Archive for November, 2010

Seven Ways Medical Conflicts of Interest are Disguised

Friday, November 12th, 2010

FoodConsumer, November 12, 2010
by Martha Rosenberg

“Trust me” used to be the punch line about how a certain obscenity is uttered by Hollywood agents.

It also used to govern the conflicts of interest policies at hospitals, universities, medical schools and scientific journals about doctors’ and researchers’ financial links.

But conflicts of interest (COI) at Harvard and other universities, medical journals, professional groups and at the FDA itself have ushered in a kind of disclosure fever. In addition to the Physician Payment Sunshine Act which requires drug and device makers to report physician payments yearly, medical schools are starting to reject industry money that traditionally funded Continuing Medical Education (CMEs).

Individual doctors’ COIs have also been a problem for medical groups and journals.

The American Psychiatric Association,  in its 240 page guide to its May annual meeting, “forgot” to mention the conflicts of interest of its own president Alan Schatzberg, MD. It had to print them on the newsletter circulated the third day of the meeting. Nor were names even alphabetized for easy information retrieval. (Schatzberg is financially linked to Eli Lilly, GSK, Merck, Pfizer, Forest, Takeda, Sanofi-Aventis and eight other companies.)

Joan Luby, MD, a pediatric depression expert says in the Archives of General Psychiatry in March she didn’t disclosure lectures she gave for AstraZeneca and other pharma ties “because they were not relevant to the subject of the article.” Maybe that’s why the New York Times magazine didn’t disclose Luby’s links in the August “Can Preschoolders be Depressed?” and five Wyeth links in April’s “The Estrogen Dilemma.”

And statin investigator, Harvard’s Paul Ridker, MD, apologized to JAMA readers in 2006 for an incomplete financial disclosure for an article about cardiovascular clinical trials. He thought he only had to report funding for the “study at hand” and had omitted mentioning funding from AstraZeneca, Bayer, Novartis, Roche, Sanofi-Aventis and five other pharmaceutical companies.

Disclosure is especially tricky for medical journals whose lifeblood is often drug ads and reprints of article for drug companies to pass out to physicians.

Here are some of the ways conflicts of interest are finessed.

1) Omnibus disclosure. All of a study’s authors are listed with all the pharma links in one block of solid type. Who goes with whom? You’ll never know — but the author with no links sure isn’t happy about shared guilt.

2) Initials. “R.L.T. has consulted for Merck” is set in 8 point type at the end of the article. Will readers return to the study’s start, five pages ago where there are eight authors, four with first names that begin with R?

3) Disclosures You Have To Work For. COIs of CME faculty are often given online but the information is tucked away in a pull-down, scroll menu. It is user-unfriendly like the drug side-effects found on the scrolling ads on the same site.

4) One Disclosure is Enough. When a previous article is cited in journal letters sections, the author disclosures are said to “be found with the original article.” Surely you have that issue, published four months ago, on your desk.

5) Protective Coloring. Disclosures of drug company links are embedded between government grants and charitable foundations. Government grants and charitable foundations are not conflicts of interest — though some say taking government money along with industry should be.

6) Paying Customers Only. 20 million citations of medical literature appear on the US National Library of Medicine web site. Many have author’s institutions and email. But do the abstracts show COIs? Not unless you’re a paid subscriber. Password please.

7) Paying Customers Only…Even When You Are Reading A Hard Copy. In hard copies of the August 5 New England Journal of Medicine, the disclosures of authors of “Suicide-Related Events in Patients Treated with Antiepileptic Drugs” are absent and said to be found with the “full text” of the article at NEJM.org.

When we asked Karen Pedersen Buckley, NEJM manager of media relations, why  disclosure information about doctors who challenge an 2008 FDA warning* were not available in the journal’s hard copy, she said the web site was being redesigned. “We hope that many of our readers will have access to the full text and disclosure forms through an institutional subscription at their hospital, university or library,” she added.

And for those who don’t? Trust us.

