Gabriel Myers Investigation

South Florida Sun-Sentinel
State officials investigating whether 7-year-old suicide victim was given mind-altering drug
By Jon Burstein
April 24, 2009

MARGATE – State officials are investigating whether a 7-year-old boy who hanged himself in his Margate foster home had been given a powerful, mind-altering drug in violation of Florida law.

Three weeks before his April 16 suicide, Gabriel Myers was prescribed the drug Symbyax, which is a combination of the generic forms of the anti-depressant Prozac and the anti-psychosis drug Zyprexa, according to state Department of Children & Families records released Friday night.

But there was no court order in place for Gabriel to use the drug, the records show. Under Florida law, parental consent or a judge’s ruling is needed before a foster child can be administered a psychotropic drug.

It’s unclear whether Gabriel was taking Symbyax. Margate police have his medication logs as they investigate his death, according to DCF spokeswoman Leslie Mann.

Mann said the agency is examining why a court order was not obtained to put Gabriel on the drug.

“We are not sure at this time if the medication played a role in Gabriel’s death, but the department will seek a professional medical review of the treatment and prescription medication in Gabriel’s case,” she said.

The U.S. Food and Drug Administration has approved Prozac for use in children, but not Symbyax and Zyprexa. Even so, doctors have the right to prescribe any drug for any patient they think it will help.

Symbyax, like all anti-depressants, carries a “black box” warning – the strongest the FDA can issue – because anti-depressants increase the risk of suicidal thoughts in minors. Studies have not linked the drugs to an increase in suicides.

The FDA first issued the warning about Paxil in 2003, then extended it to all anti-depressants the next year.

In addition to Symbyax, Gabriel also was on Vyvanse, an attention deficit/hyperactivity disorder drug, records show.

At the time of his death, Gabriel was home alone with the 19-year-old son of his foster father. Gabriel got upset with the young man during lunch, locking himself in the bathroom and saying he was going to kill himself. The young man used a screwdriver to pick the lock and found Gabriel hanging from a shower hose, according to DCF records.

Gabriel was pronounced dead one hour later at Northwest Medical Center in Margate.

DCF is also investigating why Gabriel was being watched by the 19-year-old.

“The bottom line is that (the 19-year-old) should not have been left alone with Gabriel, if in fact he was,” Mann said.

DCF began releasing more than 1,000 pages of Gabriel’s child welfare records about 7:30 p.m. Friday, detailing a tragic life in which he was both a victim and an apparent danger to other children.

A month before his death, Gabriel told a therapist he was “a bad person,” the records state.

“(Gabriel) said, ‘I lied when I was 1 years old, then I lied when I was 2 years old. I was born a liar and I will always be lying,’ ” according to the therapist’s report.

DCF first learned of Gabriel in June after his mother was found passed out in a parked car in Hallandale Beach and he was in the back seat. The boy had come from Ohio–where authorities were looking into allegations that he had been sexually abused by an older boy, according to DCF records.

While in Florida, he bounced between his uncle’s home and two foster homes. He lived in one foster home from October until March, when fears arose that he might hurt a toddler in the house, according to DCF records. He was then moved to the Margate foster home, where he lived for the three weeks leading up to his death.

Gabriel Myers and Psychiatric Drugs

Miami Herald
Answers needed in case of child’s suicide
April 24, 2009
Editorial
OUR OPINION: Mistakes apparent in death of seven-year-old Gabriel Myers

By the time it becomes necessary for the Department of Children & Families to intervene in a child’s life, the youngster almost certainly has already been severely traumatized by neglect and abuse. The agency faces tough, agonizing choices, but the objective never changes: Always act in the best interest of the child. That didn’t happen in the depressingly sad case of 7-year-old Gabriel Myers, who threw a tantrum last week and hanged himself in the shower of a foster home.

Clearly, somebody dropped the ball. Now it becomes the responsibility of police, DCF and other agencies to determine what happened, how it happened and why. Then, DCF and all of the other public entities and individuals who had a hand in this matter — including the state lawmakers — should determine what must be done to prevent another child from suffering a similar fate.

Doctor `red-flagged’

A good place to begin the examination is with the menu of potent, mind-altering drugs that Gabriel was taking under a doctor’s prescription. The boy was being treated by a Broward psychiatrist who had been red-flagged by a state agency as having ”problematic” prescribing habits, according to a state Medicaid drug-therapy expert. The term applies to doctors with a high volume of prescriptions of mental-health drugs or who prescribe potentially risky drug combinations.

DCF has of history of relying too heavily on psychotropic drugs to manage children in its care. After a series of Miami Herald stories describing the problems, the Florida Legislature passed a law that attempted to control and limit the use of psychotropic drugs on children. The legislation cited a DCF study in 2004 showing that 13 percent of all children in state custody were receiving and least one psychotropic drug. The study also showed that 25 percent of the children living in foster care were being treated with psychotropic drugs, a rate five times higher than in the general population of Medicaid-eligible children.

Sound judgment needed

Laws can be prescriptive, provide guidance, set parameters. They specify fines and penalties when the intent, if not the spirit, of a statute isn’t followed. No matter how well it is crafted, though, no law can substitute for the human intuition and sound judgment of caring individuals.

