Tuesday, March 31, 2009

U doctor scrutinized over drug research


U doctor scrutinized over drug research


Questions raised after positive review of drug conflicts with maker's

By Jeremy Olson
jolson@pioneerpress.com
Updated: 03/18/2009 11:10:15 PM CDT

A top University of Minnesota psychiatrist's ties to a drug maker have come
under scrutiny because he reported that the company's blockbuster
antipsychotic, Seroquel, was significantly superior to other drugs - despite
evidence to the contrary.

Two months after an internal analysis by the company, AstraZeneca, found
Seroquel was no better than an older, cheaper antipsychotic, Dr. S. Charles
Schulz used much of the same data to publicly report that the company's drug
was "more effective."

The disconnect between the company's private findings in March 2000 and the
psychiatrist's optimistic report to the American Psychiatric Association in
May 2000 are further evidence to critics that the drug industry can shape,
revise or even conceal negative research.

It also feeds concerns that drug companies are paying noted doctors such as
Schulz, the U's chair of psychiatry, for research results that advance their
marketing agendas.

Schulz has received $112,000 in consulting fees and university grants from
2002 through 2007 from AstraZeneca, according to state records, and nearly
$450,000 from rival drug maker Eli Lilly.

"I hope that our findings help physicians better understand the dramatic
benefits of newer medications like SEROQUEL," Schulz said in an AstraZeneca
news release on his 2000 report, "because, if they do, we may be able to
help ensure patients receive these medications first."

Fresh questions have surfaced about Schulz's old research because his name
came up in documents AstraZeneca released late last month to attorneys who
have sued the company. The release included the startling AstraZeneca
analysis and e-mails about whether to forward this negative information to
Schulz for his presentation.

"The data don't look good," one executive wrote. "In fact, I don't think we
can even get a paper out of this."

An Internet psychiatry blog first raised questions March 2 about the
research Schulz presented at the APA conference and why it lacked any of the
company's findings.

"It raises troubling questions when an independent academic author presents
results that are in direct opposition to the underlying data," wrote the
blogger, an anonymous academic.

In an interview with the Pioneer Press last week, Schulz defended his
research and presentation of Seroquel as accurate and ethical. However, he
acknowledged the corporate press release from his APA presentation might
have exaggerated in calling Seroquel "significantly superior."  "You know,"
he said, "I can't disagree with that."

Sales of Seroquel rocketed over the past decade, turning it from a
second-choice antipsychotic to a first-choice drug with one of the highest
market shares in its class. But enthusiasm for Seroquel has ebbed after U.S.
Food and Drug Administration required the makers of second-generation
antipsychotics in 2003 to include warnings about the increased risk of
diabetes.

A national comparative study also reported in 2005 that four newer
antipsychotics, including Seroquel, were no better than Trilafon, an older
drug.

CONFLICTING FINDINGS

The outlook was different in 2000, when Seroquel was new and psychiatrists
hoped it could match the effectiveness of Haldol but cause fewer side
effects. While Haldol's arrival in the 1950s helped revolutionize the
treatment of schizophrenia, the drug also caused a high rate of dystonia and
other disfiguring movement disorders.

AstraZeneca asked Schulz to conduct a "meta-analysis," a review of four
existing studies that compared the effectiveness of Seroquel with Haldol and
placebo pills. His initial look created optimism - showing in three of the
four trials that more patients responded favorably to treatment with
Seroquel than Haldol.

The results compelled AstraZeneca to look deeper into the data for more
positives. What they got were negatives. On a rating scale, patients in
these same four studies showed a greater reduction in behavioral symptoms
when taking Haldol instead of Seroquel, according to the analysis.

Company officials were caught off guard, according to copies of their
e-mails.

"My guess is that we all (including Schulz) saw the good stuff, i.e. the
meta analyses of responder rates that showed we were superior to placebo and
haloperidol and then thought that further analyses would be supportive and
that a paper was in order," e-mailed John Tumas, a head of AstraZeneca's
publications team, at the time.

Schulz in an interview said his APA study included the initial "response
rate" analysis, and not the additional findings from the company. He later
published a paper in 2003 that was similar to the AstraZeneca analysis,
measuring changes in patient behaviors and finding that Seroquel was "at
least as good as" Haldol.

However, even this 2003 study has drawn skepticism.

Schulz used data from five clinical trials to produce the paper, including
the four already used in the AstraZeneca analysis. Despite the similar
sources of data, the results in these two reports are notably different.

The AstraZeneca document found that Haldol, on average, improved patient
scores on the behavioral rating scale by 3.31 more points than Seroquel. In
Schulz's paper, Haldol was only 0.12 points better. Likewise, AstraZeneca
found that Haldol was slightly better at reducing depression and anxiety,
but Schulz reported that Seroquel was slightly better.

"These two things, they don't go together," said Glen Spielmans, an
assistant professor of psychology at Metropolitan State University, who has
reviewed the documents. "Either the (company) analysis was wrong or Schulz's
presentation was wrong."

The added fifth study showed little difference between Haldol and Seroquel
overall, and certainly couldn't account for the three-point difference
between Schulz's report and AstraZeneca's conclusions.

"Somehow, three points vanish," Spielmans said. "It's not just the spin. The
numbers are different, too."

Schulz said it probably wasn't just the fifth study but updates to the other
four studies that made the difference. He said he can "understand the
suspicions" of his work, but in the end his 2003 report only said that
Seroquel and Haldol were equivalent. Other well-accepted studies at the time
had reached the same conclusion.

The strategies in this instance seem textbook for pharmaceutical company
research, said Dr. Erick Turner, an Oregon researcher who previously
reviewed psychotic drugs for the FDA.

His study last year in the New England Journal of Medicine found that
positive drug studies are almost always published, whereas negative studies
are either not published, distorted to emphasis any positives, or combined
with positive studies to dilute their impact.

