Posts Tagged ‘Lexapro’

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America’s ‘startling’ use of mental-illness drugs: By the Numbers, A Nation of Pill-Poppers

Friday, November 18th, 2011

Note from CCHR: They’re now “trying to figure out” why so many Americans are taking drugs for “mental illness,” but the answer is ridiculously simple: because people are being diagnosed mentally ill for a multitude of behaviors or emotions that have been pathologized into a “disease” by psychiatry & promoted by Big Pharma.  Being sad, anxious, too happy, too sad, in grief,  having to much energy, too little energy, fidgeting, being shy, having too much sex, too little sex, eating too much, eating too little…the list goes on and on.  And that is the reason.  Because there are 374 ways to label you mentally ill… and the number is growing.

THE WEEK – November 18, 2011

A pharmacist counts and divides Prozac prescription pills: 29 percent more women are using antidepressants now than ten years ago. Photo: Paul Skelcher - Rainbow/Science Faction/Corbis

Americans are taking a “startling” amount of mental-health related medications, according to a big new study by Medco Health Solutions. More than 1 in 5 Americans now takes at least one drug to treat a psychological disorder, ranging from antidepressants like Prozac to anti-anxiety drugs like Xanax. Understanding why Americans are taking more pills to treat mental illness “is the next critical goal,” says Dr. Martha Sanjatovic in a statement released by Medco. Here’s a look this growing trend, by the numbers:

2.5 million
The number of Americans surveyed for prescription drug use from 2001 to 2010

1/5
One out of every five U.S. adults takes drugs to treat some type of mental health condition

22
Percent increase in the number of U.S. adults taking mental health drugs in 2010 compared to 2001

29
Percent increase in the number of women using antidepressants in 2010 compared to 2001

1/5
Proportion of women over the age of 20 who are prescribed antidepressants, like Zoloft and Lexapro

11
Percent of middle-aged women using anti-anxiety medications

5.7
Percent of middle-aged men using anti-anxiety medications

3
Number of people ages 20 to 44 using antipsychotic drugs (like Resperadol) and ADHD medications (like Ritalin) in 2010 for every one person who used them in 2001

100
Percent increase in the number of  children under age 10 taking antipsychotic medications

40
Percent increase in the number of girls being prescribed ADHD medications

23
Percent of people in the “diabetes belt” states of Tennessee, Kentucky, Mississippi, and Alabama who are on at least one psychiatric drug, according to the AP

Sources: Associated Press, Daily Beast, Huffington Post, LA Times

http://theweek.com/article/index/221575/americas-startling-use-of-mental-illness-drugs-by-the-numbers

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Harvard Expert Ties Mental Illness “Epidemic” to Big Pharma’s Agenda

Friday, July 29th, 2011

Minyanville
By Minyanville Staff
July 28, 2011

When the DSM-II was published in 1980, it became “the bible of psychiatry,” writes Angell, who adds, “but like the real Bible, it depended a lot on something akin to revelation. There are no citations of scientific studies to support its decisions.”

For any mental illness or passing mood swing that may trouble a person, the Diagnostic and Statistical Manual of Mental Disorders — better known as the DSM — has a label and a code. Recurring bad dreams? That may be a Nightmare Disorder, or 307.47. Narcolepsy uses the same digits in a different order: 347.00. Fancy feather ticklers? That sounds like Fetishism, or 302.81. Then there’s the ultimate catch-all for vague sadness or uneasiness, General Anxiety Disorder, or 300.02. That’s a label almost everyone can lay claim to.

These codes are used by doctors, psychologists, and regulators to maintain a mutual language; it’s a handy shorthand system for bureaucratic purposes. But over the past few decades, the staggering, ever-expanding influence of the ever-expanding DSM, which is published by the American Psychiatric Association, has also played a lead role in building wealth and off-label product uses for the major drug manufacturers. In an insightful essay in this week’s New York Review of Books, Marcia Angell, a senior lecturer in social medicine at Harvard Medical School and former Editor in Chief of The New England Journal of Medicine, explains how.

The medical director of the American Psychiatric Association (APA), Melvin Sabshin, declared in 1977 that “a vigorous effort to remedicalize psychiatry should be strongly supported."

Angell’s essay is based on a review of three current books examining the psychiatric industry: The Emperor’s New Drugs: Exploding the Antidepressant Myth, by Irving Kirsch; Anatomy of an Epidemic: Magic Bullets, Psychiatric Drugs, and the Astonishing Rise of Mental Illness in America by Robert Whitaker, and Unhinged: The Trouble with Psychiatry–A Doctor’s Revelations About a Profession in Crisis, by Daniel Carlat. She also cites the DSM-IV, the most recent edition of the manual, while her review traces big pharma’s role in our current mental disorder epidemic to the DSM-III, published in 1980.

To begin, Angell describes the psychiatric profession’s backlash against a developing perception in the 1960s and 1970s that the practice was a “soft” almost pseudo science:

In the late 1970s, the psychiatric profession struck back–hard. As Robert Whitaker tells it in Anatomy of an Epidemic, the medical director of the American Psychiatric Association (APA), Melvin Sabshin, declared in 1977 that “a vigorous effort to remedicalize psychiatry should be strongly supported,” and he launched an all-out media and public relations campaign to do exactly that. Psychiatry had a powerful weapon that its competitors lacked. Since psychiatrists must qualify as MDs, they have the legal authority to write prescriptions. By fully embracing the biological model of mental illness and the use of psychoactive drugs to treat it, psychiatry was able to relegate other mental health care providers to ancillary positions and also to identify itself as a scientific discipline along with the rest of the medical profession. Most important, by emphasizing drug treatment, psychiatry became the darling of the pharmaceutical industry, which soon made its gratitude tangible.

Of the 170 contributors to the current version of the DSM (the DSM-IV-TR), ninety-five had financial ties to drug companies, including all of the contributors to the sections on mood disorders and schizophrenia.

These efforts to enhance the status of psychiatry were undertaken deliberately. The APA was then working on the third edition of the DSM, which provides diagnostic criteria for all mental disorders. The president of the APA had appointed Robert Spitzer, a much-admired professor of psychiatry at Columbia University, to head the task force overseeing the project. The first two editions, published in 1952 and 1968, reflected the Freudian view of mental illness and were little known outside the profession. Spitzer set out to make the DSM-III something quite different. He promised that it would be “a defense of the medical model as applied to psychiatric problems,” and the president of the APA in 1977, Jack Weinberg, said it would “clarify to anyone who may be in doubt that we regard psychiatry as a specialty of medicine.”

When the DSM-II was published in 1980, it became “the bible of psychiatry,” writes Angell, who adds, “but like the real Bible, it depended a lot on something akin to revelation. There are no citations of scientific studies to support its decisions.”

