Monthly Archives: May 2008

Panel to review Medicaid guidelines for antipsychotic drugs

Daytona Beach News Journal
By M.C. MOEWE
Staff Writer

A panel named this month to discuss changing state guidelines on paying for antipsychotic drugs for children will meet for the first time June 25.

At stake is the future treatment of more than 18,000 children in Florida currently receiving atypical antipsychotics medication for conditions ranging from ADHD to bipolar disorder and schizophrenia.

The number of children in the Florida Medicaid program prescribed the powerful drugs has nearly doubled from 9,364 kids in 2000 to 18,137 in 2006, the Daytona Beach News-Journal reported in January.

Among those children, the most common primary diagnosis was attention deficit hyperactivity disorder (ADHD) — an ailment not approved for treatment with antipsychotics by the Food and Drug Administration or by experts on the disease.

Medicaid will pay for a drug only if it is “medically necessary and prescribed for medically accepted indications,” according to current state guidelines.

Former Florida Agency for Health Care Secretary Dr. Andrew Agwunobi created the review group in January. The panel’s 11 members were announced this month, and officials said their recommendations will be presented to the agency’s Pharmaceutical and Therapeutic Committee after the June 25 meeting.

Dr. Lisa Cosgrove, a Merritt Island pediatrician who is a member of the review group and committee, said she will rely on a state-funded study by the Medicaid Drug Therapy Management Program for Behavioral Health at the University of South Florida when making recommendations. “It’s a good baseline model to follow,” she said.

During that 2005 study, a panel of experts recommended that antipsychotics (some of these drugs include: Risperdal, Seroquel, Zyprex, Abilify and Geodon) should not be used primarily to target ADHD, nor should antipsychotics be given to children younger than age 6 except under the most extraordinary circumstances.

The review group’s meeting will be 12:30 to 1:30 p.m. June 25 via teleconference. Those interested can call 888-808-6959 and enter conference code 8509227702.

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Unwanted consequences of antipsychotic drugs

Philadelphia Inquirer
By Tom Avril

Antipsychotic drugs are often prescribed to treat agitation and other symptoms of dementia, but a new study suggests they may have unwanted consequences.

Among patients living in a community (non-nursing home) setting, those taking one of the drugs were more than three times as likely to suffer a “serious event” within 30 days of starting treatment, according to a new study in Archives of Internal Medicine.

The authors defined a serious event as one leading to an acute-care hospital admission or death. Such events ranged from hip fractures to strokes. Among the 6,894 community-dwelling patients who were on a newer class of antipsychotics – such as olanzapine, sold as Zyprexa – 960 experienced such an event in the first month. A similar effect was found for older drugs such as haloperidol.
The link was less pronounced among nursing-home patients but still significant: a serious event was about twice as likely for those on the medications as for those who were not.

The researchers, who studied data from more than 40,000 dementia patients in Canada, urged caution with such drugs – even when prescribed for a short term.

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Antipsychotics given for dementia pose risks-study

The Guardian
By Andrew Stern

Elderly dementia patients prescribed antipsychotic drugs are at three times the risk of a serious health problem or dying within a month of treatment, compared to those not given the drugs, Canadian researchers said on Monday.

The medications have been used by doctors to treat aggression in people who are not psychotic or schizophrenic, but there are risks for elderly dementia patients prescribed the drugs, according to Dr. Paula Rochon of the Institute for Clinical Evaluative Sciences in Toronto, and colleagues.

“Of residents newly admitted to a nursing home, 17 percent are started on antipsychotic drugs within 100 days of their admission,” often for short periods to control delirium, delusions or aggressive behavior, Rochon wrote.

“Antipsychotic drugs should be prescribed with caution even for short-term therapy,” she concluded in the report published in the Archives of Internal Medicine.

Three years ago, the U.S. Food and Drug Administration required warnings on antipsychotic drugs notifying patients and doctors of the risks of heart problems or infections in elderly dementia patients.

