JUNE 2007: News on SSRIs, other Psych Drugs and Related Issues

JUNE 2007: News on SSRIs, other Psych Drugs and Related Issues

Joined: January 1st, 1970, 12:00 am

June 4th, 2007, 11:30 pm #1

JUNE 2007: News on SSRIs, other Psych Drugs and Related Issues
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Joined: January 1st, 1970, 12:00 am

June 18th, 2007, 7:21 pm #2

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Joined: January 1st, 1970, 12:00 am

June 18th, 2007, 7:42 pm #3

JUNE 2007: News on SSRIs, other Psych Drugs and Related Issues
http://adage.com/article?article_id=117070

<FONT size=4><STRONG>"Big Pharma Doesn't Like How It Looks on YouTube
</STRONG></FONT>Advertising Age 2007 Jun 4


<STRONG>Critics Use Online-Video Site to Skewer Eli Lilly, Promote Documentary
</STRONG>

Forget Congress and the Food and Drug Administration. More worrisome to the pharmaceutical industry these days is YouTube.

<DIV class=photo_left>

</DIV>
The online-video site famous for exploding Diet Coke bottles is blasting Big Pharma as YouTube gains popularity among drug-industry critics as a means to influence public opinion on the industry. The most damning of the videos are two five-minute segments -- one from a former sales rep for Eli Lilly and Co.'s antipsychotic Zyprexa, who reveals what Lilly officials told him to say about the drug's side effects. The other is a trailer for a 46-minute documentary called "Big Bucks, Big Pharma" from the Media Education Foundation, a Northampton, Mass., group that produces and distributes films intended to "inspire reflection" about American mass media.

<STRONG>'Here to stay'</STRONG>

These budding Michael Moores are a worry to the industry "because there are no internal controls on YouTube," says Dorothy Wetzel, former consumer-marketing chief at Pfizer and now senior VP-management supervisor at Saatchi & Saatchi, New York, where she works on AstraZeneca accounts. "But," she added, "you have to get used to it, because it's here to stay."

"Big Bucks, Big Pharma" is a critical look at the $5 billion practice of direct-to-consumer advertising. The documentary claims the industry manipulates both consumers and physicians with ads, and includes interviews with such notables as Dr. Marcia Angell from Harvard Medical School and the former editor of the New England Journal of Medicine, along with Dr. Bob Goodman of Columbia University Medical Center, founder of No Free Lunch, a nonprofit group that condemns the practice of physicians accepting free lunches and gifts from pharmaceutical sales reps.

"I can't help but think there are millions of people taking drugs they don't need and that may even be harmful," Ms. Angell says in the documentary.

Since the film came out in November, producers not only have been selling it on the Media Education Foundation's website, they have also adopted the Mel Gibson approach of grass-roots marketing. "Big Bucks, Big Pharma" is being seeded with senior-citizen groups, civic organizations and colleges.

<STRONG>No comment</STRONG>

Eli Lilly declined to comment on the Zyprexa video on YouTube, which features the purported sales rep detailing what the company told him to say about the drug's side effects. The New York Times in December reported that studies on the frequency of weight gain among Zyprexa users were under-reported by Lilly.

"We were told ... to downplay those side effects, to focus on the efficacies of the drug," the drug rep says.

He also detailed how he could manipulate drug-study statistics without lying. "An old stats professor once told me that statistics are like prisoners: Torture them long enough, and they'll tell you whatever you want to hear," he said.

Doug Wood, a New York-based attorney for the global law firm Reed Smith, said there is little pharmaceutical companies can do unless they have been slandered.

<STRONG>Fighting back</STRONG>

But the drug companies aren't taking it lying down. In fact, some are trying to use YouTube to their own advantage by posting entertaining and positive films about their products.

GlaxoSmithKline now has its own one minute, 43-second video on YouTube for Restless Legs Syndrome.

Ms. Wetzel said she believes more drug companies and ad agencies will adopt such an approach. "The conversation about health care goes on," she said, "and we're going to have to deal with it."



<STRONG><FONT size=5></FONT></STRONG>&nbsp;

<STRONG><FONT size=5>WATCH&nbsp;VIDEOS:&nbsp;&nbsp;&nbsp;</FONT></STRONG>

<STRONG><FONT size=5>"BIG PHARMA, BIG BUCKS"</FONT></STRONG>

<STRONG>6 videos/parts:</STRONG>

http://www.youtube.com/watch?v=Hh99CN5tLrc&eurl=http%3A%2F%2Fwww%2Enetwork54%2Ecom%2FForum%2F281849%2Fmessage%2F1180946448%2FBig%2BBucks%2BBig%2BPharma%2B%2D%2Ball%2Bsix%2Bparts%2Bon%2BYouTube
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Joined: January 1st, 1970, 12:00 am

June 18th, 2007, 7:48 pm #4

JUNE 2007: News on SSRIs, other Psych Drugs and Related Issues
http://ajp.psychiatryonline.org/cgi/con ... /164/6/A38

<STRONG><FONT size=4>Pediatric Depression Treatment Declines After FDA Advisory on Antidepressants</FONT></STRONG>

