Tagged: news

What Did They Prescribe Devin Patrick Kelley?: Texas Shooter’s Friend Says ““His parents had him on high doses of ‘psych’ meds from 6th to 9th grade, the time I knew him”…


http://www.foxnews.com/us/2017/11/06/texas-church-shooting-who-is-gunman-devin-patrick-kelley.html

Texas church shooter Devin Patrick Kelley served in Air Force, was court-martialed for assaulting wife, child

Shocked former classmates who attended middle and high school with Texas church gunman Devin Patrick Kelley described him Monday as being heavily medicated and someone who kept to himself — despite a deluge of posts on his apparent Facebook profile about weapons and atheism.

Kelley — dressed entirely in black and “wearing a face mask with a white skull on it,” according to Texas Department of Public Safety’s regional director Freeman Martin — burst into the First Baptist Church in Sutherland Springs, Texas on Sunday and killed at least 26 people, one as young as 18-months old.

A former middle school classmate told Fox News that Kelley would complain about his parents and medications during school.

kelley

Devin Patrick Kelley, 26, of New Braunfels, Texas as pictured in his driver license photo.  (Texas Department of Public Safety)

 

“His parents had him on high doses of ‘psych’ meds from 6th to 9th grade, the time I knew him,” said the student, who only wished to be identified as Reid.

The student also said Kelley often posted on his Facebook page about his assault rifle and atheism, and that “a lot of friends quit talking to him by senior year.”

Courtney Kleiber, a New Braunfels High School student who identified herself as Kelley’s “best friend for a number of years,” said in a Facebook discussion about the shooting that Kelley once was heavily involved with the First Baptist Church.

“I was his best friend for a number of years and he was a happy, caring person back then. It’s crazy what time and [mental] illness can do to you,” she wrote.

“Great, now I can’t even look through my senior yearbook without seeing this,” she posted on her Facebook page late Sunday, next to a picture of her and Kelley.

Another classmate who spoke to Fox News and wished to remain anonymous described Kelley as a quiet student, though he had his share of friends.

“He recently added me on [Facebook]. I accepted hence we went to school together, and any time I saw him on my timeline he was sharing stuff about guns and being atheist,” she said. “He was pretty negative. The last post I remember was of a rifle.”

Kelley’s Facebook page has since been taken down.

Chatter amongst other students on Facebook who say they knew Kelley suggested he had a volatile relationship with his parents.

One student said Kelley used to tell her about issues with his dad, while another said they watched Kelley verbally abuse his parents.

Kelley was also a member of his high school’s football team, Reid said. One student said Kelley’s father would go “crazy” if Kelley messed up on the field.

Emergency personnel respond to a fatal shooting at a Baptist church in Sutherland Springs, Texas, Sunday, Nov. 5, 2017. (KSAT via AP)

Investigators work at the scene of a deadly shooting at the First Baptist Church in Sutherland Springs, Texas, Sunday Nov. 5, 2017.  (AP)

Brittany Adcock, a 22-year-old who told NBC News that she dated Kelley for two months when she was 13 and he was 18, said Kelley would constantly call her after she broke off the relationship.

“He would offer me money to hang out with him quite a bit. There has been one point that I called the police because he was just calling me so much I wanted to report harassment,” Adcock told the network. “One time he told me I should move in with him and his wife and that he would take care of me as long as I walked around topless.”

Kelley had previously served in the U.S. Air Force, and was stationed at Holloman Air Force Base in New Mexico from 2010 until his discharge in 2014, an Air Force spokesperson confirmed to Fox News.

He was court-martialed in 2012 for assaulting his wife and his child, and later received a bad conduct discharge from the Air Force, in addition to confinement for 12 months, and was reduced in rank.

Law enforcement officers work in front of the First Baptist Church of Sutherland Springs after a fatal shooting, Sunday, Nov. 5, 2017, in Sutherland Springs, Texas. (AP Photo/Darren Abate)

Investigators work at the scene of a deadly shooting at the First Baptist Church in Sutherland Springs, Texas, Sunday Nov. 5, 2017.  (AP)

Texas Gov. Greg Abbott on Monday said there was a connection between the “very deranged individual” and the church where the slayings took place, telling “FOX & Friends” that people will learn about a link.

“I don’t think the church was just randomly attacked,” he said. “I think there was a reason why the shooter chose this church.”

The gunman was also denied a Texas gun permit, according to Abbott.

“He was rejected either because he did not fully answer all the questions that are required to get a Texas gun permit, or he answered those questions wrong, that we still don’t know,” he said.

Wilson County Sheriff Joe Tackitt told Fox News that Kelley’s former father-in-law did attend the First Baptist Church, but he and his wife were not there Sunday.

His ex-mother-in-law’s P.O. Box was also listed as having a mailing address in Sutherland Springs, the Daily Beast reported.

Kelley previously registered to vote in Colorado in 2014 and listed his address as a parking space in a RV park in Colorado Springs, according to the New York Times.

A woman who lived in the spot next to the address said a man of similar age and description lived in that space for a few months during that time, and that he had a pit bull puppy that was left tied up in the sun all day.

She told the New York Times that there was an incident where police were called because the man — who she never learned the name of — struck the dog in the head, leading to a standoff with police in which the man refused to come out of his trailer for an hour.

Records show Kelley was charged with cruelty to animals in August 2014 but the case was dropped, the New York Times reported.

Kelley worked as a security guard for a Texas waterpark this past summer, according to a resume under his name that appeared online.

The suspect, who is from New Braunfels, a suburb outside San Antonio, was found dead in his car after he sped away from the scene of the shooting and was chased by two Good Samaritans.

Tackitt told Fox News on Monday authorities believe the gunshot wound that ultimately killed Kelley was “self-inflicted,” however, there was also an exchange of gunfire before and during the case.

“All I know is he stopped another resident right over here and said, ‘Lets go we got an active shooter, we need to get him stopped,’ and they were chasing him,” he said. “They were shooting rounds at him and then he went off the road, we don’t know if he was actually hit again or what, but wrecked out. He was from my understanding self-inflicted gun shot wound.”

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Ed Silverman: Dear Scott Gottlieb: Add new warnings to Paxil labels. You may save a life…


A little too late for many, however good to see someone of Ed Silverman’s character speaking out about the scandal of Seroxat/Paxil.

https://www.statnews.com/pharmalot/2017/05/01/paxil-suicide-warning-fda/?s_campaign=fb&utm_content=buffer12cb5&utm_medium=social&utm_source=facebook.com&utm_campaign=buffer

 

D

ear Dr. Gottlieb,

As you inch closer to becoming the new head of the Food and Drug Administration, your list of challenges must be swelling. Here is one more item to add: Whether to insist on a stronger warning label for the antidepressant Paxil.

