Featured Research

from universities, journals, and other organizations

Cancer drug labels missing key information about patients' symptoms

Date:
July 4, 2013
Source:
University of North Carolina School of Medicine
Summary:
For patients facing treatment for cancer, it is essential to understand how their symptoms will be affected. Symptoms like pain, fatigue, or nausea can result from the cancer, or from treatment side effects. The best way to collect this information is from patients themselves in research studies. But almost no drug labels in the U.S. include this information. As a result, incomplete information is available to patients and clinicians to help with treatment decisions.

"As an oncologist, when I sit with patients to discuss starting a new chemotherapy, their first questions are often 'How will it make me feel?' and 'How did patients like me feel with this treatment?'" said Dr. Ethan Basch, MD, director of Cancer Outcomes Research at the University of North Carolina.

Related Articles


In the July 10th issue of The New England Journal of Medicine, Dr. Basch calls for pharmaceutical manufacturers to collect rigorous information on how drugs impact symptoms and quality of life starting early in drug development, and for the U.S. Food and Drug Administration (FDA) to include this information in drug labels.

"As patients live longer with cancer, they must increasingly choose among agents with varying efficacy-toxicity balances. And as approved drugs continue to yield only tiny median survival benefits, patients understandably want to know how their peers felt during and after a treatment," said Dr. Basch.

In 2011, the FDA approved 15 new anti-cancer drugs, but only one of them, ruxolitinib, included symptom information in the label -- reporting that multiple symptoms improve substantially when patients take the drug. This was actually the first cancer therapy in more than a decade to include symptom information in its label. Cancer labels stand in contrast to non-cancer labels, which describe symptoms about 25 percent of the time.

Research has shown that patients who experience worse symptoms and quality of life face a worse prognosis and are more likely not to follow treatment guidelines or may stop treatment altogether. The FDA has taken several steps to include the patient perspective in drug development, issuing guidance, collaborating with industry to develop standardized tools, and requesting funds from Congress to support these efforts.

Dr. Basch argues that the culture of pharmaceutical development must shift to include direct patient input during the earliest stages of research. For patients, physicians and insurers to have a true picture of a treatment's impact, they must have access to reliable data on how a drug will impact symptoms and daily quality of life, in addition to information about tumor response and survival.

"Ideally, moving forward, whenever representatives of a pharmaceutical company and a regulatory agency sit down to discuss a product-development program, they will ask the same question my patients ask of me: "How does this product make people feel?" said Dr. Basch.

Dr. Basch is the director of Cancer Outcomes Research at the UNC Lineberger Comprehensive Cancer Center. He serves as a federally appointed member of the Methodology Committee of the Patient-Centered Outcomes Research Institute (PCORI), a member of the National Cancer Institute's Board of Scientific Advisors, a member of the Board of Directors of the International Society for Quality of Life Research (ISOQOL), Co-Chair of the Health Outcomes Committee of the Alliance for Clinical Trials in Oncology, and a member of the Board of Scientific Advisors of the National Cancer Institute. He leads an ongoing NCI initiative to develop a patient-reported adverse event monitoring system for use in clinical research (the "PRO-CTCAE"), and is study chair for multiple trials employing patient-reported endpoints.


Story Source:

The above story is based on materials provided by University of North Carolina School of Medicine. Note: Materials may be edited for content and length.


Journal Reference:

  1. Ethan Basch. Toward Patient-Centered Drug Development in Oncology. New England Journal of Medicine, 2013; 130703140022001 DOI: 10.1056/NEJMp1114649

Cite This Page:

University of North Carolina School of Medicine. "Cancer drug labels missing key information about patients' symptoms." ScienceDaily. ScienceDaily, 4 July 2013. <www.sciencedaily.com/releases/2013/07/130704094351.htm>.
University of North Carolina School of Medicine. (2013, July 4). Cancer drug labels missing key information about patients' symptoms. ScienceDaily. Retrieved March 31, 2015 from www.sciencedaily.com/releases/2013/07/130704094351.htm
University of North Carolina School of Medicine. "Cancer drug labels missing key information about patients' symptoms." ScienceDaily. www.sciencedaily.com/releases/2013/07/130704094351.htm (accessed March 31, 2015).

Share This


More From ScienceDaily



More Health & Medicine News

Tuesday, March 31, 2015

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Solitair Device Aims to Takes Guesswork out of Sun Safety

Solitair Device Aims to Takes Guesswork out of Sun Safety

Reuters - Innovations Video Online (Mar. 31, 2015) — The Solitair device aims to take the confusion out of how much sunlight we should expose our skin to. Small enough to be worn as a tie or hair clip, it monitors the user&apos;s sun exposure by taking into account their skin pigment, location and schedule. Matthew Stock reports. Video provided by Reuters
Powered by NewsLook.com
Soda, Salt and Sugar: The Next Generation of Taxes

Soda, Salt and Sugar: The Next Generation of Taxes

Washington Post (Mar. 30, 2015) — Denisa Livingston, a health advocate for the Dinι Community Advocacy Alliance, and the Post&apos;s Abby Phillip discuss efforts around the country to make unhealthy food choices hurt your wallet as much as your waistline. Video provided by Washington Post
Powered by NewsLook.com
UnitedHealth Buys Catamaran

UnitedHealth Buys Catamaran

Reuters - Business Video Online (Mar. 30, 2015) — The $12.8 billion merger will combine the U.S.&apos; third and fourth largest pharmacy benefit managers. Analysts say smaller PBMs could also merge. Fred Katayama reports. Video provided by Reuters
Powered by NewsLook.com
S. Leone in New Anti-Ebola Lockdown

S. Leone in New Anti-Ebola Lockdown

AFP (Mar. 28, 2015) — Sierra Leone imposed a three-day nationwide lockdown Friday for the second time in six months in a bid to prevent a resurgence of the deadly Ebola virus. Duration: 01:17 Video provided by AFP
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
 
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:  

Breaking News:

Strange & Offbeat Stories

 

Health & Medicine

Mind & Brain

Living & Well

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:  

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile iPhone Android Web
Follow Facebook Twitter Google+
Subscribe RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins