Saturday, May 24, 2008

The Death of Subject 13 - Victim of Antipsychotic Drug Trial - Part 1 of a 3 part series - Minnesota

St. Paul Pioneer Press (Minnesota)
The death of Subject 13
By Jeremy Olson and Paul Tosto Pioneer Press
May 18, 2008
 
Subject 13 was dead.

Enrolled in a clinical trial testing the effects of anti-psychotic drugs at the University of Minnesota, the schizophrenic had killed himself May 8, 2004, in a grisly suicide.

Tragic, a U official wrote in a "serious adverse event" memo to the U.S. Food and Drug Administration, but suicide was "unfortunately not uncommon in this study population."

Unfortunate, but not unpredicted. Subject 13 had a mother who thought that her son, Dan Markingson, wasn't getting better during his six months in the study. Mary Weiss sent five letters and made numerous calls to the researchers, complaining that her son, the 13th enrollee, didn't have the wherewithal to consent to the study and requesting that he be withdrawn.

St. Paul, Minnesota

The university disregarded her letters and calls. She later filed a lawsuit, accusing Markingson's psychiatrist and the study's director, Dr. Stephen Olson, of coercing him to sign up. The lawsuit claimed the university kept Markingson enrolled to preserve its research and to keep payments coming for his participation.

"Do we have to wait until he kills himself or someone else," she asked three weeks before the suicide, "before anyone does anything?"

The death prompted reviews by the state mental health ombudsman and the U.S. Food and Drug Administration about the conduct of the university and Olson, who was Markingson's only psychiatrist at the time he recruited him into the study. The reviews and the lawsuit probed whether Markingson was coerced into the study by the threat of commitment to a psychiatric hospital and whether the university provides adequate protection of mentally ill research subjects. The lawsuit also revealed the pressure to recruit research subjects.

Neither Olson nor the U has been blamed by any oversight agency for the death, or cited for research violations. The U was dismissed from the lawsuit in February, and Olson settled in April. Four years after Markingson's death, the university has moved on. Weiss has not. She endures the pain of a mother who says she couldn't get anyone to listen.He fit the profile

Markingson was a celebrity-tour bus driver in Los Angeles in summer 2003 when his mother, from South St. Paul, arrived for a visit. Weiss found a 26-year-old who believed that aliens had burned a spot on his carpet and that a secretive world order would call on him to kill people in a "storm."

Desperate to get her only son back home, Weiss sent him e-mails pretending to be the "guardian angel" spirit of Markingson's dead grandmother and suggesting the storm would start in Minnesota.

The deception worked, but the return home didn't seem to change Markingson's mental state. He started having visions of killing his mother in the storm. Markingson was taken Nov. 12, 2003, to Regions Hospital in St. Paul, but it had no open psychiatric beds. He was then transferred to the University of Minnesota Medical Center, Fairview.

Weiss said discussions about research started right away at the hospital. Markingson was placed in Fairview's Station 12, a new unit at the time created to treat psychotic patients and screen them for research. Olson and Dr. Charles Schulz, head of the U's psychiatry department, helped launch the unit in part to enhance the hospital's startup schizophrenia program and meet the U's mandate to bring in more research dollars.

Olson first recommended on Nov. 14 that a Dakota County District Court commit Markingson to the state treatment center in Anoka because he was not fit to make decisions about his care. He wrote to the court that Markingson was convinced his delusions were real and that he wasn't mentally ill.

The doctor changed his opinion about the commitment in less than a week, telling the court Markingson had started to acknowledge the need for help.

Reversals by patients are common, Olson explained in an interview with the Pioneer Press last month. Schizophrenics often arrive for treatment with delusions and denial but change their outlook while hospitalized.

A judge agreed Nov. 20 with Olson's new recommendation, requiring Markingson to follow the doctor's treatment plan. The next day, Markingson signed a consent form to be part of a national anti-psychotic drug study, Comparison of Atypicals for First Episode, or CAFE.

Weiss didn't understand. How could her son be deemed incapable of making decisions one day and then consent to a drug study the next?

The study, funded by drugmaker AstraZeneca and spread among 26 institutions, compared the effectiveness of three commonly used anti-psychotic drugs -- Seroquel, Zyprexa and Risperdal.

Olson had been searching for recruits for more than a year. The study required a very specific and elusive person -- a schizophrenic experiencing his first symptoms. Markingson fit that profile.

Weiss wasn't expecting a schizophrenia diagnosis. At Regions, her son responded well to a medication for bipolar disorder. The family has a history of that disorder as well.Question of bias

Full participation required Markingson to take one anti-psychotic drug for up to a year and to appear at the U for checkups. Markingson received AstraZeneca's Seroquel. As Subject 13, Markingson was worth $15,000 to the U, with some of that going to Olson's salary and the psychiatry department. Switching or adding medications could have disqualified Markingson and halted payments to Olson and the department from AstraZeneca.

Overall, the study offered $327,000 to the U and an opportunity to raise the profile of its schizophrenia program.

Weiss' lawsuit claimed that this money gave Olson a conflict of interest regarding Markingson's care.

Four experts hired by Weiss' attorneys agreed that Olson had an ethically questionable position -- as the gatekeeper over Markingson's commitment, as his treating psychiatrist, and as the researcher with a financial incentive to enroll patients.

"For a physician to exercise such medical, research and legal power and control over a research subject is an extraordinary, if not unprecedented, example of unethical coercive practices," said Dr. Keith Horton, a Minneapolis psychiatrist who gave a written opinion in Weiss' suit.

The university's own Web-based guidance on research ethics advises recruiting "in a non-biased, non-power-based manner" and states that "doctor-patient relationships between the investigator and participants should be avoided, when possible, to eliminate any power-based coercion."

In a recent interview, Olson said that it is difficult for an academic physician to avoid this conflict and that in this case the conflict didn't matter. As Olson's patient, Markingson was going to receive one of the three anti-psychotic drugs being tested in the study anyway. As a study participant, Olson said, Markingson would receive more attention and monitoring.

Olson also said in his deposition that participation in the study was never linked to the commitment decision. Markingson could have selected standard treatment or backed out of the study, Olson said.

Weiss doesn't believe her son understood he could have those options. Markingson signed a consent form that said he was "not under any obligation to participate in a research project offered by your doctor." He also signed a hospital discharge plan that warned him to follow Olson's instructions, take his medication and show up for CAFE study appointments.

"Consequences for not following this plan," it stated, "could result in court commitment to the hospital."Mother's intuition

Markingson was transferred from the hospital Dec. 8, 2003, to a West St. Paul halfway house where he was often reclusive -- spending entire days in his room -- but showed no delusions or psychotic episodes.

Notes from Fairview's day treatment program showed no problems either, though Markingson often tuned out group discussions and wore headphones.

