Friday, November 1, 2013

AstraZeneca Seroquel - The criminal cover-up that is still killing decades later - a walk down tragedy's memory lane

After all the propaganda and empty promises...From the White House, The Senate, The Congress, The Federal Courts, The DOJ, The FDA, A Billion Dollar AstraZeneca Legal Dream Team, and finally all those seedy plaintiff law firms who sold out their own clients for huge profits; No one has been held accountable for these unconscionable crimes that have either killed or severely injured many many thousands of innocent victims.

This blog has chronicled this dead-end journey from the injured parties' perspective, attempting to tell the story that is seldom reported by the news media, in the faint hope that some day justice will be served, and that these kinds of corporate criminal tragedies are not repeated in the future.

 Unfortunately, that is just not reality...the entrenched greed and corruption continues to prevail at every turn and all levels of the regulatory and judicial process. These pages have been read by all of the aforementioned parties highlighted above to no avail. This blog has been attacked, faced numerous threats/acts of intimidation for exposing and reporting the truth. Unfortunately, the only success that has been accomplished is public awareness and a living archive of what everyday citizens face when confronting institutionalized corruption.

Today, I would like to share once more an excellent program produced by BBC News years ago...nothing has really changed since this report; yet I believe it encapsulates this criminal story as well as any report to date.  I ask you to take a walk down this tragic memory lane and never was very real people just like yourself that had their lives and health destroyed simply in the name of unquenchable corporate greed. I believe you will find the time spent listening to this broadcast well worth the time invested.

Drug danger distraction?

Duration: 40 minutes
First broadcast: Tuesday 26 January 2010
A British drug company is being sued by more than 15,000 people in the United States who claim its bestselling antipsychotic drug caused severe weight gain, diabetes and other serious medical conditions. Ann Alexander investigates concerns about the way it was marketed and asks how much the public should be told about the drugs they take.

Saturday, July 27, 2013

AstraZeneca, GSK, and The Pharmaceutical Industry Crime Syndicate - Criminal Bribery, Sex, Drugs, & Fun Times in China...

                                      Hat Tip to pharmagossip for (edited) image
AstraZeneca, GSK, and The Pharmaceutical Industry Crime Syndicate - Criminal Bribery, Sex, Drugs, & Fun Times in China...

As if the latest information and news comes as any surprise to anyone with these TOO BIG TO FAIL, TOO BIG TO BE HELD ACCOUNTABLE pharmaceutical corporate giants...remember all those CIA's (corporate integrity agreements), the meaningless token fines, the ghost writing, the hidden information, crimes, and lawsuits...the shallow apologies...When it comes to money & profits it all means absolutely & weep as you peruse the following articles...

"Police also detained two members of AstraZeneca's Chinese staff for questioning on Tuesday. The employees in Astra's main Shanghai sales centre are line managers of an Astra sales representative detained on Friday.
An Astra spokeswoman said one of the managers was "continuing to assist the [Shanghai public security] bureau with their inquiries". She said there was "no reason to believe [the arrest] is related to other investigations".
Meanwhile, four more western drug companies – Sanofi, Novartis, Merck and Roche – said they had used the same travel agency that GSK allegedly used to funnel bribes to doctors. All four companies said they had stopped using the Shanghai Linjiang agency."

 "The woman, named as Ms Wang, said “some executives gave clear directives to the sales department to offer bribes to doctors with money or opportunities to attend academic conferences.”
Ms Wang said she would even go so far as fulfilling some doctors’ “sexual desires” in order to “meet their needs” and persuade them to prescribe more drugs.
A doctor from a “reputable hospital” whose real name was not given, claimed that one GSK representative had “blatantly offered kickbacks to doctors”. 

And at The 1 Boring Old Man Blog the conversation is already getting hot hot hot with new post an-irreducible-conflict and more-china

"The industry thrives by relying on irrational exuberance, well designed illusion, and a dash or two of crime. And they can’t seem to stop…"

Also, over at Pharmalot  bribes-sex-fraud-did-glaxo-violate-its-corporate-integrity-agreement

 "A violation could lead the US Department of Health and Human Services Office of Inspector General to seek to exclude the drugmaker from contracts with federal healthcare programs, such as Medicare and Medicaid. This is big business, of course, and so any whiff of trouble that could impact the CIA has investors on alert.

