PRESS-NEWS.org - Press Release Distribution
PRESS RELEASES DISTRIBUTION

Off-label marketing of medicines in the US is rife but difficult to control

2011-04-06
(Press-News.org) Despite Federal Drug Administration regulation of the approval and use of pharmaceutical products, "off-label" marketing of drugs (for purposes other than those for which the drug was approved) has occurred in all aspects of the US health care system. In a study published in this week's PLoS Medicine, Aaron S. Kesselheim from Brigham and Women's Hospital, Boston, USA and colleagues report that the most common alleged off-label marketing practices also appear to be the most difficult to control through external regulatory approaches. They identified three main goals of alleged off-label marketing programs: expansion of drug use to unapproved diseases, expansion to unapproved disease subtypes, and expansion to unapproved drug dosing strategies, typically higher doses.

In their study, the authors classified the strategies and practices used in off-label marketing by examining 41 complaints filed by whistleblowers related to 18 alleged cases of off-label marketing in federal fraud cases that were settled or unsealed between January 2004 and October 2010. These findings provide a snapshot of off-label marketing strategies and practices allegedly employed in the US, and this analysis may help to develop new and effective regulatory strategies.

All of the whistleblowers alleged prescriber-related practices (including providing financial incentives and free samples to physicians), and most alleged internal practices intended to bolster off-label marketing, such as sales quotas that could only be met if the manufacturer's sales representatives promoted off-label drug use. Payer-related practices (for example, discussions with prescribers about ways to ensure insurance reimbursement for off-label prescriptions) and consumer-related practices (most commonly, the review of confidential patient charts to identify consumers who could be off-label users) were also alleged. However, these practices were alleged by whistleblowers in cases intervened by the US Department of Justice, and were not the subject of testimony in a full trial; thus, some of the practices identified by the researchers could not be confirmed.

The authors say: "Off-label marketing has been ubiquitous in the health care system and features some behaviors and strategies that may be resistant to external regulatory approaches."

They continue: "Aside from sales representatives and other company insiders, who play important roles as whistleblowers, physicians are alone in having a full view of many of the most insidious forms of illegal marketing outlined in the complaints we reviewed. As physicians' understanding of these practices and the consequences of inappropriate off-label promotion for public health evolves, so may their enthusiasm for shutting them down."

### Funding: ASK is supported by a career development award from the Agency for Healthcare Research & Quality (K08HS18465-01), and a Robert Wood Johnson Foundation Investigator Award in Health Policy Research. MMM is supported by the Greenwall Faculty Scholars Program in Bioethics. DMS is supported by a Federation Fellowship from the Australian Research Council. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Competing Interests: ASK reports consulting for the Alosa Foundation, a non-profit organization that runs the Independent Drug Information Service and is not affiliated in any way with any pharmaceutical company. From 2008, ASK served as an expert witness for the state of Texas in a lawsuit against Merck related to improper promotion of rofecoxib (Vioxx). From 2007, ASK helped develop an educational program to encourage evidence-based prescribing, with funding from a grant derived from the settlement of a fraud case regarding improper promotion of gabapentin (Neurontin).

Citation: Kesselheim AS, Mello MM, Studdert DM (2011) Strategies and Practices in Off-Label Marketing of Pharmaceuticals: A Retrospective Analysis of Whistleblower Complaints. PLoS Med 8(4): e1000431. doi:10.1371/journal.pmed.1000431


ELSE PRESS RELEASES FROM THIS DATE:

Comprehensive approach can improve clinical care of Kenyan children

2011-04-06
A multifaceted approach that addressed deficiencies in clinical knowledge, skills, motivation, resources, and the organization of care was associated with improvements in practice for high mortality conditions in young children in rural Kenya compared with less comprehensive approaches. This finding from a novel study by Philip Ayieko from the KEMRI-Wellcome Trust Research Programme, Nairobi, Kenya, and colleagues, published in this week's PLoS Medicine, is important as it suggests that specific efforts are needed to improve pediatric care in rural areas of poor countries ...

Effects of pneumococcal vaccination program on pneumococcal carriage and invasive disease

2011-04-06
Using a cross-sectional study, Stefan Flasche and colleagues investigated the effects of the UK pneumococcal vaccination program on serotype-specific carriage and invasive pneumococcal disease. There are more than 90 Streptococcus pneumoniae serotypes that can cause invasive pneumococcal disease (IPD). The pneumococcal conjugate vaccine PCV7 contains antigens from seven serotypes responsible for IPD. Immunization with PCV7 prevents both IPD disease and carriage of these seven serotypes, but after vaccination non-vaccine serotypes could colonize the nasopharynx. There ...

Ben Cohen: The Problem Solver for Company Energy Bill Expenditures

2011-04-06
For companies facing the ongoing challenge of energy related costs a New York based entrepreneur is offering instant lower pricing options via his Energy Deregulation Business Model. "The breakup of Ma Bell offered consumers the opportunity to shop for lower phone rates and that same situation is now available for energy consumers currently in the states of Texas, Connecticut, New Jersey, New York as well as parts of Pennsylvania and Illinois," said Ben Cohen. Cohen's business solution (www.cohenenergysolutions.emexpower.com) allows clients to lock in on fixed rates ...

Sandia researchers merge gaming, simulation tools to create models for border security

Sandia researchers merge gaming, simulation tools to create models for border security
2011-04-06
VIDEO: Developed via funding from the Department of Homeland Security's Customs and Border Protection (CBP), the Borders High Level Model is a high-fidelity simulation and analysis program that aids policy and... Click here for more information. LIVERMORE, Calif. —With funding from the Department of Homeland Security's Customs and Border Protection (CBP), researchers at Sandia National Laboratories have developed a high-fidelity simulation and analysis program that aids ...