Weiss said her son no longer verbalized his most outlandish delusions -- about the killing storm or his "sister" Angelina Jolie. But Weiss still saw signs. Markingson believed he should return to California to resume an acting career he never had. He called himself bulletproof and said his mom would be bulletproof, too, while with him.

Weiss' letters to Olson and Schulz, who was a co-investigator in the study, urged them to consider different treatment options for her son, which would have disqualified him from the study. But the doctors were unconvinced by her pleas. Screenings as part of the U study showed that the drug had managed Markingson's delusions and disordered thoughts.

Weiss was infuriated. Why didn't anyone trust a mother's insights? She looked into a legal guardianship so she would have the power to withdraw her son.Recruiting pressure

Recruiting patients for psychiatric research is a challenge, but CAFE presented special problems. First-episode schizophrenics aren't easy to locate. They don't go to clinics or support groups. Some don't admit to an illness until they are brought to a hospital against their will.

CAFE was an early opportunity at the U for Olson to add research experience to his academic credentials. The U had recruited him in 2001 for his expertise in schizophrenia.

It was a slow start. Olson recruited one patient in 2002, and CAFE study leaders considered dropping him altogether, according to monthly recruiting summaries. Olson and the university had been dropped from a previous study because of low recruiting numbers, the doctor later said in his court deposition.

Exchanges between local and national study officials made it clear that there was pressure for results and a "risk" that the study would be shut down if it didn't recruit enough patients.

The opening of Station 12 -- which evaluated every patient for research -- made a difference, Olson and Schulz said. One-third of the U's patients for CAFE came from this unit. By mid-2003, CAFE leaders were praising Olson and his recruiter, Jeannie Kenney, and asking them to share recruiting tips.Warning signs

Trouble dotted Markingson's final weeks. Screenings at the U showed an increase in symptoms. Markingson neglected his appearance, wearing the same clothes daily. He read a headline about Easter and then told a halfway house worker he'd never heard of that word.

Two changes seemed to add stress for Markingson. His mother drove his car and belongings back from California. He was furious. Also, his county case manager, David Pettit, recommended he seek an apartment and a job.

More than ever, Weiss worried that the research study was failing her son. She didn't think he would listen to her face to face, so she wrote her concerns in a May 7 letter to him. Writing had always connected them, even when Markingson went to college in Michigan and then moved to California.

Her son would never open his mother's letter.

Link for story here: http://www.twincities.com/ci_9292549?IADID=Search-www.twincities.com-www.twincities.com

 

Wednesday, May 21, 2008

Patient's Suicide by Antipsychotic Drug Trial Raises Questions About Psychiatrist's Ethics - Part 2 of 3 - Minnesota

St. Paul Pioneer Press (Minnesota)
The safety net that didn't save him
Patient's suicide raises questions about psychiatrist's ethics  
By Paul Tosto and Jeremy Olson 
May 19, 2008 
 

Markingson center and Tamar Bekmedzjian, right, when Dan's mother Mary
Weiss, left, visited him in Los Angeles in August 2001. (Photo courtesy of Mary Weiss)
 
When people enter drug studies at the University of Minnesota, they're supposed to be protected by a safety net keeping watch that the vulnerable are not coerced, that standards of conduct are met and When people enter drug studies at the University of Minnesota, they're supposed to be protected by a safety net keeping watch that the vulnerable are not coerced, that standards of conduct are met and that researchers aren't tangled in conflicts that might influence their decision-making.

That system was supposed to protect Dan Markingson.

A schizophrenic, Markingson killed himself in 2004 while enrolled in a study at the U comparing anti-psychotic drugs. Documents surfacing the past year in a lawsuit over his death have raised questions about whether the U psychiatrist running the study followed university ethical guidelines. They also raise questions about why the Institutional Review Board, the internal group charged with protecting people in university studies, didn't intervene.

University officials say their nationally accredited review board — a volunteer panel of 57 experts in medicine and other disciplines — works well and rigorously reviews studies. They would not talk specifically about the Markingson case to the Pioneer Press. A judge ruled in February that as a state agency, the university and its IRB are immune from the lawsuit.

The legal ruling didn't allow questions to be explored about who's ultimately responsible for the safety of research subjects and whether the university did everything reasonable to protect Markingson from harm.

According to the U's human subjects protection guide, the IRB's first charge is "to protect human subjects involved in research at the university from inappropriate risk."

In reality, the IRB operates largely on trust. Trust that researchers will follow the rules. Trust that people will speak up when a safety plan is violated, even if they have professional or financial pressures to stay quiet.

"It's the people who implement the plan who are responsible for protecting the subjects," said Moira Keane, the U's director of research subjects protection programs.

The IRB approves all clinical research — modifying safety rules when necessary — and samples study records every year or so to make sure its conditions are met. It also has the power to shut down projects that aren't complying with safety requirements or have caused "unexpected serious harm" to subjects.

Keane recalled four studies out of thousands at the U over the past two decades that the IRB stopped.

The lawsuit by Markingson's mother, Mary Weiss, alleged that the IRB's trust was misplaced in the so-called CAFE study, led by Dr. Stephen Olson, a U psychiatrist.

A central allegation was whether Olson had too much power over Markingson, and too many conflicts that obscured his clinical judgment. Olson recruited Markingson into the study at the same time he served as Markingson's treating doctor and advised a Dakota County judge on whether Markingson should be committed to a psychiatric hospital.

Had the IRB followed its own guidelines, it would have discouraged Olson from recruiting his own patient. The IRB Web site states that "doctor-patient relationships between the investigator and participants should be avoided, when possible, to eliminate any power-based coercion."

It's impossible to know whether Markingson would have killed himself if he hadn't enrolled in the research study. He was in a sensitive early stage of his schizophrenia diagnosis, during which the suicide risk is greatest. Even so, the study's rigid guidelines meant that Markingson received only one anti-psychotic drug to help control his delusions.

Experts hired by Weiss' attorneys said in court depositions that the IRB missed opportunities to make the study safer.

Dr. Harrison Pope from Harvard Medical School called the IRB's role an "essential link in the chain of causation that improperly admitted Mr. Markingson into the CAFE study, improperly held Mr. Markingson within the CAFE study, prohibited effective treatment of Mr. Markingson, and thus became a substantial, proximate cause of Mr. Markingson's death."

The IRB could insist researchers turn over all complaints about their studies, which might have raised concerns in this case. Weiss had complained in letters to Olson and Dr. Charles Schulz, head of the U's Department of Psychiatry, that her son wasn't getting better and was at risk for harm. She had requested that the doctors try other treatments, even if he had to be withdrawn from the study.

