Mass. General disciplines three psychiatrists

Boston Business Journal
by Eric Convey
July 1, 2011

Massachusetts General Hospital on Friday disclosed sanctions against three psychiatrists for violating hospital ethics guidelines by failing to adequately report, internally, seven-figure payments they received from drug companies.

In a statement to colleagues provided by the hospital upon request from the Business Journal, Drs. Joseph Biederman, Thomas Spencer and Timothy Wilens said the disciplinary actions include:

• They must refrain from "all industry-sponsored outside activities" for one year.

• For two years after the ban ends, they must obtain permission from Mass. General and Harvard Medical School before engaging in any industry-sponsored, paid outside activities and then must report back afterward.

• They must undergo certain training.

• They face delays before being considered for "promotion or advancement."

The three doctors came under the political microscope in June 2008 during remarks Sen. Charles Grassley, R-Iowa, made to a committee investigating conflicts of interest involving clinicians.

The three Harvard doctors "are some of the top psychiatrists in the country, and their research is some of the most important in the field," Grassley said, according to an online version of the Congressional record. "They have also taken millions of dollars from the drug companies." The senator complained that Biederman and Wilens took money from drug giant Eli Lilly (NYSE: LLY) at the same time they were being paid by the National Institutes of Health to study an Eli Lilly drug.

Grassley went on to say he had requested conflict-of-interest forms from the hospitals, and they "were a mess."

"My staff had a hard time figuring out which companies the doctors were consulting for and how much money they were making," he said.

When the hospitals asked the doctors to clarify the matter, Grassley continued, "things got interesting."

"Dr. Biederman suddenly admitted to over $1.6 million dollars from the drug companies," Grassley said. "And Dr. Spencer also admitted to over $1 million. Meanwhile, Dr. Wilens also reported over $1.6 million in payments from the drug companies."

"We have learned a great deal from (the in-house investigation)," the doctors wrote in their joint statement released Friday. "And we profoundly hope that our mistakes will benefit our colleagues by bringing clarity and attention to these important issues."

They wrote earlier in the letter: "We always believed that we were complying in good faith with the institutional policies and that our mistakes were honest ones."

In its own statement, the hospital wrote: "A committee at Massachusetts General Hospital that has been looking into conflict-of-interest questions involving three MGH child psychiatrists has completed its review. Appropriate remedial actions have been taken by the hospital to address specific issues."

New Study Casts Doubts on Antidepressant Effectiveness

AboutLawSuits.com
May 3rd, 2011

Most people given antidepressants may still experience many symptoms of depression, according to the findings of a new study that casts doubts on the effectiveness of some popular medications.

In a study published in the April issue of the Journal of Clinical Psychopharmacology, researchers from the University of Texas found that 75 percent of people on an SSRI antidepressant still fought persistant symptoms that the powerful psychotropic drugs should have alleviated, including sadness, insomnia and a decreased ability to concentrate.
Researchers looked at patients who took Celexa for depression. They then checked to see how many of the 16 symptoms of depression. They found that 75% said they still experienced five or more symptoms of depression.

The most common symptom which went unchecked by Celexa was insomnia, followed by sadness and decreased concentration. The drug appeared most effective at reducing suicidal thoughts.

Celexa belongs to a class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs), which also includes the blockbuster antidepressants Zoloft, Paxil, Lexapro, and Prozac.
The questions raised about the effectiveness of antidepressants further highlights recent concerns about potential side effects of antidepressants. In recent years, the widely used medications have been linked to an increased risk of suicide and certain birth defects or malformations when taken during pregnancy. The medications have also been heavily promoted and are some of the most widely prescribed drugs in the United States.

Forrest Laboratories has faced a number of Celexa lawsuits over claims that the antidepressant raises the risk of suicide in teens. There are also similar lawsuits against a similar Forrest Laboratories drug called Lexapro.

The suicide lawsuits over Lexapro and Celexa allege that children taking the two drugs were prone to violence and suicide. The plaintiffs claim that Forest knew from studies that there was a higher risk of suicide associated with the drugs when used by children, but failed to warn patients or doctors. The lawsuits charge the company with failure to warn, negligence and fraud.
In November 2010, it was reported that Forest Laboratories was beginning to settle Celexa and Lexapro lawsuits over the failure to warn about the risk of suicide among teens. The settlements came about a month after the company agreed to pay more than $313 million as part of a settlement for illegally marketing of the drugs to children.

SSRI antidepressants have also been linked to an increased risk of birth defects when used during pregnancy. An estimated 800 Paxil birth defect lawsuits have been filed against GlaxoSmithKline over their failure to warn consumers and doctors that use of the antidepressant during pregnancy could lead to congenital heart defects in newborns. The lawsuits also claim that the company hid test results and purposefully misled doctors about the risks associated with Paxil, which is one of the most commonly prescribed drugs in the United States.

