Posts Tagged ‘FDA’

The Over-Prescribing of Psychoactive Drugs to Children: A Scourge of Our Times

Wednesday, September 1st, 2010

The Huffington Post

September 1, 2010

by Dr. Ronald Ricker and Dr. Venus Nicolino

Today, the administration of psychoactive drugs to children (6-17) is all too common and growing at an alarming rate. These drugs often cause the opposite of the intended effect, often condemning children to a life of misery and ill health. The prescription of these drugs is said to treat “chemical imbalances” which were said to cause ADHD, Depression and Bi-polar disorder. It turns out, however, that what we were calling “disease-causing chemical imbalances,” is simply incorrect . The sad irony is, the inappropriate use of these medications is in fact creating different chemical imbalances, which do cause mental disorders, many of which are both life-long and debilitating.

Furthermore, it is now clear that often we are diagnosing ordinary childhood and adolescent behavior as mental disorders (Wait, children are supposed to be bursting with energy? It’s normal for a teenager to be moody and aloof?). This diagnosing is not only based on this idea of “chemical imbalances,” but also a general and pervasive notion that every non-acceptable behavior is due to a mental illness. And last, but certainly not least, the prescribing of these medications by doctors is based on the disinformation provided them by the FDA, drug manufactures and often fraudulent studies, all in the name of making money, on the backs of our children.

In a recent lecture, respected journalist, writer and Nobel Prize Nominee, Robert Whitaker (PBS, Boston, June 15, 2010) highlighted not only the appallingly unscientific methodology used in the development, prescription and use of psychotropic drugs in school-aged children, but also how hopelessly corrupt and failed the systems that should be regulating the safety of medicines are in this country.

Unfortunately, many drug companies exist for one reason: to make money. As such, the people who run these companies have developed a worldview bereft of any more notion of ethics or morality than British Petroleum. Some drug companies’ success is not based on a drug’s usefulness or the safety of its products, but whether it makes money. The path to more money is simple: find new uses for their old drugs, invent new drugs and find new markets for both new and old drugs. Unfortunately, children are today’s newest market.

The FDA requires a “Successful Drug Trial” to approve new medications. “Trial” is often a misnomer, as the word implies some notion of impartiality and unknown outcome. These “trials” often are more like kangaroo courts. In one “trial,” in this case to prove the usefulness of Prozac, corruption and dishonesty were the rule. Children who responded to placebos were removed from the data, as were negative responders to the actual drug. This meant that the only children who were left in the study group were so-called “positive responders.” And, even then, the researchers and doctors, whose “research” funding was provided by the makers of Prozac, were the very ones to decide which subjects, if any, actually did respond “positively” to the drug. This, of course, is a massive conflict of interest. The doctors, researchers and drug companies all want the same thing — FDA approval and to make more money.

In a 2004 article published in perhaps the most prestigious British medical journal, Lancet, said the trial studies used to provide proof of the usefulness of anti-depressant drugs in children, were “nothing but fraudulent.” Following that assessment, all anti-depressants but Prozac were banned in the UK for use on children. (The fact that Prozac was not banned was based on very dubious, some say dishonest, research as documented above).

The true damage caused by the use of anti-depressant drugs like Paxil, Zoloft, Prozac, etc. (AKA of SSRI’s: Selective serotonin reuptake inhibitors) by school-aged children is only found by legitimate, longer studies, like those that continued from 17 months to six years. In one study, 25 percent of children who had been on SSRI’s for three years were re-diagnosed with the much more serious disorder of Bi-polar disease. This number increased to 50 percent after six years of SSRI use. Long-term use of new anti-psychotics may lead to even greater problems than the initial disease. Diabetes, morbid obesity and early death have all been linked to the use of these drugs. And, as written by us in a previous blog both short and long term use of stimulant drugs such as Adderall), have numerous serious side effects.

Read the rest of this article here: http://www.huffingtonpost.com/dr-ronald-ricker-and-dr-venus-nicolino/the-prescribing-of-psycho_b_665838.html

Note: To view all international drug regulatory warnings and studies on psychiatric drugs including those issued specifically for children,visit CCHR’s psychiatric drug search engine here: http://www.cchrint.org/psychdrugdangers/drug_warnings.php

Also see this video – Drugging Our Children: Side Effects – http://www.cchrint.org/videos/

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New study finds Anti-seizure drugs, increasingly prescribed for people labeled “bipolar,” induce suicide & death

Tuesday, August 31st, 2010

Natural News
By David Gutierrez
August 31, 2010

Popular anti-seizure drugs may seriously increase a patient’s risk of suicide and violent death, according to a study conducted by researchers from Brigham and Women’s Hospital and Harvard Medical School, and published in the Journal of the American Medical Association.

