By Anne Harding

Susan Craig’s brother Roger died of a pulmonary embolism in 2007, at age 38. Diagnosed with bipolar disorder in high school, he had been on antipsychotic drugs for years. At the time of his death, he was carrying 280 pounds on his 6-foot-4-inch frame.

Craig, a public relations specialist who works at Columbia University in New York City, knew that Roger’s medications could cause weight gain. But she had never been told that the drugs he was taking might be harming his heart.

“We were never counseled by his psychiatrist or his primary care provider to watch for symptoms of heart disease or any risk of sudden death at all,” Craig says. There’s no evidence that Roger’s medications caused his death, but his family might have been able to get him help sooner if they had known about the risks, Craig explains.
New research published Wednesday in the New England Journal of Medicine shows that antipsychotic drugs are not risk free, and the study’s authors are urging much more caution in their use. The drugs are associated with a risk of sudden cardiac death, particularly at higher doses. Health.com 10 best foods for your heart

Craig’s brother was taking haloperidol, which belongs to an older class of drugs called typical antipsychotics, which have long been known to increase the risk of sudden death due to cardiac causes. He was also on risperidone, a member of a newer class of drugs called atypical antipsychotics, which had been considered safer.

Doctors prescribe these newer medications, originally developed to treat schizophrenia, for a wide variety of problems — from conduct disorder in kids to aggressive behavior in Alzheimer’s patients. In fact, they’ve become so popular that three of them — olanzapine, risperidone, and quetiapine — are among the 10 top-selling drugs worldwide, with $14.5 billion in sales in 2007.

The new study suggests that among patients taking high doses of atypical antipsychotics, there are about 3.3 cases of sudden cardiac death per 1,000 patients per year, which an editorial characterizes as a risk that’s “between ‘moderate’ and ‘low,’ but not ‘rare.’” Health.com: Heart drug may be a cancer fighter

About 325,000 people in the United States each year die of sudden cardiac death, which has an incidence of 0.1 to 0.2 percent per year in adults.

“[The drugs] have potentially very serious side effects,” says Wayne A. Ray, Ph.D., the director of the division of pharmacoepidemiology at Vanderbilt University School of Medicine, in Nashville. “So whenever a decision is made to use one, consideration of potential side effects needs to be made.” Ray and his colleagues found that atypical antipsychotics doubled the risk of sudden death from heart-related causes, most likely by causing disturbances in heart rhythms.

First introduced in the mid-nineties, atypical antipsychotics were praised for having none of the troublesome side effects of their predecessors, including frequent, involuntary movements of the face and mouth that were in some cases irreversible.

But the new study shows that the increased risk of sudden cardiac death seen with the older drugs is nearly identical to that of the newer medications. There had been suspicions that the drugs were risky, especially when used in older patients, but the current study is the first to systematically investigate their association with sudden cardiac death.

Ray and his colleagues reviewed data on Tennessee Medicaid patients, comparing 44,218 people using older typical antipsychotics and 46,089 taking the newer atypical antipsychotics to 186,600 people who had never used the drugs. People with schizophrenia may have a higher rate of cardiac problems, due to smoking and other factors. To account for this, researchers also compared antipsychotic drug users without schizophrenia to non-drug users who had characteristics (in most cases, mood disorders) that made them likely candidates for the drugs.

Overall, people taking typical antipsychotics were at 1.99-times greater risk of sudden cardiac death, while the risk for those on atypical antipsychotics was increased 2.26 times. The increased risk was greater for people on higher doses of the drugs. People who had used the drugs in the past but stopped weren’t at greater risk of sudden cardiac death.

“The drugs are still very effective for conditions that there’s proven evidence for,” says Jeffrey A. Lieberman, M.D., a professor and chair of psychiatry at Columbia University, in New York City, and the director of the New York State Psychiatric Institute, who was not involved with Ray’s research. “They clearly need to still be able to be used. I think this [study] really underscores the need to be very judicious about how these medications are used and whom they’re given to.”

