Peggy O’Mara’s Response to Letter to the Editor of Mothering Magazine

Following the email on November 23 from Peggy O’Mara which stated:

We have not recommended Zyprexa in any of our articles.

I wrote Peggy a reply the same day. Her reply to me follows that on December 20. Since she has asked that I share it with everyone I am posting both here for your benefit so that her reply will be in context. I apologize for the delay – I have been extremely busy the past three weeks and out of town, etc. Our letter to the editor (a revised version) is being considered for the March/April edition of Mothering magazine.

On 23 Nov, 2010, at 11:31 PM, Amy Philo wrote:
Dear Peggy,Thank you for responding to this letter to the editor from another activist. Did you receive the letter that John Breeding and I sent you several weeks ago? After we received no response we published it as an open letter. I did see the letter published in this month’s issue which refers readers to Katherine Stone’s Postpartum Progress and claims that nothing short of medication can help PPD. Perhaps you are still considering publishing further, more accurate information for your readers.

I could have misremembered the use of the term Zyprexa from your article and inserted it in my mind into the excerpt which tells moms to use antipsychotic drugs and continue breastfeeding in 2007. If that is the case I apologize.  I recently gave away my copy of that month’s issue before seeing your September / October article which promotes antidepressants to breastfeeding mothers, so if I am mistaken then that is my fault for getting rid of your magazine before your September edition came out, which necessitated another letter.

I would be happy to clarify the Zyprexa issue in our letter to the editor and modify it to say simply that your magazine recommended the use of “antipsychotic drugs” if it’s true that the word Zyprexa or Olanzapine has not been mentioned in any Mothering articles / posts as a choice that moms should consider.

I do remember after reading your 2007 article, going to Thomas Hale’s website and looking for any studies relating to antipsychotics and discovering that he was recommending Zyprexa on the basis of a study of the blood of six babies.

I gave my copy of your May 2007 article to a friend at a speech I gave in April so I don’t have the hard copy. However this is what I found online regarding the information that you forwarded on antipsychotics. 

These quotes below are from the excerpt that was included with the “Losing It” article from 2007 (I guess you may have had another title like “Overcoming Postpartum Psychosis” or “Victory Over Postpartum Psychosis” or something to that effect on the cover.)

Here is the Losing It article where Sarah Fields from Postpartum Support International writes about how she was on antipsychotics while breastfeeding and refers readers to Thomas Hale.

“Self-Care: According to Kathleen Kendall-Tackett, PhD, IBCLC, postpartum depression can be eased by use of an “adjunct treatment to help the body heal itself, but not necessarily as primary treatment. With psychosis, medications are necessary to stabilize symptoms. After that, adjunct treatments can help prevent another episode. That would be the safest course.”8

Kendall-Tackett encourages mothers who want to continue breastfeeding to do so, even through a psychotic episode. To facilitate breastfeeding, she advises: “Mothers need a supportive environment, where mom and the baby can stay together but the baby is safe. Mothers and their care providers also need to know about which medications are compatible with breastfeeding.” The best resource for that is Dr. Thomas W. Hale’s book, Medications and Mothers’ Milk.9”

Continue reading “Peggy O’Mara’s Response to Letter to the Editor of Mothering Magazine”

Lilly Faces Mounting Legal Battles Over Zyprexa – Part I

Evelyn Pringle November 7, 2007

Since August 2006, as part of an on-going, multistate investigative effort by approximately 30 states, Eli Lilly has received civil investigative demands or subpoenas seeking a broad range of documents relating to the company’s marketing and promotion of the antipsychotic drug
Zyprexa, and more states are expected to join the effort.

In addition, a total of ten states are now suing Lilly for Medicaid fraud to recover the cost of Zyprexa purchases for persons covered by the program, along with the past and future costs of treating Zyprexa-related illnesses. Alaska, Arkansas, Louisiana, Mississippi, Montana, New Mexico, Pennsylvania, Utah and West Virginia have filed cases thus far.

Zyprexa belongs to a new generation of antipsychotic drugs known as “atypicals” which arrived on the US market in 1994, beginning with Risperdal, marketed by Johnson and Johnson subsidiary Janssen. Other drugs in this class include Seroquel, sold by AstraZeneca; Geodon, by Pfizer; Abilify, from Bristol-Myers Squibb and Clozaril, marketed by Novartis.

For the first four years that Zyprexa was on the market in the US, it was only approved to treat adults with schizophrenia, and it was not until 2000 that the FDA approved the drug for adults in the manic phase of bipolar disorder.

However, in a matter of a few short years, Lilly turned Zyprexa into its best-selling product, despite the drug’s extremely limited approved uses, by influencing doctors to prescribe the drug off-label.

In addition to prescribing a drug for unapproved uses, off-label can mean treating an approved condition for a longer duration of time, or prescribing a drug in combination with other drugs, or at a different dosage, or to a different patient population such children or the elderly, other than those specified on the FDA-approved label.

According to Lilly’s SEC filings, the Office of the US Attorney for the Eastern District of Pennsylvania has also advised Lilly that it has commenced a civil investigation related to the company’s marketing and promotion of Zyprexa, and a “number of State Medicaid Fraud Control Units are coordinating with the EDPA in its investigation of any Medicaid-related claims relating to Lilly’s marketing and promotion of Zyprexa.”

Lilly has also received subpoenas from the Office of the Attorney General of the State of Illinois, and the Florida Office of the Attorney General, Medicaid Fraud Control Unit, asking for documents relating to sales, marketing and promotion of Zyprexa.

Lilly’s SEC filings also report that the company has received requests for information related to the company’s marketing and promotion of Zyprexa from the offices of Representative Henry Waxman, Chairman of the House Committee on Oversight and Government Reform, and Senator Charles Grassley, the ranking Republican on the Senate Finance Committee.

Collectively, the Medicaid fraud lawsuits allege that Lilly illegally influenced doctors to prescribe Zyprexa off-label to patients, including children, for conditions such as behavior and mood disorders, eating disorders, anxiety, post traumatic stress disorder, insomnia, PMS, Alzheimer’s, Tourette’s syndrome, dementia and other unapproved indications.

The lawsuits also allege that Lilly concealed the adverse effects associated with Zyprexa, including drastic weight gain, high blood sugar levels, diabetes and pancreatitis.

Other serious adverse effects known to be associated with Zyprexa include Parkinson-like symptoms, akathisia, tardive dyskinesia, dystonia, hypotension, constipation, tachycardia, seizures, liver abnormalities, white blood cell disorders and death.

The Mississippi lawsuit alleges that about 10% of Zyprexa patients have developed diabetes, some of whom are children, even though Zyprexa “has never been approved for, nor found to be effective, in the treatment of children.”

An estimated 1,500 Utah Medicaid patients who took Zyprexa have developed diabetes, according to the lawsuit filed on May 29, 2007, by state attorney general David Stallard.

Utah is seeking damages including $5,000-$10,000 for each prescription that was “not medically necessary.”

Lilly recently attempted to get the Utah case dismissed, in part by arguing that the allegations of off-label promotion and failure to warn were preempted by FDA regulations under a new rule put in place by the Bush Administration, largely viewed as a gift to the pharmaceutical industry.

In 2006, the FDA published a preamble to new prescription drug labeling rules in which it asserted that its approval of the labeling would prevent the filing of lawsuits in state courts premised on a theory that a drug company should have provided additional warnings on a drug’s label.

