Posts Tagged ‘Antidepressant’

New antidepressant warning – Prozac and other drugs raise risk of heart attack and stroke

Wednesday, April 6th, 2011

The effect of antidepressants on arteries was separate and independent from any diagnoses of 'depression'

Note from CCHR: One of the most common tricks of the psychiatric/pharmaceutical industry is whenever a valid study shows psychiatric drugs as the cause of medical damage to patients,  such as heart attack, stroke, sudden death, diabetes etc, they will quickly spit out press releases  saying their studies show ‘depression’ or ‘bipolar’ or some ‘psychiatric disorder’ is the actual cause.   You’ll start seeing  headlines such as Depressed patients more likely to have heart attacks or Patients with Bipolar at risk for stroke,  or Patients with Schizophrenia Prone to Develop Diabetes….  Now that’s a nifty little trick that psycho/pharma does,  but the fact is  those studies are bogus.   And here’s how you can tell;  Psychiatrists have never proven that people diagnosed “schizophrenic” or “bipolar” or “depressed”   were more prone to develop any medical or life threatening condition – that weren’t already on drugs, or who had been on drugs. Period.   They  just omit that one key fact from all their propaganda studies.  What we found significant about this latest study is that the authors actually address this very point in preemptively stating their findings were separate and independent from any diagnoses of ‘depression.’  — CCHR


NaturalNews – April 6, 2011

by Sherry Baker, Health Sciences Editor

Millions of Americans take antidepressant drugs — most are Prozac and related antidepressant medications in the class known as selective serotonin reuptake inhibitors (SSRIs). A gigantic money maker for the drug giants, the SSRIs bring in billions to Big Pharma a year. They are promoted and prescribed as safe treatments for depression, anxiety and even premenstrual tension — despite a long list of possible side effects ranging from sexual dysfunction and headaches to dizziness and suicide.

Now you can add another reason to think twice before agreeing to take antidepressants.  At the American College of Cardiology meeting in New Orleans, Emory University School of Medicine scientists have just announced they’ve discovered that the drugs are linked to thicker arteries.  The significance? The findings  strongly suggest Prozac and similar meds could raise the risk of heart disease and stroke.

Depression is sometimes listed as a risk for heart disease. But that was not the explanation for the Emory findings, according to Amit Shah, MD, a cardiology fellow at Emory University School of Medicine. Instead, Dr. Shah said in a press statement, the data indicates the effect of antidepressant use on arteries that was revealed by the study is separate and independent from depression.

Dr. Shah worked with Viola Vaccarino, MD, PhD, chair of the Department of Epidemiology at Emory`s Rollins School of Public Health, on the groundbreaking study which involved 513 middle-aged male twins who both served in the U.S. military during the Vietnam War. Twins are genetically the same but may be different when it comes to other risk factors such as diet, smoking and exercise, so studying them is a good way to factor out the effects of genetics.

The Emory  research team measured the thickness of the lining of the main arteries in the neck (carotid intima-media thickness, or IMT) by ultrasound. The results showed that among the 59 pairs of twins where only one brother took antidepressants, the one taking the medication had a significantly higher carotid IMT — even when heart disease risk factors such as smoking were taken into account. In fact, the thicker arteries were found in antidepressant users whether or not they had ever had a stroke or heart attack in the past.

In the new study, the scientists documented higher carotid IMT in research subjects who used SSRIs (60 percent of those who took antidepressants) as well as those who used other kinds of antidepressants. Curiously, higher levels of depressive symptoms were associated with thicker arteries only in those taking antidepressants — so the Big Pharma meds themselves seem to be the key to this disturbing change in the cardiovascular system.

“One of the strongest and best-studied factors that thickens someone`s arteries is age, and that happens at around 10 microns per year,” Dr. Shah stated. “In our study, users of antidepressants see an average 40 micron increase in IMT, so their carotid arteries are in effect four years older.”

How could antidepressants have an effect on blood vessels? The Emory scientists think it may result from changes in serotonin. The SSRIs are the most commonly prescribed antidepressants and they are known to increase the level of serotonin in the brain. Other kinds of antidepressant drugs also impact serotonin levels. And, although serotonin is a chemical that helps some brain cells communicate, what is often ignored in the hyping of SSRIs is that serotonin functions outside the brain, too.

Actually, most of the body`s serotonin is found outside the brain, especially in the intestines, Dr. Shah stated in a media release. What`s more, serotonin is stored by platelets, the cells that promote blood clotting; the chemical is released when platelets bind to a clot. The chemical can, in fact, act in a variety of ways and either constrict or relax blood vessels, depending on whether the vessels are damaged or not.

“I think we have to keep an open mind about the effects of antidepressants on neurochemicals like serotonin in places outside the brain, such as the vasculature. The body often compensates over time for drugs` immediate effects,” Dr. Shah said.

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Antidepressant shocker: Popular drugs linked to heart attack

Monday, April 4th, 2011

CBS News – April 4, 2011

New research links the popular drugs to increased risk for cardiovascular disease.

(Credit: istockphoto) CBS

In a first-of-its-kind study that involved more than 500 middle-aged male twins, researchers found that those who took antidepressants of any kind were more likely to have a thickening of the inner linings of arteries in the neck. Greater “intima-media thickness” is associated with heart attack and stroke, according to a written statement issued by the American College of Cardiology.

