Friday, May 29, 2009

Florida Department of Children and Families review finds shortfalls in monitoring of foster children on psychiatric drugs

Florida Department of Children and Families review finds shortfalls in monitoring of foster children on psychiatric drugs
By Kris Hundley, Times Staff Writer
In Print: May 29, 2008

Spurred by the shocking suicide of a 7-year-old on psychiatric drugs, the agency in charge of Florida's foster children has discovered serious shortcomings in its monitoring of kids on such powerful prescriptions.

After reviewing its files, the Department of Children and Families determined it had under-counted the number of foster kids on such medications as Risperdal and Adderall, overlooking hundreds of cases.

It also has failed to meet its legal requirement that such prescriptions be given only after parental consent or court order.

On Thursday, DCF said a review of the files of more than 20,000 children currently in the state's foster care showed 2,669, or 13.19 percent, are taking one or more psychotropic medications.

That compares to about 4 or 5 percent of children in the general population who are on such prescriptions.

Of those foster children taking drugs, DCF discovered 16 percent had no proof either a parent or judge had signed off on the prescription, as required by a 2005 Florida law.

"That is unacceptable," said DCF's secretary George Sheldon. "We're going to bring every single case of a foster child on drugs into compliance with the law."

Concerns about pediatric use of anti-psychotic and anti-depressants have been growing along with increased warnings of such side effects as suicide, diabetes and weight gain. Few of the drugs have been tested or approved by the FDA for children, though physicians can prescribe them for this age group.

Robin Rosenberg, a Tampa lawyer and deputy director of Florida's Children First, said advocacy groups like hers have been fighting for oversight of psychotropic drugs for years. "We're not as far along as we should have been if the state had followed up on serious concerns starting in the late 1990s,'' she said. "It's a shame we're in this place today."

Sheldon, who was named to the top job at DCF in October, left no doubt that he had been deeply affected by Gabriel Myers, the 7-year-old who hanged himself on a shower hose in south Florida in mid-April. The boy was in his third foster home and on Vyvanse, a medication for ADHD, as well as Symbyax, a combination of anti-psychotic and anti-depressant.

Though his caseworker repeatedly said Gabriel's mother had agreed to the medications, that was not true. The boy's psychotropic medications also had not been entered in the state's tracking system.

To correct ongoing problems, Sheldon set a deadline of June 5 for action on cases without consent. This could include scheduling new doctors' appointments, gaining informed consent from parents or expediting a judge's review of the prescription.

Sheldon said he also was going to focus on the cases of 73 children under age 6 found to be on psychotropic drugs.

"I want a sense of urgency, but I also want to get it right,'' he said. "I want to move forward, but I think it's important for the agency to apologize for misinformation it may have put out in the past."

Flaws in DCF's record-keeping became clear in the immediate aftermath of Gabriel's death. An initial review of the state's database showed only 1,950 kids on psychotropic prescriptions. After a thorough review of individual records, however, that number grew by more than 700.

Preliminary data released in mid-May also showed some questionable dates on judicial consent. Though it's not inconceivable a judge might sign an order on a Saturday or Sunday, early returns showed weekend consent orders on 129 occasions.

The final database, including information on types of drugs and diagnoses, was not available Thursday. Sheldon said a summary of the drug data would be posted on the DCF Web site and updated weekly.

"I've got a lot more confidence in these numbers than I had two weeks ago," he said. "But any database is only as good as the quality of the information being put into it."

One ongoing area of concern, Sheldon said, is the validity of any consent given by parents whose kids are in the state's custody.

"A parent whose child is taken into our care is going to sign virtually anything and that's not informed consent," he said. "My preference is that the biological parent have a dialog with the psychiatrist."

Now that DCF has a handle on the number of foster children on psychotropic drugs, Sheldon said the department can begin to address the bigger issue of the efficacy of such drugs.

He has asked an independent panel investigating Gabriel Myers' death to make recommendations on improving DCF's oversight of these medications. Sheldon said a second-party review of all such prescriptions might be necessary; currently, only prescriptions for kids under age 6 require such review.

DCF has set up a page on its web site that tracks the progress of the panel investigation into the boy's suicide. The page includes a photo of the smiling boy.

"We have his face on the screen watching us to see how well we learned from his life and death," Sheldon said. "We cannot let him down." 

Source: http://www.tampabay.com/news/health/medicine/article1005344.ece

 

Benzodiazepines Linked to Post-ICU Depression

Benzodiazepines Linked to Post-ICU Depression

A recent article in MedScape Medical News says that "Intensive Care Unit (ICU) patients with adult respiratory-distress syndrome (ARDS) and other forms of acute lung injury (ALI) may need sedation to endure the stress of mechanical ventilation, but the benzodiazepine doses often used in this situation may be setting patients up for clinical depression after discharge. In a study published in the May issue of Critical Care Medicine, David W. Dowdy, MD, PhD, and colleagues, from the Johns Hopkins University School of Medicine, in Baltimore, Maryland, identified several factors associated with symptoms of depression 6 months after ICU admission for ALI. These included ... high benzodiazepine doses..."

Benzodiazepines are a class of psychiatric anti-anxiety drugs also called minor tranquilizers or sedative hypnotics. Some of the various brand names are Valium, Xanax, Klonopin, Librium, and Rohypnol.

Daily use of therapeutic doses of benzodiazepines is associated with physical dependence. Addiction can occur after 14 days of regular use. The withdrawal syndrome is similar to that of alcohol withdrawal, but can be more prolonged and more difficult than withdrawal from heroin. Typical consequences of withdrawal are depression, anxiety, sweating, cramps, nausea, psychotic reactions and seizures. Some of the side effects of taking these drugs include depression, aggressive behavior, anxiety, psychosis, and suicide.

Drug experts say that the benzodiazepine Xanax, for example, is more addictive than most illegal drugs, including cocaine or heroin.

More information about the side effects of psychiatric drugs can be found by clicking here.

[Editorial Comment: One wonders why a psychiatric drug with such already known severe side effects and withdrawal symptoms is used at all in an intensive care unit after a severe illness.]

Thursday, May 28, 2009

State records failed to accurately reflect drugs prescribed

http://www.miamiherald.com/news/florida/AP/story/1069324.html

Report focuses on Fla. foster kids' prescriptions

The Associated Press

A new state report will focus on the prescribing of antidepressants and other psychotropic drugs to foster children.

Florida Department of Children and Families Secretary George Sheldon ordered the study that's due out Thursday after the apparent suicide of a 7-year-old boy last month in Margate.

State records failed to accurately reflect the drugs he had been prescribed, nor had required consent been obtained from his parents or a judge.

The report is expected to show whether other foster children have received such prescriptions without proper authorization or record keeping.

Friday, May 22, 2009

Florida Columnist on Psych Drugs!

 

 

Rhonda Swan

Columnist Rhonda Swan - Palm Beach Post


Palm Beach Post
COLUMN: Americans' legal drug abuse

By Rhonda Swan
Palm Beach Post Editorial Writer
May 21, 2009

Maxine is not the woman she used to be.

She looks the same, except for the white Afro that used to be black.

But gone is her zany sense of humor, sharp tongue and sassy wit.

She stares into space with vacant eyes. Walks like a zombie. She speaks primarily when spoken to, her conversation devoid of her familiar quips. She complies rather than commands.

I've known Maxine my entire life - she taught me how to play pinochle and how to bake a cake - yet she seems more like a stranger I've just met.

That's because she's among the millions of U.S. seniors taking psychotropic drugs, antidepressants, antipsychotics and Alzheimer's medicines. The traits that used to make people take notice of Maxine, who suffers with post-traumatic stress disorder from an abusive marriage decades ago, are swallowed daily with her anti-psychotic Zyprexa pill.

And now, she's hardly noticeable.

The number of people older than 65 taking these drugs doubled between 1996 and 2006, according to a study released this month. Doctors prescribed 73 percent more drugs for adults with mental-health issues and 50 percent more for children during that period.

Children such as 7-year-old Gabriel Myers, who was taking Symbyax - a combination of Zyprexa and the anti-depressant Prozac, known to cause youngsters to have suicidal thoughts - when he hanged himself at his Broward County foster home last month.

