CCHR International » Johnson & Johnson

Whistleblower says antipsychotic drug maker subverted science & induced others to betray patients

admin — Fri, 20 Jan 2012 19:15:26 +0000

“Janssen ran amok,” Allen Jones, the Pennsylvania-based whistleblower on J&J’s marketing practices who was a plaintiff along with state of Texas, told reporters in the Austin courthouse.

“They trashed the Johnson & Johnson credo and they misused Texas and, I believe, well-meaning officials, to further their marketing aims,” Jones said. “They subverted science and they induced others to betray the people they were supposed to be taking care of. To me that is reprehensible.”

January 20, 2012/Reuters

J&J to pay $158 million to settle Texas Risperdal case

Johnson & Johnson said on Thursday it will pay $158 million to settle a Texas lawsuit accusing the drugmaker of improperly marketing its Risperdal anti-psychotic drug to state residents on the Medicaid health program for the poor.

The settlement fully resolves all Risperdal-related claims in Texas, the company said. The agreement is specific to the state of Texas and does not involve other ongoing state or federal Risperdal litigation.

The deal settles claims brought by Texas in 2004 and involves alleged Medicaid overpayments during the years 1994 to 2008 “and will circumvent potentially lengthy and costly appellate activities,” according to a statement from J&J’s Janssen Pharmaceuticals unit.

The settlement will be paid to the original plaintiff, his attorneys, the state of Texas and the federal government, which provides Medicaid reimbursements, the company said.

The complaint against J&J and several of its units filed in U.S. district court in Texas had alleged company representatives “targeted every level of the Texas Medicaid Program with misrepresentations about the safety, superiority, efficacy, appropriate uses and cost effectiveness of Risperdal.”

“Janssen ran amok,” Allen Jones, the Pennsylvania-based whistleblower on J&J’s marketing practices who was a plaintiff along with state of Texas, told reporters in the Austin courthouse.

The deal marks the first Risperdal settlement with any U.S. state, Janssen spokeswoman Teresa Mueller said.

J&J’s once sterling reputation has been battered in the past two years over quality control problems at several of its plants and manufacturing errors that led to massive recalls of a wide variety of its products, including hip replacements, contact lenses, insulin cartridges and heart devices.

Its biggest black eye came from its McNeil consumer healthcare unit, which in a series recalls was forced to pull hundreds of millions of bottles and packages of popular medicines, such as Children’s Tylenol, Motrin, Rolaids and Benadryl.

J&J shares were down 28 cents, or 0.4 percent, at $65 in afternoon trading on the New York Stock Exchange.

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J&J Paid Texas Official to Speak Around the U.S., Jury Told

cchrint — Wed, 11 Jan 2012 22:55:41 +0000

Johnson & Johnson’s Janssen unit paid a Texas mental health official to speak around the U.S. about state guidelines on prescribing antipsychotic drugs that gave preference to medicines like the company’s Risperdal, the official said.

Steven Shon accepted honorariums to fly to Arizona, Florida and New Jersey to discuss Texas guidelines developed in 1999 advising doctors that a newer class of drugs like Risperdal were a “first choice or option” for schizophrenia, he testified today in state court in Austin. Texas is suing J&J, saying the company fraudulently promoted Risperdal and overbilled Medicaid by at least $579 million.

State lawyers say Janssen’s payments to Shon were part of a scheme to influence development of the guidelines, known as the Texas Medication Algorithm Project, or TMAP, and tout them as a model for other states trying to advise doctors on prescribing drugs. Shon was asked how often he went around the U.S. to talk to other states about the TMAP.

“I would say once or twice a month for a period of several years,” Shon said in a video deposition shown to jurors on the trial’s second day of testimony. “I knew that Janssen paid for a substantial number of those trips.”

Texas also claims that New Brunswick, New Jersey-based J&J, the world’s largest health-care products company, defrauded the state Medicaid program by promoting Risperdal for uses not approved by U.S. regulators, including for children with psychiatric disorders. The state joined a lawsuit filed by a whistle-blower, Allen Jones, a former investigator for the Pennsylvania Office of Inspector General.

Medical Director

Attorneys for Jones questioned Shon, who served as medical director of the Texas Department of Mental Health and Mental Retardation until he involuntarily retired in 2006.

Shon testified that he served on Janssen advisory boards, was a board member of a Janssen publication called “Mental Health Issues Today” and was a continuing medical education speaker in programs sponsored by the company.

Shon was asked about six trips in which he got honorariums of $3,000 from Janssen to discuss the TMAP project. In several cases, he kept those payments, he said.

In testimony yesterday, a Texas Medicaid investigator said Shon signed several consulting agreements with Janssen, and the company paid him $47,587 over several years.

Jones’s attorney Thomas Melsheimer asked Shon about Texas regulations that bar a public official from “soliciting, accepting or agreeing to accept any honorarium for doing services” that he wouldn’t be asked to provide “but for that person’s official position or duties.”

Outside of Texas

Shon said his TMAP talks outside of Texas didn’t conflict with his official duties, and he gave them during compensatory time. When asked about a 2000 trip to Scottsdale, Arizona, when his timesheet showed he was at work, he said: “It appears that things were not recorded correctly.”

On cross-examination, Shon said Janssen had no influence over the development of the TMAP guidelines.

He said a state attorney, Cathy Campbell, told him that his appearances in other states were proper. He said he usually gave his honorariums to the state, based on Campbell’s advice.

In those cases when he kept the payments, Shon said, the lawyer advised him that his actions were proper.

‘Something Wrong’

“Did anybody ever tell you that you were doing something wrong in conjunction with your work with TMAP?” a J&J attorney asked Shon.

“No,” he answered.

Shon said he left his state job when he was told “it was time to move on,” he testified.

“Did anybody ever tell you that you had done something wrong, and that’s why it was time to move on?” he was asked.

“No,” he said.

In his opening statement yesterday, Melsheimer said J&J made $34 billion in Risperdal sales after its launch in 1994.

J&J denies wrongdoing and never acted illegally, attorney Stephen McConnico told jurors yesterday in his opening statement.

The case is State of Texas ex rel. Jones v. Janssen LP, D- 1GV-04-001288, District Court, Travis County, Texas (Austin).

Read article here: http://www.bloomberg.com/news/2012-01-11/johnson-johnson-paid-texas-official-to-speak-around-the-u-s-jury-told.html

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Texas AG suit over the drug Risperdal goes to trial Monday

cchrint — Mon, 09 Jan 2012 17:40:30 +0000

The Dallas Morning News
By Janet Elliott and Mark Curriden
January 8, 2012

AUSTIN — A routine inquiry a decade ago by an investigator for the Pennsylvania inspector general exposed a pattern in which pharmaceutical companies showered trips, meals and other perks on state officials in positions to influence which drugs would be used to treat patients under Medicaid.

The efforts appeared to have been particularly successful in Texas, which has one of the largest Medicaid populations.

In 2004, Allen Jones, a whistle-blower who worked with the Pennsylvania inspector general, filed suit alleging that pharmaceutical giant Johnson & Johnson improperly marketed its antipsychotic drug Risperdal for unapproved uses while funneling money to members of a state panel charged with recommending drug treatments for those in state health programs.

Two years later, Texas Attorney General Greg Abbott joined the lawsuit, seeking hundreds of millions of dollars in damages.

The case has been described by lawyers as the biggest lawsuit in Texas since the tobacco litigation in the 1990s. It goes to trial Monday in state court in Austin.

The high-stakes lawsuit alleging Medicaid fraud seeks $579 million in damages from Janssen, a division of New Jersey-based Johnson & Johnson, and penalties that could exceed an additional $500 million. The federal government will get half of any money recovered in the case, and Jones could receive between 10 and 25 percent.