Previous research has linked cardiovascular disease risk to depression but not to antidepressants.

“There is a clear association between increased intima-media thickness and taking an antidepressant, and this trend is even stronger when we look at people who are on these medications and are more depressed,” lead investigator Dr. Amit Shah, a cardiology fellow at Emory University in Atlanta, said in the statement. “Because we didn’t see an association between depression itself and a thickening of the carotid artery, it strengthens the argument that it is more likely the antidepressants than the actual depression that could be behind the association.”

Dr. Shah said the connection between heart health and antidepressants is poorly understood, adding that the medications may increase levels of chemical messengers like serotonin and norepineprine – which, in turn, might cause blood vessels to constrict or tighten, boosting blood pressure, a risk factor for atherosclerosis.

At a press conference held after results of the study were announced, Dr. Shah said antidepressant use appeared to “age” carotid arteries by the equivalent of about four years, Medpage Today reported.

Dr. Janet Wright, senior vice president for science and quality at the American College of Cardiology, told CBS that she was surprised by the finding but wasn’t worried that antidepressant use might be a significant contributor to the nation’s heart attack and stroke burden.

Read the rest of the article here: http://www.cbsnews.com/8301-504763_162-20050390-10391704.html

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Dealing With Depression Naturally

Tuesday, March 8th, 2011

FOX News, March 8, 2011
by Chris Kilham

If your life is making you unhappy, then making positive changes may be the very best prescription of all

According to a study published in the Archives of General Psychiatry, approximately 10 percent of Americans are taking antidepressant medications.

This means that over 31 million Americans are gobbling Prozac, Zoloft, Celexa, Elavil, Norpramin, Luvox, Paxil, Wellbutrin and other antidepressant psychiatric drugs like M & M’s. This drug use accounts for billions of dollars in pharmaceutical sales annually (9.6 U.S. billion in 2008).

Yet according to a landmark study published in the Journal of the American Medical Association, antidepressant medications work – as well as placebos and not more. In other words, people in depression studies who are given sugar pills instead of antidepressant drugs do as well as the group who gets the drugs.

Before you ask yourself whether you should simply take a Tic Tac instead of a Paxil, there is more disheartening news about these drugs. Many Americans are taking antidepressant medications instead of changing their own behavior or life circumstances. According to Maryland medical doctor Ronald Dworkin, “Doctors are now medicating unhappiness. Too many people take drugs when they really need to be making changes in their lives.” If you are beating your nose with a hammer, do you stop hitting yourself, or do you continue, and take a pain pill?

Digging more deeply into the mystery of antidepressants, George Washington University health analyst Thomas Moore examined unpublished studies conducted by drug companies  with various antidepressants. Approximately 40 percent of the studies conducted on this class of drugs have never been published — because in those 40 percent of studies, antidepressants do not demonstrate effectiveness. In other words, in the unpublished studies, they didn’t work. In even further research, Irving Kirsch of the University of Connecticut looked at results from varying doses of antidepressants. The difference in effectiveness between small doses and large doses was virtually non-existent.

It gets even gloomier. A U.S. government study released in 2006 showed that fewer than 50 percent of people become symptom-free on antidepressants, even after trying two different medications. Many who do respond to medication slip back into major depression within a short while, despite sticking with drug treatment. And then there are the “side effects,” which are really effects pure and simple. The most common effects of antidepressant drugs include nausea, insomnia, anxiety, restlessness, loss of sex drive, dizziness, weight gain, tremors, sweating, sleepiness, fatigue, dry mouth,  diarrhea, constipation and headaches. People over 65 are at extra risk of falls, fractures and bone loss, newborns of mothers on SSRI antidepressants can go through drug withdrawal, and among teens, the use of antidepressants can increase suicidal tendencies. Any sober assessment of these effects points to the fact that there is something terribly wrong with this entire class of drugs. Remember what Hippocrates said “First of all, do no harm.”

Many intangibles add up to either a happy life or a sad one. Do you spend enough time with your family? Your friends? Do you relax? Do you do things you love? Do you enjoy your work? If you answer no to these questions, you probably have good cause to feel depressed. But popping a pill won’t help if you are not living in a fulfilled way.

What about natural approaches to depression? A number of doctors believe that nutritional deficiencies play a key role in many cases of depression. After all, brain chemistry depends on nutrient intake for proper balance. Really, it’s no surprise that a junk food-eating culture would be increasingly mentally out of sorts. No brain food means poor brain function. This is where omega 3 fatty acids come in, notably DHA, which is essential for proper brain function. These essential fats greatly enhance brain health and mood. The best way to get them is to eat fresh seafood, especially wild salmon. But omega 3 fatty acid supplements from fish oil are also available.

According to the National Institutes of Mental Health, anxiety and depression often go hand in hand. Many people find that they can relieve or reduce anxiety by meditating. There are many ways to meditate. By setting aside time every day, you can calm your body and mind, change your brainwaves, and alter your mood for the better.

Regular exercise is also associated with improved mood. Exercise enhances circulation, modifies brain chemistry for the better, enhances overall energy, improves vitality and contributes greatly to well being. You don’t need to go to a gym, either. Just get outside and walk. Do so briskly for at least half an hour each day, and notice how much better you feel.

