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Tuesday, January 27, 2009

The Zyprexa Settlement and The Perils of Primary Care

We have been writing for some time about Big Pharma's primary care problem: the industry is built on an incredibly lucrative business model--selling oral medications for use by millions of patients with chronic conditions--that is going away before our eyes.

The primary care market is shrinking. The regulatory system is tilting towards smaller, niche market opportunities. The infrastructure built to support the blockbusters of yore is choking the industry. And the imperative to develop the next Lipitor is surely one reason behind the staggering lack of productivity in Big Pharma R&D.

Well, here's something you might not have realized. Apparently Big Pharma's incredible success in building massive primary care markets can now be painted as criminal conduct. That, at least, seems to be one implication from Lilly's record-setting $1.4 billion settlement agreement to resolve an investigation into its marketing of the antipsychotic Zyprexa. [UPDATE: of course records are meant to be broken, right? Pfizer's $2.3 billion Bextra settlement, astutely camoflaged by the Wyeth takeover, now takes that dubious honor.]

According to the government's memorandum supporting the entry of guilty plea by Lilly, a key element of the off-label promotion at issue was a decision by Lilly to "market Zyprexa to primary care physicians, even though there was almost no on-label use for Zyprexa in this market."

Here are some excerpts from the memo. (NB: These are described in the memo as facts that Lilly agrees would have been proven at trial.)

“Eli Lilly commissioned a report entitled ‘The Primary Care Opportunity’ from a nationally-known consulting firm. This report found that ‘larger competitors [eg. Merck, Pfizer, Bristol Myers] are migrating toward the primary care channel with drugs driven by profile improvements’ as compared to Eli Lilly, which was headed in the direction of providing drugs in specialty markets. The consulting firm advised Eli Lilly that ‘Primary care is a large opportunity that is likely to remain important. Lilly does not outperform its competitors in primary care and is leaving money on the able with current and pipeline products.’ The report identified Eli Lilly products, including Zyprexa, that if sold in the ‘primary care channel’ could significantly increase Eli Lilly's woridwide sales....

"The evidence would show that in October 2000, Eli Lilly began to detail Zyprexa to PCPs even though at least one internal Eli Lilly document acknowledged that there was virtually no on-label use for Zyprexa in the primary care market. The document, ‘ZYPREXA – Primary Care Strategy and Implementation Overview,’ provided that detailing PCPs was a major challenge because ‘Zyprexa's primary indications - schizophrenia and bipolar - are not viewed as PCP [primary care physician]-treated conditions, so there's not a specific indication for Lilly reps to promote in the PCP segment.'

"To get around the impediment that Zyprexa's indications - schizophrenia and bipolar mania - were not viewed as PCP-treated conditions, sales representatives were instructed to tout Zyprexa as a safe option for the treatment of a wide array of mood disorders commonly treated by PCPs....

"According to an internal newsletter, Eli Lilly USA Online, published on July 25, 2001, the launch of Zyprexa into primary care was a huge success."

2 comments:

Anonymous said...