The U hired its own national IRB expert to refute Pope's claims. The IRB had no legal obligation to require someone other than Olson to evaluate Markingson's competency or his ability to consent to research, said Ernest Prentice, associate vice chancellor at the University of Nebraska Medical Center.

Nor is there a requirement that complaints such as Weiss' letters be forwarded to the IRB unless there is some unanticipated risk. Had the IRB received complaints, it could have investigated, he said.

Weiss said she'd never heard of an IRB.

The CAFE study was fairly prominent, involving 26 academic institutions and 400 schizophrenic patients. Financed by the pharmaceutical company AstraZeneca, it was worth up to $327,000 to the U, with some of those funds going to Olson's salary and other study personnel.

U officials said the IRB acted ethically and within its obligations and federal regulations to protect human subjects in this study.

After the suicide, the IRB sought information from Olson on how Markingson consented to the study. But IRB officials said in depositions for the lawsuit that the review board never formally investigated Markingson's death.

The IRB investigates when there is evidence of misconduct. There was no evidence of that in the Markingson case, said Dr. Richard Bianco, a U physician who oversaw the U's research subjects program at the time Markingson participated in the study.

Bianco declined a Pioneer Press interview request. But in a court deposition, he acknowledged that the U has some 8,000 studies involving humans — research he estimated was worth about $15 million — but that the IRB doesn't track the number of people enrolled in U research, only the number of projects approved.

Bianco agreed with Keane that the IRB system operates largely on self-disclosure by researchers.

The U's top research official says researchers and IRB reviewers "are aware and understand their ethical and moral obligations to do the right thing.

"If people write with concerns and issues, they will be reviewed," said Tim Mulcahy, the U's vice president of research. "If the IRB were to become aware of a suggestion of coercion or heavy handedness," he added, "we have an obligation to act promptly and very directly."

Olson declined to talk to the Pioneer Press about Markingson's care.

He said it would be difficult for any researcher to get away with violating research rules because they are observed by so many medical students, residents, nurses and others. However, a 2006 internal audit of the U's psychiatry department challenges the notion that those workers would speak up.

Nearly 40 percent of the psychiatry department staff responding to the auditor survey said they did not believe they would be protected from retaliation for blowing the whistle on a suspected violation in the department.

Some experts believe the nation's system of review boards is dysfunctional and in need of reform.

"We have a very haphazard way of overseeing (IRBs) and collecting data on adverse events," said Dr. Ezekiel Emanuel, bioethics chair at the Clinical Center of the National Institutes of Health and a national expert on institutional review boards.

"There's no one in America who can tell you how many people are enrolled in clinical research," he said. "No one can tell you how many people died in (ways) attributable to clinical research. No one can tell you how many people got injured, and no one can tell you over time whether the system is getting less safe." 

Link: http://www.twincities.com/ci_9306735?nclick_check=1

 

Another State Sues Antipsychotic Manufacturer

ARKANSAS DEMOCRAT-GAZETTE
State suit targets AstraZeneca over antipsychotic medicine
— 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.

Link: http://tinyurl.com/3mfua8

 

Tuesday, May 20, 2008

One in Four Minnesota Psychiatrists Receive Funding from Drug Companies - Part 3 of 3

 
St. Paul Pioneer Press (Minnesota) 
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
By Jeremy Olson and Paul Tosto
05/19/2008

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."

 

Friday, May 16, 2008

Brits Continue Assault on Antipsychotic Drugging of Elderly

Loughborough News
MP speaks out on treatment of dementia patients
May 16, 2008
By P. Klein
 
David Taylor MP  [Member of Parliament] has introduced a Ten Minute Rule Bill in the House of Commons which aims to end the 'chemical cosh' approach to the prescription of anti-psychotic drugs for people with dementia in care homes.  [chemical cosh - n. a drug or mix of drugs used to subdue a patient, prisoner, or other person.]

The Bill seeks to implement the recommendations of a report Always a Last Resort by an all-party group (of which David was a member) which reached some startling conclusions and found consensus among patient and professional organisations, regulators and the care home sector that over-prescribing is currently a massive problem. It is estimated that these drugs are wrongly prescribed in an incredible 70% of cases.

Introducing the Bill, the North West Leicestershire MP said "The frail elderly in our population far too often have no-one to speak for them and are being disgracefully and unfairly treated when at their most vulnerable with some type of dementia. One third of all people over 65 will be suffering from dementia when they die, their condition will touch the lives of millions more families and friends, who will provide care and support to the victims of this cruel and relentless disease.

Loughborough Town Hall
Loughborough Town Hall

"We cannot continue to speed the decline of dementia patients through poor management with expensive and often inappropriate antipsychotic drugs in care homes. We know that the number of people with dementia in the UK is expected to reach 1 million in 2025. And last year, care homes spent £60 million on antipsychotic drugs, even though they were not appropriate forms of treatment in most cases.

"As the dementia population continues to grow, we must equip care home staff with the skills necessary to identify different forms of behaviour amongst dementia residents.

"Care homes have a large and increasing amount of responsibility for caring for our population of dementia patients. Two-thirds of the care home population suffer from a form of dementia, and dementia sufferers in care homes are more likely to be in the advanced stages of the disease.

"Too often and too quickly it seems antipsychotics are prescribed to manage behaviour that is neither distressing or threatening, such as restlessness or being vocal – often basic expressions of need.

"The Under-Secretary of State for Health has said that he wants to bring dementia out of the shadows. I hope that the Bill and our report will pierce the Stygian [extremely dark, gloomy, or forbidding] gloom and illuminate one of the bleakest and darkest recesses of that dire and degenerative chamber that faces one in three of us. There is much good practice out there in dealing with the behavioural symptoms of dementia in a non-pharmacological manner. We need to spread and entrench that in all care home settings. That is currently happening at far too slow a rate and demands urgent action now.

"The 1,000 or more people with dementia here in North West Leicestershire - and in every constituency - deserve better. In the interests of those hundreds of thousands of our fellow citizens, my Bill, like our all-party group report, aims to flag up some suggestions on the way ahead for the crucial national dementia strategy in a few months.

"The use of anti-psychotics should always be the course of last resort. "

Link: http://www.inloughborough.com/news/2008/05/11151_dementia.php

 

Wednesday, May 14, 2008

U.S. Government Forces Antipsychotic Drugs on Foreigners

Washington Post
Some Detainees Are Drugged For Deportation - Immigrants Sedated Without Medical Reason
by Amy Goldstein and Dana Priest

The U.S. government has injected hundreds of foreigners it has deported with dangerous psychotropic drugs against their will to keep them sedated during the trip back to their home country, according to medical records, internal documents and interviews with people who have been drugged.

