Fierce opposition arises to mental health screening in schools
By Karen MacPherson, Pittsburgh Post-Gazette, September 18, 2005

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WASHINGTON -- Back in 2003, a federal commission created by President Bush recommended improving and expanding mental health programs in schools to provide help as early as possible to students with learning problems or those who might turn violent or disruptive.

The commission highlighted one means of early diagnosis, the Columbia University "TeenScreen" program, that allows students -- with parental permission -- to get a mental health "check-up" via a computer-based questionnaire before graduating from high school.

The commission's 86-page report included this suggestion among a long list of recommendations to improve the U.S. mental health system. The report attracted little attention outside mental health circles.

But over the past two years, a cottage industry of fiery opposition has grown up around the proposal to expand mental health programs in the schools and has become a popular rallying cry for conservatives who see it as unwarranted government intervention in family life.

Opponents of school-based mental health programs point to parents who say their children have been misdiagnosed with problems such as attention deficit hyperactivity disorder (ADHD) and forced to take medication under pressure from school officials.

To these parents, the commission suggestion to "improve and expand' school mental health programs is the first, inexorable step toward mandatory school mental health screening for all students, and mandatory medication for many, despite repeated assurances by commission members, school officials and congressional experts that this won't happen.

Led by groups like Ablechild.org and EdAction, these parents want to prohibit schools from having anything to do with the mental health of their students, saying it is the job of parents to ensure their children's well-being.

As a first step, the groups are pushing Congress to pass legislation, sponsored by Rep. Ron Paul, R-Tex., and supported by House Majority Leader Tom DeLay, R-Texas, to prohibit any federal funding for mental health screening of students without the written consent of their parents.

"If (this legislation) is passed, it will prevent wasteful and potentially devastating federal funding while safeguarding the informed consent rights of all parents in what is a most serious matter -- their children's health and safety," said Patricia Weathers, president and co-founder of Ablechild.org.

The educators and medical professionals on the other side of the debate agree parental consent should be required for screenings. But they also think it's worth studying the idea of promoting voluntary screenings to get help for children who need it as early as possible.

"There is this curious coalition of people who are concerned about stuff that we didn't recommend, and are making a big noise about it,' said Michael Hogan, director of the Ohio Mental Health Department and chairman of what was then called the New Freedom Commission.

"The core thing that the commission was concerned about is the fact that a lot of these mental health problems are pretty clearly problems of childhood and adolescent onset.... Added to this is the fact that most children never get to see a mental health specialist.

"The fundamental logic of what the commission said is that we should take steps to facilitate access to care where children are.'

The debate over school screenings is just part of a larger discussion over the role schools should play in ensuring children's mental heath. Many educators point to a clear connection between mental health and academic achievement.

"There are a whole slew of intra-personal variables that contribute to a kid's ability to learn and are heavily related to their academic success,' said Stacy Skalski, public policy director for the National Association of School Psychologists.

"There are also inter-personal variables. Kids don't come into the world knowing how to relate to others. They need to learn that.'

Bruce Hunter, a veteran policy official with the American Association of School Administrators, said it's clear "the education business is tough enough without getting into the mental health business.

"But if a kid is going to beat the hell out of other kids regularly, and is disrupting the classroom, that's a child that needs some mental health assistance. One of the things that our members have expressed is a rising concern about students' mental health, and the ability to get them help when they have a problem,' Hunter said.

A complicating factor is that the debate over school mental health problems has become enmeshed in the vehement opposition of some people to medicating children for depression, hyperactivity and other problems. These opponents point to the nasty potential side effects of some commonly prescribed drugs, including suicide, and argue that they simply aren't safe for children.

Hogan and others supporters of school mental health programs agree that more long-term testing should be done on antidepressants and other emotion-altering drugs prescribed for children and teens.

"We (commission members) recommended that the scientists and regulatory officials get on top of the safety issue,' Hogan said.

Weathers, of Ablechild.org, is among those who believe more attention should be paid to children's nutrition and behavior management, instead of "being so quick to prescribe a drug." Her group supports legislation, sponsored by Rep. John Kline, that would prohibit schools from requiring parents to have their children medicated to attend classes.

Kline's bill would expand protections in the Individuals with Disabilities Act, which prohibited schools from requiring special education students to take certain medications, to all students. The bill also would cover more types of medication than in the disability law.

