Hurting Pharma Targets Alcoholics

Out of New Diseases and Blank Checks from Insurers, Pharma Targets Alcoholics

By Martha Rosenberg
August 2011

The gravy train of the 2000's is over for Pharma reports yesterday's Wall Street Journal. New drugs made the drug industry $11.8 billion in 2005 and only $4.3 billion last year-- almost two-thirds less.

Why? There are several reasons, says the Journal. Doctors have a "growing fear of prescribing new drugs with unknown side effects," the government is continuing to crackdown on Pharma's illegal marketing, and private and government insurers are becoming less willing to "cough up money for an expensive new drug--particularly when a cheap and reliable generic is available." Could the change be retroactive, some wonder?

It's gotten so bad, AstraZeneca, whose controversial Seroquel still makes $5.3 billion a year, now conducts "payer excellence academies" to teach reps to sell insurers and state health care systems on its latest drugs (if there's any more government money to loot, that is, or if private premiums can go any higher.)

Maybe that's why Pharma is now targeting the nation's millions of alcoholics and drugs addicts as its new revenue source. Like energetic kids who are really hyperactive and people with normal life problems who are really depressed, alcoholics and drug addicts, we are now told, really have a brain disease!

"Sixty percent of people with a substance abuse disorder also suffer from another form of mental illness, says an article in this week's New York Times' Science Times. (Another? ) They are "wired differently" and may have a "developmental brain disorder," says the article, next to a photo of Amy Winehouse, lest anyone miss The Point. But luckily, scientists are cracking the code and beginning to "find answers," says Science Times.
Pharma is mongering the "dual diagnosis" of alcoholics and addicts--they have both an addiction and a psychiatric illne$$ --with so much unbranded advertising and Madison Avenue spin, nationally known major rehab centers are telling their patients they have "co-occurring disorders," in a repudiation of basic recovery theory.
Getting the millions in bars and on street corners on antidepressants and other psychoactive drugs for their putative lack of "dopamine receptors," would certainly help Pharma through its slump as it runs out of people to call sick. But Nora D. Volkow, director of the National Institute on Drug Abuse, has bigger ideas: Let's give alcoholics and drug addicts vaccines, she said at last year's American Psychiatric Association's meeting in New Orleans. Rehabilitation professionals fell out of their seats.
Not only do we know the brains of alcoholics and addicts are different from normal people, say psychopharmacology buffs and brain researchers, not only do we know their addictions are progressive, with a little help (and more federal money) we can even identify who is At Risk. Just like we identify those with pre-asthma, pre-diabetes, pre-schizophrenia and pre-osteoporosis. Treat 'em early and often.
Let's use those gigantic government primate centers! Let's concoct more unnecessary vaccines. Let's help Pharma's decade of the biologic drug. Let's cement government/industry incest. Let's pimp the nation's alcoholics and addicts!
There's only one problem with Pharma's new buzz campaign and intended demographic. Alcoholics and addicts are neither mentally ill or suffering from a vaccine deficiency. They recover perfectly with the help of each other in self-help groups for free (a painful word for Pharma) and have done so for almost eighty years. More importantly, for alcoholics and addicts, drugs are the problem not the solution!

Martha Rosenberg is columnist and cartoonist based in Chicago.
Copyright � 2002-2011, OpEdNews

Riley's estate gets $2.5 million in lawsuits settlement with psychiatrist

The Patriot Ledger
Lane Lambert
Jan 25, 2011

BOSTON -- The attorney for Rebecca Riley’s estate said Tufts Medical Center psychiatrist Dr. Kayoko Kifuji has settled a civil lawsuit for $2.5 million.

The Suffolk Superior Court settlement comes almost a year after the 4-year-old Hull girl’s parents, Michael and Carolyn Riley, were convicted of murdering her in December 2006 with an overdose of Clonidine, which Kifjui had prescribed.

