Saturday, December 30, 2006

State's mental facilities duped into using drug, Abbott alleges

http://www.statesman.com/search/content/news/stories/local/12/16/16drugs.html

State's mental facilities duped into using drug, Abbott alleges

Lawsuit claims state official pushed drug, was rewarded with money.


AMERICAN-STATESMAN STAFF
Saturday, December 16, 2006

A major corporation and several subsidiaries misrepresented the safety and effectiveness of an anti-psychotic drug and unduly influenced at least one state official to make it a standard treatment in public mental health programs, according to a lawsuit the state has joined.

Attorney General Greg Abbott joined a lawsuit filed in Travis County district court by Allen Jones, a former investigator for the state of Pennsylvania, against Johnson & Johnson Inc. and five related companies. Jones says in the lawsuit that he learned of payments to at least one Texas mental health official in interviews he conducted as an investigator. No official is named in the lawsuit.

Jones' lawsuit alleges that the companies launched a drug named Risperdal in 1994 to treat schizophrenia. About the same time, the state was developing a protocol, or treatment guidelines, for which drugs should be used in public mental health programs. The defendants "provided substantial financial contributions to and improperly influenced the development" of the protocols, the lawsuit said, and Risperdal took precedence in the protocols over cheaper, equally effective medicines.

The drug later received recommendations as the medicine of choice in the state's mental health protocol for treating children and adolescents, even though it lacked a Food and Drug Administration indication for those age groups, the lawsuit says. It says side effects and health risks include increased chance of stroke, renal failure and hyperglycemia.

The companies pushed Risperdal in other states through paid consultants on expert panels, peer-to-peer marketing strategies and "administrative decisions made by a select few public officials," the lawsuit says. The companies sent an unnamed Texas official around the country as a spokesman for the drug, and they hired third-party contractors to conceal their control and funding of medical education programs, speakers' bureaus and clinical research that promoted the benefits and safety of Risperdal, the lawsuit says.

The lawsuit says at least 17 states, including Texas, have implemented the protocol or are doing so.

"We allege it's a scheme whereby they passed off as medical science phony representations and misleading facts about the efficacy and appropriateness of these drugs," said Thomas Melsheimer, a lawyer for Jones.

Abbott's office declined to comment on the lawsuit, as did spokesmen for Johnson & Johnson and the state's Health and Human Services Commission, which oversees the Medicaid program. A commission spokesman did say Texas paid 308,000 claims totaling $73.5 million for Risperdal in 2005.

Melsheimer described Jones as a "classic whistle-blower" who filed the lawsuit in 2004 on behalf of Texas to recover the companies' overcharges. Because of his whistle-blower status, the lawsuit was sealed from public view until Abbott joined it.

jembry  (at) statesman.com; 445-3654

wgselby  (at) statesman.com; 445-3644

Battle over drugs hits crescendo

New Freedom Commission's medication guideline is taking a beating. This is the drugging guideline recommended after Teenscreen any other screening takes place. This guideline was exported to 16 other states. I will send a better version strait from the paper later.

http://www.statesman.com/search/content/news/stories/local/12/23/23mhmrdrugs.html

Battle over drugs hits crescendo

Lawsuit claims state official who pushed drug was rewarded.


AMERICAN-STATESMAN STAFF
Saturday, December 23, 2006

Texas Attorney General Greg Abbott's effort to recoup public money spent on prescription drugs in state mental health programs highlights the growing cost of those drugs, the emotional debate about how to treat mental illness and the pharmaceutical industry's role in creating support among experts for its products.

Abbott has joined a lawsuit alleging that the makers of a schizophrenia medicine called Risperdal misrepresented the benefits of their drug so the state would purchase it for patients in public mental health programs instead of anti-psychotic drugs that cost less and were just as effective. The drug became part of a much-celebrated treatment plan not only used in Texas facilities but also exported to 16 states.

"We believe Texas has been defrauded of some money, and we're going to be looking to get our money back," Abbott said this week.

Texas is the first state to go after drug companies accused of improperly influencing state officials who decided to adopt the treatment plan. The case is not only about the hundreds of millions of dollars Texas spent on one drug. It also raises questions about the role powerful drug companies play in crafting state decisions about how to treat mental illness.

Abbott would not say how much money Texas could gain from the lawsuit.

Thomas Melsheimer, a Dallas attorney for Pennsylvania whistle-blower Allen Jones, said Texas has paid hundreds of millions of dollars for Risperdal since 2000. Jones is teaming up with Abbott to sue six drug companies.

"We certainly believe that (the treatment plan) was essentially a marketing scheme masquerading as medical science," Melsheimer said.

The lawsuit Jones filed asks that Jones receive an unspecified percentage of what the state recovers.

State officials defended the drug plan. It is "firmly grounded in the latest research and science," said Stephanie Goodman, a spokeswoman for the Health and Human Services Commission.

Representatives for Janssen, the New Jersey company that makes Risperdal, have not responded to requests for comment, and two Texas scholars involved with the development of the treatment plan said university lawyers told them not to speak to reporters.

The plan at issue was developed in the 1990s as state officials sought a standard process for treating schizophrenia, major depression and bipolar disorder. The development of such guidelines has become common in medicine in the past 20 years, said Dr. Robert Rosenheck, director of the Northeast Program Evaluation Center in the federal Department of Veterans Affairs.

"There's been movement among academic doctors to make the information available in a simple form and to encourage people to follow the evidence," said Rosenheck, a psychiatry professor at the Yale School of Medicine. "These guidelines are there not just to tell you what's a good thing to do, but to increase the likelihood that doctors will do it."

The advent of new mental health drugs spurred the state's $5.6 million project to develop the treatment plan, known as the Texas Medication Algorithm Project, or TMAP. The Robert Wood Johnson Foundation, founded by a former executive at Johnson & Johnson Inc., gave $1.8 million to the project. Janssen is a subsidiary of Johnson & Johnson, and both companies are defendants in the lawsuit.

The first two phases of the project, including a four-month trial at 16 clinic sites, produced surprisingly positive results, with good patient response, according to American-Statesman accounts at the time.

But Jones' lawsuit claims that Risperdal became part of the treatment plan because of drug companies' "improper influence" over Dr. Steven Shon, the former medical director for behavioral health at the Department of State Health Services. The lawsuit says the companies pushed Risperdal by giving state officials around the country trips, perks and speaking fees.

Shon, who lost his state job after Abbott's investigation of Jones' claims, has served as a paid Janssen consultant and traveled the country promoting the Texas plan. He denies the allegations in the lawsuit, however.

"I didn't personally benefit from this project," he said.

Doctors treating patients in state-run mental health programs are required to follow the protocol, which is still in use, unless they document why they should not. Risperdal is one of five drug options in the initial treatment options for schizophrenia.

In 1997, the year the protocol was developed, 7,314 people in state hospitals, state schools and mental health community centers were treated with Risperdal for at least one day, according to the health department. In the 2006 budget year, 21,537 people were treated with the drug.

One of the states that copied Texas' treatment plan was Pennsylvania. Jones says in his lawsuit that, while working for the state inspector general in Pennsylvania, he looked into allegations of impropriety in the adoption of the program there. One of the drug companies' representatives revealed payments made to Shon, the lawsuit says.

Jones says his supervisors in Pennsylvania sought to limit his investigation and told him drug companies "write checks to politicians on both sides of the aisle," and they eventually removed him as lead investigator on the case.

Jones left the inspector general's office in 2004, the same year he filed the lawsuit against Texas. In the process, he became a hero of sorts to people suspicious of the ways medicines are used to treat mental illness. Abbott could take on the same status as the case develops.

Jerry Boswell, president of the Citizens Commission on Human Rights of Texas, a mental health watchdog organization, commended the attorney general for taking on drug companies Boswell says have pushed certain drugs on a "captive audience": Medicaid and Medicare patients.

"This is going on all over the nation, and we can be proud that Texas is the first one to take the bull by the horns . . . to put a stop to this fraud," Boswell said.

Defenders of the Texas plan often grumble privately that Jones is propped up by the Church of Scientology and that Boswell's commission was co-founded by that church. Although his commission was indeed co-founded by the church, Boswell said, that's a red herring.

Jones "is not a Scientologist, and he is not doing this on behalf of Scientology or any other cause other than the truth," Melsheimer said.

A two-part study funded by the National Institute of Mental Health emboldened Risperdal's critics when the first part was published in 2005. It concluded that an older, less expensive drug called perphenazine performed as well in treating schizophrenia as Risperdal and three other newer drugs.

