Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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J&J CEO Gorsky Is a Follower, Not a Leader: @JNJCares - NOT!

J&J CEO Gorsky Is a Follower, Not a Leader: @JNJCares - NOT! | Pharmaguy's Insights Into Drug Industry News |

Johnson & Johnson (JNJ) chief executive officer Alex Gorsky was initially chastised last week for deciding to stay on President Trump’s manufacturing advisory council, before reversing course just as Trump announced the panel would be dissolved after a series of defections.


A trio of internal memos sent to J&J employees, reviewed by STAT, offer some insight into Gorsky’s reasoning.


An exodus from the council began with Merck chief executive Ken Frazier, one of the most prominent African-American business leaders in the country, two days after Trump’s initial comments on Saturday, Aug. 12. Originally, Gorsky planned to sit tight. In a memo distributed on Monday, Aug. 14, Gorsky essentially argued that J&J had an opportunity to influence the Trump administration:


First Gorsky defended his decision to stay: “When we are a part of the conversation, we help ensure that healthcare remains the global priority it should be.”


Simply put, there are shareholders to consider and Gorsky was willing to wait it out.


Gorsky doubled down the next morning. In yet another memo on Tuesday, Aug. 15, he more explicitly reiterated his earlier argument that a seat at the table is better than no seat at all. And he did so even after acknowledging complaints from some employees and shareholders.


“In the end, I have concluded that Johnson & Johnson has a responsibility to remain engaged, not as a way to support any specific political agenda, but as a way to represent the values of Our Credo as crucial public policy is discussed and developed. …if we aren’t there standing up for our belief in diversity and inclusion, or if we fail to speak out when the situation demands it, then we have abdicated our Credo responsibility. We must engage if we hope to change the world and those who lead it.”


The Credo, for those unaware, is a long-standing mission statement etched on the J&J headquarters building in New Brunswick, N.J., that makes a commitment to act responsibly to health care providers, employees, communities, and shareholders. . (Some will argue J&J breached its Credo for episodes of illegal marketing that generated big fines or poorly handled product recalls, but that’s another story. For more on that, read “How J&J's Alex Gorsky Tried to Negotiate a Smaller DOJ Fine”;


His Tuesday memo would have appeared to end the episode, but then, Trump struck again. Later that same day, the president outraged and upset many people once more with off-the-cuff remarks that indicated he assigned equal blame to those who attended the Charlottesville, Va., rally organized by white supremacists and neo-Nazis, and to those who protested the march.


On Wednesday, Aug. 16, Gorsky wrote a third memo to employees.


“…the president’s remarks at his press conference yesterday — equating those who are motivated by race-based hate with those who stand up against hatred — were completely unacceptable. Therefore, I decided to resign from the White House Manufacturing Advisory Council. By working with other members of the manufacturing council on a united withdrawal, I realized we would make the most significant impact.”


Trump showed his true colors with his initial remarks. Why wasn’t that enough to bail right then and there?


PharmaGuy’s comments:

In other words, Gorsky was a follower, not a leader!

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"Janssen Followed All Rules," Yet Has Paid Billions of $ to DOJ for Illegal Risperdal Marketing

"Janssen Followed All Rules," Yet Has Paid Billions of $ to DOJ for Illegal Risperdal Marketing | Pharmaguy's Insights Into Drug Industry News |

David Kessler, the former U.S. Food and Drug Administration commissioner, testified Wednesday that as a pediatrician, it "certainly is a red flag to me" that a Janssen Pharmaceuticals Inc. study of the use of its antipsychotic drug Risperdal in young children and adolescents, mainly boys, showed high rates of breast growth.

Kessler was FDA commissioner from 1990 to 1997, when Janssen, a subsidiary of Johnson & Johnson, received approval in 1993 for the drug to be prescribed to adults with psychosis. In the ensuing years, Janssen sought to expand the approved uses and the range of patients.

Kessler testified in Philadelphia Common Pleas Court as a witness for two Alabama parents who sued Janssen because their severely autistic son, now 20, was prescribed Risperdal for the first time when he was about 7½, without their fully knowing its risks. The boy developed breasts, a condition called gynecomastia.

Not until 2006 was Risperdal approved for use in autistic adolescents. By then, the boy had been on Risperdal for five years. Janssen sales reps had visited his pediatric neurologist, Jan Mathisen, 20 times between 2002 and 2004, bringing samples.

Testifying Monday, Mathisen said he had been the most frequent prescriber of Risperdal in Alabama. He said he would have liked to have known about the Janssen study.

"Janssen followed all rules for reporting data from clinical trials, and we believe that the prescribing information for Risperdal has been appropriate at all times," Janssen spokeswoman Robyn Reed Frenze said in a statement.

