Hearing: Drugging of Foster Children

A hearing held by The House Ways and Means Committee, May 8, focused on the use of psychotropic drugs for children in foster care.

A riveting testimony was delivered by Misty Stenslie, Deputy Director, Foster Care Alumni of America (below). She represents one of 12 million adults in this country who grew up in foster care, the government served as my parents. She spent 12 years in approximately 30 placements.

"My time in care resulted in a long list of diagnoses, including Post Traumatic Stress Disorder, Oppositional Defiant Disorder, Depression, and a sleep disorder. Because of the instability in my living situation, it seemed that the only option the professionals in my life were able to take for treating all of the diagnosed conditions was prescribing medication. Over the years I was on more medications than I can count--usually without my knowing what the meds were for, how I should expect to feel, side effects to watch out for, or any plan for follow up."

"The rates of post-traumatic stress disorder (PTSD) among foster care alumni are about twice as high as PTSD rates in war veterans and nearly 5 times the rates of the general public. Alumni experience panic disorder at rates more than three times that of the general population. People in and from foster care have particularly high rates of ADHD, chemical dependency, conduct disorder and depression and other mood disorders."
"Because of the insight and creativity of [my last] foster parents, I was able to see my world in a brand new way. I was able to ask that my medications be decreased and eventually discontinued, and they supported me in getting the kind of treatment that would make a sustainable difference in my life--learning new ways to cope, recognizing what is good and right in myself so that I could do more of it, identifying ways to keep myself safe without having to hide or fight. By the time I went off to college, I was no longer on any medications and I actually had the skills and knowledge I needed to take the place of the medications."

Not all children misprescribed psychotropic drugs, in and out of foster care, are as lucky as Misty Stenslie. She offered some recommendations from the foster care alumni community.

Expert testimony by Dr. Julie Zito, professor of Pharmacy and Psychiatry at the University of Maryland, testified about the what the Medicaid data shows about psychotropic drug prescriptions for under 18 year olds. Dr. Zito has done numerous state Medicaid data analyses. Below is a snippet of her testimony. For full testimony including that from AHRP, see:

Zitto Testimony
Stenslie Testimony
AHRP Testimony

High Foster Care-specific Prevalence of Psychotropic Medication Use.
From : Expert testimony by Dr. Julie Zito

Among community-based populations, foster care youth tend to receive psychotropic medication as much as or more than disabled youth and 3-4 times the rate among children with Medicaid coverage based on family income [temporary assistance for needy families (TANF) or state-Children's Health Insurance Program, (s-CHIP)]. For example, in 2004, 38% of the 32,000+ Texas foster care youth less than 19 years of age received a psychotropic prescription (Zito et al., 2008). When 2005 data were disaggregated by age group the 2005 annual prevalence of psychotropic medication was: 12.4% in 0-5 year olds; 55% in 6-12 year olds; and 66.5% in 13-17 year olds. When two-thirds of foster care adolescents receive treatment for emotional and behavioral problems, far in excess of the proportion in non-foster care population, we should have assurances that the youth are benefiting from such treatment.

• Poverty, social deprivation, and unsafe living environments do not necessarily justify complex, poorly evidenced psychopharmacologic drug regimens.
• Concomitant Psychotropic Medication Patterns in Foster Care with Little Evidence of Effectiveness or Safety. Combinations of medication are prescribed in order to address multiple symptoms. The sparse data on such practice patterns suggest that it is increasing (Safer, Zito, & dosReis, 2003). To assess concomitant psychotropic classes in the Texas foster care data, we selected a one month cohort of youth in July 2004 and found 29% (n=429) received one or more classes of these medications. Of these psychotropic-medicated youth, 72.5% received two or more psychotropic medication classes and 41.3% received 3 or more such classes. In such combinations, more than half the medicated youth had an antidepressant (56.8%); a similar proportion (55.6%) had an ADHD medication (a stimulant or atomoxetine) dispensed, and 53.2% had an antipsychotic dispensed. Most psychotropic combinations lack adequate evidence of effectiveness or safety in youth. Typically, they are adopted based on knowledge generalized from adult studies or assume that the combination is as safe and effective as each component of the regimen. Such assumptions, however, are not warranted because data reveal that children and adolescents differ from adults in adverse drug reactions to psychotropic medications (Safer, 2004; Safer & Zito, 2006).

In addition, pediatric research shows that increasing the number of concomitant medications increases the likelihood of adverse drug reactions (Turner, Nunn, Fielding, & Choonara, 1999; Martinez-Mir et al., 1999). Long-term safety and drug-drug interactions are also more problematic. Data show that poorly evidenced regimens tend to increase in complexity over the age span suggesting that polypharmacy is not effective in managing the multiplicity of problems of foster care youth and others with serious social, behavioral and mental health problems who are often referred to as treatment-resistant or difficult to treat (Lader & Naber, 1999). This is particularly true when observing youth with repeated hospitalizations.

In the Texas cohort, 13% had a psychiatric hospitalization in the study year and 42% of these had a psychiatric hospital diagnosis of bipolar disorder. As younger age youth receive psychotropic medications, the early introduction of medications to the developing youth (12% of preschoolers in these data from Texas), suggests the need for drug safety studies. Drug safety studies require access to large community-based data sets, formation of cohorts for longitudinal assessment over successive years and epidemiologic methods for conducting observational safety studies. Yet, funding and training of clinical scientists for this type of research is quite modest (Klein, 1993; Klein, 2006) while the FDA is largely focused on the pre-marketing assessment of new drugs (APHA Joint Policy Committee, 2006).

