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Dan

Why Zyprexa Got Busted:

Not long ago, I got the joy and despair of viewing many documents that were initially not to be seen by those outside of the pharmaceutical company, Eli Lilly, which were located on a blog website called: www.furiousseasons.com. The documents contained information on how this company engaged in illegal activity on how they promoted and sold their drug, Zyprexa.
The documents are evidence of the illegal activities regarding Eli Lilly’s commercial activities with Zyprexa. The documents represent what appears to be a decade of deception involving Zyprexa, which is known as an atypical antipsychotic..
While a new a new molecular entity by definition, this new class called atypical antipsychotics in fact is biochemically similar to the older and typical anti-psychotics that exist already, such as Haldol, which were available over 50 years ago. In many ways, the older antipsychotics are safer as well as being similar in efficacy compared with the atypical antipsychotics such as Zyprexa.
Perhaps this is why Eli Lilly did the things they did because they knew Zyprexa caused perhaps more harm than good for those who took this medication.
Of the several available atypical anti-psychotics now available, Zyprexa and Clozaril, which was the first atypical anti-psychotic, are believed to have the most toxic adverse events to those who take these two in this class of medications.
Launched in 1996, Eli Lilly did not appear to consider the evidence regarding the adverse effects that may occur to those who take this drug. Eli Lilly should have exercised more caution regarding what may be harmful effects that could occur with Zyprexa..
As Eli Lilly operated with the apparent belief that this maker of Zyprexa is and will be exonerated from any responsibility related to this drug, the promotional campaigns for this drug were designed was implemented, and such campaigns have continued ever since.
Evidence of this is the company receiving a warning letter received by Lilly by the FDA dueto the false and misleading claims Lilly was making about Zyprexa less than 2 months after this drug was approved by the FDA.
At the time Zyprexa was granted approval for marketing, the medication was indicated only for schizophrenia and manic episodes of bipolar disorder. Schizophrenia has been defined as a disease that causes the sufferer to deviate from true reality, along with visual and auditory hallucinations.
Bipolar disorder is another mental disorder where the victim alternates from states of heightened neurokinetics to periods of what can be brutal depression for the sufferer.
Eli Lilly, known in recent years by many for their focus on marketing and profit over science or research, greatly desired, hoped, and expected that Zyprexa would be a welcome blockbuster for them. A blockbuster is a drug that eventually exceeds revenues of over a billion dollars a year.
And Eli Lilly appeared to have constructed the obedient and manipulated sales force presumed to be a necessity for this monetary goal to occur without interference. Yet in actuality, they created a sales force to break federal laws for Eli Lilly from at least the years of 1999 to 2003.
A note about pharmaceutical promotion: pharmaceutical representatives overall are attractive and young individuals with little if any medical knowledge or training, but are determined to have charming personalities along with a perception of obedience related to the pharmaceutical culture, and this is all Eli Lilly in particular wanted from the members of their sales force.
The sales vocation is normally associated to contain members with a high affinity for money, it is believed, so corruptive acts such as off label promotion or overt kickbacks are not typically a consideration of such people, overall, as history has shown.
Therefore, if Eli Lilly’s sales representatives who happen to be instructed to sell Zyprexa for dementia or depression, the orders will likely be followed by such promoters. Or if this sales force is instructed to pay specifically targeted doctors large amounts of money for doing little or no work for this money given to such doctors, it still is not a problem for the sales force to maintain their obedience to their corporate God.
This is the perception of not only myself, but many others as well. Plan of action meetings (POAs) are meetings that are held a few times a year by sizable pharmaceutical corporations to dispense orders to their sales representatives regarding the promotion of their drugs.
A few years after Eli Lilly launched Zyprexa, the maker appeared, according to documents, anxious due to their obvious disappointment regarding the initial prediction that was speculated about the growth of this drug. Zyprexa was not meeting the expectations of Eli Lilly, or their shareholders.
As a result, Eli Lilly implemented POA meetings throughout the nation and shared with the members of their sales force that there is fact a great benefit from a monetary paradigm when what are known as ‘seeding trials’ are implemented.
Seeding trials are not unique to Eli Lilly, as others view these trials as a mechanism for generating needed, although fabricated data void of any scientific gain of knowledge (this will be discussed later). Yet the trials often do gain revenue for the sponsors of these trials. By definition, a seeding trial is a bogus research element intended to achieve monetary gain, and not scientific gain.
