Saturday, October 01, 2005
Four newspaper articles:
September 27, 2005
Implant Program for Heart Device Was a Sales Spur
By BARRY MEIER
By January, about 80 cardiologists nationwide completed an evaluation run by
the Guidant Corporation of one of its products, an improved electrical
component, known as a lead, that connects an implanted cardiac device to the
heart.
In exchange for implanting the lead in three patients and completing five
survey forms, each physician received $1,000 from Guidant.
"The primary purpose of the study was to get feedback on how well the system
worked," said Dr. Wayne O. Adkisson, a cardiologist in Portsmouth, Va., who
took part.
The program did generate feedback. But internal Guidant documents and e-mail
messages provided to The New York Times suggest that the initiative also had
another apparent goal - increasing sales of the company's most sophisticated
and expensive heart devices. Those devices are advanced pacemakers called
cardiac resynchronization therapy devices, or C.R.T.'s. They cost about
$29,000 each.
The program proved so successful in increasing Guidant C.R.T. sales that
when the survey ended in January, company executives sent around
congratulatory e-mail messages, the records show. "It generated 300+
implants," one January e-mail message stated. "Let's say that just 25% were
incremental ... that yields >$2 million in new sales with physicians who are
not necessarily Guidant friendly. We paid each physician who completed all
five surveys $1,000 so our total cost was $80,000."
In a statement, Guidant said that it ran surveys like the lead evaluation to
generate data on how doctors use company products so that it could improve
future models.
Critics of the industry have long charged that some companies have used
research studies to mask what are really marketing efforts that provide
financial incentives to doctors to get them to use a new drug. Now, the
Guidant documents and recent interviews suggest that the line between
research and product promotion may also be blurring where heart devices are
concerned.
A C.R.T. regulates the beating of one side of the heart independently from
the other. The Guidant lead was intended to be easier to use and to reduce
the chronic hiccupping that some implant patients develop when a lead from a
C.R.T. is placed too close to a nerve.
The Guidant records indicate that many doctors approached by the company to
take part in its lead study were not those who regularly implanted its heart
devices, but rather those more apt to use the units of competitors. Though
the agreement signed by doctors taking part in the lead evaluation did not
explicitly require them to implant a Guidant C.R.T. along with the lead,
they effectively had to do so because of software-related issues.
One Guidant document is a chart that indicates that, on average, the monthly
number of company C.R.T.'s implanted by physicians taking part nearly
doubled during the survey period that began last September.
A person professing to be a Guidant employee provided the documents to The
Times. The Times provided Guidant either with copies or text from the
documents. Guidant, while declining to confirm the records, did not dispute
their authenticity.
"In order to respond best to the needs of patients and preferences of
physicians, Guidant has sometimes utilized market research and evaluation
programs of our F.D.A.-approved and -cleared products," said Guidant.
The disclosure of the records comes amid a growing controversy over how
heart device manufacturers release data about product failures to doctors
and patients. Since late May, Guidant has recalled tens of thousands of
heart devices, and some units implanted during the survey were probably
among the models affected.
The two other major heart device companies, Medtronic Inc. and St. Jude
Medical, also said they run product evaluation programs. All three companies
said their payments to doctors for taking part in such surveys reflected
reasonable compensation for a physician's time.
"Any payments made in connection with such surveys are in modest amounts,"
Medtronic said in a statement.
A number of physicians who participated in the Guidant evaluation said their
involvement in such reviews did not influence which company's units they
implanted. Still, the Guidant survey and ones like it raise questions about
what doctors tell patients about any added payments they may be receiving in
connection with a heart product's use, several experts said.
Several doctors who took part in the Guidant survey said that they did not
tell their patients about the payments they received.
It is illegal under federal law in certain circumstances to provide
financial benefits to doctors to induce them to use a product or service. In
its statement, Guidant said that all of its research and evaluation programs
"are intended to comply with applicable laws."
Product evaluation surveys like the Guidant one are far less rigorous than a
traditional clinical study of a drug or a medical device in their purpose,
scientific rigor and oversight. But several heart specialists suggested in
interviews that heart device makers may also be using formal post-marketing
studies of devices that the Food and Drug Administration has already
approved - to increase sales as they battle for market share.
There is little question that many post-marketing studies of heart devices
like defibrillators and pacemakers have yielded crucial data, including
those that have shown patients implanted with defibrillators survive longer
than patients who are treated only with drugs. A defibrillator sends out an
electrical charge intended to interrupt a chaotic and often fatal type of
heart rhythm. A pacemaker regulates a heart that is beating too fast or too
slowly.
But other post-marketing studies may yield far less data. Consider, for
example, a study that St. Jude Medical is currently running.
It began recruiting doctors and medical centers last October to participate
in a study intended to follow for two years the health outcomes of 5,000
patients implanted with either a defibrillator or a C.R.T. with a
defibrillator made by St. Jude Medical.
