Posts Tagged ‘Eli Lilly’

WSJ: Feds want $1B settlement in J&J Risperdal probe

Friday, May 13th, 2011

FiercePharma
By Tracy Staton
May 13, 2011

Johnson & Johnson could be on the hook for about $1 billion to settle the government probe into its Risperdal marketing. Prosecutors are looking for a settlement about that size, the Wall Street Journal reports, citing sources. That would be the third-largest marketing settlement between a Big Pharma company and the U.S. government; only Pfizer and Eli Lilly have made larger deals with the feds.

Earlier this week, J&J disclosed to the SEC that it had set aside an unspecified amount to cover a potential Risperdal settlement. The company had already taken a $1.4 billion charge against first-quarter earnings to cover legal costs.

The WSJ says J&J officials were surprised that prosecutors were pressing for such a large settlement. Prosecutors are trying to put a settlement of Risperdal marketing claims into context, using as a benchmark Lilly’s $1.4 billion deal to resolve a Zyprexa marketing probe. The difference between the two was that Lilly’s alleged violations extended over a longer period of time, the WSJ source said. The particular allegations against J&J haven’t been disclosed.

The Justice Department has settled a number of marketing cases against Big Pharma over the last several years, and the pace of those deals increased last year. Drugmakers together have paid more than $10 billion to settle government probes; in 2010, the industry’s whistleblower settlements topped the Justice Department charts.

Read article here:  http://www.fiercepharma.com/story/wsj-feds-want-1b-settlement-jj-risperdal-probe/2011-05-13

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Internal J&J Emails Detail “Ugly” Chapter in Mismarketing of Antipsychotics

Friday, March 25th, 2011

BNET
By Jim Edwards
March 25, 2011

One of the reasons Johnson & Johnson (JNJ) lost a recent trial verdict over its misleading marketing of Risperdal was because jurors saw the company’s internal emails in which senior staff described their own actions as “ugly” and not “competent.”

Although the emails don’t reveal anything we don’t already know about Risperdal — J&J marketed the atypical antipsychotic for years by playing down the risk of weight gain and diabetes associated with the drug — the communications do give us a rare glimpse into the backbiting that happens inside drug companies when they fall afoul of the FDA. Pharmaceutical companies almost never discuss this kind of thing in public. (The documents can be downloaded at CourtroomView Network.)

In 2003, the FDA became increasingly concerned that use of drugs such as Risperdal and Eli Lilly (LLY)’s Zyprexa led to weight gain, diabetes and, in some patients, an early death. So it wrote to all antipsychotic drug companies to require them to send a “dear health care provider” letter to all U.S. doctors advising them of this risk:

But J&J began trying to figure out whether the “dear doctor letter” could actually be used to promote Risperdal, which executives believed was not as risky as similar drugs. SVP/R&D Scott Reines had seen a previous “dear doctor letter” from Eli Lilly that had used the same sleight of hand, and he asked a colleague, “how much commercial liability would we incur if we sent a similar letter about Risperdal”?:

When J&J’s letter went out, instead of heightening doctors’ awareness of the risk of diabetes it said the opposite: “Risperdal is not associated with an increased risk of diabetes”:

The FDA — unsurprisingly — hit the roof, and sent J&J a warning letter, blasting the company for being “false and misleading.”

Inside J&J, Reines was furious: “The whole management team almost got canned,” he wrote to chief medical officer Joanne Waldstreicher. “The warning letter is ugly … it’s really a black mark for J&J …  [and] no competent person would have let [the 'dear doctor letter'] go out”:

J&J faces up to $36 million in fines as a result.

Read article here:  http://www.bnet.com/blog/drug-business/internal-j-j-emails-detail-8220ugly-8221-chapter-in-mismarketing-of-antipsychotics/7743

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Profiting from mental ill-health

Tuesday, March 15th, 2011

There’s a reason psychiatrists prescribe drugs rather than talking therapy: the latter makes no money for pharmaceutical firms

The Guardian
By Harriet Fraad
March 15, 2011

More than one in ten Americans takes Prozac; the US comprises 5% of the world's population, yet consumes two thirds of psychological medications. Photograph: Stone/Jonathan Nourok/Getty

The New York Times recently led with a front-page splash about psychiatry’s propensity to prescribe pills, “Talk Doesn’t Pay, So Psychiatry Turns Instead to Drug Therapy”. That news is already widely known in the mental health field, but it has vast ramifications for Americans trying to maintain their sanity in our market-driven and medical system for delivering mental healthcare.

What does the turn to drug therapy mean for the mass of Americans?

Mental illness has not decreased with the change from talk therapy to drugs. In fact, as Robert Whitaker’s book diagnoses, mental illness in America has become an established epidemic. So-called miracle drugs like Prozac are taken by 11% of the population – and Prozac is only one of the 30 available antidepressants on the market. Antidepressants are accompanied by anti-anxiety and anti-psychotic drugs. Xanax, America’s leading anti-anxiety medication, is so ubiquitous that Xanax generates more revenue than Tide detergent, reports Charles Barber in his Comfortably Numb.

Anti-psychotics drugs alone net the pharmaceutical industry at least $14.6bn dollars a year. Psycho-pharmaceuticals are the most profitable sector of the industry, which makes it one of the most profitable business sectors in the world. Americans are less than 5% of the world’s population, yet they consume 66% of the world’s psychological medications.

Do these psycho pharmaceuticals work to restore mental health? Actually, the evidence is overwhelming that they fail. Antidepressants, the most popular psycho-pharmaceuticals, work no better than placebos. They work 25% of the time and stop working when the user stops taking them. In addition, they may actually harm patients in the long run. They disrupt brain neurotransmitters and may usurp the brain’s organic soothing functions.

Psycho-pharmaceuticals are less effective in the long run than talk therapy. Talk therapy, like drugs, does change brain and body chemistry; unlike drugs, though, talk therapy has no side-effects. Instead, talk therapy gives a patient tools that usually help to solve future problems. The latest research is most clearly expressed in both Irving Kirsch’s Antidepressants: The Emperors New Drugs and Gary Greenberg’s, Manufacturing Depression, both published last year. Kirsch is one of the world’s leading psychiatrists; Greenberg is one of the world’s most prestigious psychologists. Their views are echoed by many voices in the field of mental health. Why is prestigious and extensive research so widely ignored by doctors and patients alike? Our market-driven healthcare system gives us clues.