However, the Utah court ruled against Lilly on this issue and stated, in part: “In fields traditionally occupied by the states, such as health and safety regulation, there is a strong presumption against federal preemption,” and Lilly “has not overcome this strong presumption.”

Pennsylvania alleges that the state spent millions of dollars “for non-medically accepted indications and non-medically necessary uses of Zyprexa,” as well as “significant sums of money for the care and treatment” of patients injured by the drug.

Montana’s complaint charges that, “Lilly management participated, encouraged and authorized the unlawful payment of illegal kickbacks to physicians in order to continue generating sales of Zyprexa.”

The Montana lawsuit is asking for reimbursement on behalf of all citizens who purchased Zyprexa, and not only patients covered by public health care programs, because under the law in that state, the attorney general can request treble damages and attorneys’ fees on behalf of all consumers.

There are also several RICO class actions filed against Lilly on behalf of union insurance plans, pension funds, and other private health insurers, which accuse Lilly of violating racketeering laws and allege the drug maker engaged in illegal marketing schemes to promote the sale of Zyprexa for off-label uses and seek to recover the cost of purchasing the drug, as well as treble damages, punitive damages and attorneys’ fees.

On June 28, 2007, Lilly lost a motion for a summary judgment dismissal of the RICO claims, based on the preemption argument, when District Court Judge Jack Weinstein for the Eastern District of New York ruled against the company, In re Zyprexa Products Liability Litigation, 2007 WL 1851161.

In a written ruling rejecting Lilly’s argument that state law failure-to-warn claims are preempted, Judge Weinstein wrote that “the regulation of public health is an area traditionally occupied by the states, supporting a presumption against preemption.”

“Under the present organization of the pharmaceutical industry, the official federal Food and Drug Administration (FDA), and the plaintiffs’ bar,” he stated, “the courts are arguably in the strongest position to effectively enforce appropriate standards protecting the public from fraudulent merchandising of drugs.”

The Judge also noted that Congress had not stated an intent to preempt these claims. “The FDA cannot be allowed to usher in such a sweeping change in substantive law through the back door,” he wrote.

The Medicaid fraud lawsuits allege that many children have been turned into customers for the off-label prescribing of Zyprexa. A recent October 7, 2007, report from the Florida Agency for Health Care Administration entitled, “The Use of Antipsychotic Medications with Children,” found that pediatric use of antipsychotics increased in the late 1990’s and early 2000’s, largely due to the arrival of the atypicals on the market.

The report noted that one study documented a 75% increase with commercially insured children aged 0 to 17 from 1997 to 2001, and another study of the managed care population from 1996 to 2001 found a 127% increase among children aged 0 to 18.

The study also reported that antipsychotic use in the Medicaid populations was three to four times higher than commercial populations in the late 1990’s, and in one program in the Midwest, the rate of prescriptions grew 304% between 1996 and 2001.

The authors said the analysis showed that the drugs are being used to treat a broad spectrum of disorders, and some of the disorders, such as attention deficit hyperactivity disorder and major depression, “clearly do not call for antipsychotic treatment.”

In the 0 to 5 age group, the study found that more than 53% of the drugs were prescribed for ADHD, even though antipsychotic use with children under 6 “should be considered only in very rare circumstances.”

A report in the May 10, 2007, New York Times revealed some of the known adverse events that occurred in children who were prescribed antipychotics in 2006 alone. The FDA received reports of 29 children dying, and at least 165 other serious side effects in children, where an antipsychotic was listed as the primary suspect, according to the Times.

The FDA acknowledges that its reporting system only picks up between one and ten percent of the adverse events that take place, which means the number of deaths and injuries above must be multiplied many times over to obtain an accurate estimation of how many children have been harmed by the drugs.

Lilly Faces Mounting Legal Battles Over Zyprexa – Part II

Evelyn Pringle November 10, 2007

Several Zyprexa-related class actions have been filed against Eli Lilly on behalf of the company’s shareholders charging Lilly, and certain of its officers and directors, with violations of the Securities Exchange Act.

On April 2, 2007, the Schiffrin Barroway Topaz & Kessler law firm issued a press release to announce a class action filed on behalf of all purchasers of Lilly stock between March 28, 2002, and December 22, 2006, alleging that Lilly disseminated false and misleading statements regarding Zyprexa.

More specifically, it alleges that Lilly was aware of a “clear link” between Zyprexa and diabetes, failed to warn the public and engaged in an illicit scheme to offset a drop in sales that was certain to occur when reports of side effects emerged, by creating a marketing plan which included the evaluation and pursuit of sales for Zyprexa based on “off-label” uses, in direct violation of Lilly’s own code of conduct.

The complaint further alleges that concealing the side effects and engaging in an illegal marketing campaign subjected Lilly to substantial regulatory fines, penalties and other legal action, compromising the company’s overall financial condition and prospects.

According to the complaint, between 2002 and 2004, sales of Zyprexa grew from $3.69 billion to $4.42 billion, and between July 18, 2002, and May 7, 2004, Lilly’s stock value increased from $43.75 per share to $76.95.

But when public warnings were issued about the safety of Zyprexa, the lawsuit alleges, sales slowed and share prices dropped from $76.95 to $50.34 between May 7, 2004, and October 25, 2004, representing a loss of market capitalization of over $30 billion.

Another shareholder’s complaint claims that Lilly had knowledge of a link between Zyprexa and extreme weight gain and diabetes and when sued by private individuals who developed these adverse effects, “the Company adamantly refused to acknowledge any wrongdoing.”

Still another lawsuit alleges that Zyprexa does cause such side effects, and to a greater extent than its competitors, and the “revelations sharply curtailed the sales growth of Zyprexa and resulted in thousands of product liability lawsuits against Lilly and hundreds of millions of dollars in settlements.”

A number of Zyprexa cases have been filed against Lilly in other countries as well.
In private litigation, almost all of the federal lawsuits are part of a Multi-District Litigation proceeding before Judge Jack Weinstein in the Federal District Court for the Eastern District of New York.

Since June 2005, Lilly has entered into out-of-court settlements with approximately 30,200 claimants in the US for about $1.2 billion, and there were still about 350 lawsuits covering about 540 claims pending at the time of the company’s August 7, 2007, SEC filing.

However, on June 29, 2007, Rob Waters and Margaret Cronin Fisk reported in Bloomberg News that Lilly “may attract more lawsuits alleging it failed to warn users that a psychiatric drug was linked to diabetes after the pharmaceutical company received a letter from US regulators.”

They report that Lilly was told in March that the FDA would delay the approval of Symbyax, which contains both Zyprexa and Prozac, for hard-to-treat depression because the agency wanted more information about the risk of diabetes in the prescribing label. Symbyax was already approved for bipolar disorder.

In a letter obtained by Bloomberg, the FDA stated: “We are concerned that the proposed labeling is deficient with regard to information about weight gain and high levels of sugar and fat in the blood of patients who took the drug.”

“We do not feel that current labeling for either Symbyax or Zyprexa provides sufficient information on these risks,” the agency wrote.

According to Bloomberg, the FDA said Lilly’s proposed prescribing information for Symbyax failed to disclose that almost half of the patients who had high or borderline blood sugar levels when they started taking the drug ended up with levels high enough to be considered diabetic and that was over nine times the number of patients on placebos.

“We were troubled that this important information was not included in your proposed label,” the agency said.

“The FDA’s request,” Bloomberg points out, “may bolster plaintiffs’ suits against the Indianapolis company over side effects tied to Zyprexa,” attorneys told the reporters.