Zyprexa: Anything In Writing Is Golden

Not long ago, I got the joy and despair of viewing many documents that were initially not to be seen, by order of the Department of Justice, yet found their way on various locations on the internet- specifically, the website: www.furiousseasons.com. The documents are, or were, in fact, evidence against Eli Lilly entirely representing their decade of deception promoting and over-medicating others with their drug called Zyprexa, which is in a class of medications called atypical anti-psychotics. While a new a new molecular entity by definition, this new class called atypical antipsychotics in fact is chemically similar to the older and typical anti-psychotics that existed, 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 atypicals 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 the 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, yet it is believed that there was reason to state by Lilly that there should be caution regarding the use of Zyprexa in those patients prescribed this drug. With the belief that the maker of Zyprexa is and will be exonerated from any responsibility related to this drug, the promotional campaign was implemented, and has continued ever since. Evidence of this is a warning letter received by Lilly by the FDA as a warning due to 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 mania that exists in those with 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 over science or research, greatly desired and hoped that Zyprexa would be a welcome blockbuster for them, which is a medication that exceeds a billion dollars a year in sales as a minimum. 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 law 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 is 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 that was not meeting their expectations, so they had 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 of implementing ‘seeding trials’, as they are a mechanism for generating needed, although fabricated data void of any scientific gain of knowledge (this will be discussed later). This amazingly was done and implemented afterwards rather overtly. Even more unbelievable is that around this time, the Zyprexa sales force was instructed by Eli Lilly management to seek out clinical trial sites, along with investigators for these 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. To further saturate and corrupt the Zyprexa sales force, they were coerced 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 what appear 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 Zyprexa.
A speculative thought regarding the freedom if not acceptance for this type of promotional behavior: there exists amazing alliances between Eli Lilly and the Bush administration have existed as well. George H.W. Bush became an Eli Lilly director after leaving the CIA and lobbied to infect third world countries with Lilly medications. He also did his best to maximize tax breaks further for this industry that now employs both himself and his political affiliation. In fact, many members of this administration have some connection with Eli Lilly. It seems to be a revolving door issue once again. One could speculate that the Zyprexa campaign continued for so long because of the relationships the maker of the drug had and has with other powerful people.
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 overtly. Such events materializing resulted in many ways Eli Lilly being ostracized was because of their disregard for those they are obligated to serve in the medical community, which are those in need of restoration of their health.
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. 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. The representatives were in agreement of continuing to dodge or neutralize legitimate concerns about Zyprexa, with the promise of Eli Lilly’s management team to fill their wallets more if they maintain obedience regarding this directive that caused harm in the form of such physiological disorders as metabolic syndrome associated with Zyprexa, yet the sales force still denied the association due to the insistence of their employer. Essentially, the Zyprexa representatives with Eli Lilly were trained, perhaps aggressively, to disarm negative perceptions about Zyprexa, even though these perceptions continuously proved to be valid. This deeply troubled many Zyprexa representatives, as at this point they were aware of the dangers of the drug they were promoting, yet likely continued to do so in order to maintain employment.
Also, and of no great surprise, off label promotion with Zyprexa if not other products by Eli Lilly was a norm within the organization and certainly encouraged by Eli Lilly's management team. Encouraging doctors to prescribe Zyprexa for unapproved FDA indications are an example. Amazingly, reflecting back on the behavioral flaws by Eli Lilly for quite some time, they did not alter their method of business even though there was a strong perception regarding this company being both aggressive and greedy, and likely criminal in the way they chose to conduct their business. And depression was not the only off label claim with Zyprexa. Eli Lilly considered 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.
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 to nearly 200 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 in this patient population. 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. 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 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 called Eli Lilly ‘a sponsor’. I find that a bit disturbing. As disturbing as the covert meetings Eli Lilly had with the FDA as well.
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.
Eli Lilly appears pathologically persistent in frightening ways: next was a national implementation plan of action which focused on training the Zyprexa sales force to use what was called a J.C.P. study to emphasize the numerous off label benefits of Zyprexa. At 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.
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.
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 has about Zyprexa.
So, now we are at a point where Eli Lilly had a flash of reality 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 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 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.
Eli Lilly has had to pay well over a billion dollars for Zyprexa damage to 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.

Daniel Haszard said...

Zyprexa claims being stonewalled

Where is the $1.42 billion Eli Lily Zyprexa settlement going as many victim claimants haven't been paid yet? It's the largest pharma-fraud-whistleblower case in US history.

Whoa,how are they going to defend themselves from little ole me?
They have three certified letters from me substantiating my claim. I am a classic case for compensation having taken the stuff for four years (for off-label PTSD). I paid thousands of dollars out of my own pocket in co-payments for the Zyprexa which gave me sudden onset diabetes in 2000 with a deadly A1C of 14.2 all documented at my site.

Eli Lilly has up to 250 lawyers just on their payroll in Indy; they have NEVER contacted me except in 2005 to get a release of my medical records. My doctor says, (get this) they never contacted him to verify the information.
There must be millions out there harmed by this drug.

Daniel Haszard