On the herbal side, Rhodiola rosea is the big antidepressant. Many forward-thinking psychiatrists have turned to Rhodiola as a first line of treatment, instead of pharmaceuticals. Psychiatrists Richard Brown and Patricia Gerbarg in New York are ardent advocates of Rhodiola for depression and mood enhancement, and have written profusely about it. Dr Hyla Cass of UCLA also is an advocate. Meanwhile, dozens of studies demonstrate significant improvement in all parameters of mental function with Rhodiola rosea. My favorite brands? Rhodiola Energy by Enzymatic Therapy, and Rapid Rhodiola by EuroPharma.

If your life is making you unhappy, then making positive changes may be the very best prescription of all. Many people are so buried by work and stress that they forget to take time to live, to enjoy themselves and to savor life itself. I remember once meeting a psychiatrist at one of my talks. He was retired, and I was deeply impressed by what he shared.

“I practiced psychiatry for twenty-eight years,” he said. “And I never once gave anybody a prescription.” I asked him what he did for his patients instead.

“I talked with them,” he replied. As Rabbi Earl Grollman, author of several books on grief says, “the mentionable is manageable.” Maybe talking is a good place to start.

Chris Kilham is a medicine hunter who researches natural remedies all over the world, from the Amazon to Siberia. He teaches ethnobotany at the University of Massachusetts Amherst, where he is Explorer In Residence. Chris advises herbal, cosmetic and pharmaceutical companies and is a regular guest on radio and TV programs worldwide. His field research is largely sponsored by Naturex of Avignon, France. Read more at www.MedicineHunter.com

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Concern over high medication rate among foster kids—Review of kids’ psych drugs urged

Monday, February 21st, 2011

The Atlanta Journal Constitution, February 21, 2011

By April Hunt

photo credit: Bita Honarvar — While in foster care, Giovan Bazan, now 20, says he was put on Ritalin, anti-depressants and sleeping pills. At 18, he elected to stop all drugs, and says he learned he didn't need them.

Giovan Bazan was 6 when a doctor first gave him medicine to treat his diagnosis of hyperactivity.

Bazan admits he was unruly at the time. Perhaps it was because the only parent he had ever known, his foster mother since he was an infant, had just died.

No one asked about that. Nor did anyone check years later to see that he was on a double dose of Ritalin when another physician, seeing a boy so mellowed out that he barely reacted, prescribed an antidepressant. “They start you on one thing for a problem, then the side effects mean you need a new medicine,” Bazan said. “As a foster kid, I’d go between all these doctors, caseworkers, therapists, and [it] seemed like every time there was a new drug to try me on.”

When he turned 18, Bazan elected to stop all medications. It turned out he didn’t need any of them.

Now, the Georgia House is weighing an idea to better track the psychotropic drugs foster children take at a far greater rate than other kids.

House Bill 23 hits a rare political sweet spot. The proposal to create an independent clinic review of the drugs foster children are given has support from Democrats and Republicans because of its efforts to protect the vulnerable — and projections that it will save the state millions of dollars. The state spends $7.87 million per year in Medicaid funds on those mind-altering drugs for foster kids. “This is an idea I’m very open and willing to have a discussion about,” said Speaker David Ralston, R-Blue Ridge, adding his main concern is the cost of the review.

The issue is a national one. Only half of state child welfare systems — not including Georgia — have a policy to review usage of mind-altering drugs, even though as many as 52 percent of kids in foster care are taking them.

By comparison, about 4 percent of the general youth population is on the medications, according to a 2010 Tufts Clinical and Translational Science Institute study.

“These drugs are not something you take like an aspirin,” said state Rep. Judy Manning, a Marietta Republican and chairwoman of the House Children & Youth Committee who is co-sponsoring HB 23 with Rep. Mary Margaret Oliver, D-Decatur.

“We want to monitor it and make sure the treatment is correct,” she said. “You don’t want a tragedy.”

Lack of oversight can prove deadly. Gabriel Myers, a 7-year-old foster child in Florida, hanged himself in 2009 while taking three powerful psychotropic medications, none of which had been approved for use in children.

There have been no similar high-profile cases in Georgia. Still, one in three foster 
children on Medicaid was 
prescribed mind-altering psychotropic drugs last year, according to a January report from the state Department of Community Health. More than half of them were on a daily cocktail of more than two of the drugs — some of which lack approval for treatment in children.

Oliver argues that both the cost and number of foster children on such drugs will drop if her proposal succeeds.

Her plan calls for an independent review to kick in on red-flag cases in the system, such as when a very young child is prescribed drugs for mental health or when a youngster is on multiple medications at once.

It would be up to the Human Services or Behavioral Health departments to decide what would flag cases and how to best manage the independent psychiatrists who would monitor them.

Oliver said private foundations have expressed interest in funding the idea as a national pilot program.

“Foster children are more traumatized, for horrible reasons, and that’s why their medical care has to be better,” Oliver said. “I am excited about the number of stakeholders who want to work on solving this problem with us.”

The issue may extend to lack of oversight on what drugs foster kids are being prescribed and taking. A 2010 investigation by The Atlanta Journal-Constitution revealed several companies operating foster care homes in the state had repeatedly used psychotropic medications to “subdue” children.

“Medications dispersed often aren’t to help the child with their problems but to make the child more docile for the caregivers,” said Richard Wexler, who heads the National Coalition for Child Protection and Reform. “And the paradox of child welfare care has always been the worst thing for the kids is what costs the most.”