“When the FDA says something damning about the warnings of a drug, it’s admissible as evidence on the reasonableness of the manufacturer’s decisions,” said David Logan, dean of the Roger Williams University School of Law, in an interview with Bloomberg.

“It would likely carry some weight with juries,” he stated.

Experts say, in light of all the studies which have shown that the older cheaper antipsychotics work as well or better than atypicals for schizophrenia patients, it’s difficult to understand why Zyprexa is still being prescribed for those patients.

An October 2006 study in the Archives of General Psychiatry, funded by the British government and lead by Dr Peter Jones, a psychiatrist at the University of Cambridge, compared treatment outcomes for schizophrenia patients with the older antipsychotics with treatment results from the new atypicals and found the quality of life of patients was slightly better with the older drugs.

The study was conducted on behalf of Britain’s National Health Service to determine whether the increased cost of the new atypicals was justified and involved 227 patients who were assigned to two groups and evaluated by researchers who did not know which medication the patients were taking for over a year.

In the October 3, 2006, Washington Post, Dr Jones said a conservative interpretation of the data suggests that there is no difference, “so the notion you would pay 10 times as much would be difficult to justify.”

“Why were we so convinced?” he asked, referring to the widespread belief that the new drugs were worth the cost. “I think pharmaceutical companies did a great job in selling their products,” he said.

Experts are quick to point out that earlier studies in the US had produced the same results. In 2003, the Department of Veterans Affairs found there was no difference in compliance, symptoms or overall quality of life in patients treated with the older drug Haldol compared with Zyprexa, and a September 2005 government-funded study in the New England Journal reported that patients taking the older drug perphenazine did as well as patients on the new drugs and patients on atypicals experienced more side effects.

“The story of these newer antipsychotic drugs is a story that reveals an institutional gap,” according to Dr Robert Rosenheck, who was involved in both US studies, in the Post on October 3, 2006.

“It should not have needed 10 years to get three government studies,” he noted.

The fact is, Lilly promoted Zyprexa as being more effective than the older drugs with less side effects right from the start. On November 14, 1996, the FDA’s Division of Drug Marketing, Advertising and Communications sent a letter to Lilly addressing the company’s misrepresentations of the risks and benefits of Zyprexa in an October 2, 1996, promotional teleconference conducted by Dr Gary Tollefson, Vice President of Lilly Research Laboratories.

During the conference, the FDA said, Dr Tollefson made the false claim that Zyprexa did not cause the Parkinsons-like side effects observed in patients who received Haldol, and even though the FDA labeling for Zyprexa included weight gain as an adverse effect, during the conference Dr Tollefson claimed that it usually occurred in patients who were underweight to begin with, making it sound like weight gain was actually a benefit of the drug, according to the FDA letter.

In addition to the many serious health problems found to be associated with Zyprexa in recent years, experts say the suicide rate amongst Zyprexa patients is also high. According to an analysis of the FDA’s adverse event reports by Dr Gregory Warren, an independent researcher and statistician, since Zyprexa came on the market in 1996, there have been 532 suicide reports on the drug filed by health care professionals.

UK psychiatrist and professor Dr David Healy, one of the world’s leading authorities on pharmacology, says there has been a ten- to twenty-fold increase in the rate of suicide among patients diagnosed with schizophrenia since antipsychotics were first introduced.

All that said, apparently no amount of litigation will slow the off-label prescribing of Zyprexa. In 2006, sales were $4.3 billion, and for the second quarter and first half of 2007, US sales of Zyprexa increased 4% and 5%, respectively, and international sales increased 14% during both periods, according to the SEC filings.

Critics say going after the drug makers is not enough, that it’s time to sue the doctors who prescribe drugs off-label. Alaska human rights attorney Jim Gottstein says psychiatrists are seldom held legally responsible for their failure to adequately inform patients about the true efficacy and harms of the drugs they prescribe.

“This has likely lulled them into a false sense of security,” he notes, “because there are various factors at work which could loosen a tidal wave of legal cases against doctors who do not adequately inform their patients about the benefits and harms, including the efficacy of other approaches and of nontreatment.”

Attorney Subpoenas J&J, AstraZeneca and Lilly for Hidden Antipsychotic Data – Part I

Evelyn Pringle September 10, 2007

Alaska attorney Jim Gottstein has issued subpoenas for the discovery of any suppressed data on the atypical antipsychotic drugs Zyprexa, Risperdal, and Seroquel which he says is necessary before a Forced Drugging Petition can possibly be considered for approval for a client he is representing.

Mr Gottstein contends that the information sought from Eli Lilly, AstraZeneca and Johnson & Johnson will show that the side effects of the drugs were well-established by the drug makers’ own clinical trials and therefore, his client should not be forced to take such medications against his will.

According to Mr Gottstein, various off-label combinations of Risperdal, Seroquel, Zyprexa and the anti-seizure drug Depakote have been administered to his client in the past, over his objections, which have not been FDA approved as safe or effective for use in any patient.

The subpoena issued to Sidney Taurel, Chairman and CEO of Eli Lilly calls for the production of the same documents requested by Congressman Henry Waxman (D-Cal), as chairman of the House Oversight and Government Reform Committee, on March 1, 2007.

On March 1, 2007, Rep Waxman sent letters to both Lilly and AstraZeneca, requesting extensive information about their marketing practices. The letter to Lilly states in part, “Allegations have been raised that Eli Lilly misled physicians and inappropriately promoted off-label uses of Zyprexa,” and requests information relevant to these allegations.

The letter asks for a list of all Zyprexa trials, studies, or reports; all presentations given to employees who promoted Zyprexa; information shown to physicians; presentations related to prescribing patterns, continuing medical education, and off-label use; and all documents and correspondence related to funding for nonprofit professional organizations or consumer patient groups.

The letter to Astra basically asks for the same documents except that Rep Waxman asks for more information related to the physicians and authors involved in company sponsored studies on Seroquel and writing the reports.

However, Rep Waxman also asked Lilly to turn over a batch of documents that were kept under seal for years with a court order issued by a federal court in New York, but were provided to him by Attorney Gottstein in December 2006, which Rep Waxman subsequently returned to Lilly on December 21, 2006, to honor the court order.

Mr Gottstein originally obtained the documents by subpoenaing Dr David Egilman, who served as a plaintiffs expert witness in the Zyprexa Products Liability litigation, pending in the United States District Court in the Eastern District of New York (MDL 1596), for a case unrelated to the Products Liability case.

The MDL 1596 litigation involved tens of thousands of lawsuits filed by Zyprexa victims who alleged that Lilly illegally marketed the drug for off-label uses and concealed the serious side effects known to be associated with Zyprexa for a decade.

As soon as Mr Gottstein received the documents he provided copies to reporter, Alex Berenson, at the New York Times, and to a number of other journalists, patient rights activists and advocacy groups and several leading experts on psychotropic drugs.

Once a medication is approved to treat one condition, doctors may prescribe it off-label for other indications if they think it will be effective, but drug makers are barred by law from encouraging physicians to prescribe a drug for uses other than those listed on the FDA approved label. But in recent years, its a well-known fact that off-label promotion has become the industries primary marketing tool when it comes to psychiatric drugs.

“Off-label” use also includes treating an approved condition for a longer duration of time, or in combination with other drugs, or at a different dosage, or with a different patient population such children or the elderly, than are listed on the label.