While atypical antipsychotics have been used to ease aggressive behavior for patients with Alzheimer’s disease, for example, they are not approved for this purpose by the U.S. Food and Drug Administration; in fact, in 2005, the FDA issued a warning that these drugs increased the risk of death among elderly people, extending the warning to all antipsychotic drugs last year, notes Sebastian Schneeweiss, M.D., Sc.D., an associate professor of medicine at Harvard Medical School, in Boston, who coauthored an editorial accompanying the current study. Health.com: How is depression in the elderly different from dementia?

Given the lack of better alternatives, these drugs are still widely used in patients with dementia despite the warnings, he adds. But while there’s anecdotal evidence that they will “cool these patients down” and reduce their aggressive behaviors, there’s no scientific evidence that they really help patients or their caregivers, Dr. Schneeweiss says.

In his editorial, Dr. Schneeweiss and coauthor Jerry Avorn, M.D., also of Harvard, call for patients to undergo an electrocardiogram before and shortly after being placed on atypical antipsychotics, to determine if the drugs are causing any heart rhythm disturbances.

For people who must be on these medications, Ray says, it’s essential for their doctors to treat any other conditions, such as high blood pressure, that can harm the heart. “Sudden cardiac death usually occurs when multiple risk factors are present,” he explains. “When you add one, it’s kind of like the straw that broke the camel’s back.”

“Absolutely the lowest dose that works should be used, because we found a strong dose response,” Ray says.

Jamaison Schuler, a spokesperson for Eli Lilly and Company, the maker of Zyprexa, says, “Although the study appears to have important limitations, it provides additional information for practicing physicians to consider as they decide how to treat very complex diseases such as schizophrenia and bipolar disorder.”

The FDA has approved atypical antipsychotics for treating bipolar disorder, Ray adds. But the researcher recommends that physicians first try safer alternatives, such as the mood stabilizer lithium. “That’s a very serious illness, and it has important consequences for patients’ quality of life and relationships,” Ray notes. “If the mood stabilizer doesn’t work, I think it’s very reasonable to consider an antipsychotic, but…other drugs should be considered first.”

Finally, he says, a patient should never stop taking any drug without consulting his or her physician. Nevertheless, anyone taking an atypical antipsychotic for a non-FDA-approved use should consult his physician. “I think off-label use should be undertaken very cautiously, and its frequency should be much less than it is currently,” Ray says. Health.com: Superfoods that can save your health

For Susan Craig, the new research makes it clear that treating serious mental illness must go far beyond just prescribing pills. “We need to be supporting these people in a better, more systematic way,” she says. “There’s no magic pill. It’s treating the whole person.”

URL: http://www.cnn.com/2009/HEALTH/01/15/healthmag.antipsychotic.sudden.death/

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The study conducted at the Vanderbilt University and the Nashville Veterans Affairs Medical Center analyzed Medicaid records (from 1990 to 2005) of nearly 277,000 people aged between 30 and 74 years. While one-third of the people were taking either a newer or an older version of the antipsychotics, two-thirds were nonusers.

For each antipsychotic drug user, two age and sex matched non-users were assessed. During follow-up period, 478 sudden cardiacdefine deaths occurred among those taking the drugs – twice the rate that occurred in the control group, researchers report.

While the results reaffirmed the long held notion that charged older antipsychotic drugs to double the risk of sudden cardiac death
as compared to non-users, a graver result was put forth by the newer medications. The newer versions more than doubled the risk of sudden cardiac deaths, results confirmed.

Moreover, the risk of sudden cardiac death increased as the dosage of antipsychotic medications increased. However, the adverse effects faded once the prescription drugs were withdrawn.

However, the results do not entail that people should stop taking such drugs. “Any prescription is a balancing of risks and benefits. In some cases, there are no good alternative treatments” Dr Wayne A Raya, a Professor of preventive medicine at Vanderbilt and the Nashville veterans’ hospital marked.

“The implication of this study is that physicians need to do a very careful cardiovascular evaluation prior to prescribing these drugs” he added. The drugs should not be used in children and elderly for treating bipolar disorders like attention deficit hyperactivity disorder (ADHD) and Alzheimer’s disease.

Olanzapine (Zyprexa, Eli Lilly), risperidone (Risperdal, Janssen) and quetiapine (Seroquel, AstraZeneca) – the newer atypical drugs are among the 10 top-selling drugs worldwide. The three together, account for about 90 percent of the market.