An author of the study, which appeared in the journal Health Affairs, attributed this astounding increase in the use of these powerful drugs to improved access to mental-health care, which has become more mainstream, and more insurers willing to cover the drugs. But it's also because more doctors prescribe psychotropic drugs as the first and often only treatment, even when they're not warranted.

Years ago, when I told my primary-care doctor that I was suffering stress-related anxiety and insomnia, he handed me a prescription for Prozac. I trashed it, opting instead to exercise and change my diet.

In February, when my mother was in West Palm Beach's Columbia Hospital recovering from surgery, I requested a psychiatric consultation because she wasn't eating. I thought she might benefit from a session with an objective professional.

The hospital psychiatrist visited with her for less than 10 minutes, diagnosed her as depressed based on her answers to five questions, and then prescribed the antidepressant Zoloft and went on his merry way. Counseling wasn't even considered as an option.

What happened to psychotherapy, once the hallmark of psychiatric treatment? Because of managed care, it's going the way of the lobotomy. Why engage the human mind and heart to ease mental suffering when popping a pill is so much cheaper? According to a 2008 National Ambulatory Medical Care Survey, only 29 percent of visits to psychiatrists in 2004 and 2005 included psychotherapy, compared with 44 percent in 1996-97. Insurers reimburse more, says the report, for three 15-minute medication management visits than for one 45-to-50-minute outpatient psychotherapy session. Not surprisingly, the patients more likely to receive therapy are those who can pay out of pocket.

Granted, not everyone with a mental-health diagnosis would benefit from therapy alone. Many need these mind-altering, chemical-balancing drugs. But many others could achieve optimal mental health without the assistance of pharmaceuticals.

While we've been busy losing the multibillion-dollar war on illegal drugs, a government-sanctioned, multibillion-dollar legal drug industry has blossomed, churning out robots void of personality like Maxine and suicidal children like Gabriel.

When life is lost - mentally, spiritually or physically - does it really matter whether the drug dealer had a medical degree?

 

NEW VIDEO: Top APA Shrink Needs Lesson in Disease vs. Disorder

The President of the American Psychiatric Association (APA), Nada Stotland, obviously needs a bit of a lesson on

the difference between a disease and a mental "disorder."  So we (CCHR Int) made her this video.  Be sure to watch Part 2 at the end.

 

New Video: Top APA Shrink Needs Lesson in Disease vs. Disorder

(if you have trouble with the link, copy and paste it into your browser)

 

 

Tuesday, May 19, 2009

Lilly's Worst Zyprexa Nightmare comes True

 

May 7, 2007. By Evelyn Pringle

LawyersAndSettlements.com

 

Washington, DC: Eli Lilly is not all that worried about personal injury lawsuits related to Zyprexa because the company has enough money to pay the relatively small pay-outs that arise from such actions, according to Attorney Barry Turner, a professor of law and ethics in the UK and a leading authority on consumer fraud litigation involving the pharmaceutical industry.

But he says the Medicaid fraud lawsuits filed by 9 states thus far, under the Federal and State False Claims Act are another matter. "The biggest penalties so far in Federal and State False Claims Act violations," Mr Turner reports, "were awarded against drug companies and there are very many more cases under seal."

But an even larger nightmare for top Lilly officials, he says, arises when a product like Zyprexa causes deaths and injuries to consumers and shareholders face huge losses including the millions of people who have their pensions invested in the company.

When a blockbuster drug is announced, Mr Turner says, it attracts huge investment and if that investment has been attracted to a product that Lilly knew was faulty, the company has risked shareholder funds beyond the pale.

This kind of behavior, he notes, is a Sarbox violation. The Sarbanes-Oxley Act was enacted to restore investor confidence in publicly traded companies in the wake of Enron and similar debacles by improving corporate accountability. Its official title is the "Public Company Accounting Reform and Investor Protection Act of 2002," named after its sponsors Senator Paul Sarbanes (D-MD) and Representative Michael G Oxley (R-OH), and is commonly referred to as SOX.

One of the features of SOX is the ability to bring an action against those who recklessly and fraudulently deal with stockholder's money and, "promoting the off label use of a drug with undeclared dangerous side effects, or being negligent as to such promotion, is the kind of behavior justifying an action under Sarbanes Oxley," according to Mr Turner.

"Those at the top of Eli Lilly," he states, "gambled with the lives of patients and the money of stockholders in equal bad faith when they engaged in fraudulent and dishonest behavior that allowed a dangerous drug to be marketed."

"The lifeblood of a business," he says, "is the investment that goes into it and in the case of Eli Lilly it means the investment of millions of shareholders."

"Anyone who defrauds them," he explains, "is defrauding people not business."

Mr Tuner says it is easy to think of shareholders as "rich lazy fat cats" living off the efforts of others but it is fundamentally wrong by ethical standards to think that if they are defrauded that perhaps they deserve it. "What needs to be understood," he says, "is that many millions of people who own no stock at all get defrauded in scams all the time."

"Those who pay into pension funds," he explains, "are vulnerable to the financial shenanigans not only of fund managers but of boards of companies and CEO's that fail to police the companies activities or in some cases actively encourage fraud and reckless business practices."

The worst of all legal nightmares resulting from the Zyprexa "shenanigans," occurred over a period of 9 days between April 2, 2007 and April 11, 2007, when not one, but 4 shareholder class action lawsuits were announced against Lilly and "certain of its officers and directors" filed in the US District Court for the Eastern District of New York, for violations of the Securities and Exchange Act alleging that the defendants hid the side effects of Zyprexa and engaged in illegal off-label marketing campaigns.

On April 2, 2007, the Law Firm of Schiffrin Barroway Topaz & Kessler, issued a press release to announce that a class action was filed on behalf of all securities purchasers of Lilly from March 28, 2002 and December 22, 2006, charging the defendants with disseminating false and misleading statements regarding Zyprexa.

More specifically, it alleges that they were aware of a "clear link" between Zyprexa and diabetes; and yet failed to warn the public and engaged in an illicit scheme to offset a drop in sales that was certain to occur, and did occur, when reports of Zyprexa's side effects emerged, by creating a marketing plan which included the evaluation and pursuit of sales for the drug based on "off-label" uses and that the off-label marketing program was a direct violation of Lilly's own code of conduct.

The complaint further alleges that concealing the side effects and engaging in a massive illegal marketing campaign potentially subjected Lilly to substantial regulatory fines, penalties and other legal action, compromising the company's overall financial condition and prospects.

The complaint reports that between 2002 and 2004, sales of Zyprexa grew from $3.69 billion to $4.42 billion, and that between July 18, 2002 and May 7, 2004, Lilly's stock value increased from $43.75 per share to $76.95.

Throughout the class period, the lawsuit says, Lilly had information about the link between Zyprexa and extreme weight gain and diabetes and in the face of mounting research linking the drug to diabetes and weight gain, and the lawsuits filed by persons who developed these conditions, "Lilly emphatically denied any such link."

The complaint alleges that when public warnings were issued about the safety of Zyprexa, sales slowed and between May 7, 2004 and October 25, 2004, stock prices dropped from $76.95 per share to $50.34, representing a loss of market capitalization of over $30 billion.

The press release cites reports in the New York Times between December 17 and 21, 2006, as disclosing for the "first time" that Lilly had engaged in a decade-long effort to play down the risks of Zyprexa; and actively marketed the drug for illegal off-label uses such as treating elderly patients with symptoms of dementia.

Therefore, the lawsuits alleges, the over $30 billion decline in stock value between May 7, 2004 and October 25, 2004 was the direct result of defendants' fraudulent conduct.

In addition it says, the publication of the Times articles caused another $3.49, or 6.4%, decline in stock value and represented a further market loss of approximately $3.5 billion.

Two days after the first class action was announced, on April 5th, the Lerach Coughlin Stoia Geller Rudman & Robbins Law Firm announced that another had been filed.

The second complaint also charges Lilly and certain of its officers and directors with violations of the Securities Exchange Act, and alleges that at the beginning of the class period, defendants contended that Zyprexa did not cause diabetes-related side effects and that once the clinical data rendered that position untenable, defendants argued instead that Zyprexa did not cause any more side effects than its competitors.