That seems to have been the case for Bazan. Now 20, he can recall a brief period in high school when prescriptions had run out and his foster mother didn’t keep him on the stew of mind-altering drugs.

Fellow students noticed the no-nonsense boy was suddenly joking around and friendly.

“When I was off the medicines, everyone kept asking me why I was so happy,” Bazan said. “There was a real difference.”

The medications quickly 
returned, however. But Bazan said they didn’t help with the loss he felt over the death of 
his first foster mother or his feelings of being unwanted 
and under attack in the foster home he repeatedly ran away from.

He spent time in Department of Juvenile Justice facilities, where the medications kept coming, sometimes provoking seizures because some of them didn’t mix.

No one, he said, ever asked about his feelings. “They would have gotten a better response if someone had just taken a look at what was really going on in my life,” he said.

Bazan did that himself when he quit all medications cold turkey at age 18. But the years of medication already have hurt his future: His plan to enter the military to pay for college is blocked by the diagnosis of hyperactivity. He is ineligible to serve.

Bazan now works part time at the Division of Family and Children Services, acting as 
a liaison with community 
organizations and state agencies.

He also has started his own security company to provide nighttime patrols at his church in DeKalb County and others.

His goal is to get a full-time job with DFCS and persuade Gov. Nathan Deal to appoint him to the Georgia National Guard. With that, he could pay for college.

First, though, he is sharing his story in the hope that lawmakers and others will see him as a cautionary tale for what can happen when someone isn’t monitoring care of foster kids.

“I ask them, ‘Would you give all these people carte blanche with your kids, without any scrutiny of their medical history and a review of their life?’” Bazan said. “We’re just children. Someone has to look out for us. We need the same care and attention you give your own children.”

http://www.ajc.com/news/concern-over-high-medication-846324.html

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Finally—An Official Admission: Psychiatric Drugs Cause Violent & Homicidal Behavior

Friday, January 7th, 2011

NOTE FROM CCHRINT: Finally.  An admission.  From TIME Magazine no less.  We at CCHR would  like to take this opportunity to point out that it was due to CCHR’s efforts in 1991 that the FDA held public hearings on the antidepressant Prozac causing violence and suicide in patients.  Scores of victims and families gave testimony along with medical experts that people with no prior history of violence or suicidal behavior  became so under the influence of an antidepressant.   However, the FDA panel, comprised of individuals and psychiatrists with heavy conflicts of interest and numerous ties to the pharmaceutical industry, ignored the evidence.   It would take the FDA 13 years to finally issue black box warnings that antidepressants can induce suicidality.  They have yet to issue black box warnings on antidepressants causing violence…. despite the fact numerous school shooters have been under the influence of such drugs.   Watch CCHR’s exclusive footage of the 1991 FDA hearings on Prozac.

TIME MAGAZINE – JAN 7, 2011

Top Ten Legal Drugs Linked to Violence

by Maia Szalvitz

When people consider the connections between drugs and violence, what typically comes to mind are illegal drugs like crack cocaine. However, certain medications — most notably, some antidepressants like Prozac — have also been linked to increase risk for violent, even homicidal behavior.

A new study from the Institute for Safe Medication Practices published in the journal PloS One and based on data from the FDA’s Adverse Event Reporting System has identified 31 drugs that are disproportionately linked with reports of violent behavior towards others.

Please note that this does not necessarily mean that these drugs cause violent behavior. For example, in the case of opioid pain medications like Oxycontin, people with a prior history of violent behavior may seek  drugs in order to sustain an addiction, which they support via predatory crime. In the case of antipsychotics, the drugs may be given in an attempt to reduce violence by people suffering from schizophrenia and other psychotic disorders — so the drugs here might not be causing violence, but could be linked with it because they’re used to try to stop it.

Nonetheless, when one particular drug in a class of nonaddictive drugs used to treat the same problem stands out, that suggests caution: unless the drug is being used to treat radically different groups of people, that drug may actually be the problem. Researchers calculated a ratio of risk for each drug compared to the others in the database, adjusting for various relevant factors that could create misleading comparisons.

10. Desvenlafaxine (Pristiq) An antidepressant which affects both serotonin and noradrenaline, this drug is 7.9 times more likely to be associated with violence than other drugs.

9. Venlafaxine (Effexor) A drug related to Pristiq in the same class of antidepressants, both are also used to treat anxiety disorders. Effexor is 8.3 times more likely than other drugs to be related to violent behavior.

8. Fluvoxamine (Luvox) An antidepressant that affects serotonin (SSRI), Luvox is 8.4 times more likely than other medications to be linked with violence

7.Triazolam (Halcion) A benzodiazepine which can be addictive, used to treat insomnia. Halcion is 8.7 times more likely to be linked with violence than other drugs, according to the study.

6) Atomoxetine (Strattera) Used to treat attention-deficit hyperactivity disorder (ADHD), Strattera affects the neurotransmitter noradrenaline and is 9 times more likely to be linked with violence compared to the average medication.

5) Mefoquine (Lariam) A treatment for malaria, Lariam has long been linked with reports of bizarre behavior. It is 9.5 times more likely to be linked with violence than other drugs.

4) Amphetamines: (Various) Amphetamines are used to treat ADHD and affect the brain’s dopamine and noradrenaline systems. They are 9.6 times more likely to be linked to violence, compared to other drugs.