<EM>Diagnoses</EM> of new cases of major depression in children and adolescents, and their antidepressant treatment, <FONT color=#004586>declined sharply</FONT> over the 2 years following the first Food and Drug Administration (FDA) advisory about suicidality risk for pediatric patients taking selective serotonin reuptake inhibitors (SSRIs). Decreases in SSRIs and non-SSRI antidepressants for depressed patients ages 5–18 are shown by claims in a national database of managed health care plans analyzed by Libby et al. (p. <FONT color=#004586>884</FONT>). Psychotherapy did not increase after the advisory. This comparison of the 5 years before the FDA advisory in October 2003 with the 2 years afterward encompassed more than 65,000 children and adolescents with a new diagnosis of major depressive disorder. In addition, population-level depression rates fell in 2005 after steadily increasing. Dr. Cynthia Pfeffer comments on these trends in an editorial on p. <FONT color=#004586>843</FONT>.
<A name=F1><!-- null --></A><BR clear=right>
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<P align=center><FONT color=#4a4a4a><IMG height=190 alt="Figure 1" hspace=10 src="http://ajp.psychiatryonline.org/content ... /R80F1.gif" width=200 vspace=5 border=0>
<STRONG>View larger version</STRONG> (54K):
<NOBR><FONT color=#004586>[in this window]</FONT>
<A onmouseover="window.status='View figure in a separate window'; return true" onclick="startTarget('F1', 590, 619); this.href='/cgi/content-nw/full/164/6/A38/F1'" href="http://ajp.psychiatryonline.org/cgi/con ... 4/6/A38/F1" target=F1><FONT color=#004586>[in a new window]</FONT></A>

&nbsp;</NOBR> </FONT>
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<FONT color=#4a4a4a>FIGURE 1. </FONT>
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<FONT size=+1><STRONG>Social and Genetic Factors in Alzheimer’s Disease</STRONG></FONT>
Experience with adult day care may reduce the rate of cognitive decline for people with Alzheimer’s disease who later move to nursing homes. Of 432 older Alzheimer’s disease patients evaluated by Wilson et al. (p. <FONT color=#004586>910</FONT>), 36% were placed in nursing homes over the next 3–4 years. This transition was followed by an abrupt drop in cognitive functioning, but the subsequent rate of decline was slower for those who had previously used day care services. Patients with more education had greater cognitive declines after moving to nursing homes, but prior day care attenuated this association. A possible biological marker of cognitive decline was identified by Chen et al. (p. <FONT color=#004586>916</FONT>). They found a correlation between an individual’s "dose" of the apolipoprotein E (APOE) <IMG alt={epsilon} src="http://ajp.psychiatryonline.org/math/egr.gif" border=0>4 allele, a risk factor for Alzheimer’s disease, and the rate of brain atrophy during middle age. Magnetic resonance brain images were acquired for cognitively normal people at age 47–68 years and again 2 years later. The rate of whole brain atrophy was highest for people with two <IMG alt={epsilon} src="http://ajp.psychiatryonline.org/math/egr.gif" border=0>4 alleles and lowest for those with none. Dr. James Becker et al. discuss the roles of genes and environment in an editorial on p. <FONT color=#004586>849</FONT>.
<FONT size=+1><STRONG>Mechanisms of Change in Psychotherapy</STRONG></FONT>
In patients with borderline personality disorder, 10 of 12 symptom domains improved after 1 year of psychodynamic therapy focusing on transference, the patient’s transfer of feelings or conflicts to the therapist. In the comparison of interventions by Clarkin et al. (CME, p. <FONT color=#004586>922</FONT>), supportive treatment and behavior therapy were followed by improvements in six and five symptom domains, respectively. Transference-focused psychotherapy was associated with decreases in both suicidality and anger, whereas each of the other treatments decreased only one or the other. The relationship between treatment results and the therapist’s focus on emotion in short-term psychodynamic psychotherapy was explored in a meta-analysis by Diener et al. (p. <FONT color=#004586>936</FONT>). They identified 10 adequately designed studies that examined therapist activities facilitating the experience or expression of emotion by patients with a variety of diagnoses or problems. Emotional facilitation by the therapist was associated with a 30% greater likelihood of improvement, compared with other psychotherapy. Thus, this finding may help answer the question "What makes psychotherapy work? " An editorial on these articles by Dr. Glen Gabbard appears on p. 853.
<FONT size=+1><STRONG>Course of Borderline Personality Disorder</STRONG></FONT>
A 10-year study by Zanarini et al. (p. <FONT color=#004586>929</FONT>) supports the emerging consensus that borderline personality disorder is a treatable condition with a relatively good prognosis. Among 290 hospitalized patients with borderline personality disorder, half of the assessed symptoms resolved over time and the other half showed marked improvement. The latter symptoms primarily involved aspects of temperament, e.g., chronic dysphoria, abandonment fears, or dependency. Targeting these temperamental symptoms might improve outcomes further.
<SUP></SUP>
<BR clear=all>[font=]<A name=relation_type_61><!-- null --></A>
<FONT size=+1><STRONG>Related Articles:</STRONG>[/font]

<DL>
<DT><STRONG>The FDA Pediatric Advisories and Changes in Diagnosis and Treatment of Pediatric Depression</STRONG>
<DD>Cynthia R. Pfeffer
Am J Psychiatry 2007 164: 843-846. <NOBR><FONT color=#004586>[Full Text]</FONT> </NOBR>

