Tag Archives: fda approval

Fauber: FDA to review data on jaw implants

The Milwaukee Journal Sentinel‘s reporter John Fauber reports on the FDA’s order to review the long-term performance of certain joint implants. Fauber’s story on the agency’s failure to adequately test and regulate these products came out in late November.

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Photo by Jacob Enos via Flickr

The implants in question treat certain ailments affecting the joint that connects jaw and head, a disorder Fauber says “affects more than 10 million Americans, including a small number who undergo radical surgery to implant an artificial jaw joint.” And those people, Fauber reported and the FDA now acknowledges, have had a rough time in the long term.

Among the medical device reports it has reviewed, 52% of the devices that had to be removed were taken out less than three years after they were implanted, the agency said in an e-mail to the Journal Sentinel.
Device problems included the need for removal or replacement, loosening, difficulty removing, noise, fracture and breaking, the FDA said.
Patient problems included pain, surgical procedure or repeat surgical procedure, additional therapy and nonsurgical treatment or treatment with medication, infection, swelling, hospitalization and headache, it said.

At this point, the FDA isn’t talking about taking the devices off the market, but it is reviewing the existing data and beefing up its repeated requests that device makers supply long-term market data about the implants they’ve sold.

Beginning in 1999, the FDA approved four such devices made by three companies. At the time of approval it ordered the firms to collect the market data it now is reordering.
That data was inadequate, the agency said, noting that it did not show why or how soon the devices were being replaced. In addition, the companies had lost contact with many of the patients who had received the devices.
Without knowing that information, the agency cannot determine the true safety and effectiveness of the products or whether any of them should be removed from the market.

Diana Zuckerman, president of the National Research Center for Women & Families, credited Fauber’s reports in the Journal Sentinel and MedPage Today, a medical news website that partners with the newspaper, with prompting the FDA’s action.

Flawed approval process led to flawed jaw implants

In the Milwaukee Journal Sentinel, reporter John Fauber proves that it’s possible to do cutting-edge reporting on conflicts of interest and tie those conflicts to clinical trials of devices that hit the market a few decades ago.

His targets? Jaw joint devices that were initially grandfathered in, and for which newer treatments were approved in the late ’90s and early 2000’s. These trials, Fauber found, were too small, too conflicted and too inconclusive to provide real data, yet the devices were approved anyway. Now, he has found, patients are paying the price.

I’ll just include the first sentence here, as I’m confident that nobody will be able to resist reading the rest of Fauber’s story.

Before implanting a third artificial jaw joint in Heidi Clark’s head, doctors had to remove particles of plastic from the second failed joint that had broken apart and become embedded in muscle.

FDA, device makers, patient advocates lock horns

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.

FDA site tracks post-approval drug dangers

Thanks to new requirements, the FDA is now publishing updates on its safety evaluations of drugs that are already on the market. The evaluations get posted after the drug has been on the market for 18 months, or after 10,000 people have used it. It only includes drugs approved since Sept. 27, 2007.

The site also includes a full list of those drugs flagged by the FDA for various reasons, including ongoing safety alerts. Simply click on any drug in the list to find out what problems were identified and what action has been taken.

(Hat tip to The Plain Dealer‘s Diane Suchetka)

FDA to regulate health information technology?

Fred Schulte and Emma Schwartz, the Huffington Post Investigative Fund duo who have made it their business to stay in front of all stories related to the federal push for the adoption of health information technology, now look at the possibility of federal regulation of health IT.

Schulte and Schwartz write that “In the past two years, the agency has received reports of six patient deaths and several dozen injuries linked to malfunctions in the systems,” and officials say those voluntary reports represent just the tip of the iceberg. In case you’re interested, here are the transcripts from the relevant government hearing.

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Photo by brianjmatis via Flickr.

… digital medical systems are not risk-free. Over the past two years, the FDA’s voluntary notification system logged a total of 260 reports of “malfunctions with the potential for patient harm,” including 44 injuries and the six deaths. Among other things the systems have mixed up patients, put test results in the wrong person’s file and lost vital medical information.

Schulte and Scwartz summarize the three possible regulatory approaches outlined by officials:

  • Option 1: FDA requires HIT makers to register, submit safety reports and correct problems.
  • Option 2: FDA requires HIT makers to report safety concerns and sets minimum quality guidelines.
  • Option 3: FDA makes HIT “subject to the broader regulatory actions that new medical products must face before they ever reach the market.”

Many manufacturers argue that such regulation could be counterproductive.

The manufacturers of the systems generally have opposed regulation by the FDA, arguing in part that imposing strict controls would slow down the government’s campaign to spur widespread adoption of the technology.

Regulation will not necessarily create a “safer” electronic medical record “and might actually limit innovation and responsiveness when it is needed most,” Carl Dvorak, executive vice president of Epic Systems Corporation, a Wisconsin-based company that builds the systems mainly for hospitals and large medical practices, said in his prepared testimony for Thursday’s hearing. The hearing is being held by an advisory group created by the stimulus law.

Government Health IT also is following the issue and points to some problems the Veterans Health Administration has run into and how it dealt with the lapses.