"There was the general belief that risperidone and the newer drugs were superior and had less side effects than the older drugs," said Yale's Rosenheck, who worked on the study. It and "several other independent government studies in the last three years have led me and some other people to question whether those conclusions are warranted."

But Goodman, with the state health commission, said the new drugs "make it possible for people with serious mental health issues to control their symptoms and avoid the side effects that kept them from having normal lives. Yes, there, are still side effects with the new drugs. There are side effects with all drugs."

Rosenheck, who is familiar with the Texas protocol but said he is not an expert in it, said its development came at a time when doctors and scholars had great hope for powerful new drugs.

"The people that did TMAP are quite highly respected," he said. "I think it was developed out of the current beliefs that were widespread in the profession. I've been surprised the way it's been linked to commercial purposes. There are lots of promotional activities that many of us are aware of and wince at, but TMAP was never one of them."

Still, the attention to the Texas system comes at a time of heightened scrutiny surrounding medicine's relationship with pharmaceutical companies.

Two former editors of the New England Journal of Medicine wrote books recently voicing concerns about the drug industry's role in determining medical treatment.

Jones' lawsuit, in fact, says the Texas program was only one piece of a Risperdal marketing effort that also spanned continuing education programs, speakers bureaus, advisory boards and trade publications.

"We don't for a minute believe that Janssen was the only company out there that was doing things this way," said Charles Siegal, one of Jones' attorneys.

Mental health drugs in Texas

1950s: First anti-psychotic drugs are introduced.

1990s: Anti-psychotic drugs considered to have fewer side effects are introduced.

1997: Texas Medication Algorithm Project, or TMAP, a drug treatment plan, is developed by a panel of health experts and state officials.

1999: Texas Legislature requires the state mental health program to follow TMAP protocol.

Late 1990s-early 2000s: Texas mental health official Dr. Steven Shon travels around the country speaking about TMAP.

Sixteen other states eventually adopt the protocol.

2003: President Bush's New Freedom Commission on Mental Health recommends TMAP.

2004: After questioning drug company payments to state officials, Allen Jones is fired from his job as an investigator at the Pennsylvania inspector general's office.

2004: Because the drug protocol used by many states originated in Texas, Jones files lawsuit in Travis County District Court against Johnson & Johnson and some subsidiaries.

The lawsuit is sealed from public view because of protections that whistle-blowers such as Jones are granted.

October 2006: Shon is forced by superiors to retire from the Texas health department after officials learn of findings of a Texas attorney general investigation into whether Shon was unduly influenced by drug companies.

December 2006: Texas joins Jones' lawsuit. The lawsuit is opened to the public.

Sources: Office of Comptroller Carole Keeton Strayhorn, Health and Human Services Commission, lawsuit

jembry (at) statesman.com ; 445-3654; cmaclaggan  (at) statesman.com ; 445-3548

 

State official was paid consultant for drug company

http://www.statesman.com/news/content/news/stories/local/12/19/19mhmrdrugs.html

State official was paid consultant for drug company

Doctor forced to leave state employ says arrangement was approved by the state.


AMERICAN-STATESMAN STAFF
Tuesday, December 19, 2006

A high-ranking state health official who was ordered to leave his job in October was a paid consultant for a drug company whose product became part of a standard treatment plan in state mental health programs.

Dr. Steven Shon, former medical director of behavioral health at the Department of State Health Services, was forced to leave after Attorney General Greg Abbott investigated whether drug companies improperly influenced Shon to promote one of their medicines in a state treatment plan, according to state documents and officials.

On Friday, Abbott joined a lawsuit against Johnson & Johnson and several subsidiaries saying they misrepre- sented the safety and effectiveness of a schizophrenia drug and unduly influenced Shon.

Shon is not named in the lawsuit, but Stephanie Goodman, a spokeswoman for the Texas Health and Human Services Commission, confirmed Monday that it refers to him. Shon denies the allegations in the lawsuit.

But he acknowledged that he was a paid consultant for Janssen, a subsidiary of Johnson & Johnson. He said a health department attorney approved the consulting, which he did on vacation time.

"I was not told it was any kind of problem," he said.

He said he earned $1,000 to $1,500 on three occasions for advising Janssen on topics such as side effects his patients had experienced.

Goodman, whose agency oversees the health department, said the commission was not aware of the consulting.

"We would not have approved that arrangement," she said.

The lawsuit, filed in state district court in Travis County by a former Pennsylvania state investigator, focuses on a Janssen drug called Risperdal that became part of a standard treatment plan developed in 1997 for Texas' mental health programs. Sixteen other states use the plan, which for the first time set a drug protocol in Texas for people in state mental health programs.

The protocol requires doctors to prescribe Risperdal and other anti-psychotic drugs before trying older, less expensive medications to treat schizophrenia, major depression and bipolar disorder. If doctors decide not to follow the plan, they must document why. Shon led development of the protocol.

Despite the allegations against Shon, commission officials said Monday that they stand by the treatment plan, Goodman said.

"Because those guidelines required broad consensus, it would have been very difficult to sway them just by trying to influence the opinion of one person or a narrow group of people," she said.

Shon traveled across the country promoting the drug, the lawsuit says. Allen Jones, the former Pennsylvania official who filed the lawsuit, said some of the drug companies' representatives told him that they paid Shon.

The lawsuit says the drug companies promoted Risperdal outside Texas by influencing policymakers with trips, perks, travel expenses, speaking fees and other payments.

But Shon said that the allegations are "absolutely untrue" and that he traveled from about 1998 through this year at the request of states that wanted to learn about the Texas program.

"The project was held up as a model by the President's New Freedom Commission on Mental Health for 'better consumer outcomes, including reduced symptoms, fewer and less severe side effects, and improved functioning,' " a Health and Human Services Commission document says.

Shon said that he directed money he received for speeches to the state and that he did not keep any. He acknowledged that drug companies were sometimes the source of the money because they fund research.

Health department officials Monday were unable to immediately provide information on whether Shon had given all of his honorariums to the state.

"Our project was not done for any of us to make personal gain," Shon said. "It was made to improve the quality of care in the area of prescription medications for psychiatric illness."

The Texas protocol was developed to address concerns that "mental health patients in the public health system did not have the same access to newer, more expensive medications that had fewer side effects than older drugs," Goodman said.

The lawsuit alleges that Johnson & Johnson and some subsidiaries misrepresented side effects and long-term health risks of Risperdal to qualify for reimbursement under Medicaid, the state-federal health insurance program for low-income people. The lawsuit seeks to recover money paid under the state's Medicaid program.

Shon, however, said his recommendations were "not focused on a particular drug or medication."

An Oct. 9 letter to Shon from Dr. Charles Bell, acting commissioner of the Department of State Health Services, shows that the department intended to fire Shon.

"It is my determination that your services are no longer required by the Department," Bell wrote in the letter, which was obtained by the Austin American-Statesman under the Texas Public Information Act. "I am, therefore, terminating you as the Medical Director for Behavioral Health effective immediately."

Goodman said that she does not comment on personnel matters but that "the attorney general's office briefed Bell and other key health and human services leadership on some of what they were finding." The briefing was in mid- or late September, she said.

Shon said he was forced to retire after superiors threatened to fire him. He said he was told only that he and the department were headed in different directions.

Johnson & Johnson and Abbott's office declined to comment on the lawsuit.

cmaclaggan  (at) statesman.com, 445-3548

jembry (at) statesman.com, 445-3654

Additional material from staff writers Andrea Ball and W. Gardner Selby.

 
 

Friday, December 29, 2006

Paroxetine (Paxil or Paxil CR) can more than triple major cardiac birth defects

 
 
Paroxetine (Paxil or Paxil CR) can more than triple major cardiac birth defects


Roman Bystrianyk, "Paroxetine (Paxil or Paxil CR) can more than triple major cardiac birth defects", Health Sentinel, December 29, 2006,

Paroxetine, known by the brand names Paxil or Paxil CR in the United States, is a selective serotonin reuptake inhibitor, or SSRI, antidepressant. Paroxetine was introduced in 1992 by GlaxoSmithKline and has become one of the most prescribed antidepressants on the market. In fact, paroxetine is the third most prescribed antidepressant in the United States and the most prescribed antidepressant in Canada.

In late 2005 the FDA and Health Canada issued two warnings regarding first trimester exposure to paroxetine and the increased risk of cardiac malformation in newborns. A study in Reproductive Toxicology published in April 2006 showed a two-fold increased risk of cardiac malformations in women taken paroxetine during the first trimester. This conclusion agreed with earlier unpublished reports performed in 2005 by GlaxoSmithKline also showing a doubled risk of cardiac malformations.