On a conference call this morning to discuss the latest earnings, Glaxo ceo Andrew Witty was asked whether Glaxo staff believe the scandals in China would have an effect on the CIA, since it is known that US authorities are probing the drugmaker for violations of the Foreign Corrupt Practices Act (this is the law) and the UK's Serious Fraud Office is also conducting a probe. Witty, however, breezed past the question without offering a response."

 Some back story here --> astrazeneca-seroquel-marketing 

                                                      Image via the world renowned PharmaGiles

Friday, August 24, 2012

South Carolina Attorney General reaches $26M settlement against AstraZeneca for "willfully misleading consumers on the potentially serious side effects of the anti-psychotic drug Seroquel"

SC Attorney General reaches $26M settlement against AstraZeneca

Published: Thursday, August 23, 2012 at 5:46 p.m.
Last Modified: Thursday, August 23, 2012 at 5:46 p.m.
The S.C. Attorney General's Office has secured a $26 million settlement against the multi-billion pharmaceutical company AstraZeneca for violating the state Unfair Trade Practices Act by willfully misleading consumers on the potentially serious side effects of the anti-psychotic drug Seroquel.
The settlement order was filed Aug. 22 and is the third award, and final case against anti-psychotic drug manufacturers in South Carolina, that the Attorney General's Office has prosecuted since 2009. The cases began under former Attorney General Henry McMaster, who contracted with the Spartanburg law firm of Harrison, White, Smith and Coggins to prosecute the case on behalf of the state. The Spartanburg firm then contracted with two other firms in Columbia and Houston to assist with the litigation, which continued under Attorney General Alan Wilson.
In the lawsuit order, the company agreed to pay $26 million, which includes $20 million in damages and restitution to the state, $5 million in penalties and $1 million in trial costs. In 2010, AstraZeneca had $5.3 billion in worldwide sales including $3.75 billion in the U.S.
Bryan Stirling, deputy attorney general, said the settlement is fair to the state. A portion of the funds will go into the general fund, some will go to Medicaid and other funds to insurance companies.
Stirling said the Attorney General's Office sued on behalf of the state and the state agencies that paid additional funds because of the medication side effects.
AstraZeneca did not admit any wrongdoing or violation, but agreed to pay the sum to resolve the state action, according to the order signed by Circuit Court Judge Roger Couch."

Thursday, June 14, 2012

AstraZeneca - Seroquel - Army Apologizes for Seroquel Death

From the ArmyTimes

DoD cracks down on off-label drug use

By Patricia Kime - Staff writer
Posted : Thursday Jun 14, 2012 10:01:04 EDT
A letter landed in Stan White’s mailbox in Cross Lanes, W.Va., in April.
It began: “On behalf of the men and women of the U.S. Armed Forces … I extend my sincerest and deepest sympathy for the loss of your sons.”

But the note wasn’t simply a condolence. The message from Air Force Lt. Gen. Brooks Bash informed White that U.S. Central Command had decided in March to remove the powerful antipsychotic drug Seroquel from its approved formulary list.

Under the new rules, CENTCOM doctors now must request a waiver if they write a prescription for Seroquel, also known as quetiapine.

The change is a small victory for White, who had already lost one son to combat and has sought restrictions on the drug he believes contributed to the death of a younger son.

Marine Cpl. Andrew White died Feb. 12, 2008, at age 23 from a lethal combination of medications prescribed for post-traumatic stress disorder, mainly clonazepam, quetiapine and paroxetine — the latter two known to sometimes affect the heart’s regular rhythm.

“I have never been one to say I’m opposed to medication — I’m just opposed to these medications, which have a side effect of causing cardiac arrest,” White said June 6.