A copy of the study's protocol shows that St. Jude Medical will pay $2,000
to doctors or medical centers for every patient. Of that amount, a doctor
will get $500 when a device is implanted, with the remainder paid over a
two-year period when a physician submits patient data.
According to the protocol, the study, which is technically called an
outcomes registry, will yield data on how different types of heart patients
implanted with the St. Jude Medical devices fare over time. The Times asked
four cardiologists not involved in the study to review the protocol. Two of
the doctors said that the study might provide St. Jude Medical with some
useful data about its device. But the other two doctors said they saw little
value in it. One, Dr. Robert Rea, a cardiologist at the Mayo Clinic, said,
"The amount of information that can be gleaned from these kind of trials is
relatively limited."
St. Jude Medical, which is based in St. Paul, said it believed that the
study would produce valuable information. "We also hope that some of the
analyses from the registry will lead to additional product advancements and
help us to define specific test hypotheses for future prospective,
randomized clinical studies," the company said in a statement.
The company also said in its statement that study data would be given to
Medicare and to the F.D.A., the latter to fulfill post-marketing study
obligations imposed by the F.D.A. In order to get reimbursement, Medicare
now requires doctors to submit data to a national registry it operates when
they implant a defibrillator.
There is nothing to suggest that doctors implanting heart devices, either in
connection with clinical studies or product surveys, are doing so
unnecessarily. And several doctors, including those not involved in the
evaluation of the new Guidant lead, said that the component offered
potential benefits.
At issue is the way that electricity is conducted from an advanced pacemaker
- a C.R.T. - into the heart. A C.R.T. has three leads. Each carries
electrical impulses, which cycle at various rates, like, say, 60 beats a
minute.
But if the wire put on the heart's left ventricle is positioned too close to
a nerve, the regular electrical impulse it emits can set off involuntary
hiccupping.
While relatively rare, the problem may require added surgery, which poses
risks for the patient. The Guidant lead allows the pulsing position to be
changed electronically.
Dr. Marc J. Girsky, a cardiologist in Los Angeles who took part in the
Guidant survey, said he believed that one purpose was to collect data on the
various tests and methods that different doctors used to implant the new
lead so that a uniform technique might be developed.
"It is not clear what the established technique would be," Dr. Girsky said.
Some physicians like Dr. Girsky who took part in the survey, which was known
by the acronym MERITS, often used Guidant devices. But many other doctors
involved did not, company records indicate.
Along with the January e-mail message that refers to "physicians who are not
necessarily Guidant friendly" - an industry euphemism for doctors who are
not regular customers - another Guidant e-mail message that month stated
that the program was "targeted at our 'B' customers." A spreadsheet also
shows that some doctors had implanted few, if any, Guidant C.R.T.'s before
September of last year.
Dr. Adkisson, the cardiologist in Virginia, was one of them. In a recent
interview, he said that about 90 percent of the devices he used in recent
years were Medtronic units, and that one of the two hospitals where he
practiced had a contract with that company.
Still, when approached by a Guidant sales representative last fall about
becoming involved in the lead survey, he said he agreed because he liked
doing research. "I thought there was enough legitimacy to it to say it was
O.K.," Dr. Adkisson said.
Doctors filled out one form when the survey started, one form after each of
three implants and one form at the end of the survey. The questionnaires
sought technical data about the lead's use as well as a doctor's subjective
impressions. Dr. Adkisson said that it took him about 10 minutes to fill out
each form.
As technical data from the survey came into Guidant, company officials
projected the impact of C.R.T.'s used by doctors in the survey on revenue,
the documents indicate. C.R.T.'s are the fastest-growing and most profitable
segment of the heart device industry.
Both Ronald W. Dollens, the chief executive of Guidant, and J. Frederick
McCoy Jr., the head of its cardiac implant unit, did not respond to written
questions related to their awareness of the program
In its statement, Guidant said that the data collected from the lead survey
was already being put to good use. "In an effort to be responsive to our
physician customers, we take feedback from physicians regarding post-market
products very seriously," the company stated.
"Data collected were aggregated and provided to more than 30 Guidant product
development engineers in June 2005."
Dr. Adkisson said last week that he had yet to see it.
Copyright 2005 The New York Times Company
Patients with recalled internal defibrillators face tough choice
Devices can be replaced, but surgery carries risks, too
By Julie Schmit
USA TODAY
Nancy Bartley and Natasha Fleischman are both athletic moms, workers and
volunteers.
Both also survived sudden cardiac arrest, meaning their hearts beat so
chaotically they temporarily stopped pumping blood.
Three years ago, they both had the same implantable cardioverter
defibrillator (ICD) put into their chests to shock their hearts back to
normal should they again run amok, just as they'd seen doctors do on TV with
paddles.
