Defeat Children's Services Blog Please check out this blog at:
http://defeatdcs.blogspot.com/search/label/Press%20Release
This blog is intended to help those having to deal with an evil organization called Children's Services or often referred to as CPS. Far too often they have stolen children without evidence. They care little about fact finding and are an agency that regulates themselves. They are another example of wasteful government. This blog will tell you how you need to battle Children's Services. When all else fails sue, sue, sue!
December 21, 2009
A Press Release From June
One of the goals of Defeat DCS and other advocacy groups is to not only educate those of you who have had your lives destroyed by CPS, but to educate the general public on what we have allowed basically are entire government to become. The following is a press release sent out in June from Colorado. Never have truer words been spoken.
Help Save Our Children
For Immediate Release
June 6th, 2009
Hundreds and Thousands of children all across America are currently being affected by Child Protection Services (C.P.S.). Studies have shown that only 2 out of every 50 children that have been removed from their homes actually “fit” the criteria for a necessary removal (1).
Which means; out of every 100,000 children removed by C.P.S., there is roughly 95,000children who should have never been taken from their rightful families. These children were never physically abused or emotionally abused by their families. These children were never neglected, only unconditionally loved by their families. The Legal Definition for Kidnapping is; “The crime of unlawfully seizing and carrying away a person by force or “fraud”, or seizing and detaining a person against his or her will with an intent to carry that person away at a later time”. If these 95,000 children did not need to be removed, is that not kidnapping?
The United States Government acknowledges that children who are removed from their biological families suffer thereby irreparable, long-term emotion damage (2). According to C.P.S., emotional abuse is child abuse. C.P.S. is fully aware of these consequences, yet they continue to needlessly tear down the emotional well-being of innocent children and their families. New evidence has come to light recently that proves children in foster care are so distraught from being separated from their parents that C.P.S. is now drugging them. C.P.S. currently has approximately 85% of children residing in foster care on psychotropic drugs. Going back to the earlier studies of the 95% of children who are in foster that should not be there, this new study that shows 85% of those children are being drugged. Is C.P.S. drugging these foster children, so that the foster children can be forced into thinking that what C.P.S. has done to them in okay? Whatever their reason is, this new information proves that C.P.S. is willfully and wantonly, destroying these children’s lives! C.P.S. has complete disregard for parental rights, as most of these children are being drugged over the objections of their biological parents.
C.P.S is a government agency, created with the sole purpose of “protecting” the best interest of our children. The facts show that C.P.S. does protect approximately 5% of those 100,000 children, but what about the remaining 95% of those children’s lives that they destroy? It appears that C.P.S. is causing more harm than good.
So why do they continue to remove children that do not need to be removed? C.P.S. is a business that depends on the lives of children to increase their revenue. They benefit financially through federal funds like Title IV-E, Title IV-B, “Adoption Incentive Bonuses, as well as Adoption Subsidies. C.P.S. has now become an “empire” built on taking children and separating families.
In 2008, Former US Senator Nancy Shaefer updated her scathing report regarding the corruption within Child Protection Services. Senator Schaefer has personally worked with hundreds and hundreds of families, throughout the United States, who are desperate to remove their children from the “clutches” of C.P.S. She witnessed that C.P.S. caseworkers’ are often guilty of fraud. Caseworkers’ are known to fabricate evidence, commit perjury, as well as intentionally mislead the court in order to substantiate their false allegations of child abuse and/or neglect.
The majority of parents’, who are accused, are never charged with any crime. The reason for this is so that C.P.S. can keep child abuse and/or neglect in civil court. There are different rules for civil procedures. In civil court “hearsay” is submitted as evidence. C.P.S. relies on this, as they usually have no material evidence to support their false claims. There is no accountability for the caseworkers’ who commit these crimes against our children and their families. State laws provide them with immunity.
Not only are caseworkers’ provided with immunity, so are the judges who allow this to happen. Judges often times silence the family by not allowing the family to state their side, or submit their evidence into the court record. Judges have an obligation to the public to be fair and impartial, but this is not the case in Juvenile and family court. The best comparison to what takes place behind those courtroom doors, is the 1692 “Salem Witch Trials”, but this time they hunting our children.
Families are usually stuck with a county or state paid attorney, who offer no help. Those attorneys try to convince the family to settle with C.P.S. and they rarely ever effectively defend the family. The children are appointed a Guardian Ad Litem (GAL), who is mandated to look out for the children’s best interest. The problem with this system as a whole is that everybody involved with these cases (except the children and their families) are looking to the children to provide them with job security.
The Judges’, attorneys’, Guardian Ad Litems’, C.P.S., therapists, the list could go on and on for the bureaucracy of workers who get paid off of the lives of our children. If there were no children in the system these people would be out of a job. Senator Schaefer, as well as several other well respected individuals in the US, has come to the conclusion that C.P.S. targets low-income families. The reason for this is so that C.P.S. can take these children with little encumbrance from the families. C.P.S. knows that low-income families do not have the resources to hire an attorney to fight the system.
St. Augustine once said that an unjust law is no law at all. What is happening today in American regarding Child Protection Services is by far “unjust”. When will these children and their families receive the justice they so desperately deserve? When will this corruption be brought to an end? One might think that placing children unnecessarily in foster care is the worst part of what C.P.S. does, but it is not the end of the destruction to American Families. Once C.P.S. has held children captive for the max time allotted, they then terminate the parent’s rights permanently. The reason for this is so these children will be “readily” adoptable. This is when the children are the most profitable for C.P.S.
Once C.P.S. can adopt out our children, they receive a $4000 - $8000 cash bonus for each child from our federal government. After they receive these cash bonuses, then C.P.S. will apply for federal “Adoption Subsidies”. Adoption Subsidies are cash payments of $400 - $800 per month on behalf of each child they helped adopt out. C.P.S. can receive these cash payments until the child reaches the age of 21. That’s right folks; our children have a cash value, a bounty if you will, over their heads. No American child or American family is safe from the claws of C.P.S. If your children will help them to increase revenue to help with their budget shortfalls, they will take your children, and there is absolutely nothing you can do about it. When will someone help these children?
These children have been robbed of their innocents and deprived of the love they desperately need and deserve from their own families. These families’ have been alienated from there children and they have lost their flesh and blood. What is more heartbreaking, the fact that C.P.S. is abolishing families unnecessarily or that nobody is standing up to stop it?
Shauna D. Robinson
Founder of Colorado’s Children
9490 E 106th Avenue
Henderson, CO 80640
Email: coloradoschildren@yahoo.com
Website: http://coloradoschildren.ning.com
Posted by Defeat Dcs at 11:58 AM
Labels: Press Release
Exposing Child UN-Protective Services and the Deceitful Practices They Use to Rip Families Apart/Where Relative Placement is NOT an Option, as Stated by a DCYF Supervisor
Unbiased Reporting
What I post on this Blog does not mean I agree with the articles or disagree. I call it Unbiased Reporting!
Isabella Brooke Knightly and Austin Gamez-Knightly
In Memory of my Loving Husband, William F. Knightly Jr. Murdered by ILLEGAL Palliative Care at a Nashua, NH Hospital
Tuesday, December 22, 2009
Selling Children in America
Conchita Sarnoff.Posted: December 21, 2009 06:39 PM Selling Children in America
What's Your Reaction Child trafficking is a serious business. The latest 2008 United Nations Office on Drugs and Crime report confirms that trafficking of children has become a $67 billion annual worldwide business larger than Nike, Starbucks and Google combined
After weapons and drugs, children have become the third most important commodity to organized crime syndicates the world over, led by the Mexican cartels and closely followed in net annual revenues by the Russian and Ukrainian organized crime mafia.
A 2009 State Department Report confirmed that the United States is now the #1 destination country in the world for trafficked children. The reasons are clear: money and a high demand for underage children to be used for prostitution on "the streets" and online pornography.
Unfortunately, most members of Congress, state and local officials aren't aware of this. I recently met with U.S. Rep Ileana Ros-Lehtinen, the ranking member of the House Foreign Affairs Committee, who is a renowned workhorse in Congress, to interview her on the severity of the epidemic; she was shocked at the prevalence and the numbers.
According to the same State Department report, child trafficking is a global epidemic with tentacles that touch every nation at every level from state-run orphanages right up the latter to the most lucrative global industries including reputable modeling agencies.
Other recent government reports confirm that the fiscal aspect of the child trafficking -- that is the supply and demand structure of the global economy -- is such that the risk-reward ratio makes it both highly lucrative as well as nearly impossible to combat, much less eradicate.
Child trafficking in the 21st Century is a nondiscriminatory business: race, age, sex and socioeconomic status make no difference to the trader. The challenge: lack of awareness, resources and little if any law enforcement training. Local and State police who usually are first in line of command to bring the victims into custody are unaware that a T-Visa exists for the eligible trafficked children.
During a conversation with a former government official who wishes to remain anonymous, the Immigration, Customs Enforcement (ICE) budget, during the Bush administration used towards eradicating child trafficking was a mere $5 million out of a total budget of $800 million. Something is wrong with this picture. Still today, three hundred times more money is spent fighting drug trafficking than child trafficking. So how do we solve this?
In my opinion: Our local and state officials need to rethink strategy, reallocate the budgets and train the ``foot soldiers.'' In the meantime, as my friend and former Customs Enforcement Director coined, organize a "zero tolerance" grassroots campaign in every State by appointing local citizens to manage the small groups of community activists and spread the word to raise awareness across their neighborhoods. Over time and with a clear goal in sight these small community groups will grow into a nationwide initiative much like "Mothers against Drunk Drivers".