Meta-analysis reports can also be distorted, he said, by mixing a few
negative studies with more positive ones to forecast a desired outcome.

"They just blanket the universe with these glowing reports," he said, "and
the negative stuff is in there a little bit."

CHANGING PRACTICES

Schulz's research is not a central focus of the lawsuits against
AstraZeneca, which accuse the London-based company of withholding
information about Seroquel's elevated risk of diabetes and obesity.
Attorneys for patients who suffered these side effects are trying to prove a
pattern of cover-ups by the company, though.

Schulz said he was never asked by AstraZeneca to sell or spin his results,
nor has he ever agreed to withhold negative research. Case in point: Schulz
published an industry-funded study in 2008 that found that another
antipsychotic, Zyprexa, was no better than a placebo pill in treating
borderline personality disorder.

Schulz said he has cut back his role with drug companies - mostly forgoing
paid lectures to clinics - because of the perception of bias. University of
Minnesota leaders are also considering tighter rules about how and when
industry money can be accepted.

"As these issues have begun to unfold, I decided I didn't want to do
anything that would hurt my institution," he said. "I've curtailed
activities for that reason."

Schulz does have ongoing research projects funded by industry. An Eli Lilly
grant allowed him to examine the potential of medical imaging to analyze
brain activity in mental disorders and to then select the best treatment.

A U spokesman said that the dean of the medical school, Dr. Deborah Powell,
is aware of the controversy over Schulz's research and has offered him her
full support.

Dr. Carl Elliot, a U bioethics professor, said the conflicting AstraZeneca
studies are suspicious, but it's difficult to know if Schulz is at fault.

"Was Schulz fooled?" Elliott asked. "Or was he complicit?"

Jeremy Olson can be reached at 651-228-5583.

NYTimes.com: Drug Maker Told Studies Would Aid It, Papers Say - Biederman back again


 
 
March 20, 2009

Drug Maker Told Studies Would Aid It, Papers Say

An influential Harvard child psychiatrist told the drug giant Johnson & Johnson that planned studies of its medicines in children would yield results benefiting the company, according to court documents dating over several years that the psychiatrist wants sealed.

The psychiatrist, Dr. Joseph Biederman, outlined plans to test Johnson & Johnson’s drugs in presentations to company executives. One slide referred to a proposed trial in preschool children of risperidone, an antipsychotic drug made by the drug company. The trial, the slide stated, “will support the safety and effectiveness of risperidone in this age group.”

Dr. Biederman was the lead author of a trial published last year concluding that treatment with risperidone improved symptoms of attention deficit and hyperactivity disorder in bipolar children.

Dr. Biederman — who was director of the Johnson & Johnson Center for Pediatric Psychopathology Research at Massachusetts General Hospital, in Boston — is in the middle of two controversies: one involves the use of antipsychotic drugs in children, and the other relates to conflicts of interest in medicine.

He is the world’s most prominent advocate of diagnosing bipolar disorder in even the youngest children and of using antipsychotic medicines to treat the disease, but much of his work has been underwritten by drug makers for whom he privately consults. An inquiry by Senator Charles E. Grassley, Republican of Iowa, revealed last year that Dr. Biederman earned at least $1.6 million in consulting fees from drug makers from 2000 to 2007 but failed to report all but about $200,000 of this income to university officials.

Harvard and the National Institutes of Health are investigating whether Dr. Biederman violated federal and university research rules. He has suspended his work with the drug industry during the investigations.

Dr. Biederman has become a key witness in a series of lawsuits filed by state attorneys general claiming that makers of antipsychotic drugs defrauded state Medicaid programs by improperly marketing their medicines. His work helped fuel a rapid rise in the use of these medicines in children.

In November, the lawyers for the states released e-mail messages and internal documents from Johnson & Johnson that showed the company had intended to use its connection with Dr. Biederman to increase sales. The documents became public in a motion filed by plaintiffs’ lawyers to compel him to be interviewed.

Dr. Biederman has not responded to messages seeking comment. An article in The Boston Globe in December quoted a letter to the newspaper in which he wrote that while Johnson & Johnson had sought commercial applications to his work, “any implication that J.&J.’s interests interfered with the center’s work is wrong.”

A spokeswoman for Massachusetts General Hospital said Thursday that she could not comment on pending litigation.

Judge Jamie D. Happas of New Jersey Superior Court, who is overseeing the multistate litigation, ruled last year that Dr. Biederman should be deposed. As part of that process, Dr. Biederman provided lawyers with documents relating to his interactions with Johnson & Johnson; the documents included presentations he made over several years summarizing the work of the center, financed by the company.

Peter Spivack, a lawyer representing Dr. Biederman, filed a motion seeking to keep these documents under seal. The New York Times received copies of the documents.

In a letter filed with the court on Thursday, Mr. Spivack said articles in The Times about Dr. Biederman had “publicly embarrassed Dr. Biederman and, in part, led to an agreement to forestall contact with pharmaceutical companies.”

One set of slides in the documents referred to “Key Projects for 2004” and listed a planned trial to compare Risperdal, also known as risperidone, with competitors in managing pediatric bipolar disorder. The trial “will clarify the competitive advantages of risperidone vs. other neuroleptics,” the slide stated. All of the slides were prepared by Dr. Biederman, according to his sworn statement.

In 2005, Dr. Biederman was the lead author of a study comparing Risperdal and Zyprexa, made by Eli Lilly. The study concluded that Risperdal improved subjects’ depressive symptoms but that Zyprexa did not.

A slide listing “Key Projects for 2005” mentioned a planned study in adolescents of Concerta, a stimulant manufactured by Johnson & Johnson. The study will “extend to adolescents positive findings with Concerta in A.D.H.D. N.O.S. in adults,” the slide said, referring to unusual cases of attention deficit hyperactivity disorder.

