February 25

Activists Take on Eli Lilly Over Off-Label Marketing & Harm Caused by Zyprexa

Evelyn Pringle reports (below) that the group is also supporting Jim Gottstein in his battle with Eli Lilly over the release of the Zyprexa documents.

"If there is a case that dramatically highlights the need to stop blindly taking prescriptions drugs, this is it," says Dr Greg Tefft, co-founder of the campaign. "We’re talking 20 million people potentially at risk and more being added daily.  We are convinced that the way to solve this problem is to work the demand side of the market," Dr Tefft said. "We are going directly to consumers and encouraging them to know what they are taking."
And in testimony before the House Energy Commerce Committee, Feb. 13, at a hearing about FDA’s failure to protect the public from the toxic effects of Ketek (telithromycin), an antibiotic linked to liver failure, David Graham, MD was asked what other unsafe FDA-approved drugs are currently marketed. 

“What are some of the other red flags that we should be watching for?”
Dr Graham FDA: “I would pay careful attention to antipsychotic medications…The problems with these drugs are that we know that they are being used extensively off label.”

“In nursing homes they sedate elderly patients with dementia and other types of thought disorders. It's known that these drugs don't work in these settings and you say that it's off label use and they should do what they want. But the fact is … that it increases mortality, perhaps by a 100 percent, doubles mortality. So I did a back of the envelope calculation of this and you probably have 15 000 elderly patients, people in nursing homes, dying each year from the off label use of antipsychotic medications for an indications that …the FDA knows the drug doesn't work. This problem has been known to the FDA for years and years.”

Committee member Congressman Burgess asked: .”..Do you have another to put on our watch list?”
Dr. Graham: “Well I think it's been in the newspapers, in The New York Times, Zyprexa and diabetes. What has FDA been doing with this? All these clinical trials that we really learn about in New York Times, the weight gain from Zyprexa, the diabetes. Diabetes is a life- threatening disease….Don't kid yourself it's responsible for more lost years of life than many, many disorders.”

“Zyprexa, it turns out, the company knew for a long time apparently, based on what I read in New York Times, that it is a big problem. My question is, as I know the FDA, they knew about it too. And in talking to reviewers at the FDA about it, about FDA's approach in dealing with this safety issue, I'm told that much is to be desired.”   Video Webcast: http://energycommerce.house.gov/cmte_mtgs/110-oi_hrg.021307.FDA_drug_supply.shtml 

Ironically, the Congressional hearing took place on the same day that a federal judge, Jack Weinstein, extended a partial gag order on the dissemination of the Zyprexa documents containing evidence of harm.  http://ahrp.blogspot.com/2007/02/zyprexa-documents-court-ruling.html  

Dr. Graham’s statement is borne out by a letter from FDA’s Division of Drug Marketing, Advertising, and Communications (November 1996) to Eli Lilly. The warning letter shows that soon after Zyprexa was approved, Lilly misrepresented the drug's known risks that are indicated in its approved label. The letter warned that Lilly’s marketing included "false" and "misleading" promotional activities “in violation of the Food, Drug, and Cosmetics Act.” The letter stated that Lilly’s promotional claims "of superiority over other antipsychotic products are unsubstantiated" that Lilly’s claim that Zyprexa was "superior, highly effective, virtually free of side effects, easy to use product"  "is contrary to the approved labeling." 

The letter cited an interactive teleconference (October 1996) during which Dr. Gary Tollefson, Vice President of Lilly Research Laboratories, misrepresented the drug's adverse side effect profile. Dr. Tollefson claimed that weight gain–listed in the label as an adverse event — was “a therapeutic benefit.” “When asked a question [by a physician] about weight gain, Dr. Tollefson’s response misleadingly turned an adverse event into a therapeutic benefit.”  He said: “we really look at this, with the majority of patients, as being part of a therapeutic recovery rather than an adverse event.”
An article in SLATE, "How Lilly Sells Zyprexa," by Bonnie Goldstein, a former special investigator to the U.S. Senate and an investigative producer for ABC News, reveals the content of one of the secret documents: the “Zyprexa Retail Implementation Guide,” a  2001 memo (13 pages) instructing sales reps how to persuade primary care physicians to prescribe Zyprexa, “a versatile psychotropic proven effective in a large number of patients who suffer from mood, thought, and behavioral disturbances.”