All 30 of the available antidepressants have suffered lawsuits within five years of their appearance on the market. These suits are often settled with large payments and gag clauses. The new generation of anti-psychotics are the latest case in point. Anti-psychotics were the single biggest targets of the False Claims Act. Every major company selling anti-psychotics – Bristol Meyers Squibb, Eli Lilly, Pfizer, Johnson and Johnson and AstraZeneca – has either settled investigations for healthcare fraud or is currently being investigated for it. Two recent settlements involving charges of illegal marketing set records for the largest criminal fines ever imposed on corporations. Their corporate logic is expressed in the words of Dr Jerome Avorn, a medical professor and researcher at Harvard: “When you are selling a billion a year or more of a drug, it’s very tempting for a company to just ignore the traffic ticket and keep speeding.”

There is also the widespread practice of paying physicians and psychiatrists heavy subsidies to recommend psycho-pharmaceuticals to their colleagues in small meetings at which a drug company representative is present. If doubt or criticism of the discussed drug is expressed, the doctor’s stipend stops. Another legally acceptable tool is to publish praise of a company’s drug in a scholarly article, which is often written by drug company personnel and simply tweaked by the physician whose name appears on the article. The physician is paid handsomely for such a service.

Under the pressure of legal settlements and embarrassing disclosures, eight pharmaceutical companies began posting doctors’ names and compensation on the web. ProPublica compiled these disclosures, totaling $320m, into a single database that allows patients to search for their doctor. Receiving payments for publishing articles written by drug companies is not illegal.

Two doctors, Dr Joseph Biederman and Dr Timothy Wilens of Harvard University Medical School, illustrate the close and cozy relationship between medical “scholarship” and drug companies. Drs Biederman and Wilens netted $1.6m each from drug companies for their work in recommending powerful anti-psychotic drugs for children. Biederman, Wilens and other extremely well-rewarded child psychiatrists are in part responsible for giving children the diagnosis of paediatric bipolar disorder for which anti-psychotic drugs like Risperidal and Zyprexa are used.

Experts agree that there is no long-term improvement in children’s lives from taking anti-psychotic drugs. In fact, these drugs have a substantiated pattern of metabolic problems and rapid weight gain that often leads to diabetes. The use of bipolar diagnoses and bipolar medications is one small example of how market-driven mental healthcare works in the United States. It illustrates the transformation of US healthcare into a system dominated by some of the richest corporations in the world.

Caring about profit is first, and that is why psychiatry has turned to drug therapy.

Read article here:  http://www.guardian.co.uk/commentisfree/cifamerica/2011/mar/15/psychology-healthcare

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Billion Dollar Drug Company Law Firm Restructures Connecticut Welfare System

Thursday, March 10th, 2011

By Bob Fiddaman and Shelia Matthews
March 10, 2011

For some time now, Sheila Matthews has been suspicious about her home state of Connecticut’s treatment of its most vulnerable children. As a mother of two children and co-founder of Ablechild, her instincts led her to scrutinize the dubious relationships among Connecticut’s Department of Children and Family Services [DCF], the pharmaceutical industry and a billion dollar law firm who has defended the likes of Pfizer Inc and Merck & Co., among others.

Sheila’s investigation has led her on a journey that links a non-profit children’s advocacy group, with assets over $15 million [2009] with nationally-renowned mass tort and class action defense law firms, to the Connecticut DCF – an $865 million bureaucracy, as described by the Connecticut Mirror.

The Connecticut DCF serves approximately 36,000 children and 16,000 families across its four Mandate Areas:

1. Child welfare;
2. Children’s behavioral health;
3. Juvenile Services; and
4. Prevention.

Sheila’s Ablechild has been questioning the Connecticut DCF since 2003, when Ablechild demanded that the Connecticut DCF immediately ban the use of the antidepressant Paxil in its treatment of mental disorders after multiple studies confirmed Paxil increased the risk of suicide in children and adolescents. This was more than a year prior to America’s Food & Drug Association (FDA) announcement that all antidepressants, including Paxil, should bear a black box warning regarding this suicide risk. Ablechild was disturbed that children in state custody were being prescribed this dangerous psychotropic medication. Ablechild’s public pressure paid off, and the Connecticut DCF deemed Paxil unsafe for children and adolescents, and according to the DCF drug approval list, Paxil has not been approved for use in over eight (8) years.

In August 2003, less than one month later, Ablechild reported that the commissioner of the Connecticut DCF held a ‘behind closed doors‘ meeting with Glaxo officials. This meeting was reported by the Associated Press, who wrote:

The maker of the anti-depressant Paxil plans to meet this week with Connecticut officials, weeks after the State stopped using the drug to treat young people in its care.

GlaxoSmithKline, a British pharmaceutical company, is sending its regional medical director and a medical team to meet with officials from the Department of Children and Families. [Source]

Despite repeated requests from Ablechild, the Connecticut DCF refused to inform the public what was discussed at this secret meeting.

Eight years later, Sheila and Ablechild continue to raise concerns and investigate potential wrongdoings and conflicts within the Connecticut DCF. Last month, in February 2011, Sheila attended a meeting sponsored by the Connecticut Behavioral Health Partnership [CBHP], where its medical director, Dr Steven Kant, presented the Husky Behavioral Pharmacy Data. The CBHP is a state vendor that provides mental health services to DCF children. These services are paid, in part, by the State-run insurance program, HUSKY. Incredibly the pharmacy data presentation showed that dangerous psychotropic drugs, like Paxil, are still being prescribed to thousands of children and adolescents. In fact, the Pharmacy Data presentation showed that the HUSKY program, financed by taxpayer dollars, paid drug companies over $60 million for psychotropic drugs for Connecticut’s children and adolescents in 2009 alone – many of which are not approved by the FDA for use in the pediatric population and all of which carry the most serious warning possible regarding the risk of suicide.