More recently, momentum has been building for Zoloft lawsuits over Pfizer’s failure to warn about the risk of birth defects when taken during pregnancy. Potential side effects of Zoloft for unborn children have been reported to occur when the drug is taken as early as the first trimester, a time when many women do not even realize they are pregnant.

Related Posts
Study Links Older Antidepressant Side Effects to Increased Heart Risks (12/2/2010) Settlements Reported in Celexa and Lexapro Lawsuits Over Suicides (11/3/2010) SSRI Antidepressants May Do More Harm Than Good Against Autism: Study (8/10/2010) Antidepressants During Pregnancy Double Pre-Term Birth Risk: Study (10/6/2009) SSRI Antidepressant Side Effects May Cause Gastrointestinal Bleeding (7/14/2008)

Let's Call the Whole Thing Off

Psychiatric Times
By Irwin Feinberg, MD
May27, 2010
Dr Feinberg is Professor of Psychiatry at the University of California at Davis

A vital consideration we learn in medicine is that continuing life support for a moribund patient past a certain point is harmful to the lives of all concerned. We have reached that point with DSM5. Dr Allen Frances has outlined compelling clinical arguments against many of the new disorders DSM5 proposes and he has shown how their adoption could have far-reaching, unintended, and damaging consequences for the patients we have pledged not to harm, and for society generally.

I write from the vantage point of 50 years of psychobiological research. Most of it is in the field of sleep neuroscience. However, as often happens in science, one thing leads to another and my observations enabled me to propose that the human brain undergoes a profound reorganization during adolescence driven by synaptic pruning and that some cases of schizophrenia might be caused by errors in this process.1 My association at NIMH with Edward V. Evarts, one of the great neurophysiologists of the last half century, stimulated me to propose that the hallucinations of schizophrenia result from a failure of feed-forward mechanisms that distinguish self-initiated neural activity from that produced by external stimulation, resulting in auditory hallucinations and other first-rank symptoms.

It is difficult and time-consuming to produce reliable new knowledge; it cannot be accomplished by committee fiat, as Drs Kupfer, Schatzberg and Regier seem to be believe. Dr Frances has mentioned the damage to psychiatric research that several new, ill-conceived categories in DSM5 could inflict. He also pointed out that changing nomenclature and diagnostic standards in the absence of compelling scientific justification will severely damage psychiatric research as well as clinical practice. Many of these changes would make it impossible to compare decades of epidemiological results with new findings. Moreover, the sloppy thinking and language in the proposed revision will be apparent to any educated layman. The “field trials” and timetables proposed for new categories are laughable to any statistically trained psychologist. The inevitable public exposure of the gross defects in DSM5 will bring our entire field into disrepute and diminish public support for the research we need.

There have been no research advances that demand new diagnoses and syndromes. Despite many intriguing findings, no psychiatric disease can be diagnosed by a biological or psychological test. If the DSM5 committee believes that new genetic or imaging findings justify a revised nomenclature, they should indicate which ones. Instead of creating dangerous new categories, let us discontinue DSM5 development and use its funding to make strong bridges between DSM-IV and ICD 11. We should also work to diminish or eliminate the huge differences between the US and the UK in the incidence of diagnoses like ADHD and pediatric bipolar disorders. These differences make it impossible to compare cross-national biological research on the same diagnostic categories, even in countries with similar cultures and medical traditions.

The proposed DSM5 would be a giant step backwards for psychiatry. American psychiatrists should petition the APA to drop this ill-conceived and badly executed project.

Child Abuse, Review doctor's work again

Boston Globe
Editorial
May 3, 2010

IF THE medical care given to 4-year-old Rebecca Riley appears appropriate to the state panel that oversees doctors, that panel needs to take a new look at the case.

Rebecca was the victim of one of the most appalling child abuse cases in recent memory; in December 2006, she died on her parents’ bedroom floor of an overdose of powerful psychotropic drugs. They had been prescribed by Dr. Kiyoko Kifuji, a child psychiatrist at Tufts Medical Center, who relayed details of her treatment on the witness stand during the murder trials of Rebecca’s parents. Kifuji’s testimony — given under immunity — was so disturbing and seemingly cavalier that Plymouth District Attorney Timothy Cruz has asked the state Board of Registration of Medicine to reopen its review of her license. “If what Dr. Kifuji did in this case is the acceptable standard of care for children in Massachusetts,’’ Cruz said, “then there is something very wrong in this state.’’ He’s right.

The issue of acceptable medical care is separate from the question of responsibility for Rebecca Riley’s death. (Rebecca’s parents were both convicted of murder.) A grand jury declined to indict Kifuji for manslaughter, though a wrongful death civil suit against her is pending. After a full review, the state Board of Registration of Medicine allowed her to resume seeing patients last fall. The board’s proceedings are kept private, but in typical cases, it reviews medical records and hears testimony from experts in the field. In Kifuji’s case, the panel likely heard defenses of the controversial practice of giving powerful psychotropic drugs to small children.