We owe it to our children and our country to protect innocent life; and in following the footsteps of that once heroic Anglican clergyman, John Newton, composer of the most famous folk hymn "Amazing Grace" the world's enslaved children will finally become "Free at Last".
http://www.huffingtonpost.com/conchita-s-sarnoff/selling-children-in-ameri_b_399974.html
What's Your Reaction Child trafficking is a serious business. The latest 2008 United Nations Office on Drugs and Crime report confirms that trafficking of children has become a $67 billion annual worldwide business larger than Nike, Starbucks and Google combined
After weapons and drugs, children have become the third most important commodity to organized crime syndicates the world over, led by the Mexican cartels and closely followed in net annual revenues by the Russian and Ukrainian organized crime mafia.
A 2009 State Department Report confirmed that the United States is now the #1 destination country in the world for trafficked children. The reasons are clear: money and a high demand for underage children to be used for prostitution on "the streets" and online pornography.
Unfortunately, most members of Congress, state and local officials aren't aware of this. I recently met with U.S. Rep Ileana Ros-Lehtinen, the ranking member of the House Foreign Affairs Committee, who is a renowned workhorse in Congress, to interview her on the severity of the epidemic; she was shocked at the prevalence and the numbers.
According to the same State Department report, child trafficking is a global epidemic with tentacles that touch every nation at every level from state-run orphanages right up the latter to the most lucrative global industries including reputable modeling agencies.
Other recent government reports confirm that the fiscal aspect of the child trafficking -- that is the supply and demand structure of the global economy -- is such that the risk-reward ratio makes it both highly lucrative as well as nearly impossible to combat, much less eradicate.
Child trafficking in the 21st Century is a nondiscriminatory business: race, age, sex and socioeconomic status make no difference to the trader. The challenge: lack of awareness, resources and little if any law enforcement training. Local and State police who usually are first in line of command to bring the victims into custody are unaware that a T-Visa exists for the eligible trafficked children.
During a conversation with a former government official who wishes to remain anonymous, the Immigration, Customs Enforcement (ICE) budget, during the Bush administration used towards eradicating child trafficking was a mere $5 million out of a total budget of $800 million. Something is wrong with this picture. Still today, three hundred times more money is spent fighting drug trafficking than child trafficking. So how do we solve this?
In my opinion: Our local and state officials need to rethink strategy, reallocate the budgets and train the ``foot soldiers.'' In the meantime, as my friend and former Customs Enforcement Director coined, organize a "zero tolerance" grassroots campaign in every State by appointing local citizens to manage the small groups of community activists and spread the word to raise awareness across their neighborhoods. Over time and with a clear goal in sight these small community groups will grow into a nationwide initiative much like "Mothers against Drunk Drivers".
We owe it to our children and our country to protect innocent life; and in following the footsteps of that once heroic Anglican clergyman, John Newton, composer of the most famous folk hymn "Amazing Grace" the world's enslaved children will finally become "Free at Last".
http://www.huffingtonpost.com/conchita-s-sarnoff/selling-children-in-ameri_b_399974.html
Cut the Power of the Family Courts
Cut the Power of the Family Courts
by Phyllis Schlafly
Do you think judges should have the power to decide what religion your children must belong to and which churches they may be prohibited from attending? We have long suspected that family courts are the most dictatorial and biased of all U.S. courts, routinely depriving divorced fathers of due process rights and authority over their own children, but this December a Chicago judge went beyond the pale.
Cook County Circuit Judge Edward Jordan issued a restraining order to prohibit Joseph Reyes from taking his 3-year-old daughter to any non-Jewish religious activities because the ex-wife argued that would contribute to "the emotional detriment of the child." Mrs. Rebecca Reyes wants to raise her daughter in the Jewish religion, and the judge sided with the mother.
As Joseph Reyes' divorce attorney, Joel Brodsky, said when he saw the judge's restraining order: "I almost fell off my chair. I thought maybe we were in Afghanistan and this was the Taliban." The lawyer is appealing.
Doesn't the First Amendment extend to fathers? Apparently not, if they are divorced. This case sounds extreme, but it is a good illustration of how family courts, the lowest in the judicial hierarchy, have become the most dictatorial of all courts because of the tremendous number of families and amounts of private money they control and the lack of accountability for their decisions.
In another divorce case this year, a family court in New Hampshire (where the state motto is "Live Free or Die") ordered 10-year-old Amanda Kurowski to quit being homeschooled by her mother and instead to attend fifth grade in the local public school. Judge Lucinda V. Sadler approved the court-appointed expert's view that Amanda "appeared to reflect her mother's rigidity on questions of faith" and that Amanda "would be best served by exposure to multiple points of view."
Where did family court judges get the power to decide what church and what school the children of divorced parents must attend? Family court judges have amassed this extraordinary power by co-opting and changing the definition of a time-honored concept: "the best interest of the child."
This rule originally came from English common law as compiled by William Blackstone in 1765, and meant that parents are presumed to act in their own children's best interest. For centuries, English and American courts honored parents' rights by recognizing the legal presumption that the best interest of a child is whatever a fit parent says it is, and should not be second-guessed by a judge.
When states revised their family-law statutes in the 1970s, the "best interest of the child" became disconnected from parents' decisions, and family courts assumed the discretion to decide the best interest of children of divorced and unmarried parents.
The notion that persons other than parents should decide what is in a child's best interest is illustrated by the slogan "It takes a village to raise a child." Those who use that slogan understand "village" to mean government courts, government schools or government social workers.
The trouble with the best-interest rule is that it is totally subjective -- it's a matter of individual opinion. Parents make hundreds of different decisions, and should have the right to make their decisions even if they contravene the self-appointed experts.
Whether the decision is big (such as where to go to church or school) or small (such as playing baseball or soccer), there is no objective way to say which is "best."
Since judges are supposed to base their decisions on evidence presented in open court, and there is no objective basis for deciding thousands of questions involved in raising a child, judges call on the testimony of expert witnesses. A big industry has grown up of psychologists, psychiatrists, social workers, custody evaluators, and counselors who are eager to collect fees for giving their opinions.
Having opinions produced by persons with academic degrees is a way to make subjective and arbitrary judgments appear objective. With the volume of cases coming through family courts, judges can evade responsibility for controversial decisions by rubber-stamping opinions of these court-appointed experts.
Scientific American Mind published a scholarly paper in October 2005 by three noted psychologists who explained that the practice of allowing courts to be de facto decision makers "is legally, morally and scientifically wrong. ... Parents should determine their children's lives after separation, just as when they are married. ... Parents, not judges or mental health professionals, are the best experts on their own children."
It's time to call a halt to the practice of letting family court judges make decisions that are rightfully the prerogative of parents.
About The Author
--------------------------------------------------------------------------------
Phyllis Schlafly is a national leader of the pro-family movement, a nationally syndicated columnist and author of Feminist Fantasies.
http://townhall.com/columnists/PhyllisSchlafly/2009/12/22/cut_the_power_of_the_family_courts
by Phyllis Schlafly
Do you think judges should have the power to decide what religion your children must belong to and which churches they may be prohibited from attending? We have long suspected that family courts are the most dictatorial and biased of all U.S. courts, routinely depriving divorced fathers of due process rights and authority over their own children, but this December a Chicago judge went beyond the pale.
Cook County Circuit Judge Edward Jordan issued a restraining order to prohibit Joseph Reyes from taking his 3-year-old daughter to any non-Jewish religious activities because the ex-wife argued that would contribute to "the emotional detriment of the child." Mrs. Rebecca Reyes wants to raise her daughter in the Jewish religion, and the judge sided with the mother.
As Joseph Reyes' divorce attorney, Joel Brodsky, said when he saw the judge's restraining order: "I almost fell off my chair. I thought maybe we were in Afghanistan and this was the Taliban." The lawyer is appealing.
Doesn't the First Amendment extend to fathers? Apparently not, if they are divorced. This case sounds extreme, but it is a good illustration of how family courts, the lowest in the judicial hierarchy, have become the most dictatorial of all courts because of the tremendous number of families and amounts of private money they control and the lack of accountability for their decisions.
In another divorce case this year, a family court in New Hampshire (where the state motto is "Live Free or Die") ordered 10-year-old Amanda Kurowski to quit being homeschooled by her mother and instead to attend fifth grade in the local public school. Judge Lucinda V. Sadler approved the court-appointed expert's view that Amanda "appeared to reflect her mother's rigidity on questions of faith" and that Amanda "would be best served by exposure to multiple points of view."
Where did family court judges get the power to decide what church and what school the children of divorced parents must attend? Family court judges have amassed this extraordinary power by co-opting and changing the definition of a time-honored concept: "the best interest of the child."
This rule originally came from English common law as compiled by William Blackstone in 1765, and meant that parents are presumed to act in their own children's best interest. For centuries, English and American courts honored parents' rights by recognizing the legal presumption that the best interest of a child is whatever a fit parent says it is, and should not be second-guessed by a judge.
When states revised their family-law statutes in the 1970s, the "best interest of the child" became disconnected from parents' decisions, and family courts assumed the discretion to decide the best interest of children of divorced and unmarried parents.
The notion that persons other than parents should decide what is in a child's best interest is illustrated by the slogan "It takes a village to raise a child." Those who use that slogan understand "village" to mean government courts, government schools or government social workers.
The trouble with the best-interest rule is that it is totally subjective -- it's a matter of individual opinion. Parents make hundreds of different decisions, and should have the right to make their decisions even if they contravene the self-appointed experts.
Whether the decision is big (such as where to go to church or school) or small (such as playing baseball or soccer), there is no objective way to say which is "best."
