Monthly Archives: August 2008

Anti-psychotic drugs for kids get state look

Arkansas Democrat
BY CAROLYNE PARK

… Millions of kids nationwide are prescribed atypical antipsychotic drugs for a variety of mental-health diagnoses, including attention-deficit hyperactivity disorder, bipolar disorder, autism and schizophrenia.

In Arkansas, 11, 404 children and teenagers under 18 on the state Medicaid program took antipsychotics between July 2007 and June 2008, according to the state Department of Human Services.

But only two atypical anti-psychotics are approved by the U. S. Food and Drug Administration to treat adolescents, and there is little published research to support their use in children, said Dr. William Golden, medical director for health policy with the state Medicaid program.

“The literature to support it is almost nonexistent,” Golden said.

Arkansas is one of many states studying how the drugs are prescribed to children and teenagers and is one of about 15 states in a consortium formed to compile data and analyze prescribing trends nationwide.

The consortium plans to produce a report of initial findings by the end of January, said Dr. Jeffrey Thompson, the chief medical officer of the Washington state Medicaid program, who is leading the effort.

Arkansas spent $ 23. 5 million on atypical anti-psychotics for Medicaid recipients under age 18 in fiscal 2007. National expenditures for the drugs for all ages were estimated at about $ 13. 3 billion, according to a Rutgers University report.

Atypical anti-psychotics, which is a name applied to second-generation anti-psychotics, first came on the market in the 1990 s. They affect the neurotransmitters serotonin and dopamine, chemicals that allow communication between nerve cells in the brain.

Side effects of the drugs can include weight gain, breast milk production in both sexes, facial tics, muscle tremors and a potentially fatal neurological disorder that causes fever and stiffness, said Dr. Steven Domon, section chief of adolescent services at the State Hospital.

The 2006 death of a 4-yearold Massachusetts girl has helped raise the issue of anti-psychotic drug use in children nationally, Domon said.

Rebecca Riley was diagnosed with bipolar disorder and attention-deficit hyperactivity disorder at age 2 and was prescribed powerful medications by age 4, including the atypical anti-psychotic Seroquel. She was also taking Depakote, used to treat bipolar disorder and epilepsy, and Clonidine, used to treat high blood pressure.

Rebecca was found dead on the floor beside her parents’ bed Dec. 13, 2006.

Her parents — who are awaiting trial on second-degree murder charges filed after authorities concluded an overdose killed her — filed a malpractice lawsuit against Rebecca’s psychiatrist in April.

While many doctors prescribe medications for purposes other than indicated on their label — known as “off-label” prescribing — Domon said such prescribing should be done with caution. Atypical anti-psychotics are powerful medications, and their effects on young, developing brains are unknown.

Domon said he was alarmed by the case of a 3-year-old Arkansas boy diagnosed with autism and intermittent explosive disorder, associated with tantrums in which people throw or break things.

Despite his age, the boy was prescribed four medications for depression, anxiety and high blood pressure. One of his medications, Olanzapine, is used to treat patients with schizophrenia and bipolar disorder and is not FDA-approved for children.

Domon, a child psychiatrist, said many clinicians would be uncomfortable making a diagnosis as serious as bipolar disorder in a child so young.

In looking at initial data from Arkansas, Golden, the state Medicaid official, said concerns are whether drugs are being appropriately prescribed for children ages 5 and under. Also, the dosing for children between ages 6 and 12 varies greatly, with many children taking high doses of anti-psychotics or multiple medications.

“Some of the 6- to 12 -year-olds are on some pretty strange concoctions,” he said.

Of the 11, 404 Arkansas Medicaid recipients under 18 who were prescribed anti-psychotics in fiscal 2008, 893 were under 6. Those ages 6-12 numbered 5, 602, and 4, 909 were ages 13-18 …

Risperdal, the brand name for risperidone, is one of the two atypical anti-psychotics that’s FDA-approved for treatment of some patients under age 18, FDA spokesman Sandy Walsh said. It was approved last year for treatment of schizophrenia in ages 13-17 and short-term treatment of bipolar disorder in ages 10-17. It is also approved for treatment of children with autism between age 5-16.

This year, the FDA also approved the use of the anti-psychotic Abilify to treat schizophrenia in ages 13-17 and bipolar disorder for those age 10 and older.

Walsh said physicians may choose to use non-FDA-approved drugs off label on the basis of their own clinical knowledge and their patient’s condition.

“The FDA does not regulate the practice of medicine,” Walsh said.

FINDING SOLUTIONS Arkansas is one of several states that have filed lawsuits against pharmaceutical manufacturers AstraZeneca, Janssen Pharmaceutica of Johnson & Johnson Inc., and Eli Lilly & Co. claiming they encouraged doctors to prescribe anti-psychotics to children and the elderly beyond what is approved by the FDA and thereby harmed patients and cost the state Medicaid plan millions of dollars.

“We want to send a message that these pharmaceutical companies need to walk a straight line when they’re dealing with Arkansas and other states because the health and safety of consumers across this country depend on that,” Justin Allen, chief deputy attorney general, said when the last suit, against AstraZeneca, was filed in late May.

Golden, with the state Medicaid program, said the Department of Human Services’ study of antipsychotic drug use by children isn’t related to the lawsuits.

“The goal is to have a better understanding of what’s going on and to sensitize our mental-health community to these issues,” Golden said.