Weathers said she was pressured into medicating her then first-grade son after a school psychologist diagnosed him with attention deficit disorder. The medication eventually made him psychotic, but when she stopped giving it to him the school reported her to state children protective officials for child abuse, she said.

A lawsuit brought by Weathers against school officials is pending; her son, meanwhile, is now 15 and "doing fine," she said.

"We have 1,000 stories like this,' Weathers said. "Our group is not saying that children don't have attention or behavior problems. Some kids do. But why should we force parents to drug their children so they can attend school?"

Karen MacPherson can be reached at kmacpherson@nationalpress.com or 1-202-662-7075.

Drug company targets US state health officials
Ray Moynihan, Washington

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A major pharmaceutical company has sought to influence state government officials with trips, perks, lavish meals, and other payments, says an investigator from the Pennsylvania Office of Inspector General.

Investigator Allen Jones told the BMJ earlier this week that he had discovered that the drug company Janssen was sponsoring educational events for state employees, funding individuals' travel arrangements, and paying honorariums of up to $2000 (£1100; ¬1610) each to key officials who held influence over the drugs prescribed in state-run prisons and mental hospitals.

Yet as his investigations widened, Mr Jones was dropped from the case and told by a manager that "drug companies write cheques to politicians" on both sides of politics. Mr Jones subsequently started legal action, accusing his employer of trying to bury important evidence of wrongdoing. Although no formal report has been released, many of his findings were reported in the New York Times last Sunday (p BU1).

Janssen is the subsidiary of healthcare giant Johnson & Johnson that markets risperidone, the atypical antipsychotic medication widely used in the treatment of schizophrenia.

Along with other drug companies that make new antipsychotics, in the late 1990s Janssen funded the development of state based guidelines for the treatment of schizophrenia, heavily favouring the newer more expensive medications over older cheaper ones. The guidelines, initiated first in the Texas prison and psychiatric systems, are currently being adopted in other states, including Pennsylvania.

A spokesman for Janssen, Doug Arbesfeld, confirmed to the BMJ that the company had made payments to state officials and helped to sponsor the guidelines, but he flatly rejected claims that the company was seeking influence. "We provided funding to the Texas Department of Mental Health so their officials and physicians could share their experience with the guidelines in other statesprofessional to professional." Referring to the scientific debate about the relative merits of the newer versus older drugs, Mr Arbesfeld said some guideline groups were more aggressive in their support for the new medications, and some more conservative, but the Texas guideline was somewhere in the middle.

In 2002 the journal Psychiatric Services published an article comparing four different schizophrenia guidelines, concluding that the Texas medication algorithm project was the easiest to use, but far less scientifically rigorous than two of the others (Psychiatric Services 2000;53:888-90).

A spokesperson for the Office of Inspector General could offer the BMJ no comment on allegations of improper influence or on why Mr Jones was dropped from the case. However, Stephanie Suran, from the Pennsylvania Department of Public Welfare, although defending the guidelines as being good for patient care, said the allegations of improper influence were now before the state Ethics Commission.

Federal health authorities are also understood to be investigating, and Janssen last week received a subpoena for documents relating to risperidone.

Bush plans to screen whole US population for mental illness
Jeanne Lenzer , New York

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A sweeping mental health initiative will be unveiled by President George W Bush in July. The plan promises to integrate mentally ill patients fully into the community by providing "services in the community, rather than institutions," according to a March 2004 progress report entitled New Freedom Initiative. While some praise the plan's goals, others say it protects the profits of drug companies at the expense of the public.

Bush established the New Freedom Commission on Mental Health in April 2002 to conduct a "comprehensive study of the United States mental health service delivery system." The commission issued its recommendations in July 2003. Bush instructed more than 25 federal agencies to develop an implementation plan based on those recommendations.

The president's commission found that "despite their prevalence, mental disorders often go undiagnosed" and recommended comprehensive mental health screening for "consumers of all ages," including preschool children. According to the commission, "Each year, young children are expelled from preschools and childcare facilities for severely disruptive behaviours and emotional disorders." Schools, wrote the commission, are in a "key position" to screen the 52 million students and 6 million adults who work at the schools.

The commission also recommended "Linkage [of screening] with treatment and supports" including "state-of-the-art treatments" using "specific medications for specific conditions." The commission commended the Texas Medication Algorithm Project (TMAP) as a "model" medication treatment plan that "illustrates an evidence-based practice that results in better consumer outcomes."