Concomitant medication with antipsychotics and anticonvulsant-mood stabilizers is referred to as "off-label' usage, i.e., lacking FDA approved labeling for either the age group or the indication for treatment, e.g. an antipsychotic for ADHD or disruptive disorders. In the Texas foster care data, most antidepressant use was also off-label. Moreover, when the drug class use was compared among the leading diagnostic groups, there was little evidence of specificity. In youth with 3 or more medication classes, antipsychotic medications were used in 76.1% of those with an ADHD diagnosis; 75.8% of those with adjustment or anxiety diagnoses; and 84.1% of those with a depression diagnosis.

If medication regimens increase the risk of adverse events without robust evidence of benefits (outcomes), prudence suggests that oversight programs monitor and review therapeutic interventions in professionally competent, individualized, and caring assessments.

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Picking up the pieces of regulatory collusion - Should Kids Get These Drugs

Several state Medicaid programs are picking up where the FDA and the psychiatric profession have failed to meet their institutional the responsibility of protecting children from ever more toxic drugs--in particular the second generation of antipsychotics whose harmful effects can be measured in mortality rates among adults exposed to these drugs.

"We are at risk of treating kids before we know if these drugs are safe in the long-term," said Dr. Christopher Varley, a University of Washington professor of child and adolescent psychiatry.

The drugs are sold under the names Zyprexa, Geodon, Risperdal, Abilify, Seroquel, Clozaril and Invega. They were approved to treat adults with schizophrenia and bipolar disorder.

Among the chief drivers behind the use of atypical anti-psychotics in children, experts say, is the increasing "popularity" of bipolar disorder, previously known as manic depression.

No plausible medical justification can explain the skyrocketing increase in the number of U.S. children "diagnosed" with bipolar disorder. No rational explanation--save aggressive marketing and deceptive advertising replete with false claims about the safety of these drugs--can explain the exponential rise in the number of US children treated with antipsychotics between 1994 and 2003. The number rose from 20,000 to more than 800,000.

Dr. John Holttum, a child psychiatrist in the state of Washington, who has first hand experience in treating children who were misdiagnosed and misprescribed antipsychotics told the Tacoma Tribune: "We absolutely need some oversight of atypical anti-psychotic use in children. Some of the kids who walk into my office have been grossly mismanaged."

He went on to say that "atypical anti-psychotics are aggressive medications." Responsible experts caution that these drugs' potential long-term side effects on developing brains are worrisome.

Unfortunately, there are no responsible U.S. regulators, and no responsible U.S. professional associations that put children's safety first, commercial interests second.
AHRP applauds the effort of Washington State Gov. Chris Gregoire and Dr. Jeffrey Thompson, head of the state's Medicaid pharmaceutical program, who is working on a plan with psychiatrists and others in the mental health community to rein in the misuse of antipsychotics in children.

[Link] Tacoma, WA - Tuesday, May 13, 2008
Should kids get these drugs? Plan likely to increase scrutiny of anti-psychotics in children Doctors focus on new anti-psychotics
M. ALEXANDER OTTO

Concerned about how anti-psychotic drugs are being used in children, state officials are working on a plan due out by early fall to make sure the medications are properly prescribed for Washington kids on Medicaid.

"The data is concerning," said Dr. Jeffrey Thompson, chief medical officer for the state Medicaid program and an expert in pharmaceutical trends in the state's Medicaid population.

The long term safety and effectiveness of the drugs in children are not known, he and others say.

"We are at risk of treating kids before we know if these drugs are safe in the long-term," said Dr. Christopher Varley, a University of Washington professor of child and adolescent psychiatry.

The drugs are used to treat such conditions as bipolar disorder or schizophrenia. They're sold under the names Zyprexa, Geodon, Risperdal, Abilify, Seroquel, Clozaril and Invega.

The drugs belong to a relatively new class of anti-psychotics called "atypical." The older class of anti-psychotics has been on the market for decades.

So far, the federal Food and Drug Administration has approved only Risperdal and Abilify for use in children, and only for the short term. All have been approved for adults. Doctors are free to prescribe drugs to anyone and in any way they see fit once they have been approved for some purpose.

In the past, anti-psychotic drugs were used mostly in adults, and mostly to treat schizophrenia. Long-term use of the "atypical" drugs in adults has been linked to serious side effects, including significant weight gain, diabetes, permanent involuntary movement disorders and even early death.

TROUBLING STATISTICS

State data show that the use of atypical anti-psychotics in children enrolled in Washington's Medicaid program for low-income people increased about 25 percent between 2004 and 2007.

In 2007, 4,978 Medicaid participants 18 or younger were taking the drugs, and 187 were 5 or younger. Some children were on two or more drugs at the same time.

The most recent data available show that the state Medicaid program spent about $9.08 million last year on the drugs for children 18 or younger, up from $4.96 million in 2004.

Statistics on use of the drugs in Washington children not taking part in Medicaid are unavailable. Their use in children nationally has increased more than six-fold in the past 15 years, Varley said.

There are indications, Thompson said, that the drugs are sometimes being used when not needed, in doses sometimes too high, and in children who are too young for them.

USE THE ADHD MODEL, DOCTOR SAYS

Thompson is leading a work group in the state Department of Social and Health Services that seeks to ensure the drugs are prescribed to Medicaid children in Washington only when truly needed and at proper dosages.

