“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

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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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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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Bloomberg News – January 5, 2012

By Margaret Cronin Fisk, Jef Feeley and David Voreacos

 Johnson & Johnson will pay more than $1 billion to the U.S. and most states to resolve a civil investigation into marketing of the antipsychotic Risperdal, according to people familiar with the matter.

J&J, the world’s largest health products company, reached an accord last week with the U.S. attorney in Philadelphia, according to the people, who weren’t authorized to speak about the matter. It doesn’t resolve negotiations over a possible criminal plea, they said.

The U.S. government has been investigating Risperdal sales practices since 2004, including allegations the company marketed the drug for unapproved uses, J&J has said in Securities and Exchange Commission filings. The company said it has been in negotiations with the U.S. to settle this investigation.

J&J, based in New Brunswick, New Jersey, disclosed in August that it reached an agreement to settle a misdemeanor criminal charge related to Risperdal marketing. The company is in negotiations to pay about $400 million more to settle this portion of the investigation, one of the people said.

“We’re not going to comment on rumor or speculation,” Teresa Mueller, a J&J spokeswoman, said in a phone interview.

Company officials said in an SEC filing in May that they had reserved funds to resolve the government’s claims over Risperdal marketing. The company didn’t say how much had been set aside. The drugmaker said in an August filing it added an unspecified amount to the reserve to cover criminal penalties.

Accord Announcement

When the final settlement will be announced isn’t clear. The Justice Department typically announces civil and criminal resolutions at the same time in corporate cases.

A majority of U.S. states will join the settlement, the people said. Which ones will accept the final agreement hasn’t been determined, they said. Each state can decide whether to join the federal government’s settlement or pursue its own case.

Typically, states with cases in court continue to pursue their own. Texas alone is asking for more than $1 billion in a case that goes to trial next week.

J&J and its Janssen unit have been sued by 12 states, including Texas, South Carolina and Louisiana, over Risperdal marketing. The attorneys general of the other states “have indicated a potential interest in pursuing similar litigation against” Janssen, J&J said in its quarterly SEC filing in November.

A jury in Louisiana, weighing only the claim that the company downplayed the drug’s risks, awarded that state $257.7 million in 2010. A South Carolina judge last year ordered J&J to pay $327 million over Risperdal sold in the state.

Texas Suit

The Texas lawsuit, which involves additional allegations including off-label marketing, goes to trial next week.

“Discussions have been ongoing in an effort to resolve criminal penalties under the Food Drug and Cosmetic Act related to the promotion of Risperdal,” J&J said in its August SEC filing. “Certain issues remain open before a settlement can be finalized.”

“The ultimate resolution of the above criminal and these civil matters is not expected to have a material adverse effect on the company’s financial position,” J&J officials said in the filing.

The agreement in principle on the criminal charge is “pursuant to a single misdemeanor violation of the Food, Drug and Cosmetic Act,” the company said.

Risperdal is a member of a class of drugs, known as atypical antipsychotics, that includes Indianapolis-based Eli Lilly & Co.’s Zyprexa and London-based AstraZeneca Plc’s Seroquel.

Lilly, AstraZeneca and two other J&J competitors making these drugs have paid $2.7 billion to resolve government marketing claims, particularly that the companies pushed the drugs for unapproved uses.

Lilly paid more than $1.7 billion to resolve state and federal investigations over Zyprexa and AstraZeneca Plc has paid almost $590 million. Pfizer paid $301 million for its drug Geodon.

–With assistance from Alex Nussbaum in New York. Editors: Charles Carter, John Pickering

http://www.bloomberg.com/news/2012-01-05/j-j-to-agree-to-1b-accord-in-risperdal-probe.html

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PR Newswire – December 21, 2011

(Click image for international warnings on antipsychotic drugs) The "dear doctor" letter, sent to more than 7,000 doctors across South Carolina, and the package insert were found to be misleading about the safety and effectiveness of the antipsychotic drug Risperdal.

The jury verdict in the case of State of South Carolina versus Ortho-McNeil-Janssen Pharmaceuticals and Johnson & Johnson, Inc. has been upheld and requests for a new trial denied, affirming groundbreaking $327 million in civil penalties against the manufacturers of the drug Risperdal.

Circuit Court Judge Roger Couch announced the rulings on December 20 through two written orders. One order denies the defendant’s motion for judgment notwithstanding the verdict or, in the alternative, for a new trial; the second order denies the defendant’s motion to alter or amend the judgment and/or for a new trial. John B. White, Jr. and Donald C. Coggins, Jr. of Harrison, White, Smith & Coggins, P.C., a Spartanburg-based law firm, along with John Simmons of the Simmons Law Firm, a Columbia-based law firm, and Bailey Perrin Bailey, a Texas based law firm represented South Carolina in the case.