Off-label use soars

Prescriptions for Seroquel have exploded in the past decade, especially in the armed forces, where it often is prescribed off-label as a sleep aid.

In 2003, service members were diagnosed with insomnia at a rate of 30 per 10,000; by 2009, the rate had risen to 226 per 10,000. Prescriptions for Seroquel, or quetiapine, have subsequently soared, multiplying 27-fold in the same time period.

The drug is known to cause drowsiness and chase away nightmares associated with post-traumatic stress disorder.

Navy Capt. Mike Colston of the Office of the Assistant Secretary of Defense for Health Affairs said medications become popular as providers learn about them and as they receive new approvals for use by the Food and Drug Administration — in the case of quetiapine, as an add-on therapy for antidepressants.
Yet questions have been raised over whether its off-label use for insomnia was more than a grass-roots movement by physicians. In April 2010, manufacturer Astra-Zeneca agreed to pay $520 million to the federal government to settle a civil suit alleging that it illegally marketed Seroquel for a host of off-label uses such as Alzheimer’s disease, anxiety, PTSD and sleeplessness.

According to The Associated Press, in 2009, the Pentagon spent $8.6 million on the drug, while the Veterans Affairs Department spent $125.4 million.

Recent moves by the Pentagon to restrict prescriptions for atypical antipsychotic drugs were the result of a search for safe, proven therapies for troops, Colston said.

“We aim to … discourage the use of off-label medication treatments with antipsychotic medications before established evidence-based strategies have been implemented,” he said.

Earlier this year, Assistant Secretary of Defense for Health Affairs Dr. Jonathan Woodson asked the military services to monitor prescriptions for atypical antipsychotic medications, a class of drugs that includes quetiapine.
The medications are approved by the Food and Drug Administration for treating schizophrenia and bipolar disorder. But in the past decade, their popularity has soared for off-label use, including for treating PTSD and insomnia.

A 2011 study of 692 patients prescribed quetiapine at Madigan Army Medical Center, Wash., showed just 9.4 percent received it for an FDA-approved use, while 57 percent received it for insomnia.
In 2011, the services issued 54,581 prescriptions for Seroquel alone, the most for any antipsychotic medication — more than 2.5 times the number of prescriptions for the second-most prescribed atypical antipsychotic, Abilify, and nearly four times the number for risperidone, according to information obtained by a Military Times under a Freedom of Information Act request.

A growing alarm

Quetiapine has the strongest somnolent effect of all atypical antipsychotics, and is commonly prescribed troops for relieving nightmares.

But as its popularity has grown, evidence has mounted pointing to links between atypical antipsychotics and irregular heartbeat and even death — prompting critics and physicians, including Woodson, to sound the alarm on frequent prescriptions.

“Providers should use caution when these agents are used as sleep aids in service members struggling with substance use disorders, especially given the risk of such side effects as glucose dysregulation and cardiac effects,” Woodson wrote Feb. 22.

A study in the January 2009 New England Journal of Medicine found the rate of sudden cardiac death doubled for those taking atypical antipsychotic drugs, and there were three such deaths per year for every 1,000 patients taking the medication.

The risk of a fatal heart event also increased with dosage, and study author and Vanderbilt University researcher Wayne Ray said mixing these medications with others that cause irregular heartbeat, known medically as QT prolongation, could worsen the issue and possibly cause death.

“We saw this strong relationship between the antipsychotics and sudden death … and all the information we had pointed to the drugs as the cause,” Ray said after the study was published. “Our findings … would suggest avoiding other medications that prolong QT whenever possible because when you give two together, you’re … increasing the patient’s risk.”

The Madigan study, conducted by Army Lt. Col. Vincent Mysliwiec and presented last June at a meeting of the American Academy of Sleep Medicine, showed that of 692 patients who took quetiapine, 126 were monitored for heart arrhythmia within six months of starting on the drug, and of those, 11 showed an abnormal heart rhythm.

Ten of those cases were directly attributed to quetiapine; when the medication was stopped, their heart rhythm returned to normal, according to Psychiatric News.

