Posts Tagged ‘bipolar’

After $1.4 billion criminal fine for illegal marketing, Eli Lilly tries something new—promoting “ethical behavior”

Monday, March 8th, 2010

IndyStar.com
John Russell
March 8, 2010

Eli Lilly and Co. has agreed to add four new senior positions to “promote highly ethical and compliant behaviors” as part of a settlement of two lawsuits arising from the company’s illegal marketing and promotion of several drugs.

The Indianapolis drugmaker also has agreed to upgrade its policies and procedures to ensure that patient safety “shall be of paramount importance,” according to a government filing the company made today.

Last year, Lilly paid $1.4 billion, the largest criminal fine ever imposed on a U.S. corporation, over the illegal marketing of Zyprexa. The company also pleaded guilty to a misdemeanor and agreed to additional oversight to resolve a 5-year-old federal investigation.

Federal prosecutors had said Lilly unlawfully promoted Zyprexa for agitation, aggression, hostility, dementia, depression and generalized sleep disorder, although the drug was approved only for schizophrenia and bipolar disorder.

The company had also improperly marketed Evista, its osteoporosis drug, and Prozac, its antidepressant.

In response, several shareholders sued the company, claiming it breached fiduciary duty in connection with the illegal marketing, exposing Lilly to substantial risk of damage. The suits are known as “derivative claims” as they were brought by shareholders on behalf of the company, rather than on behalf of shareholders, seeking to force the company to take corrective steps.

Read entire article:  http://www.indystar.com/article/20100308/BUSINESS/3080383/Eli-Lilly-adding-four-ethics-watchdogs

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Drug Giant AstraZeneca to drop psychiatric drug research for schizophrenia, bipolar, depression & anxiety drugs

Tuesday, March 2nd, 2010

Reuters
By Ben Hirschler
March 2, 2010

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]

Read entire article:  http://www.reuters.com/article/idUSLDE62019Q20100302?type=marketsNews

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Kickbackers’ motto: ‘Do no harm’ (to profits)—How drug company used kickbacks to get patients on psych drugs

Tuesday, January 26th, 2010

Boston Globe
By Donald A. MacGillis
January 26, 2010

TALK ABOUT death panels. The US attorney in Boston recently filed suit against the world’s largest maker of health products, Johnson & Johnson, for using kickbacks to get more nursing home patients onto its drugs, including one that was later found to be so lethal to the elderly it had to carry a black-box warning. The government’s complaint leaves little doubt that the drug company acted in a predatory way to increase sales and market share for its products, especially Risperdal, an antipsychotic often used to keep Alzheimer’s and dementia patients under control.

Risperdal is used principally for the treatment of schizophrenia and bipolar disorder. Doping the elderly into placidity is an off-label use of the drug, one that the Food and Drug Administration finally cautioned against in 2005. The reason for the black box warning the FDA required? Too many of the elderly who got the drug were dying.

There is one other reason to thank the federal government for going after the suspect payments Johnson & Johnson made to the middleman to juice up sales of its drugs: Since Medicaid covers most of the nursing home patients, the taxpayer ends up paying much of the bill.

The middleman between Johnson & Johnson and the nursing homes is Omnicare, the country’s largest pharmacy for nursing homes. Last November, it agreed, without “any finding of wrongdoing’’ or “any admission of liability,’’ to a $98 million settlement with the government for its role in helping Johnson & Johnson boost sales to nursing homes. The government says that between 1999 and 2004 Omnicare received tens of millions of dollars in the form of escalating rebates based on greater market share for Johnson & Johnson drugs and in payments ostensibly made by Johnson & Johnson for “data’’ from Omnicare, much of which Omnicare never provided. Other kickbacks, the government says, came in the form of “grants’’ and “educational funding.’’

Read entire article:  http://www.boston.com/bostonglobe/editorial_opinion/oped/articles/2010/01/26/kickbackers_motto_do_no_harm_to_profits/

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Cooking the Books:The statistical games behind “off-label” prescription drug use

Monday, December 21st, 2009

Darshak Sanghavi
Slate
December 21, 2009

Years ago, mathematician John Allen Paulos described a brilliant stock scam, in which a crooked broker sends out a huge number of letters to potential clients. Half the letters say the market will rise; the other half predict the opposite. As Paulos explains, “No matter whether the index rises or falls, a follow-up letter is sent, but only to [people] who initially received a correct prediction.” On that half, the scam is repeated. After several iterations, the broker has hooked some fraction of his initial marks—the guy correctly predicted a half-dozen or so market moves!—and the unsuspecting rubes are ready to be fleeced.

