Tuesday, August 31, 2010

Government Sanctioned Killing of Our Veterans - Off label prescribing of AstraZeneca's Seroquel for PTSD & Insomnia

Government Sanctioned Killing of Our Veterans - off label prescribing of AstraZeneca's Seroquel for PTSD & Insomnia

This vital and important topic has recycled once again to the top of many news outlets over the past couple of days, yet it is not new news by any stretch of the imagination. This has been around for some time while absolutely nothing appears to have been done except the increased dosing of our veterans with anti-psychotic drugs for off label uses resulting in more needless and tragic deaths. Shall I repeat that for our government officials that maybe reading: NOTHING HAS BEEN DONE!! WHY?

Recent Links:

Off-label use of Seroquel, other prescription drugs for PTSD kills Veterans: Cardiac Deaths not suicide

we don’t need it…@1 boring old man

http://tinyurl.com/2g8x5j4

Questions loom over drug given to sleepless vets

Is The Drug Seroquel Killing Soldiers and Veterans

Here I will bring to the top a posting on this blog from March 7, 2010

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Pharma targets Veterans with anti-psychotic cocktails for PTSD

I really don't have much more to say, since this article speaks volumes. What it does highlight with disturbing clarity, is how far and what lengths Big Pharma will go to market their product to make money. If you happened to read my last post, you should be able to find the correlation between easy questionable DSM diagnostics and the over drugging of citizens out of pure greed and profiteering.
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alternet.org_veterans_being_given_deadly_cocktails_to_treat_ptsd

By Martha Rosenberg

Are Veterans Being Given Deadly Cocktails to Treat PTSD?

A potentially deadly drug manufactured by pharmaceutical giant AstraZeneca has been linked to the deaths of soldiers returning from war. Yet the FDA continues to approve it.
March 6, 2010


Sgt. Eric Layne's death was not pretty.

A few months after starting a drug regimen combining the antidepressant Paxil, the mood stabilizer Klonopin and a controversial anti-psychotic drug manufactured by pharmaceutical giant AstraZeneca, Seroquel, the Iraq war veteran was "suffering from incontinence, severe depression [and] continuous headaches," according to his widow, Janette Layne.

Soon he had tremors. " … [H]is breathing was labored [and] he had developed sleep apnea," Layne said.

Janette Layne, who served in the National Guard during Operation Iraqi Freedom along with her husband, told the story of his decline last year, at official FDA hearings on new approvals for Seroquel. On the last day of his life, she testified, Eric stayed in the bathroom nearly all night battling acute urinary retention (an inability to urinate). He died while his family slept.

Sgt. Layne had just returned from a seven-week inpatient program at the VA Medical Center in Cincinnati where he was being treated for post-traumatic stress disorder (PTSD). A video shot during that time, played by his wife at the FDA hearings, shows a dangerously sedated figure barely able to talk.

Sgt. Layne was not the first veteran to die after being prescribed medical cocktails including Seroquel for PTSD.

In the last two years, Pfc. Derek Johnson, 22, of Hurricane, West Virginia; Cpl. Andrew White, 23, of Cross Lanes, West Virginia; Cpl. Chad Oligschlaeger, 21, of Roundrock, Texas; Cpl. Nicholas Endicott, 24, of Pecks Mill, West Virginia; and Spc. Ken Jacobs, 21, of Walworth, New York have all died suddenly while taking Seroquel cocktails.

Death certificates and other records collected by veteran family members show that more than 100 similar deaths have occurred among Iraq and Afghanistan combat vets and other military personnel, many of whom took PTSD cocktails that included Seroquel and other antipsychotics, antidepressants, mood stabilizers, sleep inducers and pain and seizure medications.

Since the 2008 publication of "The Battle Within," the Denver Post's expose of a "pharmaco-battlefield" in Iraq, in which troops were found to be routinely propped up on antidepressants, the Department of Defense has sought to curb the deployment of troops with mental health problems to combat zones. The DOD has also stepped up monitoring of soldiers who have been medicated, according to the Hartford Courant, and with good reason: 34 percent of the 935 active-duty soldiers who made suicide attempts in 2007 were on psychoactive drugs.

But the U.S. Army's Warrior Care and Transition Office reports that soldiers are dying after coming home, many in Warrior Transition Units that were established in 2007 to prepare wounded soldiers for a return to duty or civilian life. According to the Army Times, between June 2007 and October 2008, 68 such veteran deaths were recorded -- nine were ruled suicides, six are pending investigation and six were from "combined lethal drug toxicity." Thirty-five were termed "natural causes."

The mysterious deaths -- and an alarming track record -- have cast renewed scrutiny on Seroquel. Although it has not been approved for treatment of PTSD, Pentagon purchases of Seroquel nearly doubled between 2003 and 2007. Elspeth Ritchie, medical director of the Army's Strategic Communications Office told the Denver Post the drug is "increasingly utilized as an adjunct for PTSD."

The Seroquel Scandals

It would be hard to find a drug with a wider fraud footprint than Seroquel -- at least one that's still on the market.

One of its first backers, Richard Borison, former chief of psychiatry at the Charlie Norwood VA Medical Center, lost his medical license, was fined $4.26 million and went to prison for a swindle involving Seroquel's original clinical studies.

AstraZeneca's U.S medical director for Seroquel, Dr. Wayne MacFadden, had sexual affairs with two different women doing research on Seroquel, a study investigator at London's Institute of Psychiatry and a Seroquel ghostwriter at the marketing firm, Parexel. According to court documents, MacFadden even joked about the conflicts of interest with one paramour.

Last year, the Chicago Tribune and ProPublica reported that Chicago psychiatrist Michael Reinstein, who wrote 41,000 prescriptions for Seroquel, received $500,000 from AstraZenenca. Meanwhile, a report in the Minneapolis Star Tribune discredited influential studies by AstraZeneca-funded Charles Schulz, MD, chief of psychiatry at the University of Minnesota.

Seroquel was even promoted by the disgraced former chief of psychiatry at Emory University School of Medicine, Charles Nemeroff, who was accused by congressional investigators of failing to report $1 million in pharmacological income -- in AstraZeneca-funded continuing medical education courses.

And until a Philadelphia Inquirer expose last year, Florida child psychiatrist Jorge Armenteros, a paid AstraZeneca speaker, was chairman of the FDA Psychopharmacologic Drugs Advisory Committee responsible for recommending Seroquel approvals.

In a trial that began in New Jersey last month, AstraZeneca is defending itself in one of 26,000 lawsuits, denying that Seroquel caused diabetes in Vietnam veteran Ted Baker, who was prescribed Seroquel for PTSD. Last year, London-based AstraZeneca agreed to pay $520 million last year to settle suits pertaining to clinical trials and illegal Seroquel marketing.

Yet, instead of reconsidering a drug linked to an alarming number of deaths and marred by at least eight corruption scandals in 13 years -- Seroquel was even prescribed to a 4-year-old Massachusetts girl, Rebecca Riley, before her death -- the FDA continues to issue approvals for new uses for Seroquel.

