Healthy Skepticism Library item: 17416

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Publication type: news

Cronin Fisk M, Feeley J, Voreacos D
J&J Pushed Risperdal for Elderly After U.S. Warning, Files Show
Bloomberg.com 2010 Mar 10
http://www.bloomberg.com/apps/news?pid=20601202&sid=ag4Ya8UOIob0

Full text:

Johnson & Johnson made plans to reach $302 million in geriatric sales for its antipsychotic Risperdal just months after federal regulators said the company falsely claimed the drug was safe and effective with the elderly, according to internal documents.

The U.S. Food and Drug Administration told J&J in 1999 that its marketing materials for geriatric patients overstated Risperdal’s benefits and minimized risks. A J&J business plan for the next year called for increasing the drug’s market share for elderly dementia sales, an unapproved use, according to newly unsealed documents in a lawsuit by the state of Louisiana.

“The geriatric market represents Risperdal’s second wave of growth,” J&J officials wrote in the business plan. “The aging population will continue to drive market growth well into the next century.”

Louisiana officials cited the document and dozens of other internal J&J files in its lawsuit claiming the company marketed Risperdal to the elderly and children for unapproved uses. Professor Jerry Avorn of Harvard Medical School, who isn’t involved in the case, called the papers “one of the more egregious examples” of marketing drugs to vulnerable patients.

“By 2010, most grownups in medicine know that drug companies resort to unsavory practices to promote drugs, but seeing such clear evidence in black and white of the details of a campaign like this is still pretty upsetting,” Avorn said.

Any Condition

Under U.S. law, a doctor can prescribe a medicine for any condition, as long as it’s licensed by the FDA and proven safe and effective against at least one ailment. Drug companies, however, aren’t allowed to promote a drug for uses other than those approved by the FDA. Risperdal until 2003 was approved only for psychotic disorders including schizophrenia; it was never approved for dementia.

J&J, based in New Brunswick, New Jersey, and its Ortho- McNeil-Janssen Pharmaceutical unit, deny engaging in such “off- label” marketing. They said they will fight the lawsuit, in which Louisiana seeks hundreds of millions of dollars in fines and reimbursement of public funds spent on Risperdal.

Louisiana “does not cite any evidence that Janssen made misrepresentations or engaged in off-label promotion of Risperdal and does not identify any connection between defendants’ alleged conduct and Louisiana doctors’ decisions to prescribe Risperdal rather than other drugs,” J&J said Nov. 30 in court papers asking a state judge in Opelousas to dismiss the case. The judge rejected the motion and set trial for September.

‘Body of Evidence’

Greg Panico, a spokesman for J&J’s Janssen unit, said in an e-mail that the case “should be decided on the body of evidence, including testimony, not on the basis of excerpts from documents.”

J&J has been sued by 10 states over Risperdal sales practices, and other states have expressed an interest in similar suits, according to regulatory filings. It hasn’t reserved money for a settlement. Risperdal global sales peaked at $4.5 billion in 2007, declining after the company lost patent protection, company filings showed.

“We don’t view it as a problem for J&J at this moment,” said Les Funtleyder, an analyst with Miller Tabak & Co. in New York, who recommends buying J&J shares and doesn’t own any. “The one exception, and we haven’t really seen this, is when there’s a sort of systemic problem — somebody at the top says, ‘You shall market off-label no matter what the law says.’”

Four J&J competitors that also make atypical antipsychotics paid a total of more than $2.5 billion to resolve government claims they marketed medicines for off-label uses. Eli Lilly & Co. paid more than $1.6 billion over Zyprexa and AstraZeneca Plc agreed to pay $520 million for Seroquel.

‘This Very Conduct’

“It was this very conduct — marketing an atypical antipsychotic for dementia rather than for psychosis — that led to the $1 billion plus settlement with Eli Lilly,” said Patrick Burns, of Taxpayers Against Fraud in Washington.

The Justice Department alleged that some Risperdal sales growth came illegally. It sued J&J Jan. 15, claiming the company paid kickbacks to Omnicare Inc., the largest U.S. pharmacy for nursing home patients, to buy and recommend drugs including Risperdal.

The kickbacks included payments that boosted overall J&J sales to Omnicare from $100 million in 1999 to $280 million in 2004, the Justice Department alleged. Annual purchases of Risperdal rose to more than $100 million, the U.S. said. J&J denied any wrongdoing.