For the past decade, Paxil’s label has not carried any information indicating the drug poses a statistically significant risk of suicidal behavior for anyone over 25. Yet there is scientific evidence that such a risk is real (see table 16 on page 26). A jury in Chicago recently decided that that a label warning could have prevented the death of a 57-year-old man who killed himself while taking a generic version of Paxil.

For public health reasons, the FDA should pursue a warning.

“Even recognizing the limitations of the data (found in the relevant analysis), it’s hard to understand [why] the increased risk of suicidal behavior, or attempts, is not in the label,” said Dr. David Kessler, a former FDA commissioner and now a professor at the University of California, San Francisco, School of Medicine.

Here’s the backstory: Paxil is one of several antidepressants known as an SSRI, a group that includes Prozac and Zoloft. For many years, the drugs were mired in controversy over whether they increased the risk of suicidal behavior and thoughts. The FDA eventually ordered the companies to warn of such a risk for children and young adults.

But what about issuing a warning for adults older than 25? The opportunity was bungled.

Back in 2006, GlaxoSmithKline — which makes Paxil — actually offered to revise its label to indicate a risk existed for adults. But the FDA nixed that in favor of a class-wide warning, limited to children and young adults, for all SSRI drugs. This blunted the effect of the data Glaxo had submitted to the FDA — which showed that adults on Paxil faced a much higher risk than those on all but one other antidepressant.

Instead, the FDA suggested the company could submit a supplemental warning and schedule a meeting for review. This never happened because Glaxo did not follow up (see page 127). As a result, the Paxil labeling never included information about a risk to adults.

For its part, Glaxo does not deny that its studies showed an elevated risk for adults. But the company contends that it properly conveyed all the appropriate data to the FDA and says it was the agency’s call to create a common, class-wide label instead of developing a warning more specific to Paxil.

Now, let’s fast forward to a federal courtroom in Chicago, where documents detailing these developments have been filed.

A five-week trial recently took place over a legally complicated, but significant, question — whether consumers who suffer harm after taking a generic drug should be allowed to sue the company that makes the brand-name version of the medication. In this instance, the man who committed suicide took a generic version of Paxil, made by Mylan.

Glaxo was named in the lawsuit because Mylan had to use its label on the generic. Federal regulations do not allow generic companies to independently change labeling after learning of potential risks, unless a change has already been made to the corresponding brand-name drug. That regulation was upheld in 2011 by the Supreme Court.

As a result, consumers sometimes seek to hold brand-name drug makers responsible for injuries they suffer while taking generics, although more than 100 such cases have been tossed out by courts around the country. Only two survived and one is being appealed. This time, Glaxo was the loser and was ordered to pay $3 million to the man’s widow.

The company, however, plans to appeal, which raises the possibility that not much, if anything, will change. Meanwhile, countless adult Americans will continue to be prescribed a generic version of Paxil that does not contain a warning about the risk of suicidal behavior.

But this should not be the end of the story.

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Most consumers may not realize this, but drug makers legally own the right to the labeling on their medicines. Yes, the wording is developed during talks with the FDA, but a company can certainly consider adding an additional warning.

Glaxo “had the option to go further, but chose not to do so,” said Dr. David Healy, a Bangor University psychiatry professor who helped spearhead a campaign to upgrade suicide warnings on antidepressants, and who served as an expert witness on behalf of the widow in the recent trial.

Perhaps Glaxo bet it would not face lawsuits from consumers who took the generic. Nonetheless, the possibility of harm has existed all this time. And that is something the FDA should have realized. (An FDA spokeswoman told me the agency would not comment.)

So, Dr. Gottlieb, as you look over your to-do list, consider the lack of information in the Paxil labeling. And move to fix it. You might save a life.

If They Can Remove Lariam From The Irish Market… Then Why Not Remove Seroxat?…


Seroxat, is arguably, more controversial than Lariam, and also caused similar psychiatric side effects such as suicide, etc. They remove Lariam, yet keep Seroxat on the market…why?

Note also that it was Roche (the manufacturer of lariam) who chose to remove the drug- not the Irish authorities…

-thanks to Examining Medicine for this point–

 

 

 


http://www.rte.ie/news/2016/0915/816884-lariam/

Controversial drug Lariam removed from sale

Friday 16 September 2016 16.56

Lariam's acknowledged side effects can be very severe and include anxiety, depression, paranoia and suicidal behaviour
Lariam’s acknowledged side effects can be very severe and include anxiety, depression, paranoia and suicidal behaviour

A drug at the centre of a number of legal actions against the State by members of the Defence Forces has been withdrawn from sale in Ireland.

It has emerged Lariam, an anti-malarial drug, was taken off the market at the end of July.

For many years Lariam was given to Irish Defence Forces personnel deployed to missions in sub-Saharan Africa to prevent the life-threatneing illness.

Lariam’s acknowledged side effects can be very severe and include anxiety, depression, paranoia and suicidal behaviour.

Fifty serving or former members of the Defence Forces have lodged claims against the State having been given the drug.

Legal proceedings have been served in 37 cases.

It has emerged that the drug manufacturer Roche took Lariam off the market in this country on 31 July. It remains available in other jurisdictions.

A spokesperson for the company said the decision followed a review of the products it offers here and was not related in any way to pending legal actions.

The company says Lariam was taken off sale following “a portfolio reassessment” by the company and three other products have also been discontinued.

They also point out that it remains available in 16 European countries.

The decision to withdraw Lariam ( which is also known as Mefloquine) from sale has been welcomed by some of those who allege they suffer from side-effects but they want assurances it will no longer be used by the Defence Forces.

Anthony Moore, who curates the Action Lariam Group for Irish Soldiers Facebook page, says they have asked the Defence Forces to take it off and will continue to do so.

Mr Moore is a former naval diver and soldier who served on numerous missions abroad.

A  Department of Defence statement said the Defence Forces were made aware by Roche Products Ltd that Lariam was being taken off the Irish market but the drug is still available to them via two main wholesalers.

The statement says there are no plans to withdraw Lariam from the range of anti-malarial medications they use.

The statement points out the health and welfare of Defence Forces members is of the highest priority and significant precautions are taken by medical officers in assessing the medical suitability of members to take any anti-malarial medications.

Meanwhile a Department of Defence working group initially set up in 2011 and reconvened in 2013 is continuing to examine all issues surrounding the use of the drug.

 

GSK Now Investigating Corruption In United Arab Emirates (UAE)


http://www.reuters.com/article/2014/10/07/us-gsk-emirates-idUSKCN0HW1L420141007

(Reuters) – Drugmaker GlaxoSmithKline, which was slapped with a record $489 million fine for corruption in China last month, said on Tuesday it was looking into allegations of corruption in the United Arab Emirates.

Britain’s biggest pharmaceuticals group confirmed the investigation following allegations of improper payments set out in a whistleblower’s email sent to its top management on Monday. The email, purporting to be from a GSK sales manager in the Gulf state, was seen by Reuters.

