Public Citizen: “FDA Must Stop Manufacturers' Off-Label Promotion of Dangerous Diabetes Medications”
Janssen Pharmaceutica has allegedly been engaging in illegal marketing tactics for its diabetic medication Invokana – and consumer advocacy organization Public Citizen has called them out on it.
Invokana (canagliflozin) was initially hailed as a “wonder drug” for the treatment of Type 2 diabetes. The medication regulates blood glucose levels by causing the kidneys to absorb excess blood sugar. This excess is then passed during urination. Before the drug was approved in 2013, the Food and Drug Administration's Endocrinologic and Metabolic Drugs Advisory Committee met with Janssen representatives. Those company representatives gave what amounted to an extensive sales pitch, citing the rising number of patients with Type-2 patients and the need for “more effective treatments” – namely, Japanese corporate affiliate Mitsubishi Tanabe's new product, Invokana. At that time, three highly-respected physicians – Dr. Sidney Wolfe of Public Citizen, along with Hyon Kwon and Mat Soukop – all expressed serious concerns about Invokana's possible side effects. Dr. Soukop, a biostatician, warned that patients taking Invokana were nearly seven times more likely to suffer a heart attack or stroke.
Despite the warnings, the FDA committee went ahead and approved the drug on grounds that the benefits outweighed the risks. Since then, Invokana has been implicated in serious – and sometimes fatal – ketoacidosis (high blood acidity) as well as kidney failure, heart attacks and even osteoporosis. The latter was discovered over the course of a two-year study showing significant bone density loss among geriatric patients taking Invokana.
Meanwhile, Janssen, in the great tradition of putting profits ahead of the well-being of patients, has been actively seeking to expand the market for Invokana. This is where the company has allegedly fallen afoul of the law. According to Public Citizen, Janssen has been engaged in direct-to-consumer marketing Invokana for “off-label” purposes. This means that the company is recommending the medication for treating conditions other than Type-2 diabetes. A licensed, experienced physician may legally write an “off-label” prescription if, in his/her professional judgment, the patient would benefit from the medication. However, under FDA regulations, a drug maker may not advertise, market or otherwise promote a medication for any purpose other than that for which the agency has granted approval.
Nonetheless, Janssen has been touting Invokana as an effective treatment for hypertension (high blood pressure) and weight loss. The FDA has not approved Invokana for either of these purposes. Yet, Janssen has continued to place these “added value” advertisements.
And where is the FDA on this? Asleep at the wheel, apparently. Earlier this year, Public Citizen wrote a letter to Dr. Thomas Abrams, the FDA's Director of the Office of Prescription Drug Promotion (OPDP). According to the letter, the FDA has significantly reduced enforcement of regulations prohibiting drug makers from engaging in direct-to-consumer (DTC) off-label promotions – even if the benefits are only implied. Prior to 2001, the FDA sent out over 110 “cease-and-desist” letters a year to pharmaceutical companies in violation of this regulation. Since 2010 however, that number has dropped to under 30.
In the letter, Public Citizen researcher Dr. Sammy Almashat, senior advisor Dr. Wolfe and director Dr. Michael Carome cite print ads from Janssen and other pharmaceutical companies:
The ads...all contain statements describing the alleged weight-reducing properties of the medications. However, none of the drugs is approved for weight loss and, despite the presence of disclaimers that the medications are not weight-loss drugs, the implication is clearly that weight loss is an additional potential benefit of the drugs. The deliberate placement of the claims in such close proximity to the drugs’ approved indications serves to reinforce this impression.
It's a clever tactic on Big Pharma's part in skirting regulations. It's not going to fly with Public Citizen, however. Unfortunately, the FDA's response was typical of a bureaucracy that has long been compromised by the same corporate interests it's supposed to be regulating:
Thank you for your letter...[the] OPDP's mission is to protect the public health by assuring prescription drug information is truthful, balanced and accurately communicated...OPDP appreciates your concern. Your information and insights assist us in our surveillance activities...[we] will evaluate the materials you submitted.
That was back in April. Today, Janssen is still including weight loss information about Invokana on its website. And why not? Excess body weight and high blood pressure are among the most common health problems among Americans in today's demanding, high-stress world. It's literally a golden opportunity for Janssen to push – however subtly – its dangerous medication on greater numbers of consumers.
Don't expect any help from the FDA. Levin Papantonio attorney Tim O'Brien points out that “[Invokana] is the caboose on the Type-2 diabetes drug train that the FDA just keeps shuttling down the track.” He adds, “Once you get past the approval process, and you've got your billion-dollar juggernaut going...it takes a lot of public outcry, and it takes some activity from the FDA to either make you change your label, or take the drug off the market.”
Unfortunately, until the FDA decides to grow a pair and start doing its job, it's up to the rest of us to sound the warnings.