Pharmaceutical companies employed a similar ruse to propel sales of drugs for “off-label” indications, or uses not green-lighted by the Food and Drug Administration. The FDA approves new prescription drugs only after clinical trials show a benefit in the form of a pre-specified outcome, such as fewer asthma attacks, better blood sugar control, or some other metric. (For example, Neurontin was approved to control seizures.) Companies are forbidden to advertise or promote the drug for any other problem. However, no law stops doctors from prescribing the drug for whatever reason they like—and they certainly do.

In 1996, a young researcher named David Franklin left Parke-Davis due to his disgust over off-label marketing of the anti-seizure drug Neurontin. (Franklin reported that one company executive told him, “[W]e need to be … holding [physicians'] hands and whispering in their ear, Neurontin for pain, Neurontin for monotherapy, Neurontin for bipolar, Neurontin for everything.”) A resulting class action suit was settled for $430 million in 2004, and thousands of pages of corporate documents soon ended up in a searchable digital library at the University of California-San Francisco.

Read entire article: http://www.slate.com/id/2239360/

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And yet another FDA warning – Depakote – used to treat people diagnosed “Bipolar” found to cause severe birth defects

Thursday, December 3rd, 2009

FDA MedWatch Safety Information
Dec. 3, 2009

Audience: Neurological and Obstetrical healthcare professionals

The FDA notified health care professionals and patients about the increased risk of neural tube defects and other major birth defects, such as craniofacial defects and cardiovascular malformations, in babies exposed to valproate sodium and related products (valproic acid and divalproex sodium) during pregnancy. Healthcare practitioners should inform women of childbearing potential about these risks, and consider alternative therapies, especially if using valproate to treat migraines or other conditions not usually considered life-threatening.

Read entire article:  http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192788.htm

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Pharma’s Drug Ads: From Million Dollar TV Ads to $1.7 Billion Internet Marketing Campaign

Monday, November 16th, 2009

On November 13th, 2009, Pharmaceutical companies flocked to a two-day FDA hearing into online drug advertising, which could influence their use of social media on the net. 1  Already, the explosive growth in online advertising has intensified public concerns: the pharmaceutical industry spent more than $1 billion on Internet ads last year and is projected to spend $1.7 billion on such marketing efforts in 2012, according to the Direct Marketing Association.2

Both Eli Lilly and Merck have received warning letters this year from the FDA accusing them of misleading online advertisements.3  But while the FDA scrambles to monitor online ads, who monitors the psychiatric-pharmaceutical industry’s use of front groups to indirectly market their products?

A Washington Post article of June 16, 2009 reported that an increasing number of pharmaceutical firms are turning to social media tools, such as Facebook, YouTube, Twitter and MySpace, to market their products.  It cites how a community site sponsored by drugmaker McNeil called “ADHD Allies”—aimed at adults with ADHD—was established and offered an online podcast on financial advice and an “ADHD self-assessment tool.”4

British psychiatrist Joanne Moncrieff explains how this ultimately increases drug sales because only a biomedical approach is promoted: “Drug companies…provide funds for pro drug patient and carer groups and address advertising or disease promotion campaigns to the general public…This influence has helped to create and reinforce a narrow biological approach to the explanation and treatment of mental disorders and has led to the exclusion of alternative” treatments.5

Such websites do not mention company’s product but rather market the “disease.” In advertising, it can be accomplished through a strategy known as “condition branding,” where “mental illness” can be pitched just like cars, beer or laundry detergent.  Witness the brand name “bipolar” and “social anxiety disorder” that drug companies marketed at a fever pitch.

John Read, PhD, Psychology Department, University of Auckland did an analysis of 54 random “advocacy” groups for Post Traumatic Stress Disorder (PTSD) through the Internet. The results, published in the Journal of Trauma & Dissociation this year, found 42% of the websites received drug company funding. The researchers found:

  • “Patients tend to trust these organizations to act in an unbiased manner” but as earlier researchers argued in some cases “patient organizations have become a mouthpiece for the pharmaceutical industry in influencing regulatory authorities.”
  •  “Drug company influence within the area of mental health is prevalent and now extends to the Internet. This influence is not always transparent. This study suggests that drug company sponsorship of websites leads to a greater emphasis on pharmacology in the treatment of PTSD,” Dr. Read’s report concludes.6

ADHD Allies/ADHD Moms

In June 2008 Concerta was given an expanded indication by FDA and is now indicated for patients aged 6 to 65.7 In July 2008, McNeill Pediatrics—a subsidiary of Ortho-McNeill Pharmaceuticals—launched what they called an “unbranded group” called “ADHD Moms.” ADHD Moms markets the trademarked name “Mom-bassadors” to get mothers into the Facebook page. 8

