DCF Mass., a corrupt child-drugging agency we would be better without

NOWPUBLIC.COM
by Kevin Hall

If you follow the news, you have likely stumbled upon the recent national news about of the outrageous amount of psychiatric drugging of foster children. The US General Accounting Office did a two-year investigation of the drugging of foster children (those with no parents able to protect them against this abuse) and found that the children in the five states (Florida, Massachusetts, Michigan, Oregon and Texas) reseached were, per ABC News, "being prescribed psychiatric medications at doses higher than the maximum levels approved by the Food and Drug Administration (FDA)." Please look at the short ABC News video of kids describing the harm done to them with psychiatric drugs in foster care: http://abcnews.go.com/Health/foster-kids-hope-agency-helps-wean-kids-off/story?id=15076150#.TvT61vJ_P1U .

"Children in Massachusetts fared worst. Thirty-nine percent of the foster care children aged 0-17 on Medicaid were prescribed at least one psychiatric drug. By comparison, 10 percent of non-foster care children in Massachusetts were prescribed at least one psychotropic medication under Medicaid. It's serious enough when 10 percent of non-foster care children from our poorer communities are receiving psychiatric drugs; it's even more tragic when 39 percent of our most poor and abandoned children are being inundated with these drugs".(see Huffinggton Post article http://www.huffingtonpost.com/dr-peter-breggin/foster-children_b_1149805.html ).

Here's a little story behind the story:
Three of the six states researched, Massachusetts, Texas and Florida contain three of the strongest branches of psychiatric watchdog group, Citizens Commission on Human Rights (CCHR) and all three of these branches forwarded their state's foster drugging information to the US GAO right when they announced that they were investigating this issue.

Furthermore, these CCHR branches and others had given this information to many of your legislators, media and government officials repetitively for at least seven to eight years. Here's a little section on the subject from the 2007 CCHR New England Annual Report:

Research, Legislation and Government Actions

CCHR New England found that over 10% of kids in the Massachusetts Department of Social Services (now DCF, Department of Children and Families) were on at least three psych drugs at a time; 19.4% are on antidepressants, 9.4% are on antipsychotics, and 21% are on ADHD drugs. We also knew that restraint use on DSS kids was extremely high with one facility in Western, MA doing over 7,000 restraints on kids in under two years.

CCHR met with the new Commissioner of the Department of Social Services (DSS), Angelo McClain, and presented this information to him. Although his actions to reduce the drugging weren’t adequate at all in our view, he doesn’t like restraints at all and has started implementing a program that the Department of Mental Health (DMH) has done to greatly reduce restraints. Less than 1/3rd the amount of patients are restrained in DMH as they were two years ago. DSS will follow suit which will greatly reduced the harm, fear and intimidation caused by staff whipping kids face-first to the ground, pouncing on them and tying them up on restraint tables.

CCHR also got the DSS child-drugging statistics to the Massachusetts Pharmacy Director, let him know that he was also responsible as he doesn’t have to approve payment for drugging kids on three drugs at a time and asked several times, "What are you going to do about this?" He ignored several communications by phone, email and personal visit, but couldn’t fully avoid it when CCHR got the Boston Globe to ask. As a result, they are investigating every case of a Massachusetts child ages five and under being on three or more psych drugs. This is a start in the right direction.

At the time of this report, the drugging of Massachusetts foster children was at about 34% per their documents and 64% of these children were labeled with a mental disorder. Since then it has gone up.

Now, Commissioner McClain has followed through with his promise on restraint reduction but the drugging, per the GAO report, has gone up another 5%. Restraints are a form of psychiatric control but the profit-making comes from pushing the drugs and foster children have no power to say, "No."

After the US GAO report, President Obama sent a letter to all the nation's social services agencies directors, including Massachusetts DCF Commissioner Angelo McClain, and expressed his concern about this heavy drugging. Well, I've gotten this information streaming for years to Mr. McClain, the Massachusetts legislative body, the Governor's office and several in the media yet most really don't care and nothing's being done to stop foster care children from being part of the psychiatric drug market (please see my Now Public article entitled, "Illegal Psychiatric Drug Marketing System Charted/Exposed for more details).

Once the US GAO report was released, I sent an email to Commissioner McClain and spoke to someone in his office to ask if he would now do anything to reduce the drugging of foster kids under his care in Massachusetts, statistically the worst foster child drugging state investigated. The answer was dead silence.

State social services agencies create tremendous harm and hide under the excuse that some parents are bad and aren't fit to raise them. Although that's obviously true, it certainly doesn't justify how they are generally far more abusive to kids than bad parents. For profit, they have turned these children into a psycho-pharma drug market and for that, should not be supported whatsoever. My feeling is that Commissioner McClain and all the others involved in this severe human rights violation just want this story to blow over so the money can keep flowing at the expense of children.

Please DON'T LET THIS HAPPEN! If you call your legislators and your state social services office to demand they stop drugging foster kids for profit you will help. Blogging about this issue and getting friends and neighbors involved will also help. Being silent makes you part of the problem as your tax dollars are stolen to harm these children. It's up to you. You can do something about it.