Eventually, the press release notes, more and more clinical data showed that, in fact, Zyprexa does cause such side effects and to a greater extent than its competitors and the "revelations sharply curtailed the sales growth of Zyprexa and resulted in thousands of product liability lawsuits against Lilly and hundreds of millions of dollars in settlements."

It also alleges that defendants intentionally suppressed and misrepresented data showing that Zyprexa causes weight gain, high blood sugar, and diabetes, citing the series of articles in the Times, with excerpted "documents detailing defendants' deception."

The release says the documents revealed that defendants intentionally misled patients, doctors, and investors and as a result, "the price of Lilly's stock declined almost 6% in the five trading days during which the series of articles was published."

The members of the class, it notes, invested in Lilly securities unaware that defendants' fraud had artificially inflated the prices of those securities and when "the truth was finally revealed those investors lost many millions of dollars as a result of defendants' fraud."

Four days after the second lawsuit was announced, on April 9th, the Schatz Nobel Izard Law Firm announced the third case seeking class action status on behalf of all persons who purchased or otherwise acquired securities of Lilly between March 28, 2002 and December 22, 2006.

This lawsuit also alleges that the same defendants violated securities laws by making misleading statements and specifically that they "contended that Zyprexa did not cause diabetes-related side effects," and later that, "Zyprexa did not cause more side effects than its competitors."

This press release also quotes the Times articles as showing "that defendants intentionally misrepresented the side effects of Zyprexa," and "suppressed and misrepresented data showing that Zyprexa causes weight gain, high blood sugar, and diabetes "

"In the five trading days during which the series of articles was published," the press release advises, "the price of Lilly's stock declined almost 6%."

Two days later, on April 11th, the Harwood Feffer Law Firm announced a fourth class action accusing the same defendants of making misleading statements and specifically that they failed to disclose: (i) dangerous side-effects resulting from the use of Zyprexa; (ii) the decade-long illegal campaign to increase sales by marketing Zyprexa for off-label uses not approved by the FDA, in violation of FDA regulations that proscribe such marketing.

As a result of these fraudulent business practices, the press release states, sales of Zyprexa rose from $3.69 billion to $4.42 billion between 2002 and 2004, and the value of stock increased from $43.75 per share to $76.95, between July 18, 2002 and May 7, 2004.

The release says defendants had knowledge of a link between Zyprexa and extreme weight gain and diabetes and when sued by private individuals who developed these adverse effects, "the Company adamantly refused to acknowledge any wrongdoing."

The Law Firm goes on to note that as public agencies raised warnings about Zyprexa, sales plummeted and stock price dropped from $76.95 per share to $50.34, between May 7, 2004 and October 25, 2004, amounting to a loss of market value of over $30 billion.

Subsequently, the press release alleges, after the Times published a series of articles the price of Lilly stock "collapsed" an additional $3.49 per share, or 6.4%, and amounted to a further loss of market value of approximately $3.5 billion.

Zyprexa was FDA approved for the limited use of treating adults with the most severe mental illnesses, schizophrenia and manic episodes of bipolar disorder, but it quickly became Lilly's best selling product.

In order to find that Lilly did not make the drug its top seller by illegally promoting it for off-label uses, a jury would have to believe the highly unlikely scenario that doctors in every field of medicine came up with the idea of prescribing a schizophrenia drug to patients as young as 2 and as old as 100, for every kind of condition imaginable from anxiety and attention deficit disorder to autism and dementia.

On April 25, 2007, the New York Times reported that the FDA was examining whether Lilly provided the agency with accurate data about the side effects of Zyprexa. However, that may be a dead issue in light of the fact that on May 4, 2007, Lilly issued a press release of its own to announce that Alex Azar II will be joining the company as a senior vice president, who until February 3, 2007, just happened to be the Deputy Secretary of the US Health and Human Services Department.

According to Lilly, "Azar supervised all operations of the HHS, including the regulation of food and drugs," and among others, agencies under his direction included the FDA.

Zyprexa Legal Help

If you have or a loved one has taken Zyprexa and suffered from diabetes or hyperglycemia, please contact a [Zyprexa] lawyer who will evaluate your claim at no charge.

Nevada Bill - Parental Consent - Foster Kids - Psych Drugs

"A bill before the Nevada State Legislature would require parental consent, or court approval, before psychotropic drugs can be used on the youngest foster kids."

http://www.lasvegasnow.com/Global/story.asp?S=10384827&nav=menu102_2

I-Team: Young Foster Kids on Powerful Psychiatric Drugs

Las Vegas - EyeWitnessNews
Investigative Reporter Colleen McCarty and Photojournalist Kyle Zuelke
I-Team: Young Foster Kids on Powerful Psychiatric Drugs
May 19, 2009 


Remember that kid in school who had all the answers? In Mr. Moye's honors history class, her name is Saida Brown. The Coronado High School sophomore values education like first-time drivers cherish their wheels.

Born to a drug-addicted mom, Saida entered foster care at 14-years-old when a family member discovered she was cutting herself. Frequent admissions to mental health facilities followed, along with multiple psychiatric diagnoses. "I was on so many medications. They had me on medications that zoned me out. My grades in school mean so much to me and they would send me to school on Thorazine," she said.

She says she was on Seroquel, Haldol, and Depakote, just to name a few. They're powerful, mood-altering drugs and some of them are not approved for use on children. "The medicine was making it worse. I was like, ‘I don't need any pharmaceuticals to help me cope with life. I just need someone to sit down and talk to me,' you know," she said.

A review of state insurance records suggests Saida's experience is not unique. In 2007, one in five kids in the custody of state or county agencies was prescribed one or more psychotropic medications. More than 80 children 5-years-old or younger were taking powerful anti-psychotic drugs.

"We just don't know the long term effects of many of these pharmaceuticals on kids because it's not really measured -- the anti-psychotics in particular," said child psychiatrist Dr. Norton Roitman.

Roitman is among a growing chorus seeking more oversight of the process by which children in the system receive medication. A bill before the Nevada State Legislature would require parental consent, or court approval, before psychotropic drugs can be used on the youngest foster kids.

"It's just like grammar school; you have to show your work. You have to show you've gone through the necessary steps to not overprescribe. In order to put a kid at risk, you have to be able to justify that," he said.

Roitman acknowledges, of course, some children benefit from medication but insists a lack of resources contributes to overuse.

"I decided I wasn't going to be a guinea pig anymore," said Saida. With the support of her foster mom and a therapist, Saida stopped taking her pills. "That was kind of my turning point for when I started to get on track," she said.

Saida's fellow students recently elected her junior class president and her academic achievement puts her among the top of her class. At 17-years-old, she may not really have all the answers, but Saida will be the first to tell you that she has some of them. "Everything is not going to be ok unless you push yourself to keep going," she said.

Family Services Director Tom Morton has conducted his own research into this issue. His findings show 55 children in county custody under the age of six on psychotropic medications, including a 2-year-old diagnosed with three different disorders taking five different drugs.

Policy changes are underway to keep the agency more informed about what drugs kids in their care are taking and in the future, all requests will be reviewed by clinical staff.

Morton says he supports the latest legislation.

Sunday, May 17, 2009

Florida DCF Secretary Convenes Workgroup to Evaluate Circumstances Surrounding Death of 7-year-old in Foster Care

Department of Children and Families Secretary Convenes Workgroup to
Evaluate Circumstances Surrounding Death of 7-year-old in Foster Care

TALLAHASSEE, FL-Department of Children and Families (DCF) Secretary
George H. Sheldon today announced that the Department is establishing a
workgroup to determine the facts and circumstances surrounding the
tragic death of 7-year-old Gabriel Myers. Gabriel died on April 16 when
police indicated he apparently hanged himself in the shower of his
foster parents' Margate home.

Following Gabriel's death, the Department of Children and Families
petitioned the court to release case files and notes relating to the
child while in state care. Normally, case files are only made public
following a death that is verified as a result of abuse or neglect, per
Florida Statutes. However, DCF believed it was in the public interest to
open the records to public scrutiny. A judge agreed and the petition was
granted on April 22, 2009.

"It is difficult for any of us to comprehend how a child so young could
have deliberately and consciously made the decision to end his life,"
said Secretary Sheldon. "But in order to help prevent this type of
tragedy from happening again, it is critical we review all available
information to determine the factors that led to Gabriel's death."

