Zyprexa info and Combating autism

[Guest guest]

Digest Number 762

> There are 2 messages in this issue.

>

> Topics in this digest:

>

> 1. Eli Lilly Said to Play Down Risk of Top Pill

> From: Pat Schissel

>

> 2. Fact Sheet: Combating Autism Act of 2006

> From: Pat Schissel

>

>

> Messages

> ________________________________________________________________________

>

> 1. Eli Lilly Said to Play Down Risk of Top Pill

> Posted by: " Pat Schissel " pats@... patriciars11577

> Date: Wed Dec 20, 2006 12:43 pm ((PST))

>

> Fyi

>

>

>

> Published: December 17, 2006

>

>

>

>

> Eli Lilly Said to Play Down Risk of Top Pill

>

>

>

>

>

> <http://www.nytimes.com/adx/bin/adx_click.html?type=goto & page=www.nytime

> s.com/yr/mo/day/business & pos=Frame4A & camp=foxsearch2006-emailtools13a-ny

> t5 & ad=historyboys_88x31_pic11323.gif & goto=http://www.foxsearchlight.com/

> thehistoryboys/>

>

> By ALEX BERENSON

> <http://topics.nytimes.com/top/reference/timestopics/people/b/alex_beren

> son/index.html?inline=nyt-per>

>

> Published: December 17, 2006

>

> The drug maker Eli Lilly

> <http://www.nytimes.com/mem/MWredirect.html?MW=http://custom.marketwatch

> .com/custom/nyt-com/html-companyprofile.asp & symb=LLY> has engaged in a

> decade-long effort to play down the health risks of Zyprexa, its

> best-selling medication for schizophrenia

> <http://topics.nytimes.com/top/news/health/diseasesconditionsandhealthto

> pics/schizophrenia/index.html?inline=nyt-classifier> , according to

> hundreds of internal Lilly documents and e-mail messages among top

> company managers.

>

>

>

>

>

> Darron Cummings/Associated Press

>

> Zyprexa is Lilly's top-selling drug, with sales of $4.2 billion last

> year.

>

>

>

> Borough for The New York Times

>

> B. Gottstein, a lawyer who represents the mentally ill, said the

> documents about Zyprexa's side effects raised public health issues.

>

> 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

> <http://topics.nytimes.com/top/news/health/diseasesconditionsandhealthto

> pics/obesity/index.html?inline=nyt-classifier> and its tendency to

> raise blood sugar - both known risk factors for diabetes

> <http://topics.nytimes.com/top/news/health/diseasesconditionsandhealthto

> pics/diabetes/index.html?inline=nyt-classifier> .

>

> 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.

>

> Critics, including the American Diabetes Association, have argued that

> Zyprexa, introduced in 1996, is more likely to cause diabetes than other

> widely used schizophrenia drugs. Lilly has consistently denied such a

> link, and did so again on Friday in a written response to questions

> about the documents. The company defended Zyprexa's safety, and said the

> documents had been taken out of context.

>

> But as early as 1999, the documents show that Lilly worried that side

> effects from Zyprexa, whose chemical name is olanzapine, would hurt

> sales.

>

> " Olanzapine-associated weight gain and possible hyperglycemia is a major

> threat to the long-term success of this critically important molecule, "

> Dr. Alan Breier wrote in a November 1999 e-mail message to two-dozen

> Lilly employees that announced the formation of an " executive steering

> committee for olanzapine-associated weight changes and hyperglycemia. "

> Hyperglycemia is high blood sugar.

>

> At the time Dr. Breier, who is now Lilly's chief medical officer, was

> the chief scientist on the Zyprexa program.

>

> 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

> <http://topics.nytimes.com/top/news/health/diseasesconditionsandhealthto

> pics/bipolardisorder/index.html?inline=nyt-classifier> . The company

> said it had given the Food and Drug Administration

> <http://topics.nytimes.com/top/reference/timestopics/organizations/f/foo

> d_and_drug_administration/index.html?inline=nyt-org> 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.