Kevin Hall
Citizens Commission on Human Rights
New England Director
www.cchrnewengland.org

When mental disorders aren't

Boston Herald
Psychiatrist Allen Francis
Monday, March 22, 2010

As chairman of the task force that created the current Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), which came out in 1994, I learned from painful experience how small changes in the definition of mental disorders can create huge, unintended consequences.

Our panel tried hard to be careful, but inadvertently contributed to three false “epidemics” - attention deficit disorder, autism and childhood bipolar disorder. Our net was cast too wide and captured many “patients” who might have been far better off never entering the mental health system.

The first draft of the next edition of the DSM, posted for comment last month, is filled with suggestions that would multiply our mistakes and extend the reach of psychiatry dramatically deeper into the ever-shrinking domain of the normal. This could create tens of millions of innocent bystanders who would be mislabeled as having a mental disorder. The pharmaceutical industry would have a field day.

The manual, prepared by the American Psychiatric Association, is psychiatry’s only official way of deciding who has a “mental disorder” and who is “normal.” The quotes are necessary because this distinction is very hard to make at the fuzzy boundary between the two.

Where the DSM-vs.-normality boundary is drawn also influences insurance coverage, eligibility for disability and services, and legal status - to say nothing of stigma.

What are some of the most egregious invasions of normality suggested for DSM-V? “Binge eating disorder” is defined as one eating binge per week for three months. (I, along with more than 6 percent of the population, would qualify.) “Minor neurocognitive disorder” would capture many people with no more than the expected memory problems of aging. Grieving after the loss of a loved one could be misread as “major depression.” “Mixed anxiety depression” is defined by commonplace symptoms difficult to distinguish from the emotional pains of everyday life.

The recklessly expansive suggestions go on. “Attention deficit disorder” would become much more prevalent in adults, encouraging the already rampant use of stimulants. A category for temper could capture kids with normal tantrums.

The sexual disorders section is particularly adventurous. “Hypersexuality disorder” would bring great comfort to philanderers. “Paraphilic coercive disorder” introduces the dangerous idea that rapists merit a diagnosis of mental disorder if they get sexual excitement from raping.

Experts have an almost universal tendency to expand their own favorite disorders. This therapeutic zeal creates a huge blind spot to the great risks that come with unnecessary treatment.
Allen Frances is former chairman of psychiatry at Duke University.

Medicating the Military, Use of Psychiatric Drugs has Spiked, Concerns furface about suicide, other dangers

Army Times
By Andrew Tilghman and Brendan McGarry
Wednesday Mar 17, 2010

At least one in six service members is on some form of psychiatric drug.

And many troops are taking more than one kind, mixing several pills in daily “cocktails” — for example, an antidepressant with an antipsychotic to prevent nightmares, plus an anti-epileptic to reduce headaches — despite minimal clinical research testing such combinations.

The drugs come with serious side effects: They can impair motor skills, reduce reaction times and generally make a war fighter less effective. Some double the risk for suicide, prompting doctors — and Congress — to question whether these drugs are connected to the rising rate of military suicides.

“It’s really a large-scale experiment. We are experimenting with changing people’s cognition and behavior,” said Dr. Grace Jackson, a former Navy psychiatrist.

A Military Times investigation of electronic records obtained from the Defense Logistics Agency shows DLA spent $1.1 billion on common psychiatric and pain medications from 2001 to 2009. It also shows that use of psychiatric medications has increased dramatically — about 76 percent overall, with some drug types more than doubling — since the start of the current wars.
THE FULL INVESTIGATION:

• Could meds be responsible for suicides?

• Downrange: ‘Any soldier can deploy on anything’

• How drugs enter the war zone

Troops and military health care providers also told Military Times that these medications are being prescribed, consumed, shared and traded in combat zones — despite some restrictions on the deployment of troops using those drugs.

The investigation also shows that drugs originally developed to treat bipolar disorder and schizophrenia are now commonly used to treat symptoms of post-traumatic stress disorder, such as headaches, nightmares, nervousness and fits of anger.

Such “off-label” use — prescribing medications to treat conditions for which the drugs were not formally approved by the FDA — is legal and even common. But experts say the lack of proof that these treatments work for other purposes, without fully understanding side effects, raises serious concerns about whether the treatments are safe and effective.

The DLA records detail the range of drugs being prescribed to the military community and the spending on them:

• Antipsychotic medications, including Seroquel and Risperdal, spiked most dramatically — orders jumped by more than 200 percent, and annual spending more than quadrupled, from $4 million to $16 million.

• Use of anti-anxiety drugs and sedatives such as Valium and Ambien also rose substantially; orders increased 170 percent, while spending nearly tripled, from $6 million to about $17 million.

• Antiepileptic drugs, also known as anticonvulsants, were among the most commonly used psychiatric medications. Annual orders for these drugs increased about 70 percent, while spending more than doubled, from $16 million to $35 million.

• Antidepressants had a comparatively modest 40 percent gain in orders, but it was the only drug group to show an overall decrease in spending, from $49 million in 2001 to $41 million in 2009, a drop of 16 percent. The debut in recent years of cheaper generic versions of these drugs is likely responsible for driving down costs.