Since judges are supposed to base their decisions on evidence presented in open court, and there is no objective basis for deciding thousands of questions involved in raising a child, judges call on the testimony of expert witnesses. A big industry has grown up of psychologists, psychiatrists, social workers, custody evaluators, and counselors who are eager to collect fees for giving their opinions.
Having opinions produced by persons with academic degrees is a way to make subjective and arbitrary judgments appear objective. With the volume of cases coming through family courts, judges can evade responsibility for controversial decisions by rubber-stamping opinions of these court-appointed experts.
Scientific American Mind published a scholarly paper in October 2005 by three noted psychologists who explained that the practice of allowing courts to be de facto decision makers "is legally, morally and scientifically wrong. ... Parents should determine their children's lives after separation, just as when they are married. ... Parents, not judges or mental health professionals, are the best experts on their own children."
It's time to call a halt to the practice of letting family court judges make decisions that are rightfully the prerogative of parents.
About The Author
--------------------------------------------------------------------------------
Phyllis Schlafly is a national leader of the pro-family movement, a nationally syndicated columnist and author of Feminist Fantasies.
http://townhall.com/columnists/PhyllisSchlafly/2009/12/22/cut_the_power_of_the_family_courts
Monday, December 21, 2009
Another Pathway to a Goldmine: "Parental Alienation Syndrome" in the DSM-V Will Make Them Rich
Another Pathway to a Goldmine: "Parental Alienation Syndrome" in the DSM-V Will Make Them Rich
December 14, 2009 | Washington, District of Columbia | Vetting explained
Posted by:
NCarroll
CNN producer note
iReport — This is another pathway the drug companies will have to have a bigger goldmine...by pushing drugs into kids labeled with so-called "parental alienation syndrome." They will all be making money…the court-appointed psychologists and counselors, the lawyers that churn the cases, the drug companies that put our children in a coma-like state so they can put up with the continued abuse or rape when they are handed over to the abuser when those words “parental alienation” are uttered in court.
And this is why the American Judge’s Association, the National Council of Juvenile and Family Court Judges, the National District Attorney’s Association, the American Medical Association, and the American Psychological Association have debunked it and taken a stand against it or refuse to acknowledge it, as it is a known tactic for abusers to get custody of children.
US Kids Represent Psychiatric Drug Goldmine
Saturday 12 December 2009
by: Evelyn Pringle, t r u t h o u t | Report
(Image: Jared Rodriguez / t r u t h o u t; Adapted: zaxl4, Thom Watson)
Prescriptions for psychiatric drugs increased 50 percent with children in the US, and 73 percent among adults, from 1996 to 2006, according to a study in the May/June 2009 issue of the journal Health Affairs. Another study in the same issue of Health Affairs found spending for mental health care grew more than 30 percent over the same ten-year period, with almost all of the increase due to psychiatric drug costs.
On April 22, 2009, the US Agency for Healthcare Research and Quality reported that in 2006 more money was spent on treating mental disorders in children aged 0 to 17 than for any other medical condition, with a total of $8.9 billion. By comparison, the cost of treating trauma-related disorders, including fractures, sprains, burns, and other physical injuries, was only $6.1 billion.
In 2008, psychiatric drug makers had overall sales in the US of $14.6 billion from antipsychotics, $9.6 billion off antidepressants, $11.3 billion from antiseizure drugs and $4.8 billion in sales of ADHD drugs, for a grand total of $40.3 billion.
The path to child drugging in the US started with providing adolescents with stimulants for ADHD in the early 80s. That was followed by Prozac in the late 80s, and in the mid-90s drug companies started claiming that ADHD kids really had bipolar disorder, coinciding with the marketing of epilepsy drugs as “mood stablizers” and the arrival of the new atypical antipsychotics.
Parents can now have their kids declared disabled due to mental illness and receive Social Security disability payments and free medical care, and schools can get more money for disabled kids. The bounty for the prescribing doctors and pharmacies is enormous and the CEOs of the drug companies are laughing all the way into early retirement.
Psychiatric Drugs Explained
During an interview with Street Spirit in August 2005, investigative journalist and author of “Mad in America,” Robert Whitaker, described the dangers of psychiatric drugs. “When you look at the research literature, you find a clear pattern of outcomes with all these drugs,” he said, “you see it with the antipsychotics, the antidepressants, the anti-anxiety drugs and the stimulants like Ritalin used to treat ADHD.”
“All these drugs may curb a target symptom slightly more effectively than a placebo does for a short period of time, say six weeks,” Whitaker said. However, what “you find with every class of these psychiatric drugs is a worsening of the target symptom of depression or psychosis or anxiety, over the long term, compared to placebo-treated patients.”
“So even on the target symptoms, there’s greater chronicity and greater severity of symptoms,” he reports, “And you see a fairly significant percentage of patients where new and more severe psychiatric symptoms are triggered by the drug itself.”
Whitaker told Street Spirit that the rate of Americans disabled by mental illness has skyrocketed since Prozac came on the market in 1987, and reports: (1) the number of mentally disabled people in the US has been increasing at a rate of 150,000 people per year since 1987, (2) that represents an increase of 410 new people per day and (3) the disability rate has continued to increase and one in every 50 Americans is disabled by mental illness.
The statistics above beg the question of how could this happen when the so-called new generation of “wonder drugs” arrived on the market during the exact same time period. The truth is, the “wonder drugs” cause most of the bizarre behaviors listed by doctors to warrant a mental illness disability.
Psychiatric Drug Goldmine
The CIA “World Factbook” estimate the world population to be about 6.8 billion and the US population to be a mere 307 million. In an April 2008 report, the market research firm Datamonitor reported that the “US dominates the ADHD market with a 94 percent market share.”
ADHD drug prices at a middle dose for 90 pills at DrugStore.com, are: Adderall $278, Concerta $412, Desoxyn $366, Strattera $464 and Vyvanse $385. Daytrana costs $437 for three boxes of 30 nine-hour patches.
The SSRI and SNRI antidepressants include GlaxoSmithKline’s Paxil and Wellbutrin, Pfizer’s Zoloft, Celexa and Lexapro from Forest Labs, Luvox by Solvay, Wyeth’s Effexor and Pristiq and Lilly’s Prozac and Cymbalta. The average price of these drugs is about $300 for 90 pills at DrugStore.com.
The prices for anticonvulsants can run as high as $929 for 180 tablets of Glaxo’s Lamictal, and $1170 for 180 tablets of Johnson & Johnson’s Topamax.
In 2008, the atypical antipsychotics took over the slot as the top revenue earners in the US, and include Seroquel by AstraZeneca; Risperdal and Invega marketed by Janssen, a division of J&J; Geodon by Pfizer; Abilify from Bristol-Myers Squibb; Novartis’ Clozaril and Eli Lilly’s Zyprexa. The average price on these drugs for 100 pills at DrugStore.com is about $1,000. Lilly also sells Symbyax, a drug with Zyprexa and Prozac combined, at a cost $1,564 for 90 capsules at DrugStore.com in May 2009.
The briefing material submitted to an FDA advisory panel in April 2009 reported that an estimated 25.9 million patients worldwide had been exposed to Seroquel since its launch in 1997 through July 31, 2007, in the US, and the second quarter of 2007 for countries outside the US. Of that number, an estimated nearly 15.9 million took Seroquel in the US, compared to only ten million patients in the rest of the world. In 2008, the US accounted for roughly $3 billion of Seroquel’s $4.5 billion in worldwide sales.
For the full-year of 2008, Eli Lilly reported worldwide Zyprexa sales of about $4.7 billion, with US sales of $2.2 billion and only $2.5 billion for the rest of the world.
FDA as Promotional Tool
On June 12, 2009, an FDA advisory panel gave the green light to expand the marketing of Zyprexa, Seroquel and Geodon for use with 13 to 17 year-olds diagnosed with schizophrenia and 10 to 17 year-olds diagnosed with bipolar disorder. The FDA usually follows its advisers’ recommendations.
“Such approval gives manufacturers a shield from liability – for illegally promoting the drugs for off-label use,” said Vera Hassner Sharav, president of the Alliance for Human Research Protection.
“And such approval ensures increased use of these drugs,” she warned. “Manufacturers and mental health providers will profit while children’s physical and mental health will be sacrificed.”
“The body of evidence showing these drugs to be harmful is irrefutable,” she said, “it is documented in FDA’s postmarketing database, and in secret internal company documents uncovered during litigation.”
According to Dr. Stefan Kruszewski, a Harvard-trained psychiatrist from Harrisburg, Pennsylvania, the atypicals increase the risk of obesity, type II diabetes, hypertension, heart attacks and stroke.
He said the drugs were marketed as safer and easier to tolerate than the older, cheaper antipsychotics because they would cause fewer neurological injuries like tardive dyskinesia and akathisia.
Those claims turned out to be totally false, he said, and “they continue to cause same neurological side-effects as the older antipsychotics.”
“Children are known to be compliant patients and that makes them a highly desirable market for drugs, especially when it pertains to large-profit-margin psychiatric drugs, which can be wrought with issues of non-compliance because of their horrendous side effect profiles,” according to a June 29, 2009 paper titled, “Drugging Our Children to Death,” in Health News Digest.com, by Gwen Olsen, who spent over a decade as a pharmaceutical sales rep, and authored the book, “Confessions of an Rx Drug Pusher.”
Children are forced to take their drugs by doctors, parents and school personnel, she said. “So, children are the ideal patient-type because they represent refilled prescription compliance and ‘longevity.’”
“In other words,” Olsen noted, “they will be lifelong patients and repeat customers for Pharma!”
“The initiative to drug our children for profit has exceeded all common sense boundaries and is threatening the welfare of every American child,” she stated, and it “is up to each and every one of us to stop this madness!”