>

> Lilly also said the documents should not have been made public because

> they might " cause unwarranted fear among patients that will cause them

> to stop taking their medication. "

>

> As did similar documents disclosed by the drug maker Merck

> <http://www.nytimes.com/mem/MWredirect.html?MW=http://custom.marketwatch

> .com/custom/nyt-com/html-companyprofile.asp & symb=MRK> last year in

> response to lawsuits over its painkiller Vioxx, the Lilly documents

> offer an inside look at how a company marketed a drug while seeking to

> play down its side effects. Lilly, based in Indianapolis, is the

> sixth-largest American drug maker, with $14 billion in revenue last

> year.

>

> The documents - which include e-mail, marketing material, sales

> projections and scientific reports - are replete with references to

> Zyprexa's importance to Lilly's future and the need to keep concerns

> about diabetes and obesity from hurting sales. But that effort became

> increasingly difficult as doctors saw Zyprexa's side effects, the

> documents show.

>

> In 2002, for example, Lilly rejected plans to give psychiatrists

> guidance about how to treat diabetes, worrying that doing so would

> tarnish Zyprexa's reputation. " Although M.D.'s like objective,

> educational materials, having our reps provide some with diabetes would

> further build its association to Zyprexa, " a Lilly manager wrote in a

> March 2002 e-mail message.

>

> But Lilly did expand its marketing to primary care physicians, who its

> internal studies showed were less aware of Zyprexa's side effects. Lilly

> sales material encouraged representatives to promote Zyprexa as a " safe,

> gentle psychotropic " suitable for people with mild mental illness

> <http://topics.nytimes.com/top/news/health/diseasesconditionsandhealthto

> pics/mentalhealthanddisorders/index.html?inline=nyt-classifier> .

>

> Some top psychiatrists say that Zyprexa will continue to be widely used

> despite its side effects, because it works better than most other

> antipsychotic medicines in severely ill patients. But others say that

> Zyprexa appears no more effective overall than other medicines.

>

> And some doctors who specialize in diabetes care dispute Lilly's

> assertion that Zyprexa does not cause more cases of diabetes than other

> psychiatric drugs. " When somebody gains weight, they need more insulin,

> they become more insulin resistant, " Dr. Zonszein, the director of

> the clinical diabetes center at Montefiore Medical Center

> <http://topics.nytimes.com/top/reference/timestopics/organizations/m/mon

> tefiore_medical_center/index.html?inline=nyt-org> in the Bronx, said

> when asked about the drug.

>

> In 2003, after reviewing data provided by Lilly and other drug makers,

> the F.D.A. said that the current class of antipsychotic drugs may cause

> high blood sugar. It did not specifically single out Zyprexa, nor did it

> say that the drugs had been proven to cause diabetes.

>

> The drugs are known as atypical antipsychotics and include &

>

> <http://www.nytimes.com/mem/MWredirect.html?MW=http://custom.marketwatch

> .com/custom/nyt-com/html-companyprofile.asp & symb=JNJ> 's Risperdal and

> AstraZeneca

> <http://www.nytimes.com/mem/MWredirect.html?MW=http://custom.marketwatch

> .com/custom/nyt-com/html-companyprofile.asp & symb=AZN> 's Seroquel. When

> they were introduced in the mid-1990s, psychiatrists hoped they would

> relieve mental illness without the tremors and facial twitches

> associated with older drugs. But the new drugs have not proven

> significantly better and have their own side effects, said Dr.

> Lieberman, the lead investigator on a federally sponsored clinical trial

> that compared Zyprexa and other new drugs with one older one.

>

> The Zyprexa documents were provided to the Times by B. Gottstein,

> a lawyer who represents mentally ill patients and has sued the state of

> Alaska over its efforts to force patients to take psychiatric medicines

> against their will. Mr. Gottstein said the information in the documents

> raised public health issues.

>

> " Patients should be told the truth about drugs like Zyprexa, " Mr.

> Gottstein said.

