Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Tuesday, March 12, 2013

Proposed: National Drug and Device Safety Board


March 11, 2013 by Arezu Sarvestani  FiDA hightlight

Veteran cardiologist and patient safety advocate Dr. Robert Hauser tells MassDevice.com about his new vision for healthcare surveillance, his long struggle to spur change at the FDA and what FDA regulators can learn from aviation regulation.
Veteran cardiologist Dr. Robert Hauser is eager for change, even if he has to go straight to Capitol Hill himself to make it happen.
The patient safety advocate and vocal critic of the FDA announced at this year's American College of Cardiology conference that he's working on a proposal to fundamentally change the way federal regulators monitor medical devices and drugs once they hit the market.
He's looking to "recruit a couple people and go to Congress" with a proposal that would separate the FDA's approval functions from its surveillance functions, he told MassDevice.com here in San Francisco yesterday.
In an in-depth interview, Hauser, a prominent cardiologist from the Minneapolis Heart Institute, told us about his drive to protect patients from faulty devices, his disappointment with the FDA and what healthcare regulators can learn from their counterparts in aviation.
Inspiration and disappointment
Hauser's passion for healthcare safety was inspired in part by an experience he had in the mid-1970s, when a patient died when the pacemaker that he was dependent on short-circuited, he told us.
"A 40-year-old guy dropped dead on the doorstep of his home. His wife found him," Hauser said sadly. "We then found out that it was due to moisture getting into the electronics through a defect in the circuit that the manufacturer knew about."
At the time the FDA was considering what would become the Medical Device Amendments of 1976, which put into place the 3-tiered class system by which FDA assesses the potential risk and regulatory pathway for medical devices. Hauser "totally supported the amendment" at the time, he said, in part because of his experiences with faulty pacemakers. But in the intervening 40 years he's grown pessimistic about the FDA's ability to satisfy its duty to protect U.S. patients from potentially dangerous products.
He's made it something of a life goal to promote changes at the FDA, but is growing increasingly discouraged, he told us.
"I've done everything I can to encourage the FDA to change. Nothing changes."

Hauser has been instrumental in several discussions surrounding medical device risks and recalls, most recently in the January issue of the Journal of the American College of Cardiology, in which he warned physicians clamoring over Boston Scientific's (NYSE:BSX) "leadless" implantable defibrillator to curb their enthusiasm.
He was also at the center of an April 2012 scandal over St. Jude Medical's (NYSE:STJ) recalled Riata defibrillator leads, in which the medical device maker called for the retraction of a Hauser study attributing 22 deaths to failures in the Riata or Riata ST leads.
Hauser was also 1 of the physicians who helped uncover problems with Guidant Corp.'s pacemakers after a patient he was treating died. Boston Scientific, which acquired Guidant for about $26 billion in 2006, is still dealing with the legal fallout from those issues.
"I've done everything I can to encourage the FDA to change," Hauser told us. "Nothing changes."
His remaining alternative, as he sees it, is to change the fundamental structure of medical device and drug surveillance in the U.S.
Even as he prepares to advocate for a new regulatory agency to take some responsibility away from the FDA, Hauser is acutely aware of the hurdles that stand in his way, perhaps foremost among them "inertia" at the FDA.
"There's 1 chance in 100, but it's worth taking the chance," he said. "It's worth the effort, because maybe in the conversation something will happen that'll change things."
And the FDA under the Obama administration has not welcomed recommendations for change. When the Institute of Medicine recommended in 2011 that the federal watchdog agency completely scrub its 510(k) fast-track review of medical devices, the FDA quickly responded that it was "not bound to adopt IOM recommendations."
The agency has since signed, and the White House approved, new deals with the medical device industry that raise the fees companies pay for agency review in exchange for the FDA meeting performance goals and getting applications out the door more efficiently.
What's the hurry?
Medical device companies and lawmakers often chide the FDA for taking too long to get new, potentially life-saving products to the U.S. market. The agency frequently finds itself defending its timelines or promising to improve them.
The federal watchdog agency is regularly cited as the biggest hurdle delaying new products from reaching the market and industry advocates in Congress occasionally prod the FDA to speed the review process
"I don't think we really help people by making drugs or products available more rapidly."