A new study published in Birth Defects Research Part B: Developmental and Reproductive Toxicology, examined in greater detail the association between exclusive first trimester exposure to paroxetine and the occurrence of any major congenital malformation, and more specifically, major cardiac malformations. The authors used a number of medical databases examining all pregnancies that occurred in Quebec between January 1997 and July 2003.

Adjusting for a number of variables, as well as for second and third trimester exposure to antidepressants, paroxetine exposure during the first trimester or pregnancy compared with the use of other SSRI and non-SSRI antidepressants did not significantly raise the risk of congenital malformations. Although this showed no difference in birth defects it must be taken with the information found in a recent population-based cohort study that found the use of any SSRI antidepressant in the first trimester of pregnancy resulted in a 40% increase in birth defects and more specifically a 60% increased risk in cardiac abnormalities.

When the study authors examined a dose of paroxetine of greater than 25 mg (milligrams) they found a major increase in general birth and specifically cardiac defects. “Paroxetine was significantly associated with a two-fold increase in the risk of major congenital anomalies, and more specifically with a three-fold increase in the risk of major cardiac anomalies.”

Again, this study compared paroxetine with other antidepressant drugs so the 200% increase in major congenital birth defects and 300% increase in cardiac malformations could reasonably be 240% and 360% if compared to those not taking any antidepressant medication.

The authors conclude, “using a population based pregnancy registry, our study showed no increased risk of major congenital malformations, specifically major cardiac malformations, associated with the first trimester exposure to paroxetine. For the first time, however, a dose-response relationship between average daily dose of paroxetine utilization during the first trimester of pregnancy and occurrence of major congenital malformations, and major cardiac malformations, was found. Pregnant users of more than 25 mg/day of paroxetine were at a two-fold increased risk of having an infant with a major malformation, and at a three-fold increased risk of having an infant with a major cardiac malformation.”

SOURCE: Birth Defects Research Part B: Developmental and Reproductive Toxicology, December 2006
 

Thursday, December 28, 2006

Buckeye gives TeenScreen a Black Eye

http://www.toledoblade.com/apps/pbcs.dll/article?AID=/20061227/OPINION03/612270315/-1/OPINION

 Toldeo Blade
Wednesday, December 27, 2006
Beware the dangers of antidepressants

The Blade's story that antidepressants may boost suicide risk in people 18 to 25 is something people of all ages should pay attention to. I have seen hundreds of news stories detailing suicides of people who were taking or recently taking antidepressants. In real life, people of all ages have committed suicide and other acts of violence against themselves and others while taking antidepressants.

In 2004 the FDA put a Black Box warning on antidepressants because of the suicide risk they pose to children 18 and under. It took two more years of lobbying by those who had lost husbands and wives to antidepressants before the FDA extended that warning up to age 25 for people taking antidepressants.

They had to overcome fierce counter-lobbying by drug companies and psychiatrists. Maybe in another five years that Black Box warning will be extended to the many elderly people psychiatry is now pushing on to antidepressants.

Despite the dangers antidepressants pose, the Ohio Department of Mental Health under Michael Hogan is actively assisting getting the TeenScreen Mental Health survey into Ohio public schools. The result is that thousands of kids are being newly diagnosed and misdiagnosed with mental illness and put on antidepressants.

A recent TeenScreen suicide and mental health survey done on 71 Mansfield, Ohio, ninth-graders resulted in 39 previously normal teens, or 55 percent of them, being sent to a mental health clinician for follow-up interviews. An Internet search of the word TeenScreen will educate and prepare parents on what TeenScreen is and whether they want to chance having their school child falsely labeled with a mental illness and put on suicide-inducing antidepressants..

Ernest Ryan
Temperance

Johnson and Johnson Sued by Texas in Whistleblower Case Over Drug Marketing

 
J&J Sued by Texas in Whistleblower Case Over Drug Marketing

By Rob Waters

Dec. 28 (Bloomberg) -- A Johnson & Johnson unit misled Texas health officials about the risks of an antipsychotic drug to increase prescriptions, according to a whistleblower lawsuit joined by the state attorney general.

The suit claims that J&J's Janssen Pharmaceutica unit caused Texas to overspend on Risperdal, the world's second-best-selling schizophrenia drug last year. The case is one of several against makers of antipsychotics and stems from Texas prescribing guidelines directing state-funded doctors to give priority to newer, more expensive drugs.

The guidelines and deceptive marketing techniques boosted sales of Risperdal, raising costs for Texas and endangering patients, according to the complaint, which was secret until it was unsealed Dec. 15. The state is seeking unspecified damages. Risperdal sales were $10 billion in the U.S. from 2001 through 2005, according to IMS Health Inc.

``This is a case about sales and marketing trumping medical science,'' said Thomas Melsheimer, an attorney for the original plaintiff, in a Dec. 19 phone interview. ``The basic allegation is that Janssen promoted Risperdal use not for sound medical reasons but for economic reasons.''

Tom Kelley, a spokesman for Texas Attorney General Greg Abbott, declined yesterday to comment on the case.

Johnson & Johnson, the maker of thousands of health-care products from Band-Aids to heart devices, does ``not promote our products for off-label use,'' said Ambre Morley, a spokeswoman for the New Brunswick, New Jersey-based company, in an interview this week. J&J doesn't comment on litigation, she said.

Texas Law

The complaint was initiated in 2004 by Allen Jones, a former Pennsylvania state investigator. Under Texas law, whistleblower suits are dismissed unless the attorney general joins them. Jones may collect 15 to 25 percent of any payments by J&J, Melsheimer said.

Lawsuits across the U.S. accuse drug companies of engaging in deceptive marketing by overstating the effectiveness and understating the risks of newer antipsychotics. The suits also claim companies promoted the drugs for unapproved uses.

Mississippi, Louisiana, Alaska and West Virginia sued Eli Lilly & Co. this year on behalf of their Medicaid health programs for the poor, saying the company fraudulently touted the antipsychotic Zyprexa for unapproved uses. Indianapolis-based Lilly settled about 8,000 personal-injury complaints for $700 million in 2005 and faces 4,000 more claims.

Lilly spokesman Phil Belt said yesterday that Lilly is ``committed to being transparent about the risks of Zyprexa.'' He declined to comment on specific cases.

Zyprexa was the world's top-selling schizophrenia drug with $4.2 billion in revenue last year. Risperdal was second with $3.6 billion.

AstraZeneca

London-based AstraZeneca Plc, the maker of the third-best- selling antipsychotic, Seroquel, stands accused in more than 200 federal and state lawsuits of concealing the diabetes risk faced by users. AstraZeneca is ``vigorously defending'' the cases, said spokesman Jim Minnick in an e-mailed statement. Sales rose 36 percent last year to $2.8 billion.

The Texas complaint says the health department received as much as $6 million in contributions from Janssen and other parties to implement treatment guidelines under the Texas Medication Algorithm Project, known as TMAP. The guidelines were then exported to other states through training programs.

The largest contributors, according to the lawsuit, were Janssen Pharmaceutica and the Robert Wood Johnson Foundation, a charity endowed by the co-founder of J&J.

The Princeton, New Jersey-based foundation provided three grants totaling $2.8 million to evaluate TMAP as part of an effort ``to improve treatment of chronic disease,'' said spokesman David Morse, in a phone interview this week.

Standardize Treatment

The Texas program began in 1996 as a way to standardize prescribing of medication to state mental patients, led by Steven Shon, then medical director for behavioral health for the Texas health department, and University of Texas academics.

Shon resigned effective Oct. 31 at the request of Charles Bell, acting health department commissioner, said Ted Hughes, a spokesman for the Texas Health and Human Services Commission. Bell requested the resignation after being briefed on the suit by the attorney general's office, Hughes said.

Shon also consulted for Janssen, an arrangement the department was unaware of and wouldn't have approved, Hughes said. Shon didn't respond to requests for comment left on his home telephone answering machine.

`Significant Increase'

After the guidelines were adopted, Janssen ``experienced a significant increase in sales of Risperdal'' in Texas and worked to bring the program to other states, the suit alleges. State officials ``traveled extensively, at the expense of defendants, to tout the wonders of the new drugs,'' the complaint says.

Janssen ``improperly influenced state decision-makers with trips, perks, travel expenses, honoraria,'' and paid state officials ``to speak in their official capacities'' to promote the drugs, the complaint says.

