A recent study in the April 2009, Pharmacoepidemiology and Drug Safety journal found no change in the suicide rate in teens as a result of the regulatory ban in the UK on the use of SSRI antidepressants with children under 18, which did result in a drastic reduction in SSRI use among kids.
"Anti-depressant use in under 18 year olds halved after the warnings," Pulse Today reported on April 24, 2009.
The research team from the University of Bristol concluded that "there was no evidence of an overall effect on suicides of regulatory action to restrict prescribing of SSRIs to young people."
Lead researcher, Dr Benedict Wheeler, told Pulse: "We found no clear evidence of a beneficial effect on population suicide rates. However, and equally importantly, we did not find evidence of an adverse effect on suicide rates either."
"This is important, because many mental health workers and researchers have been concerned that reduced antidepressant prescribing to children might inadvertently lead to an increase in suicides," he said.
Although "the rate of suicide among 15 to 19 year olds fluctuated to varying degrees in the 22 countries analyzed between 1990 and 2006, there was 'no consistent change' in the rate of suicide after the restrictions came into place in 2003," Pulse reported.
A year and a half ago, Medscape reported that a study found the drop in SSRI prescribing in the UK did not lead to a spike in youth suicides on February 21, 2008.
The study, also led by Dr Wheeler, was published online February 14, 2008, in the BJM. The researchers set out to evaluate the impact of changing patterns of antidepressant use on suicide or self-harm in young people in the UK, following 2003 regulatory action.
"These data for England do not indicate that reductions in antidepressant use have led to an increase in suicidal behavior," the group wrote.
"The findings are important, in that reduced access to antidepressants in young people in the United Kingdom following regulatory intervention appears not to have had an adverse impact on suicide deaths or hospital admissions for deliberate self-harm," Dr Wheeler told Medscape.
Continuing adherence to regulatory guidance on prescribing antidepressants to young people is supported by this evidence, he added.
In a related time trend study also published online February 14, 2008 in the BMJ, Lucy Biddle, PhD, and colleagues at the University of Bristol reported that the rate of death by suicide in young men in England and Wales was the lowest it had been in 30 years.
To investigate overall suicide trends, the researchers reviewed data from 1968 to 2005 for men and women aged 15 to 34, and found suicide rates in young men aged 15 to 24 and 25 to 34, peaked in 1990 and 1998, respectively, and then showed a steady decline. In 2005, suicide rates for men in these age groups were the lowest they had been since the mid-1970s.
The researchers reported that suicide rates in young women were also at the lowest level they had been in many years and they did not find any temporal correlation between the changes in antidepressant prescribing rates and changes in suicide rates.
On February 15, 2008, a researcher in both studies, Professor David Gunnell, noted in a BBC News report that concerns about the dangers of reducing antidepressant use in children, who might therefore be at an increased risk of committing suicide, had been raised by US research.
"There's been a greater fall in antidepressant prescribing in the UK but we have seen none of the potentially alarming upturn in suicides," he said.
In the Medscape report, Dr Wheeler pointed out that his findings differed from those of Robert Gibbons and colleagues, who reported in the September 2007, "American Journal of Psychiatry," that mortality rates for suicides in 5- to 19-year-olds in the US increased in 2004, following regulatory action.
In a Newsweek article titled "Trouble in a 'Black Box'", Gibbons went so far as to say: "I think the FDA has made a very serious mistake. It should lift its black-box warning because all it's doing is killing kids."
"You may induce two suicides by treatment, but by stopping treatment you're going to lose dozens to hundreds of kids. You're losing more than you're saving. That's the calculus," said Dr Robert Valuck, of the University of Colorado Heath Sciences Center, in the Newsweek article.
In the Medscape report, Dr Wheeler noted that "critiques" of the Gibbons study in "Letters to the Editor" in the Journal, suggested that the US situation might not actually differ that much from the study findings in UK.
In fact, in one such letter, the respected British Columbia researcher, Jon Jureidini, said the Gibbons study "incorrectly analyzed the relationship between U.S. selective serotonin reuptake inhibitor (SSRI) prescription rates and suicide rates among children."
The Gibbons study claimed there was a correlation between a 22% decrease in SSRI prescriptions and a 14% increase in youth suicide rates between 2003 and 2004, after warnings were issued by the FDA.
"As it turns out," Dr Jureidini wrote, "preliminary figures are now available from the Centers for Disease Control (CDC), which show that fewer people under age 25 committed suicide in 2005 (when prescribing did decrease) than in 2004."
"In the year in which suicide rates rose sharply," he said, "there was no significant drop in SSRI prescribing."
