By Katherine Hobson
It might be tough for James Wetta to get his next pharma job – then again, now that he’s a millionaire, he probably doesn’t need it.
The former AstraZeneca sales rep filed a whistleblower lawsuit against the company in 2004 that was only yesterday made public. Astra is going to pay $520 million to settle a probe into its marketing of the antipsychotic Seroquel (it denies the charges), and Wetta stands to pocket some portion of $45 million for his role in the investigation. He’s sharing the money with another whistleblower.
But the California resident has been down this road before, Dow Jones Newswires reports. He also helped the government in a similar probe of Eli Lilly, his previous employer. Lilly last year paid upwards of $1.4 billion to settle its own antipsychotic marketing issues with the Justice Department. (It, too denied the charges.) Wetta got a piece of the $100 million of that settlement reserved for whistleblowers.
According to his Astra suit, Wetta received negative evaluations at work after refusing to participate in the off-label marketing of Seroquel to child and adolescent psychiatrists, primary-care docs and elderly dementia sufferers. He was eventually let go, he claims. At Lilly, he quit after “objecting to certain sales tactics that he was informed would help him keep his job, including arranging for certain drugs to be switched on patients without their knowledge,” Dow Jones writes.
It’s a fair bet his photo is now hanging in pharma H.R. offices everywhere.
Image: iStockphoto
Friday, April 30, 2010
Whistleblower Twice Over: First Lilly, Now AstraZeneca - Health Blog - WSJ
Jay Byrne - V-Fluence and the AstraZeneca Seroquel connection
Jay Byrne
From SpinProfiles
Jay Byrne is Monsanto's former Director of Public Affairs and former Internet Outreach Programs Director. Prior to Monsanto, Byrne worked for USAID. Since leaving Monsanto, Byrne has become president of Internet PR company V-Fluence[1], whose vice-president, Richard Levine, was formerly part of the Monsanto team for Monsanto's Internet PR firm Bivings Group. V-Fluence is based, like Monsanto, in St. Louis. Monsanto is one of its clients.[2]
Covert Monsanto-Bivings campaign
Byrne is believed to have been the chief architect of the covert Monsanto-Bivings PR campaign which involved attacks on the company's critics via front e-mails, such as those of Andura Smetacek and Mary Murphy, and material posted on the website of a fake agricultural institute, the Center For Food and Agricultural Research (CFFAR). CFFAR material, attacking Monsanto's critics, was also faxed to journalists and planted at a conference.
The campaign is believed to have been a response to the growing role of the Internet in Monsanto's marketing problems in the late 1990s. As Bill Lambrecht pointed out in a September 1999 article in the St. Louis Post-Dispatch:
- The Internet is enabling mobilization like never before and, in the process, giving biotechnology companies fits. In recent months, St. Louis-based Monsanto Co. and its rivals in the new science of genetically engineering food have watched in dismay as pockets of protest have mushroomed... perhaps no single factor looms larger in biotechnology's tumble than the role of the Internet' [emphasis added].[3]
Byrne led Monsanto's counter attack. He is reported to have spent "a quarter of his time monitoring the Web for rogue and activist sites. He finds everything from activist sites to sites that provide even-sided discussions and debates about industry issues to those that paint Monsanto black."[4] Some of these he attempted to shut down. He gave advice to other PR professionals on the best ways to achieve this: "Anonymous sites often can be shut down by contacting the site's hosting company. To avoid any possible liability, hosting companies will shut down a site if they can't identify the owner, Byrne says."[5]
In February 2001 the owners of the monsanto.org site received a letter from Monsanto's lawyers telling them, "The information contained on your web site is defamatory, inaccurate and misleading". The letter also said, "if you do not immediately cease and desist from your conduct, as demanded by this letter, Monsanto will institute the appropriate proceedings against you without delay." Monsanto took legal action against the site in order to gain possession of the monsanto.org domain.[6]
Besides attacking critical sites, a significant part of Byrne's focus as an Internet strategist appears to have been on how to make Monsanto's case beyond the company's own websites and listservs. CS Prakash's campaign launched in January 2000 seems to have been of particular interest. According to one PR article:
- The site's listserv (AgBioWorld) generates more than 2,000 subscribers. Byrne subscribes and offers advice and information when relevant and ensures his company gets proper play.[7]
Byrne's exact role in the Prakash campaign's emergence can only be guessed at but there is evidence that the AgBioWorld site was designed by Monsanto's PR company Bivings Group and its original e-mail archive was covertly hosted on Bivings' main apollo server. The AgBioView list prominently circulated emails from Andura Smetacek and Mary Murphy attacking Monsanto's critics. Murphy's mails have been Bivings and Smetacek's to Monsanto, as is detailed in Andrew Rowell's book, Don't Worry, It's Safe to Eat.
At the end of 2001 Byrne ran a PR industry workshop in Chicago which was billed by its organisers, Ragan Communications, as showing how Monsanto 'brilliantly outwits its opponents at their own game of guerilla PR.' Byrne's presentation was accompanied by a PowerPoint display.[8] One of Byrne's slides, headed, "Take action/Take control", illustrated Monsanto's work on a particular search engine. Listed are the top search results for "GM food" before and after Monsanto took action. All the "before" sites are critical of GM; the "after" sites were mostly created by Bivings and include the Center For Food and Agricultural Research - the fake agricultural institute promoted by Smetacek.
Another of Byrne's slides is headed "Listservs: Directed & opt-in". It contains a single image: a thread of messages on the AgBioView list. The implication would seem to be that Monsanto uses this list for strategic PR purposes.