People who cared about Gabriel, including a guardian ad litem and some of his relatives, believed that the psychotropic drugs he was being given could have been doing more harm than good — something the 2005 law attempted to address and cautioned against. More to the point, allowing potent drugs to be used inappropriately to control a child’s behavior would be a short cut that is contrary to DCF’s mission.

With Gabriel’s death, the question to be answered is whether the DCF is living up to its goal of acting in the best interest of the child.

7 year old on Psychiatric Drugs Hangs Himself

28,481 Signatures Against TeenScreen. Petition: http://www.petitiononline.com/TScreen/petition.html Video: http://www.youtube.com/watch?v=RfU9puZQKBY

Miami Herald
Broward child’s suicide raises questions about medication
A Broward foster child who killed himself last week had been prescribed powerful psychiatric drugs, some of which the FDA does not approve for children.
BY CAROL MARBIN MILLER
April 21, 2009

Weeks before his death, Gabriel Myers, the 7-year-old Broward boy who hanged himself in the shower of his foster home, had been prescribed a powerful mind-altering drug linked by federal regulators to an increased risk of suicide in children.

In all, Gabriel had been prescribed four psychiatric drugs, two or three of which he was taking at the time of his death, said Jack Moss, Broward chief of the state Department of Children & Families. Moss said he is not sure which medications the boy was taking because Margate police took the foster home’s medication log as part of an investigation into Gabriel’s death last week.

Three of the psychotropic drugs carry U.S. Food and Drug Administration ”black box” label warnings for children’s safety, the strongest advisory the federal agency issues. Three of the medications are not approved for use with young children, though they are widely prescribed to youngsters ”off label” — meaning doctors can prescribe the drug even if not formally approved for that use.

In 2005 — reacting to a series of stories in The Miami Herald that as many as one in four foster children were prescribed potentially dangerous mind-altering drugs — state lawmakers approved a law aimed at curbing their use. Children’s advocates now question whether the law is being ignored.

Gabriel was being treated by a Broward psychiatrist who is on a list of Florida doctors that the state Agency for Health Care Administration red-flagged as having ”problematic” prescribing practices, said Robert Constantine, director of AHCA’s Medicaid Drug Therapy Management Program, which tracks prescribing of psychiatric drugs to children.

The list flags doctors with a high volume of prescriptions of mental-health drugs or potentially dangerous combinations of the medications.

Dr. Sohail Punjwani has been on the list every quarter in which regulators have monitored the prescribing of psychotropic drugs since the program was created in 2006, said Constantine, a professor at the University of South Florida’s Mental Health Institute. The practices of about 17,000 Florida doctors who prescribe medications to children on Medicaid are studied every quarter, and about 300 to 450 end up red-flagged on the list.

And though Florida law requires that either a parent or judge consent to the use of psychotropic drugs on foster children, a source with knowledge of the boy’s case said Gabriel already had been taking a three-drug cocktail when Broward Circuit Judge Lisa Porter was informed at a March 11 hearing. The judge approved the medications over the objection of a court-appointed guardian, the source said.

”We are devastated,” said Jon Myers, the boy’s maternal uncle, who cared for him from June through October 2008. “Gabriel’s problems could not be solved by a pharmacy.”

Four feet tall and 67 pounds, with short-cropped brown hair, Gabriel was a bright, charming and often sweet little boy, those who knew him say.

But he already had a sad past hinting at a troubling future. Records obtained by The Miami Herald show Gabriel may have been molested by an older boy while he was living with grandparents in Ohio, while his mother was in jail.

On Thursday, Gabriel locked himself in a bathroom and hanged himself with a detachable shower head after arguing with the 19-year-old son of his foster dad about his lunch, Moss said.

DCF petitioned a judge on Tuesday to unseal the boy’s records in response to requests from The Herald and other media, spokeswoman Leslie Mann said.

Punjwani told The Miami Herald that he is board certified as a child psychiatrist. He did not recall Gabriel, but Punjwani said he was part of a ”huge” group practice and may have been one of many clinicians to treat the boy.

Punjwani defended the use of psychiatric drugs on children, even if they are not approved for such use, saying the lack of approval stems from the reluctance of drug makers and the medical establishment to launch clinical trials on children.

The anti-psychotic drugs, he added, are used routinely to treat mood instability and insomnia among children.

Gabriel originally had been prescribed Vyvanse, an attention deficit/hyperactivity disorder drug approved for kids aged 6 through 12, Lexapro, an anti-depressant which is not approved for children, and Zyprexa, an anti-psychotic drug that also is not approved for kids, said Moss.

Both Punjwani and Moss said they think the Lexapro and Zyprexa were discontinued in recent weeks, and that a drug called Symbyax — which contains the medication in Zyprexa along with another antidepressant — was substituted.

Symbyax, recently approved for severe depression, is among a group of commonly prescribed anti-depressants, such as Prozac and Paxil, that the FDA warned in 2003 were linked to an increase in ‘’suicidal thoughts or behaviors” among children. Symbyax is not approved by the FDA for use on children.

Dr. David L. Katz, professor of public health at Yale University’s medical school, called the use of such drugs on youngsters ”extremely risky,” He questioned whether the boy needed to be taking such powerful medications absent a diagnosis of schizophrenia. ”These are medications that are potent and potentially dangerous,” Katz said. “They certainly are powerful drugs for anybody, let alone a 7-year-old boy.”