*FDA warned about seizure drugs’ suicide side effects. The authors largely find the drugs safe.

http://www.foodconsumer.org/newsite/Non-food/Healthcare/seven_ways_medical_conflicts_of_interest_are_disguised_111110061.html

See also CCHR’s expose, Shrinks For Sale: The Corrupt Alliance of the Psychiatric Pharmaceutical Industry

Joseph Biederman

Pharma Poster Boy, Psychiatrist Joseph Biederman http://www.cchrint.org/cchr-issues/the-corrupt-alliance-of-the-psychiatric-pharmaceutical-industry/

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Diagnoses aren’t the quick fix people think they are

Friday, November 12th, 2010

The Spectator, November 11, 2010

by Haley Zblewski

psychiatric drug side effects fda medwatch antidepressants antipsychotics stimulants

More and more people, especially young adults, are being diagnosed with some sort of mental disorder.

From depression and anxiety, to Attention Deficit Disorder and bipolar disorder, mental disorder diagnoses are convenient. They sum up all of our problems on a prescription bottle filled with pills that will fix everything.

Pharmaceutical companies obviously want to sell their drugs, but the selling involves deceiving the consumer. They have to sell the illness first. They present advertisements that say, “Do you have symptoms A and B? Well, this is what’s wrong with you.” It offers consumers a solution to their everyday problems. But let’s face it; when it comes to the symptoms presented by the commercials you see while watching TV, we probably all feel them at some point.

Do you ever feel sad? Tired for no reason? Do you feel this way often? You’re probably depressed … or maybe you’re just a college student.

Feel awkward speaking in front of a crowd? Do you dislike being in crowds altogether? You must have some sort of anxiety disorder … or maybe you’re just human.

Doctors want to diagnose their patients with something. It’s what the patients expect – answers. And let’s not forget that doctors make money from the pharmaceutical companies for prescribing pills.

This deception by pharmaceutical companies and doctors about the be-all, end-all cures is what allows parents and young adults to go along with the idea that it’s OK to pop pills.

I mean, in a world where we want everything handed to us as soon as it’s needed, a world that runs on fast food and cell phones, it really isn’t surprising that being medicated isn’t really taboo anymore.

Parents almost want something to be wrong with their children. They want reasoning behind the behaviors of their children. Behaviors that are, well, typical of kids today. A diagnosis gives the parents all the proof they need to tell them it wasn’t their parenting skills, but that something’s wrong with their kid. It takes the blame away from parents.

Moods that go up and down, not paying attention in class, being sad or angry for no apparent reason; that’s just the way young people act. It shouldn’t have to be defined as a mental disorder.

What’s more is that there seems to be a cool factor that comes along with it for the younger generation. Disorders that were once taboo are now a means for bragging rights. Young adults say to their friends “I live with this everyday,” as though other problems are dwarfed by it. As though they are brave and superhuman for getting out of bed every morning. There’s a sort of mystery that comes along with taking pills. Think about it. When you see someone taking some nameless medication, don’t you think to yourself “Ohhh, I wonder what’s wrong with them”?

Mental disorders can also be a good excuse to not show up to class or hand in an assignment or to go to work. “It’s not that I didn’t finish my paper, professor. My depression was acting up and I was having a hard time dealing with it.”

These diagnoses are allowing people to label themselves as sick, when for many that’s far from the case.

With the taboo of being “crazy” having been lifted, we’ve just seen an increase of laziness, and, strangely enough, it has created people who think respect and compromises should be bent in their own direction.

A diagnosis does not fix all of your problems; in some instances, it only allows you to hide from them.

http://media.www.spectatornews.com/media/storage/paper218/news/2010/11/11/Editorialopinion/Haleys.Comments.Diagnoses.Arent.The.Quick.Fix.People.Think.They.Are-3957358-page2.shtml

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Is this for real, or just more smoke and mirrors – Big Pharma Executive being prosecuted by DOJ for obstruction of justice & lies

Thursday, November 11th, 2010

Is Something Not Quite Right With Stan – A Mental Health Blog – November 10, 2010

The Big News in Pharma-land is that the DOJ is going after a former GSK lawyer/Exec for a myriad of crimes which could lead to a Fashionable Federal Prison Jump Suit & a very long stay at a Martha Steward Foo Foo Club Fed. The question still remains if this scum bag exec does go to trial and is convicted (or sings like a Canary); what effect this might have on the World Wide Pharmaceutical Drug Cartel Criminal business as usual model?