Previous research has suggested the drugs cause dry mouth and difficulty swallowing, which can lead to pneumonia. Side effects such as dizziness can increase the risk of falls.
The seven-year study of more than 40,000 people age 65 or older — half in nursing homes — found 5.2 percent of the nursing homes residents died within a month of being given one of the newer class of so-called atypical antipsychotic drugs…

Atypical antipsychotic drugs, which the study said had been available for about a decade, include risperidone, marketed by Johnson & Johnson as Risperdal; olanzapine, made by Eli Lilly and Co under the brand name Zyprexa; and quetiapine, sold by AstraZeneca Plc under the brand name Seroquel.

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Vets taking PTSD drugs die in sleep – Hurricane man’s death the 4th in West Virginia

Charleston Gazette
By Julie Robinson

A Putnam County veteran who was taking medication prescribed for post-traumatic stress disorder died in his sleep earlier this month, in circumstances similar to the deaths of three other area veterans earlier this year.

Derek Johnson, 22, of Hurricane, served in the infantry in the Middle East in 2005, where he was wounded in combat and diagnosed with post-traumatic stress disorder while hospitalized.

Military doctors prescribed Paxil, Klonopin and Seroquel for Johnson, the same combination taken by veterans Andrew White, 23, of Cross Lanes; Eric Layne, 29, of Kanawha City; and Nicholas Endicott of Logan County. All were in apparently good physical health when they died in their sleep.

Johnson was taking Klonopin and Seroquel, as prescribed, at the time of his death, said his grandmother, Georgeann Underwood of Hurricane. Both drugs are frequently used in combination to treat post-traumatic stress disorder. Klonopin causes excessive drowsiness in some patients.

He also was taking a painkiller for a back injury he sustained in a car accident about a week before his death, but was no longer taking Paxil.

On May 1, the night before he died, Johnson called his grandfather, Duck Underwood, and asked if he could pick up his 5-year-old son and take him to school the next day. Johnson and his wife, Stacie, have three children, all under 6 years old. Their car had been totaled in the accident the previous week.

When Underwood arrived to pick up the boy the next morning, his knocks were not answered at first. He heard Stacie Johnson screaming. She opened the door and told him she couldn’t wake her husband. They called paramedics, who could not revive him. Doctors did not declare an immediate cause of death.

Toxicology and autopsy results could take as long as 60 days, authorities told the family.

“I want to know the cause of death,” said Ray Johnson, Derek’s father. “Stacie said he was fine that night. Everything was normal. He kissed her goodnight and went to sleep.”

Stan White, father of soldier Andrew White, has become an advocate for families of returning veterans with post-traumatic stress disorder. During his son’s struggle with the disorder and since his death, White has tracked similar cases. He knows of about eight in the tri-state area of Kentucky, Ohio and West Virginia.

He and his wife, Shirley, introduced themselves to the Johnsons and Underwoods at Derek’s funeral and offered their help. He is in contact with the office of Sen. Jay Rockefeller, D-W.Va., who is a member of the Veterans’ Affairs Committee. Rockefeller requested an investigation into these deaths, which is ongoing, said Steven Broderick, the senator’s press secretary.

“When I talked to his family about Derek, I realized it was the same old story,” said White. “It was all too familiar. He was taking those same drugs as the others, and, yes, I believe they are still prescribing that combination.”

After speaking with family members, White wonders if the patients are taking the medicine as prescribed. He said PTSD patients suffer short-term memory loss and shouldn’t be relied upon to track their medications.

Georgeann Underwood agrees.

“You shouldn’t put vulnerable, mentally unstable people on drugs like that,” she said.

An outgoing, personable young man who worked at several jobs to support his young family, Johnson frequently was offered other jobs by customers in the stores where he worked, Underwood said.

In 2006, he returned from the Middle East depressed and short-tempered. Johnson had operated an M249 Squad Automatic Weapon, or rapid-fire machine gun, and rarely spoke about his experiences there.

After his military prescriptions ran out, Johnson’s medications were prescribed by private physicians because he refused to go the VA hospitals where he said he was required to wait long periods of time for appointments. His grandparents paid for his medications.

