Saturday, May 31, 2008

TV News Video

 

Vermont Government Officials - "Investigate Antipsychotic Child Drugging"!  "We have to stop this train." 
 
Rutland Herald
Dubie, Shumlin criticize psychotic drugs for kids

May 1, 2008
By DANIEL BARLOW

MONTPELIER — The top two leaders of the Vermont Senate joined a prominent mental health advocate Wednesday in decrying the growing trend of prescribing medication to children that has only been approved for adults.

Lt. Gov. Brian Dubie and Senate President Pro Tem Peter Shumlin said during a Statehouse press conference that Vermont needs to begin investigating how often these mind-altering drugs are given to children and why.

Shumlin said the state needs to get active in stopping the sole reliance on antipsychotic medications for treatment of children and teenagers, just as law enforcement has cracked down on the use of these drugs for recreational use.

"It should shock us all that we as a state have allowed and accepted that we are using powerful psychotic drugs on our children at an alarming rate," said Shumlin, a Democrat from Windham County.

Shumlin and Dubie joined Ken Libertoff, the executive director of the Vermont Association for Mental Health and a sharp critic of the doping trend, at Wednesday's press conference. Libertoff said he tried to jump-start the conversation over medicating children in 2007.

But a letter he wrote in March of that year to the Office of Vermont Health Access — the agency that oversees the state-run insurance programs such as Medicaid — seeking information on how many Vermont children are prescribed mental health drugs wasn't responded to until 11 months later, after a newspaper reporter asked about the delay.

''The question is, who is watching out for our children?" Libertoff said. "And my answer right now would be no one."

That information from OVHA, which Libertoff released to reporters Wednesday, gives a troubling snapshot of the trend in the state: Between April and September 2007, the state spent $10 million on anti-psychotic drugs for children through its insurance programs.

In addition, the documents show at least 6,200 Vermonters under the age of 18 who were taking at least one mental health drug. Libertoff said those numbers could be even higher because it only includes reimbursements through the state insurance programs.

He also bristled at what he called an inaccuracy in OVHA's letter this year to him that stated the "medications are approved by the Food and Drug Administration for the treatment of psychiatric disorders including those of children." Libertoff said most of the drugs in question have only been FDA-approved for adults.

"We raised a number of issues that should have been looked at, but were not," Libertoff said.

A call to OVHA was not returned Wednesday, but in its letter to Libertoff on Feb. 14, Deputy Director Ann Rugg apologized for not responding in a timely fashion.

Commissioner of Mental Health Michael Hartman agreed with Libertoff that the mental health system has a serious problem with prescribing psychiatric medications to children with little or no follow-up counseling.

That situation is compounded by the fact that the FDA often makes its regulation decisions based on studies and findings sponsored by the makers of the drugs, he added.

"It's not a good situation from top to bottom," Hartman said.

In response to the concerns, Hartman announced he is launching an inter-agency review of Vermont's medication prescribing patterns for children and teenagers. There is no timeline yet on this review, he said, and comparing the final data to what other states are experiencing will be difficult because there is no standardized reporting method.

"What we know is that as a country we have been escalating the use of these medications well above what was used a decade ago," Hartman said. "We have to stop this train."

Allowing children, whose bodies and brains are still developing, to take medications approved only for adults can be disastrous because of all the unknown consequences attached, according to Kathy Holsopple, executive director of the Vermont Federation of Families for Children's Mental Health, a nonprofit group.

More information needs to be supplied to parents before a child is prescribed psychiatric medications, she said. More research is also needed in this area, she added, to determine what the long-term consequences of this early drug use are.

"Children are not just little adults," Holsopple said. "We can't just give them adult medication."

Dubie, a Republican, took a more cautious tone than the others at the press conference Wednesday. He said he was troubled by the alleged overuse of psychiatric medications across the board — from children to prison inmates to senior citizens.

He pledged to be part of that dialogue at the state level aimed at "reducing the overall use of psychiatric medications in all areas."

"We must ensure that parents have access to timely and informed facts on the benefits and the risks of taking psychiatric medications," Dubie said.

Shumlin went one step further ashe vowed that lawmakers would look at the issue when they return to Montpelier in January 2009. He pointed to a newspaper report last month that the state spent $4 million on the drug Zyprexa in 2006, a medication that at least 10 states are suing the drugmakers over (Vermont is not involved in that litigation).

"We spent $4 million on this single drug when we all know that it has been challenged by many as a drug that has serious health consequences that were covered up by the maker," Shumlin said.

Link: http://www.rutlandherald.com/apps/pbcs.dll/article?AID=/20080501/NEWS03/805010347/1004/NEWS03

 

Friday, May 30, 2008

Antipsychotic Drugs for "ADHD"? Florida Panel to review Medicaid guidelines

Everyone can listen in on this meeting.  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.
 
Letters to the editor: letters@news-jrnl.com
 
Daytona Beach News Journal
Panel to review Medicaid guidelines for antipsychotic drugs

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.

Link to story: http://www.news-journalonline.com/NewsJournalOnline/News/EastVolusia/evlEAST07053008.htm 

 

Thursday, May 29, 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

 

Psych Drug Deaths of Soldiers - U.S. Government Investigating

 

Charleston Gazette
Vets taking PTSD drugs die in sleep
Hurricane man's death the 4th in West Virginia

By Julie Robinson
May 24, 2008

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: http://wvgazette.com/News/200805230640

 

Caution Urged on Antipsychotics for Elderly - even when prescibed for a short term

Philadelphia Inquirer
Unwanted consequences of antipsychotic drugs
By Tom Avril
May 29, 2008

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.

Link: http://tinyurl.com/3fsvg7

"Keep the shrinks and the dang blasted antipsychotics away from me."
 

Tuesday, May 27, 2008

Elderly Prescribed Antipsychotics - 3 times the risk of serious health problem or dying within a month of treatment

The Guardian
Antipsychotics given for dementia pose risks-study
By Andrew Stern
May 26, 2008
 
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.
 
 

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