In 2006, Dr. Biederman was co-author of a study showing that children given Concerta for a prolonged period did not have reduced growth, allaying a significant concern about the medicine.

Josephine Johnston, a research scholar at the Hastings Center, a bioethics research institute, said the documents “raise questions about how well-designed Dr. Biederman’s trials were in that he promised a result to his funders.”

“It’s another shadow over his work,” Ms. Johnston said.

In a contentious Feb. 26 deposition between Dr. Biederman and lawyers for the states, he was asked what rank he held at Harvard. “Full professor,” he answered.

“What’s after that?” asked a lawyer, Fletch Trammell.

“God,” Dr. Biederman responded.

“Did you say God?” Mr. Trammell asked.

“Yeah,” Dr. Biederman said.

 

About-face on drug danger advice - NZ

http://www.nzherald.co.nz/nz/news/article.cfm?c_id=1&objectid=10562590

About-face on drug danger advice

4:00AM Friday Mar 20, 2009
By Chris Barton

Tomorrow:
Antidepressants and kids: A mother's fight for fully informed consent

A health board has withdrawn advice about the risks of giving antidepressants to adolescents and children after the medicines regulator Medsafe questioned the accuracy of the information.

The Waitemata District Health Board told patients of Marinoto North's adolescent mental health unit that Prozac-type drugs "are safe in over-dosage so cannot be used by patients to commit suicide".

But after the death a year ago of Marinoto patient Toran Henry, 17, Medsafe has written to the health board's chief executive and chief pharmacist detailing its concerns about the advice.

It was particularly concerned that the advice did not say it was possible to overdose with three commonly used drugs, including the generic Prozac drug fluoxetine.

"An overdose can be fatal, or cause effects such as cardiac arrest which are potentially fatal," said Medsafe senior adviser Susan Kenyon.

Medsafe was also concerned that information about side effects was not comprehensive, and that one of the pamphlets advocated unapproved uses of antidepressants including for autism, attention deficit hyperactivity disorder, and bed wetting.

Figures from the drug funding agency Pharmac show that for the year to June 2008, 1.2 million adult prescriptions for antidepressants were issued. For children and adolescents aged 6 to 18, the figure was 14,733, and children 5 and under received 72 prescriptions. There were 263,000 prescriptions for fluoxetine at a cost of $1.2 million.

The health board advice was brought to the attention of Medsafe in January by Toran's mother, Maria Bradshaw. She says her son was prescribed fluoxetine without proper informed consent. Mrs Bradshaw has since learned that Toran often took more than his prescribed dose of the drug because it enabled him to become intoxicated from alcohol more quickly.

She said she and her son were not told of the overdosage risk or, as outlined in the Medasfe datasheet on the drug, that "the safety and efficacy of fluoxetine for the treatment of children and adolescents less than 18 years of age has not been established."

In a letter to Mrs Bradshaw, Mrs Kenyon wrote: "Medsafe considers that patients and parents/carers should be informed when medicines are used outside their approved use in order for them to make a more informed decision as to whether the potential benefits of treatment outweigh the risks."

The information for the Waitemata advice came from the Werry Centre for Child and Adolescent Mental Health at Auckland University.

"Now that Medsafe has raised concerns about the accuracy of this document we will ensure that it is no longer handed out to patients," Waitemata health board communications manager Lydia Aydon told the Herald.

She was referring to a 2004 document, Antidepressants for Children and Youth, by child and adolescent psychiatrist professor John Werry.

Werry Centre director of workforce development Sue Treanor said another document, Antidepressant Medication: A Guide for Carers, had also been removed from the centre's website.

Professor Werry said last night Medsafe had not contacted him, "but rather has chosen to go behind my back and write to another party".

Professor Werry said he was not involved with the centre, and added: "The view that Medsafe expresses on the risks associated with the use of SSRI (Prozac type antidepressants) are not those of the child and adolescent psychiatrists in New Zealand, and are inconsistent with the research data.

"This had been pointed out to them but they have refused to change their position."

Medsafe's statement that the risks of prescribing Prozac-type antidepressants outweighed the benefits "constitutes a serious threat to the mental health of adolescents."

Psychoactive Drug Effects and Public Safety - Webinar with Dr. Moira Dolan

 

Psychoactive Drug Effects and Public Safety

Tuesday, March 31
US time: 6pm PST, 8pm CST, 9pm EST


In this  60-minute presentation, Dr. Moira Dolan describes the effects of a broad spectrum of prescription medications on mood, emotion, behavior and thinking, and the impact on public safety. A question and answer period is included.
 


Discover:

• Which drugs have FDA-mandated warnings on homicidal behavior;

• Scores of medications that carry warnings on violence;

• How medical treatment of one condition can precipitate another;

• How the psychotropic side effect profiles of common medications compare to known effects of recreational drugs.

 

This presentation cuts through technical terminology to clearly explain:

 

Medical and Pharmacology Definitions
Practical Drug Classifications
Brief History of Drug Development
Detailed Case Histories
  

 

With expanded knowledge, you are able to take a wider view of the person on a medical drug, including understanding certain contributing medication factors about their condition. Easily obtained but little appreciated drug facts can lend new depth to your awareness of public health and safety the management of public safety.

Register Now:
www.BuildingStrengthWebinars.com
 
For Audio: 916-233-3089, access code 511-952-708
or
Listen Online

American Psychiatric Association Says No To Drug Industry Money

http://www.injuryboard.com/national-news/american-psychiatric-association-says-no-to-drug-industry-money.aspx?googleid=259792

American Psychiatric Association Says No To Drug Industry Money

Posted by Jane Akre
Thursday, March 26, 2009 11:28 AM EST

 

High profile and embarrassing conflict of interest news stories about doctors on the receiving end of drug industry money, has led to a purported industry-wide policy change for a professional organization of psychiatrists.  