Seroquel was first approved to treat schizophrenia in 1997. The FDA subsequently expanded its use, approving it for "acute manic episodes associated with Bipolar I Disorder" in 2004, "major depressive episodes associated with Bipolar Disorder" in 2006 and "maintenance treatment for Bipolar I Disorder" in 2009.

Last April, the FDA opened the door to prescribing Seroquel to people who have not even been diagnosed with schizophrenia or bipolar disorder, approving Seroquel as "an additional therapy in patients suffering from depression who do not respond adequately to their current medications."

Not that Seroquel needed a boost; its $4.9 billion in sales in 2009 signals usage far beyond the 1 percent of the population with schizophrenia and the 2.5 percent with bipolar disorder. North Carolina's Medicaid spends $29.4 million per year on Seroquel -- more than any other drug, according to the Charlotte News and Observer.

Most recently, in December, Seroquel was quietly approved for children between the ages of 10 and 17 who are diagnosed with bipolar mania and children between 13 and 17 with schizophrenia. It was a stealth end-of-the-year decision, announced not by the FDA itself but by AstraZeneca. (The change was reflected in an entry on Seroquel's FDA approval page that notes "Patient Population Altered.")

'When six people die from peanut butter we shut the factories down'

With veteran deaths in the news, family members hope the unsolved mysteries surrounding Seroquel-linked deaths of soldiers could finally force AstraZeneca to take responsibility for its product.

Stan and Shirley White lost two sons to war. Robert White, a staff sergeant, was killed in Afghanistan in 2005, when his Humvee was hit by a rocket-propelled grenade. But the death of Robert's younger brother Andrew, who survived Iraq only to succumb to a different battle, is in some ways "harder to accept" says his father.

Like Eric Layne, Andrew was taking Seroquel, Klonopin, Paxil and prescription painkillers for PTSD after returning home from his Iraq tour. Like Layne, he deteriorated physically and mentally on the prescribed cocktail until experiencing a sudden, inexplicable death.

"When six people die from peanut butter we shut the factories down, but at least 87 military men have died in the past six years on Seroquel and similar drugs and no alarm sounds," Stan White told AlterNet.

When White informed his representatives, Sen. Jay Rockefeller and Rep. Shelley Moore Capito of West Virginia, of Andrew's unexplained death, they were helpful, as was Tammy Duckworth, the VA's Assistant Secretary of Public and Intergovernmental Affairs. But packets White distributed to news organizations, Congress and the White House were acknowledged only by First Lady Michelle Obama, who forwarded hers to the VA, and Sen. Daniel Akaka of Hawaii, who chairs the Senate Committee on Veterans Affairs. In letters to White, both remarked that therapy, not just drugs, should be part of PSTD treatment.

A 2008 investigation by the VA's Office of Inspector General into the deaths of Andrew White and Eric Layne was inconclusive, finding "no apparent signal to indicate increased mortality for patients taking the combination of Quetiapine, Paroxetine, and Clonazepam when compared with patients taking other similar combinations of psychotropic medications."

"The direct impact of non-prescribed medications in these patient deaths cannot be determined," investigators concluded.

SSGT (Ret) Tom Vande Burgt's Army National Guard company was stationed outside Baghdad at the same time that Eric and Janette Layne were serving, in 2004 and 2005, but his story has a happier ending.

Like White and Layne, he was prescribed a PTSD cocktail that included Seroquel, along with Klonopin and the antidepressant Celexa, but as tremors, sleep apnea and enuresis (bedwetting) developed, his wife, Diane, questioned the high dosage, off-label use of a bipolar drug like Seroquel. After her husband was taken off his meds abruptly and it was discovered there were no records of the drugs being sent to him (or the doses) by a VA primary care doctor -- mistakes that "could have cost him his life," according to Diane -- the Vande Burgts filed a complaint with the VA Office of the Inspector General. It, however, found no wrongdoing, concluding the treatment was within the VA's "standard of care."

Under the care of a private psychiatrist, Vande Burgt's cocktail only grew, but eventually he went off the drugs with the help of his doctor, and his sleep apnea, urinary problems, tremors, weight gain, depression, mood swings, lethargy and paranoia subsided.

The way Vande Burgt describes it, Seroquel "drugs vets up" to such a degree that they "don't dream at all."

"It wipes out the hypervigilance factor," he told AlterNet via e-mail. "But as soon as the meds are decreased, the hypervigilance and anger and trust issues come raging back, worse than before."

Now the Vande Burgts, who live in Charleston, West Virginia, coordinate a PTSD support group and a Web site that emphasize nondrug solutions and the need for soldiers and veterans to have an advocate present during care for PTSD and traumatic brain injury to ensure clear communication between doctors and patient. Tom also uses the services of Give an Hour, a program in which local therapists donate one hour of therapy a week to veterans, soldiers and families dealing with PTSD.

"There is no cure for PTSD, especially in a magic pill," the Vande Burgts told AlterNet. "Good old-fashioned talk therapy and support groups are tried and true … all the others are just quick fixes that add to the problem, not addressing the root of the problem."

AstraZeneca: Too Big to Regulate?

Seroquel's ability to cause cardiac arrest and sudden death is well-known.

A search of the U.S. National Library of Medicine database yields 20 articles linking "Seroquel" and "sudden death," 24 linking "Seroquel" and "QT prolongation" (a heart disturbance that can led to death), 55 linking "Seroquel" and "toxicity," as well as such terms as "cardiac arrest" and "death."

A 2005 article in the Journal of Forensic Sciences says Seroquel was detected in 13 postmortem cases and the cause of death in three, observing that "little information exists regarding therapeutic, toxic, and lethal concentrations."

A 2003 article in CNS Drugs reports, "some patients have died while taking therapeutic doses," of atypical antipsychotics like Seroquel and that "toxicity may be increased by coingestion of other agents."

"The second-generation antipsychotics were termed 'atypical' based on misconceptions of enhanced safety and efficacy," Dr. Grace Jackson, a former Navy and Veterans Administration psychiatrist and author of Drug-Induced Dementia and Rethinking Psychiatric Drugs, told AlterNet in an interview. ("Atypical" antipsychotics supposedly function differently from "typical" antipsychotics and are thought to cause fewer side effects.)

"In 2002 and 2003, according to a VA study published in 2007, 20 to 30 percent of demented veterans [veterans with brain conditions including organic and psychiatric psychosis] died within the first 12 months of beginning treatment with an antipsychotic," said Jackson. "When you combine antipsychotics with antidepressants, benzodiazepines and antiepileptics -- especially in Iraq/Afghanistan veterans who have likely sustained traumatic brain injuries -- you have potential lethality from sleep apnea, endocrine anomalies and opioid intoxication."

Seroquel's record of causing sudden cardiac death was on the docket at last year's FDA hearings, which Stan and Shirley White and Janette Layne attended.

According to Dr. Wayne Ray, who testified before the FDA's Psychopharmacologic Drugs Advisory Committee, one study involving 93,300 users of antipsychotic drugs -- half of whom were on atypical antipsychotics -- showed that such users were at no less than double the risk of a "sudden, fatal, pulseless condition, or collapse … consistent with a ventricular tachyarrhythmia occurring in the absence of a known, non-cardiac cause."

