Lilly Receives Zyprexa Greetings From Capitol Hill

Evelyn Pringle April 2007

The Chairman and CEO of Eli Lilly, Sidney Taurel, has become a regular pen pal with lawmakers on Capitol Hill since the company’s ten-year campaign to increase profits by promoting the off-label use of Zyprexa for patients covered by public health care programs became the focus of investigations in both houses of Congress.

According to the March 23, 2007 edition of the New York Times, Zyprexa costs more than $300 a month and is the single biggest drug expense for state Medicaid programs, with spending of more than $1.3 billion in 2005.

Although Zyprexa is FDA-approved only for the extremely limited use of treating schizophrenia and bipolar disorder in adults, SEC filings show Zyprexa is Lilly’s top-selling drug with overall sales of $4.36 billion in 2006.

Medicaid records show that Lilly promoted Zyprexa off-label to patients of all ages for unapproved uses in treating anxiety, sleep disruption, mood swings, attention deficit hyperactivity and dementia.

According to Pennsylvania psychiatrist Dr Stefan Kruszewski, Zyprexa increases the risk of obesity, diabetes, hypertension, heart attacks and stroke and taxpayers are now footing the bill to care for patients injured by the drug.

On June 12, 2006, the New York Times reported that the cost of atypical-induced medical conditions was taking a toll on publicly-funded health care programs. “Mental illness is itself a money sponge,” it noted, “an expense borne largely by tax dollars.”

“But that cost may be dwarfed,” the Times said, “by the bill to manage the heart attacks and amputations that diabetes bestows.”

A 2003 survey by the city’s health department found that about 17% of adults surveyed, or 52,000, had diabetes. The Times noted that more mentally-ill patients were dying from diabetes and complications like heart disease than from suicide. “Uncontrolled diabetes can ruin a person’s life as much as uncontrolled schizophrenia,” Dr Newcomer, a professor of psychiatry at Washington University School of Medicine in St Louis, told the Times.

On April 4, 2007, as a ranking member of the Senate Committee on Finance, Senator Charles Grassley (R-IA), sent a letter to Mr Taurel, saying, “I have an obligation to ensure that the public’s money is properly spent to provide safe and effective treatments to the vulnerable populations that are beneficiaries of the Medicare and Medicaid programs.”

“I am aware of several pending product liability actions regarding Zyprexa,” he said, “and questions have been raised regarding safety information and marketing practices relating to that drug.”

Senator Grassley also wrote, “I understand that Eli Lilly produced certain documents in the course of these litigations that shed light on issues of interest to the Committee,” referring to documents produced in litigation that were kept under seal with a court order until they were quoted in the New York Times in December 2006, which showed that Lilly knew about the serious health risks of Zyprexa for over a decade and had engaged in an off-label marketing scheme called “Viva Zyprexa.”

Senator Grassley told Mr Taurel, “please provide to the Committee all documents and materials, including, but not limited to, emails, letters, reports, and memoranda, that were made available … pursuant to pretrial discovery in In re Zyprexa Prods. Liab. Litig.”

Anchorage attorney, Jim Gottstein, director of Law Project for Psychiatric Rights, provided the documents to the Times after he subpoenaed them for another case from Dr David Egilman, who was retained by the plaintiffs as an expert witness in the underlying Zyprexa litigation and became so alarmed by what he found in the sealed documents that he went looking for a legal way to warn the public.

According to Mr Gottstein in a February 13, 2007, interview with the Anchorage Daily News, Lilly’s hidden document showed the rate at which Zyprexa causes diabetes, massive weight gain and other metabolic problems and that Lilly trained sales staff to mislead doctors about the drug’s association with diabetes and illegally promoted Zyprexa for off-label use with children and the elderly.

Families of deceased Zyprexa victims want criminal prosecutions. “Lilly executives should go to prison for knowingly being responsible for people’s deaths, shattered families; ruined and grieving families,” says Ellen Liversridge, whose 39-year-old son gained nearly 100 pounds while taking Zyprexa before he lapsed into a coma and died 4 days later of profound hyperglycemia in October 2002.

