AstraZeneca Settles Most Seroquel Suits By DUFF WILSON

July 28, 2011, 5:50 pm

The British drug maker AstraZeneca has settled in principle nearly all of the American product liability lawsuits over Seroquel, its blockbuster antipsychotic drug, the company said in a quarterly earnings report on Thursday.
All but 250 of the 28,700 cases have been settled, most with written agreements, AstraZeneca said in the securities filing. It had previously reported settling most of those cases, but the new filing showed how far the company has whittled away at the remaining product liability litigation. Last quarter, it had reported 2,600 outstanding cases.
Most of the plaintiffs argued that they had been misled about the risks of diabetes and weight gain caused by Seroquel, the company’s second-best-selling product with $5.3 billion in worldwide sales last year, behind the cholesterol drug Crestor.
In the filing on Thursday, AstraZeneca said it added $55 million last quarter to the previously reported $592 million set-aside, for a total of $647 million to settle the litigation.
“Is it a good move?” said Les Funtleyder, health care analyst for Miller Tabak. “Yes, anytime you can settle these suits, it’s good.”
The set-aside includes the $68.5 million that the drug maker agreed to pay in March to 37 states, settling charges that it had illegally marketed Seroquel.
AstraZeneca also had to pay $520 million last year to settle federal investigations into its marketing of Seroquel.
At that time, Kathleen Sebelius, the secretary of health and human services, had accused the company of paying kickbacks to doctors while promoting the drug for unapproved uses by children, the elderly, veterans and prisoners.
AstraZeneca did not admit to any misconduct, while settling the federal case and signing a corporate integrity agreement, essentially putting it on probation with the government.
The company also said in the filing that its legal fees in Seroquel cases amounted to $743 million, partly covered by insurance. That figure has risen from $688 million estimated a year ago.
If the estimates hold, AstraZeneca will have paid a total of about $1.9 billion to defend and settle the personal injury cases and government investigations.
The figure represents less than five months of Seroquel sales.
That is far less than Eli Lilly paid to settle similar charges regarding its antipsychotic drug Zyprexa. Lilly paid more than $1.2 billion to settle lawsuits in 2007 and $1.4 billion to the government in 2009, including a criminal fine of $515 million.
At the time, that fine was the largest ever for a United States corporation. It has since eclipsed by the $1.3 billion criminal fine Pfizer paid as part of a $2.3 billion settlement of charges it had illegally marketed the painkiller Bextra and other drugs.
Drug makers have become the biggest targets of government antifraud investigations.
Legal discovery in the Seroquel cases has provided some of the most embarrassing or damaging disclosures over AstraZeneca’s past research and marketing practices, including a 1997 memo praising the company’s work to put a “positive spin” on a “cursed study” and highlighting one official who “has done a great ‘smoke-and-mirrors’ job!”
Another internal e-mail unsealed in court said AstraZeneca had “buried” unfavorable studies. A publications manager for the company wrote, “the larger issue is how we face the outside world when they begin to criticize us for suppressing data.”
 

http://prescriptions.blogs.nytimes.com/2011/07/28/astrazeneca-settles-most-seroquel-suits/

Dan Markingson - Seroquel Suicide?

This is one of the first articles I read after my Seroquel Suicide Attempt. Tragic. This could have been me. My hearts aches for Dan and his mother.

 Charles Schulz under scrutiny for Seroquel study suicide

Is U of M department of psychiatry chair in the pocket of AstraZeneca?

A A A Comments (18) By Andy Mannix Wednesday, Feb 2 2011

Mary Weiss knew something wasn't right with her son.

courtesy of Mary Weiss

Seven years after her son Dan Markingson's suicide, Mary Weiss still blames the University of Minnesota's psychiatry department

courtesy of Mill City Video Services

Charles Schulz admitted during a 2007 deposition that he'd earned more than $150,000 from drug companies