Ray, professor of preventive medicine at Vanderbilt University School of Medicine, published the findings in an article titled "Atypical antipsychotic drugs and the risk of sudden cardiac death," in the New England Journal of Medicine last year.

Unwilling to let Seroquel's approval prospects sink just because it's dangerous, the FDA's Marc Stone, a medical reviewer, donned his AstraZeneca hat at the hearing. In a presentation rebutting Ray's testimony, he asked how the death certificates in these cases were accurate when "paramedics are more likely to identify some deaths as sudden cardiac deaths?"

"Smoking as an important risk factor for sudden cardiac death is unlikely to appear in the Medicaid claims data used in this study," Stone continued, and, "How do we know smoking wasn't a factor in the deaths -- or that antipsychotic users aren't less likely to 'communicate symptoms of cardiac disease to medical personnel?'" He also pointed out that "Mental illness severe enough to require antipsychotic drugs … may also increase the chances of someone being homeless or living alone with little social contact," apparently forgetting that the purpose of the FDA hearings was to approve Seroquel for non-mentally ill people with anxiety and depression.

Elsewhere, Seroquel for PTSD gets good reviews.

"These data are encouraging for adjunctive treatment with a second-generation [atypical] antipsychotic in patients who have partially responded to an SSRI or an SNRI [antidepressants]," says the American Psychiatric Association's March 2009 Practice Guideline for the Treatment of Patients with Acute Stress Disorder and Posttraumatic Stress Disorder. Matthew J. Friedman, one of its four authors, is executive director of the U.S. Department of Veterans Affairs National Center for PTSD -- and an AstraZeneca consultant.

"Quetiapine improves sleep disturbances in combat veterans with PTSD," wrote Mark Hamner in a 2005 Journal of Clinical Psychopharmacology article. Hamner is medical director of the PTSD clinical team at the Ralph H. Johnson Department of Veterans Affairs Medical Center in Charleston, SC -- and an AstraZeneca consultant.

"Atypical antipsychotics also have an emerging place in PTSD pharmacology, particularly for symptoms of paranoia, intense hypervigilance, arousal, extreme agitation, dissociation, psychotic-type flashbacks, and brief psychotic reactions," writes Cynthia M. A. Geppert in a 2009 Psychiatric Times article. She is chief of consultation psychiatry and ethics at the New Mexico Veterans Affairs Health Care System -- and recipient of three AstraZeneca grants.

Meanwhile, critics and activists ask: What protections are afforded to veterans enrolled in Seroquel studies -- some combining Seroquel with other drugs -- that AstraZeneca-funded doctors conduct at VA medical centers?

Many say that Big Pharma, embedded in academic institutions, medical schools, military medicine, government entitlement programs and the FDA itself is too big to regulate, like Wall Street firms. But others say the incarceration of VA Chief of Psychiatry Richard Borison in 1998 is proof the system works. (Of course, he will be out soon.)
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Monday, August 30, 2010

Pharmaceutical Corporate Criminals - The Deemed Untouchables?


I thought I would bring this post back to the top today since nothing has really changed in the pharmaceutical world since it's original posting except that just possibly things have continued to get worse and more corrupt beyond all fathoming and imagination. Shall I mention recent events involving AstraZeneca and Seroquel as an example, or GSK's Avandia with that whole diabolical scenario, or a whole host of others in the criminal line of examples that could fill the pages here for many weeks and mouths to come. So let me share once more a post I wrote in Dec. 2009 shining a light on these notorious corporate practices.

Pharmaceutical Corporate Criminals - are rewarded with hundreds of billions in profits while our Justice System and Government enables them to continue their reign of terror like "criminal business as usual"


We have an criminal corporate industry with no conscience raking in hundreds of billions of dollars while destroying the health of countless millions; and not only do we have a government that is sitting on their hands doing nothing the stop this catastrophe; they are actually encouraging this criminal activity in the ruse of this being good economics, politics, and medicine.


We have seen this encouraged criminal activity all before in our banking, savings and loan, mortgage, insurance, energy, automotive, and many other areas of global business with horrendous results.

Now we see it clearly once more on a much grander scale in a completely out of control criminal Pharmaceutical Industry. Those with the power to stop it (Our Government and Justice Departments, medicine, education, and the media), are just a heaping addition to this monumental criminal problem.

This should make every corporate conspiracy theorist salivate with the body of evidence now available.


How do these multinational criminal corporations snub their nose at the law, basic ethical and moral behavior, and negatively effect the health & safety of the American people?


They either control or influence the law, the medical modality, and regulatory bodies at just about every level of our society.
The problem cuts dangerously deep into every time honored institution in America. I have listed examples of the over influence and disturbing conflicts of interest we face as a free people; which is demonstrated by how broad the reach of these Corporate entities really are.



Education - Pharmaceutical Corporations are the leaders in funding research and the supporting a medical modality - which is a huge cash cow that just about every medical university has embraced with open arms and outstretched palms. Our educational and research educational systems have become addicted to the money and prestige' Pharmaceutical Corporations can throw at them.

In return Pharma receives favorable questionable leaning research that has been skewed and tainted by egotistical greed mongers that falsely validate their products to the medical establishment and general public. Moral and ethical responsibility for their behaviors are totally lost in this process unfortunately. Pharma has basically hijacked the research and educational system to do their bidding without taking any responsibility for the dire cost this will continue to cause in real human suffering and death toll.



Medicine
- Pharmaceutical Corporations have created a money addiction among doctors and influential key opinions leaders that actually create illness and keep people sick ( let us all be reminded that there is no MONEY in healthy people). They have taken a false and questionable scientific/medical modalities which were once considered rare, and effecting very small segments of the population; and have now main streamed them into validated pandemics among the general population of astronomical and historical proportions.

Let us use "Mental Health Sector" as a stellar example:

Conservative estimates are now saying at least a 1/4 of the population is suffering from a life long psychiatric condition that must be medicated long term.


Yet, we can see that this is a manipulated falsehood by using some fairly common sense logical analysis; If these hundreds of new and dangerous medicines actually worked and mental health related supposed disease's were actually being treated; we would logically be seeing a decrease in the numbers of those disabled and afflicted by these aliments.

But this is not the case in all reality; People are not finding relief from these conditions because the treatments and the diagnosis are ineffective/suspect, and not based in traditional unbiased evidenced based hard science.

People are not getting better in fact; and the created pandemic appears to be increasing exponentially to the point now where a targeted market of "normal children" are being recruited as the next great population of life long customers.


Due to the nature of this radicalization and medicalization of human emotions/behaviors modality; medicine has accepted that harmful side effects and damage will occur from the treatments being used. This is an accepted and anticipated reality with Pharmaceutical Corporations waiting in the wings with new and block-busters treatments for those created ailments also.


Pharma is also famous for using lucrative incentives packages including the control and use the "CME" (continuing medical education) which is the educational segment of medicine used for virtually exclusive advertising and marketing platforms made directly to their best sales people "Doctors".

Pharma has created an endless trail of lucrative financial incentives directly to doctors to advertise, promote, and prescribe drugs that may in fact have little or no therapeutic value at all. The other side of this dark coin is that many of these drugs also come with inherent health risk and side effects which are being hidden from consumers and patients.

