Nobody Buys Lilly's Innocence Routine About Zyprexa

February 6, 2007

OpEdNews

Original Content at

http://www.opednews.com/articles/genera_evelyn_p_070205_nobody_buys_lilly_s_.htm

________________________________________

February 5, 2007

Nobody Buys Lilly's Innocence Routine About Zyprexa

By none

Eli Lilly is having trouble obtaining and retaining insurance coverage for

Zyprexa litigation because apparently insurance companies are no longer

willing to buy its wide eyed innocence routine when it comes to the

company's fraudulent off-label marketing schemes.

In filings with the SEC, Lilly admits that it is having problems and that

the company may end up having to pay its own Zyprexa costs, but blames it on

the insurance industry stating: " We have experienced difficulties in

obtaining product liability insurance due to a very restrictive insurance

market and therefore will be largely self-insured for future product

liability losses. "

As for the insurance that Lilly does have to cover past and future Zyprexa

lawsuits, the filing reports that carriers have raised defenses to their

liability and are seeking to rescind the policies, and Lilly further warns

that, " there is no assurance that we will be able to fully collect from our

insurance carriers on past claims. "

Some internal Lilly documents recently leaked to the press, that Lilly

somehow managed to have sealed with a court order, reveal that Lilly hid the

side effects of Zyprexa identified in its own clinical trials a decade ago

and engaged in wide-ranging off-label marketing schemes to make a drug

approved by the FDA only to treat adults with schizophrenia and bipoloar

disorder into its top selling product bringing in a reported $30 billion

thus far.

In light of these insurance problems, Lilly could be likened to a dog

chasing its tail. While on one hand, it is being sued for illegally

marketing Zyprexa off-label, if it stops the illegal conduct profits will

plummet and it won't have the money to pay the litigation costs.

However, Lilly has apparently decided to take the low road, because to date,

settling with 26,500 Zyprexa cases out of court by paying out over $1.2

billion has done nothing to lower the off-label sales figures for Zyprexa.

In fact, in 2006, sales of the drug increased 12%, according to SEC filings.

In 2003, the FDA ordered warning labels on all atypicals, of an increased

risk of high blood sugar and diabetes and said blood sugar surges in some

patients were associated with life-threatening medical conditions or death.

In 2005, the FDA added the strongest warning available, a black box, stating

that the drugs increased the risk of death in elderly patients with

dementia. The warnings did nothing to slow off-label prescribing of Zyprexa.

It is still being freely prescribed for uses never approved or intended. On

April 25, 2006, Bloomberg News reported that in 2005, nearly 7 children out

of one thousand were taking an antipsychotic, and among senior citizens 65

and older, antipsychotic use was 21 per 1000. Per patient antipsychotic

costs for children 19 and under have increased 196%, or nearly triple 2001's

total, according to Bloomberg.

An assessment by Christoph Correll, Child and Adolescent Psychiatric Clinics

of North America, January 2006, in USA Today, shows Zyprexa to be the worst

of the atypicals for children and lists side effects of diabetes and weight

gain with Zyprexa as " severe. "

Zyprexa is not approve for any on-label indication for children but even if

it was, schizophrenia is extremely rare in children at about 1 in 40,000

under the age of 18, according to the National Institute of Mental Health,

and psychiatrists do not even agree on what criteria should be used to

diagnose children with bipolar disorder.

Yet the rate of children treated with atypicals " is growing dramatically

faster than the rate for adults, " Epstein, chief medical officer for

Medco Health Solutions, pharmacy benefit managers, told USA Today.

Medco did an analysis of outpatient prescriptions for USA Today and found

that, in a sampling of about 2.5 million of its 55 million insured members,

the rate of children 19 and under with at least one atypical jumped 80% from

2001 to 2005. And that number only represents privately insured kids, and

not those in foster care or covered by Medicaid.

In what outraged critics called an unethical and dangerous experiment

conducted by Lilly on children, on May 1, 2006, the New York Times, reported

that " psychiatric researchers have been experimenting with a bold and

controversial treatment strategy: they are prescribing drugs to young people

at risk for schizophrenia who have not yet developed the full-blown

disorder. "

The study, co-funded by Eli Lilly and the National Institute of Mental

Health, and published in the May 2006, American Journal of Psychiatry,

involved 60 patients, mostly adolescents, who supposedly scored high on a

scale that assessed the risk for psychosis.

The scale rated the severity of over a dozen symptoms including categories

such as grandiosity, suspiciousness, and bizarre thoughts. The researchers

claimed that from 20% to 45% of the people who scored high would go on to

develop full-blown psychosis, in which the symptoms would become extreme.