The company is already investigating alleged bribery in a number of Middle East countries, including Lebanon, Jordan, Syria and Iraq, as well as Poland.

“As we have already said, we are undertaking an investigation into our operations in the Middle East following complaints made previously. This investigation continues and these specific claims were already being investigated as part of this process,” a GSK spokesman said.

GSK and other major drugmakers are under increased scrutiny in the wake of the high-profile Chinese case and law enforcement agencies in both the United States and Britain are clamping down on overseas corruption by multinational companies.

The China scandal has hit GSK’s drug sales in the country and tarnished the reputation of Chief Executive Andrew Witty.

Other pharmaceutical companies, too, are in the firing line for alleged improper sales behavior.

France’s Sanofi said on Monday it had informed U.S. authorities of allegations of improper payments by its employees to healthcare professionals in East Africa and the Middle East.

Novartis, meanwhile, has been ordered to face a U.S. government lawsuit accusing the Swiss drugmaker of paying multimillion-dollar kickbacks.

And two women in Poland have pleaded guilty to bribery in another case involving an unnamed company.

In the case involving GSK’s practices in the UAE, the anonymous author of the email claimed that the British company made direct payments to healthcare professionals, hospitals, clinics and pharmacies to secure business.

This included payments for educational meetings — regardless of whether or not they took place — as well as schemes to pay customers for taking prescription drugs by giving them bonus over-the-counter products, the author said.

“We have zero tolerance for unethical behavior and we welcome people speaking up if they have concerns about alleged misconduct. We are committed to taking any disciplinary actions resulting from the findings,” the GSK spokesman said.

GSK China-Gate Statement 2013: ” No Evidence Of Any Bribery Or Corruption”…

Seroxat : MPs Alerted To ‘Unfavorable Medical Trials Being Withheld’


http://www.gulf-times.com/uk-europe/183/details/366031/unfavourable-medical-trial-results-being-withheld%3A-mps

Guardian News and Media/London

Drug companies and medical researchers are putting patients’ lives in danger by failing to publish unfavourable results from clinical trials, MPs have warned.

The lack of transparency means many trials are not registered before they are done, while results are held as private documents that cannot be scrutinised by patients or independent experts.

The practice skews the information that is available to doctors because trials that show new experimental drugs in the best light are more likely to be published, and results that could prevent harm or save patients’ lives may never see the light of day.

Often, trials that indicate a new treatment is not effective are never published.

In a report delivered to ministers, MPs express dismay at the government’s efforts to tackle the problem and set out concrete proposals to make data from clinical trials more openly available.

“Many of the trials taking place today are unregistered and unpublished, meaning the information that they generate remains invisible to both the scientific community and the public. This is unacceptable, undermining public trust, slowing the pace of medical advancement and potentially putting patients at risk,” said Andrew Miller, chair of the Commons science and technology committee.

The MPs’ report broadens the traditional battleground over clinical trials data to include academic researchers who fail to publish studies of companies’ drugs or other medical interventions. The pharmaceutical industry is under intense pressure to release more clinical trial data, and some companies, such as GSK, are already committed to greater openness.

But the MPs call for government action to speed the process, by requiring all future trials to be registered, and summaries of trial results to be made public. More detailed “clinical study reports” should also be released, with redactions to protect patient privacy, when they have already been prepared for regulators.

In another recommendation, the MPs urge the government to demand the registration of past trials too, with summary results released for all publicly funded trials since 2000. Failure to release clinical trials data has led to hefty fines for some pharmaceutical companies.

In 2004, GSK paid $2.5mn to settle a consumer fraud case during which it emerged that the company had lied about the safety and effectiveness of its antidepressant Paxil, also known as Seroxat.

But academics are also guilty of suppressing data that could have helped patients. In 2006, six volunteers suffered severe reactions to an experimental drug called TGN1412 in a trial at Northwick Park hospital in London. An inquiry into the incident found that a single patient had suffered the same catastrophic reaction after taking a similar drug, but the scientists had never reported the findings.

Scientists estimate that half of all clinical trials that have been completed have never been published in academic journals, and trials with favourable results are twice as likely to be published as others.

“There have been these examples of publication bias which have resulted in lots of people suffering and dying unnecessarily, which somehow people haven’t taken seriously,” said Iain Chalmers, co-ordinator of the James Lind Initiative at Oxford University, which lobbies for better trials.

Glaxo’s Chinese Nightmares Continue…


http://www.bloomberg.com/news/2013-08-07/race-to-publish-shows-glaxo-zeal-to-get-leg-up-in-china.html

Liu Xuebin recalls working 12-hour shifts and most weekends for months, under pressure to announce research results that would distinguish his GlaxoSmithKline Plc (GSK) lab in Chinaas a force in multiple sclerosis research.

It paid off — for a while. Nature Medicine published findings about a potential new MS treatment approach in January 2010 and months later Liu was promoted to associate director of Glaxo’s global center for neuro-inflammation research in Shanghai. Two months ago, his career unraveled. An internal review found data in the paper was misrepresented. Liu, 45, who stands by the study, was suspended from duty on June 8 and quit two days later.

His story, told in a cafe a short stroll from his former workplace, offers insight into Glaxo’s zeal to succeed in the world’s fastest growing major drugs market, where the London-based company languishes in 12th place. Glaxo is now the subject of a corruption probe, and three other drugmakers have been, or are in the process of being, examined by authorities in China, where intense competition built incentives for employees to bend rules and cut corners.

“It was extremely tough, we were all very tired and everyone was competing to be first,” Liu said in an interview last week. “Everyone had many projects. The more you do, the more likely you will make mistakes.”

The China-born scientist was the first of 18 authors on the 2010 paper, which included graphs later shown to have incorrectly labeled healthy human cells as being those frommultiple sclerosis patients. Liu says he opposes a retraction of the paper.

R&D Head Fired

“It was an honest mistake, and it doesn’t affect the findings,” he said, sipping a cappuccino. “I can confidently say that I can recreate the result in any laboratory.”

Glaxo, the U.K.’s largest drugmaker, disclosed the error in astatement on its website on June 10, the day Liu resigned. The head of Chinese research and development was fired and three others were placed on administrative leave pending a final review, it said. The paper, titled “Crucial role of interleukin-7 in T helper type 17 survival and expansion in autoimmune disease” was from preclinical, early stage research and didn’t directly involve patients.

‘Clear Evidence’

“Our thorough investigation found clear evidence of data misrepresentation and 16 of the 18 authors on the paper have agreed it should be retracted,” David Daley, a Glaxo spokesman inLondon, said in an e-mailed response to questions. “We will not tolerate activity and behavior that falls short of the high standards expected from our employees.”