3) Paroxetine (Paxil) An SSRI antidepressant, Paxil is also linked with more severe withdrawal symptoms and a greater risk of birth defects compared to other medications in that class. It is 10.3 times more likely to be linked with violence compared to other drugs.

2) Fluoxetine (Prozac) The first well-known SSRI antidepressant, Prozac is 10.9 times more likely to be linked with violence in comparison with other medications.

1) Varenicline (Chantix) The anti-smoking medication Chantix affects the nicotinic acetylcholine receptor, which helps reduce craving for smoking. Unfortunately, it’s 18 times more likely to be linked with violence compared to other drugs — by comparison, that number for Xyban is 3.9 and just 1.9 for nicotine replacement. Because Chantix is slightly superior in terms of quit rates in comparison to other drugs, it shouldn’t necessarily be ruled out as an option for those trying to quit, however.

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12-year old’s suicide while on antidepressant highlights alarming rise in psychiatric drugging of military kids

Monday, January 3rd, 2011

Click image to watch video: Psychiatric Drug Side Effects

Note from CCHR: This article highlights the self-harm and suicide of a 5th grade boy who was prescribed an antidepressant by a psychiatrist at Fort Hood’s Darnall Army Medical Center.   More than 30 international drug regulatory agencies and studies have documented that antidepressants (and other psychiatric drugs) can cause self-harm (such as cutting) and suicide in under 18-year-olds.    Click here for international warnings/studies http://www.cchrint.org/psychdrugdangers/ Also see this video, Psychiatric Drug Side Effects

The Army Times – Jan 3, 2011
by Karen Jowers and Andrew Tilghman

Prescriptions increase as families struggle with repeated deployments

Before his father deployed to Iraq, Daniel Radenz was a well-adjusted fifth-grader earning straight A’s and B’s in school near Fort Hood, Texas.

But shortly after Army Lt. Col. Blaine Radenz left home in June 2008, his 11-year-old son became withdrawn and anxious. His grades at school slipped and his mother noticed mood swings. The child’s longtime pediatrician referred him for counseling.

A psychiatrist at Fort Hood’s Darnall Army Medical Center prescribed the antidepressant Celexa. Daniel also saw a psychologist there. Doctors added to and changed Daniel’s drug regimen, but his problems grew worse, said his mother, Tricia Radenz.

Daniel started cutting himself and once used his own blood to write “the end” on a bathroom wall at school. One day in band class, he began hallucinating and ran into the hall, where teachers found him crouched and hitting and scratching his face.

On June 9, 2009, Daniel hanged himself from a bunk bed in his home.

“I really feel the drugs played a significant role in Daniel’s death,” said Tricia Radenz, a 41-year-old emergency-room nurse.

It’s impossible to know precisely why a 12-year-old chose to take his own life. But the boy’s problems — and the use of powerful psychiatric drugs to treat them — highlight a concern for a growing number of military families who are struggling with the impact of long, frequent deployments on their children left at home.

The use of psychiatric medications by military children is on the rise. Overall, in 2009, more than 300,000 prescriptions for psychiatric drugs were provided to children under 18 who are Tricare beneficiaries.

That’s up 18 percent since 2005, according to data provided to Military Times — a period when the under-18 population increased by less than 1 percent. And some drug categories have shown even higher rates of increase — antipsychotic drugs are up about 50 percent and anti-anxiety drugs are up about 40 percent.

That mirrors a similar trend in the active-duty force, which has seen a 76 percent increase in prescriptions for psychiatric medications since the start of the war in Afghanistan.

Dr. Patricia Lester, a psychiatrist at University of California, Los Angeles, said the rise in drug use among children tracks with studies she and others have done showing how repeated deployments are taking a toll on military kids.

“There is a consistent story coming out showing that these kids have more distress,” Lester said. “And it’s not just the period of deployment. It appears to be during re-integration as well.”

Two studies link parents’ deployments to their children’s lower academic achievement scores, and to increased mental and behavioral health problems.

In one study, Rand Corp. researchers matched soldiers’ records with children’s academic achievement records and found lower scores among military children whose parents were cumulatively deployed for 19 months or more since 2001.

In the mental health study, led by a professor of pediatrics at the Uniformed Services University of the Health Sciences, researchers found that when a parent was deployed, outpatient visits among children ages 3 to 8 for pediatric behavioral disorders rose 18 percent, and for stress disorders by 19 percent, compared with military children whose parents were not deployed.

Prescription psychiatric drugs can help treat some of those behavioral disorders. But many of those drugs come with potential side effects, Lester said.

“Whenever one is prescribing medication, there is a risk-benefit analysis that has to occur, and the parents and patient need to be included in that,” Lester said.

Suicide risks

Tricia Radenz said nobody ever warned her about the suicide risks associated with the drugs her son was taking.

“The psychiatrist never once told me Celexa was a risk. He said he’d had great success with this drug,” Radenz said in an interview.

“Any antidepressant carries the warning, but I didn’t find out the seriousness until after he died,” she said.

Celexa, along with Wellbutrin, which Daniel was also taking at the time of his death, carry “black box” warnings from the Food and Drug Administration — the FDA’s most serious warning — about increased risks for suicidal thoughts and behavior.

