Wyeth: Independent Education in Protonix Colors

The Wyeth Protonix $55 million disgorgement resolved allegations of off-label promotion through sales representatives and supposedly independent medical education. Grants promised that Wyeth would leave educational content alone. The government alleged that its brand team shaped the programs and even insisted that their materials look like Protonix advertising.

The Justice Department announced the civil settlement on December 12, 2012. Pfizer agreed to make the payment, having acquired Wyeth in October 2009. Wyeth manufactured and promoted Protonix tablets, and the allegations covered conduct between February 2000 and June 2001.

The Justice Department called the payment a disgorgement remedy, aimed at preventing a manufacturer from profiting from misbranding its product.

What Is Considered Off-Label Promotion?

Off-label promotion means marketing a drug for a use outside its Food and Drug Administration approval. In the Protonix case, the government alleged that Wyeth pursued a much broader reflux market than the use it had obtained approval to promote.

Protonix is a proton pump inhibitor, a type of drug physicians used to treat forms of gastro-esophageal reflux disease, commonly called GERD. At the time of the alleged conduct, Protonix was approved for short-term treatment of erosive esophagitis, a condition associated with GERD that required an invasive endoscopy to diagnose.

Symptomatic GERD was far more common and could be diagnosed without an endoscopy. According to the government, Wyeth intended to promote Protonix for all forms of GERD, including that larger group.

The Food and Drug Administration had already raised the problem before Wyeth began promoting the drug. According to the government’s account, the agency warned that proposed promotional materials overstated the erosive-esophagitis indication by suggesting that Protonix was safe and effective for GERD generally. It specifically said the drug was not indicated for GERD symptoms in the absence of esophageal erosions.

Wyeth had been told. The government alleged it trained its sales force to make the broader pitch anyway.

The Nighttime Heartburn Claim Came From the Top

Wyeth allegedly promoted Protonix as the “best PPI for nighttime heartburn” without clinical evidence that it worked better for nighttime heartburn than any other proton pump inhibitor.

The government’s account placed the slogan’s origin at the highest levels of the company. It also said Wyeth retained an outside market research firm, spending tens of thousands of dollars to ensure that sales representatives delivered the superiority message.

The government also alleged that sales representatives frequently promoted Protonix for symptomatic GERD. The training and the market research connected what representatives said in doctors’ offices to decisions made above them.

Wyeth’s separate Rapamune promotion case showed another way a company could direct the sales force toward a broader patient market. The government alleged that Wyeth used financial incentives to encourage sales representatives to target all transplant patient populations to increase Rapamune sales.

How CME Became Branducation

The government alleged that Wyeth used continuing medical education to promote Protonix for unapproved uses while promising that its grants would leave the education independent.

CME programs are sponsored by accredited independent providers, including universities, nonprofit organizations and specialty societies. The educational provider was supposed to offer physicians independent scientific information.

According to the government’s account, Wyeth spent millions of dollars on “unrestricted educational grants” whose terms promised that it would not attempt to influence program content in any way. The announcement then described a very different relationship between the funder and the funded program:

The government also alleged that Wyeth insisted on CME materials with the same color and appearance as Protonix promotional materials. Wyeth and its vendor called the tactic “branducation,” according to the announcement.

Physicians came for independent science. According to the government, Wyeth used that trust as one of its core marketing tactics to drive off-label use.

The Other Protonix Case Was About Medicaid Rebates

The later Protonix rebate case concerned discounts on oral and intravenous versions of the drug. Wyeth and Pfizer agreed to a $784.6 million settlement announced on April 27, 2016, resolving allegations brought by two whistleblowers about underpaid Medicaid rebates.

The government alleged that Wyeth bundled hospital discounts on Protonix Oral and Protonix IV to encourage hospitals to use the oral drug, then kept those discounts out of the Best Price reported for Medicaid. Other oral proton pump inhibitors were competitively priced and considered at least as safe and effective, according to the government’s account.

The hospital strategy reached beyond the hospital purchase. The government alleged that patients discharged on Protonix Oral were likely to remain on it for long periods, while payers, including Medicaid, paid nearly full price. A discount at the hospital could help win the prescription that followed the patient home. The allegation was that Wyeth concealed the bundled discounts and avoided the rebates Medicaid was owed from 2001 to 2006.

The promotion resolution addressed how Wyeth marketed the drug and used medical education. The later False Claims Act settlement addressed the price information that determined what Wyeth owed Medicaid. Those are separate cases with separate payments, even though the company and product names match.

What Evidence Is Needed to Prove Fraud?

For the conduct alleged in the Protonix promotion case, we look for evidence connecting the approved use, the company’s message and the decisions that put that message in front of physicians. Sales training, market research, grant promises and decisions about speakers and content each show a different part of that connection.

Public Citizen’s 2018 study, Twenty-Seven Years of Pharmaceutical Industry Criminal and Civil Penalties: 1991 Through 2017, described systematic efforts to deceive physicians and the FDA about drug safety or effectiveness as a feature of major earlier off-label investigations. The distinction was between a companywide effort and a lone employee. In Protonix, the government alleged involvement from senior management through the sales force and education vendors.

An employee who worked on grants may know how the promise of independence compared with the actual content decisions. Someone at an education vendor may know who requested the speaker, changed the program or specified the materials’ appearance. A sales representative may know the message taught in training and how the company checked its delivery.

Off-label promotion can lead to a False Claims Act case when a manufacturer knowingly causes false claims for government payment. Our work with pharmaceutical whistleblowers connects that knowledge to the company decisions and government payments involved. A whistleblower case under the False Claims Act can pay 15% to 30% of what the government recovers.

You Know Who Shaped the Message

If the promise in the grant and the directions from the brand team told different stories, speak with our whistleblower experts about what you saw. We work with you to build your strongest pharmaceutical whistleblower case and bring in pharmaceutical fraud whistleblower lawyers who understand promotion, medical education and government payment claims. We stay beside you as your knowledge of the business becomes the foundation of the case.