Psych Diagnoses Fraud Leads to Pharmaceutical Prosecutions

NowPublic.com
Kevin Hall
October 8, 2012

Nearly all major psychiatric drug manufacturers have been convicted of illegal marketing and/or fraudulent claims. Several of these cases are linked below. Any that haven't been prosecuted, probably should be.

The reason behind this is simple. There are no medical tests to confirm or deny any mental disorder or diagnoses. A few decades back, psychiatrists "voted" that mental "illness" was caused by a "chemical imbalance of the brain." This is drug marketing, not science. Nobody votes in diabetes or cancer as medical disease and there are sound medical and lab tests for these and other medical diseases.

Psychiatric diagnoses is merely opinion of behavior. Psychiatrists simply vote on what is or is not a mental disorder and place these diagnoses into the American Psychiatric Association's "Diagnostic and Statistical Manual." Their controversial DSM5 is set to be released in 2013 and will likely lead to more pharmaceutical fraudulent marketing prosecutions and settlements.

The reason is simple. If there is no identifiable disease, there can never be a drug that will cure. In fact, there are no cures for any mental disorders. The drugs are generally uppers (ADHD drugs) or downers (anti-anxiety drugs and antipsychotics) that merely mask symptoms in some cases while having extremely dangerous side effects. The upper-type antidepressants have been proven to be very little, if any, more effective than a placebo (sugar pill) yet greatly increase sexual dysfunction while also increasing the likelihood of violence and suicide. Honest marketing would refer to them as anti-sex drugs.

The flow (explained and graphed here) is that psychiatrists create a disease by voting, then pharmaceuticals make the drug. Psychiatrists, usually at major universities, create fraudulent studies that the FDA approves on the word of the drug companies that funded the studies. Once they get approval for a certain condition (such as depression) and population (such as men over age 18, etc.), they get some paid-off psychiatrist to create and get published a study saying that the drug is helpful for other populations and diagnoses. This allows for what is termed off-label prescribing.

It's all fraud and all prosecutable.

The story printed below on Abbott Labs (Depakote) came out last week. It's the Virginia Attorney General's press release www.oag.state.va.us/Media%20and%20News%20Releases/News_Releases/Cuccinelli/100212_Abbott_Labs.html .
Here are some other links to recent settlements with:

GlaxoSmithKline (Paxil) http://www.justice.gov/opa/pr/2012/July/12-civ-842.html ;

Johnson & Johnson, (Risperdal, Invega) www.nytimes.com/2012/04/12/business/drug-giant-is-fined-1-2-billion-in-arkansas.html?_r=0, www.bloomberg.com/news/2012-08-30/j-j-will-pay-181-million-to-settle-risperdal-ad-claims.html, http://www.bloomberg.com/news/2012-08-31/j-j-loses-appeal-of-257-7-million-risperdal-verdict.html  ;

Pfizer, (Zoloft,Geodon, etc.) www.msnbc.msn.com/id/32657347/ns/business-us_business/t/pfizer-pay-record-billion-penalty/#.UHLjXVF_P1U ;

Astrazeneca, (Seroquel) www.azcentral.com/business/articles/2010/04/27/20100427astra-zeneca-settlement.html ;

Bristol-Myers Squibb (Abilify) www.justice.gov/opa/pr/2007/September/07_civ_782.html ;

Eli Lilly (Zyprexa) www.justice.gov/opa/pr/2009/January/09-civ-038.html .

Maybe it is time that some of the psychiatrists creating the fraudulent diagnoses and studies start getting criminally prosecuted for fraud?


Commonwealth of Virginia
Office of the Attorney General


For media inquiries only, contact:  Brian J. Gottstein
Email: bgottstein@oag.state.va.us (best contact method)
Phone: 804-786-5874

Sentencing in Abbott Labs Depakote case: Judge approves $1.5 billion settlement to resolve complaints of off-label promotion of drug

~ Virginia-led investigation was largest state Medicaid fraud investigation in U.S. history ~

ABINGDON, VA (October 2, 2012) - As part of the largest Medicaid fraud case ever led by a state, Attorney General Ken Cuccinelli announced the sentencing of global health care company Abbott Laboratories Inc. in the United States District Court in Abingdon, Va., today. The court approved the $1.5 billion settlement reached on May 7, 2012, among Abbott, Virginia, the United States government, and 48 other states and the District of Columbia, in which Abbott pled guilty to a criminal charge and admitted civil liability for the company's unlawful promotion of the prescription drug Depakote for uses not approved as safe and effective by the Food and Drug Administration (FDA). 

The attorney general's Medicaid Fraud Control Unit (MFCU) was the lead investigative agency in the case, partnering with the prosecutors and civil attorneys from the U.S. Attorney's Office for the Western District of Virginia. This was the largest Medicaid fraud recovery in U.S. history resulting from a state-led investigation, with the Virginia MFCU spending more than four years on the investigation, traveling to 26 states to conduct interviews and sifting through more than one million records looking for evidence.

When it pled guilty in May, Abbott agreed to pay $1.5 billion to resolve its criminal and civil liability pertaining to government health care programs that were defrauded based on reimbursements paid for Depakote due to Abbott's illegal marketing practices. The settlement that was approved today includes a criminal fine and forfeiture totaling $700 million and civil settlements with the federal government and the states totaling $800 million. The civil settlement includes $270 million for the federal government's share of the Medicaid program; $239 million for the states' share of the Medicaid program; and $291 million for Medicare and other federal programs. Abbott will also pay a $500 million fine to the federal government, $198.5 million in criminal asset forfeiture penalties, and $1.5 million to Virginia MFCU to cover investigative costs. Virginia's share of the Medicaid civil settlement is $4.2 million. 

Abbott must also agree to the terms of a Corporate Integrity Agreement with the Office of the Inspector General for the Department of Health and Human Services.

"I've made fighting Medicaid fraud a priority in Virginia by increasing the size of our fraud team by adding 30 new people over the last two years," said Cuccinelli. "I'm committed to ensuring that money intended for medical services for the poor isn't stolen from them and the taxpayers through fraud. Medicaid dollars are limited, and fraud deprives people in true need of necessary medical care."

He continued, "This settlement will allow 49 states, the District of Columbia, and the federal government to recover money fraudulently taken from Medicaid, Medicare, and other health care programs." Louisiana is pursuing separate litigation.

On May 7, Abbott pled guilty to misbranding Depakote by promoting the drug to control agitation and aggression in elderly dementia patients and to treat schizophrenia when neither of these uses was FDA approved. In an agreed statement of facts filed in the criminal action, Abbott admitted that from 1998 through 2006, the company maintained a specialized sales force trained to market Depakote in nursing homes for the control of agitation and aggression in elderly dementia patients, despite the absence of credible scientific evidence that Depakote was safe and effective for that use. In addition, from 2001 through 2006, the company marketed Depakote in combination with atypical antipsychotic drugs to treat schizophrenia, even after its clinical trials failed to demonstrate that adding Depakote was any more effective than an atypical antipsychotic alone for that use.

The FDA is responsible for approving drugs as safe and effective for specified uses. Under the Food, Drug and Cosmetic Act (FDCA), a company in its application to the FDA must specify each intended use of a drug. A company's promotional activities must be limited to only the intended uses that are FDA approved. Promotion by the manufacturer for other uses - known as "off-label" uses - renders the product misbranded, and is illegal.

 For more information on the history of the Abbott Labs settlement, please click here.