What is the authoritative establishment in medicine doing about this imposing threat and danger to your health; basically they are burying their heads in the sand and taking the money.


Government has a huge stake in this lucrative pharmaceutical corporate pie. The Pharmaceutical Industry is one of the most powerful and influential lobbyist groups in Washington DC and in every state capital across this nation. Not only do they spend tens of millions influencing your elected representatives, they also are huge contributors into both major party's election coffers.

They have also reached unabated into regulatory bodies at the FDA (Food and Drug Administration) and DOJ (Department of Justice), wielding unbridled control and influence over every medicine approved directly to you the consumer.

They "Pharma" say quite brashly that "WE ARE JUST TOO BIG AND POWERFUL" for any legislative, judicial, or regulatory body to influence or hold accountable.


Judicial
branches including our courts are not excluded from Pharma's long reaching influence either; The Medical Modality of medicating your emotions and behaviors is now confirmed case law within the justice system.

In fact we now have Mental Health Courts that are based on this very modality that are being used to imprison those deemed mentally diseased (though it's called forced institutionalization and drugging as treatment, they are in fact nothing more than prisons without basic constitutional rights afforded the innocent inmates). In fact that's all the courts are really issuing to those with mental health emotional and behavioral issues.

They have totally bought into Pharma's myth that medication is the only rational treatment for these created pandemic diseases. So now we have courts deciding what your treatment options are, and what basic human rights you may qualify for.

This is paramount to guaranteeing pharmaceutical corporations influential criminal entrenchment in our society for untold decades to come.


I should also mention here how Pharmaceutical Corporations are trying to limit your rights to compensation for the crimes they commit that damage you or your loved ones life. Pharma is hard at work influencing your elected representatives through tort reform and preemption legislation that will make it virtually impossible to hold these criminals accountable for their crimes in civil courts.

We know already that the putrid smallish criminal fines and CIA's (Corporate Integrity Agreements) do nothing what so ever to deter Pharmaceutical Corporations from profiteering further off their continued criminal endeavors. Our Justice Department has shown no willingness or desire to hold these Corporations truly accountable for their blatant transgressions.


All this prior information stated above should add some credence to embolden even the most skeptical citizens to become critical thinkers and demand that immediate action be taken. But there is one key element that really is needed to truly cement these institutionalized crimes into the beyond reproach realm. That is getting the everyday populous to buy into the false message and propaganda.

Mass Media
is that last remaining pad lock validation that is used to bring this perfect storm to a dramatic climax. The Pharmaceutical Corporate Industry has become the largest marketer/advertiser in the world. They spend billions to get their message across through a bombardment of misinformation through direct to consumer advertising on Television, Internet, and in print.

They also rein supreme in Professional Medical Journals using skewed and pseudo science/data/research/clinical studies to ingrain a distorted and false modality right into your local family doctors office.


Then they use a diabolical ruse by funding supposed patient and family advocate organizations that are willing to spread their propaganda directly to patients under the despicable vale of supposed advocacy.

Groups likes NAMI, DBSA, CABF to mention only a few in a much broader scope across all medical supposed advocacy groups/organizations encompassing just about every medical ailment upon the planet at present time. These Pharma funded organizations all walk in lock step with the medication modality because they are paid and funded to do so.

They are beholding to their masters, and their masters are anything but the patients or families; they are in fact the Pharmaceutical Corporations that fund their propaganda campaigns.


Let me personally call out all the major news networks and giant media corporations for not reporting the truth or investigating these crimes being committed upon all of society. CNN, FOX, NBC, CBS, ABC as well as numerous other newspapers, publications, and media giants.

We know these Pharmaceutical Corporations are your new "Cash Cow". We see in every magazine, broadcast, and web-sight the direct influence Pharmaceutical advertisements have on your profitability.

Yet, to not report and ignore the facts/news regarding out of control pharmaceutical corporate crimes because they are your huge "Cash Cow"; goes against all principles of a free press and integrity in journalism.
You have a innate responsibility to the people first and foremost that you obviously must be reminded of here.

I'm definitely not going to be able to portray every detail of this swirling dervish of criminal actions here on this blog; Even if I was a talented enough writer to be able to connect all the dots, and draw a crystal clear picture here for everyone; it would take volumes of data and thousands of pages to even scratch the surface of this validated evil conspiracy.

I will just have to rely on you the reader to read, become knowledgeable, and to demand action and change from your elected representatives.


I have included the following great articles for your reading; because they present a small microcosm of a much larger and entrenched problem we the people must meet head-on, or we will be truly enslaved by real corporate evil with little doubt in the not so distant future.


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from Alliance for Human Research Protection

BIG PHARMA’S CRIME SPREE


Wednesday, 02 December 2009

Rather than having a deterrent effect, the number of Big Pharma high profile criminal settlements is increasing and the settlements are getting bigger. BIG PHARMA’S CRIME SPREE is a riveting report by David Evans in the current issue of Bloomberg Markets Magazine relying on recent criminal legal settlements. It leaves no doubt about the fact that Big Pharma's business practices are defined by criminal activities. Finding cures is not even remotely a consideration by pharmaceutical executives, as it would present a financial conflict of interest.
Shorter online version :
"Across the U.S., pharmaceutical companies have been pleading guilty to criminal charges or paying penalties in civil cases when the U.S. Department of Justice finds that they deceptively marketed drugs for unapproved uses, putting millions of people at risk of chest infections, heart attacks, suicidal impulses or death. Since May 2004,
Pfizer, Eli Lilly & Co., Bristol-Myers Squibb Co. and four other drug companies have paid a total of $7 billion in fines and penalties. Six of the companies admitted in court that they marketed medicines for unapproved uses."

"About 15% of drug sales in the U.S. are for unapproved uses without adequate evidence the medicines work."

The widespread off-label promotion of drugs for untested, unapproved uses is a manifestation of a health-care system that is dysfunctional as it is costly. Americans are paying exorbitant prices for drugs that put their lives at increased risk of death. Indeed, a conservative estimate by the Institute of Medicine (2000) is 106,000 preventable deaths from non-error adverse prescription drug effects.

In September 2007, New York–based Bristol- Myers paid $515 million—without admitting or denying wrongdoing—to federal and state governments in a civil lawsuit brought by the Justice Department. The six other companies pleaded guilty in criminal cases.

The evidence is inescapable: “Marketing departments of many drug companies don’t respect any boundaries of professionalism or the law,” says Jerry Avorn, a professor at Harvard Medical School. Indeed, rather than having a deterrent effect, the number of Big Pharma high profile criminal settlements is increasing and the settlements are getting bigger.

Bloomberg documents how companies such as Pfizer and Eli Lilly--each has been prosecuted repeatedly for the same crimes--are, if anything, emboldened as repeat offenders--ignoring FDA admonitions, as well as promises made to the Department of Justice not to break the law.