Antidepressants and anticonvulsants are the most common mental health medications prescribed to service members. Seventeen percent of the active-duty force, and as much as 6 percent of deployed troops, are on antidepressants, Brig. Gen. Loree Sutton, the Army’s highest-ranking psychiatrist, told Congress on Feb. 24.

In contrast, about 10 percent of all Americans take antidepressants, according to a 2009 Columbia University study.
Suicide risks

Many of the newest psychiatric drugs come with strong warnings about an increased risk for suicide, suicidal behavior and suicidal thoughts.

Doctors — and, more recently, lawmakers — are questioning whether the drugs could be responsible for the spike in military suicides during the past several years, an upward trend that roughly parallels the rise in psychiatric drug use.

From 2001 to 2009, the Army’s suicide rate increased more than 150 percent, from 9 per 100,000 soldiers to 23 per 100,000. The Marine Corps suicide rate is up about 50 percent, from 16.7 per 100,000 Marines in 2001 to 24 per 100,000 last year. Orders for psychiatric drugs in the analysis rose 76 percent over the same period.

“There is overwhelming evidence that the newer antidepressants commonly prescribed by the military can cause or worsen suicidality, aggression and other dangerous mental states,” said Dr. Peter Breggin, a psychiatrist who testified at the same Feb. 24 congressional hearing at which Sutton appeared.

Other side effects — increased irritability, aggressiveness and hostility — also could pose a risk.

“Imagine causing that in men and women who are heavily armed and under a great deal of stress,” Breggin said.

He cited dozens of clinical studies conducted by drug companies and submitted to federal regulators, including one among veterans that showed “completed suicide rates were approximately twice the base rate following antidepressant starts in VA clinical settings.”

But many military doctors say the risks are overstated and argue that the greater risk would be to fail to fully treat depressed troops.

For suicide, “depression is a big risk factor,” too, said Army Reserve Col. (Dr.) Thomas Hicklin, who teaches clinical psychiatry at the University of Southern California. “To withhold the medications can be a huge problem.”

Nevertheless, Hicklin said the risks demand strict oversight. “The access to weapons is a very big concern with someone who is feeling suicidal,” he said. “It has to be monitored very carefully because side effects can occur.”

Defense officials repeatedly have denied requests by Military Times for copies of autopsy reports that would show the prevalence of such drugs in suicide toxicology reports.
‘Then it’s over’

Spc. Mike Kern enlisted in 2006 and spent a year deployed in 2008 with the 4th Infantry Division as an armor crewman, running patrols out of southwest Baghdad.

Kern went to the mental health clinic suffering from nervousness, sleep problems and depression. He was given Paxil, an antidepressant that carries a warning label about increased risk for suicide.

A few days later, while patrolling the streets in the gunner’s turret of a Humvee, he said he began having serious thoughts of suicide for the first time in his life.

“I had three weapons: a pistol, my rifle and a machine gun,” Kern said. “I started to think, ‘I could just do this and then it’s over.’ That’s where my brain was: ‘I can just put this gun right here and pull the trigger and I’m done. All my problems will be gone.’”

Kern said the incident scared him, and he did not take any more drugs during that deployment. But since his return, he has been diagnosed with PTSD and currently takes a variety of psychotropic medications.

Other side effects cited by troops who used such drugs in the war zones include slowed reaction times, impaired motor skills, and attention and memory problems.

One 35-year-old Army sergeant first class said he was prescribed the anticonvulsant Topamax to prevent the onset of debilitating migraines. But the drug left him feeling mentally sluggish, and he stopped taking it.

“Some people call it ‘Stupamax’ because it makes you stupid,” said the sergeant, who asked not to be identified because he said using such medication carries a social stigma in the military.

Being slow — or even “stupid” — might not be a critical problem for some civilians. But it can be deadly for troops working with weapons or patrolling dangerous areas in a war zone, said Dr. John Newcomer, a psychiatry professor at Washington University in St. Louis and a former fellow at the American Psychiatric Association.

“A drug that is really effective and it makes you feel happy and calm and sleepy … might be a great medication for the general population,” Newcomer said, “but that might not make sense for an infantryman in a combat arena.

“If it turns out that people on a certain combo are getting shot twice as often, you would start to worry if they were as ‘heads up’ as they should have been,” Newcomer said. “There is so much on the line, you’d really like to have more specific military data to inform the prescribing.”

Military doctors say they take a service member’s mission into consideration before prescribing.

“Obviously, one would be concerned about what the person does,” said Col. C.J. Diebold, chief of the Department of Psychiatry at Tripler Army Medical Center in Hawaii. “If they have a desk job, that may factor in what medication you may be recommending for the patient [compared with] if they are out there and they have to be moving around and reacting fairly quickly.”
Off-label use

Little hard research has been done on such unique aspects of psychiatric drug usage in the military, particularly off-label usage.