>

> Lilly originally provided the documents, under seal, to plaintiffs

> lawyers who sued the company claiming their clients developed diabetes

> from taking Zyprexa. Mr. Gottstein, who is not subject to the

> confidentiality agreement that covers the product liability suits,

> subpoenaed the documents in early December from a person involved in the

> suits.

>

> In its statement, Lilly called the release of the documents " illegal. "

> The company said it could not comment on specific documents because of

> the continuing product liability suits.

>

> In some ways, the Zyprexa documents are reminiscent of those produced in

> litigation over Vioxx, which Merck stopped selling in 2004 after a

> clinical trial proved it caused heart problems. They treat very

> different conditions, but Zyprexa and Vioxx are not entirely dissimilar.

> Both were thought to be safer than older and cheaper drugs, becoming

> bestsellers as a result, but turned out to have serious side effects.

>

> After being pressed by doctors and regulators, Merck eventually did test

> Vioxx's cardiovascular risks and withdrew the drug after finding that

> Vioxx increased heart attacks and strokes.

>

> Lilly has never conducted a clinical trial to determine exactly how much

> Zyprexa raises patients' diabetes risks. But scientists say conducting

> such a study would be exceedingly difficult, because diabetes takes

> years to develop, and it can be hard to keep mentally ill patients

> enrolled in a clinical trial.

>

> When it was introduced, Zyprexa was the third and most heralded of the

> atypical antipsychotics. With psychiatrists eager for new treatments for

> schizophrenia, bipolar disorder, and dementia, Zyprexa's sales soared.

>

> But as sales grew, reports rolled in to Lilly and drug regulators that

> the medicine caused massive weight gain in many patients and was

> associated with diabetes. For example, a California doctor reported that

> 8 of his 35 patients on Zyprexa had developed high blood sugar,

> including two who required hospitalization.

>

> The documents show that Lilly encouraged its sales representatives to

> play down those effects when talking to doctors. In one 1998

> presentation, for example, Lilly said its salespeople should be told,

> " Don't introduce the issue!!! " Meanwhile, the company researched

> combinations of Zyprexa with several other drugs, hoping to alleviate

> the weight gain. But the combinations failed.

>

> To reassure doctors, Lilly also publicly said that when it followed up

> with patients who had taken Zyprexa in a clinical trial for three years,

> it found that weight gain appeared to plateau after about nine months.

> But the company did not discuss a far less reassuring finding in early

> 1999, disclosed in the documents, that blood sugar levels in the

> patients increased steadily for three years.

>

> In 2000 and 2001, more warning signs emerged, the documents show. In

> four surveys conducted by Lilly's marketing department, the company

> found that 70 percent of psychiatrists polled had seen at least one of

> their patients develop high blood sugar or diabetes while taking

> Zyprexa, compared with about 20 percent for Risperdal or Seroquel. Lilly

> never disclosed those findings.

>

> By mid-2003, Lilly began to change its stance somewhat, publicly

> acknowledging that Zyprexa can cause severe obesity. Marketing documents

> make clear that by then Lilly believed it had no choice. On June 23,

> 2003, an internal committee reported that Zyprexa sales were " below

> plan " and that doctors were " switching/avoiding Zyprexa. "

>

> Since then, Lilly has acknowledged Zyprexa's effect on weight but has

> argued that it does not necessarily correlate to diabetes. But Zyprexa's

> share of antipsychotic drug prescriptions is falling, and some

> psychiatrists say they no longer believe the information Lilly offers.

>

> " From my personal experience, at first my concerns about weight gain

> with this drug were very significantly downplayed by their field

> representatives, " said Dr. Phelps, a psychiatrist in Corvallis,

> Or. 'Their continued efforts to downplay that, I think in retrospect,

> was an embarrassment to the company. "

>

> Dr. Phelps says that he tries to avoid Zyprexa because of its side

> effects but sometimes still prescribes it, especially when patients are

> acutely psychotic and considering suicide

> <http://topics.nytimes.com/top/news/health/diseasesconditionsandhealthto

> pics/suicidesandsuicideattempts/index.html?inline=nyt-classifier> ,

> because it works faster than other medicines.