Jon Myers, the uncle who cared for Gabriel after abuse investigators found him in a car in a Denny’s parking lot after his mother had passed out, questions whether Gabriel needed such potent medications to begin with.

Myers said the boy’s pediatrician had discontinued all psychotropic drugs while Gabriel lived with him, and the boy did well, earning A’s and B’s at the Hollywood Christian Academy.

”We did not have any issues with him having tantrums,” Myers said. “He would get upset, like little boys do.”

A week or two before Gabriel died, his grandfather in Ohio expressed concerns that the boy sounded overmedicated. ”My father said that the last conversation he had a couple of weeks ago Gabriel sounded like he was too drugged,” Myers said.

“He sounded like he was doped up.”

Child Drugging in the US Must End

World Experts Demand End to Child Drugging in the US – Part II
April 9, 2009
http://www.lawyersandsettlements.com/articles/01510/child-drugging-fda.html
Washington, DC: Mathy Milling Downing was a featured speaker at the annual conference of the International Center for the Study of Psychiatry and Psychology and told the audience that her anger is directed toward the FDA and drug companies, “for their incompetence and lack of concern for innocent children they have helped to kill, my little girl included.”
Her 12-year-old daughter, Candace, hung herself from the valence of her bed on January 10, 2004, after being prescribed the antidepressant drug Zoloft for “test anxiety” at school.
Experts in the field of psychiatry and child development from all over the world attended this year’s annual conference in Washington with the agenda aimed at ending the mental health screening programs put in place by the Bush Administration’s New Freedom Commission and the mass-drugging of children with psychiatric drugs.
During her presentation, Ms Downing said she objected to placing Candace on drugs but was assured that Zoloft was safe and did not learn until after her daughter’s death that “up to four children out of every hundred run a risk of dying by their own hand or at least attempt to.”
Had she been given the opportunity to have informed consent on the dangers of SSRI’s, she said, “my child would still be alive.”
“I never would have allowed my child to be placed on a drug with no proven efficacy and a history of possible harm,” Ms Downing stated.
She described how she tried to contact doctors at the FDA numerous times to express her concerns, and no one was ever available to speak to her. She filed a complaint with MedWatch on March 18, 2004, and, “I am still waiting for my reply,” she stated.
“One would think that the FDA would support the needs of Americans over the greed of the various pharmaceutical corporations,” she said, “but that continues to be a pipe dream of mine rather than a reality.”
Critics say TeenScreen, billed as a suicide prevention tool, is nothing more than a drug marketing scheme developed by the pharmaceutical industry and a front group operating under cover of Columbia University to establish a customer base within the nation’s 50-odd million school children for the new generation of psychiatric drugs, including selective serotonin reuptake inhibitor antidepressants (SSRI’s) and atypical antipsychotics.
These so-called new “wonder drugs” include the antidepressants Prozac and Cymbalta by Eli Lilly; Paxil from GlaxoSmithKline; Zoloft by Pfizer; Celexa and Lexapro from Forest Labs; Effexor by Wyeth, as well as generic versions of the drugs. The atypical antipsychotics include Zyprexa by Lilly; Risperdal, marketed by Janssen Pharmaceuticals; Abilify by Bristol-Myers Squibb; Clozaril by Novartis, and Geodon by Pfizer.
Best-selling author of “Mad in America”, Robert Whitaker, tracked the profits of these “wonder drugs” since the first SSRI, Prozac, arrived on the market in 1987 and found a tremendous rise in the cost to taxpayers. In 1987, psychotropic medication expenditures were about $1 billion, but by 2004, in a 40-fold increase, the cost had risen to $23 billion.
According to Mr Whitaker’s analysis, global sales of antipsychotics went from $263 million in 1986 to $8.6 billion in 2004, and antidepressant sales rose from $240 million in 1986 to $11.2 billion in 2004.
In the paper, “Psychiatric Drugs and the Astonishing Rise of Mental Illness in America,” published in the Spring 2005 issue of the Journal of Ethical Human Psychology and Psychiatry, Mr Whitaker also reports that, in addition to breaking sales records, within 10 years on the market, “Prozac quickly took up the top position as America’s most complained about drug.” He further states:
“By 1997, 39,000 adverse-event reports about it had been sent to MedWatch. These reports are thought to represent only 1% of the actual number of such events, suggesting that nearly 4 million people in the US had suffered such problems, which included mania, psychotic depression, nervousness, anxiety, agitation, hostility, hallucinations, memory loss, tremors, impotence, convulsions, insomnia and nausea.”
According to the paper, “It is well-known that all of the major classes of psychiatric drugs – anti-psychotics, anti-depressants, benzodiazepines, and stimulants for ADHD – can trigger new and more severe psychiatric symptoms in a significant percentage of patients.”
Ms Downing has been on a non-stop crusade to prevent the death of more children since her daughter died and the family’s tragedy is featured in the documentary, “Prescription: Suicide,” which also includes the story of 6 families effected by their encounters with SSRIs and how their lives changed forever. A copy of the film is available on the Participate Now web site at www.participatenow.net.
Candace should never have been given Zoloft because it was never approved for use with kids. Prozac is the only SSRI approved for children in the US because it is the only drug reportedly shown to be effective in two pediatric clinical trials, a requirement that must be met to obtain FDA approval.