The Texas case is separate from a reported $1 billion settlement reached just last week between Johnson & Johnson and others states over the marketing of Risperdal.

Risperdal was among antipsychotic drugs introduced in the 1990s. Initially approved for adults with schizophrenia, it soon became widely used in Texas mental hospitals and prisons for “off-label” uses, including for youths in the state’s foster care system.

“Not only was Risperdal not more effective, its risks were worse than its competitors and it was 45 times more expensive,” said Tom Melsheimer, a partner at Fish & Richardson in Dallas who represents the whistle-blower. “The company’s claim that its product was superior and its off-label promotional efforts were not supported by science.”

What did support Janssen’s promotional efforts were influential decision makers — including state employees, University of Texas faculty and mental health advocates — who received consulting fees, extravagant meals and travel accommodations, research funding and honoraria, according to the lawsuit.

Janssen denies that it misrepresented Risperdal and rejects allegations that its marketing efforts inflated the state’s spending on the drug. In court filings, the drug company points to the state’s continued use of Risperdal since joining the whistle-blower’s case in 2006.

Follow the money

In the 2010 fiscal year, Texas spent $15.016 million on Risperdal and $13.275 million on its generic equivalent for patients enrolled in Medicaid and the Children’s Health Insurance Program. The drugs cost an average of $229 per prescription, a 2006 Texas comptroller’s report said.

The program known as the Texas Medication Algorithm Project, or TMAP, started in the mid-1990s when state mental health officials contracted with the University of Texas and some of its professors to evaluate medications for treating mental illnesses and disorders.

Jones and the state allege that a process designed to be based on independent experts was co-opted by Janssen using false and misleading information, including ghostwritten articles and industry-funded studies, while playing down side effects, including weight gain and diabetes.

“Defendants thus ‘seeded the literature’ and increased the ‘noise level’ in the Texas health care community, including the Texas Medicaid community, with their false and misleading tale of Risperdal’s superiority to other antipsychotics and suitability for off-label use on vulnerable populations,” the state says in its most recent filing in the case.

Janssen is prepared to vigorously defend itself against these claims, spokeswoman Teresa Mueller said in emailed statement.

“We are committed to ethical business practices, and have policies in place to ensure that our products are only promoted for their FDA-approved indication,” Mueller said. “If questions are raised about adherence to our marketing and promotion policies, we act quickly to investigate the situation and take appropriate disciplinary action.”

Before the marketing blitz, the market was limited for Risperdal, Melsheimer said.

“Janssen determined in 1993 that the market for this drug was the 1 percent of adults with diagnosed schizophrenia, which was a $1 billion market,” he said. “So, the company created a new market for the drug. They created the perception that the drug was a breakthrough for expanded off-label treatments. As a result, the revenue generated by the sale of Risperdal jumped to $34 billion between 1997 and 2010.”

Fees, meals and trips

The most sensational allegations involve Janssen’s use of inducements, including consulting fees, meals, travel accommodations, research funding and honorariums. A key target was Dr. Steven Shon, medical director of the Texas Department of Mental Health and Mental Retardation. Records filed in the case show that Shon received $30,000 in fees and honoraria as a frequent speaker at Johnson & Johnson-sponsored events around the U.S.

David Rothman, a Columbia University professor who studies relations between medicine and the pharmaceutical industry, said in a report that Shon’s conduct was an “acute conflict of interest.” Shon, who resigned in October 2006, said in a deposition that he did not believe he influenced the placement of drugs on TMAP because he was an administrator and not a decision maker in the TMAP process.

Another potential witness in the case is M. Lynn Crismon, dean of the University of Texas College of Pharmacy. Crismon was a professor and member of the TMAP advisory panel in the mid-1990s when he “cultivated a financial relationship with J&J, accepting substantial fees and honoraria and soliciting research grants from the company,” according to Rothman’s report. “As a result, Dr. Crismon subverted the scientific integrity of his research and educational presentations, and biased his decision-making capacity as a member of TMAP.”

Crismon did not respond to a request for comment.

Jury selection is expected to take one day, with opening statements starting Tuesday. The trial could last four weeks.

Read article here: http://www.dallasnews.com/business/health-care/20120108-texas-ag-suit-over-the-drug-risperdal-goes-to-trial-monday.ece

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J&J drug protocols cost taxpayers millions—Lawsuit claims Investigator fired after going public on J&J’s anti-psychotic drug campaign

admin — Tue, 22 Nov 2011 19:29:41 +0000

The Daily Record, by Michael L. Diamond
November 22, 2011

Allen Jones was curious.

Why did Pennsylvania use a computer program that often pointed to a Johnson & Johnson drug over other, cheaper medicine to treat certain mental illnesses, the investigator for the Keystone State’s Office of Inspector General wanted to know (article continued below video)

Video: Whistleblower Allen Jones on pharmaceutical ties to nation wide efforts to screen children for ‘mental disorders’

(Cont…) While the computer program mandated doctors use a new line of anti-psychotic drugs, including Risperdal, sold by J&J’s subsidiary Janssen companies, Jones said he couldn’t find government-funded medical studies showing that these new drugs were any more effective than their generic predecessors.

Jones’ 2002 inquiry into the drug added to a chain of events that ultimately led Texas to sue New Jersey-based health care giant Johnson & Johnson on claims it orchestrated a multimillion-dollar violation of the Texas Medicaid Fraud Prevention Act.

Jones said in an interview that it was his belief that the company “substituted opinion for science.”

Johnson & Johnson’s sales strategy turned Risperdal, a drug approved by the FDA to treat only schizophrenia and bipolar disease, into a blockbuster that the company sold for those illnesses and, unlawfully, many more, according to the Texas lawsuit.

Risperdal cost substantially more than older, generic drugs and generated more than $25 billion for the company before its patent expired in 2007, according to court records. But the drug often was no more effective at treating mental disorders than older drugs, the National Institute of Mental Health found. Because Medicare and Medicaid paid many of the bills, it cost taxpayers millions, according to federal and state lawsuits.

Twelve states, including Pennsylvania and Texas, have sued Janssen to recover some of the money they spent on Risperdal. South Carolina and Louisiana each were awarded more than $250 million last year. The case brought by Pennsylvania, where Jones first made his discovery, was dismissed in June 2010 after a state judge ruled prosecutors didn’t provide enough evidence. West Virginia lost its case on appeal. The cases in Louisiana and Pennsylvania have been appealed. The company said it intends to appeal the case in South Carolina. Texas and the seven remaining cases are awaiting trial.

The U.S. Justice Department also is investigating the marketing of Risperdal. J&J said in an August filing with the U.S. Securities and Exchange Commission that it is negotiating a settlement and has agreed, “in principal,” to plead guilty to a misdemeanor for violating the Food, Drug and Cosmetic Act. No plea has been made yet.

New Jersey hasn’t filed a lawsuit. It isn’t clear how much the state spent on Risperdal in the last 10 years. New Jersey’s Division of Medical Assistance and Health Services refused to provide the information unless the Asbury Park Press paid a $5,071 processing fee. The Press declined to pay the fee.

The Risperdal legal dispute is an example of a problem that is endemic in the pharmaceutical industry, some doctors say. Government-funded studies about the drug’s effectiveness weren’t published until more than a decade after the drug was first approved.

In the case of Risperdal, “we’re spending money on a drug that isn’t superior and might be inferior to other drugs that cost a fraction as much,” said Dr. John David Abramson, a health care policy expert at Harvard University and author of “Overdosed America,” who investigated the drug for Louisiana’s lawsuit.

“It ought to make honest citizens … want to throw up to see that this money is being extracted from society for no gain, when our country is headed toward financial ruin,” Abramson said.

