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Article by: JAMES WALSH and JIM SPENCER , Star Tribune
Updated:
September 15, 2013 - 12:23 PM FiDA Highlight
Rapid growth of
medical devices in middle-age patients renews lives, remakes industry and raises
worries over long-term use.
Jay Alva’s sneakers pounded the
treadmill, set to the speed of a brisk walk. Sweat dripped off the 53-year-old
as he hit a groove during a recent workout.
For almost two decades, the youth
soccer and football coach from Eagan moved like a man who needed a walker. A
degenerative hip condition prevented Alva from running with his players or even
doing basic things like tying his shoes.
Brushing off a doctor’s advice that
he was “too young,” Alva got artificial hips four years ago. Now pain-free, he
moves with the energy of a man in his 30s, amused at the notion that he wasn’t
old enough for such treatment.
“I am living so much better now in my
50s than I did in my 40s,” Alva said.
Hundreds
of thousands of Americans are receiving medical devices that were once
considered nearly exclusive to the elderly. The shift is profoundly changing
patient care and expanding the fortunes of the medical-technology industry
while amplifying concerns over the safety and oversight of some products.
The movement is so dramatic that the
futures of major medical device companies such as Medtronic, St. Jude Medical and Boston Scientific —
corporate giants in Minnesota — are increasingly tied to younger groups and the
new markets they represent.
Middle-age Americans, in particular,
are driving this trend as they seek ways to remain physically active. The number of patients ages 45
to 64 who had a hip replacement more than doubled from 2000 to 2010,
according to a Star Tribune analysis of data from the U.S. Department of Health
and Human Services. The
increase was more pronounced for knee replacements, rising 213 percent.
“This is huge,” said Dr. Robert
Hauser, a cardiologist at the Minneapolis Heart Institute who has studied
the safety and effectiveness of heart devices for years. “I think it’s a
tremendous step forward, but there are issues that need to be dealt with.”
Though widely celebrated, some
treatments have been shadowed by reports of devices or other medical products
faltering — defective wires in defibrillators, failing artificial hips and
leaky drug pumps, among them. Patients have suffered complications, severe pain
and even death. Every year, 25 to 40 medical devices are recalled due to high
risk — meaning a patient’s life could be in jeopardy.
Device
companies are facing thousands of patient lawsuits challenging the safety of
some devices, and federal regulators are under greater pressure to intensify
their oversight. At the same time, device makers are spending millions to
promote their products to doctors and patients while simultaneously pushing to
simplify governmental reviews to quicken their products’ path to market.
Doctors and device makers are
converting technology to regulate heart rhythms or treat diabetes into new
tools for a wider range of ailments, including overactive bladders, anxiety and
migraines. The result is a wider range of devices and other medical products
being implanted or connected to more nonelderly patients.
But this growing use of medical
hardware should be tempered by a call for safety, public disclosure and
caution, consumer advocates say.
“We’re
not talking about computers or cars or toasters,” said Lisa McGiffert, director
of the Consumers Union’s Safe Patient Project, a group that campaigns for
better medical practices. “We’re talking about things that go inside people’s
bodies.”
Replacement parts — for the body
No
area of medicine is seeing more younger patients turn to medical devices than
orthopedics.
In 2000, one-third of the estimated
157,000 Americans who had hip or knee replacements were younger than 65. Ten
years later, the number had nearly tripled to 430,000, meaning almost half of those procedures
were performed on nonelderly patients.
Two contradicting forces are pushing
patients toward artificial joints. The rising rate of obesity has led to more cases of
deteriorating hips and knees from excess weight. And yet, more Americans are
playing sports or exercising in their 30s, 40s and 50s, which puts more wear
and tear on their joints.
To get active again — and quickly —
patients are more willing to consider joint replacement at a younger age than
they were a decade ago, said Dr. Daniel Berry, chairman of orthopedic surgery
at the Mayo Clinic in Rochester.
“We’re seeing higher demand,” Berry
said of younger patients who want a new hip. “And they are going to use it a
lot harder than somebody who is older.”