“We are obviously very pleased with Judge Couch’s decision and his careful consideration of this matter,” stated John B. White, Jr. one of the attorneys representing the state in the case. “The verdict handed down by the jury is just and speaks the truth. The damages awarded further substantiated the level of deception Janssen used in business practices in our state. Once again, we have sent a clear message to drug companies that deceptive business practices will not be tolerated in South Carolina.”

On March 22, 2011 a jury in the Spartanburg Court of Common Pleas found that New Jersey-based Janssen willfully violated the South Carolina Unfair Trade Practices Act by engaging in unfair or deceptive acts or practices in the conduct of any trade or commerce in the “dear doctor” letter of November 10, 2003 and the drug label (package insert). This decision represents the first jury verdict that finds the defendant violated unfair trade practices since the inception of its pharmaceutical product. The “dear doctor” letter, sent to more than 7,000 doctors across South Carolina, and the package insert were found to be misleading about the safety and effectiveness of the antipsychotic drug Risperdal. Risperdal was introduced by Janssen in 1994 and by 2005, generated annual revenues in excess of $3.5 billion.

On June 3, 2011 civil penalties amounting to $327,073,700 were ordered by Circuit Court Judge Roger Couch based upon violations found with the drug labels and “dear doctor” letters. Regarding the drug label violations, the judge ruled that 509,499 package inserts were distributed with sample boxes, and levied $300 per violation for a total drug label awarded damages of $152,849,700. Regarding the “dear doctor” letter violations, the judge ruled that 7,184 letters were mailed and 36,372 were provided during sales calls, and levied $4000 per violation for a total “dear doctor” letter awarded damages of $174,224,000.

The combination of the drug label and letter damages of $327,073,700 amounts to the highest verdict brought against Janssen for the drug Risperdal.

http://www.marketwatch.com/story/record-breaking-327-million-verdict-upheld-in-janssen-case-and-request-for-new-trial-denied-2011-12-21

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Op-Ed by Congressman Ron Paul

December 14, 2011

"There has been a persistent lobbying effort, funded by pharmaceutical companies, to increase the number of these prescriptions to even more children"

Maryanne Godboldo, a mother in Michigan, noticed that pills prescribed by her daughter’s doctor were making her condition worse, not better. So Mrs. Godboldo stopped giving them to her. That’s when the trouble began. When Child Protective Services (CPS) bureaucrats became aware that the girl was not receiving her prescribed medication, they decided the child should be taken away from her mother’s custody on grounds of medical neglect. When Ms. Godboldo refused to surrender her daughter to the state, CPS enlisted the help of a police SWAT team! On March 24 of this year a 12 hour standoff ensued and young Ariana was taken into custody. The drug involved was Risperdal, a neuroleptic antipsychotic medication with numerous known side effects. Ms. Godboldo had decided on a more holistic approach for her daughter. She is still engaged in a costly legal battle with the state over Ariana’s treatment and custody.

This is one example of how government’s increasing proclivity to medicate children with questionable psychiatric drugs violates the rights of parents. Just recently, the Government Accountability Office released a report on the astonishingly high rate of prescriptions for psychotropic drugs for children in the foster care system. It is absolutely astounding that nearly 40% of kids in foster care are on psychotropic drugs, some of them taking up to 5 different pills at a time. Some of these children are under one year of age – too young to safely take over the counter cold medication!

To fight this dangerous trend I reintroduced the Parental Consent Act of 2011, HR 2769, which prohibits federal funds from being used to establish or implement any universal or mandatory mental health or psychiatric screening program. The previous administration pushed hard for this type of federal intrusion into the medical decisions of families through its wildly misnamed “New Freedom Commission on Mental Health.” Everyone interested in parental rights and true health freedom must fight to make sure the commission’s findings and dubious psychiatric science are never used as justification to force mental health screening on American kids at school without their parents’ consent.

There has been a persistent lobbying effort, funded by pharmaceutical companies, to increase the number of these prescriptions to even more children. A universal screening program is the stated goal of these lobbyists. I would not be at all surprised to see the recent attention to the issue of schoolyard bullying used as a tool towards these ends.

Imagine the potential ramifications of a universal, mandatory psychiatric health screening program in a public school, considering how some bureaucrats are wont to behave! The diagnostic criteria for many mental illnesses remain vague and subjective. Therefore it is all too easy for a bureaucrat in a white coat to label a child with some sort of psychiatric syndrome simply because they were having a bad day, or behaving as a typical rambunctious child. That label could follow them around the rest of their school career and come with a number of prescriptions attached, which the state, as in the Godboldo case, may try to force the parents to administer, whether they want to or not.