Rebecca was 2 when Kifuji diagnosed her with bipolar disorder and attention deficit hyperactivity disorder. Rebecca was given Clonidine for attention-deficit hyperactivity disorder and Depakote for the bipolar condition.

Benjamin Novotny of the Boston law firm Lubin & Meyer confirmed the settlement Monday. The amount is the limit for Kifuji’s malpractice insurance with Tufts, where she continues to practice.
The settlement has been put into trusts for Rebecca’s older brother and sister, for education and other expenses. Their parents’ convictions keep them from claiming a share of the money.
“This is the best possible result,” Novotny said. “We got everything we could.”

In a prepared statement Monday night, Tufts said the interests of Rebecca’s brother and sister are best served by the settlement, rather than a lengthy civil trial that would again subject all those who cared about Rebecca to “the painful details brought forth during the criminal trials.”
Novotny said Tufts has also agreed to start an awareness program, so young doctors know the dangers of over-prescribing such drugs. Tufts declined comment on that but said the hospital will be looking for ways to expand education programs for caregivers who treat “psychiatrically ill children in troubled homes.”

Michael Riley was convicted of first-degree murder and Carolyn Riley of second-degree murder. The case revived a nationwide controversy over whether such drugs should be prescribed for children as young as Rebecca.

Kifuji drew widespread outrage for her role with the family, especially after she escaped indictment by a Plymouth County grand jury and regained her medical license.

Rebecca was found dead and lightly clad on the floor of her parents’ bedroom on Dec. 13, 2006. Plymouth County prosecutors said the Rileys deliberately overdosed Rebecca because they were unable to secure federal Supplemental Security Income (SSI) for Rebecca, as they had for their other two children.

Trial testimony showed that Kifuji relied mainly on Carolyn Riley’s reports of Rebecca’s behavior, while numerous witnesses said they’d raised concerns about the effects of the drugs right up to the night Rebecca died.

Kifuji testified under immunity at the Rileys’ separate trials, and proved to be a cautious, frustrating witness for prosecutors and defense attorneys alike.

Kifuji voluntarily gave up her medical license when the Rileys were charged in February 2007. A court administrator filed the civil lawsuit for Rebecca’ estate in 2008.

Kifuji was cleared of criminal charges by a grand jury in the summer of 2009. A couple of months later a state medical board said she could practice again. She regained her medical license and returned to Tufts. The civil case didn’t move forward until the Riley trials were completed in March, 2010.

Novotny said the lawsuit was settled in late December but that the money was placed into Rebecca’s brother and sister’s trusts in the last few days. Her brother is reportedly in foster care, while her sister may soon be adopted.

He said the lawsuit appeared doubtful after Kifuji was cleared and the Rileys were convicted, but was settled in part because of public outcry and questions about the medical care Rebecca Riley got.

Lane Lambert may be reached at llambert@ledger.com.
READ MORE about this issue.Copyright 2011 The Patriot Ledger. Some rights reserved

Drug Company to Pay Half a Billion Dollar Fine for ILLEGAL Marketing

Mercola.com
The World's #1 Free Natural Health Newsletter
May 20, 2010

Drugmaker AstraZeneca has agreed to pay $520 million to settle federal investigations into marketing practices for its schizophrenia drug Seroquel. This makes AstraZeneca the fourth big drug company in the last three years to admit to federal charges of illegal marketing of antipsychotic drugs.

The company was accused of misleading doctors and patients by spotlighting favorable research while failing to adequately disclose studies showing that Seroquel increases the risk of diabetes.

The New York Times reports that:

"AstraZeneca still faces more than 25,000 civil lawsuits filed on behalf of patients contending that the company did not disclose the drug's risks. "

Sources:
New York Times April 26, 2010
The United States Department of Justice April 27, 2010


Dr. Mercola's Comments:

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The illegal and unsafe actions of drug companies make headlines yet again as AstraZeneca agrees to pay a $502 million fine to settle the federal charges of using illegal marketing tactics to drive up sales of its blockbuster drug Seroquel.