Dr Darrel Regier, director of research at the American Psychiatric Association (APA), lauded the president's initiative and the Texas project model saying, "What's nice about TMAP is that this is a logical plan based on efficacy data from clinical trials."

He said the association has called for increased funding for implementation of the overall plan.

But the Texas project, which promotes the use of newer, more expensive antidepressants and antipsychotic drugs, sparked off controversy when Allen Jones, an employee of the Pennsylvania Office of the Inspector General, revealed that key officials with influence over the medication plan in his state received money and perks from drug companies with a stake in the medication algorithm (15 May, p1153). He was sacked this week for speaking to the BMJ and the New York Times.

The Texas project started in 1995 as an alliance of individuals from the pharmaceutical industry, the University of Texas, and the mental health and corrections systems of Texas. The project was funded by a Robert Wood Johnson grantand by several drug companies.

Mr Jones told the BMJ that the same "political/pharmaceutical alliance" that generated the Texas project was behind the recommendations of the New Freedom Commission, which, according to his whistleblower report, were "poised to consolidate the TMAP effort into a comprehensive national policy to treat mental illness with expensive, patented medications of questionable benefit and deadly side effects, and to force private insurers to pick up more of the tab" (http://psychrights.org/Drugs/AllenJonesTMAPJanuary20.pdf).

Larry D Sasich, research associate with Public Citizen in Washington, DC, told the BMJ that studies in both the United States and Great Britain suggest that "using the older drugs first makes sense. There's nothing in the labeling of the newer atypical antipsychotic drugs that suggests they are superior in efficacy to haloperidol [an older "typical" antipsychotic]. There has to be an enormous amount of unnecessary expenditures for the newer drugs."

Olanzapine (trade name Zyprexa), one of the atypical antipsychotic drugs recommended as a first line drug in the Texas algorithm, grossed $4.28bn (£2.35bn; 3.56bn) worldwide in 2003 and is Eli Lilly's top selling drug. A 2003 New York Times article by Gardiner Harris reported that 70% of olanzapine sales are paid for by government agencies, such as Medicare and Medicaid.

Eli Lilly, manufacturer of olanzapine, has multiple ties to the Bush administration. George Bush Sr was a member of Lilly's board of directors and Bush Jr appointed Lilly's chief executive officer, Sidney Taurel, to a seat on the Homeland Security Council. Lilly made $1.6m in political contributions in 200082% of which went to Bush and the Republican Party.

Jones points out that the companies that helped to start up the Texas project have been, and still are, big contributors to the election funds of George W Bush. In addition, some members of the New Freedom Commission have served on advisory boards for these same companies, while others have direct ties to the Texas Medication Algorithm Project.

Bush was the governor of Texas during the development of the Texas project, and, during his 2000 presidential campaign, he boasted of his support for the project and the fact that the legislation he passed expanded Medicaid coverage of psychotropic drugs.

Bush is the clear front runner when it comes to drug company contributions. According to the Center for Responsive Politics (CRP), manufacturers of drugs and health products have contributed $764 274 to the 2004 Bush campaign through their political action committees and employeesfar outstripping the $149 400 given to his chief rival, John Kerry, by 26 April.

Drug companies have fared exceedingly well under the Bush administration, according to the centre's spokesperson, Steven Weiss.

The commission's recommendation for increased screening has also been questioned. Robert Whitaker, journalist and author of Mad in America, says that while increased screening "may seem defensible," it could also be seen as "fishing for customers," and that exorbitant spending on new drugs "robs from other forms of care such as job training and shelter programmes."

But Dr Graham Emslie, who helped develop the Texas project, defends screening: "There are good data showing that if you identify kids at an earlier age who are aggressive, you can intervene... and change their trajectory."

EDaction

Texas Representative Ron Paul Fails to Stop Mental Health Screening Without Parental Consent by the US Government

Myths and Facts Regarding Mental Health Screening Programs and Psychiatric Drug Treatment for Children
Karen R. Effrem, MD, Ed/Watch / EdAction
International Center for the Study of Psychiatry and psychology  www.icspp.org
Alliance for Human Research Protection  www.ahrp.org
763-458-7119
kreffrem@pro-ns.net

Myth: The President's New Freedom Commission on Mental Health is not advocating widespread mental health screening. "&The commission proposed broad screening only in settings where many children are known to have untreated behavioral problems." (Michael Hogan, NFC chairman, Washington Times, 10/21/04)

Fact: The New Freedom Commission report frequently recommended universal mental health screening and treatment for children.