Drug Makers Busted
Most all of the psychiatric drug companies have come under investigation over the past several years for promoting their drugs for off-label use, especially with children. However, the fines they end up paying are trivial compared to the profits earned through the illegal marketing campaigns.
In September 2007, Bristol-Myers Squibb entered into a $515 million civil settlement with the US Department of Justice for illegally marketing drugs, including Abilify, for off-label uses. In the first six months of 2009, Abilify had sales of $1.9 billion. In 2008, the salary and compensation package of Bristol-Myers’ CEO, James Cornelius, was $23,150,236, according to the AFL-CIO’s Executive PayWatch Database.
On January 29, 2009, Paxil and Wellbutrin maker, GlaxoSmithKline, announced that it would record a legal charge in the fourth quarter of 2008 of $400 million relating to an ongoing investigation initiated by the US attorney’s office in Colorado into the US marketing and promotional practices for several products for the period 1997 to 2004. The government inquired about alleged off-label marketing as well as medical education programs for doctors, “other speaker events, special issue boards, advisory boards, speaker training programmes, clinical studies, and related grants, fees, travel and entertainment,” according to a Glaxo annual report.
In January 2009, Eli Lilly settled with the DOJ and more than 30 states for $1.4 billion over the off-label marketing of Zyprexa. The agreement included a $615 million fine for a federal criminal charge. But $1.4 billion was chump change considering that Zyprexa was still Lilly’s best seller in 2008, with sales of $4.69 billion. Lilly also has paid over $1 billion to settle lawsuits filed by Zyprexa patients. In the first six months of 2009, Zyprexa sales were $1.5 billion. In 2008, Lilly’s CEO, John Lechleiter, had a pay package worth $12,856,882.
In September 2009, the DOJ reached a $2.3 billion settlement with Pfizer related to the off-label promotion of several drugs, including the psychiatric drugs, Geodon, Zoloft and Lyrica, in the largest health-care fraud settlement in history. But even though Pfizer took the entire $2.3 billion as an earnings charge for the fourth quarter of 2008, the drug maker was still able to post a fourth quarter profit of $268 million. Pfizer’s CEO in 2008, Jeffrey Kindler, had a salary and pay package of $15,547,600.
Johnson & Johnson is also dealing with the DOJ and state-level investigations into the off-label marketing of Risperdal. The company’s latest SEC filing lists nine subpoenas received by the company involving promotions of Risperdal, including one “seeking information regarding the Company’s financial relationship with several psychiatrists.” In the first six months of 2009, Risperdal earned $660 million. J&J’s CEO, William Weldon, had a pay package worth $29,127,432 in 2008.
AstraZeneca’s third quarter SEC filing lists a $520 million tentative settlement agreement with the US attorney’s office in Philadelphia to resolve allegations related to the off-label marketing of Seroquel. At “least 34 states are pursuing separate investigations of AstraZeneca’s marketing practices as part of a joint investigation and others may be conducting their own probes,” according to Ed Silverman on Pharmalot.
“A half a billion dollar one-time settlement is just a small cost of doing business for a company that sold $17 billion worth of the offending drug in the last five years,” Dr. Roy Poses points out on the Health Care Renewal web site. In 2008 alone, Seroquel had world-wide sales of more than $4.4 billion.
As of July 13, 2009, AstraZeneca was also defending approximately 10,381 served or answered personal injury lawsuits and approximately 19,391 plaintiff groups involving Seroquel, according to SEC filings. Some of the cases also include claims against other drug makers such as Eli Lilly, Janssen Pharmaceutica and/or Bristol-Myers Squibb, the filing notes.
On September 23, 2009, Shire Pharmaceuticals received a subpoena from the US Department of Health and Human Services Office of Inspector General in coordination with the US attorney for the Eastern District of Pennsylvania, seeking production of documents related to the sales and marketing of Adderall XR, Daytrana and Vyvanse, according to Shire’s third quarter report for 2009.
In a November 6, 2009, SEC filing, Abbott Labs said the federal prosecutor for the Western District of Virginia was conducting an investigation for the US Justice Department of whether the company’s sales and marketing of Depakote violated civil or criminal laws, including the Federal False Claims Act and an anti-kickback statute related to reimbursement by Medicare and Medicaid programs to third parties.
In 2008, Depakote had sales of $1.36 billion and Abbott CEO, Miles White, had a salary and compensation package of $28,253,387.
In February 2009, the DOJ unsealed a lawsuit alleging that Forest Laboratories marketed the antidepressants Celexa and Lexapro for unapproved uses in children, and paid kickbacks to induce doctors to promote the drugs, including Dr. Jeffrey Bostic at Harvard University. In its latest SEC filing, Forest disclosed that it reached an agreement in principle in May 2009 to settle the civil aspects of US federal and state probes. “Penalties in the civil settlement are covered by a $170 million reserve Forest created in April,” according to a November 9 report by Dow Jones.
Forest also disclosed that the agreement “does not resolve the government’s ongoing investigation into potential criminal law violations” related to Celexa and Lexapro, and thyroid drug Levothroid, Dow Jones notes. In 2008, the salary and compensation for Forest CEO, Howard Solomon, was $6,565,324.
Over the past year and a half, a large number of so-called “Key Opinion Leaders” in the field of psychiatry have been exposed for not fully disclosing money received from many of the drug companies above through an investigation by the US Senate Finance Committee under the leadership of Iowa Republican Sen. Chuck Grassley.
The list so far includes Harvard University’s Joseph Biederman, Thomas Spencer and Timothy Wilens; Charles Nemeroff and Zackery Stowe from Emory; Melissa DelBello at the University of Cincinnati; Alan Schatzberg, president of the American Psychiatric Association from Stanford; Martin Keller at Brown University; Karen Wagner and Augustus John Rush from the University of Texas and Fred Goodwin, the former host of a radio show called “Infinite Minds,” broadcast by National Pubic Radio.
Fines as a Business Expense
The fraud settlements are “merely a cost of doing business to these pharmaceutical Goliaths and, in fact, caps their liability for these crimes,” said Alaskan attorney Jim Gottstein, the leader of the Law Project for Psychiatric Rights (PsychRights), a public interest law firm.
“Most importantly,” he noted, “these settlements have not stopped the practice of psychiatrists and other prescribers giving these drugs to children and youth and Medicaid continuing to pay for these fraudulent claims.”
“Because of the massive, harmful, increase in the psychiatric drugging of America’s children and youth, who are inherently forced, PsychRights has made addressing the problem a priority,” he said.
Gottstein conducted an investigation and determined that the vast majority of off-label psychotropic drug prescriptions for children and youth that are paid for by Medicaid constitute Medicaid fraud.
PsychRights now has a national “Medicaid Fraud Initiative Against Psychiatric Drugging of Children & Youth,” designed to address this problem by “having lawsuits brought against the doctors prescribing these harmful, ineffective drugs, their employers, and the pharmacies filling these prescriptions and submitting them to Medicaid for reimbursement,” according to its web site.
“Anyone who submits or causes claims to be submitted to Medicaid for drugs that are not for a ‘medically accepted indication’ is committing Medicaid Fraud,” said Gottstein, in a July 27, 2009 press release announcing the launch of the national campaign.
“Those guilty of this Medicaid Fraud include psychiatrists and other physicians prescribing these drugs, their employers, and pharmacies submitting the false claims to Medicaid,” he pointed out.
PsychRights estimates that over $2 billion in such fraudulent Medicaid claims are being paid by the government each year.
“Once one sues over specific offending prescriptions, all of such prescriptions can be brought in, which means that any psychiatrist on the losing end of such a lawsuit will almost certainly be bankrupted, because each offending prescription carries a penalty of between $5,500 and $11,000,” PsychRights explained.
It is hoped that once the doctors and pharmacies realize they are subject to financially ruinous Medicaid fraud judgments, the practice will be stopped or substantially reduced.
“Each prescriber may have a million dollars or few, at most, to lose, but the pharmacies’ financial exposure can run into the hundreds of millions of dollars and it is hoped this will attract attorneys to take these cases,” the web site noted.
In September and October 2009, Gottstein gave presentations on the initiative at the annual conferences of the National Association of Rights Protection and Advocacy and the International Center for the Study of Psychiatry and Psychology in order to find people who are potentially interested and willing to pursue such cases.
“This was successful and we have at least a few such cases cooking,” he reported. “PsychRights stands ready to help people interested in bringing such suits.”
In late 2006, Gottstein won international fame by subpoenaing and releasing thousands of documents involving Eli Lilly’s illegal marketing of Zyprexa, which resulted in front page stories in The New York Times.
PsychRights also has an appeal pending on a lawsuit filed against the state of Alaska and responsible state officials seeking declaratory and injunctive relief that Alaskan children and youth on Medicaid have the right not to be administered psychotropic drugs unless and until a number of specific conditions are met. The lawsuit seeks to prohibit the state from paying for psychiatric drugs prescribed off-label to children and youth.
In responding to the lawsuit, the state claimed that they do have any control over or responsibility for the psychiatric drugging of children in their custody, or any responsibility under Medicaid, and moved for dismissal on the grounds that PsychRights does not have standing, or the right to bring the suit, because it was not harmed by the state’s actions.
The court agreed and dismissed the case. “We think the judge is wrong and have filed an appeal,” said Gottstein.
In May 2009, Gottstein sent letters to Sens. Charles Grassley and Herb Kohl and Reps. Henry Waxman, Bart Stupak, John Dingell and Barney Frank, describing the massive Medicaid fraud involved in the prescribing of psychiatric drugs to children in the US and asked for “assistance in stopping these illegal reimbursements.”
As of November 8, 2009, Gottstein reported, “I haven’t gotten as much as an acknowledgment of receipt from any of the members of Congress to whom I wrote.”
