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Source: Wikimedia Commons and Psychonaught

Pfizer’s Quirky Settlement Raises Brows

Jessica Mehta • Tue, June 13th, 2017

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Settling isn’t an unusual way to end a lawsuit, especially for mega companies like Pfizer Inc. However, what is unorthodox is what Louisiana Attorney General Jeff Landry asked of Pfizer instead of cash in an antitrust lawsuit. The pharmaceutical company agreed to give the state of Louisiana $1 million worth of their generic Naloxone—and Landry couldn’t be happier.

Naloxone is colloquially known as the “save shot” and also called Narcan. It’s known for its ability to bring someone back from an opioid overdose by blocking opioid receptors short-term. If given in time, it restores breathing and can save lives. Naloxone has been shown to be easy to use with minimal training, similar to an EPI pen. This allows the drug to be quickly and easily administered by anyone. The opioid reversal agent is often carried by emergency medical technicians. CNN’s Dr. Sanjay Gupta, M.D. reports there’s an increasing push for it to be available to first responders as well as drug abusers.

Granted, the antitrust lawsuit was passed down to Landry. He inherited it in 2015 from former Attorney General Buddy Caldwell.

Landry’s well aware of the American opioid epidemic, particularly in Louisiana. In his pre-political life, he was a sheriff’s deputy in St. Martin Parish and previously a police office in Parks. He’s also been an attorney, worked for the St. Martin Economic Development Authority, and was a small business owner. The native Louisiana republican leader has seen first-hand, through his work in law enforcement, the results of opioid abuse.

Landry says he saw a chance to improve Louisiana’s growing opioid problem while simultaneously putting the lawsuit to bed. In the filings, it’s alleged that Pfizer was maneuvering to put a stop to others from manufacturing generic versions of their Neurontin drug (an anti-convulsant unrelated to opioids). It just so happens that Pfizer also manufactures Naloxone, currently the fastest and most effective opioid-reversal drug. Landry saw the opportunity and jumped on it.

Two Birds, One Lawsuit

On May 15, 2017 Landry made the official announcement. In lieu of the cash settlement, Pfizer agreed to give the state 60,000 Naloxone bottles. First, the bottles will be distributed to first responders through a voucher program. Every voucher is worth 10 doses. During a press conference, which went live on Facebook, Landry explained how the distribution would work.

The single draw-down Naloxone doses are available to state first responders who request them via a short application. Managed by the Louisiana Department of Justice (LADOJ), first responders can redeem the Naloxone at any local pharmacy with their voucher. Landry said in his press conference statement, “I am appreciative of the partnership between our office and Pfizer, as well as the continued support from our first responders who strive daily to rid Louisiana of opioid related overdoses and deaths.”

Landry was joined by sheriffs, police chiefs and fire chiefs. Lafayette Parish Sheriff Mark Garber said, “We, along with other communities throughout the country, have seen our heroin overdose cases quadruple. Equipping our deputies with Narcan will aid in our efforts to save lives as we respond to overdose calls.” He called the drug a valuable life-saving tool for police agencies, and since it comes at no cost it will be readily adopted.

“In working with Pfizer,” Landry said, “we saw an opportunity to get at one of the dimensions … in this fight against the opioid epidemic.” He’s also working with police and fire departments around Louisiana to make sure they’ll have enough Naloxone available.

Louisiana State Senator Fred Mills was also at the press conference. He pointed out that while other states had agreed to cash settlements with Pfizer in their own antitrust cases, Louisiana’s leaders thought Naloxone was more beneficial to the residents of the state. Currently, Louisiana is one of the top ten states for opioid overdoses according to the Centers for Disease Control (CDC). In 2015, 861 people died from opioid abuse in the state. Nationally, more than 33,000 people died of opioid-related causes in 2015, including prescription opioid abuse and heroin. “This is the most unique settlement in the United States,” Mills said.

According to a report in the Journal of the American Academy of Orthopaedic Surgeons, orthopedic surgeons are the third highest prescriber of painkillers including opioids in the United States. Internists and general physicians take first and second place. This makes sense according to co-author Dr. Brent J. Morris, M.D. “Orthopedic injuries including broken bones can be very painful and may requires casting or surgery to treat and these are often treated with an opioid pain medication during the initial recovery period,” said Morris in the study’s narrative statement. “It is very reasonable to use a short course of opioid pain medications to help with recovery.” However, given the highly addictive nature of opioids, Dr. Morris urges caution.

Landry’s announcement comes on the heels of his “End the Epidemic LA” educational campaign which launched in April 2017. Landry partnered with the Louisiana Ambulance Alliance to create the effort. The campaign provides information and resource for those with an opioid addiction or know someone struggling with abuse. “This is a real problem that has directly affected our families and friends and it must be stopped in order to make our State a safe and healthier place,” he stated at the conference.

Pfizer’s Take

An email from a Pfizer spokesperson to Fierce Pharma said, “We are pleased to have reached an agreement with the Louisiana Attorney General that helps to address the serious public health concern of prescription opioid abuse.” However, for Pfizer, they’re no stranger to collaborating with lawmakers to tackle opioid abuse. In the summer of 2016, Pfizer established an agreement with the City of Chicago addressing painkiller marketing. Pfizer played a key role in making its own rules for opioid sales more transparent to be used as a model. This was the result of Chicago filing lawsuits against a number of other pharmaceutical companies such as Purdue Pharma L.P. and Teva Pharmaceuticals Industries Ltd. Allegedly, the City of Chicago said unfair marketing practices encouraged patients to pursue opioids instead of other, safer, less addictive methods of pain management. Although Pfizer wasn’t involved in the lawsuits filed by the City of Chicago, the Pfizer spokesperson said that the company thought partnering with the city to tackle opioid abuse was vital for public health.

National Attention

Coincidentally, Pfizer settled with Landry on the same day Orange County, New York, sued four drug makers, claiming deceptive marketing tactics led to the risks of opioids not being full understood. Orange Country, with a population of 379,000, had 943 opioid-related admissions to emergency rooms in 2014. In 2015, 44 opioid-related deaths were reported. In the New York lawsuit, Tevo, Endo Pharmaceuticals Inc., Purdue Pharma and Johnson & Johnson are named as defendants. Pfizer is not named in the New York lawsuit. Already, Johnson & Johnson has released a statement claiming the lawsuit is “unfounded” and reiterates that all its drugs have US Food and Drug Administration (FDA) warnings.

Still, settling for Naloxone doses instead of a cash settlement also benefits Pfizer. The company has been fighting antitrust charges since 2002. The Neurontin dilemma isn’t a new one. A number of customers who bought Neurontin have filed antitrust lawsuits against Pfizer, claiming that the pharma company was rigorously safeguarding its brand from generic competitors by filing their own “sham patent cases.” Ultimately, these claims led to a class action lawsuit, and Pfizer did make a financial settlement in that case—to the tune of $190 million.

Louisiana is one of a handful of states with lingering lawsuits against Pfizer because of Neurontin. According to Landry’s press conference, even though the 60,000 bottles of Naloxone technically retail for $1 million, it’s actually “priceless” to the state of Louisiana.

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