Through an Army spokesman, Mysliwiec declined to release the study but said it was available to Defense Department physicians on request.

A 2008 Dutch study also showed patients taking more than one QT-interval-prolonging drug had 4.8 times the risk of cardiac arrest.

‘He just died’

White attributes his son’s death, and those of at least three others from West Virginia — Army Pfc. Derick Johnson, 22; Army National Guard Sgt. Eric Layne, 29; and Marine Cpl. Nicholas Endicott, 24 — to at least two heart-rhythm-altering drugs, quetiapine and paroxetine.

Since their cases were publicized, others have stepped forward, including Alicia McElroy, whose husband, Army National Guard Staff Sgt. James McElroy, 30, was found dead in his barracks while receiving treatment for PTSD at Fort Benning, Ga.

She said that among his many medications were Paxil, Seroquel and Klonopin.
“This wasn’t a long, slow death. It wasn’t an overdose. He wasn’t found unconscious. He just died,” said Alicia McElroy, who is still awaiting autopsy results. Her husband died June 6, 2011.

Seroquel maker AstraZeneca stands behind the safety record of its medication, which it made exclusively until March 2012, when the patent expired.

“Patient safety is a priority for AstraZeneca, and we think Seroquel is safe and effective when it’s used as recommended,” Stephanie Andrzejewski said.

She added the company does not condone prescribing Seroquel for off-label uses.
“We trust doctors to use medical judgment in … determining when it is appropriate to prescribe medications,” she said.

In July 2011, the FDA required AstraZeneca to add a warning to the drug’s label regarding its potential cardiac risk.

The services take action

The service surgeons general have responded to Woodson’s request for their policy guidance on atypical antipsychotics, Defense Department spokesman Navy Capt. Michael Colston said June 4. According to documents released by Colston:

• The Army decided risperidone should not be prescribed because its risks outweigh its benefits, and providers who prescribe other such drugs, including quetiapine, “must clearly document their rationale” and receive informed consent from the patient.

• The Navy Department agreed to monitor providers and flag those who prescribe the most atypical antipsychotics off-label for additional review.

• The Air Force, which prescribes atypical antipsychotics to “fewer than 0.15 percent of airmen,” will review provider prescribing practices and counsel those who show a pattern.

• The Washington, D.C., area medical command will conduct periodic evaluations of drugs prescribed to patients with PTSD and follow-up evaluations to see whether further monitoring is needed.

White, who had another son, Army Sgt. Robert White, killed in combat, said he is glad the military is moving away from medications for PTSD.

“I know people who have died from medication,” he said. “I don’t know anyone who’s ever been killed by counseling.”

Staff writer Andrew Tilghman contributed to this report.


for further reading on this topic Pharmalot has written a related article 

The US Military And Off-Label Antipsychotic Use

By Ed Silverman // June 14th, 2012
But growing concern over links between antipsychotics – especially Seroquel, which is the most widely prescribed antipscyhotic by the US military – and irregular heartbeats is prompting moves to restrict usage. For instance, a retrospective review of 692 patients who were prescribed Seroquel at the Madigan Army Medical Center in 2007 and 2008 found that only 3.4 percent received the drug for an approved use, which would also include adjunct treatment for depression.

However, 60 percent received the drug for insomnia, 19 percent for anxiety, 12 percent for mood disorders and 8 percent for post-traumatic stress disorder. Yet, only 18 percent were screened for irregular heartbeats and 126 underwent an EKG, with 11 percent showing abnormal heart rhythms, according to a presentation at the American Academy of Sleep Medicine annual meeting (here is the presentation – see page A179).

Such findings underscore the concerns. Last year, the armed services issued 54,581 prescriptions for Seroquel alone, the most for any antipsychotic — and more than 2.5 times the number of prescriptions for the second-most prescribed atypical antipsychotic, Abilify, and nearly four times the number for Risperdal, according to information obtained by Military Times under a Freedom of Information Act request.