Only a year before, Dan Markingson had seemed perfectly normal. But his latest letter from Los Angeles suggested a troubled mind.
He claimed he was about to become famous. He was at a crossroads in his life, and would soon have more free time. He even had a big movie premiere in the works.
"I knew then that something was wrong," says Weiss. "I knew that there wasn't a premiere, and when he said he was going to have a lot more free time, I thought he was quitting his job."
Weiss immediately jumped in her car and drove to California. When she arrived, she found her son far worse off than she'd feared. He was talking nonsense and couldn't be reasoned with.
Weiss tried to convince Markingson to come back to Minnesota, where she could look after him. But he had a stipulation: He would only return home if his dead grandmother Daisy told him to.
Weiss went to an internet cafe down the street and created an email account under the name "GuardianAngelDaisy." Pretending to be her own deceased mother, she urged Markingson to return to Minnesota. Eventually, he agreed.
He was home for only 10 days before he decided to return to California. Weiss pleaded with him to stay, but he refused. She could either drive him to the airport, or never see him again.
Weiss followed him to Los Angeles, where she again tried to urge her son to go back to Minnesota. But this time, his grandmother's emails weren't enough. Markingson wanted to talk to a higher authority: Michael the Archangel.
Weiss created another fake email account as Archangel Michael. The two exchanged emails for more than a week before Markingson finally agreed to fly home.
Once he was back, Weiss called the South St. Paul police. An officer came to her home to evaluate her son. During the interview, Markingson casually mentioned he would soon be attending a devil-worshipping event in Duluth, and might be ordered to kill people.
That triggered a trip to Fairview University Medical Center, where Markingson was diagnosed with psychosis and placed on a 72-hour hold.
In order to be released, Markingson agreed to a stay of commitment, which would allow him to leave the hospital as long as he followed a treatment plan. The plan involved Markingson enrolling in a study called Comparison of Atypicals in First Episode, or CAFE. The research was sponsored by AstraZeneca, maker of Seroquel, one of the anti-psychotic drugs being investigated.
When Weiss found out her son was a human guinea pig, she was furious. She called the hospital and tried to pull her son out of the treatment plan, to no avail. Although Markingson was mentally unfit, he was somehow able to consent to the drug trial.
Over the next few months, Markingson's condition only worsened, Weiss says. His doctor wouldn't return her calls, so she tried writing a letter to the head of the department, Dr. S. Charles Schulz. He didn't reply.
It wasn't until April 28, after Weiss's third letter, that she received a cursory response, in which Schulz wrote, "it was not clear to me how you thought the treatment team should deal with this issue."
Ten days later, on May 8, Markingson sat in the bathtub of the halfway house where he was staying and stabbed himself to death with a box cutter.
"I left this experience smiling!" read the suicide note.
   
MARKINGSON'S SUICIDE HAS cast a harsh spotlight on the University of Minnesota psychiatry department. The Federal Drug Administration, the Attorney General's Office, and the college's Internal Review Board all wanted to know how a 26-year-old research subject ended up dead.
So did his mom. After a year of combing through studies and public records, Weiss filed a malpractice suit against Schulz and the U of M, accusing them of putting Big Pharma's bottom line ahead of her son's mental health.
In December, a group of eight bioethicists at the U of M wrote a letter to the college's Board of Regents, demanding the appointment of an independent board to investigate whether lapses in ethics and judgment led to Markingson's suicide.
"This goes beyond everything and anything, and this should have brought the house down on the university," says Vera Sharav, president of the Alliance for Human Research Protection, a patient-advocacy group. "There has to be zero tolerance, because a lot hangs on it, including lives."
The issue will soon come to a head. The U of M has been investigating a complaint about Schulz's connections to Big Pharma and is expected to issue the results in a matter of weeks.
"If there's any question that the investigation was superficial, it ought to be by an independent group that can determine what the facts are," says Jerome P. Kassirer, former editor of the New England Journal of Medicine, who is familiar with the circumstances surrounding the Markingson case. "It looks worrisome to me."

http://www.citypages.com/2011-02-02/news/charles-schulz-under-scrutiny-for-seroquel-study-suicide/

Seroquel Suicide

I was not feeling well physically and emotionally. I felt out of balance. I would fluctuate between feeling helpless, sad, anxious and irritable, to feelings of optimism, coupled with racing thoughts and an inability to concentrate. I am a wife and mother of four wonderful children and I tried to suck it up...if Mama ain't happy, ain't nobody happy.

I improved my diet, exercised and took vitamins and supplements but nothing helped me to feel better.

I finally decided that I needed the help of a professional and made an appointment with a Psychiatrist. I explained my symptoms to him and was diagnosed as Bipolar Type 2.