Although this sounds like a lot of money, it's little more than a symbolic slap on the wrist when you consider how much money they've made from the drug already. According to the New York Times, the antipsychotic drug Seroquel pulled in $4.9 BILLION in sales last year!

You see from the company's perspective it's merely another cost of doing business. For every dollar they are fined they are making ten. While not all of their profit was due to their illegal marketing practices, the fine was only a one-time fine, while revenues have poured in over many years and will continue to do so in the future, as a result of these illegal activities.

How Did Potent Antipsychotics Become the Top Selling Drug Category in US?

Amazingly, and something that not even I had realized until this article was being written, is that this class of antipsychotics has now surpassed cholesterol-lowering drugs as the top-selling category of drugs in the US!

This fact, in and of itself, should be a red flag that something has gone seriously awry, because no nation could possibly have that many psychotic residents.

And that's just... We don't.

Using illegal marketing tactics to promote the use of Seroquel and other drugs like it has greatly expanded the sale of these types of drugs for far less serious, and at times completely unrelated, ailments.

Making matters even worse, they've also been heavily promoted for seniors and children - groups in which this drug can be far more dangerous.

Seroquel has been found to cause rapid weight gain and diabetes, for example. And seniors with dementia are at a higher risk of death when taking this drug. These are just a couple of reasons why Seroquel has been unable to gain FDA approval for certain uses. And yet, AstraZeneca, like so many other drug companies, chose to put profits before safety and health once again.

Puny Fines after Making Massive Illegal Profits Seem to Be the Norm

Just last month I discussed the case of Pfizer, the world's largest pharmaceutical company, that was "punished" with a fine that amounted to three month's worth of profit for the illegal marketing of the painkiller Bextra.

In 2005, when Bextra was pulled from the market due to its increased risks of heart attack and stroke, about half of its $1.7 billion in profits that year were due to unapproved off-label uses.

There's no doubt that Seroquel's blockbuster status and massive sales are in large part due to dangerous off-label uses as well.

Seroquel was approved by the FDA in September 1997 for "the treatment of manifestations of psychotic disorders."

Three years, later, the FDA actually considered NARROWING its approval to the short term treatment of schizophrenia only. However, by January, 2004, the drug was approved for the short term treatment of acute manic episodes associated with bipolar disorder (bipolar mania), and two years later, they also approved it for bipolar depression.

Schizophrenia and bipolar disorder are serious mental disorders that in many cases may warrant drug treatment, at least short term. However, AstraZeneca also pushed Seroquel for things like anger management, ADHD, Alzheimer's disease, and even difficulty sleeping!

No federal criminal charges have been filed against the company, but I wonder if that wouldn't be justified. After all, they're promoting a potent drug for diseases that they were never formally studied or approved for.Without this important proof of safety and effectiveness, they have put countless human lives at risk for serious side effects, including premature death.

How is this NOT a crime?

But wait, of course no criminal charges will be filed because, just like Wall Street bankers, these companies are "too big to fail". What a load of horse manure, pardon my language. Nevertheless, that is what happens when your profits are so large you can afford to lobby and payoff the right people in government, to effectively insulate you from any prosecution.

Yes these companies are VERY clever.

Off-Label Use of Drugs Increase Your Risk of Harmful Side Effects

While doctors can legally prescribe FDA-approved medications off-label for any use, drugmakers are not allowed to market them for anything other than approved uses.

Many physicians, however, for all intents and purposes rely nearly exclusively on drug reps to educate them about the indications for drugs and what other leading physicians are using them for, and drug companies are not shy about suggesting off-label uses.

As demonstrated by this recent rash of lawsuits, drugmakers actually go several steps further, by fraudulently manipulating doctors into prescribing their drugs for ailments that they could not gain approval for in the first place.

Complicating matters further is the fact that it can be difficult for physicians to determine what certain medications are approved for, based on the Summary of Product Characteristics (SPC) -- the information given to physicians about drugs.