Hauser fundamentally disagrees with those efforts, he told us, challenging the underlying assumption that faster is better.
"I don't think we really help people by making drugs or products available more rapidly," Hauser said. "There are occasional drugs and devices that really are game-changers, that deserve expedited study and review and approval. Many, many drugs and devices are incremental improvements – or they are in competition with other drugs or devices that are safe and effective.
"Thank God we've got pharma, thank God we've got the medical device companies. There have been revolutionary products, there will continue to be revolutionary products," he added. "But there's rarely great urgency to get something into the marketplace."
The healthcare industry thrives, Hauser said, by pushing out new products and marketing incremental differences, no matter how small, in order to get a leg up on the competition.
Part of that is sustained by what he called "loopholes" in the FDA's approval process, problems that Hauser said go beyond the scope of an independent monitoring authority.
The FDA's unintended loopholes
"There are other issues that need to be addressed, separate from a National Drug & Device Safety Board," Hauser told us. "We need to get rid of these loopholes that allow drugs or allow devices to get approved without adequate testing."
He named the FDA's premarket approval supplement system among the vulnerabilities in the agency's review that allow potentially dangerous products to reach patients.
"Supplements to the original PMA allow manufacturers to make changes to medical devices that presumably improve design, manufacturing or labeling," Hauser told an audience during a presentation at the ACC meeting on Saturday. "However, the PMA supplement has been employed – I should say abused – to introduce essentially new products that are significantly different than the original PMA devices.
"This is another pathway whereby high-risk Class III devices have been FDA-approved for widespread use without clinical trials or any human testing," he added.
A classic example of how that process may fail, Hauser said, involved medical device giant Medtronic (NYSE:MDT) and its Sprint Fidelis ICD lead. The Sprint Fidelis, which was approved as a supplement to the Transvene lead, was the cause of a high-profile, precedent-setting recall after it had already been implanted in some 268,000 patients.Medtronic pulled the Sprint Fidelis in 2007, when it was announced that they were prone to fracture – meaning they could either fail to deliver life-saving therapy or else send unneeded shocks.
The defective leads were implicated in more than 100 deaths, although Medtronic has said that only 13 fatalities listed the leads as a "possible or likely contributing factor."
Hauser further targeted the FDA's popular 510(k) medical device fast-track as an antiquated system that has outlived its usefulness. He agreed with a 2011 report released by the Institute of Medicine, the culmination of nearly 2 years and $1.3 million dollars, which recommended that the FDA scrub the 510(k) program completely.
The institute took issue with the foundation of the 510(k) program, that devices which are "substantially equivalent" to already-approved products (so-called "predicate devices") need not be subject to the more stringent pre-market approval process required for entirely new medical technologies.
The IOM report also found that 3 out of 4 devices recalled between 2005 and 2009 had been approved under 510(k) applications or had escaped review entirely.
The FDA's failure to respond to recalls
The FDA has the authority to mandate recalls and investigate medical devices and drugs after they have been cleared for the U.S. market, but it rarely does so, Hauser explained.
"It's a passive regulator," he told us. "It tends to wait for manufacturers to voluntarily recall devices rather than pro-actively compelling manufacturers to take their products of the market or even, perhaps, to stop distributing while the potential problem is investigated."
"How objective can a group be, inside the agency, when it's discussing, potentially, the performance of another group inside the agency?"