>

> " I wind up using it as an emergency medicine, where it's superb, " he

> said. " But I'm trying to get my patients off of Zyprexa, not put them

> on. "

>

> Letters to the Editor December 20th

>

>

> Eli Lilly and the Dangers of a Drug (5 Letters)

>

>

> <http://www.nytimes.com/2006/12/17/business/17drug.html?pagewanted=1>

>

> To the Editor:

>

> " Eli Lilly Said to Play Down Risk of Top Pill

> <http://www.nytimes.com/2006/12/17/business/17drug.html> " (front page,

> Dec. 17), about the company's decision to cover up health effects of its

> top-selling schizophrenia medication, Zyprexa, is a good example of the

> strong link between product safety and product liability.

>

> Lawsuits are often the only means for the public to learn about

> dangerous drugs. This is especially true today, as the Food and Drug

> Administration has proved unable to keep some unsafe drugs off the

> market.

>

> The article also illustrates the problems caused when companies settle

> cases and force the injured to sign confidentiality agreements, as was

> apparently done in this case. In such cases, wrongdoers can prolong

> misconduct and suppress information for years.

>

> If lawsuits had not been brought in this case and a lawyer who was not

> bound by a confidentiality agreement had not come forward, the dangers

> of this drug would never be known to the wider public.

>

> Joanne Doroshow

> Executive Director

> Center for Justice and Democracy

> New York, Dec. 17, 2006

>

> *

>

> To the Editor:

>

> It seems from your article about Eli Lilly's marketing of Zyprexa, and

> from what I know from my experience as a psychiatrist, that the company

> has behaved as any for-profit corporation would.

>

> While it may not have suppressed important information, it has certainly

> tried to present the situation in a way that maximizes sales of its

> product.

>

> For it to do anything else would be a dereliction of duty, which is to

> shareholders, not patients.

>

> The main hope for patients, then, lies in an objective physician, whose

> only duty is the good of his patient.

>

> The physician must remain as free as possible from financial incentives

> and concerns, whether from drug companies or insurance companies, and

> exert his efforts to obtain objective information about drugs from as

> many sources as possible, and use this knowledge solely for his

> patient's benefit.

>

> It is in the public's interest for physicians to remain objective, and

> devoted solely to their patients' well-being, free from financial

> entanglements with drug or insurance companies.

>

> Marshal Mandelkern, M.D.

> New Haven, Dec. 17, 2006

> The writer is an assistant clinical professor of psychiatry at Yale

> School of Medicine.

>

> *

>

> To the Editor:

>

> Zyprexa is a miracle drug for some of us. That should not be forgotten

> in light of all that is coming out about Eli Lilly's marketing

> practices. It opened up the world, allowed me to read and feel a

> crackling enthusiasm for life for the first time in years, and it cut

> down drastically on the voices and strange thoughts.

>

> Zyprexa was also the worst drug I have ever taken, making me gain 65

> pounds, adding 100 points to my cholesterol and raising my triglycerides

> sky-high. I was both ecstatic to be involved in the world and miserable,

> obese and unhealthy.

>

> The problem is to solve the difficulties with Zyprexa, not simply take

> it off the market. It is too helpful a drug, especially for those who

> can tolerate it. I could not.

>

> I now take three different antipsychotics that are effective but not as

> miraculous.

>

> I miss Zyprexa.

>

> Pamela Spiro Wagner

> Wethersfield, Conn., Dec. 18, 2006

>

> *

>

> To the Editor:

>

> Zyprexa is also prescribed in an " off label " manner to some children

> with autism whose behaviors may be self-injurious, dangerous to others

> or sometimes merely annoying to the " typical " population.

>

> It is administered by desperate parents who, in the midst of an autism

> epidemic, are faced with no cure, no other answers and often inadequate

> educational and support systems.

