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Exposing Psychology, Exalting Christ |
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Lilly
Whistleblower
Shares His Story ALLIANCE FOR HUMAN RESEARCH PROTECTION Promoting Openness, Full Disclosure, and Accountability http://www.ahrp.org and http://ahrp.blogspot.com
FYI
"You have to remember, with Zyprexa people lost their lives." Robert Rudolph, one of nine Eli Lilly whistleblowers in the case brought by the Department of Justice, acknowledges the human casualties resulting from the illegal marketing of Zyprexa.
However, the focus of major class-action liability lawsuits against pharmaceutical companies is money-in particular the size of the settlements. The human casualties of corporate crimes remain buried under the shield of confidentiality. Companies pay their way and continue to market their drugs much by breaking the law-in a "business as usual" fashion.
When Eli Lilly agreed to a $1.4 billion settlement (Jan. 2009), it also pled guilty to criminal misdemeanor of misbranding of a drug. Zyprexa sales by then had reached about $39 billion since FDA approval in 1996. So why would anyone think that a settlement amounting to 3.5% of Zyprexa sales would serve as a deterrent from future criminal marketing?
Indeed, the record reveals that some major pharmaceutical companies are not only felons, they're repeat offenders. In his book, Whistleblower: Confessions of a Healthcare Hitman, Dr. Peter Rost, former Pfizer V-P of Marketing included a long list of pharmaceutical company crimes. These are posted at: http://www.ahrp.org/cms/content/view/413/29/
In an article titled "Crimes and Confidentiality," posted on The Pump Handle, David Egilman MD, writes: "In 1985, Lilly pleaded guilty to 25 counts of unintentional deception in the marketing of its anti-arthritic drug Oraflex, including hiding 28 death cases from the FDA; in 2005, Lilly pleaded guilty and paid $36 million to criminal off-label marketing of Evista, a drug used to treat and prevent osteoporosis in postmenopausal women. http://www.usdoj.gov/opa/pr/2005/December/05_civ_685.html
Dr. Egilman has served as an expert witness in numerous drug-related cases-including Zyprexa. Indeed, he released some of the Zyprexa documents that had been sealed by a federal judge at the request of both plaintiffs' and defense counsel. The same documents served the Department of Justice in its criminal case. However, he paid Lilly $100,000 to avoid possible jail time for releasing the documents.
Dr. Egilman points out that DOJ's willingness to accept a misdemeanor plea and a trivial fine is troubling given Lilly's two prior convictions for criminal conduct in the marketing of its drugs.
"Under statutes like California's notorious "three strikes" law, repeat criminals receive life sentences for committing non-violent crimes that involve far less money or harm to society (e.g., shoplifting $153 worth of videotapes). Even excluding Zyprexa, Lilly's crimes resulted in the deaths of tens, if not thousands, of innocent victims, but have had far less severe consequences for the company than for individuals convicted of petty crimes."
Dr. Egilman also faults plaintiff lawyers who enrich themselves with settlements, while agreeing to seal documents that include information that their clients' doctors need to treat them.
Contact: Vera Hassner Sharav veracare@ahrp.org 212-595-8974
http://thepumphandle.wordpress.com/2009/01/22/crimes-and-confidentiality/ Crimes and Confidentiality January 22, 2009 in Sequestered Science | by The Pump Handle By David Egilman
On September 15, 2008 pharmaceutical giant Eli Lilly pleaded guilty to committing the crime of off-label marketing of Zyprexa, an antipsychotic. Lilly has profited handsomely from the marketing of this drug, making over $30 billion. The Department of Justice (DOJ) claims that the $1.42 billion dollar fine agreed to by Lilly as part of its guilty plea is the largest ever paid to settle such a violation, but it represents only 3.5% of the company's Zyprexa sales. DOJ's willingness to accept a misdemeanor plea and a trivial fine is troubling given Lilly's two prior convictions for criminal conduct in the marketing of its drugs. In 1985, Lilly pleaded guilty to 25 counts of unintentional deception in the marketing of its anti-arthritic drug Oraflex, including hiding 23 death cases from the FDA. And in 2005, Lilly pleaded guilty to off-label marketing of Evista, a drug used to treat and prevent osteoporosis in postmenopausal women.
Under statutes like California's notorious "three strikes" law, repeat criminals receive life sentences for committing non-violent crimes that involve far less money or harm to society (e.g., shoplifting $153 worth of videotapes). Even excluding Zyprexa, Lilly's crimes resulted in the deaths of tens, if not thousands, of innocent victims, but have had far less severe consequences for the company than for individuals convicted of petty crimes.
I have a certain personal familiarly with the Zyprexa case, since I released some of the documents upon which the criminal case was based. These same documents had been sealed by a federal judge at the request of both plaintiffs' and defense counsel. (About a year before I released the documents to a lawyer in Alaska, some plaintiffs' counsel sought to unseal them, but the Judge never ruled on this motion.) In the end, these same documents were used by DOJ to build its criminal case against Lilly, and it is unclear whether that case would ever have proceeded had the documents remained secret. Most judges should be able to recognize that documents that reveal evidence of crimes should not be treated as "trade secrets" and protected from disclosure. After all, some drug companies are convicted felons for doing similar things (Pfizer and AstraZeneca) and almost all have violated FDA marketing rules, so the techniques of off-label marketing and lying are well known and commonly practiced.