Zyprexa is no longer referred to as an antipsychotic specifically approved for patients diagnosed with schizophrenia (1996) then for short-term bipolar disorder (2000).  Instead, sales reps are instructed to persuade primary care physicians to prescribe Zyprexa for “symptoms associated with various mental disorders frequently observed in patients.” Since such patients do not meet the diagnostic criteria for which the drug was approved, Lilly’s marketing violates federal law.  http://www.slate.com/id/2159880/entry/2159881/

Evelyn Pringle has been covering the Zyprexa issue extensively in OpEdNews. “More Zyprexa Postcards From the Edge,” February 14, 2007, reveals that a secret Eli Lilly memo, "Diabetes Update," dated July 7, 2003, suggests a strategy for counteracting news of the diabetes risk which threatened sales. See: http://www.counterpunch.org/pringle02152007.html

"Indemnification represents the most meaningful demonstration of confidence in Zyprexa–both with our customers and with our employees," the Update stated. "We must embrace the fact that many physicians are curtailing their use of Zyprexa (particularly in the moderately-ill patient and in the maintenance phase)," the memo said, "solely on the basis of personal fear (of being sued)."
Pringle translates the comment to mean that company executives were anxious about doctors who might curtail the use of Zyprexa in patients who may not need it because they are no longer psychotic.  Lilly's memo suggests that the company should try to convince doctors to keep patients on Zyprexa for life as a maintenance program.
She notes that Lilly apparently used this physician indemnification tactic when the truth about the risks of Prozac leaked out from documents that had also been sealed under a court order. The memo states:  "Our experience with Prozac, confirms the impact and goodwill of such an initiative."
However, it is not clear from the memo whether Lilly did in fact indemnify doctors for prescribing Zyprexa. The memo states:  "We are investigating the viability of this action, and are preparing a business case analysis for senior management's consideration–ASAP."

Pringle notes that the memo does make one thing clear; that Eli Lilly knew the plan was improper as evidenced by a comment that the American Medical Association considered indemnification an "inappropriate incentive" to doctors.
Of further interest, the same memo discussed a plan to pay the National Alliance on Mental Illness millions of dollars to help downplay the news about diabetes and Zyprexa. The memo describes a plan to "mobilize our allies" and provide "NAMI a multimillion dollar grant to stage a national screening" to "help educate physicians and patients on the inherent risks of diabetes–regardless of the antipsychotic."
The memo confirms that NAMI, an organization that purports to represent the interests of patients diagnosed with a mental disorder and their families, is not only a front group for Eli Lilly–but an accomplice in downplaying lethal drug effects. 

In her latest article (below), Pringle that a letter from Dr Albert Marrero, a psychiatrist at the Ventura County Behavioral Health Department, to Lilly's medical director (November 12, 1999) describes the blood sugar problems occurring specifically with Zyprexa patients: "We have had eight patients out of possibly thirty-five patients on Zyprexa show up with high blood sugars."

Dr Marrero further informed Lilly that, "Two patients had to be hospitalized due to out of control diabetes….We have certainly never seen this with Haldol, Navane, Risperdal and others to this extent."

In other words, the psychiatrist indicates that Zyprexa is not only not an improvement over other antipsychotics—he says it’s worse than the old or the new.  Yet, this drug is Lilly’s most profitable mega-seller.