"The workgroup will conduct a full inquiry into the facts of the case,
in light of case management and judicial decisions, as well as determine
the contributing effects that psychotropic drugs and sexual abuse had,"
Sheldon continued.

The workgroup will be led by former assistant commissioner of the
Florida Department of Law Enforcement Jim Sewell. Other members include
DCF Assistant Secretary for Substance Abuse and Mental Health Bill
Janes; Pharmacy Director for the Agency for Health Care Administration
Ann Wells; attorney and child advocate from Florida's Children First
Robin Rosenberg; and Rajiv Tandon, MD, psychiatrist with the University
of Florida. The Secretary has asked that the workgroup consult with
professionals from many different areas during this process, including
those in law enforcement, the courts, the school system, child welfare
officials, the Department of Health, the Agency for Health Care
Administration and health care practitioners.

"When a child comes into state care, we become the parent of that child
and must actively participate in all decisions regarding that child. To
do otherwise would be shirking the responsibility of this Department,"
said Sheldon.

The workgroup will be asked to prepare a report based on their findings.
The report will be submitted to the Secretary and to the Department's
Task Force for Fostering Success, chaired by former Attorney General Bob
Butterworth.
The Secretary will ask the Task
Force to provide recommendations based on the workgroup's report.

Last week Secretary Sheldon directed DCF staff to do a thorough review
of every foster child's file to determine how many children in foster
care have been prescribed psychotropic drugs and to what extent. A 2005
study found that 6% of children under the age of
18 in Florida were prescribed at least one psychotropic drug. That
figure was nearly four times higher for foster children. "Much progress
has been made since that 2005 study, but we need to continually review
protocols to ensure children are not unnecessarily medicated or
inadequately monitored if medicated," said Sheldon.

"We need to develop a refined protocol for the use of these types of
drugs in our children," said Secretary Sheldon. "I want to ensure that
prescription drugs of this nature are used appropriately, always under
medical and judicial supervision and with consultation with DCF staff."

"By reviewing the facts of this case carefully, we can work to continue
to improve the child welfare system in Florida. While much progress has
been made, Gabriel's death starkly reminds us that when it comes to a
child's life, we cannot relax. Every decision we make profoundly affects
the life of that child," said Sheldon.

###

Florida Correcting Numbers on Drugged Kids


According to the Miami Herald  (May 8, 2009) consent from a parent was not obtained on Florida foster kids when a psychiatric drug was used for a non-psychiatric purpose. 
 
Example: If the antipsychotic drug Zyprexa was used on a foster child for "bed wetting" or some other non-psychiatric purpose - no consent from a parent was obtained. 
 
Thereforethe state did not include these drugs (non-psychiatric purpose) when adding up the number of kids in foster care on psychiatric drugs.
 
That is changing now - the state is now tallying up a more accurate count of the number of foster kids on psychiatric drugs.
 

 
 
South Florida Sun-Sentinel
Number of foster children in Florida on mood-altering drugs underreported, state study finds
Jon Burstein
May 14, 2009

FORT LAUDERDALE - The number of foster children in Florida prescribed mood-altering drugs has been significantly underreported, according to the early results of a statewide study sparked by a 7-year-old boy's suicide in Margate.

The revelation came Thursday at the end of an intense, day-long hearing by a panel appointed to scrutinize Gabriel Myers' tumultuous journey through the child welfare system that ended with him hanging himself at his foster home on April 16. Gabriel had been prescribed two psychotropic drugs.

Since then, the state Department of Children & Families has been reviewing case files on the more than 20,000 foster children in Florida. Before Gabriel's death, just under 10 percent -- 1,954 -- were listed as being on mood-altering drugs, said John Cooper, the department's acting assistant secretary for operations.

That number will rise markedly when DCF releases the findings of its current study next week, Cooper said.

"I don't know by how much, but it will be significant," he said.

In Gabriel's case, he only was listed in the database as being on Adderall, an attention deficit/hyperactivity drug, that he had been taken off of months before his death, said DCF Secretary George Sheldon. The two drugs that Gabriel was taking when he died--Symbyax and Vyvanse--had not been approved by either his parents or a judge--a violation of state law.

Child welfare officials acknowledged that failure Thursday to the six-member panel as they traced the last 10 months of Gabriel's life. Throughout the eight-hour hearing, questions arose about communication between social services providers and whether vital information about Gabriel's behavior and background was being shared and acted upon quickly.

No one checked to see why Gabriel had been prescribed Adderall before moving to Florida from Ohio or if he had been on any medications prior to that. No one obtained a copy of his child welfare history from Ohio until after his death.

In his last month, Gabriel saw his world turned upside down--going to a new foster home, changing therapists, changing after-school programs and his mother being transferred from the Broward County Jail to an Ohio jail. His behavior worsened during that time with him destroying property and threatening to hurt others.

"Was Gabriel spiraling out of his control or was his environment spiraling out of control?" asked panel member Bill Janes, DCF assistant secretary for substance abuse and mental health.

Sheldon, who attended part of Thursday's hearing, told the panel he wants every aspect of Gabriel's case investigated and people held accountable.

"We got to get every component of this system right," he said. "When you deal with children, no one can have a bad day."


 

Stress Testing the MOTHERS Act

 
(NaturalNews) The Mothers Act is due to be voted on soon by the U.S. Senate. This is the Big Pharma-advocated law that would require the mandatory screening of all expectant mothers for depression -- with the intent of drugging them if symptoms are present.

Investigative journalist Kelly Patricia O'Meara has authored an important op-ed piece on the dangers of the Mothers Act, and I'm publishing it here, with her permission, to share this with NaturalNews readers.

Those wanting to stay up to date on the battle against psych drugs may also be interested in following CCHR on Twitter:
http://www.twitter.com/CCHRINT

What follows here is authored by Kelly Patricia O'Meara:

Stress Testing the MOTHERS Act

It seems these days that everything is a test. Yes, the powers that be have decided that taxpayer benevolence now is contingent upon passing a stress test. But much to the dismay of those being tested, the results may reveal, for example, that the nation's financial wizards and auto giants are actually bankrupt midgets and unworthy of America's support.

Given that officialdom has embraced the stress test as a barometer of future viability and success and a determinant for public financing, it seems reasonable to request that other important issues that very personally impact the
health and welfare of the American people be subjected to similar stress tests. There is none more deserving of stress testing than the proposed MOTHERS Act.

On the surface, the MOTHERS Act reflects its sponsors overwhelming compassion and empathy for women suffering from alleged
mental health disorders resulting from childbirth – often referred to as Postpartum Depression. But when one conducts a brief stress test on important sections of the legislation, taxpayers may find that this costly and sweeping mental health legislation actually fails women of America, but goes a long way in inflating the balance sheets of one of the most lucrative industries in the nation – big Pharma.

For instance, the MOTHERS Act legislation that currently is pending in the U.S. Senate states that the Secretary of Health and Human Services may "make grants to eligible entities…" to deliver essential services to individuals with a postpartum condition. What the legislation doesn't delineate is who and what entities may receive these grants. Are these "entities" funded by
pharmaceutical companies? Lawmakers have not specified what constitutes an "entity" so it will be impossible to know if there are conflicts of interest between those who develop the screening tools and conduct research and the pharmaceutical companies who most certainly will benefit financially from the increased diagnosing.

Furthermore, no research guidelines have been provided for public disclosure. This is no small issue, given that the Senate Finance Committee recently exposed the conflicts of interest of the top ten psychiatric researchers in the U.S. who had received millions of dollars in pharmaceutical funding. Where is the guarantee that the "entities" are not pharmaceutical front-men?

The legislation also allows for the "expansion and intensification of activities" into the research of Postpartum conditions and "evaluation of new treatments." This is a humdinger. Despite ever-increasing published data and clinical studies challenging the safety of antidepressants and other antipsychotic drugs, there is no guidance provided by
lawmakers to mandate that the public be made aware of the avalanche of scientific data that not only questions the efficacy of the drugs available to mothers suffering from these conditions, but also warning of the dangers associated with currently available "treatments."

LANDMARK vaccine injury settlement (video) MMR!!!!

