Pure Pedantry

Yet again, a drug company is playing damage control for failing to come clean about a drug’s side effects. It makes me so mad when companies do stuff like this because it is such a preventable problem. In this case, the drug in question is Zyprexa (olanzapine) — presently one of the go-to drugs for the treatment of schizophrenia — and the company in question is Eli Lilly:

The drug maker Eli Lilly has engaged in a decade-long effort to play down the health risks of Zyprexa, its best-selling medication for schizophrenia, according to hundreds of internal Lilly documents and e-mail messages among top company managers.

The documents, given to The Times by a lawyer representing mentally ill patients, show that Lilly executives kept important information from doctors about Zyprexa’s links to obesity and its tendency to raise blood sugar — both known risk factors for diabetes.

Lilly’s own published data, which it told its sales representatives to play down in conversations with doctors, has shown that 30 percent of patients taking Zyprexa gain 22 pounds or more after a year on the drug, and some patients have reported gaining 100 pounds or more. But Lilly was concerned that Zyprexa’s sales would be hurt if the company was more forthright about the fact that the drug might cause unmanageable weight gain or diabetes, according to the documents, which cover the period 1995 to 2004.

Zyprexa has become by far Lilly’s best-selling product, with sales of $4.2 billion last year, when about two million people worldwide took the drug.

In 2000, a group of diabetes doctors that Lilly had retained to consider potential links between Zyprexa and diabetes warned the company that “unless we come clean on this, it could get much more serious than we might anticipate,” according to an e-mail message from one Lilly manager to another.

And in that year and 2001, the documents show, Lilly’s own marketing research found that psychiatrists were consistently saying that many more of their patients developed high blood sugar or diabetes while taking Zyprexa than other antipsychotic drugs.

The documents were collected as part of lawsuits on behalf of mentally ill patients against the company. Last year, Lilly agreed to pay $750 million to settle suits by 8,000 people who claimed they developed diabetes or other medical problems after taking Zyprexa. Thousands more suits against the company are pending.

On Friday, in its written response, Lilly said that it believed that Zyprexa remained an important treatment for patients with schizophrenia and bipolar disorder. The company said it had given the Food and Drug Administration all its data from clinical trials and reports of adverse events, as it is legally required to do. Lilly also said it shared data from literature reviews and large studies of Zyprexa’s real-world use.

“In summary, there is no scientific evidence establishing that Zyprexa causes diabetes,” the company said. (Emphasis mine.)

I have a one word response to that: horseshit.

The suggestion that the Zyprexa is not correlated with obesity and by extension diabetes requires sticking your fingers in your ears and going la-la-la-la to the outcome of nearly every patient who takes the drug. Later in the article, they analogize Zyprexa to Vioxx. I take issue with that analogy because the cardiovascular side effects of Vioxx were exceedingly rare events. Zyprexa causing weight gain and diabetes isn’t rare. It is a side effect so common that they make you memorize it in medical school pharmacology courses. That is the definition of common as I understand it.

What is so frustrating about this is that it didn’t need to be this way. What would have happened if Lilly had done the right thing and told the patients and doctors the truth?

I assert that would have done little or nothing to hurt sales. Zyprexa is an atypical antipsychotic. Atypicals were developed because earlier anti-psychotics have side effects that are even worse than diabetes — like tardive dyskinesia. Given the choice between this and side effects that are even worse, doctors are going to pick the drug that has the best outcome even if that drug can give you spectacular weight gain.

When are drug companies going to learn that you make way more money in the long run by being honest. By being dishonest, you are risking huge litigation to prevent side effects from being known that in most cases are not fatal to sales. I don’t necessarily agree with all the litigation that is going on, but you know that you are opening yourself up to lawsuits when you behave like this.

When it comes to fights over drug pricing, I tend to argue that drug companies should be able to charge what they want. When they do stuff like this, it makes it more and more difficult to argue for an unregulated drug market. Therefore, drug companies who do this not only hurt themselves — they hurt the entire industry.

Comments

  1. #1 natural cynic
    December 18, 2006

    Lilly shouldn’t have waited so long to ‘fess up about this. However, among many people [psychiatrists] this should have been *common knowledge*. The American Diabetes Assn. has had warnings about antipsychotics and other psych meds for some time and has info for MDs that commonly treat diabetes about them.

  2. #2 Stephen
    December 21, 2006

    How long ago was Lilly supposed to have been concealing this information? In the Wayback archives, as far back as 2003, I find warnings on the official Zyprexa website that the medication’s side effects include weight gain. In the warnings section on the drug information sheet, the first two sections are about hyperglycemia and diabetes and increased risk of death in elderly patients with dementia. It doesn’t look like anything was being hidden.

  3. #3 Daniel Haszard
    December 28, 2006

    At a glance,zyprexa was promoted ‘off label’ to uses that weren’t FDA approved.This opens up a can of worms for patients like myself took it for PTSD for which it was ineffective and moreover gave me diabetes.

    True,leaked documents don’t convey the ‘whole picture’ but what is compelling is that zyprexa is the 7th some say 5th largest drug sell in the world and Eli Lilly’s #1 drug sale by their own admission.
    This is for a drug that won’t get you “high” cost $2.50 a pill and only indicated for less than 1% of the population.

    Hello! Somebody in Lilly land is pushing zyprexa hard-Daniel Haszard

  4. #4 Dan
    September 29, 2008

    Eli Lilly’s Wrongdoing Illustrates The Real Dangers of Anti-Psychotics

    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: http://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 that, while a new molecular entity by definition, are in fact chemically similar to the older and typical anti-psychotiics, such as Haldol, which have proven to be safer than the new class that appears to be quite damaging to those who ingest these atypical antipsychotics. Of the several available atypical anti-psychotics now available, Zyprexa and Clozaril, which was the first atypical anti-psychotic, are believed to be the most adverse to the consumer of these medications compared with other medications in this class of drugs.