“Thanks to the FDA,” she says, “there was no warning on the label of Zyprexa even though two other countries had made Lilly place warnings about diabetes, hyperglycemia, and death.”

For its part, the secret documents show that Lilly was not the least bit concerned that patients like Ellen’s son were developing diabetes. The company’s one and only worry was that sales would fall when the news about Zyprexa’s link to diabetes became made public. A July 7, 2003, “Diabetes Update” memo discussed the company’s strategy to counter the negative impact on doctor’s prescribing habits when news of the FDA’s decision to add a black box warning about the diabetes risk to the label of Zyprexa became public.

“We must embrace the fact that many physicians are curtailing their use of Zyprexa (particularly in the moderately-ill patient and in the maintenance phase),” the Update said, “solely on the basis of personal fear (of being sued).”

To ward off the drop in Zyprexa prescriptions because doctors were afraid of being sued, the Update said Lilly should offer to indemnify doctors, in other words, cover any lawsuits filed against doctors as a result of prescribing Zyprexa. “Indemnification represents the most meaningful demonstration of confidence in Zyprexa–both with our customers and with our employees,” the Update stated.

This plan was apparently successful with doctors after the risks of Prozac became public when documents disclosed in litigation that were also kept hidden under a court order were revealed in a subsequent lawsuit. “Our experience with Prozac,” the Lilly memo states, “confirms the impact and goodwill of such an initiative.”

The Update also describes a plan to pay millions of dollars to the most notorious industry-funded front group in the US, the National Alliance on Mental Illness, to organize nationwide campaigns to discount the claim that diabetes was caused by Zyprexa.

The strategy for NAMI described in the memo was to “mobilize our allies” and provide “NAMI a multimillion dollar grant to stage a national screening” to “help educate physicians and patients on the inherent risks of diabetes–regardless of the antipsychotic.”

On February 13, 2007, Dr David Graham, the FDA whistleblower of Vioxx fame, testified at a hearing before the House Energy and Commerce subcommittee and recommended that lawmakers also investigate the FDA’s handling of the Zyprexa matter, saying that the agency knew “for a long time” about the risk of weight gain and diabetes.

About 2 weeks later, on March 1, 2007, Mr Taurel received greetings from Rep Henry Waxman (D-CA), chairman of the Committee on Oversight and Government Reform, in a letter that requested information related to communications between Lilly and the FDA, including a list of trials, studies, or reports for any New Drug Application or Investigational New Drug application, including any supplemental applications submitted to the FDA.

The letter began by stating: “Allegations have been raised that Eli Lilly misled physicians and inappropriately promoted off-label uses of Zyprexa.”

“As part of the Committee’s ongoing oversight of the pharmaceutical industry’s research and marketing practices,” Rep Waxman wrote, “I am writing to request information relevant to Zyprexa and these allegations.”

Rep Waxman also asked Lilly for copies of the secret documents obtained by Mr Gottstein, and a list of all trials, studies, or reports initiated, supported or sponsored by Lilly relating to Zyprexa, including any conducted outside the US, along with an exhaustive list of documents related to the promotion, marketing and sale of Zyprexa.

Federal law prohibits drug companies from promoting drugs for uses other than those approved by the FDA, and since 1998, FDA records show companies have been cited over 70 times for promoting drugs off-label. However, drug makers obviously continue to engage in these illegal marketing schemes because, in the end, the profits far outweigh any fines.

For example, Lilly continued to market Zyprexa for unapproved uses, even while the company was under investigation for doing the exact same thing with another drug. In December 2005, the US Department of Justice announced that Lilly had agreed to pay a $36 million fine and plead guilty to illegally marketing Evista for the prevention of breast cancer and cardiovascular disease although it was only approved for treating post-menopausal women with osteoporosis.