Despite its lack of citations, that DSM named 265 disorders doctors were meant to identify by matching (or mostly matching) a list of symptoms in the book with symptoms described by a patient. The drug companies were quick to see this radical shift in psychiatry as an opportunity. From the 1980s until now, as Angell demonstrates, the drug makers have supported the move away from talk therapy to the drug therapy, which also benefits practitioners, since doling out drugs and tweaking prescriptions earns a psychiatrist more money for less time spent with a patient.

Here Angell explains how companies influence the DSM itself. The bold typeface is ours.

Drug companies are particularly eager to win over faculty psychiatrists at prestigious academic medical centers. Called “key opinion leaders” (KOLs) by the industry, these are the people who through their writing and teaching influence how mental illness will be diagnosed and treated. They also publish much of the clinical research on drugs and, most importantly, largely determine the content of the DSM. In a sense, they are the best sales force the industry could have, and are worth every cent spent on them. Of the 170 contributors to the current version of the DSM (the DSM-IV-TR), almost all of whom would be described as KOLs, ninety-five had financial ties to drug companies, including all of the contributors to the sections on mood disorders and schizophrenia.

The drug industry, of course, supports other specialists and professional societies, too, but Carlat asks, “Why do psychiatrists consistently lead the pack of specialties when it comes to taking money from drug companies?” His answer: “Our diagnoses are subjective and expandable, and we have few rational reasons for choosing one treatment over another.” Unlike the conditions treated in most other branches of medicine, there are no objective signs or tests for mental illness—no lab data or MRI findings—and the boundaries between normal and abnormal are often unclear. That makes it possible to expand diagnostic boundaries or even create new diagnoses, in ways that would be impossible, say, in a field like cardiology. And drug companies have every interest in inducing psychiatrists to do just that.

Eli Lilly gave $551,000 to NAMI

In addition to the money spent on the psychiatric profession directly, drug companies heavily support many related patient advocacy groups and educational organizations. Whitaker writes that in the first quarter of 2009 alone, “Eli Lilly gave $551,000 to NAMI [National Alliance on Mental Illness] and its local chapters, $465,000 to the National Mental Health Association, $130,000 to CHADD (an ADHD [attention deficit/hyperactivity disorder] patient-advocacy group), and $69,250 to the American Foundation for Suicide Prevention.”

And that’s just one company in three months; one can imagine what the yearly total would be from all companies that make psychoactive drugs. These groups ostensibly exist to raise public awareness of psychiatric disorders, but they also have the effect of promoting the use of psychoactive drugs and influencing insurers to cover them. Whitaker summarizes the growth of industry influence after the publication of the DSM-III as follows:

“In short, a powerful quartet of voices came together during the 1980’s eager to inform the public that mental disorders were brain diseases. Pharmaceutical companies provided the financial muscle. The APA and psychiatrists at top medical schools conferred intellectual legitimacy upon the enterprise. The NIMH [National Institute of Mental Health] put the government’s stamp of approval on the story. NAMI provided a moral authority.”

And now here we are in 2011, with almost everyone we know taking two or three different mood disorder drugs. (This trend is not limited to mental disorder, mind you. See Disease Branding.)

Work started on the DSM-V in 1999, which is due out in 2013. It will contain many new disorders, such as “binge eating” and “restless leg disorder.” It will also expand existing categories by tacking on words like “spectrum” to the end of a known disorder, Angell reports. “It looks as though it will be harder and harder to be normal,” she writes.

But the curtain gets pulled back further still.

In her review of Daniel Carlat’s book, Angell calls attention to the “disillusioned insider’s” frank admission that when he prescribes a drug, his decision process is largely guesswork. Carlat’s view is that although any psychiatrist will acknowledge that he or she has had great success with mental disorder drugs for say, depression or anxiety, no doctor can say with certainty whether the drugs are working or if a placebo effect has taken effect.

[Carlat's] work consists of asking patients a series of questions about their symptoms to see whether they match up with any of the disorders in the DSM. This matching exercise, he writes, provides “the illusion that we understand our patients when all we are doing is assigning them labels.” Often patients meet criteria for more than one diagnosis, because there is overlap in symptoms. For example, difficulty concentrating is a criterion for more than one disorder. One of Carlat’s patients ended up with seven separate diagnoses. “We target discrete symptoms with treatments, and other drugs are piled on top to treat side effects.” A typical patient, he says, might be taking Celexa for depression, Ativan for anxiety, Ambien for insomnia, Provigil for fatigue (a side effect of Celexa), and Viagra for impotence (another side effect of Celexa).

As for the medications themselves, Carlat writes that “there are only a handful of umbrella categories of psychotropic drugs,” within which the drugs are not very different from one another. He doesn’t believe there is much basis for choosing among them. “To a remarkable degree, our choice of medications is subjective, even random. Perhaps your psychiatrist is in a Lexapro mood this morning, because he was just visited by an attractive Lexapro drug rep.”

Messy. And, of course, the whole system is now being exported to China and other countries where the middle class is growing and the mental health industry is still in a developing stage.

Angell’s latest book is The Truth About the Drug Companies: How They Deceive Us and What to Do About It.

Read the rest of her essay, which examines the controversial use of brain chemistry drugs to treat children, here.

http://www.minyanville.com/dailyfeed/2011/07/25/harvard-expert-links-our-mental/

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PEOPLE’S PHARMACY:Can drugs cause violent behavior?

Thursday, July 21st, 2011

Tuscaloosa News – July 21, 2011

PEOPLE’S PHARMACY

Americans revere personal responsibility. It resonates with our respect for accountability and frontier justice. That may explain why we have a hard time believing that medications could alter people’s personalities or lead them to behave badly.

Violence as a drug side effect seems preposterous to patients, pharmacists, physicians and even juries. Trying to use the “Prozac defense” to justify killing or hurting someone is often met with scorn.

Although drug-induced hostility or aggression has not been well-studied, a surprising number of medications come with precautions about violent acts.

Antidepressant prescribing information, for example, warns physicians that, “All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior.” Drugs such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac), paroxetine (Paxil) and sertraline (Zoloft) carry warnings about aggressiveness, agitation, hostility, impulsivity and irritability.

The stop-smoking medication varenicline (Chantix) also comes with warnings about agitation, hostility, depressed mood and changes in behavior. The trouble with such warnings is that people don’t imagine that these bad things could happen to them. But many readers have shared scary stories about Chantix and violence. Here is one:

“I started taking Chantix early in January 2011 because I promised my son I’d quit. After about two weeks on the drug, my husband and I got into a disagreement, and I ended up giving him a black eye and busting out his tooth. Rage and panic attacks were occurring every day, so I quit taking Chantix.

“I figured it was just the stress of having to live with my in-laws, so I stayed off it until I left my husband and got my own place with my son. I’ve now been taking Chantix for about two weeks, and I’m having emotional outbursts and extreme rage again. I have no stress in my life right now, so it can’t be anything else but the drug.

“I’ve researched this, and apparently Chantix is at the top of a list of drugs that cause violent behavior. Chantix worked very well for a friend of mine to help her stop smoking, but now I wonder if it contributed to her breakup with her fiance.”

