 |  | | Re: Health Risks of Zyprexa: unmanageable weight gain &/or diabetes. Discuss Re: Health Risks of Zyprexa: unmanageable weight gain &/or diabetes, on Health Forums.
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12-17-2006, 08:19 PM
| | | Re: Health Risks of Zyprexa: unmanageable weight gain &/or diabetes When there is a healthier appetite from the right medications, it is
the false belief that "hunger is bad" that causes the overeating
leading to weight gain and diabetes: http://HeartMDPhD.com/HolySpirit/overweight.asp
May GOD continue to heal our hearts with HIS living water curing our
diabetes, depression, anxiety or panic so that we can love our
neighbors a little more and LORD Jesus Christ a lot more, dear neighbor
whom I love unconditionally.
Prayerfully in Christ's amazing love,
Andrew <><
--
Andrew B. Chung
Cardiologist, Atlanta, Georgia, USA http://HeartMDPhD.com/HolySpirit
As for knowing who are the very elect, these you will know by the
unconditional love they have for everyone including their enemies
(Matthew 5:44-45, 1 Corinthians 13:3, James 2:14-17). http://HeartMDPhD.com/Love
Witchy Way wrote:
> http://www.nytimes.com/2006/12/17/bu...gewanted=print
>
> December 17, 2006
> Eli Lilly Said to Play Down Risk of Top Pill
> By ALEX BERENSON
>
> 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.
>
> 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. 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.
>
> 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 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.
>
> 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. Joel Zonszein, the director of
> the clinical diabetes center at Montefiore Medical Center 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 Johnson &
> Johnson's Risperdal and AstraZeneca'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. Jeffrey 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 James 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 significant 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 sales force 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.
>
> 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. James Phelps, a psychiatrist in Corvallis,
> Ore. '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, 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
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