>

> Children with autism often gain weight on Zyprexa, too, and the specter

> of their also developing diabetes is horrifying in light of the

> injections and other additional medication they may need and the

> inability of some of those afflicted with autism to regulate such a

> disease without a great deal of assistance.

>

> Barbara Fischkin

> Long Beach, N.Y., Dec. 17, 2006

>

> *

>

> To the Editor:

>

> Re " Playing Down the Risks of a Drug

> <http://www.nytimes.com/2006/12/19/opinion/19tue2.html> " (editorial,

> Dec. 19):

>

> Congressional hearings into Eli Lilly's playing down Zyprexa's side

> effects, which you call for, will dabble only with the surface of the

> problem. The rules make the game, and with " nearly every major drug

> company ... under civil or criminal investigation for alleged efforts "

> to promote drugs for unapproved uses, it's time to consider that there's

> something fundamentally wrong with our privatized pharmaceutical

> industry.

>

> Conservative dogma is that market forces lead to innovation and quality,

> but our experience in the drug business is that the profit motive leads

> to price-gouging, cover-ups and expensive litigation.

>

> Meanwhile, even when Big Pharma is obeying the law, vital medicines for

> poor children and rare diseases are neglected, while research and

> development budgets are spent on advertising to a market that is flooded

> with erection enhancers.

>

> We need to get the money-changers out of medicine, and make drugs for

> people, not for profit.

>

> Berman

> New York, Dec. 19, 2006

>

>

>

>

>

> Pat Schissel, President AHA

>

> PO Box 916

>

> Bethpage, NY 11714-0916

>

>

>

> Pats@...

>

> www.ahany.org

>

>

>

>

> Messages in this topic (1)

> ________________________________________________________________________

> ________________________________________________________________________

>

> 2. Fact Sheet: Combating Autism Act of 2006

> Posted by: " Pat Schissel " pats@... patriciars11577

> Date: Wed Dec 20, 2006 12:51 pm ((PST))

>

> Fyi

>

>

>

> http://www.whitehouse.gov/news/releases/2006/12/20061219-3.html

>

> December 19, 2006

>

> Fact Sheet: Combating Autism Act of 2006

>

> President's Statement on Combating Autism Act of 2006

> <http://www.whitehouse.gov/news/releases/2006/12/20061219-1.html>

> President Signs H.R. 5466, H.R. 6143, S. 843, and S. 3678

> <http://www.whitehouse.gov/news/releases/2006/12/20061219-2.html>

>

> " For the millions of Americans whose lives are affected by autism, today

> is a day of hope. The Combating Autism Act of 2006 will increase public

> awareness about this disorder and provide enhanced federal support for

> autism research and treatment. By creating a national education program

> for doctors and the public about autism, this legislation will help more

> people recognize the symptoms of autism. This will lead to early

> identification and intervention, which is critical for children with

> autism. I am proud to sign this bill into law and confident that it will

> serve as an important foundation for our Nation s efforts to find a cure

> for autism. "

>

> - President W. Bush, 12/19/06

>

> Today, President Bush Signed The Combating Autism Act Of 2006. This Act

> authorizes expanded activities related to autism research, prevention,

> and treatment through FY 2011. There are more than 1.5 million cases of

> autism in the United States.

>

> * Since The President Took Office, National Institutes Of Health

> (NIH) Funding For Autism-Related Research Has Increased By Over 80

> Percent From $56 Million In FY 2001 To An Estimated $101 Million In The

> FY 2007 Budget, Including Support For Autism Centers of Excellence. In

> addition, the Budget includes approximately $15 million at the Centers

> for Disease Control and Prevention (CDC) for autism surveillance and

> research, including five regional Centers of Excellence for Autism and

> Developmental Disabilities Research and Epidemiology. In October, CDC

> initiated a $5.9 million study to help identify factors that may put

> children at risk for autism spectrum disorders and other developmental

> disabilities.