One of the first states to adopt prescribing guidelines was Pennsylvania. Jones, the whistleblower who filed the suit, was an investigator for Pennsylvania's Office of the Inspector General in Harrisburg. Assigned to look into payments made to state agencies and employees, he interviewed Janssen officials, the complaint says.

Jones says he was blocked by his superiors from investigating company marketing practices and was fired when he continued to do so and leaked information to reporters.

The case is Texas v. Janssen LP, No. GV-401288 in Travis County District Court, Austin.

To contact the reporter on this story: Rob Waters in San Francisco at rwaters5  at bloomberg.net .

Last Updated: December 28, 2006 10:10 EST
 
 

Saturday, December 23, 2006

TeenScreen Smoked by Facts in Iowa Newspaper

Fort Madison Daily Democrat

http://www.dailydem.com/articles/2006/12/11/opinion/opinion2.txt
Statistics don't indicate a significant danger

I am writing in response to the letter “Here are the facts about the TeenScreen Program.” This letter makes it sound like suicide is a pervasive threat for Iowa children...one of such grave dimensions that it requires wholesale screening through the schools to catch the many desperate children whose difficulties would otherwise go unnoticed. Statistics from the Centers for Disease Control, however, would indicate otherwise: In 2004, 19 Iowa children between the ages of 0 - 18 committed suicide out of a total of 724, 095. That is a percentage of .00262%, or 2.62 per 100,000 people. That is hardly an epidemic.

For the rare child who really is in trouble, though, it seems reasonable to ask whether TeenScreen and the recommendations that follow it will actually do him any good. First of all, is it not unlikely that his unhappiness will have been noticed already by somebody - parents, teachers, minister, coaches, or friends? Are we so unobservant that only an official suicide questionnaire will uncover a child on the edge? I doubt it.

Secondly, even if this were likely, does it really justify asking leading, suggestive questions to thousands upon thousands of other children, subjecting them to the possibility of misdiagnosing, mislabeling, and potentially damaging treatments? I don't think so.

And last, supposing that we screen everybody and really do catch a child who appears to be in trouble - then what? In the wake of this assessment - whatever else is recommended - the follow-up is very likely to include a referral, a diagnosis, and a prescription. Once in the hands of a psychiatric professional, diagnosis will be made on the basis of the Diagnostic and Statistical Manual, which has been thoroughly discredited. Then, prescription, and no help there. Black box warnings have been added to various psychiatric drugs on the basis that they can actually increase the likelihood of suicide.

So what do we do? We get this TeenScreen program out of the schools, and help children without hurting them. Caring parents and teachers and ministers and friends can do far more to bring children up to an enthusiasm for life than all the assessments and diagnoses and prescriptions in Christendom.

Elizabeth Neal Cameron

http://www.dailydem.com/articles/2006/12/08/opinion/opinion1.txt
There are “facts” and then there is the truth

Your recently published a letter from two social workers - Ms. Gutman and Ms. Jarvis - on the subject of TeenScreen. Curiously, it was entitled the "facts" about the TeenScreen program.

I think the social workers should crack open a dictionary and look up what a "fact" is. Obviously with no investigation of their own, they accept and spew the "facts" given to them by TeenScreen. One of the definitions for facts is "something said to be true or supposed to have happened," as in this example: "The facts given by the witness are highly questionable." Yet the public doesn't want or need that kind of "facts" to be presented as truth. They need real facts, as in this definition: "something that actually exists; reality; truth."

Ms. Gutman's and Ms. Jarvis' letter is full of assertions, none of which can be proven by evidence. TeenScreen spawned a lawsuit in Indiana because a teen was screened and labeled with a mental disorder without her parents' knowledge.

TeenScreen refuses to release the identity of their mysterious donors. Many members of TeenScreen's executive board have connections to drug companies. TeenScreen's biggest supporter and co-conspirator is NAMI, which receives millions from drug companies, a verifiable fact because NAMI is a non-profit organization required to reveal its contributors.

TeenScreen is intimately involved in treatment, as evidenced by the fact that TeenScreen always partners with a local mental health provider so that identified youth can be directed into treatment. That information can be found on TeenScreen's own website.

Suicide IS a horrible tragedy. No one is denying that. Yet, suicide is very, very, very rare. If you want to see how rare, click on
http://www.psychsearch.net/rare/iowa.html You'll see that the suicide rate for youth in Iowa as reported by the CDC is 2.62 per 100,000. That's a very small number. Screening identifies 30% or higher youth as needing further evaluation. Screening is obviously good for finding new customers for the mental health system but it's complete folly to pretend that its purpose is finding those at risk and preventing suicide.

Add to that the FACT that the FDA requires a black box warning on antidepressants, the same ones that will be given to some of these kids entering the mental health system via TeenScreen. This warning states that the drugs can CAUSE suicidal tendencies and violence in young people. Ms. Gutman and Ms. Jarvis neglected to mention that fact.

Everything I have stated here is verifiable, backed up by evidence. Though this may be an editorial, I am not stating an opinion. I am stating documented, provable fact.

Doyle Mills


Video: http://www.youtube.com/watch?v=RfU9puZQKBY  Petition: http://www.petitiononline.com/TScreen/petition.html 

 

Friday, December 22, 2006

NIH researcher fined for failing to disclose consulting work

"While he was illegally accepting Pfizer's money, Mr. Sunderland was making pious statements about how, unlike bureaucrats and health policymakers, he was devoted to the cause of "pure" science," Zuvekas wrote in the letter. "Meanwhile, he's still on the taxpayers' payroll."
 
NIH researcher fined for failing to disclose consulting work
 
By ALEX DOMINGUEZ, The Associated Press
Dec 22, 2006 12:22 PM (2 hrs 54 mins ago)
 
BALTIMORE - An NIH researcher was ordered Friday to forfeit $300,000 and perform 400 hours of community service but will not have to pay a fine for failing to disclose lucrative consulting work with pharmaceutical giant Pfizer.

Pearson "Trey" Sunderland III, a prominent Alzheimer's expert who ran a geriatric research unit at the National Institute of Mental Health, pleaded guilty earlier this month to a misdemeanor conflict of interest charge. Sunderland admitted he shared thousands of NIH human tissue samples with Pfizer at the same time he was paid as a private consultant. Many of the samples are highly sought-after in Alzheimer's research.

Sunderland told U.S. District Judge Frederick Motz at his sentencing he didn't have a good explanation for his actions.

"I cannot tell you why except to say this is not part of my normal character," Sunderland said.

However, the researcher acknowledged the case had harmed the "trust I had generated with both patients and colleagues."

The conditions of the sentence conformed to those specified in Sunderland's plea agreement, except for an unspecified fine that could have been as much as $100,000. Motz said the forfeiture, to be paid in stages without interest, was adequate and did not impose a fine.

Prosecutors said Sunderland failed to get prior approval for consulting work that related to his federal research, and did not properly report the fees and travel expenses from Pfizer.

Before sentencing prosecutor Martin Clarke told the judge the work with Pfizer was not a "boondoggle created simply for him to personally profit from," noting the work was "very significant and important research" that had the support of fellow researchers and patients.

Clarke said afterward that he did not mean to suggest the best science was conducted despite the conflict of interest.

Clarke also told Motz before sentencing that prosecutors did not find any evidence of a "quid pro quo," or a tit-for-tat exchange of samples for consulting work. U.S. Attorney Rod Rosenstein also said after Sunderland entered his plea earlier this month that there was no evidence that giving Sunderland the consulting work helped Pfizer get the samples.

Prosecutors have said they hoped Sunderland's case will send a message to other government scientists. However, the plea deal prompted one study volunteer to write a letter to The Washington Post decrying the leniency of the agreement.

Ann Zuvekas, of Annandale, Va., said she was one of the healthy volunteers in Alzheimer's studies "who gave our time and our tissue because we had watched loved ones suffer and die from this dread disease," only to have the samples "passed on without the volunteers' knowledge or permission for personal and corporate gain."

"While he was illegally accepting Pfizer's money, Mr. Sunderland was making pious statements about how, unlike bureaucrats and health policymakers, he was devoted to the cause of "pure" science," Zuvekas wrote in the letter. "Meanwhile, he's still on the taxpayers' payroll."

The case is believed to be the first conflict-of-interest prosecution against a federal scientist since 1992, when NIH researcher Prem Sarin was convicted of embezzling a drug company payment to the agency that was intended to help with AIDS research. Sarim was ordered to pay $25,000 and two months community service.