According to the pharmacy data presentation: [Which can be downloaded as a Powerpoint presentation HERE]

More than 50% of HUSKY Youth Behavioral med utilizers are on stimulants.
Close to 30% of HUSKY Youth Behavioral med utilizers are on antipsychotics.

The pharmacy data also revealed the following:

Most Frequently Used Behavioral Meds for DCF-Involved Youth

Medications for ADHD

Ritalin (10%)
Adderall (5%)
Vyvanse (4%)
Strattera (3%)

Atypical Antipsychotics

Abilify (11%)
Risperdol (10%)
Seroquel (8%)

Anti-anxiety

Hydroxyzine (2.5%)

Antidepressants

Prozac (4.5%)
Zoloft (4%)
Zyban (3%)
Desyrel (2.5%)
Celexa (2%)

Mood Stabilizers

Lithum (3%)
Depakote (3%)
Lamictal (2.5%)

Curiously, none of the above medications are on the Connecticut DCF list of approved/unapproved drugs listed in its DCF PMAC document.

With this in mind, Sheila Matthews contacted Dr Steven Kant and inquired as to whether any of the above drugs were approved by the Connecticut DCF for use in children.

Dr Kant replied:

… the answer to your question is not that straight forward.. . . Medications may be indicated by age and/or by specific treatment needs so it is not either a simply “yes” or “no”. Also, some medications may have the age indication but for a totally different condition, such as anti epileptic condition. . .Also FDA indications are static, they do not change over time though medical practice is constantly evolving…

Contradicting the very document that lists Connecticut’s approved and unapproved drugs, a “check-off” list that verifies the status of medications, Dr Kant replied, “I don’t think a “check off” for each medication would work in terms of verifying their status.”

With such an ambiguous response from Dr. Kant, we found the DCF Approved Medication List on the Internet. This particular version was revised in 2009.

It appears that the DCF has approved drugs in children that have not been approved for children by the FDA. In fact, the FDA has issued multiple advisories and alerts since 2004 about the increased risk of suicide in children, adolescents and young adults up to age 25 who are treated with psychotropic medications.

And while Fluoxetine (Prozac) is the only medication approved by the FDA for use in treating depression in children ages 8 and older, it still carries a black box warning regarding the risk of suicide.

In contrast, the DCF seems to be ignoring the conclusions of the FDA. Its list of approved medication in children and adolescents include every single antidepressant except paroxetine [Paxil] and venlafaxine [Effexor].

Forest Lab’s citalopram [Celexa] – APPROVED

Forest Lab’s escitalopram [Lexapro] – APPROVED

Solvay Pharmaceuticals’ fluvoxamine [Luvox] – APPROVED

Pfizer’s sertraline [Zoloft] – APPROVED

GlaxoSmithKline’s bupropion [Wellbutrin -also marketed as an anti-smoking cessation drug under the name of Zyban] – APPROVED [1]

Alarmingly, the DCF has produced a guide entitled, “MEDICATIONS USED FOR BEHAVIORAL & EMOTIONAL DISORDERS – A GUIDE FOR PARENTS, FOSTER PARENTS, FAMILIES, YOUTH, CAREGIVERS, GUARDIANS, AND SOCIAL WORKERS” where it writes, “Most of the side effects from the medications are mild and will lessen or go away after the first few weeks of treatment.” The guide also points out possible side effects of SSRI’s/SNRI’s:

SSRIs and SNRIs:

Headache
Nervousness
Nausea
Insomnia
Weight Loss

One of the most dangerous side effects of these medications, suicidal thoughts/ideation, doesn’t even make the 5 bullet-pointed list. The Guide does, however, add the following: “Watch for worsening of depression and thoughts about suicide.”

The DCF Approved Medication List writes:

“The DCF Approved Medication List is a list of psychotropic medications that has been carefully established by the Psychotropic Medication Advisory Committee, a group of DCF and community professionals.”

Sheila has since investigated other advocacy groups that were concerned about the off-label prescribing of psychiatric medications to youths in state custody. This is where she stumbled upon Children’s Rights, a non-profit charity based in New York City.

In 2005, Children’s Rights employed ten (10) attorneys and a staff of 31. It claims to use its expertise to change child welfare red tape and scrutinize failing systems. If the child welfare system fails to respond, Children’s Rights files a lawsuit. If successful, it enforces reform and then monitors its implementation.

In 1989, Children’s Rights had in fact filed a suit against William O’Neill and the Connecticut state Department of Children and Youth Services [DCYS].

The suit charged that an overworked and underfunded DCYS failed to provide services including abuse and neglect investigations, adoption, foster care, mental health care, caseloads and staffing. The case has been pending for over twenty (20) years, and while there have been numerous arguments that DCYS should be more inclusive or has failed to provide certain services, the issue of massive off-label prescription of psychotropic medications has never been brought to the court’s attention.

Children’s Rights is chaired by Alan C Myers, a partner at Skadden, Arps, Slate, Meagher and Flom, a billion dollar law firm which represents the pharmaceutical industry in mass torts and class actions. Myers is also co-head of the firm’s REIT Group [Real Estate Investment Trust].

Also, listed on the Children’s Rights website are individuals and law firms that have served as co-counsel on Children’s Rights’ legal campaigns to reform America’s failing child welfare systems, including:

Missouri - Shook Hardy & Bacon – Eli Lilly Co. and Forest Labs, defended the original Wesbeker Prozac trial in Kentucky and still defend Prozac, Celexa and Lexapro.

New JerseyDrinker Biddle & Reath – GlaxoSmithKline attorneys – defended Paxil as local counsel in Philadelphia cases.

OklahomaKaye Scholer LLP – provides work in Pharmaceutical Products Liability defense and employs an attorney who was former General Counsel of Pfizer, Inc.

A particular success for Skadden Arps occurred in 2010 when it secured a summary judgement ruling for Pfizer Inc. in a suit filed by two insurance companies who sought $200 million in damages for Pfizer’s predecessors alleged “off-label” marketing of its epilepsy drug, Neurontin.