The linchpin of the plan is the requirement of an expert second opinion if the drugs are prescribed outside of certain parameters: for instance, to very young children, or in combination, or in very high doses.

Some kids are on "doses that are far beyond any reasonable maximum dose," said Varley, who is a member of the DSHS work group.

Such a plan already is in place for drugs to treat attention deficit hyperactivity disorder, or ADHD. The plan has helped standardize the use of stimulants such as Ritalan since 2005, when similar concerns were raised about ADHD drugs being used inappropriately in Medicaid children.

Among the chief drivers behind the use of atypical anti-psychotics in children, experts say, is the increasing popularity of bipolar disorder diagnoses. Bipolar disorder was previously known as manic depression.

Between 1994 and 2003, the number of children treated for bipolar disorder in the United States increased to more than 800,000 from 20,000, according to researchers.

The treatment trend is defended by some, questioned by others.

"Bipolar disorder is a very debilitating disease," said Jamaison Schuler, a spokesman for Eli Lilly, which makes Zyprexa. "The earlier you can capture it, the better off you are."

DOCTOR QUESTIONS DIAGNOSES Zyprexa, like most of the atypical anti-psychotics, is not approved for children. Schuler said the company has produced data to support that use and has submitted them to the FDA.

For now, though, "to the extent doctors might be prescribing it (for children)," they are doing so without the data, Schuler said.

Among those who question the widespread use of atypical anti-psychotics in children and the popularity of bipolar diagnosis of kids is Dr. John Holttum. The Tacoma child psychiatrist treats 300 to 400 children a year, almost all referred to him by family doctors and general psychiatrists for additional help.

"At times, yes, (atypical anti-psychotics) help," Holttum said. "Kids do get psychotic, and they do have mania, but both are very rare."

What he sees more in his practice, he said, are violent or aggressive children who are labeled as bipolar, but who do not show the traditional signs of mania, depression and delusions of grandeur that are hallmarks of the traditional definition of bipolar disorder in adults.

He and others say the definition of bipolar disorder is expanding and now captures children who 10 or 15 years ago might have been seen as troubled or irritable, and more likely treated with counseling, parenting training for their caregivers or other social interventions.

Furthering the trend is extensive marketing of atypical anti-psychotics by the companies that make them, and media coverage of bipolar disorder as a childhood disease.

"Almost everybody in the field would agree there's been a relative underrecognition of bipolar in children and adolescents over the past two decades," Varley said. "But I'm skeptical of the way bipolar disorder is being used in terms of this new conceptualization."

Holttum has seen the effects in his office on Division Avenue in Tacoma. He said he used to struggle to persuade parents to put their children on an anti-psychotic drug in the rare cases he thought one was needed.

But now, he said, "people come in and tell me (their child) is bipolar. I spend a lot of time convincing parents to remove that diagnosis, and explaining they have a child that is just angry."

He also spends a lot of time taking children off atypical anti-psychotics, sometimes replacing them with antidepressants or ADHD drugs that have fewer side effects.

"We absolutely need some oversight" of atypical anti-psychotic use in children, Holttum said. "Some of the kids who walk into my office have been grossly mismanaged."

Atypical anti-psychotics "are aggressive medications," he said, and their potential long-term side effects on developing brains worry experts.

Holttum said atypical anti-psychotics are useful in the short-term to calm violent children before switching them to other drugs or looking for other solutions. Overall, though, "not a lot of children with unstable moods are bipolar," Holttum said.

By early fall, the state Department of Social and Health Services will issue guidelines for the appropriate age and dose of anti-psychotic drugs for children whose medical bills are covered by the state's Medicaid program.

Use of the drugs outside the parameters - using more than one of the "atypical anti-psychotics" at high doses in a child under 5, for instance -will trigger a review by an expert.

Either the pharmacy dispensing the drug or the prescriber will be required to alert the state and get a second opinion before the drug can be dispensed.

Dr. Jeffrey Thompson, head of the state's Medicaid pharmaceutical program, is working on the plan with psychiatrists and others in the mental health community.

The hope, he said, is to make the system as user-friendly as possible for doctors and patients, so there's no delay in care.

Over the past three years, a similar approach to curb inappropriate use of stimulants in children with attention deficit hyperactive disorder found that required second opinions resulted in a change in drug dosage or the treatment plan 56 percent of the time.

For ADHD drugs, Thompson said, the program resulted in fewer young children being prescribed stimulants, fewer given multiple ADHD drugs at a time, and lower doses.

"Now we are working with the mental health community for the same thing with anti-psychotics," he said.

The plan was triggered in part by a wide-ranging law to improve mental health care for children, signed by Gov. Chris Gregoire in May 2007.

The law required DSHS to "set standards for reducing the number of children that are prescribed anti-psychotic drugs and receive no outpatient mental health services with their medication."

To meet the second goal, on July 1 the department will bump up the number of mental health visits the agency covers for participants 12 to 20, so that stress factors, family situations and other problems can be more thoroughly addressed before they lead to psychiatric symptoms.

Earlier|Later|Main Page

Several state Medicaid programs are picking up where the FDA and the psychiatric profession have failed to meet their institutional the responsibility of protecting children from ever more toxic drugs--in particular the second generation of antipsychotics whose harmful effects can be measured in mortality rates among adults exposed to these drugs.