Other readers have shared stories of people who had no history of aggressiveness, violence or mental-health problems going berserk while taking Chantix. One man beat his wife and called police but had no recollection of the incident.

A recent article in the European Journal of Clinical Pharmacology (online, June 7, 2011) “confirms the risk of violence associated with benzodiazepines and related drugs (zopiclone and zolpidem). … Physical aggressiveness, rapes, impulsive decision making and violence have been reported, as have autoaggressiveness and suicide.”

Benzodiazepines are anti-anxiety agents such as alprazolam (Xanax), clonazepam (Klonopin), diazepam (Valium) and lorazepam (Ativan). Eszopiclone and zolpidem are popular prescription sleep aids. Americans need to know how prescribed drugs might affect their behavior. Only then can they take responsibility for their actions.

http://www.tuscaloosanews.com/article/20110721/NEWS/110719697/1005/sitemaps04?p=2&tc=pg

(Note from CCHR:  Our psychiatric drug database, comprised of international drug regulatory agency warnings and clinical studies,  contains 19 warnings of psychiatric drugs causing violence, aggression and hostility -  type in aggression in the red search box – or suicide which has 66 warnings)  http://www.cchrint.org/psychdrugdangers/drug_warnings.php )

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18 U.S. veterans commit suicide daily; largely due to psychiatric drugs

Saturday, June 4th, 2011

NaturalNews.com – June 3, 2011

by Neev M. Arnell

Prior to the Iraq war, American soldiers in combat zones did not take psychiatric drugs - by 2007, more than 20,000 troops were taking antidepressants & sleeping pills

“If mentally incapacitated troops are being drugged with dangerous, mind-altering drugs and deployed to battle against their will, how can we say that we have a volunteer army?” asked Alliance for Human Research Protection, the national network dedicated to advancing responsible and ethical medical research practices.

This is just one of the many criticisms being levied against the U.S. military in light of its liberal use of prescription medication, which is now being linked to rising suicide rates among soldiers.

A study released by the Army in June 2009 indicated that nearly as many American troops at home and abroad committed suicide in the first six months of 2006 as the number who had been killed in combat in Afghanistan during the same time period (http://www.npr.org/templates/story/…).

An average of 18 American veterans commit suicide every day (http://abcnews.go.com/Health/MindMo…). Now, the increasingly high number of deaths among both veterans and active duty soldiers–including suicides, accidental overdose, and lethal drug interactions–have now been linked to the exponential increase in the prescribing of drugs for post traumatic stress disorder, depression and other psychological illnesses.(http://www.ahrp.org/cms/content/vie…)

Prior to the  Iraq war, American soldiers in combat zones did not take psychiatric medications, according to PBS Frontline documentary The Wounded Platoon, which aired in May 2010. (http://www.pbs.org/wgbh/pages/front…) But by the time of the 2007 surge more than 20,000 of our deployed troops were taking antidepressants and sleeping pills.

These drugs allowed soldiers with post-traumatic stress disorder to remain in combat when they otherwise could not.

“What I use medications for is to treat very specific side effects,” said Army psychiatrist Col. George Brandt. “I don’t want somebody in a helpless mode in a combat environment. I want to make sure I don’t have someone with suicidal thoughts where everyone is armed.”

Well over 300,000 troops have returned from Iraq or Afghanistan with P.T.S.D., depression, traumatic brain injury or some combination of those, according to The New York Times (http://www.nytimes.com/2011/02/13/u…). Following the lead of civilian medicine, the military has relied heavily on medications to treat those problems, resulting in more widespread use of drugs in the military than in any previous war.

The aforementioned Army report on suicide recognized that one-third of the troops were taking at least one prescription medication and stated that prescription drug use was on the rise. The report also noted that one-third of the 162 active-duty soldiers who committed suicide in 2009 were taking medication.

Frontline’s The Wounded Platoon looked at the problem of PTSD, depression and prescription medication in the military from the perspective of one platoon from Fort Carson, CO. 18 soldiers from Fort Carson have been charged with or convicted of murder, manslaughter or attempted murder committed in the United States, since the beginning of the “War on Terror,” and 36 have committed suicide.

Jose Barco, who was once known as the hero who saved his fellow soldiers during a suicide-bombing, is now serving a 52-year prison sentence for attempted murder. Barco suffered traumatic brain injury as a result of his heroics and was also diagnosed with PTSD for which he was prescribed nine different medications.

“We have someone who’s been emotionally traumatized, and they’ve got PTSD,” said retired military psychiatrist Stephen Xenakis. “They’re anxious, and they’re depressed, and they’ve got TBI, which means that they’ve got problems in decision making. They can’t think as clearly. They are really vulnerable to just overreacting.”

The rate of PTSD diagnosis at Fort Carson rose 4,000 percent between 2002 and 2010, and the increase in medications being prescribed for both veterans and those in combat rose to meet the demand.

Kenny Eastridge, another platoon member that Frontline spoke with who is in jail for murder and other crimes, was prescribed a cocktail of medications while in combat.

“I was having a total mental breakdown. Every day we were getting in battles and never having a break. It seemed like, it was just crazy,” he said. “They put me on all kinds of meds, and I was still going out on missions. They had me on Ambien, Remeron, Lexapro, Celexa, all kind of different stuff.”

Eastridge was sent to a remote combat outpost for weeks at a time with no medical supervision or mental health provision, despite the recommendation that patients on this medication should be monitored. Frontline footage showed Eastridge’s unstable behavior, which included wandering into Iraqi homes, lying in the people’s beds, and trying to hug local people.

As more soldiers return home to Fort Carson, concern abounds.”We’re all wondering what’s going to happen,” says Colorado Springs psychotherapist Robert Alvarez. “It’s a scary thought, you know, what’s going to happen in this community. Are we going to have more murders? Are we going to have more suicides, or are we going to have more crime? I think the answer to that is probably yes.”

http://www.naturalnews.com/z032598_veterans_suicide.html


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The Small Group of Thoughtful, Committed Citizens Has Been Drugged

Tuesday, May 24th, 2011

OpEdNews
By David Swanson
May 23, 2011

Movements for justice have historically been driven by a small percentage of any population. One percent of Americans nonviolently occupying Washington, D.C., could make Cairo and Madison and Madrid look like warm-up acts. It is certainly true that a small group of thoughtful, committed citizens is the only thing that ever has changed the world for the better.

So, what happens if a society picks out a significant slice of its population, one including many thoughtful and committed citizens, and drugs them?

The Drug Enforcement Administration (DEA) held a first-time, one-day, little publicized event last September that allowed people to turn in their extra prescription drugs. The DEA reports collecting 242,000 pounds or 121 tons. A second such day was held in April with 376,593 pounds or 188 tons of pills collected. This is the stuff nobody wants and is willing to hand in to the government. This is not the amount that’s out in circulation. That amount is no doubt in proportion to the roaring flood of television ads for the stuff. “More Americans currently abuse prescription drugs,” says the DEA, “than the number of those using cocaine, hallucinogens, and heroin combined. . . . [I]ndividuals that abuse prescription drugs often obtained them from family and friends, including from the home medicine cabinet.” And that’s just the users said to be abusing.