The government's forced use of antipsychotic drugs, in people who have no history of mental illness, includes dozens of cases in which the "pre-flight cocktail," as a document calls it, had such a potent effect that federal guards needed a wheelchair to move the slumped deportee onto an airplane.

"Unsteady gait. Fell onto tarmac," says a medical note on the deportation of a 38-year-old woman to Costa Rica in late spring 2005. Another detainee was "dragged down the aisle in handcuffs, semi-comatose," according to an airline crew member's written account. Repeatedly, documents describe immigration guards "taking down" a reluctant deportee to be tranquilized before heading to an airport.

U.S. Government Forces Antipsychotic Drugs on Foreigners

In a Chicago holding cell early one evening in February 2006, five guards piled on top of a 49-year-old man who was angry he was going back to Ecuador, according to a nurse's account in his deportation file. As they pinned him down so the nurse could punch a needle through his coveralls into his right buttock, one officer stood over him menacingly and taunted, "Nighty-night."

Such episodes are among more than 250 cases The Washington Post has identified in which the government has, without medical reason, given drugs meant to treat serious psychiatric disorders to people it has shipped out of the United States since 2003 -- the year the Bush administration handed the job of deportation to the Department of Homeland Security's new Immigration and Customs Enforcement agency, known as ICE.

Involuntary chemical restraint of detainees, unless there is a medical justification, is a violation of some international human rights codes. The practice is banned by several countries where, confidential documents make clear, U.S. escorts have been unable to inject deportees with extra doses of drugs during layovers en route to faraway places.

Federal officials have seldom acknowledged publicly that they sedate people for deportation. The few times officials have spoken of the practice, they have understated it, portraying sedation as rare and "an act of last resort." Neither is true, records and interviews indicate.

Records show that the government has routinely ignored its own rules, which allow deportees to be sedated only if they have a mental illness requiring the drugs, or if they are so aggressive that they imperil themselves or people around them.

Stung by lawsuits over two sedation cases, the agency changed its policy in June to require a court order before drugging any deportee for behavioral rather than psychiatric reasons. In at least one instance identified by The Post, the agency appears not to have followed those rules.

In the five years since its creation, ICE has stepped up arrests and removals of foreigners who are in the country illegally, have been turned down for asylum or have been convicted of a crime in the past.

If the government wants a detainee to be sedated, a deportation officer asks for permission for a medical escort from the aviation medicine branch of the Division of Immigration Health Services (DIHS), the agency responsible for medical care for people in immigration custody. A mental health official in aviation medicine is supposed to assess the detainee's medical records, although some deportees' records contain no evidence of that happening. If the sedatives are approved, a U.S. public health nurse is assigned as the medical escort and given prescriptions for the drugs.

After injecting the sedatives, the nurse travels with the deportee and immigration guards to their destination, usually giving more doses along the way. To recruit medical escorts, the government has sought to glamorize this work. "Do you ever dream of escaping to exotic, exciting locations?" said an item in an agency newsletter. "Want to get away from the office but are strapped for cash? Make your dreams come true by signing up as a Medical Escort for DIHS!"

The nurses are required to fill out step-by-step medical logs for each trip. Hundreds of logs for the past five years, obtained by The Post, chronicle in vivid detail deviations from the government's sedation rules.

An analysis by The Post of the known sedations during fiscal 2007, ending last October, found that 67 people who got medical escorts had no documented psychiatric reason. Of the 67, psychiatric drugs were given to 53, 48 of whom had no documented history of violence, though some had managed to thwart an earlier attempt to deport them. These figures do not include two detainees who immigration officials said were given sedatives for behavioral rather than psychiatric reasons before being deported on group charter flights, which are often used to return people to Mexico and Central America.

Even some people who had been violent in the past proved peaceful the day they were sent home. "Dt calm at this time," says the first entry, using shorthand for "detainee," in the log for the January 2007 deportation of Yousif Nageib to his native Sudan. In requesting drugs for his deportation, an immigration officer had noted that Nageib, 40, had once fled to Canada to avoid an assault charge and had helped instigate a detainee uprising while in custody. But on the morning of his departure, the log says, he "is handcuffed and states he will do what we say." Still, he was injected in his right buttock with a three-drug cocktail.

In one printout of Nageib's medical log, next to the entry saying he was calm,  is a handwritten asterisk. It was put there by Timothy T. Shack, then medical director of the immigration health division, as he reviewed last year's sedation cases. Next to the asterisk, in his neat, looping handwriting, Shack placed a single word: "Problem."

When he landed in Lagos, Nigeria, Afolabi Ade was unable to talk.

"Every time I tried to force myself to speak, I couldn't, because my tongue was . . . twisted. . . . I thought I was going to swallow it," Ade, 33, recalled in an interview. "I was nauseous. I was dizzy."

As he was being flown back to Africa, his American wife alerted his parents there that he was on his way. His father was waiting at the Lagos airport. It was the first time in three years that they had seen one another. Shocked by how woozy the young man was, his father decided not to take him home and frighten the rest of the family. Instead, he checked his son into a hotel.

Ade was in the hotel for four days before the effects of the drugs began to abate.

Part of a prominent Nigerian family, Ade asked The Post to identify him by only a portion of his name to protect their reputation. He had come to the United States as a college student in the mid-1990s. Five years later, he was in a car belonging to cousins when police found fraudulent checks in the trunk. He pleaded guilty.

After finishing his sentence, Ade was living in Atlanta, and was two semesters away from a telecommunications degree at DeVry University, when immigration officers came looking for him one day in January 2003. They wanted to deport him for the old crime. He called his probation officer to ask whether he could wait to surrender until he took his upcoming final exams. But when he went to the probation office, immigration officers were there to arrest him.

His records offer little explanation of why he was sedated. The one-page medical record in his file mentions one condition: chronic nasal allergy. The log of his trip does not mention mental illness; in the space to list current medical problems, a nurse wrote merely that Ade was anxious.

His drugging, however, fits a pattern that emerges from the cases analyzed by The Post: The largest group of people who were sedated had resisted attempts to deport them at least once before.

One summer day in 2003, deportation officers arrived at the rural Alabama jail where Ade was being held. Pack your bags, they told him. When they reached an immigration office in Atlanta, Ade recalled, half a dozen "big guys came to meet me and said I was there to be deported."

"I can't be deported," he replied. "I have a wife I love very much." Besides, he told them, he was still appealing his immigration case. He shouldn't have to leave, he protested, until the judge had ruled. That day, he was returned to Alabama. But he said that immigration officers warned him, "We'll find a way to get you on a plane."

A few weeks later, the officers came back and again took him to a holding cell in Atlanta. He was, the medical log says, becoming "increasingly anxious and non-cooperative per flt. to Nigeria." At 1:30 p.m., the log says, "Dt taken down by four" guards.