 

Minn. patient wants right to refuse electroshocks

http://www.am1500.com/categoryfolders/Stories/S924315.shtml



Minn. patient wants right to refuse electroshocks

Ray Sandford doesn’t like electroshock treatments.

After more than 40 of them, he finds it hard to remember names and other things. His bipolar disorder is under control, he says, and he should have the right to say no.

But at age 55, after being in and out of mental hospitals for nearly four decades and being declared legally incompetent, Sandford has no choice. His caregivers persuaded a judge after he hit a low point last year that he had no alternative but electroconvulsive therapy (ECT) plus a combination of anti-psychotic drugs.

"I just don’t like the idea of them being able to force these treatments," Sandford said.

Now a group in the "Mad Pride" movement that advocates for the mentally ill has taken up Sandford’s cause, arguing that nobody but him should dictate how he’s treated.

David Oaks, executive director of MindFreedom International, led about 24 people in a rally at the Minnesota Capitol in early May to draw attention to Sandford’s case. The Eugene, Ore.-based group opposes involuntary psychiatric treatment and all use of ECT, and Oaks calls Sandford a victim of torture.

"This is worse than waterboarding," Oaks said. "Offer somebody the choice between waterboarding or forced electroshock and a lot of our people who know what it is will say waterboarding."

But defenders say ECT is safe and effective in many severely depressed patients for whom drugs have failed.

"It’s not torture," said Dr. William McDonald, a psychiatry professor at Emory University who chairs an American Psychiatric Association committee on ECT. "That’s a completely unfair characterization. It’s inflammatory."

Sandford’s legal guardian, Lutheran Social Service of Minnesota, mostly declined to talk about his case because of privacy rules. Eric Jonsgaard, senior director of its guardianship program, said ECT was the court’s decision, not the agency’s.

"We would love to be able to say here’s what’s going on in this case, but we have to look out for his best interest," Jonsgaard said. "Frankly, here’s a man with capacity issues who doesn’t understand all that this is doing to his life."

Experts aren’t sure why ECT works. It triggers a seizure, and one theory is that it somehow "resets" the brain.

McDonald said ECT patients typically are put under general anesthesia for about 10 minutes and given muscle relaxants to prevent spasms. He said they get just enough electricity to cause a seizure. When patients wake, they have little or no memory of being shocked. Some patients have side effects such as temporary memory loss, headaches and nausea, but they are manageable and there is no brain damage, McDonald said.

ECT is given to selected people suffering severe depression including bipolar disorder, not generally for other mental illnesses. McDonald said it can be 80 to 90 percent effective in causing at least a temporary remission in a patient’s disorder. Most of the thousands of patients who undergo the treatment every year do so voluntarily, he said.

Sandford did, too _ at first.

Sounding lucid and alert in a phone interview, he said he "agreed very nicely" to the treatments at first, even though he found them frightening. He thought he would get only three, he said.

"It just went way beyond that," he said.

His mother, Marilyn Sandford, said she also supported a few treatments for her son. A retired nurse from Edina, she was familiar with ECT because she actually helped administer it during her career and had seen its benefits. But she said the more than 40 he has received is unjustified.

A court order authorizing ECT for Sandford said he has been admitted more than 30 times to the Anoka-Metro Regional Treatment Center over the years. When he arrived at the psychiatric hospital in January 2008, the order says, he was "grossly psychotic, yelling violently, smearing feces all over, urinating whenever and wherever he felt like it."

While at the hospital that time, the order said, Sandford "required seclusion and restraints on many occasions. His behavior was unpredictable and uncooperative. He was violent, striking out at staff and other patients, and he exhibited delusional and grandiose behavior."

Two court-appointed examiners _ a psychiatrist and a psychologist _ reported to the court last summer that Sandford had improved significantly as a result of the subsequent ECT and drug therapy, but they agreed he remained a danger to himself and needed continued ECT. He failed to persuade a judge last December to stop the treatments.

Sandford now lives in a small assisted-living home in Columbia Heights, and undergoes ECT once every 30 days.

"They can actually tie me up, take me by ambulance to the place and give me the shock treatments if they wanted to do that," he said.

Pamela Stuntz, a psychology professor at Texas Christian University who hasn’t been involved in the case, said the fact that Sandford was moved into a less restrictive setting suggests that "the people who’ve been treating him have been doing a very good job."

Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania, said unwanted invasive procedures can be justified if they’re in the patient’s best interest, are something they’d want if they were competent, and if nothing less intrusive would work.

"The real issue for the family, the guardian and the court is, ’Is it working?’ And if it is working, how do we get him the minimal amount that keeps him functioning. And I would say that about any treatment," Caplan said.

Oaks said Sandford acknowledges he needs help, but he considers Sandford competent enough to refuse ECT. He noted that Sandford was functioning well enough to use the Internet to find his group and ask for help.

"He’s been consistent and focused and clear and reasonable about why he doesn’t want shock. ... No should mean no for extreme, controversial, potentially irreversible, intrusive procedures," Oaks said.

The "Mad Pride" movement includes groups and individuals that seek not only an end to forced treatment, but to redefine their conditions as something to be respected instead of diseases to be suppressed.

Most members of MindFreedom International are "psychiatric survivors" who’ve been abused by the mental health establishment, said Al Galves, a MindFreedom board member and psychologist from Las Cruces, N.M.

Caplan, the ethicist, said it’s good that groups like MindFreedom are trying to reduce the stigma faced by people with mental illnesses. But he said it’s wrong to lump all mental health challenges together.

"The mental health area is a big tent, but some of the people in the tent really do have severe problems and I’m not sure one-size-fits-all is the right answer," Caplan said.

(Copyright 2009 by The Associated Press. All Rights Reserved.)

Lawmaker wants investigation of psychiatrist who prescribed drugs - Gabriel Myers

Comments can be made here: http://www.miamiherald.com/news/broward/story/1043611.html (short registration required)

Letters to the editor here:
HeraldEd@MiamiHerald.com

Miami Herald
Probe sought of doctor who prescribed drugs to 7-year-old
A lawmaker who chairs a state Senate committee on children has asked the state to investigate the doctor who treated a foster child who killed himself in Margate.
By CAROL MARBIN MILLER

A powerful Florida lawmaker has asked two state agencies to investigate a Broward County psychiatrist who had been treating Gabriel Myers, a 7-year-old who hanged himself last month in the bathroom of his Margate foster home.

In separate letters to the Florida Board of Medicine and the Agency for Health Care Administration, state Sen. Ronda R. Storms, a Brandon Republican who chairs the Children, Families and Elder Affairs Committee, requested investigations leading to a ``full report.''

Gabriel died April 16 after locking himself in a bathroom and hanging himself with a retractable shower cord. His death spurred DCF Secretary George Sheldon to appoint a work group to study the agency's use of psychiatric drugs, and its compliance with a 2005 reform law on the use of such medications on children in state care.

`SERIOUS CONCERNS'

The work group will meet for the first time Thursday in Fort Lauderdale.

''In my view, this case raised serious concerns which demand attention and answers,'' Storms wrote in a May 1 letter to AHCA Secretary Holly Benson. Under the 2005 law, AHCA oversees a state program that monitors the prescribing of mental-health drugs to children under Medicaid, the state insurance program for the needy.

The program, called the Medicaid Drug Therapy Management Program, tracks the prescribing of mental-health drugs to children, and flags psychiatrists whose practices veer outside generally accepted protocols.

Among the practices that might draw attention: doctors with a high volume of prescriptions of mental-health drugs or potentially dangerous combinations of the medications. The program looks at the practices of about 17,000 doctors who prescribe medications to children on Medicaid, and about 300 to 450 end up red-flagged.

Dr. Sohail Punjwani, who was treating Gabriel, had been red-flagged by the medication program every quarter that the list was kept, one of the administrators told The Miami Herald.

Punjwani did not return calls from The Miami Herald for a comment.

In her letter to Benson, Storms asked what AHCA was doing to monitor the activities of doctors whose prescribing practices were identified as ``problematic.''

''What guidelines or repercussions for red-flagged physicians are in place to prevent practices that result in a loss of life?'' Storms wrote. ``What actions, legislative remedies or otherwise, should be taken which would provide the citizens of our state a greater level of protection?''

