[Luke_Wilbur]

PHARMACEUTICAL COMPANY ELI LILLY TO PAY RECORD

$1.415 BILLION FOR OFF-LABEL DRUG MARKETING

Criminal Penalty is Largest Individual Corporate Criminal Fine

PHILADELPHIA – United States Attorney General Michael B. Mukasey and Acting United States Attorney Laurie Magid today announced the filing of a criminal information against, and a civil settlement with, pharmaceutical company Eli Lilly and Company, headquartered in Indianapolis, Indiana, for the off-label marketing of the anti-psychotic drug Zyprexa.

The monetary settlement, totaling $1.415 billion, is the largest amount paid by a single defendant in the history of the United States Department of Justice (“DOJ”).
Joining Mukasey and Magid in today’s announcement were Assistant Attorney General Gregory Katsas, who is in charge of DOJ’s Civil Division; Director of DOJ’s Office of
Consumer Litigation, Eugene Thirolf; Special Agent-in-Charge of the Defense Criminal Investigative Service Ed Bradley; Special Agent-in-Charge of the Food and Drug Administration, Office of Criminal Investigations Kim Rice; and Special Agent-in-Charge Patrick Doyle of the Office of Inspector General of the Department of Health and Human Services.

The Criminal Charge

The information charges Eli Lilly with the misdemeanor of introducing misbranded drugs into interstate commerce between September 1999 and November 2003. The Food and Drug Administration (“FDA”) had approved Zyprexa for use by adults for treatment of schizophrenia and certain types of bipolar disorder. Eli Lilly has admitted that it illegally marketed Zyprexa for uses never approved by the FDA. Among other things, the government alleges that these uses included treatment of elderly patients for such things as sleep disorders and dementia.

According to the information, Eli Lilly targeted its illegal marketing of Zyprexa to two types of doctors: those who treat the elderly in nursing homes and assisted living facilities, and primary care physicians. In September 1999, Eli Lilly began encouraging doctors to prescribe the drug for the treatment of dementia, Alzheimer’s, agitation, aggression, hostility, depression, and generalized sleep disorder.

Zyprexa was not approved for use for any of these disorders, which, unlike schizophrenia, are prevalent in the elderly population.

Nevertheless, Eli Lilly’s long-term care sales force promoted the use of Zyprexa in elderly populations for these symptoms. Because one of Zyprexa’s side effects is sedation, Eli Lilly directed its long-term care sales force to tell doctors that Zyprexa would help patients with sleep problems, behavioral issues, and dementia.

They claimed this side effect was a therapeutic benefit, not an adverse event, with the sales slogan “5 at 5,” that five milligrams of Zyprexa at 5 p.m. would help their patients sleep.

Then in 2000, Eli Lilly expanded its illegal marketing to primary care physicians with its primary care sales force in the “Viva Zyprexa” campaign, adding even more sales representatives.

The goal of the campaign was to make Zyprexa an “everyday agent in primary care” even though the company recognized that schizophrenia and bipolar disorder were not viewed as conditions typically treated by primary care physicians.

Lilly instructed the sales force to recommend Zyprexa for all adult patients with behavioral symptoms like agitation, aggression, hostility, mood and sleep disturbances, and depression.

The information alleges that Eli Lilly’s illegal off-label marketing campaign raised safety issues and posed potential risk to patients. Eli Lilly knew that significant weight gain and obesity were adverse side effects of Zyprexa and that weight gain and obesity were factors in causing hyperglycemia and diabetes.

Yet despite written caution from the FDA, Eli Lilly continued to promote these adverse events as therapeutic benefits of Zyprexa use, particularly in the elderly.
Eli Lilly’s management created marketing materials promoting Zyprexa for off-label uses, trained its sales force to disregard the law, and directed its sales personnel to promote Zyprexa for off-label uses.

Anticipating the possibility of resistance from primary care physicians to prescribing Zyprexa, defendant Eli Lilly specifically trained its sales representatives on how to
respond to doctors’ concerns about off-label uses of Zyprexa, and how to continue to promote Zyprexa for off-label conditions. Eli Lilly retained medical professionals to speak to doctors during peer-to-peer sessions about off-label uses of Zyprexa.