From the rumblings being heard around the Pharma CEO world it appears this maybe a circle the wagons strategy developing orgy with a huge PR campaign of “we need to be more open and listen themes” while prospects of huge corporate take overs, turf wars, and more profits shine like stars in their beady & greedy CEO eyes ( read here–> AstraZeneca CEO: Pharma Must Be Open, Work With Stakeholders – FoxBusiness.com and here Glaxo sees more industry consolidation - Pharma Not Well Equipped to Handle a PR Cyber Storm-VOX

For a little back story)

This all sounds like a big wonderful hug fest & one giant “can’t we all just get along” moment for all those that have been watching these corporate crimes being waged against society and humanity go unchecked for decades now. But the caution bells are ringing in distance as we have learned the hard way many times before with Big Pharma; words are always cheap, while honesty & accountability is something of an abomination to the holy pharmaceutical corporate stone tablet creed.

So as they say, the proof will lay/lie in the pudding. Will AstraZeneca finally do the right thing when it’s comes to the many thousands injured by Seroquel, will J&J make good on the Risperdal crime settlements and get clean/sober, will GSK come in with a apology mop with groveling pledges of restitution and pay outs for damage caused by Paxil, Wellbutrin, Avandia, as we just name a few of the many ongoing Big Pharma Cartel horrendous criminal actions that have seriously harmed or killed consumers.

If you believe the sweet smell of change is in the air, you might want to ask/consider why is Big Pharma trying to close the honesty door at the same time they are saying they want it to be wide open? read here–>And Here Is The SEC Whistleblower Program

Now if one was to place this in the framed context that Big Pharma is still pumping huge amounts of money into the drug influence game involving doctors and research here—> http://projects.propublica.org/docdollars/ and here–>http://www.madinamerica.com/madinamerica.com/Leo/F7BDF895-0DE9-4605-8C73-A25177CBA9FE.html

Or here where they continue funding front marketing groups – AstraZeneca Funds DBSA http://www.speakaboutdepression.com/ and AstraZeneca funds NAMI -http://www.namimi.org/astrazeneca-bipolar-journey-exhibit-appearing-2010-nami-walks as stellar examples.

One might would get the distinct impression that Big Pharma has no intention of changing their profitable criminal ways, or their seedy business as usual model.  Definitely give us all some food for thought as the DOJ finally appears on it’s face to be taking some substantive action against the world largest criminal organization.

http://bipolar-stanscroniclesandnarritive.blogspot.com/2010/11/is-this-for-real-or-just-more-smoke-and.html

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Another Psychiatric Drug, Another Potential Criminal Investigation—J&J’s Antipsychotic Risperdal

Thursday, November 11th, 2010

Wall Street Journal, November 10, 2010

by Peter Loftus of Dow Jones Newswires

Johnson & Johnson (JNJ) said it’s in discussions with the government to resolve a long-running investigation of whether it improperly marketed the antipsychotic Risperdal.

“Discussions are ongoing in an effort to resolve potential criminal and civil litigation arising from these matters,” J&J disclosed in a regulatory filing Wednesday. “Whether a resolution can be reached and on what terms is uncertain.”

J&J spokesman Jeff Leebaw declined further comment.

Risperdal, which is approved to treat schizophrenia and bipolar disorder, was once J&J’s best-selling drug, with global sales of about $4.9 billion in 2007, according to IMS Health, before its oral formulation lost patent protection and cleared the way for generic competition.

J&J has previously disclosed government inquiries regarding Risperdal and later, a newer antipsychotic, Invega, but hadn’t previously said it was in talks for a settlement.