  • McNeill spuriously claims “the group is not product-specific, nor are there any advertisements for the company’s ADHD drug Concerta (methylphenidate).” Well not directly, but providing material for the site is a Dr. Quinn, a paid consultant and speaker for McNeil Pediatrics. 9  April White, who also provides content is a paid spokesperson for McNeil Pediatrics.10
  • On April 22 2009, McNeill launched a second ADHD-focused Facebook page called “ADHD Allies,” this time targeting adults.  The “Allies” are board members of another front group Attention Deficit Disorder Association (ADDA), funded by McNeill.11
  • The pharmaceutical company has trademarked “ADHD Allies” and “ADHD Moms.”  ADHD Allies was responsible for a “2008 Harris Interactive survey of 1,000 adults with ADHD.” Not surprisingly, the survey found the condition significantly affects them. 12

Log onto The Bipolar Journey: Living With Bipolar Depression website and while it does show AstraZeneca on the home page, there’s no mention of its blockbuster antipsychotic drug Seroquel, approved by the FDA in 2006 for “bipolar.”  The site looks like a patient information site providing facts about the “disease” and misleadingly saying that it may be caused by a chemical imbalance—for which there is no evidence.

It refers people to the National Alliance for the Mentally Ill (NAMI) that has received $23 million recently from at least 18 drug companies. The site shows that of 17 cites for the exhibit’s showing in 2009, 12 are conferences or events put on by NAMI.

It also links to The Depression and Bipolar Support Alliance, a group that received close to $1 million in pharmaceutical company funding in 2007.

According to an August 27 2009 press announcement, AstraZeneca launched its interactive exhibit, endorsed by New York psychiatrist Janet Taylor. The press release does not mention that Dr. Taylor has financial ties to the company.13

In 2005, global sales for Seroquel reached $2.8 billion.  October 20, 2006, company announced Seroquel was FDA approved for bipolar.14 Within a year, sales reached $3 billion and then soared again in 2008 to $4.66 billion.15

By funding social media front groups that talk only about the “disorder,” drug companies can overcome fears of running afoul of FDA regulations that govern drug advertising and “are embracing social networks to help brand and position their companies in a positive light with consumers and practitioners.”  The top 10 drug companies using social media are: Pfizer, Johnson and Johnson, Novartis, Boehringer Ingelheim, AstraZeneca US, Bayer, GlaxoSmithKline, Sanofi-Aventis, Roche, and Merck.16

This post was written by CCHR International.
Coming next from CCHR Int: Psycho Pharma Front Groups

1 “FDA Addresses Drug Ads in Online Social Media,” Red Orbit, 13 Nov. 2009.

3 “FDA Addresses Drug Ads in Online Social Media,” Red Orbit, 13 Nov. 2009.

5 Joanne Moncrief, in a “Study of the Influence of the Pharmaceutical Industry on Academic and Practical Psychiatry,” http://www.critpsynet.freeuk.com/pharmaceuticalindustry.htm

6 http://www.isst-d.org/jtd/mansell_&_read_ptsd_drug_cos_&_internet%20.pdf; Journal of Trauma & Dissociation, 10:9–23, 2009

12 “Adults ‘Facing’ ADHD: ADHD Allies™ Offers Unique Online Community for Adults with ADHD on New Facebook® Page,” http://multivu.prnewswire.com/mnr/concerta/36533/

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Pfizer pays $300 million to resolve allegations of off-label marketing of its antipsychotic drug Geodon

Wednesday, September 2nd, 2009

PRNewswire
September 2, 2009

PHILADELPHIA — Pfizer, Inc. announced today it has agreed to plead guilty to criminal conduct and to pay more than $2 billion in criminal and civil fines, penalties and damages to settle allegations made in multiple whistleblower lawsuits that the pharmaceutical giant defrauded Medicare, Medicaid and other government-funded health care programs in connection with its market practices for four of its drugs. The settlement is the largest qui tam settlement in U.S. history.

Brian Kenney and Tavy Deming of Kenney Egan McCafferty & Young represented the Geodon whistleblowers and served as co-counsel to the Zyvox whistleblower.

As part of the record settlement, Pfizer agreed to pay $300 million to resolve allegations that it engaged in off-label marketing of its blockbuster atypical antipsychotic Geodon, which generated over $1 billion dollars in sales in 2008. The allegations were first made in a qui tam lawsuit filed by Kenney and Deming on behalf of Harrisburg psychiatrist, Dr. Stefan Kruszewski. Pfizer also agreed to pay $100 million to resolve allegations that it improperly marketed its antibiotic Zyvox. That case was filed by Ronald Rainero, a former Pfizer sales manager from New Jersey.

Read entire article: http://news.prnewswire.com/DisplayReleaseContent.aspx?ACCT=104&STORY=/www/story/09-02-2009/0005087128&EDATE

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