And they both recently learned that their pager-sized ICDs had a rare flaw
that could cause them to short-circuit and fail just when they might need
them to save their lives. The ICD maker, Guidant, left it to them to decide
whether to replace the device with another, free of charge. On that, the two
women diverged. Bartley, 41, kept her Guidant device. Fleischman, 36,
replaced hers in June.
They are among tens of thousands of people facing similar decisions
regarding ICDs that were recalled in recent months because of a slight
chance they could fail.
In making their choices, ICD patients weighed potentially incomplete data on
device failure rates, the risks of replacement surgery and their own fears
that their device might be the rare one that fails. They've also had to face
the truth that no ICD is guaranteed to work 100% of the time ‹ even if their
lives depend on it.
³I think about it every single day,² says Bartley. ³What if this is the day
it decides not to work?²
Guidant, the nation's second-biggest ICD maker, offered replacement devices
to almost 21,000 patients who had one of three ICDs that were recalled in
June. Other recalled Guidant ICDs could be fixed with software or
programming changes. One recalled family of ICDs went back on the market
after Guidant changed its switch.
Medtronic, the No. 1 ICD maker, offered replacements to 87,000 patients who
had Marquis ICDs that were recalled in February because they could short out
and quickly lose battery power. About 13,000 patients had replaced those
ICDs by mid-May and more were expected to, Medtronic says.
The recalls, and Guidant's issues, have spurred calls for change as to when
companies tell doctors about device malfunctions and the need for more data
on ICDs in use. They've also worried patients.
³There's a lot of unease out there,² says Pierce Vatterott, Fleischman's
heart doctor, who has counseled dozens of patients on what to do.
Bartley, decided to keep her ICD after weighing the risks with her heart
doctor, Kelly Kim.
Her device, the Ventak Prizm 2 DR Model 1981, poses a known failure rate of
slightly more than 1 in 1,000, Guidant says. She faces about a 1 in 100 risk
of infection from the replacement surgery and a far lower risk of fatal
infection.
There's also no guarantee that a new device would be any more reliable than
the one she has.
While flaws in ICDs are rare, ³Low-level rates of imperfection are a physics
and engineering fact,² says Fred McCoy, president of Guidant's $2.5 billion
cardiac rhythm management division.
Guidant says doctors should review Ventak Prizm 2 DR Model 1861 patients
case by case. But it has recommended against replacement because a new
device might not leave patients better off, given the risks of surgery.
The company has also said there is no way to predict which particular device
will suffer the short-circuit problem.
Still, Bartley, of Golden, Colo., takes comfort in knowing that her
³built-in ambulance² has worked.
Bartley, a marketing executive, got her ICD after passing out one day while
running. She awoke bruised and in a ditch. In three years, her ICD has
shocked her six times. The first time, she was running. The force, along
with her movement, caused her to fly five feet and left her with burn marks
on her fingers where the electricity exited her body. Yet her heart kept
pumping. Her father had died of a heart attack at age 45.
³I know my device has worked,² Bartley says. ³If I get a replacement device,
I'm not so sure.²
Fleischman, a part-time teacher of Lake Elmo, Minn., got her ICD after
³falling over dead² one day at work. Her co-workers thought she had choked
on a carrot. Instead, the heart that had powered her on long bike rides and
while presiding over her PTA was failing to pump blood to her brain and
other vital organs.
A co-worker revived her with CPR, and she survived sudden cardiac arrest,
which claims about 1,000 American lives a day.
Fleischman had surgery a few days later and got her ICD, the same model as
Bartley. Vatterott says he chose it due to Guidant's strong track record.
Fleischman left the hospital feeling reassured.
Her confidence weakened in May when she and Bartley learned from a story in
The New York Times that their devices had a slight risk of failing
unexpectedly.
Guidant had discovered the short-circuit problem shortly after both women
had received their ICDs. The company redesigned the model that year. It
didn't tell doctors about the change or alert already-implanted patients. It
also continued to sell devices made before the April 2002 manufacturing
change because, at the time, data did not show an unusual failure rate, the
company has said.
Fleischman, after learning of the news report from her mother, pulled out
her ICD card to check what model she had.
She decided almost immediately to replace her Ventak Prizm. It had never
shocked her, even though her heart had gone into irregular rhythms three
times. Each time, her heart corrected itself and the device properly
monitored the situation, her doctor said.
³But in the back of my mind, I was wondering maybe it didn't go off because
it wasn't OK,² Fleischman says. Typically, ICDs last four to seven years
before batteries run out. Replacement surgery takes about an hour and a week
of recovery. ³I would need to have it replaced in a couple years anyway. I
figured, let's just rest easier and have it replaced now,² she says.
Both women have doctors who supported their decisions. Other respected
doctors have suggested the same paths for their patients for many of the
same reasons expressed by Bartley and Fleischman.
Yet both decisions were also based in part on imprecise data.
Guidant received reports of 28 failures, out of 26,000 devices implanted
worldwide for the ICD used by Fleischman and Bartley. One person died, it
says, although it's not known when his ICD failed.
