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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The $70 Million Breast Job: That's What J&J Must Pay to Male Teen Who Took Risperdal and Developed Large Breasts

The $70 Million Breast Job: That's What J&J Must Pay to Male Teen Who Took Risperdal and Developed Large Breasts | Pharmaguy's Insights Into Drug Industry News |

In a blow to Johnson & Johnson, the company was ordered last Friday to pay $70 million to a male Tennessee teenager who claimed its Risperdal antipsychotic pill caused him to grow enlarged breasts. The finding by a Pennsylvania state court jury was not only the latest, but it is the biggest defeat to date in what has become another sprawling litigation over the drug.

In reaching its decision, the jury found that J&J failed to properly warn Risperdal could cause gynecomastia, which is the abnormal development of large mammary glands in males. Moreover, the jury also determined that the company “intentionally falsified, destroyed, or concealed records” that Risperdal could cause boys to develop breasts.

Last week’s verdict, which only included compensatory damages, dwarfs the $2.5 million that was awarded last year to an Alabama man, who sued J&J after he developed size 46 DD breasts. The latest case was brought by Andrew Yount, who was born in 1998, and was given Risperdal in 2003 to treat a psychiatric problem, according to one of his attorneys.

Pharma Guy's insight:

Speaking of films, Two "Unbroke Girls" & George Clooney Aim to Give J&J Its Comeuppance in New Film “America’s Most Admired Lawbreaker”; The film should depict "How Gorsky Drove 46% - 66% of Risperdal Sales for Off-Label Use"; 

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J&J: America’s Most Admired #Pharma Lawbreaker - Chapter One

J&J: America’s Most Admired #Pharma Lawbreaker - Chapter One | Pharmaguy's Insights Into Drug Industry News |
A shocking story about the biggest company in the US's most profitable industry.

The Food and Drug Administration had prohibited Johnson & Johnson salespeople from trying to promote Risperdal to doctors to treat children because of its feared side effects, including hormonal disorders. The company was also not allowed to promote it to treat the elderly except for the most serious psychotic disorders; it was thought to cause strokes, diabetes and other ailments in that population. But by the time young Austin started growing breasts, Johnson & Johnson was reaping more than half of its Risperdal sales from prescriptions written for children to alleviate all kinds of behavior disorders, and for the elderly, who were given the drug for simple symptoms of dementia or restlessness.

Johnson & Johnson emails, sales training manuals and business plans produced as evidence in the case revealed that the company organized special sales units illegally targeting doctors who treated the elderly and children. State mental institutions treating children, whose drugs would be paid for by Medicaid, were targeted, too.

When it came time to explain their conduct at trials and to federal investigators, Johnson & Johnson executives and salespeople have unwaveringly, even indignantly, defended themselves. One salesman, who otherwise fit the salt-of-the-earth mold that R.W. Johnson had envisioned for his company’s employees, gave thousands of Risperdal samples in child-sized doses to Austin Pledger’s doctor in Birmingham, Alabama. Yet he insisted under oath in February he didn’t recall stepping around kiddie furniture and toys as he walked into an office with a sign that said “pediatric neurologist,” and that he had no way of knowing that the doctor wasn’t treating adults.

Pharma Guy's insight:

Meanwhile, you might want to read this: How J&J's Alex Gorsky Tried to Negotiate a Smaller DOJ Fine 

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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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J&J Slams Ex-FDA Chief David Kessler in Risperdal Male Breast-Growth Case

J&J Slams Ex-FDA Chief David Kessler in Risperdal Male Breast-Growth Case | Pharmaguy's Insights Into Drug Industry News |

Johnson & Johnson’s lawyers, in a trial over whether the antipsychotic drug Risperdal caused boys to develop abnormal breasts, attacked a former government health regulator as a biased witness with a penchant for finding that drugmakers hide their medicines’ risks.

David Kessler, the former head of the U.S. Food and Drug Administration, has become a “hired gun” for consumers suing drugmakers since he left government service in 1997 and now routinely finds companies fail to adequately warn the public about their products’ risks, Diane Sullivan, one of J&J’s lawyers, said Friday in state court in Philadelphia.

During cross-examination, Sullivan accused Kessler of “cutting and pasting” findings from other cases into his conclusion that officials of J&J’s Janssen unit knew Risperdal caused some boys to develop female breasts and failed to alert patients, doctors and regulators about it. Kessler testified on behalf of the parents of a 20-year-old autistic man suing over the side effect.

“Each case is complex and there is an enormous amount of details associated with them,” Kessler countered. “To say I’ve testified each and every time the same way would be incorrect.”

J&J, based in New Brunswick, New Jersey, faces more than 1,000 cases over the Risperdal side effect in state court in Philadelphia. The current case may be the first in which a jury decides whether J&J and Janssen are liable for mishandling the antipsychotic medicine.

Pharma Guy's insight:

The Department of Justice (DOJ) just updated its commemorative poster highlighting the now seven highest multi-million/billion dollar settlements that drug companies have agreed to pay for inappropriately, and in some cases illegally, promoting prescription drugs.

The latest addition to the poster is Johnson and Johnson, which will pay $2.2 billion to the U.S. government to end civil and criminal investigations into kickbacks to pharmacists and the marketing of pharmaceuticals for off-label uses. According to an NBC News story (here), "The settlement with the company and its subsidiaries covers the marketing of schizophrenia treatment Risperdal and of heart drug Natrecor, said the source, who spoke on condition of anonymity."

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