The U.S. Food and Drug Administration is mulling over slapping a black-box warning — the strongest warning possible — informing about the heightened risk of death in elderly patients.

URL: http://www.themedguru.com/articles/newer_antipsychotics_just_as_risky_as_old-86120080.html

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Eli Lilly sells a drug that can cause diabetes and then turn a profit on the drugs that treat the condition that they may have caused in the first place! Zyprexa is the product name for Olanzapine,it is Lilly’s top selling drug.It was approved by the FDA in 1996 ,an ‘atypical’ antipsychotic a newer class of drugs without the motor side effects of the older Thorazine.

Zyprexa has been linked to causing diabetes and pancreatitis. Zyprexa, which is used for the treatment of psychiatric disorders, such as schizophrenia and bipolar disorder, accounted for 32% of Eli Lilly’s $14.6 billion revenue last year.Did you know that Lilly made nearly $3 billion last year on diabetic meds, Actos,Humulin and Byetta? Yes! They sell a drug that can cause diabetes and then turn a profit on the drugs that treat the condition that they may have caused in the first place!

Where Eli Lilly’s negligence comes in,is their KNOWING and not informing consumers (black box warning) until the FDA demanded it. Lilly’s incentive not to readily disclose is they had billions coming in from state medicaid scripts.

Daniel Haszard http://www.zyprexa-victims.com

URL: http://www2.islandpacket.com/blogs/post/33276

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American psychiatry has been rocked by Congress. Congressional investigators first exposed the financial relationships between high-profile psychiatrists and drug companies. “But now the profession itself is under attack in Congress,” reported the New York Times on July 12, 2008.

Specifically under attack is psychiatry’s premier professional organization, the American Psychiatric Association. The New York Times stated, “In 2006, the latest year for which numbers are available, the drug industry accounted for about 30 percent of the association’s $62.5 million in financing. About half of that money went to drug advertisements in psychiatric journals and exhibits at the annual meeting, and the other half to sponsor fellowships, conferences and industry symposiums at the annual meeting.”

The American Psychiatric Association is, as the New York Times notes, “the voice of establishment psychiatry.” It publishes the Diagnostic and Statistical Manual of Mental Disorders (DSM), which is the standard diagnostic manual. It also publishes influential professional journals. And it is the primary lobbying organization for American psychiatry.

The president-elect of the American Psychiatric Association is Alan Schatzberg of Stanford University, and his $4.8 million stock holdings in a drug development company raised a red flag for Congressional investigators. Sen. Charles Grassley, R-Iowa, informed the American Psychiatric Association, “I have come to understand that money from the pharmaceutical industry can shape the practices of nonprofit organizations that purport to be independent in their viewpoints and actions.”

One example of how psychiatric treatment practices are corrupted by drug-company money was revealed in a 2007 analysis of Minnesota psychiatrists. The analysis showed that psychiatrists who received at least $5,000 from makers of newer-generation antipsychotic drugs wrote, on average, three times as many prescriptions to children for these drugs as psychiatrists who received less money or none.

The New York Times did track down one psychiatrist in private practice not on the take from drug companies, William Niederhut. Niederhut said that studies have shown that researchers who are paid by drug companies are more likely to report positive findings when evaluating that company’s drugs. Niederhut was upset that drug company influence has pushed psychiatrists to prescribe expensive drugs rather than the off-patent inexpensive ones.

While the truly anti-psychiatry establishment psychiatrists were not quoted by the New York Times, reporters Benedict Carey and Gardiner Harris did provide an important service by using the term establishment psychiatry, which at least gives a clue that there are anti-establishment psychiatrists. Among this group of anti-establishment psychiatrists, two of the most well known are Peter Breggin and Grace Jackson, both of whom have testified at Food and Drug Administration advisory meetings. Breggin and Jackson, for several years, have been reporting that the dangers of psychiatric drugs are downplayed or ignored by establishment psychiatry, that many blockbuster psychiatric drugs are no more effective than sugar pill placebos, and that the chemical imbalance theories that sell these drugs are based on drug-company marketing rather than legitimate science.