The Sunderland case is part of an ethics controversy that prompted the nation's premier medical research agency to issue new consulting restrictions last year.

The conflict began in 1998 when Sunderland was arranging for NIH to work with Pfizer on an Alzheimer's project. At the same time, he began negotiations to be a paid consultant on the same project, prosecutors alleged. Government scientists are not allowed to take money for their official collaborations with private companies.

The NIH has so far identified at least 44 government researchers who were improperly paid for working on the side for biotechnology and drug companies. Most have been given written or verbal reprimands or were permitted to retire.

Sunderland - who refused to testify before Congress last June, citing his Fifth Amendment right against self-incrimination - remains on the government payroll although he asked to retire after House investigators began unraveling his fincial ties with Pfizer two years ago.

NIH spokesman Don Ralbovsky said after Sunderland's plea hearing that the researcher remains an NIMH employee, but added that he could not comment on whether the guilty plea would affect his job.

Electroconvulsive Therapy Causes Permanent Amnesia And Cognitive Deficits, Prominent Researcher Admits

Electroconvulsive Therapy Causes Permanent Amnesia And Cognitive Deficits, Prominent Researcher Admits

Main Category: Psychology / Psychiatry News
Article Date: 22 Dec 2006 - 0:00 PST


In a stunning reversal, an article in the journal Neuropsychopharmacology in January 2007 by prominent researcher Harold Sackeim of Columbia University reveals that electroconvulsive therapy (ECT) causes permanent amnesia and permanent deficits in cognitive abilities, which affect individuals' ability to function.

"This study provides the first evidence in a large, prospective sample that adverse cognitive effects can persist for an extended period, and that they characterize routine treatment with ECT in community settings," the study notes.

For the past 25 years, ECT patients were told by Sackeim, the nation's top ECT researcher, that the controversial treatment doesn't cause permanent amnesia and, in fact, improves memory and increases intelligence. Psychologist Sackeim also taught a generation of ECT practitioners that permanent amnesia from ECT is so rare that it could not be studied. He asserted that most people who said the treatment erased years of memory were mentally ill and thus not credible.

The National Institute of Mental Health (NIMH) estimates that more than 3 million people have received ECT over the past generation. "Those patients who reported permanent adverse effects on cognition have now had their experiences validated," said Linda Andre, head of the Committee for Truth in Psychiatry, a national organization of ECT recipients.

Since the mid-1980s, Sackeim worked as a consultant to the ECT device manufacturer Mecta Corp. He never revealed his financial interest in ECT to NIMH, as required by federal law, and, until 2002, did not reveal it to New York officials as required by state law. Neuropsychopharmacology has endured negative publicity over its failure to disclose financial conflicts of journal authors, resulting in the editor's resignation and a promise to disclose such conflicts in the future; yet there is no disclosure of Sackeim's long-term relationship with Mecta, nor did Sackeim disclose his financial conflict when his NIMH grant was renewed to 2009 at approximately $500,000 per year.

The six-month study followed about 250 patients in New York City hospitals, an unusually large number; most ECT studies are based on 20 to 30 patients. Sackeim's previously published studies were short term, making it impossible to assess long-term effects. "However, in other contexts over the years -- court depositions, communications with mental health officials, and grant protocols -- Sackeim has claimed to follow up patients for as long as five years. This raises serious questions as to how long he has actually known of the existence and prevalence of permanent amnesia and why it wasn't revealed until now," Andre said.

Besides finding that ECT routinely causes substantial and permanent amnesia, the study contradicts Sackeim's oft-published statements that ECT increases intelligence and that patients who report permanent adverse effects are mentally ill.

"The study is a stunning self-repudiation of a 25-year career," Andre said.

Committee for Truth in Psychiatry
http://www.nature.com/npp/journal/v32/n1/pdf/1301180a.pdf

Saturday, December 16, 2006

TeenScreen's Evil Sister Sued by Texas Attorney General

TeenScreen's Evil Sister - TMAP, Texas Medication Algorithm (guidelines) Project is  a sick  plan concocted by drug companies to influence government officials to push the newest most expensive antipsychotic drugs.   The below story is the first of surely many more to come. 

Both TMAP and TeenScreen were "recommended" by the President's New Freedom Commission on Mental Health.    

http://www.statesman.com/search/content/news/stories/local/12/16/16drugs.html

Austin American Statesman
State's mental facilities duped into using drug, Abbott alleges
Lawsuit claims state official pushed drug, was rewarded with money.
By Jason Embry, W. Gardner Selby
AMERICAN-STATESMAN
December 16, 2006

A major corporation and several subsidiaries misrepresented the safety and effectiveness of an anti-psychotic drug and unduly influenced at least one state official to make it a standard treatment in public mental health programs, according to a lawsuit the state has joined.

Attorney General Greg Abbott joined a lawsuit filed in Travis County district court by Allen Jones, a former investigator for the state of Pennsylvania, against Johnson & Johnson Inc. and five related companies. Jones says in the lawsuit that he learned of payments to at least one Texas mental health official in interviews he conducted as an investigator. No official is named in the lawsuit.

The lawsuit, which came to light Friday, seeks to recover for the state untallied alleged overcharges to the state's Medicaid program, which pays for health care for low-income people.

Jones' lawsuit alleges that the companies launched a drug named Risperdal in 1994 to treat schizophrenia. About the same time, the state was developing a protocol, or treatment guidelines, for which drugs should be used in public mental health programs. The defendants "provided substantial financial contributions to and improperly influenced the development" of the protocols, the lawsuit said, and Risperdal took precedence in the protocols over cheaper, equally effective medicines.

The drug later received recommendations as the medicine of choice in the state's mental health protocol for treating children and adolescents, even though it lacked a Food and Drug Administration indication for those age groups, the lawsuit says. It says side effects and health risks include increased chance of stroke, renal failure and hyperglycemia.

The companies pushed Risperdal in other states through paid consultants on expert panels, peer-to-peer marketing strategies and "administrative decisions made by a select few public officials," the lawsuit says. The companies sent an unnamed Texas official around the country as a spokesman for the drug, and they hired third-party contractors to conceal their control and funding of medical education programs, speakers' bureaus and clinical research that promoted the benefits and safety of Risperdal, the lawsuit says.

The lawsuit says at least 17 states, including Texas, have implemented the protocol or are doing so.

"We allege it's a scheme whereby they passed off as medical science phony representations and misleading facts about the efficacy and appropriateness of these drugs," said Thomas Melsheimer, a lawyer for Jones.

Abbott's office declined to comment on the lawsuit, as did spokesmen for Johnson & Johnson and the state's Health and Human Services Commission, which oversees the Medicaid program. A commission spokesman did say Texas paid 308,000 claims totaling $73.5 million for Risperdal in 2005.

Melsheimer described Jones as a "classic whistle-blower" who filed the lawsuit in 2004 on behalf of Texas to recover the companies' overcharges. Because of his whistle-blower status, the lawsuit was sealed from public view until Abbott joined it.

+++

To see how TeenScreen and TMAP  relate, here are additional references: 

Bush's Texas Two-Step: TeenScreen and TMAP: http://www.onlinejournal.com/health/052705Pringle/052705pringle.html

A Lone Wolf Takes on the Drug Leviathan http://www.rutherford.org/Oldspeak/Articles/Interviews/oldspeak-jones.htm

 

Friday, December 15, 2006

GAO Report Calls for Increased FDA Oversight of Direct-to-Consumer Advertising

Prescription Drugs: Improvements Needed in FDA's Oversight of Direct-to-Consumer (DTC) Advertising, Full text GAO-07-54, and Highlights, November 16, 2006. "Studies...

Read more

Texas Comptroller blasts psych drugging in Texas foster care

 
Click on the report on the right.
 
Press on it.
 
The Texas state foster system folks talk about a 7 percent reduction since this report.   That's real nice but not good enough by a long shot.
 
Jim

Another contained group getting drugged for profit...

http://www.cpa.state.tx.us/specialrpt/hccfoster06/hccfoster06.pdf

Page 94

Caseworkers, however, are trained in how to  make behavioral assessments, not medical  assessments. The entire placement system,  in fact, is built around behavioral assessments;  the more difficult the child’s behavior,  the higher the service level and the higher the reimbursement.

 

Page 97

Medically Fragile Children  and Psychotropic Drugs

Almost half (44 percent) or 717 of the medically fragile foster children were on psychotropic drugs in fiscal 2004. The most common psychotropic medications prescribed to these children were antidepressants, followed closely by antipsychotics and stimulants

(Exhibit 13).