And just as Lilly concealed the health problems associated with Zyprexa, at the time that the company was promoting Evista to prevent cancer, Lilly in fact knew that the drug caused cancer. An October 24, 2002, press release by the Cancer Prevention Coalition reported that Lilly had suppressed a study in which Evista was “shown to induce ovarian cancer in rats and, at doses well below the therapeutic, in mice.”

The press release noted “the strong scientific consensus that the induction of cancer in well-designed studies in two species creates the strong presumption of human risk.”

Dr Samuel Epstein, Chairman of the Coalition, cited data showing “an 8 percent increased incidence of ovarian cancer in white females over 65, those most likely to be treated with Evista, from 1997 to 1999.”

A $36 million fine was pocket change for Lilly in a year where the company reported 3rd-quarter sales for Evista of $770.8 million, compared to $755.4 million for the same period in 2004.

In the case of Zyprexa, Lilly has so far agreed to pay about $1.2 billion to settle cases out of court with roughly 28,000 victims. But here again, $1.2 billion for claims spanning a 10-year period amounts to petty cash for a drug with sales of $4.36 billion in 2006, and a 10% increase to $1.108 billion reported in the first quarter of 2007, over the first quarter of 2006.

Allen Jones, a former fraud investigator in the Pennsylvania Office of Inspector General, Bureau of Special Investigations, has calculated the death rate in the US for patients taking atypicals in correlation with the total annual sales and determined that the ratio would be nearly 7 deaths for every million dollars, or about $162,000 per patient death.

In the latest development in the Zyprexa saga, on April 25, 2007, Alex Berenson reported in the New York Times that the FDA has “questions about a Lilly document from February 2000 in which the company found that patients taking Zyprexa in clinical trials were three and a half times as likely to develop high blood sugar as those who did not take the drug.”

Alex Berenson is the reporter who broke the story on the secret documents and reported that doctors were provided information about the blood-sugar risks of Zyprexa which did not match data circulated inside the company, in the Times on December 21, 2006.

He quoted documents which showed that Lilly had examined 70 clinical trials and found that 16% of patients taking Zyprexa for a year had gained over 66 pounds. But instead of making these findings public, Lilly used data from a smaller group of trials that showed roughly 30% of Zyprexa patients gained 22 pounds.

According to SEC filings, about 1,300 Zyprexa lawsuits against Lilly are still pending, and the company is also facing Medicaid fraud lawsuits filed by attorneys general in 9 states so far.

Off-Label Use Of Lilly’s Evista Multiplies Risks

Evelyn Pringle February 26, 2006

On October 24, 2002 the Cancer Prevention Coalition issued a press release that said women taking the osteoporosis drug Evista, marketed since 1997 by Eli Lilly, were at an increased risk of developing ovarian cancer.

“There is ample scientific evidence that Evista poses risks of ovarian cancer,” wrote Samuel Epstein, MD, Chairman of the Prevention Coalition.

“Whether the large-scale treatment of women with Evista since 1997 has resulted in an increased incidence of ovarian cancer cannot yet be determined,” Dr Epstein said, “as the latest NCI cancer incidence data are now two years old.”

However, the data reveals “an 8 percent increased incidence of ovarian cancer in white females over 65, those most likely to be treated with Evista, from 1997 to 1999,” he added.

“Lilly’s own study, specifically designed to prove the drug’s safety, found that the drug was shown to induce ovarian cancer in rats and, at doses well below the therapeutic, in mice,” Dr Epstein said. He noted “the strong scientific consensus that the induction of cancer in well-designed studies in two species creates the strong presumption of human risk.”

In addition, a study by University of Southern California researchers, presented at the July 2001 annual meeting of the European Society of Human Reproduction and Embryology provides further evidence of the drug’s cancer risk. The study shows Evista increases the growth rate of ovarian cancer cells in laboratory studies, and may increase risks of recurrence of ovarian cancer, Dr Epstein advises.

He called Lilly’s suppression of its own evidence about ovarian cancer risk “reckless and threatening to women’s health and life.”