According to initial data, it appears that Arkansas children are being prescribed anti-psychotics at a higher rate than other states, Domon said.

For example, 12 per every 1, 000 children up to age 18 on Florida Medicaid were prescribed antipsychotics in 2005, compared with 27. 8 per every 1, 000 children up to age 18 on Arkansas Medicaid in 2007, Domon said.

“We’re two to three times more likely to prescribe anti-psychotics to young children than Florida, and Florida thinks they have a problem,” Domon said.

Most of the prescribing of antipsychotics to children is in central Arkansas, but Domon said that doesn’t surprise him. There are only about 30 child psychiatrists in the state, and most of them practice in and around Pulaski County.

Golden said Arkansas’ first focus is on foster-care children. Last fiscal year, 982 of the 6, 957 children in foster care were prescribed anti-psychotics.

Golden said state officials are considering developing guidelines on how and when anti-psychotics should be prescribed. But there are no plans to regulate prescribing.

“We need flexibility with these kids,” Golden said. “You can’t have a cookie-cutter formula for these kids. Very often these are very difficult cases.” Several other states, including Texas, Washington and Florida, are taking similar steps.

In the aftermath of Rebecca Riley’s death, Massachusetts set up an early-warning system to identify preschoolers who might be getting excessive medication and now reviews Medicaid records of children under 5 who are on an anti-psychotic or at least three psychiatric medications.

Thompson, with the Washington Medicaid program, said the consortium will help states compare data and learn what other states are doing to help curb inappropriate prescribing of anti-psychotics.

Participating states will submit their data in September and hold a national meeting in Washington, D. C., in October. Preliminary findings will be presented to the National Association of State Medicaid Medical Directors in November. Rutgers University is helping to analyze the data.

“This isn’t just about drugs. It’s really about appropriate mental health care for kids and adults,” Thompson said. “Drugs are only a component of that care.”

Leave a comment

Filed under Uncategorized

Antipsychotic Drugs Boost Stroke Risk

ABC News
Antipsychotic Drugs Boost Stroke Risk
Patients with dementia face a more than 3-fold danger
By Steven Reinberg

All antipsychotic drugs can increase the risk of stroke, but the risk is greatest among older patients with dementia, British researchers report.

Concerns about the risk of stroke and antipsychotics were first raised in 2002, especially in people with dementia. In 2004, Britain’s Committee on Safety of Medicines recommended that antipsychotics not be used in people with dementia. And, in 2005, the U.S. Food and Drug Administration ordered manufacturers of atypical antipsychotics to add a black box warning to their products about the increased risk for stroke…

Both typical (first generation) and atypical (second generation) antipsychotics are associated with an increased risk of stroke, Douglas said. “This risk is substantially higher in patients with dementia than those without. These findings need to be factored into prescribing decisions made by doctors caring for patients with often-distressing and difficult-to-treat psychiatric symptoms.”

For the study, Douglas and his colleague Liam Smeeth, a professor of clinical epidemiology, collected data on 6,790 patients who had suffered a stroke and were taking antipsychotic drugs. Patients taking antipsychotic drugs were 1.7 times more likely to have a stroke, and patients with dementia taking antipsychotics were 3.5 times more likely to have a stroke.

The risk for stroke was slightly higher for people taking the newer atypical antipsychotics, compared with people taking the older typical antipsychotics. Atypical antipsychotics include drugs such as Abilify, Clozaril and Zyprexa. Typical antipsychotics include Thorazine, Haldol and Clopixol.

Leave a comment

Filed under Uncategorized

Allegations halt drug recommendations

The Daily Texan
By Stephany Garza

The Texas Attorney General’s Office has halted a guideline that lists preferred psychiatric drugs for children in light of allegations of drug companies influencing researchers.

UT researchers based the children’s guideline on an adult version called the Texas Medication Algorithm Project, which came under scrutiny after the state of Texas filed a lawsuit in 2004 against the pharmaceutical company Janssen. The suit alleges that Janssen provided state mental health program decision makers with grants, trips, perks, travel expenses and other payments. Companies also paid decision makers to promote their medications.

The lawsuit states that some “proponents” who worked on the adult project began to work on the children’s version.

“[Janssen’s] product, Risperdal, received a preferential recommendation as a medication of choice on the [project] algorithms used to treat children and adolescents,” according to the lawsuit. “Defendants’ product did not have an FDA-approved indication for use in children and adolescents when it was placed on the TCMAP algorithms.”

The research is state-funded but also includes money from private sponsors. The Robert Wood Johnson Foundation, an arm of Johnson & Johnson, donated $2.4 million for the initial creation of the Texas Medication Algorithm Project. Johnson & Johnson is the parent company of Janssen Pharmaceutica, maker of Risperdal. The program also received $191,183 from Janssen, $146,500 from Pfizer and $103,000 Eli Lily.

UT Pharmacy Dean Miles Crismon received grant support from at least 10 companies, including Eli Lily, Forest, Janssen and Shire, according to the procedural manual of Schizophrenia Treatment Algorithms found on the Department of State Health Services’ Web site.

Crismon was not available for comment.

According to the court document, Janssen experienced an increase in prescriptions and sales of Risperdal throughout Texas after it was made the preferred drug through new programs in the state.