In fact, according to a 2009 study, it was impossible for physicians to determine the licensing status for about 20 percent of drug... which means it's even more likely they'll rely on drug reps' opinions and suggestions.

Off-label drug use is actually extremely common, for drugs of all kinds.

According to studies conducted in Britain, when a "suitable alternative" did not exist, doctors used unlicensed or "off label" medicine in:

* 90 percent of babies in neonatal intensive care units
* 70 percent of children in pediatric intensive care units
* Two-thirds of children on general medical and surgical pediatric wards in the UK

According to two of the studies, children taking these medicines face a higher risk of side effects, with one estimate suggesting they suffer up to three times more side effects as a result.

This is why it's so important that drug companies refrain from these illegal marketing tactics, because doctors mislead by their pharmaceutical reps are literally putting their patients' lives at risk!

As Michael L. Levy, U.S. Attorney for the Eastern District of Pennsylvania stated:

"People have a legal right to know that pharmaceutical companies are marketing their drugs only for uses approved by the FDA and that their doctors' judgment has not been affected by misinformation from a pharmaceutical company trying to boost revenues."

In the end that's all it is... Promoting drugs for off-label uses has nothing to do with trying to help more people. It's all about making more money off a drug that has a limited market.

The Dangerous Side Effects of Seroquel

It's hard to believe that anyone would agree to take such a potent antipsychotic unless they were suffering from a serious mental illness, but the numbers prove that plenty of people do.

This choice can be a devastating one. (And remember, it IS a choice. Your doctor cannot force you to take any drug, and in many cases, people see an ad on TV and voluntarily ask for the drug.)

The potential side effects of taking Seroquel are numerous, and some of them can be fatal.

For example, elderly patients who have lost touch with reality as a result of dementia are at an increased risk of death, which is why Seroquel is not approved for this use.

Seroquel can also increase your risk of suicidal thoughts and actions, especially in children, teens and young adults.

It's worth noting that the list of serious side effects is far longer - and these reactions are FAR MORE COMMON - than the list of the non-life threatening adverse reactions.

For example, some of the most common side effects of Seroquel include:

* High triglycerides in 23 percent of patients
* Weight gain in 23 percent of patients
* Agitation in 20 percent of patients
* High cholesterol in 17 percent of patients

Meanwhile, mild side effects like nausea, congestion and stomach pain are far less common, occurring in only two to ten percent of patients.

Be One Less Victim

Fortunately, you can avoid becoming the next victim by taking control of your health. This means educating yourself about your condition, any symptoms you may have, the drugs your doctor recommends, and other alternatives.

I can't stress this enough: You are NOT REQUIRED to take a drug recommended by your doctor.

You ARE allowed to demand detailed answers to any questions you have about the drug prescribed to you, and if you decide that the risks are greater than the potential benefit, you can "just say no," and seek out alternatives.

Remember, this is your life, and your health, so take an active role in it!. If your doctor pressures you to take it, remember that there are other doctors out there and it is probably best to find someone else who will actually LISTEN to you.

Leading a healthy lifestyle and staying educated about drug-free and non-invasive treatment options are the keys to your long-term well-being.

It's unfortunate, but many are still completely unaware of the pervasive corruption that exists within the field of pharmaceuticals. You need to understand that any corporation's primary and essential responsibility is to their shareholders -- NOT to you.

Drug companies have accumulated so much wealth, power and political influence that they're able to escape any serious consequences linking them to profiting from permanently disabling, crippling or even killing consumers. This is why it's so imperative you make your own informed decisions rather than blindly trusting the system.

Physicians must also, en masse, come to the realization that drug reps cannot be trusted. This may be one of the most difficult areas to change, as the pharmaceutical industry has devised a highly effective system of indoctrination and very specific psychological techniques to manipulate physicians.

Doctors usually believe they are immune to persuasion tactics, and drug reps know just how important it is to maintain that illusion -- which is why it works so well. However, the idea that reps provide a valuable, informative service to physicians is total fiction, created and perpetuated by the drug industry, to keep this deadly, but profitable, scheme going.