Ted Rall suggested drugging to me as a possible explanation for the big mystery staring us in the face, namely why Americans sit back and take so much more than other people from their government. The Patriot Act is being put on steroids with hardly a peep of protest. The “Defense Authorization Act” now before Congress would give presidents virtually limitless power to single-handedly make wars or imprison people. This is the biggest formal transfer of power in the U.S. government since the drafting of its Constitution. This undoes the American War for Independence. But perhaps we’d still be 13 colonies if Prozac and Zoloft had come along sooner.

“Like many people,” says Rall, “I have often wondered why so many Americans seem so emotionally flat and politically apathetic in response to a political and economic landscape that cries out for protest, or at least complaint. Could it be that our society’s most angry — justifiably angry — are being medicated into quiescence?” It does seem possible. I don’t mean to discount the fact that the United States imprisons record numbers of people. I’m willing to share some blame with our education system, our so-called news media, our religiosity, the two-party trap, and several other likely factors. But drugs looks like the big one that is nonetheless hardest to see. People don’t usually tell you they’re drugged, but chances are at least one in 10 people you meet is.

Two years ago, a study found that “the number of Americans taking antidepressants doubled to 10.1 percent of the population in 2005 compared with 1996, increasing across income and age groups.” One year earlier, another study had found that close to 10 percent of men and women in America were taking drugs to combat depression, and that 11 percent of women were taking antidepressants.”

Author and clinical psychologist Bruce Levine tells me this may be even worse than it sounds. “If you are around certain populations,” Levine says, “that 10 percent stat seems very low, especially among healthcare professionals and college students.” College students? I can remember them getting pretty thoughtful and committed in times past. “And that 10 percent,” Levine adds, “only includes the ‘official antidepressants’ such as Prozac, Paxil, Zoloft, Lexapro, Wellbutrin, Effexor, etc. This stat doesn’t include people using ADHD drugs such as Ritalin, Adderall, etc. to stimulate themselves.”

Adderall, Levine explained, is an amphetamine that affects the same neurotransmitters as cocaine (dopamine, serotonin, and norepinephrine), “and if one takes the antidepressant Effexor (affects serotonin and norepinephrine) at the same time one is taking the antidepressant Wellbutrin (affects dopamine), one can sense the hypocrisy in labeling certain psychotropics (drugs that affects neurotransmitters) as ‘antidepressants’ and other psychotropics as ‘ADHD psychostimulants.’ Lots of people — especially young people — are popping ‘Addies’ (street name for Adderall) to ‘motivate’ them to get them through their lives, especially during exam time.”

Levine said he’s counseling a young man who is supplementing his income by selling ADHD psychostimulant drugs to his fellow college students. He gets the best price around final exam time. “He told me, ‘Bruce, you’ve got to do better improving the self-esteem of these young kids who you are counseling.’ Why, I ask him, why do you care? ‘Well,’ he says, ‘these little brats who are getting their freebie prescription Addies feel so crappie about themselves that they are giving away their Addies to their older brothers for free just so they will hang out with them, and all those freebie Addies on the market are driving price down for me.”

Levine stresses that Adderall, like nicotine or caffeine or cocaine, provides a buzz that antidepressants do not. In fact, he points out, the so-called antidepressant drugs make people twice as likely to commit suicide. Levine concedes that some people swear antidepressants have saved their lives, but points out that people will say that about a placebo as well. The evidence, Levine says, shows antidepressants working no better than a placebo at lifting people out of depression.

Antidepressants may bear as Orwellian a name as the Patriot Act, but Levine finds the latter easier to talk about with people. “I get less grief,” Levine tells me, “when I talk about something like anarchism and Emma Goldman than when I talk about antidepressants’ effectiveness and [author] Irving Kirsch, as abstract political ideologies are far less threatening than people’s very own drugs.” Political movements may in fact be less threatening to those in power, because of people’s drugs.

Read article here:  http://www.opednews.com/articles/The-Small-Group-of-Thought-by-David-Swanson-110523-181.html

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You’re Fired: Forest Lab’s CEO May Be Banned from Federal Healthcare

Tuesday, April 19th, 2011
Project on Government Oversight, April 19, 2011
By Paul Thacker

In a civil complaint, federal prosecutors alleged that Forest hid from parents and doctors the results of a study indicating that Lexapro might increase the risk of suicide in kids.

As reported at Pharmalot, the CEO of Forest Laboratories received an unfortunate letter last week, demanding that he explain within 30 days why he should not be excluded from participation in federal healthcare programs. Banning Mr. Howard Solomon would prevent Forest from billing the government—every pharma company’s largest customer—and effectively end his over thirty-year tenure as CEO.

The company’s board expressed shock.

“It would be completely unwarranted to exclude a senior executive against whom there has never been any allegation of wrongdoing whatsoever,” said board member William J. Candee III, in a Forest statement. “Mr. Solomon has always set a tone of the highest integrity from the top.”

Oh, really?

The move to exclude Mr. Solomon apparently stems from Department of Justice accusations of fraud in 2009 related to Lexapro, an antidepressant. In a civil complaint, federal prosecutors alleged that Forest hid from parents and doctors the results of a study indicating that Lexapro might increase the risk of suicide in kids. Meanwhile, the complaint alleges, the company was promoting another clinical trial—financed by Forest, naturally—showing Lexapro’s effectiveness.

Prosecutors also charged the company with providing kickbacks to doctors in the form of sports tickets, expensive meals, and paid vacations.

For this last allegation, we really don’t need to rely on the good word of attorneys at DOJ. Take a gander yourself at Forest Lab’s “Fiscal Year 2004 Marketing Plan” for Lexapro. As reported by The New York Times, 80 pages of this confidential document were made public by investigators working for Senator Charles Grassley (R-IA).

“Fiscal Year 2004 Marketing Plan”

Under “Marketing Tactics,” the document said the company planned to create bylined “or ghostwritten” articles. “We will identify a Lexapro thoughtleader to place 2-3 bylined articles in trade journals, consumer publications and on the Internet.”

The estimated cost for the ghostwriting program was $100,000.

Bylined articles

Another sales tactic was funding continuing medical education (CME) courses, the classes doctors take to remain current about patient treatment. Believe it or not, doctors actually allow companies to pay for their education. And get this: some doctors believe that companies won’t use this opportunity to influence prescribing. Makes you want to question your doctor’s intellect, no?

Forest’s estimated CME budget to push Lexapro in 2004? $11.9 million.

Maybe we should change the acronym’s meaning to Corporate Marketing Education (CME)?

Other marketing schemes included “lunch and learns” for $36 million. “Providing lunch for a physician creates an extended amount of selling time for representatives,” the document said.