“TMAP and TCMAP proved to be powerful marketing tools for Risperdal,” the lawsuit states. “Driven by these gains and revenues, defendants turned to developing a concerted marketing plan to replicate these programs, and the dramatic revenue and market share generated by TMAP and its progeny in other states.”

Whistle-blower Allen Jones worked as a state official for Pennsylvania and discovered that the state’s chief pharmacist pocketed money from Janssen while designing a similar drug plan for Texas.

The Texas Attorney General’s Office will not comment due to pending litigation.

Because of restraints on information from officials and researchers, there is only speculation that researchers who worked on the adult health plan were paid by pharmaceutical companies, and the court document mentions the possibility of a conflict of interest.

A spokesman on behalf of two researchers with the UT Southwestern Medical Center at Dallas who worked on the children’s project said they were not influenced by drug companies. The anonymous spokesman also said most of the researchers who worked on the children’s version of the state mental health plan were not involved with the adult plan.

The UT System required all four researchers who worked on the child algorithm to fill out an extensive disclosure form about who supports their work. All researchers mention financial support or work as a consultant or speaker for a list of pharmaceutical companies, according to publications separate from the children’s algorithm project.

Leave a comment

Filed under Uncategorized

Antipsychotic Drug Use Up in Elderly Despite Warnings

U.S. News & World Report

Safety warnings slowed the use of antipsychotic drugs in seniors with dementia. But the overall use of the drugs in the elderly increased, a finding which suggests that warnings may not be sufficient to protect patients, Canadian researchers say.

Between late 2002 and June 2005, Health Canada issued three warnings that three new atypical antipsychotic drugs increased the risk of stroke and death in elderly patients with dementia.

The researchers analyzed prescription drug data in the province of Ontario and found that antipsychotic drug use among the elderly increased 20 percent from the month prior to the first warning in September 2002 to February 2007. About 70 percent of the seniors receiving antipsychotic drugs lived in nursing homes, and about 40 percent of them were 85 or older.

“This finding highlights the limited impact of warnings and suggests that more effective approaches are needed to protect vulnerable populations from potentially hazardous medications,” wrote Dr. Geoffrey Anderson, of the University of Toronto, and colleagues.

The study was published in the Canadian Medical Association Journal.

1 Comment

Filed under Uncategorized

Texas AG seizes hard drives in Antipsychotic Drug Scheme

The Dallas Morning News

MEDICATION PROTOCOL
By EMILY RAMSHAW

AUSTIN – A state mental health plan naming the preferred psychiatric drugs for children has been quietly put on hold over fears drug companies may have given researchers consulting contracts, speakers fees or other perks to help get their products on the list.

The Children’s Medication Algorithm Project, or CMAP, was supposed to determine which psychiatric drugs were most effective for children and in what order they should be tried at state-funded mental health centers. In April, high-ranking state health officials gave researchers the go-ahead to roll out the guidelines.

A month later, the officials delayed the protocol, after Texas Attorney General Greg Abbott’s office objected to it.

At most, the suspension indicates that state investigators fear fraud has occurred. At the least, it reflects nationwide unease with potential conflicts of interest between leading medical researchers and the pharmaceutical firms that fund much of their work.

Publicly, officials say it’s because the state is suing a pharmaceutical company alleged to have used false advertising and improper influence to get its drugs on Texas’ now-mandatory adult protocol, the Texas Medication Algorithm Project.

Privately, individuals with knowledge of the case – who spoke only on condition of anonymity because of the pending litigation – say the attorney general’s investigation of possible fraud in the adult protocol has spread to the children’s version.

There’s no way to know exactly what authorities are investigating. But their probe into the adult protocol turned up allegations of drug companies paying researchers who worked on the adult protocol speaking fees, and footing the bill for trips to market the Texas program.

The researchers who designed the children’s protocol, who are not parties to the lawsuit over the adult drug program, insist they are motivated only by children’s health. No evidence has emerged to disprove that; many have dedicated their careers to advancing child psychiatry.

And grants and consulting fees from drug companies are legal and increasingly common, despite fears that they may influence doctors’ prescription habits. In the last quarter-century, drug makers have replaced the federal government as the nation’s main source of research funding, even though some studies suggest this money affects the outcome of clinical trials.

At least four of CMAP’s key developers – all affiliated with the University of Texas system, and all of them published child psychiatry experts – have received research funding from drug companies, or have been consultants and speakers for several different pharmaceutical firms, according to their own published papers and financial disclosure forms filed with the university. Drugs made by some of these manufacturers appear in the children’s drug protocol.

The doctors say there’s no room for improper influence when their reputations are at stake. If the drugs weren’t effective, they wouldn’t endorse them – and the research they conducted to craft CMAP wouldn’t have been published in prestigious medical journals.

“When you really look at the investigators involved and the procedures they followed, they were all within what has been defined as appropriate in every medical field,” said Dr. Steven Shon, who led the effort to create the adult drug list, and was forced to resign in 2006 over allegations he was improperly influenced by a drug company, according to previously published reports. “To block access to this protocol is really hurting the people who need it most.”

Dr. Graham Emslie, a UT-Southwestern psychiatry expert, said he never once witnessed improper influence from drug companies while he helped conduct CMAP research. “There’s much more influence relative to day-to-day prescribing” of drugs than there is doing university research or designing a protocol, he said.