Until real change takes place, I urge you to not risk your money or your life on a paradigm designed to profit from your ill health.

Instead, take control by adopting natural lifestyle strategies that will promote your body's natural healing abilities without the need for the drug companies' latest creations.

Nursing Home Drug Use Puts Many at Risk, Antipsychotics given to some with dementia

The Boston Globe
By Kay Lazar, Globe Staff
March 8, 2010

Nearly 2,500 nursing home residents in Massachusetts were given powerful antipsychotic drugs last year that were not intended or recommended for their medical condition, a practice that is more common here than in most other states, according to a Globe analysis of federal data.

Data collected by the federal Centers for Medicare and Medicaid Services show that 28 percent of Massachusetts nursing home residents were given antipsychotics in 2009. Of that group, 22 percent - or 2,483 - did not have a medical condition that calls for such treatment.

That rate was the 12th highest in the nation, according to the federal data.

The use of such drugs is especially worrisome in nursing homes because a substantial number of residents suffer from dementia, a condition that puts them at greater risk of death when given antipsychotic medications.

The drugs, also known as “‘psychotropics,’’ were developed to treat people with severe mental illnesses such as schizophrenia, not dementia, which is the progressive loss of memory or other intellectual function than can result from aging or Alzheimer’s disease.

Twice in the past five years, federal regulators have issued nationwide alerts about troubling and sometimes fatal side effects when antipsychotics are taken by people with dementia, including increased confusion, sedation, and weight gain.

Scott Plumb, senior vice president of the Massachusetts Senior Care Association, the trade group representing the state’s 440 nursing homes, said Massachusetts’ consistent ranking as one of the heaviest users of psychotropic drugs indicates much more training is needed in nursing homes.

“We recognize the number is too high,’’ Plumb said, “and we are working to try to bring it down.’’

As the nation ages - up to 14 million baby boomers are expected to develop Alzheimer’s disease or a similar dementia - the drugging of such vulnerable patients takes on increasing urgency. While there has been much focus on the increasing use of antipsychotic drugs among children - highlighted by the recent overdose death of 4-year-old Rebecca Riley - much less attention has been paid to the similar problem among seniors.

“Way too many patients in nursing homes are treated with antipsychotics purely to sedate them or to control behaviors that are difficult for the staff,’’ said Robert A. Stern, an Alzheimer’s specialist and brain researcher at Boston University School of Medicine.

“To the defense of nursing homes and nursing home staff,’’ Stern said, “they are indeed understaffed, they are indeed under-trained, and it takes an awful lot of well-trained people to manage the difficult behaviors that can be exhibited by people with dementia.’’

While there is no barometer for what is considered an appropriate amount of antipsychotic use in nursing homes - and there is no law governing the matter - specialists in caring for the elderly note that the use of antipsychotics is much lower in some homes than others, and in some states than others.

They also point to the federal government’s recent legal action against the largest provider of drugs to nursing homes in the United States. The company, Omnicare, agreed in November to pay $98 million to settle charges that it took kickbacks from Johnson & Johnson to recommend the drug maker’s products, including the antipsychotic Risperdal. The government said Omnicare persuaded physicians to prescribe the medication to dementia patients with behavioral problems. A government suit against J&J is pending.

Specialists say antipsychotics can improve the quality of life for some dementia patients who suffer from extreme agitation and sleeplessness, common symptoms of Alzheimer’s. But too often nursing homes don’t regularly reevaluate patients’ medications to determine whether the antipsychotics are, in fact, effective and whether the dose can be lowered or eliminated, said psychologist Paul Raia, vice president of clinical services for the Massachusetts and New Hampshire Alzheimer’s Association.

Raia helps train nursing home staff in behavior management techniques that can ease agitation and the need for the drugs - skills and training that, specialists say, are often lacking in nursing homes in Massachusetts and across the country. In these homes, he said, as many as 80 percent of the residents are on antipsychotic drugs.