The old lunch n learn

I suspect Forest was not serving PB&J.

And of course, Forest’s marketing plan taps Zelig himself, Dr. Charles Nemeroff. Can we ever escape him? In this case, Dr. Nemeroff’s bounty was a mere $100,000 in the form of an “unrestricted educational grant” to Emory University.

“Public relations activities surrounding this initiative to raise the awareness of Forest’s support in the field of psychiatry will be explored,” the document said.

At POGO, we’re more than happy to help Forest in this public relations endeavor.

So here’s where things get a little tricky and a tad bit confusing. Despite the damaging evidence staring them in the face, Forest seems nonplussed by DOJ’s action against their CEO.

“Numerous other major pharmaceutical companies have plead guilty to much more egregious offenses, and none of them has faced the exclusion of a senior executive who has not himself been convicted of a crime or pleaded guilty to a crime,” stated Herschel S. Weinstein, Vice President and General Counsel.

True. But we thought the “everybody else was doing it too, Mom,” defense went out in middle school. Guess we were wrong.

The government has been signaling for the last couple years that pharmaceutical executives should expect to become targeted for prosecution or debarment. Mr. Solomon is just the latest turn of the screw.

Expect more activity in the future.

Full Disclosure: The Forest Laboratories marketing document was released as part of my duties as an investigator for Senator Grassley

Paul Thacker is a POGO Investigator.

http://pogoblog.typepad.com/pogo/2011/04/youre-fired-forest-labs-ceo-may-be-banned-from-federal-healthcare.html

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Panel to Examine Murder and Suicide Associated With Antidepressants

Tuesday, March 22nd, 2011

The Huffington Post, March 22, 2011
by Dr. Peter Breggin

Click image to visit the Psychiatric Drug Database

On Saturday morning April 9th of this year, a panel discussion will be held for the public and professionals on the theme of “Psychiatric Drug Tragedies: Personal, Legal and Medical Perspectives.”

The two-hour presentation focuses on suicide and murder potentially caused by antidepressant medications. It is part of the international Empathic Therapy Conference put on by the Center for the Study of Empathic Therapy, Education & Living (April 8-10, 2011 in Syracuse, New York).

The panel will present a unique examination of an antidepressant-related suicide from three perspectives: Mathy Downing, the mother of a twelve-old-child who committed suicide; Karl Protil, the lawyer in her case, which was settled without any admission of negligence; and myself as the medical expert in the case. Mathy will be accompanied by her surviving daughter. Other family members will tell the stories of two more children who committed suicide, a father who committed suicide, and a husband who murdered his two young children–all while taking prescribed antidepressants.

A great deal is now known about suicide and violence in association with the newer antidepressants such as Prozac (fluoxetine), Paxil (paroxetine), Zoloft (sertraline), Luvox (fluvoxamine), Celexa (escitalopram), Lexapro (escitalopram), Cymbalta (duloxetine), Effexor (venlavaxine), Pristiq desvenlafaxine), and Wellbutrin (bupropion).

The FDA has imposed a Black Box on all antidepressant labels that warns against the risk of suicidal behavior in children, youth and young adults. Click here to find the example of Prozac’s official prescribing information. More importantly and more broadly, the new labels also warn about the risk of aggression, hostility, mania, and an overall worsening of the individual’s mental condition, for all ages. The new FDA-approved labels also include a Medication Guide, which the FDA urges prescribers to give to patients and their families. Originally intended for children taking antidepressants, it now has no age limitation and pertains to all ages. The Medication Guide warns patients and their families to be aware of the possibility of suicidal and violent behavior, mania, and a long litany of other dangerous mental abnormalities.

The new FDA-approved antidepressant labels confirm that the risks are highest at the start of medication therapy or during changes in dose, either up or down. To a great extent, the labels read like my prior publications, one of which was given by the FDA to its outside expert committee that recommended the changes to the labels.

Unfortunately, many psychiatrists, internists, family doctors, nurse practitioners and other professionals continue to prescribe these medications, too often without providing adequate information to the patient and the family. As a result, I was asked to write about the implications of these new labels for the most widely read psychiatric journal for primary care prescribers. The panel at the Empathic Therapy Conference, the first of its kind, will explore these tragedies and put a human face on them through the presence and presentations of surviving family members.

Other aspects of the conference will describe empathic approaches to helping a wide variety of emotional conditions and problems in children and adults. Speakers will bring unique and inspiring approaches to children and adults given psychiatric diagnoses, ordinary folks who are suffering from stress, street people overcome by psychosis, military personnel recovering from PTSD and head injuries, and elderly victims of dementia. Professionals and the general public are welcome at the Empathic Therapy Conference in Syracuse, New York, April 8-10, 2011. Continuing education credits (CEs) for 29.5 hours are available.

Peter R. Breggin, MD is a psychiatrist in private practice in Ithaca, New York, and the author of dozens of scientific articles and more than twenty books including Toxic Psychiatry: Why Therapy, Empathy and Love Must Replace the Drugs, Electroshock and Biochemical Theories of the “New” Psychiatry, as well as his newest book, Medication Madness. The Empathic Therapy Conference brings together more than forty presenters and a diverse audience from around the world. Professionals and nonprofessionals are welcome. Learn about the conference at http://www.empathictherapy.org.

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Billion Dollar Drug Company Law Firm Restructures Connecticut Welfare System

Thursday, March 10th, 2011

By Bob Fiddaman and Shelia Matthews
March 10, 2011

For some time now, Sheila Matthews has been suspicious about her home state of Connecticut’s treatment of its most vulnerable children. As a mother of two children and co-founder of Ablechild, her instincts led her to scrutinize the dubious relationships among Connecticut’s Department of Children and Family Services [DCF], the pharmaceutical industry and a billion dollar law firm who has defended the likes of Pfizer Inc and Merck & Co., among others.

Sheila’s investigation has led her on a journey that links a non-profit children’s advocacy group, with assets over $15 million [2009] with nationally-renowned mass tort and class action defense law firms, to the Connecticut DCF – an $865 million bureaucracy, as described by the Connecticut Mirror.

The Connecticut DCF serves approximately 36,000 children and 16,000 families across its four Mandate Areas:

1. Child welfare;
2. Children’s behavioral health;
3. Juvenile Services; and
4. Prevention.

Sheila’s Ablechild has been questioning the Connecticut DCF since 2003, when Ablechild demanded that the Connecticut DCF immediately ban the use of the antidepressant Paxil in its treatment of mental disorders after multiple studies confirmed Paxil increased the risk of suicide in children and adolescents. This was more than a year prior to America’s Food & Drug Association (FDA) announcement that all antidepressants, including Paxil, should bear a black box warning regarding this suicide risk. Ablechild was disturbed that children in state custody were being prescribed this dangerous psychotropic medication. Ablechild’s public pressure paid off, and the Connecticut DCF deemed Paxil unsafe for children and adolescents, and according to the DCF drug approval list, Paxil has not been approved for use in over eight (8) years.