When promoting Zyprexa to health care providers, Lilly emphasized that the weight gain side effect of the drug was a therapeutic benefit for patients who had trouble maintaining their weight.

"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 Magid.

“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 a plea agreement with the United States, Eli Lilly will pay a total of $615 million, including a $515 million fine and $100 million in forfeiture.

“Off-label promotion of pharmaceutical drugs is a serious crime because it undermines the FDA’s role in protecting the American public by determining a drug is safe and effective for a particular use before it is marketed,” said Gregory G. Katsas, Assistant Attorney General for the Civil Division. “This settlement demonstrates the Department’s ongoing diligence in prosecuting cases involving violations of the Food, Drug, and Cosmetic Act, and recovery of taxpayer dollars used to pay for drugs sold as a result of off-label marketing campaigns.”

The Civil Settlement

In a separate civil settlement agreement, Eli Lilly agreed to pay the United States approximately $438,171,543.58 to settle allegations that it caused invalid claims for payment for Zyprexa to be submitted to various government programs such as Medicaid, TRICARE, and the Federal Employees Health Benefits Program and caused purchases of Zyprexa by the Department of Veterans Affairs, the Bureau of Prisons, the Department of Defense, the Defense Logistics Agency, the Department of Labor, and Public Health Service entities for unapproved off-label uses.

Also, Eli Lilly agreed to pay various state Medicaid programs more than $361,828,456.42
to settle similar claims.

“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,” said Special Agent-in-Charge Kim Rice, of FDA’s Office of Criminal Investigations.

“The FDA will continue to devote resources to criminal investigations targeting pharmaceutical companies that disregard the safeguards of the drug approval process and recklessly promote drugs for uses for which they have not been proven to be safe and effective.”

“The illegal scheme used by Eli Lilly significantly impacted the integrity of the Department of Defense’s healthcare system,” said Special Agent-in-Charge of the Defense
Criminal Investigative Service Ed Bradley. “This illegal activity increases patients’ costs, threatens their safety and negatively affects the delivery of health care services to the more than nine million military members, retirees and their families who rely on this system.

Today’s charges and settlement demonstrate the ongoing commitment of the Defense Criminal Investigative Service and its partners in law enforcement to investigate and prosecute those that abuse the government’s healthcare programs at the expense of the taxpayers and patients.”

“Today’s disclosures should send a clear message to those doing business with the Government that they will be held accountable for their decisions and actions that have an
adverse impact on health care programs, such as Medicare and Medicaid,” said Special Agent-in- Charge Patrick Doyle, HHS, Office of Inspector General, Office of Investigations.

“Our office is committed to pursuing those companies and individuals who choose to put profits ahead of the law.”

The civil settlement also resolves four whistle-blower lawsuits filed in federal court here: United States of America ex rel. Robert Rudolph v. Eli Lilly and Company, Civil Action No. 03- 943; United States of America ex rel. Joseph Faltaous v. Eli Lilly and Company, Civil Action No. 05-1471; United States of America ex rel. Steven Woodward v. Eli Lilly and Company, Civil Action No. 06-5526; and United States of America ex rel. Jaydeen Vincente v. Eli Lilly and Company, Civil Action No. 07-1791.

Those cases were filed by former sales representatives who identified Eli Lilly’s off-label marketing practices. To encourage individuals to come forward and identify companies and individuals that defraud the government, federal law permits whistle blowers to share in the recovery for such fraud.

In this case, the whistle blowers will share in 18%, or $78,870,877, of the federal share of the (civil) settlement.

The HHS Office of Inspector General and Eli Lilly entered into an agreement that requires Eli Lilly to cease off-label marketing and to put certain programs in place to prevent the illegal conduct from recurring. This agreement, called a Corporate Integrity Agreement, requires Eli Lilly to send doctors letters advising them of this resolution and give them a way to report questionable conduct of sales representatives, list payments to doctors on its website, and assure that its board of directors and top management regularly certify that the company obeys the law and has an effective compliance program.