The drugs, known as anticonvulsants, were initially designed for the treatment of epilepsy but are now widely prescribed “off-label” for conditions such as bipolar disorder, migraine headaches and pain.

“We all know the range of uses of these medications is very, very wide,” researcher Elisabetta Patorno said.

The researchers examined the prescription and medical records of more than 300,000 people above the age of 14 who had been prescribed an anticonvulsant for the first time between July 2001 and December 2006.

All of the drugs, they found, significantly increased a patient’s risk of attempted or successful suicide, as well as violent death by other causes. During the course of the study, there were 801 attempted suicides, 26 successful suicides and 41 violent deaths.

“We found increased risk for suicidal acts beginning within the first 14 days after treatment initiation, opening the possibility that anticonvulsant medications could induce behavioral effects prior to the achievement of their full therapeutic effectiveness,” the researchers wrote.

Based on prior studies, the FDA ruled in 2008 that all anticonvulsants must carry labels warning that they double the risk of suicidal thoughts and actions. These older studies had not been able to determine if any drugs posed higher risks than others, however.

Read entire article here:  http://www.naturalnews.com/029614_suicide_anti-seizure_drugs.html

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The US Military’s Drugged Troops: Survey finds at least 1 in 6 service members is on some form of psychiatric drug

Tuesday, August 31st, 2010

Pharmalot
By Ed Silverman
August 31, 2010

The widely used Seroquel antipsychotic was never approved to treat post-traumatic stress disorder or the insomnia sometimes related to the afflication, but that hasn’t stopped the drug from being prescribed for that purpose by the US Department of Veteran Affairs and, in the process, becoming one of the VA’s biggest expenditures.

Since 2001, VA spending on Seroquel jumped more than 770 percent, while the number of patients covered by the VA increased just 34 percent, the Associated Press writes. Seroquel is now the VA’s second-biggest prescription drug expenditure since 2007, behind the Plavix bloodthinner. The agency spent $125.4 million last fiscal year on Seroquel, up from $14.4 million in 2001, and the growth in spending outpaces the growth in personnel who have gone through the military during that time.

Meanwile, thousands of soldiers have taken the med, and several soldiers and veterans have died, raising concerns among some military families the government is not being forthcoming about the risks, the AP writes, noting that they want Congress to investigate. The trend, by the way, is not confined to Seroquel. An investigation earlier this year found that at least one in six service members is on some form of psychiatric drug (background).

According to the VA, Seroquel is only prescribed as a third or fourth option for patients with difficult-to-treat insomnia stemming from PTSD, the AP writes. And the US Defense Department’s deputy director for force health protection, Michael Kilpatrick, tells the news service that the government has not seen any increase in dangerous side effects from Seroquel and other drugs.

Read entire article:  http://www.pharmalot.com/2010/08/the-military-post-traumatic-stress-and-seroquel/

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Antipsychotic Drugs, U.S. Vets & Sudden Deaths: Families Call on Congress to Investigate

Monday, August 30th, 2010

Note from CCHR:  Our psychiatric drug database lists FDA advisory warnings on Seroquel causing sudden death, death, suicide, suicidal ideation, heart problems, as well as a Journal of Toxicology report dating back to 2001, warning of antipsychotic drugs causing stroke, cerebrovascular events (such as loss of brain function) seizures, toxicity, confusion and coma. Simply keyword search Seroquel here (or for a broader search, newer antipsychotics)  http://www.cchrint.org/psychdrugdangers/drug_warnings.php

Questions loom over drug given to sleepless vets

By MATTHEW PERRONE (AP) – 1 hour ago

WASHINGTON — Andrew White returned from a nine-month tour in Iraq beset with signs of post-traumatic stress disorder: insomnia, nightmares, constant restlessness. Doctors tried to ease his symptoms using three psychiatric drugs, including a potent anti-psychotic called Seroquel.

Thousands of soldiers suffering from PTSD have received the same medication over the last nine years, helping to make Seroquel one of the Veteran Affairs Department’s top drug expenditures and the No. 5 best-selling drug in the nation.

