Friday, October 23, 2009

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."

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Thursday, October 15, 2009

$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.

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Judge Rotenberg's Matthew Israel Fined & Reprimanded


State fines center for allowing clinicians to call themselves ’psychologists’
October 6, 2009
By Abbie Ruzicka, Globe Correspondent


The director of the Judge Rotenberg Center in Canton has been fined by the state’s Division of Professional Licensure for allowing 14 unlicensed clinicians at the school to use the title ‘‘psychologist,’’ the Massachusetts Board of Registration of Psychologists announced today.

Dr. Matthew Israel was fined $29,600 and a reprimand was placed on his license, according to the board. Israel has been licensed to practice psychology in Massachusetts since 1974, according to state records.

The Rotenberg center ceased using the title of ‘‘psychologist’’ in 2006 after the Board of Registration of Psychologists first brought forth its concern over the misuse of the title, and changed their titles to ‘‘clinicians,’’ Rotenberg spokesman Ernie Corrigan said.

The center’s use of ‘‘psychologist’’ for clinicians prior to 2006 was consistent with what it believed the word meant at the time.

‘‘There’s genuine confusion,’’ Corrigan said, citing a 1996 change in state law that requires psychologists to be licensed by the state. Before 1996, doctorate and master’s degree-level clinicians trained in psychology were allowed to use the psychologist title.

‘‘These were highly educated people,’’ he said.

The Rotenberg center, which treats adults and children from across the country with autism, mental retardation, and emotional problems, is believed to be the only facility in the country that uses electric shock therapy to curb its students' behaviors.

In the past, the center has been the target of numerous government investigations and legislators have put forth efforts to limit the use of skin shock and aversion therapy.
In total, Israel and the Rotenberg center have paid over $200,000 to the state in fines, according to a court settlement in July of this year.

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Thursday, October 1, 2009

Pfizer Turned NAMI Into "Trojan Horse" to Push Geodon Off-Label to Kids, Suit Claims

BNET.com
By Jim Edwards | Sep 16, 2009


Pfizer funded the National Alliance for the Mentally Ill in order to turn the nonprofit into a “Trojan Horse” that would promote the antipsychotic drug Geodon for off-label use in children, according to a former pharmaceutical sales rep.

Mark R. Westlock of Fenton, Mo., was a rep for Pfizer from 1991 to 2007, when he claims he was forced to resign. His whistleblower suit against Pfizer was included in the $2.3 billion Bextra settlement.

Pfizer denied Westlock’s claims:

Pfizer denies all federal, state and qui tam allegations, with two exceptions. We
acknowledge certain improper actions related to the past promotion of Bextra and
Zyvox. Beyond those two exceptions we deny all federal and state and qui tam claims.

Following Pfizer’s funding, the NAMI web site suggested that Geodon be used in children even though the FDA had approved it only for adults, Westlock claims:

"79. Pfizer became one of the largest contributors among pharmaceutical
manufacturers to NAMI, turning Defendant NAMI into a Trojan Horse for the illegal
marketing scheme to promote Geodon. As but one example, NAMI's website unabashedly
25
Filed Under Seal
129894.00601/35928051v.1
goes so far as to promote the off-label use of Geodon in children and the elderly, as well as
for long-term use in the treatment of bipolar disease, a potential violation of NMI's stated
policy against endorsing any drug product:
While not approved by the FDA for other uses, ziprasidone may be used
alone or with other medications to treat other symptoms such as agitation
or other behavior problems in older persons with memory loss or people
with developmental disabilities, children with mental illnesses like
schizophrenia or bipolar disorder, or depression. It may also be used for
long-term management of bipolar disorder."

Westlock’s suit breaks down Big Pharma’s funding of NAMI like this. From 1996-1999, companies gave NAMI $11.72 million:

* Janssen $2.08 million
* Novartis $1.87 million
* Pfizer $1.3 million
* Abbott Laboratories $1.24 million
* Wyeth-Ayerst Pharmaceuticals $658,000
* Bristol-Myers Squibb $613,505

From 2002-2003, companies gave NAMI a further $4 million per year, the suit alleges:

… the organization operates through significant financial support from Defendant Pfizer and other drug makers. Defendant NAMI reciprocates Defendant Pfizer’s support by the promotion of the off-label use of Pfizer products, including Geodon …

Even the president of NAMI, James McNulty, was on Pfizer’s payroll, the suit alleges:

During the time he was president of NAMI, James McNulty received thousands of dollars for regularly speaking on behalf of Pfizer and other drug makers at various company sponsored events. In an arrangement ethicists say is highly irregular, McNulty would process the “grants” through NAMI Rhode Island. In order to reduce paperwork, according to McNulty, the drug maker would then give NAMI Rhode Island a check and NAMI Rhode Island would in turn give McNulty a check. At no time did McNulty disclose to the audiences at his various speaking engagements, or to NAMI’s membership, that he was being paid to speak by drug makers.

The number of antipsychotic scripts written for children doubled to 4.4 million between 2003 and 2006, Westlock claims.

* Previously:
* “Pfizer Math” Showed Lyrica Superiority Even Though Studies Never Said That, Rep Claims
* Pfizer Rep Claims Bextra Pushed on NHL’s Blue Jackets
* Pfizer Rep Claims Zoloft Touted for Failed Cheerleaders; Viagra for Women
* Pfizer Rep Alleges Viagra Promoted With Unapproved Materials: “Get Those Things Cleaned Up!”
* Pfizer Stock Shrugs Off $2.3B Bextra Fine; Can Anything Deter Off-Label Promotion?
* Pfizer Rep Describes Pushing Zyvox With Flawed Data
* Pfizer’s West Side Story: How “the Sharks” Sold Bextra Off-Label
* 10 Amazing Facts About Pfizer’s $2.3B Bextra Settlement

Jim Edwards, a former managing editor of Adweek, has covered drug marketing at Brandweek for four years, and is a former Knight-Bagehot fellow at Columbia University's business and journalism schools. Follow him on Twitter or send him an email.

***Qui Tam Action (Dictionary.com - Function: noun
: an action that is brought by a person on behalf of a government against a party alleged to have violated a statute esp. against defrauding the government through false claims and that provides for part of a penalty to go to the person bringing the action qui tam action against the contractor for presenting fraudulent claims for payment.)

***Geodon is an antipsychotic
***Bextra is used to reduce pain, inflammation, and stiffness caused by osteoarthritis and adult rheumatoid arthritis. Bextra is also used to treat painful menstruation. It was withdrawn from the market by its manufacturer in 2005 due to side effects.