In January, 2004, "the Pfizer unit, Warner-Lambert, pleaded guilty to two felony counts of marketing a drug for unapproved uses. New York–based Pfizer agreed to pay $430 million in criminal fines and civil penalties, and the company’s lawyers assured prosecutor Michael Loucks and three other prosecutors that Pfizer and its units would stop promoting drugs for unauthorized purposes. What Loucks, who’s now acting U.S. attorney in Boston, didn’t know until years later was that Pfizer managers were breaking that pledge not to practice so-called off label marketing even before the ink was dry on their plea."

"Jeff Kindler, who became Pfizer’s general counsel in 2002, supervised the lawyers who made the promises to prosecutors. By 2004, Kindler increased the compliance budget 12-fold."

"What Pfizer’s lawyers didn’t tell the prosecutors was that Pfizer was at that moment running an off-label marketing promotion using more than 100 of its salespeople" who were pitching Bextra for pain, a use the FDA explicitly forbade Pfizer to promote! In 2001, the FDA had rejected Pfizer's application to market Bextra for pain because in clinical trials the drug had shown it could cause heart damage and death.

In her guilty plea (March 30, 2009), Mary Holloway, a Pfizer regional sales manager for the Northeastern US, acknowledged that her team promoted Bextra to doctors without disclosing the risks, and also acknowledged that her team "had solicited hospitals to create protocols to buy Bextra for the unapproved purpose of acute pain relief. Her representatives didn't mention the increased risk of heart attacks in their marketing..."

Kindler became chief executive officer in 2006. In Pfizer’s ethics guide, he says stories about misbehaving companies and executives abound. “Pfizer truly stands apart,” he says. “I am proud of our record.”

Instead of being held accountable for criminal marketing practices Pfizer and its corporate divisions engaged in, on Oct. 1, Kindler was elected to the board of the Federal Reserve Bank of New York.

ESCALATING PENALTIES
Includes criminal fines and civil penalties. Source: Court records

RAP SHEET
Pharmaceutical companies paid about $7 billion in fines or penalties for illegal off-label marketing during the past five years. Here are some of the biggest.
COMPANY DATE OF PENALTY DRUG(S) Amount MILLIONS
Pfizer September 2009 Bextra, others $2,300.
Lilly January 2009 Zyprexa 1,415.
Serono October 2005 Serostim 704.
Purdue May 2007 Oxycontin 634.
Cephalon September 2008 Actiq, Gabitril, Provigil 425.
Schering-Plough August 2006 Temodar, Intron A 435.
Pfizer (Warner-Lambert) May 2004 Neurontin 430.

Source: Bloomberg / Federal court records
The amounts of Eli Lilly’s fines and penalties have soared during the past 25 years.
$25,000 APRIL 1985: Pleads guilty to 25 misdemeanors for misbranding Oraflex.
$36,000,000 DECEMBER 2005: Pleads guilty to one misdemeanor count for misbranding Evista.
$1,415,000,000 JANUARY 2009: Pleads guilty to one misdemeanor count for misbranding Zyprexa.don’t
But those fines are tiny compared to the revenues from criminally marketed sales:
Eli Lilly Zyprexa sales from criminal marketing yielded the company $36 billion from 2000 to 2008.

And Pfizer's recent $2.3 billion settlement in fines and penalties for the illegal marketing of Bextra, Geodon, Zyvox and Lyrica pales in comparison to the $16.8 billion the company garnered from its criminal marketing of these drugs. Indeed, the total penalties Pfizer has paid in settlements--$2.75 billion, since 2004--is but 1% of the company's revenue of $245 billion from 2004 to 2008.

Dr. Avorn points out that “The Pfizer and Lilly cases involved the illegal promotion of drugs that have been shown to cause substantial harm and death to patients.”

Despite the fact that in five company-sponsored clinical trials, 31 people out of 1,184 participants died after taking Zyprexa for dementia—twice the death rate for those taking a placebo--Lilly aggressively marketed the drug for off-label use in children and the elderly.

Even more shameful than the pharmaceutical industry’s blatant criminal practices, drug companies "find ready and willing partners in physicians" who wantonly prescribe dangerous drugs for untested, off-label uses for cash kickbacks.

Bloomberg reports that "Pfizer's marketing program offered doctors up to $1,000 a day to allow a Pfizer salesperson to spend time with the physician and his patients." If profits “uber ales” is the overriding goal, and human casualties are viewed as so much shrapnel, then Big Pharma has been hugely successful—billions in sales and hundreds of thousands buried.

In 2004, Neurontin sales reached $2.12 billion-- according the prosecutors' sentencing memo, 94% of those sales came from off-label use.

Much like the large financial institutions, Big Pharma companies are shielded by the rationale, "too big to fail." The government is reluctant to use the ultimate sanction which would put an end to criminal marketing—namely, a felony conviction that would render a company's drugs ineligible for reimbursement by state health programs and the federal government.

However, "a legal fig leaf" allows a parent company (such as Pfizer) to continue to receive government federal reimbursement for hazardous drugs that have been criminally marketed--even as one after another of the company's subsidiaries has pleaded guilty.

Pfizer and its executives have thus successfully avoided criminal culpability while paying the settlements but maintaining that it was not responsible for the illegal actions of the dozens of companies it acquired--actions that continued after Pfizer acquired them:

Bloomberg reports:
"From 1995 to 2005, Pfizer purchased more than 20 companies. Since 2004, companies that are now Pfizer divisions have pleaded guilty to off-label marketing of two drugs. Pfizer continued off-label promotions for these medications after buying the firms, according to Pfizer’s Sept. 2 guilty plea and FDA correspondence with Pfizer.
Pfizer first stepped into an off-label scheme in 1999, when it offered to buy Morris Plains, New Jersey–based Warner-Lambert Co. Prosecutors charged that Warner-Lambert marketed Neurontin off-label between 1995 and 1999. Warner-Lambert admitted doing so for one year in a May 2004 guilty plea for which Pfizer paid $430 million in fines and penalties."

Despite all this, "Pfizer maintains its good standing with such agencies because its subsidiaries, Warner-Lambert and Pharmacia-Upjohn, and not the corporation itself, entered the guilty pleas to felony charges."

While Big Pharma executives have evaded justice, Scott Harkonen, one former CEO of a small company, InterMune, has been convicted of illegal marketing of its only drug, Actimmune, for uses not approved by the FDA. He's out on bail, awaiting sentencing.

"As prosecutors continue to uncover patterns of deceit in off-label marketing by pharmaceutical companies, millions of patients across the nation remain in the dark.”

Doctors have become pill pushers who blindly prescribe the latest, most expensive medications based on deceptive marketing by drug company salesmen.

The result is documented in hundreds of thousands of preventable drug-induced deaths, and unsustainable healthcare expenditure. What’s especially disturbing is that nowhere in the proposed healthcare reform bills are life-threatening crimes by pharmaceutical companies in collusion with doctors who abuse their medical prescribing licenses even addressed.

Expanded Bloomberg Market Magazine version with tables, side-bars, upon request


Posted by Vera Hassner Sharav

____________________________________________

from pharmagossip

AstraZeneca - Seroquel: the story so far

In November, a federal judge recommended that as many as 6,000 lawsuits against drug giant AstraZeneca for the ill effects of the company’s anti-psychotic Seroquel should be returned to their home state courts for trial. Seroquel, the company’s second-best selling drug with annual sales of $4.45 billion, is notorious for the company’s cover-up of data from clinical trials showing potentially harmful effects from the drug, including diabetes, weight gain, stroke and death.