Omnicare provided a physician prescriber list in June 1999 to the ElderCare sales force of the Janssen unit, according to a J&J document filed in the U.S. lawsuit. The names were intended “to increase the call frequency on these resistant prescribers and to eventually influence them to use more Risperdal in the elderly demented patient.”

‘Lawful and Appropriate’

Janssen spokesman Panico said that the company’s conduct with regard to Omnicare was “lawful and appropriate.” Covington, Kentucky-based Omnicare agreed Nov. 3 to pay $98 million to settle state and federal kickback claims, without admitting any wrongdoing.

More than 5,000 pages of documents were made public by J&J after Bloomberg News filed a motion asking the judge to unseal them. The records detail a decade-long campaign by Janssen to convince doctors, regulators and insurers that Risperdal was superior to older, cheaper antipsychotics.

At the time of the 2000 plan, Risperdal competed with Zyprexa and Seroquel. The antipsychotic market grew from $1.4 billion in 1994 to $14.6 billion by 2008.

Risperdal sales rose to $589 million in 1997, making it the top antipsychotic, according to the documents. Schizophrenia sales constituted 37 percent of Risperdal’s business, with off- label sales for bipolar, dementia and other disorders accounting for the remainder, according to the minutes of a company medical-development team meeting.

Achilles Heel

“Lack of data in support of off-label” was termed the Achilles heel of Risperdal, according to a summary of the meeting prepared by Janssen employee Robert Jones.

In 1993, Janssen won FDA approval to sell the drug for psychotic disorders including schizophrenia. That market is limited, since only 1.1 percent of adults suffer from the condition, according to the National Institute of Mental Health.

“Schizophrenia represents only 35 percent” of antipsychotic prescriptions, Ivo Caers, a Janssen executive, wrote in a 1994 report. “Aggressive expansion of Risperdal use in other indications is therefore mandatory.”

Unapproved Uses

Janssen sought to sell Risperdal for bipolar disorder, dementia, mood and anxiety disorders and other unapproved uses, the documents show. Sales exceeded Janssen’s expectations, according to the plans. Though Janssen predicted in 1993 it would take seven years to reach $295 million, U.S. sales hit $343 million in 1995.

Hundreds of Janssen salespeople sold to doctors, nursing homes, Veteran’s Administration facilities and jails, the records show. Marketers gave doctors materials about studies of unapproved uses for Risperdal. Janssen sponsored clinical trials of the drug’s effect on other illnesses.

In 1994, 1999 and 2004, the FDA ordered Janssen to stop making false and misleading marketing claims about Risperdal’s superiority.

Janssen set sales goals for 2000 of $302 million for geriatric sales, or 57 percent of the market, and $175 million in bipolar sales, or 32 percent, according to the business plan. That same year, Janssen planned to expand its geriatric sales force by 50 to 136 people, according to the business plan.

It wasn’t until 2003 that the FDA approved Risperdal for bipolar disorder. In 2006, the regulator approved it for symptoms related to autism in children and teens. The FDA approved it to treat bipolar children and teens the next year.

The drug was never approved for dementia.

Drive Sales

To drive sales, Janssen paid doctors to speak at continuing medical education, or CME, programs about Risperdal, according to the documents. Janssen armed them with slides touting its effectiveness, the documents show.

“Medical Services/Affairs has little input on speaker’s slides,” according to a January 2003 e-mail from Jeni Bastean, a Janssen executive. “The content of the Speakers Slide Kit is driven by marketing as they are promotional in nature.”

At a 2003 meeting, a Janssen executive praised the use of coached questioners at programs, according to a transcript. A doctor identified in the transcript as Randy told Janssen employees that he signed a letter agreeing he would only talk about permitted uses of Risperdal.

‘Plant a Shill’

“However, I always plant a shill because if I get asked a question from the audience, I can then speak off-label,” Randy said. “You never like to go to a CME meeting without knowing ahead of time that somebody is going to ask you, ‘what about dementia?’”

“That’s good practical advice,” replied Dr. Andrew Greenspan, an executive in Janssen’s medical affairs department, according to the transcript.

The lawsuit is Foti ex rel. State of Louisiana v. Janssen Pharmaceutical, 04-C-3967, 27th Judicial Court, St. Landry Parish, Louisiana (Opelousas).