When broken down into separate age groups, government statistics for 2005, show the number of suicides was lower for all young people in the US, on the website of the National Center for Injury and Prevention and Control.
For children aged 5 to 14, there were only 270 in 2005, compared to 285 suicides in 2004. In the age group of 15 to 24, the number of suicides dropped to 4,139 in 2005, from 4,316 in 2004.
The statistics show that overall, when children are combined in the age group of one through eighteen, suicides fell from 1,471 in 2004, down to 1,408 in 2005. In 2006, the latest year posted, there were only 1,296 suicides in this age group.
On July 24, 2008, Pharmalot's Ed Silverman reported on data from the Agency for Healthcare Research and Quality that showed antidepressant prescriptions rose in 2005. "The increase amounted to roughly 10 percent, and that occurred in a year in which new and controversial Black Box warnings were added to the labeling," he wrote.
A survey of doctor and hospital visits in 2005, by the CDC, found the most commonly prescribed drugs were antidepressants, with 48% of the prescriptions written by primary care physicians.
Yet, as recently as January 30, 2009, in a Medscape Continuing Medical Education seminar, sponsored by Lexapro and Celexa maker, Forest Labs, Robert Gibbons was still saying: "we have seen in 2004 and 2005, the years for which CDC [Centers for Disease Control] has available data on youth suicide rates, the largest increases in youth suicide rates in history since they initially were monitored," in citing his own discredited study.
"There have been significant decreases in the prescriptions overall of antidepressants to children and adolescents," Gibbons said "And that has spilled over to the young adult and middle-aged adult range as well."
The disclosure section for the seminar shows Gibbons has served as an expert witness for Zoloft maker, Pfizer, and Wyeth Pharmaceuticals, maker of the antidepressants, Effexor and Pristiq.
Gibbons is a Professor of Biostatistics and Psychiatry and Director of the Center for Health Statistics at the University of Illinois at Chicago College of Medicine, according to his bio on the Department of Psychiatry's webpage.
In 2007, the American Foundation for Suicide Prevention, and Paxil maker, GlaxoSmithKline, donated between $10,000 and $24,000, to UIC College of Medicine, according to the Spring 2008 "UIC Medicine," newsletter. Zoloft peddler, Pfizer, donated between $50,000 and $99,000.
A co-author on the Gibbons study was Dr John Mann, a former president of the AFSP, and a professor of psychiatry at Columbia University.
Columbia University's 2007 Annual Report shows donations of between $100,000 and $499,000 from the AFSP, GlaxoSmithKline, Pfizer Incorporated and Pfizer International. The Pfizer Foundation gave $1 million or more.
The report also shows gifts of between $50,000 to $99,999 from Wyeth, the GlaxoSmithKline Foundation, Eli Lilly and Company, and the Eli Lilly Foundation.
Mann has served as a paid expert witness for antidepressant makers Pfizer and Glaxo. He testified in the only Paxil suicide-homicide case ever to make it to a jury. During his testimony, Houston attorney, Andy Vickery, brought out the fact that Mann had received more than $30 million in research funding from drug companies over the previous decade.
Mann admitted during cross-examination that he had written in three articles that there was possibly a small, subpopulation of patients vulnerable to suicide or violence under the drug, Vickery told Lawyers Weekly.
On June 6, 2001, the jury ruled against the drug maker and found that Paxil "can cause some people to become homicidal and/or suicidal," and awarded the plaintiffs over $6 million.
In nearly all the studies and papers published over the years that claim SSRIs work with children and do not cause suicide, the same academic quacks appear as investigators and co-authors. The list of names includes, but is not limited to, Joseph Biederman, David Brent, Jeffrey Bridge, David Dunner, Graham Emslie, Daniel Geller, Robert Gibbons, Frederick Goodwin, Martin Keller, Andrew Leon, Anne Libby, John Mann, John March, Charles Nemeroff, John Rush, Neal Ryan, David Shaffer, Karen Wagner and Robert Valuck.
Many of the same names also appear on the ever-growing list of so-called "Key Opinion Leaders," who have been exposed in an investigation by the US Senate Finance Committee, under the leadership of Senator Charles Grassley, as not disclosing Big Pharma money, which thus far includes, Harvard's Biederman, Thomas Spencer and Timothy Wilens; Nemeroff and Zachary Stowe from Emory; Melissa DelBello at the University of Cincinnati; Stanford University's Alan Schatzberg, president of the American Psychiatric Association; Keller at Brown University; Wagner and Rush from the University of Texas; and Goodwin, the former host of a radio show called "Infinite Minds."