The board of the American Psychiatric Association (APA) voted to phase out industry-sponsored meetings and meals.

This May’s scheduled industry-sponsored annual meeting in San Francisco, where more than 38,000 member physicians are invited, will continue as scheduled and a spokesperson said it is possible that such events will still take place at the group’s annual meeting next year as well.

So when will the phase out occur?

The timetable still remains to be worked out, says an APA spokeswoman to Med Page Today.

"There is a perception that accepting meals provided by pharmaceutical companies may have a subtle influence on doctors’ prescribing habits,” said James H. Scully Jr. M.D. who is the organization’s CEO in a statement.

“Although we took great care to avoid biased reporting at all our symposia, we came to the conclusion that the only way to totally eliminate the risk is to have the symposia supported by the APA alone," said the APA's president, Nada L. Stotland, M.D., M.P.H., in a statement.

Sen. Charles Grassley (R-Iowa) has asked for a complete accounting of the APA income from pharmaceutical companies since 2003.

Exempted is money from advertising placed in professional journals.  

Sen. Grassley’s probe has uncovered the ties between Dr. Fred Goodwin, who hosted “The Infinite Mind” radio program, Dr. Joseph Biederman of Harvard, and Dr. Charles Nemeroff of Emory University who had been on the receiving end of money from pharmaceutical companies and either under-reported the funds to their universities or in the case of Goodwin, failed to disclose to his audience or producer his ties to industry.

In 2006, Sen. Grassley found that the APA had received nearly of third of its revenue from the drug industry.

With a public increasingly skeptical of professional opinion encouraging drug use, the organization feels change is necessary. 

“What was acceptable five years ago isn’t necessarily acceptable today,” says Dr. Scully.  “Change is necessary, and the APA wants to stay at the forefront of a new and better way of doing things.” 

Conflicts Over Conflicts of Interest

In another turnabout, the editors of the Journal of the American Medical Association (JAMA) say that whistleblowers are invited to tell them about drug industry conflicting interests of doctors, but telling anyone else, including the media, is forbidden. 

The rule came about as two Ph.D’s reported on a lead author who failed to report a relationship with a drug manufacturer.  The two whistleblowers eventually went to the New York Times to tell their story which the editors of JAMA heavily criticized on their pages saying the disclosure compromised their ability to do a complete, fair and thorough investigation.

“A rush to judgment may spark heat and controversy, but rarely sheds light or advances medical discourse,” says JAMA in a March 20 editorial.

No word on what will befall whistleblowers if they violate this directive.  #

MI allows drug industry suits


 
Michigan Legislature Passes Bills That Would Allow Residents To Sue Drug Companies Over FDA-Approved Drugs

     The Michigan House on Thursday passed a package of bills that would repeal a 13-year-old law that provides pharmaceutical companies with immunity from lawsuits involving FDA-approved products, the Detroit News reports. The main bill was passed by a 61-48 vote and the other bills passed with similar or narrower margins, according to the News. Current law allows plaintiffs to collect legal damages only if they can prove that a company withheld or misrepresented information that would result in FDA revoking its approval of a drug. The legislation would repeal the law retroactive to 1996 (Heinlein, Detroit News, 3/26).


Good news: New rules cause drop in strong drugs for kids!

This  is the St. Pete Times story http://www.tampabay.com/news/health/article987612.ece#comments

The AP put it out  a very short version like this:
http://www.bradenton.com/331/story/1326311.html

Saturday, Mar. 28, 2009
New rules cause drop in strong drugs for Fla. kids
The Associated Press

The number of antipsychotic drug prescriptions written for children has plummeted since Florida health officials began requiring that doctors get approval before giving the powerful drugs.

That's according to the St. Petersburg Times, which reported on Saturday that there were 75 percent fewer prescriptions written between May and December 2008, compared the same period a year earlier. The new rules went into effect April 2008. The figures focus on children under the age of 6 on the public Medicaid health insurance program.

The so-called atypical antipsychotics were created to treat adult schizophrenia and bipolar disorder, but have been used for conditions ranging from mild dementia to insomnia. They've also been used in children with behavioral problems, although side effects can include high blood sugar and diabetes. 


http://www.wtxl.com/global/story.asp?s=10088161&ClientType=Printable
New rules cause drop in strong drugs for Fla. kids
WTXL ABC 27 Tallahassee, Thomasville, Valdosta - Your Local News ... 

http://www.wtsp.com/news/local/story.aspx?storyid=103073
WTSP, Tampa,  Channel 10 New rules cause drop in strong drugs for Fla. Kids
 

http://www.channel10.com/news/local/story.aspx?storyid=103073&catid=8
Tampa,  Channel 10 New rules cause drop in strong drugs for Fla. kids 

 

http://www.firstcoastnews.com/printfullstory.aspx?storyid=134808
New Rules Cause Drop in Strong Drugs for FL Kids Firstcoastnews.com | Jacksonville, St. Augustine and Brunswick
WTLV, Channel 12, WJXX Channel 25, Jacksonville 

 

 

http://www.fox4now.com/Global/story.asp?S=10088161&nav=menu563_7_1_1
New rules cause drop in strong drugs for Fla. Kids
WFTX-TV/FOX 4, Cape Coral, FL 

 


http://www.wflxfox29.com/Global/story.asp?S=10088161&nav=menu98_3
New rules cause drop in strong drugs for Fla. kids

WFLX Fox 29, West Palm Beach 

 

New rules cause drop in strong drugs for Fla. kids


http://www.bradenton.com/331/story/1326311.html
New rules cause drop in strong drugs for Fla. kids 