It’s not the board’s role to arbitrate among different schools of thought within a medical field. But even if one grants that medication — when prescribed responsibly and monitored closely — can help children with extreme and dangerous symptoms, Kifuji’s actions remain highly questionable. She diagnosed Rebecca with bipolar disorder and attention deficit hyperactivity disorder based largely on her mother’s description, sometimes during brief visits when Rebecca was asleep. She kept prescribing medication even when Rebecca’s mother increased the dosage to unauthorized levels. Kifuji also refilled prescriptions more than once when the mother said she had lost the pills. The doctor disregarded concerns raised by a family friend, pharmacists, a therapist, and a preschool nurse who complained that the child was as limp as “a floppy doll.’’

Parental observations are critical in child psychiatric cases, and the parents of young patients shouldn’t be presumed dishonest or dangerous from the start. But a responsible clinician — especially one trained to examine behavioral nuances — should be able to detect when a parent is malicious or untrustworthy. In the case of the Rileys, the signs were numerous and extreme.

Doctors have a legal obligation to report child abuse. By extension, their treatment of children should come with particular vigilance and caution. The medical board should reopen Kifuji’s case to determine whether she truly did everything she could to prevent the death. If anything positive can come from Rebecca Riley’s short, miserable, tragic life, it’s an affirmation that, when it comes to treating the state’s youngest, most vulnerable patients, doctors should be held to the highest of standards.

© Copyright 2010 Globe Newspaper Company.

AstraZeneca drops psychiatric, other drug research

Reuters
March 2, 2010

LONDON, March 2 (Reuters) - AstraZeneca (AZN.L) is to stop researching some disease areas that form the backbone of its current business -- including schizophrenia and acid reflux -- in a drive to focus R&D efforts and cut costs.

The Anglo-Swedish drugmaker, which faces one of the sector's worst "cliffs" of expiring drug patents, told its staff on Tuesday it would cease discovery in 10 of its current disease areas, or around one quarter of the total.

A wide-ranging overhaul had been expected since the group said in January it was cutting a further 8,000 staff, or some 12 percent of the workforce, including a net 1,800 in research. But it is only now that staff know where the axe will fall.

AstraZeneca is not alone in taking the knife to previously sacrosanct R&D, though its cuts are particularly deep. Pfizer (PFE.N) and GlaxoSmithKline (GSK.L) are also ditching drug discovery work that does not pay its way. [ID:nLDE61408I]

AstraZeneca will still invest across the same therapy areas but said it would drop discovery in schizophrenia, bipolar disease, depression, anxiety, acid reflux, thrombosis, ovarian and bladder cancers, systemic scleroderma and hepatitis C.

It also plans to end early vaccine research other than for flu and respiratory syncytial virus (RSV).

"AZ is going to continue to be a research-focused company. We will not diversify to the extent that some of the others are doing," development head Anders Ekblom told Reuters.

"We are focusing on the diseases areas where we would like to be."

UNPREDICTABLE TRIALS

The decision to drop psychiatry drug research reflects the unpredictable and risky nature of clinical trials to assess medicines working on the brain, as well as a lack of good scientific opportunities, he said.

For AstraZeneca, this a major shift, since its second biggest seller is schizophrenia drug Seroquel and it recently struck a deal worth up to $1.24 billion for an antidepressant from Targacept (TRGT.O). [ID:nGEE5B208U]

Ekblom said he remained confident about the Targacept drug, which is shortly to start final Phase III tests, but saw limited longer-term opportunities in the psychiatric field.

His views echo those of Glaxo CEO Andrew Witty, who last month said Glaxo would stop researching antidepressants because of uncertain returns.

The move away from acid reflux ends a line of AstraZeneca drug development that created the stomach ulcer and heartburn treatments Losec and Nexium, its biggest sellers, while exiting thrombosis comes just as its big new blood-thinner hope Brilinta awaits regulatory approval.

Despite the decision to exit certain areas, Ekblom said AstraZeneca would still advance those products already in the pipeline and might also license in drugs, if the opportunity was right.

There will be major changes for staff as the research machine is reorganised.

In the United States, early-stage discovery research will cease at Wilmington, Delaware, while the Swedish research site in Lund will close, as will the British site at Charnwood, as respiratory and inflammation work moves to Moelndal in Sweden.

AstraZeneca also aims to sell its Arrow Therapeutic antiviral business in London, acquired in 2007 for $150 million. (Editing by Jon Loades-Carter)

AstraZeneca facing 26,000 suits over Seroquel

Bloomberg News
February 4, 2010
By JEF FEELEY and MARGARET CRONIN FISK

AstraZeneca PLC is facing as many as 26,000 lawsuits over its antipsychotic drug Seroquel as the drug maker prepares for its first jury trial over claims the medicine causes diabetes, according to court filings.