“And then I walk into a good place, one with training, and see 2 or 3 percent on these medications,’’ he said.

A nursing home’s track record for antipsychotic use often is a good predictor for future patients, according to new research from the University of Massachusetts Medical School. The scientists analyzed data from 1,257 nursing homes nationwide and found that patients newly admitted to facilities with some of the highest rates for prescribing antipsychotics are 37 percent more likely to receive the drugs than patients entering homes with the lowest prescribing rates.

Nicki Solomon of Norwood has seen those highs and lows. In 2007, she placed her mother, Corinne, in a nursing home. Although the retired surgical nurse suffered from dementia, she was still able to feed herself and converse clearly, but she had lost her short-term memory, was sometimes agitated and anxious, and would wander off.

Solomon said the nursing home, High Gate Manor in Dedham, asked her permission to prescribe her mother an antipsychotic but didn’t explain the potential side effects. Within weeks, Solomon said, her mother was transformed into someone she didn’t know.

“My mother was out of it all the time. She was asleep and noncommunicative,’’ Solomon said. “She was smothered.’’

She had been given Seroquel, Solomon said, one of the drugs that federal regulators months later would specifically warn against for dementia patients.

High Gate, citing patient confidentiality laws, declined to comment on Solomon’s care.

In June 2008, Solomon transferred her mother to a Needham nursing home that specializes in using alternatives to medication in caring for dementia patients. Her mother rebounded, she said, living another 15 months before her death last November.

Alice Bonner, the state’s top nursing home regulator as director of the Bureau of Health Care Safety and Quality, said “culture change,’’ including a growing consumer movement that focuses on more closely involving families and patients in care decisions, can lower the use of psychotropic drugs.

“We can do better, and use fewer drugs, and do more with behavioral interventions by changing the way we deliver care in nursing homes,’’ she said. Her agency is developing a brochure for nursing homes to give new residents and their families, encouraging them to ask y about the medications prescribed.

For Sharlene Hemp, a North Andover resident who says her father died from side effects of psychotropic drugs just 34 days after entering a nursing home, the answer is legislation. Her father had Alzheimer’s, but she said the family was never told about the medications nor of the potential lethal side effects, until after his death in 2001.

Hemp persuaded her state senator, Steven A. Baddour, to file legislation that would require all Massachusetts nursing homes and their prescribing physicians to obtain written permission from a patient’s health care proxy, which is often a family member, and a court appointed guardian before using antipsychotic medications. A public hearing was held on the bill in January, and it remains in committee.

“When you put a loved one in a nursing home, you are putting your trust in the nursing home and the doctor,’’ Hemp said. “But you don’t know when they go in that they are given all these drugs, and especially dementia patients, because they can’t tell you what they are given.’’

Kay Lazar can be reached at klazar@globe.com.
© Copyright 2010 The New York Times Company

AstraZeneca drops psychiatric, other drug research

Reuters
March 2, 2010

LONDON, March 2 (Reuters) - AstraZeneca (AZN.L) is to stop researching some disease areas that form the backbone of its current business -- including schizophrenia and acid reflux -- in a drive to focus R&D efforts and cut costs.

The Anglo-Swedish drugmaker, which faces one of the sector's worst "cliffs" of expiring drug patents, told its staff on Tuesday it would cease discovery in 10 of its current disease areas, or around one quarter of the total.

A wide-ranging overhaul had been expected since the group said in January it was cutting a further 8,000 staff, or some 12 percent of the workforce, including a net 1,800 in research. But it is only now that staff know where the axe will fall.

AstraZeneca is not alone in taking the knife to previously sacrosanct R&D, though its cuts are particularly deep. Pfizer (PFE.N) and GlaxoSmithKline (GSK.L) are also ditching drug discovery work that does not pay its way. [ID:nLDE61408I]

AstraZeneca will still invest across the same therapy areas but said it would drop discovery in schizophrenia, bipolar disease, depression, anxiety, acid reflux, thrombosis, ovarian and bladder cancers, systemic scleroderma and hepatitis C.