The content of Byrne's concluding slide is a quote: "Think of the Internet as a weapon on the table. Either you pick it up or your competitor does - but somebody is going to get killed."
Graydon Forrer and Philip Angell were colleagues of Byrne's at Monsanto.
What is the AstraZeneca Seroquel connection, you ask?
It looks like Byrne's company have a contract with AZ to monitor what is being said about Seroquel on the blogosphere.
But their system has a fault and one of those being watched got into the watchers system!
LOL
Explain that to your client Jay!
Thursday, April 29, 2010
Introducing v-fluence blog
Why, you ask?
Well they seem to be interested in PharmaGossip!!
Stan explains!
Update:
Thank you for the note and introduction. We do monitor and analyze a wide range of online content for many companies. The data and items noted in this posting do not represent the views any individual client. Draft content summaries, such as this, are frequently developed by reviewers for the many items we abridge in our reporting to enable our clients to absorb the very large volume of online items of interest to them daily.
Please feel free to contact me if you have any questions or want more information about our company.
Sincerely,
Jay Byrne, president
v-Fluence Interactive
-- It starts online!
www.v-Fluence.com
Direct: 314-880-8001
Mobile: 314-650-2441
AOL IM: VFJByrne
LinkedIn: http://www.linkedin.com/in/jaybyrne
Fax: 877-568-4848
SKYPE: Jay_Byrne
AHRP Proposal - How to Stop Epidemic Antipsychotic Drug Prescribing
| How to Stop Epidemic Antipsychotic Drug Prescribing |  |  |  |
| Wednesday, 28 April 2010 | |
| AHRP PROPOSAL: Any FDA-approved drug, whose manufacturer has been found by a court of law or the Department of Justice--to have illegally marketed the drug by concealing risks or incidence of adverse effects, or making unsupported claims of clinical benefit--should be denied coverage by taxpayer funded insurance programs--including Medicaid, Medicare, VeteranstAffairs. AstraZeneca is the fourth giant prescription drug manufacturer to be busted by the U.S. Department of Justice for illegal drug marketing. See: Industry BNET : Behind Two Big Drug Company Settlements: Professional Whistleblowers. AHRP Proposal:
THE NEW YORK TIMES FAIR USE NOTICE: This may contain copyrighted (© ) material the use of which has not always been specifically authorized by the copyright owner. Such material is made available for educational purposes, to advance understanding of human rights, democracy, scientific, moral, ethical, and social justice issues, etc. It is believed that this constitutes a 'fair use' of any such copyrighted material as provided for in Title 17 U.S.C. section 107 of the US Copyright Law. This material is distributed without profit. |
http://www.ahrp.org/cms/content/view/695/9/
J&J - Topamax: some call it Justice
The department says Ortho-McNeil Pharmaceutical LLC will plead guilty to promoting the sale of Topamax for psychiatric uses. Federal drug regulators approved it as an anti-epileptic drug.
The government says Ortho-McNeil-Janssen Pharmaceuticals will pay over $75 million for alleged illegal promotion of Topamax for a variety of psychiatric uses.
http://www.courant.com/business/nationworld/wire/sns-ap-us-doj-jj,0,3681933.story
BMJ - AstraZeneca pays $520m fine for off label marketing of Seroquel
391m) fine to settle allegations it had marketed the antipsychotic drug quetiapine fumarate (Seroquel) for unapproved off label uses, the US Department of Justice announced on 27 April. The drug was a bestseller for AstraZeneca in 2009, with sales of $4.9bn. Eric Holder, the US attorney general, took the unusual step of announcing the settlement at a news conference. He said that illegal acts by drug companies and false claims for government health programmes "can put the public health at risk, corrupt medical decisions by health care providers, and take billions of dollars directly out of taxpayers’ pockets."
The Justice Department said that by promoting off label uses, AstraZeneca caused "false claims for payment to be submitted to federal insurance programmes including Medicaid, Medicare," and other government programmes.
The federal government will receive about $302 000 in the settlement and Medicaid programmes for the poor in the states and the District of Columbia [Washington, DC] will share about $218 000.
AstraZeneca denied wrongdoing but signed the civil settlement with the Department of Justice and other federal agencies and whistleblowers. The company also entered into a corporate integrity agreement with the US Department of Health and Human Services that will be in effect for five years.
The integrity agreement calls for annual reviews within the company to certify that its departments are compliant with the integrity agreement.
AstraZeneca must also send doctors a letter telling them about the settlement. It must post on its website payments to doctors such as honoraria, travel, or hotels.
Quetiapine is approved in the United States only for the treatment of psychotic disorders and short term treatment of schizophrenia and manic episodes of bipolar disorder.
AstraZeneca was charged with off label promotion of the drug to psychiatrists and general physicians for aggression, Alzheimer’s disease, anger management, anxiety, attention deficit hyperactivity disorder, bipolar maintenance, dementia, depression, mood disorder, post-traumatic stress dissorder, and sleeplessness.
The Department of Justice said AstraZeneca promoted the off label uses by "improperly and unduly influencing the content of, and speakers in, company sponsored medical educational programmes. The company also engaged doctors to give promotional speaker programmes on unapproved uses for Seroquel and to conduct studies on unapproved uses of Seroquel. In addition, the company recruited doctors to serve as authors of articles that were ghostwritten by medical literature companies and about studies the doctors in question did not conduct. AstraZeneca then used those studies and articles as the basis for promotional messages about unapproved uses of Seroquel." The Justice Department said that was a violation of a federal anti-kickback law.
