An ex-lobbyist has sued pharma giant Eli Lilly, alleging sexual discrimination and harassment, and accusing one executive of ‘sexual self-groping’ during meetings

The logo of Lilly is seen on a wall of the Lilly France company unit, part of the Eli Lilly and Co drugmaker group, in Fegersheim near Strasbourg, France, February 1, 2018. Picture taken February 1, 2018. REUTERS/Vincent Kessler
The logo of Lilly is seen on a wall of the Lilly France company unit, part of the Eli Lilly and Co drugmaker group, in Fegersheim near Strasbourg

  • Former lobbyist Sonya Elling sued Eli Lilly, saying the behavior of high-ranking staff forced her to resign.
  • The lawsuit claimed a senior vice-president at the pharma giant demeaned female employees.
  • An exec also engaged in inappropriate sexual behavior in the office, the lawsuit, filed Friday, said.
  • See more stories on Insider’s business page.

A former top lobbyist for pharmaceutical giant Eli Lilly accused a high-ranking executive and another senior manager of engaging in sexual discrimination, harassment, and retaliation against women in its Washington D.C. office, according to a lawsuit filed Friday.

The suit, filed in federal court by in-house lobbyist Sonya Elling, alleges that a Lilly senior vice-president, Leigh Ann Pusey, repeatedly demeaned Elling and other women, and eventually forced Elling to resign. Elling’s lawsuit seeks unspecified damages for lost pay and alleged reputational and emotional harm.

Pusey, senior vice-president of corporate affairs and communications, was one of CEO Dave Ricks’s first appointments when he took the role in 2017.

Read more: Silicon Valley’s demand for rapid startup growth is a recipe for disaster in healthcare

Eli Lilly is the only named defendant in the suit. Pusey did not respond to requests for comment.

A Lilly spokeswoman denied the allegations in the suit.

“Lilly is committed to fostering and promoting a culture of diversity and respect, and a work environment free of discrimination, harassment, or retaliation of any kind,” the spokeswoman said. “We hold all employees accountable to our core values and believe our executives carry an even higher burden in ensuring those values are upheld.”

The lawsuit comes as other allegations of inappropriate or retaliatory actions by Lilly executives against employees at Lilly have surfaced. Last month, Lilly announced that the company’s chief financial officer, Josh Smiley, resigned after Lilly said in a securities filing that he had engaged in “consensual though inappropriate personal communications” with employees. Smiley declined to comment.

Reuters reported earlier this month that a former Lilly human resources manager alleged she had been forced out of her job because she repeatedly raised concerns with executives about manufacturing problems at a New Jersey factory. Lilly told Reuters it has rigorous quality assurance programs in place and welcomes employee feedback.

Elling had worked as an in-house lobbyist for Lilly since 2003, rising to become a senior director in 2005.

Pusey, named to her post in the wake of former president Donald Trump’s election, has worked for several Republican leaders and organizations including the Republican National Committee, according to her online Lilly executive bio.

The suit alleges that Elling and other women were subjected to sexist comments by Pusey and another senior manager, including that they were “nasty,” “b*****s,” “disruptive,” “aggressive,” and “rude.” Pusey regularly mocked Elling’s appearance and that of other women while noticeably treating male employees more favorably, the suit states.

In 2018, according to the suit, another woman lobbyist at Lilly filed an internal complaint against Pusey, alleging that she had created a hostile workplace and made several offensive comments about Elling and others. That lobbyist is not named in the lawsuit.

In May of that year, a Lilly human resources investigator interviewed Elling about the other lobbyist’s complaint, which Elling corroborated, the suit said. Ultimately the investigator found the complaint to have merit, according to the suit.

Exec engaged in “sexual self-groping” during meetings, lawsuit says

After that, the lawsuit said, Pusey began to exclude Elling and others who participated in the complaint investigation from briefings of senior leaders.

In 2019, Pusey hired an executive, Democrat Shawn O’Neail, to directly supervise Elling and other lobbyists, the suit states. O’Neail engaged in inappropriate sexual behavior in the office, including “sexual self-groping,” during meetings with Elling in her office, the lawsuit said.