Pharma Guy's insight:

Read: How J&J's Alex Gorsky Tried to Negotiate a Smaller DOJ Fine

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How Gorsky Drove 46% - 66% of Risperdal Sales for Off-Label Use

How Gorsky Drove 46% - 66% of Risperdal Sales for Off-Label Use | Pharmaguy's Insights Into Drug Industry News |

In November 2000, Johnson & Johnson research scientists got troubling numbers related to the goal Gorsky and his team had set at the Risperdal “Brand Strategic Planning” meeting two years earlier. They had hoped that the scientists would generate data that would rebut the competition’s claim that Risperdal raised levels of the hormone prolactin to a degree that could cause young boys to grow breasts. But the largest study done yet by J&J of the effects of long-term Risperdal use among children and adolescents—in which, according to the study’s protocol, “special attention” was paid to prolactin—had now found that of 319 children, including 266 males, 8.6 percent of the males had developed gynecomastia, or breasts. When the final results including more participants were tabulated, the percentage of males was 5.5 percent.

Five and a half-percent was a big number. If 400,000 boys took Risperdal, that would mean 22,000 might end up with breasts. Attention deficit disorder was no picnic, but doctors and parents might not think treating it was worth those odds of their son having to wear a bra. And that risk was in addition to all the other known side effects already listed on the Risperdal label, such as somnolence, nausea or significant weight gain.

An updated Risperdal business plan that management signed off on in September 2000 unabashedly signaled that Johnson & Johnson would ignore the regulators and any bothersome data and keep going after children.

hildren and adolescents were now the fastest growing segment of the market—and they accounted for 21 percent of all Risperdal users. The second fastest uptick was in the geriatric market, which comprised 25 percent of all Risperdal users. That meant markets that J&J was forbidden from promoting to accounted for 46 percent of all sales in the year 2000, a percentage that was likely to grow quickly because, as the plan noted, the legitimate market, schizophrenic adults, was “flat.” In fact, a study later published by the Journal of the American Medical Association would put the off-label percentage at 66 percent in 2001.

The plan then mapped steps to be taken in the coming year to “grow and protect share in child/adolescents via medical education initiatives and effective [sales] rep-targeting, with a year-end exit share of 70%.” Respected doctors—called “Known Opinion Leaders,” or “KOLs”—would be paid to “drive pediatric acute medical education” with a blizzard of J&J-financed articles, symposiums and supporting PR.

Pharma Guy's insight:

According to the DOJ, Gorksy was the "go-to guy" when it came to illegal kickbacks made to nursing home pharmacies for prescribing Risperdal, and "no one else possesses the same level of knowledge." 

So how come Gorsky never went to jail? Could it be possible that DOJ and Gorsky actually negotiated these settlements in such a way as to keep Gorsky insulated from criminal charges? There may have even been one or two phone calls between Gorsky and Attorney General Holder to discuss this. One such call might have gone like this: 

Gorsky: Let me tell you the reason I’m calling. I'm a little concerned about some . . . criminal charges stuff. Like, that maybe you guys are thinking of, uh, bringing criminal charges against ME personally. 

Holder: Yeah, we’re definitely thinking of doing that. 

Gorsky: Huh. And this is something you feel strongly about? 

Holder: Pretty strongly, yeah. 

Gorsky: I see. And you have, like, evidence and stuff? 

Holder: I can’t really talk about that, but yeah . . . like, boatloads. 

Gorsky: So listen, do you ever . . . 

Holder: What? 

Gorsky: Do you ever . . . do you ever look out the window in the late afternoon and just get . . . sad? Like, for no reason? 

Holder: Nope. 

Gorsky: Really? Anyway, in terms of a fine . . . 

Holder: Yeah?

Gorsky: I was talking with some of the guys here and we were thinking, like, a Billion maybe would be good. Do you think that would be a good number? Without charging me with a felony or even a misdemeanor, that is. 

Holder: Hmmmmm... 

Gorsky: Oh. What were you thinking, hypothetically? 

Holder: Hypothetically? Not less than FIVE to SIX Billion, including federal and state lawsuits.

Gorsky: Yikes! Does it really have to be that much? If it were say $3.1 Billion, it would be the highest fine paid by a pharma company to the US government and it would give you great creds. 

Holder: That's true, but we can't forget the states. Tell you what, let's announce a 2.2 Billion settlement against J&J for drug-related violations and later announce a $2.5 billion fine to settle the device violations without a hint of an extra lien of $0.6 Billion to cover Medicare/Medicaid liens. The $2.2 Billion figure would include $1.6 Billion against Janssen… but we'll hide that in the details so it won't look so bad for you who used to be President of Janssen.

Gorsky: Whew! Convoluted! O.K., then. Well . . . I should probably talk with my lawyers. 

Holder: Yes, you talk to your lawyers. 

Gorsky: Dinner soon? 

Holder: Can’t wait.

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