Thursday, December 6, 2007

Zyprexa: Lilly Tweaks the Risk


Although Eli Lilly's Zyprexa is an effective antipsychotic, it causes more weight gain, hyperglycemia, hyperlipidemia, and overall metabolic havoc than just about any other medication known to medicine. Because of this, Lilly has been sued by patient groups, and recently settled with 18,000 patients who alleged they were never properly warned about Zyprexa's side effects.

Now Lilly's fighting back. Its weapon: educating doctors about risk management. I recently received this flyer in the mail. Published by PV Updates, a medical education company favored by Lilly, the title of this educational activity is "GET THE FACTS: Understanding Professional Liability Risk Associated with Prescribing Medications." You can watch the slide show here.

Here's the bottom line educational message: You can prescribe whatever medication you want, no matter how toxic, as long as you clearly document your rationale. So go ahead, prescribe Zyprexa--you won't be sued.

This strikes me as one of the more devious drug marketing campaigns in recent memory.

11 comments:

Philip Dawdy said...

great one. btw it's more like 29000 patients they've settled with.

yvonne said...

Well, This is where Eli-Lilly will start to tell the doctors they are on their on. Remember they told the doctors, don't worry we have your back, write all the off-label prescriptions you can get away with. I want to include the doctors in the hospital in my lawsuit, my hushand was having slow kidney failure and finally died at home the hospital never said a word. My lawyer have not agreeded yet,but let Eli-Lilly keep talking.

Tiny Shrink said...

A friend of mine went to a drug rep dinner, hosted by Lilly. His report on the dinner: "They were discussing a 'certain atypical antipsychotic that might be associated with weight gain' without mentioning it by name. The rep said, 'well, the drug might cause people to be prone to weight gain, but it certainly didn't make them eat the lasagna!'"

Joe said...

The Lilly letter mentions nothing about the "Learned Intermediary" doctrine. Shame on them.

Joe Lex
ER doc, counter-detailer
Philadelphia

http://www.thefederation.org/documents/pratt.htm

The term “learned intermediary” was first used in 1966 in an Eighth Circuit decision[1] and since that time the doctrine has been adopted in “an overwhelming number of jurisdictions.”[2] The learned intermediary doctrine provides that manufacturers of prescription drugs and medical devices discharge their duty of care to patients by providing warnings to the prescribing physicians.[3] The Fifth Circuit Court of Appeals stated the policy behind the doctrine as follows:

Prescription drugs are likely to be complex medicines, esoteric in formula and varied in effect. As a medical expert, the prescribing physician can take into account the propensities of the drug, as well as the susceptibilities of his patient. His is the task of weighing the benefits of any medication against its potential dangers. The choice he makes is an informed one, an individualized medical judgment bottomed on a knowledge of both patient and palliative. Pharmaceutical companies then, who must warn ultimate purchasers of dangers inherent in patent drugs sold over the counter, in selling prescription drugs are required to warn only the prescribing physician, who acts as a “learned intermediary” between manufacturer and consumer.[4]

The justification for the learned intermediary doctrine is grounded in the fact that consumers cannot buy prescription drugs directly. Rather, they must first consult with and receive the approval of a physician.[5] By providing adequate warnings to a prescribing physician, who in turns provides appropriate patient-specific warnings, the manufacturer discharges its warning responsibilities.[6)

[1] Sterling Drug v. Cornish, 370 F.2d 82, 85 (8th Cir. 1966).

[2] Pumphrey v. C.R. Bard, Inc., 906 F. Supp. 334, 338 (N.D.W.Va. 1995).

[3] Restatement (Third) of Torts: Products Liability § 6 cmt. d, reporters’ note (1997).

[4] Reyes v. Wyeth Labs., 498 F.2d 1264, 1276 (5th Cir. 1974).

[5] Karl E. Seib Jr. & Andrew E. Miller, Courts Should Rebuff Assault on ‘Learned Intermediary’ Rule, Andrews Pharmaceutical Litigation Reporter, December 1997, at 12,515.

[6] Justin T. Toth, Prescription Drugs and Medical Devices: The Impending Impact of the Restatement (Third) of Torts in Texas, Houston Lawyer, March/April 1998, at 40, 41.

James M. La Rossa Jr. said...