"We are at risk of treating kids before we know if these drugs are safe in the long-term," said Dr. Christopher Varley, a University of Washington professor of child and adolescent psychiatry.

The drugs are sold under the names Zyprexa, Geodon, Risperdal, Abilify, Seroquel, Clozaril and Invega. They were approved to treat adults with schizophrenia and bipolar disorder.

Among the chief drivers behind the use of atypical anti-psychotics in children, experts say, is the increasing "popularity" of bipolar disorder, previously known as manic depression.

No plausible medical justification can explain the skyrocketing increase in the number of U.S. children "diagnosed" with bipolar disorder. No rational explanation--save aggressive marketing and deceptive advertising replete with false claims about the safety of these drugs--can explain the exponential rise in the number of US children treated with antipsychotics between 1994 and 2003. The number rose from 20,000 to more than 800,000.

Dr. John Holttum, a child psychiatrist in the state of Washington, who has first hand experience in treating children who were misdiagnosed and misprescribed antipsychotics told the Tacoma Tribune: "We absolutely need some oversight of atypical anti-psychotic use in children. Some of the kids who walk into my office have been grossly mismanaged."

He went on to say that "atypical anti-psychotics are aggressive medications." Responsible experts caution that these drugs' potential long-term side effects on developing brains are worrisome.

Unfortunately, there are no responsible U.S. regulators, and no responsible U.S. professional associations that put children's safety first, commercial interests second.
AHRP applauds the effort of Washington State Gov. Chris Gregoire and Dr. Jeffrey Thompson, head of the state's Medicaid pharmaceutical program, who is working on a plan with psychiatrists and others in the mental health community to rein in the misuse of antipsychotics in children.

[Link] Tacoma, WA - Tuesday, May 13, 2008
Should kids get these drugs? Plan likely to increase scrutiny of anti-psychotics in children Doctors focus on new anti-psychotics
M. ALEXANDER OTTO

Concerned about how anti-psychotic drugs are being used in children, state officials are working on a plan due out by early fall to make sure the medications are properly prescribed for Washington kids on Medicaid.

"The data is concerning," said Dr. Jeffrey Thompson, chief medical officer for the state Medicaid program and an expert in pharmaceutical trends in the state's Medicaid population.

The long term safety and effectiveness of the drugs in children are not known, he and others say.

"We are at risk of treating kids before we know if these drugs are safe in the long-term," said Dr. Christopher Varley, a University of Washington professor of child and adolescent psychiatry.

The drugs are used to treat such conditions as bipolar disorder or schizophrenia. They're sold under the names Zyprexa, Geodon, Risperdal, Abilify, Seroquel, Clozaril and Invega.

The drugs belong to a relatively new class of anti-psychotics called "atypical." The older class of anti-psychotics has been on the market for decades.

So far, the federal Food and Drug Administration has approved only Risperdal and Abilify for use in children, and only for the short term. All have been approved for adults. Doctors are free to prescribe drugs to anyone and in any way they see fit once they have been approved for some purpose.

In the past, anti-psychotic drugs were used mostly in adults, and mostly to treat schizophrenia. Long-term use of the "atypical" drugs in adults has been linked to serious side effects, including significant weight gain, diabetes, permanent involuntary movement disorders and even early death.

TROUBLING STATISTICS

State data show that the use of atypical anti-psychotics in children enrolled in Washington's Medicaid program for low-income people increased about 25 percent between 2004 and 2007.

In 2007, 4,978 Medicaid participants 18 or younger were taking the drugs, and 187 were 5 or younger. Some children were on two or more drugs at the same time.

The most recent data available show that the state Medicaid program spent about $9.08 million last year on the drugs for children 18 or younger, up from $4.96 million in 2004.

Statistics on use of the drugs in Washington children not taking part in Medicaid are unavailable. Their use in children nationally has increased more than six-fold in the past 15 years, Varley said.

There are indications, Thompson said, that the drugs are sometimes being used when not needed, in doses sometimes too high, and in children who are too young for them.

USE THE ADHD MODEL, DOCTOR SAYS

Thompson is leading a work group in the state Department of Social and Health Services that seeks to ensure the drugs are prescribed to Medicaid children in Washington only when truly needed and at proper dosages.

The linchpin of the plan is the requirement of an expert second opinion if the drugs are prescribed outside of certain parameters: for instance, to very young children, or in combination, or in very high doses.

Some kids are on "doses that are far beyond any reasonable maximum dose," said Varley, who is a member of the DSHS work group.

Such a plan already is in place for drugs to treat attention deficit hyperactivity disorder, or ADHD. The plan has helped standardize the use of stimulants such as Ritalan since 2005, when similar concerns were raised about ADHD drugs being used inappropriately in Medicaid children.

Among the chief drivers behind the use of atypical anti-psychotics in children, experts say, is the increasing popularity of bipolar disorder diagnoses. Bipolar disorder was previously known as manic depression.

Between 1994 and 2003, the number of children treated for bipolar disorder in the United States increased to more than 800,000 from 20,000, according to researchers.

The treatment trend is defended by some, questioned by others.

"Bipolar disorder is a very debilitating disease," said Jamaison Schuler, a spokesman for Eli Lilly, which makes Zyprexa. "The earlier you can capture it, the better off you are."

DOCTOR QUESTIONS DIAGNOSES Zyprexa, like most of the atypical anti-psychotics, is not approved for children. Schuler said the company has produced data to support that use and has submitted them to the FDA.