This case was investigated by the Defense Criminal Investigative Service, the FDA’s Office of Criminal Investigations, and the Department of Health and Human Services Office of the Inspector General. The case is being prosecuted by Assistant United States Attorneys Catherine L. Votaw, Marilyn May, Joseph Trautwein, and Denise S. Wolf, and DOJ Office of Consumer Litigation Trial Attorneys Jeffrey Steger and Ross Goldstein.

Assistance was provided by representatives of FDA’s Office of Chief Counsel and the National Association of Medicaid Fraud Control Units.

The Corporate Integrity Agreement was negotiated by the Office of Inspector General of the Department of Health and Human Services.

Eli Lilly’s guilty plea and sentence are not final until accepted by the United States District Court.

UNITED STATES ATTORNEY'S OFFICE Contact: PATTY HARTMAN
EASTERN DISTRICT, PENNSYLVANIA Media Contact
Suite 1250, 615 Chestnut Street 215-861-8525
Philadelphia, PA 19106
COPIES OF NEWS MEMOS AND RELATED DOCUMENTS CAN ALSO BE FOUND AT

http://www.usdoj.gov/usao/pae

[joeknight]

I am so angry at the DC for not thinking of my disability and my health. Now I am very sick because I do not have my medication and I have diabetes and gastritis and I need help to get my medications. I do not understand why you took my money and it makes me so mad I hope you all will help a mental disabled person in need. Please help me very soon; I am tired of being sick it's making my new family is so concerned. I have been taking my medications for over twenty years and now since I lost my money I have not taken my zyprexa and Zoloft for a period of time and now I can't take it because of my stomach and now I need medication to help me get better and be sick free and be a happy disabled person and I have a little baby nephew and I want to be around for him. I do not want to past on and leave my new family. I am hoping to live up to be at least 86 to 90 at the most for my family. Please let me know if you can give me plenty of help for my self a mental disabled individual that need his health back and to get new medication to help me get better and have a great life with my new family. My name is Joe knight and I am a mental disabled person with needs.

[Luke_Wilbur]

joeknight, on Jun 8 2009, 10:52 AM, said:

I am so angry at DC for not thinking of my disability and my health. Now I am very sick because I do not have my medication and I have diabetes and gastritis and I need help to get my medications. I do not understand why you took my money and it makes me so mad I hope you all will help a mental disabled person in need. Please help me very soon; I am tired of being sick it's making my new family is so concerned. I have been taking my medications for over twenty years and now since I lost my money I have not taken my zyprexa and Zoloft for a period of time and now I can't take it because of my stomach and now I need medication to help me get better and be sick free and be a happy disabled person and I have a little baby nephew and I want to be around for him. I do not want to past on and leave my new family. I am hoping to live up to be at least 86 to 90 at the most for my family. Please let me know if you can give me plenty of help for my self a mental disabled individual that need his health back and to get new medication to help me get better and have a great life with my new family. My name is Joe knight and I am a mental disabled person with needs.

Joe. Do not worry. We are in this together.


Eli Lilly Plea and Settlement
Eli Lilly and Company (Eli Lilly) and the government (the Office of the United States Attorney for the Eastern District of Pennsylvania and the Office of Consumer Litigation of the Department of Justice) entered into an agreement whereby Eli Lilly agrees to plead guilty to the introduction into interstate commerce of quantities of its drug, Zyprexa, that were misbranded in violation of 21 U.S.C. §§ 331(a), 333(a)(1) and 352(f)(1). Specifically, Eli Lilly will plead guilty to promoting Zyprexa in elderly populations as treatment for dementia, including Alzheimer's dementia, between September 1999 and March 31, 2001.

The entry of plea and sentencing hearing in this matter will be held before the Honorable Robert F. Kelly on Friday, January 30, 2009, at 10:00 a.m. in Courtroom 11B, 11th floor of the United States District Court, United States Courthouse, 601 Market Street, Philadelphia, Pennsylvania. The case has been assigned the criminal docket number 09-020.