Graham Emslie's earnings from antidepressant makers were highlighted in the media last year due to his role in the "Texas Children's Medication Algorithm Project." Emslie was chairman of the panel that issued guidelines in 1998, instructing doctors to prescribe SSRIs off-label to children for depression.
On August 18, 2008, the Dallas Morning News ran the headline: "Conflict of interest fears halt children's mental health project."
"A state mental health plan naming the preferred psychiatric drugs for children has been quietly put on hold over fears drug companies may have given researchers consulting contracts, speakers fees or other perks to help get their products on the list," the News reported.
Emslie "has made at least $130,000 in drug company speakers fees and consulting contracts since 2002," the paper noted, citing University disclosure forms. Co-authors on guidelines of the "Texas Children's Medication Algorithm Project," include Karen Wagner, John Rush and Neil Ryan.
The SEC filings for Cypress Bioscience provide a good source for estimating the amount of money these "KOLs" are pulling in per year, from each separate company.
Keller and Nemeroff have served on the board of directors, the scientific advisory board, and as consultants for Cypress. Under their 2004 consulting agreements, the firm was required to pay $50,000 per year for services rendered up to and including "two days per fiscal quarter." In addition, Cypress could request additional services at a rate of $5,000 per day.
Nemeroff was paid $19,000 for additional services in 2003, and Keller made an extra $18,000. For serving on the scientific advisory board, Nemeroff was paid $19,000 and Keller earned $18,000, in 2003. As members of the board of directors in 2002, they each received $24,000.
A July 25, 2002, bio for Keller in the agenda for a Cypress annual meeting, shows he was also a consultant to, "Bristol-Myers Squibb, Eli Lilly, Forest Laboratories, Janssen, Merck, Inc, Organon, Otsuka Pharmacia/Upjohn, Pharmastar, Pfizer, Inc. and Wyeth-Ayerst Laboratories."
The bio also reports that Keller served on the scientific advisory boards of, "Bristol-Myers Squibb, Cephalon, Cyberonics, Inc., Eli Lilly, Forest Laboratories, Merck, Inc, Mitsubishi, Organon, Pfizer, Sepracor, Scirex, SmithKline Beecham, Somerse, Vela Pharmaceuticals and Wyeth-Ayerst."
Suicide Victims on Antidepressants
In the first seven months of 2008, the "Evansville Courier & Press," reported a near record number of 23 suicides in Vanderburgh County, Indiana. On August 11, 2008, the County's chief deputy coroner, and a member of the local suicide prevention coalition, told the Courier that in the results of a preliminary investigation "one element" stood out: "In a majority of the cases investigated, the victim was on antidepressant medication. And none of the victims were in counseling."
A study in the August, 2006, Archives of General Psychiatry, found children aged 6 to 18, who took antidepressants in an inpatient setting, were 52% more likely to attempt suicide in the 60 days following discharge than children who were not taking the drugs.
This study analyzed data from the national Medicaid Analytic Extract Files, including information from all 50 states, and determined that children who filled prescriptions for antidepressants after an inpatient stay were over 15 times more likely to die by suicide than kids who were not taking antidepressants.
On May 25, 2007, MedPage Today reported a study that found young suicide victims were significantly more likely to have SSRIs in their bloodstream than were young homicide or accident victims.
"In an analysis of 'unnatural' deaths recorded by the Virginia Medical Examiner's Office for 1987 through 2003," MedPage wrote, "Antony Fernandez, MD, and colleagues, found that selective serotonin reuptake inhibitors or the serotonin-norepinephrine reuptake inhibitor venlafaxine appeared significantly more often in post-mortem toxicology of suicides than of accident or murder victims."
Studies show the SSRIs were passed out like candy to children during this time period. According to FDA estimates, in 2003, eleven million antidepressant prescriptions were written for under 19-year-olds, representing a 27% increase in 3 years.
Dr Thomas Moore, with the Drug Safety Research group, conducted a study of antidepressant use with kids during the 4-period of 1998 to 2001, and found the use of SSRIs with children doubled, and in 90% of the cases the drugs were prescribed off-label for uses not approved by the FDA.
For example, among boys 6 to 12-years-old, 52% of the prescriptions were written for attention deficit or conduct disorders, and typically, Dr Moore says, in combination with an antipsychotic or a stimulant.
There is "no scientific evidence that says that combination therapy is effective in these disorders and I know of no evidence that it is safe either," he advises.
The study found that 17% of the children were taking drugs that were ineffective in clinical trials, and 42% were taking two or more antidepressant drugs. "So, what we are seeing is when drugs are ineffective, rather than abandoning them or trying alternatives, doctors increase the dose or combine the drugs in ways, the safety of which we are not aware," Dr Moore warns.