Rank

ton of awesome antidepressant videos

 
I found this guy earlier, went back and searched SSRIGUY and youtube.com said there was nothing there. Searched google and found this link that has all the great videos.
 
Definitely watch these, I was blown away at the stuff this guy has collected.
 

Thursday, December 14, 2006

John Mann, MD AP press quote and full disclosure, who's this guy working for?

 http://www.nature.com/npp/journal/v31/n3/full/1300958a.html

J John Mann, MD
Task Force Co-Chair
The Paul Janssen Professor of Translational Neuroscience in Psychiatry and Radiology, Columbia University College of Physicians and Surgeons
Chief, Department of Neuroscience,
New York State Psychiatric Institute
ACNP

Industry Affiliations:

  • Consultant: GlaxoSmithKline, Pfizer, 2001 (expert trial witness)
  • Grants/Research Support: PET ligand development grant from Pfizer (2003), Beta-amyloid imaging grant from GlaxoSmithKline (2005)
  • Attended a 2002 GlaxoSmithKline Advisory group meeting on lamotrigine
 
Dr. John Mann, a Columbia University psychiatrist, suggested simply replacing the proposed expanded warnings with the recommendation that doctors more closely monitor their patients.

"We can do more good by providing more treatment for depressed children and adults," Mann said.

Battling The Blues With Exercise

drugs = remission, brain damage, deformed babies, violence, suicide and loss of inhibitions
 
exercise = sore muscles and a feeling of accomplishment, a better looking tush, productivity and no remission
 
Hmmmm....
 
 
 
"Researchers at Duke University Medical Center in Durham have studied the benefits of exercise for relieving depression. They’ve found, in many cases, regular workouts are as helpful as antidepressants.

One study followed 156 patients who were age 50 and older and had been diagnosed with major depression. After 16 weeks, those who exercised for 30 minutes at least three times a week improved as significantly as those who either took antidepressants or combined the two therapies. Six months later, only 8 percent of those in the exercise-only group had become depressed again. That’s especially impressive when compared to the other two groups’ relapse rates: 38 percent for those who only took medication; 31 percent for those who combined drugs with physical activity."
 

Antidepressants a Suicide Risk for Young Adults - good excerpts

Emotions ran high at the meeting of expert advisers yesterday, with both advocates for the drugs and their critics warning the federal regulators that a wrong move would cost lives.

Critics of the drugs said they were deeply distrustful of both the medical profession and FDA itself because of conflicts of interest with the pharmaceutical industry. Allen Jones, of the consumer advocacy group Alliance for Human Research Protection, said, "the love affair between the pharmaceutical industry and our government institutions has to end."

Gwen Olsen, a former pharmaceutical industry representative, told the panel she had influenced doctors by offering them free food, gifts and gimmicks to get access and then presented them with skillfully manipulated data. Olsen said she had a change of heart after her 20- year-old niece committed suicide following a withdrawal reaction from the antidepressant Paxil. She said her niece first tried to hang herself from a ceiling fan. When the fan broke, Olsen said, she doused herself in oil and set herself alight.

Two experts critical of the drugs, British psychiatrist David Healy and Joseph Glenmullen, a psychiatrist who lectures at Harvard University, said the FDA analysis played down the magnitude of the suicide risk. Information uncovered in lawsuits, they said, suggested that several suicides in industry trials were never disclosed.

"Industry controls the data, and industry with the aid of FDA have miscoded the data so all the articles in all the journals that purport to represent clinical trial data are misleading," Healy said in an interview. His own analysis, published in the British Medical Journal in 2005, found a two-fold increase in risk among all adults taking the drugs.

"The idea you would have a risk in one age group but not another is just wrong," Healy said.

Saturday, December 09, 2006

Community vs. corrupt commerce - How money really works

 
"As a government official, one of the things Fitts constantly witnessed was how policies were engineered to promote higher stocks for corporations. “There was tremendous synergy between how policies are designed and what drove the New York Stock Exchange up,” she says. 
 
 As an illustration, Fitts cites a 1999 report by journalist Kelly O’Meara on the single common denominator found in cases of high school shootings in the US. O’Meara claims the shooters were on Ritalin or other prescribed psychotropic drugs. Pointing to an overhead slide, Fitts shows a profit breakdown of the nine million American children on Ritalin, with the profit per child to the maker at an estimated $54 per annum.
 
 “I have a close family member who was a teacher in the Tennessee school system who was constantly pressured by parents to sign something that said their kids need to be put on Ritalin, because if your kid was disabled you could get a social security cheque,” she adds."

Parents worry about prescription drugs, too

Quote from below article: "Instead of dealing with the overprescription of drug cocktails for children, our government is telling us we have a mental health crisis, and the remedy is universal mental health screening. A major government campaign is now under way, sweetened with federal grants, to subject all children to mental health screening."
 
 
Copley News Service
December 1, 2006
Parents worry about prescription drugs, too
By: Phyllis Schlafly

Methamphetamine and marijuana aren't the only drugs parents worry about. The problems caused by prescription combinations called "drug cocktails" have finally broken into the national news stream.

A recent Page 1 of the New York Times described Stephen, age 15, who takes antidepressants Zoloft and Desyrel, plus anticonvulsant Lamictal to moderate his moods, plus the stimulant Focalin XR to improve concentration. His brother Jacob, age 14, takes Focalin XR for concentration, plus the anticonvulsant Depakote to moderate his moods, plus the antipsychotic Risperdal to reduce anger, plus Catapres to induce sleep.

Over the last three years, each boy has been prescribed 28 different psychiatric drugs and has seen 11 psychiatrists. Gone are the days when a visit to a psychiatrist meant lying on a couch to recite your troubles. Treatment today means taking prescription drugs, lots of them.

More than 3 million children are using the most commonly prescribed drug, Ritalin, and it is routinely combined with other drugs. Last year, 1.6 million children and teenagers were given at least two psychiatric drugs in combination, and 500,000 were given at least three.

The U.S. Food and Drug Administration requires manufacturers to prove the safety of each drug. But hardly any studies have examined the safety or effectiveness of drugs used in combination.

The American Journal of Psychiatry in 2003 found only six controlled trials of two-drug combinations, four of which failed to show any benefit, and a fifth showed bad side effects. Scientific studies of combinations of three or more drugs are nonexistent.

There are no studies showing long-term safety of psychiatric drugs used on children or the effect on children's developing brains and bodies. The vast majority of these drugs are not FDA-approved for use in children, but they are prescribed for children nevertheless.

Two of the three classes of these drugs are under the FDA's stringent warnings for suicide and violence. They also interfere with learning, causing violence, neurological problems, diabetes and heart attacks.

Ritalin is prescribed to address what is called attention deficit hyperactivity disorder, a disorder first defined in 1980. The pediatric guidelines for diagnosing ADHD are subjective, such as, child often has difficulty awaiting his turn, occasionally may do things compulsively, easily distracted from tasks, fails to give close attention to details, and makes careless mistakes.

A few years later, ADHD was classified as a disability and a federal cash incentive program was initiated for low-income families with children who are said to have ADHD. A family could get $450 a month for each child diagnosed with ADHD, with the cost of treatment and medication for low-income children covered by Medicaid.

The Individuals with Disabilities Education Act, passed in 1990, mandates that "eligible children receive access to special education and related services." The school is required to craft an Individualized Education Plan to accommodate each child, which may include drugs prescribed by a medical doctor.

The U.S. Department of Education classified ADHD as a handicap, and in 1991 schools began receiving education grants of $400 a year for each ADHD child.

Since labeling kids ADHD brings more money to the schools, it's not surprising that schools often pressure parents to get an ADHD diagnosis and put their child on Ritalin. School have also found it useful to deal with behavioral and discipline problems by giving boys a drug to get them to sit down, shut up, and do what they're told.

The FDA reported on Feb. 8 that 25 people (including 19 children) died and 54 suffered serious cardiovascular problems after taking drugs prescribed to treat ADHD between 1999 and 2003. An FDA advisory panel finally voted in favor of requiring the famous "black box" warning on these drugs.

Instead of dealing with the overprescription of drug cocktails for children, our government is telling us we have a mental health crisis, and the remedy is universal mental health screening. A major government campaign is now under way, sweetened with federal grants, to subject all children to mental health screening.

The screening usually means having the child fill out a survey about his own behavior. If his answers don't comport with what the so-called experts want, the kid can be referred for treatment, and treatment usually includes medication.