“He had a very short fuse,” Ray Johnson said. “That was the biggest difference in his personality after he came back.”

Until his death, he worked 12 or 16 hours a day. He was an electrical apprentice at the John Amos Power Plant until he was let go when his work hours approached the union limit for apprentices. He was on his way to apply for another job when the car he drove was rear-ended on April 24.

Johnson died May 2.

Link to story:

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Psychiatry Makes War on “Bipolar Children”

Huffington Post
Dr. Peter Breggin

The front cover of the May 26, 2008 Newsweek has a banner headline, “Growing Up Bipolar” with a split-face photograph of a ten-year-old boy. The headline should have read, “Victim of Psychiatric Assault.”

Dr. Peter Breggin
In daycare 18-month old Max kicked, bit and spat on his larger peers. Apparently before he was two years old, his overwhelmed parents took him to a famous Boston psychiatrist — having been trained in psychiatry at Harvard, I can confirm that famous Boston psychiatrists are among the most arrogantly pro-drug — and within an hour the toddler had been diagnosed as bipolar. Right away he was put on the adult “mood stabilizer,” Depakote. Depakote is an anti-seizure drug that is so sedating that it can, however briefly, subdue a child, at least until the effect wears off.

Dr. Peter Breggin

According to the parents, the doctor told them that the bipolar diagnosis was a “life sentence.” It was a life sentence — to being pharmacologically abused by psychiatrists. At the age of ten, Max is now eight years into his sentence, and getting increasingly abused by his physicians.

The doctor must have put Max on a lot of drugs because a second famous psychiatrist wanted to “streamline” the meds. Reducing anyone’s drugs is nowadays a rarity in psychiatry; Max’s first psychiatrist must have been over the top.

A mere ten years old, Max has already been on 38 different psychoactive drugs. “His parents aren’t happy about it, but they have made their peace with it.” Newsweek concludes, “Max will never truly be OK” because of his “disease.” In reality, toxic chemicals are impairing and distorting the growth of Max’s brain. Psychiatric drugs commonly drive suicidality in children and Max now leaves suicide notes. Tragically, he has become so afraid of psychiatry that after writing his last suicide note he sobbed, “Please don’t send me to the hospital.”

From now on, Max, his family and his doctors will almost certainly have to face an increasingly impossible dilemma common to children who are prescribed multiple psychiatric drugs for a period of years. When trying to withdraw these children from multiple psychiatric medications, they almost certainly go through severe withdrawal problems with extreme emotional instability and the risk of worsening violence and suicidality. But if they are kept on drugs indefinitely, their brain, mind and overall condition will further deteriorate.(1)

It can be relatively easy and safe to withdraw a child from one or even two psychiatric drugs, especially if the parents are willing to learn improved methods of discipline. But when multiple drugs are involved, when the drugs have been taken for a long time, and when the parents are deeply distressed or cannot agree on how to raise their child, withdrawing the child from psychiatric medication can be difficult and hazardous.

Newsweek makes clear that Max’s parents have serious conflicts over how to raise their son, but they have not pursued therapy, marriage counseling or, apparently, not even parenting classes. In every case of an out-of-control child I have seen in my psychiatric practice, either the parents were unable to reach agreement on a consistent approach to disciplining their child, or a single working mom was trying to raise a young boy without the aid of a male adult in the child’s life.

In glimpses that we are given of this family, Max’s father is somewhat like his son; he doesn’t deal well with feelings, and he thinks his wife is much too permissive, calling her a “Caspar Milquetoast.” Reading between lines, it appears that Mom is left with the lion’s share of trying to discipline the desperate child, and perhaps has her hands full with her husband who has a “temper” and is “inflexible.” While not have the opportunity to personally evaluate Max and his family, we can speculate that Max might have trouble figuring out how he is supposed to behave. Meanwhile, this family’s story sounds like a clarion call for a combination of therapy, marriage counseling and parenting classes.