Zyprexa (Lilly), Risperdal (J&J) and Seroquel (AstraZeneca) belong to a class of drugs known as “atypical” antipsychotics. The other atypical drug include Abilify (Bristol Meyers Squibb), Geodon (Pfizer) and Clozril (Novartis).

The drugs were FDA approved only to treat schizophrenia and the manic phase of bipolar disorder in adults and have never been approved for use in combination with each other.

The many lawsuits filed against Lilly allege that the company’s off-label marketing campaigns included influencing doctors to prescribe the drug to millions of patients ranging from toddlers to the elderly for an exhaustive list of unapproved uses such as anxiety, sleep disruption, mood swings, post-partum depression, autism, attention deficit hyperactivity and dementia.

According to Harrisburg Pennsylvania psychiatrist, Dr Stefan Kruszewski, the atypical drugs can increase the risk of drastic weight gain, diabetes, pancreatitis, hypertension, heart attacks and stroke.

“The drugs can cause both a severe metabolic syndrome consisting of obesity, diabetes and cardiovascular problems,” he explains, “at the same time that they cause the neurological side effects as the older antipsychotics such as akathesis, a severe restlessness and tardive dyskinesia an often irreversible movement disorder.”

As an expert witness in the case, Dr Egilman reviewed the Lilly documents kept under seal by the court order and learned that Lilly had indeed engaged in a massive off-label marketing scheme to increase profits by encouraging doctors to prescribe the drug for unapproved uses and had concealed the drug’s serious side effects.

As a physician, after learning what was in the documents and knowing the harm that was sure to come to patients who continued to take Zyprexa, Dr Egilman was clearly facing a major ethical dilemma.

At the time, Lilly had already managed to keep the documents hidden by settling out of court with about 8,000 Zyprexa victims in 2005 by paying close to $700 million, after only five plaintiffs had provided depositions and before any substantive depositions could be taken from any of the Lilly defendants.

And the first batch out of court settlements did nothing to deter the off-label sales of Zyprexa. According to Lilly’s SEC filings, sales in the second quarter of 2006 totaled $1.12 billion, or a 2% increase over the second quarter of 2005.

In addition, Dr Egilman was aware that the company was getting ready to settle with about 18,000 more Zyprexa victims, and that the second round of settlements would guarantee that the secret documents would remain sealed.

And as a condition of settlement, the 28,000 plaintiffs had to sign agreements promising never to discuss the charges made against the company related to Zyprexa.

According to several plaintiffs who settled out of court, they we were not aware that there were documents that showed in many instances that Lilly knew full well that the injuries suffered could occur and had intentionally concealed the information from doctors and patients because it would have had a negative impact on Zyprexa sales.

In fact, these plaintiffs said they were never told that these secret documents even existed much less that by signing settlement agreements they would be allowing more patients to be injured or killed because the documents would remain sealed.

They also said that they were completely surprised to learn that their attorneys had access to documents that could have been presented to a jury to prove that the allegations in their lawsuits were true when the media began reporting the story in December 2006.

For instance, a November 12, 1999, letter from a Dr Albert Marrero, to Lilly’s medical director, described the blood sugar problems occurring in patients. “We have had eight patients out of possibly thirty-five patients on Zyprexa show up with high blood sugars,” he stated.

Dr Marrero also told Lilly: “Two patients had to be hospitalized due to out of control diabetes….We have certainly never seen this with Haldol, Navane, Risperdal and others to this extent,” he wrote.

A November 1999 report showed that after examining 70 clinical trials, Lilly found that 16% of patients on Zyprexa for a year had gained over 66 pounds but instead of informing doctors of this information, the company used data from a smaller group of trials to say about 30% of patients gained only 22 pounds.

Another document showed that in 2000, after a group of diabetes doctors retained by Lilly substantiated the diabetes risk, a Lilly manager stated in an email, “unless we come clean on this, it could get much more serious than we might anticipate.”

A email dated two years later in March 2002, shows that Lilly shot down a plan to provide doctors with information about diabetes, because it would draw too much attention the risk. “Although M.D.’s like objective, educational materials, having our reps provide some with diabetes would further build its association to Zyprexa,” the email stated.

Although the documents clearly show that Lilly had knowledge of these life-threatening health risks in 1999, it did not add a warning about blood sugar levels and diabetes to the Zyprexa label until the FDA forced it to in the fall of 2003. In fact, Japan and the UK issued warnings about the increased risk of diabetes in 2002.

According to Ellen Liversridge, whose son took Zyprexa and gained 100 pounds before he fell into a coma and died of profound hyperglycemia in 2002, “both the FDA and Lilly fought putting a warning on the label, until articles on the front pages of the New York Times, Baltimore Sun, and Wall Street Journal so embarrassed the FDA that they finally gave in to adding the warnings.”

But even then she says, the FDA required the same warning on the labels of all atypical drugs, “when Zyprexa was associated with a 37% higher increase in the risk of diabetes when compared to other medications.”

However, the secret documents show that Lilly was hard at work behind the scenes to make sure that the new warnings would have minimal effects on Zyprexa sales. A July 7, 2003, memo titled, “Diabetes Update,” described a plan to protect doctors who were afraid of being sued for prescribing Zyprexa after the news of the diabetes risk became public that would indemnify doctors who continued to prescribe drug

“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).”

“Indemnification represents the most meaningful demonstration of confidence in Zyprexa–both with our customers and with our employees,” it stated.

The memo also discussed a plan to pay millions of dollars to the National Alliance on Mental Illness, the most notorious industry backed front group in the nation, to help downplay the news about the diabetes risk.

The public health crisis created by patients who developed diabetes as a result of using Zyprexa is real. A Medicaid fraud lawsuit filed against Lilly by the attorney general of Mississippi in July 2006, alleges that about 10% of patients who used Zyprexa in that state have developed insulin-dependent diabetes and some are children, the complaint says.

When forced to make a decision on whether to warn the public about Zyprexa or abide by a court order that could result in the death and injury of thousands upon thousands of more people, Dr Egilman obviously followed the natural instinct of any decent human being and gave up the documents.

Whether or not he actually realized what consequences he might face is anyone’s guess, but he no doubt recognizes the consequences of crossing the drug giant today.

On September 7, 2007, Lilly issued a press release with the headline: “Egilman Admits Wrongdoing in Illegally Releasing Documents to New York Times and Resolves Case to Avoid Possible Civil and Criminal Sanctions”.

The release said that Dr Egilman will pay $100,000, and in return, the company “agreed to forego seeking criminal and civil penalties against Dr. Egilman for his illegal activities.”

Although it will be interesting to see how many “Good Samaritans” will stick their neck out for the common good after hearing about Dr Egilman’s fate, it is apparently still easy to find doctors willing to prescribe Zyprexa off-label because SEC filings show Lilly earned $4.36 billion from the drug in 2006

With all that said, on September 6, 2007, it was certainly a Deja Vue moment when the judge in Mr Gottstein’s latest case against forced drugging in Alaska, issued an order to have the court hearing and file closed, even though the client had elected to have it open.

Attorney Subpoenas J&J AstraZeneca and Lilly for Hidden Antipsychotic Data – Part II

Evelyn Pringle September 10, 2007

Attorney Jim Gottstein is the director of the Law Project for Psychiatric Rights, a public interest law firm that has mounted a campaign against forced psychiatric drugging all over the country. He represents mostly indigent clients through his non-profit organization and is not involved in the lawsuits filed against the atypical makers by patients or their families.