It's up to parents to stop this unscientific, ineffective, and dangerous government intrusion into the minds and values of our children. State laws should require parental consent for all mental health screening, and Congress should pass the Child Medication Safety Act, to prohibit schools from denying entry to a child whose parents choose not to put him on drugs.

Phyllis Schlafly is a lawyer, conservative political analyst and the author of the newly revised and expanded "Supremacists." She can be contacted by e-mail at
phyllis (at) eagleforum.org.

FDA Suicidality Probe Targets Mood Stabilizers - Sept 2005

FDA Suicidality Probe Targets Mood Stabilizers
Kenneth J. Bender, Pharm.D., M.A.
1506 words
1 September 2005
14
2210
English
Copyright 2005 CMP Media LLC. All rights reserved

Having determined that antidepressants can cause suicidality in children and should bear black box warning labeling, the U.S. Food and Drug Administration has now responded to a personal injury attorney's petition by asking 14 manufacturers to reanalyze anticonvulsant drug trial data for behavioral signals of suicidality.

Russell Katz, M.D., director of the FDA Division of Neuropharmacological Drug Products, wrote a letter in April to New York attorney Andrew Finkelstein according to the Boston Globe, which broke the story April 20. The letter assured Finkelstein that the agency is "taking this matter very seriously," and said the drug manufacturers will be required to complete the reanalysis within six months.

One and a half years before, Finkelstein had purchased a 15-second national television ad seeking individuals who had become suicidal while on Neurontin (gabapentin). (One of his clients with bipolar depression had attempted suicide while receiving Neurontin.) According to the Globe, Finkelstein subsequently compiled and submitted to the FDA more than 200 adverse-event reports of patients who became suicidal while receiving this medication and filed more than 70 personal injury lawsuits against the drug's manufacturer, which remain unresolved. In May 2004, with lawsuits pending, Finkelstein filed a citizen's petition for the FDA to require a black box warning on the gabapentin drug label.

Although an association of the drug with suicide, if it exists, may reflect a lack of efficacy for bipolar disorder rather than a causative drug effect, previous findings that Neurontin was promoted for unapproved and unproven uses could leave the manufacturer vulnerable to additional civil actions. It also appears to some that the FDA investigation may be prompted less by indications of drug effect than by congressional pressure on the agency for lapses in drug safety and the long-term vacancy of an FDA commissioner (Psychiatric Times July, p1).

Approximately 8% to 10% of patients with untreated bipolar affective disorder die by suicide, according to Frederick K. Goodwin, M.D., professor of psychiatry and director of the Center on Neuroscience at George Washington University. Goodwin's research has revealed different suicide rates with different mood stabilizer treatments, but he implicates the illness rather than the treatments. "Anything that [effectively] treats the illness should be associated with reduction in the suicide rate," Goodwin told Psychiatric Times.

Goodwin suggested that the FDA investigation of the anticonvulsants could reflect a heightened susceptibility of the agency to outside pressure as an acting commissioner awaits congressional confirmation and the U.S. Congress investigates the FDA record on drug safety. "This whole thing ... got started with a trial lawyer, and the trial lawyers have gotten very smart at using the FDA," Goodwin asserted.

Asked whether his research into different rates of suicide in treated patients could suggest provocation by a mood stabilizer rather than lack of protective effect, Goodwin replied, "I've never seen anything in the research literature or in my clinical experience that would have led me to that conclusion.

"Now, in the case of [selective serotonin reuptake inhibitors], there is reason to ask the question," Goodwin added. "People who are treated with SSRIs-it's a well known clinical reality that the risk period for suicide is highest as they start to recover."

Goodwin cited a meta-analysis that ascertained the risk of completed suicide in patients with bipolar disorder to be 13 times less with lithium (Eskalith, Lithobid) treatment than without it (Baldessarini et al., 2001). "Lithium, perhaps more than the others, reduces [suicide rates], but it does not mean the others increase it; it just means that lithium may decrease it more," Goodwin said.

In the FDA investigation of suicidality in children receiving antidepressants, behavioral data from the clinical trials were not consistently classified by the study sponsors to distinguish suicidal behavior from other self-injury or psychodynamic. The FDA had referred the data to a group at Columbia University with expertise in adolescent suicides for assistance in classifying the emergent behaviors.

Asked whether the agency would provide the resultant classification guidelines to the manufacturers of the anticonvulsant drugs to facilitate more useful initial data assessment, FDA spokesperson Karen Mahoney told PT, "We are asking sponsors to use the same approach to searching for and classifying adverse events that might be considered possibly suicide-related that was used in evaluating the suicidality data in children. Once we have the data from manufacturers, we will do the data analysis, as we did with the pediatric data."

Mahoney added, "Columbia's only role was in classifying cases, and we are expecting manufacturers to use a similar approach to that used by Columbia."

To the question of whether the FDA anticipates the drug companies' reports will be sufficient to reveal or rule out suicidality drug effect, without additional hearings or outside analysis, Mahoney replied, "The database should be large enough to detect a signal if there is one. Of course, it's not possible to ever absolutely rule out an effect. The absence of a signal would provide some reassurance."

The manufacturer of Lamictal (lamotrigine) was among those receiving the request for reanalysis of emergent behaviors in clinical trials. Ann Rhyne, the manufacturer's spokesperson, told PT in April, "We're still at early stages and working with the FDA, deciding which studies should be included and what data reported."

Lamotrigine was approved in 2003 for long-term treatment of bipolar disorder and has demonstrated benefit for bipolar depression. Of the clinical trials conducted for that indication, Rhyne commented, "We found no evidence that Lamictal is associated with increased risk of suicide, suicide attempt or suicidal ideation."

The risk for suicide in bipolar disorder was characterized in a JAMA editorial as "extraordinarily high" (Baldessarini and Tondo, 2003). The authors estimated such risk at 0.4% per year, in contrast to the international general population average of 0.017% per year. The highest suicide risk in bipolar disorder, they noted, occurs with dysphoric-agitated (mixed) states, and with the more severe, recurrent depression of bipolar II disorder.

The authors added (Baldessarini and Tondo, 2003):

Moreover, suicide attempts by patients with bipolar disorder have an increased lethal potential. Among patients with bipolar disorder, rates of suicide attempts are only 5 times the rates of completed suicides, whereas in the general population, rates of suicide attempts are 10 to 20 times the rates of completed suicides.

In their meta-analysis of 33 studies with sufficient data to estimate annual rates of suicide, lithium treatment appeared to reduce the risk, with a 0.197% annual rate of attempted or completed suicide, compared to a 13-fold greater rate of 2.57% without lithium treatment (Baldessarini et al., 2001). Even with lithium treatment, Baldessarini and Tondo (2003) emphasized, the rate of completed suicides in bipolar disorder is approximately 10 times that in the general population.

With little data to differentiate mood stabilizers for affecting suicide risk, Goodwin and colleagues (2003) undertook a retrospective study of more than 20,000 patients with bipolar disorder in two comprehensive health plans. The patients had been treated with either lithium, divalproex (Depakote), carbamazepine (Equetro, Tegretol) or a combination in the period of 1994 through 2001. The investigators assessed the incidence in this population of suicide mortality, suicide attempts resulting in hospitalization, and attempts or suicidal behavior resulting in emergency department visits without inpatient admission.

Goodwin and colleagues found that at both health plan sites, rates of suicide attempts and suicide death were substantially greater during treatment with divalproex than with lithium. Comparisons of lithium treatment with carbamazepine or combinations were less consistent, with a statistically significantly higher hazard ratio (2.9) with carbamazepine only in attempts resulting in hospitalization (Table).

From these and other data, lithium might be considered a candidate to join clozapine (Clozaril) as an FDA-approved treatment to prevent suicidal behavior. Baldessarini and Tondo (2003) observed in their JAMA editorial, "Hopefully, such renewed interest in the potentially treatment-modifiable lethality of major mental disorders will be sustained and increasingly successful."

A putative protective effect of lithium, however, does not imply that other mood stabilizers heighten risk. Nor do the adverse-event reports of suicidal behavior in patients receiving gabapentin necessarily evidence causality, Robert Temple, M.D., associate director for medical policy at the FDA Center for Drug Evaluation and Research explained to the Boston Globe. These reports, he said, "Can't really tell you whether the suicidal event is because of the drug or despite the drug."

References

Baldessarini RJ, Tondo L (2003), Suicide risk and treatments for patients with bipolar disorder. [Published erratum JAMA 291(2):186.] JAMA 290(11):1517-1519 [editorial].