It also plans to end early vaccine research other than for flu and respiratory syncytial virus (RSV).

"AZ is going to continue to be a research-focused company. We will not diversify to the extent that some of the others are doing," development head Anders Ekblom told Reuters.

"We are focusing on the diseases areas where we would like to be."

UNPREDICTABLE TRIALS

The decision to drop psychiatry drug research reflects the unpredictable and risky nature of clinical trials to assess medicines working on the brain, as well as a lack of good scientific opportunities, he said.

For AstraZeneca, this a major shift, since its second biggest seller is schizophrenia drug Seroquel and it recently struck a deal worth up to $1.24 billion for an antidepressant from Targacept (TRGT.O). [ID:nGEE5B208U]

Ekblom said he remained confident about the Targacept drug, which is shortly to start final Phase III tests, but saw limited longer-term opportunities in the psychiatric field.

His views echo those of Glaxo CEO Andrew Witty, who last month said Glaxo would stop researching antidepressants because of uncertain returns.

The move away from acid reflux ends a line of AstraZeneca drug development that created the stomach ulcer and heartburn treatments Losec and Nexium, its biggest sellers, while exiting thrombosis comes just as its big new blood-thinner hope Brilinta awaits regulatory approval.

Despite the decision to exit certain areas, Ekblom said AstraZeneca would still advance those products already in the pipeline and might also license in drugs, if the opportunity was right.

There will be major changes for staff as the research machine is reorganised.

In the United States, early-stage discovery research will cease at Wilmington, Delaware, while the Swedish research site in Lund will close, as will the British site at Charnwood, as respiratory and inflammation work moves to Moelndal in Sweden.

AstraZeneca also aims to sell its Arrow Therapeutic antiviral business in London, acquired in 2007 for $150 million. (Editing by Jon Loades-Carter)

AstraZeneca facing 26,000 suits over Seroquel

Bloomberg News
February 4, 2010
By JEF FEELEY and MARGARET CRONIN FISK

AstraZeneca PLC is facing as many as 26,000 lawsuits over its antipsychotic drug Seroquel as the drug maker prepares for its first jury trial over claims the medicine causes diabetes, according to court filings.

Attorneys for AstraZeneca, which has its U.S. headquarters in Fairfax, met with plaintiffs' lawyers in court-ordered mediation sessions last month to discuss a possible settlement, according to court filings. Consumers' lawyers said they had about 26,000 cases in their inventories, Stephen Saltzburg, a George Washington University Law School professor who served as mediator, said.

"I wish there were a magic wand that could be waved to settle all Seroquel cases instantly," Saltzburg said in the filing. "Such a wand does not exist."

In a Securities and Exchange Commission filing last week, AstraZeneca executives noted the company has paid about $656 million to defend itself in Seroquel cases. That's an increase of 28 percent, or $144 million, over last year's Seroquel defense costs, according to regulatory filings. The company said it had insurance of $521 million to cover Seroquel defense costs as of December.

The company said in the SEC filing it faces more than 25,000 claims that Seroquel caused diabetes. That's a 65 percent increase in cases over the number the company reported in a January 2009 regulatory filing. Many of the suits also claim AstraZeneca promoted Seroquel, approved for schizophrenic and bipolar patients, for unapproved uses.

Saltzburg said the two-day talks didn't generate a resolution, but he expects negotiations will take place at some point between the company and individual users' lawyers.

"The question is what is fair for plaintiffs and what is fair for AZ," the professor said in the report. "The parties are far apart at the moment on resolving that question."

AstraZeneca's stock fell last week after the drug maker's sales forecast and stock-buyback plan disappointed some analysts and fourth-quarter profit missed estimates. The company plans to buy back as much as $1 billion of shares this year, managers said Jan. 28.

A New Jersey judge has set a Feb. 16 trial date for the first of thousands of Seroquel cases filed in that state to go before a jury. Seroquel, which generated sales of $4.9 billion last year, is AstraZeneca's second-biggest seller after the ulcer treatment Nexium.