Part of the problem is that the FDA is responsible for both approving devices and as well as monitoring them for problems, creating a fundamental conflict of interest within the agency, as Hauser sees it.
"Right away, you have a conflict because the group that approved the drug is going to question the group that is now criticizing the drug," he said. "They're all in 1 agency, and I doubt that the lines of authority, responsibility, accountability are clear. How objective can a group be, inside the agency, when it's discussing, potentially, the performance of another group inside the agency?"
Hauser's solution is to separate those responsibilities and task a new healthcare regulatory organization with monitoring and investigating healthcare products after the FDA has cleared them for the U.S. market. Lucky for Hauser, a model exists that exemplifies the segregation of approval and monitoring: the U.S. government's regulatory oversight of the airline industry.
Learning from the FAA and the NTSB
The FAA and the National Transportation Safety Board are 2 sides of the same coin, regulating the aviation industry and monitoring it for issues, but the agencies are entirely separate. The NTSB has independent authority to investigate potential issues and reports only to Congress.
The pair of agencies were originally lumped into a single authoritative body that Congress later separated on the grounds that "no federal agency can properly perform investigatory functions unless it is totally separate and independent," Hauser highlighted in his Saturday ACC presentation.
The NTSB has no regulatory authority and can't induce airline companies to make changes or ground flights. It conducts investigations and makes recommendations, leaving it up to the FAA to take action.
That's precisely what Hauser prescribed for U.S. healthcare regulation.
"We need an independent organization to look at major adverse events associated with drugs and devices, separate from the FDA and which has no regulatory authority, whose only job is to investigate and then report their findings," Hauser said. "The other thing NTSB does that we need on the medical side is they then share what they've learned about an accident with all the stakeholders. That doesn't happen now with drugs and devices."
He proposed that the NTSB participate in post-market studies, watch registries from around the world and make the data completely transparent and available to the public at large.
Hauser's National Drug & Device Safety Board
Hauser aims to form the new healthcare regulatory agency by spinning out the FDA's post-market surveillance efforts into an independent body modeled after the NTSB in purpose and structure.
"There would be a chairman appointed by the president and 4 board members, all of whom would have 3-5 year terms," he told us. "The chairman would report to Congress, the board would report to Congress. They'd be an organization separate from any agency in the federal government, entirely independent."
The new bureau would include engineers, scientists, statisticians and administrators to help monitor healthcare products on the market and collaborate with registries around the world to create a global network and public database of medical device and drug information.
The database might confer an added benefit for medical device companies and drug makers, giving them access to a comprehensive database of adverse events to help them avoid similar problems in newer products, Hauser noted, but the boon to industry is incidental to Hauser's goal.
"It's the end user that we're really concerned about," he said. "I'm not interested in helping the companies, necessarily. I'm interested in making a safer device or drug for a patient."