Just days before the judge’s order, an independent review commissioned by the British government found severe side effects, including stroke and death, suffered by people with dementia when taking Seroquel and other anti-psychotics. In response to the report, the UK government stated, “There is inevitably an element of risk with the prescribing of any medication. However, there is clear evidence that anti-psychotic drugs are currently being over prescribed, when alternative non-pharmacological approaches to dealing with anxiety and behavioural problems are available and should be used.” The report found that only about 20% of dementia patients prescribed antipsychotics receive any benefit from the risky drugs.

A recent Chicago Tribune report found that Illinois nursing homes were cited for thousands of cases in which elderly residents who exhibited no symptoms of psychosis were improperly dosed with Seroquel and other antipsychotics. AstraZeneca paid one Chicago-area psychiatrist nearly $500,000 over a decade for establishing a customer base of thousands of indigent, mentally ill residents in Chicago-area nursing homes.

The litigation against AstraZeneca has exposed a litany of company misdeeds around Seroquel:

  • AstraZeneca covered-up knowledge that use of Seroquel could lead to severe weight gain and diabetes. A New York Times reportOne expert has stated that the risk of diabetes for people on Seroquel is 70 percent greater than for the general population. noted the company’s fraudulent interpretation of studies to minimize the risk began as early as 1997, and noted a 1999 email from a company executive who asked, “…how do we face the outside world when they begin to criticize us for suppressing data.”
  • AstraZeneca engaged in illegal off-label promotions of Seroquel, and company documents suggest that questionable marketing was approved at the highest levels. In one off-label scheme, sales staff were told to use Winnie-the-Pooh characters (Tigger as bipolar, Eeyore as depressed) in order to market the psychiatric drug for pediatric patients. As theNew York Times noted, “As a result of aggressive marketing, Seroquel has been increasingly used for children and elderly people for indications not approved by the Food and Drug Administration.” Also, a company employee appears to have altered the wikipedia entry for Seroquel, deleting a National Institute of Health warning that teens taking the drug could be prone to suicide. In late October, the company paid $520 million to settle two lawsuits and two federal investigations of illegal promotions of Seroquel.
  • AstraZeneca covered-up a company study showing that Seroquel performed worse than several other drugs; two months after the company learned of the study findings, a doctor paid by the company presented the data at a medical conference as showing Seroquel to be “more effective” than the other drugs.
  • The company’s medical director for Seroquel admitted to lawyers in 2007 that he hadnumerous sexual relationships with women involved in clinical research on the drug, and traded sex for trade secrets.

The recent problems are only the latest in a string of AstraZeneca misdeeds. AstraZeneca was one of three drug makers found guilty in 2008 of defrauding Medicare by overcharging for drugs and encouraging doctors to prescribe their products over competitors through pricing that rewarded the physicians for prescribing certain drugs. Former New England Journal of Medicine editor Marcia Angell has charged that the company’s clinical trials of its top-selling drug Nexium were rigged to show greater efficacy than a cheaper competing product. In 1996, aBusiness Week cover story exposed “dozens of cases” of women who accused then-CEO of Astra USA Lars Bildman and other top executives with sexual harassment. One male sales manager told the magazine, “If ever there was a company where sexual harassment was rampant, this is it.”

In 2008, AstraZeneca CEO David Brennan took home over $2.5 million.

http://corporatecrime.wordpress.com/2009/12/03/astrazeneca-tales-of-a-deadly-drug-pusher/


Friday, August 27, 2010

story of a scientific scandal, one that the public needs to know about: STAR* D


The STAR*D Scandal: A New Paper Sums It All Up - Link http://tinyurl.com/26wsljq

Robert Whitaker author of "anatomy of an epidemic" unearths the nasty cover up in the NIMH STAR*D antidepressant effectiveness study. This study was government funded @ the tune of $35 million of your tax dollars.

The key to this scandal is in the numbers and misinformation that was reported to the public and health care providers.

original report findings - an inflated 67% remitted/effectiveness rate - this is a misleading and gross inflation of the truth (in most accepted circles this would be considered "lying")

The actual findings - fact that only 3% of the entering patients had a "sustained remission" (and this finding may actually be inflated do to some other unknown factors)

In layman terms this new accurate analysis of the data shows that antidepressant medications are paramount to worthless for treating depression. Let me repeat that; anti-depressant medications are not any more effective than doing absolutely nothing.

I can only imagine the cringing psychiatrist, researchers, and pharmaceutical CEO's sitting in their cushy professionally decorated offices figuring out a new plan and strategy to quash/bury this information from the general public knowledge once again. They tend to call that simply damage control and spin when your a multi-billion dollar corporate empire.

Here is a great marketing idea that with keep the masses befuddled & comatose:

How about we change/convert powerful anti-psychotics drugs into anti-depressants!! Brilliant!!! It will take them decades before they catch on....




You might want to start asking the real questions just about now
  • How deeply corrupted is the NIMH?
  • Who was or is responsible?
  • Was this a criminal act perpetrated upon the American public and consumer?
  • If "NIMH" The National Institute of Mental Health is willing to bury pertinent public health and safety information from you the American citizen to protect pharmaceutical interest, what else are they hiding from us?

I encourage you to go over and read the entire article written by Robert Whitaker @ the link posted above.

Thursday, August 26, 2010

Disease Mongering Alert - Can the New York Times write an unbiased mental health article? NO - Can Preschoolers be defined as clinically depressed? NO


Disease Mongering Alert - Can the New York Times ever write an unbiased mental health article? NO - Can Preschoolers be defined as clinically depressed/bipolar? NO

I came across this article in the NY Times that I find extremely disturbing. It's another article in a major American Newspaper promoting new psychiatric diagnosis in preschool aged children.

We know from recent experiences that new psychiatric childhood diagnosis has a direct correlation to the catastrophic rise of dangerous psychiatric medications being used in toddlers with devastating consequences that will be with us and our society for many many generations to come. We are in essence abandoning our children as sacrificial lambs to greedy pharmaceutical corporate interest, and to horribly conflicted sold out charlatans that benefit financially and in academic stature from prostituting their profession to this legalized drug cartel.

I have taken excerpts from the NY Times article here for you to read. But, I also invite you to follow the link and read the whole 6 page article.

Now let me give you a little background on the main doctor they are quoting and using in this article to promote another early childhood psychiatric condition. Don't let Joan L. Luby, MD Puppet Master's facade fool you into thinking this not a deeply conflicted pharmaceutical minion that strongly believes in the drugging of children "along with the brain chemical imbalance theory" that is being now generally debunked as Hocus Pocus lunitic insanity along the same lines of Harvard's J. Biederman "second to God" and "this ain't no tushy massage" infamy .