Fewer pills for young patients 

 

http://hosted.ap.org/dynamic/stories/F/FL_ANTIPSYCHOTIC_DRUGS_CHILDREN_FLOL-?SITE=FLPEJ&SECTION=HOME&TEMPLATE=DEFAULT
New rules cause drop in strong drugs for Fla. kids 

 

http://www.tcpalm.com/news/2009/mar/30/decline-seen-antipsychotic-drugs-prescribed-childr/
Decline seen in antipsychotic drugs prescribed to children in state
 

 
http://www.theledger.com/article/20090328/APN/903282445
New rules cause drop in strong drugs for Fla. Kids 

 

http://content.usatoday.net/dist/custom/gci/InsidePage.aspx?cId=montgomeryadvertiser&sParam=30442633.story
New rules cause drop in strong drugs for Fla. kids

http://www.examiner.com/a-1930619~New_rules_cause_drop_in_strong_drugs_for_Fla__kids.html 

New rules cause drop in strong drugs for Fla. Kids

http://www.miamiherald.com/news/florida/AP/story/972554.html
New rules cause drop in strong drugs for Fla. Kids

http://www.palmbeachpost.com/state/content/gen/ap/FL_Antipsychotic_Drugs_Children.html 

New rules cause drop in strong drugs for Fla. kids 

Friday, March 20, 2009

Video: "ADHD" can be caused by Tics

Video here: http://www.youtube.com/watch?v=prn6anlSO48

Text below: 

 

 

http://www.nbc-2.com/articles/readarticle.asp?articleid=27282&z=3
March 19, 2009 by Nancy Alvarez

ADHD misdiagnosis

LEE COUNTY: Every year, millions of children are medicated for Attention Deficit Hyperactivity Disorder, but a local doctor says they could be misdiagnosed and taking drugs they don't need.

"He was such a good kid. So calm, so laid back, never argued," said Jenny Miner.

That's how Kenny Standish was before kindergarten.

Then he changed.

"A little overactive. A little bit hyper," said Miner. "When he would get upset he would just go in his room and tear everything off the walls."

Kenny's behavior worsened. By first grade he was diagnosed with Attention Deficit Hyperactivity Disorder.

"I wanted him to feel well and do well in school," said Miner.

Miner set out on a road shared by millions of parents and medicated her son to control the ADHD.

"He calmed down and regained focus and we were hopeful and I thought okay. But then it wore off and we had to up the dose," said Miner.

Specialists followed, so did stronger medications.

"It made me feel dizzy. I was going across the room and it was going this way," said Kenny.

"I took it. The same dose and I kid you not, the kitchen floor went diagonal on me. I said that's it. This is not for children," said Miner.

Miner searched desperately for answers, but all along she had a hunch.

"Did I think he was born with what he had? No," said Miner.

It turns out she was right.

In his bloodwork, doctors saw bacteria around his cells. The bacteria match the symptoms of ADHD and are transmitted by ticks.

She learned he had bartonella, which caused his rage and temper flare-ups, and babesia, which caused him to feel miserable.

Dr. James Schaller is a leading researcher of parasites and infections passed on to humans by ticks.

He says bartonella and babesia are rarely discovered.

"It's going to be missed 99.9 percent of the time," he said.

Schaller says that's because most major labs don't have the time or technology to check for them.

"You may need 2 hours to see this and no lab will do this so it's routinely missed on a manual blood smear," said Schaller.

Schaller has written five books to raise awareness about babesia and bartonella. He has one simple message.

"You are at risk any place in the U.S., anyplace including Florida," said Schaller.

Dr. Schaller treated Kenny with medications including antibiotics.

Now there are no more episodes of rage, no hyperactivity or lack of focus.

"I feel a lot better," said Kenney.

Miner says it's now her mission to tell other people.

She says she remembers finding a tick on Kenny when he was just a few months old. Over the years they've spent around $200,000 on doctors and medications.

In the end- the special blood test that found the bartonella and babesia cost $265.

The Collier County Health Department is working to confirm Kenny's case with the CDC.

Thursday, March 19, 2009

Article Using Statistics from SSRI Stories: Journal of American Physicians and Surgeons: Volume 14: Number 1: Spring 2009

Subject: Article Using Statistics from SSRI Stories: Journal of American Physicians and Surgeons: Volume 14: Number 1: Spring 2009


In the Journal of American Physicians and Surgeons: Volume 14: number 1: Spring 2009, there is an article by Joel M. Kauffman, Ph.D., [Professor of chemistry emeritus at the University of the Sciences, Philadelphia, Pa.] which is titled:  Selective Serotonin Reuptake Inhibior [SSRI] Drugs:  More Risk Than Benefits?"  

In regard to SSRI Stories,   www.SSRIstories.com    Dr. Kaufmann made the following statement on page 10: "Since no clinical trial involving multiple homicides is ever likely to be run, no firmer evidence is likely to be found.  Healy noted that much of the evidence for suicide and murder came from the efforts of journalists and lawyers".

To read the full article go to:

http://www.jpands.org/jpands1401.htm

or

http://www.jpands.org/vol14no1/kauffman.pdf

Rosie Meysenburg
SSRI Stories:  Moderator

German Shooter Kretschmer was treated for depression and recently abondoned the treatment

Remember that being on these drugs and on the withdrawal period can incite homicidial rages and suicidial thoughts... Just another tragedy of psychotropic drugs -- how many more must die?

http://worldblog.msnbc.msn.com/archive/2009/03/12/1833653.aspx

"Kretschmer had been receiving psychological treatment for depression, but according to the police, he had recently abandoned his therapy."

Germans bewildered after school shooting

Posted: Thursday, March 12, 2009 11:09 AM
Filed Under:

WINNENDEN, Germany – Why? That is the predominant question for the shocked residents of the small southern German town of Winnenden and for TV stations and newspapers across the country this morning.