</DD></DL>
<DL>
<DT><STRONG>Gene-Environment Interactions With Cognition in Late Life and Compression of Morbidity</STRONG>
<DD>James T. Becker, Luis Tarraga Mestre, Scott Ziolko, and Oscar L. Lopez
Am J Psychiatry 2007 164: 849-852. <NOBR><FONT color=#004586>[Full Text]</FONT> </NOBR>

</DD></DL>
<DL>
<DT><STRONG>Decline in Treatment of Pediatric Depression After FDA Advisory on Risk of Suicidality With SSRIs</STRONG>
<DD>Anne M. Libby, David A. Brent, Elaine H. Morrato, Heather D. Orton, Richard Allen, and Robert J. Valuck
Am J Psychiatry 2007 164: 884-891. <NOBR><FONT color=#004586>[Abstract]</FONT> <FONT color=#004586>[Full Text]</FONT> </NOBR>

</DD></DL>
<DL>
<DT><STRONG>Nursing Home Placement, Day Care Use, and Cognitive Decline in Alzheimer’s Disease</STRONG>
<DD>Robert S. Wilson, Judith J. McCann, Yan Li, Neelum T. Aggarwal, David W. Gilley, and Denis A. Evans
Am J Psychiatry 2007 164: 910-915. <NOBR><FONT color=#004586>[Abstract]</FONT> <FONT color=#004586>[Full Text]</FONT> </NOBR>

</DD></DL>
<DL>
<DT><STRONG>Correlations Between Apolipoprotein E <IMG alt={epsilon} src="http://ajp.psychiatryonline.org/math/egr.gif" border=0>4 Gene Dose and Whole Brain Atrophy Rates</STRONG>
<DD>Kewei Chen, Eric M. Reiman, Gene E. Alexander, Richard J. Caselli, Richard Gerkin, Daniel Bandy, Alisa Domb, David Osborne, Nick Fox, William R. Crum, Ann M. Saunders, and John Hardy
Am J Psychiatry 2007 164: 916-921. <NOBR><FONT color=#004586>[Abstract]</FONT> <FONT color=#004586>[Full Text]</FONT> </NOBR>

</DD></DL>
<DL>
<DT><STRONG>Evaluating Three Treatments for Borderline Personality Disorder: A Multiwave Study</STRONG>
<DD>John F. Clarkin, Kenneth N. Levy, Mark F. Lenzenweger, and Otto F. Kernberg
Am J Psychiatry 2007 164: 922-928. <NOBR><FONT color=#004586>[Abstract]</FONT> <FONT color=#004586>[Full Text]</FONT> </NOBR>

</DD></DL>
<DL>
<DT><STRONG>The Subsyndromal Phenomenology of Borderline Personality Disorder: A 10-Year Follow-Up Study</STRONG>
<DD>Mary C. Zanarini, Frances R. Frankenburg, D. Bradford Reich, Kenneth R. Silk, James I. Hudson, and Lauren B. McSweeney
Am J Psychiatry 2007 164: 929-935. <NOBR><FONT color=#004586>[Abstract]</FONT> <FONT color=#004586>[Full Text]</FONT> </NOBR>

</DD></DL>
<DL>
<DT><STRONG>Therapist Affect Focus and Patient Outcomes in Psychodynamic Psychotherapy: A Meta-Analysis</STRONG>
<DD>Marc J. Diener, Mark J. Hilsenroth, and Joel Weinberger
Am J Psychiatry 2007 164: 936-941. <NOBR><FONT color=#004586>[Abstract]</FONT> <FONT color=#004586>[Full Text]</FONT> </NOBR></DD></DL></FONT>
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Joined: January 1st, 1970, 12:00 am

June 18th, 2007, 7:51 pm #5

JUNE 2007: News on SSRIs, other Psych Drugs and Related Issues
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Joined: January 1st, 1970, 12:00 am

June 18th, 2007, 7:54 pm #6

JUNE 2007: News on SSRIs, other Psych Drugs and Related Issues
http://www.app.com/apps/pbcs.dll/article?AID=/20070605/BUSINESS/70605010/1003


Posted by the Asbury Park Press on 06/5/07
BLOOMBERG NEW SERVICE

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<STRONG><FONT size=4>Bristol-Myers Squibb Co., </FONT></STRONG>which has about 7,700 workers in New Jersey, asked U.S. regulators for permission to sell its antipsychotic drug Abilify to treat schizophrenia in adolescents.

The U.S. Food and Drug Administration will consider whether the pill, cleared for adult use in 2002, can safely treat patients ages 13 to 17, the company said today in a statement. The FDA typically reviews pediatric medicines within six months.

No drugs are approved in the U.S. to treat schizophrenia in teens, <FONT size=4><STRONG>although doctors often prescribe them </STRONG></FONT>to patients in that age group. <STRONG><FONT size=5><FONT size=4>Eli Lilly & Co. and Johnson & Johnson have also asked the FDA to clear drugs for use in teenagers.</FONT> </FONT></STRONG>Sales of Abilify surged 41 percent last year, the biggest increase among antipsychotics, helped by studies showing it caused less weight gain than competing drugs.

"I would expect Abilify to gain the most prescriptions from an approval for adolescent use because younger patients appear to be more susceptible to weight gain than adults,'' said Jeffrey Lieberman, chairman of psychiatry at Columbia University in New York.

