Pharma leaders: Heroes, and villains?

Trump
Johnson & Johnson CEO Alex Gorsky (at right), with President Trump at a January breakfast of business leaders in the Roosevelt Room of the White House.

It’s autumn, when Jefferson Health honors successful business people who give it money at its yearly Award of Merit dinner. Past honorees include real estate investor Ira Lubert, Home Depot founder Bernie Marcus, and SAP boss Bill McDermott. On Nov. 28, it will be Alex Gorsky, CEO at Johnson & Johnson.

Premier teaching hospital honors pharma leader: a good Philly story. Gorsky has won other honors, and Wall Street’s approval: Johnson & Johnson shares topped $140 for the first time last week, on higher-than-expected profits.

But this fall, the painkiller business is deep into another of America’s lethal opioid cycles, reminding us how powerful drugs also kill. And that other Philadelphia business, the plaintiffs bar, is seeking millions for aggrieved survivors. So even good-deed doers are getting extra scrutiny.

Under Gorsky, J&J has been generous to medical, nursing, health-economics, “outcomes” research, and clinical trials, said Jefferson’s Gail Benner. Jefferson wouldn’t total what it has collected from J&J, which reported $17 billion in profits on $72 billion in sales last year, or from Gorsky, paid $25 million in cash and stock. Jeff gave Gorsky an honorary degree three years back.

“It’s beyond disgusting” that one of Philadelphia’s noted medical organizations is honoring Gorsky, said Steven Sheller, a Philadelphia lawyer. Sheller has sued J&J and other drugmakers, accusing them of selling medicine for unapproved uses, overstating benefits, hiding risks, and hurting patients.

Writer and lawyer Steven Brill, in his 2015 report “America’s Most Honored Lawbreaker,” traced Gorsky’s years overseeing the marketing of Risperdal, the J&J anti-psychotic drug whose sales topped $3 billion a year in the early 2000s. In 2013, the company agreed to pay $2.2 billion to settle civil and criminal charges with the Justice Department and 45 states. Justice said the company pushed Risperdal and two other drugs “for uses not approved as safe and effective by the Food and Drug Administration,” including for autistic children and dementia patients, and paid “kickbacks” to doctors and pharmacy officials. The deal “allows us to move forward,” the company said at the time.

“The Houdini act that enabled Gorsky, the then-Risperdal sales manager, not only to escape responsibility but also to be promoted to the top of his industry’s most admired company raises equally significant questions about the standards of conduct we can expect from those who run what is becoming the world’s most powerful industry, and about how much we can rely on the medicines they sell,” Brill wrote. Actor George Clooney’s production company plans a movie of Brill’s story.

In 2015, lawyers including Sheller won a $70 million award against J&J for pushing unapproved Risperdal on boys whose families said they developed breasts. That decision is under appeal. Appeals reversed multimillion-dollar Risperdal judgments in other states.

Government investigations and product-liability lawsuits filled 13 pages in J&J’s last annual report; the company says it is “not feasible” to predict what it will pay for damages or defense lawyers.

A company statement called Risperdal “a life-saving medicine, supported by more than 20 years of extensive scientific research and clinical studies, that has helped millions of people suffering from schizophrenia and other serious mental illnesses” since its FDA approval in 1993.  Risperdal’s active substance is also “on the World Health Organization’s List of Essential Medicines, which requires that this medication be available at all times in adequate amounts around the world.”

J&J said it was “proud to support the Thomas Jefferson University annual gala, which this year will help fund a powerful, new approach to address some of the most important health-care issues impacting the people of Philadelphia and the surrounding area.”

J&J isn’t the only area drugmaker whose success and generous acts have been complicated by questions about patients and profits.

Cephalon (now part of Israel-based Teva), founded by the late Frank Baldino, illegally marketed sugary Actiq opioid lollipops to people with migraines and other unapproved users, according to an FDA complaint the company settled for $425 million in 2008. Nine years later, Cephalon is defending itself against more recent suits by Ohio, Chicago, and 18 others alleging failure to protect Actiq users from addiction.

Shares of Irish-owned Endo Pharmaceuticals soared in the 2000s after quadrupling sales of painkiller Percocet and modernizing its much-abused opioid Numorphan under the new Opana brand. Carol Ammon, who led the team that spun the company off from DuPont and boosted painkiller sales, retired in 2005 after collecting stock options worth $200 million-plus. She became a philanthropist; Jefferson and Christiana Health named facilities for her. Ammon helped Christiana “greatly increase access to care,” said Christiana spokesman Hiran Ratnayake.

But Endo shares lost most of their value as its painkiller sales fell under new opioid restrictions. It is under investigation in New Jersey and at least five other states, and is being sued by Ohio, Chicago, and at least nine other state and local governments that say Endo knew or should have known its painkillers would be readily, fatally, and extensively abused.  Endo told investors it is “cooperating” with investigators, and “vigorously” fighting lawsuits.