Moreover, neither drug is recommended for children, although doctors may legally prescribe them after determining that they may benefit individual patients.

Experts say any medication should be matched with intensive therapy or counseling as a way to monitor for side effects and treat underlying problems that drugs cannot address.

Radenz said Daniel saw the psychologist and psychiatrist once or twice a month. She said the psychiatry department didn’t respond to her pleas for help when she called after Daniel had cut himself at school and used his blood to write on the bathroom wall.

The mother left a phone message with the psychiatry department, with details about what had happened, asking that someone call back for an appointment. Nobody returned her call, she said.

“I was essentially staying with him 24/7,” Radenz said. “I was outside the bathroom if he was in there. He was sleeping with me.”

She said that after she was unable to get help from the child psychiatry department, she e-mailed her husband in desperation, and he came home from Iraq on emergency leave May 25.

Daniel was thrilled to see his father. For days as the family spent time together, Radenz said, Daniel laughed and joked and said many times: “I’m so glad Dad is home.”

Daniel’s father went to the local clinic and asked why his wife’s phone calls had not been returned, even by June 1. He told them he was on emergency leave because of his son’s decline.

The clinic staff apologized, Tricia Radenz said, and explained that no one was checking the answering machine because the staff was overwhelmed.

Her son’s death a week later “was completely preventable, had he received competent care instead of being herded through the system like a piece of cattle at an auction,” she said. “I want someone held accountable, and I don’t want anyone to ever have to go through this again.”

Officials at Darnall Army Medical Center said they conducted an investigation into Daniel’s treatment, but a spokeswoman declined to disclose any of its findings. However, the spokeswoman said, “rest assured that all medical treatment was thoroughly evaluated” and “any lessons learned as a result of that review have been incorporated into our practices here at Fort Hood.”

Tricia Radenz knows nothing can bring her son back.

“But why can’t they say they were wrong? That they’ve made changes? All I want is to know they’ve corrected their process that cost me my son.

“No other family should ever have to endure the agony my family suffers daily. My husband made more than the ‘ultimate sacrifice’ … he sacrificed his son to serve.”

Read the rest of the article here:  http://www.armytimes.com/news/2011/01/military-children-taking-more-psychiatric-drugs-010211w/

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Wyeth Execs Can’t Hide Behind Silence on Antidepressant Data

Wednesday, December 1st, 2010

BNET – December 1, 2012

Image by Francesco Marino

by Jim Edwards

lawsuit that alleges Wyeth executives told a series of lies about the antidepressant Pristiq — suggesting that it was a good treatment for post-menopause hot-flashes when they were sitting on study data showing a risk of heart and liver problems — gives new guidance to management on what counts as a false or misleading disclosure to investors.

In the case, the judge ruled that front-loading your investor presentations with a bunch of boilerplate language about “safe-harbor” predictions and “forward-looking statements” that ought to be treated with caution does not allow you to stay silent about negative data that you know will affect the fortunes of your company. (The order was reaffirmed just before Thanksgiving.)

A pension plan that was invested in Wyeth stock (before it merged with Pfizer (PFE)) alleged that Wyeth CEO Bernard Poussot and others knew by 2005 that using Pristiq for post-menopausal vasomotor symptoms (hot flashes) carried increased risks of liver and heart damage. The ruling says:

Of the 707 participants [in a Phase III clinical trial], 27 suffered serious adverse effects (“SAEs”), including three coronary occlusions and two heart attacks.

No one taking the placebo experienced a serious adverse event. Wyeth did not reveal this data to investors, however, and instead applied to the FDA for approval to market the drug as if nothing was wrong.

At the time, Pristiq was crucial to Wyeth’s fortunes. It previous antidepressant, Effexor, was losing its exclusive patent protection and the company’s two post-menopause drugs, Prempro and Premarin, turned out to be associated with blood clots and cancer. If the company could get Pristiq approved for hot flashes, it would be a double-blockbuster.

In 2007, however, Wyeth announced that the FDA turned down Pristiq for hot flashes. Wyeth’s stock dropped more than 10 percent, losing $5.70 per share.

Between learning of the negative data in 2005 and the FDA’s thumbs down in 2007, Poussot’s team fed investors a stream of upbeat chatter about the likelihood of getting Pristiq approved for post-menopausal women:

February 9, 2006, Merrill Lynch Pharma Conference, CFO Kenneth Martin: The opportunity clearly is there. The market clearly is there. And if the profile of the product is where we hope it be, we think this is a –- this could be a very big opportunity. … This is a drug that we’re very optimistic about.

October 5, 2006, annual investor conference, svp/president Joseph Mahady: [Pristiq] begins to really differentiate itself with its ability to reduce the frequency and severity of moderate to several [sic] vasomotor symptoms associated with … menopause. … [W]e predict that Pristiq has the potential to exceed $2 billion in peak sales, and that’s the cost of the two indications that we’ve spoken about, MDD and VMS.

At the same conference, svp R&D Robert Ruffolo: We think that [Pristiq] will also be important for the vasomotor indication where – it would obviously be our intent for this drug to be used as another option for women who are suffering from vasomotor symptoms, which is the number one reason women will go to the doctor to seek treatment. … In fact, the way Pristiq looks like it’s positioning itself right now, it’s a drug primarily for women’s health.