The lawsuit against AstraZeneca was triggered by a whistleblower lawsuit filed by James Wetta. He will receive more than $45m from the federal government’s share of the fine. The Wall Street Journal and other reports say that Wetta previously helped the government investigate illegal drug marketing practices.
Cite this as: BMJ 2010;340:c2380Gordon Brown to unveil statue of Harold Shipman in effort to win Rochdale voters | NewsBiscuit
Gordon Brown has announced he will taken personal charge of all Labour Party strategy this morning in an effort to improve his party’s popularity and began his fightback by unveiling a statue to the well known local doctor Harold Shipman. ‘At a time when the NHS is coming in for a great deal of criticism, I understand this Dr Shipman chap did a great deal to reduce hospital waiting lists in the North West.’
Mr Brown went on to say that it was a great privilege to be in Yorkshire, but that he couldn’t stay long as he was going on Mumsnet to announce an OBE for famous mother Rosemary West.
Standing below the image of the famous doctor, the Prime Minister announced ‘I thought he deserved his own statue, when one of my team told me I was now as popular as Harold Shipman. He must have been quite a guy!’
Edward Hack (hat tip to Mighty Blair)
Click to send this story to a friendPosted: Apr 29th, 2010 by Guest
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Health Care Renewal: Explaining Health Care Executives' Impunity - the (Unexplained) Leniency of Prosecutors
Explaining Health Care Executives' Impunity - the (Unexplained) Leniency of Prosecutors
On Health Care Renewal, we noted many legal settlements and criminal convictions in cases alleging unethical behavior by health care organizations. Some organizations have settled, and/or pleaded guilty, and/or been convicted numerous times. And we have said repeatedly, (e.g., here) such legal actions will not deter unethical behavior by health care organizations until the people who authorize, direct or implement bad behavior fear some meaningfully negative consequences. Relatively small fines imposed on large corporations pain workers on the line and stockholders while sparing the richly paid top hired management and the boards that will not reign them in.
A recent article in the New York Times about a plea agreement in a case in which the Guidant subsidiary of Boston Scientific was alleged to have withheld information about defects in its implantable cardiac defibrillators that were associated with six patient deaths (see most recent post here) throws some light onto the apparent impunity of top health care leaders. The article reiterated:
In recent years, the Justice Department has won hundreds of millions of dollars in fines from drug and device makers, including a string of cases in which the companies have pleaded guilty to violating federal laws.But corporate executives rarely face criminal charges in such actions....
The article noted:
“Prosecutors want the money,” said Mr. Fleder, of Hyman, Phelps & McNamara. “And at least in the big money settlements they have had in pharma cases, it appears that prosecutors are willing to settle even if it means forgoing prosecutions against individuals.”
Yet, as we have said,
Short of executives facing prosecution, companies see the hefty financial settlements demanded by the Justice Department as another price of doing business, industry critics say.
There does not seem to be a legal barrier to holding these executives accountable:
... they can be held liable under federal law for regulatory violations that occur on their watch — whether or not prosecutors can prove the executives participated in the wrongdoing or even knew about it.
But if this is so, why have corporate leaders not faced such penalties before? An experienced prosecutor explained it at one level:
A former prosecutor in many drug and medical device-related cases, Michael K. Loucks, said he never charged corporate executives with misdemeanors — which apply in cases when the violations are deemed unintentional — because he believed that being barred from the industry was too harsh a consequence.
“I think that if you are going to take actions that take away someone’s liberty or livelihood, you should have to prove felony conduct,” said Mr. Loucks, who spent over 20 years as an assistant United States attorney in Boston.
This ends up as a very disturbing response. Professionals who hold positions of trust in society, most particularly health care professionals, can lose their livelihood for unprofessional conduct or unethical actions that are not felonies, or even criminal. In health care (and in some other fields, like law), professionals are held to a higher standard that merely avoiding conviction for felonies. (For examples, peruse the lists of doctors and other health care professionals whose licenses were suspended or revoked by state medical boards.)In our current world of commercialized health care, leaders of large health care organizations can take actions that have as important consequences for peoples' health and safety as the individual actions of doctors and nurses. Why should they not be at risk of the loss of their current livelihood for actions that risk peoples' health and safety?
I do not know why an experienced prosecutor felt that health care executives deserved so much more leniency than health care professionals may receive from medical boards. Maybe in the future we will begin to hold those who authorized or directed unethical actions that risk health and safety accountable.
Labels: Boston Scientific, crime, impunity, legal settlements
posted by Roy M. Poses MD at 5:03 PM
Links to this post
Great quote
Dr. Stefan Kruszewski
Why PLoS Sponsored a Roundtable of Medical Whistleblowers
Wednesday, April 28, 2010
Testimony of Sidney M. Wolfe, M.D. Director, Health Research Group at Public Citizen - Avandia
Summary
The TIDE trial continues to recruit patients despite a lack of clinical equipoise, exposing thousands of high-risk patients with diabetes to a drug with an unfavorable safety profile and no clinical advantage over its comparator. It is almost certain that prospective study subjects are deprived of the opportunity to make a fully informed decision because the consent form does not present an accurate portrayal of existing safety concerns. It is difficult to imagine that a patient would willingly participate in a trial involving a drug that, according to the American Diabetes Association and its European equivalent, has safety concerns that leave it with no present-day role in the management of type 2 diabetes. The TIDE trial can only continue with the misplaced objective of proving definitive proof of what many studies have already suggested — that rosiglitazone is indeed more dangerous than pioglitazone. The price of such definitive proof will almost certainly be measured in the lives of study subjects who have been incompletely informed about the available evidence regarding the risks and benefits of participation.