Several soldiers and veterans have died while taking the pills, raising concerns among some military families that the government is not being up front about the drug’s risks. They want Congress to investigate.

In White’s case, the nightmares persisted. So doctors recommended progressively larger doses of Seroquel. At one point, the 23-year-old Marine corporal was prescribed more than 1,600 milligrams per day — more than double the maximum dose recommended for schizophrenia patients.

A short time later, White died in his sleep.

“He was told if he had trouble sleeping he could take another (Seroquel) pill,” said his father, Stan White, a retired high school principal.

An investigation by the Veterans Affairs Department concluded that White died from a rare drug interaction. He was also taking an antidepressant and an anti-anxiety pill, as well as a painkiller for which he did not have a prescription. Inspectors concluded he received the “standard of care” for his condition.

It’s unclear how many soldiers have died while taking Seroquel, or if the drug definitely contributed to the deaths. White has confirmed at least a half-dozen deaths among soldiers on Seroquel, and he believes there may be many others.

Spending for Seroquel by the government’s military medical systems has increased more than sevenfold since the start of the war in Afghanistan in 2001, according to documents obtained by The Associated Press under the Freedom of Information Act. That by far outpaces the growth in personnel who have gone through the system in that time.

Seroquel is approved to treat schizophrenia, bipolar disorder and depression, but it has not been endorsed by the Food and Drug Administration as a treatment for insomnia. However, psychiatrists are permitted to prescribe approved drugs for other uses in a common practice known as “off-label” prescribing.

But the drug’s potential side effects, including diabetes, weight gain and uncontrollable muscle spasms, have resulted in thousands of lawsuits. While on Seroquel, White gained 40 pounds and experienced slurred speech, disorientation and tremors — all known side effects.

Last year, researchers at Vanderbilt University published a study suggesting a new risk: sudden heart failure.

The study in the January 2009 edition of the New England Journal of Medicine found that there were three cardiac deaths per year for every 1,000 patients taking anti-psychotic drugs like Seroquel. Seroquel’s unique sedative effect sets it apart from others in its class as the top choice for treating insomnia and anxiety.

AstraZeneca PLC, maker of the drug, said it is reviewing the study. The FDA is conducting its own review, citing the limited scope of the Vanderbilt study.

According to the Veterans Affairs Department, Seroquel is only prescribed as a third or fourth option for patients with difficult-to-treat insomnia stemming from PTSD.

Marine Cpl. Chad Oligschlaeger, 21, was being treated for PTSD when he died in his sleep at Camp Pendleton, Calif., in May 2008. Oligschlaeger was taking six types of medication, including Seroquel, to deal with anxiety and nightmares that followed two tours of duty in Iraq.

The military medical examiner attributed the death to “multiple drug toxicity,” indicating that Oligschlaeger, too, died from a drug interaction. Because of the complex reactions between various drugs, medical examiners do not attribute such deaths to any one medication.

After consulting with physicians, parents Eric and Julie Oligschlaeger now believe their son died of sudden cardiac arrest caused by Seroquel.

“Right now, I’m so angry, and I believe someone needs to be held accountable,” said Julie Oligschlaeger, of Austin, Texas. “The protocol absolutely has to change.”

The Defense Department’s deputy director for force health protection, Dr. Michael Kilpatrick, said the government has not seen any increase in dangerous side effects from Seroquel and other drugs.

Physicians interviewed by the AP said they began prescribing Seroquel because it was the only drug that offered relief from the nightmares and anxiety of PTSD.

“By accident, some people were giving them Seroquel for anxiety or depression, and the veterans said, ‘This is the first time I have slept six or seven hours straight all night. Please give me more of that.’ And the word spread,” said Dr. Henry Nasrallah of the University of Cincinnati, who has treated PTSD patients for more than 25 years.

Most of the soldiers and veterans seeking treatment for PTSD do so at hospitals run by the VA or the Defense Department.

The VA’s spending on Seroquel has increased more than 770 percent since 2001. In that same time frame, the number of patients covered by the VA increased just 34 percent.

Seroquel has been the VA’s second-biggest prescription drug expenditure since 2007, behind the blood-thinner Plavix. The agency spent $125.4 million last fiscal year on Seroquel, up from $14.4 million in 2001.