This amazingly was done and implemented after such company meetings rather overtly. Even more unbelievable is that around this time was the fact that the Zyprexa sales force was instructed by Eli Lilly management to seek out clinical trial sites, along with investigators for these seeding trials.
Preferred by Eli Lilly was that the investigators had to either be Eli Lilly prescribing supporters or high volume prescribers. This protocol described was written internally, along with the etiology for performing these sham clinical trials. Anything in writing can be golden, from an illegal situation such as this.
In addition to the clinical trial plan of action of no scientific benefit identified, Eli Lilly instructed its sales force to utilize what was in fact inaccurate promotional material that Eli Lilly gave its Zyprexa sales representatives to be used on their sales calls without exception. Even though this material was largely if not entirely false and misleading, which was the intent of Eli Lilly, they encouraged their hired promoters that such material was entirely accurate and for their own monetary benefit.
To further saturate and corrupt the Zyprexa sales force, they were coerced by their employer to blunt assertively what are at this time widely recognized adverse effects of this medication, such as massive weight gain, along with glucose and lipid abnormalities- all of which are dangerous to the user of this medication.
The corrosive promotion of Zyprexa by Eli Lilly continued as this dangerous medical corporation continued their efforts by intentionally altering certain Zyprexa articles by essentially rewriting them- followed by being reviewed internally and not externally by those who are called, 'regulators'.
The purpose was to stimulate what Eli Lilly believed was clearly absent, which was much needed commercial interest related to Zyprexa. It unfortunately worked to a noticeable degree. This is according to information on what appears to be internal documents from Eli Lilly.
Then it came time to essentially buy benign support groups, if not create what are essentially front groups, in hopes that this would improve the growth of Zyprexa. One example is that Eli Lilly paid the American Diabetes Association for their assistance in obtaining endocrinologist consultants, which is a medical specialty that treats, among other things, diabetes.
To reduce any possibility of an unexpected contingency doing this, they went ahead and hired a good sized team of diabetes educators. In 1999, Eli Lilly altered a Zyprexa report that originally illustrated the glucose problem with the medication, and did so with deliberate intent and reckless disregard for others. Eventually, the American Diabetes Association became quite the critic of Eli Lilly because of their harmful behavior regarding their promotion of Zyprexa.
The next related psychotic tactic (pun somewhat intended) Eli Lilly created was an advisory board paid well by this company to focus on the progressing concerns of Zyprexa. This tactic did work briefly, but did not change the view of the drug by the medical community in any way perceptually regarding their embellished drug.
Understandably, the health care professionals in the medical community began to get vexed and irritated by Eli Lilly’s deceptive and overtly destructive promotional tactics regarding Zyprexa- which included the company’s own speakers that were utilized in the past expressing concerns to members of this organization responsible for those who prescribed and took Zyprexa As a result, Eli Lilly was possibly being ostracized from the medial community because of their behavior in their community. This behavior illustrated a reckless disregard for the health and well-being of others, and their actions that were harmful were done so with deliberate intent.
Perhaps most disturbing and harmful was the Eli Lilly's intentional holding of crucial safety information related to Zyprexa even before the drug was even approved, apparently. For example, Eli Lilly’s Zyprexa representatives were instructed without doubt to neutralize the legitimate concerns doctors may have about Zyprexa, if not outright fear regarding this deadly drug they now perceived as being a clear reality by health care providers.
The representatives were in agreement of continuing to dodge or neutralize legitimate concerns about Zyprexa. The agreement was perhaps a result of the promise of Eli Lilly’s management team to fill their wallets more if they maintain obedience regarding this directive. What was not considered is that such directives ignored the possible harm to others who may take Zyprexa prescribed to them.
Essentially, the Zyprexa representatives with Eli Lilly were trained in a very assertive manner to continue to disarm any negative perceptions about zyprexa. Eventually, these orders by Eli Lilly began to deeply trouble several of their sales reps. Most of their sales reps at this point were aware of the dangers of the drug they continued to promote to presribers. And they only did so to maintain employment that provided them with benefits rare in any other vocational environment. .