Daley didn’t respond to a question regarding the competitive environment Liu described. Nature Publishing Group declined to comment specifically on the status of Liu’s paper.

“The only people who can retract papers are authors or editors,” Editor-in-Chief Phil Campbell said in an Aug. 3 e-mail. “Editors may be requested to retract a paper over the heads of authors, whether by the authors’ institution or company or by anyone else.”

In those situations, Nature’s editors will decide in consultation with the authors, Campbell said.

The disputed research isn’t part of the investigation of Glaxo China announced in late June by the nation’s Public Security Ministry of alleged economic crimes involving 3 billion yuan ($489 million) of spurious travel and meeting expenses, and trade in sexual favors. Glaxo’s head ofemerging markets Abbas Hussain said on July 22 after meeting with government officials in Beijing that some of its employees may have broken China’s laws. The drugmaker has said it’s cooperating with the government’s investigation.

Rapid Expansion

Still, Liu’s experience tells of the rapid expansion in research from immune diseases to herbal medicines that Glaxo underwent in China and of the competitive environment in which he and colleagues worked.

Johnson & Johnson was fined for monopolistic practices last week. Eli Lilly & Co. was reviewed earlier this year by authorities in Shenyang, the company said on Aug. 1. An unidentified whistle-blower alleged that Sanofi gave about 1.69 million yuan ($276,000) in bribes to 503 doctors in China, the 21st Century Business Herald reported today.

Sanofi “takes very seriously” the allegations in the report and has established processes in place for reviewing and addressing such issues, the company said in an e-mailed statement today, adding it was premature to comment further.

‘Virgin Territory’

“For Glaxo and for other multinationals, China represented virgin territory — it could build up its sales force and R&D effort in parallel there,” said Navid Malik, head of life sciences research atCenkos Securities Plc (CNKS) in London. “Because it’s still under-penetrated, they could think about how to target certain disease areas where they can build sales infrastructure and roll out their R&D cheaply and efficiently.”

The China-based research units of most global drugmakers tend to support centers located in the U.S. and Europe. Glaxo’s facility in Shanghai was different: it was conceived to lead the company’s global efforts in research into neurodegeneration.

It would “eventually direct the global discovery and development activities” for disorders such as multiple sclerosis, Parkinson’s disease and Alzheimer’s disease, Glaxo said in a May 2007statement.

Establishing the center didn’t only enable Glaxo to tap a pool of talented Chinese researchers — many of whom had worked overseas, as Liu had — it was also politically savvy, said Fabian Wenner, a health-care analyst with Kepler Capital Markets in Zurich.

‘Solid Presence’

“If you want a government contract, it’s easier for you to negotiate if you have a solid presence in China,” Wenner said in a telephone interview.

Liu, who moved to the U.S. after obtaining a doctorate in immunology from Beijing Medical University in 1999, was part of the diaspora of Chinese researchers returning home.

A U.S. permanent resident, he worked as a senior biologist at the Bethesda, Maryland-basedNational Institutes of Health before becoming the 30th person hired at Glaxo’s Shanghai research center in December 2007. The center, located in a technology park on the eastern outskirts of Shanghai, now has a staff of about 500.

“This was my first job in industry and there was a very different culture,” Liu said behind thick, rimless glasses and dressed in a short-sleeve checked shirt tucked neatly into his belted trousers. “I was also not experienced with compliance back then, and we didn’t pay enough attention to things such as recording of reports from our collaborators.”

Colleague Competitors

There was also a culture in which Glaxo scientists were grouped into competitive teams, known as discovery performance units, which vied internally for funds every three years, he said. Those who failed to meet certain targets risked being disbanded.

The publication of Liu’s paper in Nature Medicine was initially lauded by Glaxo, he said, adding that the company rewarded his 30-strong team with 20,000 yuan ($3,300), which they spent on a team-building trip.

“We heard Pfizer (PFE) and a few other universities and research institutes were working on something similar,” Liu said of his research. “If someone else had published ahead of us, it would have screwed up our plans. The novelty would have been lost.”

He’s now unemployed and contemplating returning to the U.S. to escape damage done to his reputation in China.

“This situation has destroyed my past and maybe even my future, but I still hope someday to be back researching drugs,” Liu said.

To contact Bloomberg News staff for this story: Daryl Loo in Beijing at dloo7@bloomberg.net

To contact the editor responsible for this story: Jason Gale at j.gale@bloomberg.net

New American : Psychiatric Meds: Prescription for Murder?


Psychiatric Meds: Prescription for Murder?

Written by  

  • Psychiatric Meds: Prescription for Murder?

In a frenzied cry for gun-control, the media is rife with details about the firearms Adam Lanza used to kill 20 children and six adults before turning a handgun on himself at Sandy Hook Elementary School in Newtown, Connecticut, on December 14, 2012. But information about Lanza’s medical history is scarce, feeding speculation that he may fit the profile of school shooters under the influence of psychotherapeutic medication.

“In virtually every mass school shooting during the past 15 years, the shooter has been on or in withdrawal from psychiatric drugs,” observed Lawrence Hunter of the Social Security Institute. “Yet, federal and state governments continue to ignore the connection between psychiatric drugs and murderous violence, preferring instead to exploit these tragedies in an oppressive and unconstitutional power grab to snatch guns away from innocent, law-abiding people who are guaranteed by the U.S. Constitution the right to own and bear arms to deter government tyranny and to use firearms in self defense against any miscreant who would do them harm.”

There is a striking connection between school shootings and psychotherapeutic drugs, also known as psychotropics. Consider these examples:

• Toby Sincino, a 15-year-old who shot two teachers and himself in 1995 at his South Carolina school, was taking the antidepressant Zoloft.

• Kip Kinkel, an Oregon teen who murdered his parents and proceeded on a shooting rampage at his high school in 1998, killed two and wounded 25 while in Prozac withdrawal.

• Shawn Cooper fired two shotgun rounds in 1999 at his Idaho high school while on an antidepressant.

• T.J. Solomon, Jr. was 15 years old when he shot six classmates in Atlanta in 1999. He was taking Ritalin and was also being treated for depression.

• Eric Harris was one of the assailants at Columbine High School in Colorado in 1999. His autopsy revealed a therapeutic level of the antidepressant Luvox in his system.

• Jason Hoffman wounded five people with a shotgun at his California high school in 2001 while on two antidepressant medications, Celexa and Effexor.

• Jeffrey Weise, a student at Red Lake High School in Minnesota, killed 10 and wounded seven in 2005 while on Prozac.

• Matti Saari, a college student in Finland, shot and killed 10 people before committing suicide at his university in 2008. The Finnish Ministry of Justice later reported he was taking an antidepressant and an anti-anxiety medication.

• Steve Kazmierczak killed six including himself at Northern Illinois University in 2008 while in withdrawal from the antidepressant Prozac.