Drugmakers sold more than $15 billion in antipsychotic medicines last year, according to data compiled by Bloomberg.

<FONT size=4><STRONG>About 15 percent of sales came from doctors writing so-called off-label prescriptions for unapproved uses such as treatment of teens, analysts say.
</STRONG></FONT>
"There's no gold standard for treating schizophrenia in teens, and the first company to get FDA approval for this will have an edge in this very crowded market,'' said Les Funtleyder, an analyst at Miller Tabak & Co. in New York, in a telephone interview.

The shares of Bristol-Myers, based in New York, fell 18 cents to $30.26 at 9:49 a.m. in New York Stock Exchange composite trading. The stock has climbed 16 percent this year.

Johnson & Johnson, of New Brunswick, said the FDA may decide as early as
this month whether its antipsychotic Risperdal can be used for schizophrenia and bipolar disorder in adolescents. FDA action on Indianapolis-based Lilly's antipsychotic Zyprexa was slowed in April, when the agency requested more time to review that pill for the same two conditions.

Abilify had sales of $1.3 billion last year. Sales of Zyprexa grew 3.8 percent to $4.4 billion last year. J&J's Risperdal generated $4.2 billion, an 18 percent increase.

Use of the newer antipsychotics in younger patients has risen sharply in recent years, prompting concern among doctors and parents because the drugs aren't approved for children and can cause weight gain and diabetes.
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<TD vAlign=top width="100%">Lilly is shopping for more bodies. They tried giving the drug to seniors with dementia, off-label (against the law). They have been urging doctors to give it to children off-label (against the law). Now they are trying to "go legal" and give it to adolescents- not for schizophrenia. Adolescents don't get schizophrenia. But they will urge it for every possible use under the sun. The company; most companies, expecially with psychiatric drugs, go for the most vulnerable groups. First, people who are mentally ill. Zyprexa is approved for brief use for bipolar mania: My son was given it for TWO years until he died of it from profound hyperglycemia. Second, old people (all those dead people who had dementia). And now, what we have been expecting, children. Many children take it and the other antipsychotics already, and many are dead or have suffered permanent metabolic harm.

Do not use this drug. It kills.

Posted by: elliel on Tue Jun 05, 2007 11:18 am</TD></TR>
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<TD vAlign=top width="100%">Zyprexa promotion


Eli Lilly makes billions on diabetes treatment and also gets $4.2 billion a year in sales of their biggest cash cow Zyprexa which has been scandalized as *causing* diabetes as a major side effect.
In 2004, the American Diabetes Association found that Zyprexa was more likely to cause diabetes than many other antipsychotic drugs.
Zyprexa off label promotion scandal is all over the news now.
Lilly drug reps are alleged to have called their marketing ploy,"Viva zyprexa".

Zyprexa which is only FDA approved for schizophrenia (.5-1% of pop) and some bipolar (2% pop) and then an even smaller percentage of theses two groups.

There are now 8 states (and counting) going after Lilly for fraud and restitution.

--
Daniel Haszard http://www.zyprexa-victims.com

Posted by: DannyHaszard on Tue Jun 05, 2007 11:13 am</TD></TR>
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June 18th, 2007, 8:08 pm #7

JUNE 2007: News on SSRIs, other Psych Drugs and Related Issues
http://www.nytimes.com/2007/06/06/health/06fda.html?hp

<STRONG><FONT size=5>Diabetes Drug Still Has Heart Risks, Doctors Warn </FONT></STRONG>

</NYT_BYLINE>

<DIV id=articleBody><NYT_TEXT>
A medical study intended to demonstrate the heart safety of a well-known <A title="Recent and archival health news about diabetes." href="http://topics.nytimes.com/top/news/health/diseasesconditionsandhealthtopics/diabetes/index.html?inline=nyt-classifier"><FONT color=#004276>diabetes</FONT></A> treatment seems, instead, to have added to the controversy over the drug.

Its manufacturer, <A title="More information about GlaxoSmithKline P.L.C." href="http://topics.nytimes.com/top/news/business/companies/glaxosmithkline_plc/index.html?inline=nyt-org"><FONT color=#004276>GlaxoSmithKline</FONT></A>, says preliminary results of the clinical trial provide reassurance that the drug, Avandia, an oral medication for Type 2 diabetes that has been used by an estimated seven million people worldwide, does not raise the risk of a heart attack or death from cardiovascular disease.

Influential doctors said that the data published online yesterday in a major medical journal did nothing to ease their concerns about the heart risks. The doctors raised their concerns in three editorials accompanying the Avandia study in The <A title="More articles about New England Journal of Medicine" href="http://topics.nytimes.com/top/reference/timestopics/organizations/n/new_england_journal_of_medicine/index.html?inline=nyt-org"><FONT color=#004276>New England Journal of Medicine</FONT></A>.

Questions about the safety of Avandia and how regulators have dealt with its risks are to be the subject of a Congressional hearing today. The data could intensify criticism, expected at the hearing, that the <A title="More articles about the U.S. Food And Drug Administration." href="http://topics.nytimes.com/top/reference/timestopics/organizations/f/food_and_drug_administration/index.html?inline=nyt-org"><FONT color=#004276>Food and Drug Administration</FONT></A> should have warned about the potential heart risks years ago.

A supervisor in the drug safety office at the agency said in an interview yesterday that she was rebuked last year after calling for a stronger warning label on Avandia and a competing drug, Actos.