Prior to exposing the American Psychiatric Association’s financial dependency on Big Pharma, Congressional investigators had focused on individual establishment psychiatrists’ financial relationships with drug companies. One high-profile example being Joseph Biedeman, about whom the New York Times reported: “A world-renowned Harvard child psychiatrist whose work has helped fuel an explosion in the use of powerful antipsychotic medicines in children earned at least $1.6 million in consulting fees from drug makers from 2000 to 2007.” Biederman and two of his colleagues in the psychiatry department at Harvard Medical School (who received an additional $2.6 million from drug companies from 2000 to 2007), by failing to report income from drug companies while at the same time receiving federal funds from the National Institutes of Health, violated rules designed to police conflicts of interest, according to Sen. Grassley.

I can only hope that Congress and the mainstream media will get around to the most important issue of all: How Big Pharma corruption of psychiatry has eliminated options for people with severe emotional problems who have been failed by establishment psychiatric treatments. One such option that was eliminated is Soteria House, the creation of psychiatrist Loren Mosher.

Loren Mosher (1933-2004) was chief of the National Institute of Mental Health’s Center for the Study of Schizophrenia from 1968 to 1980. Mosher wanted to create an effective and more humane way to help psychiatry’s most seriously troubled patients. Using National Institute of Mental Health funds, Mosher opened the first Soteria House in Santa Clara, California in 1971.

Mosher’s Soteria House experiment is detailed by former Boston Globe reporter Robert Whitaker in Mad in America. In Soteria House, newly diagnosed schizophrenic patients lived medication-free with a young, nonprofessional staff trained to listen to and understand them and provide companionship. Mosher tested his idea that “schizophrenia can often be overcome with the help of meaningful relationships rather than with drugs, and that such treatment would eventually lead to unquestionably healthier lives.”

The Soteria House experiment worked better than Mosher had expected. Over the initial six weeks, patients recovered as quickly as those treated with medication in hospitals. Whitaker notes, “Even more striking, the Soteria patients were staying well longer. Relapse rates were lower for the Soteria group at both one-year and two-year follow-ups. The Soteria patients were also functioning better socially — better able to hold jobs and attend schools.”

Mosher’s success with nonprofessional caregivers and without drugs embarrassed establishment psychiatry. The National Institute of Mental Health choked off funding causing Soteria House to close down. By 1998 Mosher was so disgusted with establishment psychiatry that he wrote a widely publicized letter of resignation from the American Psychiatric Association. Establishment psychiatry, which in recent times usually ignores anti-establishment psychiatrists such as Mosher, had to respond and did so by accusing Mosher of wanting to abolish drug treatments. However, abolishing the option of drug treatment was never Mosher’s goal.

Loren Mosher remains a hero for many anti-establishment consumer- and patient-rights organizations such as MindFreedom. MindFreedom also does not advocate for abolishing the option of drug treatment but instead advocates for truly informed choice as well as for alternatives beyond establishment psychiatric treatments — alternatives such as Soteria House. I recently spoke with two members of MindFreedom, a married couple. Both wife and husband had been diagnosed in the past with schizophrenia. The wife chose to stay on psychiatric drugs, while the husband — who had especially debilitating adverse effects with his psychiatric drugs — chose to go without drugs. Their different paths initially created tension in the marriage but both ultimately quite graciously accepted each other’s decision.

These are the true issues: Do Americans have mental health treatment choices that are informed choices? Why, when Big Pharma corruption has long been known, does it take Congressional investigations for the mainstream media to inform Americans of the financial relationships that drug companies have with high-profile psychiatrists and major psychiatry institutions? And most importantly, when will Americans get real choices when it comes to their mental health?

A real choice is not a choice between Prozac or Zoloft, not between Zyprexa or Risperdal. One example of a real choice is the choice between establishment psychiatry or Soteria House.

Bruce E. Levine, Ph.D., is a clinical psychologist and author of Surviving America’s Depression Epidemic: How to Find Morale, Energy, and Community in a World Gone Crazy (Chelsea Green, 2007).
© 2008 Independent Media Institute. All rights reserved.
View this story online at: http://www.alternet.org/story/92264/

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Seventeen state representatives wrote New Hampshire Attorney General Kelly Ayotte in May, asking her to seek financial compensation from pharmaceutical companies that have improperly marketed or not fully disclosed side effects of antipsychotic drugs.