While pursuing causes on behalf of PsychRights, Gottstein donates all of his time on a pro bono basis.
http://www.ireport.com/docs/DOC-368870?ref=feeds%2Fhighestrated
December 14, 2009 | Washington, District of Columbia | Vetting explained
Posted by:
NCarroll
CNN producer note
iReport — This is another pathway the drug companies will have to have a bigger goldmine...by pushing drugs into kids labeled with so-called "parental alienation syndrome." They will all be making money…the court-appointed psychologists and counselors, the lawyers that churn the cases, the drug companies that put our children in a coma-like state so they can put up with the continued abuse or rape when they are handed over to the abuser when those words “parental alienation” are uttered in court.
And this is why the American Judge’s Association, the National Council of Juvenile and Family Court Judges, the National District Attorney’s Association, the American Medical Association, and the American Psychological Association have debunked it and taken a stand against it or refuse to acknowledge it, as it is a known tactic for abusers to get custody of children.
US Kids Represent Psychiatric Drug Goldmine
Saturday 12 December 2009
by: Evelyn Pringle, t r u t h o u t | Report
(Image: Jared Rodriguez / t r u t h o u t; Adapted: zaxl4, Thom Watson)
Prescriptions for psychiatric drugs increased 50 percent with children in the US, and 73 percent among adults, from 1996 to 2006, according to a study in the May/June 2009 issue of the journal Health Affairs. Another study in the same issue of Health Affairs found spending for mental health care grew more than 30 percent over the same ten-year period, with almost all of the increase due to psychiatric drug costs.
On April 22, 2009, the US Agency for Healthcare Research and Quality reported that in 2006 more money was spent on treating mental disorders in children aged 0 to 17 than for any other medical condition, with a total of $8.9 billion. By comparison, the cost of treating trauma-related disorders, including fractures, sprains, burns, and other physical injuries, was only $6.1 billion.
In 2008, psychiatric drug makers had overall sales in the US of $14.6 billion from antipsychotics, $9.6 billion off antidepressants, $11.3 billion from antiseizure drugs and $4.8 billion in sales of ADHD drugs, for a grand total of $40.3 billion.
The path to child drugging in the US started with providing adolescents with stimulants for ADHD in the early 80s. That was followed by Prozac in the late 80s, and in the mid-90s drug companies started claiming that ADHD kids really had bipolar disorder, coinciding with the marketing of epilepsy drugs as “mood stablizers” and the arrival of the new atypical antipsychotics.
Parents can now have their kids declared disabled due to mental illness and receive Social Security disability payments and free medical care, and schools can get more money for disabled kids. The bounty for the prescribing doctors and pharmacies is enormous and the CEOs of the drug companies are laughing all the way into early retirement.
Psychiatric Drugs Explained
During an interview with Street Spirit in August 2005, investigative journalist and author of “Mad in America,” Robert Whitaker, described the dangers of psychiatric drugs. “When you look at the research literature, you find a clear pattern of outcomes with all these drugs,” he said, “you see it with the antipsychotics, the antidepressants, the anti-anxiety drugs and the stimulants like Ritalin used to treat ADHD.”
“All these drugs may curb a target symptom slightly more effectively than a placebo does for a short period of time, say six weeks,” Whitaker said. However, what “you find with every class of these psychiatric drugs is a worsening of the target symptom of depression or psychosis or anxiety, over the long term, compared to placebo-treated patients.”
“So even on the target symptoms, there’s greater chronicity and greater severity of symptoms,” he reports, “And you see a fairly significant percentage of patients where new and more severe psychiatric symptoms are triggered by the drug itself.”
Whitaker told Street Spirit that the rate of Americans disabled by mental illness has skyrocketed since Prozac came on the market in 1987, and reports: (1) the number of mentally disabled people in the US has been increasing at a rate of 150,000 people per year since 1987, (2) that represents an increase of 410 new people per day and (3) the disability rate has continued to increase and one in every 50 Americans is disabled by mental illness.
The statistics above beg the question of how could this happen when the so-called new generation of “wonder drugs” arrived on the market during the exact same time period. The truth is, the “wonder drugs” cause most of the bizarre behaviors listed by doctors to warrant a mental illness disability.
Psychiatric Drug Goldmine
The CIA “World Factbook” estimate the world population to be about 6.8 billion and the US population to be a mere 307 million. In an April 2008 report, the market research firm Datamonitor reported that the “US dominates the ADHD market with a 94 percent market share.”
ADHD drug prices at a middle dose for 90 pills at DrugStore.com, are: Adderall $278, Concerta $412, Desoxyn $366, Strattera $464 and Vyvanse $385. Daytrana costs $437 for three boxes of 30 nine-hour patches.
The SSRI and SNRI antidepressants include GlaxoSmithKline’s Paxil and Wellbutrin, Pfizer’s Zoloft, Celexa and Lexapro from Forest Labs, Luvox by Solvay, Wyeth’s Effexor and Pristiq and Lilly’s Prozac and Cymbalta. The average price of these drugs is about $300 for 90 pills at DrugStore.com.
The prices for anticonvulsants can run as high as $929 for 180 tablets of Glaxo’s Lamictal, and $1170 for 180 tablets of Johnson & Johnson’s Topamax.
In 2008, the atypical antipsychotics took over the slot as the top revenue earners in the US, and include Seroquel by AstraZeneca; Risperdal and Invega marketed by Janssen, a division of J&J; Geodon by Pfizer; Abilify from Bristol-Myers Squibb; Novartis’ Clozaril and Eli Lilly’s Zyprexa. The average price on these drugs for 100 pills at DrugStore.com is about $1,000. Lilly also sells Symbyax, a drug with Zyprexa and Prozac combined, at a cost $1,564 for 90 capsules at DrugStore.com in May 2009.
The briefing material submitted to an FDA advisory panel in April 2009 reported that an estimated 25.9 million patients worldwide had been exposed to Seroquel since its launch in 1997 through July 31, 2007, in the US, and the second quarter of 2007 for countries outside the US. Of that number, an estimated nearly 15.9 million took Seroquel in the US, compared to only ten million patients in the rest of the world. In 2008, the US accounted for roughly $3 billion of Seroquel’s $4.5 billion in worldwide sales.
For the full-year of 2008, Eli Lilly reported worldwide Zyprexa sales of about $4.7 billion, with US sales of $2.2 billion and only $2.5 billion for the rest of the world.
FDA as Promotional Tool
On June 12, 2009, an FDA advisory panel gave the green light to expand the marketing of Zyprexa, Seroquel and Geodon for use with 13 to 17 year-olds diagnosed with schizophrenia and 10 to 17 year-olds diagnosed with bipolar disorder. The FDA usually follows its advisers’ recommendations.
“Such approval gives manufacturers a shield from liability – for illegally promoting the drugs for off-label use,” said Vera Hassner Sharav, president of the Alliance for Human Research Protection.
“And such approval ensures increased use of these drugs,” she warned. “Manufacturers and mental health providers will profit while children’s physical and mental health will be sacrificed.”
“The body of evidence showing these drugs to be harmful is irrefutable,” she said, “it is documented in FDA’s postmarketing database, and in secret internal company documents uncovered during litigation.”
According to Dr. Stefan Kruszewski, a Harvard-trained psychiatrist from Harrisburg, Pennsylvania, the atypicals increase the risk of obesity, type II diabetes, hypertension, heart attacks and stroke.
He said the drugs were marketed as safer and easier to tolerate than the older, cheaper antipsychotics because they would cause fewer neurological injuries like tardive dyskinesia and akathisia.
Those claims turned out to be totally false, he said, and “they continue to cause same neurological side-effects as the older antipsychotics.”
“Children are known to be compliant patients and that makes them a highly desirable market for drugs, especially when it pertains to large-profit-margin psychiatric drugs, which can be wrought with issues of non-compliance because of their horrendous side effect profiles,” according to a June 29, 2009 paper titled, “Drugging Our Children to Death,” in Health News Digest.com, by Gwen Olsen, who spent over a decade as a pharmaceutical sales rep, and authored the book, “Confessions of an Rx Drug Pusher.”
Children are forced to take their drugs by doctors, parents and school personnel, she said. “So, children are the ideal patient-type because they represent refilled prescription compliance and ‘longevity.’”
“In other words,” Olsen noted, “they will be lifelong patients and repeat customers for Pharma!”
“The initiative to drug our children for profit has exceeded all common sense boundaries and is threatening the welfare of every American child,” she stated, and it “is up to each and every one of us to stop this madness!”
Drug Makers Busted
Most all of the psychiatric drug companies have come under investigation over the past several years for promoting their drugs for off-label use, especially with children. However, the fines they end up paying are trivial compared to the profits earned through the illegal marketing campaigns.
In September 2007, Bristol-Myers Squibb entered into a $515 million civil settlement with the US Department of Justice for illegally marketing drugs, including Abilify, for off-label uses. In the first six months of 2009, Abilify had sales of $1.9 billion. In 2008, the salary and compensation package of Bristol-Myers’ CEO, James Cornelius, was $23,150,236, according to the AFL-CIO’s Executive PayWatch Database.
On January 29, 2009, Paxil and Wellbutrin maker, GlaxoSmithKline, announced that it would record a legal charge in the fourth quarter of 2008 of $400 million relating to an ongoing investigation initiated by the US attorney’s office in Colorado into the US marketing and promotional practices for several products for the period 1997 to 2004. The government inquired about alleged off-label marketing as well as medical education programs for doctors, “other speaker events, special issue boards, advisory boards, speaker training programmes, clinical studies, and related grants, fees, travel and entertainment,” according to a Glaxo annual report.