A 2009 VA study found that 60 percent of veterans receiving antipsychotics were taking them for problems for which the drugs are not officially approved. For example, only two are approved for treating PTSD — Paxil and Zoloft, according to the Food and Drug Administration. But in actuality, doctors prescribe a range of drugs to treat PTSD symptoms.

To win FDA approval, drug makers must prove efficacy through rigorous and costly clinical trials. But approval determines only how a drug can be marketed; once a drug is approved for sale, doctors legally can prescribe it for any reason they feel appropriate.

Such off-label use comes with some risk, experts say.

“Patients may be exposed to drugs that have problematic side effects without deriving any benefit,” said Dr. Robert Rosenheck, a professor of psychiatry at Yale University who studied off-label drug use among veterans. “We just don’t know. There haven’t been very many studies.”

Some military psychiatrists are reluctant to prescribe off-label.

“It’s a slippery slope,” said Hicklin, the Army psychiatrist. “Medication can be overused. We need to use medication when indicated and we hope that we are all on the same page … with that.”

Combinations of drugs pose another risk. Doctors note that most drugs are tested as a single treatment, not as one ingredient in a mixture of medications.

“In the case of poly-drug use – the ‘cocktail’ — where you are combining an antidepressant, an anticonvulsant, an antipsychotic, and maybe a stimulant to keep this guy awake — that has never been tested,” Breggin said.

Newcomer agreed. “When we go to the literature and try to find support for these complex cocktails, we’re not going to find it,” he said. “As the number of medications goes up, the probability of adverse events like hospitalization or death goes up exponentially.”
Looking for answers

Pinpointing the reasons for broad shifts in the military’s drug use today is difficult. Each doctor prescribes medications for the patient’s individual needs.

Nevertheless, many doctors in and outside the military point to several variables — some unique to the military, some not.

A close look at the data shows that use of the antipsychotic and anticonvulsant drugs, also known as “mood stabilizers,” are growing much faster than antidepressants. That may correlate to the challenges that deployed troops face when they arrive back home and begin to readjust to civilian social norms and family life.

“The ultimate effect of both of these drugs is to take the heightened arousal — the hypervigilance and all the emotions that served you once you were deployed — and help to turn that back down,” said Dr. Frank Ochberg, former associate director for the National Institute of Mental Health and a psychiatry professor at Michigan State University who reviewed the Military Times analysis.

Dr. Harry Holloway, a retired Army colonel and a psychiatry professor at the Uniformed Services University of the Health Sciences in Bethesda, Md., said the increased use of these medications is simply another sign of deployment stress on the force.

“For a long time, the ops tempo has been completely unrelieved and unrestrained,” Holloway said. “When you have an increased ops tempo, and you have certain scheduling that will make it hard for everyone, you will produce a more symptomatic force. Most commanders understand that and they understand the tradeoffs.”

Jurors outraged by psychiatrist's conduct Felt she should share culpability in toddlers death

By Patricia Wen
Globe Staff
February 11, 2010

BROCKTON - The jury that convicted a South Shore woman this week of killing her 4-year-old daughter with an overdose of psychotropic drugs was also outraged by the conduct of the child’s psychiatrist and hoped the doctor would be held responsible in some way for the girl’s death, according to several jurors interviewed a day after the verdict.

“Every one of us was very angry,’’ said one juror, who requested anonymity to avoid retaliation for her role in Tuesday’s second-degree murder conviction of Carolyn Riley. “Dr. Kifuji should be sitting in the defendant’s chair, too.’’

Another juror said that while the 12-member panel found that the 35-year-old mother was primarily responsible for Rebecca’s death, many jurors were “off the wall’’ when they heard the testimony of Dr. Kayoko Kifuji of Tufts Medical Center. She said they were struck by how quickly Kifuji diagnosed Rebecca with bipolar and hyperactivity disorders, as well as how little the doctor seemed to supervise the mother’s dispensing of medications.

“It blew me away,’’ said that juror, who asked to remain unidentified for fear of reprisals.

Rebecca’s psychiatrist was the focus of some of the most powerful reactions from the jurors after a three-week trial that left them emotionally and physically exhausted.

While Kifuji’s attorney defended the psychiatrist and said jurors saw “only pieces of the full extent of diagnosis and treatment’’ of the girl, several jurors said they feel Kifuji bears some responsibility for the child’s overdose of psychiatric drugs, which were dispensed by a troubled mother.

Kifuji is facing a medical malpractice case filed by the estate of Rebecca Riley, though that case is not expected to go to trial for at least a year.

Other than the nationwide publicity given to the Riley case, in which Kifuji is mentioned repeatedly, the only overt sign that Kifuji had potentially questionable conduct is on the Board of Registration of Medicine’s website.

In a section dealing with disciplinary matters, the website lists the dates, from February 2007 to September 2009, in which Kifuji started and was permitted to end a “voluntary agreement’’ to stop practicing psychiatry.

Still, when asked if the board’s investigation concluded that Kifuji acted within acceptable medical standards, spokesman Russell Aims responded by saying that the board “closed the complaint against Dr. Kifuji without discipline.’’ He said the board, however, “reserves the right to reopen a case if new information comes to light.’’