Wyeth’s defense was that safe harbor statements about future predictions ought to be treated with caution as “forward-looking statements” — i.e. all the legal disclaimers you see in front of every investor presentation — so Wyeth could not have predicted the FDA’s decision.

The judge agreed with that, but he then ruled that managers’ statements about Pristiq’s safety were not forward-looking because Wyeth already had all the safety data in hand when the statements were made.

Wyeth also argued that the adverse events were not statistically significant, and that they were disclosed at a poster-session at an ob-gyn conference and in a single analyst’s note to investors. The judge dismissed both of those arguments, as statistical significance is an issue of fact to be decided by a jury not a matter of law, and because the conference poster disclosure was too minimal to count as a disclosure to investors.

The case is a warning from the federal judiciary that sometimes CEOs and their lieutenants go too far in concealing negative data. Recently, the federal judiciary has sided with executives who lie to investors and to the federal government. Nonetheless it appears there is still a limit to judges’ sympathy for managers who have difficulty disclosing the whole truth.

http://www.bnet.com/blog/drug-business/wyeth-execs-can-8217t-hide-behind-silence-on-antidepressant-data/6592

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Psychiatrist on Payroll of Glaxo Pleads Guilty to Research Fraud

Monday, November 29th, 2010

NaturalNews, November 29,2010

by David Gutierrez

GlaxoSmithKline, manufacturer of Paxil, paid Palazzo $5,000 for every child she enrolled in the study.

A psychiatrist on the payroll of GlaxoSmithKline has been sentenced to 13 months in prison after pleading guilty to committing research fraud in trials of the company’s antidepressant Paxil on children.

Maria Carmen Palazzo is already serving a sentence of 87 months for defrauding Medicare and Medicaid.

Palazzo was accused by the FDA of enrolling children in a clinical trial even though she knew they did not actually suffer from major depressive or obsessive compulsive disorder, the conditions being studied. Palazzo then falsified records and psychiatric diagnoses.

GlaxoSmithKline, manufacturer of Paxil, paid Palazzo $5,000 for every child she enrolled in the study.

The case’s significance goes beyond simple research fraud, as Glaxo is now defending itself against charges that for 15 years it deliberately concealed evidence that Paxil increases the risk of suicide in children.

Glaxo is also defending itself against accusations that it manipulated data to conceal the risks of its diabetes blockbuster Avandia, and that it failed to warn parents that Paxil may cause birth defects if taken by pregnant women. The company has already agreed to pay more than $1 billion to settle roughly 700 birth defect lawsuits; another 100 or so suits are pending.

Although the FDA eventually required Paxil to carry a warning about the risk of birth defects and an even more prominent “black box” warning about suicide risk, many critics allege that the agency acted too slowly.

“There [had] been hints for many years that antidepressants, such as Paxil, when given to children, can cause serious side effects, including suicide, but the FDA delayed taking any action to prevent these drugs from being prescribed for children,” writes Brent Hoadley in Too Profitable to Cure.

Palazzo will not actually serve any additional prison time for potentially placing children’s safety at risk; her new term will be served concurrently with her first.

http://www.naturalnews.com/030557_psychiatry_fraud.html

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Justice to Pharma: “Do the Perp Walk!”

Wednesday, November 17th, 2010

PharmaExec.com – November 17, 2010

by Walter Armstrong

Former GSK counsel is the first target in government’s executive-liability crackdown. Could J&J be next?

The US Department of Justice filed criminal charges last week against Lauren Stevens, a former VP and assistant general counsel at GlaxoSmithKline. Going after pharma execs marks a seismic shift in the government’s efforts to stem the tide of fraud and other illegal pharma marketing practices, which a raft of billion-dollar settlements have so far failed to end. Stevens is charged with obstruction of an investigation, concealment and falsification of documents, and making false statements to the FDA in its 2002 investigation of off-label promotion of the antidepressant Wellbutrin for weight loss, an indication for which it has never been approved but has shown some clinical benefit. The DoJ says that it has evidence, in the vast paper and electronic documentation turned over by GSK, showing that Stevens hid and otherwise misled the agency about some 1,000 instances of GSK-paid doctors promoting Wellbutrin for weight loss to other doctors.

Officials had warned that they would target “repeat offenders,” and GSK certainly qualifies for that dubious distinction. The British firm has racked up some of the biggest settlements of the past decade, including $750 million in October to put to rest civil and criminal charges arising in part from a whistleblower suit filed by a quality-control cop who was fired after she advised temporarily shutting down one of its major manufacturing plants because it was routinely producing adulterated drugs (and selling some of them on the black market) between 2001 and 2005. GSK execs chose instead to look the other way. The former compliance advisor’s cut of the settlement was a record-setting $96 million.

In fact, GSK has been making headlines for all the wrong reasons this year: Prior to the whistleblower suit settlement news came the denouement of the Avandia side effects case revealing that the company had failed to disclose damaging data and otherwise misled the FDA about the diabetes drug’s heart-attack risks.

But the new charges against a former VP in its legal department and all the bad press are almost certainly coincidental, says Daniel Carpenter, a professor of political science at Harvard and leading expert on the FDA. “I am not inclined to read anything political into the fact that it is a Glaxo employee,” he says. “The real symbolic feature of this action is the general message that any criminal proceeding sends to the pharmaceutical industry, namely that the FDA general counsel is now willing to use criminal proceedings—something it has had the power to do for seven decades.” Lauren Stevens, who was said by a GSK spokesperson to be “retired,” has hired a high-profile team of defense attorneys who told the media that their client was innocent and looking forward to her day in court. Be that as it may, if convicted, Stevens could spend at least some of her retirement years in the slammer because the charges are felonies carrying lengthy prison sentences.