Virginia's role in the Abbott case

In September 2007, the Virginia attorney general's Medicaid Fraud Control Unit (MFCU) was contacted with allegations of off-label drug marketing by Abbott Pharmaceuticals.

Although neither the whistleblowers nor the defendant in this case were located in Virginia, the whistleblowers came to Virginia because the MFCU has a national reputation for successfully investigating major national cases, such as the Purdue Pharma Oxycontin case, the Octagon case, and others.

Following Virginia MFCU's initial investigation, the unit contacted the U.S. Attorney's Office for the Western District of Virginia because of their history of working together on such cases. They then began a joint investigation.

On October 31, 2007, the first qui tam ("whistleblower") suit was filed in the United States District Court in Abingdon, Va., against Abbott Laboratories for marketing the drug Depakote for off-label uses. Three other qui tam complaints from other relators were subsequently filed.

MFCU investigators operating out of the attorney general's offices in Roanoke and Abingdon were assigned to the investigation full-time and spent more than four years and 38,000 man-hours on the investigation, traveling to 26 states to conduct interviews and sifting through more than one million records looking for evidence.

The investigation uncovered that Abbott illegally marketed Depakote for non-approved uses, including as an alternative to antipsychotics to treat dementia patients in nursing homes, and for schizophrenia. The investigation also revealed that Abbott paid rebates to health care professionals and long-term care pharmacies for increasing their off-label use of Depakote. 

Attorney General Cuccinelli would like to thank Randall "Randy" Clouse, Director and Chief of Health Care Fraud and Elder Abuse section, and the following MFCU investigators and attorneys for their work in this case: Erica Bailey, Mary Blackburn, Steve Buck, Beverly Darby, Harold Erwin, Elizabeth Fitzgerald, William Clay Garrett, Doug Johnson, John Johnston, Kristy Knighton, Adele Neiburg, John Peirce, and Joey Rusek.

Virginia's MFCU: A history of stopping Medicaid fraud

The Virginia MFCU was established in 1982 within the attorney general's office to investigate and prosecute insurance fraud against the federally funded Medicaid program for indigent health services. MFCU employs a professional staff of criminal investigators, auditors, and several assistant attorneys general who are experienced in commercial and financial investigations. MFCU works regularly with federal and state law enforcement agencies, as well as private insurance companies operating within Virginia.

Over the past 30 years, prior to the Abbott case, Virginia's MFCU had recovered nearly $800 million by tracking down and prosecuting Medicaid fraud offenders. This fiscal year alone, MFCU has recovered more than $22 million. MFCU was also involved in the recovery of more than $634 million after a joint criminal investigation revealed that Purdue Pharma Company fraudulently misbranded the drug OxyContin by marketing the drug to physicians as a slower release -- and thus less addictive -- drug than other prescription opioids. 

From 2010 to today, Attorney General Cuccinelli increased the number of Medicaid fraud and elder abuse staff by more than 50 percent (from 56 to 86) to better combat fraud in Virginia's Medicaid program and to protect the elderly from individuals who abuse and neglect them in nursing homes and health care facilities. It is the only section of the office that he has grown significantly during his tenure, while he has maintained a smaller general fund budget allocation than when he came into office.

Inside 60 Minutes placebo story, antidepressants no better than placebo

CBS News
February 17, 2012

Some new scientific research is causing quite a stir in the medical community.

The fight is over antidepressants, and whether they work any better than a simple placebo.

In an report airing this Sunday, "60 Minutes" correspondent Lesley Stahl spoke to the psychologist behind the study, Irving Kirsch, associate director of the Placebo Studies Program at Harvard Medical School.

Preview: Treating Depression

He says that his research challenges the very effectiveness of antidepressants. Kirsch says the difference between the effect of a placebo and the effect of an antidepressant is minimal for most people.

In her interview with Kirsch, Stahl asks, "You're saying if (patients taking antidepressants) took a sugar pill, they'd have the same effect?"

Kirsch replied, "They'd have almost as large an effect, and whatever difference it would be, would be clinically insignificant."

Stahl presses, "But people are getting better taking antidepressants, I know them. We all know them."

"People get better when they take the drug, but it's not the chemical ingredients of the drugs that are making them better," Kirsch said. "It's largely the placebo effect."

Kirsch's specialty has been the study of the placebo effect -- the taking of a dummy pill without any medication in it, that creates an expectation of healing that is so powerful, symptoms are actually alleviated.

In addition to an interview with Kirsch, Stahl interviewed doctors who don't agree with Kirsch's study.

On "CBS This Morning," Friday Stahl called the report "explosive."

She said, "Basically (this report) is saying that -- except for those very severely depressed, because everybody says that these antidepressants do work if you're -- if it's a depression that you just can't get over. But if you're moderately depressed or mildly depressed, a sugar pill would be just as good."

"It's the placebo effect," Stahl continued. "And part of our story involves how the mind is so powerful over the body that the placebo effect shows up even if you have knee surgery, with osteoporosis, if you have Parkinson's disease. All these diseases that somehow involve the mind and it's not just in the mind. A sugar pill can actually change your blood pressure, they've monitored the brain, it can change the brain chemistry and the doctor giving you the pill, if it's a sugar pill, just telling you he cares and, 'Yes, I know you're sick and here's something to help you, that doctor is part of the placebo effect.'"

So are doctors prescribing sugar pills?

Stahl said she asked that question throughout her reporting, but learned it's not an ethical practice.

"There are side effects with antidepressants," she said. "It's not ethical. But you know, in my head, to give a pill that is as good as a placebo with side effects isn't ethical either. So I think why not give a sugar pill. But they don't do it, they won't do it."

For more with Stahl on her upcoming report, including what it means for people taking antidepressants and the companies that make these prescription drugs, watch the video in the player above.

Accident risk doubled by SSRI use: study

Pharmacy News
Chris Brooker
3 May 2011

The use of psychotropic medications, especially SSRIs, significantly increases the risk of having a traffic accident, a large study has confirmed.

Findings from a Dutch study of 3963 users of psychotropic medications showed that, when compared to controls, users of anxiolytics had a 54 per cent greater risk of an accident, while SSRI users had more than twice the risk of such an accident.

Other classes, including other antidepressants, and sedatives had a lesser, but still significant risk. Hypnotics were associated with .... Please login to read full article.

New Study Casts Doubts on Antidepressant Effectiveness

AboutLawSuits.com
May 3rd, 2011

Most people given antidepressants may still experience many symptoms of depression, according to the findings of a new study that casts doubts on the effectiveness of some popular medications.

In a study published in the April issue of the Journal of Clinical Psychopharmacology, researchers from the University of Texas found that 75 percent of people on an SSRI antidepressant still fought persistant symptoms that the powerful psychotropic drugs should have alleviated, including sadness, insomnia and a decreased ability to concentrate.
Researchers looked at patients who took Celexa for depression. They then checked to see how many of the 16 symptoms of depression. They found that 75% said they still experienced five or more symptoms of depression.

The most common symptom which went unchecked by Celexa was insomnia, followed by sadness and decreased concentration. The drug appeared most effective at reducing suicidal thoughts.

Celexa belongs to a class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs), which also includes the blockbuster antidepressants Zoloft, Paxil, Lexapro, and Prozac.
The questions raised about the effectiveness of antidepressants further highlights recent concerns about potential side effects of antidepressants. In recent years, the widely used medications have been linked to an increased risk of suicide and certain birth defects or malformations when taken during pregnancy. The medications have also been heavily promoted and are some of the most widely prescribed drugs in the United States.