• Tim Kretschmer murdered 15 students and teachers at his secondary school in Germany in 2009, and then committed suicide. Police reported Kretschmer was taking prescriptions to treat depression.

A 2002 Fox News interview with Cory Baadsgaard sheds some light on the possible mental state of these criminals. The year before, at age 16, Baadsgaard held a high-school class hostage at gunpoint in Washington state. Fortunately, no one was killed or physically hurt during the incident. The young man remembers the day in this way: “In the morning I didn’t feel like going to school. I felt sick; didn’t feel like I could get up very well. So I went back to bed. And the next thing I remember I’m in juvie in the detention center where I used to live.” Baadsgaard says he has no memory of the incident. He was tried as an adult but spent only 14 months in prison because expert psychiatric testimony convinced the jury his crime was the result of adverse reactions the antidepressants Effexor and Paxil.

Despite the abundance of such evidence and a glut of scientific studies proving real danger, “there has yet to be a federal investigation on the link between psychiatric drugs and acts of senseless violence,” according to the Citizens Commission on Human Rights International (CCHRI), a non-profit mental health watchdog group. CCHRI states that government officials are well aware of the connection. “Between 2004 and 2011, there have been over 11,000 reports to the U.S. FDA’s MedWatch system of psychiatric drug side effects related to violence,” including 300 homicides. The FDA estimates this total is less than 10 percent of the actual number of incidents since most go unreported.

However, there has been little government action at all, with one exception. Due to the “large body of scientific research establishing a connection between violence and suicide and the use of psychotropic drugs,” the New York State Senate introduced a bill in 2000 to “require police to report to the Division of Criminal Justice Services (DCJS), certain crimes and suicides committed by persons using psychotropic drugs.” The bill died in committee, and the issue remains unresolved.

Instead, in response to the Sandy Hook tragedy and ignoring the obvious, Senator Toni Nathaniel Harp and Representative Toni E. Walker, both Democrats of the Connecticut General Assembly, introduced Bill 374, “requiring behavioral health assessments for children,” mandating psychiatric testing for public school students in grades 6, 8, 10, and 12 and for homeschooled children at ages 12, 14, and 17. The assessments would have to be reported to the State Board of Education, and there is great likelihood that more children would end up on psychiatric meds after such tests.

There is also plenty of official agitation for gun control. Hunter suggests instead, “It is pharmaceutical makers, not law-abiding gun owners or gun manufacturers, who should be held to account for the series of ‘lone-wolf’ mass shootings that have occurred since the widespread use of psychiatric drugs began.”

Drugs on the Firing Line

Antidepressants are psychiatric drugs that form a common thread in school shootings. There are five categories of anti depressants: selective serotonin reuptake inhibitors (SSRI), selective norepinephrine reuptake inhibitors (SNRI), monoamine oxidase inhibitors (MAOI), tricyclic antidepressants (TCA), and atypical antidepressants. Despite the moniker, doctors prescribe these medicines for much more than depression. They use them to treat such ailments as obsessive-compulsive disorder (OCD), bipolar disorder, bulimia nervosa, panic disorder, social anxiety disorder (SAD), premenstrual dysphoric disorder (PMDD), and attention deficit hyperactivity disorder (ADHD). Other suspect medications, such as Ritalin, Adderal, and Concerta, are sympathomimetic amines, prescribed to treat ADHD.

These medicines act on the body’s nervous system — altering its chemical communication pathways to affect areas of the brain involved in judgment, abstract reasoning, memory, emotions, and the fight-or-flight response — explains Michelle Morrison-Valfre, MHS, FNP in her 2005 book, Foundations of Mental Health Care. The expected result is a calm mood and clear thinking. However, in some cases unexpected results occur.

The Physicians’ Desk Reference (PDR), an authoritative source of all FDA-approved drug labeling information, identifies the potential hazardous side effects of psychotherapeutics, including suicidal and homicidal ideation. Unfortunately, such effects are not uncommon. In fact, when taking a particular medication poses serious risks, the FDA requires drug manufacturers to highlight the dangers in eye-catching boxes on pharmaceutical packaging. A drug’s “black box warning” alerts consumers to the major hazards they face when taking that medicine. Most prescriptions do not have black box warnings — only those that can cause extreme adverse reactions compared to the potential benefit. Among psychotherapeutics’ black box warnings are:

• “Increased risk of suicidal ideation in short-term studies in children and adolescents with ADHD.” (Strattera, SNRI)

• “Antidepressants increased risk of suicidal thinking and behavior (suicidality) in short-term studies in children, adolescents and young adults with major depressive disorder and other psychiatric disorders.” (Zoloft, SSRI)

• “Monitor appropriately and observe closely for clinical worsening, suicidality or unusual changes in behavior for all patients who are started on antidepressant therapy.” (Parnate, MAOI)

• “High potential for abuse; avoid prolonged use. Misuse of amphetamine may cause sudden death and serious cardiovascular events.” (Adderal, sympathomimetic amine)

Additionally, all depression and ADHD therapies contain FDA-mandated warnings for caregivers to monitor for suicidal thinking, worsening of depression symptoms, and unusual changes in behavior. Patients taking the tricyclic Elavil are cautioned to “seek medical attention for symptoms of mania, increasing psychosis or paranoia.” Literature warns parents of children on Ritalin that “stimulants at usual doses can cause treatment emergent psychotic or manic symptoms (hallucinations, delusional thinking, mania) in children and adolescents without prior history of psychotic illness.” (Emphasis added.) The PDR also reports clinical trials have identified aggressive behavior and hostility as notable side effects of ADHD medications.

The advent of these drugs coincides disturbingly with a rise in the adolescent suicide rate. Ritalin was introduced in 1956. Antidepressants made their debut in the early 1960s, according to Morrison-Valfre, who noted elsewhere in her text that statistics from the U.S. Bureau of the Census reveal, “from 1960 to 2000 the rate of adolescent suicide more than doubled.” This may be coincidental, but it is unnerving in light of these drugs’ well-known adverse effects.

One thing, however, is certain. Prior to the advent of antidepressants, there was little relation between depression and violent behavior. “One of the things in the past that we’ve known about depression is that it very, very rarely leads to violence,” observed psychiatrist Peter Breggin in a Fox News report. “It’s only been since the advent of these new SSRI drugs that we have murderers, sometimes even mass murderers, taking antidepressant drugs.”

Dr. Breggin is an expert in the mental health field and an outspoken critic of psychiatric drug overuse. Among his more than 20 books on the topic is Brain-Disabling Treatments in Psychiatry (2008), in which he recounts a significant clinical trial involving children taking Prozac. Fourteen percent of the study’s subjects became aggressive and even violent on the drug, but the experience of a 12-year-old boy is particularly disturbing. Quoting the study, Breggin writes:

Thirty-eight days after beginning the protocol, F. experienced a violent nightmare about killing his classmates until he himself was shot. He awakened from it only with difficulty, and the dream continued to feel “very real.” He reported having had several days of increasingly vivid “bad dreams” before this episode; these included images of killing himself and his parents dying. When he was seen later that day he was agitated and anxious, refused to go to school, and reported marked suicidal ideation that made him feel unsafe at home as well.