In January 2009, Eli Lilly settled with the DOJ and more than 30 states for $1.4 billion over the off-label marketing of Zyprexa. The agreement included a $615 million fine for a federal criminal charge. But $1.4 billion was chump change considering that Zyprexa was still Lilly’s best seller in 2008, with sales of $4.69 billion. Lilly also has paid over $1 billion to settle lawsuits filed by Zyprexa patients. In the first six months of 2009, Zyprexa sales were $1.5 billion. In 2008, Lilly’s CEO, John Lechleiter, had a pay package worth $12,856,882.
In September 2009, the DOJ reached a $2.3 billion settlement with Pfizer related to the off-label promotion of several drugs, including the psychiatric drugs, Geodon, Zoloft and Lyrica, in the largest health-care fraud settlement in history. But even though Pfizer took the entire $2.3 billion as an earnings charge for the fourth quarter of 2008, the drug maker was still able to post a fourth quarter profit of $268 million. Pfizer’s CEO in 2008, Jeffrey Kindler, had a salary and pay package of $15,547,600.
Johnson & Johnson is also dealing with the DOJ and state-level investigations into the off-label marketing of Risperdal. The company’s latest SEC filing lists nine subpoenas received by the company involving promotions of Risperdal, including one “seeking information regarding the Company’s financial relationship with several psychiatrists.” In the first six months of 2009, Risperdal earned $660 million. J&J’s CEO, William Weldon, had a pay package worth $29,127,432 in 2008.
AstraZeneca’s third quarter SEC filing lists a $520 million tentative settlement agreement with the US attorney’s office in Philadelphia to resolve allegations related to the off-label marketing of Seroquel. At “least 34 states are pursuing separate investigations of AstraZeneca’s marketing practices as part of a joint investigation and others may be conducting their own probes,” according to Ed Silverman on Pharmalot.
“A half a billion dollar one-time settlement is just a small cost of doing business for a company that sold $17 billion worth of the offending drug in the last five years,” Dr. Roy Poses points out on the Health Care Renewal web site. In 2008 alone, Seroquel had world-wide sales of more than $4.4 billion.
As of July 13, 2009, AstraZeneca was also defending approximately 10,381 served or answered personal injury lawsuits and approximately 19,391 plaintiff groups involving Seroquel, according to SEC filings. Some of the cases also include claims against other drug makers such as Eli Lilly, Janssen Pharmaceutica and/or Bristol-Myers Squibb, the filing notes.
On September 23, 2009, Shire Pharmaceuticals received a subpoena from the US Department of Health and Human Services Office of Inspector General in coordination with the US attorney for the Eastern District of Pennsylvania, seeking production of documents related to the sales and marketing of Adderall XR, Daytrana and Vyvanse, according to Shire’s third quarter report for 2009.
In a November 6, 2009, SEC filing, Abbott Labs said the federal prosecutor for the Western District of Virginia was conducting an investigation for the US Justice Department of whether the company’s sales and marketing of Depakote violated civil or criminal laws, including the Federal False Claims Act and an anti-kickback statute related to reimbursement by Medicare and Medicaid programs to third parties.
In 2008, Depakote had sales of $1.36 billion and Abbott CEO, Miles White, had a salary and compensation package of $28,253,387.
In February 2009, the DOJ unsealed a lawsuit alleging that Forest Laboratories marketed the antidepressants Celexa and Lexapro for unapproved uses in children, and paid kickbacks to induce doctors to promote the drugs, including Dr. Jeffrey Bostic at Harvard University. In its latest SEC filing, Forest disclosed that it reached an agreement in principle in May 2009 to settle the civil aspects of US federal and state probes. “Penalties in the civil settlement are covered by a $170 million reserve Forest created in April,” according to a November 9 report by Dow Jones.
Forest also disclosed that the agreement “does not resolve the government’s ongoing investigation into potential criminal law violations” related to Celexa and Lexapro, and thyroid drug Levothroid, Dow Jones notes. In 2008, the salary and compensation for Forest CEO, Howard Solomon, was $6,565,324.
Over the past year and a half, a large number of so-called “Key Opinion Leaders” in the field of psychiatry have been exposed for not fully disclosing money received from many of the drug companies above through an investigation by the US Senate Finance Committee under the leadership of Iowa Republican Sen. Chuck Grassley.
The list so far includes Harvard University’s Joseph Biederman, Thomas Spencer and Timothy Wilens; Charles Nemeroff and Zackery Stowe from Emory; Melissa DelBello at the University of Cincinnati; Alan Schatzberg, president of the American Psychiatric Association from Stanford; Martin Keller at Brown University; Karen Wagner and Augustus John Rush from the University of Texas and Fred Goodwin, the former host of a radio show called “Infinite Minds,” broadcast by National Pubic Radio.
Fines as a Business Expense
The fraud settlements are “merely a cost of doing business to these pharmaceutical Goliaths and, in fact, caps their liability for these crimes,” said Alaskan attorney Jim Gottstein, the leader of the Law Project for Psychiatric Rights (PsychRights), a public interest law firm.
“Most importantly,” he noted, “these settlements have not stopped the practice of psychiatrists and other prescribers giving these drugs to children and youth and Medicaid continuing to pay for these fraudulent claims.”
“Because of the massive, harmful, increase in the psychiatric drugging of America’s children and youth, who are inherently forced, PsychRights has made addressing the problem a priority,” he said.
Gottstein conducted an investigation and determined that the vast majority of off-label psychotropic drug prescriptions for children and youth that are paid for by Medicaid constitute Medicaid fraud.
PsychRights now has a national “Medicaid Fraud Initiative Against Psychiatric Drugging of Children & Youth,” designed to address this problem by “having lawsuits brought against the doctors prescribing these harmful, ineffective drugs, their employers, and the pharmacies filling these prescriptions and submitting them to Medicaid for reimbursement,” according to its web site.
“Anyone who submits or causes claims to be submitted to Medicaid for drugs that are not for a ‘medically accepted indication’ is committing Medicaid Fraud,” said Gottstein, in a July 27, 2009 press release announcing the launch of the national campaign.
“Those guilty of this Medicaid Fraud include psychiatrists and other physicians prescribing these drugs, their employers, and pharmacies submitting the false claims to Medicaid,” he pointed out.
PsychRights estimates that over $2 billion in such fraudulent Medicaid claims are being paid by the government each year.
“Once one sues over specific offending prescriptions, all of such prescriptions can be brought in, which means that any psychiatrist on the losing end of such a lawsuit will almost certainly be bankrupted, because each offending prescription carries a penalty of between $5,500 and $11,000,” PsychRights explained.
It is hoped that once the doctors and pharmacies realize they are subject to financially ruinous Medicaid fraud judgments, the practice will be stopped or substantially reduced.
“Each prescriber may have a million dollars or few, at most, to lose, but the pharmacies’ financial exposure can run into the hundreds of millions of dollars and it is hoped this will attract attorneys to take these cases,” the web site noted.
In September and October 2009, Gottstein gave presentations on the initiative at the annual conferences of the National Association of Rights Protection and Advocacy and the International Center for the Study of Psychiatry and Psychology in order to find people who are potentially interested and willing to pursue such cases.
“This was successful and we have at least a few such cases cooking,” he reported. “PsychRights stands ready to help people interested in bringing such suits.”
In late 2006, Gottstein won international fame by subpoenaing and releasing thousands of documents involving Eli Lilly’s illegal marketing of Zyprexa, which resulted in front page stories in The New York Times.
PsychRights also has an appeal pending on a lawsuit filed against the state of Alaska and responsible state officials seeking declaratory and injunctive relief that Alaskan children and youth on Medicaid have the right not to be administered psychotropic drugs unless and until a number of specific conditions are met. The lawsuit seeks to prohibit the state from paying for psychiatric drugs prescribed off-label to children and youth.
In responding to the lawsuit, the state claimed that they do have any control over or responsibility for the psychiatric drugging of children in their custody, or any responsibility under Medicaid, and moved for dismissal on the grounds that PsychRights does not have standing, or the right to bring the suit, because it was not harmed by the state’s actions.
The court agreed and dismissed the case. “We think the judge is wrong and have filed an appeal,” said Gottstein.
In May 2009, Gottstein sent letters to Sens. Charles Grassley and Herb Kohl and Reps. Henry Waxman, Bart Stupak, John Dingell and Barney Frank, describing the massive Medicaid fraud involved in the prescribing of psychiatric drugs to children in the US and asked for “assistance in stopping these illegal reimbursements.”
As of November 8, 2009, Gottstein reported, “I haven’t gotten as much as an acknowledgment of receipt from any of the members of Congress to whom I wrote.”
While pursuing causes on behalf of PsychRights, Gottstein donates all of his time on a pro bono basis.
http://www.ireport.com/docs/DOC-368870?ref=feeds%2Fhighestrated
Supporting & Preserving Families
(This is from the Child Welfare Information Gateway and are Federal Child Welfare Laws-Why aren't these laws adhered to by DCYF/CPS? Why do they still get their
federal funding when they do not abide by these laws?)
All families can benefit from information, guidance, and help in connecting with resources as they meet the challenges of parenthood and family life. Find resources and information on family support and family preservation services.
Overview
Explains the importance of supportive services for children and families, including frequently asked questions.
Cultural competence
The importance of cultural competence in family support and family preservation services and links to additional resources.
Assessing family strengths & needs
The role of assessment in family support and family preservation services and links to additional resources.
Family support services
Planning and implementing family support programs, specific types of programs, and program effectiveness.
Family preservation services
Underlying values and principles of family preservation services, core elements, policy implications, program approaches, and State and local examples. Also intensive family preservation services and evaluations of the effectiveness of family preservation services.