Forrest Laboratories has faced a number of Celexa lawsuits over claims that the antidepressant raises the risk of suicide in teens. There are also similar lawsuits against a similar Forrest Laboratories drug called Lexapro.

The suicide lawsuits over Lexapro and Celexa allege that children taking the two drugs were prone to violence and suicide. The plaintiffs claim that Forest knew from studies that there was a higher risk of suicide associated with the drugs when used by children, but failed to warn patients or doctors. The lawsuits charge the company with failure to warn, negligence and fraud.
In November 2010, it was reported that Forest Laboratories was beginning to settle Celexa and Lexapro lawsuits over the failure to warn about the risk of suicide among teens. The settlements came about a month after the company agreed to pay more than $313 million as part of a settlement for illegally marketing of the drugs to children.

SSRI antidepressants have also been linked to an increased risk of birth defects when used during pregnancy. An estimated 800 Paxil birth defect lawsuits have been filed against GlaxoSmithKline over their failure to warn consumers and doctors that use of the antidepressant during pregnancy could lead to congenital heart defects in newborns. The lawsuits also claim that the company hid test results and purposefully misled doctors about the risks associated with Paxil, which is one of the most commonly prescribed drugs in the United States.

More recently, momentum has been building for Zoloft lawsuits over Pfizer’s failure to warn about the risk of birth defects when taken during pregnancy. Potential side effects of Zoloft for unborn children have been reported to occur when the drug is taken as early as the first trimester, a time when many women do not even realize they are pregnant.

Related Posts
Study Links Older Antidepressant Side Effects to Increased Heart Risks (12/2/2010) Settlements Reported in Celexa and Lexapro Lawsuits Over Suicides (11/3/2010) SSRI Antidepressants May Do More Harm Than Good Against Autism: Study (8/10/2010) Antidepressants During Pregnancy Double Pre-Term Birth Risk: Study (10/6/2009) SSRI Antidepressant Side Effects May Cause Gastrointestinal Bleeding (7/14/2008)

Fact-Checking the New Yorker

The real results from the STAR*D trial
Psychology Today
from Robert Whitaker Mad In America Blog

March 14, 2010

In the March 1 issue of the New Yorker, Louis Menand surveyed the topsy-turvy world of treatments for depression, writing in part of the conflicting evidence regarding the efficacy of antidepressants. The strongest evidence for the drugs, he suggested, came from the NIMH's STAR*D trial. Here's what he wrote:

Response to antidepressants is extremely variable. It can take several different prescriptions to find a medication that works. Measuring a single antidepressant against a placebo is not a test of the effectiveness of antidepressants as a category. And there is a well-known study, called the Sequence Treatment Alternatives to Relieve Depression, or STAR*D trial, in which patients were given a series of different antidepressants. Though only thirty-seven percent recovered on the first drug, another nineteen percent recovered on the second drug, six percent after the third, and five percent after the fourth-a sixty-seven-percent effectiveness rate for antidepressant medication, far better than the rate achieved by a placebo.

That statistic--that two-thirds of the patients eventually "recovered" in the STAR*D trial--has become an oft-cited one. The implication is that if depressed patients try a succession of antidepressants, they are likely to find one that "works" and keeps them well. Unfortunately, the results from the STAR*D trial do not support that belief.

Here's the data that was reported by lead investigator John Rush and several of his colleagues in a 2006 article titled: "Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: A STAR*D report."

There were 3671 adults with major depression who entered the "first stage" of the study. Of that group, 1,346 patients (36.8%) saw their depressive symptoms remit. Of those who didn't remit, 1,439 entered the second stage of the study and switched to a new antidepressant (the rest of the non-remitters dropped out.) In this second stage, 439 remitted (30.6%). Only 390 non-remitted patients agreed to give a third antidepressant a try; 53 remitted in that stage (14%.) In stage four, 16 of 123 patients remitted (13%).

In sum, of the 3671 patients that entered the study, 1,854 remitted (50.5%). Yet, Rush and the other STAR*D investigators reported in their various articles that the "overall cumulative remission rate was 67%," which of course raises the question of where this number came from.

The higher remission rate was purely "theoretical." The researchers assumed that if those who dropped out during the various stages had instead stayed with the protocol all the way through stage four, they would have remitted at the same rate (in the various stages) as those who did stay in the study. This, of course, is a big assumption, and it also hides the fact that if this multiple drug-therapy strategy is employed in the real world, a significant percentage of patients won't stay with it.

This brings us to the second part of the STAR*D story: what percentage of the patients who saw their symptoms remit stayed well through a 12-month followup? In the New Yorker story--and this is how the data is usually presented to the public--the implication was that once a patient finds a drug that "works," he or she stays well. But this study didn't document any such long-term recovery.

According to the follow-up protocol, the remitted patients were supposed to make a call to an "interactive voice response system" monthly so that their depressive symptoms could be assessed. However, only 1,174 of the 1,854 remitted patients made at least one call to the interactive system. In other words, many remitted patients did not participate in the follow-up study, and even many of those who did only remained in it for a short time, rather than for a full year. During this incomplete followup, 37% of the 1,174 patients reported that they had relapsed.

In other words, of the 3,671 patients who entered the trial, only 737 individuals (20%) remitted and then reported, at some point during the 12-month followup, that they had stayed well. The remaining patients (80%) either never remitted, or dropped out at some point, or relapsed during the followup. Moreover, it's unclear from the published results how many of the 737 non-relapsed patients stayed in the followup study for a full year.

In short, the study data did not tell of a form of care that helps two-thirds of all patients recover and stay well for a longer period of time. The 67% recovery rate reported in the New Yorker, a figure that has been often cited to show that if patients are tried on multiple antidepressants they are very likely to find one that works for them, isn't a "real-world" number. It's a number that tells of a "theoretical" remission rate, and it hides the fact that many remitted patients then quickly relapse.

In his article, Louis Menand concluded that the STAR*D trial proved that antidepressants, as a class, have a much higher effectiveness rate than placebo. That claim raises a question to be explored in a follow-up post to this blog: What is the long-term recovery rate for unmedicated depression? Although there was no placebo group in the STAR*D study, in the past decade NIMH-funded investigators did conduct a study of the long-term course of untreated depression. Thus, we can compare the results from that study to see if STAR*D proved, as the New Yorker reported, that antidepressants, as a class, are much more effective than placebo in helping patients recover. Most readers, I believe, will find the results eye-opening.

Antidepressants May Permanently or Reversibly Affect Fetal Brain Development

Laurie Barclay, MD
Medscape.com

March 2, 2010 — Antidepressants may permanently or reversibly affect fetal brain development depending on the timing of exposure during pregnancy, according to the results of a study reported online February 22 in the March issue of Pediatrics.

"In animals, antidepressant exposure in early life causes changes that persist into adulthood," write Lars Henning Pedersen, MD, PhD, from Aarhus University in Aarhus, Denmark, and colleagues. "Results from human studies have been equivocal and either found no association between antidepressants and fetal brain development or suggested subtle effects on fine motor development."

The goal of the study was to evaluate whether there is an association between antidepressant exposure in utero and achievement of developmental milestones at ages 6 and 19 months, using data from the Danish National Birth Cohort. Of the pregnant women in this cohort who were eligible for the study, 415 reported use of antidepressant medication, 489 reported depression without medical treatment, and 81,042 reported neither depression nor use of psychotropic medication.

Compared with children of women not exposed to antidepressants, children with second- or third-trimester exposure to antidepressants were able to sit up 15.9 days later (95% confidence interval [CI], 6.8 - 25.0) and to walk 28.9 days later (95% CI, 15.0 - 42.7). However, these milestones were still within the normal range of development.