All night, forensic experts collected evidence in search of clues that could possibly explain why 17-year-old Tim Kretschmer went on a wild rampage at his former school and killed 15 people before taking his own life on Wednesday.

During a press conference on Thursday investigators revealed more clues that may explain Kretschmer’s possible motive for the rampage.

At 2:45 a.m., just hours before the attack, officials said that Kretschmer warned of his plans on an Internet chatroom. He wrote that he was tired of his life, he felt everyone was laughing at him and that nobody recognized his potential.

He added that he would be visiting his former school and wrote, "Tomorrow you will hear from me, just remember the name of a place called Winnenden."

Police experts said that in the process of their investigation, they searched Kretschmer's computer, his music collection, his clothing and spoke to friends and relatives. They said they found a limited amount of pornographic material, horror films, and violent computer games such as "Counter-Strike."

Kretschmer had been receiving psychological treatment for depression, but according to the police, he had recently abandoned his therapy.

‘Randomly shooting’
The young man was described as an unremarkable and introverted student with no criminal record. But, his shooting rampage painted a different picture.

Dressed in black, Kretschmer, a 2008 graduate of the school, entered three classrooms on Wednesday morning and shot several students at close range, firing mostly into the heads of his victims. Police officials said that only one male was among the 12 victims that were left dead at the school.

"Some of the dead children were still holding their pencils in their hands," said Erwin Hetger, the state interior minister, indicating that the shooting went very quickly and took the students by surprise.

After police intervention teams responded to the first emergency calls within two minutes, they briefly encountered the gunman inside the school before he fled on foot.  He then shot a by-passer near a psychiatric clinic before kidnapping a driver in his car. When their journey ended in a small town 20 miles away, Kretschmer shot a salesman and his customer at a local car dealership, "execution style" police say.

"At that point, the gunman was randomly shooting at almost everything that moved, severely injuring two undercover police officers, who had just arrived at the scene," said Hetger.

 Police said that Kretschmer had fired at least 112 shots and was in possession of more than 250 bullets.

Strict gun laws in Germany
But, how did the minor get access to the weapon and ammunition in a country that has strict weapons laws?

Gun-holders have to fulfill criteria on age and weapons expertise to obtain a firearms license. And only licensed hunters or members of gun clubs have access to pistols and rifles.

Kretschmer's father is a gun club member who kept 14 weapons locked up, but had one handgun – the one used in the rampage – laying in his bedroom and ammunition accessible in the house, according to police.

Officials say Kretschmer regularly visited the gun club with his father and that he was believed to be an experienced shooter.

While critics are using the incident to argue for even stricter gun laws, the police stressed during Thursday’s press conference that the attack should be a call for even more vigilance of teens’ behavior in chat rooms, in schools, and with their families. 

A town paralyzed, a nation in shock
"Nobody can understand it," said Roberto Seifert, who works near the school. "You can see it in the faces of the police too. Everyone is in shock. The mood's very subdued here."

Last night, the center of Winnenden resembled a ghost town. Many restaurants and bars remained closed. The biggest gathering of residents could be seen outside the high school, where many young students and their parents put down candles and flowers.

In small groups, teenagers were flocking to the crime scene, many crying, seeking the support of their friends and classmates.

"It is a shock that sits very, very deep. My daughter lost one of her teachers," the mother of one student, who did not want to be identified, said last night.

The Albertville high school in Winnenden remained closed Thursday. Students from the school were receiving counseling from psychologists and clergymen, while the terrifying incident left the town in shock and continued to be the talk of the day.

Meanwhile police say that they have received numerous phone calls in the last 24-hours threatening copy-cat attacks in other cities across Germany.

Does Antipsychotic Treatment Impact Pediatric Health Care Costs? Yes

 

Does Antipsychotic Treatment Impact Pediatric Health Care Costs?

16 Mar 2009   

Declining health care costs in pediatric patients treated with antipsychotic agents are being offset by the health care costs associated with the development of adverse events related to these medications.

Using retrospective data from South Carolina's Medicaid medical and pharmacy claims between January, 1996 and December, 2005, researchers Jeanette Jerrell, Ph.D., and Roger McIntyre, M.D., identified 4140 children and adolescents prescribed antipsychotic medications, and a random sample of 4500 children not treated with psychotropic medications. Their main outcome measures were total health care costs and emergency, inpatient, and outpatient services use over time, but they included pre-existing medical conditions, receipt of multiple psychotropic medications, and individual risk factor differences for gender, age group, and ethnicity in the analyses.

Dr. Jerrell, a professor of neuropsychiatry at the University of South Carolina School of Medicine, reported, "The development of adverse medical conditions related to antipsychotic medication use in children and adolescents is significantly associated with higher total health care costs and to use of outpatient, emergency, and inpatient services over time. The difference is about 34% higher, on average, over 8-9 years of service through Medicaid, compared to those without these conditions."

Detailed results regarding the impact of antipsychotic medications on pediatric health care costs will be discussed in their upcoming article "Health care costs of pediatric clients developing adverse events during treatment with antipsychotics," in a future issue of Value in Health, the official journal of the International Society for Pharmacoeconomics and Outcomes Research.

Value in Health (ISSN 1098-3015) publishes papers, concepts, and ideas that advance the field of pharmacoeconomics and outcomes research and help health care leaders to make decisions that are solidly evidence-based. The journal is published bi-monthly and has a regular readership of over 4,000 clinicians, decision-makers, and researchers worldwide.

ISPOR is a nonprofit, international organization that strives to translate pharmacoeconomics and outcomes research into practice to ensure that society allocates scarce health care resources wisely, fairly, and efficiently.