The psychiatrist will not face criminal prosecution. A grand jury last summer declined to indict her, and Kifuji testified in Carolyn Riley’s trial only after being granted immunity from prosecution.

With her Boston attorney, Bruce Singal, at her side in court, Kifuji had initially declined to testify by invoking her right against self-incrimination. That move forced the government to grant her immunity as the only way to compel her to testify.

Singal defended the 55-year-old psychiatrist, saying by e-mail yesterday that her treatment of Rebecca has been “reviewed and cleared on numerous levels.’’ He said a Tufts Medical Center review found her care appropriate.

Singal went on to say that he is confident that any thorough examination of the doctor’s care of Rebecca would show she acted “in the best interests of this seriously ill child, and diagnosed and treated her in full accord with acceptable medical standards.’’

Several jurors in the mother’s trial said they never questioned whether Carolyn Riley was culpable, and an acquittal was never a possibility. When faced with a choice between first-degree murder and two lesser options of second-degree murder and manslaughter, the panel was divided.

Throughout much of their discussions, roughly half the members tilted toward a conviction of first-degree murder, one juror sought a manslaughter conviction, and the rest were focused on a second-degree murder conviction, according to a third juror, who also asked to remain anonymous.

Jurors wrestled over the meaning of “malice,’’ a condition they felt was necessary for a murder conviction but not for manslaughter. Ultimately, they decided the mother acted with malice through her routine use of pills to sedate her toddler, and her dispensing of toxic levels of clonidine in the hours before the girl died on Dec. 13, 2006. They united on a second-degree murder conviction, instead of a first-degree murder conviction, as a compromise.

The jurors said that during the 19 hours of deliberations behind closed doors, many wept while looking at photos of the girl’s body on the floor next to her parents’ bed. They said everyone felt the girl had pneumonia, but that she would not have died without dangerous levels of drugs in her body.

Patricia Wen can be reached at wen@globe.com
© Copyright 2010 Globe Newspaper Company.

AstraZeneca facing 26,000 suits over Seroquel

Bloomberg News
February 4, 2010
By JEF FEELEY and MARGARET CRONIN FISK

AstraZeneca PLC is facing as many as 26,000 lawsuits over its antipsychotic drug Seroquel as the drug maker prepares for its first jury trial over claims the medicine causes diabetes, according to court filings.

Attorneys for AstraZeneca, which has its U.S. headquarters in Fairfax, met with plaintiffs' lawyers in court-ordered mediation sessions last month to discuss a possible settlement, according to court filings. Consumers' lawyers said they had about 26,000 cases in their inventories, Stephen Saltzburg, a George Washington University Law School professor who served as mediator, said.

"I wish there were a magic wand that could be waved to settle all Seroquel cases instantly," Saltzburg said in the filing. "Such a wand does not exist."

In a Securities and Exchange Commission filing last week, AstraZeneca executives noted the company has paid about $656 million to defend itself in Seroquel cases. That's an increase of 28 percent, or $144 million, over last year's Seroquel defense costs, according to regulatory filings. The company said it had insurance of $521 million to cover Seroquel defense costs as of December.

The company said in the SEC filing it faces more than 25,000 claims that Seroquel caused diabetes. That's a 65 percent increase in cases over the number the company reported in a January 2009 regulatory filing. Many of the suits also claim AstraZeneca promoted Seroquel, approved for schizophrenic and bipolar patients, for unapproved uses.

Saltzburg said the two-day talks didn't generate a resolution, but he expects negotiations will take place at some point between the company and individual users' lawyers.

"The question is what is fair for plaintiffs and what is fair for AZ," the professor said in the report. "The parties are far apart at the moment on resolving that question."

AstraZeneca's stock fell last week after the drug maker's sales forecast and stock-buyback plan disappointed some analysts and fourth-quarter profit missed estimates. The company plans to buy back as much as $1 billion of shares this year, managers said Jan. 28.

A New Jersey judge has set a Feb. 16 trial date for the first of thousands of Seroquel cases filed in that state to go before a jury. Seroquel, which generated sales of $4.9 billion last year, is AstraZeneca's second-biggest seller after the ulcer treatment Nexium.

"The evidence, looked at fairly and fully, does not back up the allegations that Seroquel was responsible for the plaintiffs' alleged injuries," AstraZeneca spokesman Tony Jewell said in an e-mail.

In November, a judge in Florida who is overseeing all federal-court litigation over Seroquel ordered the company to meet with plaintiffs' lawyers and Saltzburg to discuss settlement.
U.S. District Judge Anne Conway in Florida, who is overseeing pre-trial proceedings in federal Seroquel litigation, said in November that she would ask a panel of judges to return the 6,000 cases consolidated before her to their home courts for trial.

Pfizer's huge fine: A disturbing trend Do the increasing penalties against drug companies really cure the problem?

Salon.com
By Vincent Rossmeier
Sep. 03, 2009 |

$2.3 billion: That's the price pharmaceutical giant Pfizer agreed to pay in a settlement Wednesday over its misleading marketing for the painkiller Bextra, the antipsychotic Geodon, the antibiotic Zyvox, and another painkiller, Lyrica. It's a record settlement that included the highest fine charged in U.S. history and came as the result of a lengthy Department of Justice investigation into healthcare fraud.