Newsweek declares “At least 800,000 children in the United States have been diagnosed as bipolar, no doubt some of them wrongly,” but then immediately adopts the extremist psychiatric viewpoint, “The bipolar brain is miswired … ” After warning in passing that the drugs inflicted on these children can be useless and even dangerous, Newsweek then justifies them by declaring, “Yet untreated bipolar disorder can be disastrous; 10 percent of sufferers commit suicide.”

Drug companies wrote this script and none of it is true.

First, all of these preadolescent children are being wrongly diagnosed by conventional psychiatric standards. We have no evidence at all that temper tantrums and other unruly behavior, however extreme, is a precursor to being diagnosed with bipolar disorder as an adult.

Second, since there is no known connection between children diagnosed bipolar growing into adults diagnosed bipolar, the data about a 10% risk of suicide is misleading and irrelevant.

Third, there’s no evidence whatsoever that individuals diagnosed “bipolar” have a “miswired brain.” There’s not even any such evidence for a biological flaw in adults who suffer from full-blown manic-like episodes, let alone children whose parents and teachers cannot control them. (1)

The concept that children have bipolar disorder and should be treated with highly toxic adult psychiatric drugs is strictly a drug-company marketing ploy. If it’s true that 800,000 children have been diagnosed, it has become an enormously successful marketing strategy with tragic results for children and their families.

There’s an even more sinister aspect to all this. There has been a real increase in teenagers and young adults who display episodes of manic-like symptoms such as insomnia, excessive energy, racing thoughts, grandiose ideas about themselves, irrational and outrageous behaviors, extreme irritability, paranoia, and psychosis. However, in my three and one-half years of intensive psychiatric training in the 1960s, I saw only one case of a young person suffering from these symptoms. In the following years through approximately 1990, I saw few other cases. Yet nowadays I evaluate many teens and young adults with manic-like symptoms in my medical and forensic practice. The reason for the change? As I document in detail in Brain-Disabling Treatments in Psychiatry (2008), antidepressant drugs, so freely given to children and youth, cause a high rate of manic-like behaviors.

These changes — diagnosing children bipolar and driving other youngsters into states of drug-induced mania — has not occurred by chance. Joseph Biederman, one of those famous Boston psychiatrists, has led the way in pinning the bipolar diagnosis on children who are having temper tantrums and outbursts of rage. Biederman, well situated at Harvard, is a long-time henchman of the drug companies, so much so that even the Wall Street Journal found it necessary to comment on his deep financial connections to his industry patrons. (2)

The promotion of drugging “bipolar children,” has been enormously successful. Before the 1990s, doctors hardly ever diagnosed bipolar disorder in children. In fact, I do not recall hearing the diagnosis given to any children prior to the 1990s. A recent survey in the scientific literature showed that there was a forty-fold increase in diagnosing bipolar children between 1994 and 2003. (3) The survey found that 90.6% were receiving psychiatric medications, including 60.3% on mood stabilizers like Depakote and 47.7% on antipsychotics like Risperdal and Zyprexa, with most on combinations. To compound the tragedy, the study found that more children were being given the most toxic psychiatric drugs, the so-called antipsychotic drugs, than a similar group of adults labeled bipolar. Psychiatry is bombarding children more heavily than adults with similar diagnoses, even though the drugs are not approved for these purposes in children.

The advantages to the drug companies are obvious. If most “bipolar” children get several drugs at once, several dozen over their childhoods, they transform from being patients into being cash cows from psychiatry and the drug companies. Further administration of multiple psychiatric drugs at once complicates the clinical picture so that it is impossible to pinpoint which drugs may be most responsible for the adverse reactions the child experiences. Because so many doctors and so many drug companies will share the blame for mistreating these children, they will be unable to seek redress against individual perpetrators through the courts when they grow up.