At stake is the psychiatric care of tens of thousands of children treated at state and community mental health centers across Texas – many of whom are covered by Medicaid and don’t have access to private health care. Without the protocol, experts say, these children will continue to be treated by individual doctors who have their own personal influences.

“This attack is causing us to go back to the system we had before, with individual doctors who may have individual influence, instead of using a standardized protocol,” said Aaryce Hayes, a mental health policy specialist with Advocacy, Inc.

The News’ investigation into the doctors prescribing psychiatric drugs to children in state foster care has found that many doctors received money from pharmaceutical companies, for tasks such as running clinical trials and consulting.

Most states don’t require doctors to report such financial arrangements with drug companies. The few that do have found some evidence their work was affected, including doctors with drug company connections writing more prescriptions for children.

About the protocols

Drug protocols are designed to ensure all patients with a particular diagnosis receive the most effective, proven treatment available. They’re created by bringing together academics, researchers and public health experts, who run trials, compare best practices and recommend a road map, or algorithm, for which drugs should be used.

While the protocols are generally created with the best intentions, they can be controversial, particularly when drug companies have a hand in designing them.

Some lawmakers and activists say it’s time the state took a close look at the financial motivations of experts making drug decisions for hundreds of thousands of Texans. The adult protocol determines treatment decisions in state mental health facilities, despite the lawsuit and studies that have played down the benefits of some of the drugs chosen for it.

“In our country, there’s been a switch from taking care of people to focusing on big corporate money,” said Rep. Juan Escobar, D-Kingsville, who unsuccessfully offered legislation last year that would have banned researchers or government employees funded by the pharmaceutical industry from designing state psychiatric drug protocols. “There need to be restrictions on how these things are done, because the victims are our children.”

State health officials and the attorney general’s office refused to comment on either the adult or child drug protocols or on the formal letter the office sent ordering that CMAP not be rolled out. The News found no evidence that any particular drug companies had been pulled into the Medicaid fraud investigation into CMAP.

The CMAP research wasn’t funded by drug companies, but most of the country’s renowned scientists have used industry money for their work. Without the private dollars, which are more readily available than government grants, many pharmaceutical advances would be drastically delayed, researchers contend.

The flip side is that the scientists conducting the research become familiar with and invested in the drugs, making them, in effect, some of the pharmaceutical firms’ best salespeople.
Some universities, like UT, require that their researchers fill out extensive financial disclosure forms, and document every case where they conduct research on drugs manufactured by a company they consult for. Most of the CMAP researchers appear to have complied with these guidelines.

But many of the nation’s researchers must do little more than disclose their relationships in fine print at the bottom of their published papers. There’s no way to verify these disclosures are accurate; in all but a handful of states, drug companies aren’t required to reveal their payments.

Last month, Sen. Charles Grassley revealed that three Harvard psychiatry experts whose research contributed to the explosion of antipsychotic use in children had failed to report a combined $3.2 million in drug company consulting fees to the university, a violation of Harvard’s rules.

Mr. Grassley, R-Iowa, has proposed legislation to force drug companies to disclose their payments to physicians. But he faces an uphill battle. In 2007, drug companies spent an industry record – $168 million – lobbying lawmakers on Capitol Hill, according to a Center for Public Integrity study. That’s up more than 30 percent from 2006.

Patricia Ohlendorf, UT-Austin’s vice president for legal affairs, said several university system researchers, including the head of UT’s pharmacy college, M. Lynn Crismon, have been asked to give depositions for the lawsuit over the adult protocol. They are not named in the civil suit.

Dr. Crismon, who led the effort to create the children’s protocol and has received research or consulting dollars from at least 10 different drug manufacturers, according to his published papers, said he was “not at liberty” to comment on the drug protocol or the lawsuit.

Last month, an e-mail sent to some employees at the Department of State Health Services indicated that “all CMAP activities” were to be “removed from the UT College of Pharmacy” – where Dr. Crismon and a key piece of the roll-out program were centered.

An official close to CMAP said that within the last month, investigators from the attorney general’s office seized hard drives from state health offices and questioned employees. That has not happened at UT, Ms. Ohlendorf said.

The adult protocol

Texas’ adult-drug protocol, spearheaded in the mid-1990s, aimed to provide better and more consistent treatment to adult patients in state mental health facilities. The plan was designed and tested by a team of university researchers, state government experts and mental health advocates, and a presidential mental health commission lauded it in 2004 as a model for the nation.

But there were criticisms from the start by clinicians who feared the protocol would override their judgment and Scientologists opposed to all use of drugs for psychiatric care. And its research funding from 11 pharmaceutical companies prompted allegations of improper influence after several cutting-edge, high-dollar drugs were chosen over traditional generics.

Most researchers involved in the protocol, many of whom also conducted research for the children’s version, declined to comment for this report. But privately, they say their financial relationships with drug companies didn’t cloud their judgment. While the newer drugs were costly, the researchers believe they are better and that they should be available for people in state care, not just for those with private insurance.

State lawmakers moved forward with the adult protocol, using it in state psychiatric hospitals and community mental health facilities. Texas researchers were shuttled across the nation to give drug company-hosted lectures about the protocol’s merits, according to previous newspaper reports and allegations in the state lawsuit. Within years, 16 other states were using similar protocols, and Texas was designing its own for children.