Guidant, in letters to doctors, acknowledges that failure rates for the
Ventak Prizm 2 DR Model 1861 and two others for which it is offering
replacements may be higher than reported because the company may not learn
about all failures.
That's especially true if someone dies for a seemingly unrelated cause, say
a car accident, says Kim, Bartley's doctor. The ICD may not be checked to
see if it failed and the driver suffered cardiac arrest, which caused the
accident. ³The failure rate is probably higher,² says Kim. ³We just don't
know.²
Even so, most of Kim's and Vatterott's Ventak Prizm 2 DR Model 1861 patients
aren't replacing their devices early.
Kim has three such patients. One chose replacement because, having never
been shocked, ³He's a little more nervous,² Kim says. Vatterott says about
10% to 20% of his practice's Ventak Prizm 2 DR Model 1861 patients are
replacing them.
Most often, those are high-risk patients who have survived sudden cardiac
arrest, Vatterott says. Or, knowing about the flaw, they cannot rest easy.
Some people who get ICDs may never again have a sudden cardiac arrest event,
so the device isn't called upon.
Less likely to replace them are patients at low risk of cardiac arrest and
who have the ICD because they've had heart attacks or have congestive heart
failure.
Heart attacks occur when vessels get blocked and blood doesn't flow to the
heart. In congestive heart failure, the heart pumps inefficiently. Either
can put patients at risk for cardiac arrest, a heart-rhythm disturbance that
prevents the heart from operating properly.
Patients who are older, chronically ill or diabetic are less suitable for
replacement because of higher infection risks, Vatterott says.
He expects more patients to confront such decisions in the future.
Guidant's decision not to tell doctors sooner about problems with the Ventak
Prizm 2 DR Model 1861 has spurred calls for guidelines for when companies
tell doctors about ICD malfunctions. As a result, doctors and patients might
know about flaws that they wouldn't have in the past.
Also, the number of people with ICDs is rapidly expanding. More than 300,000
a year are already implanted ‹ about half in the USA ‹ and Medicare recently
expanded the type of heart patients it will cover to get ICDs.
Yet Eric Prystowsky, director of the ICD unit at St. Vincent Hospital in
Indianapolis and a Guidant consultant, fears the headlines about ICDs may
still scare away potential patients. He's had one ICD candidate decline
because he had the false impression that they don't work, the doctor says.
Bartley and Fleischman would be first in line to convince the patient
otherwise. Both volunteer for WomenHeart, an organization devoted to
educating women about heart disease.
Both know they are at high risk of death and see their ICDs raising their
chances of living longer.
And both accept that no human-made device is perfect.
³But it's better than the one God gave me,² Fleischman says.
© Copyright 2005 USA TODAY, a division of Gannett Co. Inc.
While Pacemaker Failures Fall, Defibrillator Malfunctions Rise
By THOMAS M. BURTON
Staff Reporter of THE WALL STREET JOURNAL
September 16, 2005;
Malfunctions have been increasing in heart defibrillators and decreasing in
cardiac pacemakers, according to Food and Drug Administration research to be
made public today.
The research, conducted by FDA consultant and Harvard medical professor
William H. Maisel along with doctors from the federal agency, comes at a
moment of controversy for defibrillators, which are implanted to steady
erratic heartbeats as well as jump-start those in cardiac arrest. In recent
months, both Guidant Corp. and Medtronic Inc. have recalled defibrillators
because of rare defects in the devices.
The research concluded that malfunctions requiring the surgical replacement
of defibrillators increased from 7.9 per 1,000 devices in 1998 to 38.6 in
2001, before falling to the mid-20s by 2002, the last year examined. The
research, which surveys in part manufacturers' reports to the FDA, is
scheduled to be made public today at a hearing in Washington, D.C., on
medical-device safety. The conference is jointly sponsored by the FDA and
the Heart Rhythm Society, which represents electrophysiologists,
cardiologists who specialize in heart-rhythm aberrations.
Dr. Maisel and colleagues also found that over 12 years, from 1990 to 2002,
31 patients died because their defibrillators malfunctioned and 30 died
because their pacemakers didn't work.
These malfunctions are the focus of the hearing, and could lead the FDA to
change its practices regarding what sorts of malfunctions need to be
disclosed, and when, to doctors and patients. Pacemakers, which use
low-level electricity to speed up sluggish hearts, have been around for
decades. Defibrillators, which use a massive dose of electrical current to
jolt a heart out of cardiac arrest, are more recent and have become
increasingly complex.
Dr. Maisel and FDA officials underscored that malfunctions of the devices
are extremely rare, given the numbers of them that have been implanted in
patients. More than 2.25 million pacemakers and more than 415,000
defibrillators were surgically implanted in U.S. patients between 1990 and
2002. "It's important to take these findings in the context of lives saved,"
Dr. Maisel said in an interview. "You're talking about hundreds of thousands
of lives that are saved by these devices."