In 2003, Military Times reports, service members were diagnosed with insomnia at a rate of 30 per 10,000. By 2009, the rate had jumped to 226 per 10,000. Prescriptions for Seroquel rose 27-fold in the same time period. And according to The Associated Press, in 2009, the Pentagon spent $8.6 million on the drug, while the Veterans Affairs Department spent $125.4 million. That same year, results of a proof-of-concept study showed Seroquel benefited patients with post-traumatic stress disorder (see this and this).

Meanwhile, a 2008 study in the British Journal of Clinical Pharmacology showed patients taking more than one drug that can cause irregular heartbeats had 4.8 times the risk of cardiac arrest (look here). A study the following year in The New England Journal of Medicine found the rate of sudden cardiac death doubled for those taking atypical antipsychotics, and there were three such deaths each year for every 1,000 patients taking such a drug (here is the abstract). The risk of a fatal heart event also increased with dosage, the Military Times notes.

Moreover, mixing antipsychotics with others that cause irregular heartbeat, known medically as QT prolongation, could cause more harm and, possibly, death.

**read full article at the link provided above**

Saturday, April 28, 2012

Seroquel, sexual favors and unretracted research papers: Martha Rosenberg asks "Why Are These Fraudulent Papers Unretracted?"

From CounterPunch Why Are These Fraudulent Papers Unretracted? by Martha Rosenberg

Why Are These Fraudulent Papers Unretracted?

"According to Science Times[1], the Tuesday science section in the New York Times, scientific retractions are on the rise because of a “dysfunctional scientific climate” that has created a “winner-take-all game with perverse incentives that lead scientists to cut corners and, in some cases, commit acts of misconduct.”
But elsewhere, audacious, falsified research stands unretracted–including the work of authors who actually went to prison for fraud!
Richard Borison, MD, former psychiatry chief at the Augusta Veterans Affairs medical center and Medical College of Georgia, was sentenced to 15 years in prison for a $10 million clinical trial fraud[2] but his 1996 US Seroquel® Study Group research is unretracted.[3] In fact, it is cited in 173 works and medical textbooks, misleading future medical professionals.[4]
Scott Reuben, MD, the “Bernie Madoff” of medicine who published research on clinical trials that never existed, was sentenced to six months in prison in 2010.[5] But his “research” on popular pain killers like Celebrex and Lyrica is unretracted.[6] If going to prison for research fraud is not enough reason for retraction, what is?
Wayne MacFadden, MD, resigned as US medical director for Seroquel in 2006, after sexual affairs with two coworker women researchers surfaced[7], but the related work is unretracted and was even part of Seroquel’s FDA approval package for bipolar disorder.[8]"
Read the article in its entirety here

CEO David Brennan Quits Under Pressure From Investors 
"While the company would not comment about his retirement package, which is still being finalised, Brennan could walk away with about £5m – after receiving more than £9m in pay, perks and shares last year.
Shares in the group, which also announced a 38% drop in three-month profits to £1.34bn and a reduction in its 2012 earnings target, were the biggest fallers in the FTSE 100, down 6.1% at £26.66, wiping £2.2bn from the company's market value.
Brennan will be replaced temporarily by finance director Simon Lowth from 1 June. Former Volvo boss Leif Johansson will take over as chairman from Louis Schweitzer, 69, on the same day – three months earlier than planned. Johansson will then lead the hunt for a permanent successor to Brennan. Headhunters Spencer Stuart have been hired to scout out internal and external candidates.
Brennan, 58, said he had been contemplating his departure for some time and told the board formally of his intention to quit on Wednesday, following private conversations with the chairman. The board then decided to accelerate the process by appointing Lowth as interim CEO, a move backed by Brennan.
Both Brennan and Schweitzer were reportedly encouraged to retire earlier than planned by non-executive directors on the board. However, Brennan insisted: "The decision to retire was entirely my decision. I've been contemplating it for a while. It was time to give someone else the chance to take the company to the next level."
He said he wanted to spend more time with his family (he is married with four grown-up children and has six grandchildren) and to "figure out ways to influence healthcare from a different position"."