Breggin notes the boy cannot be labeled a copycat since the study was conducted in 1991, long before the highly publicized school shootings of more recent years. Once the child stopped taking Prozac, his symptoms disappeared.

The Drug Pushers

Instead of investigating psychiatric drugs’ connection to acts of mass violence, public policymakers and healthcare professionals actually promote the use of psychotropic drugs by children and adolescents. The New York Review of Books published a June 2011 review by Dr. Marcia Angell, former editor of The New England Journal of Medicine, called “The Epidemic of Mental Illness: Why?” She summed up the problem saying:

The tally of those who are so disabled by mental disorders that they qualify for Supplemental Security Income (SSI) or Social Security Disability Insurance (SSDI) increased nearly two and a half times between 1987 and 2007 — from one in 184 Americans to one in seventy-six. For children, the rise is even more startling — a thirty-five-fold increase in the same two decades. Mental illness is now the leading cause of disability in children, well ahead of physical disabilities like cerebral palsy or Down syndrome, for which the federal programs were created.

Angell relates that psychiatric treatment shifted from “talk therapy” to drug therapy in the 1950s when doctors noticed new drugs meant to treat infections also “blunted disturbing mental symptoms” by affecting the levels of certain chemicals in the brain. Out of that observation was born the theory that mental illness is a result of chemical imbalances. “Thus, instead of developing a drug to treat an abnormality, an abnormality was postulated to fit a drug,” observed Angell. “That was a great leap in logic.” She noted that subsequent studies have proven such chemical imbalances do not in fact exist in patients diagnosed with psychiatric disorders such as depression. It is only after a person takes a psychiatric medication that the brain begins to function abnormally.

Moreover, diagnosing mental illness is largely a subjective endeavor, unlike other fields of medicine that rely on objective lab data or scans and x-rays for diagnosis. So says psychiatrist Daniel Carlat in his 2010 book Unhinged: The Trouble With Psychiatry — A Doctor’s Revelations About a Profession in Crisis. “Our diagnoses are subjective and expandable, and we have few rational reasons for choosing one treatment over another,” admits Carlat.

Eager to exploit the benefits of the chemical theory and aware of the “subjective and expandable” nature of diagnosing mental illness, drug companies vigorously subsidize the psychiatric profession. In his 2010 exposé Anatomy of an Epidemic, Robert Whitaker notes that besides the gifts and fringe benefits given directly to psychiatrists, especially those at influential academic centers, drug companies generously support psychiatric associations, patient advocacy groups, and educational organizations. They fund around one-fifth of the budget of the American Psychiatric Association. In the first quarter of 2009 alone, pharmaceutical company Eli Lilly donated more than $1.2 million to mental health non-profits.

Angell goes on to explain how drug companies peddle their wares. In order to have a drug approved, pharmaceutical manufacturers must submit to the FDA two clinical trials proving a product more effective than a placebo. Drug companies can perform as many trials as they wish in order to achieve the two successful tests they need. Positive studies are highly publicized while the negative are suppressed. In a review of tests for the six most widely used antidepressants between 1987 and 1999 — Prozac, Paxil, Zoloft, Celexa, Serzone, and Effexor — Angell reported, “Most of them were negatives. Overall, placebos were 82 percent as effective as the drugs.… The average difference between drug and placebo … was clinically meaningless.”

Convinced by positive reports of the drugs’ benefits, doctors prescribe them liberally. The Centers for Disease Control and Prevention divulged in 2011 that 11 percent of Americans age 12 years and over take antidepressant medication. CDC statistics also revealed a 400-percent increase in the rate of antidepressant use in the United States between 1988 and 2008. As of 2008, antidepressants were the most frequently used drug by persons aged 18-44 years.

The problem is not confined to the United States. Last year the Guardian reported prescriptions for Ritalin in the U.K. quad rupled from 2000 to 2010, and between 2006 and 2010 the United States witnessed an 83-percent increase in sales. The U.K.’s Association of Educational Psychologists complains that physicians are ignoring the professional union’s recommendation not to prescribe ADHD medication to most children under age six. “We need to show young people how to deal with the normal stresses and strains of growing up,” argues Member of Parliament Tessa Munt. “Resorting to powerful drugs only stores up trouble for the future.”

The University of Utah’s Genetic Science Learning Center says that Ritalin is currently prescribed to approximately six million people in the United States, of which 75 percent are children. Its data also confirm between 30 and 50 percent of adolescents in drug treatment centers report abusing Ritalin. And because of the medication’s similarity to cocaine, once these teens reach adulthood they are more prone to cocaine addiction.

Angell acknowledges the long-term effects of psychiatric drugs have yet to be proven. But she quotes several psychiatric researchers, including a former director of the National Institute of Mental Health, who contend that by upsetting normal brain chemistry, these medications cause brain cells to become desensitized to or overcompensate for the disturbances the drugs cause. In other words, the drugs can trigger chemical imbalance where none existed in the first place, hence the emergence of adverse effects like mania and suicidal/homicidal ideation, especially when a psychotropic drug is first started or stopped. Other research shows a relation between these drugs and brain atrophy, an often irreparable decrease in the size and number of brain cells.

The Connecticut Case

Fox News reported, after an initial search of Lanza’s home, investigators found no indication the 20-year-old was taking prescriptions. Other evidence suggests he was. Louise Tambascio, a friend of Lanza’s mother, told CBS News’ Scott Pelley on 60 Minutes, “I know he was on medication and everything.” ABC News also interviewed Tambascio, who repeated, “I knew he was on medication.”

Connecticut’s chief medical examiner, H. Wayne Carver II, is currently conducting toxicology exams to determine if Lanza was using any behavior-modifying drugs. Many think it likely. Days after the Sandy Hook massacre, standing outside Lanza’s home, CNN’s chief medical correspondent Dr. Sanjay Gupta commented, “What medications was he on? I’m specifically talking about antidepressants. If you look at the studies of other shootings like this that have happened, medications like this were a common factor.” In a December 16 Fox News interview, former Secretary of Homeland Security Tom Ridge also warned of the undeniable link between youth violence and psychiatric drugs.

Most media choose to ignore such warnings and even downplay the obvious. The Associated Press published a January 11 report entitled, “Connecticut shooting: Medical examiner says gunman’s body won’t reveal much.” It claims that “Connecticut’s chief medical examiner says he doubts toxicological tests and genetic analysis of the body of the gunman who fatally shot 20 children and six educators at an elementary school will explain his actions.” In a glaring contradiction the same article later notes, “The toxicology exam, which could take several weeks, involves testing body fluids for psychiatric medications or illegal substances. Carver said the result could provide ‘potentially valuable information’ in creating a full picture of Lanza.”