In the first year of what was scheduled to be a 2-year trial, five of the 31

patients on the drug developed full-blown psychosis, compared to 11 of the

29 who were on placebos. However, by the end of the first year, more than

two-thirds of the patients had quit, making it impossible to interpret any

differences between the 2 groups.

The only definite finding of the study was that patients taking the drug

gained an average of 20 pounds, once again documenting a side effect that

has been known for 15 years.

Experts say the rapid weight gain is the most worrisome side effect of

Zyprexa because obesity leads to so many other serious health problems like

diabetes, hypertension and heart disease.

Public health programs are throwing good money after bad paying for Zyprexa.

A recent study published in the October 12, 2006, New England Journal of

Medicine, funded by the National Institute of Mental Health, found atypical

use with Alzheimer patients was no more effective than a placebo for most

patients and put them at risk of serious side effects including confusion,

sleepiness and Parkinson like symptoms.

According to the report, about a third of the roughly 2.5 million Medicare

beneficiaries in nursing homes have taken atypicals, and their use accounts

for an estimated $2 billion in annual sales, much of it paid by Medicare and

Medicaid.

All that said, Lilly cannot claim to be unaware of the continued off-label

sale of Zyprexa in the US, because it buys the detailed prescribing records

for every doctor in the country and provides them to sales representatives

so they can better direct the company's promotion efforts.

Lilly knows exactly which doctors are prescribing Zyprexa, in what dose, and

how often, on any given day of the year and that places Lilly in the best

position to contact doctors to tell them to halt the off-label prescribing

but that obviously has not happened.

Allowing Lilly to keep documents that were produced in litigation hidden

even after the cases were settled has done nothing to curb the off-labeling

prescribing of Zyprexa either.

And, the fact that a judge would even entertain Lilly's demands to place the

recently released documents back under seal has resulted in outrage voiced

by health care professionals all over the US. The pubic health crisis

created by Lilly's off-label sale of Zyprexa for 10 years without warning

about the health risks is no small matter.

On November 16, 2005, USA Today interviewed FDA scientist, Dr Graham,

the man famous for blowing the whistle on the mishandling of the Vioxx

disaster, who estimates that there are 62,000 deaths each year from the

off-label use of atypical drugs.

The allegations made by the plaintiffs in the underlying litigation are all

verified in the leaked documents. For instance, the California law firm,

Hersh and Hersh, represented plaintiffs in the first settlement, who alleged

that Lilly " fraudulently withheld relevant information from potential users

of Zyprexa. "

The lawsuits also alleged a failure to warn doctors and patients that

Zyprexa carried potentially lethal risks from weight gain and diabetes, and

one of the leaked documents dated 6 years ago, written by a panel of

diabetes doctors hired by Lilly to assess the diabetes risk, warned Lilly

back then that " unless we come clean on this, it could get much more serious

than we might anticipate. "

According to Leonard Roy , in " Zyprexa: A Prescription for Diabetes,

Disease and Early Death, " in the August 2005, edition of Street Spirit, if

Lilly had issued the warnings, " there undoubtedly would have been fewer

cases of diabetes and fewer deaths from taking Zyprexa. "

" But truthfulness is not one of Eli Lilly's strong suits when profits are at

stake, " Mr s says.

" Telling the truth, " he points out, " would undoubtedly have cut into sales

for its blockbuster drug (the fifth best-selling prescription drug in the

world), which, in 2004, produced revenues of $4.4 billion, almost a third of

the company's total revenues and more than a third of its profits. "

This is not the first time that the judge's Zyprexa protective order has

been criticized. In 2005, the Swedish Academy of Pharmaceutical Sciences

journal ran an article titled, " Lilly is hiding negative information about

Zyprexa, " featuring an interview with Dr Curt Furberg, Professor of Public

Health Sciences, at Wake Forest University.

Dr Furberg said that he had seen secret documents on Zyprexa in his capacity

as an expert witness and stated that the most hazardous effects of Zyprexa

were hidden from prescribing physicians and the public.

The hidden Zyprexa evidence is said to be worse than that revealed on Vioxx

and Dr Furber's interview provides good insight into why Lilly would early

on agree to pay a $690 million settlement to the first round of Zyprexa

plaintiffs, which allowed the company to keep the damaging evidence buried.

According to Lilly, the company has produced approximately 11 million

documents and the court has, without any stated reasons, allowed Lilly to

designate all 11 million as confidential pursuant to Case Management Order

3, an August 9, 2004, protective order.

Attorneys involved in the case say Lilly was even permitted to designate

reports and articles about Zyprexa that appeared in the media as

confidential.

In mid-December 2006, Alaskan attorney, Jim Gottstein, obtained some of the

sealed documents by issuing a subpoena for Dr Egilman, another expert

witness who evaluated the Zyprexa documents for a law firm in the underlying

litigation, to appear for a deposition.