    Launched in 1996, Eli Lilly did not appear to consider any 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 its use. With the belief that the maker of Zyprexa is and will be exonerated from any responsibility related to Zyprexa, many surmise that Eli Lilly was pleased that others were taking Zyprexa , and was confident that they would be exonerated from any responsibility from the adverse effects of the drug.
    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 for their focus on marketing over science or research, greatly desired and hoped that Zyprexa would be a welcome blockbuster, which is a medication that exceeds a billion dollars a year in sales as a minimum. Likely because of this state of greed of Eli Lilly, they did not consider or evaluate any possible damage this flagship drug may cause others. And Eli Lilly appeared to have the obedient and manipulated sales force presumed to be a necessity for this monetary goal to occur without interference.

    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, 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, 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. 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.
    A few years after Eli Lilly launched Zyprexa, they appeared 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 meetings throughout the nation, known as ‘plan of action’ meetings, and concluded afterwards that there is 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 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. One voiced stipulation 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, Eli Lilly instructed its sales force to utilize inaccurate promotional material that Eli Lilly gave its Zyprexa reps without exception, even though this material was false and misleading, which was the intent of Eli Lilly, according to others, along with this material being greatly unbalanced and suggested uses for Zyprexa that were not indicated if not unproven, which can and has been harmful to patients because of this. 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 the dangerous company intentionally altered certain Zyprexa articles by rewriting them, followed by being reviewed internally after this art work. The purpose was to stimulate what Eli Lilly believed was clearly absent, which was much needed commercial interest related to Zyprexa.

    Then it came time to essentially buy benign support 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.

    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 psychotic tactic 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, or the maker of this drug.

    It is at this point that the medical community began to get vexed and irritated by Eli Lilly’s deceptive and overtly destructive tactics, which included the company’s own speakers that were utilized in the past. This event of Eli Lilly being ostracized was because of their disregard for those they are obligated to serve in the medical community. Perhaps most disturbing was the company’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 in order to maintain employment.

    Also, and of no great surprise, off label promotion with Zyprexa was a norm within the organization and certainly encouraged by Eli Lilly management. Encouraging doctors to prescribe Zyprexa for depression is one 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’. Another example of their absurdity:

    In the year 2000, Eli Lilly greatly expanded what was called their long term care sales force to expand Zyprexa intake in the elderly. This, as a reminder, is dangerous, as Zyprexa is harmful to older citizens- specifically pneumonia and eventual premature death result from Zyprexa intake. At the same time, Eli Lilly developed a strategy to neutralize the obvious weight gain associated with Zyprexa with other patient populations. Does the whole corporation believe U.S. citizens are without thought or intelligence?

    Yet in 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. Well, if you are going to have a friend….. or friends, as around this time, Eli Lilly also bribed select reporters to speak or annotate favorably about Zyprexa, and they did.

    As the new millennium progressed over a 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 patients. Around this time, Eli Lilly needed and did hire a public relations firm because of their image crisis. About the 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. Equally deviating from reality of Eli Lilly’s behavior is that they actually thought they could increase Zyprexa growth by hammering home astronomical efficacy with the drug which, of course, does not outweigh the damage of the drug to the patient who takes it.
    Another failure illustrated above caused Eli Lilly to hire a group called Lifeplan Marketing, who convinced the organization to create a brand new market establishing Zyprexa as the standard of care. Another psychotic act by this Midwest group of manipulators who were at one time a well respected pharmaceutical corporation. Humans do not forget. Especially pain.

    At least one human wanted to let everyone know he did not, nor will he ever forget his experience as a Zyprexa representative with Eli Lilly. His name is Shahram Ahari and he aligned with a group called Pharmedout, which was created due to a state settlement from another pharmaceutical company. He spends his days now making others aware of things such as what you have read. I’ve spoken with Shahram, and I admire his assistance with others trying to correct this medical mess.

    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. 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. Again, citizens are overall not catatonic about such actions.

    While on this off label role with Zyprexa, they resurrected their long term care efforts by taking on Aricept, and alzheimers drug, and encouraged others to switch to Zyprexa. The reaction for this misbehavior was Zyprexa being removed from Medicaid in 2004.

    Allan Reier was the Zyprexa product team leader at the 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.

    So, now we are at a point where Eli Lilly had a flash of reality and preferred no media contact. Gosh, what a surprise.

    The other 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. 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’.

    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 substandard research investigators and the sponsor of these clinical trials, Eli Lilly, has the ability to alter aspects of such trials for their own benefit. This was done as they still encouraged children to consume Zyprexa- near a million of them due to an arrangement that Zyprexa will be promoted by the 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 http://www.furiousseasons.com, which is what this article is based upon entirely. Perhaps the documents should have been exposed immediately instead of being held from public view. Many facts that you have read in this article are from these authentic documents that are more disturbing than fiction. The information is accurate, and many others are finally informed instead of deceived or denied their right to know.

    “Character is what a man is in the dark” — Dwight Moody

    Dan Abshear
    Author’s note: What has been written is based upon information and belief

  5. #5 anonymous
    June 20, 2010

    before this information came out these drugs were not approved for people under 18 now they approved for children and being given to kids as young as 2; with support by doctors like some quack from harvard who got caught for receiving millions off the books from phara companies(Rebecca Riley case 60 minutes)… educated guess they are europeans trying to hurt as many americans as possible and from what i heard turn the US into the equivalent of Argentina