Friday, January 16, 2009

Zyprexa: Lilly Admits Guilt, But Also Blame Physicians

In February 2007, I wrote a post in which I described evidence that Lilly's antipsychotic olanzapine (Zyprexa) was marketed off-label for dementia. The evidence I discussed was based on documents generously and bravely hosted at Furious Seasons. At the time, I was careful to avoid labeling the practices as illegal -- they were definitely unethical but I couldn't really say for sure what if a law was broken. However, a law firm known to represent Lilly was regularly visiting my website at the time, which made me think that Lilly was seriously concerned about legal troubles. I suppose they had good reason to be worried.

I can now officially say that the off-label marketing of Zyprexa for dementia was criminal. Lilly just admitted to committing a crime in the off-label marketing of the drug for dementia and settled legal charges for a cool $1.4 billion. And there are more cases still on the books.

For a really interesting take on this situation, listen to New York Times reporter Gardiner Harris. You can find his talk embedded in the New York Times story from January 14, 2009, which is linked here. The plea agreement in the latest case is available here.

It is important to remember that pimping Zyprexa for dementia is far from a victimless crime. Antipsychotics, including Zyprexa, have been linked to an increased rate of death in elderly patients and have also been shown to be of little to no more benefit than a placebo in reducing dementia-related symptoms (1, 2). For a disturbing account of the widespread inappropriate use of such medications, read this post and weep.

This is truly a case where lust for profits likely led to the early demise of who-knows-how-many patients. And we're just talking about dementia, not the other cases where Lilly went berzerk with marketing Zyprexa (1, 2).

Blame the Physicians Too: While much of the blame for the overuse of antipsychotics in the elderly can be placed on corporations such as Lilly, it is also true that Lilly does not directly administer the drugs. Physicians need to understand that prescribing drugs which have been found to offer little benefit but are linked to killing patients -- how is that legitimately practicing medicine? First, do no harm?? Yes, I know that dementia is a hell of a difficult condition to handle. But does that mean we should be doling out ineffective and potentially deadly treatments to "manage" persons with dementia. Yes, reps from Lilly (and likely others) wined and dined physicians, "educating" them about the benefits of Zyprexa and other antipsychotics. That's their job -- to positively spin their products. No different than a used car salesperson except that drug reps are typically much better looking.

Doctors need to use critical thinking skills -- you don't just listen to a drug rep or skim a drug-company provided journal article reprint then jump on the Zyprexa bandwagon. How about learning how to evaluate evidence so that junky marketing disguised as science does not persuade you to write inappropriate scripts? Yes, we can be outraged that Lilly and others pimp ineffective and dangerous treatments, but the physicians are the most important link. If they cannot be better educated to understand clinical trial results, and cannot take time to critically review the scientific literature, then this pattern will repeat itself over and over again. It takes tricky pharmaceutical marketing in combination with an audience that is unwilling to think critically for this type of tragedy to occur. And occur again, it will.

Unfortunately, the published scientific literature is quite biased, as negative studies tend to vanish rather than grace the pages of our journals. But it's still a much better idea for prescribers to actually read journals and critically examine their findings, as opposed to relying on marketing alone. Better yet would be for research data on medications (negative and positive) to be available for all to see.

6 comments:

Bernard Carroll said...

One way for physicians to respond to these criminal pleas by corporations would be to deny the corporations access to professional medical organizations and meetings. So, no more Lilly presence at the annual meeting of the American Psychiatric Association for the duration of its 5-year probation under a federal monitor’s review. Likewise, no more Lilly sponsorship of any APA-related CME programs. And while we are at it, how about a 5-year suspension of Lilly’s corporate membership in the American College of Neuropsychopharmacology? That will get their attention.

Here is an issue on which the fearless leaders of our professional societies have an opportunity to demonstrate that they are not just chocolate soldiers.

But don't hold your breath -- Alan Schatzberg, the incoming president of the APA is in very tight with Lilly as a consultant and as a recipient of Lilly grant funding to his corporation.

Bernard Carroll

Anonymous said...

Zyprexa- And Promotion
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 believe 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.
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.
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.
Allan Reier was the Zyprexa product team leader at this time. 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.

Anonymous said...

I believe the harm was both to the elderly and children with zyprexa. with the elderly, alzheimers and dementia were targeted, as they apparently experience some sort ofsunshiner's syndrome- particularly in the evening at night. symptoms of agitation and restlessness. May be a circadian thing. Yet a syndrome, which is just a group of symptoms. medications could cause the same effect. zyprexa can be harmful if not deadly in the elderly population. LTC Lilly reps generated more revenue for their employer than any other sales division within the organization. their number of reps with LTC approached 200. the cruelness is the sedation of both elderly and children with a potent drug with devastating side effects. And I become ill if I speak with the use of Zyprexa with children. Lilly did this with deliberate intent and reckless disregard. And forced subordinates to perform their marketing objectives. their overtness in their tactics may indicate psychopathic tendencies

therapyfirst said...

A little sunshine for my weekend. I just hope this spreads to Astra Zeneca and Bristol Meyers for Zyprexa's cousins Seroquel and Abilify. These two companies' marketing is beginning to somewhat put Lilly to shame.

Depression? Anxiety? I hope we can read about these bastards being caught marketing antipsychotics for an indication so off base, the fines could close down a company.

We can dream, right?

Daniel Haszard said...

Eli Lilly: Indy-based pharmaceutical company pleads guilty to promoting Zyprexa for unapproved uses; is slapped with $1.4 billion criminal fine, the largest ever placed on a U.S. company.

Zyprexa Claims being Stonewalled.
Where is the money going as many victim claimants haven't been paid yet?

Something fishy going on here?


Conflict of interest.

Eli Lilly promotes sales of their #1 drug (Zyprexa $4.8 billion year) that can *cause* diabetes and then turn around and make billions selling more drugs to treat the diabetes.


Eli Lilly's # 1 cash cow Zyprexa has been overprescribed and linked to a ten times greater risk of causing type #2 diabetes and increased risk of heart attacks.

Daniel Haszard Zyprexa patient who got the diabetes from it.
www.zyprexa-victims.com

Stephany said...

I'd like to see prison time for those who are behind the marketing of Zyprexa in 1999, the year my daughter was placed on it at age 11,and her psych would tell her to take walks and stop drinking sodas (in the Zyprexa documents)because she was gaining weight (gained 100 pounds!)when she did not even drink sodas! It's complete and total disregard for human life, these ppl should be prosecuted, not slapped on the hand with a monetary fine.

Yes, I hope AstraZeneca is next. Off-label use samples were given to me in 2006 for insomnia and anxiety. It's an antipsychotic!