For now, though, "to the extent doctors might be prescribing it (for children)," they are doing so without the data, Schuler said.

Among those who question the widespread use of atypical anti-psychotics in children and the popularity of bipolar diagnosis of kids is Dr. John Holttum. The Tacoma child psychiatrist treats 300 to 400 children a year, almost all referred to him by family doctors and general psychiatrists for additional help.

"At times, yes, (atypical anti-psychotics) help," Holttum said. "Kids do get psychotic, and they do have mania, but both are very rare."

What he sees more in his practice, he said, are violent or aggressive children who are labeled as bipolar, but who do not show the traditional signs of mania, depression and delusions of grandeur that are hallmarks of the traditional definition of bipolar disorder in adults.

He and others say the definition of bipolar disorder is expanding and now captures children who 10 or 15 years ago might have been seen as troubled or irritable, and more likely treated with counseling, parenting training for their caregivers or other social interventions.

Furthering the trend is extensive marketing of atypical anti-psychotics by the companies that make them, and media coverage of bipolar disorder as a childhood disease.

"Almost everybody in the field would agree there's been a relative underrecognition of bipolar in children and adolescents over the past two decades," Varley said. "But I'm skeptical of the way bipolar disorder is being used in terms of this new conceptualization."

Holttum has seen the effects in his office on Division Avenue in Tacoma. He said he used to struggle to persuade parents to put their children on an anti-psychotic drug in the rare cases he thought one was needed.

But now, he said, "people come in and tell me (their child) is bipolar. I spend a lot of time convincing parents to remove that diagnosis, and explaining they have a child that is just angry."

He also spends a lot of time taking children off atypical anti-psychotics, sometimes replacing them with antidepressants or ADHD drugs that have fewer side effects.

"We absolutely need some oversight" of atypical anti-psychotic use in children, Holttum said. "Some of the kids who walk into my office have been grossly mismanaged."

Atypical anti-psychotics "are aggressive medications," he said, and their potential long-term side effects on developing brains worry experts.

Holttum said atypical anti-psychotics are useful in the short-term to calm violent children before switching them to other drugs or looking for other solutions. Overall, though, "not a lot of children with unstable moods are bipolar," Holttum said.

By early fall, the state Department of Social and Health Services will issue guidelines for the appropriate age and dose of anti-psychotic drugs for children whose medical bills are covered by the state's Medicaid program.

Use of the drugs outside the parameters - using more than one of the "atypical anti-psychotics" at high doses in a child under 5, for instance -will trigger a review by an expert.

Either the pharmacy dispensing the drug or the prescriber will be required to alert the state and get a second opinion before the drug can be dispensed.

Dr. Jeffrey Thompson, head of the state's Medicaid pharmaceutical program, is working on the plan with psychiatrists and others in the mental health community.

The hope, he said, is to make the system as user-friendly as possible for doctors and patients, so there's no delay in care.

Over the past three years, a similar approach to curb inappropriate use of stimulants in children with attention deficit hyperactive disorder found that required second opinions resulted in a change in drug dosage or the treatment plan 56 percent of the time.

For ADHD drugs, Thompson said, the program resulted in fewer young children being prescribed stimulants, fewer given multiple ADHD drugs at a time, and lower doses.

"Now we are working with the mental health community for the same thing with anti-psychotics," he said.

The plan was triggered in part by a wide-ranging law to improve mental health care for children, signed by Gov. Chris Gregoire in May 2007.

The law required DSHS to "set standards for reducing the number of children that are prescribed anti-psychotic drugs and receive no outpatient mental health services with their medication."

To meet the second goal, on July 1 the department will bump up the number of mental health visits the agency covers for participants 12 to 20, so that stress factors, family situations and other problems can be more thoroughly addressed before they lead to psychiatric symptoms.

Earlier|Later|Main Page

FDA Scraps Helsinki Declaration on Protecting Human Research Subjects

Merril Goozner head of Integrity in Science reports (below) that "FDA Scraps Helsinki Declaration on Protecting Human Subjects."

In so doing, the FDA has taken a quantum leap down the slippery slope toward uncivilized medical experimentation.

The agency is lending the US government seal of approval to unethical medical experiments (primarily commercial drug and medical device tests).

A recent example of an FDA approved, lethal experiment is a trial testing Northfield's artificial blood product, PolyHeme--even as the company and the FDA had evidence showing that patients' exposed to the product were at higher risk of death than those who were given saline.

In one Illinois town where the product was tested, 83% of the population is black. "If you look at the absolute number of deaths, it kills more patients than saline does."

Such experimentation harks back to the Nazi regime's version of medicine--not civilized medicine that America is supposed to represent.

See: [Link]
See also:

1. Charles Natanson; Steven J. Kern; Peter Lurie; Steven M. Banks; Sidney M. Wolfe Cell-Free Hemoglobin-Based Blood Substitutes and Risk of Myocardial Infarction and Death: A Meta-analysis JAMA, Apr 2008; doi:10.1001/jama.299.19.
2. Dean A. Fergusson; Lauralyn McIntyre The Future of Clinical Trials Evaluating Blood Substitutes. Editorial. JAMA, Apr 2008; doi:10.1001/jama.299.19.