Ade was being held down, he recalled, when he noticed a nurse "with a needle and a bottle with some kind of substance in it." He said he told the guards: "Okay, fine, fine. If it's going to be like this, don't inject me. I will go on my own free will."

The nurse went ahead, the log shows, injecting him in the left shoulder with two milligrams of a powerful drug, Haldol, used to treat psychosis, and one milligram of an anti-anxiety drug, Ativan. He was injected with two more rounds, as well as a third drug, in progressively larger doses, during the trip.

The effects of those injections are what alarmed Ade's father after the plane landed in Lagos. Yet the medical log says Ade arrived "alert and oriented."

His family's doctor, who visited him on each of the four days his father hid him in the hotel, had a different view. "He was groggy -- somebody under the influence of drugs or drunkenness," recalled Olakunle Adigun, a general practitioner. He couldn't figure out what sedatives his patient had been given, so he tried to detoxify him with saline infusions.

Ade's pulse was dangerously low, and when he tried to walk around the hotel room, "he leaned on the wall," Adigun said. "He was talking, but a slurred kind of speech."

* * *

Internal government records show that most sedated deportees, such as Ade, received a cocktail of three drugs that included Haldol, also known as haloperidol, a medication normally used to treat schizophrenia and other acute psychotic states. Of the 53 deportees without a mental illness who were drugged in 2007, The Post's analysis found, 50 were injected with Haldol, sometimes in large amounts.

They were also given Ativan, used to control anxiety, and all but three were given Cogentin, a medication that is supposed to lessen Haldol's side effects of muscle spasms and rigidity. Two of the 53 deportees received Ativan alone. One person's medications were not specified.

Haldol gained notoriety in the Soviet Union, where it was often given to political dissidents imprisoned in psychiatric hospitals. "In the history of oppression, using haloperidol is kind of like detaining people in Abu Ghraib," the infamous prison in Iraq, said Nigel Rodley, who teaches international human rights law at the University of Essex in Britain and is a former United Nations special investigator on torture.

For people who are not psychotic, said Philip Seeman, a University of Toronto specialist in psychiatry and pharmacology, "prescribing Haldol . . . is medically and ethically wrong." Seeman studied the drug in the 1960s and later discovered the brain receptors on which several antipsychotic drugs work.

The only circumstances in which small amounts of Haldol are appropriate for non-psychotic people, Seeman said, are when a person comes into a hospital emergency room violent and agitated from an overdose of a drug such as PCP, or when someone with severe dementia is delusional or combative. "You or I wouldn't get it if we were emotionally upset," he said.

In addition, Seeman said, typical doses to help psychotic patients accustomed to the drug are perhaps five to 15 milligrams a day. Several deportees were given a total of 30 milligrams, which Seeman characterized as "really high," especially for people who have never taken the drug before.

Even when used for its intended patients, people with psychosis, Haldol has drawn warnings from the U.S. government. In September, the Food and Drug Administration issued an alert citing "a number of case reports of sudden death" and other reports of dangerous changes in heart rhythm. It is, important, the FDA warned, to inject Haldol only into muscles, not veins, and to avoid doses that are too high.

"Pharma non grata" is the way Emergency Medicine News magazine described the drug after the FDA alert.

Beyond the specific drugs used, Rodley said, is a deeper question: "What is the least intrusive means of restraint consistent with the human dignity of the person? . . . I'd be very surprised if the injection of disabling chemicals against somebody's will that affect one's psychological well-being . . . is likely to be the least intrusive means."

Asked to explain the reason for using Haldol and other psychotropic drugs with people who are not mentally ill, ICE responded, "The medications used by Aviation Medicine are widely used in psychiatry." Agency officials said that medical escorts administer "the lowest dose possible." Combining Haldol and Ativan "allows you [to] use less of each," they said, and produces a quicker and longer sedative effect.

In the years before Ade was drugged, there had been an internal debate within the U.S. government over whether sedating deportees against their will is legal, according to confidential legal memos obtained by The Post. There was agreement that mentally ill people could be forced to take psychotropic medicine on their way out of the country. At dispute were cases in which the detainees were not mentally ill but combative -- known as "behavioral cases."

Near the end of the Clinton administration, Health and Human Services lawyers  sent around a memo that warned, "[U]sing chemical restraints in cases in which medication is not clinically indicated . . . may put the government at risk of potential liability."

Another memo went further, concluding that it could be done only if a federal judge gave permission in advance. "[R]egarding detainees who are not mentally ill," the November 2000 document said, "involuntary medication of such persons for the sole purpose of subduing them during deportation, without a court order, is not supported by any legal authority and raises ethical issues, as well.

"After the Sept. 11, 2001, attacks, and after the Bush administration assumed a tough new stance on immigration in its campaign against terrorism, the Justice Department still sounded wary about drugging deportees. In March 2002,  a Justice lawyer laid out two options. One choice, he wrote, was to "seek a court order . . . in every case where the alien's medication is not therapeutically justified." The other choice was to create a regulation to grant immigration officials explicit permission to sedate deportees, perhaps including safeguards that would give people a warning that they might be medicated -- and a chance to object.

Top immigration officials chose neither. Instead, in May 2003, just after ICE was created,  they internally circulated a new policy: "[A]n ICE detainee with or without a diagnosed psychiatric condition who displays overt or threatening aggressive behavior . . . may be considered a combative detainee and can be sedated if appropriate under the circumstances."

Under that policy, scores of people have been sedated every year since then, usually with heavy psychotropic drugs.

Some countries forbid the practice. The medical files for several deportees recount disputes between U.S. officials, who wanted to inject a subject, and foreign officials, who would not allow it.

Immigration guards and a public health nurse ran into trouble in May 2004, during a stopover on a trip from Colorado to Guinea. The deportee had been given the three-drug cocktail at the airport gate before leaving Denver, the nurse wrote in the log. Three "booster doses" followed.

The last booster was given shortly before the plane landed in Belgium. "[N]o problem initially with Belgium security," the log says. "[T]hen approached and informed illegal to medicate detainee against their will in Belgium. Informed them pt wasn't medicated in Belgium airspace for which they replied that he is medicated in Belgium." In the end, the security officers let the deportation go ahead.

Immigration guards and a nurse had more trouble during another deportation to Guinea in April 2006, as they escorted a 34-year-old man from Atlanta, with a stop in France.

He had been given 15 milligrams of Haldol, as well as the two other drugs, by the time the flight reached Paris at 9:45 a.m. According to  a nurse's report on the incident, the guards, nurse and deportee were met at the plane by French national police, who accompanied them to an airport police station to await the connecting flight to Africa later in the day.