Whistleblower Suits Against AstraZeneca Settle for $520 Million
Drug maker AstraZeneca has agreed to pay $520 million to settle whistleblower lawsuits filed in federal court in Philadelphia that accused the company of engaging in illegal tactics -- including kickbacks to doctors -- to promote so-called "off-label" uses for one of its drugs.
The drug, Seroquel, is an anti-psychotic that was approved by the Food and Drug Administration only for narrow uses, such as combating schizophrenia or acute manic episodes in those with bipolar disorder. But prosecutors said AstraZeneca set out to market the drug directly to doctors for a wider range of ailments including Alzheimer's disease, anger management, depression and sleeplessness.
Among the alleged illegal tactics AstraZeneca used, the suits alleged, were payments to doctors to pose as authors of articles written by the company, or to deliver lectures encouraging unapproved uses of the drug.
The settlement, announced in Washington, D.C., is the largest amount ever paid by a company in a civil-only settlement of off-label marketing claims.
The federal government will receive $302 million, and states will share up to $218 million.
"People have a legal right to know that pharmaceutical companies are marketing their drugs only for uses approved by the FDA and that their doctors' judgment has not been affected by misinformation from a pharmaceutical company trying to boost revenues," U.S. Attorney Michael L. Levy said.
"When pharmaceutical companies interfere with the FDA's mission to ensure that drugs are safe and effective, they undermine the doctor-patient relationship and put the health and safety of patients at risk," Levy said.
For attorneys Stephen A. Sheller and Brian J. McCormick Jr. of Sheller PC in Philadelphia, the settlement marks the third time in the past 15 months that they have represented a leading whistleblower in a massive pharmaceutical fraud settlement.
Sheller represented whistleblowers in January 2009, when Eli Lilly paid more than $1.4 billion to settle claims over improper marketing of Zyprexa, and again in September 2009, when Pfizer paid more than $2.3 billion to settle claims stemming from the marketing of four of its drugs.
In the AstraZeneca case, Sheller's client, James Wetta, will be paid a $45 million reward for his work in exposing the company's alleged frauds.
Serving as co-counsel with Sheller were attorneys Michael Mustokoff, Mark Lipowicz and Teresa Cavenagh of Duane Morris.
Mustokoff said that a second whistleblower, whose suit was filed two years later than Wetta's, will share in the reward money. Typically, Mustokoff said, the Justice Department strikes a deal with the "first-filer" and encourages settlement with any subsequent filers whose cases are deemed to have contributed to the investigation.
For the U.S. Attorney's Office in Philadelphia, too, the AstraZeneca settlement caps a string of massive civil settlements in pharmaceutical fraud cases, with Assistant U.S. Attorneys Virginia A. Gibson, the former civil division chief who now serves as first assistant, and Margaret L. Hutchinson, the current chief of the civil division, overseeing the investigations.
In the AstraZeneca case, prosecutors alleged that the Wilmington, Del.-based company used illegal tactics to market Seroquel.
In September 2000, the FDA proposed narrowing the approval for Seroquel to the short-term treatment of schizophrenia only. In January 2004, the FDA approved Seroquel for short-term treatment of acute manic episodes associated with bipolar disorder, and later approved Seroquel for bipolar depression.
But the whistleblower suits alleged that AstraZeneca sales reps were pressing doctors to use the drug for a wide range of less serious disorders and maladies, including aggression, Alzheimer's disease, anger management, anxiety, attention deficit hyperactivity disorder, bipolar maintenance, dementia, depression, mood disorder, post-traumatic stress disorder and sleeplessness.
Promoting such off-label uses amounts to fraud under the False Claims Act, the suits alleged, because the unapproved uses were not medically accepted indications for which the federal and state Medicaid programs provided coverage for Seroquel.
According to the settlement agreement, AstraZeneca targeted its illegal marketing of Seroquel toward doctors who do not typically treat schizophrenia or bipolar disorder, such as physicians who treat the elderly, primary care physicians, pediatric and adolescent physicians, and in long-term care facilities and prisons.
Prosecutors also said AstraZeneca violated the federal Anti-Kickback Statute by offering and paying illegal remuneration to doctors it recruited to serve as authors of articles written by AstraZeneca and its agents about the unapproved uses of Seroquel.
AstraZeneca also offered and paid illegal remuneration to doctors to travel to resort locations to "advise" AstraZeneca about marketing messages for unapproved uses of Seroquel, and paid doctors to give promotional lectures to other health care professionals about unapproved and unaccepted uses of Seroquel, prosecutors said.
Under the terms of the settlement agreement, AstraZeneca denied the allegations but agreed to enter into a corporate integrity agreement with the Office of Inspector General of the U.S. Department of Health and Human Services. The corporate integrity agreement will be in effect for five years.
AstraZeneca was represented in the settlement by attorney John C. Dodds of Morgan Lewis & Bockius.
FT.com / Health - AstraZeneca to pay $520m Seroquel fine
Tuesday, April 27, 2010
Pharma Giles writes ...
Phoni has suffered through a rash of lousy legal news recently but there’s one area — Priapic litigation — where everything is going the company’s way. It’s even forcing a rethink on the quality of published research that suggests that Phoni’s cut down formulation of Priapic for those partial to a periodic Jodrell – Priapic Lite- can cause blindness.
