the market Invokana reached over 420,000 patients with Type 2 diabetes. But after 457 patients developed serious side-effects arguably worse than their diabetes, the Institute for Safe Medication Practices (ISMP) began to publicly question if Invokana's benefits actually outweigh the possible consequences -- a necessity for FDA approval.
To the ordinary public, 457 may seem low when compared to the hundreds of thousands of prescribed patients; but, it's actually higher than 92 percent of the other Type 2 diabetes drugs regularly monitored.
Of those patients, side effects ranged from dehydration and UTIs, as the warning label initially stated, to hypersensitivity, kidney damage or failure and heart problems. The ordered postmarket studies lead to discovering at least two of these side effects. But interestingly enough, none of the latter raised the most concern.
The FDA now warned doctors to watch for their Type 2 diabetes patients on Invokana developing diabetic ketoacidosis (DKA), a blood condition typically only found in Type 1 patients. DKA is when the body produces high levels of ketones, or blood acids. When the body can't produce enough insulin to support the muscles and tissues with energy it starts to break down fat instead, producing a buildup of ketones. It's a slow process and previously almost never formed in Type 2 patients. DKA can lead to diabetic comas, long-term hospitalization and death.
With serious side effects exposing themselves one after another, Invokana users are left with serious questions. Is it worth the risk? Why was Invokana approved with no long-term studies? If the five postmarket studies occurred before the drug went public, would I be suffering? Lawyers are asking the same questions, and the makers of the top-grossing Type 2 diabetic drug are now bracing for Invokana lawsuits.
Last month, the FDA added even more fuel to the fire by releasing a second safety alert involving Invokana, again as a result of the postmarket studies now ordered two years prior. They strengthened Invokana's, as well as other SGLT2 inhibitors, warning label to include risk of bone fracture and decreased bone mineral density, meaning bone strength. The alert states fractures can occur as early as 12 weeks after taking the drug and bone density is most commonly lowered at the hip and lower spine.
It's still unclear what effect this most recent safety alert will have on Invokana's reputation and popularity. The FDA says they are continuing to evaluate these risks and encourages all doctors and patients to continue reporting any side effects associated with Invokana. The drug remains on the market.