Source
ISPOR

Exclusive: GPs face crackdown on dementia prescribing


http://www.healthcarerepublic.com/news/GP/LatestNews/888639/Exclusive-GPs-face-crackdown-dementia-prescribing/

Exclusive: GPs face crackdown on dementia prescribing

12-Mar-09

Alzheimer's Society proposes checks on antipsychotic scrips and publication of prescribing rates.

GPs could face three-monthly checks on prescribing of antipsychotic drugs under plans being considered by the DoH.

Proposals by the Alzheimer's Society would increase pressure to cut antipsychotic use by publishing PCT-wide prescribing rates for the drugs.

The charity has made seven recommendations as part of the DoH's review into inappropriate prescribing of antipsychotics, results of which are expected this spring.

The review was launched after reports that GPs were prescribing risperidone and olanzapine despite safety concerns.

The Alzheimer's Society advice, seen by GP newspaper, calls for 'compulsory regulation and audit of antipsychotic drugs'.

It wants national and local audits to gather data on their use and to inform regulation.

The charity calls for 'a formal requirement for the prescriptions to be recorded and then reviewed at a minimum of every three months and more regularly if appropriate'.

GPs should review prescribing when patients move so those who enter care homes are not left on antipsychotics because of a lack of follow-up care.

Louise Lakey, senior policy officer at the Alzheimer's Society told GP newspaper that audits would identify 'where most over-prescribing is taking place'. She called for support 'through education and information'.

Steve Iliffe, professor of primary care for older people at University College London, said: 'Auditing prescribing in people with dementia is sensible and should be part of any inspection process.' But he warned 'naming and shaming' could lead to resentment and evasive action.

This site is intended for healthcare professionals only

Forest Labs' Lexapro Flap Over JAMA Article Will Likely Be Examined by the Feds


 

Forest Labs' Lexapro Flap Over JAMA Article Will Likely Be Examined by the Feds

By Jim Edwards | March 16th, 2009 @ 11:35 am

An editor of the Journal of the American Medical Association called a university professor “a nobody and a nothing” after he pointed out, correctly, that a JAMA author had failed to disclose a financial relationship with Forest Labs in an article about Lexapro, according to the WSJ.

The spat, although entertaining, will probably be examined carefully by the U.S. Department of Justice, which is currently suing Forest for, among other things, the “placement” of positive news stories in the media about Lexapro.

The author, Dr. Robert Robinson of the University of Iowa, had published a study of the use of Lexapro vs. therapy in patients who had suffered strokes, to see if either helped the patients avoid becoming depressed. The study concluded that both helped, with only 9 percent of Lexapro patients becoming depressed and 12 percent of those on therapy. About 22 percent of those who received a placebo became depressed.

Jonathan Leo, associate professor of neuroanatomy at Lincoln Memorial University, noticed that Robinsons’s study contained something strange:

… we were confused by a subtle but seemingly critical omission from the published paper. While the authors compared both Lexapro and therapy to placebo, they did not report on the direct comparison of therapy to Lexapro …

Leo pointed this out in a rival publication, the British Medical Journal. And then the folks at JAMA seem to have gone completely crazy. WSJ:

Leo says he received an angry call from JAMA executive deputy editor Phil Fontanarosa last week, shortly after Leo’s article was published on the BMJ Web site. “He said, ‘Who do you think you are,’ ” says Leo. “He then said, ‘You are banned from JAMA for life. You will be sorry. Your school will be sorry. Your students will be sorry.”

The call from Fontanarosa was followed up by ones from JAMA editor-in-chief Catherine DeAngelis to Leo’s superiors, Leo says. He said she asked his superiors to get him to retract his article in the BMJ.

… “This guy is a nobody and a nothing” she said of Leo. “He is trying to make a name for himself. Please call me about something important.” She added that Leo “should be spending time with his students instead of doing this.”

When asked if she called his superiors and what she said to them, DeAngelis said “it is none of your business.” She added that she did not threaten Leo or anyone at the school.

As Leo notes, however, in addition to not doing a head-to-head comparison between Lexapro and therapy, Robinson also failed note that he had taken money from Forest Labs. Leo:

In a letter to JAMA, we pointed this out. Five months later, our letter was published along with an acknowledgement from the original authors that indeed the difference between therapy and medication was not statistically significant.

You can read the JAMA correction here.

A Silenced Drug Study Creates An Uproar

 
A Silenced Drug Study Creates An Uproar

By Shankar Vedantam
Washington Post Staff Writer
Wednesday, March 18, 2009; A01

The study would come to be called "cursed," but it started out just as Study 15.

It was a long-term trial of the antipsychotic drug Seroquel. The common wisdom in psychiatric circles was that newer drugs were far better than older drugs, but Study 15's results suggested otherwise.

As a result, newly unearthed documents show, Study 15 suffered the same fate as many industry-sponsored trials that yield data drugmakers don't like: It got buried. It took eight years before a taxpayer-funded study rediscovered what Study 15 had found -- and raised serious concerns about an entire new class of expensive drugs.

Study 15 was silenced in 1997, the same year Seroquel was approved by the Food and Drug Administration to treat schizophrenia. The drug went on to be prescribed to hundreds of thousands of patients around the world and has earned billions for London-based AstraZeneca International -- including nearly $12 billion in the past three years.

The results of Study 15 were never published or shared with doctors, even as less rigorous studies that came up with positive results for Seroquel were published and used in marketing campaigns aimed at physicians and in television ads aimed at consumers. The results of Study 15 were provided only to the Food and Drug Administration -- and the agency has strenuously maintained that it does not have the authority to place such studies in the public domain.

AstraZeneca spokesman Tony Jewell defended the Seroquel research and said the company had disclosed the drug's risks. Since 1997, the drug's labeling has noted that weight gain and diabetes were seen in study patients, although the company says the data are not definitive. The label states that the metabolic disorders may be related to patients' underlying diseases.