Patients
who get a device at a younger age usually must replace it more often. Each
replacement means an expensive surgery, possible complications and significant
rehabilitation.
“You have to find a happy medium,”
Berry said. “Think about it like the tires on your car. There’s no point in
getting new tires if you’re not driving … but if you speed up, they wear out
faster.”
Medical device companies are working
to create joints that are more durable and feel more like the original.
Stryker, an international medical device company based in Michigan, had younger
customers in mind when it developed hip and knee products that have more
natural range in motion, said Joe Cooper, Stryker’s director of global
communications.
“Designing implants that return this
active and high-demand patient population to their lifestyles and everyday
activities is a priority,” he said.
TGS Knee Innovations, a start-up
device company in Plymouth, created a partial-knee replacement
system that is designed to be a good option for younger patients facing a knee
replacement, said Wesley Johnson, the company’s co-founder.
TGS has a relatively “small
footprint” in the orthopedic field, but Johnson sees a future filled with
youthful patients who want new knees to do more than they did before.
“For orthopedics, that tidal wave is
a broader patient population with higher expectations,” he said.
They don’t last forever
Most artificial hips have a life span
of 15 to 20 years, depending on how much patients weigh and how hard they push
their bodies. Some companies developed
a hip that used all-metal components in the belief it would improve durability.
It didn’t necessarily turn out that way.
Many
patients reported problems that have included loosening of the hip, dislocation
and metal particles circulating in the bloodstream. They question whether the U.S. Food and Drug Administration,
which has oversight of medical devices, adequately scrutinized the devices
before approval.
Terri Wagner-Morley of St. Paul had what is commonly referred to as a
metal-on-metal hip — produced by DePuy Orthopedics Inc. — implanted in 2008.
Within two years, the hip began “popping.” Soon, the pop turned to pain.
Wagner-Morley had the hip removed,
but infection prevented doctors from putting in a new one. Plastic “spacers”
were implanted instead, and she was bedridden. Last summer, she had a metal and
ceramic hip implanted, but a stress fracture during rehabilitation has left the
55-year-old woman limping and angry. She remains disabled and without a job.
“I have had four surgeries now,”
Wagner-Morley said. “As I get older, I’m probably going to be wheelchair bound.
I might have a positive view, but really, I’m pissed off.”
In 2010, DePuy recalled the hip that
had been implanted in Wagner-Morley.
That
same year, hospitals, patients and med-tech companies reported 230,000 adverse
events involving medical devices. About 30,000 of those incidents resulted in
hospitalization, according to an analysis by DeviceMatters, a company which
interprets data on medical devices.
“You’ve got to get this right — or
people are going to suffer,” said Hauser, who discovered flaws in the wires of
some defibrillators that led to a major recall.
Alva said he doesn’t worry about
complications or the durability of his new hips. Being able to pace the
sideline of his son’s games, ride a bike or refinish his floors overrides such
concerns.
“When I need [new hips] again, I’m
confident the technology will be better,” Alva said. “How can it not be?”
Something old, something new
Minnesota’s med-tech giants —
Medtronic, St. Jude Medical and Boston Scientific — have generated billions in
sales over the past 15 years through the development of devices and technology
designed to keep the heart beating in aging patients.
Now they are expanding those
innovations to treat a variety of other ailments, many afflicting patients who
haven’t reached their golden years.
Brent Peterson, a former professional
hockey player and coach who lives in Nashville, relies on a small,
pacemaker-like gadget to calm his Parkinson’s symptoms by sending a stream of
electricity to a spot deep within his brain.
The 55-year-old is a special adviser
to the Nashville Predators of the National Hockey League. He learned that he
had Parkinson’s disease more than a decade ago. At one point, he was taking 25
pills a day.
When Peterson’s device was implanted
in 2011, his hands immediately relaxed, and his movements steadied. “The day
they turned it on, I knew I didn’t want to be without it ever again,” he said.