>

> The Combating Autism Act Enhances Research, Surveillance, And Education

> Regarding Autism Spectrum Disorder

>

> The Act Authorizes Research Under NIH To Address The Entire Scope Of

> Autism Spectrum Disorder (ASD). Autism, sometimes called " classical

> autism, " is the most common condition in a group of developmental

> disorders known as the autism spectrum disorders (ASDs). Other ASDs

> include Asperger syndrome, Rett syndrome, childhood disintegrative

> disorder, and pervasive developmental disorder not otherwise specified

> (usually referred to as PDD-NOS).

>

> The Act Authorizes Regional Centers Of Excellence For Autism Spectrum

> Disorder Research And Epidemiology. These Centers collect and analyze

> information on the number, incidence, correlates, and causes of ASD and

> other developmental disabilities. The Act also authorizes grants to

> States for collection, analysis, and dissemination of data related to

> autism.

>

> The Act Authorizes Activities To Increase Public Awareness Of Autism,

> Improve The Ability Of Health Care Providers To Use Evidence-Based

> Interventions, And Increase Early Screening For Autism. The Act

> authorizes the Secretary of Health and Human Services to:

>

> * Provide information and education on ASD and other developmental

> disabilities to increase public awareness of developmental milestones;

> * Promote research into the development and validation of reliable

> screening tools for ASD and other developmental disabilities and

> disseminate information regarding those screening tools;

> * Promote early screening of individuals at higher risk for ASD

> and other developmental disabilities as early as practicable;

> * Increase the number of individuals who are able to confirm or

> rule out a diagnosis of ASD and other developmental disabilities;

> * Increase the number of individuals able to provide

> evidence-based interventions for individuals diagnosed with ASD or other

> developmental disabilities; and

> * Promote the use of evidence-based interventions for individuals

> at higher risk for ASD and other developmental disabilities as early as

> practicable.

>

> The Act Calls On The Interagency Autism Coordinating Committee (IACC) To

> Enhance Information Sharing. The IACC provides a forum to facilitate the

> efficient and effective exchange of information about autism activities,

> programs, policies, and research among the Federal government, several

> non-profit groups, and the public. The Combating Autism Act requires the

> IACC to provide information and recommendations on ASD-related programs,

> and to continue its work to develop and update annually a strategic plan

> for ASD research.

>

> # # #

>

>

>

>

>

> Pat Schissel, President AHA

>

> PO Box 916

>

> Bethpage, NY 11714-0916

>

>

>

> Pats@...

>

> www.ahany.org

>

>

>

>

> Messages in this topic (1)

> ________________________________________________________________________

> ________________________________________________________________________

>

>

>

> ------------------------------------------------------------------------

>

[Guest guest]

Great. My son took Zyprexa when he was little….around ages 4-7…he gained

over 50 pounds (doubled his entire body weight because he weighed only 45

lbs when he started it).

Eventually he ended up hospitalized and even more out of control

behaviorally than ever before.

Just shows that, once again, medication is not always the answer nor is it a

quick fix.

I still feel guilty for allowing him to be put on it. It affected his life

for years afterward. Just shows you can’t always trust the docs and

medications. It should always be a last resort.

nna

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12:23 PM

[Guest guest]

Amen to your last statement but drop the guilt! You were only doing

what you thought would help him with the recommendation of professionals

that you were supposed to be able to trust. MANY would do the same!

Look at all you learned and how many you have helped as a result. Yes,

there were consequences for your son, but good came of it too.

Tonya

Re:Zyprexa info and Combating autism

Great. My son took Zyprexa when he was little..around ages 4-7.he gained

over 50 pounds (doubled his entire body weight because he weighed only

45

lbs when he started it).

Eventually he ended up hospitalized and even more out of control

behaviorally than ever before.

Just shows that, once again, medication is not always the answer nor is

it a

quick fix.

I still feel guilty for allowing him to be put on it. It affected his

life

for years afterward. Just shows you can't always trust the docs and

medications. It should always be a last resort.

nna

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Checked by AVG Free Edition.

Version: 7.5.432 / Virus Database: 268.15.28/604 - Release Date:

12/26/2006

12:23 PM