"For consumers of all ages, early detection, assessment, and linkage with treatment and supports can prevent mental health problems from compounding&" (p. 19)

"Since children develop rapidly, delivering mental health services and supports early and swiftly is necessary to avoid permanent consequences and to ensure that children are ready for school." (p. 65)
"Screen for mental disorders in primary health care, across the life span, and connect to treatment and supports." (p. 65)
"Because of this important interplay between emotional health and school success, schools must be partners in the mental health care of our children" (p. 66)

Myth: Informed parental consent is an important component of programs recommended by the NFC.
Fact: The NFC report never uses the word "voluntary" in the context of screening and treatment and uses the phrase "parental consent" just once to describe a program that uses passive, opt-out parental consent.

"Parents at Penn and other schools could withhold their children from the screening by returning a form mailed to their houses. Parents who did not sign the form and return it were considered to have given permission for TeenScreen&'We would probably see the level of participation drop way off (if active consent were required),' he said." (Rumbach, South Bend Tribune, 1/19/2005)

Myth: Psychiatric diagnostic criteria are scientifically validated and non-controversial among experts in the field.
Fact: Mental health diagnostic criteria are very vague and subjective. The very studies and reports cited by proponents of universal screening are full of contradictions. These experts admit the lack of science underlying psychiatric labels.

"In other words, what it means to be mentally healthy is subject to many different interpretations that are rooted in value judgments that may vary across cultures." (Surgeon General Report on Mental Health. 1999. p. 1-5

"The diagnosis of mental disorders is often believed to be more difficult than diagnosis of somatic or general medical disorders since there is no definitive lesion, laboratory test or abnormality in brain tissue that can identify the illness." (Surgeon General, p. 2-18, The Fundamentals of Mental Health and Mental illness)

"No consistent structural, functional, or chemical neurological marker is found in children with the ADHD diagnosis as currently formulated." (Attention Deficit Hyperactivity Disorder State of the Science - Best Practices, Peter S. Jensen and James R. Cooper, Eds, Civic Research Institute, Kingston, N.J. 2000,p. 3-7)

"DSM-IV criteria remain a consensus without clear empirical data supporting the number of items required for the diagnosis . . . Furthermore, the behavioral characteristics specified in DSM-IV, despite efforts to standardize them, remain subjective . . . " (American Psychiatric Association Committee on the Diagnostic and Statistical Manual (DSM IV- 1994), pp.1162-1163)

Myth: It is possible to accurately diagnose mental illness in young children, even infants. "Even before their first birthday, babies can suffer from clinical depression, traumatic stress disorder, and a variety of other mental health problems." (Florida Strategic Plan for Infant Mental Health)
Fact: Due to rapid developmental changes, it is very difficult to accurately diagnose young children.

"Childhood and adolescence being developmental phases, it is difficult to draw clear boundaries between phenomena that are part of normal development and others that are abnormal." (World Health Organization, World Health Report, 2001)

"The science is challenging because of the ongoing process of development. The normally developing child hardly stays the same long enough to make stable measurements. Adult criteria for illness can be difficult to apply to children and adolescents, when the signs and symptoms of mental disorders are often also the characteristics of normal development." (Surgeon General, 1999)

Myth: Children would never be labeled potentially violent or mentally based on their worldview or politics.
Fact: Federally funded school violence prevention programs do label children based on their beliefs. A federally funded study held that people of a particular political philosophy had hallmarks of mental illness.

A school violence prevention program funded by the federal government called Early Warning, Timely Response lists "intolerance for others and prejudicial attitudes" as an early warning sign for violence and mental instability, saying, "All children have likes and dislikes. However, an intense prejudice toward others based on racial, ethnic, religious, language, gender, sexual orientation, ability, and physical appearance when coupled with other factors may lead to violent assaults against those who are perceived to be different."(U.S. Department of Education - Early Warning, Timely Response Action Guide

"In August 2003, the National Institute of Mental Health and the National Science Foundation announced the results of their $1.2 million taxpayer-funded study. It stated, essentially, that traditionalists are mentally disturbed. Scholars from the Universities of Maryland, California at Berkeley, and Stanford had determined that social conservatives, in particular, suffer from 'mental rigidity,' 'dogmatism,' and 'uncertainty avoidance,' together with associated indicators for mental illness."