But according to ICSPP founder and leading SSRI authority Dr Peter Breggin, the term “effective” has little meaning because all a drug company has to do is show better results in kids treated with an SSRI than in children taking a placebo and can conduct 100 trials if need be to get the two positive studies. It stands to reason that with 50-50 odds, if enough trials are conducted, an SSRI is bound to do better than a placebo eventually.
However, with that in mind, experts say it’s important to note that, other than Prozac, the SSRI makers have not been able to provide the FDA with 2 positive studies out of all the clinical trials that have been conducted in hopes of obtaining FDA approval for the sale of SSRI’s to kids.
That said, SSRI makers have made a fortune by getting doctors to prescribe the drugs for unapproved uses. A University of Georgia study in the June 2006 Journal of Clinical Psychiatry found that 75% of persons prescribed antidepressants received them off-label. The researchers reviewed records of more than 106,000 Medicaid recipients in 2001 to examine the rates of off-label prescribing of drugs that act on the central nervous system and found 75% of antidepressant patients received the drugs for unapproved uses.
“More than two-thirds of the studies of antidepressants given to children showed that the medications were no more effective than a placebo, and most of the positive results came from drug company sponsored trials,” Dr Karen Effrem reported in her presentation at the ICSPP conference.
Litigation against drug companies has established this fact. In 2004, New York State Attorney General Eliot Spitzer brought fraud charges against Glaxo for hiding studies that “not only failed to show any benefit for the drug in children but demonstrated that children taking Paxil were more likely to become suicidal than those taking a placebo.” Two months later, Glaxo agreed to pay $2.5 million to settle the charges.
Mr Spitzer pointed out that Paxil was never approved to treat any condition in children, and yet doctors prescribed the drug to kids two million times in 2002, the same year that Paxil became Glaxo’s top seller with $3.8 billion in sales.
On November 1, 2006, the Associated Press reported that Glaxo “has agreed to pay $63.8 million to settle a lawsuit’s claims that it promoted its antidepressant drug Paxil for use by children and adolescents while withholding negative information about the medication’s safety and effectiveness.”
Critics say it’s not difficult to track the industry money involved in the promotion of TeenScreen. The program’s Executive Director, Laurie Flynn, was the Executive Director of National Alliance for the Mentally Ill (NAMI) for 16 years, which bills itself as a patient advocacy group, but in reality is the most heavily industry-funded front group in the US.
Mother Jones Magazine obtained NAMI documents for the period between 1996 and mid-1999, while Ms Flynn was running the show, which revealed that NAMI received a total of $11.72 million during that 3-year period from 18 drug companies, including Janssen, $2.08 million; Novartis, $1.87 million; Pfizer, $1.3 million; Abbott Laboratories, over $1.24 million; Wyeth-Ayerst, $658,000, and Bristol-Myers Squibb, $613,505.
NAMI’s top donor during that period was none other than Lilly, the maker of Prozac and Zyprexa, which coughed up a total of $2.87 million out of the goodness of its heart.
Ms Flynn also wrote an article promoting TeenScreen entitled, “Before Their Time: Preventing Teen Suicide,” in which she stated: “The TeenScreen Program developed 10 years ago by Columbia University and offered in partnership with the National Alliance for the Mentally Ill helps communities across the nation identify teens with mental illness who might be at risk for suicide.”
If TeenScreen is “offered in partnership” with NAMI, critics say, it goes without saying that millions of dollars of drug company money was invested in the program.
The efforts to implement TeenScreen by use of “this partnership” cannot be understated. A video-taped presentation at the annual convention of NAMI, obtained by researcher Sue Weibert, shows the TeenScreen crew telling the army of NAMI members from all across the country that helping set up TeenScreen might require contacting a child’s insurance company to check on coverage or driving a child to an appointment with a psychiatrist.
The video also shows the presenter passing around a notebook for signatures from members who would be willing to act as volunteers and rise up against anyone who speaks out against TeenScreen.
The presenter also explains the importance of bribing kids with movie coupons, pizza or other perks, because parents won’t agree to allow the children to be screened, so they need to win the kids over first and send them home to talk the parents.
Early on, NAMI and TeenScreen did not even hide the fact that drug money was funding the screening. In June 2002, the Tennessee Department of Mental Health and Developmental Disabilities Update Newsletter reported that NAMI and Columbia University sponsored the screening of 170 Nashville students with TeenScreen and that the survey was funded by grants from AdvoCare and Eli Lilly.
But two years later, in March 2004, Ms Flynn appeared at a congressional hearing trying to drum up the allocation of tax dollars to set up TeenScreen in public schools. During her testimony, she as much as defined the customer base the drug companies were after when she told the lawmakers that, “close to 750,000 teens are depressed at any one time, and an estimated 7-12 million youth suffer from mental illness.”
On September 27, 2007, psychologist Michael Shaughnessy, professor in Educational Studies at the Eastern New Mexico University and columnist for the educational news and information site, EdNews.org, was interviewed about his views on TeenScreen by Doyle Mills, an independent researcher in Clearwater, Florida who was instrumental in blocking TeenScreen from setting up shop in schools in Pinellas and Hillsborough Counties, two of Florida’s most populated counties, and has published several articles critical of TeenScreen.