All government filings, both criminal and civil, are available for your convenience on the following links:

• Information
• Guilty Plea Agreement
• Government's Memorandum For Entry Of Plea and Sentencing
• Corporate Integrity Agreement
• Settlement Agreement
• Government's Supplemental Motion in Anticipation of Sentencing and Judgment and Order of Forfeiture

To see the statement issued by Acting United States Attorney Laurie Magid, click here.

To see a press release issued by the United States Attorney's Office for the Eastern District of Pennsylvania, click here.

To see a press release issued by the United States Attorney's Office for the Eastern District of Pennsylvania, click here.

[joeknight]

My doctor Gaurang Thaker is my health doctor and he is located at 3411 olawood court Olney md 20832, my doctor Harold I.Eist, md., DLFAPA, FRCP [c], P>A 5515 Grosvenor Lane [office entrance Bethesda, Maryland 20814, I am trying to get my doctors to help me with my health condition and I also need Doctor Gaurang Thaker to give me my medical health records to me. Now Doctor Eist is helping me with my Diagnose that he is sending a letter to DDs saying he told me and Luke that my Diagnose is that I have been Mentally Disabled all my life. I am happy that things are moving forward, one step at a time and I hope DDS will look and read my post today. I am a good person and I love people and animals and plants and sports and playing basketball and football and baseball and I love bowling and camping and being with my family and having camp fires at are Christmas tree farm in west virgina and I love helping do Real hard Christmas tree work too for my family and my two best friends that work on the farm. I am a mentally Disabled person and I am doing a great job for my family in DC and my co workers at work. My name is Joseph Knight.

[Luke_Wilbur]

Joe and I went over to Dr. Eist's office today. We asked him about the letter he promised to fax last month that we still have not received. Dr Eist responded that he did fax the letter for Joe. He stated that he will fax it again. I told him that we could just pick it up. He told me that he is going to try again to fax it. If it does not go through then we will come pick it up.

Harold I Eist, MD
5515 Grosvenor Ln
Bethesda, MD 20814
Get Directions Phone:

(301) 530-0510

This post has been edited by wiley: 30 October 2009 - 09:53 AM

[joeknight]

Today I called Alice Anderson 12 times and she did not answer my phone calls. Micelle Hawkins received the email of my in take application and both of my doctors letters and I am confident that things will work out for me soon and I will be fine. I heard that Micelle Hawkins received a call from Alice Anderson returning Micelles call to her about receiving the application and the doctor’s letters. Ed sent the Email and Micelle Hankins received the application and my Doctors letters. All in all Luke and I our so happy that this is done and now we will hear from either Alice Anderson or Micelle Hawkins. Its been a week that the fax machine was down and we had to send a Email to Micelle Hawkins to get this done finally and we are all happy

[Luke_Wilbur]

joeknight, on Jul 23 2009, 12:12 PM, said:

<br />Today I called Alice Anderson 12 times and she did not answer my phone calls. Micelle Hawkins received the email of my in take application and both of my doctors letters and I am confident that things will work out for me soon and I will be fine. I heard that Micelle Hawkins received a call from Alice Anderson returning Micelles call to her about receiving the application and the doctor's letters. Ed sent the Email and Micelle Hankins received the application and my Doctors letters. All in all Luke and I our so happy that this is done and now we will hear from either Alice Anderson or Micelle Hawkins. Its been a week that the fax machine was down and we had to send a Email to Micelle Hawkins to get this done finally and we are all happy

I received a response from Mrs. Hawkins

Quote

We need:

Birth Certificate (copy)
Proof of District of Columbia residency(DC identification card, and utility or phone bill, etc)
Any additional documents before 18th birthday (IEPs, medical records, etc) –We can do developmental history w/someone who knew him before 18
Psychological evaluations administered before the 18th birthday
Current psychological evaluation
Proof of health insurance for the person in need of services (i.e., Medicaid, private) – Your stated he was not eligible for Medicaid because of income from deceased Dad.
Social Security Card (copy)
Current physical exam (form enclosed)


You will be assigned an intake service coordinator. They will call and send you a letter with a face-to-face appointment. You can bring in as many documents that you can obtain at that time.

