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A picture is worth a thousand words - Public Citizen

This report is a "must read"!

The "Ven-A-Care boys" aka the X-Men of health care whistleblowing

When Attorney General Mike Hatch last week announced a multimillion-dollar price-fraud lawsuit against New Jersey drug manufacturer Pharmacia Corp., he was flanked by two unfamiliar men whose deep tans suggested they weren't from around here.

In the new world of pharmaceutical litigation, Zachary Bentley, 49, T. Mark Jones, 45, and their two other business partners are emerging as the whistle-blowing equivalents of tobacco company insider Jeffrey Wigand, crusading paralegal Erin Brockovich or Minnesota FBI agent Coleen Rowley.

Without the inside knowledge of prescription-drug buying and insurance billing possessed by the "Ven-A-Care boys" as they've been called (also the "X-Men of health care"), the recent lawsuits against the giant drug companies by the federal government, Minnesota, Texas, Nevada and other states might never have been considered.

"They've been invaluable," said Ann Bildtsen, an assistant attorney general in Hatch's office.

"They're a breed apart," said attorney Carolyn McElroy, who worked with Ven-A-Care when she was president of the National Association of Medicaid Fraud Control Units.

http://www.highbeam.com/doc/1G1-87723399.html

http://pharmagossip.blogspot.com/search?q=ven-a-care

http://www.frohsinbarger.com/pdf/tlr.pdf

GSK - Cheryl Eckard speaks

Carolina native Cheryl Eckard came to the federal courthouse in Boston on Tuesday and left $96 million richer -- her share as a company whistleblower of a $750 million penalty paid by GlaxoSmithKline over a subsidiary's drug-manufacturing lapses in Puerto Rico.
 
"I'm a little emotional, so you'll have to forgive me for that,'' Eckard, 51, who grew up near Raleigh, said as she spoke to reporters after federal officials announced the penalty. "This is not something I ever wanted to do.''
 
Yes, she is now a multimillionaire -- but after the former Glaxo quality-assurance manager complained repeatedly to superiors about drug plant lapses at a manufacturing site she oversaw in Cidra, Puerto Rico, she got fired in June 2003. Represented by attorneys Neil V. Getnick and Leslie Ann Skillen of Getnick & Getnickin New York, she's been fighting ever since 2004 in court until GlaxoSmithKline finally agreed Tuesday to plead guilty and pay the $750 million in fines, penalties, and settlements. The Getnick firm believes Eckard's award is the single-biggest U.S. whistleblower award in history.
 
"I think it's very, very difficult to survive this,'' Eckard said. "It's difficult to survive this financially, emotionally, you lose all your friends, because all your friends are people you have at work.'' But she added: "You really do have to understand that it's a very difficult process, but very well worth it.''
 
The $750 million and guilty plea from Glaxo resolve allegations that drugs made at its former SB Pharmco Puerto Rico plant -- including a controlled-release version of its antidepressant Paxil and Type II diabetes treatment Avandamet -- may have been contaminated or made above or below the properly calibrated dosage.
 
"We will not tolerate corporate attempts to profit at the expense of the ill and needy in our society,'' said Carmen Ortiz, U.S. Attorney for Massachusetts, at a press event Tuesday announcing the resolution. She said the government was not aware of anyone getting sick because of the Glaxo drugs in question, but said it was critical to sound a strong message that the government will not tolerate any lapses in safety standards for pharmaceutical manufacturers.
 
Highly profitable GlaxoSmithKline manufactured hundreds of millions of dollars worth of pharmaceuticals at the Cidra plant between 2001 and 2005, the time period covered by the legal actions. So I asked Ortiz how the $750 million penalty compared to Glaxo's net income -- in other words, could wrongdoing have turned out to be on net profitable? "The fine is significantly higher than the profits that were made by the company,'' Ortiz said, not offering any more specific numbers.
 