In turning the secret Eli Lilly documents over to the press, Mr Gottstein’s goal was the same as Dr David Egilman’s, to alert the public about Lilly’s off-label marketing schemes aimed at getting doctors to prescribe Zyprexa to more patients who were unaware of the serious health risks associated with the drug.

Zyprexa was approved only for the treatment of adults with schizophrenia in 1996, and it wasn’t until several years later, that it was approved for short-term treatment of adults with manic episodes associated with bipolar disorder.

In a February 13, 2007, interview with the Anchorage Daily News, Mr Gottstein explained that the secret document showed the rate at which Zyprexa caused diabetes, massive weight gain and other metabolic problems and how 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.

As the playing field stands today, the average American alone would be lucky to find any law firm financially strong enough to take a drug giant like Lilly with its billions of dollars of power and a well that will never run dry in large part because the illegal off-label marketing of Zyprexa is ongoing and continues to earn billions of dollars each year.

However, a small group of patient advocates that included some of the most well-known psychiatric drug experts, journalists, and attorneys in the US went head to head with Lilly in the public battle in a US District Court in New York that dragged out over 2 months to lift an injunction that barred the public disclosure of information about the serious adverse effects of Zyprexa that Lilly had successfully kept hidden under a court order until the documents were leaked to the press in December 2006.

Lilly filed the motion for the injunction in attempt to get the documents back under seal and succeeded in muzzling just about every expert in the US involved in the fight to dismantle the mass-drugging schemes put in place by the pharmaceutical industry over the past 10 years including Dr Peter Breggin, Dr Grace Jackson, Dr David Cohen, and Dr Stefan Kruszewski, as well as the award winning journalist, Robert Whitaker, who wrote “Mad in America,” and revealed all the negative information that showed up in the clinical trials conducted on Zyprexa and the other atypicals.

The score looked bad for the home team early on when Lilly won the second round by getting the court to add the names of two of the world’s most powerful patient advocacy groups to the injunction, along with their internet web sites and leaders, including Vera Sharav, director of the Alliance for Human Research Protection, and Judy Chamberlin and David Oaks from the international organization MindFreedom, a coalition of about 100 advocacy groups in 13 different countries.

At the time, Mr Oaks said, “This appears to be about Eli Lilly using its billions of dollars to try to intimidate grassroots critics.”

The New York legal battle turned into an all out war when Ms Sharav and Dr Cohen brought in the high profile attorney, Alan Milstein, to file their own motion asking the judge to unseal the documents because they should have never been designated confidential to begin with.

“What is abundantly clear,” Mr Milstein told the judge in a hearing, “is that they are not trade secrets.”

“Lilly in no way fears dissemination of these documents to their competitors, to Merck or to Glaxo,” he said.

“What Lilly wants to prevent, is the public at large, the consumers of its products, from seeing these documents and learning the truth about the product that Lilly produces and the way it markets it,” Mr Milstein said in the hearing.

Alaskan Attorney, John McKay, stepped in to represent Mr Gottstien and his wife Terrie, and then attorney, Fred von Lohmann of the Electronic Frontier Foundation, widened the battlefield by filing a brief on behalf of John Doe, described as a citizen-journalist who wanted to publish the secret documents on web sites because they were “plainly related to a matter of overriding public concern.”

California attorney, Ted Chabasinski, jumped in the ring on behalf of Robert Whitaker, Judi Chamberlin, and David Oaks. “While the injunction purports to be an attempt to recover the documents,” he wrote in a letter to the judge, “it is clear that its real purpose is to intimidate Lilly’s critics, and the court should refuse to cooperate with this.”

Mr Chabasinski told the court that criminal charges should be filed against Lilly executives for illegally marketing Zyprexa for unapproved uses, with full knowledge that thousands of patients were being injured and killed. “If executives can go to prison for stealing their companies’ money,” he told the judge in a letter, “surely those who steal people’s lives deserve at least the same fate.”

Mr Chabasinski informed the court that the secret documents were evidence of Lilly executives’ “criminal behavior” and their “willingness to kill people for profit.” He also made it known that he was encouraging members of the public to contact state attorney generals and was directing private citizens to a list of current contact information for each state posted on the Mindfreedom web site.

And some citizens did just that. Richard Bleecker, whose nephew died unexpectedly of hyperglycemia due to Zyprexa, wrote to the New Jersey attorney general and stated: “In your capacity as New Jersey’s Attorney General, I ask that you launch an investigation into Eli Lilly’s violation of the public interest by its concealment of the risks of Zyprexa.”

“Despite the FDA restrictions on use and warning labels,” he wrote, “the drug continues to be vigorously promoted by Lilly and prescribed for patients in record numbers, including children.”

He pointed that the state itself had an interest in the matter “since government programs like Medicare and Medicaid purchase over 70% of the Zyprexa sold in the USA, taxpayers in our State as well as across the nation are footing most of the bill.”

“I appeal to you, to investigate Eli Lilly’s willingness to see patients suffer and die to enhance its profits,” Mr Bleeker wrote.

Over 10 states have now sued Lilly for Medicaid fraud over the off-label marketing of Zyprexa. And for good reason according to a report in the March 23, 2007, New York Times, that said 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.

During court hearings, several people restrained by the injunction testified about why the documents should be made public which resulted in media reports about what was in them before the legal battle even ended.

For instance, at a January 17, 2007, hearing, Mr Gottstein was asked, “at the time you subpoenaed Dr. Egilman, had you the impression that Eli Lilly had deliberately withheld from the public and from physicians adverse side effects of Zyprexa?”

And he answered: “Absolutely.”

He was then asked whether he feared there would be thousands more cases of harm to people from Zyprexa, while Lilly was settling cases out of court, and Mr Gottstein said yes, and that he wanted the documents released “to protect people from this drug.”

Mr Milstein told the judge that the documents were critically important to saving human lives and said, “this Court should in no way assist Lilly in keeping them from the public.”

At the same hearing, Lilly attorneys asked Ms Sharav why she was interested in the documents and she said because they documented the fact that Lilly knew in 2000, that Zyprexa caused diabetes, “from a group of doctors that they hired who told them you have to come clean.”

“And instead of warning doctors who are widely prescribing the drug, Eli Lilly set about in an aggressive marketing campaign to primary doctors,” she testified.

Ms Sharav told the court, “This is a safety issue,” and “to continue to conceal these facts” from the public “is not in the public interest.”

She said, “this is about the worst that I have seen.”

“It borders on indifference to human life,” she told the judge. “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.”

She said Lilly taught primary care doctors to diagnose patients as bipolar if they experienced mania after taking antidepressants. “That is absolutely outrageous and that is one of the reasons that I felt that this should involve the Attorney General,” she testified.

Mr Sharav also objected to the off-label sale of Zyprexa to kids. “Little children are being exposed to horrific diseases that end their lives shorter,” she testified.

She said, “the reason the drug became a four and a half billion dollar seller in the United States is because they encouraged the prescription for children, for the elderly, for all sorts of reasons.”

“I consider that a major crime,” she told the judge and said she asked Mr Gottstein for 2 copies of the documents so that she could deliver one copy to the New York attorney general.

By the time of that hearing, Ms Sharav no doubt was aware that the crime was ongoing because in January 2006, USA Today reported that although the atypicals are not approved for any use with children, the prescription rate for children “is growing dramatically faster than the rate for adults,” quoting Robert Epstein, chief medical officer for Medco Health Solutions, pharmacy benefit managers.