Judges should stop sealing documents that contain evidence of criminal conduct and important information on drug side effects. Moreover, they should send all discovery in pharmaceutical cases to the DOJ and the FDA for review if they intend to seal them. More than pursuit of criminals and deterrence is involved here. Special Agent-in-Charge Kim Rice of FDA's Office of Criminal Investigations said, "Today's announcement of the filing of a criminal charge and the unprecedented terms of this settlement demonstrate the government's increasing efforts aimed at pharmaceutical companies that choose to put profits ahead of the public's health." Documents produced in discovery often contain important health information that drug companies have hidden from the FDA.
The plaintiff lawyers who enrich themselves with settlements are most negligent for agreeing to these agreements, because they agree to seal documents that include information that their clients' doctors need to treat them. The lawyers do not inform their clients or seek their approval of the secrecy agreements.
I paid Lilly $100,000 to avoid possible jail time for releasing the documents. As I have previously published, confidentiality agreements that prohibit disclosure of important information that may impact public health to state and federal authorities (such as NIOSH, OSHA, and the FDA) should be illegal. Criminal penalties should be applied to corporations and private physicians who fail to disclose this information, and Congress should grant immunity from litigation to physicians and others for violation of confidentiality agreements in these situations.
David S. Egilman, MD, MPH is Clinical Associate Professor at Brown University's Department of Community Health.
http://www.philly.com/inquirer/breaking/business_breaking/20090119_Whistle-b lowers_perspective_on_Lilly_case.html PHILADELPHIA INQUIRER Posted on Mon, Jan. 19, 2009 Whistle-blower's perspective on Lilly case By Miriam Hill
Robert Rudolph knew he was about to end his lucrative career at Eli Lilly & Co., but he had to say something.
Why, he asked management, was the Indianapolis pharmaceutical company marketing its antipsychotic drug Zyprexa to elderly people when the drug was not approved for that group?
Why had the company violated privacy rules by culling patient lists at doctors' offices?
Why was the company counting drug samples as sales, which would boost the stock price?
He went on for about 10 minutes during a sales meeting in 2002. The other 25 Lilly sales representatives stared at him, stunned.
"I'd just been wrestling with this stuff for so long," he said in a telephone interview today. "I was put in a position of breaking the law, in my view, or quitting."
Rudolph and eight other whistle-blowers brought their allegations to federal prosecutors. That led Lilly to agree Thursday to a record $1.4 billion fine to settle charges of marketing Zyprexa illegally.
Zyprexa had been approved by the Food and Drug Administration for schizophrenia and bipolar disorder - but in 2001, the company began promoting it for other uses, such as treating anxiety, agitation and confusion in the elderly.
Drug companies are permitted to market drugs only for approved uses, though doctors may prescribe as they see fit. Lilly did an end run around the process by telling doctors Zyprexa could ease agitation, anxiety, and other everyday symptoms, according to the Philadelphia U.S. Attorney's Office, which brought the case.
In a statement today, Lilly insisted its employees always adhered to strict ethics. "Doing things the right way at Lilly is more important than securing a prescription," the statement said.
Rudolph and several other whistle-blowers found their way to prosecutors through their attorneys, Steve Sheller of Sheller P.C. and Michael Mustokoff of Duane Morris L.L.P., both of Philadelphia, and Gary Farmer of Florida.
Lilly's Zyprexa marketing material included pictures of composite patients such as Martha, a confused and agitated widow. "If you looked at it, you would say this was an Alzheimer's dementia patient," Rudolph said in the interview from his home in Oregon.
Other tactics bothered him, too. Company employees were allowed into doctors' offices on weekends to collect names of patients taking certain drugs in hopes of switching them to Lilly products. "We're not selling soap. We're selling chemicals that can be dangerous if they're not used in the right way," he said.
That was especially true of Zyprexa, which caused weight gain. And diabetes is a risk of the drug.
Rudolph, who was a pharmacist before joining Lilly in 1976, chose the company because of its sterling reputation. But gradually, as financial markets boomed and stock options became a bigger part of executive pay, Lilly's culture began to change, Rudolph said.
Instead of the pharmacists it had traditionally hired, Lilly started bringing in recent college graduates who had no medical background and were easy to train to parrot the company line. Instead of a profit-sharing program that all employees participated in - "even the guy who swept the floor," Rudolph said - compensation shifted to rewards-based on sales. "This new way of compensation kind of opened the door for a lot of unscrupulous practices, I felt," Rudolph said. He warned management of his concerns. Their response: "You're not a team player."
He began talking to other sales representatives about the issue, including Hector Rosado, another whistle-blower in the case. As he pondered what to do, Rudolph's son, then 15, provided a moment of clarity: "He came up to me and said, 'Dad, what's wrong is wrong.' I had taught my kids that. It was wrong, and I wanted to make it right."
So he raised his hand at the Lilly district sales meeting in Sacramento, Calif., in January 2002.
The stress of the job had thrown him into a depression. Managers made it clear they wanted him to leave, so six months after he made his stand at the meeting, he retired from his $115,000-a-year job.
He and the eight other whistle-blowers will split $78 million to $100 million of the settlement. Rudolph, 60, says the settlement against Lilly will only go so far in changing business practices. He wants jail time for wrongdoing by companies and executives.
Zyprexa sales were about $39 billion since FDA approval in 1996. Lilly did plead to a single misdemeanor of misbranding of a drug. "You have to remember, with Zyprexa," he said, "people lost their lives."
Contact staff writer Miriam Hill
at 215-854-5520 or hillmb@phillynews.com.
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