Whistle-blower fired

Allen Jones, the Pennsylvania investigator, was fired in 2004 after going public with his claims, but he continued to investigate, eventually becoming a plaintiff and whistle-blower in a Texas state lawsuit against Janssen. That trial is scheduled to start Jan. 9.

Risperdal was approved by the FDA in 1993 to treat patients with schizophrenia and, a decade later, patients with bipolar disorder. Janssen, on its website, also says the drug can help treat some symptoms of autism in children and adolescents.

With it came the chance for Janssen to replace Haldol, an anti-psychotic drug that Belgian scientist Paul Janssen himself helped develop in the 1950s, just before Johnson & Johnson bought his company in 1961.

Older anti-psychotic drugs had been available in generic form for decades. Risperdal and a new generation of anti-psychotics came to market in the 1990s at a cost that far exceeded the older drugs, according to the Texas lawsuit.

J&J said Risperdal not only would be safer and more effective than the first generation of anti-psychotic drugs, but also could treat mental disorders other than schizophrenia and bipolar disorder, according to the Texas lawsuit.

Janssen’s medical studies weren’t conclusive enough for the FDA to claim Risperdal was more effective than either Haldol and its generic versions or the new anti-psychotic medicine on the market, the Texas lawsuit said.

Unable to tout Risperdal’s superiority, Janssen got the message to doctors anyway, according to legal documents and interviews. The methods included:

Middlemen. Johnson & Johnson teamed with Omnicare, the nation’s largest pharmacy manager for long-term care facilities, to ensure Omnicare’s pharmacists would recommend Johnson & Johnson’s drugs, according to a lawsuit against J&J filed in Massachusetts in 2010 by the U.S. Justice Department.

Omnicare cared for 1.4 million clients in 47 states. Its annual purchases of Johnson & Johnson drugs climbed from $100 million in 1999 to $280 million in 2004. And its purchases of Risperdal alone exceeded $100 million a year, according to the lawsuit.

The lawsuit claims J&J paid Omnicare tens of millions of dollars in grants, rebates, sponsorships and educational funding — payments that the federal government considered kickbacks.

A substantial portion of the prescriptions were paid by taxpayers through Medicaid, the government said. (Omnicare in 2009 agreed to pay $98 million and settle separate charges by the U.S. that it took kickbacks from J&J. The company didn’t admit wrongdoing).

Read the rest of the article here

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Risperdal drug maker faces $1B in lawsuits, yet mother charged for refusing use on child

admin — Tue, 16 Aug 2011 16:49:17 +0000

NaturalNews – August 16, 2011

by Monica G. Young

Click image to visit CCHRInt's Psychiatric Drug Side Effects Search Engine

What irony. Detroit mother, Maryanne Godboldo, was just charged with child neglect for refusing to obey a Child Protective Services order to give her daughter Risperdal, a powerful psychoactive drug. Meanwhile federal and multiple state prosecutors are suing Johnson & Johnson for deceptively marketing the drug – including mismarketing its use on children – and hiding dangerous adverse effects. J&J now faces a potential $1 billion in damages.

Having earlier observed the drug’s dreadful effects on her child, Maryanne was correctly pursuing holistic treatment for the child instead when the legal battle began. The jury’s ruling, now handed down against the mother, is not only a travesty of justice, but a reflection of psychopharma’s vast propaganda machine. (http://www.naturalnews.com/033295_p…)

Fortunately not everyone is fooled. The US Department of Justice (DOJ) has been investigating J&J for years in regards Risperdal – its sales practices, pay-offs to doctors to promote the drug, and failures to disclose harmful effects. The pharma giant has now tentatively agreed to settle a misdemeanor criminal charge, however the DOJ and US attorney’s office are pursuing additional criminal actions.

The government plans to join civil lawsuits filed by company whistleblowers, aiming to recover millions of dollars paid for prescriptions via government health programs like Medicare and Medicaid.

Already multimillions in fines have been levied against J&J for this powerful antipsychotic which is widely prescribed not only for schizophrenia but mood and anxiety disorders, dementia and other unapproved uses.

In June, a South Carolina judge demanded the company pay $327 million to the state for deceptively marketing Risperdal and concealing its dangers. The judge called J&J’s practices “detestable.” Last October, a Louisiana jury ordered the company to ante up $257.7 million for misleading claims about the drug’s safety.

Recently, Massachusetts Attorney General joined the fight, filing a lawsuit against J&J for illegal marketing and failing to disclose “an increased risk of death” connected with the drug.

In Texas the Attorney General Office has joined forces with whistleblowers, with a jury trial scheduled for this fall. This lawsuit alleges that Janssen, J&J’s pharmaceutical division, intentionally marketed Risperdal for use on children even though it was only approved for adult schizophrenia. The suit also involves a company scheme to boost prescriptions by paying hundreds of thousands of dollars to “experts” to evaluate and recommend the drug state-wide and nationally. Awarded damages are anticipated to be much larger than in South Carolina or Louisiana. Texas has paid more than $500 million for the drug since it was first brought to the market.

Attorneys general in about 40 other states have shown interest in suing the company.

Users speak out – beware of this drug!

(Note from CCHRInt –search Risperdal or antipsychotic drug side effects in CCHR’s Psychiatric Drug Database here http://www.cchrint.org/psychdrugdangers/drug_warnings.php – simply type in Risperdal in the Red Search box or choose it from the drop down menu)

Risperdal’s documented “side effects” include huge weight gain, diabetes, lethargy, muscular tics, breast development in males, and many more.

Below are just a few sample statements made online by individuals from their experience with this so-called “medication” (the root word of medicate means “to heal”):

“Basically I lost the drive for everything. Total shut down to my outgoing personality. Massive weight gain.”

“Tardive dyskinesia [involuntary movement disorder], diabetes, gained 100 pounds in the first year, was a zombie… I was put on this nightmare drug when I was six. I was forced to take it against my will, and it ruined my life… This is a horrible, HORRIBLE drug, and should be banned.”

“Apathy, not talking, just staring, sleeping constantly, tongue movements, loss of sexual function. This is a very BAD DRUG…a mental straight jacket. DO NOT put children on this drug!!! It’s poison.”

“I gained weight, became very tired, and of course that just led them to put me on antidepressant medications…. I have been on it since fifth grade and hardly knew what was happening to me.”

“My son has gained over 100 pounds… He was an excellent student, received a doctorate and now cannot even remember what he studied. He sleeps all day and cannot work a job. His quality of life is nil. His mouth twitches and he has no control over it… It is like taking a dose of legalized poison every day. This is a LIFE WASTED AND RUINED, a brilliant mind destroyed and tortured. As a mother, it rips out my heart every day.”

Yet per Johnson & Johnson annual reports, global Risperdal sales from 1994-2010 totaled nearly $29 billion.

http://www.naturalnews.com/033336_Risperdal_child_neglect.html

Sources for this article include:

http://www.google.com/hostednews/ap…

http://www.thefix.com/content/jj-su…

http://www.reuters.com/article/2011…

http://www.kxan.com/dpp/news/invest…

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Big Pharma’s Slimy Crusade to Push Anti-Psychotics on Kids

admin — Mon, 08 Aug 2011 20:25:24 +0000

The Fix – Aug 5, 2011

by Walter Armstrong, Deputy Editor, The Fix.

Pharmaceutical giants spend billions a year to get doctors to prescribe drugs to American kids. Johnson & Johnson even passes out Legos advertising its latest anti-psychotic, ignoring mounting evidence that the drug causes diabetes, wild weight gain, and grows breasts in boys and girls who take it. Their solution? More pills

Plastic Legos stamped "RISPERDAL" are a fixture at pediatricians' offices nationwide.