As soon as he received the documents, Mr Gottstein set out to publicize the

information by immediately providing copies to journalists and authors

including Dr Breggin, Dr Grace , Dr Cohen, Dr Stefan

Kruszewski, Judy Chamberlin, Vera Sherav, Whitaker, and Berenson

at the New York Times.

When articles began appearing in the Times, Lilly obtained an injunction

that required Mr Gottstein to return the documents and identify everyone

they were disclosed to.

After Lilly received the names, on December 29, 2006, the court issued a

second temporary injunction to prohibit the dissemination of the documents

by Terrie Gottstein, Jerry Winchester, Will Hall, Bruce Whittington, and

Ziegler.

The injunction also barred the disclosure of the information about Zyprexa

by many of the most well-known experts on psychiatric drugs in the US, who

are also journalists and authors, to include Dr Breggin, Dr Grace

, Dr Cohen, Dr Stefan Kruszewski, Judy Chamberlin, Vera Sherav,

and Whitaker.

At Lilly's request, in early January, 2007, more names were added to the

injunction including two websites belonging to the consumer protection and

patient advocacy organization, the Alliance for Human Research Protection

(AHRP), at www.ahrp.org and www.ahrp.blogspot.com, and the web site of the

international patient advocacy organization, MindFreedom, at

www.mindfreedom.org, and Whalen and his web site at www.joysoup.net.

The name of New York Times reporter, Berenson, the only journalist who

actually quoted from the documents in the press was not included in any

injunction. Lilly in fact never asked for an injunction against the Times,

and Judge Jack Weinstein announced in one hearing that he was not going to

issue an injunction against the Times.

However, for the others journalist, the litigation process has dragged out

at snail's pace and Lilly has been successful in getting the court to bar

them from discussing or writing about the public health risk created by the

continued off-label prescribing of Zyprexa.

Attorney, Alan Milstein, representing Ms Sharav, the AHRP, and Dr Cohen, has

filed a motion asking the judge to unseal the documents in question from the

original protective order on the grounds that they should not have been

designated confidential to begin with.

At a January 17, 2007, hearing Mr Milstein told Judge Weinstein that the

documents are critically important to saving human lives, to prevent human

suffering and " this Court should in no way assist Lilly in keeping them from

the public. "

The above statement by Mr Milstein is not an exaggeration. According to

recently updated estimates by , a former Medicaid fraud

investigator, in considering the $10 billion a year spent on atypicals in

the US, the death rate would be close to one patient per $162,000 spent on

Zyprexa, or nearly six deaths for every million.

Lilly is now seeking civil and criminal contempt charges against Mr

Gottstein and Dr Egilman for their part in warning the public, which Mr

Gottstein admits will hopefully have a negative impact on the sale of

Zyprexa for unapproved uses.

Dr Egilman has recently notified Lilly that he will not be attending what

could be seen as his own funeral in refusing to testify against himself at a

deposition based on his right against self-incrimination under the Fifth

Amendment of the US Constitution.

Several of the authors and journalists restrained by the injunction have

obtained private attorneys to file briefs arguing against their inclusion

based on rights guaranteed by the First Amendment and some have testified in

person or by phone at court hearings.

Attorney, Fred von Lohmann, of the Electronic Frontier Foundation, filed a

brief to object to the injunction on behalf of Doe, referred to as a

citizen-journalist who contributes to the Wiki web site and states: " The

information that Doe desires to publish on the Wiki (including links to

sites where the Lilly Documents can be obtained) plainly relate to a matter

of overriding public concern. "

Lilly apparently believes that showing that there has not been widespread

viewing of the documents is important. However, after Lilly told the judge

that they were not available on the internet and that a grassroots campaign

to disseminate them had " fallen flat, " Mr von Lohmann filed a brief saying

Lilly " appears to have been incorrect, " and supplied the court with

affidavits by two persons who said they easily found and downloaded the

files on the internet, and in one instance it only took 19 minutes.

Ted Chabasinski, the attorney for Whitaker, Judi Chamberlin, and

Oaks, the Director of Mindfreedom, is calling for criminal charges

against Lilly executives for illegally marketing Zyprexa for unapproved

uses, with full knowledge that thousands of patients were being injured and

killed. In his latest brief filed on Feb 1, 2007, Mr Chabasinski says the

documents that Lilly claims should be kept secret show this:

" Certain executives of defendant corporation, motivated by greed,

deliberately engaged in a course of action that they knew would cause, and

did cause, the injury and death of thousands of people.