Spending on Seroquel by the Department of Defense, has increased nearly 700 percent since 2001, to $8.6 million last year, according to purchase records.

Read the rest of this article here: http://www.google.com/hostednews/ap/article/ALeqM5iPPHBQ6w28w4kTXzANGm6kCzPN1gD9HTRUQ80

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New Review of FDA antidepressant drug trials suggests antidepressants only “marginally better” than placebo – Ineffectiveness of antidepressants called “jaw-dropping”

Tuesday, August 24th, 2010

Medscape
By Deborah Brauser
August 24, 2010

A new review of 4 meta-analyses of efficacy trials submitted to the US Food and Drug Administration (FDA) suggests that antidepressants are only “marginally efficacious” compared with placebo and “document profound publication bias that inflates their apparent efficacy.”

In addition, when the researchers also analyzed the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial, “the largest antidepressant effectiveness trial ever conducted,” they found that “the effectiveness of antidepressant therapies was probably even lower than the modest one reported…with an apparent progressively increasing dropout rate across each study phase.

“We found that out of the 4041 patients initially started on the SSRI [selective serotonin reuptake inhibitor] citalopram in the STAR*D study, and after 4 trials, only 108 patients had a remission and did not either have a relapse and/or dropped out by the end of 12 months of continuing care,” lead study author Ed Pigott, PhD, a psychologist with NeuroAdvantage LLC in Clarksville, Maryland, told Medscape Medical News.

Sustained Benefit “Jaw Dropping”

“In other words, if you’re trying to look at sustained benefit, you’re only looking at 2.7%, which is a pretty jaw-dropping number,” added Dr. Pigott.

Overall, “the reviewed findings argue for a reappraisal of the current recommended standard of care of depression,” write the study authors.

“I believe there are likely some people where [antidepressants] are truly beneficial beyond placebo. The problem right now is that we simply have no way of knowing who those people are,” noted Dr. Pigott. “My hope is that this kind of analysis creates ‘more oxygen’ for looking at other kinds of approaches to treatment.”

The study was published in the August issue of Psychotherapy and Psychosomatics.

When registering new drug application trials with the FDA, drug companies must prespecify the primary and secondary outcome measures, the investigators report. “Prespecification is essential to ensure the integrity of a trial and enables the discovery of when investigators selectively publish the measures that show the outcome the sponsors prefer following data collection and analysis, a form of researcher bias known as HARKing or ‘hypothesizing after the results are known’,” they write.

For this article, Dr. Pigott and his team reviewed the following meta-analyses:

  • 1. Rising and colleagues (reviewed all efficacy trials for new drugs between 2001 and 2002)
  • 2. Turner and colleagues (reviewed 74 past trials of 12 antidepressants)
  • 3. Kirsch and colleagues, 2002 (reviewed 47 trials of 6 FDA-approved antidepressants)
  • 4. Kirsch and colleagues, 2008 (reviewed depression severity and efficacy in 35 trials)

The researchers also sought to reevaluate the methods and findings of STAR*D, a randomized, controlled trial of patients with depression. Its prespecified primary outcome measure was the Hamilton Rating Scale for Depression (HRSD), whereas the Inventory of Depressive Symptomatology–Clinician-Rated (IDS-C30) was secondary for identifying remitted and responder patients.

“STAR*D was designed to identify the best next-step treatment for the many patients who fail to get adequate relief from their initial SSRI trial,” the study authors write.

“When I first read about STAR*D’s step 1 phase, it just seemed biased to me,” explained Dr. Pigott. “I thought of it as the ‘tag, you’re healed’ research design. Patients who were scored as having a remission during the first 4 to 6 weeks of up to 14 weeks of acute care treatment were counted as remitted, taken out of the subject pool, and put into the follow-up care phase. In other words, they didn’t have the ability to have a relapse. But as most people know, depression ebbs and flows.

“So what made me want to continue to follow this study was that it became clear that the only way that people were really going to be able to evaluate the antidepressants’ effectiveness was to wait for the publication of the follow-up findings,” he added. “After their major final summary study was published, I felt as though the results weren’t really being portrayed in a manner that was consistent with the study’s prespecified criteria.”

High Dropout, Low Remission Rates

In addition to reporting on low efficacy of antidepressants compared with placebo, the 4 meta-analyses “also document a second form of bias in which researchers fail to report the negative results for the prespecified primary outcome measure submitted to the FDA, while highlighting in published studies positive results from a secondary or even a new measure, as though it was their primary measure of interest,” the investigators write.