In the past decade, America’s pharmaceutical industry has knowingly marketed dozens of dangerous drugs to millions of children, a group that executives apparently view as a lucrative, untapped market for their products. Most kids have no one to look out for their interests except anxious parents who put their trust in doctors. As it turns out, that trust is often misplaced. Big Pharma spends massive amounts to entertain physicians, send them on luxury vacations and ply them with an endless supply of free products. As a result, hundreds of thousands of American kids—some as young as three years old—have become dependent on amphetamines like Adderall and a pharmacopeia of other drugs that allegedly treat depression, insomnia, aggression and other mental health disorders.

The fact that none of these powerful mood-altering medications have been approved by the FDA to treat children under 10 has posed no obstacle to the industry’s marketing masterminds. They’ve waved off objections by some some doctors who wonder how these complex drugs will affect the vulnerable brains and bodies of their young patients. Other experts have warned that children exposed to this multi-molecular barrage on their central nervous systems could potentially be at much higher risk of becoming adults who are addicted to chemicals, prescription and otherwise. But thanks to a billion-dollar advertising campaign, millions of kids across the nation are now taking pills to control a long litany of “behavioral problems.”

Luckily, Johnson and Johnson is not getting off scot-free. Last week, Massachusetts Attorney General Martha Coakely announced that the state was suing the world’s biggest pharmaceutical firm, Johnson & Johnson, for illegally promoting Risperdal, an “atypical anti-psychotic”, for off-label treatment of childhood schizophrenia, bipolar disorder, autism, hyperactivity and attention deficit disorder, depression and anxiety, sleep disorders, anger management, mood enhancement or stabilization. As BNet’s Placebo Effect blog recently reported, the list of maladies is grotesquely long. J&J, which prides itself on its high-minded credo of “always putting patients first,” began moving its new drug into this new market as soon as Risperdal won approval in adults—even though the FDA explicitly forbid it from doing so, for the simple reason that the firm had never done a single test of the drug in children who suffered from these or any other conditions.

Though Risperdal was marketed as a less dangerous—if not more effective—alternative to older “typical” anti-psychotics, it quickly became apparent that the drug had many worrisome side effects in adults, including the rapid onset of diabetes and alarming weight gains. But despite a growing weight of evidence about the drugs, J&J only stepped up its promotion of the drug for children—aiming for more conditions and in ever-younger kids—no doubt to squeeze as many profits as possible out of this lemon before the FDA ordered them to stamp a warning on the label or withdraw it from the market altogether.

Unsurprisingly, teens and kids started developing symptoms of drug-induced diabetes and weight gain. Several also developed a bizarre condition called galactorrhea, in which milk flows spontaneously from the nipples of your breasts—girls and boys alike—a happening that is likely to drive even the most balanced teen around the bend. What may be even more bizarre, when doctors alerted J&J sales reps to this side effect, sales reps relayed the warning to their managers, who advised the sales reps to tell the doctors (in a frankly illegal reversal of medical protocol) that rather than take the kids off Risperdal, they could be treated with yet another drug.

The Massachusetts case is the third of about 10 state lawsuits in which jurors will be asked to pass judgment on whether J&J’s Risperdal promotional practices constitute medical fraud. Class-action suits by patients (or parents) claiming injury are also in the works. The Obama administration has shown some guts in not simply allowing the giant drug makers to settle such lawsuits for giant fees ($2 billion is not unusual, however ho-hum to pharma) but in holding individual company executives personally liable for the criminal activity.

In fact this code of misconduct is what we have come to expect from the pharmaceutical industry: Always put profits first, break the law now, pay the fine years later. Given the high-risk nature of drug development—a novel compound costs close to $1 billion and a decade to get to market—Big Pharma has tried all manner of dark arts to increase its odds. Criminal activity, once largely limited to the sales divisions, has overtaken the entire endeavor. Clinical trials that produce negative data—including health risks—are hidden from the FDA. Early signals of serious side effects are covered up, as are promised follow-up studies upon which approval is conditioned. Like other industries, pharma and its lobbyists have regulators and Congress by the balls.

But it’s the corruption of the medical profession by the pharmaceutical industry that has proved most insidious, and nothing illustrates the perilous consequences better than J&J’s illegal marketing of Risperdal to kids. Making 100,000 sales calls on psychiatrists and pediatricians, the company lined the pockets of willing MDs employing familiar pharma ploys, from the small-change items like lavishing free samples, free lunches and—this may be a first—even free colorful plastic Lego blocks printed with the word RISPERDAL for children to play with in the waiting room, to the big-ticket items such as “educational” meetings at fancy resorts and “advisory board” soirees at the Four Seasons. The company even paid certain leading specialists hundreds of thousands of dollars a year to conduct J&J-designed trials and sign their name to J&J-written studies published in the top medical journals—providing a “scientific” spin to the promotional materials. In this amorphous manner, a professional consensus emerged that the atypical anti-psychotics were effective in very young children for attacks of rage, poor impulse control, defiant and oppositional behavior—the transient, irrational, sometimes frightening “acting out” that sends overworked adults around the bend.

By means of this closed circle or deceit and kickbacks, J&J beat out the competition to grab 50 percent of the pediatric market for anti-psychotics. And although many other psychiatrists and pediatricians were arguing that anti-psychotics should never be given to children under 10 in the first place, the white wall of silence in the medical profession generally prevents doctors from becoming whistleblowers unless prodded by investigative news reporting.

Everybody was profiting, it seemed, except for the kids.

Consider Kyle Warren, who as an 18-month-old Louisiana toddler began taking Risperdal prescribed by a pediatrician on the J&J payroll (plastic RISPERDAL Legos and all). Kyle suffered from frequent temper tantrums, and his mother, Brandy Warren, then 22, was a new mother on Medicaid and, as she told the New York Times, “at my wit’s end.” But like any good mother, Brandy kept on searching for the right diagnosis and the right treatment, going from doctor to doctor and amassing a contradictory set of assessments, such as autism, psychosis, schizophrenia, bipolar disorder, and attention deficit hyperactivity disorder. By the time he was age three, Kyle’s daily pill regimen resembled that of someone very old or very sick, including Risperdal, the antidepressant Prozac, uppers for ADHD and downers for insomnia. He was sedated, he drooled, and he was ballooning with fat from the side effects of the Risperdal—but, look Ma, no more temper tantrums!

read the rest of the article here: http://www.thefix.com/content/jj-sued-illegal-promotion-drugs-kids?page=all

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Claim: J&J Wrongly Marketed Antipsychotic Drug Risperdal to Kids

admin — Wed, 03 Aug 2011 16:31:36 +0000

BNET – August 3, 2011
by Jim Edwards
The FDA told Johnson & Johnson (JNJ) in 1997 that its request to market the antipsychotic drug Risperdal for children was “without any justification.” In the following years, J&J’s army of pharmaceutical sales reps made 100,000 sales calls on child and adolescent psychiatrists, justifying this by “qualifying” the docs if they had as few as one adult patient exhibiting signs of schizophrenia, according to a lawsuit.

It was a distinction only a lawyer can love, and now the Massachusetts attorney general is using it against J&J and its Janssen unit, alleging that J&J’s promotion of Risperdal for children was misleading.

J&J had initially asked the FDA to approve the drug for use in children, and the FDA eventually allowed limited use in the over-10s in the 2006 and 2007. But in 1997, without clinical evidence to back its request, the FDA frowned on use of the drug for children. In a latter the J&J, the FDA wrote:

To permit the inclusion of the proposed vague references to the safety and effectiveness in pediatric patients and the nonspecific cautionary advice about how to prescribe Risperdal for the unspecified target indications would serve only to promote the use of this drug in pediatric patients without any justification.