But as new research about the drugs chosen for the protocol emerged, questions resurfaced. A 2005 study by the federal government’s National Institute of Mental Health showed the new antipsychotic drugs, which cost roughly 10 times more than the traditional drugs, performed no better and had nearly as many side effects.

“Taken as a whole,” the report notes, “the newer medications have no substantial advantage over the older medication.”

A year later, a British national study mirrored those findings.

Meanwhile, a Pennsylvania official became an unlikely whistle-blower when he discovered the state’s chief pharmacist – who was designing a drug plan based on Texas’ protocol – was reportedly on the payroll for a drug company, according to previously published news reports.

Allen Jones’ bosses in the Pennsylvania inspector general’s office told him to lay off, Mr. Jones alleges, and when he didn’t, he was fired. Mr. Jones traced the pharmaceutical influence all the way back to the TMAP protocol, filing a whistle-blower lawsuit in Texas that quickly caught the eye of state authorities.

Mr. Jones could not be reached for comment. His Dallas-based attorney did not return phone calls.

Not long after, Dr. Shon, then the medical director for the Department of State Health Services, was ousted over allegations the pharmaceutical company Janssen improperly influenced him to include its schizophrenia drug in the protocol, according to previous news reports and the TMAP lawsuit.

Dr. Shon was accused of accepting consulting money from the company – income he says was unrelated to his work for the state – and of taking dozens of trips underwritten by drug companies to promote the protocol.

In 2006, the Texas attorney general’s office joined Mr. Jones’ lawsuit, accusing Janssen of concealing the risks and exaggerating the benefits of the drug, Risperdal, and of trying to persuade researchers with “trips, perks, travel expenses, honoraria and other payments.” As a result, the state says, the protocol includes high-priced drugs instead of cheaper generics, which costs Texas’ Medicaid program more money.

Executives with Janssen did not return repeated phone calls. In court papers filed in Travis County, the drug company denied any wrongdoing, calling Mr. Jones an “opportunistic ‘late-comer’ ” who had “at best, only secondhand knowledge of the alleged fraud.”

Dr. Shon, who retired to Las Vegas, says for every speaking engagement where he represented the state of Texas, he gave the payment he received to the state. Over the course of 15 years, he said, he probably earned less than $15,000 from private consulting gigs with drug companies – jobs that weren’t related to his state position.

“They were done on my own time, and they followed all the guidelines,” he said. “In terms of what I’ve been involved with, I haven’t seen anybody paid by the industry to promote a product.”

Leave a comment

Filed under Uncategorized

Not approved by the FDA for children

North Dakota – WDAY-TV

Video NewsCast, click here:

Leave a comment

Filed under Uncategorized

Texas foster kids’ doctors have ties to drug firms

The Dallas Morning News
By EMILY RAMSHAW

AUSTIN – One in three Texas foster children has been diagnosed with mental illness and prescribed mind-altering drugs, including some that the federal government has not approved for juveniles, state records show.

Many of these drugs are prescribed by doctors who have a financial stake in pharmaceutical companies’ success, a Dallas Morning News investigation has found. Dozens of physicians who treat children in state custody supplement their salaries with tens of thousands of dollars in consulting and speakers’ fees, and they use drug company grants to fund their research projects.

Accepting this money is not illegal, nor is it frowned upon in most medical circles. Many of the state’s leading medical experts receive income or grants from drug companies, money that has funded groundbreaking scientific advances. And financial ties between doctors and pharmaceutical firms are frequently self-reported by physicians on their Web sites, conference programs and journal articles.

But while the psychiatric drugs given to foster children cost millions of taxpayer dollars a year, it’s hard to know how much the doctors prescribing them are making from pharmaceutical companies. Texas, like most states, does not require disclosure.

The most prominent researchers can easily make $15,000 a year from each drug company they consult for, plus fees for speaking engagements that top $1,500 an event, according to financial disclosure forms some researchers are required to file because they work for state universities. Research grants often exceed $100,000, these records show.

Texas health officials say the overwhelming majority of these doctors have dedicated their careers to improving the mental health of foster kids, who have far higher rates of mental illness than the average child. They sacrifice time that could be spent on private-insurance patients, for whom doctors say they are paid more.

And officials say there are strict and effective rules to ensure that doctors’ relationships with drug companies don’t affect their prescriptions, including a ban on enrolling foster children in most clinical trials and guidelines on which drugs they should prescribe. A new health management policy was implemented this year to help oversee children’s doctors’ appointments, medication and health records – all of which state officials say will continue to curb unnecessary prescriptions.

Concerns about how much children in state custody are medicated continue, though. Some advocates have reported cases of multiple drugs being prescribed by doctors who weren’t psychiatrists or pediatricians, and who spent less than 10 minutes examining their young patients. Foster care providers, who, until recently, had poor access to children’s full medical records, are often the ones seeking the treatment for troubled children.

A brother lost

Wellbutrin for depression. Trazodone for insomnia. Paxil for anxiety. And Adderall for hyperactivity. That was teenager Kristie Garcia’s daily regimen in 2001, months after white CPS vans pulled up to take her and her five siblings away from their suicidal father.

Days after she arrived at a campus that housed dozens of foster kids, Ms. Garcia received a routine psychiatric evaluation. Homesick, angry and miserable, she answered hundreds of questions from doctors whose names she no longer recalls – then swallowed every pill her care providers gave her.