In addition, an assessment by Christoph Correll, of the Child and Adolescent Psychiatric Clinics of North America, showed Zyprexa to be the worst of the atypicals for kids and listed the side effects of diabetes and weight gain with the drug as “severe.”

Technically, on February 13, 2007, Lilly scored a knock-out punch when the judge issued a permanent injunction prohibiting Mr Gottstein and Dr Egilman from further disseminating the documents and allowed Lilly to keep them sealed under a court order.

However, the judge also acknowledged in his written ruling that there was no way he could not enjoin the world by extending the injunction to the internet and by that time the worldwide web was flooded with all the damning information.

And Lilly would soon learn that the push to make the information public extended far beyond the courtroom. On February 23, 2007, a grass roots advocacy group issued a press release to rally support for Mr Gottstein for providing the documents to the media and to announce the “The Just Say “Know” to Prescription Drugs Campaign,” with a goal of getting one million people reevaluate the prescription drugs they were taking.

“If there is a case that dramatically highlights the need to stop blindly taking prescriptions drugs, this is it,” said Dr Greg Tefft, co-founder of the Campaign.

“We’re talking 20 million people potentially at risk and more being added daily,” he added.

The group set out to educate the public about off-label prescribing and what consumers must do to protect themselves against Zyprexa, or other drugs, when they are prescribed without warnings about side effects or unapproved uses.

“We are convinced that the way to solve this problem is to work the demand side of the market,” Dr Tefft said. “We are going directly to consumers and encouraging them to know what they are taking.”

Chairman of the Campaign, Dr Dominick Riccio, hosted a Zyprexa radio series and Dr Laurence Simon provided information to consumers about the drug and they set up an official web site for the Campaign is

A month and a half later, on April 4, 2007, the ranking Republican on the Senate Committee on Finance, Senator Charles Grassley (R-Iowa), was knocking on Lilly’s door with a letter to the CEO 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 products 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 leaked documents and said, “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.”

And in the end, it could be said that injunction or no injunction, the small group of warriors led by Mr Gottstein and Dr Egilman, who bravely banded together against the billion dollar giant helped make Lilly’s worst nightmare come true by fighting against the injunction and keeping the spotlight on the documents that the company fought so hard to keep hidden, not so much from the public, but from the stockholders.

According to legal experts, Lilly’s desperate filing for the injunction had nothing to do with the lawsuits filed by private plaintiffs because that litigation was the least of its worries being the company was settling the cases for peanuts with plaintiffs signing confidentiality agreements that would shut them up for life.

However, following the public disclosure of proof that Lilly had engaged in a 10-year illegal off-label marketing scheme while concealing the adverse effects of Zyprexa, the company was hit with the big Kahoona, when 4 class action lawsuits were filed in April 2007 on behalf of shareholders, alleging the fraud by Lilly and its top executives had cost them more than $30 billion, and the evidenced cited to support the allegations was the information from the secret documents that resulted in the battle over the injunction.

It remains to be seen whether these shareholder lawsuits will do anything to stop the drugging of kids in the US because as it stands right now the mass drugging campaign appears to be unstoppable. On September 5, 2007, Rob Waters reported that the number of antipsychotic prescriptions for children doubled to 4.4 million between 2003 and 2006, citing data provided to Bloomberg News by Wolters Kluwer NV, a drug-tracking firm.

Mr Waters also reported that the growth was most dramatic in the youngest children with 20,280 prescriptions written for kids aged 4 and younger, a five-fold increase over 2003, and with 5- to 9-year-olds, prescriptions increased almost six-fold to 710,937 in 2006.

Lilly’s Worst Zyprexa Nightmare Comes True

Evelyn Pringle May 7, 2007

Eli Lilly is not all that worried about personal injury lawsuits related to Zyprexa because the company has enough money to pay the relatively small pay-outs that arise from such actions, according to Attorney Barry Turner, a professor of law and ethics in the UK and a leading authority on consumer fraud litigation involving the pharmaceutical industry.

But he says the Medicaid fraud lawsuits filed by 9 states thus far, under the Federal and State False Claims Act are another matter. “The biggest penalties so far in Federal and State False Claims Act violations,” Mr Turner reports, “were awarded against drug companies and there are very many more cases under seal.”

But an even larger nightmare for top Lilly officials, he says, arises when a product like Zyprexa causes deaths and injuries to consumers and shareholders face huge losses including the millions of people who have their pensions invested in the company.

When a blockbuster drug is announced, Mr Turner says, it attracts huge investment and if that investment has been attracted to a product that Lilly knew was faulty, the company has risked shareholder funds beyond the pale.

This kind of behavior, he notes, is a Sarbox violation. The Sarbanes-Oxley Act was enacted to restore investor confidence in publicly traded companies in the wake of Enron and similar debacles by improving corporate accountability. Its official title is the “Public Company Accounting Reform and Investor Protection Act of 2002,” named after its sponsors Senator Paul Sarbanes (D-MD) and Representative Michael G Oxley (R-OH), and is commonly referred to as SOX.

One of the features of SOX is the ability to bring an action against those who recklessly and fraudulently deal with stockholder’s money and, “promoting the off label use of a drug with undeclared dangerous side effects, or being negligent as to such promotion, is the kind of behavior justifying an action under Sarbanes Oxley,” according to Mr Turner.

“Those at the top of Eli Lilly,” he states, “gambled with the lives of patients and the money of stockholders in equal bad faith when they engaged in fraudulent and dishonest behavior that allowed a dangerous drug to be marketed.”

“The lifeblood of a business,” he says, “is the investment that goes into it and in the case of Eli Lilly it means the investment of millions of shareholders.”

“Anyone who defrauds them,” he explains, “is defrauding people not business.”

Mr Tuner says it is easy to think of shareholders as “rich lazy fat cats” living off the efforts of others but it is fundamentally wrong by ethical standards to think that if they are defrauded that perhaps they deserve it. “What needs to be understood,” he says, “is that many millions of people who own no stock at all get defrauded in scams all the time.”

“Those who pay into pension funds,” he explains, “are vulnerable to the financial shenanigans not only of fund managers but of boards of companies and CEO’s that fail to police the companies activities or in some cases actively encourage fraud and reckless business practices.”

The worst of all legal nightmares resulting from the Zyprexa “shenanigans,” occurred over a period of 9 days between April 2, 2007 and April 11, 2007, when not one, but 4 shareholder class action lawsuits were announced against Lilly and “certain of its officers and directors” filed in the US District Court for the Eastern District of New York, for violations of the Securities and Exchange Act alleging that the defendants hid the side effects of Zyprexa and engaged in illegal off-label marketing campaigns.

On April 2, 2007, the Law Firm of Schiffrin Barroway Topaz & Kessler, issued a press release to announce that a class action was filed on behalf of all securities purchasers of Lilly from March 28, 2002 and December 22, 2006, charging the defendants with disseminating false and misleading statements regarding Zyprexa.

More specifically, it alleges that they were aware of a “clear link” between Zyprexa and diabetes; and yet failed to warn the public and engaged in an illicit scheme to offset a drop in sales that was certain to occur, and did occur, when reports of Zyprexa’s side effects emerged, by creating a marketing plan which included the evaluation and pursuit of sales for the drug based on “off-label” uses and that the off-label marketing program was a direct violation of Lilly’s own code of conduct.

The complaint further alleges that concealing the side effects and engaging in a massive illegal marketing campaign potentially subjected Lilly to substantial regulatory fines, penalties and other legal action, compromising the company’s overall financial condition and prospects.