“Promote use of this drug in pediatric patients” is exactly what J&J then did, according to the suit:

From January 1994 through September 2006, Janssen sales representatives directly promoted Risperdal to thousands of child and adolescent psychiatrists and pediatricians even though Risperdal was not approved to treat any pediatric conditions until October 2006.

Doctors were paid $1,000 to attend J&J’s pediatric “advisory board” meetings held at posh resorts, and eventually Risperdal reached a 50 percent share of pediatric antispychotic category, the suit alleges.

Kids grew breasts, docs went to the Four Seasons

This success came at some price to the children receiving the drug, as Risperdal’s side effects include weight gain, diabetes and “galactarhea,” the premature production of breast milk in both boys and girls. One of J&J’s sales reps made this internal sales call note on that issue:

An August 2, 2001 call note (000000244279 ) reports on a sales call with a Braintree doctor: “. . . . She is using Risperdal with great success in kids ala Biederman. She did mention galactarhea so I told her how Biederman is using Dostinex. She is going to get more info on this dopamine agonist. She is going to attend the 4 Seasons event.”

“4 Seasons” is likely a reference to the posh Four Seasons hotel in Boston (its indoor pool is pictured). The Biederman

name is familiar to anyone following the Risperdal saga, of course. Joseph Biederman was the Harvard medical school doctor who was paid by J&J to churn out reams of studies promoting Risperdal in kids. He became infamous when he suggested in a deposition that he was one pay-scale below God.

http://www.bnet.com/blog/drug-business/claim-j-j-wrongly-marketed-antipsychotic-drug-risperdal-to-kids/9344

For more information on Joseph Biederman – http://www.cchrint.org/2011/07/22/pharma-funded-psychiatrists-behind-bogus-child-bi-polar-epidemic-disciplined-for-conflicts-of-interest/

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Drug firms paid ‘independent’ experts

cchrint — Thu, 28 Jul 2011 17:09:34 +0000

Practice led to AG-whistleblower lawsuit

KXAN.com
By Nanci Wilson
July 27, 2011

Watch video: Allen Jones, former investigator, Office of the Inspector General, Pennsylvania

AUSTIN (KXAN) – When Cliff Gay was told to switch medications to treat his bipolar disorder, he never dreamed a significant gain in weight and then to twice-daily injections of insulin would follow.

In 1999, Gay’s doctor recommended he begin taking Zyprexa, which then was a new antipsychotic medication. At the time, Gay says it seemed like a good idea.

“The side effects were going to be less,” he said.

Gay says he immediately noticed a profound change — not so much in his symptoms, but in his appetite. Within a few months, he put on about 60 pounds, and that was followed by diabetes.

Records maintained by the U.S. Food and Drug Administration show that such stories are not uncommon among patients across Texas who, who beginning in the middle to late 1990s, were switched to medications called “atypical antipsychotics.”

Many who have been put on the new class of drug reported similar gains in weight over time.

Doctors working in state hospitals and community mental health centers began switching patients to the atypical antipsychotics because they were deemed the best treatment by an expert panel convened by the Texas Department of Mental Health and Mental Retardation.

But a detailed examination of public records documents on file in a whistleblower lawsuit that has been joined by the Texas Attorney General’s Office allege that the experts hired to evaluate the drugs and make recommendations for their usage were also accepting hundreds of thousands of dollars in payments from the companies developing and marketing the medications.

It started in the middle 1990s when MHMR contracted with University of Texas and some of its professors to evaluate the medications and develop a set of treatment guidelines.

The program was named the Texas Medication Algorithm Project, or TMAP. The result was step-by-step guidelines for treating major depression, bipolar disorder, schizophrenia, attention-deficit hyperactivity disorder.

TMAP was supposed to be based on the latest science, evaluated by an independent group of experts in the field.

But a 2004 lawsuit filed by whistleblower Allen Jones and the Texas Attorney General’s Medicaid Fraud Division against Janssen Pharmaceuticals, a division of Johnson & Johnson, suggests that the project was actually a vehicle for boosting sales of expensive new drugs that government funded studies found were not more effective, but cost far more than conventional medications.

According to records compiled from company documents, Janssen was making substantial payments over several years to the decision makers, many of whom were University of Texas professors.

While the professors were under contract with the state of Texas to provide their expert opinions on medications, records show many were also being paid by the companies whose drugs were being evaluated.

The suit alleges that Janssen improperly influenced the development of TMAP and compromised the objectivity of the decision makers by paying consulting fees, funding research and providing extravagant meals and lavish travel.

Such relationships were not always disclosed in TMAP manuals distributed to state hospitals and community mental health centers.

The depth of the financial relationship between the drug companies and the Texas Department of Mental Health weren’t always disclosed, either.

Extent of funding not fully disclosed

Steven Shon, who then was medical director for Texas MHMR, publicly reported in media interviews pharmaceutical company funding for TMAP was only $285,000.

However, documents obtained through the Texas Public Information Act show far more funding from the companies whose drugs were recommended as a first-line treatment in the TMAP guidelines.

Donations to the Texas Department of Mental Health/Mental Retardation from pharmaceutical giants Eli Lilly, Pfizer, GlaxoSmithKline, Abbott, Bristol-Myers Squibb, Forest, AstraZeneca, Novartis, Janssen and Forest and Wyeth-Ayerst totaled more than $1.2 million.

An additional $2.8 million was donated by the Robert Woods Johnson Foundation, which stock portfolio benefits from sales of Janssen’s medication.

Shon claimed he never personally received any money from the drug companies. A claim that was disputed in financial records turned to the court over by Janssen.

According to court records, Janssen paid Shon nearly $30,600 in honoraria and travel expenses. An additional $17,000 was directed to Association of Korean Americans at Shon’s direction.

In June, 2002, Janssen hosted a meeting and paid the travel expenses for seven TMAP decision makers. The meeting was held at the lavish Mansion on Turtle Creek Resort in Dallas with the purpose of advising Janssen on its newest antipsychotic.

Attendees included Steve Shon MD, Madhukar Trivedi MD, Tricia Suppes MD, John Rush MD, Larry Ereshefsky MD, Lynn Crismon, John Chiles MD and Alexander Miller MD.

Trivedi, Suppes, Rush and Ereshefsky were employees of University of Texas Southwestern Medical Center in Dallas.

Crismon was a professor

at the University of Texas School of Pharmacy in Austin.

Chiles and Miller were professors at University of Texas Health Science Center in San Antonio.

According to an expert report filed in the Janssen lawsuit, the meeting cost the company $114,000. The report says that the investment paid off. Shortly after, emails between some of the TMAP decision makers and Janssen discuss where the company wanted to place its newest antipsychotic on the guidelines.

The expert report, notes that other similar meetings were held at resorts in Scottsdale, Ariz., and the Ritz Carlton in Amelia Island, Fla. In most cases, participants were paid an honorarium.

Court records show Janssen paid Crismon, now the dean of the UT College of Pharmacy, more than $61,200 for various consulting fees and speaking engagements, including some that took place in state hospitals and community MHMR clinics.

Janssen reported paying Alexander Miller, professor at UT Health Science Center in San Antonio, $82,485.42. John Chiles, a UT professor at the time, was paid $151,254.73. Crismon, Miller and Chiles served on the TMAP panel at the time they received the payments.

Huge boosts in sales

The pharmaceutical companies funded trips for certain members of the TMAP team for travel to other states to expand TMAP to other states. More than a dozen states adopted the guidelines.

It meant huge sales for the drug companies because TMAP not only recommended their drugs for disorders in which the FDA had granted approval.