A recent ruling by a judge in Dry Prong, Louisiana, is a rare case of product liability litigation actually helping a company. In this case, Phoni discovered that a study of Priapic Lite that showed the drug triggered eye abnormalities in its users was riddled with errors.
Phoni launched the special formulation of Priapic®™, Phoni’s treatment for male erectile dysfunction, back in 2003. Called Priapic Lite®™, the treatment was widely acccredited with winning George Bush a second term.
As early as 1999 and 2003, there were reports that many Priapic Lite users suffered from impaired vision, watching Fox News, listening to Rush Limburgh and even voting Republican. Thirty percent of Priapic Lite users also experienced hairy palms, pains in the arms and mental impairment, according to Dr. Thaddeus Pyle.
The plaintiffs in the case wanted to use Dr. Pyle as an expert witness. He was the author of a study titled “Onanism and Blindness –a Punishment From God” in February 1856, which found that men with a history of “strangling the ferret” had a statistically significant increased risk of suffering from eye damage and other harmful side-effects, Dr. Pyle alleged.
Normally, when plaintiffs sue drug companies, the discovery process turns up a bunch of embarrassing internal documents and emails. This time, the embarrassment occurred on the plaintiffs’ side. Phoni found that in fact, Dr. Pyle had made his entire study up.
For those reasons, Phoni successful persuaded the judge to remove Dr Pyle, the plaintiffs’ only remaining expert witness, from the case. The judge wrote:
“… the notion that “bashing your Bishop” can cause the effects alleged by the plaintiffs is clearly ludicrous. Now where are my glasses, dammit?…”
Wayne Kerr, Phoni’s Global Director of OTC Marketing, was delighted with the news. “It’s outrageous that anyone can fabricate clinical trials evidence in studies on our drugs and just publish it,“ he said. “That’s our job.”
“We feel that this product has always satisfied an otherwise unmet clinical need,” Kerr continued. “Many “punishers of the Purple-Headed Custard Chucker” welcome a little help with their harmless pastime, and we think that wire-twangers everywhere will welcome this verdict. Indeed, Phoni middle management is particularly relieved as the product has been widely used amongst them for a considerable time.”
Mr. Kerr sounded a word of caution, however. “We would advise anyone intending to vote in the UK General election that use of Priapic Lite has been associated with voting Labour,” he said.
Jim Edwards brings us related tales from the real world
Pharmaceutical Giant AstraZeneca to Pay $520 Million for Off-label Drug Marketing
AstraZeneca LP and AstraZeneca Pharmaceuticals LP will pay $520 million to resolve allegations that AstraZeneca illegally marketed the anti-psychotic drug Seroquel for uses not approved as safe and effective by the Food and Drug Administration (FDA), the Departments of Justice and Health and Human Services’ Health Care Fraud Enforcement Action Team (HEAT) announced today. Such unapproved uses are also known as "off-label" uses because they are not included in the drug’s FDA approved product label.
The Wilmington, Del.-based company signed a civil settlement to resolve allegations that by marketing Seroquel for unapproved uses, the company caused false claims for payment to be submitted to federal insurance programs including Medicaid, Medicare and TRICARE programs, and to the Department of Veterans Affairs, the Federal Employee Health Benefits Program and the Bureau of Prisons.
Under the terms of the settlement, the federal government will receive $301,907,007 from the civil settlement, and the state Medicaid programs and the District of Columbia will share up to $218,092,993 of the civil settlement, depending on the number of states that participate in the settlement. The allegations were originally brought in a lawsuit under the qui tam or whistleblower provisions of the False Claims Act and various state False Claims Act statutes.
Under the Food, Drug and Cosmetic Act, a company must specify the intended uses of a product in its new drug application to the FDA. Before approving a drug, the FDA must determine that the drug is safe and effective for the use proposed by the company. Once approved, the drug may not be marketed or promoted for off-label uses.
The FDA originally approved Seroquel in September 1997 for the treatment of manifestations of psychotic disorders. In September 2000, FDA proposed narrowing the approval for Seroquel to the short term treatment of schizophrenia only. In January 2004, the FDA approved Seroquel for short term treatment of acute manic episodes associated with bipolar disorder (bipolar mania). In October 2006, the FDA approved Seroquel for bipolar depression.
The United States alleges that AstraZeneca illegally marketed Seroquel for uses never approved by the FDA. Specifically, between January 2001 through December 2006, AstraZeneca promoted Seroquel to psychiatrists and other physicians for certain uses that were not approved by the FDA as safe and effective (including aggression, Alzheimer’s disease, anger management, anxiety, attention deficit hyperactivity disorder, bipolar maintenance, dementia, depression, mood disorder, post-traumatic stress disorder, and sleeplessness). These unapproved uses were not medically accepted indications for which the United States and the state Medicaid programs provided coverage for Seroquel.
According to the settlement agreement, AstraZeneca targeted its illegal marketing of the anti-psychotic Seroquel towards doctors who do not typically treat schizophrenia or bipolar disorder, such as physicians who treat the elderly, primary care physicians, pediatric and adolescent physicians, and in long-term care facilities and prisons.
In March 2006, AstraZeneca brought certain conduct to the attention of the government and then cooperated in the investigation of the allegations being settled today.
The United States contends that AstraZeneca promoted the unapproved uses by improperly and unduly influencing the content of, and speakers, in company-sponsored continuing medical education programs. The company also engaged doctors to give promotional speaker programs on unapproved uses for Seroquel and to conduct studies on unapproved uses of Seroquel. In addition, the company recruited doctors to serve as authors of articles that were ghostwritten by medical literature companies and about studies the doctors in question did not conduct. AstraZeneca then used those studies and articles as the basis for promotional messages about unapproved uses of Seroquel.