Compared with children of women not exposed to antidepressants, fewer children with second- or third-trimester exposure to antidepressants could sit without support at age 6 months (odds ratio [OR], 2.1; 95% CI, 1.23 - 3.60), and fewer could occupy themselves at age 19 months (OR, 2.1; 95% CI, 1.09 - 4.02). There were no statistically significant associations of any of the other milestones measured with in utero antidepressant exposure.

Limitations of this study include possible confounding by the severity of disease, lack of blinding of the participants or the interviewers, and not all women completing the 4 interviews.

"The results of this study suggest a permanent or reversible effect of antidepressant exposure on fetal brain development, which may depend on the timing of exposure during pregnancy," the study authors write. "We found associations between exposure to antidepressants in late pregnancy and motor development, particularly for boys. The clinical and public health relevance of the results is not known, and longer follow-up monitoring of the children is needed."

The Lundbeck Foundation funded this study, which also received support from the National Danish Research Foundation, Aarhus University, the Danish Society of Obstetrics and Gynecology, the Ville Heise Foundation, and the Rosalie Petersen Foundation. Drs. Pedersen and Olsen received grants from the Lundbeck Foundation, which is an independent foundation supported by the pharmaceutical company Lundbeck.

Pediatrics. Published online February 22, 2010.

]
Authors and Disclosures
Journalist
Laurie Barclay, MD

Freelance writer and reviewer, Medscape, LLC

Disclosure: Laurie Barclay, MD, has disclosed no relevant financial relationships.

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)

Glaxo to Shift Away from Antidepressant Research CEO admits antidepressant research only based on subjective mood surveys

Wall Street Journal
By Jeanne Whalen
February 5, 2010

GlaxoSmithKline PLC said it will stop research into new antidepressants and focus on diseases for which it believes it can develop more valuable drugs, a major shift for a company that developed some of the biggest-selling antidepressants of the past 20 years.

Profits at the U.K. drug giant, which posted a 66% increase in fourth-quarter earnings Thursday, were long fueled by the antidepressants Paxil and Wellbutrin, which at their peak generated billions of dollars a year in sales. Similar medicines, such as Eli Lilly & Co.’s Prozac and Pfizer Inc.’s Zoloft, also generated big sales for those companies.

However, low-cost generic copies have eroded demand for name-brand antidepressants, which accounted for just 2.3% of Glaxo’s total sales last year, down from 14% in 2002. Chief Executive Andrew Witty said Thursday that the company thinks further investment in the market wouldn’t be prudent.

Part of the reason is financial risk. Clinical trials of antidepressants are among the “most expensive and highest-risk” of all drug trials, Mr. Witty said, because companies often don’t know until the end of very large studies whether a drug works. It is also hard to prove that a depression drug is working, he said, because patient improvement is measured by subjective mood surveys, and not by the clear-cut blood tests and biological measures used in other diseases.

That’s a drawback in an era when insurers and other health-care payers want to see clear value for their money, Mr. Witty said.

Payers “want big benefits to make it worth their while to invest their resources,” he said, adding that Glaxo would scrap research into pain drugs for the same reasons, focusing instead on diseases including Alzheimer’s, Parkinson’s, multiple sclerosis and a clutch of rare diseases.

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)

Kin sue Harvard over son's suicide - Allege neglect in health services' drug prescription

Boston Globe
Shelley Murphy
December 4, 2009
Harvard sophomore John Edwards was studying to become a doctor and training for the Boston Marathon in June 2007 when he sought help at the university’s Health Services because he could not study for as many hours as some of his friends.

A nurse practitioner prescribed a drug to treat attention deficit hyperactivity disorder, a condition the overachieving Edwards had never been diagnosed with. Later, she prescribed two powerful antidepressants, Prozac and Wellbutrin, when he began complaining of anxiety, depression, and other side effects. Meanwhile, he was taking a fourth drug for acne, Accutane, that has been linked to suicidal thoughts.

“The Wellbutrin is having the effect that we were seeking . . . but unfortunately I feel like it has canceled out the anxiety-reducing effects of the fluoxetine [Prozac], as recently I’ve been pretty nervous,’’ Edwards wrote in a Nov. 27, 2007, e-mail to the nurse practitioner, Marianne Cannon. “Let me know if I should schedule to come in and meet with you soon, or if I should change the med plan.’’

Cannon replied that she was concerned and told Edwards to schedule an appointment with her. Two days later, Edwards, 19, of Wellesley committed suicide in a bathroom at Harvard Medical School by suffocating himself with a plastic bag.

His father, John B. Edwards II of Wellesley, filed a suit Wednesday in Middlesex Superior Court alleging gross negligence by Cannon; Dr. Georgia Ede, who was the doctor who supervised her; and Harvard College, for causing his son’s wrongful death

Harvard released a statement yesterday, saying, “We understand how difficult it must be for John Edwards’ family to cope with such a tragic loss, but we are confident that the care he received at Harvard University Health Services was thorough and appropriate and he was monitored closely by its physicians and allied health specialists.’’

Lisa G. Arrowood, a Boston attorney who represents Edwards, said, “We’re alleging that the supervising physician in this case did not do her job, which was to supervise the nurse who didn’t have medical training that a physician has. She was writing prescriptions for powerful drugs that were inappropriate in this combination and are associated with an increase of suicide.’’
The US Food and Drug Administration has warned that anyone taking Accutane, Prozac, or Wellbutrin should be monitored closely for suicidal thoughts.

“If a college such as Harvard cannot properly care for somebody like Johnny, I think it’s very concerning who can,’’ Edwards’s father said. “They are leaders in medicine and psychiatry, and it’s just astounding that at a school such as Harvard that something like this could happen.’’
Edwards was class president and valedictorian of Wellesley High School class of 2006 and played on the school’s championship tennis team. His father said he was an A student at Harvard and was conducting stem cell research at Harvard Medical School.

He said he “thought it was bizarre’’ when his son told him he had been prescribed medication for attention deficit disorder, because “he never had an attention issue.’’

The suit accuses Cannon of prescribing Adderall, an amphetamine, which caused Edwards to have chest pains and anxiety, then several months later prescribing Prozac and then Wellbutrin, even though Edwards told her he had taken Prozac when he was younger and experienced “out-of-control feelings.’’

Edwards said his son was upset by a break-up with a girlfriend two months earlier, but there was no indication he contemplated taking his own life. He was training for the marathon and had created a Harvard College Marathon Challenge Web page, with a goal of raising $2,000 for two charities. “In six months, I hope to cross the finish line of the Boston Marathon,’’ Edwards wrote.
His father said he last saw him when he dropped him off at his dorm two days after Thanksgiving. “He seemed to be in a good mood,’’ Edwards said. “I gave him a kiss on the head and hugged him. He hugged me. I told him I loved him and left. He seemed to be fine.’’
Edwards said his son, a guitarist, was planning to perform “High and Dry’’ by Radiohead with a friend at a talent show the night after his death. The show was canceled because of the suicide, then held three months later. His only sister, Julia, now 16, learned the song and played it in his memory.

Edwards said he always hated to run, but after his son’s death he started training and ran the Boston Marathon this year.

“I put some of Johnny’s ashes in my back pocket,’’ Edwards said, his voice cracking. “Together we ran the marathon.’’