But for some illnesses that were not approved. Doctors are allowed to prescribe a drug with FDA approval for any reason, but manufacturers are only allowed to promote drugs for disorders that have been approved by the FDA.

While TMAP was touted as evidence-based or based on science and actual experience, the medications chosen to be included in the guidelines raised questions to exactly what evidence was considered by decision makers.

For example, several of the participants were involved in one of the largest independently funded studies to determine which medications provide the best treatment for schizophrenia.

The Clinical Antipsychotic Trials of Intervention Effectiveness Study, known as CATIE compared several of the new antipsychotics, risperidone (Risperdal), olanzapine (Zyprexa), quetiapine (Seroquel) and ziprasidone (Geodon) with an older, cheaper drug, perphenaxine (Trilafon).

The results, announced in 2005, found the new drugs, which cost roughly 10 times as much, had no substantial advantage over the older medication.

Despite the scientific findings, the TMAP team continued to recommend the more expensive drugs as a first-line treatment.

In 2008, the TMAP guideline for major depression was revised. The first non-medication treatment was added. The Vagal Nerve Stimulator, or VNS, manufactured by Cyberonics, is a medical device that is surgically implanted and sends electrical impulses to the brain.

The studies provided to the FDA during the approval process were conducted by several of the members of the TMAP team, including John Rush of the University of Texas Southwestern Medical Center in Dallas.

Reviewers with the FDA found the evidence submitted to the FDA to be lacking.

They recommended against approval. However, their decision was overruled and the device was approved.

Alarm bells sounded

The reviewers sounded an alarm, and the U.S. Senate Finance Committee launched an investigation into the approval process. Its findings raised questions about how the device could be approved by the FDA absent the scientific data showing the product was safe and effective.

In a speech on the floor of the Senate about the investigative report, U.S. Senator Charles Grassley said the conclusions of the person overruling the decision raise serious questions.

He read from the override memo, “I think it needs to be stated clearly and unambiguously that [certain VNS data]failed to reach, or even come close to reaching, statistical significance with respect from its primary endpoint. I think that one has to conclude that, based on [that] data, either the device has no effect, or, if it does have an effect, that in order to measure that effect a longer period of follow-up is required.”

The FDA approved the VNS with the condition that the company would conduct further studies and report the results to the FDA.

The Centers for Medicare/Medicaid refused to pay the estimated $25,000 bill for VNS treatment for depression. Most insurance companies wouldn’t pay, either.

But that didn’t deter the TMAP team from including the VNS on the revised guideline for treating depression. Such decisions were made behind closed doors and records revealing which members approved the inclusion are not available.

Rush’s relationship with Cyberonics was not fully disclosed to the University of Texas in his annual Statement of Financial Interest filing. His filing dated Aug. 7, 2006, lists his role as a member Cyberonics Speakers Bureau with an annual income equal or

less than $10,000.

But in records submitted to the office of U.S. Sen. Charles Grassley, R-Iowa, by Cyberonics, Rush was paid $100,000 in 2006 by the maker of the VNS. Cyberonics also reported paying Rush more than $75,000 in 2003 and 2004, and $62,000 in 2005.

Of the 10 decision makers who worked on the revision to the TMAP guideline for depression, six reported they owned stock or had a financial relationship with Cyberonics, including the project director, Crismon. Such disclosures were made to their employers or though industry publications.

The UT School of Pharmacy reported Cyberonics was the source of funding for a $54,938 research project in which Crismon was the principal investigator.

In a news release by Cyberonics, the company said the purpose of funding the research was to use the data to convince Medicaid and insurance companies to pay for VNS.

“By demonstrating the cost-effectiveness of VNS Therapy for treatment resistant depression (TRD) through this standardized, extensive and thorough analytical approach,” the release said, “it is our expectation that many more payers will come to recognize and understand the unique safety, effectiveness and cost effectiveness of VNS Therapy and grant psychiatrists and Americans with TRD access to VNS Therapy through national and regional coverage policies.”

Several TMAP panel members wrote letters urging the Centers for Medicaid to reconsider and pay for VNS treatment for depression.

Cyberonics cited it’s inclusion in the revised TMAP guideline for depression as reason for the government to pay.

It didn’t work.

CMS ruled the evidence did not show the treatment was effective for treating depression. A year after the ruling, the revised TMAP guideline was published recommending VNS, although many patients in the states hospitals and community centers would have had to pay out-of-pocket for the treatment.

Travel and out-of-state lobbying

Some of the TMAP team members were instrumental in expanding its usage across the nation. Largely funded by the drug companies, UT professors and state employees traveled to other states to lobby state legislatures and conduct training sessions.

But not all doctors in Texas centers and state hospitals were on board with the program. Emails between the TMAP team blamed a reluctance to change.

Texas MHMR paid two University of Texas at Dallas professors $100,000 to design a change management program.

Doctors were still reluctant, so the state made complying with the TMAP program a condition of its contract with community centers. The centers were required to show they were in compliance or would lose a percentage of their medication funding.

TMAP was at one time heralded. It was included in recommendation by the White House New Freedom Commission Report.

Psychiatrist Daniel Fisher, who was appointed to the commission said, members were encouraged to include TMAP in the recommendations, but never told of the pharmaceutical company involvement or that members of the consensus panel that developed the guidelines received money from the drug companies.

Fisher said he was stunned to learn the depth of involvement of the drug companies.

“This is the story of the century,” he said.

The pharmaceutical involvement came as a surprise to Cliff Gay. He was asked to participate in TMAP activities early on in the development. His role was as a patient and family advocate.

“I am totally blown away by the amount of money that was put into this thing,” said Gay. “I didn’t find out about the extent of the payments until I went to work for NAMI Texas.”

According to expert reports filed in the lawsuit against Janssen, NAMI, the National Alliance on Mental Illness in Texas, played a big role in helping TMAP and the pharmaceutical companies.

The expert report quotes from internal Janssen memos and depositions, efforts to utilize advocacy groups to their advantage, particularly NAMI Texas executive director Joe Lovelace.

The expert report filed in court reads “Lovelace received funding from J&J not only for the organization but personally, noting in his deposition that he deposited the monies in his wife’s law firm account because “she needed the money…there was a loss there.”

One of Janssen’s employees explained that “Lovelace desired to partner with Janssen as a consultant.”

Lovelace became a frequent speaker for J&J between 2000 and 2003. The report details the value of Lovelace when company officials asked if he would have NAMI members “come up to testify and relate their personal stories”, he responded by noting the when he had a chairman of a legislative insurance committee from Amarillo, he “made sure that a person in his church sat down in front of him.”

Lovelace no longer works for NAMI Texas. He is now the Associate Director of Behavioral Health for Texas Council of Community Centers.

TMAP’s rapid expansion began to crumble in 2004, when the first whistleblower lawsuit was filed against one of the drug companies involved. The State of Texas

Attorney General’s office joined in the lawsuit and filed suits against the other companies. Attorney Generals in other states filed suits, too.

Big-dollar settlements

To date, all but one of the suits has settled.

Bristol-Myers Squibb paid $15.7 million to Texas under a national settlement for allegations relating to its anti-depression drug, Serzone.

According to the press release issued by the Attorney General, the investigation also revealed BMS unlawfully marketing and promoting, Abilify, an atypical antipsychotic drug. It’s marketing partner, Otsuka paid $220,OOO to settle that claim.

Eli Lilly paid more than $30 million to Texas in a state and federal lawsuit over the marketing of its drug Zyprexa. In total, Eli Lilly paid $1.6 billion in criminal fines and reimbursing the government for charges to Medicaid.

The Texas Attorney General and 42 other states reached a $33 million agreement with Pfizer to settle claims of its marketing of Geoden to health care providers.