For example, they note, the meta-analysis from Rising and colleagues found that studies with favorable outcomes were almost 5 times more likely to be published and that over 26% of primary outcome measures were left out of journal articles. Turner and colleagues found that antidepressant studies were 16 times more likely to be published if favorable compared with those with unfavorable outcomes.

In reanalyzing the STAR*D methods, the researchers found that the high dropout rate resulted in frequently missed exit HRSD and IDS-C30 interviews. So the revised statistical analytical plan dropped the IDS-30 for the Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR), which was given at each visit.

“Even with the extraordinary care of STAR*D, only about one fourth of patients achieved remission in step 1 [and] the dropout rate was slightly larger than the success rate,” the study authors write. Steps 2 through 4 also each showed increasingly fewer success rates and larger dropout rates.

Of the 4041 patients at the study’s initiation, 370 (9.2%) dropped out within 2 weeks, and only 1854 patients (45.9%) obtained remission “using the lenient QIDS-SR criteria.” Of these, 670 dropped out within a month of their remission, and only 108 “survived continuing care” and underwent the final assessment.

Dr. Pigott described reanalyzing STAR*D as being “a bit like an onion. Each time we thought we understood the results, we found another layer. It wasn’t until about a year and a half ago that we discovered that the secondary outcome measure, the QIDS-SR, was not originally supposed to be used as a research measure. What was particularly disconcerting to me was that in their summary article, they basically used the QIDS-SR to report all of the results, which clearly had an inflationary effect on the outcome.”

He also noted that STAR*D did not have a placebo design. “Because the patients knew they were receiving the active medication, I would have expected a higher remission rate than what you’d find normally in a placebo-controlled study.

“The inescapable conclusion from the STAR*D results is that we need to explore more seriously other forms of treatment (and combination thereof) that may be more effective. This effort will require developing new service delivery models to ensure that as treatments are identified, they are widely implemented,” the investigators conclude.

Read entire article here:  http://www.medscape.com/viewarticle/727323
(Free registration required)

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Glaxo Still Haunted by Faked Paxil Studies in Kids; Crooked psychiatrist expected to plead guilty to criminal charges today

Thursday, August 19th, 2010

“The use of Paxil in children became extremely controversial after it emerged that GSK knew for 15 years, but didn’t tell anyone until 2006, that the drug may carry a risk for suicide. The drug now carries a black-box warning for suicide risk in children.”

BNET
By Jim Edwards
August 19, 2010

A crooked doctor who faked data in a GlaxoSmithKline (GSK) study of the antidepressant Paxil in children pled guilty to criminal charges today, causing groans among GSK’s senior management as the company hopes to fend off a different criminal investigation into whether it manipulated clinical data on its diabetes drug, Avandia. She was sentenced to 13 months in prison.

The two cases are technically completely separate, but they’re both about data manipulation. GSK has been accused of sitting on data showing risks on both drugs; and the FDA previously shut down one of GSK’s factories where both drugs were made.

Thus, the expected guilty plea of Dr. Maria Carmen Palazzo today is a reminder to managers everywhere that cutting ethical corners can cause unwanted chickens to return to their roosts, even years later.

Palazzo was indicted in 2007 on 40 counts of defrauding Medicare and Medicaid at her New Orleans clinic, and 15 counts of conducting fraudulent clinical trials. The charges followed an FDA accusation that she had enrolled 26 children in studies of Paxil for obsessive-compulsive disorder and major depressive disorder. She included children in the trial — which was given the cutesey nickname “Kiddie-Sads-Present and Lifetime” — who did not have the diagnoses being studied. GSK gave her more than $5,000 for each child she enrolled.

At trial, Palazzo was convicted on 39 counts of healthcare fraud and was sentenced to 87 months in prison and forfeiture of $655,000. The clinical trial fraud charges were thrown out, but prosecutors appealed and won a ruling this year reinstating those charges. That appears to be the reason Palazzo is reappearing in court to make a plea.

The use of Paxil in children became extremely controversial after it emerged that GSK knew for 15 years, but didn’t tell anyone until 2006, that the drug may carry a risk for suicide. The drug now carries a black-box warning for suicide risk in children.