Myth: Mental health screening instruments are scientifically validated and screening programs are effective at preventing suicide.
Fact: Screening instruments are not validated or effective and fail to prevent suicide.

"(TeenScreen has) reasonable specificity identifying students at risk for suicide. A second-stage evaluation would be needed to reduce the burden of low specificity.... As with other suicide risk instruments, the CSS has the potential of having high (0.88) sensitivity at the expense of specificity (false positives)&" (Journal of the American Academy of Child & Adolescent Psychiatry, 2004, v. 42, 71-79)

"USPSTF found no evidence that screening for suicide risk reduces suicide attempts or mortality. There is limited evidence on the accuracy of screening tools to identify suicide risk in the primary care setting, including tools to identify those at high risk." (US Preventative Services Task Force)

Myth: Children are not adequately treated for mental illness.
Fact: Children are over diagnosed and over treated with psychiatric medications and both problems will increase with wide spread screening programs.

300% increase in psychotropic drug use in 2-4 year old children between 1991-1995
300% increase in psychotropic drug use in children between 1987 and 1996
More spent on psychiatric medications for children than on antibiotics or asthma medication in 2003

Myth: The decision to treat a child with psychotropic medications is always between a parent and their physician.
Fact: Parent all over the country have been coerced with threats of child abuse or to place their children on or continue psychiatric medications prompting over 20 state legislatures and the US Congress to introduce or pass legislation prohibiting coercion.

Both Matthew Smith and Shaina Dunkle died of medication toxicity after their parents were coerced to place their children on drugs by the schools.

Paul Johnston was institutionalized with drug-induced psychosis after his parents were coerced to put him on 16 different psychiatric medications over seven years. A Parent's Nightmare:
Losing a Child to Drug-Induced Psychosis

Myth: Psychiatric drug treatments are effective in children.
Fact: Neither antidepressants like Prozac nor stimulants like Ritalin are effective in children, but pharmaceutical companies, with the approval of the FDA, only published positive studies despite having evidence for years of their ineffectiveness.

"More than two-thirds of studies of antidepressants given to depressed children, for instance, found the medications were no better than sugar pills, but companies published only the positive trials" (Vedatam, Washington Post, 9/9/04, p. A02)

"No antidepressants have demonstrated greater efficacy than placebo in alleviating depressive symptoms in children and adolescents"( Baker (1995) as quoted in Breggin, P. and Cohen, D. (1999) Your Drug May Be Your Problem: How and Why to Stop Taking Psychiatric Medications, Perseus Books, Reading, MA)
"However, psychostimulants do not appear to achieve long-term changes in outcomes such as peer relationships, social or academic skills, or school achievement." (Pelham, et. al. as quoted in Surgeon General, 1999)

Myth: Psychiatric drugs are safe for children.
Fact: Evidence of dangerous and sometimes deadly side effects of psychiatric medication has been covered up for years by the pharmaceutical manufacturers, sometimes with the help of the FDA.

"Dr. Robert Temple, director of the FDA's office of medical policy, said after an emotional public hearing here that analyses of 15 clinical trials, some of which were hidden for years from the public by the drug companies that sponsored them, showed a consistent link with suicidal behavior." (Harris, New York Times, 9/14/04, p. A01)

"TCAs (tricyclic antidepressants) have been linked to cardiac arrhythmias, and "sudden death." (Wilens TE, et al, 1996. Cardiovascular effects of therapeutic doses of tricyclic antidepressants in children and adolescents. Journal of The Association Of American Child & Adolescent Psychiatry. 35: 1491-501)
"These drugs also impair flexible problem-solving and divergent thinking. James Swanson, a researcher for the U.S. Department of Education and leading Ritalin advocate, stated in a 1992 review of the medical literature that this type of 'cognitive toxicity' may occur at commonly prescribed clinical doses of stimulants, and in up to 40% of patients." (Breggin, P., (2001) Talking Back to Ritalin, Cambridge, Massachusetts, Perseus, pp. 49-50)

Zyprexa linked to Diabetes (Eli Lilly's Big Seller, Zyprexa, Can Help Schizophrenics; Is It Linked to Diabetes? --- Warnings Abroad, Not in U.S.  Wall Street Journal, 4/11/03, Risperdal Linked to Stroke; Zyprexa linked to Diabetes)

Myth: The pharmaceutical industry has no vested interest in the treatment recommendations made by the NFC.
Fact: The pharmaceutical industry steered TMAP treatment recommendations toward their products and have profited mightily from those recommendations, despite the fact that the drugs are more expensive, less effective and have severe side effects.