In light of a recent $36 million dollar settlement agreement between Eli Lilly and the US Department of Justice, the number of women at risk of developing ovarian cancer as a result of using Evista is likely to be much higher than previously thought.

The DOJ criminal filing accuses Lilly of marketing Evista in 1998 for uses that had not been approved by the FDA after sales for its approved use of the treatment of osteoporosis were disappointing. In its first year on the market, Evista only generated sales of $120 million, far less than the company’s original forecast of $401 million.

In December 2005, Lilly agreed to pay $6 million in criminal fines, a $6 million forfeiture to the Federal government, and $24 million in civil disgorgement to settle charges that the company illegally sold Evista for unapproved uses, including breast cancer prevention and the reduction of cardiovascular disease.

The unapproved-use campaign continued into 2000, the DOJ said, with physician seminars and one-on-one meetings with doctors, all aimed to boost Evista sales by increasing prescription rates for unapproved uses.

The settlement includes a permanent injunction and a consent decree under which Lilly agreed to not engage in illegal promotional and marketing practices.

Since Evista gained FDA approval for the treatment of osteoporosis, Lilly spent a fortune on creative methods of promoting the drug to women over 50 for daily life-long use. In 1998 alone it spent $39 million in direct to customer advertising according to Competitive Media Reporting.

“The surest route to high profits is the expensive drug that must be taken daily for years, preferably for life, out of fear of a disease that might create symptoms 10, 20, 30 years down the road,” according to How to Read A Drug Ad by Maryann Napoli, associate director of the Center for Medical Consumers in New York City, December 2001.

Ms Napoli describes a Lilly Evista commercial as an example of this technique.

“Osteoporosis – Could you be at Risk” was the headline of a TV advertising campaign which purposely did not mention Evista, as a treatment for osteoporosis.

With the ad, instead of identifying a specific drug, Lilly sells the dangers of the disease because if a drug and its purpose appear together, the side effects of the drug must be included in the ad.

This particular ad also involved other marketing tricks. “Up to half of women over age 50 will break a bone due to osteoporosis in their lifetime,” the ad warns. “And the risk increases when menopause ends,” it said.

“The statement is true,” says Ms Napli, “but choosing the age of 50 as the cut-off is guaranteed to instill fear.”

The truth is that a woman’s odds of having an osteoporosis-related hip fracture between the age of 50 and 70 are low. “Half of all hip fractures in women occur after the age of 80,” Ms Napli points out.

Although the above ad may be legal, creating ways to intentionally avoid warning patients about a drug’s dangerous side effects is certainly deceptive. But Lilly has been under fire for outright illegal marketing techniques in promoting Evista for years.

Back in March 1999, Zeneca Pharmaceuticals filed a lawsuit against the company alleging it had misled doctors in promoting Evista as a treatment for reducing the risk of breast cancer.

At the time, Zeneca, had FDA approval to market the drug Nolvadex to lower the risk of breast cancer with high-risk women. Zeneca said Lilly’s promotion of Evista violated the Latham Act, New York Business Law and the common law of the State of New York.

According to the allegations in the lawsuit, Lilly’s sales representatives “systematically and deliberately attempted to mislead doctors into believing that Evista has been proven to reduce the incidence of breast cancer and that Evista can now be prescribed as an alternative to Nolvadex.”

The lawsuit further alleged that “as many as one in three oncologists surveyed have been detailed on Evista by Lilly, despite the fact that Evista has no indication for use in an oncologist’s office.”

Zeneca said the lawsuit is intended to “put an end to the risk to the public health caused by confusion among physicians and patients which Lilly has purposefully orchestrated.”

The US District Court for the Southern District of New York determined that Lilly’s statements were literally false and ordered the company to implement a training program to prevent the claims from being made in the future and granted Zeneca’s request for an injunction against Lilly’s continued dissemination of such claims.

In a 106-page opinion, the court accepted Zeneca’s position that Lilly’s dissemination of false information has created a “grave public health risk.”

The court said since at least October 1998, Lilly representatives had been “systematically communicating to physicians that Evista has been proven to reduce the risk of breast cancer and that Evista is comparable or superior to Nolvadex in reducing the risk of breast cancer.”