I plan to continue the fight to ban federal funding of any universal screening program that imposes mental healthcare screening on children without express informed consent from parents.

Sign the petition in support of the Parental Consent Act here: http://www.petitiononline.com/rppca/petition.html

Watch video on Parental Consent Act featuring Kent Snyder, former Executive Director of the Liberty Committee

For more information on this bill click here 

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The Huffington Post
By Anthony Turner
December 3, 2011

This is a teen-written article from Represent Magazine, a platform for and by young people in foster care.

It all started when I said something stupid in school. A girl was ignoring me, and I got mad and said, “F-ck this sh-t. I’m gonna do some Virginia Tech sh-t.” I only said it so the girl would pay attention to me. But I shocked all my classmates and teachers, and the school said I’d made a “terrorist threat.”

I was in the 9th grade, and I had recently moved out of an abusive situation with my mom and into a foster home I knew nothing about. I needed someone to listen so I could get my feelings out. But there was no one I could really trust.

My caseworker came to my foster mom’s house and told me that he would take me to KFC and then to a “nice place to get help.” I thought, “OK, that sounds cool. I get my favorite food and I go to a center to feel better.”

The next stop we made was a psychiatric hospital for kids. We went through door after door, and it dawned on me that every door had a lock. Once the door shut you couldn’t open it. The doors locked you in. They intended to keep me here. That realization gave me a panic attack. I started running and the security tackled me. I was forcibly dragged in.

What Was I Signing?

When I got inside, the kids peeked out of their rooms to see who was coming. I was so scared I thought I would pee on myself. I had never been to a place like this. When I entered a dayroom, a place where the kids hang out, they slowly introduced themselves. I shook my head in fright. I wasn’t like these kids. Some were twitching and others drooled. I kept to myself and didn’t speak a word to anyone.

I felt forced into signing a bunch of papers. I didn’t realize I was signing consent to take medication.

The first things they prescribed were Depakote and Risperdal. I didn’t get a say in what I wanted, and that made me feel powerless.

At the hospital, staff joked about it in a perverse way. “Hey kids, come and get your happy pills!” “Come right up for your Skittles, it makes the world a better place!” I was disgusted that the staff were making light of my situation. I wondered how they’d feel if they were forced to take pills in a lockdown facility.

The meds made me feel bad. Sometimes I over-ate, ate too little, or had trouble sleeping. I hated the fake smile the nurses gave me after I took my medication.

I didn’t want to talk to anyone, especially my therapist, because I believed that my depressing stories about my mom’s abuse might make the doctors prescribe more medication.

I was afraid if I kept taking medication I would be just like every kid in the hospital. I wanted to be the kid who stood out, the kid who didn’t take medication. There were kids already looking up to me but I wanted them to think, “Wow, Anthony doesn’t take medication. I want to follow his lead.”

I tried hiding the pills in my hand. I learned how to put pills deep in my throat and spit them out later. It worked for a while but then one pill got stuck there. The staff helped get it out. After that they checked me carefully.

Another way I avoided pills was simply putting them under my tongue. I would hide them in a soap bar box until my roommate saw it and told the nurse. Then I was forced to take liquid medication, which was disgusting.

A Target

The Depakote was supposed to make me feel “calmer” and “happy.” Instead I gained over 30 pounds, and that brought my self-esteem down. I felt fat and I wasn’t comfortable with myself. Some of the kids and even staff called me names like fat ass or b-tch tits. I went off on one staff once because he said, “I know the perfect birthday present for you—a training bra!”

I really wanted to do well, and I tried to behave and present myself in a mature manner. But it didn’t seem to make a difference. And the uncontrollable and unpredictable behavior around me started to affect me.

The one and only time I truly flipped out, though, was when the whole unit tried to jump me. “Yo, let’s f-ck up this p-ssy n-gga Anthony,” said one kid. Suddenly everyone turned to me grinning sinisterly, like they’d just found their new target.

“Nah, come on guys, let’s play some board games or something,” I suggested.

“You ain’t gonna get out this, b-tch,” said a fat kid with squinty eyes. “You think you Mr. Goody Two Shoes. We gonna straighten you out.”

I ended up getting chased down by 12 guys. One person caught me and then they stomped me out. I thought I would beg for them to leave me alone, but suddenly I felt myself becoming so enraged that I no longer felt the pain. I got up and screamed, “LEAVE ME ALONE!!!”