The petitioners didn’t know it at the time, but the attorney general’s office had been investigating one of those companies, Bristol-Myers Squibb, since 2004.

Just last week, the state’s Medicaid fraud unit announced a $1.2 million settlement with the company and a former subsidiary over several alleged practices, including its marketing of Abilify to treat children and dementia patients, for whom it was not approved.

The $1.2 million is New Hampshire’s share of a $515 million national civil settlement, which involved 43 states and the federal government.

The settlement also includes allegations that Bristol-Myers Squibb overpriced various drugs and made illegal payments to doctors to promote the sale of some drugs.

The lead petitioner, Rep. Al Baldasaro, R-Londonderry, said last week that he is happy with Ayotte’s progress, but he wants continued action.

Each year, New Hampshire and the federal government split the cost of Medicaid, which helps pay for health care for the needy, aged and disabled, as well as low-income families with children.

What first caught Baldasaro’s attention was a huge increase in state spending on newer antipsychotic drugs for children — almost $4 million last year, up from less than $300,000 in 2000.

“What got me going is how much money we are spending on Medicaid dollars to drug our kids, and on prescriptions that are designed for adults and not tested for use by children,” he said.

When Baldasaro and other officials saw other states taking drug manufacturers to court to recover money wrongfully collected from them, the legislators wanted the Granite State to follow suit.

In particular, the petition asked Ayotte to sue Bristol-Myers Squibb, manufacturer of Abilify, and Eli Lilly, manufacturer of Zyprexa. Both drugs are prescribed for schizophrenia and bipolar disorder.

Lilly has paid at least $1.2 billion in settlements to Zyprexa users nationwide, over claims they developed diabetes or other diseases from using the drug.

Baldasaro also wants the attorney general to consider joining the U.S. Department of Justice to criminally prosecute drug company executives, where appropriate, again as a deterrent to protect children and others from being placed on powerful medications.

Jeff Cahill, director of the state’s Medicaid fraud unit, won’t talk about any pending investigation. He said it is his office’s policy to neither confirm nor deny any active investigation.

Regarding Ayotte’s response to the petition, Baldasaro said he got a letter from her last month saying that New Hampshire has taken on cases against eight drug companies.

“I can assure you that we continue to be very active in investigating improper conduct and in seeking to recover any funds wrongfully collected from the state,” Ayotte wrote.

Ultimately, Baldasaro and the other petitioners want a deterrent against improper marketing of powerful drugs.

Petition signer Rep. Gene Charron, R-Chester, said full disclosure is needed to protect consumers, and too often those safeguards are lacking.

Consumers are more likely to see an automobile recall than a drug recall, he said.

Charron and Rep. Marilinda Garcia, R-Salem, said too much is at stake — people’s lives, children’s lives.

“We want to make sure that with the increased use of medications by school-age children, that the kids are safe,” Garcia said.

Baldasaro said, as a society, people should think more about prescription habits.

“In general, I think we are too quick to drug our kids,” he said.

URL: http://www.eagletribune.com/punewsnh/local_story_201230245.html
?keyword=topstory

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In 2005, the FDA announced similar labeling changes for “atypical” antipsychotic drugs. At that time, Boxed Warnings, the FDA’s strongest, were added. The Boxed Warning will now be added to an older class of drugs known as “conventional” antipsychotics. The warning for both classes of drugs will say that clinical studies indicate that antipsychotic drugs of both types are associated with an increased risk of death when used in elderly patients treated for dementia-related psychosis.

“It is important that health care professionals and consumers have the most up-to-date drug safety information,” said Thomas Laughren, M.D., director of the FDA’s Division of Psychiatry Products in the Center for Drug Evaluation and Research. “The prescribing information for all antipsychotic drugs will be updated to describe the risk of death in elderly patients being treated for symptoms associated with dementia.”