The signs and symptoms of  Bipolar II disorder can be viewed at:
http://www.mayoclinic.com/health/bipolar-disorder/DS00356/DSECTION=symptoms

Well, this diagnosis really freaked me out. I was not "crazy!!!" But I knew that I did not want to continue to live with the sometimes debilitating symptoms I was experiencing so I decided to keep an open mind. The doctor decided to put me on 100 mg of Seroquel and would then increase the dose to 200 mg. Looking back I realize that at no time did he discuss the side effects of the drug which I feel was very negligent. When administering this potentially dangerous medication it was his responsibility to sit with me and discuss what I may expect and what to watch out for. This medical professional is treating patients who suffer from mental illness. There is a significant possibility that a patient like myself who is suffering from depression, anxiety, racing thoughts and an inability to concentrate may not read the leaflet attached to the medication or go online to do further research.  But I guess my 45 minutes was up and he had to get on to his next patient.

I read the leaflet attached to the med and went online to research it...scarey !!!!!!!

According to AstraZeneca (the makers of Seroquel) some of the side effects are as follows: Increased risk of suicidal thoughts or actions, high blood sugar and diabetes, increase in triglycerides and LDL, feeling dizzy or lightheaded upon standing, decreases in white blood cells (which can be fatal), tardive dyskinesia, weight gain, rapid heart beat, disturbance in speech or language, drowsiness.
http://www.seroquelxr.com/
Now you can understand why it was scarey to take this medication. So I made an informed decision to start taking Seroquel with an "it can't happen to me" mindset.

I took it before bedtime and it really knocked me out. In the morning I was extremely groggy and my speech was slurred. It was very upsetting for my family to see me this way. I explained that it was a side effect of Seroquel and would soon taper off which it did. 

I started feeling better...more balanced. Most of my symptoms subsided...yea !!!!! It felt good to feel good. Then my psychiatrist increased the dose to 200 mg. I asked him why he had to do this and was told that 200 mg was the optimum dose for me. Well OK

I started to feel very very sick. Rapid heartbeat (my pulse was 105 and is usually in the 70s), extreme agitation, nausea, confusion, twitching, fight or flight. I spoke with my doctor and told him how I was feeling and he told me that maybe I needed counseling. OMG he seriously said that. I wish that at that point I would have gone to the hospital and maybe someone would have recognized that my symptoms were directly related to Seroquel use. My family and I could have been spared the trauma and tragedy that was about to be slammed upon us.

One Saturday three weeks ago my husband and I were saying that this is one of the most exciting times of our lives. Among the many things to rejoice we were starting a business with great potential for success. At 5pm we met with a web developer to get a website built. I had to leave the meeting early to take our daughter to a party. Then fast forward to me that evening in my bathroom swallowing massive amounts of pills. Looking back I felt like I was in a trance, but that's not quite right, I really didn't feel anything, I was just doing it!! The next thing I remember was looking over and seeing a dark shadow sitting in the corner which turned out to be my husband. I heard him say to me, "Do you know where you are? You are at the hospital in ICU." 

My husband found me lying on my back on the bathroom floor. I was blue, had thrown up and was literally drowning in my own vomit. I was barely breathing. He told the kids to call 911 and started doing CPR. Then the house was filled with paramedics, fire fighters and police. Terrible, terrible that my family had to witness this. My son said he saw my arm and it was blue. He later told me that it looked like a dead arm but that it couldn't be because it was his mom's arm.

I was taken to the hospital to ICU with a slim chance of survival. My husband was told that if I did survive there was a good possibility that I would suffer from brain and/or heart damage. Needless to say the waiting was agonizing for my loved ones. Two days later I regained consciousness and my first foggy thought was, "How did I get here?" The tests performed proved that I did not have any of the physical damage suspected but the emotional damage is beyond words.

I was then put on a 72 hour hold and transferred to a psych hospital.  I felt like I was living someone else's life. How did this happen? Why did this happen? There was no reason, no motivation, no catalyst. This was not me. I did not do this. Yet here I was in a mental hospital, super groggy and foggy, terrible pain, angry, confused, disgusted, ashamed. 

Going home was bittersweet. Ecstatic to be back with my sweet family but extremely painful to face them with what I had done. My young daughter asked me, "Why were you so unhappy Mommy? Why did you want to leave me?" I wasn't and I didn't. We are moving on with the strength of our love for one another but I can't help to have a heart wrenching pain that this will be remembered as the summer that Mom tried to commit suicide.