by JAMES WALSH , Star Tribune Updated: April 28, 2012 FiDA highlight
St. Jude Medical Inc. isn't the only medical device manufacturer to chafe at Dr. Robert Hauser's scrutiny -- just the latest.
In 2005, the Minneapolis Heart Institute cardiologist blew the whistle on a defective defibrillator made by Guidant after it failed to revive a young patient. In 2007, Medtronic Inc. pulled its Sprint Fidelis lead off the market after a study by Hauser found that some of the wires, used to connect a defibrillator to the heart, failed. Aggrieved patients eventually won a $114 million settlement from the Fridley-based company.
Now, St. Jude and its recalled Riata defibrillator leads are facing questions after Hauser last month published an article in Heart Rhythm Journal tying the lead to at least 20 patient deaths. St. Jude has assailed Hauser's research as biased and flawed and asked for a retraction. Hauser and the editor of the online publication refused, saying they stand by the findings and that the work was peer-reviewed. The week after St. Jude made its request and disputed Hauser's findings, the Little Canada-based company's stock price fell 10 percent.
Hauser has made a career out of monitoring and sometimes challenging the medical device industry over the safety of its products. It's a role that has repeatedly brought him into conflict with the industry, several of whose biggest players are in Minnesota.
Ask Hauser to describe his role, and his answer is basic: "I am an advocate for patients."
Even his targets say they respect his work, even if they don't always agree with his findings.
Those who have worked with Hauser during his four decades of prodding device-makers and the U.S. Food and Drug Administration toward greater safety and accountability use other terms to describe him -- ethical, passionate, persistent.
"It's not anything against any company. He is out to find the truth to serve patients best," said Dr. William Katsiyiannis, director of clinical electrophysiology and vice chairman of cardiology at Abbott Northwestern Hospital's Minneapolis Heart Institute. "I think it takes quite a man to stand up for that and to keep your head down and do the right thing."
Years fighting
Hauser's passion for medical device safety began, he said, when he was a cardiology fellow in Chicago more than 40 years ago. He participated in a research project involving nuclear battery pacemakers with the help of funding from the National Institutes of Health.
"We were told, 'Go ahead and test them and write a favorable report,'" Hauser said. "All of them failed."
Hauser later started a program at Rush University Medical Center in Chicago to follow pacemaker recipients and a registry to keep track of how they're doing. In 1987, Hauser left Rush to join Cardiac Pacemakers Inc. and served as its president and CEO from 1988 to 1992 -- before it was acquired by Guidant. Guidant would later be purchased by Boston Scientific.
In 1992, Hauser joined the staff at the Minneapolis Heart Institute and used seed money to start an Internet-based device registry. He has continued his advocacy for patient safety and device accountability, conducting his own research and challenging a device establishment that he says sometimes puts profits ahead of prudence.
"It's not good business to put bad devices out there," he said.
Linda Callinan has worked with Hauser for 25 years, since starting a pacemaker follow-up program at the Minneapolis Heart Institute.
"He's got drive that is unbelievable," she said of the research that he often does on his own time.
Hauser, 72, doesn't wait for the FDA or device-makers to spot issues. Callinan said their program actively follows about 6,000 patients with pacemakers and defibrillators from a variety of manufacturers, alert for signs of problems.
Hauser acknowledges that devices aren't perfect -- and likely never will be. Still, he said, in a marketplace where manufacturers feel pressure to quickly develop devices to grab market share, the FDA has an obligation to remain vigilant. The agency should require more premarket testing of lifesaving devices and enact more stringent post-market surveillance of implanted devices, he said.
"You have to go out and look for problems," Hauser said. "If you wait for problems to come to you, it's too late."
Of course, he was saying the same thing back in 2005.
Going public
In March 2005, Joshua Oukrop, a 21-year-old college student from Grand Rapids, Minn., was on a spring break bicycling trip in Utah. He took a break from a ride, saying he was tired. He then collapsed to the ground and died.
Oukrop, who had a genetic heart disease, had a Guidant defibrillator. But the device short-circuited and failed to keep the young man alive.
Oukrop's doctors, Hauser and Barry Maron, later learned that Guidant had known that some devices short-circuited years before Oukrop collapsed. Guidant had changed its manufacturing processes to fix the problem.
But, after the company failed to disclose the problem to doctors and patients who still had the device, Hauser and Maron took their concerns to the media. Guidant eventually recalled the device.
Boston Scientific Corp., which acquired Guidant in 2006, paid $240 million in 2007 to settle lawsuits brought by patients. In 2011, the company pleaded guilty to federal charges, including making false statements to the FDA about the devices' safety, and paid a $296 million fine.
Oukrop's father credits Hauser and Maron for fighting for greater device oversight.
"If it hadn't have been for those two, it would have just blown over and nothing would have happened," Lee Oukrop said. "He has the courage of his convictions."
Sally Hauser knows all about her husband's persistence. More than 50 years ago, he saw her climb a hill at the University of Cincinnati and wanted to get to know her better. A year later, they eloped.
She also knows what kind of doctor he is.
"It's all about integrity," she said.
Fighting to get information into patients' hands about the devices in their bodies has been his passion -- even at the expense of friendships over the years. Not all doctors, many of whom are paid consultants to device-makers, have been willing to take the stands her husband has, she said.
"You lose friends. People are really funny," Sally Hauser said one day last week. "You know what the bottom line is? It's money."
Dr. Paul Friedman, a heart rhythm specialist at the Mayo Clinic in Rochester, has collaborated with Hauser on several studies.
"He has a passion for improving patient care and providing information to guide caregivers," Friedman said. "I think he has demonstrated that when you are committed to a goal, if you are persistent and consistent, I think with time you can lead to important changes."
Work continues
Hauser's most recent work has led to a public tussle with St. Jude Medical.
In December 2010, St. Jude discontinued selling its Riata lead after studies showed that the wires could work free from their outer insulation. Last December, St. Jude told doctors that the problem was more prevalent than previously thought. The FDA recalled the device.
In an article posted March 26, Hauser said he found least 20 deaths caused by high-voltage failures in the Riata leads.
St. Jude quickly went on the offensive, calling Hauser's report biased and inaccurate. It asked Heart Rhythm Journal Editor Douglas Zipes to retract the article. Zipes refused.
In recent weeks, St. Jude's rhetoric has softened a bit. St. Jude CEO Dan Starks said in a recent earnings conference call that "very sincerely, we have a lot of respect for Dr. Hauser's contributions over the years to raising awareness about medical device safety issues."
Starks said in a recent e-mail that he had not spoken to Hauser about his study, but "that my sense is that we have agreed to disagree."
He added that "St. Jude Medical shares Dr. Hauser's focus on patient safety and on getting as much accurate information as possible to physicians to help them make the best decisions for their patients."
Sally Hauser admitted that she and her husband are relying on that commitment to safety. Robert Hauser had a St. Jude heart valve implanted last May.
"He said to me: "Well, I guess I really have to trust them that it's a good valve,'" she said, smiling.
James Walsh • 612-673-7428

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