BNet’s Jim Edwards has raised the possibility on his Placebo Effect blog that the DoJ may offer Stevens immunity for spilling the beans on other misdeeds at GSK, especially those committed by top management. That lineup include, of course, several of the industry’s most powerful players: former GSK CEO Jean-Pierre Garnier; his successor in 2008, Andrew Witty; Chris Veihbacher, who was GSK’s head of US pharmaceuticals from 2003 to 2008, when he became the CEO of Sanofi-Aventis; and David Stout, the head of global pharma operations from 2003 to 2008.

But the most probable scenario, according to Pharm Exec’s legal sources, is that the DoJ has picked a first case that it is confident it can win a conviction in. And Stevens is likely merely the first shoe to drop. It is widely assumed that the coming months will offer other executives at other firms the opportunity to do a perp walk, with some insiders betting that J&J is next on deck following recent congressional hearings into the company’s recent series of OTC product recalls, including a “phantom” recall of defective Motrin during which consultants posing as consumers attempted to buy out the product.

Slammed for failing to announce an official recall in a speedy fashion, FDA deputy commissioner Josh Sharfstein told Congress last June that J&J had misled the agency about the scope of the retrieval, not to mention its bizarre counterfeit style. But when J&J CEO William Weldon took the hot seat, he countered that his firm had informed the agency of its plans.

One of the two men is lying to Congress, so this line of speculation goes, and if it’s Weldon, the FDA may be expected to pounce—calling its no. 2 a liar only adds insult to injury.

http://blog.pharmexec.com/2010/11/17/lauren-stevens-charged-with-obstruction/

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U.S. Justice Department Charges Former GlaxoSmithKline VP — A Top Lawyer—with Fraud over Illegal Marketing of Antidepressant Wellbutrin

Wednesday, November 10th, 2010

The New York Times, November 9, 2010

by Duff Wilson

In a rare move, the Justice Department on Tuesday announced that it had charged a former vice president and top lawyer for the British drug giant GlaxoSmithKline with making false statements and obstructing a federal investigation into illegal marketing of the antidepressant Wellbutrin for weight loss.

The indictment grabbed the attention of pharmaceutical executives who have been bracing for a long-promised government crackdown on company officials — rather than the corporations themselves — in drug-fraud cases that have resulted in billions of dollars in fines and payments.

“This is absolutely precedent-setting — this is really going to set people’s hair on fire,” said Douglas B. Farquhar, a Washington lawyer who recently presided at a panel on law enforcement during a drug industry conference where federal officials warned they were focusing on individuals. “This is indicative of the F.D.A. and Justice strategy to go after the very top-ranking managing officials at regulated companies.”

The indictment accuses the Glaxo official, Lauren C. Stevens of Durham, N.C., of lying to the Food and Drug Administration in 2003, by writing letters, as associate general counsel, denying that doctors speaking at company events had promoted Wellbutrin for uses not approved by the agency. Ms. Stevens “made false statements and withheld documents she recognized as incriminating,” including slides the F.D.A. had sought during its investigation, the indictment stated.

Tony West, assistant attorney general for the civil division, said in a statement, “Where the facts and law allow, the Justice Department will pursue individuals responsible for illegal conduct just as vigorously as we pursue corporations.”

Ms. Stevens has assembled a high-powered legal defense team. “She’s pleading not guilty,” said Reid H. Weingarten, one of her lawyers, who previously represented Bernard J. Ebbers, former chief executive of WorldCom, and Mark A. Belnick, former Tyco counsel. “We’re going to trial and looking forward to it, and we fully expect her to be vindicated.”

Brien T. O’Connor, a lawyer with Ropes & Gray, said in a statement, “Lauren Stevens is an utterly decent and honorable woman. She is not guilty of obstruction or of making false statements. Everything she did in this case was consistent with ethical lawyering and the advice provided her by a nationally prominent law firm retained by her employer specifically because of its experience in working with F.D.A.”

Ms. Stevens, who is 60, could not be contacted Tuesday. No one answered her home telephone.

She is retired, according to Mary Anne Rhyne, a spokeswoman for GlaxoSmithKline. Ms. Rhyne said the company was cooperating fully with a federal investigation into allegations of illegal sales and marketing of Wellbutrin. Last year, it set aside $400 million to resolve the case, which is still pending.

Two weeks ago, in an unrelated case, GlaxoSmithKline agreed to pay $750 million to the government to settle civil and criminal complaints that it sold tainted or ineffective products from a large manufacturing facility in Puerto Rico.

The theme of the drug-law industry conference last month was “more individuals, more often.” In a presentation, Eric M. Blumberg, a deputy chief counsel at the F.D.A., warned: “If you are a corporate executive — or counsel advising such a client — do not wait for the first case to decide now is the time to comply with the law.”

“Once you threaten somebody with jail, people really start paying attention,” said Frances H. Miller, a Boston University law professor and expert on health care policy. “This fits in that framework of sending very high-profile messages very fast.”

http://www.nytimes.com/2010/11/10/health/10glaxo.html

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