Medical device makers didn’t set out
to adapt pacemakers to treat other parts of the body, but it made sense to
expand the technology as doctors explored what else could be treated with an
electrical pulse, said Martin Gerber, senior research and development director
at Medtronic.
Peterson’s device, a Medtronic Activa
neurostimulator, can be programmed and adjusted to change as his symptoms
evolve. More than 100,000 patients worldwide have received Medtronic’s
deep-brain stimulation therapy.
The treatment is part of what is
called neuromodulation. Implanted devices are used to send medication or
electrical pulses into the brain or to the spine to block pain, relax
overactive bladders by targeting nerves near the tailbone or ease chronic
migraines at the base of the skull. Researchers are exploring electrical
stimulation to treat epilepsy, obsessive-compulsive disorder and severe
depression for those who have not responded to medication.
The
emerging innovations are expanding the products and profits for medical device
makers.
At Fridley-based Medtronic, the
world’s largest medical-technology company, nearly half of its $16 billion in
revenues last fiscal year came from treating something other than the heart,
its core market. And at St. Jude Medical, based in Little Canada, officials
expect sales from the company’s nonheart rhythm products to surpass the heart
rhythm business this year.
Med-tech
executives say they are not specifically targeting young patients with these
technologies. But they acknowledge these new treatments are attracting younger
patients.
“It’s a tremendous growth
opportunity,” St. Jude Medical Executive Vice President John Heinmiller said.
“How can we innovate those technologies to attack these expensive epidemic
diseases that are out there? We are looking at investments that treat a broad
patient population.”
Most patients — more than 14,000
estimated in 2010 — who turn to spinal, brain or other stimulation devices are
well below retirement age. Of those patients who had a spinal cord stimulator
implanted, an estimated 69 percent were younger than 64, with more than 21
percent between the ages of 18 and 44.
Dr. Mehul J. Desai, director of spine,
pain medicine and research at Metro Orthopedics & Sports Therapy in Silver
Spring, Md., believes the numbers will continue to climb.
“There has been a push by clinicians
to think about these therapies earlier on,” he said.
Marketing vs. patient demand
Medical
device makers invest heavily to promote their devices to doctors, health
organizations and patients.
The average marketing budget for
companies of various sizes was $14.4 million in 2013, according to a survey of
medical device executives by Medical Marketing & Media.
Most
of those funds will not be spent on consumer education, according to the marketing survey. Instead, promotional
budgets will focus on persuading health care professionals to use a particular
brand of device on their patients.
Medtronic’s advertising and
promotional spending in 2012 exceeded $128 million, according to Carol
Greenhut, president of Schonfeld & Associates, which produces reports on
medical device marketing for clients. That same year, Greenhut said, St. Jude
Medical spent nearly $45 million and Boston Scientific $20 million.
Medtronic and Boston Scientific
declined to confirm those figures, offer their own or discuss their marketing
strategies. A St. Jude spokeswoman said Schonfeld & Associates’ figure
“significantly overestimates our advertising and marketing expenses,” but she
declined to provide an alternative.
Advocates
for more extensive testing say device makers’ promotional emphasis remains on
sales, not safety.
“One
thing is obvious: They spend a lot more on advertising and lobbying than they
spend on testing,” said Diana Zuckerman, president of the National Research
Center for Women & Families.
But it remains unclear whether
corporate marketing is driving the expanded use of medical devices. Certainly,
more doctors are willing to consider them before other options have been
exhausted.
In many cases, doctors remain
hesitant because they simply don’t know how long a device will last and under
what conditions, said Joseph Galatowitsch, president of Dymedex, a consulting
firm that works with medical technology companies.
“The tension is that clinicians want
to use these technologies in younger patients,” Galatowitsch said. “But they
feel frustrated because they feel forced into weighing the risk versus the
benefit.”
In the spine business, where many
patients begin experiencing pain in their 40s and 50s, Medtronic is seeing a
growing demand for more options, depending on their activity, said Rob
Fredericks, vice president of global marketing, R&D and strategy for Medtronic
Spinal.
