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

BNET
By Jim Edwards
August 19, 2010

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

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

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

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

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

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

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

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

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Spero News
By Asia News
April 30, 2010

Four officials of the district government of Luohe (Henan) were removed for having interned a petitioner in a psychiatric hospital for over 6 years.  Protests are growing in the country over local authorities systematic abuse of protesters.

Xu Lindong, the author of a petitioner from Daliu city has been interned in two psychiatric hospitals since October 2003. Xu began presenting petitions in 1997, both to local and central authorities. In 2003, dissatisfied with the response of local authorities, he decided to go to Beijing to petition. In response, local authorities had him forcibly repatriated, first sent him Zhumadian psychiatric hospital and later Luohe Psychiatric hospital, where was diagnosed with obsessive-ompulsive disorder and was subjected to 54 electroshock treatments.

Shi Hongtai and Yang Yaoqin, then secretary and deputy secretary of the Communist Party of Daliu, later promoted to higher positions, have been charged with his internment. It appears that they used false documents to have Xu interned.

The news has caused widespread protests and a campaign of online subscriptions, denouncing “the growing trend of regional authorities to restrict the freedom of citizens through similar measures [internment in psychiatric hospitals].”

Now the lawyer Boyang Chang, co-organizer of the signature campaign and family lawyer for Xu, has announced legal action against the Communist officials and hospital responsible for the illegal internment and is demanding compensation.

Read entire article:  http://www.speroforum.com/site/article.asp?idCategory=33&idsub=128&id=31951&t=China%3A+++Interned+in+psychiatric+hospital+for+6+%BD+years+for+presenting+petitions

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Benedict Carey
The New York Times
November 26, 2009

One was a middle-aged man who refused to get into the shower. The other was a teenager who was afraid to get out.

The man, Leonard, a writer living outside Chicago, found himself completely unable to wash himself or brush his teeth. The teenager, Ross, growing up in a suburb of New York, had become so terrified of germs that he would regularly shower for seven hours. Each received a diagnosis of severe obsessive-compulsive disorder, or O.C.D., and for years neither felt comfortable enough to leave the house.

But leave they eventually did, traveling in desperation to a hospital in Rhode Island for an experimental brain operation in which four raisin-sized holes were burned deep in their brains.

Today, two years after surgery, Ross is 21 and in college. “It saved my life,” he said. “I really believe that.”

The same cannot be said for Leonard, 67, who had surgery in 1995. “There was no change at all,” he said. “I still don’t leave the house.”

Both men asked that their last names not be used to protect their privacy.

The great promise of neuroscience at the end of the last century was that it would revolutionize the treatment of psychiatric problems. But the first real application of advanced brain science is not novel at all. It is a precise, sophisticated version of an old and controversial approach: psychosurgery, in which doctors operate directly on the brain.

Read entire article: http://www.nytimes.com/2009/11/27/health/research/27brain.html?_r=3&partner=rss&emc=rss

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Beverly K. Eakman
The John Birch Society
August 6, 2009

Fox News just informed viewers that 27 million Americans are being treated for depression. The Washington Times ran a three-part series this week on the tsunami of mental illness in New Orleans four years after Hurricane Katrina, mostly depression and post-traumatic stress disorder (PTSD). A rash of additional articles has appeared nationwide on obsessive-compulsive disorder (OCD), including one from last Sunday’s (August 2) Washington Times “Pure suffering for OCD Patients,” by Cheryl Weinstein. All news sources, regardless of political persuasion, lend the aura of medical legitimacy to these phenomena.

But just three years ago, we were hearing a vastly different story: “Cheer up: U.S. not so depressed,” a 2006 Washington Times headline proclaimed, the gist being that reports of epidemic levels of clinical depression were greatly exaggerated — and possibly bogus, along with statistics on alcoholism and anxiety.

The problem — and nearly every news source and medical professional acknowledges it — is that mental illnesses, especially depression, PTSD and OCD, are difficult, if not impossible, to diagnose or quantify.  There is no X-ray, blood test, DNA or other chemical analysis that nails these as bona fide sicknesses, such as one might seek, say, for a brain injury or diabetes. And while there is little question that people do suffer from acute, long-term sadness, stress and compulsive behaviors, there exists no direct, medical proof for the notion of biologically-based brain disorders, contrary to the claims of pharmaceutical companies and mental-health advocacy groups like the National Alliance on Mental Illness (NAMI).

What that means for average citizens is that there is no magic bullet, no medication, to “cure” what are essentially human phenomena, not medical conditions.

Read entire article:  http://www.jbs.org/jbs-news-feed/5190

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