Read entire article here:  http://www.bnet.com/blog/drug-business/10-years-later-glaxo-still-haunted-by-faked-studies-of-paxil-in-kids/5545

Read more about Palazzo here:
http://medicaresmostwanted.blogspot.com/2007/06/dr-maria-carmen-palazzo-has-been.html

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Following 7-year-old’s psychiatric drug-induced suicide—Florida bans foster children from clinical drug trials

Wednesday, August 11th, 2010

Education News
By Pareesha Narang
August 9, 2010

Sixteen months after 7-year-old Gabriel Myers committed suicide while taking psychotropic drugs, the state of Florida has banned allowing any children in the state’s custody from participating in clinical drug trials.

It is unclear if Gabriel was involved in any clinical trials. The doctor who prescribed the medicines to him was conducting clinical trials involving psychotropic drops and the Food and Drug Administration sent him a warning letter earlier this year about overdosing children who were involved in those trials.

The Florida ban was imposed  after the state tried to find out from the FDA if Gabriel or any other foster care child in Florida was a participant in such trials, and the FDA said it could not disclose such information and that mostly they know participants by only coded identifiers.

Though Florida officials had suggested that, under such circumstances, the Federal Food and Drug Administration ban all foster care children from participating in such trials, the agency refused, saying the children might benefit from the drugs.

In a letter last month,  George Sheldon, secretary of the state’s Department of Children and Families (DCF), announced that regardless of the FDA’s stance the state, using “administrative procedures,” was precluding children in state care from participating in such trials.

“Children who come into our care are often the victims of abuse, neglect, and abandonment,” Sheldon said in the letter. “It is therefore imperative that the state do all in its power to stabilize their environment, to protect them from further trauma, and to foster their successful growth into adulthood.”…

Before he hanged himself in his foster home, Gabriel had been taking different drugs for a variety of psychological problems – and some of the drugs were not approved for use in children.  Some of these drugs, including Lexapro, Vyvanse and Symbyax, had “black box” warnings cautioning dangerous side effects such as suicidal thoughts.

Read entire article here:  http://www.educationnews.org/educationnewstoday/97911.html

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“The widespread use of antidepressants by soldiers could be contributing to the Army’s escalating suicide rate”

Tuesday, August 3rd, 2010

USA Today
By Lou A. Murphy
August 3, 2010

The widespread use of antidepressants by soldiers could be contributing to the Army’s escalating suicide rate (“Leaders criticized in Army suicides,” News, Friday).

Antidepressants can increase the risk of suicide or suicidal behavior in certain population groups. The warning required by the Food and Drug Administration on antidepressants states that children and young adults up to age 25 are particularly at risk.

In 2008, Time magazine published the article “America’s Medicated Army.” At that time, it was estimated that 12% of combat troops in Iraq and 17% in Afghanistan were taking antidepressants or sleeping pills.

Antidepressants alter the brain in ways not fully understood.

Read entire article here:  http://www.usatoday.com/news/opinion/letters/2010-08-04-letters04_ST2_N.htm

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Long Awaited Army Report on Suicides Ignores Role of Suicide-Causing Drugs such as Antidepressants/Antipsychotics

Monday, August 2nd, 2010

OpEdNews
By Martha Rosenberg
August 1, 2010

Why are troops killing themselves?

The long awaited Army report, “Health Promotion, Risk Reduction, Suicide Prevention” considers the economy, the stress of nine years of war, family dislocations, repeated moves, repeated deployments, troops’ risk-taking personalities, waived entrance standards and many aspects of Army culture.

What it barely considers is the suicide-inked antidepressants, antipsychotics and antiseizure drugs whose use exactly parallels the increase in US troop suicides since 2005.

In the report Chief of Staff General Peter W. Chiarelli acknowledges antidepressant risks, saying there’s “fair quality evidence that second generation antidepressants (mostly SSRI) increase suicidal behavior in adults aged 18 to 29 years” but adds that “other research evidence shows the benefit of antidepressant use”.

And nowhere does he acknowledge the suicide potential of antiseizure drugs so widely used for pain and as “mood stabilizers” by troops even though the FDA mandated suicide warnings on Lyrica, Topamaz, Depakote, Lamictal, Tegretol, Depakene, Klonopin and 16 others in 2008.