It is interesting to note that the District of Columbia agencies do not share information in one database or contact each other when information is needed.

We already gave this Information to the DC DMV, DC DHS, Eckington Service Center. That is why the disabled fall through the cracks to get money that was already granted.

Will nationalized Healthcare be the same way.

[Luke_Wilbur]

Joe never received letter from the District. After calling Alice Anderson 41 times he came over to me upset that she will not answer his calls.

I decided to use my contact:

Michelle Hawkins
Community Outreach Specialist
Intake and Eligibility Unit
202.730-1813

Michelle was very pleasant and gave me the number of his new case worker.

Irban Scott
202.730-1807

[joeknight]

Dear DDS I am not happy with you people because you are not caring about me and I am not feeling well and I have a wisdom tooth that needs to be pulled right away and my stomach hurts all the time and you all seem not to care about my health condition and I am going to call my new social worker today and make an a appointment to get this done so I can feel better and feel good about my life and be happy and not make my family worry all the time and stress about this any more. Do you all understand what I am saying to you people at DDS right now? I am beyond tick off that you all will not really care about people with developmental disabilities like you all say you do and I hope you people prove me that you care about us and will help us people with developmental disabilities a lot because we can not do it on our own DDS. Your friend with developmental disabled learning disability! JOE knight!

[Luke_Wilbur]

Here is the latest update on Joe. This is a letter to his former social worker in Montgomery County Maryland.

Quote

Hi Denise,Joe still has not been accepted in the District's Developmental Disability Program. As you know that his case worker at the Eckington Service Center stated that Joe would have to go through DDS to qualify for his Medicaid. I relayed this message to DDS Supervisor, Alice Anderson, last June. She told me she would expedite the process, but DDS needs information to prove that Joe was mentally disabled before he was 18. At this point we have met twice with Irvin Scott, Joe's case worker. We have filled out all paperwork. Given legal authorization of the DIstrict government to attain all of his records. We have given Irvin Scott, all of his high school and current psychatric evaluations done on Joe while he was living in Maryland. Mr. Scott stated that Joe is borderline mild retarded with an IQ of 70. He needs to be able to prove without a doubt that Joe is mentally disabled. At the end of each meeting Mr. Scott stated that he had all the information needed and he would present his case to his supervisor, Alice Anderson. I sent Mr. Scott an email below last week. My wife, Jenna Mack, contacted Mr. Scott today. He stated that DDS has requested more information. They need a copy of Joe's school records as well. It is my understanding that since we did give the District government legal authorization then they should be able to access this. Being Joe's former social worker in Montgomery County can you give DDS some guidance on how to obtain his school records? Mr. Scott is unable to obtain them. I just want this process to be done. It is causing alot of stress in my family and with Joe. I never thought it would be so difficult for Joe to get his Medicaid transferred. I am CC'ing Mrs. Wilson as well since you corresponded with her this Summer. Thanks again, Luke Wilbur

Here is the message I sent to Joe's current DDSCase worker in the District.

Quote

Good Afternoon Irvin,Before we departed from our last meeting you stated that you would be going on the behalf of Joe to your supervisor on Thursday, October 22. I would like to know the outcome of that meeting.I do appreciate you going up to bat for Joe. Our priority is that Joe get's proper treatment. He has psycotic ephisodes daily. His sickness is progressing. It has taken me days of explaining tohim about your evaluation of him. I still am not sure he understands. I have told him that you needed to know this information to better guage his mental retardation. His outburst at your meeting was quiteshocking. But, he has now calmed down. I await your response. All the Best, Luke A. Wilbur

[Luke_Wilbur]

I got this message today from the DC DDS.

