Endo's off-label Lidoderm mantra, whistleblower says: 'Put the patch where the pain is'

Endo whistleblower Peggy Ryan--Courtesy of James, Hoyer, Newcomer & Smiljanich

For former Endo sales rep Peggy Ryan, the pivotal moment came about three years into her employment with the Malvern, PA-based company. She was at a national meeting, where the topic of discussion was how to distribute off-label studies in an unsolicited way, she says.

"My district manager stood up and said, 'Here's our loophole.' And I thought to myself, 'Peggy, this entire Lidoderm scheme is one big loophole,'" she told FiercePharmaMarketing in a phone interview.

So in 2005, Ryan filed a whistleblower suit accusing Endo Health Solutions ($ENDP) sales managers of pushing Lidoderm, a treatment for postherpetic neuralgia (PHN)--a shingles complication--for other pain problems. Nine years later, it paid off: Last Friday, the company settled three suits with the Department of Justice for $193 million, admitting it promoted the pain patch for uses not approved by the FDA from 2002 to 2006, prosecutors say. The whistleblowers' share of the settlement has yet to be determined; under the False Claims Act (FCA), whistleblowers can receive between 15% and 25% in cases where the government intervenes.

"The company takes its responsibility to patients, healthcare providers and our shareholders very seriously," Endo CEO Rajiv De Silva said in a statement at the time. "We are pleased to resolve this matter and are confident that we have robust programs in place to assist us in satisfying our legal and regulatory agreements."

As Ryan recounts, her Endo superiors urged her from the onset of her training in 2002 to open the door to off-label dialogues with physicians. "The company's direct marketing message was to discuss the mechanism of action and say, 'Doctor, do you know that the Lidoderm patch is actually indicated for the pain associated with PHN, which is a type of neuropathic pain? What other types of neuropathic pain do you suppose it might work for? What about the patients in the waiting room--do you think it would help them?' That would cast the net and help them think outside the box and outside of the PHN indication," she said.

"Put the patch where the pain is," was another broad, undefined message to doctors, opening conversation to off-label discussions and prompting doctors to ask themselves, 'Well, if it's pain, can I put a Lidoderm patch on it?'" Ryan recalls. Sales forces also distributed off-label studies that led to the same end, she said.

And then there were the sales quotas. When Ryan first began, her goal was 300 scripts a month. But at a high point in her career, she said, her goal was more than 2,500--an impossible act to keep up while sticking to Lidoderm's approved indication, which affects about 200,000 U.S. patients a year. Call plans included specialists Ryan said "would never in a million years come across a PHN patient," like anesthesiologists and neurosurgeons.

For Ryan, filing the suit was just the beginning of a 9-year journey that culminated with Friday's settlement. For 5 of those years, she stayed on as an Endo employee working under the instruction of the FBI, wearing a wire to record several days' worth of meetings and conversations. Later, she cooperated with several other branches of the government including the Department of Health and Human Services, whose inspector general she helped draft a subpoena.

"It's a very stressful situation," she said of wearing a wire. "You're thinking about the questions that the government or the FBI wants you to ask specific individuals, and you're constantly having that third conversation in your head, thinking, 'Does anyone know?'"

But while blowing the whistle on underhanded marketing practices comes with its challenges, the pharma industry has seen more and more reps taking matters into their own hands with the help of FCA incentives for whistleblowers. Ryan joins a slew of recent informants, including former Amgen ($AMGN) rep Jill Osiecki and former Johnson & Johnson ($JNJ) rep Judith Doetterl, both of whom also went undercover to help bring about settlements. Whistleblowers also put some of Big Pharma's biggest in the spotlight this summer, calling out GlaxoSmithKline ($GSK) and, later, others like Novartis ($NVS) and Sanofi ($SNY), for alleged bribery in China.

And though her role in the Endo settlement proved stressful, in the end, Ryan called the experience "very rewarding."

"It's such a difficult decision to say, 'I'm going to be the one to stand up for what's right here," said Jillian Estes, an attorney with James, Hoyer, Newcomer & Smiljanich who worked on the case. "You put your professional career at risk, and for 9 years she had a secret from her colleagues and her family. But she did the right thing to come forward. I think it's probably the most important takeaway from what her role was."

- read the DOJ release
- see Endo's release

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