Once at the station, one of the guards asked a French officer "where we could inject the detainee when needed." First, they were shown into a private area. But five minutes later, the nurse's report says, "a superior French police officer approached and informed me that any type of involuntary injection was strictly forbidden in France, and that we would have to wait until we were in the aircraft if we were to inject our detainee."

Six hours later, the entourage returned to the boarding area for the flight to Guinea. "When we arrived at the plane, the detainee became very argumentative, refusing to enter plane until [the guards] produced paperwork showing a final deportation order," the nurse wrote. The immigration officers tried to coax him onto the plane. He refused.

"I asked the French police if the ramp on the gate would be an appropriate place to medicate," the nurse wrote. "The French police's reply was that it was strictly forbidden." The plane's captain came over to say that he would not allow the deportee onto the flight. The guards and the nurse flew him back to Atlanta.

Five weeks later they tried again, and this time, they reached Guinea. By the time they arrived, a nurse had given the deportee nine injections of Haldol totaling 55 milligrams -- nearly four times as much as before.

One deportee who was sedated last year had convictions for armed robbery and assault. Another kept telling immigration officers, "I am God." But many of those injected with psychotropic drugs, records show, are neither violent nor mentally ill. They simply do not want to go home.

"[M]ild anxiety and agitation" is how a deportation log describes Remmy Semakula's state on the afternoon he was taken from his cell in the Middlesex County jail in New Jersey to be deported to Uganda in early April 2007. According to a memo from his deportation officer, he had said earlier that he would "fight with the officers and obstruct the operation of the airline" if guards tried to force him to go home. Semakula, 42, said that he had not tried to thwart his deportation and had not known it was imminent because his immigration case still was before a federal judge. "I never fought violently or physically," he said. "They just grabbed me and injected me with a sleeping drug."

The first time immigration agents tried to deport Michel Shango, he slammed his head, hard, against the outside of the van that had come to pick him up at Atlanta's city jail. Instead of being driven to the airport, then flown to the Democratic Republic of Congo, he was brought back to the jail so his wound could be tended to.

"I asked him why he feared being returned back to his country," an immigration officer wrote of the incident. Shango, now 42, replied that he had been a journalist and had written articles critical of the Congolese government. "Detainee stated . . . that he might as well die trying to avoid deportation," a second officer wrote, "because they will kill him as soon as he gets to the D.R. of the Congo."

Until early 1996, Shango worked in Congo, ghostwriting articles and supplying information to foreign correspondents about the repressive administration of President Mobutu Sese Seko, he said in telephone interviews from locations in Congo, Gabon and Equatorial Guinea, where friends are now helping him hide. Eventually Shango was arrested, he and two of his lawyers said, but he escaped to Canada, then settled in North Carolina, where he started a limousine business with a cousin in Charlotte. He married an American, who at first offered to help him become a citizen. The marriage dissolved. He applied for political asylum. He was turned down.

He was remarried to a Congolese woman by the time immigration officers came to his house at 4:30 one morning in May 2006. As his wife and their three American-born children cried at the frightening scene, the officers led him away at gunpoint.

On Feb. 28, 2007, three months after the first deportation attempt was aborted because of the head-banging incident, seven guards arrived at the Atlanta jail to make a second attempt. Shango glanced at his watch and noted that it was 1:45 p.m. "They pushed me against the wall," he recalled. "They pulled my pants down." His medical log shows that he was given seven shots in his right buttock and right shoulder before he boarded the airplane.

The log says his only psychological problem was "anxiety disorder."

By the time Shango reached Congo,  records show, he had been injected with 32.5 milligrams of Haldol and 7.5 milligrams of Ativan. As he was thrown into a prison after he got off the plane, and even as friends helped him escape, he was so disoriented, he said, that he did not fully know where he was. For two weeks, Shango said, "It was like I was dreaming. . . . I started crying, crying, crying all day long. . . . I was like crazy, because [of] the drugs, knocking me down."

* * *

Of all the detainees who have been forcibly drugged, only two have drawn much public attention. Neither, in the end, was deported. And compared with other deportees, neither got large doses of sedatives. But publicity about their cases sent shock waves through the immigration bureaucracy. Raymond Soeoth, a Christian minister from Indonesia, had tried and failed to win asylum in the United States. While in custody at an immigration compound near Los Angeles, his medical log notes, Soeoth, now 39, he said he would kill himself if deported -- a statement his lawyers say he never made.

On Dec. 7, 2004, he was injected in the left buttock with five milligrams of Haldol and four milligrams of Cogentin before being taken to the airport. As it turned out, his deportation was canceled before takeoff because immigration officials had not alerted airline security in Singapore, a stopover point.

Amadou Diouf came to the United States from Senegal as a student in 1996 and got a degree in information systems from California State University at Northridge. He married a U.S. citizen and was trying to change his immigration status when, in March 2005, he was arrested and brought to the same compound as Soeoth.

Eleven months later, as he was still appealing his case and, according to his lawyers, had a court order blocking his deportation, immigration officers came for him and took him to the airport for the trip back to Senegal.

At first, records show, Diouf, now 32, was calm. He was already sitting in a window seat, 4A, when he demanded to speak to the plane's captain. He "became more agitated, anxious and loud in his dialogue," according to the medical log. A nurse said he would be given "some calming medicine," but when Diouf saw the needle, he lunged. Guards "proceeded to take down the detainee to the ground" in the plane's galley, and the nurse injected him with five milligrams of Haldol, two milligrams of Ativan and two milligrams of Cogentin.

At that point, the guards and nurse called off the trip. Diouf was returned to his cell. In early May 2007, a lawyer for the American Civil Liberties Union of Southern California was drafting a lawsuit on behalf of Soeoth and Diouf and told a local newspaper, the Los Angeles Daily Journal, about their sedations. Across the continent, inside the immigration health division's headquarters in downtown Washington, the publicity's effect was electric.

The next day, the chief of psychiatry for the division's aviation medicine branch dispatched a memo. "I have stopped all planned non-psychiatric behavioral escorts, of which 10 are currently planned," he wrote, until government lawyers "have formalized policy in regards to this type of escort activity."

A month and a half later, the medical escort rules were changed. Except in psychiatric cases,  according to a confidential June 21 memo from ICE, the health division "must have a court order to assist. . . . [ICE in] removal of problematic detainees." In January,  the language was made even stronger: "DIHS may only involuntarily sedate an alien to facilitate removal where the government has obtained a court order. There are no exceptions to this policy."

The newest rules were issued less than three weeks before the government tentatively settled the lawsuit with Soeoth and Diouf, who are now out of custody. The government is no longer trying to deport Soeoth; Diouf is still fighting to remain in the country.

How well the government is following its new rules is unclear. Asked how many court orders the government has sought, immigration officials said that none "have been issued to involuntarily sedate an alien for removal purposes," but they declined to discuss whether any requests are pending.