Mr Mills shared his interview with Dr Shaughnessy at the ICSPP conference, in which the Professor called TeenScreen “a program aimed at locating, identifying and procuring new customers for the mental health industry.”
He says TeenScreen is a creation of psychiatrist David Shaffer, a paid spokesman for Lilly and paid consultant for drug companies Hoffman la Roche, Wyeth and Glaxo.
TeenScreen started out by claiming the program was free and required no government funding. But as it turns out, taxpayers are funding this marketing scheme from start to finish. Government money is being used to set up TeenScreen in schools all over the US and tax dollars are paying not only for the follow-up visits to prescribing shrinks but also for the majority of drugs prescribed.
The pilot programs of TeenScreen in five counties in Ohio were funded by five $15,000 grants allocated by mental health boards within the Ohio Department of Mental Health.
Medicaid record show that taxpayers in Ohio are footing the bill for most of the child drugging as well. In July 2004, over 39,000 children covered by Medicaid were found to be taking drugs for depression, anxiety, delusions, hyperactivity and violent behavior, and Medicaid spent more than $65 million for mental health drugs prescribed to children in 2004, according to an investigation by the Columbus Dispatch.
The massive drugging of patients covered by public health care programs is similar in states all across the US. In 5 years, prescription costs for Iowa Medicaid increased 82.5%, and by class, antipsychotics reflected the largest increase for mental health drugs.
In 2005, while the average cost for a first generation antipsychotic to Medicaid was only $36 a month, a month’s supply for a new antipsychotics cost between $100 – $1,000, according to the December 8, 2005, Mental Health Subcommittee Report to the Medical Assistance Pharmaceutical and Therapeutics Committee.
For the record, TeenScreen is not free, and it is costing tax payers a bundle. On November 17, 2004, the University of South Florida announced the receipt of a grant of $98,641 from the US Substance Abuse and Mental Health Services Administration to expand the TeenScreen program in the Tampa Bay area.
Florida Medicaid is also being bilked. On July 29, 2007, the St Petersburg Times reported that, in the last 7 years, the cost to taxpayers for atypicals prescribed to kids rose nearly 500%, and on average it cost Medicaid nearly $1,800 per child in 2006.
The Times reported that more than 18,000 kids on Medicaid were prescribed antipsychotics in 2006, including 1,100 under the age of 6 and some as young as 3, even though guidelines from the Florida Agency for Health Care Administration says that, with children under 6, psychotropic drugs should “only be considered under the most extraordinary of circumstances.”
In setting up TeenScreen to screen students in Brimfield, Illinois, “organizing the system and employing a part-time counselor specifically for the program is estimated to cost about $100 per student,” the July 11, 2005, Peoria, Illinois Journal Star reported.
Overall, the “Brimfield High School program alone will cost around $20,000 for the first semester,” the Journal noted.
The TeenScreen gang claims that it always obtains parental consent prior to screening students and that it does not diagnose students with mental disorders.
However, Michael and Teresa Rhoades, from Indiana, attended the DC conference and as a featured speaker, Teresa described how her daughter was TeenScreened in December 2004, without parental consent, and was told that she had not one, but 2 mental illnesses.
Teresa recalled the day that her distraught daughter came home and informed her parents that she had been diagnosed with obsessive compulsive disorder and a social anxiety disorder.
Michael and Teresa say they were furious to the point that they filed the nation’s first lawsuit against TeenScreen, charging that their daughter was wrongly screened, diagnosed, and labeled mentally ill in a public school without their consent.
“TeenScreen itself is a questionnaire with invasive and probing questions which indoctrinate young people into a belief that all their feelings and behaviors are indications of a mental disorder,” Dr Shaughnessy told Mr Mills in the interview.
He said, “the child is convinced of it, the parent is convinced of it, and then the child becomes a customer of TeenScreen’s local mental health ‘partner,’ which sells counseling or drugs and profits tens of thousands of dollars per child.”
Dr Shaughnessy acknowledged that adolescence is a hard time for everyone but said, “maybe it’s supposed to be,” that’s how we learn.
He says TeenScreen labels the normal pain and uncertainty of adolescence as a mental disorder for profit and asks, “When did adolescence become a disease or something unnatural or deadly that needs intervention if anyone is going to make it through?”
“”What a ridiculous concept,” Dr Shaughnessy added.
He also points out that school records for children are intended to be secure but says, once committed to paper or computer, nothing can be 100% secure. “Normal school records are fairly harmless no matter who sees them,” he states.
“TeenScreen records on the other hand,” he warns, “contain unscientific evaluations which can be taken to mean that the child has a permanent, incurable mental disorder.”
He also says these records can then be used against a child as an adult, to take away his rights, limit his opportunities or “just as a horrible embarrassment.”
“As there is no scientific way to prove that anyone has a mental disorder,” Dr Shaughnessy points out, “there is likewise no scientific way to disprove it.”
He told Mr Mills that this is one aspect that parents are never made aware of prior to allowing TeenScreen access to their children. “Once a person is diagnosed, he may never be able to escape that label,” he warns.