The complaint reports that between 2002 and 2004, sales of Zyprexa grew from $3.69 billion to $4.42 billion, and that between July 18, 2002 and May 7, 2004, Lilly’s stock value increased from $43.75 per share to $76.95.

Throughout the class period, the lawsuit says, Lilly had information about the link between Zyprexa and extreme weight gain and diabetes and in the face of mounting research linking the drug to diabetes and weight gain, and the lawsuits filed by persons who developed these conditions, “Lilly emphatically denied any such link.”

The complaint alleges that when public warnings were issued about the safety of Zyprexa, sales slowed and between May 7, 2004 and October 25, 2004, stock prices dropped from $76.95 per share to $50.34, representing a loss of market capitalization of over $30 billion.

The press release cites reports in the New York Times between December 17 and 21, 2006, as disclosing for the “first time” that Lilly had engaged in a decade-long effort to play down the risks of Zyprexa; and actively marketed the drug for illegal off-label uses such as treating elderly patients with symptoms of dementia.

Therefore, the lawsuits alleges, the over $30 billion decline in stock value between May 7, 2004 and October 25, 2004 was the direct result of defendants’ fraudulent conduct.

In addition it says, the publication of the Times articles caused another $3.49, or 6.4%, decline in stock value and represented a further market loss of approximately $3.5 billion.

Two days after the first class action was announced, on April 5th, the Lerach Coughlin Stoia Geller Rudman & Robbins Law Firm announced that another had been filed.

The second complaint also charges Lilly and certain of its officers and directors with violations of the Securities Exchange Act, and alleges that at the beginning of the class period, defendants contended that Zyprexa did not cause diabetes-related side effects and that once the clinical data rendered that position untenable, defendants argued instead that Zyprexa did not cause any more side effects than its competitors.

Eventually, the press release notes, more and more clinical data showed that, in fact, Zyprexa does cause such side effects and to a greater extent than its competitors and the “revelations sharply curtailed the sales growth of Zyprexa and resulted in thousands of product liability lawsuits against Lilly and hundreds of millions of dollars in settlements.”

It also alleges that defendants intentionally suppressed and misrepresented data showing that Zyprexa causes weight gain, high blood sugar, and diabetes, citing the series of articles in the Times, with excerpted “documents detailing defendants’ deception.”

The release says the documents revealed that defendants intentionally misled patients, doctors, and investors and as a result, “the price of Lilly’s stock declined almost 6% in the five trading days during which the series of articles was published.”

The members of the class, it notes, invested in Lilly securities unaware that defendants’ fraud had artificially inflated the prices of those securities and when “the truth was finally revealed those investors lost many millions of dollars as a result of defendants’ fraud.”

Four days after the second lawsuit was announced, on April 9th, the Schatz Nobel Izard Law Firm announced the third case seeking class action status on behalf of all persons who purchased or otherwise acquired securities of Lilly between March 28, 2002 and December 22, 2006.

This lawsuit also alleges that the same defendants violated securities laws by making misleading statements and specifically that they “contended that Zyprexa did not cause diabetes-related side effects,” and later that, “Zyprexa did not cause more side effects than its competitors.”

This press release also quotes the Times articles as showing “that defendants intentionally misrepresented the side effects of Zyprexa,” and “suppressed and misrepresented data showing that Zyprexa causes weight gain, high blood sugar, and diabetes “

“In the five trading days during which the series of articles was published,” the press release advises, “the price of Lilly’s stock declined almost 6%.”

Two days later, on April 11th, the Harwood Feffer Law Firm announced a fourth class action accusing the same defendants of making misleading statements and specifically that they failed to disclose: (i) dangerous side-effects resulting from the use of Zyprexa; (ii) the decade-long illegal campaign to increase sales by marketing Zyprexa for off-label uses not approved by the FDA, in violation of FDA regulations that proscribe such marketing.

As a result of these fraudulent business practices, the press release states, sales of Zyprexa rose from $3.69 billion to $4.42 billion between 2002 and 2004, and the value of stock increased from $43.75 per share to $76.95, between July 18, 2002 and May 7, 2004.

The release says defendants had knowledge of a link between Zyprexa and extreme weight gain and diabetes and when sued by private individuals who developed these adverse effects, “the Company adamantly refused to acknowledge any wrongdoing.”

The Law Firm goes on to note that as public agencies raised warnings about Zyprexa, sales plummeted and stock price dropped from $76.95 per share to $50.34, between May 7, 2004 and October 25, 2004, amounting to a loss of market value of over $30 billion.

Subsequently, the press release alleges, after the Times published a series of articles the price of Lilly stock “collapsed” an additional $3.49 per share, or 6.4%, and amounted to a further loss of market value of approximately $3.5 billion.

Zyprexa was FDA approved for the limited use of treating adults with the most severe mental illnesses, schizophrenia and manic episodes of bipolar disorder, but it quickly became Lilly’s best selling product.

In order to find that Lilly did not make the drug its top seller by illegally promoting it for off-label uses, a jury would have to believe the highly unlikely scenario that doctors in every field of medicine came up with the idea of prescribing a schizophrenia drug to patients as young as 2 and as old as 100, for every kind of condition imaginable from anxiety and attention deficit disorder to autism and dementia.

On April 25, 2007, the New York Times reported that the FDA was examining whether Lilly provided the agency with accurate data about the side effects of Zyprexa. However, that may be a dead issue in light of the fact that on May 4, 2007, Lilly issued a press release of its own to announce that Alex Azar II will be joining the company as a senior vice president, who until February 3, 2007, just happened to be the Deputy Secretary of the US Health and Human Services Department.

According to Lilly, “Azar supervised all operations of the HHS, including the regulation of food and drugs,” and among others, agencies under his direction included the FDA.

April 2007 Big Pharma Litigation Update – Drugs – Part I

Evelyn Pringle April 5, 2007

For the last two decades, illegal drug marketing schemes have paid off well for Big Pharma. However, as the old saying goes, all good things must come to an end, and every major drug company is currently involved in massive litigation.

Some companies are facing thousands of lawsuits with a common complaint that the drug maker deliberately concealed the side effects of their products while illegally promoting the drugs for off-label use.

Off-label refers to prescribing drugs to treat conditions other than those approved by the FDA and listed on the label. It can include prescribing drugs to unapproved populations, such as children or the elderly, or in higher doses than specified on the label.

It is illegal for drug companies to promote a drug for off-label uses, but doctors are allowed to prescribe a drug for any use they choose. Almost without exception, the lawsuits currently pending accuse the pharmaceutical companies of influencing doctors to prescribe the product for unapproved uses.

On August 18, 2006, Bloomberg News reported that Wyeth has accumulated more than 175,000 lawsuits since the Fen-Phen diet combination was removed from the market after studies revealed that the drugs caused heart valve damage, and primary pulmonary hypertension, or PPH, a life-threatening lung disorder. All total, Wyeth has set aside more than $21 billion to cover legal costs and settlements since the drugs were withdrawn, according to Reuters on May 24, 2006.

There was a national class-action settlement involving claims for heart valve damage, but it did not include claims for PPH which are proving to be costly. In one 2004 case alone, a Texas jury awarded over $1 billion to the family of a woman who died of PPH after taking Fen-Phen for about two years, including $113.4 million in compensatory damages and $900 million in punitive damages, according to Wyeth’s 2005 Annual Report. The case was later settled for an undisclosed amount.