For some, the stability of spinal
fusion, in which vertebrae are fused together to relieve back pain after a disc
has been damaged, might be the way to go. For others who seek greater range of
motion, artificial discs may be the best option.
“They want to get back on their feet,
back to work, back to activity — more quickly,” Fredericks said. Doctors say a
patient’s age — and how the patient intends to spend his or her remaining years
— weighs heavily over the decision to implant a device.
For Doug McConnell, that meant
finding a way back into the water. The 55-year-old from Barrington, Ill., is an
open water swimmer, swimming hours at a time through tough waves and inclement
weather. So, when he suffered two herniated discs in his neck in late 2009, he
wanted alternatives to the lengthy downtime and loss of mobility from spinal
fusion.
“Quite apart from swimming, I wanted
to be able to stay active — work in the garden and play catch with the kids,”
he said. Then a Chicago physician suggested he try “this whiz-bang thing from
Medtronic.”
An artificial cervical disc — the
Prestige — was implanted. Six weeks after surgery, McConnell was back in the
water. Eight weeks after that, he finished a 10-kilometer race.
A year after surgery, McConnell swam
across the English Channel.
“It never occurs to us that we have
to dial back our activities or interests,” he said. “We can anticipate living a
lot longer than our parents … and we want to be able to take advantage of
that.”
‘You gave me my life’
Peter Quimby of Plymouth likes to say
that he’s “the healthiest dying person you’ll ever know.”
Quimby is waiting for a heart
transplant. He received an implanted defibrillator and a left ventricular
assist device in 2011 to help his weakened heart pump blood. Doctors told him
not to overexert himself — don’t run, just shuffle.
To hell with that, Quimby says. The
former paratrooper and college baseball player who graduated from West Point
uses the devices to get in a good workout — and prove a point.
Six days a week, he sweats through
intense workouts. He teaches a spinning class at the Andover YMCA. Recently, he
finished the Minneapolis Duathlon, which combines a 15-kilometer bike race with
two 5K runs — all while wearing a cumbersome device with wires that extend from
his abdomen and batteries tucked into a shoulder holster.
Nobody knows whether the devices will
hold up. Quimby said he won’t stop. “You didn’t give me a life,” he tells
doctors and device makers. “You gave me my life.”
Federal
regulators say their primary mission is to determine whether a technology is
safe and saves lives — not address longevity or durability, said Christy Foreman, who directs the Office of Device
Evaluation in the Center for Devices and Radiological Health at the Food and
Drug Administration (FDA).
“The pacemakers that we had in 1976
were often times implanted in the abdomen because they were so big. And their
battery didn’t last as long,” Foreman said. “We wouldn’t say no to the
pacemaker … because we thought it was too big or didn’t last the entire patient
life because we know that it is lifesaving technology. So we have to review it
for what it is.”
The
FDA also doesn’t regulate how physicians use medical devices. By law, doctors are allowed to use devices in any way they
think will benefit their patients, even if the FDA never approved or cleared the device for that
purpose.
Ralph Hall, a University of Minnesota
law professor who has worked as a liaison between medical technology companies
and the FDA, said the current regulatory approach will have to change as the
trend toward younger patients builds momentum. It may not have been critical to
assess how long a device would last in an older patient population, he said,
but a wave of younger patients requires new ways of determining the life span
of devices. The marketplace will demand it.
“This is going to require changes in
testing methodology — less on human clinical study and more on bench testing
and computer simulations and other types of tools assessing long-term
performance,” Hall said.
Ultimately,
it is up to the patient to decide whether to follow
a doctor’s orders or the manufacturer’s recommended ways to use the device.
Dr. David Feldman, Quimby’s
cardiologist, is seeing more young patients who need heart devices. Many want a
treatment that will last forever.
Feldman explains that medical devices
don’t work that way.
“What
electronic piece of equipment that you buy now do you expect to last more than
five years?”
Staff writer Glenn Howatt contributed
to this report.
jwalsh@startribune.com • 612-673-7428
jim.spencer@startribune.com •
202-383-6123