It will be very difficult, if not impossible, for any child to outgrow his early behavior problems, and become a normal adult, while being pharmacologically overwhelmed with toxic agents for most of his childhood. The growing brain is literally being bathed in substances like antidepressants, stimulants, mood stabilizers, and antipsychotic drugs that cause severe, and potential permanent biochemical imbalances. All of these drugs have been shown to distort the shape of brain cells (neurons) and in some cases to destroy the cells. (1) Some of the drugs, including Risperdal, Zyprexa, Geodon and other so-called ‘anti-psychotics’ expose the child to permanent and potentially devastating drug induced neurological injury called tardive dyskinesia. They also cause potentially fatal diabetes and pancreatitis, as well as morbid obesity. (1)

The mass drugging of America’s children has become such an outrageous practice with such vast public health and societal implications, it is difficult to know how to conclude my observations. I can understand how parents who feel confused and overwhelmed can be pushed by psychiatrists into trying to control their children’s behavior with drugs. But shame, shame, and more shame should be heaped upon a profession that has forsaken its sacred trust to protect and to care for children, and instead has become a major child abuser of epidemic proportions.

(1) Breggin, P. (2008). Brain-disabling treatments in psychiatry: Drugs, electroshock and the psychopharmaceutical complex. New York: Springer Publishing Company.

(2) Abboud, L. (2005, May 25). Treating children for bipolar disorder? Doctors try powerful drugs on kids as young as 4. Wall Street Journal, p. D1.

(3) Moreno, C., et al. (2007). National trends in the outpatient diagnosis and treatment of bipolar disorder in youth. Archives of General Psychiatry, 64, 1032-1039.

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State suit targets AstraZeneca over antipsychotic medicine

ARKANSAS DEMOCRAT-GAZETTE
BY CAROLYNE PARK

LITTLE ROCK — Arkansas Attorney General Dustin McDaniel filed suit Tuesday against drug manufacturer AstraZeneca claiming the company encouraged doctors to prescribe a dangerous drug to children and the elderly for uses beyond its federal approval, harming patients and costing the state millions of dollars.

The suit filed in Pulaski County Circuit Court claims London-based AstraZeneca PLC and four of its related companies in the U.S. and abroad misled doctors and the public to increase sales of the antipsychotic drug Seroquel, even though the company knew people taking it were at risk of injury, disease and sickness.

AstraZeneca is the last of three major drug companies the state is suing with claims they illegally marketed the antipsychotic drugs Zyprexa, Risperdal and Seroquel to be paid for by the state Medicaid and employee health-insurance programs.

McDaniel filed suit against Titusville, N.J.-based Janssen Pharmaceutica of Johnson &Johnson Inc., in November 2006 and Eli Lilly & Co. of Indianapolis on May 1. McDaniel’s office is working on the cases with the help of private firm Bailey Perrin Bailey LLP of Houston, which is handling similar suits in at least six other states.

“We want to send a message that these pharmaceutical companies need to walk a straightline when they’re dealing with Arkansas and other states because the health and safety of consumers across this country depend on that,” said Justin Allen, chief deputy attorney general.

Arkansas is one of several states, including Pennsylvania, Connecticut and South Carolina,suing the companies in hopes of recouping Medicaid payments for the drugs and for treatment of patients who suffered ill effects after taking them.

Eli Lilly settled its case with Alaska in the midst of a jury trial in March for $15 million.

AstraZeneca spokesman Jim Minnick said Tuesday the company couldn’t comment about Arkansas’ lawsuit because officials had not been notified of its filing or had a chance to review it.

“Seroquel has helped millions of people suffering from mental illness and has made a meaningful difference in their lives,” Minnick said.

Seroquel was approved by the U.S. Food and Drug Administration for treatment of adults with schizophrenia in September 1997. In 2004 it was approved for treatment of adults with acute mania and in 2006 for major depressive episodes associated with bipolar disorder.

Aside from its approved uses, the lawsuit claims the company also marketed the drug for nonmedically necessary uses including sleeplessness, attention deficit-hyperactivity disorder, depression, anxiety, mood disorder, and aggression associated with late-onset dementia.

Seroquel is an atypical antipsychotic, also known as second generation antipsychotics. Such drugs first came on the market in the 1990s as an alternative to “typical” antipsychotics, which cause physical problems, such as spasms or involuntary movement, according to the lawsuit.

