The NPR “Shots” blog and the Star Tribune were the only mainstream news organizations I saw that reported on a new survey by the Union of Concerned Scientists (opens as pdf file).
Under the headline, “FDA Survey uncovers concerns over influence,” the Strib reported:
Some workers in the medical device approval section of the Food and Drug Administration feel pressure to approve devices even when they have doubts about their safety, a new survey reveals.
The revelations were among the results of a 2011 survey released Wednesday by the Union of Concerned Scientists (UCS). One in four participants answered yes when asked, “Have you ever been pressured to approve or recommend approval for a device or product despite reservations about the safety, efficacy or quality of the product?”
The survey showed employees in the FDA’s Center for Devices and Radiological Health had much more trust in leadership than in a UCS poll taken in 2006. The workers were generally convinced that the agency was headed in the right direction.
At the same time, many participants said political and corporate interests have too much clout in the decisionmaking process. Dozens of employees reported experiences in the past year where they believe the medical device industry hurt public health by withholding information or by forcing changes in FDA policy.
…
Some respondents worried about the FDA’s ability to monitor the performance of medical devices once they hit the market. One in four survey participants was not confident that the FDA had enough power to assure patient safety from medical devices that malfunction after manufacturers offer them for sale.
Others said they had experienced a situation in the past year where the FDA used incomplete scientific data to justify specific outcomes in device approval.
…
The FDA’s Goodman acknowledged there were findings within the survey that “should still concern us.” In particular, Goodman noted, “some scientists still fear retribution for sharing concerns about the FDA. Some believe that business interests frequently influence science-based regulatory decisions.”
The paper reminded its Minnesota readers that Minnesota legislators have recently been trying to speed up device approval. Minnesota is home to hundreds of medical technology companies, include giants like Medtronic.
Comments
Please note, comments are no longer published through this website. All previously made comments are still archived and available for viewing through select posts.
Comments are closed.
Our Comments Policy
But before leaving a comment, please review these notes about our policy.
You are responsible for any comments you leave on this site.
This site is primarily a forum for discussion about the quality (or lack thereof) in journalism or other media messages (advertising, marketing, public relations, medical journals, etc.) It is not intended to be a forum for definitive discussions about medicine or science.
We will delete comments that include personal attacks, unfounded allegations, unverified claims, product pitches, profanity or any from anyone who does not list a full name and a functioning email address. We will also end any thread of repetitive comments. We don”t give medical advice so we won”t respond to questions asking for it.
We don”t have sufficient staffing to contact each commenter who left such a message. If you have a question about why your comment was edited or removed, you can email us at feedback@healthnewsreview.org.
There has been a recent burst of attention to troubles with many comments left on science and science news/communication websites. Read “Online science comments: trolls, trash and treasure.”
The authors of the Retraction Watch comments policy urge commenters:
We”re also concerned about anonymous comments. We ask that all commenters leave their full name and provide an actual email address in case we feel we need to contact them. We may delete any comment left by someone who does not leave their name and a legitimate email address.
And, as noted, product pitches of any sort – pushing treatments, tests, products, procedures, physicians, medical centers, books, websites – are likely to be deleted. We don”t accept advertising on this site and are not going to give it away free.
The ability to leave comments expires after a certain period of time. So you may find that you’re unable to leave a comment on an article that is more than a few months old.
You might also like