Shelley Murphy can be reached at shmurphy@globe.com.
© Copyright 2009 The New York Times Company

Drug Makers Are Advocacy Group's [NAMI's] Biggest Donors

New York Times
By GARDINER HARRIS
October 21, 2009

WASHINGTON — A majority of the donations made to the National Alliance on Mental Illness, one of the nation's most influential disease advocacy groups, have come from drug makers in recent years, according to Congressional investigators.

The alliance, known as NAMI, has long been criticized for coordinating some of its lobbying efforts with drug makers and for pushing legislation that also benefits industry.

Last spring, Senator Charles E. Grassley, Republican of Iowa, sent letters to the alliance and about a dozen other influential disease and patient advocacy organizations asking about their ties to drug and device makers. The request was part of his investigation into the drug industry's influence on the practice of medicine.

The mental health alliance, which is hugely influential in many state capitols, has refused for years to disclose specifics of its fund-raising, saying the details were private.

But according to investigators in Mr. Grassley's office and documents obtained by The New York Times, drug makers from 2006 to 2008 contributed nearly $23 million to the alliance, about three-quarters of its donations.

Even the group's executive director, Michael Fitzpatrick, said in an interview that the drug companies' donations were excessive and that things would change.

"For at least the years of '07, '08 and '09, the percentage of money from pharma has been higher than we have wanted it to be," Mr. Fitzpatrick said.

He promised that the industry's share of the organization's fund-raising would drop "significantly" next year.

"I understand that NAMI gets painted as being in the pockets of pharmaceutical companies, and somehow that all we care about is pharmaceuticals," Mr. Fitzpatrick said. "It's simply not true."

Mr. Fitzpatrick said Mr. Grassley's scrutiny, which he described as understandable given the attention paid to potential conflicts of interest in medicine, had led his organization to begin posting on its Web site the names of companies that donate $5,000 or more. And he predicted that other patient and disease advocacy groups would be prodded by Mr. Grassley's investigation to do the same.

"Everyone I talk to wants to have more balanced fund-raising," Mr. Fitzpatrick said.

In a statement, Mr. Grassley praised the alliance for its disclosures. "It'd be good for the system for other patient groups to do what NAMI has done," he said.

Mr. Grassley's scrutiny has been unnerving for patient and disease advocacy groups, which are often filled with sincere people who are either afflicted with serious illnesses themselves or have family members who have been affected. Many join the groups in the hope of making sense of their misfortune by helping to find a cure or raising awareness of a disease's risks and frequency.

Drug makers are natural allies in these pursuits since cures may come out of corporate laboratories and the industry's money can help finance public service campaigns and fund-raising dinners. But industry critics have long derided some patient organizations as little more than front groups devoted to lobbying on issues that affect industry profits, and few have come under more scrutiny for industry ties than the mental health alliance.

For years, the alliance has fought states' legislative efforts to limit doctors' freedom to prescribe drugs, no matter how expensive, to treat mental illness in patients who rely on government health care programs like Medicaid. Some of these medicines routinely top the list of the most expensive drugs that states buy for their poorest patients.

Mr. Fitzpatrick defended these lobbying efforts, saying they were just one of many the organization routinely undertook.

The close ties between the alliance and drug makers were on stark display last week, when the organization held its annual gala at the Andrew W. Mellon Auditorium on Constitution Avenue in Washington. Tickets were $300 each. Before a dinner of roasted red bell pepper soup, beef tenderloin and tilapia, Dr. Stephen H. Feinstein, president of the alliance's board, thanked Bristol-Myers Squibb, the pharmaceutical company.

"For the past five years, Bristol-Myers has sponsored this dinner at the highest level," Dr. Feinstein said.

He then introduced Dr. Fred Grossman, chief of neuroscience research at Bristol-Myers, who told the audience that "now, more than ever, our enduring relationship with NAMI must remain strong."

Documents obtained by The New York Times show that drug makers have over the years given the mental health alliance — along with millions of dollars in donations — direct advice about how to advocate forcefully for issues that affect industry profits. The documents show, for example, that the alliance's leaders, including Mr. Fitzpatrick, met with AstraZeneca sales executives on Dec. 16, 2003.

Slides from a presentation delivered by the salesmen show that the company urged the alliance to resist state efforts to limit access to mental health drugs.

"Solutions: Play Hard Ball," one slide was titled. "Hold policy makers accountable for their decisions in media and in election," it continued.

The alliance's own slides concluded by saying, "We appreciate AstraZeneca's strong support of NAMI."

Mr. Fitzpatrick said that the alliance frequently had such meetings and that the organization would fight for better access to mental health drugs "even if we had no relationship with pharmaceutical companies."

Tony Jewell, an AstraZeneca spokesman, said that the company was "committed to improving health through partnerships with nonprofit organizations" and that "includes striving to ensure people can access our medicines through formularies managed by state Medicaid agencies."

$2.5M verdict over birth defects blamed on Paxil

Associated Press
By MARYCLAIRE DALE (AP)
October 14, 2009

PHILADELPHIA — A jury ordered GlaxoSmithKline to pay $2.5 million to a woman whose son was born with serious heart defects after she took the antidepressant Paxil during her pregnancy.

The closely watched verdict handed down Tuesday in Philadelphia was the first of about 600 similar cases pending across the country that blame Paxil for heart problems and other birth defects.

The jury found GlaxoSmithKline guilty of negligence but not outrageous conduct, and rejected punitive damages. The company vowed to appeal.

"The adverse events started to come in the late 1990s, early 2000. The evidence was overwhelming and alarming," said lawyer Jamie Sheller, who represented plaintiff Michelle David. "They could have known this way, way before they did, way before they changed the label in 2005."

Paxil was classified as a drug with no known link to increased birth defects from its introduction in 1992 through 2005. The Food and Drug Administration began warning in September 2005 that Paxil may be associated with birth defects and strengthened the warning four months later.

David, 28, of Bensalem delivered her full-term son, Lyam Kilker, in October 2005.

He was diagnosed with heart defects two months later and spent five months in a Philadelphia hospital, undergoing surgery to repair two holes in his heart, lawyer Jamie Sheller said Wednesday. He also has a third, separate heart defect and will need at least one more surgery as he grows, she said.

David, a dance teacher and former Philadelphia 76er cheerleader, has no history of heart defects in her family, her lawyer said.

GlaxoSmithKline argues that birth defects occur in 3 to 5 percent of all live births, whether or not the mother took medication during pregnancy.

"The scientific evidence does not establish that exposure to Paxil during pregnancy caused his condition," the drugmaker said in a statement. "Once approved for use, the company acted properly in marketing the medicine, including monitoring its safety, updating pregnancy information in the medicine's labeling as new information became available, and in communicating important safety information to regulatory agencies, the scientific community and the public.

Plaintiffs lawyers will continue to pursue punitive damages in the hundreds of remaining cases, the next of which is set for trial in Philadelphia in November.

"We're starting to chip away at this story, but even as we speak, we're still fighting them, documents are still being produced, depositions are still being taken," Sheller said.

Sales of Paxil totaled $849 million last year.

Paxil has competed fiercely in the marketplace at times with rival antidepressant blockbusters like Eli Lilly's Prozac and Pfizer's Zoloft. The drug no longer has patent protection and now competes against cheaper generic versions.

Copyright © 2009 The Associated Press. All rights reserved.

Pfizer's huge fine: A disturbing trend Do the increasing penalties against drug companies really cure the problem?