Antipsychotic drugs commonly are categorized into two classes, the older “conventional” antipsychotics and the newer “atypical” antipsychotics. Both classes of drugs are dopamine receptor antagonists that work by blocking the action of naturally occurring dopamine in the brain. They differ primarily in their side effects, with the atypical drugs having a lower incidence of neurological side effects such as involuntary movements or “tics.”

Neither class of antipsychotic is FDA-approved for use in the treatment of dementia-related symptoms, which can include forgetfulness, poor memory, and an inability to recognize familiar objects, sounds, or people. The drugs are FDA-approved primarily for the treatment of symptoms associated with schizophrenia. The decision to use antipsychotic medications in the treatment of patients with symptoms of dementia is left to the discretion of the physician. Such use is often called “off-label” use and falls within the practice of medicine.

Recently, two observational epidemiological studies were published that examined the risk of death in elderly patients with dementia who were treated with conventional antipsychotic drugs. The investigators compared the risk for death with use of an atypical antipsychotic versus either no antipsychotic or the use of a conventional antipsychotic. These studies have limitations that preclude reaching a definitive conclusion about comparative death rates for atypical and conventional antipsychotic drugs. Nevertheless, the FDA has concluded that these studies, along with the earlier evidence for atypical antipsychotic drugs, suggest that both classes of drugs should be considered to have an increased risk of death when used in elderly patients treated for dementia-related psychosis.

An explanation of the data and advice for treating patients is available in an FDA notice to health care professionals being issued today.

The FDA today issued letters to the manufacturers of both types of antipsychotic drugs, under the new authority of FDAAA, notifying the manufacturers that they should make changes to drug labeling. Manufacturers of both classes of drugs are being asked to change labeling so that all of the drugs carry uniform warning language. Manufacturers of these drugs are required to submit new language to the FDA within 30 days, or to provide a reason why they do not believe such labeling changes are necessary. If they do not submit new language, FDAAA provides strict timelines for resolving the issue and allows the agency to initiate an enforcement action if necessary.

People taking antipsychotic drugs should not abruptly stop taking them. Caregivers and patients should talk to the patient’s health care professionals about any concerns.

The medications involved in this action are:

For more information, see

FDA Information for Healthcare Professionals: Antipsychotics

http://www.fda.gov/cder/drug/InfoSheets/HCP/antipsychotics_conventional.htm

FDA Historical Information on Atypical Antipsychotic Drugs

http://www.fda.gov/cder/drug/infopage/antipsychotics/antipsychotics_historical.htm

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Antipsychotic therapy is widely used to manage behavioural problems such as aggression which is sometimes associated with dementia; they are often prescribed prior to admission to a nursing home.

They are commonly used to treat psychosis with conditions such as schizophrenia, bipolar disorder, mania and delusional disorder.

The researchers from the Institute for Clinical Evaluative Sciences (ICES) in Ontario say elderly patients who are given antipsychotic drugs are at an increased risk of having an event that is serious enough to lead to hospitalization or death within a month of starting the therapy.

In a study which looked at all Ontario residents aged 66 years and older diagnosed with dementia, 20,682 older adults with dementia living in the community were compared with another 20,559 individuals living in nursing homes.

In a period stretching from April 1, 1997 to March 31, 2004 the researchers looked at the risk of developing serious events that led to hospitalization or death within 30 days of starting the therapy.

Lead author Dr. Paula Rochon, says it is a double edged sword because while the drug may make life easier in some very difficult situations, it may cause serious harm to the frail elderly and on the other.

Dr. Rochon says caution is needed even when short term therapy is being prescribed, to ensure that the benefits of the drug outweigh the risks for the individual.

The research revealed that 5.2 percent of the nursing homes residents died within a month of being given one of the newer class of antipsychotic drugs, compared to 3.3 percent of residents who did not take the drugs who died within a month.

Among community-dwelling patients, nearly 14 percent taking the drugs suffered a “serious health event” within 30 days, compared to about 4 percent not on the drugs.

The researchers say the study demonstrates the importance of the post-marketing surveillance of new drugs as clinical trials often fail to detect problems that occur when such drugs are used in wider community by frail individuals.

Dr. Rochon says regulatory bodies need to consider their findings in future with regard to deciding the future of such drugs and suggests the research has merely revealed “the tip of the iceburg”.