Einstein HR Announces New Offices To Meet High Demand For Outsourced HR Solutions

2011-04-06
Company founder and CEO Layne Davlin today announced that EinsteinHR has inaugurated new offices which will allow the company to better serve its expanded client-base. A dramatic increase in demand for outsourced HR solutions necessitated the move. "EinsteinHR is strategically positioned for growing with existing accounts and acquiring new customers with a limited ramp-up time," says Layne Davlin. Top-tier small- and medium-sized businesses rely on EinsteinHR in outsourcing everything from payroll and paying employment related taxes, to risk management, providing ...

NYU Langone Medical Center cardiologists present at ACC 60th Annual Scientific Session

2011-04-06
Cardiologists from the Cardiac & Vascular Institute at NYU Langone Medical Center presented new research findings at the American College of Cardiology 60th Annual Scientific Session held April 2-5, 2011 in New Orleans, Louisiana. Significant research findings presented by NYU Langone cardiologists included: The Relationship between Bleeding and Mortality in Patients on Dual Antiplatelet Therapy vs. Aspirin Alone: Results from the CHARISMA Trial Author: Jeffrey S. Berger, MD, MS, FACC, assistant professor, Medicine and director of Cardiovascular Thrombosis Little is ...

From Afghanistan, Djibouti and Saudi Arabia to The Las Vegas Strip, Comedian Don Barnhart Brings Laughter Nightly In His Own Show At The Clarion Hotel

2011-04-06
The Clarion Hotel is located at 305 Convention Center Dr. (In the shadow of the WYNN Hotel) with plenty of free parking! Tickets are $29.95 making it one of the best bargains in Las Vegas. Unlike other comedy venues on the strip, Barnhart's showroom serves a full dinner and bar menu, bottle service and VIP Booths. Show information, reservations or group sales: 702-466-4121 An award-winning comedian, writer, director and actor Barnhart received the Bob Hope Award in 2010 for his continued service entertaining the troops stationed overseas and in 2007 he won the Grand ...

Climate change is making our environment 'bluer'

2011-04-06
The "colour" of our environment is becoming "bluer", a change that could have important implications for animals' risk of becoming extinct, ecologists have found. In a major study involving thousands of data points and published this week in the British Ecological Society's Journal of Animal Ecology, researchers examined how quickly or slowly animal populations and their environment change over time, something ecologists describe using "spectral colour". Ecologists have investigated the link between fluctuations in the environment and those of animal populations for the ...

Better a sprint than a marathon: Brief intense exercise better than endurance training for CVD

2011-04-06
Exercise is important for preventing cardiovascular disease, especially in children and adolescents, but is all exercise equally beneficial? New research published today in the American Journal of Human Biology reveals that high intensity exercise is more beneficial than traditional endurance training. "Cardiovascular disease (CVD) is a leading cause of mortality throughout the world and its risk factors have their origins in childhood," said lead author Duncan Buchan from the University of the West of Scotland. "Our research examines the effects of brief, intense exercise ...

New Collection of Short Fiction Released on Amazon From Damaged to Broken by Award Winning Bari.Ann Kyle

2011-04-06
The long awaited collection of fiction, From Damaged to Broken, includes both short fiction and flash fiction. This collection of short stories is best described by the author herself as "...sometimes melancholy, sometimes dark, but humorous and often detailed vividly... Different looks at life from the characters that showed up to tell their story." These voyeuristic glimpses into the lives of different characters offer a wide variety of fictional storytelling but the main consistency is the ability to grab the reader and keep them hooked to the very end. The author, ...

LAST 30 PRESS RELEASES:

High-quality nanodiamonds for bioimaging and quantum sensing applications

New clinical practice guideline on the process for diagnosing Alzheimer’s disease or a related form of cognitive impairment or dementia

Evolution of fast-growing fish-eating herring in the Baltic Sea

Cryptographic protocol enables secure data sharing in the floating wind energy sector

Can drinking coffee or tea help prevent head and neck cancer?

Development of a global innovative drug in eye drop form for treating dry age-related macular degeneration

Scientists unlock secrets behind flowering of the king of fruits

Texas A&M researchers illuminate the mysteries of icy ocean worlds

Prosthetic material could help reduce infections from intravenous catheters

Can the heart heal itself? New study says it can

Microscopic discovery in cancer cells could have a big impact

Rice researchers take ‘significant leap forward’ with quantum simulation of molecular electron transfer

Breakthrough new material brings affordable, sustainable future within grasp

How everyday activities inside your home can generate energy

Inequality weakens local governance and public satisfaction, study finds

Uncovering key molecular factors behind malaria’s deadliest strain

UC Davis researchers help decode the cause of aggressive breast cancer in women of color

Researchers discovered replication hubs for human norovirus

SNU researchers develop the world’s most sensitive flexible strain sensor

Tiny, wireless antennas use light to monitor cellular communication

Neutrality has played a pivotal, but under-examined, role in international relations, new research shows

Study reveals right whales live 130 years — or more

Researchers reveal how human eyelashes promote water drainage

Pollinators most vulnerable to rising global temperatures are flies, study shows

DFG to fund eight new research units

Modern AI systems have achieved Turing's vision, but not exactly how he hoped

Quantum walk computing unlocks new potential in quantum science and technology

Construction materials and household items are a part of a long-term carbon sink called the “technosphere”

First demonstration of quantum teleportation over busy Internet cables

Disparities and gaps in breast cancer screening for women ages 40 to 49

[Press-News.org] Off-label marketing of medicines in the US is rife but difficult to control