In 2004, the Office of the Inspector General of the U.S. Office of Personnel Management issued a subpoena seeking documents regarding sales and marketing of Risperdal, as well as payments to physicians and clinical trials for the drug, from 1997 to 2002.

The U.S. Attorney’s Office in Philadelphia sent an additional subpoena in 2005, seeking information about Risperdal marketing and adverse reactions associated with the drug. Grand jury subpoenas have been issued seeking testimony from various witnesses.

Earlier this year, J&J, of New Brunswick, N.J., disclosed the government had served civil investigative demands seeking additional information about the marketing of Risperdal and Invega.

Other makers of popular antipsychotics have settled government probes of marketing practices in recent years. In April, AstraZeneca PLC (AZN) agreed to pay about $520 million to resolve Justice Department allegations that it promoted Seroquel off label, or for uses not approved by the Food and Drug Administration.

Last year, Eli Lilly & Co. (LLY) agreed to pay more than $1.4 billion and pleaded guilty to a criminal charge, admitting it promoted the antipsychotic Zyprexa for off-label uses including treatment of dementia in the elderly.

The drugs also have been linked to safety risks, including increased risk of death if used by elderly patients with dementia-related psychosis, as well as weight gain.

Several U.S. states have filed lawsuits against J&J seeking reimbursement of Medicaid funds used to pay for off-label uses of Risperdal, as well as compensation for treating beneficiaries for alleged adverse reactions to the drug.

In October, a jury in Louisiana awarded the state $257.7 million after concluding that J&J minimized the drug’s risk of causing weight gain leading to diabetes. J&J said it would appeal the verdict because the jury wasn’t properly told of applicable legal standards, and certain evidence was excluded. J&J said it didn’t violate the law.

Read the rest of the article here: http://online.wsj.com/article/BT-CO-20101110-717532.html

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

Wednesday, November 10th, 2010

The New York Times, November 9, 2010

by Duff Wilson

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

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

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

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

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

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

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

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

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

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

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

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

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

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Drug-firm executives under new scrutiny in Medicare fraud

Tuesday, November 9th, 2010

The Washington Post, November 9, 2010

By Anna Edney

Federal inspectors want to prevent drug-company executives from doing business with the U.S. government when their companies are convicted of Medicare fraud.

Under guidelines from the Department of Health and Human Services’ Office of Inspector General, executives can be barred from contracting with federal health programs when they knew, or if the inspector general concludes they should have known, about fraud at their firms. The guidelines were posted Oct. 20 on the office’s Web site.

Authorities have been spurred by large settlements, said Robert DeConti, chief of the administrative and civil remedies branch in the inspector general’s Office of Counsel.

GlaxoSmithKline was ordered to pay $750 million on Oct. 26 for sale of defective drugs, and Pfizer agreed to pay $2.3 billion in September 2009 for fraudulent marketing of medicine. A company that employs someone barred from doing business with the government cannot receive federal payments.

That is definitely a renewed emphasis, maybe a new emphasis, on holding individuals accountable,” DeConti said in an interview last month.

Certain crimes, such as patient abuse or a felony conviction of health-care fraud, require automatic exclusion by law, according to the inspector general’s Web site.

The inspector general has the discretion to bar a person in other cases, such as a misdemeanor conviction.

Company executives might also be sanctioned if their employers are convicted of misconduct or they may be blocked from doing business with federal agencies. The inspector general has used this option 31 times since 1996. Most cases involved smaller, closely held companies such as those that make durable medical equipment, DeConti said. Twenty-eight people have been barred, he said.

Federal inspectors are targeting “complex cases that might involve global pharmaceutical manufacturers that are settling larger cases,” he said. “We have cases under development right now against individuals in that kind of company.”

In 2008, the inspector general barred three executives at Purdue Pharma. The officials at the drugmaker, based in Stamford, Conn., pleaded guilty to a misdemeanor for misbranding the painkiller OxyContin.

They were excluded from doing business with the government for 15 years. Purdue paid $634 million to settle criminal and civil claims that it misled patients and doctors about the addictiveness of OxyContin.