In August 2003, less than one month later, Ablechild reported that the commissioner of the Connecticut DCF held a ‘behind closed doors‘ meeting with Glaxo officials. This meeting was reported by the Associated Press, who wrote:

The maker of the anti-depressant Paxil plans to meet this week with Connecticut officials, weeks after the State stopped using the drug to treat young people in its care.

GlaxoSmithKline, a British pharmaceutical company, is sending its regional medical director and a medical team to meet with officials from the Department of Children and Families. [Source]

Despite repeated requests from Ablechild, the Connecticut DCF refused to inform the public what was discussed at this secret meeting.

Eight years later, Sheila and Ablechild continue to raise concerns and investigate potential wrongdoings and conflicts within the Connecticut DCF. Last month, in February 2011, Sheila attended a meeting sponsored by the Connecticut Behavioral Health Partnership [CBHP], where its medical director, Dr Steven Kant, presented the Husky Behavioral Pharmacy Data. The CBHP is a state vendor that provides mental health services to DCF children. These services are paid, in part, by the State-run insurance program, HUSKY. Incredibly the pharmacy data presentation showed that dangerous psychotropic drugs, like Paxil, are still being prescribed to thousands of children and adolescents. In fact, the Pharmacy Data presentation showed that the HUSKY program, financed by taxpayer dollars, paid drug companies over $60 million for psychotropic drugs for Connecticut’s children and adolescents in 2009 alone – many of which are not approved by the FDA for use in the pediatric population and all of which carry the most serious warning possible regarding the risk of suicide.

According to the pharmacy data presentation: [Which can be downloaded as a Powerpoint presentation HERE]

More than 50% of HUSKY Youth Behavioral med utilizers are on stimulants.
Close to 30% of HUSKY Youth Behavioral med utilizers are on antipsychotics.

The pharmacy data also revealed the following:

Most Frequently Used Behavioral Meds for DCF-Involved Youth

Medications for ADHD

Ritalin (10%)
Adderall (5%)
Vyvanse (4%)
Strattera (3%)

Atypical Antipsychotics

Abilify (11%)
Risperdol (10%)
Seroquel (8%)

Anti-anxiety

Hydroxyzine (2.5%)

Antidepressants

Prozac (4.5%)
Zoloft (4%)
Zyban (3%)
Desyrel (2.5%)
Celexa (2%)

Mood Stabilizers

Lithum (3%)
Depakote (3%)
Lamictal (2.5%)

Curiously, none of the above medications are on the Connecticut DCF list of approved/unapproved drugs listed in its DCF PMAC document.

With this in mind, Sheila Matthews contacted Dr Steven Kant and inquired as to whether any of the above drugs were approved by the Connecticut DCF for use in children.

Dr Kant replied:

… the answer to your question is not that straight forward.. . . Medications may be indicated by age and/or by specific treatment needs so it is not either a simply “yes” or “no”. Also, some medications may have the age indication but for a totally different condition, such as anti epileptic condition. . .Also FDA indications are static, they do not change over time though medical practice is constantly evolving…

Contradicting the very document that lists Connecticut’s approved and unapproved drugs, a “check-off” list that verifies the status of medications, Dr Kant replied, “I don’t think a “check off” for each medication would work in terms of verifying their status.”

With such an ambiguous response from Dr. Kant, we found the DCF Approved Medication List on the Internet. This particular version was revised in 2009.

It appears that the DCF has approved drugs in children that have not been approved for children by the FDA. In fact, the FDA has issued multiple advisories and alerts since 2004 about the increased risk of suicide in children, adolescents and young adults up to age 25 who are treated with psychotropic medications.

And while Fluoxetine (Prozac) is the only medication approved by the FDA for use in treating depression in children ages 8 and older, it still carries a black box warning regarding the risk of suicide.

In contrast, the DCF seems to be ignoring the conclusions of the FDA. Its list of approved medication in children and adolescents include every single antidepressant except paroxetine [Paxil] and venlafaxine [Effexor].

Forest Lab’s citalopram [Celexa] – APPROVED

Forest Lab’s escitalopram [Lexapro] – APPROVED

Solvay Pharmaceuticals’ fluvoxamine [Luvox] – APPROVED

Pfizer’s sertraline [Zoloft] – APPROVED

GlaxoSmithKline’s bupropion [Wellbutrin -also marketed as an anti-smoking cessation drug under the name of Zyban] – APPROVED [1]

Alarmingly, the DCF has produced a guide entitled, “MEDICATIONS USED FOR BEHAVIORAL & EMOTIONAL DISORDERS – A GUIDE FOR PARENTS, FOSTER PARENTS, FAMILIES, YOUTH, CAREGIVERS, GUARDIANS, AND SOCIAL WORKERS” where it writes, “Most of the side effects from the medications are mild and will lessen or go away after the first few weeks of treatment.” The guide also points out possible side effects of SSRI’s/SNRI’s:

SSRIs and SNRIs:

Headache
Nervousness
Nausea
Insomnia
Weight Loss

One of the most dangerous side effects of these medications, suicidal thoughts/ideation, doesn’t even make the 5 bullet-pointed list. The Guide does, however, add the following: “Watch for worsening of depression and thoughts about suicide.”

The DCF Approved Medication List writes:

“The DCF Approved Medication List is a list of psychotropic medications that has been carefully established by the Psychotropic Medication Advisory Committee, a group of DCF and community professionals.”

Sheila has since investigated other advocacy groups that were concerned about the off-label prescribing of psychiatric medications to youths in state custody. This is where she stumbled upon Children’s Rights, a non-profit charity based in New York City.

In 2005, Children’s Rights employed ten (10) attorneys and a staff of 31. It claims to use its expertise to change child welfare red tape and scrutinize failing systems. If the child welfare system fails to respond, Children’s Rights files a lawsuit. If successful, it enforces reform and then monitors its implementation.

In 1989, Children’s Rights had in fact filed a suit against William O’Neill and the Connecticut state Department of Children and Youth Services [DCYS].

The suit charged that an overworked and underfunded DCYS failed to provide services including abuse and neglect investigations, adoption, foster care, mental health care, caseloads and staffing. The case has been pending for over twenty (20) years, and while there have been numerous arguments that DCYS should be more inclusive or has failed to provide certain services, the issue of massive off-label prescription of psychotropic medications has never been brought to the court’s attention.

Children’s Rights is chaired by Alan C Myers, a partner at Skadden, Arps, Slate, Meagher and Flom, a billion dollar law firm which represents the pharmaceutical industry in mass torts and class actions. Myers is also co-head of the firm’s REIT Group [Real Estate Investment Trust].

Also, listed on the Children’s Rights website are individuals and law firms that have served as co-counsel on Children’s Rights’ legal campaigns to reform America’s failing child welfare systems, including:

Missouri - Shook Hardy & Bacon – Eli Lilly Co. and Forest Labs, defended the original Wesbeker Prozac trial in Kentucky and still defend Prozac, Celexa and Lexapro.

