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.

CCHR INTERNATIONAL Announces FDA Reported Psychiatric Drug Side Effects Search Engine

PRNEWSWIRE
August 4, 2009

Citizens Commission on Human Rights International Announces FDA Reported Psychiatric Drug Side Effects Search Engine: Decrypted FDA reports reveal 4,260 suicides, 2,452 additional deaths, 195 homicides from 2004-2006 alone

Los Angeles, CA (PRWEB) August 4, 2009 -- For the first time the side effects of psychiatric drugs that have been reported to the U.S. Food and Drug Administration (FDA) by doctors, pharmacists, other health care providers and consumers have been decrypted from the FDA's MedWatch reporting system and been made available to the public in an easy to search psychiatric drug side effects database and search engine. The database is provided as a free public service by the mental health watchdog, Citizens Commission on Human Rights International (CCHR).

The report totals reveal that between 2004-2008 the FDA's MedWatch system received pregnancy-related psychiatric drug adverse reaction reports which included 2,442 babies born with heart disease, 3,372 other birth defects, as well as 1,072 miscarriages, abortions and other deaths.

The database also reveals that, between 2004-2008 there were reports submitted to MedWatch including 4,895 suicides, 3,908 cases of aggression, 309 homicides and 6,945 cases of diabetes from people taking psychiatric drugs. These numbers reflect only a small percentage of the actual side effects occurring in the consumer market, as the FDA has admitted that only 1-10% of side effects are ever reported to the FDA.

The database is searchable by individual reports (for the 2004-2006 period), type of drug, age of patient, the side effect reported (suicide, homicide, heart attack, stroke, mania, etc.), and whether the drug in question carries a black box warning (the agency's strongest warning--short of banning a drug).

It is searchable by drug name and age group and includes who reported the psychiatric drug reaction (doctor, pharmacist, consumer, etc.). It also includes the top 20 reported adverse reactions to all psychiatric drugs to the FDA and combined summaries of all psychiatric drug reactions for the years 2004-2006 and 2004-2008.

Since the reform of the Prescription Drug User Fee Act (PDUFA) in 2007, ads for psychiatric and other drugs must include statements encouraging consumers to report adverse drug reactions to the FDA's MedWatch system--Adverse Events Reporting System (AERS). However, consumers or doctors attempting to access the AERS online were confounded by a system so complex that it was impossible to use. Although the FDA should have made the information collected readily accessible, it failed in that duty to the public. It took a computer programmer over 1,000 hours to decipher four years' worth of data to make this information available.

The programmer identified the main psychiatric drugs in the AERS, wading through quarterly reports of seven different reporting systems, including the drug name, demographics, adverse reactions, patient outcomes, reporting source, therapy start and end dates and the indication (diagnosis). The result: A database and search engine that unravels the 94,000 pages of codified psychiatric drug adverse reactions reported each year from 2004-2006 and 2004-2008 to the FDA's MedWatch system.

Reporting of adverse reactions to psychiatric drugs by doctors, pharmacists, other health care providers and consumers once those drugs are out in the consumer market, is fundamental to drug safety monitoring. Yet these reports have been frequently ignored or dismissed as "anecdotal" by the FDA even when serious side effects number in the thousands. The FDA approves the majority of psychiatric drugs only after Phase 2 (short term) clinical trials. However, once the drugs are out in the consumer market, the FDA is supposed to require longer clinical trials, or post-marketing studies of the drugs, however this rarely happens. Subsequently, dangerous and deadly drugs have been left without black box warnings, or on the market for far too long. The best "signal" event for the FDA to direct its resources in identifying or pulling dangerous drugs is what is happening out in the real world, with consumers and patients, not in a controlled short term clinical trial, funded by the pharmaceutical companies seeking approval for their drugs to go to market.

For years the information contained in the FDA's MedWatch reporting system has been inaccessible and therefore virtually useless for consumers and doctors. CCHR's stance has always been that consumers have the right to this information for then ̶ and only then ̶ can consumers have full "informed consent" regarding the risks of psychiatric drugs, and so it has provided this database as a free public service.

The psychiatric drug search engine features a promotional video as well as an instructional video for users on CCHR's newly launched website so they can get the information from the database they are looking for in the shortest amount of time.

About The Citizens Commission on Human Rights:

The Citizens Commission on Human Rights is a mental health watchdog co-founded in 1969 by Professor of Psychiatry Emeritus Thomas Szasz and the Church of Scientology. It is a non-profit, non political, non-religious organization that has been responsible for more than 100 reforms that help protect patients rights against abuses in the field of mental health. For more information about CCHR go to http://www.cchrint.org

Pharma-funded CME gets the lash [CME- def. - Continuing Medical Education]

Fierce Pharma
By tracy
Created Jul 30 2009 - 10:37am

Continuing medical education (CME [1]) has been bastardized by pharma funding, an HHS inspector general told Congress, and needs a complete overhaul. Lewis Morris, chief counsel for the HHS office of inspector general, said that industry doesn't just shape the courses, it has also used CME to promote off-label uses. And Morris was just the first of several witnesses expected to criticize industry-funded CME during a Senate Committee on Aging hearing.

Pharma-backed CME has grown by leaps and bounds. Dow Jones reports that industry funding for medical education has more than tripled over the past 10 years to $1.2 billion. That's more than half the courses many doctors are required to take to stay current. "CME has become an insidious vehicle for the aggressive promotion of drugs and medical devices," said Dr. Steve Nissen (photo [2]), the Cleveland Clinic cardiologist who rarely minces his words.

But others--including PhRMA--protest that the industry can offer the best, most up-to-date info on new treatments, and that drugmakers are an important part of medical education. Dr. Thomas Stossel of Harvard Medical School--who has started an organization balking at the current backlash against pharma funding and doc payments--told the committee that companies make an important contribution to scientific understanding of disease. "I want the best information. I don't care who pays for it," Stossel said (as quoted by Dow Jones). "The nonprofit societies just can't get up to speed fast enough."

The hearing is just the latest salvo in an ongoing battle over how much pharma funding is too much, and whether all financial ties between industry and doctors, academia, and CME should be disclosed. Medical schools and hospitals have established conflicts-of-interest policies, some of which are so strict they don't even allow reps to hand out logo notepads. Drugmakers have promised to disclose payments to doctors [3], and some have bowed out of CME funding. This particular Senate committee is considering legislation that would require companies to disclose doc payments. The debate is far from over.