Quote

From: "Scott, Irvin L. (DDS)" <irvin.scott@dc.gov>
Subject: RE: DDS - Joe Knight
Date: Fri, 6 Nov 2009 16:02:29 -0500

Mr. Wilbur, in an effort to correct someapparent misconceptions as indicated in your email, please note that the DCDevelopmental Disabilities Administration participates with persons who arediagnosed with Mental Retardation. The Department of Mental Health participateswith persons who are mentally ill. The information that you provided indicatesthat at age 16 while attending the School for Contemporary Education; Mr. Knightrequired a "highly structured behavioral program in a class of no morethat ten students and two adults. Clear limits and consequences for hisbehavior are still necessary supports in order for him to experience success".While references to inappropriate behavior and low frustration tolerance aremade, no references are made to signs and symptoms of mental retardation. Letterswere provided that addresses the results of a neurological evaluation completedon 11/10/81 when Mr. Knight was 10 yrs. old. Dr. Cassidy stated that he "founddifficulty getting a coherent overview of the child's situation. Therehave been long-standing problems in school, and he has been in specialeducation at McKenny Hills for some time". Another physician'sletter states that "that there was no reason to feel that there is anyneurological disease accounting for his problems in adjustment at home, and Iwould recommend some counseling".

No psychological evaluations or IndividualEducation Plan (IEP) reports have been submitted to DDA that would support apre-18 diagnosis of Mental Retardation, however; there seems to be support foran unspecified psychiatric diagnosis. The only reference to a diagnosis ofmental retardation was made by Harold I. Eist, M.D. who mentioned it in aletter stating that Mr. Knight was referred to him after a suicide attempt andhospitalization at Suburban Hospital in January 1993.(Mr. Knight would have been 22 yrs. old at the time.) Mr. Knight overdosed onMellaril. Based on his letter it appears that Dr. Eist treated Mr. Knight forsigns and symptoms of a psychiatric disorder and monitored Mr. Knight'suse of prescribed psychotropic medications (Zyprexa to stabilize manicbehavior). Please note that we try to determine eligibility within a 90 dayperiod, however; this requires that there is sufficient evidence to support adiagnosis of mental retardation. At this time there is no compellingevidence to support a diagnosis of mental retardation. In addition, DDA hasno relationship to whether or not a person receives or is denied Medicaid. Itis the individual's responsibility to apply for Medicaid in his or her homejurisdiction, and DDA is not involved in the process that determines if aperson receives Medicaid. I hope that this information gives you a clear pictureDDA, the status of Mr. Knight's application and the process fordetermining eligibility to participate with DDA programs.

No evidence he says. Then why did Joe have Montgomery County disability benefits all his life? Why does Joe have Medicare?

This was my response to DDS.

Quote

Mr Scott,

Thanks for finally writing back. Stating Joe does not have a developmental disability is criminal.

What you stated in front of Joe and I was quite different than this email response. Who made this decision?

Joe clearly is on the lower scale of mild mental retardation.

Youstated that you were the gatekeeper and you had all the paperwork youneeded. You further stated that you were going to pitch Joe's case toAlice Anderson.

During our last meeting you made a copy of the following:

Montgomery County Public Schools
Office for Special and Alternative Education.
Diagnostic and Professional Support Team

This was done when Joe was 16

It was you that explained to me that Mild retardation ranges from 55 to 69

Joe's 1980 evaluation yielded a Dated April 1987. This makes Joe 16 at the time

WISC-R Verbal IQ of 54
WISC-R Performance IQ of 70
And a full scale IQ of 59

Further his report states that he is the age equivalent of a 6 to 9 year old.

If you have lost this copy then I can send it back to you. Also, whatr esearch have you done on Joe's behalf? What records did you receive besides the ones I provided you.
I would like all of this documentation.

Ifthis is going to be an example of government run health care, then I vote "No." I am going to share this story with anyone that will listen.

Regards,

Luke

This has made Joe upset. I am just getting tired of this fight. This city's stone age government appears to immovable.
I feel sorry for all the others in shelters with no one to help them. Say a prayer for my buddy.

This post has been edited by Luke_Wilbur: 06 November 2009 - 09:53 PM

[JT Allen]

Who is Mr. Scotts' boss??
I think it extremely imprudent to deny Mr. Knight (although he is a kind, loving, decent man) is mentally retarded.

Mr. Knight is, by definition, "Mildly Mentally Retarded" (aka "developmentally disabled") according to DSM IV (which is the benchmark in the USA).
That's a fact.

John Allen