• by Thom Forbes  @tforbes, September 19, 2018

Using information from a whistleblower, California insurance commissioner Dave Jones filed suit against AbbVie Inc. yesterday, charging that it has been giving illegal kickbacks to healthcare providers to encourage them to prescribe Humira, which the state claims is “an expensive and dangerous drug with potentially deadly side effects.” 

The injectable anti-inflammatory drug was the top-selling pharmaceutical in the U.S. for the fifth straight year in 2017 according to IQVIA, WebMD’s Marcia Frellick reports. Its data show sales tripling from $4.5 billion in 2012 to more than $13.6 billion last year (other reports go as high as $18.4 billion) for the heavily advertised medication.

But, as Jones charges and North Chicago-based AbbVie adamantly denies, it has also been boosting sales illicitly. 

“AbbVie spent millions convincing patients and health care professionals that AbbVie Ambassadors were patient advocates -- in fact, the Ambassadors were Humira advocates hired to do one thing, keep patients on a dangerous drug at any cost,” insurance commissioner Dave Jones claims in a release. 

“We believe the allegations are without merit. AbbVie operates in compliance with the many state and federal laws that govern interactions with healthcare providers and patients,” the company replied in a statement cited by Reuters’ Ankur Banerjee and Tamara Mathias.

The suit, filed on behalf of the state of California in Alameda County Superior Court, charges that AbbVie shelled out $1.2 billion to the so-called ambassadors. 

“The kickback scheme ‘resulted in patients being directed to use the drug, being denied information that they would otherwise need to rely on to make determinations about whether it was appropriate for them to use the drug and significant additional insurance payments for the drug,’" Jones tells the Associated Press’ Sudhin Thanawala in a telephone interview.

“AbbVie paid for doctors' meals, drinks and travel to get them to write more prescriptions for Humira, according to the lawsuit. The kickback scheme also included nurses whom the company sent to the homes of patients taking the drug, the lawsuit says,” reports the AP’s Thanawala.

“The key to AbbVie's success in pulling off its scheme, and among the most troubling aspects of it, is the fact that AbbVie inserts its own personnel directly into the homes of patients. When doctors prescribe Humira, AbbVie sends its registered nurses -- which AbbVie calls ‘Ambassadors’ - - into patients' homes, representing them to be an extension of the doctor’s office,” the suit maintains.

Calling the allegations “without merit” in an interview with the Los Angeles Times’ James Rufus Koren, AbbVie spokeswoman Adelle Infante defended the company’s use of nurses to work with patients.

“AbbVie provides a number of support services for patients, once they are prescribed Humira, that both educate and assist patients with their therapy, including nursing support, and these resources are beneficial to patients dealing with a chronic condition,” she said. “They in no way replace or interfere with interactions between patients and their healthcare providers.”

At least one nurse disagrees.

“The allegations were initially raised by Lazaro Suarez, a registered nurse who worked for a contractor -- QuintilesIMS, which is now part of IQVIA -- that was hired by the drug maker to develop the network of nurses. Suarez trained nurses who visited Humira patients around the U.S., although these nurses also accompanied AbbVie sales reps on visits to physician offices,” reports Ed Silverman for Stat.

“The suit was brought under the state Insurance Frauds Prevention Act, which prohibits fraud against private health insurers. It seeks civil penalties of $10,000 per fraudulent claim -- for a total of up to $6.3 billion in penalties and injunctive relief against AbbVie, and a court order to halt AbbVie from engaging in the alleged practice,” Catherine Ho writes for the San Francisco Chronicle. 

“The lawsuit, by the way, was heavily redacted because AbbVie argued much of the information was confidential, or trade secrets, according to a spokeswoman for the California insurance department which, she added, hopes to convince the court that the redactions should be lifted,” Stat’s Silvermanreveals.

“Critics have accused AbbVie of seeking an excessive number of patents on trivial improvements to keep competition for Humira off the market, a technique known as ‘evergreening,’ writesBloomberg’s Robert Langreth.

“AbbVie has sought some 247 U.S. patent applications on the drug, with 89 percent of those filed after the drug was approved by U.S. regulators in 2002, according to a study by the Initiative for Medicine, Access and Knowledge, a consumer group that’s blasted drugmakers over high drug prices,” he continues.

“A low-cost copy of the medicine will be available in Europe in October, while the U.S. version won’t be allowed until 2023, under the terms of a settlement AbbVie reached last year with Amgen Inc. The patent on the active ingredient for Humira expired in 2016.”