“These communications have been determined by the court to be approved and directed by Eli Lilly management and to be false,” the court wrote.

In regard to whether calls to doctors by Lilly representatives constituted promotional activity, the court noted that “[c]ourts have consistently held that oral statements by a company’s sales representatives concerning a product constitute ‘commercial advertising or promotion’ under the Lanham Act.”

In 1999, a month before Zenaca filed its lawsuit, the FDA sent a warning letter to Lilly about its promotional materials. The agency said Lilly was overstating the benefits of Evista and implying that it was indicated for wider use than supported by the drug’s labeling and pointed out that it was only approved for prevention of osteoporosis in postmenopausal women.

In 2002, the DOJ informed Lilly of its investigation and then in late March 2004, the US Attorney’s office in Pennsylvania announced it was investigating Lilly’s marketing practices for Evista.

But through it all, Lilly continued to make a fortune off Evista. According to Bloomberg News on March 26, 2004, the drug generated $922.1 million in sales in 2003.

The recent $26 million settlement marks the end of an exhaustive 3-year investigation that resulted in a number of specific findings on Lilly’s illegal marketing activities. The DOJ said Lilly sales representatives were ”encouraged” to send unsolicited letters to doctors to promote off-label uses, and they were ”trained to prompt or bait questions by doctors in order to promote” off-label uses.

The company had also produced a videotape for use by sales representatives in which Lilly claimed Evista was “the best drug” for the prevention of osteoporosis, breast cancer and heart disease, according to the DOJ.

Lilly also trained representatives to promote Evista with a medical reprint that highlighted key results of the drug but told representatives to hide the disclosure page of the reprint that said: “All of the authors were either employees or paid consultants of Eli Lilly at the time this article was written,” and the prescribing information portion that said: “The effectiveness of [Evista] in reducing the risk of breast cancer has not yet been established.”

The DOJ also determined that Lilly organized “consultant meetings” for physicians who prescribed Evista during which unapproved uses were discussed; and then calculated “the incremental new prescriptions for doctors who attended Evista advisory board meetings in 1998.”

“By measuring and analyzing incremental new prescriptions for doctors who attended the advisory board meetings, Lilly was using this intervention as a tool to promote and sell Evista,” the DOJ noted.

In marketing surveys, doctors said they were told Evista might reduce the risk of breast cancer and the DOJ settlement information lists calls in Illinois, Texas, California, and Alabama, in which sales representatives promoted Evista for off-label use.

And finally, Lilly ran an advertisement in Prevention Magazine that said Evista “lowers cholesterol (and) addresses concerns about breast cancer,” the DOJ said.

On December 21, 2005, Don Woodley, a principal with Woodley Ferra Manion Porfolio Management told the Washington Post: “This settlement is very reasonable and affordable. It’s chump change for a company of Lilly’s size.”

$36 million is chump change considering that in October 2005, Lilly reported 3rd quarter global sales of Evista through September 30, 2005, of $770.8 million, compared to $755.4 million in sales for the same period the year before.

Eli Lilly The Habitual Offender

January 27, 2007

Evelyn Pringle

The revelations that Eli Lilly concealed the side effects of Zyprexa and promoted the drug for unapproved uses is not newly discovered misconduct. It is a persistent pattern of conduct indicative of a nasty habit that needs breaking.

After the secret company documents were leaked to the press last month by attorney, Jim Gottstein, the focus has been on Zyprexa; but a year ago it was Evista, and before that it was Prozac.

In the case of Evista, approved for treating post-menopausal women with osteoporosis, Lilly concealed data that showed an increased risk of cancer. On October 24, 2002, the Cancer Prevention Coalition issued a press release that said Lilly suppressed evidence that women taking the drug were at an increased risk of developing ovarian cancer.

“There is ample scientific evidence that Evista poses risks of ovarian cancer,” said Dr Samuel Epstein, MD, Chairman of the Prevention Coalition.