I was surprised at my sudden outburst, but most of the guys just laughed. Then everything turned red and my surroundings became a blur. I didn’t gain full consciousness until I was near the dayroom area. I noticed some of the guys holding their lip or arm. “Did I do this?” was the only thought that came to mind.

I was shocked that I’d stood up to them, much less beaten them up. A weird feeling came over me then. I wondered for the first time in the hospital if I was losing my sanity and just becoming one of maybe thousands of nut jobs who end up staying in hospitals.

Suppressing My Feelings

But most of the time I was quick to disengage and try to find ways to occupy myself when I saw these kinds of incidents starting. I tried reading, writing, talking with a staff I could trust, or daydreaming. These were ways to block out any negativity that surrounded me. Although these strategies were very helpful, I was still suppressing my feelings because there were overwhelming situations I wasn’t familiar with and didn’t know how to deal with emotionally.

While I was in the hospital, I saw two people commit suicide, including my roommate. They said I was “further traumatized” by that and put me in a state hospital, which was even more restrictive.

Looking at it now, I can see that the suicides did really impact me. However, I felt outpatient therapy (therapy where you see your therapist but you’re not confined to a psychiatric unit) could’ve been more effective. I didn’t see how living in the state hospital was going to help. I just wanted to be back in the community where I’d be able to interact more freely, go out, and feel more like a normal kid.

I was glad to leave the first hospital, but this was no better. I wanted to get off medication completely. Some doctors finally decided I was stable enough to behave without meds. They started to take me off a little at a time. I was happy to be off the medication, but if I messed up or acted out one bit, like by cursing, I was back on it.

For example, once a staff ticked me off by yelling at me for not doing my laundry. I cursed at him because he kept pressuring me. The doctors and staff said the fact that I cursed meant I was too unstable to stay off medication. But wouldn’t anyone curse if they felt pressured or nervous that a staff he hardly knew started yelling at him?

I had seen some staff do terrible, abusive things to the kids, like getting them to fight each other in exchange for Chinese food (a special treat). Of course I was on edge around some of the staff. The doctors didn’t know that, though.

Can’t We Talk About This?

I felt trapped. Some doctors said, “Well, Anthony, it’s possible to get off medication, but will it benefit you in the long run?” What were they trying to say? That I couldn’t function properly without the use of a drug?

I didn’t question it further because the mental health system had trained my brain to think that meds were my solution to everything. If I felt angry the doctor would say, “Maybe it’s time for Abilify, a drug that stabilizes your mood swings.” If I felt anxious the doctor would try to prescribe Zoloft, a pill that helps with some types of anxiety. I thought, “Have you guys ever heard of talking your feelings out? NOT EVERYTHING CAN BE SOLVED WITH THE USE OF A DRUG!”

I was receiving therapy at the time, and I felt it helped more than the meds. I had a really good therapist, and it was such a physical release to be able to express my feelings. I’m sure the meds did improve my moods somewhat; I was less likely to curse and talk back. But what helped the most was having a direct connection with a trusted adult like I got in therapy.

I sat down one day and wrote how I felt the pills were helping me—pros—and how they weren’t—the cons. I wanted time to reflect on where I was going in life, to feel some control. The cons on my list—the physical side effects, and the depressing feeling I got from taking meds—outnumbered the pros. I wasn’t going to tell the doctor that everything I was taking was all right with me. It wasn’t and I had to put a stop to it.

I was tired of taking meds and then being taken off just to get back on again. No one even gave me a real explanation. Their excuse was usually, “We’re putting you back on because we feel you could be in a more stable condition.” Being on and off meds made me really jumpy. My eyes would twitch sometimes.

I also felt mentally tired because I’d been on drugs for over a year and I wasn’t getting better. I was constantly sleeping and I couldn’t focus. Emotionally, I was tired of the need to even be on meds in the first place.

I believed that in order for me to be better I had to be exposed to the community because then I could feel how a teenage life is supposed to be. To me this meant a cell phone so I could communicate with friends, my own room, decent curfews, a real home, and to be around my family. It wasn’t pills I needed; it was the chance to feel like a normal teenager after years of abuse and being institutionalized.

Love Is the Best Medicine

After eight months at the second hospital, I was sent to a group home at a Residential Treatment Facility (RTF), where I continued to take medication. I began to wonder when I would ever get back in the community. I had just started going on visits with my aunt and I had decided that I would like to go live there. I just wanted to stay somewhere permanently and feel cared for. Thinking about all this moving made me as depressed as when I first came into the hospital.