The lawsuit alleges that O’Neail had a history of misogynist and racist conduct at pharmaceutical giant Novartis AG, where he had previously worked, and that he once used the N-word to refer to a Black executive at a rival drug company. The company, Pfizer, declined to comment.

O’Neail, who was not named as a defendant in the suit, did not respond to requests for comment. Novartis declined to comment.

O’Neail was brought in to “clean house” by terminating Elling and another employee, the lawsuit said. According to the suit, O’Neail falsely accused Elling of making disparaging statements about Lilly to congressional staff. He eventually put Elling on a job performance improvement plan, according to the suit.

On December 1, 2019, Elling sent a resignation email to top executives, saying she was forced into the decision due to Pusey and O’Neail’s discrimination and retaliation against her, the suit said.

Read the original article on Business Insider

Eli Lilly falls 9% after its Alzheimer’s drug data underwhelms Wall Street

FILE PHOTO: The logo of Lilly is seen on a wall of the Lilly France company unit, part of the Eli Lilly and Co drugmaker group, in Fegersheim near Strasbourg, France, February 1, 2018. Picture taken February 1, 2018. REUTERS/Vincent Kessler
The logo of Lilly is seen on a wall of the Lilly France company unit, part of the Eli Lilly and Co drugmaker group, in Fegersheim near Strasbourg

  • Eli Lilly fell 9% on Monday after additional data for its Alzheimer’s drug, donanemab, was released in The New England Journal of Medicine over the weekend.
  • The drug showed “no substantial difference” than a placebo in secondary outcomes like an improvement in scores on the Clinical Dementia Rating Scale Sum of Boxes.
  • An effective Alzheimer’s drug has been viewed as the holy grail in the biotech industry as it represents a significant unmet need.
  • Sign up here for our daily newsletter, 10 Things Before the Opening Bell.

Eli Lilly fell as much as 9% on Tuesday after additional data for its Alzheimer’s drug candidate, donanemab, was released in The New England Journal of Medicine and presented at the 2021 International Conference on Alzheimer’s and Parkinson’s Diseases over the weekend.

The data reinforced previously released top-line data that showed donanemab slowed the cognitive decline in patients with early symptoms of dementia.

But donanemab showed “no substantial difference” than a placebo for secondary outcomes, like improvement in scores on the clinical dementia rating scale-sum of boxes and the 13-item Alzheimer’s disease assessment scale-cognitive subscale, according to the data.

“The use of donanemab resulted in a better composite score for cognition and for the ability to perform activities of daily living than placebo at 76 weeks, although results for secondary outcomes were mixed,” researchers said in The New England Journal of Medicine.

A successful Alzheimer’s drug has been viewed as the holy grail in the biotech industry, as it would help combat a devastating disease that represents a large unmet need. Biogen is another biotech company that is working on a highly anticipated Alzheimer’s drug candidate, aducanumab.

JPMorgan analyst Cory Kasimov said in a note on Monday based on the data so far, Eli Lilly’s donanemab “isn’t yet a clearly superior drug to [Biogen’s] aducanumab,” and that “it’s less likely donanemab is approved early on the basis of these results.”

Another phase 2 trial for donanemab is underway to gauge the safety, tolerability, and efficacy of the drug.

Read the original article on Business Insider

New data on Eli Lilly’s experimental Alzheimer’s drug backs a hotly debated scientific theory, but shows mixed benefits for patients

FILE PHOTO:  Patients with Alzheimer's and dementia are sit inside the Alzheimer foundation in Mexico City April 19, 2012. REUTERS/Edgard Garrido
Patients sit inside the Alzheimer’s Foundation in Mexico City

  • Eli Lilly’s experimental treatment slowed down cognitive decline by 32% in a midstage trial.
  • But the drug missed most of the secondary trial goals, including one watched by experts.
  • An Eli Lilly executive told Insider the data was mixed, but very exciting.
  • See more stories on Insider’s business page.

The latest test of Eli Lilly’s Alzheimer’s disease drug ended with a mixed bag of results, but experts say there are signs the experimental treatment may curb the disease’s decimation of cognition and memory.

Lilly gave an in-depth look at the performance of its drug, called donanemab, on Saturday at the International Conference on Alzheimer’s and Parkinson’s Diseases. The drug met the trial’s primary goals, reducing a harmful substance that builds up in the brains of patients with Alzheimer’s disease. It also slowed down the rate of cognitive decline by 32%, according to data scheduled to be published Saturday in a medical journal. But it missed the mark on several secondary tests.