At first, she slept all the time. When the exhaustion and constant fogginess gave way to strange voices in her head, Ms. Garcia said, she asked staff to take her off the drugs. They said no and told her if she refused them, she would be banned from swimming or watching movies.

As soon as she turned 16, Ms. Garcia got out of foster care and took herself off of the drugs. But her relief was short-lived. In late 2005, she learned that her little brother was dead – the result, autopsy reports show, of either suffocation or a heart attack while being restrained in foster care.

Toxicology reports show that Christening “Mikie” Garcia had four drugs in his bloodstream: an attention deficit medicine, an antidepressant, a mood stabilizer and an antipsychotic not federally approved for use in children. The drugs did not appear to reach toxic levels.

Authorities deemed the 12-year-old’s death accidental, and the employee who restrained him was not charged with a crime.

“He didn’t need any meds. He was the kind of kid who if someone had just threatened to call his mother, he probably would’ve stopped what he was doing,” Ms. Garcia said, kneeling in a Kerrville cemetery to pull fistfuls of weeds from Mikie’s grave. “I understand drugs for high blood pressure, for diabetes. But I know Mikie and I didn’t need emotional stabilizers to live our lives.”

No strings attached?

Many pharmaceutical companies fund studies and conferences with no strings attached, meaning they don’t have control over outcomes or content. And drug companies don’t pay doctors by the number of prescriptions they write – evidence, physicians say, that they aren’t improperly influenced in the treatment of their patients.

Researchers say that doctors with the best reputations are the most sought out by major pharmaceutical firms.

“The people who are most respected are the ones who talk to drug companies, who become consultants for multiple companies, because their opinion is really valued,” said Dr. Lawrence Ginsberg, whose Houston clinic has prescribed psychiatric drugs to nearly 2,000 foster children since 2002, according to state Medicaid records.

Dr. Ginsberg, an expert whose work has been published in various top medical journals, has consulted for nearly 20 pharmaceutical firms throughout his career.

“We prescribe the medication that works best for the patient irrespective of our relationship with a drug company,” he said. “If a physician talks to all the companies and prescribes for all the companies, then no company has an edge.”

States that require doctors who write prescriptions to foster children to report their financial arrangements have found evidence that their work can be affected.

In Minnesota, more than a third of the state’s psychiatrists were found to take money from drug companies. A review of that state’s data by The New York Times last year found that psychiatrists who received at least $5,000 from drug companies that make new antipsychotic drugs wrote three times more prescriptions to children than doctors who didn’t receive the funding.

In Vermont, drug companies gave more to psychiatrists in 2007 than to doctors in any other field. Eleven psychiatrists received an average $57,000 each. Other national studies have shown that researchers who are on pharmaceutical company payrolls are more likely to report positive findings when reviewing those drugs.

Although such entanglements are common in the medical industry, they are increasingly raising concerns about improper influence.

This summer, The New York Times reported that three prominent Harvard University researchers responsible for discovering bipolar disorder in children – and for treating it with psychiatric drugs – were found to have failed to report a combined $3.2 million in income from drug companies to their university. Between 1994 and 2003, the number of children diagnosed with bipolar depression increased 40-fold, and the sales of the drugs used to treat it doubled.

Now an influential senator is asking that the American Psychiatric Association reveal its own financing. In 2006, the drug industry made up 30 percent of the association’s $62.5 million in funding. Many mental health associations have also acknowledged accepting large sums from drug companies.

Collaborations between researchers and pharmaceutical firms are essential to the development of groundbreaking treatments and are painstakingly monitored to remove even the appearance of improper influence, said Ken Johnson, the senior vice president for the Pharmaceutical Research and Manufacturers of America, the advocacy group for the country’s drug research and technology companies.

Mr. Johnson said in a written statement that clinical trials and research grants are designed and implemented with the oversight of the Food and Drug Administration and independent review boards “in order to ensure that the data procured is as reliable and accurate as possible.”

“Clinical research is a critical element in the development of revolutionary medicines that help patients live longer, healthier lives,” Mr. Johnson said.

Gwen Olsen, a drug industry watchdog, says drug companies are often holding the strings. She said she spent 15 years as a pharmaceutical sales rep trying to influence psychiatrists by minimizing drug side effects, sidestepping safety questions, and using marketing materials doctored to water down negative studies.

“You could take statistics and bar charts and make them look pretty much how you wanted them to,” Ms. Olsen says in a video interview linked from her Web site,
http://www.gwenolsen.com. “I saw firsthand several circumstances where my minimization of side effects or misinforming a physician had actually resulted in the patient being damaged and/or killed.”

Ms. Olsen, who could not be reached for comment, came forward after her 20-year-old niece who had been taking Paxil committed suicide, according to published reports – first attempting to hang herself from a ceiling fan, then setting herself on fire.

How it works

All children entering Texas’ foster care system get a routine health screening, and any who show symptoms of mental illness receive psychiatric evaluations. Until this year, the doctors who performed those exams were chosen by individual foster parents, caseworkers or the directors of residential treatment providers – the only stipulation being that they accepted patients on Medicaid.

Child-welfare watchdogs say these doctors, many of whom were in private practice or affiliated with private mental hospitals, operated for years with little oversight. Short on time and swamped with patients, some rarely spent more than a few minutes with their foster patients, they said, and relied on drugs instead of more time-consuming behavioral therapy.