New Jersey – Drinker Biddle & Reath – GlaxoSmithKline attorneys – defended Paxil as local counsel in Philadelphia cases.

Oklahoma – Kaye Scholer LLP – provides work in Pharmaceutical Products Liability defense and employs an attorney who was former General Counsel of Pfizer, Inc.

A particular success for Skadden Arps occurred in 2010 when it secured a summary judgement ruling for Pfizer Inc. in a suit filed by two insurance companies who sought $200 million in damages for Pfizer’s predecessors alleged “off-label” marketing of its epilepsy drug, Neurontin.

Furthermore, in February 2011, Skadden Arps secured the dismissal of over 200 cases in a multi-district litigation pending against their client, Pfizer Inc. The plaintiffs had alleged injuries related to the use of Pfizer’s anti-epilepsy drug, Neurontin.

Neurontin, the generic version is called gabapentin, is prescribed by psychiatrists for a variety of “off-label” indications. It is often tried as an alternative treatment, when patients are unable to tolerate the side effect of more proven mood stabilizers such as lithium. [2]

Gabapentin has also been associated with an increased risk of suicidal acts or violent deaths.

This is a drug that has been known to cause behavioral problems, which include unstable emotions, hostility, aggression, hyperactivity or lack of concentration.

Children dependent on child welfare systems have rights and, according to its web page, Children’s Rights is dedicated to protecting them.

It should come as no surprise that the site fails to discuss the off-label prescription of non-approved psychotropic medications to children and adolescents, unless this falls under the ‘abuse and neglect’ category?

If Children’s Rights’ motive was to accomplish fixing the child welfare system then why hasn’t it investigated why thousands of children under state care are prescribed “off-label” psychiatric drugs? With a partner in a billion dollar pro-pharmaceutical law firm as its Chair, and supporters who also defend pharmaceutical products, is it safe to assume that its stance on the drugging of children is one that is being ignored?

Children’s Rights push to remove abused and neglected children into safety.

The basic question always comes down to trust. When power, money and a good cause is mixed, it is imperative to check motives. We would be less of a society if we didn’t check out all the facts. Abuse and neglect exist, always has and always will, but society is obligated to ensure those victims are not transformed into “good cause victims” and expensed out. There is no doubt we have a right to question the system and those who claim to promote change for the good of the children within it.

Children’s Rights Chairman, Alan C. Myers, Medical Director of Connecticut Behavioral Health Partnership, Steven Kant and the Connecticut Department of Children and Families may get their knickers in a twist with regard to an advocate of Ablechild and a blogger from Birmingham, UK questioning their motives but hey, what’s the downside of shinning a light on all these players, be they good or bad players?

Sheila’s concern is that Children’s Rights with its multi-million dollar budget and with the help of its billion dollar law firms, will continue to ignore the risks of these unapproved and dangerous medications, under the guise of helping our nation’s most vulnerable children. The question remains: how can the lawyers who defend psychotropic drugs also be the same lawyers who advocate for abused and neglected children to get into state welfare programs which place these children on the same drugs? The conflict is clear and obvious – and it poses an unmistakable danger to children who truly need our help.

[1] Bupropion [also known as Wellbutrin, Zyban] is a non-tricyclic antidepressant.
[2] Gabapentin

Bob Fiddaman is the author of the Seroxat Sufferers blog and the book, “The evidence, however, is clear… the Seroxat scandal.” Chipmunka Publishing.

Sheila Matthews is the co-founder of Ablechild and a mother of two children.

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Forest Pharmaceuticals Sentenced to Pay $164 Million for Criminal Violations

Wednesday, March 2nd, 2011

UNITED STATES DEPARTMENT OF JUSTICE

Office of Public Affairs—March 2, 2011

WASHINGTON — Drug manufacturer Forest Pharmaceuticals Inc. was sentenced today by U.S. District Judge Nancy Gertner to pay a criminal fine of $150 million and forfeit assets of $14 million following the company’s guilty plea in November 2010 to one felony count of obstructing justice, one misdemeanor count of distributing an unapproved new drug in interstate commerce and one misdemeanor count of distributing a misbranded drug in interstate commerce, the Justice Department announced. The company, a subsidiary of New York City-based Forest Laboratories Inc., pleaded guilty to charges related to obstruction of an FDA regulatory inspection, to the distribution of Levothroid, which at the time was an unapproved new drug, and to the illegal promotion of the anti-depressant drug Celexa for use in treating children and adolescents.

Today’s sentencing of Forest was the final component of a global resolution totaling more than $313 million to resolve criminal and civil allegations against Forest and its parent company in connection with the distribution and marketing of certain drugs. In September 2010, Forest Laboratories and Forest Pharmaceuticals entered a civil settlement to resolve False Claims Act charges involving three of its drugs: Levothroid, Celexa and Lexapro. As part of the civil settlement, Forest agreed to pay more $149 million, including more than $88 million to the federal government and more than $60 million to the states.

According to court documents, Forest Pharmaceuticals began distributing Levothroid for treatment of hypothyroidism in the early 1990s without first obtaining Food and Drug Administration (FDA) approval. In 1997, the FDA, after determining that the drugs were medically necessary, gave manufacturers a certain amount of time to conduct the necessary studies and obtain FDA approval. In 2001, the FDA stated that it would continue to permit manufacturers of unapproved levothyroxine sodium drugs to distribute their unapproved drugs after Aug. 14, 2001, on certain conditions. One of those conditions was that any manufacturer which had not obtained approval needed to comply with a gradual distribution phase-down of its unapproved drug until it obtained FDA approval. According to court documents, Forest made a deliberate decision to continue distributing its unapproved Levothroid product in quantities far exceeding the amounts permitted by the FDA’s distribution phase-down plan.

The FDA sent a warning letter to Forest Pharmaceuticals on Aug. 7, 2003, informing the company that it was no longer entitled to distribute its unapproved Levothroid product.

According to prosecutors, after Forest received the letter, the company directed its employees at its St. Louis distribution center to work overtime until approximately 1:00 a.m. the following morning and, during that time, to continue shipping as much of its unapproved Levothroid as possible.

Court documents also indicate that Forest obstructed an FDA regulatory inspection relating to Levothroid at Forest’s Cincinnati plant in November 2003. According to prosecutors, management personnel at the Cincinnati plant were aware that serious equipment malfunctions had resulted in testing conditions that, for hundreds of days and thousands of hours, did not comply with the FDA’s requirements for Levothroid that had been manufactured for research purposes. Prosecutors stated that in an attempt to remedy this problem, certain Forest management personnel at the Cincinnati plant decided to use a portable home humidifier in the testing room as a temporary fix. Later, when FDA inspectors saw this humidifier in the testing room during a regulatory inspection of the plant, certain management personnel falsely told the investigators that the portable humidifier was merely being stored in the room and had not been used for humidity control. This conduct was the basis for the felony obstruction charge to which Forest pleaded guilty.