Dr. Maisel and FDA colleagues also looked at separate databases in Europe of
reports from doctors and hospitals about malfunctions of defibrillators. The
researchers reported a similar trend there -- increased malfunctions in
defibrillators in recent years. Reported malfunctions rose from 6.5 per
1,000 "person-years" in 1998 to 26.8 in 2001 before falling slightly in
2002. Dr. Maisel said the consistency of the trends suggests a true
incidence of more malfunctions rather than changes in the way doctors and
hospitals report them.
"This examination of the FDA data is very important, showing that the
pacemaker malfunction rate has actually gone down, but we appear to be
seeing a rise in the malfunction rate" for defibrillators, said Bram
Zuckerman, the FDA's chief of the cardiovascular device division, who also
participated in the research. For pacemakers, the number of replacements due
to malfunctions ranged from 1.4 per 1,000 to 9 per 1,000, and that number
has been declining in the past several years.
The meeting is part of a broader FDA initiative to forge closer
relationships with medical societies, in an effort to promote research using
agency data and get out the FDA's safety messages. FDA warnings about drugs
and devices are often missed or ignored by doctors. The agency plans to
revamp the rules that govern the so-called "Dear Doctor" letters sent to
physicians to inform them of side effects and other problems, and also make
them available digitally. Scott Gottlieb, the FDA's deputy commissioner for
medical and scientific affairs, said there now is pressure for the agency to
release information about safety concerns much earlier, even if the issue
hasn't come completely into focus.
Write to Thomas M. Burton at tom.burton@wsj.com Copyright © 2005 Dow Jones &
Company, Inc. All Rights Reserved
Study shows increase in defibrillator defects
By Steve Sternberg
USA TODAY
Heart specialists and federal regulators are joining forces in a broad
effort to improve the safety of implantable defibrillators and to restore
patient confidence in the devices.
A new study conducted by Harvard researchers and funded by the Food and Drug
Administration found that recalls by the leading makers of these
defibrillators indicate a steady increase in malfunctions that has gone
largely unnoticed by government regulators.
Since January, all of the leading manufacturers ‹ Guidant, Medtronic and St.
Jude Medical ‹ have issued safety alerts or recalls involving thousands of
defibrillators.
From 1990 to 2002, doctors implanted 2.25 million pacemakers and 416,000
defibrillators in patients across the USA. The study found malfunctions
occurred in 20 of every 1,000 defibrillators implanted. Device failures
caused 31 deaths, says study lead author William Maisel of Harvard Medical
School.
³In hindsight, the agency perhaps could have connected the dots sooner,²
says Bram Zuckerman, director of the FDA's cardiovascular device division
and a co-author of the study. ³The agency is very interested in evaluating
our current system and making sure we can implement changes that will make
it work better.²
Maisel notes, however, that in the same period, implanting 416,000
defibrillators in vulnerable heart patients saved about 30,000 lives. ³For
every 1,000 lives saved, there might be one death attributable to device
malfunction,² he says.
But Maisel sees a troubling trend. In the mid-1990s, doctors replaced 7.9 of
1,000 implanted defibrillators because of malfunctions. By 2001, the rate
rose to 38.6 per 1,000 implants. It fell slightly to 20.7 of every 1,000 by
2002. More than half of the malfunctions occurred in the study's last three
years.
The pacemaker replacement rate fell during the study to a low of 1.4 per
1,000 implants.
Unlike pacemakers, which regulate the heart's rhythm, defibrillators shock
the heart back to life. When defibrillators malfunction, they sometimes must
be removed and replaced, an operation that can lead to infection in 1% of
patients.
The recalls often force doctors and patients to weigh the risks of replacing
a potentially troublesome device against the risks of leaving it in place.
The Heart Rhythm Society met Friday with heart specialists, regulators and
device makers to consider safety issues and a strategy for dealing with
recalls.
© Copyright 2005 USA TODAY, a division of Gannett Co. Inc.
September 27, 2005
Implant Program for Heart Device Was a Sales Spur
By BARRY MEIER
By January, about 80 cardiologists nationwide completed an evaluation run by
the Guidant Corporation of one of its products, an improved electrical
component, known as a lead, that connects an implanted cardiac device to the
heart.
In exchange for implanting the lead in three patients and completing five
survey forms, each physician received $1,000 from Guidant.
"The primary purpose of the study was to get feedback on how well the system
worked," said Dr. Wayne O. Adkisson, a cardiologist in Portsmouth, Va., who
took part.
The program did generate feedback. But internal Guidant documents and e-mail
messages provided to The New York Times suggest that the initiative also had
another apparent goal - increasing sales of the company's most sophisticated
and expensive heart devices. Those devices are advanced pacemakers called
cardiac resynchronization therapy devices, or C.R.T.'s. They cost about
$29,000 each.