In a separate action, Pfizer also settled another case involving Geoden and another medication by paying $55 million to Texas as part of a $1 billion multi-state agreement.

Texas and 38 states reach a $68.5 million settlement with AstraZeneca stemming from a federal suit charging the company with unlawfully marketing Seroquel.

Texas share of the settlement was $3.8 million.

Janssen settled multiple Medicaid fraud and deceptive drug marketing cases related to its drug, Topamax, by agreeing to pay $50.7 million to several states.

Texas share is $2.86 million.

The Texas case against Janssen is pending and scheduled to go to trial in November.

Shon was fired as medical director for the state of Texas on Oct. 9, 2006. However, he was allowed to stay on the payroll in an unpaid capacity until he qualified to retire with full benefits.

He is now living in Las Vegas.

Crismon was promoted from professor to Dean of the UT School of Pharmacy. His work on TMAP was cited in the press release announcing his promotion. He continues to consult on guidelines for mental health treatment through a contract with the Reach Institute.

Rush left the University of Texas Southwestern Medical Center and is now working for Duke University in Singapore.

The other TMAP professors are still employed at various University of Texas System campuses.

Crismon declined to grant an interview for the report. KXAN’s request for an interview with Chancellor Francisco Cigarroa was denied, but UT System Vice Chancellor Barry Burgdorf said outside employment arrangements decisions are made by the individual campuses within the system.

“Supervisors are charged with evaluating requests to approve outside employment by assessing whether the potential outside employment constitutes a conflict of commitment — whether the time required to fulfill the outside employment would interfere with UT job duties — or a conflict of interest,” said Burgdorf, also the system’s general counsel.

“With regard to conflicts of interest in some cases the employee requesting approval of outside employment is required to enter into a conflict of interest management plan designed to prevent potential conflicts from maturing to an actual conflict,” he added. “Many times approved outside employment is synergistic with UT employment such as when a faculty member works for a start -up company spun out from UT using technology invented by the faculty member.”

In 2010, The Texas Department of State Health Services approved recommendations by a committee tasked to review the TMAP to stop using the guidelines.

Cliff Gay said he feels betrayed. He is among those who they were supposed to be helping.

“I don’t think any of them could look me in the eye and tell me they were doing it for me,” said Gay. “They did it for the money. It’s all about the money.”

http://www.kxan.com/dpp/news/investigations/drug-firms-paid-independent-experts

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Pharma-Funded Psychiatrists Behind Bogus Child ‘Bi-Polar’ Epidemic- Disciplined for Conflicts of Interest

admin — Fri, 22 Jul 2011 16:32:21 +0000

Harvard Psychiatrists Disciplined for Conflicts of Interest

Alliance for Human Research Protection – July 21, 2011

by Vera Sherav

Psychiatrist Joseph Biederman was funded millions by Pharma while promoting child "bipolar" disorder

The primary promoters–inventors, one might say– of diagnosing children with “bipolar” disorder, who for over a decade, aggressively promoted the biopolar diagnosis and use of antipsychotics in children, were disciplined by Harvard University and its affiliated Massachusetts General Hospital.

An investigation, prompted by Sen. Charles Grassely, was conducted by Harvard University-affiliated Massachusetts General Hospital. It concluded (earlier this month) that psychiatrist Joseph Biederman and two of his proteges, Thomas Spencer and Timothy Wilens -each of who failed to disclose millions of dollars they had each received from the makers of antipsychotics, the drugs they promoted for the treatment of bipolar in children–had indeed violated the University’s/ and hospital’s conflict of interest reporting standards.

The three wrote a mea culpa letter stating “we want to offer our sincere apologies…” acknowledging “our mistakes…”

However, no mention was made anywhere about the profound consequences of these psychiatritsts’ commercially-driven clinical recommendations. No mention about the corruption of the scientific literature, about clinical practice that deviated from the Hippocratic Oath, “First, do no harm,” nor was any mention made about the harm suffered by children whose doctors were misled about the safety and efficacy of highly toxic drugs.

Child psychiatrists and pediatricians throughout the US were guided by these exceedingly influential Harvard psychiatrists.

As Sen. Chuck Grassley noted in 2008 in the Congressional Record, “they are some of the top psychiatrists in the country, and their research is some of the most important in the field. {But] They have also taken millions of dollars from the drug companies.”

The companies that paid them millions include: Eli Lilly, Johnson & Johnson, Pfizer, GlaxoSmithKline and Bristol-Myers Squibb.

The Senator brought public attention–and to Harvard University administrators’ attention–the financial conflicts of interest, “Out of concern about the relationship between this money and their research.”

Indeed, documents uncovered during litigation confirmed that the research was scientifically corrupt and commercially-driven. The New York Times reported that Dr. Biederman promised Johnson a& Johnson that a study (yet to be conducted) in preschool children who would be given the company’s antipsychotic, Risperdal (risperidone) “will support the safety and effectiveness of Risperdal in this age group.”

“The psychiatrist, Dr. Joseph Biederman, outlined plans to test Johnson & Johnson’s drugs in presentations to company executives. One slide referred to a proposed trial in preschool children of risperidone, an antipsychotic drug made by the drug company. The trial, the slide stated, “will support the safety and effectiveness of risperidone in this age group.”

Dr. Biederman was the lead author of a trial published last year concluding that treatment with risperidone improved symptoms of attention deficit and hyperactivity disorder in bipolar children.”

Another of Biederman’s Harvard ignoble disciples was Jeff Bostic, who is also at Massachusetts General Hospital. He was named in a 2009 lawsuit joined by the US Department of Justice alleging Forest Laboratories promoted its antidepressants for pediatric use without FDA approval and paid kickbacks to docs to encourage prescriptions. He received $750,000 in payments for giving talks on using these drugs in children.

Strangely, the National Institute for Mental Health, which had awarded thse psychiatrists millions of dollars at taxpayers expense. It appears that NIMH officials did not see fit to even conduct an investigation into the corruption of science and violation of federal regulations. This demonstrates a lack of professional and moral integrity at the NIMH whose administrators think nothing about the misappropriation of public money for commercially-driven, junk research.

http://www.ahrp.org/cms/content/view/828/9/

Backstory from Pharmalot:

Pharmalot

Harvard Docs Disciplined For Conflicts Of Interest

By Ed Silverman // July 2nd, 2011 // 9:03 am

Three years after they were fingered in a US Senate probe into the interplay between academics who receive grant money from both pharma and the National Institutes of Health, three prominent psychiatrists from Harvard Medical School and Massachusetts General Hospital have been sanctioned for violating conflict of interest rules and failing to report the extent of their payments.

In a mea culpa addressed to their colleagues, Joseph Biederman, Thomas Spencer and Timothy Wilens wrote that “we want to offer our sincere apologies to HMS and MGH communities…We always believed we were complying in good faith with the institutional polices and our mistakes were honest ones. We now recognize that we should have devoted more time and attention to the detailed requirements of these policies and to their underlying objectives.”

And what is their punishment? They must refrain from “all industry-sponsored outside activities” for one year; for two years after the ban ends, they must obtain permission from the med school and the hospital before engaging in any of these activities and they must report back afterward; they must undergo certain training and they face delays before being considered for promotion or advancement (you can read their letter here).

The hospital had this to say: “A committee at Massachusetts General Hospital that has been looking into conflict-of-interest questions involving three MGH child psychiatrists has completed its review. Appropriate remedial actions have been taken by the hospital to address specific issues (read the statement). And a Harvard Med School spokesman sent us this: “We confirm that the review of their compliance with the Harvard Medical School Policy on Conflicts of Interest and Commitment has concluded, and appropriate actions have been taken.” He added that the conflicts policy was revised last year.