Though Pfizer voluntarily withdrew Bextra from the market in 2005, in the settlement, the company concedes that they had pushed doctors to prescribe unsafe doses of the drug prior to that point. The drug was approved by the FDA in 2001 for the treatment of pain associated with menstrual cramps and arthritis, but Pfizer encouraged its sales representatives to entice doctors to prescribe the drug in doses higher than those approved by the FDA. The escalated doses increased the chances that users of the drug would suffer a heart attack or a stroke. Pfizer also marketed Zyvox as a treatment for specific kinds of bacteria on which the drug had no effect.

A former Pfizer sales representative, John Kopchinski, whose questioning of the company's marketing tactics helped lead to the investigation, will receive over $51 million from the settlement. Kopchinski lost his job as a result of blowing the whistle on Pfizer's illegal schemes. Pfizer will have to pay settlements in 42 states and the District of Columbia.

However, the hefty cost will probably barely affect Pfizer's overall profit margins: The company purchased rival Wyeth in January for $68 billion and had revenues of over $48 billion last year. As the New York Times pointed out, "While the government said the fine was a record sum, the $2.3 billion fine amounts to less than three weeks of Pfizer’s sales." This is the fourth time Pfizer has reached a settlement over fraudulent marketing since 2002.

In the wake of Pfizer's settlement, here's a look at some of the larger Big Pharma settlements in recent history:

* Zyprexa, 2009 -- Eli Lilly was accused of selling its top-selling drug Zyprexa widely -- even to those people without bipolar disorder or schizophrenia for which the drug was supposed to be used. The drug can cause severe weight gain, as well as increasing the risk of a patient developing diabetes. In January, Eli Lilly reached a settlement with the government for $1.4 billion.
* OxyContin, 2007 -- Introduced in 1996 by Purdue Pharma, OxyContin was advertised as a softer, gentler painkiller. However, the drug is actually highly addictive, acting like heroin if taken incorrectly. OxyContin has become a scourge to communities across the U.S. and has also led to numerous overdose deaths. Perhaps the most notorious abuser of OxyContin was conservative radio talk show host Rush Limbaugh. In 2007, Purdue Pharma agreed to cough up $634.5 million in fines for its false claims about the drug.
* Vioxx, 2007 -- When 47,000 people are involved in a lawsuit against you, you know you have a problem. Thus, Merck, the maker of the painkiller Vioxx, reached a $4.85 billion settlement in 2007 to get rid of all the pending cases brought against it due to Vioxx's negative side effects. Vioxx was found to double the risk of heart attacks and strokes and thus Merck pulled the pill from pharmacies in 2004.
* Serostim, 2005 -- Serono, a Swiss technology company, had to pay $700 million in 2005 as a result of its fraudulent marketing for the AIDS drug Serostim. Serono developed a test that inflated the seriousness of the symptoms of a patient afflicted with AIDS and also sponsored junkets for doctors in order to get them to prescribe the drug.
* Neurontin, 2004 -- Pfizer reached a settlement of $430 million to end criminal and civil charges about its practice of paying doctors to prescribe Neurontin, a drug for epilepsy, to patients with bipolar disorder, for which it was not approved.
* Cipro, 2003 -- Bayer reached a $257 million settlement in 2003, the largest Medicaid fraud settlement at that time, after being charged by federal investigators with overcharging for the antibiotic Cipro. Bayer, however, didn't act alone: It received advice on how to go about the scheme from healthcare giant Kaiser Permanente.
* Paxil and Flonase, 2003 -- GlaxoSmithKline allegedly didn't want to miss out on all the fun and profits Bayer was having in overcharging for Cipro. It was accused of running a scheme with Kaiser Permanente to bilk Medicaid for the antidepressant Paxil and the allergy spray medication Flonase. GlaxoSmithKline paid $87.6 million in 2003 to settle the case.
* Lupron, 2001 -- TAP Pharmaceuticals Inc. came up with a clever way to get doctors to use its prostate cancer drug, Lupron, instead of those of rival drug companies: namely, pay them. TAP offered one doctor $25,000 to go back to prescribing Lupron after he'd switched to a competitor's drug. But the doctor alerted authorities, who conducted a massive sting resulting in TAP dishing out a $875 million settlement in 2001.
* Fen-Phen, 1999 -- Billed as a miracle diet drug by the drug company American Home Products Corp. (AHP), Fen-Phen was just as good at promoting heart valve disease as it was at helping people shed excess pounds. AHP removed Fen-Phen in 1997 after a damaging report showed that those who took the drug for more than two years increased their risk of developing heart valve disease by 17 percent. Though AHP agreed to pay $3.75 billion to the users of the drug, it did not have to admit to any wrongful actions in its marketing of Fen-Phen.