[Link]GoozNews
May 08, 2008
FDA Scraps Helsinki Declaration on Protecting Human Subjects

In the mid-1990s, the National Institutes of Health ran a clinical trial in Africa testing whether a new antiretroviral drug to combat AIDS worked to prevent mother-child transmission. The trial created an ethical uproar because the control group received a placebo instead of an older anti-AIDS drug called AZT, which had already been proven successful in reducing the number of babies who contracted HIV from their mothers.

To critics, failure to provide a proven therapy to participants in this and similar trials was a basic violation of standards outlined in the Helsinki Declaration on protecting human subjects in research, originally adopted by the World Medical Association in 1964. But to the U.S. Food and Drug Administration and the drug industry, to which it had grown increasingly close over the course of the 1990s, it contradicted its longstanding policy of only requiring trials showing that a new drug was "better than nothing," i.e., better than placebo, to win regulatory approval. If the drug industry were to closely adhere to the Helsinki Declaration, it would always have to run comparison trials if an effective drug were already available.

Rather than accede to international norms, the FDA and the U.S. government in the succeeding years lobbied hard to get the WMA to amend its rules. And it has, several times. For instance, it now allows use of placebo-controlled trials for less serious illnesses. But the basic guidelines protecting human trial subjects' access to best available therapies remained intact.

Why is any of this relevant today? Last week, the FDA formally declared that it will no longer require that clinical trials submitted to the agency to get regulatory approval for a new drug adhere to the Helsinki Declaration. The new rule, which goes into effect next October, was supported by the drug industry but opposed by numerous public interest, patient advocacy, and consumer groups. The new rule requires only that trials conducted abroad by drug manufacturers follow good clinical practices (GCP) and include a review and approval by an independent ethics committee. There's nothing in GCP guidelines that requires patients in the control arm of a trial get access to already proven therapies. They only need receive the standard of care in that country.

What will this mean for the concept of "informed consent" in a poor country? Imagine for a moment that you live on $2 a day in, say, Zimbabwe, and have high blood pressure. Since the disease isn't life-threatening, you skip buying the available anti-hypertensives being sold in the village pharmacy because you can't afford them and none are on the national formulary. Hence, there is no local standard of care.

Now say you learn while visiting the village clinic that an international pharmaceutical company is recruiting patients for a clinical trial testing a new anti-hypertensive drug. If you join the trial, you may only get the placebo. But there's a 50-50 chance you will get the new drug, which hasn't been proven yet, but might work.

Are there risks associated with taking this new drug? Well, so far, none that the doctors think are serious enough to cancel the trial. But it says right on the form that something may turn up in the clinical trial in which you are being asked to participate. You sign up. After all, a 50-50 chance of getting a drug that has a good chance of working (the drug industry wouldn't be here testing it if it didn't, right?) is better than no drug at all. And how much risk could there be, anyway?

Is that really non-coerced, informed consent?

It's getting tougher and tougher to recruit patients in the U.S. to participate in clinical trials. It's also getting a lot more expensive for drug companies to run them here. The result is that 35 percent of all trials submitted to the FDA in new drug applications now take place abroad. This new rule will only make that number grow.

Moreover, many of those trials conducted abroad (or about 15 percent of all trials) aren't even be registered with the FDA. Unlike trials conducted in the U.S., companies do not have to submit an investigative new drug application (IND) to the FDA before beginning research in foreign countries. The FDA estimates about 575 of the foreign trials submitted to the agency each year as part of new drug applications do not go through the IND process. In other words, the FDA has no record that they even exist.

The FDA is required by law to monitor clinical trials conducted under INDs to protect their human subjects. But an Inspector General's report released last September found that the FDA had no registry of trials (which was rectified by passage of the FDA reform law last October); no registry of the Institutional Review Boards that were supposed to be monitoring trials conducted under its auspices; and independently monitored fewer than one percent of the trials it knew about.

And now it has passed a rule that increases the likelihood that more trials will go abroad and that more of them will not even be registered with the FDA, which makes them all but impossible to monitor.

In the final rule published in the Federal Register, the FDA rejected the notion that adopting the self-regulating GCP standard and eliminating references to the Helsinki Declaration "will hurt subjects in developing countries or result in less protection for subjects in foreign studies." The agency noted that GCP requires trial sponsors closely monitor trial behavior and report adverse events. If I were a headline writer at the New York Daily News, the headline on that story would have been: FDA to Global Poor: Drop Dead.

What I can't understand is why no one in the U.S. press, including in the medical literature, paid attention to this story in the past year as this change was underway. Has the U.S. become entirely callous about the impact its ill-conceived policies are having on the rest of the world? Or am I off-base and this stuff really doesn't matter. Posted by gooznews May 8, 2008

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Stealth Marketers - The ties that bind

The New York Times reports that an examination by CSPI. Integrity in Science, found that the panels that crafted the new DSM-psychiatry's diagnostic "Bible"-is as riddled with financial conflicts of interest as the previous panels had been: "More than half the 28 new members of writers of the next edition of the American Psychiatric Association's (APA) Diagnostic and Statistical Manual of Mental Disorders (DSM) have ties to the drug industry."

The responses to the NY Times' blog are worth reading: [Link]

An article in SLATE by Shannon Brownlee and Jeanne Lenzer also focuses on prominent doctors who exploit their medical license as stealth marketers. A prominent case is psychiatrist Dr. Frederick Goodwin, former head of the National Institute of Mental Health, who was the architect of the controversial "violence initiative" targeting inner city minority boys whose behavior, Dr. Goodwin sought to contain with powerful psychotropic drugs. The concept is not unlike the Soviet "solution" to containing political dissidents with psychotropic drugs.

