Diabetic drugs dominated the “payments and perks” from drug manufacturers to U.S. doctors and hospitals in 2014. Invokana, a prescription drug used to treat Type 2 diabetes, was second on a list detailing which companies paid out the most money to promote their drug. Johnson & Johnson and its subsidiaries, Bayer and Janssen, paid out $19.8 million in 2014 to doctors and hospitals, topped only by AstraZeneca’s diabetic drug Bydureon, with payments of $22.5 million.
AstraZeneca defended the practice, saying patients benefit when physicians are well informed about medications. Many people feel these payments are more of a payoff to doctors and hospitals for prescribing one drug over another. In fact, Jerry Avorn, professor of medicine at Harvard Medical School, said many of the diabetes drugs linked to bigger payments are not the recommended first choices to treat Type 2 diabetes. Avorn notes “It’s striking that the top two drugs are expensive new products for diabetes that are by no means first-line choices.”
Avorn went on to say that metformin manufacturers are not spending money to educate doctors about the inexpensive generic drug which happens to be the most important treatment for diabetes. A spokesman for Johnson & Johnson countered those statements by saying that since Invokana is a newer drug, it is normal to spend more money promoting it in order to ensure physicians know how to prescribe it correctly.
Safety of SGLT-2 Inhibitor Drugs Questioned by FDA
Despite the fact that the FDA recently questioned the safety of SGLT-2 inhibitor drugs, Invokana took a huge jump in sales in the first quarter of 2015—and is expected to hit “blockbuster” status during 2015, passing the $1 billion sales mark. Invokana, like other SGLT-2 inhibitor drugs such as Farxiga, Invokamet, Jardiance, Xigduo XR and Glyxambi, treats Type 2 diabetes by inhibiting the carrier which assists reabsorption of glucose into the bloodstream.
How SGLT-2 Drugs Work
SGLT-2 inhibitor drugs such as Invokana flush excess glucose through the kidneys and out of the body. Because Invokana works as a powerful diuretic, it can lower blood pressure in the patient, causing dizziness and fainting. More concerning, during the first two years Invokana was on the market, more than 450 adverse event reports regarding the drug were received by the FDA. Fifty-four of those adverse event reports concerned patients who took Invokana and experienced renal failure. More than twenty patients developed serious diabetic ketoacidosis after taking Invokana.
Understanding Diabetic Ketoacidosis
Normally, diabetic ketoacidosis occurs only in those with Type 1 or juvenile diabetes. When the body becomes unable to use sugar as a fuel source due to the lack of insulin in the body, fat is used as a fuel source instead of glucose. The fat in the body breaks down and blood acids, called ketones, build up in the blood and urine. Vomiting for more than two hours, decreased alertness, a flushed face, severe headache, stiff muscles, stomach pain, dry mouth or skin, rapid breathing, frequent urination, excessive thirst or fruity smelling breath are symptoms related to diabetic ketoacidosis. Complications of diabetic ketoacidosis include heart attack, kidney failure, bowel tissue death and fluid buildup in the brain.
Did Johnson & Johnson Exhibit a Failure to Warn Consumers?
Due to the high number of adverse event reports as well as studies implicating Invokana in kidney disease, kidney failure, heart attack, blood clots, stroke and diabetic ketoacidosis, it would seem J & J and Janssen were aware of the potential risks associated with the drug. Yet no changes were made to the labeling accompanying Invokana, and no warnings or recalls were issued by the manufacturer. One NCBI article, in particular, noted urogenital infections, arterial hypotension, dehydration and altered renal function were associated with Invokana and that the drug has an unfavorable harm-benefit balance.