The program proved so successful in increasing Guidant C.R.T. sales that
when the survey ended in January, company executives sent around
congratulatory e-mail messages, the records show. "It generated 300+
implants," one January e-mail message stated. "Let's say that just 25% were
incremental ... that yields >$2 million in new sales with physicians who are
not necessarily Guidant friendly. We paid each physician who completed all
five surveys $1,000 so our total cost was $80,000."
In a statement, Guidant said that it ran surveys like the lead evaluation to
generate data on how doctors use company products so that it could improve
future models.
Critics of the industry have long charged that some companies have used
research studies to mask what are really marketing efforts that provide
financial incentives to doctors to get them to use a new drug. Now, the
Guidant documents and recent interviews suggest that the line between
research and product promotion may also be blurring where heart devices are
concerned.
A C.R.T. regulates the beating of one side of the heart independently from
the other. The Guidant lead was intended to be easier to use and to reduce
the chronic hiccupping that some implant patients develop when a lead from a
C.R.T. is placed too close to a nerve.
The Guidant records indicate that many doctors approached by the company to
take part in its lead study were not those who regularly implanted its heart
devices, but rather those more apt to use the units of competitors. Though
the agreement signed by doctors taking part in the lead evaluation did not
explicitly require them to implant a Guidant C.R.T. along with the lead,
they effectively had to do so because of software-related issues.
One Guidant document is a chart that indicates that, on average, the monthly
number of company C.R.T.'s implanted by physicians taking part nearly
doubled during the survey period that began last September.
A person professing to be a Guidant employee provided the documents to The
Times. The Times provided Guidant either with copies or text from the
documents. Guidant, while declining to confirm the records, did not dispute
their authenticity.
"In order to respond best to the needs of patients and preferences of
physicians, Guidant has sometimes utilized market research and evaluation
programs of our F.D.A.-approved and -cleared products," said Guidant.
The disclosure of the records comes amid a growing controversy over how
heart device manufacturers release data about product failures to doctors
and patients. Since late May, Guidant has recalled tens of thousands of
heart devices, and some units implanted during the survey were probably
among the models affected.
The two other major heart device companies, Medtronic Inc. and St. Jude
Medical, also said they run product evaluation programs. All three companies
said their payments to doctors for taking part in such surveys reflected
reasonable compensation for a physician's time.
"Any payments made in connection with such surveys are in modest amounts,"
Medtronic said in a statement.
A number of physicians who participated in the Guidant evaluation said their
involvement in such reviews did not influence which company's units they
implanted. Still, the Guidant survey and ones like it raise questions about
what doctors tell patients about any added payments they may be receiving in
connection with a heart product's use, several experts said.
Several doctors who took part in the Guidant survey said that they did not
tell their patients about the payments they received.
It is illegal under federal law in certain circumstances to provide
financial benefits to doctors to induce them to use a product or service. In
its statement, Guidant said that all of its research and evaluation programs
"are intended to comply with applicable laws."
Product evaluation surveys like the Guidant one are far less rigorous than a
traditional clinical study of a drug or a medical device in their purpose,
scientific rigor and oversight. But several heart specialists suggested in
interviews that heart device makers may also be using formal post-marketing
studies of devices that the Food and Drug Administration has already
approved - to increase sales as they battle for market share.
There is little question that many post-marketing studies of heart devices
like defibrillators and pacemakers have yielded crucial data, including
those that have shown patients implanted with defibrillators survive longer
than patients who are treated only with drugs. A defibrillator sends out an
electrical charge intended to interrupt a chaotic and often fatal type of
heart rhythm. A pacemaker regulates a heart that is beating too fast or too
slowly.
But other post-marketing studies may yield far less data. Consider, for
example, a study that St. Jude Medical is currently running.
It began recruiting doctors and medical centers last October to participate
in a study intended to follow for two years the health outcomes of 5,000
patients implanted with either a defibrillator or a C.R.T. with a
defibrillator made by St. Jude Medical.
A copy of the study's protocol shows that St. Jude Medical will pay $2,000
to doctors or medical centers for every patient. Of that amount, a doctor
will get $500 when a device is implanted, with the remainder paid over a
two-year period when a physician submits patient data.
According to the protocol, the study, which is technically called an
outcomes registry, will yield data on how different types of heart patients
implanted with the St. Jude Medical devices fare over time. The Times asked
four cardiologists not involved in the study to review the protocol. Two of
the doctors said that the study might provide St. Jude Medical with some
useful data about its device. But the other two doctors said they saw little
value in it. One, Dr. Robert Rea, a cardiologist at the Mayo Clinic, said,
"The amount of information that can be gleaned from these kind of trials is
relatively limited."
St. Jude Medical, which is based in St. Paul, said it believed that the
study would produce valuable information. "We also hope that some of the
analyses from the registry will lead to additional product advancements and
help us to define specific test hypotheses for future prospective,
randomized clinical studies," the company said in a statement.