Glaxo had disclosed on July 15 was taking a $750 million charge in anticipation of the fine. GSK senior vice president P.D. Villarreal said in a statement: "We regret that we operated the Cidra facility in a manner that was inconsistent with current Good Manufacturing Practice requirements and with GSK's commitment to manufacturing quality.  GSK worked hard to resolve fully the manufacturing issues at the Cidra facility prior to its closure in 2009 and we are committed to continuous improvement in our manufacturing processes.  Our commitment to compliance with cGMP is demonstrated by the fact that we have not received an FDA warning letter at any plant since the Cidra facility was cited in July 2002.''
 
While $750 million is an eye-popping sum for a company to pay after a government legal action, it's not the biggest pharma fine in U.S. history, or the second, or the third -- but the fourth, according to Tony West, assistant U.S. attorney general in the civil division. The biggest is the $2.3 billion Pfizer agreed to pay in the summer of 2009 for improperly marketing Pfizer drugs as treatments not authorized by the government. 
 
Cheryl Eckard hopes for all she's lost -- and won -- she may inspire others who see lapses to fight for what's right. "You have to believe in your heart this this is the right thing ... In my case, I was very, very concerned about patient safety.''
 
Her giant payday came about from a law dating to the days of Abraham Lincoln, the False Claims Act, which allows private citizens who know of fraud on the government -- in this case, government health programs paying for Glaxo drugs that turned out to be impure or sub-potent or with improperly calibrated dosages -- to sue and if their charges, reap typically 15 to 20 percent of what the government recoups. Whistleblower laws current also encourage private citizens to get involved in -- and get bounties for -- government prosecutions of tax, securities, and commodities fraud, and other kinds of fraud against federal and state government agencies.
 
Several states are sharing in the $750 million, including Massachusetts, which will get $8 million for its Medicaid program from Glaxo, according to state Attorney General Martha Coakley.

Cheryl Eckard - "a role model for whistleblowers" gets $96 million

BOSTON, Oct 26, 2010 (BUSINESS WIRE) -- GlaxoSmithKline (GSK) has agreed to pay the government $750 million to settle civil and criminal charges that it manufactured and sold adulterated drug products to Medicaid and other government health plans, the Department of Justice announced today. The settlement was the result of a whistleblower lawsuit filed in 2004 by the law firm of Getnick & Getnick LLP on behalf of Cheryl Eckard, a former Quality Assurance Manager with GSK.

This is a groundbreaking case, the first time the whistleblower law has been successfully used to hold drug makers accountable for violations of government manufacturing standards. The civil settlement of $600 million resolves charges that GSK released to the market Bactroban ointment, a topical antibiotic used to treat skin infections in babies, that contained microorganisms and Kytril injection, an anti-nausea drug used by cancer patients, that was not sterile. The settlement also covers the release of Paxil CR tablets that lacked the active ingredient and Avandamet tablets that were superpotent and subpotent. Paxil CR is an anti-depressant and Avandamet is a derivative of the diabetes drug Avandia. GSK also paid a criminal fine of $150 million.

GSK reached the settlement with the U.S. Attorney's Office in Boston after more than six years of investigation and negotiations, which began when Ms. Eckard reported GSK's fraud to the FDA and filed a qui tam whistleblower lawsuit. This law allows a private citizen with knowledge of fraud on the government to sue on the government's behalf and receive a share of the proceeds. Ms. Eckard was fired by GSK in 2003 after repeatedly complaining to management about conditions at its former top-producing plant in Cidra, Puerto Rico.

"The success of this whistleblower lawsuit will change the way that drug companies run their factories," said Neil Getnick, managing partner of the Getnick firm. "Now every employee who works with manufacturing issues -- from quality assurance executives like Cheryl Eckard to machine operators -- has a viable option if they have evidence that management is putting profits ahead of patient safety by letting bad products out the door."

"Drug manufacturing is vulnerable to abuse because consumers can't see the defects," said Getnick partner Lesley Ann Skillen. "Once the pill is swallowed, it's gone and there may be no way of telling whether someone got sick because the product was bad. As a result of this settlement and guilty plea, drug makers will now have more reason to live up to their motto that patient safety is their first priority."