Professor of Psychiatry Busted

Martin Keller is a Professor or Psychiatry and Human Behaviour at The Warren Alpert Medical School of Brown University.
He has resigned after being busted for having financial ties to pharmaceutical companies.

TeenScreen Petition

Please sign. Your signature is important.
28,401 Signatures Against TeenScreen. Petition: http://www.petitiononline.com/TScreen/petition.html Video: http://www.youtube.com/watch?v=RfU9puZQKBY

Mental Health Advocacy Groups Have Funding Probed

http://www.bloomberg.com/apps/news?pid=20601124&sid=a4V6UEpXf_mY&refer=home

Bloomberg News
Grassley Probes Financing of Advocacy Group for Mental Health
By Nicole Gaouette
April 6
U.S. Senator Charles Grassley expanded his investigation into drug company influence on the practice of medicine by asking a nonprofit mental-health- advocacy group about its funding.

In a letter sent today to the National Alliance for Mental Illness , based in Arlington, Virginia, Grassley asked the nonprofit group to disclose any financial backing from drug companies or from foundations created by the industry.

The Iowa Republican, in a series of hearings and investigations, has focused on financial ties between the drug industry, doctors and academic institutions. His efforts have led New York-based Pfizer Inc. to begin disclosing consulting payments to U.S. doctors, and Harvard Medical School in Boston to reexamine its conflict-of-interest policies. Now Grassley is expanding his inquiries to nonprofit groups.

“I have come to understand that money from the pharmaceutical industry shapes the practices of nonprofit organizations which purport to be independent in their viewpoints and actions,” Grassley wrote in his letter.

Officials at the National Alliance for Mental Illness didn’t return calls for comment.

The group identifies itself as the largest grassroots organization in the U.S. for people with mental illness and their families. The group came under scrutiny in 1999, when the magazine Mother Jones reported that 18 drug companies gave the group $11.7 million from 1996 to mid-1999. The article reported that at one point an executive of Indianapolis-based Eli Lilly & Co. worked out of the nonprofit group’s headquarters.

A 2007 annual report showed that the group’s corporate partners at that time included Madison, New Jersey-based Wyeth ; London-based GlaxoSmithKline Plc ; Eli Lilly, which makes Prozac; and the Washington-based trade group Pharmaceutical Research and Manufacturers of America.

Financial Report

A separate financial report shows the National Alliance for Mental Illness brought in $10.5 million in contributions in the year that ended June 30, 2007. The donors aren’t broken out.

Vera Sharav , president of the Alliance for Human Research Protection , a New York-based nonprofit that promotes ethical research, said the National Alliance for Mental Illness may have drawn Grassley’s attention because it lobbies Congress for mental-health funding.

“Academics and physicians give an appearance of authority,” Sharav said by telephone. “Industry gives them the money. Grassley has been going after each group systematically, and the dots are being connected.”

In January, Grassley and Senator Herb Kohl , a Wisconsin Democrat, reintroduced the Physician Payment Sunshine Act, which would require manufacturers to report on payments to doctors and any physician-owned facility.

Pfizer Announcement

Grassley’s investigations have led to changes in industry and academia. Pfizer made its announcement about disclosing physician payments in February. In March, the American Psychiatric Association said it would no longer accept industry support for symposiums and meals at its annual meetings.

On April 1, Stanford University School of Medicine , near Palo Alto, California, said it would post on a Web site all income faculty earned from royalty payments and outside consulting.

In the March 31 issue of the Journal of the American Medical Association, a group of researchers and physicians called for professional medical associations to transform their operations to avoid conflicts of interest posed by “extensive funding from pharmaceutical and device companies.” The group included Steven Nissen , a Cleveland Clinic cardiologist.

Drug Reps Use Sophisticated Bribes

St. Petersburg Times
To move more prescription drugs, sales reps sling swag
By Kris Hundley  
Sunday, April 5, 2009

  
Ben Schaefer, a cardiologist in Maine, rid his practice of pharma-freebies last summer,
before drug companies voluntarily banned them. 
 
The transformation of a Jacksonville psychiatrist from a skeptic on Seroquel into a super-prescriber was marked by months of gentle pestering, generous $1,500 speaking engagements and giveaways of everything from a plastic brain to gourmet chocolates.

A neurologist in Tampa joked with Seroquel sales reps that she doled out so much of the powerful antipsychotic drug for migraines that they probably thought she was psychiatrist. She was rewarded with free trips to Scotland and Spain. “I want to go too ! =)” her Seroquel rep wrote.

A busy Panama City physician had no problem leaving patients to stew in the waiting room while he listened to a pitch about Seroquel from a persistent saleswoman.

“Dr had 3 pat (patients) waiting and did sit down w (with) me,” the rep wrote after a series of snubs at the front desk. “You never know what you will get w/dr b.”

Every day, legions of drug reps troop into doctors’ offices, then scoot back to their cars and enter notes about their encounters onto laptops or handheld devices. They include reminders about everything from medical questions to the doctor’s new Nissan 350Z or his kid’s Eagle Scout badge.

The notes are uploaded to a secure database at company headquarters and used by the drug rep, her partners and managers as the company refines its sales spiel.