Forest halted its commercial distribution of its unapproved version of Levothroid as of August 9, 2003. Since the fall of 2003, Forest has been commercially distributing a different orally administered levothyroxine sodium drug, also called Levothroid. This resolution does not involve that product.

Regarding Celexa, court documents state that Forest promoted the drug for use in treating children and adolescents suffering from depression despite the fact that the FDA had only approved the drug to treat adult depression. Prosecutors stated that Forest’s off-label promotion consisted of various sales techniques, including directing its representatives to promote pediatric use of Celexa in sales calls to doctors who treated children and adolescents, and hiring outside speakers to talk to pediatric specialists about the benefits of prescribing Celexa to children and teens. Prosecutors stated that in conjunction with this off-label promotion, Forest aggressively publicized the positive results of a double-blind, placebo-controlled Forest study on the use of Celexa in adolescents while, at the same time, Forest Pharmaceuticals suppressed the negative results of a contemporaneous double-blind, placebo-controlled European study on the use of Celexa in adolescents.

” Forest Pharmaceuticals pleaded guilty to obstructing justice and marketing drugs for unapproved uses, including improperly promoting an anti-depressant to children and adolescents,” said Tony West, Assistant Attorney General for the Justice Department’s Civil Division. “As the court’s stiff sentence demonstrates, not only is such conduct unacceptable, taxpayers should not foot the bill for practices that violate the law.”

“Both the criminal and civil cases were predicated upon the fact that Forest Pharmaceuticals made a calculated decision to place a higher priority on increasing corporate sales than on complying with the basic, legal requirements that Congress and the FDA created to protect the American public,” said Carmen Ortiz, U.S. Attorney for the District of Massachusetts.

In addition to its sentence today, and previously agreeing to a civil settlement, Forest also previously signed a Corporate Integrity Agreement with the Department of Health and Human Services, Office of Inspector General (HHS-OIG).

“Today’s sentencing of Forest Pharmaceuticals is a victory for the system designed to protect patients from potentially harmful prescription drugs,” said Daniel R. Levinson, Inspector General of the Department of Health & Human Services. “Attempts to circumvent that system by selling misbranded and unapproved drugs simply will not be tolerated.”

The criminal case was investigated and prosecuted by Assistant U.S. Attorney James E. Arnold of the U.S. Attorney’s Office for the District of Massachusetts and Trial Attorney Jeffrey I. Steger of the Justice Department’s Office of Consumer Litigation. The case was investigated by agents from the FBI, the HHS-OIG, the FDA’s Office of Criminal Investigations and the Department of Veterans Affairs’ Office of Inspector General. Assistance was also provided by the FDA’s Office of General Counsel and the Office of Personnel Management.

http://www.justice.gov/opa/pr/2011/March/11-civ-270.html

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Parents Warn of Possible Psychiatric Drug Dangers

Saturday, November 27th, 2010

The Post & Courier

by Glen Smith

Matthew Steubing committed suicide by jumping from the Silas Pearman Bridge in Charleston on July 18, 2003. He was 18.Matthew Steubing committed suicide by jumping from the Silas Pearman Bridge in Charleston on July 18, 2003. He was 18.

Darkness hung over Charleston Harbor as Matthew Steubing parked his Ford pickup truck on the aging bridge and left a note on the seat beside his Bible. He put on a life jacket and began to climb — up, up, into the span’s superstructure.

Then, he jumped.

His parents were waiting for Matthew to arrive home in Winchester, Va., when they received the news on July 18, 2003. Their 18-year-old son plunged more than 160 feet from the Silas Pearman Bridge before slamming into the Cooper River. He was gone.

“Our world blew apart,” his mother, Celeste Steubing, said. “We couldn’t imagine this happening because this wasn’t Matthew. … It made no sense.”

Matthew, the youngest of six children, had been a vibrant kid, happy and full of life. But after a rough patch in his senior year of high school left him feeling down, a psychologist suggested he would benefit from the antidepressant drug Lexapro. He soon became withdrawn and anxious, his parents recalled during a recent visit to Charleston.

Matthew committed suicide just nine weeks after starting on the drug. Only later did his family learn that antidepressants carry a heightened risk of suicide in children, the Steubings said.

The Steubings have made it their mission to warn other parents about the hidden dangers of psychiatric drugs. To that end, Celeste Steubing was featured in the recently released documentary, “Dead Wrong,” produced by the Los Angeles-based Citizens Commission on Human Rights.

The 90-minute film profiles Matthew’s story and documents Celeste Steubing’s travels to speak with doctors, health experts, drug counselors and other mothers with painful tales of loss associated with psychiatric drugs.

Forest Laboratories, makers of Lexapro, would not comment on Matthew Steubing’s case but defended the drug’s safety in a prepared statement. The company stated that antidepressants such as Lexapro have been associated with a substantial reduction in the suicide rate in the United States.

“Forest has tremendous sympathy for any family dealing with the suicide of a loved one, and Forest understands that family members dealing with such a tragedy often are looking for answers,” the statement read. “However, Lexapro is a safe and effective medication for the treatment of major depressive disorder in patients as young as 12, when used according to the FDA-approved package insert.”

Celeste Steubing and her husband, Daniel, said Matthew had never been suicidal before going on the drug, which was prescribed by a doctor to correct a perceived chemical imbalance.

The couple said they would not have given Matthew the Lexapro had they known it carried a risk of increased suicidal thinking and behavior in children and young adults. The drug’s label now carries that “black box” warning.

Matthew quickly went downhill on the drug, the Steubings said. He had trouble sleeping, lost weight and seemed agitated and out of sorts. Normally outgoing, he became distant and isolated, they said.

“He was like a caged cat,” his father said. “We couldn’t understand what was happening to him.”

After balking at a long- anticipated beach trip with friends, Matthew opted to travel to Charleston in July 2003 to visit his older brother Eric, who was attending college here. He stayed for 10 days before bidding his brother goodbye on July 18, 2003. Matthew called his mother that day to report his progress heading home. His last call indicated he had just passed through Roanoke, Va.

In reality, Matthew was still in the Charleston area, apparently planning his own death. In the note he left behind, he indicated that he wore a life vest so his family wouldn’t have to look for his body and worry about where he was.

After reading an article about a possible link between antidepressants and suicide, the Steubings started digging and doing research of their own. The more they learned, the angrier they got.

They went on to testify at a 2004 Food and Drug Administration hearing in Washington, D.C., that led to the warning labels. Telling Matthew’s story still brings pain and tears, but they continue to speak out.

“It’s important so that other parents don’t have to go through the heartache and anguish we have,” Celeste Steubing said. “So that other parents don’t have to miss their children for the rest of their lives like we do.”

http://www.postandcourier.com/news/2010/nov/27/parents-warning-others/

To view the documentary, Dead Wrong: How Psychiatric Drugs Can Kill Your Child,  click here http://www.cchr.org/take-action/parents/message-to-parents.html

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