"Illegal acts by pharmaceutical companies and false claims against Medicare and Medicaid can put the public health at risk, corrupt medical decisions by health care providers, and take billions of dollars directly out of taxpayers’ pockets," said Attorney General Eric Holder. "This Administration is committed to recovering taxpayer money lost to health care fraud, whether it’s by bringing cases against common criminals operating out of vacant storefronts or executives at some of the nation’s biggest companies."
The United States also contends that AstraZeneca violated the federal Anti-Kickback Statute by offering and paying illegal remuneration to doctors it recruited to serve as authors of articles written by AstraZeneca and its agents about the unapproved uses of Seroquel. AstraZeneca also offered and paid illegal remuneration to doctors to travel to resort locations to "advise" AstraZeneca about marketing messages for unapproved uses of Seroquel, and paid doctors to give promotional lectures to other health care professionals about unapproved and unaccepted uses of Seroquel. The United States contends that these payments were intended to induce the doctors to prescribe Seroquel for unapproved uses in violation of the federal Anti-Kickback Statute.
"Rooting out health care fraud is a top priority for the Obama Administration, said Kathleen Sebelius, Secretary of the Department of Health and Human Services. "Today’s settlement sends a clear warning to any individual or company seeking to defraud our health care system and returns hundreds of millions of dollars of taxpayer money to the Medicare trust fund where they belong. It reflects the unprecedented energy, resources, and new ideas that this administration has devoted to identifying, prosecuting, and ultimately preventing health care fraud. With the new anti-healthcare fraud resources in the Affordable Care Act, there has never been a worse time to try to steal from our health care system."
"Consumers are entitled to rely on the claims pharmaceutical companies make about the drugs they sell," said Tony West, Assistant Attorney General for the Civil Division of the Department of Justice. "Working with our federal and state partners, we will protect the integrity of our public health programs by ensuring that kickbacks from drug companies do not taint the medical decisions of health care professionals."
"When pharmaceutical companies interfere with the FDA’s mission to insure that drugs are safe and effective, they undermine the doctor-patient relationship and put the health and safety of patients at risk," said Michael L. Levy, U.S. Attorney for the Eastern District of Pennsylvania. "People have a legal right to know that pharmaceutical companies are marketing their drugs only for uses approved by the FDA and that their doctors’ judgment has not been affected by misinformation from a pharmaceutical company trying to boost revenues."
In addition to the civil settlement agreement, resolution of the matter includes a Corporate Integrity Agreement (CIA) between AstraZeneca and the Office of Inspector General of the Department of Health and Human Services. The five-year CIA requires, among other things, that a board of directors committee annually review the company’s compliance program and certify its effectiveness; that certain managers annually certify that their departments or functional areas are compliant; that AstraZeneca send doctors a letter notifying them about the settlement; and that the company post on its website information about payments to doctors, such as honoraria, travel or lodging. AstraZeneca is subject to exclusion from Federal health care programs, including Medicare and Medicaid, for a material breach of the CIA and subject to monetary penalties for less significant breaches.
"As a result of this Corporate Integrity Agreement, the actions of AstraZeneca will be more transparent, its Board of Directors held more accountable, and the names of physicians receiving payments will be disclosed -- all leading to better protection for patients," said Department of Health and Human Services Inspector General Daniel R. Levinson.
The government’s investigation was triggered by a whistleblower lawsuit filed under the FCA’s qui tam provisions in the Eastern District of Pennsylvania. As part of today’s resolution, James Wetta, the whistleblower in that action, will receive more than $45 million from the federal share of the civil recovery.
This settlement is part of the government’s emphasis on combating health care fraud and another step for the HEAT initiative, which was announced by Attorney General Holder and Secretary Sebelius in May 2009. The partnership between the two departments has focused efforts to reduce and prevent Medicare and Medicaid fraud through enhanced cooperation. One of the most powerful tools in that effort is the FCA, which the Justice Department has used to recover almost $2.8 billion since January 2009 in cases involving fraud against federal health care programs. The Justice Department’s total recoveries in FCA cases since January 2009 are over $3.75 billion.
The civil settlement was reached by the U.S. Attorney’s Office for the Eastern District of Pennsylvania and the Commercial Litigation Branch of the Justice Department’s Civil Division. This investigation was conducted by the Department of Health and Human Services Office of Inspector General, U.S. Postal Service’s Office of Inspector General and the FDA’s Office of Criminal Investigations. Assistance was provided by representatives of FDA’s Office of Chief Counsel and the National Association of Medicaid Fraud Control Units.
Remarks as Prepared for Delivery By Attorney General Eric Holder at the AstraZeneca Settlement Announcement -- WASHINGTON, April 27 /PRNewswire-USNewswire/ --
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Remarks as Prepared for Delivery By Attorney General Eric Holder at the AstraZeneca Settlement Announcement
WASHINGTON, April 27 /PRNewswire-USNewswire/ -- The following are remarks as prepared for delivery by Attorney General Eric Holder:
"Over the past 15 months, Secretary Sebelius and I have made it a top priority of both our Departments to crack down on health care fraud, which we know costs taxpayers billions of dollars each year. Through our Health Care Fraud Prevention and Enforcement Action Team, or HEAT, we have brought the full resources of the federal government to bear against individuals and corporations who illegally divert taxpayer resources for their own gain.