When Dr. Goodwin compared inner city youths to monkeys in the wild, he was forced to resign whereupon he went on to a hugely profitable career as a pharmaceutical consultant.

Ms. Shannon and Ms. Lenzer report how the pharmaceutical ties to Dr. Goodwin as well to the National Public Radio series, The Infinite Mind, which he hosts, are undisclosed: "a crucial detail that was never revealed to listeners: All four of the experts on the show, including Goodwin, have financial ties to the makers of antidepressants. Also unmentioned were the "unrestricted grants" that The Infinite Mind has received from drug makers, including Eli Lilly, the manufacturer of the antidepressant Prozac."

Whereas the Infinite Mind provides Dr. Goodwin a forum for influencing public opinion about the benefits of psychotropic drugs, Dr. Goodwin's reach is even greater as a partner in Best Practices, a strictly commercial enterprise. "The partners of Best Practice are among the world's leading minds in neuropsychiatry. Together, they bring over 100 years of clinical research experience and service to the pharmaceutical industry and government."

"Our partners have served Presidents of the United States, the United Nations, the FDA, the National Institutes of Health, and pharmaceutical and biotech firms of all sizes. Among them, our partners have published almost a thousand books and articles; their books are some of the basic texts in their fields. They have served on the editorial boards of the opinion making journals most read by their colleagues, and they have won the most prestigious awards offered in their fields."

"Our partners and affiliates have no peer in the field. Our partners identify the right people, bring together the right team, and manage efforts on behalf of our clients. Best Practice has the long-term relationships and collaborations to know where to go, whom to ask, and how to get the response our clients need. "[Link]

According to its website, Best Practices provides marketing and "scientific" expertise to the drug industry, including: "Pre-approval support for all phases of drug development. Opinion leadership consultation.Regulatory advice...Drug abuse risk management program design for FDA review." The company also provides "Post-marketing design and consulting services.Retrospective analyses of specific managed care.Consensus conference organization and sponsorship in areas of clinical controversy" as well as "Scientific evaluation for business and legal purposes" and "Litigation support."

Indeed, a ghostwritten "consensus conference" report penned by prominent psychiatrists, among them, Dr. Thomas Laughren, FDA's chief of psychiatric drugs, was sponsored by Best Practices. [Link]

The clinical controversy that this "consensus conference" attempted to lend legitimacy to is, no other than Dr. Goodwin's reconditioned "violence initiative." This time, the prominent leaders in psychiatry-including FDA's chief-promoted "Impulsive Aggression as a symptom across Diagnostic Categories in Child Psychiatry."

See: Jensen PS, Youngstrom EA, Steiner S, Findling RL, Meyer RE, Malone RP, Carlson GA, Coccaro EF, Aman MG, Blair J, Dougherty D, Ferris C, Flynn L, Green E, Hoagwood K, Hutchinson J, Laughren T, Leve LD, Novins DK, Vitiello B. Consensus Report on Impulsive Aggression as a Symptom across Diagnostic Categories in Child Psychiatry: Implications for Medication Studies. Journal of the American Academy of Child and Adolescent Psychiatry, 2007:6(3):309-322.

[Link] CSPI. Integrity in Science
Psych Working Group Again Rife with Conflicts of Interests

More than half the 28 new members of writers of the next edition of the American Psychiatric Association's (APA) Diagnostic and Statistical Manual of Mental Disorders (DSM) have ties to the drug industry. The conflicts of interests were posted online by the APA last week. They ranged from small to extensive. Leading the pack was William Carpenter, Jr., director of Maryland Psychiatric Research Center at the University of Maryland, who over the past last five years worked as a consultant for 13 drug companies, including Pfizer, Eli Lilly, Wyeth, Merck, Astra Zeneca, and Bristol-Myers Squibb. APA President Carolyn B. Robinowitz claimed that "we have made every effort to ensure that DSM-V will be based on the best and latest scientific research, and to eliminate conflicts of interest in its development." The fifth DSM, produced in conjunction with the National Institute of Mental Health, will be published in 2012. It is used by mental health professionals to classify mental illnesses.

See also: THE NEW YORK TIMES. Psychiatry Handbook Linked to Drug Industry by Tara Parker-Pope May 6, 2008 [Link]

[Link] Stealth Marketers Are doctors shilling for drug companies on public radio?
By Shannon Brownlee and Jeanne Lenzer Posted Tuesday, May 6, 2008

A few weeks ago, devoted listeners of National Public Radio member stations* were treated to an episode of the award-winning radio series The Infinite Mind called "Prozac Nation: Revisited." The segment featured four prestigious medical experts discussing the controversial link between antidepressants and suicide. In their considered opinions, all four said that worries about the drugs have been overblown.

The radio show, which was broadcast nationwide and paid for in part by the John D. and Catherine T. MacArthur Foundation, had the air of quiet, authoritative credibility. Host Dr. Fred Goodwin, a former director of the National Institute of Mental Health, interviewed three prominent guests, and any radio producer would be hard-pressed to find a more seemingly credible quartet. Credible, that is, except for a crucial detail that was never revealed to listeners: All four of the experts on the show, including Goodwin, have financial ties to the makers of antidepressants. Also unmentioned were the "unrestricted grants" that The Infinite Mind has received from drug makers, including Eli Lilly, the manufacturer of the antidepressant Prozac.