The off label claims of the benefits of Zyprexa in those patients with such disorders as depression or dementia were viewed rather passively by Eli Lilly. They appeared to consider such criminal acts as off label promotion as ‘redefining the market’. This is yet another example of their absurdity. The overt demonstration of profits over patients is clearly absurd and inexcusable in any situation- especially perhaps when there is a higher danger element with a drug like zyprexa for those who take this drug.
In the year 2000, Eli Lilly greatly expanded what was called their long term care sales force to increase the utilization of Zyprexa intake in the elderly. The expansion resulted in an addition of nearly 200 long term specialty sales representatives. This patient population prescribed Zyprexa can be deadly- as Zyprexa is harmful to older citizens- specifically pneumonia and eventual premature death result from Zyprexa intake with elderly patients.
The intent was to promote Zyprexa for those certain elderly patients with dementia and Alzheimer’s disease, as a set of symptoms are thought to occur in such patients called, “Sunshiner’s syndrome- which includes elevated agitation and confusion in such patients in the evening hours primarily. The syndrome is vague and non-specific with unknown etiology, yet the intent was to sedate such patients with Zyprexa for this syndrome.
Furthermore, the purpose was to have Zyprexa to be used in these patients to sedate them, a process known as 'snowing'. As a result, each long term care Lilly sales representative increased revenues for their employer more than other sales representatives in different divisions within the organization.
Yet in the year 2002, Eli Lilly was having financial disappointments, which again did not shock many outside of the organization. So to stay in form, they went on a mission to develop speakers to align with them and to not educate others, but to pacify other doctors in hopes that their problems with Zyprexa would disappear.
After the speaker episode, Eli Lilly had the audacity to claim that Zyprexa was indeed the best in the class of atypical antipsychotics. Such a statement appears ironically psychotic, to say the least. And now the market for atypicals is about 5 billion a year, so there seemed to be no end as to what Eli Lilly might try next. Also in this year our FDA apparently at one point referred to Eli Lilly as one of the FDA’s ‘sponsor’. I find that a bit disturbing. As disturbing as the covert meetings Eli Lilly had with the FDA as well, it is believed.
As the new millennium progressed over the next few years, lawsuits became a concern for Eli Lilly regarding Zyprexa. Doing what any responsible corporate entity would most certainly do, the upper management of Eli Lilly had the audacity to blame the media for the way they handled their drug Zyprexa.
Around this time, Eli Lilly needed and did hire a public relations firm because of their image crisis that was likely well-deserved. About this same time, Eli Lilly implemented a nationwide program entitled, “Operation: Restore Confidence”.
I’m not sure how a fully rational and conscious group of Eli Lilly people could create something so ridiculous and unrealistic considering what has materialized due to their crimes. Equally deviating from reality of Eli Lilly’s behavior is that they actually thought they could increase Zyprexa growth by hammering home astronomical efficacy of Zyprexa and continue on the path they have created.
Another failure to add to what has been annotated so far was when Eli Lilly hired an organization called Lifespan Marketing, who colluded with Eli Lilly to create a brand new market establishing Zyprexa as the standard of care. Maybe Eli Lilly needs to adopt a standard of care for itself. This, it is understood, was largely ineffective.
At least one human insider within Eli Lilly wanted to let everyone know he did not, nor will he ever, forget his experience as a Zyprexa representative with Eli Lilly for years. His name is Shahram Ahari, and he aligned with a non-profit advocacy group called Pharmedout after this experience, which was created due to a state settlement from another pharmaceutical company's wrongdoing.
Sharam spends his days now making others aware of things such as what you have read so far. I’ve spoken with Shahram, and I admire his assistance with others trying to correct this medical mess. He sacrificed much, and continues to do so.
At about the same time, Eli Lilly determined that primary care doctors should be their number one Zyprexa targets for increasing the growth of their drug. With this new focus, the sales force for Zyprexa were somehow convinced to tell doctors that fatigue is really the only side effect that presents itself with Zyprexa use by their patients, which of course is false. Again, citizens are overall not catatonic about such actions if they are aware of them with understanding.
Furthermore, Eli Lilly’s sales force were directed to speak of the symptom relief provided by zyprexa only, and not the disease states for which zyprexa treats. The reason for this is that, usually, primary care physicians are not comfortable diagnosing others with complex mental disorders such as psychosis or schitzophrenia.