PPH is a life-threatening condition that can require a heart-lung transplant. According to the FDA, PPH “results in death in about 40% of affected individuals within 4 years.”

The Fen-Phen combination was never FDA approved for any use, which means every prescription was off-label. Patients were able to get Fen-Phen on the internet, and Jenny Craig and Nutri-System set up weight-loss programs where doctors would prescribe the drugs to customers.

And there appears to be no end in sight for Fen-Phen lawsuits. On December 5, 2006, five more women who took the drugs in 1996 and 1997, filed lawsuits against Wyeth after being diagnosed with PPH. When it comes to liability, a plaintiff’s attorney, Paul Rheingold, in “Fen-Phen and Redux: A Tale of Two Drugs,” says, “there is blame enough to go around.”

The doctors who set up store-front Fen-Phen clinics and prescribed the drugs are obvious culprits, he says, and so are drug companies that profited financially from the fad and may have neglected to pass on information about deadly side effects.

On August 18, 2006, Bloomberg reported that Wyeth was facing 5,000 lawsuits over the menopause drug, Prempro, alleging that Wyeth misled the plaintiffs through deceptive marketing about the cancer risks associated with estrogen and progestin. As many as 6 million women took Prempro before it was linked to cancer in a 2002 study.

Financial analysts are predicting that, Merck in the end, will pay out as much as $50 billion for Vioxx litigation. On March 12, 2007, Reuters reported that a New Jersey jury found the drug was responsible for a plaintiff’s heart attack and awarded $20 million in damages.

According to Reuters, the jury also found that Merck committed consumer fraud by making misrepresentations concerning the heart risks, and intentionally concealing safety information from doctors prior to the plaintiff’s heart attack.

A large number of lawsuits have also been filed against Merck, over the osteoporosis drug Fosamax, and against Johnson and Johnson, over the Ortho-Evra birth control patch. The plaintiff’s allege that Fosamax causes jaw-bone death (OJN) and that the patch causes blood clots, which in turn lead to strokes.

Legal experts predict causation in cases involving Fosamax and the Ortho patch will be easy to prove because the plaintiffs have what is referred to as a “signature disease,” meaning a condition easily tied to the drug because it is rare.

The jaw-bone death occurring in people taking Fosamax is extremely uncommon. Kenneth Hargreaves of the University of Texas, noted the increasing cases in the April 3, 2006 LA Times. “We’ve uncovered about 1,000 patients in the past six to nine months alone,” he said, “so the magnitude of the problem is just starting to be recognized.”

FDA approved in 1995, Fosamax is a relatively new drug, and unreported cases may be higher than expected because doctors may attribute the pain caused by ONJ to osteoporosis, according to Diane Wysowski of the FDA’s Office of Drug Safety.

Dr Salvatore Ruggiero, an oral surgeon and one of the first doctors to notice the rise in ONJ in 2001, told the Times, “Even though the chances of getting this are small, considering there are 23 million women taking this drug, we could be talking about a significant number of people.”

The same goes for the Ortho patch. Blood clots seldom develop in young women of childbearing age. And legal experts say, for that reason, many Ortho patch lawsuits have already ended in confidential settlements with hardly a peep in the mainstream press, and J&J has made it clear to other plaintiffs’ attorneys that the company is willing to cut a deal.

Experts predict that many more lawsuits will be filed because there are thousands of young patch victims who are still unaware that the patch caused the health problems. In 2005 alone, more than 9.4 million prescriptions were written for the Ortho patch, according to IMS Health, an industry-tracking firm.

The FDA says it has received about 9,000 reports of adverse events related to the patch, but the agency also acknowledges that only between 1% and 10% of adverse events are ever get reported.

There are over a hundred more lawsuits filed against J&J involving the Duragesic pain patch. The device is supposed to deliver controlled doses of fentanyl, a drug so powerful that high doses can turn off the respiratory center in the brain.

On July 8, 2006, the Associated Press reported that a Houston jury had awarded $772,500 to the daughter of a woman who died after a leak on the patch increased the dose of the painkiller, and the jury found J&J negligent in the way the patch was made.

Another fentanyl product that legal experts say will bring a wave of lawsuits in the next couple of years, is Cephalon’s painkilling lollipop, Actiq. The product was only approved to treat cancer patients in chronic pain who are already on an opioid drug, because life-threatening conditions can occur at any dose in patients without a built-up tolerance for opioids. But a recent study by Prime Therapeutics found Actiq is being prescribed off-label nearly 90% of the time.

Fentanyl is reportedly 80 times stronger than morphine, and is a Schedule II narcotic drug, in the same category as cocaine, opium, methamphetamine and methadone, a class known to have the highest potential for abuse and overdose.

In 2004, there were an estimated 8,000 emergency-room visits for fentanyl overdoses, according the US Substance Abuse and Mental Health Services Administration. Overdose can result in sudden death through respiratory arrest, cardiac arrest, severe respiratory depression, cardiovascular collapse or severe anaphylactic reaction, according to the agency. As of November 16, 2006, there were 653 deaths confirmed in the US since 2005.

In November 2006, the Wall Street Journal, said evidence obtained in litigation showed Cephalon had set high sales quotas for its sales representatives that could not be reached without promoting Actiq off-label.

Internal company documents show sales reps were regularly sent to doctors who treated no cancer patients, with free coupons for doctors to pass out to patients. According to the Journal, Dr Stephen Leighton, a general practitioner with only 3 cancer patients at any given time, said a Cephalon saleswoman stop by once a month and gave him about 60 to 70 coupons to pass out to patients for 6 Actiq lollipops.

He told the Journal that the coupons led him to try the drug for migraines and back pain and said he prescribes Actiq 15 to 20 times a month to patients who do not have cancer.

According to the November 3, 2006, report in the Journal, Actiq sales increased from $15 million in 2000, to more than $400 million today.

The consequences of the off-label prescribing of this product are far reaching. On January 22, 2006, the Free Press reported that the wife of a minister, a former schoolteacher and mother of three, was charged with involuntary manslaughter because she gave Actiq to a friend for a migraine, and the friend died of a drug overdose.

More lawsuits are sure to be filed against Eli Lilly since secret internal documents obtained in litigation by attorney, Jim Gottstein, from Dr David Egilman, an expert in previous Zyprexa litigation, prove that the company concealed Zyprexa’s link to severe weight gain, high blood sugar, and diabetes for a decade, while Lilly promoted the drug for so many off-label uses that more than 20 million people have taken Zyprexa.

To date, Eli Lilly has spent well over $1 billion to settle about 26,000 Zyprexa lawsuits, with still more litigants waiting in line. Zyprexa has been linked to serious side effects, including diabetes, hyperglycemia and pancreatitis.

On January 14, 2005, a class-action lawsuit was filed in Canada with claims that Lilly also withheld information on the safety of Prozac. The plaintiffs allege that the reason Lilly failed to disclose the documents was because they showed a drastic increase in suicide attempts and other violent acts in patients taking Prozac, when compared to patients taking 4 other drugs.

All through the 1990s, Lilly swore that Prozac did not increase the risk of suicide or violence, while the company was quietly settling lawsuits out of court which made it possible to keep the incriminating evidence hidden with court orders, just as it has been doing with Zyprexa until the secret documents showed up in the press in December 2006.

Similar lawsuits are being filed against AstraZeneca over its antipsychotic drug, Seroquel, which reportedly has been used by more than 16 million people since it came on the market in 1997. The plaintiffs in those cases also claim that Astra downplayed the diabetes risks and concealed safety information.