Featured Research

from universities, journals, and other organizations

Cardiovascular devices often approved by FDA without high-quality studies, study suggests

Date:
December 30, 2009
Source:
JAMA and Archives Journals
Summary:
Pre-market approval by the FDA of cardiovascular devices is often based on studies that lack adequate strength or may have been prone to bias, according to a new study. Researchers found that of nearly 80 high-risk devices, the majority received approval based on data from a single study.

Pre-market approval by the FDA of cardiovascular devices is often based on studies that lack adequate strength or may have been prone to bias, according to a new study. The researchers found that of nearly 80 high-risk devices, the majority received approval based on data from a single study.

Related Articles


Cardiovascular devices are increasing in number and usage. "In 2008, at least 350,000 pacemakers, 140,000 implantable cardioverter-defibrillators, and 1,230,000 stents were implanted. Although there has been recent scrutiny of evidence used in the U.S. Food and Drug Administration (FDA) drug approval process, less attention has been paid to the approval process for medical devices," the authors write. They add that the study data on which FDA approval is based should be of high quality. "Ideally, this evidence should consist of randomized, double-blinded studies with adequate controls, sufficient duration, and thorough follow-up on prespecified primary end points without bias."

Sanket S. Dhruva, M.D., of the University of California, San Francisco, and colleagues analyzed the type and quality of study evidence used by the FDA for the premarket approval (PMA) of cardiovascular devices. These types of devices were included in the study because it was expected they would undergo the most stringent approval process, given their increasing usage and potential impact on illness and risk of death. The authors conducted a systematic review of 123 summaries of safety and effectiveness data (SSEDs) for 78 PMAs for high-risk cardiovascular devices that received PMA between January 2000 and December 2007, examining the methodological characteristics and primary end points. SSEDs are intended to present a reasoned, objective, and balanced critique of the scientific evidence which served as the basis of the decision to approve or deny the PMA.

The researchers found that of the 78 PMAs, 51 (65 percent) were supported by a single study. Of the 123 studies, only 98 SSEDs (80 percent) reported the number of participants enrolled. Of 123 studies in SSEDs, 27 percent were randomized and 14 percent were blinded. Fourteen percent of the studies reported did not have a primary end point stated. Of the 213 primary end points, 52 percent were compared with controls.

"In the SSEDs, there were 157 primary end points for which both the number enrolled and analyzed were stated. Of these, 122 (78 percent) had a discrepancy between the number enrolled and those analyzed," the authors write. One hundred thirteen discrepancies (93 percent) were that more patients were enrolled than analyzed. They add that the discrepancies between the number of enrolled patients and the number analyzed for primary end points may introduce bias because patients with less favorable outcomes may be lost to follow-up and safety concerns may underlie this missing data.

The researchers also found that of the 213 primary end points reported in the SSEDs, the results of 15 percent were noninterpretable. The most common reason was that no target goal for device performance was stated in 25 end points (78 percent), and in one instance the results were not stated. The authors state, "In some instances, end points were interpreted to meet their targets when they may have met only a part of them."

The authors write that there are several possible reasons why the criteria on which FDA device approval is based appear to be less rigorous than those for drug approvals. "First, device approvals are a more recent activity for the FDA, having begun in 1976 with the FDA Device Amendment, so the agency has less experience with devices than it does with drugs. Further, the last decade has brought a significant increase in the number and complexity of devices." They add that new surgical operations do not require FDA approval, and new devices, which are nearly always implanted, are between surgical operations and drugs on the FDA approval continuum.

The authors note that their study was based on the information presented in the SSEDs and some study information may be missing. However, they argue that SSEDs "should be a thorough and accurate compilation of the FDA's critique of evidence."

"The emphasis at the FDA in the last 17 years since the Prescription Drug User Fee Act has been rapid approval of new drugs. This study suggests that the emphasis for the FDA in 2009 and beyond must be approvals based on research that meets rigorous scientific standards for evidence of benefit and lack of harm to patients. To uphold the FDA's mission of ensuring 'safe and effective' medical devices, it is essential that high-quality studies and data are available."


Story Source:

The above story is based on materials provided by JAMA and Archives Journals. Note: Materials may be edited for content and length.


Journal Reference:

  1. Sanket S. Dhruva; Lisa A. Bero; Rita F. Redberg. Strength of Study Evidence Examined by the FDA in Premarket Approval of Cardiovascular Devices. JAMA, 2009;302(24):2679-2685 [link]

Cite This Page:

JAMA and Archives Journals. "Cardiovascular devices often approved by FDA without high-quality studies, study suggests." ScienceDaily. ScienceDaily, 30 December 2009. <www.sciencedaily.com/releases/2009/12/091229164936.htm>.
JAMA and Archives Journals. (2009, December 30). Cardiovascular devices often approved by FDA without high-quality studies, study suggests. ScienceDaily. Retrieved November 26, 2014 from www.sciencedaily.com/releases/2009/12/091229164936.htm
JAMA and Archives Journals. "Cardiovascular devices often approved by FDA without high-quality studies, study suggests." ScienceDaily. www.sciencedaily.com/releases/2009/12/091229164936.htm (accessed November 26, 2014).

Share This


More From ScienceDaily



More Health & Medicine News

Wednesday, November 26, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Pet Dogs to Be Used in Anti-Ageing Trial

Pet Dogs to Be Used in Anti-Ageing Trial

Reuters - Innovations Video Online (Nov. 26, 2014) Researchers in the United States are preparing to discover whether a drug commonly used in human organ transplants can extend the lifespan and health quality of pet dogs. Video provided by Reuters
Powered by NewsLook.com
From Popcorn To Vending Snacks: FDA Ups Calorie Count Rules

From Popcorn To Vending Snacks: FDA Ups Calorie Count Rules

Newsy (Nov. 25, 2014) The US FDA is announcing new calorie rules on Tuesday that will require everywhere from theaters to vending machines to include calorie counts. Video provided by Newsy
Powered by NewsLook.com
Daily Serving Of Yogurt Could Reduce Risk Of Type 2 Diabetes

Daily Serving Of Yogurt Could Reduce Risk Of Type 2 Diabetes

Newsy (Nov. 25, 2014) Need another reason to eat yogurt every day? Researchers now say it could reduce a person's risk of developing type 2 diabetes. Video provided by Newsy
Powered by NewsLook.com
Madagascar Working to Contain Plague Outbreak

Madagascar Working to Contain Plague Outbreak

AFP (Nov. 24, 2014) Madagascar said Monday it is trying to contain an outbreak of plague -- similar to the Black Death that swept Medieval Europe -- that has killed 40 people and is spreading to the capital Antananarivo. Duration: 00:42 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