"&Dr. Peter J Weiden, who was a member of the project's [TMAP] expert consensus panel, charges that the guidelines are based on 'opinions, not data' and that bias due to funding sources undermines the credibility of the guidelines since 'most of the guideline's authors have received support from the pharmaceutical industry.'" (Lenzer, Jeanne (5/15/04) British Medical Journal, Whistleblower removed from job for talking to the press)

KEYE Investigation (Wilson N. KEYE News Investigates. Psychiatric drugs (July 23, 2004); Drugs and your tax dollars (September 30, 2004).

Drug Company
Expenditures on the Texas Medication Algorithm Project
Profits from Texas Medicaid involving that Company's Psychiatric Drugs

Pfizer
$232 thousand
$ 233 MILLION

Janssen
$224 thousand
$ 272 MILLION

Eli Lilly
$109 thousand
$ 328 MILLION

The National Mental Health Screen is a Potential Nightmare for Citizens, Boon to Drug Companies

Psychiatry: Betraying and Drugging Children
Psychiatry: Committing Fraud; Extortion in the Name of Mental Healing

Fight For Kids
Parent stories
Fight For Kids Bills and Resolutions

Teen Boot Camps: Behavior Modification or Torture Centers?

Whistleblower removed from job for talking to the press
Jeanne Lenzer, New York

A whistleblower who uncovered evidence that major drug companies sought to influence government officials has been removed from his job and placed on administrative leave.

Allen Jones, an investigator at the Pennsylvania Office of the Inspector General (OIG), was escorted out of his workplace on 28 April and told "not to appear on OIG property" after OIG officials accused him of talking to the press. Reports of Mr Jones's findings were widely reported in the New York Times, BMJ (7 February, p 306), and elsewhere.

His findings showed that the pharmaceutical company Janssen had paid honorariums to key state officials who held influence over the drugs prescribed in state-run prisons and mental hospitals.

Mr Jones filed a suit on 7 May against his supervisors charging that the OIG's policy of barring employees from talking to the media was "unconstitutional." Mr Jones claims, in the complaint filed in the Middle District Court of Pennsylvania, that he is being harassed by his superiors and Pennsylvania governmental institutions in order to "coverup, discourage, and limit any investigations or oversight into the corrupt practices of large drug companies and corrupt public officials who have acted with them."

Mr Jones had been earlier removed as lead investigator on the case after being told by a manager that "drug companies write cheques to politicians on both sides of the aisle."

In July 2002 Mr Jones was appointed lead investigator when he uncovered evidence of payments into an off-the-books account. The account, earmarked for "educational grants" was funded in large part by Pfizer and Janssen Pharmaceuticals. Payments were made from the account to state employees who developed formulary guidelines recommending expensive new drugs over older, cheaper drugs with proved track records.

One of the recommended drugs was Janssen's antipsychotic medicine risperidone (Risperdal)a drug that has recently been found to have potentially lethal side effects. The Food and Drug Administration issued a warning letter to Janssen on 27 April saying that Janssen's "Dear Healthcare Provider" letter about risperidone was "false or misleading" because it failed to disclose or minimised risks of the drug relating to "serious adverse events including ketoacidosis, hyperosmolar coma, and death."

Don Bailey, Mr Jones's attorney, said the case is a critical test of the right to a free press. "If they shut the employee up and they have all the documents locked up in a drawer there is no free press," he said.

Amy Wasserleben, spokeswoman for the OIG, said they would not comment on Mr Jones or the corruption allegations. When asked about the status of the corruption investigation she refused to answer. In response to a question about whether the state OIG could withhold information of public interest, she said, "The OIG is specifically exempt from right-to-know laws."

The Pennsylvania formulary is based on the Texas Medication Algorithm Project that has been exported to about 12 states and was recently commended as a model programme by President Bush's New Freedom Commission.

However, Dr Peter J Weiden, who was a member of the project's expert consensus panel, charges that the guidelines are based on "opinions, not data" and that bias due to funding sources undermines the credibility of the guidelines since "most of the guideline's authors have received support from the pharmaceutical industry."