Below Philip Dawdy at Furious Seasons Blog questioned Luby about her not disclosing her obvious conflicts of interest in Sept 2009:

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American Journal Of Psychiatry Ignores Unreported Conflicts In Its Journal:

Earlier this month, I noted that Washington University psychiatry professor Joan Luby appeared to have possible unreported conflicts of interest on three separate papers, including one on "early childhood depression" that appeared in this month's issue of the American Journal of Psychiatry. I queried the AJP's editor and the American Psychiatric Association about the situation, asking if they look into the matter and make whatever correction was appropriate. I got no reply from either the editor or the APA's press office.

Luby had reportedly received monies from AstraZeneca in 2003 and 2004. AZ makes Seroquel, an atypical antipsychotic that is being widely used off-label in children (and adults) as a treatment for depression and agitation.

Joan L. Luby, MD replies here http://archpsyc.ama-assn.org/cgi/content/extract/67/3/311-a in the General Psychiatry Journal - March 2010:

A reader questioned a discrepancy between the financial interests disclosed in an article that I published in 20061 and my recent Archives article2 in which I revealed no financial interests. In the prior article, I disclosed grant support from Janssen for a clinical trial of risperidol in autism completed in 2003, some academic lectures sponsored by AstraZeneca, and a consultation with Shire Pharmaceuticals, all in 2004. I did not disclose these financial interests in the Archives article because they were not relevant to the subject of the article. The article reported on the longitudinal course of preschool depression and made no recommendations about treatment. Furthermore, my program of research has not supported the use of antidepressants in preschool depression and none of these pharmaceutical companies market antidepressant drugs. However, as some feel that any financial relationships with a pharmaceutical company imply a potential conflict of interest, . .

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This was also followed by a bnet-pharma article By Jim Edwards | August 28, 2009

http://www.bnet.com/blog/drug-business/updated-doc-who-urged-antipsychotics-for-3-year-olds-funded-by-j-j-az-and-shire/2712

Doc Who Urged Anti-psychotics for 3-Year-Olds Funded by J&J, AZ and Shire. A doctor who wrote in an academic journal that preschoolers may suffer from depression and could be good candidates for atypical antipsychotics received funding from three drug companies that make mental health medicines. Dr. Joan Luby, a professor of child psychiatry at the Washington University School of Medicine in St. Louis, wrote that children as young as three years old may suffer from bipolar disorder, and that there are “promising findings for the use of atypical antipsychotic agents and mood stabilizers, both singly and in combination” in the very young. Atypical antipsychotics are not FDA-approved for such use. Her article, in a 2009 journal titled Child and Adolescent Psychiatric Clinics of North America, does not disclose that in the past Luby’s work has been funded by Janssen (the unit of Johnson & Johnson that markets Risperdal), or that she has given talks sponsored by AstraZeneca (maker of Seroquel), and has been a consultant for Shire (maker of Adderall XR and Vyvanse. Luby disclosed her relationships with drug companies in a 2006 article in the Journal of the American Academy of Child & Adolescent Psychiatry, which was also about depression in preschoolers. Her disclosure said: Disclosure: Dr. Luby has received grant/research support from Janssen, has given occasional talks sponsored by AstraZeneca, and has served as a consultant for Shire Pharmaceuticals.

Luby did not return an email or two phone calls requesting comment. It is not clear whether academic journal rules at the time required her disclosures. AZ said:Also in 2007, Luby signed as an author to a Special Communication in the same journal written by a group of child psychiatrists called The Preschool Psychopharmacology Working Group. The purpose of their group, Luby and her colleagues wrote, was:to promote responsible treatment of young children, recognizing that this will sometimes involve the use of medications. The other authors of that paper disclosed a wealth of company ties, including Eli Lilly, Organon, Forest Labs, GlaxoSmithKline, Wyeth-Ayerst, McNeil, Novartis, Pfizer, Bristol-Myers Squibb, Abbott, AstraZeneca, Sepracor, Cephalon, Sanofi-Aventis, Boehringer-Ingelheim, and Janssen. Regarding Luby, the paper said:

The other authors have no financial relationships to disclose.

In Luby’s 2009 editorial, she wrote:

The need for large-scale and focused studies of this issue is underscored by the high and increasing rates of prescriptions of atypical antipsychotics and other mood stabilizing agents for preschool children with presumptive clinical diagnosis of bipolar disorder.

She cited a paper by Harvard’s Dr. Joseph Biederman, who was subpoenaed by federal prosecutors investigating J&J’s promotion of Risperdal, much of which was allegedly off-label to children. Separately, hundreds of lawsuits have been filed alleging that Seroquel has dangerous side effects such as weight gain and diabetes.

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Now you can put this NY Times disease mongering propaganda article in it's proper context with full disclosure and all the facts. That was something real reporters and newspapers used to do before they became just paid shills for multi-billion dollar corporations.

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http://www.nytimes.com/2010/08/29/magazine/29preschool-t.html?pagewanted=1&_r=1

Can Preschoolers Be Depressed?

By PAMELA PAUL Published: August 25, 2010

Kiran’s parents took him to see a child psychiatrist. In the winter of 2009, when Kiran was 5, his parents were told that he had preschool depression, sometimes referred to as “early-onset depression.” He was entered into a research study at the Early Emotional Development Program at Washington University Medical School in St. Louis

Is it really possible to diagnose such a grown-up affliction in such a young child? And is diagnosing clinical depression in a preschooler a good idea, or are children that young too immature, too changeable, too temperamental to be laden with such a momentous label? Preschool depression may be a legitimate ailment, one that could gain traction with parents in the way that attention deficit hyperactivity disorder (A.D.H.D.) and oppositional defiant disorder (O.D.D.) — afflictions few people heard of 30 years ago —

The answer, according to recent research, seems to be earlier than expected. Today a number of child psychiatrists and developmental psychologists say depression can surface in children as young as 2 or 3. “The idea is very threatening,” says Joan Luby, a professor of child psychiatry at Washington University School of Medicine, who gave Kiran his diagnosis and whose research on preschool depression has often met with resistance.

“In my 20 years of research, it’s been slowly eroding,” Luby says of that resistance. “But some hard-core scientists still brush the idea off as mushy or psychobabble, and laypeople think the idea is ridiculous.”

For adults who have known depression, however, the prospect of early diagnosis makes sense. Kiran’s mother had what she now recognizes was childhood depression. “There were definite signs throughout my grade-school years,” she says. “My parents knew my behavior wasn’t right, but they really didn’t know what to do.”

Though research does not support the use of antidepressants in children this young, medication of preschoolers, often off label, is on the rise. One child psychologist told me about a conference he attended where he met frustrated drug-industry representatives. “They want to give these kids medicines, but we can’t figure out the diagnoses.” As Daniel Klein warns, “Right now the problem may be under diagnosis, but these things can flip completely.”

says Alicia Lieberman, a professor in the department of psychiatry at the University of California, San Francisco. This is problematic, as 10 to 20 percent of mothers go through depression at some point, and 1 in 11 infants experiences his mother’s depression in the first year.

Washington University in St. Louis’s School of Medicine, Joan Luby is trying to figure out exactly what constitutes preschool depression. For a new clinical diagnosis to gain sanction with psychologists, schools, doctors and insurance companies, it requires entry into the Diagnostic and Statistical Manual of Mental Disorders, the field guide to psychiatric illness.