<STRONG>The supervisor, Dr. Rosemary Johann-Liang, said that in March 2006 she approved a recommendation from a safety reviewer at the agency that the drugs be required to carry the strongest warning, a so-called black box warning, because they posed a risk of unusual swelling that could lead to heart failure. </STRONG>

<STRONG>But after officials at the agency who dealt more closely with Glaxo complained, Dr. Johann-Liang said she was ordered to retract her approval of the warning, lost her power to approve such assessments and no longer supervised reviews of the safety of Avandia and Actos.</STRONG>

<STRONG>“This was a very careful review that came to an inescapable conclusion,” Dr. Johann-Liang said in the interview. “They decided to act like the review never happened and punish me for approving it.”</STRONG>

Senator <A title="More articles about Charles E. Grassley." href="http://topics.nytimes.com/top/reference/timestopics/people/g/charles_e_grassley/index.html?inline=nyt-per"><FONT color=#004276>Charles E. Grassley</FONT></A>, Republican of Iowa, has investigated Dr. Johann-Liang’s accusations. Mr. Grassley sent a letter on Monday to the Food and Drug Commissioner Andrew C. von Eschenbach demanding that he investigate the case.

“I hope you recognized what is wrong with this picture,” Mr. Grassley wrote. “I also sincerely <STRONG>hope</STRONG> that this is not standard practice within the F.D.A.”

A spokeswoman for the agency, Susan Cruzan, said it was investigating the accusations.

Avandia has been awash in controversy since an article in The New England Journal of Medicine on May 21 and an accompanying editorial cited evidence from clinical trials indicating that Avandia, in addition to the risk of heart failure, could raise a patient’s risk of heart attacks.

Since then, Glaxo and the drug agency have cautioned doctors and patients to await the results of a long-term patient trial, the Record, created to test the heart safety.

It was the interim results of that study that Glaxo rushed to submit for publication by yesterday in advance of the hearing today by the House Oversight and Government Reform Committee. The company had intended the study in the prestigious peer-reviewed New England Journal to be part of a news media blitz to counter negative publicity about the drug, which generates annual revenues exceeding $3.2 billion.

Concerns about the drug were raised in the May 21 article, when Dr. Steven E. Nissen and colleagues from the Cleveland Clinic wrote an analysis suggesting that <STRONG>the popular medication increased the risk of heart attacks by 43 percent</STRONG>. Dr. Nissen’s paper was based on a review of more than <STRONG>40 studies of the drug</STRONG>. It was also published by The New England Journal of Medicine.

Dr. Nissen, chief of cardiovascular medicine at the prominent clinic, is among witnesses scheduled to testify today along with Dr. von Eschenbach.

In a conference call yesterday with reporters, a vice president for clinical development at Glaxo, Dr. Murray Stewart, an endocrinologist, said data did not support Dr. Nissen’s conclusions. “Nissen suggested that there were more cardiovascular deaths,” Dr. Stewart said. “This does not support that. This shows less cardiovascular deaths.”

Since the study, involving 4,447 people, began nearly four years ago, 29 patients in the Avandia group have died from cardiovascular causes. A greater number, 35, have died of cardiovascular problems in the group taking other drugs.

Several doctors who wrote the accompanying editorials published yesterday, including the Journal editors, saw the results less positively than Glaxo did. <STRONG>The editorials questioned the structure of the study and pointed out that although fewer Avandia patients have died, more had heart attacks than in the group taking other drugs, 43 to 37. </STRONG>

Although those heart attacks represented a relatively tiny number in the overall study, one editorial, by the Journal’s editors, struck an anxious tone. “In short, there is continued uncertainty about the cardiovascular safety of rosiglitazone,” they wrote, referring to the generic name of the medicine.

Of the patients in the Record study, which is to continue through late next year, about half take Avandia in combination with other medications and half take two diabetes medications, metformin with sulfonylurea.

The editorials raised questions about the structure of the Record study. In his editorial, Dr. David M. Nathan, a diabetes expert who teaches at Harvard, questioned the high number of patients who dropped out of the study without explanation and further monitoring, as well as the decision by the creators of the study to use a combination of metformin and sulfonylurea as the comparison group. That combination was associated with a 96 percent increase in diabetes-related mortality in another study, Dr. Nathan wrote.

Glaxo said the metformin-sulfonylurea combination was chosen because it is the most common Type 2 diabetes treatment worldwide.

“The interim results of the Record trial do <STRONG>not</STRONG> provide any assurance of the safety of treatment with rosiglitazone,” Dr. Nathan said, suggesting in his editorial that doctors should use medications other than Avandia.

An editorial by Dr. Bruce M. Psaty of the <A title="More articles about University of Washington" href="http://topics.nytimes.com/top/reference/timestopics/organizations/u/university_of_washington/index.html?inline=nyt-org"><FONT color=#004276>University of Washington</FONT></A> and Dr. Curt D. Furberg of <A title="More articles about Wake Forest University" href="http://topics.nytimes.com/top/reference/timestopics/organizations/w/wake_forest_university/index.html?inline=nyt-org"><FONT color=#004276>Wake Forest University</FONT></A> recalculated Dr. Nissen’s analysis using interim results of the Record study in addition to the studies that Dr. Nissen used. <STRONG>They found that Avandia increased a patient’s risk of having a heart attack 33 percent. </STRONG>

<STRONG>“In my mind, it’s not small,” Dr. Furberg said, calculating that such a risk, extrapolated to the millions of patients who have taken Avandia, would translate to thousands of extra heart attacks</STRONG>.