The Alzheimer’s drug-development field has been marked by failure after failure, so the news that Lilly may have a working drug sent a surge of energy through the field when the drugmaker first disclosed some information about the results in January.

Those earlier failures – even within Lilly’s own drug-development pipeline – may have tempered expectations for donanemab. Dr. Mark Mintun, the vice president of the Alzheimer’s disease unit at Lilly, said he couldn’t think of a similar Alzheimer’s disease trial that hit its primary goal.

At this point, any news is good news, Dr. Howard Fillit, executive director of the Alzheimer’s Drug Discovery Foundation, told Insider.

“We’ve basically had a 100% failure rate on drug approvals since 2003. The thing that we’re going for is incremental benefits,” he said.

The donanemab data may give hope to the scientific community and other drug companies, but Fillit said the jury is still out on how effective the drug will be for patients themselves.

Donanemab missed the mark on a memory assessment experts were watching

Donanemab was designed to target a plaque that builds up in the brains of Alzheimer’s patients called amyloid beta. The hope is that getting rid of the plaque will reduce the rate of decline of a person’s memory and cognition.

Scans of trial participants’ brains showed that people taking donanemab did see their plaques fade away. That’s not only a boon to Eli Lilly, but other drugmakers that are working on treatments targeting amyloid beta, such as Biogen and Roche.

FILE - In this May 19, 2015, file photo, a doctor points to PET scan results that are part of a study on Alzheimer's disease at a hospital in Washington. Scientists know that long before the memory problems of Alzheimer's become obvious, people experience more subtle changes in their thinking and judgment. (AP Photo/Evan Vucci, File)
FILE – In this May 19, 2015, file photo, a doctor points to PET scan results that are part of a study on Alzheimer’s disease at a hospital in Washington. Scientists know that long before the memory problems of Alzheimer’s become obvious, people experience more subtle changes in their thinking and judgment. (AP Photo/Evan Vucci, File)

It wasn’t as clear how much benefit donanemab had on subjects’ ability to recall words, follow instructions and other abilities lost to dementia.

The drug passed the main test of memory and cognition.

But Alzheimer’s experts had their eyes on one datapoint in particular: the scores from a widely accepted dementia assessment known as CDR-SB. The tool is used to measure things like memory and judgement, as well as a person’s ability to do household chores and maintain their personal hygiene. The higher the score, the more skills have been lost to dementia like Alzheimer’s.

Eli Lilly’s drug didn’t meet expectations there.

The company reported that trial participants taking donanemab had a 0.36 point score difference compared to the participants that received a placebo treatment.

For comparison, Dr. Lon Schneider, director of the California Alzheimer’s Disease Center at University of Southern California, had hoped to see at least a one-point difference, according to the Wall Street research firm Mizuho.

Mintun, the Eli Lilly executive, said he hadn’t expected that donanemab would pass all five dementia tests, calling it statistically impossible. But giving patients more time to hold onto memories is meaningful for them, he said.

The clinical trial took a ‘Goldilocks approach,’ and more testing is needed

The donanemab trial assessed a small and very specific group of patients. The trial was limited to participants with amyloid plaques, as well as another protein linked to Alzheimer’s called tau. Fillit called it a Goldilocks approach – in the end, Lilly ended up with participants whose Alzheimer’s disease wasn’t too early or too advanced.

Fillit and Alzheimer’s disease researcher Rudy Tanzi said that Lilly will need to run another clinical trial, preferably a much larger late-stage test with participants from multiple countries, if it wants to bring the treatment to the US Food and Drug Administration for approval. In particular, the company would need to show the drug works, as measured by the CDR-SB score, Tanzi said.

Eli Lilly’s current plan is to run at least one more mid-stage trial. The format of that trial had already been set, but Mintun said the drug giant is discussing possible changes with the FDA, including potentially removing a significant CDR-SB change as the main goal.

Changing that CDR-SB requirement, particularly given that the original Phase 2 trial failed on that regard, would make investors skeptical of the drug, according to a note from Morgan Stanley analysts before the full results were announced.

Read the original article on Business Insider