Baldessarini RJ, Tondo L, Hennen J (2001), Treating the suicidal patient with bipolar disorder. Reducing suicide risk with lithium. Ann N Y Acad Sci 932:24-38; discussion 39-43.

Goodwin FK, Fireman B, Simon GE et al. (2003), Suicide risk in bipolar disorder during treatment with lithium and divalproex. JAMA 290(11):1467-1473 [see comments].

Experts Battle Over Safety And Efficacy Of SSRIs

Experts Battle Over Safety And Efficacy Of SSRIs

By Evelyn Pringle

08 December, 2006
Countercurrents.org

Every time the FDA is even thinking about taking measures to protect the public from the increased risk of suicide associated with SSRIs, Big Pharma sends out the hired guns to publish some half-baked study to dispute the suicide risk.

An FDA advisory committee is holding a public meeting on December 13, 2006 to once again review the data that experts say show SSRIs to be associated with suicide in adults and is expected to vote on whether to add a Black Box label to SSRIs, including Paxil, Prozac, Zoloft, Lexapro, and Celexa, about on the risk.

So true to form, last month Big Pharma's hired guns attempted to pass off a bogus study as science that claims suicide risks do not increase in children taking SSRIs. The so-called "research," was published in the American Journal of Psychiatry.

In the study, the researchers contend that if no prescriptions for SSRIs were written, there would be 253 more suicides each year among children and adolescents in the US.

To reach their conclusions, the researchers say they looked at county by county suicide data across the US for children aged 5 to 14, for the 2-year period of 1996 through 1998, and found that the counties with the highest prescription rates for SSRIs had the lowest suicide rates in this age groups.

According to Dr Stefan Kruszewski, MD, a Psychiatrist and Addictionologist, from Harrisburg, Pennsylvania, studies such as this are fiction. "These retrospective data analysis," he says, "generally cherry-pick the suicide statistics that the authors wish to use to attempt to transform an association of facts to something that it is not."

"For several decades," he notes, "reports have appeared periodically in the psychiatric and mental health literature that suggest or infer a casual relationship between the enormous rise in prescriptions written for antidepressants and apparent changes in the numbers of completed suicides."

"However," he reports, "there is no evidence that there is a causal relationship."

Who are these guys?

One of the study’s co-authors, John Mann, is a member of the, American College of Neuropsychopharmacology Task Force on SSRIs and Suicidal Behavior in Youth.

ACNP has served as a major shill for Big Pharma for years. This same gang issued a report complete with a press conference, ten days in in advance of the scheduled February 2, 2004, FDA advisory committee hearings on SSRI use with children, that said after reviewing the evidence it was the task force’s view that SSRIs were safe and effective and well-tolerated by children.

At the time the ACNP report was called a thinly veiled attempt by the drug companies to preempt the FDA by making a public announcement in favor of SSRI use with children.

Mr Mann himself has served as a paid speaker, consultant, and expert witness for SSRI makers and has received tens of millions of dollars in grants from the same companies to fund his research over the years - resulting in studies that always just happen to favor the drug makers' position.

While testifying in a jury trial in Cheyenne, Wyoming, on May 21, 2006, Mr Mann served as an expert witness for Paxil maker, GlaxoSmithKline, and the now famous Houston attorney, Andy Vickery, asked Dr Mann about how much money he had received from drug companies to conduct his research.

According to the trial transcript, Mr Vickery said, "we've looked at it just straight from your CV from 1990 or '91 to the present, and it looks like the total amount of grants was $31,520,124."

He asked Mr Mann whether that sounded about right and Mr Mann flippantly said, "I've never added it up."

Mr Vickery then asked whether it sounded like the amount was in the right ballpark, "over $30 million?" and Mr Mann said, "It is possible."

In addition to fraudulent studies, thirty million apparently buys a lot of publicity because news of Mr Mann's latest research was pumped out and accepted by just about every major media outlet in the US and Canada.

One headline by the Austin American-Statesmen and CBC News Canada, read: "Antidepressants Lower Kids' Suicide Risk, New Research Finds"

Another CBS News headline read: "Child Suicide: No Antidepressant Link?"

Reuters, News Max, Dominican Republic, and Scientific American all ran the headline:

"Antidepressants Tied to Lower Suicide Rates in Kids"

However, conspicuously missing in a google news search are any headlines disputing this unscientific study.

Dr David Healy, a professor at North Wales Department of Psychological Medicine, at Cardiff University, in the UK, will be testifying at the December 13, FDA hearing. He says there is little difference in the research on the suicidality risks associated with SSRIs with adults verses with children. "There is a striking overlap between the results in trials from adults and pediatric trials," he notes.

"While the rate of suicidal acts is higher in pediatric trials of depression," he explains, "the relationship between active treatment and placebo is the same in both adult and pediatric groups."

Dr Healy has authored 12 books on psychiatric drugs, including, "The Creation of Psychopharmacology," and "The Antidepressant Era," and he plans to testify about the manipulation of data from clinical trials on SSRIs. According to Dr Healy, "There is probably no other area of medicine in which the academic literature is so at odds with the raw data."

A possible explanation, he explains, is that the literature has had a significant ghostwriting input, a possibility that the ACNP Report, he says, that was published 10 days before the February 2004, hearing, did nothing to dispel.

"The Task Force," Dr Healy says, "reported SSRIs to be effective, safe and well-tolerated, but the authors claimed that they might be mistaken in that they had not seen the raw data."

Yet the some of authors of the report, he points out, including Graham Emslie and Karen Wagner, were also authors on almost all of the randomized trials on SSRIs, so Dr Healy questions how these people can claim that they have not seen the raw data.

"Science depends on access to, or a fair representation of, all of the data," he says.

"Portraying positive only results as science," he points out, "in other settings, has been called fraud."

Along with Dr Mann, Dr Healy also testified as an expert in the Paxil trial in Wyoming but on behalf of the plaintiff. He told the jury that all SSRIs can trigger suicidal and violent behavior in some patients. On the stand, he described his own studies that showed that SSRIs could even cause one in four "healthy volunteers" to become agitated, and in some cases suicidal.

Healthy volunteers, he explains, means the subjects were not mentally ill or depressed to begin with.

To support his testimony, Dr Healy used data from the drug company's own clinical trials and presented a summary of a study involving more than 2,000 healthy volunteers in which hundreds of people on Paxil had experienced adverse reactions, ranging from insomnia or anxiety to attempted suicide, that doctors in the study coded as "possibly," "probably" or "definitely" caused by Paxil.

For the record, in the battle of the experts in the Wyoming trial, Mr Vickery and his chosen expert, Dr David Healy, won the day and obtained the first guilty verdict by a jury in a Paxil-related suicide case.

Mr Vickery is expected to be at the FDA's December 13, hearing, as are most well-recognized experts on SSRIs, including Dr Joseph Glenmullen, Dr Ann Blake-Tracy, and Dr Peter Breggin.

A review of all of the studies that led to the ban on SSRI use with children in the UK, by Tim Kendall, deputy director of the Royal College of Psychiatrists' Research Unit in London, and colleagues, was discussed in the April 23, 2004, New Scientist journal.

After he learned that there were hidden pediatric studies, Mr Kendall contacted the SSRI makers directly and asked for the unpublished studies and when none of the companies supplied the data, he contacted a government agency and obtained 6 unpublished studies on three SSRIs.

After the researchers added the unpublished pediatric studies to those that were published, the risk benefit balance completely changed. "When we got the unpublished data and put it in with the published data, something happened," Mr Kendal told New Scientist. "Instead of being safe and effective, the risk-benefit reversed."

In fact, the unpublished studies on Zoloft, New Scientist said, "suggested the drug increased suicide-related events such as suicidal thoughts or attempts by 14 times compared with placebo."

An editorial accompanying the study in the journal, Lancet, said the research on SSRI use with children is marked by "confusion, manipulation, and institutional failure."

Analyses of published studies that governments rely on to set regulations, the editorial stated, are "made entirely redundant if results are so easily manipulated by those with potentially massive financial gains."

The review of all the SSRI studies also showed the drugs to be practically useless with children and adults. "This data confirms what we found in adults with mild to moderate depression: SSRIs are no better than placebo," Mr Kendall said, "and there is no point in using something that increases the risk of suicide."

With all that said, the FDA has set up another advisory committee meeting, at great expense to the tax payers, to re-re-re-review exactly what about SSRIs?


(Evelyn Pringle is a columnist for OpEd News and an investigative journalist focused on exposing corruption in government and corporate America Email:
evelyn-pringle (at) sbcglobal.net)