As a general concept, I don't see the harm in minimizing physician liability, or, rather, educating doctors about real-world legal boundaries — which they don't teach in medical school. As we all know, the "rationale" behind medical lawsuits run the gamut — from real malpractice — to plain greed and avarice — so why not applaud a program that tries to even the playing field? Is the uniform criticism here because the advice is from Lilly? Or that Lilly's antipsychotic has become a lightening rod for these lawsuits — and, thus, this kind of physician-education is a ruse of Lilly's construct?

Isn't Lilly, in effect, giving physicians the kind of advice that the Eight Circuit court in determining the "Learned Intermediary" doctrine, could not have envisioned in 1966? (Mentioned by Joe Lex in a prior blog.) In today's climate, is the avoidance of false legal claims against the prescriber of a drug part of what constitutes "disclosure of information from the manufacturer to the doctor, who must then weigh the benefits of any medication against its potential dangers?"

Zyprexa's a great case-in-point: When it was first released there was almost unanimous agreement that it was a very efficacious drug with a lousy side-effect trade off (weight gain) that was looked at, by some clinicians, as a necessary evil.

The emergence of drug-induced diabetes was learned over time after reportage in medical journals. (See, Disturbed Glucose Metabolism Among Patients Taking Olanzapine and Typical Antipsychotics, By Boadie W.Dunlop, MD, Maya Sternberg,PhD, Lawrence S. Phillips, MD,
Judy Andersen, RN, and Erica Duncan, MD.
Psychopharmacology Bulletin.2003;37 (3):99-117.)

The big question for me, then, is... When Lilly actively disputed those findings, was the company's credibility so damaged as to negate legitimate future benefit to physicians who prescribe atypicals? Many of you seem to be answering in the affirmative. I honestly don't know. I look forward to reading future blogs on this.

James M. La Rossa Jr.
MedWorks Media Global
Los Angeles

madandhurt said...

Determination of how Lilly's actions influenced what physicians prescribed will reguire a trial. This is the crime they will have to deal with, Iam glad we all will be watching. People can see what they want to see ( James) .

james larossa said...

Yes, I agree, the cause and effect is the issue. As you say — how Lilly's actions influenced what physicians prescribed, and whether those prescriptions hurt patients unnecessarily.

My devil's advocacy in this debate stems from the absolute conviction that medicine is never advanced in a courtroom, in addition to my utter disbelief that there is such an entity as an "objective jury pool." Passions run too high and prejudice too deep when it comes to psychiatry. So if a bunch of smart people from Indiana can help prevent physicians from being impleaded into these circus lawsuits (while, albeit, helping themselves), so be it. I'd rather root for the guy who is trying to build a better mousetrap than support the other guy suing him for patent infringement.

madandhurt said...

Absolute conviction in the court rooms is to have justice. This might be hard to conceive but Mr. Carlat can explain it to you. A doctor should not give a wrong diagnosis just because it is easy. When dementia become paranoid scizophrenia and a death sentence you need too be a victim to understand so you won't be on the wrong side of the courtroom. Yes, a good doctor is also a victim when a drug company can get away with this.

Anonymous said...

Recently, I happened to discover and read on another website those documents regarding zyprexa that were under seal.

1. They instructed sales reps to find clinical trial sites and lead investigators for thier future trials.
2. Spoke to reps openingly and in writing about how they should speak off label about zyprexa
3. Specifically formed a long term care sales force to call on nursing homes to sell zyprexa at these locations for dementia. Zyprexa increases pneumonia, hospitalizations, and death in the elderly.

There is much more that has been discovered about thier wrongdoing with zyprexa that harmed so many others.

Anonymous said...

Zyprexa’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: www.furiousseasons.com. The documents are,in fact, evidence against Eli Lilly that represents 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 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

Karen said...

With all this information about harmful side effects, especially with the elderly, would that make doctors who prescribe Zyprexa in the year 2011 more liable? If a yahoo like me who has little or no expertise in the medical field can do enough research online to discover that this drug is too dangerous for my 90-year-old mother (who was physically healthy & died suddenly after about 20 days on Zyprexa - she died one week ago) - couldn't her psychiatrist, Dr. Murdock, have seen the danger, too? Or was he practicing some subtle form of euthanasia? Karen Taylor ktgrammarmatters@gmail.com