Furthermore, in February 2011, Skadden Arps secured the dismissal of over 200 cases in a multi-district litigation pending against their client, Pfizer Inc. The plaintiffs had alleged injuries related to the use of Pfizer’s anti-epilepsy drug, Neurontin.

Neurontin, the generic version is called gabapentin, is prescribed by psychiatrists for a variety of “off-label” indications. It is often tried as an alternative treatment, when patients are unable to tolerate the side effect of more proven mood stabilizers such as lithium. [2]

Gabapentin has also been associated with an increased risk of suicidal acts or violent deaths.

This is a drug that has been known to cause behavioral problems, which include unstable emotions, hostility, aggression, hyperactivity or lack of concentration.

Children dependent on child welfare systems have rights and, according to its web page, Children’s Rights is dedicated to protecting them.

It should come as no surprise that the site fails to discuss the off-label prescription of non-approved psychotropic medications to children and adolescents, unless this falls under the ‘abuse and neglect’ category?

If Children’s Rights’ motive was to accomplish fixing the child welfare system then why hasn’t it investigated why thousands of children under state care are prescribed “off-label” psychiatric drugs? With a partner in a billion dollar pro-pharmaceutical law firm as its Chair, and supporters who also defend pharmaceutical products, is it safe to assume that its stance on the drugging of children is one that is being ignored?

Children’s Rights push to remove abused and neglected children into safety.

The basic question always comes down to trust. When power, money and a good cause is mixed, it is imperative to check motives. We would be less of a society if we didn’t check out all the facts. Abuse and neglect exist, always has and always will, but society is obligated to ensure those victims are not transformed into “good cause victims” and expensed out. There is no doubt we have a right to question the system and those who claim to promote change for the good of the children within it.

Children’s Rights Chairman, Alan C. Myers, Medical Director of Connecticut Behavioral Health Partnership, Steven Kant and the Connecticut Department of Children and Families may get their knickers in a twist with regard to an advocate of Ablechild and a blogger from Birmingham, UK questioning their motives but hey, what’s the downside of shinning a light on all these players, be they good or bad players?

Sheila’s concern is that Children’s Rights with its multi-million dollar budget and with the help of its billion dollar law firms, will continue to ignore the risks of these unapproved and dangerous medications, under the guise of helping our nation’s most vulnerable children. The question remains: how can the lawyers who defend psychotropic drugs also be the same lawyers who advocate for abused and neglected children to get into state welfare programs which place these children on the same drugs? The conflict is clear and obvious – and it poses an unmistakable danger to children who truly need our help.

[1] Bupropion [also known as Wellbutrin, Zyban] is a non-tricyclic antidepressant.
[2] Gabapentin

Bob Fiddaman is the author of the Seroxat Sufferers blog and the book, “The evidence, however, is clear… the Seroxat scandal.” Chipmunka Publishing.

Sheila Matthews is the co-founder of Ablechild and a mother of two children.

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Why Mental Health “Advocacy” Groups Aren’t Calling for Psychiatric Drug Investigation in Arizona Shooting: They’re Pharma Funded

Friday, January 14th, 2011

Note from CCHR:  In the wake of the Jared Loughner shooting in Arizona, we pointed out that the press seemed more interested in featuring Pharma-funded mouthpieces speculating on why Loughner wasn’t “treated” (drugged)  and using this tragedy to start banging the drum for more government funding for more mental health treatment, (drugs) before even bothering to find out whether or not Loughner was, or had been, on psychiatric drugs.  The logical question for anyone concerned with mental health would be;  Was Loughner yet another in the long list of  mass shooters already under the influence of psychiatric drugs documented to cause mania, psychosis, violence, homicidal and suicidal ideation that have resulted in 54 dead and 105 wounded in 10 such similar massacres? Isn’t that something we should know before spending billions more dollars on a pharmaceutically based mental health agenda?  Shouldn’t we be investigating that instead of using this tragedy to get more funding for mental health “treatment”?     So let’s just cut to the chase.   The most prominent “mental health” groups using this shooting to cry out “give us billions more funding,” are themselves, funded by Pharma.   Perhaps this sheds light on why despite the overwhelming evidence psychiatric drugs cause violence and even homicide,  groups such as the National Alliance for Mental Illness (NAMI), which claims to be a “patient’s rights” organization for the “mentally ill”  are not calling for an investigation of what, if any role, psychiatric drugs played in this or any other mass shooting in the last 10 years,  we are.

To find out more about these pharmaceutical front groups and their real agenda, click here.

Study: Drug firms fund health advocacy group

The Chicago Tribune – January 13th, 2011
by Judith Graham

Many health advocacy organizations rely on financial support from drug companies. But few disclose the extent of that funding or make information easily accessible, according to a new report published Thursday by researchers at Columbia University’s Mailman School of Public Health.

The groups often sit on important federal advisory boards and press lawmakers for greater funding for medical research, more generous reimbursement for brand-name drugs, and easy access to diagnostic tests and medical devices for people afflicted by various illnesses.

Because of this, “our feeling is that a lot more openness and disclosure needs to take place,” said Sheila Rothman, lead author of the report in the American Journal of Public Health and a professor at the Mailman School.

The study analyzed data from Eli Lilly & Co. from the first half of 2007 and found that only 25 percent of 161 organizations disclosed funding they received from the drug giant on their Web sites. Just 18 percent acknowledged Lilly’s grants in their annual reports, and 1 percent listed Lilly on a corporate sponsors page.

Lilly gave $3.2 million to advocacy groups during this period, 10 percent of all the grants awarded to doctors, medical organizations, non-profits and other entities.

Rothman called the information a “baseline picture” of how secretive organizations were about industry funding before pharmaceutical firms began releasing this information under terms of legal settlements. Lilly began releasing details of its grants in May 2007, becoming the first drug company to do so.

“These were practices at the time,” she said.

Since then some groups have changed their practices, prodded by heightened concern over potential conflicts of interest and an ongoing, high-profile investigation of drug industry funding to physicians and non-profit health groups by Sen. Charles Grassley, R-Iowa.