Whistleblower charges medical oversight bureau with corruption
Jeanne Lenzer, New York

LINK

Dr Stefan Kruszewski, a psychiatrist hired by the Bureau of Program Integrity in the Pennsylvania Department of Public Welfare, filed a law suit on 1 July in a federal court in the Middle District of Pennsylvania, charging that he was fired on 11 July 2003 after he uncovered widespread abuse and fraud in the bureau.

Dr Kruszewski's role at the bureau was to oversee the state's mental health and substance misuse programmes to protect against fraud, waste, and abuse. When he uncovered serious abuses, including deaths of children in the state's custody possibly due to substandard care and the off-label use of potent atypical antipsychotic medications, "they fired the messenger," Dr Kruszewski told the BMJ.

Dr Kruszewski's efforts to clarify the causes of death in four children and one adult in the state's care were blocked when he was denied postmortem or coroner's reports and hospital records. Some of the patients were taking as many as five antipsychotic medications at the same timesomething Dr Kruszewski says is "hard to justify."

When Dr Kruszewski warned that off-label use of the drugs was potentially harmful to patients and could expose the state to liability he was told that "it's none of your business," said Dr Kruszewski.

Dr Kruszewski charges in his suit that a number of drug companies used "political friendships, money, and other emoluments" to achieve "a level of influence with Pennsylvania's state government" and with the "current president of the United States, George W Bush" to promote "the use of their products in violation of the law and of the rights of Pennsylvania citizens."

Dr Kruszewski charges that corrupt practices, supported by political contributions from drug companies, resulted in off-label use of medication, misuse of medication that resulted in the deaths of children under the care of the Pennsylvania Office of Medical Assistance and the Bureau of Program Integrity, overmedication of adults and children, and fraudulent billing, among other abuses.

His charges mirror those of other whistleblowers, including Allen Jones, who reported that drug companies gave money to officials with influence over the Pennsylvania state formulary (19 June, p 1458), and David Franklin, who recently won a $240m (£131m; 195m) settlement with Pfizer for its promotion of the off-label use of gabapentin (Neurontin) (22 May, p 1217).

Dr Kruszewski told the BMJ that it was money and influence, not good medicine, that drove prescribing practices. "There was horrendous polypharmacy," said Dr Kruszewski. "They were putting almost all patients on the same concoction of antipsychotic and antiseizure drugsbut many of the patients weren't psychotic and they didn't have seizures. Many were simply drug addicts. This kind of prescribing didn't happen five years ago."

Political and drug company influence, said Dr Kruszewski, was evident when George W Bush, then governor of Texas, bragged about the Texas Medication Algorithm Plan (TMAP) during his presidential campaign while at the same time receiving large campaign contributions from the same drug companies that fundedand benefit fromthe medication algorithm (19 June, p 1458). TMAP recommends the use of newer, more expensive, antipsychotics and antidepressantsdrugs manufactured by the same companies that paid for the development of TMAP. One of Dr Kruszewski's supervisors was instrumental in bringing TMAP to Pennsylvania.

When Allen Jones, an investigator with the Office of the Inspector General of Pennsylvania, discovered that an off the record bank account was funded by drug companies to pay state officials to promote TMAP, he was fired for persisting with the investigation after he was warned off, according to his whistleblower suit.

Dr Kruszewski, who voted for Bush in the 2000 presidential election, now regrets his vote, saying, "I was terminated because I did my job. It turns out that drug companies and politicians were influencing the drugs prescribed for patients."

A spokeswoman for the Pennsylvania Department of Public Welfare said the department never commented on pending litigation.

Drug prescribing and Corruption:role of pharmaceuticals?
A letter to BMJ from Dr. Naseem A. Qureshi MD, IMAPA, LMIPS, Locum Psychiatrist

Sir:

Almost every week, we are informed about the corrupt practices at the interface of pharmaceuticals, drug regulatory agencies and politicians that ultimately have also plagued every corner of our life as academicians and medical practitioners. Unfortunately, our drug prescribing behavior is by and large is guided by medical representatives. Notably, physicians prescribe drugs for off-label reasons causing tremendous harms to both children and adolescents and elderly population in whom most medications are neither indicated nor justified.

The ill-directed influence of pharmaceutical companies is obviously pervasive in changing the behavior of prominent politicians and drug regulators and sadly finally patients have to pay the huge price unnecessarily and moreover they are the sufferers of such malpractices.