The company also said in its statement that study data would be given to
Medicare and to the F.D.A., the latter to fulfill post-marketing study
obligations imposed by the F.D.A. In order to get reimbursement, Medicare
now requires doctors to submit data to a national registry it operates when
they implant a defibrillator.
There is nothing to suggest that doctors implanting heart devices, either in
connection with clinical studies or product surveys, are doing so
unnecessarily. And several doctors, including those not involved in the
evaluation of the new Guidant lead, said that the component offered
potential benefits.
At issue is the way that electricity is conducted from an advanced pacemaker
- a C.R.T. - into the heart. A C.R.T. has three leads. Each carries
electrical impulses, which cycle at various rates, like, say, 60 beats a
minute.
But if the wire put on the heart's left ventricle is positioned too close to
a nerve, the regular electrical impulse it emits can set off involuntary
hiccupping.
While relatively rare, the problem may require added surgery, which poses
risks for the patient. The Guidant lead allows the pulsing position to be
changed electronically.
Dr. Marc J. Girsky, a cardiologist in Los Angeles who took part in the
Guidant survey, said he believed that one purpose was to collect data on the
various tests and methods that different doctors used to implant the new
lead so that a uniform technique might be developed.
"It is not clear what the established technique would be," Dr. Girsky said.
Some physicians like Dr. Girsky who took part in the survey, which was known
by the acronym MERITS, often used Guidant devices. But many other doctors
involved did not, company records indicate.
Along with the January e-mail message that refers to "physicians who are not
necessarily Guidant friendly" - an industry euphemism for doctors who are
not regular customers - another Guidant e-mail message that month stated
that the program was "targeted at our 'B' customers." A spreadsheet also
shows that some doctors had implanted few, if any, Guidant C.R.T.'s before
September of last year.
Dr. Adkisson, the cardiologist in Virginia, was one of them. In a recent
interview, he said that about 90 percent of the devices he used in recent
years were Medtronic units, and that one of the two hospitals where he
practiced had a contract with that company.
Still, when approached by a Guidant sales representative last fall about
becoming involved in the lead survey, he said he agreed because he liked
doing research. "I thought there was enough legitimacy to it to say it was
O.K.," Dr. Adkisson said.
Doctors filled out one form when the survey started, one form after each of
three implants and one form at the end of the survey. The questionnaires
sought technical data about the lead's use as well as a doctor's subjective
impressions. Dr. Adkisson said that it took him about 10 minutes to fill out
each form.
As technical data from the survey came into Guidant, company officials
projected the impact of C.R.T.'s used by doctors in the survey on revenue,
the documents indicate. C.R.T.'s are the fastest-growing and most profitable
segment of the heart device industry.
Both Ronald W. Dollens, the chief executive of Guidant, and J. Frederick
McCoy Jr., the head of its cardiac implant unit, did not respond to written
questions related to their awareness of the program
In its statement, Guidant said that the data collected from the lead survey
was already being put to good use. "In an effort to be responsive to our
physician customers, we take feedback from physicians regarding post-market
products very seriously," the company stated.
"Data collected were aggregated and provided to more than 30 Guidant product
development engineers in June 2005."
Dr. Adkisson said last week that he had yet to see it.
Copyright 2005 The New York Times Company
Patients with recalled internal defibrillators face tough choice
Devices can be replaced, but surgery carries risks, too
By Julie Schmit
USA TODAY
Nancy Bartley and Natasha Fleischman are both athletic moms, workers and
volunteers.
Both also survived sudden cardiac arrest, meaning their hearts beat so
chaotically they temporarily stopped pumping blood.
Three years ago, they both had the same implantable cardioverter
defibrillator (ICD) put into their chests to shock their hearts back to
normal should they again run amok, just as they'd seen doctors do on TV with
paddles.
And they both recently learned that their pager-sized ICDs had a rare flaw
that could cause them to short-circuit and fail just when they might need
them to save their lives. The ICD maker, Guidant, left it to them to decide
whether to replace the device with another, free of charge. On that, the two
women diverged. Bartley, 41, kept her Guidant device. Fleischman, 36,
replaced hers in June.
They are among tens of thousands of people facing similar decisions
regarding ICDs that were recalled in recent months because of a slight
chance they could fail.
In making their choices, ICD patients weighed potentially incomplete data on
device failure rates, the risks of replacement surgery and their own fears
that their device might be the rare one that fails. They've also had to face
the truth that no ICD is guaranteed to work 100% of the time ‹ even if their
lives depend on it.
³I think about it every single day,² says Bartley. ³What if this is the day
it decides not to work?²
Guidant, the nation's second-biggest ICD maker, offered replacement devices
to almost 21,000 patients who had one of three ICDs that were recalled in
June. Other recalled Guidant ICDs could be fixed with software or
programming changes. One recalled family of ICDs went back on the market
after Guidant changed its switch.