To get a sense of what a young child is feeling, Luby’s team uses a technique called the Berkeley Puppet Interview, which was developed to help children articulate how they perceive themselves and process their emotions. I watched as a wiry, blond 5-year-old boy responded to a therapist’s dog-faced puppets.

“My parents care a lot about me,” the first puppet said in an upbeat tone.
“My parents don’t care a lot about me,” the second said in an equally cheerful voice. “How about you?”

“Sometimes they care about me,” the boy replied, and then paused. “They don’t care a lot about me,” he added with emphasis.

“When I do something wrong, I feel bad,” the first puppet said.

“When I do something wrong, I don’t feel bad,” the second said. “How about you?”

“When I do something wrong, I do feel bad,” the boy responded.

Later he told the puppets that he didn’t like to be alone. He worried that other kids didn’t like him, and he wished he had more friends. His insecurity, low self-image and, in particular, his sense of guilt and shame mark him as a possible depressive: it’s not only that I did this thing wrong, it’s I’m a bad boy.

But generally speaking, preschool depression, unlike autism, O.D.D. and A.D.H.D., which have clear symptoms, is not a disorder that is readily apparent to the casual observer or even to the concerned parent. Depressed preschoolers are usually not morbidly, vegetatively depressed. Though they are frequently viewed as not doing particularly well socially or emotionally, teachers rarely grasp the depth of the problem. Sometimes the kids zone out in circle time,

Further complicating the picture is the extent to which depressed children have other ailments. In Egger’s epidemiological sample, three-fourths of depressed children had some additional disorder. In Luby’s study, about 40 percent also had A.D.H.D. or O.D.D.,

to avoid stigmatizing young children, two catch-all diagnosesadjustment disorder with depressed mood, as well as depressive disorder not otherwise specified (N.O.S.) — are frequently applied. benefits to such diffuse diagnoses: they spare parents the crushing word “depression”

“We don’t like to diagnose depression in a preschooler,” says Mary O’Connor, from U.C.L.A. “These kids are still forming, so we’re more likely to call it a mood disorder N.O.S. That’s just the way we think of it here.”

But this way of thinking frustrates Luby and Egger, who say they fear that if a depressed child isn’t given the proper diagnosis, he can’t get appropriate treatment. You wouldn’t use the vague term “heart condition,” they argue. Egger asks. Is it right that rather than treat children for depression, clinicians wait and see what might happen three or four years down the road?

THEIR TENDERNESS OF age may render preschoolers especially vulnerable to depression’s consequences. Young children are acutely sensitive but lack the skill, experience and self-sufficiency to deal with strong feelings.

For a diagnosis of preschool depression to have any meaningful impact, an appropriate treatment must be found. Talk therapy isn’t practical for children who don’t have the verbal or intellectual sophistication to express and untangle their emotions. Play therapy, a favorite of preschool counselors, has yet to be proved effective.

she and other researchers say, 84,000 of America’s 6 million preschoolers may be clinically depressed. Intervention could potentially forestall, minimize or even prevent depression from becoming a lifelong condition. At a minimum, it could teach them ways to better manage future bouts. If we wait, their only options may be medication and ongoing talk therapy, forever.

“The promise of early-childhood mental health is that if you intervene early enough to change negative conditions, rather than perpetuate negative behaviors, you really are preventing the development of a full-fledged diagnosis,” says Alicia Lieberman at U.C.S.F. “Of course, you would never then know if the child would have become a depressed adult.”

Parent-Child Interaction Therapy, or P.C.I.T. Originally developed in the 1970s to treat disruptive disorders — which typically include violent or aggressive behavior in preschoolers — P.C.I.T. is generally a short-term program, usually 10 to 16 weeks under the supervision of a trained therapist, with ongoing follow-up in the home. Luby adapted the program for depression and began using it in 2007 in an ongoing study on a potential treatment.

SUCCESS WITH P.C.I.T. rests heavily on parents, who are essentially tasked with reprogramming their child’s brain to form new, more adaptive habits. Not all parents are equipped to handle the vigilance, the consistency, the sensitivity.

______________________________________________________________

BUT THEN WE HAVE LOTS AND LOTS OF PSYCHOTROPIC DRUGS WE CAN USE ON PRESCHOOLERS CORRECT DR. LUBY?

Oh By the way, AstraZeneca who you were getting those nice lucrative payments from do make an anti-depressant
(maybe you forgot on your way to a sponsored speaking engagement?) it's called "SEROQUEL", the anti-psychotic, turned anti-depressant, turned anti-blushing, or whatever else they can get doctors like you to pimp it for.....

----------------------------------------------------------------------

Update: August 30, 2010 - Jim Edwards @
bnet-pharma has written a great follow up article concerning this matter you should also read and truly weep over (for the children of course).

Link - http://bit.ly/9mVzFs

----------------------------------------
Update Sept 1, 2010

I found this interesting article & honesty from David L Bransford M.D. @www.davidbransford.com blog that I believe adds some credence to the crisis fire of childhood mental health diagnosis and drugging we are now experiencing.

Having finally witnessed the end of summer and having my office filled with desperate parents and students, preparing to start the new school year;

I am overwhelmed with seeing what is happening to the many young children with disruptive behaviors and “hyperactivity” Over the summer months of just June, July, and August, far too many were prescribed potent antipsychotic medications by their child psychiatrists, their local family doctors, pediatricians, and nurse practitioners.

No informed consent from the parents or legal guardians, no interventions other than potent medications. Little or no screening for neuropsychological disorders, developmental LDs, nor base line lab work. Just medicating children with antipsychotic medications for disruptive behaviorsd out the script and if the med doesn’t seem to be effective, up the dosage and/or add yet another medication from the same family.

By summer’s end, these prepubescent children have typically experienced profound weight gain, are having hyperprolactinemia, with subsequent breast enlargement with often leakage……………the adverse effects are so alarming.

No family intervention and education…just following Big pharma’s push to prescribe the SGAs (second generation antipsychotics) and tremendous cost to the consumer, the State, the private insurance companies, etc.

But the greatest cost of all is to the children, as they develop type two diabetes and numerous other metabolic changes. These practices must somehow be more closely regulated.

Experienced Nurses and PCPs believe the handouts of the studies from the drug detail men and women, in spite of volumes of evidence most studies with kids are flawed, ghost written, and filled with informercial conclusions. Doctors must reclaim the role as protector of their patients and first do no harm. As of today – Sept 1st – 2010 – I have decided to no longer meet with drug reps, no “free samples” no labeled pens nor postit pads. We have followed the no free lunch or gift policy now for the past several years.

A video in the NYT (Not a leading medical journal) was posted today and I hope it will load onto this blog. It describes far better than I can express, the current crisis….aside for a plug for Vyvanse ( an amphetamine tweak by Shire….really no better than generic amphetamines from > 50 years ago) the video, I believe, tells an accurate story of the crisis at hand.

http://video.nytimes.com/video/2010/09/01/business/1248068952581/medicating-kids.html

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Though we may disagree in prospective and interpretation of what is shown on this video, I must stand up and applaud David L Bransford's M.D. integrity, openness, and honesty in his post.



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