Salon.com
By Vincent Rossmeier
Sep. 03, 2009 |

$2.3 billion: That's the price pharmaceutical giant Pfizer agreed to pay in a settlement Wednesday over its misleading marketing for the painkiller Bextra, the antipsychotic Geodon, the antibiotic Zyvox, and another painkiller, Lyrica. It's a record settlement that included the highest fine charged in U.S. history and came as the result of a lengthy Department of Justice investigation into healthcare fraud.

Though Pfizer voluntarily withdrew Bextra from the market in 2005, in the settlement, the company concedes that they had pushed doctors to prescribe unsafe doses of the drug prior to that point. The drug was approved by the FDA in 2001 for the treatment of pain associated with menstrual cramps and arthritis, but Pfizer encouraged its sales representatives to entice doctors to prescribe the drug in doses higher than those approved by the FDA. The escalated doses increased the chances that users of the drug would suffer a heart attack or a stroke. Pfizer also marketed Zyvox as a treatment for specific kinds of bacteria on which the drug had no effect.

A former Pfizer sales representative, John Kopchinski, whose questioning of the company's marketing tactics helped lead to the investigation, will receive over $51 million from the settlement. Kopchinski lost his job as a result of blowing the whistle on Pfizer's illegal schemes. Pfizer will have to pay settlements in 42 states and the District of Columbia.

However, the hefty cost will probably barely affect Pfizer's overall profit margins: The company purchased rival Wyeth in January for $68 billion and had revenues of over $48 billion last year. As the New York Times pointed out, "While the government said the fine was a record sum, the $2.3 billion fine amounts to less than three weeks of Pfizer’s sales." This is the fourth time Pfizer has reached a settlement over fraudulent marketing since 2002.

In the wake of Pfizer's settlement, here's a look at some of the larger Big Pharma settlements in recent history:

* Zyprexa, 2009 -- Eli Lilly was accused of selling its top-selling drug Zyprexa widely -- even to those people without bipolar disorder or schizophrenia for which the drug was supposed to be used. The drug can cause severe weight gain, as well as increasing the risk of a patient developing diabetes. In January, Eli Lilly reached a settlement with the government for $1.4 billion.
* OxyContin, 2007 -- Introduced in 1996 by Purdue Pharma, OxyContin was advertised as a softer, gentler painkiller. However, the drug is actually highly addictive, acting like heroin if taken incorrectly. OxyContin has become a scourge to communities across the U.S. and has also led to numerous overdose deaths. Perhaps the most notorious abuser of OxyContin was conservative radio talk show host Rush Limbaugh. In 2007, Purdue Pharma agreed to cough up $634.5 million in fines for its false claims about the drug.
* Vioxx, 2007 -- When 47,000 people are involved in a lawsuit against you, you know you have a problem. Thus, Merck, the maker of the painkiller Vioxx, reached a $4.85 billion settlement in 2007 to get rid of all the pending cases brought against it due to Vioxx's negative side effects. Vioxx was found to double the risk of heart attacks and strokes and thus Merck pulled the pill from pharmacies in 2004.
* Serostim, 2005 -- Serono, a Swiss technology company, had to pay $700 million in 2005 as a result of its fraudulent marketing for the AIDS drug Serostim. Serono developed a test that inflated the seriousness of the symptoms of a patient afflicted with AIDS and also sponsored junkets for doctors in order to get them to prescribe the drug.
* Neurontin, 2004 -- Pfizer reached a settlement of $430 million to end criminal and civil charges about its practice of paying doctors to prescribe Neurontin, a drug for epilepsy, to patients with bipolar disorder, for which it was not approved.
* Cipro, 2003 -- Bayer reached a $257 million settlement in 2003, the largest Medicaid fraud settlement at that time, after being charged by federal investigators with overcharging for the antibiotic Cipro. Bayer, however, didn't act alone: It received advice on how to go about the scheme from healthcare giant Kaiser Permanente.
* Paxil and Flonase, 2003 -- GlaxoSmithKline allegedly didn't want to miss out on all the fun and profits Bayer was having in overcharging for Cipro. It was accused of running a scheme with Kaiser Permanente to bilk Medicaid for the antidepressant Paxil and the allergy spray medication Flonase. GlaxoSmithKline paid $87.6 million in 2003 to settle the case.
* Lupron, 2001 -- TAP Pharmaceuticals Inc. came up with a clever way to get doctors to use its prostate cancer drug, Lupron, instead of those of rival drug companies: namely, pay them. TAP offered one doctor $25,000 to go back to prescribing Lupron after he'd switched to a competitor's drug. But the doctor alerted authorities, who conducted a massive sting resulting in TAP dishing out a $875 million settlement in 2001.
* Fen-Phen, 1999 -- Billed as a miracle diet drug by the drug company American Home Products Corp. (AHP), Fen-Phen was just as good at promoting heart valve disease as it was at helping people shed excess pounds. AHP removed Fen-Phen in 1997 after a damaging report showed that those who took the drug for more than two years increased their risk of developing heart valve disease by 17 percent. Though AHP agreed to pay $3.75 billion to the users of the drug, it did not have to admit to any wrongful actions in its marketing of Fen-Phen.

Pfizer Pays $2.3 Billion to Settle Marketing Case

New York Times
September 3, 2009

By GARDINER HARRIS
,
WASHINGTON — The pharmaceutical giant Pfizer agreed to pay $2.3 billion to settle civil and criminal allegations that it had illegally marketed its painkiller Bextra, which has been withdrawn.

It was the largest health care fraud settlement and the largest criminal fine of any kind ever.

Although the investigation began and largely ended during the Bush administration, top Obama administration officials held a news conference on Wednesday to celebrate the settlement, thank each other for resolving it and promise more crackdowns on health fraud.

“It’s another step in the administration’s ongoing effort to prosecute any individual or organization that tries to rip off health care consumers and the federal government,” said Kathleen Sebelius, secretary of health and human services.

Republicans and Democrats on Capitol Hill have accused the Obama administration of failing to crack down adequately on health care fraud, arguing that huge savings in government health programs could be found with better enforcement. The settlement had been expected. Pfizer, which is acquiring a rival, Wyeth, reported in January that it had taken a $2.3 billion charge to resolve claims involving Bextra and other drugs. It was Pfizer’s fourth settlement over illegal marketing activities since 2002.

“Among the factors we considered in calibrating this severe punishment was Pfizer’s recidivism,” said Michael K. Loucks, acting United States attorney for the Massachusetts district.

Amy W. Schulman, Pfizer’s general counsel, said that Pfizer had reformed — again.

“The reasons to trust Pfizer are because, as I have walked the halls at Pfizer, you would see that the vast majority of our employees spend their lives dedicated to bringing truly important medications to patients and physicians in an appropriate manner,” she said.

The government charged that executives and sales representatives throughout Pfizer’s ranks planned and executed schemes to illegally market not only Bextra but also Geodon, an antipsychotic; Zyvox, an antibiotic; and Lyrica, which treats nerve pain. While the government said the fine was a record sum, the $2.3 billion fine amounts to less than three weeks of Pfizer’s sales.

Much of the activities cited Wednesday occurred while Pfizer was in the midst of resolving allegations that it illegally marketed Neurontin, an epilepsy drug for which the company in 2004 paid a $430 million fine and signed a corporate integrity agreement — a companywide promise to behave.

John Kopchinski, a former Pfizer sales representative whose complaint helped prompt the government’s Bextra case, said that company managers told him and others to dismiss concerns about the Neurontin case while pushing them to undertake similar illegal efforts on behalf of Bextra.

“The whole culture of Pfizer is driven by sales, and if you didn’t sell drugs illegally, you were not seen as a team player,” said Mr. Kopchinski, whose personal share of the Pfizer settlement is expected to exceed $50 million. Mr. Kopchinski left Pfizer in 2003.