Thanks to thousands of lawsuits pending against Seroquel, AstraZeneca’s best-selling antipsychotic, hundreds of pages of call notes concerning several Florida doctors recently were made public. Though specific to Seroquel, the salespeople’s notes reflect industry-wide practices. They give insights into what happens behind closed doors while patients cool their heels.

It’s not a pretty picture, with sales reps laying on the swag and doctors complaining about late honoraria and angling to get on the AstraZeneca’s “advisory board.”

Company spokesman Tony Jewell said the drug maker’s philosophy is that “any interaction with health care providers should be about providing information that helps them decide on the right medicines, for the right patients, at the right time.”

But notes from pharma’s emissaries reflect two different goals: Get the doctor to prescribe the drug. Then push him to boost the dosage.

A sales rep in Jacksonville was ecstatic when a nurse practitioner prescribed Seroquel at twice the dosage used by the psychiatrist in the same practice.

“Gave him goodies,” the rep wrote. “Biggest user of Seroquel in the office!”

• • •

AstraZeneca’s sales reps have worked wonders. Though approved only for schizophrenia and bipolar disorder, relatively rare mental illnesses, Seroquel has been one of the world’s best sellers. Last year sales reached $4.5 billion.

But Seroquel’s widespread use for everything from insomnia to anxiety has also triggered lawsuits alleging the drug caused weight gain, diabetes and other health problems. AstraZeneca, a U.K.-based company, denies the charges, noting that the FDA has repeatedly upheld the safety of Seroquel.

It also has denied that its salespeople illegally promoted unapproved, or off-label, uses of the drugs to doctors. Reps “are trained to ensure that every product promotion discussion with (a) health care provider conforms to the FDA-approved prescribing information,” Jewell said.

Company lawyers vigorously opposed unsealing sales reps’ notes, saying they contained confidential, proprietary information. But at a recent hearing in Orlando’s federal court, AstraZeneca agreed to release call notes from before January 2004, when Seroquel received FDA approval for bipolar mania.

Heavily redacted, the notes comprise what the company’s commercial brand leader, Alfred Paulson, described as sales reps’ “continuous conversation” with a half-dozen Florida health care providers who prescribed Seroquel to plaintiffs in pending lawsuits.

Depicting sales pitches, on which millions of dollars of revenue hinge, as simple “conversations” is an apt description for what, in the end, comes down to the chemistry between two people. Shahram Ahari, a drug rep for competitor Eli Lilly & Co. in 1999 and 2000, now lectures physicians on how to avoid being manipulated by well-trained marketing reps.

“As much as doctors want to think the relationship with a sales person is about the transfer of knowledge, it’s the affinity between two people that’s the big money-maker for the drug company,” said Ahari, who is part of Pharmedout.org, a physician-education group in Washington, D.C. “That’s why drug companies hire former cheerleaders and athletes as drug reps instead of scientists. It’s a question of how gregarious and engaging you can be.”

While AstraZeneca declined to comment on its employees’ compensation, industry data shows drug reps earn an average of nearly $100,000 a year, including bonuses based on sales.

They learn sales techniques more often associated with door-to-door soliciting than medical offices. Doc too busy to see you? Send in several sales people, daily if necessary, until you get a sit-down. Show up on rainy days when patients cancel. And even highly paid physicians find it hard to resist a free lunch.

In 1999, Seroquel reps tried to waylay Dr. Maria Carmen Wilson, the Tampa neurologist, four times before hitting gold.

“We were able to speak to her at lunch that we brought for the office,” a rep wrote.

Wilson moved from free food to free trips to medical meetings in Spain and Scotland. By early 2002, a drug rep noted that Wilson was using a “ton of Seroquel” for patients with migraines.

Wilson, who says she was surprised to learn that drug reps recorded their interactions with her, denies that she was ever a big Seroquel prescriber. Despite her initial hopes, she says the drug did not turn out to be effective against chronic headaches.

“I still use it in low doses for people with intractable insomnia,” said Wilson, an associate professor at the University of South Florida. “But I make sure patients are acutely aware of the potential for weight gain, especially if they have a predisposition to diabetes.”

Wilson says the industry-funded jaunts to Europe did not unduly influence her.

“I went because I want to be up-to-date and learn,” she said of the seminars, which she did not report, as required, to USF officials. “But frankly, I’d prefer they were in Orlando.”

• • •

The call notes show that massaging doctors’ egos consumed an inordinate amount of a drug rep’s time.

Saleswomen in Miami quickly honed in on psychiatrist Dr. Heriberto Cabada’s need for extra schmoozing. “Would not pay attention, all about him,” wrote one frustrated sales rep in 2001. So the line worker pulled in a “customer solutions” specialist who offered to redo the doc’s patient history forms with a personalized logo.

She agreed to Cabada’s demands for multiple revisions, “one side only and … marbled type paper.” More attention was funneled his way through a “preceptorship,” in which a sales rep shadows the doctor for the day and pays for the honor.

In a few months, Cabada went from prescribing what he called “chicken dosages” of Seroquel to higher doses. Soon after his conversion, however, Cabada closed his practice and moved to Spain, where he now lives. He did not respond to an e-mail seeking comment.