The company’s decision to release interim results of the Record trial were highly unusual and reflected Glaxo’s concern about the controversy and the concerns of patients in the trial. As a result of the negative publicity about the drug, two patients have dropped out, the Glaxo medical director, Dr. Ronald L. Krall, said yesterday.

Dr. Stewart said the telephones of doctors involved in the Record trial throughout Europe, Australia and New Zealand had been ringing with calls from concerned patients, raising questions about whether the trial can continue. "
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&nbsp;

<STRONG><FONT size=5>GSK:&nbsp; CONVICTED FELONS:</FONT></STRONG>

<FONT size=3><EM>http://www.abc.net.au/news/newsitems/200703/s1882695.htm</EM></FONT>

<EM>"...In fact tests showed ready-to-drink Ribena contained no detectable vitamin C at all.Anna Devathasan and Jenny Suo, the teenagers who first blew the whistle on Ribena three years ago, were in court to hear the <STRONG>company's guilty plea</STRONG>.</EM>

<EM><STRONG>GlaxoSmithKline</STRONG>, which last week made similar admissions in Australia, <STRONG>faces fines </STRONG>of up to $2.5 million..."</EM>

<FONT size=3></FONT>&nbsp;
<FONT size=3><EM>http://www.leighday.co.uk/doc.asp?cat=984&doc=259</EM><!-- PRINT_CONTENT_END --><!-- Start Story Attachments --><!-- End Story Attachments --><!-- Start Print and Email Table --></FONT>
<EM>"GlaxoSmithKline found <STRONG><FONT size=4>guilty </FONT></STRONG>of misleading the public</EM>

<EM>The international watchdog for the drugs industry has&nbsp;published a report finding the drugs company <STRONG>GlaxoSmithKline guilty </STRONG>of misleading the public about one of its products. The finding followed complaints about claims made by a senior executive of the company on national American TV about the anti-depressant drug <STRONG>Seroxat (known as Paxil </STRONG>in the United States)..."</EM>

<EM>".... GlaxoSmithKline have been found <STRONG>guilty</STRONG> of breach of sections 1.3 and 1.7 of the IFPMA Code of Pharmaceutical Marketing Practices. S. 1.3 states that 'Information in promotional material should be based on an up-to-date evaluation of evidence that is scientifically valid and should not give an incorrect or misleading impression.' S. 1.7 states that 'Where it is permitted by law to communicate directly with patients regarding their prescription medicines, all such information should be accurate, fair and not misleading.'..."</EM>

<EM></EM>&nbsp;

<EM>http://www.mindful-things.com/psych_news_archive/psych_news_depression.html</EM>

<EM><STRONG>"...Court finds GlaxoSmithKline guilty
</STRONG>June 15, 2001 -- GlaxoSmithKline has been <STRONG>ordered</STRONG> by a Cheyenne, Wyoming jury to pay US $6.5 million to relatives of a man who killed himself and three family members after taking Paxil, an antidepressant. Glaxo will appeal the ruling. Although this is the first time a court has come down against a drug maker on charges of inducing violence, Lilly still faces 10 wrongful death suits over its drug Prozac, a cousin to Paxil. No antidepressant manufacturer includes a warning about violent behavior in its prescribing literature.."</EM>

<EM></EM>&nbsp;

<EM>http://www.aidshealth.org/index.php?option=com_content&task=view&id=851&Itemid=193</EM>

<P align=left><EM>"... On October 16, 2003, the Commission announced its findings that <STRONG>GSK had indeed engaged in illegal acts,</STRONG> including excessive pricing and anticompetitive practices. </EM>

<P align=left><EM>"...AHF President Michael Weinstein said, "AHF requested voluntary licensing from GSK and demands immediate approval. The time has come for GSK to stop being a<STRONG> rogue company </STRONG>and join the ranks of <STRONG>corporate responsibility</STRONG>".&nbsp; The text of the filed complaint can be found at: </EM><STRONG><FONT color=#ab003c><EM>http://www.aidshealth.com/newsroom/news/GSKComplaint.doc</EM></FONT></STRONG><EM>..."</EM>

<P align=left><EM></EM>&nbsp;

http://topics.nytimes.com/top/news/business/companies/glaxosmithkline_plc/index.html?query=FRAUDS%20AND%20SWINDLING&field=des&match=exact
<FONT size=4>"Glaxo Settles US Fraud Charges...</FONT>
<P class=summary>WASHINGTON, Sept. 21 (AP) - GlaxoSmithKline has agreed to pay more than $<STRONG>150 million to settle fraud </STRONG>accusations over the pricing and marketing of two antinausea drugs, the Justice Department said on Tuesday the Justice Department said on Tuesday.<SPAN class=date><FONT face=Arial color=#b13b39 size=2>September 21, 2005</FONT></SPAN>&nbsp;..."

