Physicians' knowledge about FDA approval standards for 'breakthrough therapy'

April 12, 2016

In a study appearing in the April 12 issue of JAMA, Aaron S. Kesselheim, M.D., J.D., M.P.H., of Brigham and Women's Hospital, Boston, and colleagues surveyed internists and specialists to examine their knowledge about Food and Drug Administration (FDA) approval standards and perceptions of the "breakthrough therapy" designation.

Since 2012, the FDA can designate a drug as a "breakthrough therapy" if preliminary clinical evidence--such as an improvement in a pharmacodynamic biomarker--suggests an advantage over existing options. The term is routinely used in press releases and prescribing resources. Although the term breakthrough leads consumers to overly optimistic beliefs about drug effectiveness, it is not known how physicians understand this term, or more generally, what FDA approval means.

Of 1,148 physicians contacted, 692 physicians (60 percent) responded. Participants were asked 3 questions about FDA approval and 5 about breakthrough therapies. Respondents showed limited knowledge of FDA approval: 73 percent incorrectly believed FDA approval meant comparable effectiveness to other approved drugs; 70 percent incorrectly believed approval required both a statistically significant and clinically important effect. Among the 3 breakthrough knowledge questions, 52 percent incorrectly believed that strong evidence (randomized trials) is needed to earn the breakthrough designation.

"The misconceptions identified may lead physicians to overprescribe newly approved drugs--particularly breakthrough therapies-- and inadequately communicate how well these drugs work to the patients who will use them," the authors write. (doi:10.1001/jama.2015.16984; this study is available pre-embargo at the For The Media website.)

Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

The JAMA Network Journals

Related Physicians Articles from Brightsurf:

Needlestick, sharps injuries among resident physicians
Rates and characteristics of needle stick and other sharps injuries among resident physicians and other staff at a large health care center were examined in this study.

Prevalence of suicide-related behaviors among physicians
An analysis of published studies has found a relatively high prevalence of suicidal behaviors among physicians.

To support lactating emergency physicians, consider these strategies
A new paper highlights strategies that emergency departments can implement to support lactating emergency physicians.

Physicians call for an end to conversion therapy
Historically, conversion therapies have used electroshock therapy, chemical drugs, hormone administrations and even surgery.

Racial bias associated with burnout among resident physicians
Symptoms of physician burnout appear to be associated with greater bias toward black people in this study of nearly 3,400 second-year resident physicians in the United States who identified as nonblack.

Survey finds physicians struggle with their own self-care
Despite believing that self-care is a vitally important part of health and overall well-being, many physicians overlook their own self-care, according to a new survey released today, conducted by The Harris Poll on behalf of Samueli Integrative Health Programs.

Less burnout seen among US physicians, Stanford researcher says
The epidemic levels of physicians reporting burnout dropped modestly in 2017, according to a study by researchers at the Stanford University School of Medicine, the Mayo Clinic and the American Medical Association.

Payments to physicians may increase opioid prescribing
US doctors who receive direct payments from opioid manufacturers tend to prescribe more opioids than doctors who receive no such payments, according to new research published by Addiction.

Is marketing of opioids to physicians associated with overdose deaths?
This study examined the association between pharmaceutical company marketing of opioids to physicians and subsequent death from prescription opioid overdoses across US counties.

Nearly half of resident physicians report burnout
Resident physician burnout in the US is widespread, with the highest rates concentrated in certain specialties, according to research from Mayo Clinic, OHSU and collaborators.

Read More: Physicians News and Physicians Current Events
Brightsurf.com is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to Amazon.com.