CCHR INTERNATIONAL Announces FDA Reported Psychiatric Drug Side Effects Search Engine

PRNEWSWIRE
August 4, 2009

Citizens Commission on Human Rights International Announces FDA Reported Psychiatric Drug Side Effects Search Engine: Decrypted FDA reports reveal 4,260 suicides, 2,452 additional deaths, 195 homicides from 2004-2006 alone

Los Angeles, CA (PRWEB) August 4, 2009 -- For the first time the side effects of psychiatric drugs that have been reported to the U.S. Food and Drug Administration (FDA) by doctors, pharmacists, other health care providers and consumers have been decrypted from the FDA's MedWatch reporting system and been made available to the public in an easy to search psychiatric drug side effects database and search engine. The database is provided as a free public service by the mental health watchdog, Citizens Commission on Human Rights International (CCHR).

The report totals reveal that between 2004-2008 the FDA's MedWatch system received pregnancy-related psychiatric drug adverse reaction reports which included 2,442 babies born with heart disease, 3,372 other birth defects, as well as 1,072 miscarriages, abortions and other deaths.

The database also reveals that, between 2004-2008 there were reports submitted to MedWatch including 4,895 suicides, 3,908 cases of aggression, 309 homicides and 6,945 cases of diabetes from people taking psychiatric drugs. These numbers reflect only a small percentage of the actual side effects occurring in the consumer market, as the FDA has admitted that only 1-10% of side effects are ever reported to the FDA.

The database is searchable by individual reports (for the 2004-2006 period), type of drug, age of patient, the side effect reported (suicide, homicide, heart attack, stroke, mania, etc.), and whether the drug in question carries a black box warning (the agency's strongest warning--short of banning a drug).

It is searchable by drug name and age group and includes who reported the psychiatric drug reaction (doctor, pharmacist, consumer, etc.). It also includes the top 20 reported adverse reactions to all psychiatric drugs to the FDA and combined summaries of all psychiatric drug reactions for the years 2004-2006 and 2004-2008.

Since the reform of the Prescription Drug User Fee Act (PDUFA) in 2007, ads for psychiatric and other drugs must include statements encouraging consumers to report adverse drug reactions to the FDA's MedWatch system--Adverse Events Reporting System (AERS). However, consumers or doctors attempting to access the AERS online were confounded by a system so complex that it was impossible to use. Although the FDA should have made the information collected readily accessible, it failed in that duty to the public. It took a computer programmer over 1,000 hours to decipher four years' worth of data to make this information available.

The programmer identified the main psychiatric drugs in the AERS, wading through quarterly reports of seven different reporting systems, including the drug name, demographics, adverse reactions, patient outcomes, reporting source, therapy start and end dates and the indication (diagnosis). The result: A database and search engine that unravels the 94,000 pages of codified psychiatric drug adverse reactions reported each year from 2004-2006 and 2004-2008 to the FDA's MedWatch system.

Reporting of adverse reactions to psychiatric drugs by doctors, pharmacists, other health care providers and consumers once those drugs are out in the consumer market, is fundamental to drug safety monitoring. Yet these reports have been frequently ignored or dismissed as "anecdotal" by the FDA even when serious side effects number in the thousands. The FDA approves the majority of psychiatric drugs only after Phase 2 (short term) clinical trials. However, once the drugs are out in the consumer market, the FDA is supposed to require longer clinical trials, or post-marketing studies of the drugs, however this rarely happens. Subsequently, dangerous and deadly drugs have been left without black box warnings, or on the market for far too long. The best "signal" event for the FDA to direct its resources in identifying or pulling dangerous drugs is what is happening out in the real world, with consumers and patients, not in a controlled short term clinical trial, funded by the pharmaceutical companies seeking approval for their drugs to go to market.

For years the information contained in the FDA's MedWatch reporting system has been inaccessible and therefore virtually useless for consumers and doctors. CCHR's stance has always been that consumers have the right to this information for then ̶ and only then ̶ can consumers have full "informed consent" regarding the risks of psychiatric drugs, and so it has provided this database as a free public service.

The psychiatric drug search engine features a promotional video as well as an instructional video for users on CCHR's newly launched website so they can get the information from the database they are looking for in the shortest amount of time.

About The Citizens Commission on Human Rights:

The Citizens Commission on Human Rights is a mental health watchdog co-founded in 1969 by Professor of Psychiatry Emeritus Thomas Szasz and the Church of Scientology. It is a non-profit, non political, non-religious organization that has been responsible for more than 100 reforms that help protect patients rights against abuses in the field of mental health. For more information about CCHR go to http://www.cchrint.org

Video-Risperdal Creating Lactating Breasts on Boys

CBS Evening News [click for graphic video]
– May 25, 2009 – Risperdal

Graphic CBS Video Covering Law Suit Against Johnson & Johnson for their Antipsychotic Risperdal Creating Lactating Breasts in Male Children

“Caution: Graphic Content:” For children “diagnosed” with ADD and bi-polar disorder, Risperdal is used for “treatment”. The side effects are putting them at serious risk.

2 Comments

2 Comments on Video

• Lisa Jones RN
  May 26, 2009 at 7:30 pm

  I cried the first time I had to give my son Risperdal. I am now homeschooling and have him OFF the medication. He is doing well….now.

