On October 1, 2015 my wife and I along with our two daughters met with the director of FDA's Center for Devices and Radiological Health, Dr. Jeffrey Shuren - along with associate commissioner, Dr. Lurie, CDRH ombudsman, Mr. Desta, and members of the CDRH legal team.
We had taken our two daughters, ages 11 and 12, out of school that day to join us, because we feel it's so important for our children to understand both our fight to defend public health and their own responsibilities as U.S. citizens.
Unfortunately Dr. William Maisel, CDRH's chief scientist, was unable to join this meeting. We were disappointed by his absence given this man's key role in the FDA action taken regarding the power morcellator, the device that has devastated our family and many others.
You can read about the power morcellator disaster in women's health here.
We found Dr. Shuren's comments and outlook on the CDRH regulatory process very concerning.
He said he sees no patient safety concern with the agency's predominant regulatory mechanism for clearance of medical devices - known as 510(k). Yet this piece of legislation does nothing to ensure medical device safety or to minimize risk to patients' lives. It was never designed to do so.
You can read about 510(k) here.
He appeared satisfied that the action taken following the "morcellator disaster's" public revelation is "proof" that the FDA process is "working well" for the public.
But, we asked him as politely as was possible "How can you say it is working and it is safe if for over 20 years a device is harming and killing people and FDA does not even know about it?"
It was not even the FDA itself that detected that problem. Rather it was a small group of affected citizens reporting the deadly problem to Associate Commissioner Lurie.
We came to the unfortunate and inevitable conclusion that the CDRH director is not seeing the public health hazard posed by the FDA's misuse of 510(k) – as many others have.
Director Shuren is, at best, approaching the problem of patient safety from a theoretical perspective, while focusing far more on industry's real needs to get "innovative and life-saving devices" on the market efficiently.
He is married, by the way, to a prominent lawyer whose clients include "pharmaceutical, medical device, and biotechnology companies,'' as her biography indicates.
We find this connection particularly troubling for a center director at the Food and Drug Administration. Because when lives are at stake, even the appearance of impropriety is unacceptable.
But it's the director's own words and actions that are most disturbing. In his testimony before the U.S. Senate Health, Education, Labor and Pensions Committee on November 15, 2011, he virtually dismissed the Institute of Medicine's (IOM) clear red flag regarding patient safety in device regulation.
In that hearing, he was supported by the industry's legal advocates and Sen. Al Franken, while other senators seemed oblivious or absent.
We are, however, encouraged that the Congress and the Government Accountability Office (GAO) are taking this issue seriously.
You can read about the upcoming GAO investigation here.
At our meeting with Dr. Shuren at FDA headquarters, we also discussed the agency's recent hearing on the Essure gynecological coils.
Essure was approved using the FDA's most stringent mechanism for ensuring patient safety, known as the "Pre-Market Approval" (PMA).
The Essure hearing made it clear that the PMA was issued without adequate safety testing regarding the potential allergic and hypersensitivity reactions to nickel. Moreover, evidence of data tampering in some subjects was presented by the National Center for Health Research.
At the end of our meeting, we reminded director Shuren that his agency's motto is "Protecting and Promoting YOUR health" - it is NOT "Protecting and Promoting Industry Health and Streamlining".
"Enough is enough,'' we both thought as we left the meeting. Not the kind of civics lesson we had hoped to impart to our young daughters, but despite their youth they took it all in with great interest.
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