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.
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.
"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."
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.
"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