Altogether, six whistle-blowers will collect $102 million from the federal share of the settlement and more from states’ shares. Forty-nine states and the District of Columbia will collect $331 million, with New York State alone getting $66 million. Only South Carolina chose not to participate in the settlement.

As news of the riches earned by whistle-blowers spread through the industry in recent years, scores of fraud cases have been filed by former drug sales representatives using a Civil War-era law that pays a bounty for fraud alerts. The cases charge that illegal drug marketing cost the federal Medicare and Medicaid program millions.

Under the agreement with the Justice Department, Pfizer will pay a $1.3 billion criminal penalty related to Bextra and $1 billion in civil fines related to other medicines. In addition, a Pfizer subsidiary, Pharmacia and Upjohn, will plead guilty to violating the Food, Drug and Cosmetic Act for its promotion of Bextra. The company has agreed to sign another corporate integrity agreement that requires senior company executives to annually certify legal compliance and mandates that Pfizer post on its Web site many of its payments to doctors.

Consumer advocates heaped scorn on Pfizer and said that illegal marketing was still common in the drug industry.

“Consumers should ask their doctor whether the medication being prescribed is F.D.A.-approved for their condition,” advised Lisa Gill, editor of Consumer Reports Best Buy Drugs. If a drug is not approved for their condition, patients should press their doctors to explain their reasoning for the drug’s use.

Almost every major drug maker has been accused in recent years of giving kickbacks to doctors or shortchanging federal programs. Prosecutors said that they had become so alarmed by the growing criminality in the industry that they had begun increasing fines into the billions of dollars and would more vigorously prosecute doctors as well.

Dr. Scott Gottlieb, a top F.D.A. official in the Bush administration who now consults for drug makers, said that government prosecutors were increasingly criminalizing “what reasonable people might argue is a reasonable exchange of important clinical information between drug companies and doctors.”

Bextra was approved in 2001 by the Food and Drug Administration to treat arthritis and menstrual cramps. The drug was not approved for the treatment of acute pain, nor was it shown to be any more powerful than ibuprofen. But Pfizer instructed its sales representatives to tell doctors that the drug could be used to treat acute and surgical pain and at doses well above those approved, even though the drug’s dangers — which included kidney, skin and heart risks — increased with the dose, the government charged. The drug was withdrawn in 2005 because of its risks to the heart and skin.

Mr. Loucks, the prosecutor, accused Pfizer of aggressive marketing tactics.

“Among other things, Pfizer did the following: Pfizer invited doctors to consultant meetings, many in resort locations. Attendees expenses were paid; they received a fee just for being there,” he said. Such weekend getaways for doctors are still common throughout the drug and medical device industries.

Top Republican officials rarely publicized drug marketing cases or appeared during news conferences about them. Eli Lilly agreed to pay $1.4 billion over its marketing of Zyprexa, an antipsychotic, in January, before President Obama took office. The announcement was made by prosecutors in Philadelphia.

Ms. Sebelius’s decision to make the Pfizer announcement in Washington suggests that the political environment for the pharmaceutical industry has become more treacherous despite the industry’s commitment to save the government $80 billion as part of efforts to change the health care system.

Copyright 2009 The New York Times Company

Glaxo used ghostwriting program to promote Paxil

Associated Press
August 19, 2009

By MATTHEW PERRONE (AP)

WASHINGTON — Drugmaker GlaxoSmithKline used a sophisticated ghostwriting program to promote its antidepressant Paxil, allowing doctors to take credit for medical journal articles mainly written by company consultants, according to court documents obtained by The Associated Press.

An internal company memo instructs salespeople to approach physicians and offer to help them write and publish articles about their positive experiences prescribing the drug.

Known as the CASPPER program, the paper explains how the company can help physicians with everything from "developing a topic," to "submitting the manuscript for publication."

The document was uncovered by the Baum Hedlund PC law firm of Los Angeles, which is representing hundreds of former Paxil users in personal injury and wrongful death suits against GlaxoSmithKline. The firm alleges the company downplayed several risks connected with its drug, including increased suicidal behavior and birth defects.

A spokeswoman for London-based Glaxo said the published articles noted any assistance to the main authors.

"The program was not heavily used and was discontinued a number of years ago," said Mary Anne Rhyne.

According to the memo, which dates from April 2000, the CASPPER program was designed to "strengthen the product positioning and overcome competitive issues."

At the time, Paxil was competing with rival antidepressant blockbusters like Eli Lilly's Prozac and Pfizer's Zoloft. Paxil has since lost its patent protection and competes against cheaper generic versions. Sales of Paxil last year totaled $849 million.

Drug companies frequently hire outside firms to draft a manuscript touting a company's drug, retain a physician to sign off as the author and then find a publisher to unwittingly publish the work.

But the use of ghostwriting by drug companies has come under increased scrutiny by members of Congress, including Sen. Charles Grassley, R-Iowa, a longtime critic of the industry's influence over physicians. Grassley and Sen. Herb Kohl, D-Wis., are pushing a bill that would require companies to disclose all payments to physicians over $100.

According to ghostwriting expert Dr. Leemon McHenry, Glaxo's program was unusually intertwined with its internal sales and marketing department.

"We know that GSK has engaged in ghostwriting for many years," said McHenry, who works as a research consultant for Baum Hedlund. "But to create an internal ghostwriting program and have the gall to name it after a cartoon ghost demonstrates their juvenile attitude and careless disregard for patients."

McHenry acknowledged that ghostwriting is legal in principal, but said it could contribute to illegal activity if the information is misleading and causes harm.

"If these ghostwritten publications are contributing to the harm of patients because they're making false claims, then that's illegal," McHenry said.

Articles from the company's program appeared in five journals between 2000 and 2002, including the American Journal of Psychiatry and the Journal of the American Academy of Child and Adolescent Psychiatry.

Drug company salespeople often present medical journal articles to physicians as independent proof that their drugs are safe and effective.

Publication in a medical journal also is a point of prestige for physicians, a fact Glaxo's memo seems to acknowledge: "Physicians will be eager to participate in CASPPER regardless of their professional stature," the brief notes.

(This version CORRECTS spelling of 'Baum' in graf 4.)

Copyright © 2009 The Associated Press. All rights reserved.

Vermont Acts to Make Drug Makers' Gifts Public

New York Times
By NATASHA SINGER
Published: May 19, 2009

Cracking down on medical industry payments to doctors, the Vermont legislature has passed a law requiring drug and device makers to publicly disclose all money given to physicians and other health care providers, naming names and listing dollar amounts.

The law, scheduled to take effect on July 1, is believed to be the most stringent state effort to regulate the marketing of medical products to doctors. It would also ban nearly all industry gifts, including meals, to doctors, nurses, medical staff, pharmacists, health plan administrators and health care facilities.

In practice, the new law would let Vermonters learn each year which doctors have been paid, and how much, by the makers of the brand-name drugs for which they wrote prescriptions — or how much money certain surgeons have received from the makers of the stents, pacemakers, artificial knees and such that the doctors implanted.

The action by Vermont has been watched around the country, as national legislators and medical groups look for links between industry marketing and health care costs.

Minnesota already requires drug companies to report payments to doctors. New Massachusetts regulations limit gifts to health care practitioners and call for disclosure of any payment or benefit worth $50 or more.

In Congress, Senators Charles E. Grassley, Republican of Iowa, and Herb Kohl, Democrat of Wisconsin, have sponsored a bill requiring disclosure of pharmaceutical industry payments to doctors.