Drug reps are taught to use free samples as a strategic weapon: Parcel them out sparingly, even if there are box loads in the trunk.

“It makes the doctor even more grateful,” said former Lilly rep Ahari. “And when he gives a freebie to the patient, the doctor feels like a hero.”

Dribbling samples out in small caches, and requiring the doctor’s signature each time, also gives the rep another chance at valuable face time.

“Samples are key to access,” wrote a sales rep who was routinely brushed off by Dr. John Roy Billingsley in Panama City.

AstraZeneca said it has voluntarily banned many of its “reminder” giveaways to docs — free pens, pads and hand wash emblazoned with drug names. But the company declined to say how such changes have affected its spending on physicians.

Ahari said he doubts drug companies have pared back their marketing budgets. “The money going to influence physicians is exactly the same,” he said.

“There’s absolutely no enforcement of these voluntary guidelines. All the incentives are still in place to wine and dine doctors at Hooters if he needs to.”

The reason: it works.

Case in point: Dr. Mohamed O. Saleh, a Jacksonville psychiatrist who was involved in early clinical studies of Seroquel. In 1998, he was telling AstraZeneca reps that their product wasn’t effective and two years later he was still dodging salesmen.

By 2003, however, the rep was crowing that Saleh “really loves seroquel for elderly… said that he would — dose of 800 (mg) and even higher if necessary!”

Saleh and his nurse practitioner, Richard Daniel Malcolm, were wooed with everything from holiday treats (“Left pumpkin candy baskets … put seroquel labels on them”) to a video of Saleh for his use during a visit to Africa in 2002.

AstraZeneca also furnished Saleh with freebies for the trip. The payoff: the doctor told the drug rep he would put a picture on his Web site showing “African healthcare workers holding the Seroquel bags filled with (a text book) and pens/etc. Appreciated our support.”

Saleh, who said in July that he is still receiving $10,000 to $15,000 a year as a speaker for Seroquel, seemed aware of the persuasive power of drug company payola. In October 2003, he told AstraZeneca reps that he was concerned about his nurse practitioner, who had taken a fishing trip with the Seroquel rep and was pushing for his own speaking gigs.

“Concerned about payments to Dan (Malcolm) and can be inducement for scripts b/c paying so much,” wrote one of the two reps assigned to Saleh’s office.

Malcolm joined Saleh’s office in June 2001, four months after he was disciplined by the Florida Board of Medicine for pleading guilty to charges of domestic battery, driving with a suspended license and fraud in obtaining a medicinal drug.

Neither Saleh nor Malcolm returned calls or e-mails seeking comment.

• • •

When doctors complained that patients were ballooning up on Seroquel, sales reps often handed them a study by Chicago psychiatrist Dr. Michael J. Reinstein. Its startling message: “Use of S (Seroquel) to reduce weight and reduce risk,” according to a salesman who visited Panama City’s Billingsley.

Back at headquarters, however, company executives had serious questions about the validity of Reinstein’s findings. “Our clinical colleagues have significant and numerous issues in the past with the quality of research that this group has produced,” a note from Seroquel’s brand manager said in 2001.

While sales reps were not allowed to explicitly promote Seroquel for anything other than schizophrenia prior to 2004, the notes reflect a not-so-subtle, broad-based push.

In early 2000, Billingsley’s sales rep wrote, “S best in new Schizo’s, kids, adolescents, bi-pols, blacks and asians.”

Dr. Guido Nodal, Jr., a psychiatrist in Hialeah, at first was cautious about Seroquel, fearing potential links to cataracts. In late 2001, he told a male sales rep he would keep the drug in mind only for “smoking sciz pts.”

Two months later, however, a female rep wrote that Nodal “LOVES SER. FOR ELDERLY.” By year’s end he had 15 nursing home patients on the drug. (Later the FDA made all anti­psychotics warn that use in elderly with dementia could cause death.)

“Claims that he is switching patients from Risperdal to Seroquel at the nursing homes,” a sales rep wrote in 2003. “Writing as much as he can to all patients.”

Notes show that in the interim, Nodal received a textbook, mug, penlights (“Using lots”), payment for a preceptorship and dinner at Ruth’s Chris Steak House. He denies the giveaways influenced his prescribing.

“If drug companies stopped marketing, I think prescribing (patterns) would be more or less the same as they are now,” said Nodal, who said he tried to become a Seroquel speaker but was not accepted. “It didn’t affect me at all.”

Nodal closed his private practice last year and now works for the state’s Department of Corrections in Florida City. The agency does not allow drug reps to lobby its physicians.

Times researcher Carolyn Edds contributed to this report. Kris Hundley can be reached at hundley@sptimes.com or (727) 892-2996.


By the numbers

$7 billion

Amount drug industry spent on marketing directly to doctors (2004)

$2 billion

FDA budget (FY 2008)

1/3

Drug industry’s research & development budget compared to marketing budget

1 to 2.5

Ratio of drug reps to doctors in the United States

$96,700

Median annual total cash compensation for a drug rep (2008)

16 percent

Favorable change in a doctor’s prescribing habits after less than 1 minute with a sales rep

52 percent

Prescribing change seen after 3 minutes with a sales rep

Source: Pharmedout.org’s “Why Lunch Matters”