Today atypical antipsychotics account for more than 90 percent of all drugs prescribed for psychiatric purposes, regardless of whether they are approved for those indications.

Seroquel is the fastest-growing atypical antipsychotic in terms of sales, according to the lawsuit.

AstraZeneca failed to properly warn consumers that the drug had the potential to cause diabetes, stroke, pancreatitis, seizures and other illnesses, according to the lawsuit. The FDA reprimanded AstraZeneca in May 1999 and October 2006 for giving misleading information about the drug.

Allen said the state Medicaid program spent about $200 million on Zyprexa, Risperdal and Seroquel since they came onto the market.

“We believe that the evidence will bear out that a largemajority of that $200 million was improperly paid for improper prescriptions of those drugs – not based on the fault of the physicians, but based on the off-label marketing efforts of the companies in pushing those drugs to be given to people to whom they shouldn’t be given,” Allen said.

According to the lawsuit, AstraZeneca violated several state laws by engaging in “a protracted and willful course of corporate misconduct and misrepresentation.”

The state is charging Astra-Zeneca with eight counts including Medicaid fraud, which entitles the state to triple damages, and violation of the Arkansas Deceptive Trade Practices Act, for which the state could receive up to $10,000 for each of “many, many violations,” he said.

“Several hundred million webelieve the state could ultimately prove up in damages in trial,” Allen said.

Allen said the AstraZeneca filing was delayed because attorneys for the company contacted the state about the case but “that dialogue recently came to a close.”

“There were discussions of the issues,” Allen said “It’s safe to say that given that we’re filing suit, certainly no resolution was reached.”

Eli Lilly has until early June to respond to Arkansas’ lawsuit.

Janssen attempted to move its case with the state to federal court, but it was remanded back to state court about a month ago, Allen said. The case is now undergoing discovery as the company and state exchange information and documents.

It will be at least a year before any of the cases go to trial, Allen said. A trial is expected to take six to eight weeks.

“This is not going to be a quick process. It’s going to take time and a lot of work by this office and this office’s lawyers, but we’re hopeful it will reveal some bad improper behavior by these companies that was injurious not only to the Medicaid program, but potentially to consumers in Arkansas,” Allen said.

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What they spend: A look at drug company spending in Minnesota — on top specialties and select psychiatrists. Critics say drug firms’ payments to doctors are conflict of interest

St. Paul Pioneer Press (Minnesota)

By Jeremy Olson and Paul Tosto

Drug companies have given $88 million in gifts, grants and fees to Minnesota doctors and caregivers since 2002, according to state payment records, including $782,000 to the two University of Minnesota psychiatrists who oversaw Dan Markingson’s participation in a clinical drug trial.

A lawsuit over Markingson’s suicide, which happened during the drug trial, accused Dr. Stephen Olson and Dr. S. Charles Schulz, chairman of the U’s psychiatry department, of coercing the schizophrenic Markingson into the study.

The lawsuit, brought by Markingson’s mother, Mary Weiss, charged that the doctors were under pressure to recruit patients such as Markingson to maximize payments from AstraZeneca and gain prestige by participating in the drug company’s national study.

Both doctors said in court depositions that their roles were appropriate and that the money didn’t influence their decisions over Markingson — including when his mother argued that he wasn’t getting better in the study and should be withdrawn.

Schulz was dismissed from the lawsuit in February; Olson settled this spring for an amount a university official described as little more than court costs. Federal reviews of the death didn’t result in any penalties against the doctors or the university.

The case nonetheless offered an inside look at the kind of financial payments to doctors that some health policy experts and congressional representatives say should be restricted or at least fully disclosed to the public.

It also scrutinized the ethics of drug company funding of research — something that has received less public attention and criticism than the free lunches, dinners and trips that drug companies have provided to doctors to promote their drugs.

Markingson, 27, killed himself May 8, 2004, in the bathroom of a West St. Paul halfway house. He had been enrolled for more than five months in the university’s “CAFE” study, which compared three antipsychotic drugs.