Supporting families across the service continuum
Family empowerment and participation, focusing on strengths, and community-based support can be employed in a variety of settings across the child welfare service continuum and in other service systems.
http://www.childwelfare.gov/supporting/
federal funding when they do not abide by these laws?)
All families can benefit from information, guidance, and help in connecting with resources as they meet the challenges of parenthood and family life. Find resources and information on family support and family preservation services.
Overview
Explains the importance of supportive services for children and families, including frequently asked questions.
Cultural competence
The importance of cultural competence in family support and family preservation services and links to additional resources.
Assessing family strengths & needs
The role of assessment in family support and family preservation services and links to additional resources.
Family support services
Planning and implementing family support programs, specific types of programs, and program effectiveness.
Family preservation services
Underlying values and principles of family preservation services, core elements, policy implications, program approaches, and State and local examples. Also intensive family preservation services and evaluations of the effectiveness of family preservation services.
Supporting families across the service continuum
Family empowerment and participation, focusing on strengths, and community-based support can be employed in a variety of settings across the child welfare service continuum and in other service systems.
http://www.childwelfare.gov/supporting/
Witness-A Child's Testimony Is Key In Murder Trial
Witness
A Child's Testimony Is Key In Murder Trial
By Mary Jayne McKay
.
Foster father Charles Forshee is accused of killing 2-year-old Dillon Farrer. (CBS)
. Charles Forshee was a devoted father who had taken in more than 90 foster children. (CBS)
.
The Forshees, once honored as "foster parents of the year," seemed to be the answer to mother Amanda DeBerry's prayers. (CBS)
.How credible are child witnesses? Find out more about other cases in which child witnesses played a key role.
Find out more about forensics, DNA and some cases in which DNA has made a difference.
.(CBS) Everyone thought Charles Forshee was a devoted father.
Then, he was accused of killing 2-year-old Dillon Farrer. The prosecution's main witness against Charles was Dillon's 4-year-old brother, Lucas.
Can a jury trust the testimony of such a young child? Correspondent Troy Roberts reports on this 48 Hours Mystery, which first aired on Nov. 15, 2002.
--------------------------------------------------------------------------------
The story begins with Amanda DeBerry. Her parents divorced when she was a child, and she always wanted a family of her own.
She gave birth to Lucas when she was 16, and Dillon just a year later. By the time she was 19, she was trapped in an abusive relationship with Lucas’ father and pregnant with her third child.
Amanda sought refuge in a shelter for battered women in Houston, Texas. She decided to give the baby she was carrying up for adoption. But when doctors put her on bed rest, the shelter urged her to have someone else take care of her boys until she gave birth.
She says it was a decision that would haunt her for the rest of her life: "I really thought when I put my kids into foster care, I was doing the smart thing. And it didn't turn out like that at all."
The Homes of St. Mark, a private foster care agency licensed by the state of Texas, found Charles and Linda Forshee, a couple with 17 years of experience as foster parents.
Over the years, The Forshees had taken in more than 90 foster children.
"For us this wasn't chaotic; it was normal," Charles says.
Charles was a technician for Southwestern Bell, while Linda stayed home and took care of the children. The Forshees, once honored as “foster parents of the year,” seemed to be the answer to Amanda’s prayers.
The Forshees say Dillon – then almost 2 years old – seemed to adjust especially well to his new environment.
“He was Charlie’s favorite,” says Linda. “He would run to Charlie, give him big hugs and kisses.”
But on the evening of June 21, 2001, after Lucas and Dillon had gone to bed, Linda went into the room and found Dillon unconscious in his crib.
“I picked him up and took him out in the front room and told Charlie something was wrong,” she remembers. “And I happened to notice that he was a little blue around the lips, and Charlie took him and started CPR on him.”
Linda dialed 911 and the paramedics arrived and took Dillon to the hospital. By the time Amanda and her mother were called to the hospital, Dillon was dead.
Amanda and her mother, Judy, were in shock. The Forshees say they were just as devastated.
“I felt I lost a child that night,” says Charles. “You know, he was my child and I lost him.”
Everyone wondered how Dillon could suddenly die, one month shy of his second birthday. The answer came three months later when the autopsy report was released. The cause of death was asphyxia due to suffocation. It was ruled a homicide.
Charles was charged with murder, based on the statement of the only eyewitness to the murder – Dillon’s brother Lucas, who was only 3 at the time.
--------------------------------------------------------------------------------
Lucas repeated his story the next day in a videotaped statement obtained exclusively by 48 Hours.
"Charlie yelled at him, he said, 'Lay down,' and he put the pillow on his face and police took him to the hospital," says Lucas.
A little over a year later, Charles, 56, found himself waiting to go on trial for murder. “At my age with what the charges are, if I go to jail I probably won’t come out,” he says.
“Kids don’t just say things like that off the top of their head,” says Amanda.
But don't children have wild imaginations? Yes, says Amanda, "About monsters, about creepy things in their closet. Not about someone they know walking into a room and hurting their best friend. Not about things like that.”
Forshee’s two adopted sons, Richard and Brian say he was a great father, a firm disciplinarian but never physical.
"So many people even at church would tell us, 'Oh, you've got a special gift, you're going to be rewarded in heaven," says Linda. "I feel like I don't know why we're going through this hell right now."
--------------------------------------------------------------------------------
Prosecutor Anshu “Sunni” Mitchell says Charles snapped that night because he was exhausted from working overtime for 13 days straight. She says Charles couldn’t cope with Dillon’s crying and smothered him.
“Anybody’s capable of snapping at any point,” she says, “I mean, anything can change how you’ve been all along.”
One thing, however, is undisputed. Dillon and Lucas were rambunctious and refused to go to sleep that night. First, Linda tried several times to calm Dillon down. Then her husband went into the room and says he tried soothing the baby with a backrub.
“I flipped him over onto his stomach. I then placed my hand on the middle of his back to hold him down," Charles said in a police statement. "Dillon was trying to get up and I held him down. I had my hand on his back for about a minute.”
He said Dillon was still crying – and therefore very much alive - when he left the room. Shortly afterwards, Linda found Dillon unconscious in his crib.
The Forshees hired prominent defense attorney Stanley Schneider, who launched a controversial defense strategy. He says Lucas killed his brother: “I don’t think it was intentional, I don’t think he realized what he was doing."
The Forshees say that from the beginning they were concerned about Lucas’ overly aggressive behavior. They knew Lucas’ father had physically abused Amanda, and that Lucas had seen the violence.
Linda Forshee documented Lucas’ behavior in her monthly reports to the foster care agency. She even took a photo of bruises she claims were from Lucas kicking and punching her. Then, one night, Lucas said something that worried Linda.
“He came in and told me he was going to kill his brother, his mother and me,” she says. “And I got on the phone and I called the agency right away.”
The agency set up a meeting for the following week, but it was too late. Dillon died two days after.
Will a jury believe a child so young could be so violent?
Part II: The Trial
© MMII, CBS Worldwide Inc. All Rights Reserved
http://www.cbsnews.com/stories/2002/11/14/48hours/main529398.shtml
A Child's Testimony Is Key In Murder Trial
By Mary Jayne McKay
.
Foster father Charles Forshee is accused of killing 2-year-old Dillon Farrer. (CBS)
. Charles Forshee was a devoted father who had taken in more than 90 foster children. (CBS)
.
The Forshees, once honored as "foster parents of the year," seemed to be the answer to mother Amanda DeBerry's prayers. (CBS)
.How credible are child witnesses? Find out more about other cases in which child witnesses played a key role.
Find out more about forensics, DNA and some cases in which DNA has made a difference.
.(CBS) Everyone thought Charles Forshee was a devoted father.
Then, he was accused of killing 2-year-old Dillon Farrer. The prosecution's main witness against Charles was Dillon's 4-year-old brother, Lucas.
Can a jury trust the testimony of such a young child? Correspondent Troy Roberts reports on this 48 Hours Mystery, which first aired on Nov. 15, 2002.
--------------------------------------------------------------------------------
The story begins with Amanda DeBerry. Her parents divorced when she was a child, and she always wanted a family of her own.
She gave birth to Lucas when she was 16, and Dillon just a year later. By the time she was 19, she was trapped in an abusive relationship with Lucas’ father and pregnant with her third child.
Amanda sought refuge in a shelter for battered women in Houston, Texas. She decided to give the baby she was carrying up for adoption. But when doctors put her on bed rest, the shelter urged her to have someone else take care of her boys until she gave birth.
She says it was a decision that would haunt her for the rest of her life: "I really thought when I put my kids into foster care, I was doing the smart thing. And it didn't turn out like that at all."
The Homes of St. Mark, a private foster care agency licensed by the state of Texas, found Charles and Linda Forshee, a couple with 17 years of experience as foster parents.
Over the years, The Forshees had taken in more than 90 foster children.
"For us this wasn't chaotic; it was normal," Charles says.
Charles was a technician for Southwestern Bell, while Linda stayed home and took care of the children. The Forshees, once honored as “foster parents of the year,” seemed to be the answer to Amanda’s prayers.
The Forshees say Dillon – then almost 2 years old – seemed to adjust especially well to his new environment.
“He was Charlie’s favorite,” says Linda. “He would run to Charlie, give him big hugs and kisses.”
But on the evening of June 21, 2001, after Lucas and Dillon had gone to bed, Linda went into the room and found Dillon unconscious in his crib.
“I picked him up and took him out in the front room and told Charlie something was wrong,” she remembers. “And I happened to notice that he was a little blue around the lips, and Charlie took him and started CPR on him.”
Linda dialed 911 and the paramedics arrived and took Dillon to the hospital. By the time Amanda and her mother were called to the hospital, Dillon was dead.