In one known case in which  government lawyers sought a court order, they withdrew the request after a congressman intervened. On Oct. 1, a federal judge in Texas was asked for permission to sedate Rrustem Neza. Immigration officers had canceled their first attempt to deport him to Albania because he created a scene at the Dallas/Fort Worth International Airport, screaming, "I am not a terrorist."

One week after the government filed its motion, Rep.  Louie Gohmert (R-Tex.), a former judge,  wrote to the court, saying he had "grave concerns" about the government's desire to medicate his constituent to deport him. "Mr. Neza fled Albania after telling a crowd in Tropoje the names of the men who were seen killing Azem Hajdari, who organized a student movement against the Communist Party. Mr. Neza's cousins were fatally shot while fleeing with him," the congressman wrote. "[S]edating Mr. Neza amounts to a death sentence for an innocent man."

Last March, after Gohmert had spoken about Neza's case with Secretary of State Condoleezza Rice, and after he had introduced legislation to block Neza's deportation, the issue was dropped.

* * *

In at least one instance since the rules were changed, the government apparently drugged a deportee without permission from a judge. Maher Ayoub, now 44, was sent back to Egypt last August. A month later, immigration officials told Congress that they had not yet asked for a court order in any case.

Ayoub had thwarted the first attempt to deport him, a few months earlier, by sitting in a van and demanding all the paperwork in his immigration file. He said he spent the next three months in segregation in an Elizabeth, N.J., detention center. The next time they tried to send him home, immigration officers were determined to make sure he would go quietly.

His record offers contradictory evidence about whether there was psychiatric justification for the drugs he got, though it seems to suggest that there was not. A one-page "patient summary" for Ayoub says "Med/Psych Alert Documents: None." His medical escort log labels him a mental health case and says he had a "depressed mood" and an "anxiety state."

A handwritten note in his escort file, from a psychiatrist who saw him at the Elizabeth center, first says Ayoub was not likely to endanger himself or anyone else -- then, lower on the same page, says he might. On the next page of the file is another note, this one written two days before his flight, from the psychiatrist in charge of aviation medicine. It says that Ayoub's case is a "behavioral escort," not a psychiatric one, and that the nurse "is only to give medications to the patient if he agrees to take them. He will only use involuntary treatment if the patient is at imminent risk of hurting himself or others."

That is not what happened.

"Detainee tearful and wringing hands," his medical log begins. An hour later, it says: "Detainee increasingly agitated and resisting clothing change. Detainee is now crying and screaming" at two guards. A nurse at the Elizabeth detention center slid two milligrams of the anti-anxiety drug, Ativan, into his left shoulder.

Immigration officials said his deportation was "consistent" with the June policy that allows medication only when a detainee "may be a risk to himself or others."

"I was feeling my head was leaving my body," Ayoub remembers. "I was losing control over my body." He was groggy but awake when he arrived with guards and the nurse at New York's John F. Kennedy International Airport and boarded the nonstop flight to Egypt.

Before the plane took off, he remembers, he called over a flight attendant and "asked them to tell the pilot I didn't want to leave." The nurse stuck a needle into his right arm this time. That injection put him to sleep.

Link: http://www.washingtonpost.com/wp-srv/nation/specials/immigration/cwc_d4p1.html

Thursday, May 08, 2008

"Zombie drug" kids on the rise

Metro (4th largest newspaper in the UK)
"Zombie drug" kids on the rise
May 5, 2008

The number of children being prescribed anti-psychotic drugs not officially approved for youngsters has risen sharply since the early 1990s.

The increase – from a rate of four children per 10,000 in 1992 to seven youngsters per 10,000 in 2005 – was despite fears over side effects.

The use of the drugs designed for adults, which are prescribed for conditions such as hyperactivity and autism, tripled in children aged seven to 12-years-old.

But critics claim the medication, which can also be used to treat manic depression, may have side-effects such as weight gain and heart problems.

'The long-term risks of these drugs are, as yet, unknown', said Prof Stephen Scoot of the Institute of Psychiatry, King's College London. 'These drugs can also have substantial side-effects, for example Risperidone (Risperdal), typically leads to considerable weight gain.

'There is only modest evidence for their effectiveness in children with conduct disorders who have an average IQ and do not have attention-deficit hyperactivity disorder.
Pharmiatry

'However, medication may dramatically reduce aggression in unusual cases and, in children with prolonged rages, anti-psychotics prescribed for short periods of up to four months may help the families to cope.'

Risperdal – an adult schizophrenia treatment that is sometimes used to curb irritability and aggression in autism – is one of the most commonly used drugs in Britain.

Its side effects include drowsiness and weight gain.

The use of thioridazine which is prescribed for hyperactivity, decreased after 2000 following fears of heart-related side effects.

'This highlights the need for long-term safety investigations and ongoing clinical monitoring, particularly if the prescribing rate of these medicines continues to rise', said researchers from the University of London.

The study was published in Pediatrics journal.

 

Tuesday, May 06, 2008

psych conflicts.COM

psych conflicts.COM:
New WebSITE AND VIDEO expose PSYCHIATRIC-PHARMA CONFLICTS
 
Heavy Pharma Funding Increasing Antipsychotic Prescriptions to Kids
 
A new video exposing the extensive conflicts of interest between the American Psychiatric Association (APA) and the pharmaceutical industry was released today on a newly launched website, (http://www.psychconflicts.com), to coincide with the 161st anniversary of the APA and its annual convention being held in Washington, D.C.  Widespread psychiatric drugging of children has become an increasingly contentious issue, with pharma-funded psychiatrists at the center of the controversy.  The psychiatric drugging of foster children in particular is now the subject of a May 8th congressional hearing.  A study in the May issue of the journal Pediatrics, now garnering international attention, found that American children take antipsychotics at about six times the rate of UK children, while a January New York Times (NYT) investigation revealed that “the more psychiatrists have earned from drug makers, the more they have prescribed a new class of powerful medicines known as atypical antipsychotics to children.”  According to the psychiatric watchdog Citizens Commission on Human Rights (CCHR), which produced the new webpage and video, the soaring increase in psychotropic drugs to children is a result of the incestuous relationship between the APA and the pharmaceutical industry—totaling more than $10 million a year in conflicts of interest.
 
Today, about 30% of the APA’s income derives from pharmaceutical industry advertising and nearly 20 drug companies this year have invested an estimated $3 million into the APA’s convention alone.  Of the nearly 30 pharmaceutical industry-supported symposiums, speakers’ fees could run as high as $250,000.  The APA has also made an estimated $40 million from sales of its Diagnostic & Statistical Manual of Mental Disorders (DSM), an “insurance billing bible” that pharmaceutical interests potentially influence.
 