“An exclusion for 15 years is basically a career-ender,” said Cory Andrews, senior litigation counsel at the Washington Legal Foundation, who has criticized the Food and Drug Administration for what he calls excessive enforcement.

Pfizer has “invested substantial resources” to create a compliance program under which every employee gets mandatory training, said Christopher Loder, a spokesman for the New York-based drugmaker. He declined to comment on whether Pfizer executives might be targeted with exclusion.

Mary Anne Rhyne, a spokeswoman for London-based Glaxo, also declined to comment.

Tens of thousands of people and companies are excluded, including nurses, physicians, dentists, pharmacies and durable medical equipment suppliers.

“The current administration is feeling that they want to increase enforcement in this area, and they’re of the belief that monetary settlements aren’t sufficient, and they need to charge individuals to deter the conduct,” Jeffrey Senger, a lawyer at Sidley Austin LLP in Washington and former acting chief counsel with the FDA, said in a telephone interview.

Read the rest of the article here: http://www.washingtonpost.com/wp-dyn/content/article/2010/11/08/AR2010110805757.html

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Glaxo Failed to Warn About Paxil Risks, Lawyer Says at Philadelphia Trial

Tuesday, November 9th, 2010

Note from CCHR: Also see attorney Karen Barth Menzies interview on Paxil withdrawal effects and documents withheld from the public http://www.youtube.com/cchrint#p/c/B9EA75455D155D89/3/Mpex0n0DXuc

Bloomberg News

by Jeff Feeley, November 9, 2010

GlaxoSmithKline Plc,  the U.K.’s largest drugmaker, failed to properly warn consumers that its antidepressant drug Paxil could cause birth defects, a lawyer for the family of an injured teenager told jurors.

Glaxo officials had research from the 1980s showing Paxil caused deaths among the offspring of animal test subjects and didn’t provide clear warnings about those deaths, Kimberly Baden, a lawyer for Anna Blyth and her family, told a Philadelphia jury. Baden said the drug caused a narrowing of the aorta leading from the heart of Anna, now 14 years old.

“We believe the evidence will show Paxil caused Anna’s birth defects,” Baden said in opening statements in the trial. “We believe the warnings and instructions put out in 1995 weren’t appropriate and reasonable.”

The Blyth family’s case is the first over Paxil’s birth- defect risks to go to trial since the company agreed in July to pay more than $1 billion to settle 800 cases alleging the company failed to adequately warn consumers and their doctors about the drug’s hazards. The Blyth case wasn’t part of the settlement.

In the first Philadelphia trial, a jury ordered Glaxo in October 2009 to pay $2.5 million to the family of a 3-year-old boy born with heart defects his mother blamed on the drug.

$11.7 Billion in Sales

Glaxo officials contend Paxil played no role in Anna’s heart defects. They were most likely caused by genetics or the fact that her mother became pregnant late in life, Chilton Varner, a lawyer for the drugmaker, told jurors in her opening statement.

The deaths of Paxil animal test subjects had nothing “to do with Anna Blyth’s heart defects,” Varner said.

Approved in 1992 for U.S. use, Paxil generated about $793 million in sales in 2009, or about 1.8 percent of Glaxo’s total revenue. The company had $11.7 billion in U.S. Paxil sales over nine years starting in 1997, according to documents made public last year in a Pennsylvania trial over birth-defect claims.

Chief Executive Officer Andrew Witty has moved to replace revenue lost to generic versions of drugs such as Paxil. The drugmaker said in May it plans to double revenue from India and China by 2015 as it cuts prices to match competitors in emerging markets.

The company has paid out more than $2 billion to resolve a wave of litigation over Paxil, including claims the anti- depressant caused suicides in some users and withdrawal symptoms. In July, Glaxo set aside $2.4 billion to resolve litigation over Paxil and its Avandia diabetes drug.

Second Wave

After announcing its settlement of Paxil suits this summer, the company faced a second wave of suits over the drugs, said Carl Tobias, a University of Richmond law professor who teaches classes about mass-tort cases. That’s not unusual once a big- dollar settlement is on the table, he said.