Amanda and her mother, Judy, were in shock. The Forshees say they were just as devastated.
“I felt I lost a child that night,” says Charles. “You know, he was my child and I lost him.”
Everyone wondered how Dillon could suddenly die, one month shy of his second birthday. The answer came three months later when the autopsy report was released. The cause of death was asphyxia due to suffocation. It was ruled a homicide.
Charles was charged with murder, based on the statement of the only eyewitness to the murder – Dillon’s brother Lucas, who was only 3 at the time.
--------------------------------------------------------------------------------
Lucas repeated his story the next day in a videotaped statement obtained exclusively by 48 Hours.
"Charlie yelled at him, he said, 'Lay down,' and he put the pillow on his face and police took him to the hospital," says Lucas.
A little over a year later, Charles, 56, found himself waiting to go on trial for murder. “At my age with what the charges are, if I go to jail I probably won’t come out,” he says.
“Kids don’t just say things like that off the top of their head,” says Amanda.
But don't children have wild imaginations? Yes, says Amanda, "About monsters, about creepy things in their closet. Not about someone they know walking into a room and hurting their best friend. Not about things like that.”
Forshee’s two adopted sons, Richard and Brian say he was a great father, a firm disciplinarian but never physical.
"So many people even at church would tell us, 'Oh, you've got a special gift, you're going to be rewarded in heaven," says Linda. "I feel like I don't know why we're going through this hell right now."
--------------------------------------------------------------------------------
Prosecutor Anshu “Sunni” Mitchell says Charles snapped that night because he was exhausted from working overtime for 13 days straight. She says Charles couldn’t cope with Dillon’s crying and smothered him.
“Anybody’s capable of snapping at any point,” she says, “I mean, anything can change how you’ve been all along.”
One thing, however, is undisputed. Dillon and Lucas were rambunctious and refused to go to sleep that night. First, Linda tried several times to calm Dillon down. Then her husband went into the room and says he tried soothing the baby with a backrub.
“I flipped him over onto his stomach. I then placed my hand on the middle of his back to hold him down," Charles said in a police statement. "Dillon was trying to get up and I held him down. I had my hand on his back for about a minute.”
He said Dillon was still crying – and therefore very much alive - when he left the room. Shortly afterwards, Linda found Dillon unconscious in his crib.
The Forshees hired prominent defense attorney Stanley Schneider, who launched a controversial defense strategy. He says Lucas killed his brother: “I don’t think it was intentional, I don’t think he realized what he was doing."
The Forshees say that from the beginning they were concerned about Lucas’ overly aggressive behavior. They knew Lucas’ father had physically abused Amanda, and that Lucas had seen the violence.
Linda Forshee documented Lucas’ behavior in her monthly reports to the foster care agency. She even took a photo of bruises she claims were from Lucas kicking and punching her. Then, one night, Lucas said something that worried Linda.
“He came in and told me he was going to kill his brother, his mother and me,” she says. “And I got on the phone and I called the agency right away.”
The agency set up a meeting for the following week, but it was too late. Dillon died two days after.
Will a jury believe a child so young could be so violent?
Part II: The Trial
© MMII, CBS Worldwide Inc. All Rights Reserved
http://www.cbsnews.com/stories/2002/11/14/48hours/main529398.shtml
Safety data from kid drug trials often unpublished
Safety data from kid drug trials often unpublished
Megan Brooks
Tue, Nov 3 2009NEW YORK (Reuters Health) - When drugs approved for adults are studied in youngsters, the research yields important safety data that could guide the use of these medications in children, a report published this week indicates.
Health
But in most cases these studies never appear in peer-reviewed journals, and when they do, half of them don't focus on the important new safety data that's been generated, Dr. Daniel K. Benjamin Jr., from Duke Clinical Research Institute in Durham, North Carolina and colleagues found.
"Specifically, trials that uncover new safety findings are less likely to be published than other types of trials, and trials that uncover results unfavorable to a company (or its product) are less likely to be published than those with favorable results," they report in the Archives of Pediatrics and Adolescent Medicine.
Prescription drugs are often administered "off-label" to children largely because many of them have only been tested in and approved for use in adults. As such, drugs are often given to children without fully knowing if they will be beneficial, harmful, or neither.
To address this problem, the US Congress passed the Food and Drug Administration (FDA) Modernization Act in 1997, which, in part, extends the exclusive marketing rights for a particular drug if the drug maker conducts FDA-requested studies of its effects in children. However, it is unclear how often the results of pediatric drug trials are published in peer-reviewed medical journals and just what information gets published.
In the first 10 years of the so-called "pediatric exclusivity" program, more than 95,000 children were enrolled in 365 pediatric trials for the 153 drugs that were granted pediatric exclusivity extensions. Overall, there were 137 pediatric labeling changes, which means that changes were made to the information the drug company gives to doctors about how the drug should be used.
Benjamin and his team reviewed 129 of the 137 labeling changes. They found that for 96 products (74 percent), no new safety information was added to the product label. For 33 products (26 percent), new pediatric safety information was added to the product label. For 12 of these products, "unexpected and important neuropsychiatric safety findings" emerged in the pediatric drug trials.
For example, in a pediatric trial of ribavirin and interferon alpha for hepatitis C infection, FDA medical reviewers found an increase in suicidal thoughts compared with adults.
Agitation was observed in young children given the stomach acid drug famotidine (marketed as Pepcid or Fluxid). Aggressive and hyperactive behavior was more often seen in children exposed to the bladder-control drug tolterodine (Detrol), and post-marketing data for the migraine drug sumatriptan showed "serious adverse events" in children, which have been only rarely seen in adults, including stroke, vision loss and death.
In addition to the 12 products with neuropsychiatric safety issues, 21 products tested in children had "other important safety findings."
What's concerning, the researchers say, is that less than half of the trials (16 of 33) that generated new safety issues were ever reported in a peer-reviewed medical journal.
What's more, of the 16 trials that were published in reputable journals, 7 articles (44 percent) substantially differed in their presentation and interpretation of the data submitted to the FDA.
In an email to Reuters Health, Benjamin said: "The results investigators and pharmaceutical companies -- who have a conflict of interest -- emphasize in the peer-review literature are often different than what FDA reviewers report."
"Greater access to data will result in greater dissemination of findings, and thus improve children's health," Benjamin and colleagues conclude in their report.
SOURCE: Archives of Pediatrics and Adolescent Medicine, December 2009.
www.reuters.com/article/idUSTRE5B84UL20091209
Megan Brooks
Tue, Nov 3 2009NEW YORK (Reuters Health) - When drugs approved for adults are studied in youngsters, the research yields important safety data that could guide the use of these medications in children, a report published this week indicates.
Health
But in most cases these studies never appear in peer-reviewed journals, and when they do, half of them don't focus on the important new safety data that's been generated, Dr. Daniel K. Benjamin Jr., from Duke Clinical Research Institute in Durham, North Carolina and colleagues found.
"Specifically, trials that uncover new safety findings are less likely to be published than other types of trials, and trials that uncover results unfavorable to a company (or its product) are less likely to be published than those with favorable results," they report in the Archives of Pediatrics and Adolescent Medicine.
Prescription drugs are often administered "off-label" to children largely because many of them have only been tested in and approved for use in adults. As such, drugs are often given to children without fully knowing if they will be beneficial, harmful, or neither.
To address this problem, the US Congress passed the Food and Drug Administration (FDA) Modernization Act in 1997, which, in part, extends the exclusive marketing rights for a particular drug if the drug maker conducts FDA-requested studies of its effects in children. However, it is unclear how often the results of pediatric drug trials are published in peer-reviewed medical journals and just what information gets published.
In the first 10 years of the so-called "pediatric exclusivity" program, more than 95,000 children were enrolled in 365 pediatric trials for the 153 drugs that were granted pediatric exclusivity extensions. Overall, there were 137 pediatric labeling changes, which means that changes were made to the information the drug company gives to doctors about how the drug should be used.
Benjamin and his team reviewed 129 of the 137 labeling changes. They found that for 96 products (74 percent), no new safety information was added to the product label. For 33 products (26 percent), new pediatric safety information was added to the product label. For 12 of these products, "unexpected and important neuropsychiatric safety findings" emerged in the pediatric drug trials.
For example, in a pediatric trial of ribavirin and interferon alpha for hepatitis C infection, FDA medical reviewers found an increase in suicidal thoughts compared with adults.
Agitation was observed in young children given the stomach acid drug famotidine (marketed as Pepcid or Fluxid). Aggressive and hyperactive behavior was more often seen in children exposed to the bladder-control drug tolterodine (Detrol), and post-marketing data for the migraine drug sumatriptan showed "serious adverse events" in children, which have been only rarely seen in adults, including stroke, vision loss and death.
In addition to the 12 products with neuropsychiatric safety issues, 21 products tested in children had "other important safety findings."
What's concerning, the researchers say, is that less than half of the trials (16 of 33) that generated new safety issues were ever reported in a peer-reviewed medical journal.
What's more, of the 16 trials that were published in reputable journals, 7 articles (44 percent) substantially differed in their presentation and interpretation of the data submitted to the FDA.
In an email to Reuters Health, Benjamin said: "The results investigators and pharmaceutical companies -- who have a conflict of interest -- emphasize in the peer-review literature are often different than what FDA reviewers report."
"Greater access to data will result in greater dissemination of findings, and thus improve children's health," Benjamin and colleagues conclude in their report.
SOURCE: Archives of Pediatrics and Adolescent Medicine, December 2009.
www.reuters.com/article/idUSTRE5B84UL20091209
Subscribe to:
Comments (Atom)