"The evidence, looked at fairly and fully, does not back up the allegations that Seroquel was responsible for the plaintiffs' alleged injuries," AstraZeneca spokesman Tony Jewell said in an e-mail.

In November, a judge in Florida who is overseeing all federal-court litigation over Seroquel ordered the company to meet with plaintiffs' lawyers and Saltzburg to discuss settlement.
U.S. District Judge Anne Conway in Florida, who is overseeing pre-trial proceedings in federal Seroquel litigation, said in November that she would ask a panel of judges to return the 6,000 cases consolidated before her to their home courts for trial.

Bipolar diagnosis jumps in young children: study

Ros Krasny
(Reuters)
BOSTON

Fri Jan 15, 2010

BOSTON (Reuters) - The number of children aged 2 to 5 who have been diagnosed with bipolar disorder and prescribed powerful antipsychotic drugs has doubled over the past decade, according to research released on Friday.

Health

The research suggests that while it is still rare to prescribe powerful psychiatric drugs to 2-year-olds, the practice is becoming more frequent.

The data, compiled from 2000 to 2007, and published in the Journal of the American Academy of Child & Adolescent Psychiatry, could inform testimony at the upcoming Boston-area murder trials of the parents of 4-year-old Rebecca Riley. The girl died of an overdose of mood-stabilizing medication in 2006.

A Boston child psychiatrist, Kayoko Kifuji, diagnosed Riley with bipolar disorder and attention deficit hyperactivity disorder when she was 30 months old, and placed her on several powerful drugs: Depakote, an antiseizure medication also used for bipolar disorder, and clonidine, a blood pressure medication.

Kifuji's testimony may be crucial to the fate of Michael and Carolyn Riley, who face first-degree murder charges. A grand jury and a review by the state's medical licensing board cleared the doctor of wrongdoing.

Prosecutors claim the Rileys deliberately overmedicated their daughter to subdue her. The couple say they were following Kifuji's instructions and their daughter died of pneumonia.

The case has shone the spotlight again on a debate within the psychiatric profession about whether bipolar disorder can be diagnosed in very young children and whether it is wise to prescribe powerful medications.

BIPOLAR TODDLERS?

Bipolar disorder, characterized by severe mood swings, was once thought to emerge only during adolescence or later. But Dr. Joseph Biederman, a child psychiatrist at Harvard University, transformed views on the subject by arguing that children could have the disorder at extremely young ages.

He is credited with spearheading a more than 40-fold increase in the number of children diagnosed with bipolar disorder over the past decade.

Biederman was accused in 2008 by Republican U.S. Senator Charles Grassley of failing to fully disclose payments by drug companies, including some that produced medication for bipolar disorder. Biederman declined to be interviewed about the latest study.

"The psychiatric diagnosis of very young children is anything but an exact science," said Harry Tracy, a psychologist and publisher of NeuroInvestment, a monthly publication specializing in central nervous system disorders.

"Such disparate causes as ADHD, depression, bipolar disorder, sexual abuse, and family dysfunction can produce very similar symptoms in a toddler."

The report's author, Mark Olfson, professor of clinical psychiatry at Columbia University, said about 1.5 percent of all privately insured children between the ages of 2 and 5, or one in 70 children, received some sort of psychotropic drug -- whether an antipsychotic, a mood stabilizer, a stimulant or an antidepressant -- in 2007.

If a child is diagnosed with bipolar disorder between the ages of 2 and 5, about half are prescribed an antipsychotic, such as Eli Lilly & Co's Zyprexa, AstraZeneca Plc's Seroquel, and Johnson & Johnson's Risperdal. They are prescribed to about one in 3,000 2-year-olds, according to his report.

"There might be a role for these drugs but only after you've tried other interventions, with the parents, or with the parents and child together, but that is not happening when you examine the billing records," Olfson said.

(Additional reporting by Toni Clarke; Editing by Peter Cooney)