David Graham, MD, Testimony, House Energy Commerce Committee, Feb. 13, 2007,   Archived Video Webcast:  http://energycommerce.house.gov/cmte_mtgs/110-oi_hrg.021307.FDA_drug_supply.shtml  Time: 04.25.33

How Lilly Sells Zyprexa: Primary sources exposed and explained.  By  Bonnie Goldstein,  SLATE, Thursday, Feb. 15, 2007

More Zyprexa Postcards From the Edge. By Evelyn Pringle, OpEdNews, Feb. 14, 2007, http://www.opednews.com/articles/genera_evelyn_p_070214_more_zyprexa_postcar.htm


Contact: Vera Hassner Sharav
Evelyn Pringle on February 26, 2007 
On February 23, 2007, a new grass roots advocacy group issued a press release to rally support for attorney, Jim Gottstein, in his legal battle with Eli Lilly over his role in providing secret company documents obtained in litigation to the media to alert the public about the health risks associated with Zyprexa that were kept hidden since the mid-90s.

In turning the document over to the press, Mr Gottstein’s goal was also to alert the public about Lilly's illegal off-label marketing schemes aimed at getting doctors to prescribe Zyprexa, a drug FDA approved only for adult patients with schizophrenia or bipolar disorder, to patients of all ages for uses that were not approved as safe and effective.
Although a doctor may prescribe a drug for an unapproved use, it is illegal for Lilly to promote Zyprexa for an off-label use. The illegal marketing in this case includes influencing doctors to prescribe the drug to millions of consumers for conditions not listed on the label, prescribing Zyprexa in combination with other drugs or for a longer duration than recommended, and prescribing a drug for children that was only approved for adults.

Activists say most consumers are not even aware that it is legal for a doctor to prescribe a drug for an off-label use and take for granted that a prescribed drug picked up at a pharmacy is approved to treat their condition and their children.

The recent overdose death of 4-year-old, Rebecca Riley, in Massachusetts, demonstrates the dire need to educate the public about the practice of prescribing drugs for unapproved uses and the dangers of prescribing drugs like Zyprexa to children.
At 2-and-a-half-years-old, Rebecca was diagnosed with attention deficit disorder and bipolar disorder and was prescribed Zyprexa's atypical cousin, Seroquel, along with Clonidine, an adult high blood pressure drug, and Depakote, a drug approved to treat adults with epilepsy. None of these drugs were approved for children and they were prescribed in a combination that has never been tested even with adults.

From age 2 on, Rebecca remained on this daily drug off-label concoction until she was found dead on the floor in her parent's home on December 13, 2006. The autopsy report stated that she died of the "combined effects" of the drugs and that her lungs and heart were damaged by "prolonged abuse of these prescription drugs, rather than one incident."

Experts say, this case reinforces the assertion that judges have got to quit allowing drug makers to seal documents with court orders that show the side effects of drugs and the illegal conduct of promoting the sale of drugs for unapproved uses.

With the Zyprexa documents, as soon as the New York Times began running articles about Lilly's off-label marketing scheme and the side effects of Zyprexa, Lilly went to court and got the judge in the underlying litigation to issue a permanent injunction against Mr Gottstein, and other persons who obtained the documents from Mr Gottstein, ordering them to return the documents to the court.

However, after a couple months of legal wrangling, the court recognized that it could not restrain the world because the documents were all over the internet and lifted the part of the injunction that enjoined certain web sites from revealing the documents.

One of the documents that Lilly fought to keep secret, is a November 12, 1999, letter from a psychiatrist at the Ventura County Behavioral Health Department, Dr Albert Marrero, to Lilly's medical director, and describes the blood sugar problems occurring specifically with Zyprexa patients stating: "We have had eight patients out of possibly thirty-five patients on Zyprexa show up with high blood sugars."

Dr Marrero further informed Lilly that, "Two patients had to be hospitalized due to out of control diabetes….We have certainly never seen this with Haldol, Navane, Risperdal and others to this extent."

And yet, despite this clearly stated notification of these serious adverse events in 1999, Lilly did not revise the labeling on Zyprexa to include a warning about high blood sugar and diabetes until the fall of 2003, and then it was only because the FDA said do it.

With the health risks of Zyprexa concealed for all that time, doctors were led to believe Lilly sales representatives who said they could safely prescribe Zyprexa and Lilly gained millions of new customers.