While on this off label role with Zyprexa combined with being void of fair balance regarding presenting this drug to others, Eli Lilly attempted to revive their long term care efforts by taking on Aricept, and Alzheimer’s drug, and encouraged others to switch to Zyprexa. The reaction for this misbehavior was Zyprexa being removed from Medicaid in 2004, according to documents that are authentic, and are available to others.
While Lilly filed with the FDA an indication for Alzheimer’s disease as well as dementia, Zyprexa lacked the evidence to prove that this drug did more good than harm for such patients, and did not get the indications they applied for with the FDA.
Allan Reier was the Zyprexa product team leader at one point for this drug. He may have developed the unbelievable strategy of visiting psychiatrists to assure them they will not be sued if they prescribe Zyprexa for their patients. Literature and documents prove this strategy was implemented. That in itself illustrates the concern Lilly had about Zyprexa.
So, now we are at a point where Eli Lilly had a flash of reality once again and preferred no media contact. Gosh, what a surprise. There was also the disclosure of Eli Lilly continuing to create, if not fund, the deceptive front groups to screen others in order to sell more Zyprexa as well.
The next tactical plan from Eli Lilly was to re-implement those adverse events blunting techniques regarding Zyprexa. My guess is that they dragged this into a week- long meeting with their sales force. This of course included dodging concerns by doctors that they are normally encouraged to partner with, historically.
Such tactical plans of action were associated with such clever names as, ‘Viva Zyprexa’, or Zyprexa Limitless”. Maybe the next one will be ‘Zyprexa Revenue Regression’. Zyprexa for atrophy, maybe?
Another tactic authorized by Eli Lilly was to use those bonafide contract research organizations (CROs) to manufacture safety, health, and outcomes database studies. A deceptive publication plan followed. CROs are hired by such pharmaceutical companies as Eli Lilly to conduct the seeding trials mentioned earlier. Here is the definition of CROs:
CROs are commercial research organizations that include often what may be substandard research investigators to work with the sponsor of such clinical trials. Eli Lilly, as a sponsor, has the ability to alter aspects of such trials for their own benefit. This was done- as they still encouraged as a result children to consume Zyprexa- near a million of them involved due to an arrangement that Zyprexa will be promoted by Lilly’s ADD drug Strattera.
As stated earlier, previously sealed and damaging documents got exposed at the end of 2006, and are accessible on the internet and some websites, such as www.furiousseasons.com, which is what this article is based upon, overall, these internal documents that appear to be authentic.
Perhaps the documents should have been exposed immediately instead of being held from public view. Perhaps prosecutors should not keep such information from others due to a collusive relationship with such corporations. One may only speculate as to why this occurs.
Eli Lilly makes over 4 billion dollars a year on Zyprexa, and has made close to 40 billion dollars on their drug so far. The company is frequently positively reinforced to fracture federal laws and cause harm to others, because it proves profitable for the organization.
Eli Lilly has had to pay well over a billion dollars for Zyprexa and the damage this drug has caused others between 2006 and 2007. The company recently paid the largest one-time payment to settle accusations of their wrongdoing regarding Zyprexa at nearly 1.5 billion dollars- with pending cases involving over half of the United States. I'm sad to say I'm unconvinced this will change their behavior regarding their tactics. Cynical, perhaps I am. History proves this is often the case:
"We deeply regret the past actions covered by the misdemeanor plea (1.4 billion dollar settlement with the DOJ). At Lilly, we take seriously our responsibilities to abide by all the laws governing our business practices, and we realize that we have a tremendous responsibility to the patients and healthcare professionals we serve. Every day and with every interaction we strive to operate in a responsible and compliant manner. Doing the right thing is non-negotiable at Lilly, and I remain personally committed to all of us at Lilly maintaining the highest standards of conduct. The company's comprehensive compliance program is an embedded part of the company's culture. These are not just words to us- we continue to implement a range of programs and policies to help ensure that we operate in a manner consistent with all applicable laws and regulations. These programs apply to all parts of our business, and all of our employees are aware of the imperative for them to be models of compliance and of ethical behavior."
------ John C. Lechleiter, C.E.O., Eli Lilly
Psychosis-
One with a personality disorder manifested in aggressive, perverted, criminal, or amoral behavior without empathy or remorse.
Dan Abshear
Author’s note: What has been written is based upon information and belief.

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