But Vermont has gone further with its new law, which Gov. Jim Douglas, a Republican, is expected to sign by early next month. It will require public disclosure of all payments by companies to any health care provider with authority to write prescriptions for drugs, medical devices and biologics, drugs that are typically administered by injection or infusion.

The law is also the first to ban all free meals, long a favorite gift in marketing to doctors. The law also closes a loophole in previous regulations that had allowed companies to keep specific expenses private by claiming them as trade secrets.

The required disclosures, though, do not include payments for clinical research on products under review by the Food and Drug Administration.

"This is a much more comprehensive law because it makes clear — whether devices, biologics or drugs are involved — the issue is inappropriate gift-giving," said Sharon Treat, the executive director of a nonprofit group, the National Legislative Association for Prescription Drug Pricing, and a Democrat in the Maine House of Representatives.

The Vermont law promises to provide a window into the considerable efforts and spending by device and drug makers to woo doctors even in a small state.

Makers of medical products spent about $2.9 million in fiscal year 2008 on marketing to health care professionals in Vermont, according to a report last month from the state's attorney general. Of Vermont's 4,573 licensed health practitioners, almost half received remuneration, including payments for lectures, meals or lodging from pharmaceutical companies in the 2008 fiscal year, the report said.

"If the drug industry gives $3 million on average for three years now to physicians in a small state like Vermont, what is happening in California and New York?" said Ken Libertoff, director of the Vermont Association for Mental Health, an advocacy group that supported the law.

The Vermont attorney general's report, compiled before passage of the law, provides only aggregate data because companies declared 83 percent of the payments to be trade secrets. Even so, without naming names, the disclosed expenses highlighted a widely used industry strategy of focusing much of the marketing money on a group of influential doctors.

Of the $2.9 million spent in Vermont, for example, about $1.8 million went to only 100 health care providers. That meant only about 4 percent of doctors received 60 percent of the payments, the report said.

A psychiatrist received about $112,000, the highest amount spent on one person. But specialists in internal medicine, neurology, endocrinology and diabetes also received more than $100,000 each during the year.

To reduce the perception of undue industry influence, the Pharmaceutical Research and Manufacturers of America or PhRMA, a trade association, instituted a voluntary code in January that prohibits noneducational gifts to doctors and restricts meals. About 50 manufacturers the code.

With such a code, Vermont's new reporting requirements seem redundant, said Marjorie E. Powell, a senior lawyer for PhRMA.

"We think this is unnecessary, and it is not going to improve patient care," Ms. Powell said. "It makes it onerous not only for the company but also for the physician in Vermont, because this is going to be on a Web site."

But the Vermont Medical Society, which represents 65 percent of the physicians in the state, supported the bill.

Peter Shumlin, president pro tempore of the Vermont state senate, said he hoped his state would provide a model on marketing disclosures for the rest of the country.

"Our goal is not to prohibit this practice," Mr. Shumlin said, "but to have the first system in this country where providers' acceptance of this money is on full public record."

Children's Use Of Psychiatric Drugs Begins To Decelerate

The Wall Street Journal
By David Armstrong
May 18, 2009

The growth in antipsychotic-drug prescriptions for children is slowing as state Medicaid agencies heighten their scrutiny of usage and doctors grow more wary of the powerful medications.

The softening in sales for children is the first sign that litigation, reaction to improper marketing tactics, and concern about side effects may be affecting what had been a fast-growing children's drug segment.

The six so-called atypical antipsychotics that dominate the market have limited approval from the FDA to treat patients under 18 years of age. Only one is cleared for children under age 10 -- risperidone, branded by Johnson & Johnson as Risperdal -- to treat irritability associated with autism.
[psychotic drugs for kids]

But doctors can prescribe drugs as they see fit, and many have turned to the atypicals to treat serious mental conditions in children, including schizophrenia and bipolar disorder. Use of Risperidone by those 18 and under accounts for about 25% of the drug's sales, while SDI Health, a medical market-research company that gathers sales information from drugstores, estimates that sales of all antipsychotics to that age group account for 15% of the drugs' sales, or $2.18 billion.

Data on use among children are hard to come by, but SDI's figures show that antipsychotic prescriptions for children under 18 rose 5.2% between 2007 and 2008, compared with an increase of 8.73% in the year-earlier period.

The slowdown is more pronounced among younger children. The nation's second largest pharmacy-benefits manager, Medco Health Solutions Inc., which handles 586 million prescriptions a year, estimates that prescriptions for antipsychotics for patients under 10 fell 4% last year. From 2001 through 2007, use in that age group increased 85%, Medco says.

SDI Health estimates that prescriptions for psychiatric drugs for children under 10 increased 3.5% last year. In contrast, between 2002 and 2007, such prescriptions rose 44.6%, it says. SDI also says it saw a 1% drop in prescriptions for those under seven last year.

"I was never a big prescriber to begin with, but I have definitely been more careful as information has come to light about the serious side effects being downplayed in the marketing of these drugs," says Michael Houston, a child psychiatrist in Chevy Chase, Md.

Others who treat children with serious and dangerous behavioral problems worry that misconceptions about the drugs will prompt some parents or doctors to balk at their use.

"For those children who are seriously mentally ill, although these side effects can be potentially significant, the benefits far outweigh the side effects," says Louis Kraus, the chief of child psychiatry at Rush University Medical Center in Chicago.

Antipsychotics have faced heightened scrutiny and investigation over the past year. In November, a Food and Drug Administration advisory committee asked the FDA to research children's use of the drugs and expressed concern about possible side effects such as weight gain and increased diabetes risk. And 11 state attorneys general are investigating alleged marketing of Eli Lilly & Co.'s antipsychotic Zyprexa for uses the FDA hasn't approved.

In January, Eli Lilly agreed to pay $1.4 billion to settle allegations it improperly marketed Zyprexa. The company also agreed to plead guilty to a criminal charge of promoting the drug for unapproved uses.

A Lilly spokesman declined to comment on ongoing litigation and said the company doesn't track the drug's use in children.

Bristol-Myers Squibb Co. agreed to pay $515 million in September 2007 to settle allegations it promoted Abilify for use in children. The FDA didn't approve of the use of the drug in children older than 10 until 2008.

State Medicaid agencies began to question "off label" use of antipsychotics after the December 2006 death of Rebecca Riley, a four-year-old Massachusetts girl whose family received Medicaid benefits. After being diagnosed with bipolar disorder at age two, she was prescribed a cocktail of drugs, includingan antipsychotic, court records show.

Some states began moving to require special approval before they would cover a claim for an antipsychotic. A group of 16 states started studying the use of psychiatric medication in children in 2007 in an effort they dubbed "too many, too much, too young," says Jeffrey Thompson, the medical director of the Washington state Medicaid program.

In California, the number of children six and under using psychiatric medications has fallen to 4,200 from 5,686 since a 2006 prior-authorization plan was put in place, the state's top Medicaid official says.

Florida's state Medicaid agency says the number of prescriptions for atypical antipsychotics written for children under age six in the second half of last year dropped to 1,137 from 3,167 a year earlier.

The agency says the decline was the result of a state program started last year under which prescriptions for children under six are reviewed for appropriateness by state-hired psychiatric consultants before Medicaid will cover them.

Washington has created a system to flag the use of psychiatric drugs that may contain too high a dose for young children or have side effects that it regards as particularly dangerous. From May 2006 to April 2008, the system flagged 1,032 cases for review by outside consultants.