Politicans need funds for contesting elections, academecians need funds for running universities and CME&R need funds for updating knowledge and improving clinical practice of doctors and so on. But finances from whom? Pharmaceuticals have huge financial resources to assist these people but with their own hidden agenda. This is a give and take phenomenon and it is very hard to stop this behavior despite strict guidelines, regulations and legislations.

Whistleblowers in rarity such as Allen Jones and mentioned psychiatrist are doing the fine job but history suggests that monority always suffers on the hands of majority. I personally support the whistleblowers for their encouraging behavior for coming out with such corrupt practices of high officials who have illegal relationships with drug pharmaceutical companies.

We need to reduce the sufferings of health consumers by offering them good medications, counseling and other excellent services but such care is far from the medical scenario. We are deep in pharmaceutical waters and coming out from it seems impossible.

Dr. Naseem A. Qureshi MD, IMAPA, LMIPS,
Locum Psychiatrist
Postcde:64399, SBAHC, Riyadh, Saudi Arabia

Whistleblower charges drug company with deceptive practices
Jeanne Lenzer, New York

LINK

A former drug company insider has spoken to reporters for the first time since he filed a whistleblower lawsuit in 1996 in a US federal court.

At a press conference last week he gave details of the suit he has filed.

The suit charges that Parke-Davis engaged in elaborate inducement schemes to persuade doctors to promote the off-label use of one of its best selling drugs, gabapentin (Neurontin), an anti-epileptic drug approved as adjunctive treatment for partial seizures. It also says the company ran ghost writing schemes, in which it paid specialists to "author" articles that were actually written by technical writers hired by the company.

Prescribing drugs off label accounts for over 78% of sales of gabapentin, according to Parke-Davis. Although off-label prescribing is legal, the US Food and Drug Administration prohibits drug companies from promoting such use to doctors. Parke-Davis, which was a division of Warner-Lambert when the promotional activities are alleged to have occurred, was acquired by Pfizer in 2000.

Dr David Franklin, a microbiologist and former fellow of Harvard Medical School, sought legal assistance from the Boston law firm Greene and Hoffman when he became concerned about patients' safety and that his employers might retaliate against him because of questions he had been raising about apparent illegal marketing practices.

Dr Franklin, 41, said he had been working as a "medical liaison" employee for Parke-Davis for only four months when a company executive warned that he "couldn't guarantee what is going to happen to you or your career" if Dr Franklin continued to challenge the marketing scheme.

Dr Franklin says Parke-Davis executives were worried about its market for gabapentin, as its original patent was set to expire in December 1998and because it was approved for use only as adjunctive treatment in patients with partial seizures.

In an amended complaint filed in July 2001 Dr Franklin alleges: "After performing extensive economic analysis, senior officials at Parke-Davis determined that it was not sufficiently profitable for Parke-Davis to obtain FDA approval for Neurontin's alternative uses."

Although federal regulations would not allow Parke-Davis to promote gabapentin for un-approved uses, drug companies are allowed to distribute third party publications promoting off-label use in response to unsolicited requests.

Dr Franklin charges that the company undertook an elaborate programme to exploit this "narrow window of opportunity." He said "tens of thousands of payments" to doctors were made for "consultations" and "studies" and served as a "surrogate sales force," violating Medicaid regulations on kickbacks.

According to Dr Franklin, "Significant ingenuity and resourcefulness was necessary in order to execute this unlawful scheme without detection."

A thinly disguised incentive scheme to get doctors to prescribe the drug off label was to pay them as "consultants" to attend lavish, all expenses paid trips to resorts where doctors were encouraged to prescribe the drug for disorders ranging from migraine to bipolar disor-der to attention deficit disorder.

Even though the doctors were listed as consultants, Dr Franklin says their comments were not even recorded at some of the events. "Studies" supporting such uses of the drug, alleges Dr Franklin, ranged from occasional case reports falsely labelled as studies to non-existent data. In the case of bipolar disorder no study has actually shown that the drug has any benefit over placebo.

Dr Franklin also says that Parke-Davis paid specialists to "author" articles that were actually ghost written by non-physician technical writers hired by the company. The articles were then filtered through "medical education" companies, which in turn submitted the articles for publication. Court documents cite 20 articles produced in this manner.

Pfizer would not comment on any aspects of the various actions, saying only, "We acquired Warner-Lambert in June 2000, and the events date back to many, many years before that. Pfizer does not promote off-label use of drugs."

Opening the Black Box of Clinical Judgement