Spokespersons for both state agencies declined to discuss the requests by Storms.

`VERY SERIOUS'

Eulinda Smith, a spokeswoman for the state Department of Health, which oversees the Board of Medicine, said the agency does not comment on investigations of doctors unless or until a finding of probable cause has been made. ''If someone files a complaint,'' she said, ``that's how we begin our disciplinary process.''

''It's very serious when we get a head's-up from a legislator,'' Smith added. ``That would prompt us to begin the disciplinary process.''

Punjwani has not been disciplined before by the Board of Medicine, Smith said.

Shelisha Durden, a spokeswoman for AHCA, would only confirm that her agency received Storms' letter and that the agency is reviewing it.
 

Gabriel Myers, 7 yrs old, drug induced suicide in state care -No Parental Consent

 
 
Letters to the editor: http://www.sptimes.com/letters/


St. Petersburg Times
DCF must do better
A Times Editorial
May 12, 2009

A little boy in foster care is dead by his own hand, but a poorly functioning child welfare system also is responsible. Last month, 7-year-old Gabriel Myers hanged himself on an extendable shower hose while in a South Florida foster home. At the time he was taking a combination of psychotropic medications, one of which carries a warning that it might lead to suicidal behavior in children. State law was ignored in giving the child the medicines without consent from his mother or a judge. In the final outrage, this child was given risky drugs but not the intense attention he so obviously needed.

St. Petersburg Times staff writer Kris Hundley reported that at the time of his death, Gabriel was taking Vyvanse, an ADHD drug, and Symbyax, a combination antipsychotic and antidepressant, which warns of heightened suicide risk in children particularly when first prescribed. 

Six times, Gabriel's caseworker had documented that the Department of Children and Families had parental consent for the medication. But there was no such consent. Gabriel's mother signed a general medical authorization on the same day she was found unconscious in her car with powder cocaine, crack and oxycodone in her possession. But when a child is in state custody, a parent must give explicit consent after being "expressly informed" about changes in a child's medication, including being told of medications' benefits and risks and about alternative treatments.

That never happened in Gabriel's case, and it appears this case is not unique. It has been a common practice for DCF workers and physicians to fail to obtain parental consent when a psychotropic drug is for a nonpsychotherapeutic use, under the mistaken impression that the law didn't require it.

And foster care advocates say that DCF's internal records are abysmal in tracking children taking psychotropic medications. This also suggests that proper consents are not being obtained.

DCF Secretary George Sheldon is responding appropriately to Gabriel's tragic death. He is closing the loophole that allowed the prescribing of mood-altering drugs without parental consent. He has named an impressive committee to investigate Gabriel's death and make recommendations. Sheldon also made public the details of Gabriel's situation rather than try to cover up DCF's failings. That alone bodes well for an honest accounting and a sincere desire to reform.

But to prevent a similar situation, Sheldon will have to look beyond a caseworker's failure to inform a parent and address a system's failure to adequately meet Gabriel's needs.

Gabriel said he had been a victim of sexual abuse before moving to Florida, which means he should not have been placed in any foster home where there were small children present. As Gabriel started engaging in inappropriate touching, he was bounced from one foster placement to another to protect other children. This kind of shuffling can add trauma to a child who is already at risk.

Gabriel also didn't receive all the behavioral therapy he needed, and he lost the therapist with whom he had established a relationship. Sheldon noted that in the days before his suicide Gabriel changed medications, moved to a new foster home and received a new therapist.

Sheldon has it right when he says that Gabriel's death "ought to mean something." State law needs to be followed when prescribing medication for children in foster care. And particularly when it comes to damaged children, there has to be a recognition that drugs are no substitute for basic human care and attention.

Autism linked to vaccines

 
Autism linked to vaccines    
Written by Neil Godbout   
Friday, 01 May 2009
The hype is on. There's a photo in the April 29 Citizen of a public health nurse (not wearing gloves) just finishing up a shot to a crying child. But there are grave problems.
Since mass vaccination of infants and children in the 1980s, reports of serious brain, cardiovascular, metabolic and other injuries started filling medical journals. The incredible number of children diagnosed with autism seems to directly correlate with the hepatitis B and hemophilius influenza Type B vaccines given to infants in the early 1990s.
These two vaccines are promoted by Health Canada, for two-month-olds, four-month-olds, etc., along with vaccines for diphtheria, pertussis, tetanus and polio. All six are rolled into one "multiple" vaccine. Further, infants are given two more vaccines: pneumococcal and meningococcal conjugate. That's three shots in one sitting: the six-in-one "muitiple" vaccine and the two conjugates. Altogether eight vaccines.
Now each vaccine may have as many as 18 ingredients. So do the math: 144 ingredients. Any doctor or health official would be lying if they said a "multiple" vaccine does not collectively consist of many high-toxic compounds: mercury, aluminum, formaldehyde, etc.
It's well-documented that many doctors don't approve of "multiple" vaccines or inoculating an eight-week old. All vaccines are immune-suppressing, leaving the recipient vulnerable to many diseases. The infant's immune system, barely developed, needs time to settle down. Many doctors recommend giving just one vaccine at a time. Some claim the child should be two-years-old before any vaccination - then they be given one vaccination only every six months. (Source: www.donaldmiller.com)
Delay in DPT immunization until two years of age in Japan resulted in a dramatic decline in adverse side effects, an 85% to 90% reduction in severe cases and death.
In the U.S., vaccine manufacturers have paid out nearly $2 billion in damages to parents whose children were harmed by one of the childhood jabs. In all, 2,000 families have received compensation payments.
Children who receive multiple vaccines are at risk of autism, attention deficit disorder or attention disorder hypersensitivity addiction). Estimates show in the U.S. at least two million children have these diseases. By 1995 well over 1.5 million children were taking Ritalin to treat these illnesses.
Dr. Meyer Eisenstein, medical director of Homefirst Health Services in Pennsylvania, founded the practice in 1973. He has treated 30,000 children over the years, most Amish. He claims the Amish have two things in common: they have never been vaccinated and they have never developed autism.
Marilyn Juds
Prince George

State Medicaid policy encourages use of drug under fire

 
5/5/2009 11:04:00 AM Email this articlePrint this article 
State Medicaid policy encourages use of drug under fire
Despite federal advisories, state does not restrict Risperdal’s use
Richard Moore
Investigative Reporter

A Lakeland Times investigation

The second in a series

As a thick thunderhead of concern over so-called atypical antipsychotic drugs continues to rumble across the country, the state of Wisconsin is keeping some of the medicines on its Medicaid Preferred Drug List, including the most controversial one, risperidone, thereby encouraging through official policy its widespread use in nursing homes and by doctors.

In contrast, a number of states, including South Carolina and Texas, have filed lawsuits against the drug's brand-name manufacturer, Janssen Pharmaceutica, calling its product, Risperdal, among other things, inherently dangerous and hazardous to human health and seeking the return of millions of dollars in Medicaid reimbursements paid to the company.

Not in Wisconsin, however, where Risperdal and, as of last year, its generic formulation remain popular with the medical establishment, and the preferred drug designation means it can be dispensed without medically necessary prior authorization (though since November using Risperdal rather than the generic product requires a brand-necessary prior authorization).

But as the drug flows as freely as ever to patients often unaware of the threats, an equally steady stream of studies continues to connect Risperdal and other so-called atypicals to a broad array of health risks and side effects.

The federal Food & Drug Administration issued a warning in 2003 after clinical trials linked the drug to a significant increase in the risk of stroke and diabetes. In 2005, FDA whistleblower Dr. David Graham estimated that off-label use of atypicals could cause as many as 62,000 excess deaths a year.

More recent studies have underscored the high risk of mortality in all of the atypicals.

For example, patients ages 30 to 74 who took atypical antipsychotics such as Risperdal, Seroquel, Zyprexa and Clozaril had a significantly greater chance of sudden death from cardiac arrhythmias and other cardiac causes than patients who did not take them, according to a report released in January by the federal Department of Health & Human Services' Agency for Healthcare Research and Quality.

The higher the dose, the greater the risk of death, the study found.