The sanctions result from a long-standing controversy over the explosive use of antipsychotics in children. Biederman, in particular (see photo), had been one of the most influential researchers in child psychiatry. Although his studies were small and often financed by drugmakers, his work helped fuel a 40-fold increase from 1994 to 2003 in the diagnosis of pediatric bipolar disorder.

For more than a decade, Biederman and his colleagues aggressively promoted the diagnosis and use of antipsychotics to treat childhood bipolar disorder, a problem that once was largely believed to be confined to adults. But the docs maintained this was underdiagnosed in kids and the meds could be used for treatment, even though they had not been approved for most pediatric use at the time. Meanwhile, the relationships with drugmakers were never properly disclosed (back story).

And for years, payments they received from drugmakers were not thoroughly reported to university officials. Yet, millions of dollars in NIH grants, which were administered by the hospital, were awarded to the docs at the same time they were receiving money from various drugmakers that make and sell antipsychotics and antidepressants. Which ones? Eli Lilly, Johnson & Johnson, Pfizer, GlaxoSmithKline and Bristol-Myers Squibb.

At one point, Biederman pushed J&J to fund a research center at MassGen that would focus on the use of its Risperdal antipsychotic in children, well before the med was approved for pediatric use. He was then placed in charge of the institute and began a study of 40 children between 4 and 6 years old who were given Risperdal and Lilly’s Zyprexa, another antipsychotic. At the time, Harvard and MGH rules forbid researchers from running trials with drugmakers if they receive more than $10,000 from a company that makes the drug (back story).

But in June 2008, US Senator Chuck Grassley made a far-reaching statement before Congress that pulled the curtain back on the money involved. The statement is memorialized in the Congressional Record. Referring to the three docs, he said “they are some of the top psychiatrists in the country, and their research is some of the most important in the field. They have also taken millions of dollars from the drug companies.”

“Out of concern about the relationship between this money and their research, I asked Harvard and Mass General Hospital last October to send me the conflict of interest forms that these doctors had submitted to their institutions. Universities often require faculty to fill these forms out so that we can know if the doctors have a conflict of interest. The forms I received were from the year 2000 to the present. Basically, these forms were a mess. My staff had a hard time figuring out which companies the doctors were consulting for and how much money they were making.”

How much were they making? At first, maybe a couple of hundred thousand dollars combined. But at his behest, the med school and hospital asked the docs to take a second look. “And this is when things got interesting. Dr. Biederman suddenly admitted to over $1.6 million dollars from the drug companies. And Dr. Spencer also admitted to over $1 million. Meanwhile, Dr. Wilens also reported over $1.6 million in payments from the drug companies.

“The question you might ask is: Why weren’t Harvard and Mass General watching over these doctors? The answer is simple: They trusted these physicians to honestly report this money.” And as Grassley then noted, there was still more money that went unreported (to read the Congressional record, click here and then check the box for 2008 and type in the name ‘Biederman’ in the search box. Then click on ‘payments to physicians’ to read the complete statement and the chart showing payments to each doc).

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Cause for alarm: Antipsychotic drugs for nursing home patients

cchrint — Tue, 31 May 2011 21:17:06 +0000

CNN
By Daniel R. Levinson, Special to CNN
May 31, 2011

Daniel Levinson, inspector general for the OIG in the Department of Health and Human Services.

When a loved one moves into a nursing home, the support of family and friends is particularly important. This is especially true when the nursing home patient has dementia and can’t adequately advocate on his or her own behalf.

A newly released report from my office — the Office of the Inspector General for the Department of Health and Human Services — makes clear just how crucial it is for families to monitor and ask questions about medications that such patients receive. The report found that too often, elderly residents are prescribed antipsychotic drugs in ways that violate government standards for unnecessary drug use.

Frequently, they are prescribed in ways that don’t qualify as medically accepted for Medicare coverage. In addition, the drugs were predominately prescribed for uses that are not approved by the Food and Drug Administration.

But the most potentially troubling finding of the study is this: Researchers found that 88% of the time, these drugs were prescribed for elderly people with dementia.

This is precisely the population that faces an increased risk of death when using this class of drugs, according to the FDA. That’s why the agency puts its strongest safety warning, called a “black box warning” on these antipsychotic drugs, cautioning about the risk of death when taken by elderly people with dementia.

The report didn’t investigate why patients with dementia are prescribed antipsychotic drugs so often. But a series of lawsuits and settlements that my office helped bring about suggests that many pharmaceutical companies have improperly promoted these drugs to doctors and nursing homes for many years.

Another view: In defense of antipsychotics for dementia

The study began a few years ago, when a member of Congress questioned how many nursing home residents received a class of antipsychotic drugs introduced in the 1990s, among them risperidone and olanzapine. These drugs are known as “atypical” or “second generation” antipsychotics. They replaced the antipsychotic drugs introduced in the 1950s and 1960s to treat schizophrenia — and, incidentially, are far costlier.

The report found about 305,000 nursing home residents (about 14%) had Medicare claims for atypical antipsychotic drugs. Of these, about one in five residents was prescribed these antipsychotics in a way that violated government standards for their use. For example, residents were on a drug for too long, or at too high a dose.

Another finding: A little more than half the antipsychotic drug claims for which Medicare paid should not have been covered. Why? The claimed drugs were not used for medically accepted reasons or there were no records the drugs were actually provided.

To be clear: Most physicians and nursing homes dispense antipsychotic drugs with the best interests of patients in mind. Physicians can use their medical judgment to prescribe drugs for uses unapproved by the FDA, and also to patients for whom the boxed warning applies. Ideally, however, doctors who prescribe in such ways first determine that the benefits outweigh the risks.

Yet it remains a concern that so many elderly nursing home residents with dementia are prescribed antipsychotics. And, unfortunately, examples abound of companies’ improper promotion of these drugs.

Government investigations of Bristol-Myers Squibb, AstraZeneca and Pfizer found that they improperly promoted their antipsychotic drugs for unapproved uses.

Federal prosecution is pending against Johnson & Johnson for allegedly paying millions of dollars in kickbacks to induce Omnicare, the nation’s largest long-term care pharmacy, to recommend the use of Risperdal in treating nursing home patients, many of whom had dementia.

And Eli Lilly pleaded guilty to criminal charges associated with illegally marketing its drug Zyprexa, including to doctors who treat elderly nursing home patients.

Pharmaceutical companies have paid billions to resolve civil and criminal liabilities under federal health and safety laws. But money can’t adequately compensate for corporate campaigns that could put vulnerable, elderly patients at risk.

How do we solve this problem? There’s plenty to do.

Family members of nursing home residents must learn about their loved ones’ medications, the reasons for their use, proper dosages and possible side effects.

Nursing homes and pharmacies that serve the elderly must keep the best interests of the patient in mind when dispensing pharmaceuticals and not base the decision on the improper influence of drug companies.

Doctors, too, should rely on their best medical judgments and engage in an especially careful analysis when prescribing drugs for off-label use.

Government must combat illegal off-label promotion of these powerful and potentially lethal drugs and uphold nursing home safety standards.

And drug companies should follow the laws, and refrain from promoting drugs for unapproved uses — or paying kickbacks to influence doctors and institutions. About 46 million people are enrolled in Medicare. That will only grow as the huge baby boomer population retires. We cannot afford to leave unaddressed the urgent problem of antipsychotic drug use among elderly nursing home residents.

The opinions in this commentary are solely those of Daniel Levinson.

Read article here: http://www.cnn.com/2011/OPINION/05/31/levinson.nursing.home.drugs/

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CCHR International » Johnson & Johnson

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