The data revealed “an 8 percent increased incidence of ovarian cancer in white females over 65, those most likely to be treated with Evista, from 1997 to 1999,” he said.

“Lilly’s own study,” Dr Epstein wrote, “found that the drug was shown to induce ovarian cancer in rats and, at doses well below the therapeutic, in mice.”

He noted, “the strong scientific consensus that the induction of cancer in well-designed studies in two species creates the strong presumption of human risk.”

Dr Epstein also cited a 2001 study by the University of Southern California that found Evista increases the growth rate of ovarian cancer cells in laboratory studies, and may increase risks of recurrence of ovarian cancer.

He called Lilly’s suppression of its own evidence “reckless and threatening to women’s health and life,” and the FDA’s approval of Evista without the cancer warning “equally reckless.”

Also in 2002, the US Department of Justice began looking at Lilly’s off-label marketing of Evista, and in March 2004, the US Attorney’s office in Pennsylvania announced it was investigating the company’s marketing practices for Evista, Zyprexa and Prozac.

The DOJ’s three-year investigation found that Lilly illegally marketed Evista for the prevention of breast cancer and heart disease. The DOJ noted that sales reps sent letters to doctors to promote unapproved uses and that Lilly produced a videotape in which the company claimed Evista was “the best drug” for the prevention of osteoporosis, breast cancer and heart disease.

In December, 2005, Lilly agreed to pay $36 million to settle criminal and civil charges related to the illegal marketing of Evista. The company paid a $6 million criminal fine, a $6 million forfeiture to the federal government, and $24 million to settle a civil lawsuit.

Lilly’s settlement agreement also included the standard, but useless, permanent injunction and consent decree in which Lilly agreed not to engage in illegal marketing and promotional practices.

In the case of the antidepressant, Prozac, a selective serotonin reuptake inhibitor (SSRI), Lilly’s concealment of the increased risk of suicide and violence associated with the drug is legendary.

FDA approved in 1988, Prozac was promoted off-label for everything from shyness to eating disorders to low self esteem. Within three years, annual sales of the drug were nearly $800 million. Newsweek put a Prozac pill on its cover with a headline calling it a breakthrough drug. Even healthy people were asking for Prozac, the magazine noted.

But with the massive off-label sales, so came the less newsworthy adverse events. The reporting system for prescription drugs in the US is called Medwatch. Within 10 years of Prozac’s arrival on the US market, there were 39,000 adverse events submitted to Medwatch, a number said to represent only between 1% and 10% of the actual number.

“So, if we get 39,000 adverse event reports about Prozac, the number of people who have actually suffered such problems is estimated to be 100 times as many, or roughly four million people,” investigative journalist Robert Whitaker explained in an interview for Street Spirit in August 2005.

“This makes Prozac,” he said, “the most complained about drug in America, by far.”

“There were more adverse event reports received about Prozac in its first two years on the market than had been reported on the leading tricyclic antidepressant in 20 years,” he added.

On December 18, 2003, Lilly sent letters to healthcare professionals in the UK, saying that Prozac was not recommended for children for any use, but issued no warning to doctors in the US.

In a situation similar to the Zyprexa document case, a couple years ago, the British Medical Journal received a series of internal Lilly documents and studies on Prozac from an anonymous source. The BMJ sent the documents to authorities, including US Congressman Maurice Hinchey and the FDA.

Congressman Hinchey sent the materials to psychiatrist, Dr Peter Breggin, author of Talking Back to Prozac, and The Anti-Depressant Fact Book, who reviewed the documents and issued a January 12, 2005 report.

After examining the documents, Dr Breggin confirmed their authenticity as those that he had evaluated in the early 1990s when he served as an expert for the combined Multi-District Litigation concerning Prozac. He in fact testified about the documents during a trial in 1994 after which, he says, they seemed to just disappear.