Meanwhile, government officials and anti-gun activists continue to use the tragedy in the Constitution State to deprive Americans of the constitutionally protected right to keep and bear arms. Whether Adam Lanza’s toxicology tests reveal psychiatric medications were involved in his rampage is not likely to deter their frenzied zeal.

Thi

Families face battle with GSK over dangerous diabetes drug


GSK..
Helping people to do more, feel better and live longer!!!... 
YEAH RIGHT!..

http://www.guardian.co.uk/business/2013/jan/29/glaxosmithkline-legal-fight-uk-diabetes

Families face battle with GSK over dangerous diabetes drug

Exclusive: Pharmaceutical giant resists claims despite settlement with victims in US

Avandia pill bottle
GlaxoSmithKline has agreed to payouts in US lawsuits alleging Avandia pills could cause heart attacks. Photograph: Bloomberg/Getty Images

Thousands of families in the UK could be deprived of compensation for the death or harm of a relative caused by the diabetes drug Avandia, even though the British maker has agreed to pay billions of dollars to settle similar claims in the US.

The licence for Avandia was revoked in Europe, in September 2010, because of evidence that it could cause heart failure and heart attacks. The drug can still be prescribed in the US, but not to patients at risk of heart problems.

A scientist with the Food and Drug Administration estimated that Avandia could have been responsible for 100,000 heart attacks in the US.

The manufacturer, GlaxoSmithKline, has admitted concealing data about the damaging side-effects of the drug, and there is evidence of the drug’s harmful effects. But, despite this, GSK is not prepared to settle claims in the UK without a court fight.

The history of drug litigation in the UK suggests that families might not easily get  compensation.

Daniel Slade, with the Express company of solicitors in Manchester, has 19 cases on his books and has begun proceedings against GSK in four of them.

The pharmaceutical firm has told the solicitors that it will contest the cases. In just one of the cases it has indicated a willingness to spend £600,000 on its defence, which, the solicitor says, would be a fraction of what the claim is worth.

“It is very disappointing,” said Slade. “We anticipate that these claims do have a good prospect of success, but they still have to prove their case in the UK with suitable evidence. They are tasked with having to produce that evidence, including medical expert opinion. It is a burden one would have thought they might not have to go through.”

He expected that, if GSK fought in the courts rather than settled outside, as it had done in the US, it would take years for bereaved relatives, or those who have been harmed, to get any sort of payment.

A spokesman for GSK said: “We have every sympathy for people with complications associated with diabetes and those who care for them, but unfortunately we are unable to comment on individual legal cases. We continue to believe that the company acted appropriately and responsibly in its management of Avandia.”

Liz Thomas, policy manager at the patient safety charity Action against Medical Accidents, said it had “become increasingly difficult in the UK to challenge large corporations such as pharmaceutical companies, an incredibly expensive form of litigation”.

Corporations have a vast amount of money at their disposal to contest legal cases, but legal aid is about to cease for medical negligence cases.

The Avandia cases in Manchester will be fought on a “no win, no fee” basis by Express solicitors.

The cases in the US were settled by GSK extremely quickly, said Thomas. “I would hope they would not take advantage [in Britain] of the inequality of arms.”

Avandia was first introduced in the NHS in July 2000. It was given to people with type 2 diabetes whose glucose levels were no longer being properly controlled by the standard drugs – metformin and a sulphonylurea drug. Avandia could be prescribed with those drugs or on its own.

The drug, which generically is known as rosiglitazone, was designed to lessen the body’s resistance to insulin. It was available as a standalone drug – Avandia – or in a combination with metformin, and known as Avandamet.

When both drugs were withdrawn by the European Medicines Agency, there were about 90,000 people taking them in the UK.

The first warnings of trouble with Avandia came in 2007, when a prominent US scientist, Steve Nissen, published data from a review of 42 clinical trials which had been carried out on the drug. The trials involved 28,000 patients, and showed that Avandia could cause heart attacks. Further trials, the results of which were published in 2010, found people on Avandia were 27% more likely to have a stroke, 25% more likely to have heart failure, and 14% more likely to die, than patients on an alternative diabetes drug.

Potentially yet more damaging for GSK was its guilty plea to federal charges of concealing data about the drug’s side effects. Most of the data on the drug comes from GSK’s own trials. In November 2011 GSK agreed to pay $3bn to the US government over the Avandia issue and to end investigations into its marketing of the antidepressants Paxil (Seroxat in the UK) and Wellbutrin.

“This is a significant step toward resolving difficult, long-standing matters which do not reflect the company that we are today,” Andrew Witty, chief executive of GlaxoSmithKline, said at the time.

GSK is also still defending cases in the UK from people who claim to have been badly affected by Seroxat. A group action, involving people who say they suffered severe withdrawal problems when they tried to stop the drug, has been going on for years though many claims have been settled in the US.

The same is true of Vioxx, made by Merck, the painkiller that was withdrawn after it emerged eight years ago that it doubled the risk of a heart attack.

http://spirithappydiet.blogspot.ie/2013/01/diabetes-drug-causes-death-and-now-they.html