While complete results of Grassley’s investigation are not yet available, some details have emerged. For instance, the New York Times reported that the National Alliance on Mental Illness received almost $23 million from pharmaceutical firms between 2006 and 2008; state NAMI chapters have received millions more, according to a letter sent to the organization by Grassley’s office last year.

NAMI now lists corporate grants of $5,000 or more for its national operations on its Web site, but individual chapters’ funding sources aren’t included. The organization has a strict policy against endorsing specific products or services, its Web site says.

Lilly targeted funding to advocacy groups representing patients with neurological or psychiatric disorders such as schizophrenia, bipolar illness, and depression; endocrine disorders such as diabetes; and cancer, the new report found. These were the three largest categories of U.S. sales, worth $10.1 billion for the drugmaker in 2007.

The researchers arrived at their conclusions by checking advocacy organizations’ 2007 annual reports and federal tax forms and performing a comprehensive review of their Web sites between Sept. 30, 2008, and Jan. 12, 2009. All mentions of Eli Lilly funding were noted, but some information may have been missed if it was posted on Web sites earlier.

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Drug-Company Tweeting: Still Awaiting FDA Rules

Wednesday, December 29th, 2010

Note from CCHR:  Let’s  see if we’ve got this straight…..last year, Pfizer paid $1.2 billion for illegal off-label promotion -the largest criminal fine in U.S.history. The company also paid $2.3 billion to settle claims that it had marketed numerous drugs for unapproved purposes.  Other corporate violators included GlaxoSmithKline, Eli Lilly, Schering-Plough, Bristol-Myers Squibb, AstraZeneca, TAP Pharmaceutical, Merck, Serono, Purdue, Allergan, Novartis, Cephalon, Johnson & Johnson, Forest Laboratories, Sanofi-aventis, Bayer, Mylan, Teva and King Pharmaceuticals.  Criminal or civil illegalities included  (1) overcharging government health programs, (2) unlawful promotion, (3) monopoly practices, (4) kickbacks, (5) concealing study findings, (6) poor manufacturing practices, (7) environmental violations, (8) financial violations and (9) illegal distribution. And after all that, the FDA is going to allow Big Pharma to launch into social media?   Seriously?  The article below claims the FDA monitors drug ads –for accuracy.  No they don’t.  The FDA doesn’t bother verifying the ads big Pharma inundates us with on TV & in print, to ensure these ads are not fraudulent or misleading even though its the FDA’s job to do this, and now they’re going to let Big Pharma loose on social media?   Sounds to us  like once again,  the FDA has Big Pharma’s back instead of the general public’s.

TIME Magazine  – December 28, 2010

Tweets are supposed to be quick and to the point, but the Food and Drug Administration (FDA) is neither in its ever lengthening quest to tell the world’s drugmakers how they can promote their potions via Twitter, Facebook and other social media. More than a year ago, after criticizing 14 pharmaceutical companies for posting misleading messages on such sites, the FDA held hearings on the topic and declared it would issue rules by the end of 2010. Now it’s delaying them until sometime early next year, perhaps later.

For more than a decade, the FDA has regulated how drug companies sell their products in newspapers, magazines, television and radio. But as the rest of the business world jumps into booming social-media marketing, there are no rules yet for medicine merchants. The pharmaceutical industry had hoped the FDA would stick to its pledge and issue guidelines this year. Earlier this month, in fact, agency officials said that was still the plan. But last week, the FDA office responsible for drafting the new regs said, without elaboration, that it is going to wait at least until the first quarter of 2011 before issuing them. (See TIME’s best pictures of 2010.)

The companies wish the agency would act. “Without guidance, our activities are limited in a manner that we believe is not in the best interests of informed health care decision making,” the drugmaker AstraZeneca has told the FDA. “In our absence, consumers will turn to information sources that are not regulated and not always well informed.” Not everyone agrees the companies have such altruistic aims. The Center for Digital Democracy (CDD), a consumer group based in Washington, D.C., that is focused on marketing and public-health issues, has told the FDA to take as much time as it needs. The agency, says Jeff Chester, CDD’s executive director, “needs to take a deep breath, and shouldn’t open the floodgates and allow pharmaceutical companies to purposely mislead consumers.” (See how drug companies are taking their pitch to social media.)

Despite such qualms, there’s reason to be concerned by the foot-dragging. About 60% of U.S. adults get health information online, often for a partner or child. We’re what experts call “e-patients,” who regularly march into doctors’ offices demanding prescriptions for what ails us. Many of us pore over the Internet, seeking ways to get better, and often surrender personal information to get it. The drug industry surely recognizes the value of such online contact, and is steadily increasing the share of its $4 billion annual marketing budget dedicated to online offerings.

Yet tough questions need to be answered before Big Pharma starts tweeting about our tummy aches. How can drug companies safely sell their products — which often require pages of fine print or speed-talking announcers — in a 140-character tweet? If a drug’s risks and benefits are wrongly cited in a Wikipedia entry, is the company responsible for correcting it? Does that then become advertising regulated by the FDA? Does the drug industry’s proposal to include a symbol, inside a tweet, that links consumers to more detailed information make sense? (Comment on this story.)

It’s enough to give you a headache. In which case, you may want to take two tweetless aspirin, along with a dollop of patience, while awaiting the FDA’s rules.
Read more: http://www.time.com/time/business/article/0,8599,2039794,00.html#ixzz19WlEIgcZ

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Drug Industry Fraud—The Whistle Has Been Blown, But Where’s the Enforcement?

Tuesday, December 28th, 2010

Counter Punch, December 28, 2010

by Ralph Nadar

The corporate defrauding of taxpayers (eg. Medicaid and Medicare) and prescription drugs with skyrocketing prices was the subject of a report by Public Citizen’s Dr. Sidney Wolfe and his associates (see citizen.org).

Dr. Wolfe’s team compiled a total of 165 federal and state settlements since 1991 totaling $19.8 billion in penalties. A key finding is that the drug industry’s penalties under the Federal False Claims Act exceed even those assessed against the overcharging defense industry for fraud.