<P class=summary>&nbsp;

<P class=summary>http://topics.nytimes.com/top/news/business/companies/glaxosmithkline_plc/index.html?query=FRAUDS%20AND%20SWINDLING&field=des&match=exact

<P class=summary>"...The civil lawsuit contends that GlaxoSmithKline engaged in fraud by failing to tell doctors that some studies of Paxil showed the drug did not work in adolescents...." <SPAN class=date><FONT face=Arial color=#b13b39 size=2>June 3, 2004</FONT></SPAN>

<P class=summary><SPAN class=date><FONT face=Arial color=#b13b39 size=2></FONT></SPAN>&nbsp;

http://query.nytimes.com/gst/fullpage.html?sec=technology&res=9C00E2D6103EF934A1575BC0A9629C8B63&n=Top%2fNews%2fBusiness%2fCompanies%2fGlaxoSmithKline%20P%2eL%2eC%2e

Glaxo Agrees to Post Results Of Drug Trials on Web Site
August 27, 2004

In a <STRONG>settlement that the New York attorney general </STRONG>said would transform the drug industry, <STRONG>GlaxoSmithKline</STRONG> agreed yesterday to post on its Web site the results of all clinical trials involving its drugs.

''This settlement is transformational in that it will provide doctors and patients access to the clinical testing data necessary to make informed judgments,'' the attorney general, Eliot Spitzer, said.

<STRONG>While the case involves only GlaxoSmithKline</STRONG>, the British drug maker, Mr. Spitzer predicted that other companies would follow its lead by posting the results of their studies online. Eli Lilly, for example, has said it would create a Web site on which it would list the results of clinical tests of approved drugs. Other companies, including Johnson & Johnson and Merck, have said they support the concept of a public database that would list trial results.

If drug makers do not act, Mr. Spitzer <STRONG>threatened more lawsuits</STRONG>..."
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Joined: January 1st, 1970, 12:00 am

June 18th, 2007, 8:12 pm #8

JUNE 2007: News on SSRIs, other Psych Drugs and Related Issues
http://www.medicalnewstoday.com/medical ... wsid=73094

"<STRONG><FONT size=4>Minnesota Physicians Continue To Receive Pharmaceutical Company Payments Despite Sanctions</FONT></STRONG>

Article Date: 06 Jun 2007

The New York Times examined Minnesota state medical records showing that more than 100 physicians who had been <STRONG>cited for misconduct </STRONG>by the Minnesota Board of Medical Practice continued to receive drug company payments, and some continued to participate in clinical trials of experimental drugs. Although Minnesota is the only state to make its records public, many experts say the problem is national.

The Times' examination of Minnesota's records on drug company payments found that from 1997 to 2005, at least 103 physicians who had been disciplined or criticized by the state medical board received a total of $1.7 million from drug makers. The median payment during that period was $1,250, and the largest was $479,000. Sanctions issued by the board included reprimands, required retraining and suspension of licenses. Of the 103 doctors, 39 had been disciplined for inappropriate prescribing practices, 21 for substance abuse, 12 for substandard care and three for mismanagement of drug studies.

David Rothman, president of the Institute on Medicine as a Profession at Columbia University, said, "There's no reason to think Minnesota is unique" from other states in the nation. He added, "Clinical trial investigators must be culled from only the finest physicians in the country since they work on the frontiers of new knowledge. That drug makers are scraping the bottom of the medical barrel is an outrage." Karl Uhlendorf, a spokesperson for the Pharmaceutical Research and Manufacturers of America, said the trade group would not comment on the Times' findings.

The Times profiled Faruk Abuzzahab, a Minnesota psychiatrist who received more than $55,000 in drug company payments from 1997 to 2005 despite being disciplined in December 1997. According to the board, Abuzzahab inappropriately discharged from the hospital a suicidal patient who declined to enroll in a clinical trial for which the doctor was recruiting. The patient later committed suicide (Harris/Roberts, New York Times, 6/3). "

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Joined: January 1st, 1970, 12:00 am

June 18th, 2007, 8:18 pm #9

JUNE 2007: News on SSRIs, other Psych Drugs and Related Issues
<P class=date>http://interactive.snm.org/index.cfm?Pa ... &RPID=6272

<P class=date><STRONG><FONT size=5>Hypothyroidism Clearly Linked to Mood Swings</FONT></STRONG>
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Results of Molecular Imaging of Brain Metabolic Activity With PET Released at SNM's 54th Annual Meeting June 2–6 in Washington, D.C.

WASHINGTON, D.C.—Hypothyroidism is often associated with mood changes like depression lethargy. Researchers, studying underlying brain processes in search of "why" this happens, reported their results at the 54th Annual Meeting of SNM, the world's largest society for molecular imaging and nuclear medicine professionals.

"The aim of our study was to investigate—with positron emission tomography (PET) imaging—how physical health and mental health are interrelated," said Waltraud Eichhorn, a nuclear medicine physician at Johannes Gutenberg University in Mainz, Germany. "We found that hypothyroidism is correlated to regional metabolic changes in the thalamus—an area of the brain that helps process information from the senses and transmit it to other parts of the brain" she said. "In other words, hypothyroid patients—compared to healthy individuals—have decreased metabolism in special parts of the brain that are responsible for processing information, " said Eichhorn. "Remarkably, this reduction in metabolism remains detectable after thyroid hormone replacement therapy," she added.