Finally, they let me go live at my aunt’s house. I think the reason why the RTF agreed to it was because I kept advocating for myself. I felt excited and at peace. I felt that I had achieved the impossible and that I deserved to be with my aunt and my family who would love me for me, instead of living with the institution’s idea of “support.” I had worked two and a half years to get to this point. I would not let it go to waste.

Alone in my room at my aunt’s house, I thought quietly. I looked to the left. There was no nurse ready to give me a cup full of meds. I looked to my right. There was no doctor trying to switch my meds or giving me higher doses. It dawned on me then. There were obviously rules and expectations, but ultimately I could make my own decisions now. I didn’t have to continue the medication. So I made an appointment with the doctor and said, “I no longer feel like I need medication.”

The doctor seemed a little concerned that I was in a rush. She said, “Anthony, you’re a very bright kid, but are you sure that you want to get off? I want you to perform at your highest and do well.” I told her I was sure of my choice and that I wouldn’t regret it. And I don’t.

The Community Transformed Me

Now that I don’t take medication I feel a lot happier, more powerful, and in control. Yeah, I had to get adjusted to living back in Brooklyn, but I adapted quickly. It felt good to see my neighborhood friends and the employees I always talked to at the Burger King across the street. I never ever felt this happy when I was on medication. I always felt drugged or out of it. I’m not always happy, but when I do feel bad I talk my feelings out with people I trust, and I write. Writing allows me to get overwhelming or negative things off my mind onto paper.

Being in the community is what I’ve always wanted. Now I have a sense of freedom. I go to regular school, I have easy access to friends, and I socialize on my time. I’m not on someone else’s schedule and I don’t have to be cooped up inside all day feeling anxious. The community has transformed me.

Read the rest of the article here

http://www.huffingtonpost.com/2011/12/02/foster-teens-i-needed-emo_n_1126659.html?page=1

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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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The New York Times, November 20, 2011

by Benedict Carey

Click image to see video on psychiatric drug warnings for kids

Foster children are being prescribed cocktails of powerful antipsychosis drugs just as frequently as some of the most mentally disabled youngsters on Medicaid, a new study suggests.

The report, published Monday in the journal Pediatrics, is the first to investigate how often youngsters in foster care are given two antipsychotic drugs at once, the authors said. The drugs include Risperdal, Seroquel and Zyprexa — among other so-called major tranquilizers — which were developed for schizophrenia but are now used as all-purpose drugs for almost any psychiatric symptoms.

“The kids in foster care may come from bad homes, but they do not have the sort of complex medical issues that those in the disabled population do,” said Susan dosReis, an associate professor in the University of Maryland School of Pharmacy and the lead author.

The implication, Dr. dosReis and other experts said: Doctors are treating foster children’s behavioral problems with the same powerful drugs given to people with schizophrenia and severe bipolar disorder. “We simply don’t have evidence to support this kind of use, especially in young children,” Dr. dosReis said.

In recent years, doctors and policy makers have grown concerned about high rates of overall psychiatric drug use in the foster care system, the government-financed program that provides temporary living arrangements for 400,000 to 500,000 children and adolescents. Previous studies have found that children in foster care receive psychiatric medications at about twice the rate among children outside the system.

The new study focused on one of the most powerful classes of drugs, antipsychotics. It found that about 2 percent of foster children took at least one such drug, even though schizophrenia and bipolar disorder, for which the drugs are approved, are extremely rare in young children.

“It’s a significant and important finding, and it should prompt states to improve the quality of care in this area,” said Dr. Mark Olfson, a professor of clinical psychiatry at Columbia University who did not contribute to the research.

In the study, mental health researchers analyzed 2003 Medicaid records of 637,924 minors from an unidentified mid-Atlantic state who were either in foster care, getting disability benefits for a diagnosis like severe autism or bipolar disorder, or in a program called Temporary Assistance for Needy Families. All of these programs draw on Medicaid financing. The investigators found that 16,969, or about 3 percent of the total, had received at least one prescription for an antipsychotic drug.

Yet among these, it was the foster children who most often got more than one such prescription at the same time: 9.2 percent, versus 6.8 percent among the children on disability, and just 2.5 percent of those in the needy families program.

Antipsychotic drugs, the authors said, also cause rapid weight gain and increase the risk for metabolic problems in many people, an effect that may be amplified by the use of two at once.

Doctors who treat such children are aware of the trade-offs and often prescribe lower doses of the medications as a result. And when they add a second such drug, it is often to counteract side effects of the first medication.

read the rest of the article here:  http://www.nytimes.com/2011/11/21/health/research/study-finds-foster-children-often-given-antipsychosis-drugs.html?_r=3&adxnnl=1&adxnnlx=1321895404-XjlZbL3lXs10CI4v4o6z6w

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