Tag Archives: device manufacturers

FDA, device makers, patient advocates lock horns

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

In MedPage Today, Joyce Frieden breaks down the FDA’s day-long town hall meeting that brought together device makers, federal officials and patient advocates last week. Frieden’s report points to more contention than consensus, with the debate crystallizing around a few key issues, most of them related to the FDA’s device approval process.

Predictably, the device makers’ griped about the FDA approval process, one which patient advocates say is lacking in clinical trials, especially long-term ones.

“The overall tone is that the predictability and certainty of our interactions with the FDA are worsening,” Paul LaViolette, venture partner at SV Life Sciences, said at the session, which was part of the Transcatheter Cardiovascular Therapeutics meeting. “Where is the problem? It’s at the review level.”

LaViolette, who is also a member of the board of directors of AdvaMed, a trade group for the medical device industry, said he had “a sense that turnover at the reviewer level is intensifying. Companies report that four out of every 10 submissions experience turnover at the reviewer level. So we have reviewers that are less confident in making a decision, and more meetings are required.”

The FDA blames the slowing approval process in part to the increased reliance on clinical trials conducted outside the U.S., which introduces a swarm of additional variables which regulators must take into account. The recession and an accompanying blow to the venture capital supply and investor confidence also helped reduce the number of devices approved, an industry representative said.

Other topics of discussion included the industry’s request that the FDA’s approval for use and CMS’ approval for Medicare reimbursement be “harmonized,” as well as the FDA’s request that industry look into ways to increase minority patient participation in clinical trials, which is disproportionately low at present.

Identical tubing demonstrates FDA’s inaction

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

In The New York Times, Gardiner Harris  outlines the problem of medical tubing that looks very similar leading to medical errors – then deftly works his way up the chain in an attempt to find the source of device regulator’s failure to solve a problem that seems entirely solvable.

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Many medical device tubing looks the same, which leads to horrific mix-ups like the delivery of food straight into the bloodstream. In 2007, The Wisconsin State Journal‘s David Wahlberg earned first place in the medium newspapers category of AHCJ’s Awards for Excellence in Health Care Journalism for his Medical Misconnections series, which detailed the same problems. He even wrote an AHCJ article teaching journalists how to investigate patient safety problems.

euPhoto by bennylin0724 via Flickr

Since then, not much has changed. Which is not all that surprising, when you consider that not much had changed in the decades before Wahlberg’s story either. Harris’ mission is to dig past the finger-pointing and figure out why. In the end, it all seems to point to some remarkable systemic flaws in the FDA’s device approval system, as well as an unwillingness on the industry to change without the threat of brute regulatory force. In addition to compelling analysis, Harris punctuates each argument with a few spicy quotes.

You’ll have to read Harris’ story to truly understand the perversity of the FDA system and how its lent such inertia to the status quo, but here’s a sample:

Dr. Robert Smith, an F.D.A. device reviewer who left the agency on July 31 and was among nine agency employees who in 2009 decried the agency’s device approval process as illegal and dangerous, said that the tubing problem, which has gone on for decades, was another example of how the agency failed to protect the public. “F.D.A. could fix this tubing problem tomorrow, but because the agency is so worried about making industry happy, people continue to die,” Dr. Smith said.

And, from Nancy Pratt, a senior vice president at Sharp HealthCare in San Diego who believes that “Nurses should not have to work in an environment where it is even possible to make that kind of [tubing] mistake.”

“The regulators have been waiting for the manufacturers to come up with a solution,” Ms. Pratt said, “and the manufacturers won’t spend the money to design and produce something different until the regulators force them to. And now the international standards organization is taking forever to get the whole world onto the same page.”

Conference walks back description of partnership with heart news website

About Pia Christensen

Pia Christensen (@AHCJ_Pia) is the managing editor/online services for AHCJ. She manages the content and development of healthjournalism.org, coordinates AHCJ's social media efforts and edits and manages production of association guides, programs and newsletters.

A medical conference has retreated from a claim suggesting a trade website was being used to promote it and that supporters would be able to “reach new audiences” through a partnership between the conference and the website.

The 2010 Dallas-Leipzig International Valve conference has issued a correction after it came to light that it was promoting its partnership with theheart.org as a “highly influential source of publicity” and said theheart.org will “cover the benefits of attending DLIV 2010; it will forecast key aspects the meeting will offer; it will report on the highlights of the two-and-half day event – and more.”

Conference organizers have since posted the following note on its website (emphasis added):

Given the success of DLIV 2009 and its potential to grow in years to come, the meeting organizers have partnered with theheart.org to promote DLIV through their banner advertisements and e-blasts. [Correction: the previous material erroneously stated that industry would have the opportunity to gain exposure through theheart.org’s news and editorial programs: this is incorrect, and the meeting organizers apologize for the error. theheart.org had no other involvement with DLIV’s offers to industry.]

Shelley Wood, managing editor for Heartwire news and theheart.org, said, “There is a firm firewall between news activities and any advertising or sponsored content on theheart.org and at no point would outside parties be able to dictate the news or editorial content of theheart.org.”  She pointed out theheart.org includes a staff of seven journalists.

Larry Husten, on his CardioBrief blog, pointed out details about sponsorships at the conference, including the opportunity for supporters to pay large amounts of money to meet with faculty members. He noted that its website linked to an Industry Prospectus, a document listing opportunities for exhibitors and sponsors. Sometime after he published the post with a link to the Industry Prospectus (now archived on Husten’s site), conference organizers removed it from the website.

In the prospectus the conference announced its partnership with theheart.org:

Given the success of DLIV 2009 and its potential to grow in years to come, theheart.org recognizes the impact the meeting has in the field of cardiac care. Through its website, online blog and print publications, theheart.org will cover the benefits of attending DLIV 2010; it will forecast key aspects the meeting will offer; it will report on the highlights of the two-and-half day event – and more.

With this highly influential source of publicity, DLIV 2010 offers to its supporters new benefits. By participating in DLIV 2010, you will not only reach the physician leaders who attend the meeting; you will also have the opportunity to make contact and establish relationships with a worldwide audience. Don’t miss out on the chance to reach new audiences, gain additional media benefits and connect your company with the specialty source for news and information.

Theheart.org’s editorial policy says it is committed to providing “balanced, accurate health information” and it “employs editorial professionals who are responsible for content selection, development and maintenance process.” It says it discloses “sources of funding and site contributors’ possible conflicts of interest.” It also says it complies with the HONcode standard for health information (more here).

It should be noted that Husten (aka @cardiobrief on Twitter) is the former editor of theheart.org, something he is quite open about.