What's more, the state approved Risperdal as a preferred drug without any diagnostic restrictions almost a full year after the FDA issued a black-box warning about giving Risperdal and other atypicals to the elderly. The FDA acted after 15 out of 17 clinical trials showed morbidity rates rising 70 percent among elderly patients with dementia after being treated with the drugs.

In the Badger State, one northern Wisconsin family says their elderly father died last year after being put on Risperdal at Taylor Park Nursing Home in Rhinelander, and The Lakeland Times has confirmed other cases where elderly patients treated for dementia or aggression have suffered adverse reactions.

Many of those affected are pointing fingers at doctors and nursing homes, but, whether or not that blame is justified, the rise of Risperdal is a story that starts with the state itself - and in the obscure committees that recommend approval of drugs for preferred use.

The preferred drug list

The state initially adopted a preferred drug list in 2004, after Gov. Jim Doyle pressed for the measure in his first budget address. Doyle said the program would save Wisconsin taxpayers $15 million a year.

It works like this: The state selects brand-name prescription drugs to include on the list, which means they do not require "prior authorization" before Medicaid will reimburse payments for them. Non-preferred drugs in the same classes do require prior sanction, though a doctor can seek the use of a non-preferred drug if the patient meets certain medical criteria.

For those considered for a spot on the preferred list, the state tries to negotiate a deal with the pharmaceutical companies in which a certain percentage of the costs are rebated to the state.

For example, Wisconsin paid $10 million in atypical antipsychotic reimbursements in the first quarter of 2006, though, after rebates, the final cost was about $7.5 million. That's a pace of about $30 million a year just for atypicals, but it also represents a savings of about $10 million over the price had the rebates not existed.

"I am committed to ensuring that people get the prescription drugs they need, while taxpayers are protected by smart buying at better prices," Doyle said in announcing the preferred drug list program. "These new measures will result in the largest drug discounts and lowest drug prices ever received by the state for the Medicaid, BadgerCare, and SeniorCare programs."

At the time, a Department of Health and Family Services division administrator, Mark Moody, said the preferred drug list was based on the "therapeutic significance and cost effectiveness of each drug."

To establish drugs on the list, he said, the state's Medicaid Prior Authorization Advisory Committee reviewed the most current research and clinical information available, as well as drug price information submitted by manufacturers.

But what were the real criteria the prior authorization advisory committee - a group of physicians, pharmacists, and advocates, according to the Doyle administration - used in making its decision?

To answer that question requires a look at the committee as well as the minutes of the meeting during which the decision about atypicals was made.

A fateful day

Risperdal's run in the sun in Wisconsin began on March 29, 2006, when the state's Medicaid prior authorization advisory committee convened to consider the class of drugs known as "atypical antipsychotics."

The committee's members were Tom Frazier, the executive director of the Coalition on Aging; Nancy Phythyon, the president of the Wisconsin chapter of the National Alliance on Mental Illness (NAMI); Michael Witkovsky, a child psychiatrist; Steve Mailke, a 25-year professional in the pharmaceutical healthcare industry and a vice president of Trivantage Pharmacy Strategies, a pharmacy benefit consulting and auditing firm; Alicia Walker; and Rosanne Barber.

In all 14 people offered "public" testimony that day before the committee, according to the meeting summary; not one opposed the inclusion of the atypicals on a preferred drug list nor did anybody request diagnostic limitations. Indeed, most cautioned the panel not to restrict physicians' prescribing options but to give doctors wide discretion to choose among the various brands.

There was Carol Mixdorf, a parent of a consumer, who said prescribing flexibility had given her the ability to obtain a variety of drugs for a family member - drugs that had led to less frequent hospitalizations and allowed the family member to work.

Jennifer Lowenberg, of NAMI, also favored no prescribing limitations, as did Dr. Luis Vazquez, a Milwaukee psychiatrist who said restricted access would increase emergency room and other physician-related costs.

Six industry representatives touted their own brands for the preferred drug list, while Gary Yeast of the Wisconsin Coalition for Advocacy, Dr. Burr Eichelman of UW Hospital and Jerry Halverson of the Wisconsin Psychiatric Association also testified in favor of including atypicals without prescribing limitations.

Without question, speakers with affiliate connections or personal ties to the pharmaceutical industry dominated the session. The clamor for PDL inclusion of the drugs by industry representatives was obvious, but some of the "advocacy group" testimony cannot be accepted at face value, either, given long-standing and recently renewed questions about pharmaceutical industry influence within that sphere.

Take NAMI, for instance, which has a history of association with such pharmaceutical giants as Ely Lilly, which manufactures Zyprexa. According to a report in Mother Jones Magazine, pharmaceutical companies donated $11.7 million to the group between 1996 and 1999 alone.

A 2001 NAMI publication, "Access to Effective Medications," promoted the atypicals, and the organization has conducted a decade-long lobbying effort at the state level for the drugs. The group also pushes another program - TeenScreen - which critics blame for an exponential increase in antipsychotic prescriptions for teenagers.

More recently, NAMI's 2007 annual report lists the makers and developers of major antipsychotics - Janssen; GlaxoSmithKline Plc; Eli Lilly - among the group's corporate partners, along with the Washington-based trade group Pharmaceutical Research and Manufacturers of America.

Grassley launches probe

Just three weeks ago, Sen. Charles Grassley (R-Iowa) broadened his probes of pharmaceutical influence in health care policymaking by homing in on the finances of non-profits, especially NAMI. Grassley acted after a piece in the Journal of the American Medical Association rekindled concerns about the cozy relationships between advocacy groups and industry.

On April 6, Grassley sent a letter to NAMI asking the organization to disclose its industry funding.

"For the last three years, the (Senate Finance) Committee has been investigating various aspects of the pharmaceutical industry, including consulting arrangements and industry funding for Continuing Medical Education (CME)," Grassley wrote. "... I have come to understand that money from the pharmaceutical industry shapes the practices of non-profit organizations which purport to be independent in their viewpoints and actions. Specifically, it is alleged that pharmaceutical companies give money to non-profits in an attempt to garner favor in ways that increase sales of their products."

Grassley has asked NAMI to document any transfer of value from a pharmaceutical company, including grants, donations, and sponsorship for meetings or programs from January 2005 to the present.

The American Psychiatric Association has also come under scrutiny from Grassley and his committee for its ties to the industry. The senator asked for an accounting of its finances last year.

In 2006, according to the New York Times, the drug industry accounted for about 30 percent of the association's $62.5 million in financing, with 50 percent coming from advertisements in psychiatric journals and exhibits at its annual meeting, and the other half to sponsor fellowships, conferences and industry symposiums.

In March, the association said it would no longer accept industry support for symposiums and meals.

Consulting independence?

If the public at the prior authorization advisory committee's March 2006 meeting was largely a subset of what might be called the pharmaceutical industry public, the consultant-driven reviews following the testimony did little to cast doubt on what committee members had just heard.

Following a closed session, the committee entertained Dr. Valerie Taylor from Provider Synergies - which has signed a consulting contract to manage Wisconsin's PDL and to provide rebate contracting services - who presented a therapeutic class review of atypicals, and Dr. Mike Mergener from APS Healthcare, who provided summary conclusions from the Drug Effectiveness Review Project (DERP).

Neither addressed any concerns with the drugs, at least according to the meeting summary, but rather restated pharmaceutical company arguments.

"The side effect profiles differ from conventional antipsychotics by producing low EPS (movement disorders) and they also are effective in decreasing negative symptoms associated with schizophrenia," the minutes summarize Taylor's presentation.

Taylor did not mention - or the minutes do not reflect it - that several studies had, by March 2006, challenged the claim that atypicals have fewer side effects and were more effective than the older antipsychotics.

For example, a 2000 Oxford University analysis of 52 studies published in the British Medical Journal found no difference in effectiveness between the newer and older drugs, while a 2003 German review in The Lancet found only Clozaril to have fewer side effects than the older medications.

A 2003 U.S. Veterans Affairs study of 309 patients with schizophrenia or schizoaffective disorder found "no significant differences" between the two groups in terms of schizophrenia symptoms, dropout rates, quality of life, or EPS.

Also lacking in the official record of Taylor's presentation was any mention of the FDA's 2003 warnings about an increased risk of diabetes and stroke and its 2005 black-box warning about increased risks of death among the elderly, which had been issued only 11 months before.

