COI declarations and off-label drug use

August 7, 2012 in Other

Conflict-of-interest statements made by physicians and scientists in their medical journal articles after they had been allegedly paid by pharmaceutical manufacturers as part of off-label marketing programs are often inadequate, highlighting the deficiencies in relying on author candidness and the weaknesses in some journal practices in ensuring proper disclosure, according to a study by international researchers published in this week's PLoS Medicine. Off-label marketing is the promotion by a manufacturer of a drug for use in a condition or age group, or in a dose or form of administration that has not been specifically approved by a drugs regulatory body; it is illegal in the United States.

In an analysis led by Aaron Kesselheim from Brigham and Women's Hospital in Boston, the authors from the US and Australia found that overall, only one in seven authors reported by whistleblowers to be involved in off-label marketing activities fully disclosed their in published articles.

The authors reached these conclusions by examining 26 whistleblower complaints of illegal off-label promotion and identified the 91 doctors and scientists recorded as being involved in this practice. The researchers found 39 (43%) of these 91 experts had authored 404 publications related to the drugs at issue in the complaints. However, only 62 (15%) of these articles had adequate disclosures. Among the articles without adequate disclosures, 43% (148) had no disclosure at all, 4% had statements denying any conflicts of interest, 40% had disclosures that did not mention the , and 13% had disclosures that mentioned the manufacturer but inadequately conveyed the nature of the relationship between author and drug manufacturer reported in the complaint.

The authors argue that such failures in relation to off-label marketing schemes are especially troubling because off-label use is an area of clinical practice in which opinion is likely to be divided about appropriate care and there is no guidance from regulatory authorities. Therefore, high-profile ''opinion leaders'' may exert considerable influence on prescribing practices through their publications. The authors argue: "More adequate disclosure of financial ties in these situations would give readers an opportunity to weigh the potential for bias."

The authors conclude: "Our findings suggest that approaches to controlling the effects of that rely on author candidness and variable policing by journals have fallen short of the mark. Readers are left with little choice but to be sceptical."

More information: Kesselheim AS, Wang B, Studdert DM, Avorn J (2012) Conflict of Interest Reporting by Authors Involved in Promotion of Off-Label Drug Use: An Analysis of Journal Disclosures. PLoS Med 9(8): e1001280. doi:10.1371/journal.pmed.1001280

Journal reference: PLoS Medicine search and more info website

Provided by Public Library of Science search and more info website

not rated yet  

Rank not rated yet
Relevant PhysicsForums posts

More news stories

ACP issues recommendations for management of high blood glucose in hospitalized patients

High blood glucose is associated with poor outcomes in hospitalized patients, and use of intensive insulin therapy (IIT) to control hyperglycemia is a common practice in hospitals. But the recent evidence does not show a ...

Other created 19 hours ago | popularity not rated yet | comments 0

Future doctors unaware of their obesity bias

Two out of five medical students have an unconscious bias against obese people, according to a new study by researchers at Wake Forest Baptist Medical Center. The study is published online ahead of print in the Journal of ...

Other created May 23, 2013 | popularity not rated yet | comments 0

Plastic realistic: Medical students to use plastinated human bodies for anatomy learning

Nanyang Technological University's (NTU) new medical school will be pioneering the use of plastinated bodies for medical education in Singapore.

Other created May 23, 2013 | popularity not rated yet | comments 0

Survey points out deficiencies in addictions training for medical residents

A 2012 survey of internal medicine residents at Massachusetts General Hospital (MGH) – one of the nation's leading teaching hospitals – found that more than half rated the training they had received in addiction and other ...

Other created May 22, 2013 | popularity 5 / 5 (1) | comments 0

Early use of tracheostomy for mechanically ventilated patients not associated with improved survival

For critically ill patients receiving mechanical ventilation, early tracheostomy (within the first 4 days after admission) was not associated with an improvement in the risk of death within 30 days compared to patients who ...

Other created May 21, 2013 | popularity not rated yet | comments 0


Researchers identify first drug targets in childhood genetic tumor disorder

Two mutations central to the development of infantile myofibromatosis (IM)—a disorder characterized by multiple tumors involving the skin, bone, and soft tissue—may provide new therapeutic targets, according to researchers ...

Engineered cytomegalovirus protects monkeys from HIV equivalent

(Medical Xpress)—A new study by researchers in the US has shown that an ancient virus can be modified to help in the fight against the simian immunodeficiency virus SIV, which is the equivalent in monkeys ...

Hormone levels may provide key to understanding psychological disorders in women

Women at a particular stage in their monthly menstrual cycle may be more vulnerable to some of the psychological side-effects associated with stressful experiences, according to a study from UCL.

Driving and hands-free talking lead to spike in errors, study shows

Talking on a hands-free device while behind the wheel can lead to a sharp increase in errors that could imperil other drivers on the road, according to new research from the University of Alberta.

Going live: Immune cell activation in multiple sclerosis

Biological processes are generally based on events at the molecular and cellular level. To understand what happens in the course of infections, diseases or normal bodily functions, scientists would need to ...

Pollen count apps for smartphones are nothing to sneeze at

Kate O'Reilly's spring allergy survival kit includes the usual stuff - nasal sprays, allergy pills and a box of tissues. This season, she's added a new weapon to her line of defense: an app on her smartphone.