One group of documents he examined, contained a study by the FDA on the increased post marketing reports of “hostility” and “intentional injury” by patients on Prozac. For this study, the FDA compared patients using the antidepressant, trazodone, with Prozac patients, and found a 24-fold relative increase of reports of hostility and intentional injury per prescription of Prozac compared to trazodone.

The documents Dr Breggin reviewed also contained graphs showing a 40-fold relative increase in reports of suicide attempts, overdose, and psychotic depression in patients on Prozac compared to patients on trazodone.

An August 6, 1989, Lilly document says that doctors should be warned that Prozac patients were at a higher risk of suicide unless they receive a sedative, stating: “The counterindication because of acute suicidality should become a warning whereby the physicians should be advised that in the absence of sedation, the risk of higher suicidality should be taken into account.”

A June 13, 1990, letter to Lilly from a concerned doctor states: “There appears to be growing concern that Prozac may somehow trigger a suicidal preoccupation in a small subset of patients and that their families should be warned of this potential risk. It is certainly possible that some of the cases reported are “coincidence” in that the depressed person may have attempted suicide independently of Prozac. However, some of these cases appear to be in patients taking Prozac for reasons other than depression.”

Yet two months later, on August 31, 1990, Lilly sent out a Dear Doctor letter assuring health care professionals that there is no “causal relationship between Prozac and suicidality (ideation or acts).”

The hidden Prozac documents have come back to haunt Lilly. On January 14, 2005, a class action lawsuit was filed in Canada with claims that Lilly withheld information on the safety of Prozac. The plaintiffs contend that the reason Lilly failed to disclose the documents was because they showed a drastic increases in suicide attempts and other violent acts in patient using Prozac when compared to four other drugs.

Throughout the 1990s, while swearing publicly that Prozac did not increase the risk of suicide or violence, Lilly quietly settled lawsuits out of court and was able to keep the incriminating evidence hidden by obtaining court orders to seal the documents, just as it had been doing with Zyprexa until the latest batch of documents was leaked to the press.

Since the FDA was placed on permanent vacation when George W Bush took up residence in the White House, these days litigation appears to be about the only means available for unearthing hidden studies that show a drug’s adverse effects.

In the case of Zyprexa, Lilly has so far settled with an estimated 26,000 plaintiffs, at a cost of over $1 billion. The incriminating documents leaked to the press last month, came to light during litigation with these plaintiffs but even after the litigation was settled, they were kept under seal with a court order.

Since the documents were made public, Lilly’s legal team has spent about every other day in court trying to silence the messengers, Dr David Egilman and Jim Gottstein, and get the incriminating evidence back under seal, albeit without much success.

In a January 15, 2007, legal filing, a Lilly attorney quotes a comment by Judge Brian Cogan in a previous court hearing who said, Mr Gottstein had “deliberately and knowingly aided and abetted Dr. David Egilman’s breach of CMO-3.”

A responsive filing from Mr Gottstein should say that by issuing a protective order to suppress these documents to begin with, the court deliberately and knowingly aided and abetted Lilly in the off-label sale of Zyprexa by concealing the drug’s side effects from tens of millions of consumers and prescribing physicians.

The secret documents show that Lilly concealed information about Zyprexa’s link to severe weight gain, high blood sugar, and diabetes for a decade and because Lilly promoted Zyprexa off-label for so many uses, more than 20 million people have taken the drug. It is Lilly’s best-selling product, with sales of about $30 billion since its arrival on the market in 1996, according to the January 20, 2007, New York Times.

In the latest development in the Zyprexa saga, last week Illinois and Vermont joined a coordinated five-state investigation of Lilly’s marketing practices.

“The states are investigating whether Lilly tried to hide Zyprexa’s risk of causing weight gain and other risks associated with diabetes and whether the company promoted Zyprexa for use in patients who do not have schizophrenia or bipolar disorder,” the Times reports.

The larger question would seem to be, were the roughly 26,000 plaintiffs who entered into out-of-court settlements aware of the contents of the hidden documents and did they understand that by settling out of court Lilly would be permitted to keep the information secret knowing full well that more victims would be injured or killed by Zyprexa?