Diabetes drug causes death and now they want another pill approved

Spirit Happy has reported on the shady practices of Glaxo Smith Kline for many years. As far back as 2008 we reported that their drug Avandia would cause heart attacks and that is exactly what the drug did. Unfortunately this has not stopped them from seeking another Billion dollar profit drug for diabetes. They refuse to stop making diabetic drugs because it profits them over 4 Billion dollars a year.
Here is their History in Diabetes drugs
  1. Glaxo was ordered to pay 90 million dollars in the Unites States for the heart attacks and deaths related to their drug Avandia. We warned the public but few listened back in 2009, we told the public that very few people need a drug Type 2 diabetes, it can be reversed naturally. We informed the public that Avandia, Actos, and other high blood sugar medications were all dangerous drugs that destroyed the heart valve. The drug maker simply lie and they do it because the billions are too great a temptation for them. They simply want the money at any cost, even death to the person taking the drugs.
    1. 90 million is a low settlement seeing as the drug profited over 5 Billion dollars each year for 5 years. Each family victimized is reported to receive 53 thousand dollars. In addition the drug maker makes much more money on stocks once the drugs receive approval. When a diabetic drug is approved the company’s stocks fly up because it means millions in straight profit. This is the billion dollar big money game in pharmaceutical drugs.
    2. The story about Glaxo gets sicker as they were also found guilty of fraud, a 9 year investigation showed that the company lied to the public and hide information that the diabetes drug and other drugs they made were dangerous. They bribed doctors to promote their drugs. Did you know doctors get cash and vacations for prescribing a certain number of drugs? Glaxo sales reps lied and told doctors that the drug Avandia would even help the heart( while the drug really causes heart attacks) Drug companies have sales people who push the drugs on the doctors( Legal street drugs are not the only dirty drug game, prescription drugs may be more dirty)
    3. Glaxo salesmen get commissions( $) based on how many doctors they can get to prescribe the drug
    4. Glaxo was found guilty of hiding the heart attack risks from the FDA.
    5. Glaxo moved the dirty operation and had the drugss made in  factories in Puerto Rico to save tax dollars. What a shame.
These are the things they were found guilty of, this is not just an opinion, they admitted lying and hiding the truth and they pleaded guilty to all the charges above.
In total Glaxo has paid back the largest suit in US drug history 5 billion dollars, yet Glaxo profited over 20 billion dollars in 5 years from the diabetes drug
The drug business is a dirty business operated for huge profits.
In an amazing development Glaxo filed to the FDA to have a new diabetes drug approved and they have been approved last week!
The USA reported the story
GSK Diabetes Drug Receives FDA Approval As Initial Therapy
and here is the statement for Glaxo’s spokesperson
“GlaxoSmithKline is committed to developing diabetes therapies to treat a disease that has reached epidemic proportions in the United States and throughout the world,” said Anne Phillips, vice president of Clinical for North America Cardiovascular-Metabolic at GSK,
What hypocrisy, they have admitted lying and defrauding the diabetic yet they say they are committed to helping the diabetic. . They caused deaths which no settlement could ever make up for. Glaxo stocks went up 1.6 % after the settlement and the stockholders were said to be “happy”  that they did not lose their investments in the company.
Diabetes for them is a stock market game with billions dollar of dollars at stake. Their executives make more money than the average person will ever see. Ask your doctor if type 2 diabetes can be reversed without drugs and he will inform you that it can. The drugs are part of a billion dollar con game.
We reported on Glaxo in 2009 and here in 2011 see here  Dangerous diabetes drugs

GlaxoSmithKline fraud case: Does crime pay?


FOR FULL VIDEO AND DISCUSSION OF GSK FINE FOR FRAUD SEE LINK BELOW:

http://www.aljazeera.com/programmes/insidestoryamericas/2012/07/201271084038662313.html

In the biggest health care fraud settlement in US history, a federal judge approved a fine totalling $3bn for criminal and civil violations by the British pharmaceutical giant, GlaxoSmithKline, last week.

“Most of the examples … are of a drug that is approved for disease A and it is thought to be safe and effective for disease A but they’re not selling enough. It’s still on patent … as long as it’s on patent, as long as they can charge more, they will start pushing it for disease B and C and D for which there is no evidence that the benefits outweigh the risks so this is a strategy widely used by companies to increase their sales.– Dr Sidney Wolfe, co-founder and director of the Health Research Group

The company admitted illegally marketing the popular antidepressants Paxil and Wellbutrin and also withholding the data on the health risks of its best-selling diabetes drug, Avandia.

For seven years Glaxo failed to report data showing drug Avandia increased the risk of heart attack by as much as 40 per cent.

And the company claimed Wellbutrin was beneficial for weightloss and treating sexual dysfunction.

In the case of Paxil, GlaxoSmithKline promoted the drug for use by children and teenagers, despite the US Food and Drug Administration not approving it for patients under 18.

In fact, a clinical trial had found that the drug made adolecents more likely to attempt suicide.

Whistleblowers said that the company gave doctors lavish trips and spa treatments in order to pursuade them to prescribe the drug for uses not approved of through testing – what are known as off-label prescriptions.

Glaxo also hired a company to write a medical journal article downplaying the risks.

The US deputy attorney general called the settlement historic, saying it sent a clear warning to any company that chooses to break the law.

“They are doing the calculation … and it comes out in their favour that you might as well take the risk here. The basic economics are fairly straight forward, we know that these drugs could be produced, with few exceptions, very cheaply …. There is an enormous incentive for them to lie, cheat, steal, whatever, try and push these drugs.– Dean Baker, co-director of the Center for Economic and Policy Research

But there have been some other big drug companies that have been caught acting illegally.

In January 2009, the American pharmaceutical giant Eli Lilly agreed to pay more than $1.4bn for illegally promoting the drug Zyprexa.

Prior to Glaxo, the previous record-setting case involved Pfizer Inc., which in September 2009 paid $2.3bn for improperly marketing 13 different drugs, including Viagra.

In April 2012, Johnson & Johnson and a subsidiary were ordered to pay more than $1.2bn for minimising or concealing dangers associated with the antipsychotic drug Risperdal.

And in May, Abbott Laboratories settled for $1.6bn in regard to false marketing of the antiepileptic and mood-stabilising drug Depakote.

So, with the profits over more than a decade of illegal selling far larger than the amount Glaxo agreed to pay, will pharmaceutical companies really be put off? And do drug companies put profits before patients in the US?

Inside Story Americas, with presenter Shihab Rattansi, discusses with guests: Dr Sidney Wolfe, the co-founder and director of the Health Research Group; Dean Baker, the co-director of the Center for Economic and Policy Research; and Wendell Potter, an author and corporate health analyst.

Inside Story Americas also invited GlaxoSmithKline to take part in this discussion, but the company declined.

“Many observers, including myself believe that as long as it is just money that’s involved, it’s not a sufficient deterrent. The drugs that were involved in this settlement earned tens of billions of dollars over a long period of time. So the settlement was less than a single year’s sales of just one of those drugs, Avandia, the drug that I was involved in exposing the risks of. And so it’s just money, and it’s just part of doing business. Many people, particularly on Capitol Hill, believe that it’s time to begin holding these executives accountable for actual jail time when they commit this kind of criminal fraud.”Dr. Steven Nissen, a cardiologist at the Cleveland Clinic who in 2007 published findings that showed the health risks of the drug Avandia

___________________________________________________________________________________________________

THE GLAXOSMITHKLINE FRAUD CASE:

  • GlaxoSmithKline promoted antidepressants for unapproved uses
  • Glaxo failed to disclose diabetes drug increased heart attack risk
  • The company pleaded guilty and agreed to pay $3bn fines – the largest settlement ever by a drug company
  • The fine includes $1bn criminal fine and $2bn for the civil settlement
  • The $2bn civil settlement involved asthma drug Advair and claims that Glaxo overcharged the US government
  • The criminal charges involved Paxil Wellbutrin and Avandia
  • The antidepressant, Paxil, brought in $11.6bn in sales for Glaxo
  • Sales of the diabetes drug, Avandia, brought in $10.4bn
  • Sales of Wellbutrin, another antidepressant, brought in $5.9bn for Glaxohttp://aje.me/Mi1MVF
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