In August 2002, Ms. Eckard, then a Global Quality Assurance Manager with GSK, was sent to the Cidra factory to lead a team of 100 scientists and quality experts brought from around the globe to fix manufacturing violations cited by the FDA. Cidra was then GSK's No. 1 factory in the world, making over 20 products worth $5.5 billion annually, including blockbuster drugs Avandia, Paxil and Coreg.

What she discovered went far beyond the manufacturing violations previously uncovered by the FDA. Her whistleblower lawsuit, filed by the Getnick firm in February 2004, included details about mixed-up products, super and subpotent diabetes drugs, an area of the factory used to make injectible drugs that was not sterile, air handling systems that misdirected the flow of product powders, a water system contaminated with microorganisms, and a host of other manufacturing and quality testing problems that led her to conclude that GSK could not assure that its product was free from contamination and made according to the drug formula registered with the FDA.

From August 2002 to her firing in May 2003, Ms. Eckard urged GSK managers to take swift and decisive action at Cidra, including shutting down the plant. She made a full report to the GSK Compliance Department, which treated her complaints as unsubstantiated. She then reported the fraud to the FDA in San Juan.

The FDA executed search warrants in October 2003 and in February 2005 seized all stocks of Avandamet and Paxil CR in the largest seizure in FDA history, estimated by the FDA to be worth $2 billion. The FDA also placed the Cidra plant under a Consent Decree, requiring that all products released to the market be approved by an independent monitor. The Cidra plant closed in 2009.

"Cheryl Eckard is a role model for whistleblowers," said Skillen. "Cheryl and our firm worked with the government and established a true public-private partnership. This result is a great credit to the vision and talent of the government's team in the Boston U.S. Attorneys Office, the Department of Justice, the VA, FDA, FBI, HHS, DCIS, OPM and other federal agencies, and the state Medicaid Fraud Control Units."

"The 'take-away' for corporate America should be that dedicated employees who try to do the right thing can't be silenced and made to go away," said Getnick. "The whistleblower laws -- which now cover tax, securities and commodities fraud, as well as health care and other frauds on federal and state government programs -- make sure that they have a voice and a remedy."

Pfizer try to stop Rost's "Whistleblower" book in court

Dr. Peter Rost, author of “The Whistleblower—Confessions of a Healthcare Hitman,” today revealed that Pfizer has asked the US District Court, NY, to advise on relief and for sanctions against Dr. Rost for writing “The Whistleblower,” per recently released court records, case no. 05-CV-10384.

In a separate legal communiqué, Pfizer’s lawyer writes, “Be advised that we are in the process of evaluating the extent to which this book likewise violates the Protective Order.” Pfizer has also requested “Confidential” designation of virtually all documents used to write “The Whistleblower.”

“Pfizer’s attempt to stop ‘The Whistleblower’ and deny the public the right to view associated documents may not be surprising considering the explosive content and Pfizer’s infamous history as the only drug company forced by the government to sign not just one, but two separate Corporate Integrity Agreements,” said Dr. Rost.

The New York Post wrote the following review, “A drug company executive is about to blow the lid off the pharmaceutical industry . . . revealing everything from sex in the corner office to private investigators spying on employees, company phone surveillance, FBI investigations and financial shenanigans resulting in million-dollar payouts.”

And L Magazine stated, “In this Enron-esque exposé of the healthcare industry, an . . . executive reveals everything you should already be assuming about most multinational corporations. You know, greed, spying, million-dollar payouts, and sex in the corner office.”

Medical Marketing & Media, a drug industry publication, concluded that “The Whistleblower” is “a scathing account of the allegedly 'insidious' practices of the industry that once paid [Dr. Rost’s] salary and of the US healthcare system. The media is sure to lap it up.”

Soft Skull Press sold the entire first printing during the first day of sale, September 10, 2006.

For more information on “The Whistleblower,” sample pages, news, reviews, and the “Whistleblower Video,” go to: http://the-whistleblower-by-peter-rost.blogspot.com/

Dr. Peter Rost daily blog: http://peterrost.blogspot.com/

Insider's review of the book can be found here.