(Lamictal also has the distinction of wasting more taxpayer money than any other drug according to a July American Enterprise Institute report. Medicaid spent an unnecessary $51 million on Lamictal instead of buying a generic last year, thanks to GSK salesmen. You go, guys,)

When asked by NPR’s Robert Siegel if the high number of medicated troops contributed to suicide, Gen. Chiarelli said, “The good thing about those numbers is…the prescriptions were all made by a doctor.” Asked why troops who had not even deployed were among the suicides, Chiarelli said there were other stressors involved.

In June Marine Times reported 32 deaths on prescription drugs in Warrior Transition Units (WTUs) since 2007 and said an internal review “found the biggest risk factor may be putting a soldier on numerous drugs simultaneously, a practice known as polypharmacy.”

But instead of citing dangerous drugs and drug cocktails for turning troops suicidal (and accident prone and at risk of death from unsafe combinations) the Army report cites troops’ illicit use of them along with street drugs. (The word “illicit” appears 150 times in the Army report and “psychiatrist” appears twice.)

No, it’s not the 8,000 urine samples in 2009 which showed prescription drug traces according to the Army report — it’s the fact that 21 percent of the drugs were “illicit.”

No wonder the revised suicide report form suggested by the Army report doesn’t even have a box to enter “adverse reactions to drug or drug combinations.” Instead, it has a box that asks how long before a suicide a patient was “compliant” with the prescription. Was the medication “taken as prescribed? Skipped?” Taken “In excess of prescription? In different manner (e.g., crushed instead of in capsule)?”

Read entire article here:  http://www.opednews.com/articles/Army-Suicide-Report-Ignore-by-Martha-Rosenberg-100801-596.html?show=votes

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Incredibly, FDA urged Florida not to bar foster kids from drug trials, arguing “benefits” can outweigh risks.

Monday, July 26th, 2010

HeraldTribune.com
By Tom Lyons
July 25, 2010

Apparently the U.S. Food and Drug Administration had at least heard about the suicide of Gabriel Myers.

The real reason: He was 7 years old.

Whatever else might have helped lead such a young child toward ending his life, one detail was impossible to ignore: The boy was being treated with three different psychotropic medications.

Medications of that sort make some people more depressed or even suicidal, and their effects when combined are harder to predict, especially in children.

So DCF did a quick check on how many foster children were being given such drugs. Troubling facts emerged.

Not only was the percentage high, it was not really known. And, in more than a third of known cases, required approval permission documents were missing.

DCF Secretary George Sheldon quickly acknowledged the problem and started a study group to learn more and give advice. And a year later, the picture is at least more clear. Very few files lack required documentation now. And when I asked for the most current numbers, they were available, and somewhat lower. In the Sarasota-Manatee-DeSoto county region, 11 percent of foster children are given psychotropic meds. Statewide, it is 13 percent.

Some critics insist too many foster parents, lacking the skill or patience to work with troubled children who arrive as strangers, are still too quick to see medication as the way to curb problem behavior or just keep foster children quiet, no matter the side effects.

But whatever the truth of that, the study group recommended some good changes, and one made sense immediately, I thought: Ban the use of foster kids in drug trials.

Drugs helpful to some adults can react differently in children, who may suffer more extreme and unintended side effects. And so, clinical trials on children are needed, but it it is a scary field of study. The most alert and caring parents are key for monitoring the children during such trials, I would think.

So I was surprised at the FDA’s response when Sheldon wrote to ask how many Florida foster children were involved in drug studies as they bounce from foster family to foster family.

Jill Hartzler, an associate FDA commissioner, responded that the FDA — which oversees the studies to make sure children’s involvement is approved and understood by parents or guardians — didn’t have an exact number. Or even an estimate. The FDA, in fact, doesn’t have the slightest idea how many Florida foster kids are or have been involved in its drug studies.

But that wasn’t the weirdest part. Hartzler and the FDA also urged that Florida not bar foster kids from drug trials, arguing that benefits can outweigh risks.

I’m happy to say Sheldon is not taking that advice. But as he explains his reasoning more tactfully than does Richard Wexler of the National Coalition for Child Protection Reform, I’ll quote Wexler, who says the FDA’s position is absurd.

Myers’ death by hanging happened in a Florida foster home last year, but that wasn’t the main reason it triggered a major reaction at Florida’s Department of Children and Families.

Read entire article here: http://www.heraldtribune.com/article/20100725/COLUMNIST/7251032/2055/NEWS?p=1&tc=pg

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