Antipsychotics first came into use in the 1950s – most of the drugs in the second generation, known as atypical antipsychotics, have more recently been developed and have commonly been in use with Alzheimer patients.

The FDA has now ordered the manufacturers of these newer antipsychotic medications which include Risperdal, Zyprexa and Seroquel, to add a new warning to already existing black-box warnings that the drugs are associated with an increased risk of death related to psychosis and behavioural problems in elderly patients with dementia.

The study also found that the older antipsychotic drugs such as Haldol, posed even higher risks, as much as four times the risk, of serious health problems or death.

The study was funded by the Canadian Institutes for Health Research.

URL: http://www.news-medical.net/?id=38665

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I’ve encountered an interesting video that discusses the Eli Lilly’s drug, Zyprexa by a formal Zyprexa sales representative

[youtube]http://www.youtube.com/watch?v=nj0LZZzrcrs[/youtube]

NEW YORK (Reuters) – Eli Lilly and Co (LLY.N: Quote, Profile, Research) said on Monday its first-quarter earnings rose on higher sales of its treatments for diabetes, cancer and depression.

The Indianapolis-based drugmaker earned $1.06 billion, or 97 cents a share, compared with $508.7 million, or 47 cents per share, in the year-earlier period.

(Reporting by Euan Rocha and Ransdell Pierson; Editing by Derek Caney)

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Bloomberg News

March 15, 2008

ANCHORAGE — Eli Lilly and Co.’s chief operating officer said the company should “seize the opportunity” to market its antipsychotic drug Zyprexa to teenagers and children in 2003, the state of Alaska claimed in a trial, citing a company e-mail.

John Lechleiter sent the March 17, 2003, e-mail to other company employees, noting that among child psychiatrists Zyprexa ranked “a distant third across a range of disorders” for drugs doctors were prescribing at the time. Along with Zyprexa, Lechleiter referred in his e-mail to Strattera, a Lilly drug approved for treating attention deficit hyperactivity disorder in children and adults.

“It appears to me that the fact we are talking to child” psychiatrists and pediatricians “and others about Strattera means that we must seize the opportunity to expand our work with Zyprexa in this same child- adolescent population,” he said in the e-mail shown at a hearing without the jury present.

Lechleiter is slated to replace Sidney Taurel as Lilly’s chief executive officer in April.

Alaska sued Lilly, the world’s largest maker of psychiatric medicines, in 2006, claiming the company withheld data on Zyprexa’s side effects on blood sugar, costing its Medicaid program millions of dollars by increasing the incidence of diabetes. The drug was approved only for adults with schizophrenia and bipolar disorder.

The state’s attorneys said the “seize the opportunity” phrase showed the company was marketing the drug for unapproved uses, in violation of federal law.

On Tuesday, Anchorage Superior Court Judge Mark Rindler denied Alaska’s motion to introduce the e-mail as evidence because he previously dismissed the state’s claim that Lilly marketed the drug for off-label uses. The state had said marketing for off-label uses was a form of failing to warn doctors and patients.

The e-mail was flashed before the jury briefly Thursday while attorneys for the state presented portions of Lechleiter’s deposition, taken last year. The exhibit was removed immediately.

The e-mail doesn’t indicate any improper marketing of Zyprexa, Lilly spokeswoman Tarra Ryker said Friday in a phone interview.

“The wording is unfortunate,” Ryker said. “What he meant was we needed to expand our clinical work so that we are able to answer doctors’ questions about using Zyprexa in adolescent patients.”

Lilly has conducted two clinical trials studying Zyprexa in teens and is awaiting an FDA decision whether it can expand the label allowing adolescent use, she said.

Before 2007, no so-called atypical antipsychotics had been approved for adolescents, Ryker said. Doctors were prescribing these drugs, and Lilly needed to provide safety and drug information, she said.

Alaska is seeking as much as $270 million in damages. The state claims Lilly withheld information about the drug’s risks to boost sales. Sales of Zyprexa tablets rose 9 percent to $4.76 billion last year, accounting for about a quarter of Lilly’s revenue.

Lilly shares fell $1.35, or 2.8 percent Friday, closing at $47.81, the lowest point in nearly 11 years.

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