Taylor did say that, in comparing the atypicals among themselves, the drugs showed a similar efficacy, with Risperdal causing the most EPS.

Mergener reviewed the so-called DERP report.

The Drug Effectiveness Research Project, or DERP, is part of the Oregon Evidence-based Practice Center at the Oregon Health and Science University. It was established in 1997 as a collaboration of public and private organizations, now including 18 states, that have joined together to provide systematic evidence-based reviews of the comparative effectiveness and safety of drugs and then to use the findings to make public policy decisions, such as which drugs to include on PDLs.

The pharmaceutical industry has never been crazy about the DERP program, but, on the other side of the unsympathetic coin, critics have said the findings drive patients to certain drugs, and that many of the findings are too narrowly drawn.

That may or may not be. Consumer Reports used DERP data to draw its own conclusions, and it did report that the older antipsychotics were as safe and effective as the newer atypicals. Still, that didn't stop the group from naming Risperdal one of its Best Buy drugs, and the official record of Mergener's 2006 presentation does not cite any problems that might be contained within the DERP data.

"... the report found that in head-to-head studies, different drugs in the class have different superiorities, in efficacy depending on the study," the minutes cite Mergener as reporting. "Overall, no agent demonstrated consistent benefit over any other drug. There are a wide variety of differences in the side-effect profiles of the drugs. In summary, there are no clear-cut first line agents in indications, efficacy or side-effect profiles."

That said, the advisory committee proceeded to a vote, a unanimous approval of Risperdal and other atypicals for the PDL list, without diagnostic restrictions. Only Zyprexa and Symbyax were left off.

A state mental health advisory committee reviewed the recommendation the following month; the DHFS secretary then approved it.

To be sure, the official record of the March 29 meeting does not reflect discussions about atypicals that might have occurred in prior meetings, and it is itself only a summary of that meeting, but at the committee's subsequent August meeting no one challenged its accuracy and voted unanimously to approve the summary - a record that tilted heavily toward broad use of the drugs.

Then, too, the vote to put certain atypicals on the list itself ratified the official record, but, given the limited testimony and omitted hazards, was the decision based on what Moody had said would be "the therapeutic significance" of the drugs or on something else? It was a question a member of the mental health advisory group would ask the following month.

During that April 12 meeting, Moody acknowledged the limited testimony, according to the meeting summary: "He indicated that they reserved time for consumers to testify but had limited consumer testimony due to a variety of factors."

The variety of factors was not defined.

Then, at one point, committee member Harold Harsch "questioned the logic behind not including Symbyax and Zyprexa," the summary states. "Mr. Moody responded that he could not speak for the committee members but indicated the discussion focused on side effects and cost."

Mental Health Advisory Committee member Barry Blackwell commented that both of the recommended non-preferred drugs were from the same manufacturer, which did not offer supplemental rebates. He questioned whether the decision was based on science or finances.

According to the summary, Moody responded that the committee was advised to consider the clinical evidence first. All in all, though, the discussion was confined to a dialogue about which atypicals should be on the lists, not about the efficacy of whether any should be on the list.

The die was cast.

To live or let die?

Certainly Risperdal and other atypicals had been prescribed by doctors and used in nursing homes long before that March 2006 vote, but the decision that day set the stage for the drugs' continued and, indeed, even more widespread, dispensation.

As one mental health advisory group member said in the April meeting, if a drug is not on the PDL, a doctor isn't likely going to use it.

The decision may have led to other serious ramifications.

For instance, the state did not update its medical consent form to include the federal black-box warning until this past month, four years after its issuance. That form is used by nursing homes to get treatment consent from patients and families.

Meanwhile, until very recently, studies have shown a marked increase in the use of Risperdal and other atypicals in nursing homes, particularly to elderly dementia patients. About 30 percent of all nursing home residents receive antipsychotic drugs, according to the U.S. Centers for Medicare & Medicaid Services, and about 20 percent of residents who do not have a psychosis diagnosis are on the drugs, CMS reports.

Citations for violations of drug-misuse rules have increased by nearly 40 percent since 2004, CMS states, though many facilities are reducing their use of antipsychotic drugs and more carefully monitoring residents who use them.

The numbers vary greatly from state to state, and, with increasing criticism directed at the drugs, many facilities are using them only as a last resort.

That does not appear to be the case in Wisconsin.

Back in 2006, a member of the state's mental health advisory committee put his finger on the problem.

For 20 years, according to the minutes, Ted Collins said he had been looking at nursing home populations. Twenty-five years earlier, he stated, there was an overuse of traditional antipsychotics in nursing homes, which regulations had dramatically decreased. Now, though, he said, the introduction of atypicals had become no less problematic.

As a preferred drug in the state of Wisconsin, in 2009, it has likely become even more problematic, and, many say, more deadly than ever.

Next: A risperidone death at Taylor Park Nursing Home?

Parental Consent Act of 2009


H.R. 2218:  Parental Consent Act of 2009

Bill here: 
http://www.govtrack.us/congress/bill.xpd?bill=h111-2218
To prohibit the use of Federal funds for any universal or mandatory mental health screening program.

Speech here: 
http://thomas.loc.gov/cgi-bin/query/z?r111:E30AP9-0060
 

                                                                                                SPEECH OF
                                                                                            HON. RON PAUL
                                                                                                 OF TEXAS
                                                                       IN THE HOUSE OF REPRESENTATIVES
                                                                                   THURSDAY, APRIL 30, 2009


Mr. PAUL. Madam Speaker, I rise to introduce the Parental Consent Act. This bill forbids Federal funds from being used for any universal or mandatory mental-health screening of students without the express, written, voluntary, informed consent of their parents or legal guardians. This bill protects the fundamental right of parents to direct and control the upbringing and education of their children.

The New Freedom Commission on Mental Health has recommended that the federal and state governments work toward the implementation of a comprehensive system of mental-health screening for all Americans. The commission recommends that universal or mandatory mental-health screening first be implemented in public schools as a prelude to expanding it to the general public. However, neither the commission's report nor any related mental-health screening proposal requires parental consent before a child is subjected to mental-health screening. Federally-funded universal or mandatory mental-health screening in schools without parental consent could lead to labeling more children as ``ADD'' or ``hyperactive'' and thus force more children to take psychotropic drugs, such as Ritalin, against their parents' wishes.

Already, too many children are suffering from being prescribed psychotropic drugs for nothing more than children's typical rambunctious behavior. According to Medco Health Solutions, more than 2.2 million children are receiving more than one psychotropic drug at one time. In fact, according to Medico Trends, in 2003, total spending on psychiatric drugs for children exceeded spending on antibiotics or asthma medication.

Many children have suffered harmful side effects from using psychotropic drugs. Some of the possible side effects include mania, violence, dependence, and weight gain. Yet, parents are already being threatened with child abuse charges if they resist efforts to drug their children. Imagine how much easier it will be to drug children against their parents' wishes if a federally-funded mental-health screener makes the recommendation.

Universal or mandatory mental-health screening could also provide a justification for stigmatizing children from families that support traditional values. Even the authors of mental-health diagnosis manuals admit that mental-health diagnoses are subjective and based on social constructions. Therefore, it is all too easy for a psychiatrist to label a person's disagreement with the psychiatrist's political beliefs a mental disorder. For example, a federally-funded school violence prevention program lists ``intolerance'' as a mental problem that may lead to school violence. Because ``intolerance'' is often a code word for believing in traditional values, children who share their parents' values could be labeled as having mental problems and a risk of causing violence. If the mandatory mental-health screening program applies to adults, everyone who believes in traditional values could have his or her beliefs stigmatized as a sign of a mental disorder. Taxpayer dollars should not support programs that may label those who adhere to traditional values as having a ``mental disorder.''

Madam Speaker, universal or mandatory mental-health screening threatens to undermine parents' right to raise their children as the parents see fit. Forced mental-health screening could also endanger the health of children by leading to more children being improperly placed on psychotropic drugs, such as Ritalin, or stigmatized as ``mentally ill'' or a risk of causing violence because they adhere to traditional values. Congress has a responsibility to the nation's parents and children to stop this from happening. I, therefore, urge my colleagues to cosponsor the Parental Consent Act.