“You’ll have plaintiffs lawyers who hope to get in on a settlement by going out and finding some new cases,” Tobias said. “Glaxo probably feels it had to litigate this case to send a signal that it’s not going to settle every one of these birth-defect cases, especially if they are weak.”

Sarah Alspach, a Glaxo spokeswoman, didn’t immediately return a call for comment on how many Paxil birth-defect cases remain outstanding.

In Anna’s case, the Summerville, South Carolina, resident had to undergo two rounds of open-heart surgery within nine months of her birth, Baden told jurors.

Her mother, Marsha Blyth, had taken Paxil for a short time during her pregnancy to deal with depression, Baden noted.

Glaxo’s Paxil warning label didn’t make it clear that offspring from animals on which the drug had been tested died, she said.

Read the rest of the article here: http://www.bloomberg.com/news/2010-11-09/glaxo-failed-to-warn-about-paxil-risks-lawyer-says-at-philadelphia-trial.html

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Former GSK lawyer indicted for lying and obstructing an investigation into the company’s promotion of an anti-depressant drug

Tuesday, November 9th, 2010

WZCO.Com, November 9, 2010

Ex-Glaxo lawyer indicted for role in U.S. drug probe

WASHINGTON (Reuters) – A former lawyer for pharmaceutical giant GlaxoSmithKline Plc has been indicted for lying and obstructing an investigation into the company’s promotion of an anti-depressant drug, the U.S. Justice Department said on Tuesday.

The lawyer, Lauren Stevens, was indicted on four counts of making false statements, one count of obstruction of justice and one count of falsifying and concealing documents related to Glaxo’s promotion of the drug for weight loss, which had not been approved by the Food and Drug Administration.

“Where the facts and law allow, the Justice Department will pursue individuals responsible for illegal conduct just as vigorously as we pursue corporations,” said Tony West, head of the Justice Department’s civil division.

The Justice Department did not name the drug or Glaxo, but the company confirmed she had worked in its legal department but retired. A legal directory described Stevens as a Glaxo vice president and associate general counsel.

A lawyer for Stevens was not immediately available for a comment.

The case emerged after the FDA sought information from Glaxo in 2002 about its promotion of the drug.

A Glaxo spokeswoman declined to comment about any FDA probe of marketing of its drug for an unapproved use.

Such charges against corporate executives in these kinds of instances are rare. Justice Department officials could not immediately recall a similar case in recent years.

Stevens knew the company had sponsored programs to promote the drug for unapproved uses, including payments to doctors to give hundreds of talks to other doctors, according to the indictment.

The indictment also accused Stevens of withholding slides that were used by doctors who were paid by Glaxo to promote the drug and that she prepared a memorandum about the benefits and risks of providing the information to the FDA.

The obstruction charges carries a maximum sentence of 20 years in prison, while each false statements charge has a maximum sentence of five years in prison.

(Reporting by Jeremy Pelofsky; editing by Andre Grenon)

http://wkzo.com/news/articles/2010/nov/09/ex-glaxo-lawyer-indicted-for-role-in-us-drug-probe/

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Psychiatric diagnoses prone to abuse

Tuesday, November 9th, 2010

Note from CCHR: The below article is short but the point made by author Richard Vatz, Professor of political rhetoric, is all to often overlooked—quite simply that psychiatric diagnoses are completely subjective and there is no known scientific or medical means by which any “psychiatric diagnosis” can be proven.  For more information see video of CCHR Co-founder, Professor Thomas Szasz, Professor of Psychiatry Emeritus, of whom Vatz has called,  “the preeminent critic of psychiatry in the world.” http://www.cchrint.org/videos/experts/thomas-szasz/

The Baltimore Sun, November 8, 2010

by Richard  E. Vatz,  Professor of political rhetoric at Towson University.

One of the few issues not thoroughly covered in Scott Calvert’s well-researched, comprehensive articles on Baltimore Behavioral Health (“Hooked on treatment,” Nov. 7 and “Sheltered addicts, strained recovery,” Nov. 8)  is why psychiatric diagnoses are particularly prone to misdiagnosis and overdiagnosis.