Often, children missed doctors’ appointments and doses of medicine – the result of poor record-keeping as they were shuttled between foster families and facilities.

In April, the state implemented a new health care system for foster children, one that makes appointments and selects doctors for them using a standardized list. Under the new program, any children with diagnoses other than minor depression or attention deficit hyperactivity disorder must be seen by a child psychiatrist. The system also keeps track of all the children’s medical records, creating a “continuity of care.”

Despite the heightened regulations, however, many of the doctors on the list are the same as were seeing many foster children before.

Texas health officials acknowledge past problems with foster children being overmedicated. A scathing 2004 report by the state comptroller found hundreds of foster kids as young as 3 were being given psychiatric drugs; one older child had 14 prescriptions for 11 different medications, at a monthly cost of more than $1,000.

But state health officials say that since 2005, they’ve made significant strides, reducing the share of kids taking psychiatric medicine from 38 percent to 32 percent. They’ve also whittled the number of 3-year-olds on mind-altering drugs by more than 25 percent and reduced the number of juveniles on five or more drugs by 20 percent, according to state data.
Prescriptions still common

Experts say the raw numbers are still high. In fiscal year 2007, nearly 15,000 of the 40,000 Texas children in state custody were prescribed at least one behavioral drug, costing the state $37.9 million.

It’s hard to tell how this compares with the broader population; there are few national studies documenting the number of children on psychiatric drugs. In a 2006 analysis of more than 2 million patients served by Medco Health Solutions, a pharmacy benefit manager, 4.3 percent of children under 19 were on an ADHD drug, and 2.4 percent were on an antidepressant. Less than 1 percent were taking antipsychotic drugs, which are considered the most powerful.

Of the top five drugs most often prescribed to Texas foster children in 2007, two psychotropic drugs – Risperdal and Seroquel – were not approved for use in juveniles. Risperdal, an antipsychotic, has since been approved.

Many adult drugs are commonly prescribed to juveniles without federal approval, and not just foster kids. But some that have been proved perfectly safe in adults have had dangerous effects on children, including hallucinations and suicidal tendencies that have led to so-called black box warnings on drug labels.

And even drugs approved for use in children, while effective in treating mental illness, can have serious side effects, including twitching and tremors, muscle stiffness, severe exhaustion and excessive weight gain. Some studies have found that placebos are as effective as certain psychiatric drugs at treating juvenile depression, raising questions about the usefulness of the drugs in the first place.

Despite doctors’ relationships with drug companies, there’s no evidence that clinical trials have ever been run on foster children in Texas. The most prominent case of experimentation on foster children occurred in New York City in the late 1980s and early 1990s, when the city’s child welfare administration enrolled hundreds of kids in AIDS drug trials.

The trials, which proved highly successful and dramatically reduced pediatric AIDS deaths, still sparked outrage years later over allegations that the children were enrolled without proper consent.

“It makes me wonder what real safeguards there are here to protect foster children in Texas from being involved in clinical trials,” Jack Downey, president and CEO of the Children’s Shelter of San Antonio, said of the Texas doctors’ drug company relationships. “Whether any wrong is being done or not, there’s certainly the perception” that doctors are benefiting from the foster care prescriptions.

Ties to companies

The News’ review of the top-prescribing psychiatrists and clinics turned up many with financial relationships with pharmaceutical companies. Among these connections:

•An El Paso psychiatrist who prescribed psychiatric drugs to nearly 300 foster kids between 2002 and 2005 won nearly $150,000 in research funding from Pfizer and Eli Lilly, according to the Web site of the university he is affiliated with. He was also a guest lecturer for an AstraZeneca-sponsored conference at a California beach resort, according to the conference’s brochure. He did not return repeated phone calls to his office.

•A Houston psychiatrist who prescribed psychiatric drugs to 490 foster children since 2002 has helped run ADHD, depression and schizophrenia clinical trials. His research facility has received funding from Eli Lilly, Glaxo SmithKline and Janssen, according to the facility’s Web site. He did not return phone calls, and his assistant said he no longer works with foster children.

•A Houston doctor has given talks at Eli Lilly-funded events, held teleconferences for Eli Lilly sales representatives, and has pitched one of the company’s drugs in speeches, according to her practice Web site. She has prescribed drugs to nearly 150 foster children. She did not return phone calls seeking comment.

Psychiatrists who work with foster children and for drug companies say one doesn’t influence the other. Dr. Giancarlo Ferruzzi, a San Antonio psychiatrist who treats foster children and has consulted for at least five pharmaceutical firms, said professional relationships with drug companies have no effect on his prescribing patterns. And, he said, he frequently relies on drugs from companies he’s never worked for; anything else “would be a dereliction of duty.”

As a psychiatrist who treats children in foster care and also conducts clinical trials for new drugs, Dr. Carlos Guerra of Houston works with lots of pharmaceutical companies.
“But I don’t sit there and think, ‘Hey, a Concerta rep came in today,’ ” he said. “There is more data out for the newer drugs, which makes doctors more likely to use them. That’s why it appears there’s something unethical going on with the drug companies when there’s not.”

Fighting for her son

Mary Kitchens was in the next room when her autistic 8-year-old dropped a lighted candle onto her bed and was unable to communicate what he’d done. After the house burned and Ms. Kitchens depleted her other children’s college funds to put Evan in a private psychiatric hospital, the state took custody of her son, telling Ms. Kitchens the second-grader was a danger to his family.