Attorneys for AstraZeneca, which has its U.S. headquarters in Fairfax, met with plaintiffs' lawyers in court-ordered mediation sessions last month to discuss a possible settlement, according to court filings. Consumers' lawyers said they had about 26,000 cases in their inventories, Stephen Saltzburg, a George Washington University Law School professor who served as mediator, said.

"I wish there were a magic wand that could be waved to settle all Seroquel cases instantly," Saltzburg said in the filing. "Such a wand does not exist."

In a Securities and Exchange Commission filing last week, AstraZeneca executives noted the company has paid about $656 million to defend itself in Seroquel cases. That's an increase of 28 percent, or $144 million, over last year's Seroquel defense costs, according to regulatory filings. The company said it had insurance of $521 million to cover Seroquel defense costs as of December.

The company said in the SEC filing it faces more than 25,000 claims that Seroquel caused diabetes. That's a 65 percent increase in cases over the number the company reported in a January 2009 regulatory filing. Many of the suits also claim AstraZeneca promoted Seroquel, approved for schizophrenic and bipolar patients, for unapproved uses.

Saltzburg said the two-day talks didn't generate a resolution, but he expects negotiations will take place at some point between the company and individual users' lawyers.

"The question is what is fair for plaintiffs and what is fair for AZ," the professor said in the report. "The parties are far apart at the moment on resolving that question."

AstraZeneca's stock fell last week after the drug maker's sales forecast and stock-buyback plan disappointed some analysts and fourth-quarter profit missed estimates. The company plans to buy back as much as $1 billion of shares this year, managers said Jan. 28.

A New Jersey judge has set a Feb. 16 trial date for the first of thousands of Seroquel cases filed in that state to go before a jury. Seroquel, which generated sales of $4.9 billion last year, is AstraZeneca's second-biggest seller after the ulcer treatment Nexium.

"The evidence, looked at fairly and fully, does not back up the allegations that Seroquel was responsible for the plaintiffs' alleged injuries," AstraZeneca spokesman Tony Jewell said in an e-mail.

In November, a judge in Florida who is overseeing all federal-court litigation over Seroquel ordered the company to meet with plaintiffs' lawyers and Saltzburg to discuss settlement.
U.S. District Judge Anne Conway in Florida, who is overseeing pre-trial proceedings in federal Seroquel litigation, said in November that she would ask a panel of judges to return the 6,000 cases consolidated before her to their home courts for trial.

Ritalin Linked with Sudden Death of Children

Ritalin Linked With Sudden Death of Children
NaturalNews

Research from The National Institute of Mental Health has revealed that popular Attention Deficit Disorder (ADD) drugs like Ritalin are responsible for causing sudden death in many children. Study numbers indicate a 500 percent increased risk in childhood death from taking such mental health drugs.

For years, many experts, scientists, and health practitioners have speculated that ADD drugs are dangerous and can cause serious injury and death. Etta Brown, a licensed educational psychologist and author of Learning Disabilities: Understanding the Problem and Managing the Challenges explained in response to the study that drugs like Ritalin actually destroy the neural function in children’s brains. As a result, children who have undergone treatment with Ritalin will actually have a much more difficult time processing information and learning new things.

Brown also notes that Ritalin is responsible for causing a permanent tic in the face, neck, and head of many of the children who have taken or are taking it. Ironically, Ritalin is responsible for causing far more serious neurological damage than the problems it is alleged to treat. Comprehensive studies over the years have revealed that while drugs like Ritalin visibly calm children, these drugs destroy their delicate, developing nervous systems and can permanently cripple their ability to function as normal human beings.

Ritalin remains one of the primary drugs prescribed for children with supposed behavioral problems. Rather than be encouraged to modify diet and increase exercise, children are being given drugs by their doctors instead. Increases in behavioral and learning problems among children have been increasing right alongside escalating levels of environmental toxins. Children are also spending more time at home alone while their parents work, eating greater amounts of junk food, and not getting adequate sleep.

Etta Brown, and others, suggest better nutrition, adequate sleep, and increased exercise and physical activity as a proper treatment for children with behavioral and learning disabilities. Nutrition alone is of vital importance since inadequate nutrient intake is arguably the most significant factor in children’s inability to behave and learn. Proper brain function cannot be achieved if the brain is not being fed what it needs to process information and grow.

Parental guidance in regulating and maintaining a proper lifestyle for their children is also vital if true improvement is ever to be achieved. Medical professionals, child psychologists, and others will have to come to grips with the fact that drugs are not the answer to childhood developmental problems.

Sources for this story include: http://www.examiner.com/x-26079-SF-…

http://www.naturalnews.com/027833_ritalin_sudden_death.html