"Today, we are here to announce the latest results of that effort. The pharmaceutical company AstraZeneca has agreed to pay $520 million to federal and state taxpayers to settle claims that it illegally marketed the anti-psychotic drug Seroquel for uses that were not approved as safe and effective by the Food and Drug Administration. As part of this scheme, AstraZeneca was accused of illegally promoting Seroquel to physicians and violating the federal Anti-Kickback statute, all in furtherance of supporting the drug's use for a host of illnesses for which it was never approved.
"According to the settlement, AstraZeneca's illegal marketing of the drug led to millions of dollars in false claims against federal and state programs like Medicare and Medicaid.
"These were not victimless crimes – illegal acts by pharmaceutical companies and false claims against Medicare and Medicaid can put the public health at risk, corrupt medical decisions by health care providers, and take billions of dollars directly out of taxpayers' pockets.
"As we have said, we will not let such actions stand. This Administration is committed to recovering taxpayer money lost to health care fraud, whether it's by bringing cases against common criminals operating out of vacant storefronts or executives at some of the nation's biggest companies.
"The settlement we are announcing today is a major accomplishment in that effort. It is the largest amount ever paid by a company in a civil only settlement of off-label marketing claims. The federal government will receive $302 million, and states will share up to $218 million.
"Over the past 15 months, we have recouped more than $2.8 billion in health care fraud cases through use of the False Claims Act, money that will be fed back into federal coffers. In 2009, the Justice Department also reached an all-time high in the number of health care fraud defendants charged, with more than 800 indictments and more than 580 convictions. Our Strike Forces now operate in seven cities and we plan to expand to more this year.
"These are major success stories with our partners at HHS, but we know that we must not rest – and we will not. As long as health care fraud pays, and as long as it goes unpunished, our health care system will remain under siege, with tremendous costs to the quality of health care provided in this country and to the nation's fiscal health. As Secretary Sebelius and I both said when we launched HEAT in May 2009, you should expect to hear from us again on this subject. The American people expect results, and we are committed to delivering them.
"Before I turn it over to Secretary Sebelius, I'd like to thank the Civil Division for its hard work on this case and its anti-fraud efforts across all sectors. Over the past 15 months, the Civil Division in partnership with U.S. Attorney's offices across the nation has recovered more than $5.7 billion in civil recoveries and criminal fines by uncovering fraud in a range of areas. I'd also like to thank U.S. Attorney Michael Levy of the Eastern District of Pennsylvania and his great office for their fine work on this case.
"And of course, I would like to thank our partners at the Department of Health and Human Services, who have made invaluable contributions to this effort. I'll now turn it over to Secretary Kathleen Sebelius."
SOURCE U.S. Department of Justice
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AstraZeneca Settles Case for $520 Million - NYTimes.com
AstraZeneca paid kickbacks to doctors as part of an illegal scheme to market drugs for unapproved uses,
AstraZeneca to Pay $520 Million to Settle Drug Probe (Update1)
AstraZeneca to Pay $520 Million to Settle Drug Probe (Update1)
By Justin Blum
April 27 (Bloomberg) -- AstraZeneca Plc agreed to pay $520 million to resolve U.S. allegations that it illegally marketed the schizophrenia drug Seroquel for uses that weren’t approved by regulators.
AstraZeneca, the U.K.’s second-largest drugmaker, promoted Seroquel to doctors for unapproved uses including aggression, Alzheimer’s disease and anger management, the Justice Department said today in a statement. The payment is the largest settlement by a company in a strictly civil case involving unapproved marketing claims for drugs.
“What they did endangered patients and drives up health costs,” said Kathleen Sebelius, the secretary of the Health and Human Services Department, at a news conference at the Justice Department in Washington.
With sales of $4.87 billion last year, the drug was the company’s second-biggest seller after the ulcer medicine Nexium. The agreement follows similar settlements by drugmakers including New York-based Pfizer Inc. and Eli Lilly & Co. of Indianapolis.
AstraZeneca’s American depositary receipts, each representing one ordinary share, fell $1.07, or 2.4 percent, to $43.84 at 2:44 p.m. in New York Stock Exchange composite trading.
AstraZeneca’s Denial
AstraZeneca denies the allegations, the company said in a statement. The company entered into a corporate integrity agreement with the U.S. that will last for five years, the statement said.
“It is in the best interest of AstraZeneca to resolve these matters and to move forward with our business of discovering and developing important, life-changing medicines while avoiding the delay, uncertainty and expense of protracted litigation,” said Glenn Engelmann, the company’s U.S. general counsel, in the statement.
The agreement is part of an effort by the Obama administration to crack down on health-care fraud, said Attorney General Eric Holder at the news conference.
AstraZeneca, based in London, paid kickbacks to doctors it recruited to serve as authors of articles about unapproved uses of the drug that were actually written by the company and its agents, according to the Justice Department. The company also paid doctors to travel to resorts to advise on marketing messages for unapproved uses, the department said.
Unapproved Uses
AstraZeneca promoted unapproved uses by influencing the content of company-sponsored medical education programs, according to the Justice Department. The company promoted the drug for use in the elderly and children, said Sebelius.
The Food and Drug Administration clears drugs for safety and effectiveness. Doctors may prescribe medicines for unapproved uses. Companies are barred from marketing them for uses not cleared by regulators.
The government’s investigation was triggered by a whistleblower lawsuit filed in Pennsylvania, according to the Justice Department.