In 2006, a Psychotherapy and Psychosomatics study determined that 56% of psychiatrists on panels determining what “disorders” would be included in the DSM-IV had undisclosed financial interests in drug companies.  Researchers also found that 100% of the psychiatrists on panels overseeing so-called “mood disorders” (which includes the lucrative “bipolar disorder”) and “schizophrenia/psychotic disorders” were financially involved with drug companies that manufacture the drugs prescribed for these conditions, the sales of which are around $40 billion a year worldwide.
 
Lisa Cosgrove, a clinical and research psychologist from the University of Massachusetts, Boston and co-researcher in the 2006 study reported that these disorders are not based on medical science: “No blood tests exist for the disorders in the DSM.  It relies on judgments from practitioners who rely on the manual,” she stated.
 
Last December, U.S. News and World revealed that 19 out of the 27 task force members for DSM-V, due to be published in 2012, had financial ties to drug companies.
 
The January NYT investigation further found that psychiatrists earn more money from drug makers than doctors in any other specialty.  In one state, Vermont, drug company payments to psychiatrists more than doubled from $20,835 in 2005 to an average of $45,692 in 2006.  Antipsychotic drugs were among the largest expenses for the state’s Medicaid program.  On September 4, 2007, the NYT reported, “Drug makers and company-sponsored psychiatrists have been encouraging doctors to look for [bipolar] disorder.”  The expanded use of bipolar as a pediatric rather than adult disorder has made it the fastest-growing part of the $11.5 billion U.S. market for antipsychotics, reported Bloomberg News the next day.
 
Melissa Delbello, research psychiatrist with the University of Cincinnati who is speaking at the APA convention on May 7, was recently cited by Senator Charles Grassley for her failure to disclose to the university how much she had earned from pharmaceutical companies.  In 2002, she was the lead author of a study that concluded that children responded well to the antipsychotic drug Seroquel, which is manufactured by AstraZeneca, one of the companies funding symposiums at the APA this year.  She disclosed that she’d received $100,000 from the company between 2005 and 2007, but Senator Grassley discovered it was more than double that—$238,000.

SAMPLE OF Speakers at the APA convention include:
 
·         David Kupfer, Professor and Chair, Department of Psychiatry, University of Pittsburgh School of Medicine, was a member of the DSM-IV Task Force and is Chair of the DSM-V Task Force. He has been a consultant to Eli Lilly & Co., Hoffman-LaRoche, Pfizer, Forest Labs and Servier and also sat on the advisory boards of Eli Lilly & Co., Forest Labs and Pfizer.
 
Kupfer’s wife, Ellen Frank, Ph.D., has received research support from Eli Lilly & Co. and Pfizer and was also a member of the DSM-IV Task Force.
Joseph Biederman, Chief of the Clinical & Research Program in Pediatric Psychopharmacology, Massachusetts General Hospital is giving seminars on pediatric bipolar disorder and Attention Deficit Hyperactivity Disorder, the latter funded by Ortho-McNeil Janssen Scientific Affairs.  He was a member of the DSM-IV committee overseeing what infant, childhood and adolescent disorders would be included.  Biederman has received research funds from 10 pharmaceutical companies, including manufacturers of antipsychotic drugs prescribed for bipolar. Last year, his promotion of pediatric bipolar disorder was blamed, in part, for the death of 4-year-old Rebecca Riley from Massachusetts from a prescribed cocktail of psychiatric drugs which included antipsychotics for bipolar.  Dr. Lawrence Diller, a California behavioral pediatrician, told the Boston Globe, “I find Biederman and his group to be morally responsible in part.  He didn't write the prescription, but he provided all the, quote, scientific justification to address a public health issue by drugging little kids.” 
 
David Shaffer, Professor of Child Psychiatry at Columbia University and Director, Division of Child Psychiatry, New York State Psychiatric Institute, is part of a symposium discussing “disorders of childhood: A DSM-V research agenda.”  Shaffer was a member of the DSM-IV Task Force and is responsible for inventing TeenScreen, a subjective survey conducted on teens in schools to determine if they are potentially suicidal.  He admits there’s a potential 84% chance of wrongly identifying students using his survey.
 
S. Charles Schulz, Professor and head of the Department of Psychiatry, University of Minnesota Medical School Minneapolis, Minnesota, was a DSM-IV project participant.  His industry-supported seminar about “medication treatment for youth” is funded by AstraZeneca, the manufacturer of the antipsychotic Seroquel.  The company faces multiple suits alleging that it downplayed the risk of diabetes with the drug.  Schulz has been a consultant for AstraZeneca and Eli Lilly & Co. and has received grants from them and Abbott Laboratories and Janssen Pharmaceutica.
Charles Nemeroff, Professor of Psychiatry and Behavioral Sciences and Chairman of Psychiatry and Behavioral Sciences, Emory University School of Medicine in Atlanta, is conducting a seminar on depression supported by Sanofi-Aventis.  Dr. Nemeroff was one of the psychiatrists on an FDA Advisory Panel in 1991 that exonerated Prozac (the first SSRI antidepressant) from causing suicidal behavior—a fact established 13 years later when the FDA ordered drug companies to add a black box warning that all SSRIs induce suicidal behavior in children and teens.  Nemeroff is a consultant for at least 20 pharmaceutical companies and has received research funds from at least 8 psychiatric drug manufacturers.

CCHR has released the new webpage and video on the APA and its conflicts of interest to raise awareness on the fact the DSM medicalizes all human troubles as “mental disorders” in order to sell psychiatric drugs.  In 1969, the Church of Scientology and Dr. Thomas Szasz, Professor of Psychiatry Emeritus from SUNY Health Science in Syracuse, New York, co-founded CCHR to investigate and expose psychiatric human rights violations.  For more information on CCHR -- http://www.cchr.org
 
 

"Should we Demand Criminal Prosecution?" New Hampshire Newspaper on Antipsychotics

North Country News (New Hampshire)
$4 Million Spent on Antipsychotics for NH Kids in 2007
Should we Demand the State to Seek Damages and Criminal Prosecution?

May 5, 2008
By Bryan Flagg

Last January, Northcountry News exposed that New Hampshire had led the nation in per capita  methylphenidate (includes drugs like Ritalin and Concerta) purchases for eight straight years. While proponents of the drug try to convince you that this amphetamine-type drug is safe, only a little internet research will show you that it’s similar to, but more powerful than cocaine, can cause tourette’s syndrome, heart problems, suicide, hallucinations and much more. While few kids were on any type of psychiatric drug when I was young, about 4 million nationally are prescribed this and other amphetamines today.

Drug Chart 

Nobody would ever even try to claim that psychiatry’s most powerful drugs, antipsychotics, are mild and there’s very l