With this in mind, the new advocacy group has launched, "The Just Say "Know" to Prescription Drugs Campaign," with a goal of getting one million people to stop and reevaluate the medications they are taking. It is also supporting Mr Gottstein in his battle with Eli Lilly over the release of the Zyprexa documents.

"If there is a case that dramatically highlights the need to stop blindly taking prescriptions drugs, this is it," says Dr Greg Tefft, co-founder of the Just Say "Know" Campaign. "We’re talking 20 million people potentially at risk and more being added daily," he says.

But instead of focusing on Lilly or the judge who suppressed the documents, the Campaign says, it will educate the public about off-label prescribing and what consumers can do to protect themselves against unwittingly taking Zyprexa, or other drugs, without knowledge of the side effects or that the drugs are not approved for their condition.

"We are convinced that the way to solve this problem is to work the demand side of the market," Dr Tefft said. "We are going directly to consumers and encouraging them to know what they are taking."

To that end, a Zyprexa radio series, hosted by Dr Dominick Riccio, Chairman of the Campaign, and Dr Laurence Simon, provides information to consumers about the drug. The official web site for the Campaign is http://justsayknow.kpncradio.com
This group has a lofty goal because the off-label sale of Zyprexa has literally been unstoppable so far. Throughout years of litigation, while settling out of court with an estimated 26,000 Zyprexa victims, Lilly has been successful in keeping the company's off-label marketing schemes sealed under the ruse that they contain trade secrets and confidential information.

Mr Gottstein obtained the documents from Dr David Egilman, who had discovered that Lilly had failed to disclose Zyprexa's link to rapid weight gain, high blood sugar levels, and diabetes, while he was serving as an expert witness in the underlying litigation.
It's likely that Dr Egilman also knew that by settling the second batch of Zyprexa lawsuits out of court, that Lilly planned to go right on concealing the information.

The men had every reason to believe that the off-label prescribing would continue because even after paying over $1 billion in settlements, Zyprexa was still Lilly's top-selling product with sales of more than $4 billion in 2006.

The story behind Rebecca Riley's death, gives a clear picture of how blatant the off-label marketing scams have become. After she died, investigators discovered that her 2 siblings, ages 6 and 11, were also fed the same 3 drug cocktail every day and that the parents were on psychiatric medications as well.

Which means, if not for the disruption by Rebecca's untimely death, this family represented five steady customers for the "mental health industry," with 100% of the costs for doctor's visits and prescriptions paid for by public health care programs.

Psychotropic drug expert, Dr Ann Blake Tracy, Director, International Coalition for Drug Awareness, and author of "Prozac: Panacea or Pandora?," says, “this is what is referred to as the “Family Discount,” when everyone in the family is drugged.” And this is the type of tragedy she worries about, Dr Tracy says. “The parents unable to function, the children acting up and unable to function – all due to the effects of the drugs.”
She states that she would not be surprised to learn that the mother was on psychiatric drugs while she carried Rebecca which also may have caused problems for the child.

One of the world's leading experts pharmacology experts, former Secretary of the British Association for Psychopharmacology, Dr David Healy, also maintains that there is no justification for giving these drugs a 2-year-old and "certainly not for the combinations mentioned here," he states.

Testing a 2-year-old for these mental disorders, he says, can not be done.

Rebecca’s parents have been charged with first-degree murder for the overdose death of a child, but many legal experts and advocacy groups say the main perpetrator is still on the loose. That being the psychiatrist with the prescription pad, Dr Kayoko Kifuji of Tufts-New England Medical Center, who diagnosed these kids with bipolar disorder and ADHD, and prescribed the drugs for all 3 children.

Attorney, Ted Chabasinski, who works on cases involving psychiatric drugs, says he is shocked that the parents are charged with the death, “while the psychiatrist who prescribed the drugs that killed her will probably never be held accountable.”  “The prosecutor makes much of the fact that the parents gave drugs to their daughter that were not approved for use in children,” he points out, “but it is the doctor, not the parents, who is responsible for that.”
Mr Chabasinski says the drug company executives, and the psychiatrists who collude with them, are criminally responsible for Rebecca's death. “This is an example,” he states, “of how the drug industry and the psychiatric profession are out of control.”