Weiss sued the university and the psychiatrists. In an interview, she said doctors have a conflict of interest when they are financially benefiting from studies and caring for patients in those studies at the same time.

“I think they lose sight that these are people,” she said, “not their own special little guinea pigs.”

Minnesota is unique in requiring drug companies to report how much money they give to each doctor, but the reporting system has limitations. It doesn’t always distinguish between money for a doctor’s travel expenses and money for a research trial, nor does it distinguish money that was in a doctor’s name but was passed directly to a research institution.
U.S. Sen. Chuck Grassley, R-Iowa, is urging a national reporting system. Grassley held a hearing last year in which two doctors said their colleagues have become trapped by the lures and pressures of drug company money.

“Physicians face a difficult choice,” testified Dr. Greg Rosenthal, an Ohio eye specialist. “One path is to go along. With drug company money, you can increase your income, prestige, build your practice or fund a department, research or professorships. The middle ground is to simply look away. The hard choice is to fight back.”

Olson received $220,000 from six companies since 2002, including $149,000 from AstraZeneca, according to the state records. Schulz received $562,000, including $112,000 as a researcher and consultant to AstraZeneca.

Olson said his AstraZeneca money went straight to the U but did support his salary. Markingson’s full participation in the yearlong study meant up to $15,000 for the university.

The amounts aren’t unusual, according to the payment records collected by the Minnesota Board of Pharmacy. The records, which were updated this month to include 2007 figures, show 167 Minnesota doctors who have received $100,000 or more since 2002. One in four psychiatrists has received funding from pharmaceutical companies, averaging about $50,000 over the six years.

Greater awareness of drug company payments has prompted tighter rules among some Minnesota health care organizations. The Mayo Clinic prohibits its doctors from being paid by drug companies to serve on their speaker’s bureaus. Doctors in speaker’s bureaus give lectures to other doctors about the company’s medications.

The St. Mary’s clinic system in Duluth recently banned pens, mugs or other freebies bearing drug company logos.

There have been fewer steps to restrict drug company funding of research, though most medical journals long ago required doctors to disclose the funding source of any research results they publish. Some health officials are now questioning the drug companies’ use of “ghostwriters” to revise articles about research results to promote the drugs they sell.

Many universities view industry-sponsored research as a necessity amid tightening state and federal science budgets. Drug company funding makes up less than 7 percent of the psychiatry department budget at the University of Minnesota, but Schulz said it is needed as the U tries to move up the list of top-funded U.S. research institutions.

Since Olson was recruited in 2001 to boost the university’s expertise in schizophrenia, he has led the U’s efforts in three drug trials funded by AstraZeneca. He also took part in the federally funded “CATIE” trial, which suggested that older antipsychotic drugs were as effective as AstraZeneca’s Seroquel and other newer drugs.

A growing body of research suggests that drug company money has an influence on study outcomes. One analysis found that industry-funded research was four to five times more likely to produce positive outcomes for a paying company’s drug than federally funded research. A report last year found that drug company-funded studies of cholesterol medications were much more likely to produce results that favored their own drugs as well.

The CAFE results didn’t show that AstraZeneca’s Seroquel offered much benefit over two competitors — Zyprexa and Risperdal. Patients gained control over schizophrenic symptoms and tended to stop taking the medications at the same rate, regardless of which drug they took. The level of unhealthy weight gain was comparable, too, albeit slightly higher among the Zyprexa patients.

Weiss sued AstraZeneca as well, though the company also was dismissed from the lawsuit. Her attorneys argued that AstraZeneca’s goal with the CAFE study was to gain a marketing edge and that the company used selective information from the study to promote Seroquel.

The attorneys cited internal documents, which have been sealed under court order, in which AstraZeneca discussed its use of ghostwriters and strategies to present CAFE results in a way that “sells” Seroquel.

AstraZeneca declined to discuss documents from the case, but brand corporate affairs manager Abigail Baron said the company’s financial arrangements with doctors are necessary to improve health through drug discovery.

“That mission cannot be fulfilled,” she said, “without close partnership with those on the front lines of patient care and … research.”

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