The reason is that psychiatric diagnosis is not based on pathological criteria. The closest the article comes to addressing this problem is the statement that “Even in the best clinical scenario, a psychiatric diagnosis is tricky, experts say; doctors have no X-rays to help apply the criteria defining a mental illness.”

In fact a diagnosis can never be indisputably ruled in or ruled out in psychiatry. All we have is testimony by differing psychiatrists, psychologists and social workers. In somatic medicine there is an array of pathological tests which often permit much greater diagnostic certainty. A biopsy of a lump in the breast will almost always tell you whether it’s benign or malignant.

The ability of professionals and patients to play the system financially and to exculpate addicts from responsibility will forever be aided by makeshift diagnoses which can neither be confirmed nor ruled out.

Richard E. Vatz

http://articles.baltimoresun.com/2010-11-08/news/bs-ed-pschiatric-diagnoses-letter-20101108_1_psychiatric-diagnoses-criteria-addicts

For more information on psychiatry as a pseudo-science,  visit CCHR’s Thomas Szasz pages http://www.cchrint.org/about-us/co-founder-dr-thomas-szasz/

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Quarter of children with sleep problems being put on psych drugs

Monday, November 8th, 2010

Note from CCHR:  The most glaring omission in this study is whether the children who were having sleep problems,  and who were all under psychiatric “care”,  were being prescribed psychostimulants (Ritalin, Adderall, Concerta)  in the first place.   These drugs are in the same category of highly addictive substances as cocaine according to the U.S. Drug Enforcement Administration.    That would account for the children’s inability to sleep.    And instead of referring to this condition as  “sleep disorder” a term which enables psychiatrists to prescribe  even more drugs, (as stated in the article posted below)  we should demand to know what drugs  psychiatrists had prescribed these children that stripped them of  one of the most vital natural functions every child needs—sleep.

NaturalNews, November 8, 2010

by David Gutierre

One in four children with difficulty sleeping is given a psychoactive drug, according to a study conducted by researchers from Hasbro Children’s Hospital, St. Joseph’s University/Children’s Hospital of Philadelphia and Case University School of medicine.

Although no sleep drugs have been approved by the FDA for use in children under the age of 18, “treatment of insomnia symptoms with both over-the-counter and prescription medication is a common clinical practice, particularly for children and adolescents with special needs and co-morbid psychiatric disorders,” said lead author Judith Owens.

Researchers surveyed almost 1,300 members of the American Academy of Child and Adolescent Psychiatry about their school-aged and adolescent patients, finding that one in three suffer from trouble sleeping. Ninety-six percent of respondents said they recommend at least one prescription sleep drug in an average month, while 88 percent recommend at least one over-the-counter drug. Medications used include antihistamines, sedatives, antidepressants, anticonvulsants and antipsychotics, and even stimulant drugs for attention deficit hyperactivity disorder (ADHD).

Prior studies have found that sleep disorders are one of the main reasons for psychiatric drug use in children. Yet behavioral treatments such as cognitive behavioral therapy, relaxation techniques and sleep restriction have been shown to be effective treatments, without the risk of side effects.

The over-sedation of children continues a dark tendency in the history of U.S. psychiatric medicine.

“[In the early 20th century,] bromides were given to pregnant women for ‘nerves,’ to children for ‘overactivity,’ and to just about anybody who couldn’t sleep well at night,” writes Sydney Walker in A Dose of Sanity: Mind, Medicine, and Misdiagnosis.

“By 1930, four out of every ten prescriptions written by doctors were for drugs containing bromides,” Walker writes. “It took doctors nearly half a century to recognize (and admit) that bromides were terribly toxic, and that thousands of Americans were suffering from anxiety, dementia, or schizophrenia-like symptoms brought on entirely by ‘bromide intoxication.’ By then, many of their patients were in mental institutions.”

http://www.naturalnews.com/030323_children_psychiatric_drugs.html

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