AstraZeneca said in October that it had reached an “agreement in principle” to settle allegations it marketed Seroquel for unapproved uses.
AstraZeneca is facing as many as 26,000 lawsuits over Seroquel, according to court filings. The company in March won the first of the cases to come to court. The suits claim the drug caused diabetes, and many also claim the company promoted Seroquel, approved for schizophrenic and bipolar patients, for uses that hadn’t been approved on the drug’s label.
Seroquel is approved by U.S. regulators for use in treating adults and adolescents with bipolar disorder or schizophrenia and as an add-on therapy for adults taking antidepressants.
GlaxoSmithKline Plc is the U.K.’s largest drugmaker.
To contact the reporter on this story: Justin Blum in Washington at jblum4@bloomberg.net
Whistleblower Drug Rep Helped Justice Dept. To Probe AstraZeneca And Eli Lilly
A former AstraZeneca PLC (AZN, AZN.LN) sales representative who helped the government to investigate allegations of illegal marketing practices at the drug maker is no stranger to blowing the whistle.
James Wetta's 2004 whistleblower lawsuit against AstraZeneca triggered a U.S. probe of whether the U.K.-based company marketed the antipsychotic Seroquel for unapproved uses, the Justice Department said Tuesday. AstraZeneca and Justice officials confirmed Tuesday that the company has formally agreed to pay $520 million to settle the probe, though Astra denies the allegations.
Before he worked for AstraZeneca, Wetta was a sales rep for Eli Lilly & Co. (LLY), and he assisted a separate government probe of Lilly's marketing practices that was settled last year when Lilly paid more than $1.4 billion and pleaded guilty to a criminal charge, according to court documents.
Wetta's role in both settlements stand to make him a millionaire many times over. He got a cut of the Lilly settlement and stands to get a share of the AstraZeneca pact, in accordance with laws designed to encourage people to come forward with information about companies they believe are defrauding the government.
He stands to receive $45 million of the federal share of the AstraZeneca settlement; he will share an undisclosed portion of that with another whistleblower in the case. And his role in last year's Lilly settlement entitled him to receive an undisclosed portion of about $100 million reserved for several whistleblowers in that case. His exact share of both settlements couldn't immediately be determined.
Wetta couldn't be reached for comment. His attorney, Mark Lipowicz, said his client declined to be interviewed. He said Wetta had knowledge of much of the allegations made by the Justice Department in announcing the AstraZeneca settlement Tuesday, and that he cooperated over a period of years with the government.
The Justice Department alleged that, between 2001 and 2006, AstraZeneca promoted Seroquel for certain uses not approved by the FDA as safe and effective, including for dementia in the elderly. The government alleged the company paid doctors to speak at events to other doctors about unapproved uses of Seroquel, among other allegations.
AstraZeneca spokesman Tony Jewell confirmed Wetta was a sales rep for the company, but declined to say when. Jewell said the company denies the allegations.
According to Wetta's earlier lawsuit, he was a sales rep for Indianapolis-based Lilly in 2001 when a manager told Wetta that his sales performance wasn't meeting company expectations.
Wetta objected to certain sales tactics that he was informed would help him keep his job, including arranging for certain drugs to be switched on patients without their knowledge, according to the lawsuit. Wetta resigned from Lilly in 2002, according to the lawsuit.
Lilly's settlement last year resolved the various whistleblower lawsuits, but the company admitted only to illegal conduct surrounding its marketing of the antipsychotic Zyprexa.
A Lilly spokeswoman couldn't immediately be reached to comment on Wetta's allegations and role in the government probe.
-By Peter Loftus, Dow Jones Newswires; 215-656-8289; peter.loftus@dowjones.com
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Astra Zeneca to Settle Case for $520 Million
The Department of Justice plans a news conference on Wednesday to reveal details of the case, according to two people close to the negotiations who were not authorized to discuss it publicly.
AstraZeneca will sign a corporate integrity agreement with the federal government over its aggressive marketing of Seroquel for unapproved uses, but will not face criminal charges, the people said. The company, based in Britain, has been accused of hiding evidence that Seroquel increases the risk of diabetes.
The deal would make formal an agreement in principle the company reached last October with the United States attorney in Philadelphia. At that time, AstraZeneca said in a filing with the Securities and Exchange Commission that it had set aside $520 million in respect to the investigation.
The company was facing two federal investigations and two whistle-blower lawsuits involving Seroquel sales and marketing practices. One of the investigations related to physicians who participated in clinical trials, the other to sales staff, and details are expected to be revealed this week.
As a result of aggressive marketing, Seroquel has been increasingly used for children and elderly people for indications not approved by the Food and Drug Administration. Doctors are permitted to prescribe any approved drug for off-label uses.
Tony Jewell, a company spokesman, declined to comment on Monday. Patricia Hartman, a spokeswoman for Michael L. Levy, the United States attorney in Philadelphia, said she would neither confirm nor deny the report. “We don’t have anything public on AstraZeneca,” Ms. Hartman said.
AstraZeneca, which reported $4.9 billion in Seroquel sales in 2009, plans to report its first-quarter financial results on Thursday.
The company will join a series of American pharmaceutical companies that have admitted to illegal marketing after federal investigations and whistle-blower filings and have signed agreements with the government to monitor and avoid such activity in the future. Pfizer paid $2.3 billion and Eli Lilly paid $1.4 billion to settle similar cases.
AstraZeneca also faces thousands of civil lawsuits over Seroquel. It was accused of hiding the risk of diabetes and other health problems for people who take the drug.