The thyroid, a butterfly-shaped gland in the neck just above the collarbone, is an endocrine gland that makes hormones and helps set a body's metabolism (how the body gets energy from food). Hypothyroidism, a condition in which your body produces too little thyroid hormone, often leads to exhaustion and depression, affecting millions of Americans, many of them women or the elderly. There are 27 million Americans who have underactive or overactive thyroid glands, but more than half remain undiagnosed, according to recent statistics.

Hypothyroidism can be treated by doses of thyroid hormone. Once the blood levels of thyroid hormone reach a normal range—called euthyroid—lethargy and depression often lift. However, in some patients, the depression persists, which means that successful therapy must address depression directly.

In this study, 10 patients with hypothyroidism underwent a cerebral 18-FDG/PET examination. She indicated that additional research is needed to determine whether special brain regions are responsible for increased depression or anxiety in patients suffering from hypothyroidism.

PET is a safe, highly specialized, noninvasive imaging technique that uses short-lived radioactive substances to produce three-dimensional images of those substances functioning within the body. A special type of camera works with computers to provide precise pictures of the areas of the body being imaged and molecular images of the body's biological functions.

Scientific Poster 1228: W.A. Eichhorn, K. Bose, H. Buchholz, T. Siessmeier and M. Schreckenberger, Nuclear Medicine Department, and U. Egle, Department of Psychosomatic Medicine and Psychotherapy, all at Johannes Gutenberg University, Mainz, Germany; P. Bartenstein, Department of Nuclear Medicine, Ludwig Maximilians University, Muenchen, Germany; and G. Kahaly, Department of Medicine I, Johannes Gutenberg University, Mainz, Germany, "Neuronal Correlates of Overt Hypothyroidism Measured by FDG PET," SNM's 54th Annual Meeting, June 2–6, 2007.

<HR width="35%" color=navy>

About SNM—Advancing Molecular Imaging and Therapy
SNM is holding its 54th Annual Meeting June 2–6 at the Washington Convention Center in Washington, D.C. Session topics for the 2007 meeting include brain amyloid imaging, hybrid imaging, molecular imaging in clinical drug development and evaluation, functional brain imaging in epilepsy and dementia, imaging instrumentation, infection imaging, lymphoma and thyroid cancer, cardiac molecular imaging, general nuclear medicine, critical elements of care in radiopharmacy and more.

SNM is an international scientific and professional organization of more than 16,000 members dedicated to promoting the science, technology and practical applications of molecular and nuclear imaging to diagnose,manage and treat diseases in women, men and children. Founded more than 50 years ago, SNM continues to provide essential resources for health care practitioners and patients; publish the most prominent peer-reviewed journal in the field (the Journal of Nuclear Medicine); host the premier annual meeting for medical imaging; sponsor research grants, fellowships and awards; and train physicians, technologists, scientists, physicists, chemists and radiopharmacists in state-of-the-art imaging procedures and advances. SNM members have introduced—and continue to explore—biological and technological innovations in medicine that noninvasively investigate the molecular basis of diseases, benefiting countless generations of patients. SNM is based in Reston, Va.; additional information can be found online at http://www.snm.org.
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Joined: January 1st, 1970, 12:00 am

June 18th, 2007, 8:26 pm #10

JUNE 2007: News on SSRIs, other Psych Drugs and Related Issues
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Urgent safety studies are needed for newer anti-epilepsy drugs that are being increasingly prescribed for children, say UK researchers.

The British Journal of Clinical Pharmacology report says prescriptions have risen five-fold in 13 years.
Yet the drugs' long-term safety has not been established, say the researchers.
Many medicines are not fully tested on children before licensing, meaning consultants have no official guidance on doses to refer to when prescribing. <!-- E SF -->
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Instead they often have to estimate a safe and effective dose based on the age and the size of the child.
Lead author Professor Ian Wong, from the Centre for Paediatric Pharmacy Research in London, studied antiepileptic drugs given to nearly 8,000 children over a 13-year period.
The centre is a collaborative project run by the School of Pharmacy at the University of London, the UCL Institute of Child Health and Great Ormond Street Hospital.
Professor Wong and his colleagues found three drugs in particular - lamotrigine, topiramate and levetiracetam - had seen a "massive" rise in prescribing.
Professor Wong said this was concerning.
"The uptake of these drugs has been rapid, yet their long-term safety has not been established and further research must now be seen as a priority."
Side-effects
He said that while newer drugs were less likely to react with other prescribed drugs, it was possible that restrictions in their use might have to be introduced as any side-effects in children became more apparent.
He said multi-organ failure, renal failure, blood disorders and skin reactions had been reported in patients using lamotrigine.
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Dr Jeffrey Aronson, a reader in clinical pharmacology at Oxford University, said many drugs were not tested on children because of the difficulties that including children in clinical trials posed.
"This means that clinicians often have to rely on their experience and scale down adult drugs for paediatric use, which is widely regarded as most unsatisfactory," he said.
Dr Colin Ferrie, a consultant paediatric neurologist at Leeds General Infirmary, said that not only were new trials important, but pharmaceutical companies should be encouraged to carry out "clinically relevant" trials prior to the original granting of a licence.
"Obviously it's an area of concern, and when you are prescribing a drug 'off licence' to a child, it's important to let the family know exactly the implications of this.
"However, it is often possible to find data, either from journal abstracts or the drug company, which can help you calculate a safe and effective dose of a drug."
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