The FDA, Jewell added, had access to Study 15 when it declared Seroquel safe and effective. The trial, which compared patients taking Seroquel and an older drug called Haldol, "did not identify any safety concerns," AstraZeneca said in an e-mail. Jewell added, "A large proportion of patients dropped out in both groups, which the company felt made the results difficult to interpret."

The saga of Study 15 has become a case study in how drug companies can control the publicly available research about their products, along with other practices that recently have prompted hand-wringing at universities and scientific journals, remonstrations by medical groups about conflicts of interest, and threats of exposure by trial lawyers and congressional watchdogs.

Even if most doctors are ethical, corporate grants, gifts and underwriting have compromised psychiatry, said an editorial this month in the American Journal of Psychiatry, the flagship journal of the American Psychiatric Association.

"The public and private resources available for the care of our patients depend upon the public perception of the integrity of our profession as a whole," wrote Robert Freedman, the editor in chief, and others. "The subsidy that each of us has been receiving is part of what has fueled the excesses that are currently under investigation."

Details of Study 15 have emerged through lawsuits now playing out in courtrooms nationwide alleging that Seroquel caused weight gain, hyperglycemia and diabetes in thousands of patients. The Houston-based law firm Blizzard, McCarthy & Nabers, one of several that have filed about 9,210 lawsuits over Seroquel, publicized the documents, which show that the patients taking Seroquel in Study 15 gained an average of 11 pounds in a year -- alarming company scientists and marketing executives. A Washington Post analysis found that about four out of five patients quit taking the drug in less than a year, raising pointed doubts about its effectiveness.

An FDA report in 1997, moreover, said Study 15 did offer useful safety data. Mentioning few details, the FDA said the study showed that patients taking higher doses of the drug gained more weight.

In approving Seroquel, the agency said 23 percent of patients taking the drug in all studies available up to that point experienced significant weight increases, compared with 6 percent of control-group patients taking sugar pills. In 2006, FDA warned AstraZeneca against minimizing metabolic problems in its sales pitches.

In the years since, taxpayer-funded research has found that newer antipsychotic drugs such as Seroquel, which are 10 times as expensive, offer little advantage over older ones. The older drugs cause involuntary muscle movements known as tardive dyskinesia, and the newer ones have been linked to metabolic problems.

Far from dismissing Study 15, internal documents show that company officials were worried because 45 percent of the Seroquel patients had experienced what AstraZeneca physician Lisa Arvanitis termed "clinically significant" weight gain.

In an e-mail dated Aug. 13, 1997, Arvanitis reported that across all patient groups and treatment regimens, regardless of how numbers were crunched, patients taking Seroquel gained weight: "I'm not sure there is yet any type of competitive opportunity no matter how weak."

In a separate note, company strategist Richard Lawrence praised AstraZeneca's efforts to put a "positive spin" on "this cursed study" and said of Arvanitis: "Lisa has done a great 'smoke and mirrors' job!"

Two years after those exchanges, in 1999, the documents show that the company presented different data at an American Psychiatric Association conference and at a European meeting. The conclusion: Seroquel helped psychotic patients lose weight.

The claim was based on a company-sponsored study by a Chicago psychiatrist, who reviewed the records of 65 patients who switched their medication to Seroquel. It found that patients lost an average of nine pounds over 10 months.

Within the company, meanwhile, officials explicitly discussed misleading physicians. The chief of a team charged with getting articles published, John Tumas, defended "cherry-picking" data.

"That does not mean we should continue to advocate" selective use of data, he wrote on Dec. 6, 1999, referring to a trial, called COSTAR, that also produced unfavorable results. But he added, "Thus far, we have buried Trials 15, 31, 56 and are now considering COSTAR."

Although the company pushed the favorable study to physicians, the documents show that AstraZeneca held the psychiatrist in light regard and had concerns that he had modified study protocols and failed to get informed consent from patients. Company officials wrote that they did not trust the doctor with anything more complicated than chart reviews -- the basis of the 1999 study showing Seroquel helped patients lose weight.

For practicing psychiatrists, Study 15 could have said a lot not just about safety but also effectiveness. Like all antipsychotics, Seroquel does not cure the diseases it has been approved to treat -- schizophrenia and bipolar disorder -- but controls symptoms such as agitation, hallucinations and delusions. When government scientists later decided to test the effectiveness of the class of drugs to which Seroquel belongs, they focused on a simple measure -- how long patients stayed on the drugs. Discontinuation rates, they decided, were the best measure of effectiveness.

Study 15 had three groups of about 90 patients each taking different Seroquel doses, according to an FDA document. Approximately 31 patients were on Haldol. The study showed that Seroquel failed to outperform Haldol in preventing psychotic relapses.

In disputing Study 15's weight-gain data, company officials said they were not reliable because only about 50 patients completed the year-long trial. But even without precise numbers, this suggests a high discontinuation rate among patients taking Seroquel. Even if every single patient taking Haldol dropped out, it appears that at a minimum about 220 patients -- or about 82 percent of patients on Seroquel -- dropped out.

Eight years after Study 15 was buried, an expensive taxpayer-funded study pitted Seroquel and other new drugs against another older antipsychotic drug. The study found that most patients getting the new and supposedly safer drugs stopped taking them because of intolerable side effects. The study also found that the new drugs had few advantages. As with older drugs, the new medications had very high discontinuation rates. The results caused consternation among doctors, who had been kept in the dark about trials such as Study 15.

The federal study also reported the number of Seroquel patients who discontinued the drug within 18 months: 82 percent.

Jeffrey Lieberman, a Columbia University psychiatrist who led the federal study, said doctors missed clues in evaluating antipsychotics such as Seroquel. If a doctor had known about Study 15, he added, "it would raise your eyebrows."

© Copyright 1996- 2009 The Washington Post Company