Before we become overly impressed with the cumulative amount of the penalties, specialists in corporate crime law enforcement believe that adding more federal cops on the corporate crime beat, backed by a determined law and order Justice Department with White House backing, would have greatly increased the number of cases and imposition of penalties on these drug industry giants.

Nonetheless, Dr. Wolfe’s study shows that the pace of penalties has picked up over the past five years. This is due to “a combination of increased violations by companies and increased law enforcement on the part of federal and state governments,” says the report.

Many of these cases were initiated by company whistleblowers, who under the False Claims Act can receive a share of the settlements. Since the corporate bosses of these drug firms are almost never prosecuted, what these executives fear the most are company employees who go public with the evidence of corporate misdeeds.

These violations do more than financial damage to consumers and government health insurance programs. One of the worst violations involves companies promoting unproven, often dangerous uses for their medicines. Last year, Pfizer paid $1.2 billion for illegal off-label promotion -the largest criminal fine in U.S.history. Other major corporate violators were GlaxoSmithKline, Eli Lilly, Schering-Plough, Bristol-Myers Squibb, AstraZeneca, TAP Pharmaceutical, Merck, Serono, Purdue, Allergan, Novartis, Cephalon, Johnson & Johnson, Forest Laboratories, Sanofi-aventis, Bayer, Mylan, Teva and King Pharmaceuticals.

The violations by these and other drug companies point to the wide range of impacts, including taking many lives of patients, which stems from these recurrent activities. These criminal or civil illegalities cover (1) overcharging government health programs, (2) unlawful promotion, (3) monopoly practices, (4) kickbacks, (5) concealing study findings, (6) poor manufacturing practices, (7) environmental violations, (8) financial violations and (9) illegal distribution.

Outside the purview of the Public Citizen study are the ravages of counterfeit drugs and poorly inspected ingredients in drugs, now mostly coming from China and India, due to the outsourcing by U.S. and European drug companies in their thirst for even greater profits.

Drug company sales are huge, growing from $40 billion in 1990 to $234 billion in 2008, and far exceeding inflation with their annual price gouging. To make matters worse, in 2003, the Congressional Republicans, with decisive support from some Democrats, passed the drug benefit bill which explicitly prohibited Uncle Sam, the payer, from bargaining for volume discounts with drug companies.

With over 400 full-time drug company lobbyists putting pressure on Congress, and tens of millions of dollars flowing into the legislators’ campaign coffers, budgets for federal investigators, prosecutors and inspectors are kept to a minimum. Unfortunately, crime in the suites pays over and over again, despite occasional penalties.

A bright spot is the increasing enforcement action at the state level.

By last year, 32 states had enacted false claims acts, including fourteen states that qualified as strong laws by federal standards.

Still, the Wolfe report concludes that the “current system of enforcement is not working.” He gives the examples of the $7.44 billion in financial penalties assessed over the past twenty years on GlaxoSmithKline and Pfizer, as compared to their combined total of $16.5 billion in global net profits in one year alone.

What would deter these illegal practices and risks to public safety? Dr. Wolfe says “the lack of criminal prosecution that would result in jailing of company executives.” is key. Moreover, the report notes that “a felony conviction could result in their companies becoming ineligible for reimbursement from federal and state health programs, a critical source of pharmaceutical company revenues.”

A flicker of hope that a little change is on the way came from the Food and Drug Administration’s Deputy Chief Counsel for Litigation, Eric Blumberg. He indicated that the government is considering going after drug company executives for violations such as off-label promotions. He stated: “.unless the government shows more resolve to criminally charge individuals-at all levels in the corporate hierarchy–.we can not expect to make progress in deterring off-label promotion.”

The problem is that the final operating decision is in the hands of the Justice Department-historically short-staffed and short-willed to entreaties for prosecution by the FDA and other regulatory agencies.

Furthermore, for over 30 years, the Justice Department has stone-walled requests that it start a corporate crime database as it has done with street crimes. Congress likes it this way, as it continues to cash corporate campaign checks.

Just last week, however, outgoing Judiciary Committee Chairman, Democrat John Conyers introduced a bill (H.R. 6545) to create such a corporate crime data base in the Justice Department. Well, as the saying goes, everything starts with a gesture!

http://www.counterpunch.org/nader12282010.html

Ralph Nader is the author of Only the Super-Rich Can Save Us!, a novel.

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Once Again Psychiatrists Top the List of Top Prescribers—And Are Heavily Funded by Pharma

Wednesday, December 8th, 2010

Note from CCHR:   The reason why we repeatedly see psychiatrists on the list of top drug prescribers is pretty simple.  It’s so easy to prescribe psychiatric drugs to patients. Think about it.  It’s not like cancer or diabetes, or even high cholesterol where there’s a test to show some disease or imbalance requiring “medication” to treat it.   Sure there are medical conditions that may not have a “test” to prove anything is wrong.  There are some.  But there are no tests to prove anyone has a mental disorder.  Not one.  So psychiatrists can make a killing when it comes to writing unnecessary prescriptions.  Literally.   All while raking in the bucks from Pharma.

San Diego Union Tribune – December 8, 2010

By Christina Jewett

Three San Diego doctors who prescribe medications at the same time they are paid by drug companies as experts on the products figure into a broader national debate about whether playing both roles poses a conflict.

California Watch, a project of the independent, nonprofit Center for Investigative Reporting, compared two sets of data at the center of the debate — one a database of payments by drug companies to doctors nationwide and the other a list of the top antipsychotic prescribers in California’s Medi-Cal program for the poor and disabled.

Among California’s top prescribers, three accepted more than $20,000 in educational or speaker’s fees from the company that makes the drug they prescribe to Medi-Cal patients. All three practice in San Diego County.

Accepting drug company payments and then prescribing the products to patients is not illegal or even unethical, in and of itself. But some inside the profession and out are concerned such marketing could induce over-prescription of drugs or otherwise corrupt the process.

Two of the San Diego-area psychiatrists share a La Mesa office — Samuel O. Etchie and John W. Allen.