" Because of defendant executives' depraved disregard for human life,

thousands upon thousands of innocent people were left with their bodies

bloated, their health ruined, and their lives severely shortened or rapidly

ended. "

Mr Chabasinski is advising members of the public to contact state attorneys

general to direct their attention to the Times articles and the existence of

the secret Zyprexa files and a list of current state attorneys general is

posted on the Mindfreedom web site.

Ms Sharav testified at a January 17, hearing that the public needs to be

warned " because vulnerable people such as children and the elderly and

disabled people are being targeted to take drugs that are doing them more

harm than there is any evidence of benefit. "

She freely expressed her views about Lilly which prompted Lilly's legal team

to ask that her comments be stricken from the record but the request was

denied. When asked what the secret documents showed with respect to the

practices of Lilly, she stated:

" In my opinion, this is about the worst that I have seen. It borders on

indifference to human life. Eli Lilly knew that Zyprexa causes hypoglycemia,

diabetes, cardiovascular damage and they set about both to market it

unlawfully for off label uses to primary care physicians and they even set

about to teach these physicians who were not used to prescribing these kind

of drugs to, they taught them to interpret adverse effects from their drug

Prozac and the other antidepressants which induce mania.

" They taught them that if a patient presented with mania after having been

on antidepressants, that that was an indication for prescribing Zyprexa for

bipolar which is manic depression. That is absolutely outrageous and that is

one of the reasons that I felt that this should involve the Attorney

General. "

" The sales of a drug that was approved for very limited indications, for

schizophrenia and for bipolar, " Mr Sharav stated. " Each one of these is

about one to 2 percent of the population, " she pointed out.

" But the reason the drug became a four and a half billion dollar seller in

the United States, " she testified, " is because they encouraged the

prescription for children, for the elderly, for all sorts of reasons. "

She said her organization had disseminated a video on U-Tube in which a

" former Zyprexa salesman tells exactly what they were taught and how they

were taught to defuse doctors's concerns who saw their patients as he put it

blow up. "

Ms Sharav testified that she asked Mr Gottstein for 2 copies of the

documents because she wanted to deliver one to the New York State Attorney

General.

Attorney, Meadows, who represented some of the plaintiffs in cases

settled out of court was called to testify and attorneys were able to

establish that the information contained in the leaked documents is

basically nothing new.

He admitted that the two central allegations in the underlying lawsuits was

that Zyprexa was marketed off-label and that when Lilly sought FDA approval

of the drug that Lilly had information that showed that there were dangers

in regard to the drug.

Near the end of the hearing, Attorney Milstein argued that the foundation

for the injunction was that the Lilly documents were trade secrets and " yet

in all of the papers they filed, all they do is say, without any kind of

support, that they are trade secrets. "

He objected to the blanket court order for 11 million documents. " You heard

the testimony of the plaintiffs' attorney, " he told the judge, " who said to

his knowledge, that virtually every document produced by Lilly in this case

is marked confidential. "

In one of the latest development in this bizarre legal battle, Judge

Weinstein has issued a court order with the word " Invitation " asking Mr

Berenson to appear in court, apparently to guarantee him a front row seat at

his own hanging, by giving testimony on whether he participated in what the

judge called a " conspiracy " with Dr Egilman and Mr Gottstein to violate the

order that sealed the secret documents to begin with.

On the other side of the coin, if the documents remain sealed, Mr s

warns that users of the drug, doctors, and the public are still almost

totally in the dark about the clinical trials and what he calls, " Zyprexa's

shameful history. "

He says Zyprexa was approved based on the results of a six-week clinical

trial that involved 2,500 subjects, and two-thirds of them did not even

successfully complete it. " Among those who stuck it out, " he reports, " 22

percent of the Zyprexa subjects suffered a " serious " adverse effect,

compared to 18 percent in the group taking Haldol. "

Besides severe weight gain, Mr s says, other adverse effects included

shaking, spasms, sedation, diabetic complications, rapid heartbeat,

restlessness, constipation, seizures, liver problems, white blood cell

disorders, and decreased blood pressure.

There were a total of 20 deaths, including 12 suicides, in the Zyprexa

group. Information documenting these deaths was obtained from FDA files

using the Freedom of Information Act, by one of the currently muzzled

journalists, Whitaker, who wrote that one in every 145 subjects who

entered the trials for Zyprexa, and the other atypicals, died in his best

selling book, " Mad in America: Bad Science, Bad Medicine, and the Enduring

Mistreatment of the Mentally Ill. "

According to Mr , Lilly has another perverse reason for pushing

Zyprexa. " It's a cruel irony, " he says, " that while the company is filling

its coffers by selling a drug that can cause diabetes, four of its

top-selling drugs are treatments for diabetes. "

" Eli Lilly gets the customer coming and going, " he states.

Pringle

evelyn-pringle@...

February 6, 2007