  It is the pubic school system that pushes this !! When will it ever stop?

  Reply
• 
  

  Rikki
  May 27, 2009 at 2:04 pm

  It would never cross my mind to give a kid or anyone a substance to “solve” a behavioral problem.

  Why?

  Look around you – look at the ever-growing population of insane people and compare that to the ever-growing, billion-dollar drug sales business in the United States.

  People need to come to their senses and stop buying into this practice, this money-making racket, and justice needs to be brought once and for all to everyone involved in these CRIMINAL activities.

Children's Use Of Psychiatric Drugs Begins To Decelerate

The Wall Street Journal
By David Armstrong
May 18, 2009

The growth in antipsychotic-drug prescriptions for children is slowing as state Medicaid agencies heighten their scrutiny of usage and doctors grow more wary of the powerful medications.

The softening in sales for children is the first sign that litigation, reaction to improper marketing tactics, and concern about side effects may be affecting what had been a fast-growing children's drug segment.

The six so-called atypical antipsychotics that dominate the market have limited approval from the FDA to treat patients under 18 years of age. Only one is cleared for children under age 10 -- risperidone, branded by Johnson & Johnson as Risperdal -- to treat irritability associated with autism.
[psychotic drugs for kids]

But doctors can prescribe drugs as they see fit, and many have turned to the atypicals to treat serious mental conditions in children, including schizophrenia and bipolar disorder. Use of Risperidone by those 18 and under accounts for about 25% of the drug's sales, while SDI Health, a medical market-research company that gathers sales information from drugstores, estimates that sales of all antipsychotics to that age group account for 15% of the drugs' sales, or $2.18 billion.

Data on use among children are hard to come by, but SDI's figures show that antipsychotic prescriptions for children under 18 rose 5.2% between 2007 and 2008, compared with an increase of 8.73% in the year-earlier period.

The slowdown is more pronounced among younger children. The nation's second largest pharmacy-benefits manager, Medco Health Solutions Inc., which handles 586 million prescriptions a year, estimates that prescriptions for antipsychotics for patients under 10 fell 4% last year. From 2001 through 2007, use in that age group increased 85%, Medco says.

SDI Health estimates that prescriptions for psychiatric drugs for children under 10 increased 3.5% last year. In contrast, between 2002 and 2007, such prescriptions rose 44.6%, it says. SDI also says it saw a 1% drop in prescriptions for those under seven last year.

"I was never a big prescriber to begin with, but I have definitely been more careful as information has come to light about the serious side effects being downplayed in the marketing of these drugs," says Michael Houston, a child psychiatrist in Chevy Chase, Md.

Others who treat children with serious and dangerous behavioral problems worry that misconceptions about the drugs will prompt some parents or doctors to balk at their use.

"For those children who are seriously mentally ill, although these side effects can be potentially significant, the benefits far outweigh the side effects," says Louis Kraus, the chief of child psychiatry at Rush University Medical Center in Chicago.

Antipsychotics have faced heightened scrutiny and investigation over the past year. In November, a Food and Drug Administration advisory committee asked the FDA to research children's use of the drugs and expressed concern about possible side effects such as weight gain and increased diabetes risk. And 11 state attorneys general are investigating alleged marketing of Eli Lilly & Co.'s antipsychotic Zyprexa for uses the FDA hasn't approved.

In January, Eli Lilly agreed to pay $1.4 billion to settle allegations it improperly marketed Zyprexa. The company also agreed to plead guilty to a criminal charge of promoting the drug for unapproved uses.

A Lilly spokesman declined to comment on ongoing litigation and said the company doesn't track the drug's use in children.

Bristol-Myers Squibb Co. agreed to pay $515 million in September 2007 to settle allegations it promoted Abilify for use in children. The FDA didn't approve of the use of the drug in children older than 10 until 2008.

State Medicaid agencies began to question "off label" use of antipsychotics after the December 2006 death of Rebecca Riley, a four-year-old Massachusetts girl whose family received Medicaid benefits. After being diagnosed with bipolar disorder at age two, she was prescribed a cocktail of drugs, includingan antipsychotic, court records show.

Some states began moving to require special approval before they would cover a claim for an antipsychotic. A group of 16 states started studying the use of psychiatric medication in children in 2007 in an effort they dubbed "too many, too much, too young," says Jeffrey Thompson, the medical director of the Washington state Medicaid program.

In California, the number of children six and under using psychiatric medications has fallen to 4,200 from 5,686 since a 2006 prior-authorization plan was put in place, the state's top Medicaid official says.

Florida's state Medicaid agency says the number of prescriptions for atypical antipsychotics written for children under age six in the second half of last year dropped to 1,137 from 3,167 a year earlier.

The agency says the decline was the result of a state program started last year under which prescriptions for children under six are reviewed for appropriateness by state-hired psychiatric consultants before Medicaid will cover them.

Washington has created a system to flag the use of psychiatric drugs that may contain too high a dose for young children or have side effects that it regards as particularly dangerous. From May 2006 to April 2008, the system flagged 1,032 cases for review by outside consultants.