Allen was among the state’s top prescribers of Zyprexa, an antipsychotic drug. Allen dispensed 418 prescriptions at a cost to the state of $346,569. This year and last, the drug’s maker, Eli Lilly and Co., paid him about $27,000 to educate other medical professionals.

Allen said he conducts speeches about Zyprexa for Lilly based on information contained in the FDA-approved literature that comes with the drug. He said he speaks for a variety of drugmakers if he has done research and treated patients with the medication.

“I think it’s unfortunate that there’s in implication in articles that we’re robots for drug companies,” Allen said. “We have to have our own experience with medications and find out what works best. We’re not 5-year-olds in front of TV watching cereal and toy commercials.”

Allen said the prescribing numbers reflect the many bipolar and schizophrenic patients he treats in his practice. He said he prescribes a wide variety of medications, new and old.

“Whatever works for the patient is most important,” Allen said.

Etchie, who shares and office with Allen, prescribed Seroquel more than 1,000 times in 2009 at a cost of $449,000 to the state, according to Medi-Cal records collected by the Pro Publica news organization and provided to California Watch. The drug’s maker paid him $25,350 this year to speak to health professionals.

Etchie said he’s been paid by drug companies to give talks for about 10 years, and sees it as a way to keep himself informed about new and approved uses for medications and to share that information with colleagues who may be too busy to keep track of the research themselves. He said his presentations on Seroquel are an overview of the research drugmaker AstraZeneca has given the FDA about the medication.

“Whatever I do in the area of medicine, I want to get paid,” he said. “But my motive in doing this is to keep my knowledge base current and then to pass on that information to colleagues. Whether a doctor prescribes a medication or not is none of my business. I’m not a salesman.”

The third San Diego-area doctor is Harinder Grewal, a child psychiatrist who sees patients throughout the county.

According to Medi-Cal records, she issued nearly 3,000 prescriptions for antipsychotic medications in 2009, half of them for the drug Seroquel. This year AstraZeneca, that company that sells the drug, paid her $21,600 to educate other health workers.

Grewal did not return calls from California Watch or The San Diego Union-Tribune.

Grewal was also among the state’s top prescribers of the antipsychotic medication Geodon. That drug’s maker, Pfizer, spent $3,750 to compensate Grewal for leading an educational forum.

The three doctors showed up on a list provided by Medi-Cal officials to Sen. Charles Grassley, R-Iowa, who is reviewing prescribing rates of psychiatric and pain medications nationwide.

Grassley’s investigation comes on the heels of numerous government lawsuits that have accused pharmaceutical companies of illegally marketing drugs beyond their approved uses. California authorities who provided the information to Grassley’s office warned against viewing the data as a sign of wrongdoing.

Read the rest of the article here:  http://www.signonsandiego.com/news/2010/dec/06/paid-drug-experts-also-prescribe-products/

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New Mental Hospital Unveiled but Nurse Ratched Now Pusher for Big Pharma

Thursday, December 2nd, 2010
“Never console yourself into believing that the terror has passed, for it looms as large and evil today as it did in the despicable era of Bedlam. But I must relate the horrors as I recall them, in the hope that some force for mankind might be moved to relieve forever the unfortunate creatures who are still imprisoned in the back wards of decaying institutions.”
Actress  Frances Farmer—who was  drugged, electroshocked and lobotomized in  a psychiatric ward

Natural News, December 2, 2010
by Monica C. Young
Oregon state officials recently unveiled part of a state mental hospital that will replace the asylum which once served as a real-life set for “One Flew Over the Cuckoo’s Nest”. While using the occasion to trumpet psychiatry’s “modern” mental health treatment, they ignore the industry’s contemporary atrocities, most notably its reliance on highly debilitating drugs as chemical straitjackets. Although the Oregon State Hospital was not specifically named in Ken Kesey’s novel, on which the 1975 Academy-award winning movie was based, it could have been. For its legacy of real abuses spans over a century.

Just two years ago the U.S. Department of Justice warned Oregon that care and conditions at the hospital violated patients’ rights. One person had been in seclusion for a year with no other treatment. Another patient with a condition that causes excessive thirst was left at a water fountain and gained 13 pounds in water weight in one day.

The Oregonian newspaper revealed the death last year of a 42-year-old man who succumbed to a heart attack in his bed hours before anyone in the facility found his body. Nobody checked on him even though he’d missed two meals.

Although the chilling film starring Jack Nicholson is now decades old, it wasn’t until state lawmakers toured the facility in 2004 that they discovered the cremated remains of 3,600 patients who had been locked away and forgotten inside. “You can see the place where they showered. You can see their scratchings on the wall,” said Oregon Senate President Peter Courtney. “They lived there. And then often people forgot them. They just took them there and it was over.”

Gov. Ted Kulongoski, in dedicating the new building, said, “It will be the life at the end of despair and the start of a new dawn that will help patients recover.” Nice speech writing, but how true is this?

Psychiatric institutions today commonly put patients on cocktails of multiple drugs which numb the brain and have potentially lethal side effects. And as withdrawal can itself create intense physical and emotional disturbances, they hook patients on meds for life.

Prolonged use of the older “typical” antipsychotics, still in use today, can cause tardive dyskinesia (involuntary writhing movements of the facial muscles and tongue, an irreversible neurological disorder). Yet the newer, heavily marketed and much more costly “atypical” drugs have their own array of serious effects. Eli Lilly’s blockbuster antipsychotic typically generates excessive weight gain and can predisposition an individual to early heart attacks and type-2 diabetes. Ironically, this same drug maker counts diabetic medications as some of its top-sellers.

While these extremely toxic drugs are highly profitable for drug makers and make institutional patients more submissive, they also deaden their sensibility and threaten their life expectancy.

So does the new Cuckoo’s Nest building truly reflect a restoration of human rights, or has Nurse Ratched forged a more lucrative alliance with Big Pharma?

http://www.naturalnews.com/030593_mental_hospital_Big_Pharma.html#ixzz16yjVzKva

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Disciplined doctors receiving pharmaceutical funds

Thursday, November 18th, 2010

San Francisco Chronicle, November 18, 2010

by Victoria Colliver

About 48 of the more than 1,730 California doctors who received money from pharmaceutical companies over the past 21 months have been the subject of disciplinary action, a database compiled by the investigative news organization ProPublica found.