Houston Attorney, Andy Vickery, has been representing persons harmed by psychiatric drugs for many years and he also finds this story “appalling.”
He states that the father seems to be a bad actor and he may have purposely overdosed the child, but says, "he isn’t the one that started her on the psychoative medications and someone needs to do something to hold the prescribing physician accountable.”

David Oaks, director of MindFreedom, an international human rights organization, also believes the psychiatrist should be charged with criminal negligence. “It's revealing,” he notes, “that the criminal justice system has so far targeted the parents and not the psychiatrist.”
MindFreedom is calling for criminal penalties against physicians for this level of abuse, Mr Oaks says, because it may be the only way to change their behavior.

Vera Sharav, the Director of the Alliance for Human Research Protections, also believes that the only way to stop the prescribing assault on children is to put the professionals who prescribe the toxic drug cocktails on trial in open court. "Let the public bear witness," she states, "to the proceedings that will demonstrate the absence of scientific-medical evidence to support the widespread misprescribing of harmful drugs for children."

Kelly Patricia O'Meara, author of, “Psyched Out: How Psychiatry Sells Mental Illness and Pushes Pills That Kill,” says the most important issue raised in the media is the response by the psychiatrist who prescribed the drugs. "Given the known adverse reactions to many of these drugs, and that they are not approved for children," she also says, "the psychiatrist needs to be held responsible."

As for the behaviors of family members described in the media, Ms O'Meara says, the prescription drugs they were taking could have caused many of the same. "Hostile, violent behavior," she says, "is a possible side effect of many of the mind-altering drugs."

Dr Healy also notes that it is at least possible that some of the alleged behaviors of the parents could be caused by the drugs they were on. As far as drugging the whole Riley family, he says, there is no mental illness that effects an entire families.

The off-label drugging of the Riley children is not an isolated incident. None of the atypicals drugs are approved for children, yet on May 11, 2006, the Associated Press reported that the number of prescriptions written for children had increased 73% over a four year period, according to Medco Health Solutions, a pharmacy benefits manager.

In addition to Zyprexa, the other atypicals in the same class include Seroquel (AstraZeneca) the drug given to the Riley children, Abilify (Bristol-Myers Squibb); Risperdal (Johnson & Johnson); Geodon (Pfizer); and Clozril (Novartis).

Dr Timothy Scott, author of, “America Fooled: The Truth about Antidepressants, Antipsychotics and How We've Been Deceived, reports a 2005 study that found there are approximately 30,000 children under 5 on these drugs.

Overall, child neurologist, Dr Fred Baughman, author of "The ADHD Fraud: How Psychiatry Makes "Patients" of Normal Children," reports that 10 million of the 50 million school children in the nation are on one or more psychiatric drugs and states: "This is death by psychiatry."

Along with Lilly, many of the above drug makers are currently under investigation by Federal and state law enforcement agencies for promoting the atypicals for off-label use. Lawsuits have also been filed to recover the money paid by public health care programs for the actual purchase of the drugs, as well as the cost of medical treatment for patients who developed diabetes and other health problems as a result of taking them.

While Mr Gottstein and Dr Egilman may have set themselves up for big trouble by releasing the Zyprexa documents to the press; in light of the harm to the public from off-label prescribing, evidenced well by the Riley case, drastic measures were called for and they obviously believed the risks were worth taking.

According to Dr Lawrence Diller, a behavioral-developmental pediatrician, and author of “The Last Normal Child,” and A Prescription for Disaster: “The extensive prescription of these medications for children, without adequate testing for safety and effectiveness in children constitutes a hidden time bomb that could explode with still more casualties.”

“Catastrophic side effects,” he says, “may be rare, but they become predictable when we treat so many children with so many drugs.”

As for Lilly, the company has billions of reasons to keep the documents buried because they prove beyond any doubt that the company knew about the health problems caused by Zyprexa and intentionally kept the information hidden while it influenced doctors to write off-label prescriptions for million of consumers in the name of the almighty dollar.

Evelyn Pringle

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