We don't know just how much funding or when the show last received it, since neither Goodwin nor the show's producers responded to repeated requests for interviews. But the larger point is that undisclosed financial conflicts of interest among media sources seem to be popping up all over the place these days. Some experts who appear independent are, in fact, serving as stealth marketers for the drug and biotech industries, and reporters either don't know about their sources' conflicts of interests, or they fail to disclose them to the public.

Take the November 2006 NBC Nightly News story that asked, "Can lung scans really prevent cancer death?" Reporter Mike Taibbi, a former smoker, underwent scanning by Dr. Claudia Henschke, a professor of radiology at Weill Cornell Medical College in New York. Henschke claimed on the show that early detection with lung scans could prevent 80 percent of deaths from lung cancer. Although Taibbi included another expert who said that Henschke's claim was "outrageous," viewers were left with little way to evaluate the two conflicting viewpoints. And Taibbi himself concluded that early detection was his "best chance." At no point did viewers learn that Henschke's research was funded by a tobacco company, which has an investment in making the risks of smoking appear to be manageable-or that many experts warn that more research is needed to determine whether the potential benefits of scanning outweigh its harms.

How frequently are journalists glossing over such conflicts? Gary Schwitzer, a professor of journalism at the University of Minnesota, is the publisher of HealthNewsReview.org, a Web site that reviews health care news for balance, accuracy, and completeness. Schwitzer and his team of reviewers have looked at 544 stories from top outlets over the two-year period from April 2006 to April 2008. Journalists had to meet several criteria in order to receive a satisfactory score, among them: They had to quote an independent expert-someone not involved in the relevant research-and they had to make some attempt to report potential conflicts of interest. Half the stories failed to meet these two requirements, Schwitzer says.

Conflicts of interest abound even in unexpected places. A recent survey of academic medical centers published in the Journal of the American Medical Association found that 60 percent of academic department chairs have personal ties to industry-serving as consultants, board members, or paid speakers, while two-thirds of the academic departments had institutional ties to industry. Such ties can be extremely lucrative. And according to these articles in the medical literature, researchers who receive funding from drug and medical-device manufacturers are up to 3.5 times as likely to conclude their study drug or medical device works than are researchers without such funding.

An equally clever way for companies to get out their marketing messages is to go through a consumer group. Drug companies often seed "pharm teams," consumer groups that start out as legitimate advocacy organizations and are subtly manipulated by funding from pharmaceutical companies to convey the desired talking points. Unless reporters ask where groups and individual researchers get their money, they have no idea that their sources may be biased-and neither do their readers, viewers, and listeners.

Which brings us back to The Infinite Mind and "Prozac Nation: Revisited," a show that may stand in a class by itself for concealing bias. In addition to the show's unrestricted grants from Lilly, the host, Goodwin, is on the board of directors of Center for Medicine in the Public Interest, an industry-funded front, or "Astroturf" group, which receives a majority of its funding from drug companies. CMPI President Peter Pitts was one of Goodwin's three guests for "Prozac Nation." We don't know which companies fund his group because when we asked him, Pitts said, "I don't want to go into that." But CMPI took in more than $1.4 million in 2006 and, according to its tax forms, spent $210,000 to influence the media through a large conference, a blog the group maintains, op-eds published in major newspapers, and multimedia programs and podcasts. Pitts has another title that might have been relevant to The Infinite Mind; he is the senior vice president for global health affairs at the PR firm Manning Selvage & Lee, which represents Eli Lilly Inc., GlaxoSmithKline, Pfizer, and more than a dozen other pharmaceutical companies. Yet on the show, Pitts was identified only by his title as "a former FDA official."

The second guest on "Prozac Nation," Andrew F. Leuchter, is a professor of psychiatry at UCLA who has received research money from drug companies including Eli Lilly Inc., Pfizer, and Novartis. The third guest, Nada Stotland, president-elect of the American Psychiatric Association, has served on the speakers' bureaus of GlaxoSmithKline and Pfizer. None of Leuchter and Stotland's ties to industry was revealed to listeners-instead, each was introduced as a prominent academic. The Infinite Mind's Web site states, "Our independence is perhaps our greatest asset." Perhaps, indeed. Neither Goodwin nor the show's producers responded to our repeated requests for interviews and queries about their funding. Pitts, who to his credit did give us an interview, said he didn't know why his ties to industry weren't revealed on the show. Curious, we tried to learn more about the funding for The Infinite Mind-and could discover only that the show's award-winning production company, Lichtenstein Creative Media, was dissolved by the state of Massachusetts on March 28 for failing to file a single annual report since its establishment in 2004.

Some reporters and producers argue that they can't be expected to ask every source whether he or she gets money from the drug industry. But there are obvious first steps to take. A list of academic researchers who are known to have financial ties to the drug and medical-device industries is available through the Center for Science in the Public Interest. (Yes, the name is a lot like the Astroturf group we mentioned earlier-coincidence?) To be fair, the list is inevitably incomplete, and Astroturf groups and academics with undeclared financial ties can make it difficult to ferret out their financial conflicts.

In hopes of making reporters' jobs a little easier, we've created for journalists an international list of prestigious and independent medical experts who declare they have no financial ties to drug and device manufacturers for at least the past five years. We have nearly 100 experts from a wide array of disciplines. E-mail us at Brownlee.Lenzer@gmail.com and we'll be happy to name names.

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