Wyeth's Effexor me-too drug, Pristiq, was approved for adults with depression in May 2008. By the end of 2008, the FDA's adverse event reporting system showed 17 death reports for which Pristiq was listed as the primary suspect, including twelve completed suicides. Another 31 reports turned up with a search for "Suicidal Ideation."
On July 17, 2009, a press release issued by "Wichita Family Examiner.com," announced a "Child and Adolescent Depression Study in Wichita." The Clinical Research Institute in Wichita, Kansas, is "looking for children from 7 to 12 years of age that are suffering with depression to participate in the trial of Pristiq," the press release states.
"Pristiq is a FDA approved antidepressant," the announcement states, without informing parents that the drug is not FDA approved for use by children under 18.
"Participants are compensated for their time up to $750," according to the press release.
Suicides Skyrocket Among Young Men and Women in the Military
On July 23, 2009, the "Air Force Times," reported that the US Senate has ordered "an independent study to determine whether an increase in military suicides could be the result of sending troops into combat while they are taking antidepressants or sleeping pills."
Senator Benjamin Cardin (D-Md), who pushed for the study, said he does not know whether there is a link, but he believes prescription drug use, especially when it is not closely supervised by medical personnel, needs a closer look, the Times noted.
"One thing we should all be concerned about is that there are more and more of our soldiers who are using prescription antidepressant drugs ... and we are not clear as to whether they are under appropriate medical supervision," Cardin told the Times.
"Surveys ... have shown that as many as 12 percent of those who are serving in Iraq and 17 percent of those who are serving in Afghanistan are using some form of prescribed antidepressant or sleeping pills," he said. "That would equal 20,000 of our service members."
"Death by suicide is at record levels in the armed services," according to Dr Peter Breggin, one of the top experts on psychiatric drugs in the US.
"Simultaneously," he says, "the use of antidepressant drugs is also at record levels."
"The army confirms that since 2002 the number of suicide attempts has increased six-fold," he notes. "And more than 128 soldiers killed themselves last year."
The FDA requires antidepressant makers to list the following adverse effects on the labels of their drugs: "anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity ... and mania."
"We are giving our troops drugs that provide a prescription for uncontrolled, disinhibited violence, including agitation, irritability, impulsivity, hostility, and aggressiveness," Dr Breggin points out.
"During Vietnam, a mere 1% our troops were taking prescribed psychiatric drugs," he reports. "By contrast, in the past year one-third of marines in combat zones were taking psychiatric drugs."
"Instead of shortening tours of duty, instead of temporarily removing stressed-out soldiers from combat zones, and instead of providing counseling--the new army policy is to drug the troops," he notes.
In his latest book, "Medication Madness," Dr Breggin describes dozens of cases in which peace-loving citizens became suicidal, violent and psychotic from taking antidepressants.
As of July 19, 2009, on the website, "SSRI Stories - Antidepressant Nightmares," (http://www.ssristories.com), there were over 3,200 news stories, mainly criminal in nature, that have appeared in the media (newspapers, TV, scientific journals), or were part of testimony at FDA hearings on SSRIs in either 1991, 2004 or 2006, in which antidepressants are mentioned.
"Even these 3200+ documented stories only represent the tip of an iceberg since most stories do not make it into the media," the website points out.
Drugs Drugs and More Drugs
From 1996 to 2006, prescriptions for psychiatric drugs in the US increased by 73% among adults and 50% with children, according to a study in the May/June 2009 issue of the journal "Health Affairs."
Another study in the same issue, found spending for mental health care grew more than 30% over the same 10-year period, with almost all of the increase due to psychiatric drug costs.
According to the latest statistics from the Agency for Healthcare Research and Quality, the number of people treated for mental disorders increased from 19 million to 36 million between 1996 and 2006. "The overall treatment costs for mental disorders rose from $35 billion (in 2006 dollars) to nearly $58 billion, making it the costliest medical condition between 1996 and 2006," Medical News Today reported on August 5, 2009.
The "National Survey on Drug Use and Health," published by the Federal Substance Abuse and Mental Health Services Administration, in December, 2008, reported that in 2007, 10.9 percent of adults aged 18 or older, or an estimated 24.3 million persons, had experienced serious psychological distress in the past year, and 44.6% had received mental health services in the past year.
Of those adults who received services, 87% were given prescription medication, and 34.6% received drugs only. In contrast, only 10.7% received outpatient treatment alone with no medication.
The successful peddling of the new generation of psychiatric drugs, evidenced in the ten year period above, was accomplished through a suicide prevention racket. However, in 1996 there were 30,903 suicides in the US, and in 2006, there were 33,292, according to the National Center for Injury Prevention and Control.
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