While that represents less than 3 percent of the California doctors who take pharmaceutical money, the fact that drug companies are paying those doctors – some of whom have multiple disciplinary actions – for their expertise calls into question how closely these companies vet the physicians who serve as the spokespeople for their drugs.

California doctors have received $28.6 million from top pharmaceutical companies since 2009, with at least three physicians collecting more than $200,000 and 36 others making more than $100,000 for promoting drug firm products. That cash flowing from drug companies to doctors has raised ethical concerns from some observers.

“If they’re getting as much money from pharmaceutical companies as they do for being a doctor, what are they really? Are they working for a pharmaceutical company, or are they being a doctor?” asked Lisa Bero, a pharmacy professor at UCSF who studies conflicts of interest in medicine and research.

Bero also questioned why drug companies – which presumably would want medical leaders who could influence prescribing patterns – would use doctors with a history of disciplinary actions.

“Are those really the most influential physicians?” she asked. “I don’t think they’re (the drug companies) on top of this.”

Company payments

Payments to doctors and other health professionals made by Eli Lilly, GlaxoSmithKline, AstraZeneca, Pfizer, Merck, Johnson & Johnson and Cephalon, some of the world’s largest drug companies, added up to more than $281.9 million in 2009 and 2010 nationwide. The figures do not include drug samples, the cost of continuing education programs, and meals brought to doctors’ offices.

In total, 384 of the approximately 17,700 health professionals in the 30 states surveyed who received some money from drug companies in ProPublica’s database, almost all of them physicians, earned more than $100,000 apiece for their promotional and consulting work on behalf of one or more of the seven companies in 2009 through Oct. 19 of this year.

ProPublica found that the seven drug companies paid $6.7 million to 290 doctors who faced disciplinary action or other regulatory sanctions in various states.

San Francisco psychiatrist Karin Hastik, for example, took $168,658 in speaking and consulting fees from Eli Lilly, AstraZeneca and GlaxoSmithKline since 2009.

But in May, the Medical Board of California placed Hastik on probation for negligence, prescribing drugs without prior examination, and failing to keep adequate records about a patient she had been caring for since 2000. Hastik did not return calls for comment.

Dr. Gerald Sacks, an anesthesiologist with offices in Los Angeles and Santa Monica, was California’s top earner in the database, receiving $249,822 from drug companies since 2009. More than half – $150,097 – came from Pfizer.

In 2003, the state medical board cited Sacks, who did not return calls for comment, for failing to maintain adequate records of a patient he treated for back pain.

Undermining trust

While the disciplinary actions in the database vary greatly – everything from failing to maintain accurate paperwork to sexual misconduct – some experts say the very act of taking large sums of money from pharmaceutical companies raises ethical concerns.

“It undermines the trust in the doctor-patient relationship,” said Maryann O’Sullivan, executive director for the Campaign for Effective Patient Care, a nonprofit based in Fairfax. O’Sullivan said patients shouldn’t have to worry if their doctors are making medication recommendations because they are beholden to drug company money.

Officials for several of the pharmaceutical firms told ProPublica that they intended to tighten and improve their selection and screening processes in light of the disciplinary results. ProPublica provided each company with lists of all speakers who had been disciplined in the 30 states and by the U.S. Food and Drug Administration.

A survey conducted in 2004 found that more than 80 percent of physicians had some relationship with the pharmaceutical industry, ranging from accepting drug samples to collecting consulting fees and participating in paid clinical trials.

Since that time, greater attention has been placed on the relationship between doctors and drug companies, and many hospitals and medical schools have adopted rules that limit these ties.

A survey published this month in the Archives of Internal Medicine found that more than 80 percent of doctors still had industry relationships, but the level of involvement had decreased. For example, the survey found the percentage of physicians receiving payment for speaking engagements and other services dropped from more than one-fourth in 2004 to 14.1 percent last year.

Several doctors who were not the subject of any disciplinary action but did take large sums from pharmaceutical companies told The Chronicle they spoke on behalf of only those drugs they believed in and thought they were performing an important educational service for other physicians.

A teaching tool

Dr. Rona Hu, clinical associate professor at Stanford University School of Medicine, said she earned more money from speaking engagements in 2009 than usual because several drugs she prescribes became available for new uses. The psychiatrist said she has since stopped getting paid by drug firms to speak because Stanford tightened its policy regarding industry gifts to staff.

One of the top earners in Northern California, Palo Alto psychiatrist Manoj Waikar, who earned $185,875 since 2009, ended his affiliation with Stanford as an adjunct professor after the school extended its ban to adjunct staff in March.

“Speaking for drug companies is a great vehicle for me for teaching. I end up reaching more people who are eager to learn, especially in rural parts of the country,” he said, adding he does not disclose what drugs he prescribes to pharmaceutical companies so they hire him for his expertise, not because of his prescribing patterns. “As much as I loved teaching at Stanford, abiding by their rules would (keep) me from teaching as many people in as many ways as I can.”

Dr. Michael Lenoir of Oakland, who collected $112,600 from GlaxoSmithKline, said he uses his speaking engagements to visit urban and underserved areas around the country to discuss the high rate of asthma in black communities and the treatment options.

A San Francisco pain doctor who has earned $176,771 since 2009 from Pfizer and Cephalon said he doesn’t believe speaking for drug companies poses a conflict because he discloses the payments to his patients.

“So far, every patient has been OK with it,” said Dr. Wayne Anderson, adding that doctors who take money from equipment manufacturers and other medical suppliers don’t fall under the same scrutiny. “I don’t get bonus payments at the end of the month. I’m not trying to do anything secretive. I have complete transparency and honesty, and I tell people when I have been paid to promote a drug.”

About this story: It was produced in partnership with ProPublica, a nonprofit investigative news organization. To read the stories in the investigation and to search the ProPublica database on pharmaceutical company payments to doctors, go to projects.propublica.org/docdollars.

Read the rest of the article here: http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2010/11/18/MNJU1GDLRF.DTL

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