The piles of leftover drugs in Ms. Kitchens’ carefully appointed Bandera home tell the rest of the story. Seroquel. Lithium. Depakote. Losartan. Trileptal. Risperdal. Concerta.
“You name it,” Ms. Kitchens said wearily, her voice breaking with each drug’s name. “He was given three times the amount given to adult patients. Each of these drugs was given to us by a child psychiatrist.”

In foster care in a residential treatment center, Evan, who was not treated by doctors discussed in this report, grew progressively worse. He ballooned from a size 8 to a size 14 – a side effect of many psychiatric drugs. His eyes crossed, and he convulsed with tremors. He had nightmares and panic attacks and hallucinated that bats were chasing him.
Ms. Kitchens, horrified that she’d ever agreed to turn over her son, took out a loan and hired an experienced attorney. On her 40th birthday, she brought Evan home, carefully weaning him off all but one of the medications. Evan’s behavior is far from perfect, Ms. Kitchens says, but he’s safe and he’s happy.

“He was supposed to be in state care, but nobody was looking after Evan but me,” said Ms. Kitchens, watching the boy, now 12, wriggling on the kitchen floor with Puppy, his dachshund. “Now my kids don’t take medications. I won’t ever trust doctors again.”

Are drugs needed?

Brett Ferguson, a Kerrville attorney who has represented the interests of foster children, said many in-custody diagnoses seem unwarranted. Almost every child he has represented has been placed on a psychiatric drug while in state care, Mr. Ferguson said, even for minor behavioral problems. Some were so drowsy with medication that they could hardly communicate, he said, and caseworkers refused his requests to reduce their dosages.

“The state takes a child that is upset, crying, yelling and screaming because they’ve just been taken from their families and, with all those symptoms, prescribes them medication,” Mr. Ferguson said. “They think that if the child is unruly, it’s easier to deal with them by medicating them than by counseling.”

One former operator of a foster treatment center, who spoke only on condition of anonymity for fear of damaging his business relationship with the state, said that half of the children at his facility “could’ve done with less” psychiatric medication or none at all – and that many were already “zombies” by the time they arrived.

“It’s a medical model. We didn’t have any other options,” said the operator, who acknowledged that sometimes doctors didn’t even spend 10 minutes with a child before prescribing a drug. “I always questioned, ‘If they didn’t need them out there in the real world, why do they need them in here?’ But I wasn’t about to go against the doctor’s orders.”

Curbing this kind of overmedication has been a priority, said Darrell Azar, communications manager for the Texas Department of Family and Protective Services. So far in 2008, nearly 22 percent of all Texas foster children have been prescribed psychiatric drugs for more than 60 days, down from 26 percent in 2005.

The percentage is expected to keep dropping – the result of the new health management program and a review this fall of the state’s drug procedures for children in foster care.
“We’re a lot more confident today that children who don’t need these medications aren’t getting them,” Mr. Azar said.

AT A GLANCE: MOST COMMON DRUGS

Of the top five psychotropic drugs most commonly prescribed to Texas foster children in fiscal year 2007, four cost more than $100 per prescription, and two cost more than $200 per prescription – some of the most expensive drugs given to foster kids. The following five drugs alone accounted for half of the $37.9 million the state spent on psychiatric drugs for foster children in 2007:

RITALIN
Company: Novartis
What it treats: Attention deficit hyperactivity disorder, or ADHD
Foster children who took it in 2007: 4,439
Total cost: $3.4 million

RISPERDAL
Company: Janssen
What it treats: Autism, schizophrenia
Foster children who took it in 2007: 3,753
Total cost: $6 million

CLONIDINE
Company: Now a generic
What it treats: ADHD
Foster children who took it in fiscal year 2007: 3,450
Total cost: $215,500

SEROQUEL
Company: AstraZeneca
What it treats: Schizophrenia and psychotic disorders
Foster children who took it in FY2007: 3,418
Total cost: $6.5 million

ADDERALL
Company: Shire
What it treats: ADHD
Foster children who took it in FY2007: 3,169
Total cost: $2.6 million

SOURCES: Department of Family and Protective Services, Texas Health and Human Services Commission

OUR METHODOLOGY

The Dallas Morning News researched this report by starting with a list of all Texas doctors, psychiatrists or clinics that have received state Medicaid payments since 2002 for prescribing mind-altering drugs to children in state foster care.

Focusing on the 300 doctors who have filed more than 200 Medicaid claims since 2002 for prescribing psychiatric drugs to children in foster care, a reporter found that 25 had close ties to drug companies – meaning they had received consulting contracts, grants or other substantial funding. Two dozen more had minor affiliations, receiving small grants, speaker’s fees or other honoraria. This information was found by:

•Scanning the “financial disclosure” section of hundreds of studies published in medical journals

•Searching university Web sites for lists of pharmaceutical grants awarded to researchers

•Reviewing records of pharmaceutical drug trials for the names of doctors and clinics running the experiments

•Obtaining programs and fliers from drug company-sponsored conferences and lectures, which featured some of these Texas doctors as guest speakers

The News tried to contact all 15 of the doctors mentioned in today’s package. Five returned phone calls. The major drug companies mentioned in the series were also asked to respond, though most did not.

Leave a comment

Filed under Uncategorized