Medtronic, the No. 1 ICD maker, offered replacements to 87,000 patients who
had Marquis ICDs that were recalled in February because they could short out
and quickly lose battery power. About 13,000 patients had replaced those
ICDs by mid-May and more were expected to, Medtronic says.
The recalls, and Guidant's issues, have spurred calls for change as to when
companies tell doctors about device malfunctions and the need for more data
on ICDs in use. They've also worried patients.
³There's a lot of unease out there,² says Pierce Vatterott, Fleischman's
heart doctor, who has counseled dozens of patients on what to do.
Bartley, decided to keep her ICD after weighing the risks with her heart
doctor, Kelly Kim.
Her device, the Ventak Prizm 2 DR Model 1981, poses a known failure rate of
slightly more than 1 in 1,000, Guidant says. She faces about a 1 in 100 risk
of infection from the replacement surgery and a far lower risk of fatal
infection.
There's also no guarantee that a new device would be any more reliable than
the one she has.
While flaws in ICDs are rare, ³Low-level rates of imperfection are a physics
and engineering fact,² says Fred McCoy, president of Guidant's $2.5 billion
cardiac rhythm management division.
Guidant says doctors should review Ventak Prizm 2 DR Model 1861 patients
case by case. But it has recommended against replacement because a new
device might not leave patients better off, given the risks of surgery.
The company has also said there is no way to predict which particular device
will suffer the short-circuit problem.
Still, Bartley, of Golden, Colo., takes comfort in knowing that her
³built-in ambulance² has worked.
Bartley, a marketing executive, got her ICD after passing out one day while
running. She awoke bruised and in a ditch. In three years, her ICD has
shocked her six times. The first time, she was running. The force, along
with her movement, caused her to fly five feet and left her with burn marks
on her fingers where the electricity exited her body. Yet her heart kept
pumping. Her father had died of a heart attack at age 45.
³I know my device has worked,² Bartley says. ³If I get a replacement device,
I'm not so sure.²
Fleischman, a part-time teacher of Lake Elmo, Minn., got her ICD after
³falling over dead² one day at work. Her co-workers thought she had choked
on a carrot. Instead, the heart that had powered her on long bike rides and
while presiding over her PTA was failing to pump blood to her brain and
other vital organs.
A co-worker revived her with CPR, and she survived sudden cardiac arrest,
which claims about 1,000 American lives a day.
Fleischman had surgery a few days later and got her ICD, the same model as
Bartley. Vatterott says he chose it due to Guidant's strong track record.
Fleischman left the hospital feeling reassured.
Her confidence weakened in May when she and Bartley learned from a story in
The New York Times that their devices had a slight risk of failing
unexpectedly.
Guidant had discovered the short-circuit problem shortly after both women
had received their ICDs. The company redesigned the model that year. It
didn't tell doctors about the change or alert already-implanted patients. It
also continued to sell devices made before the April 2002 manufacturing
change because, at the time, data did not show an unusual failure rate, the
company has said.
Fleischman, after learning of the news report from her mother, pulled out
her ICD card to check what model she had.
She decided almost immediately to replace her Ventak Prizm. It had never
shocked her, even though her heart had gone into irregular rhythms three
times. Each time, her heart corrected itself and the device properly
monitored the situation, her doctor said.
³But in the back of my mind, I was wondering maybe it didn't go off because
it wasn't OK,² Fleischman says. Typically, ICDs last four to seven years
before batteries run out. Replacement surgery takes about an hour and a week
of recovery. ³I would need to have it replaced in a couple years anyway. I
figured, let's just rest easier and have it replaced now,² she says.
Both women have doctors who supported their decisions. Other respected
doctors have suggested the same paths for their patients for many of the
same reasons expressed by Bartley and Fleischman.
Yet both decisions were also based in part on imprecise data.
Guidant received reports of 28 failures, out of 26,000 devices implanted
worldwide for the ICD used by Fleischman and Bartley. One person died, it
says, although it's not known when his ICD failed.
Guidant, in letters to doctors, acknowledges that failure rates for the
Ventak Prizm 2 DR Model 1861 and two others for which it is offering
replacements may be higher than reported because the company may not learn
about all failures.
That's especially true if someone dies for a seemingly unrelated cause, say
a car accident, says Kim, Bartley's doctor. The ICD may not be checked to
see if it failed and the driver suffered cardiac arrest, which caused the
accident. ³The failure rate is probably higher,² says Kim. ³We just don't
know.²
Even so, most of Kim's and Vatterott's Ventak Prizm 2 DR Model 1861 patients
aren't replacing their devices early.
Kim has three such patients. One chose replacement because, having never
been shocked, ³He's a little more nervous,² Kim says. Vatterott says about
10% to 20% of his practice's Ventak Prizm 2 DR Model 1861 patients are
replacing them.
Most often, those are high-risk patients who have survived sudden cardiac
arrest, Vatterott says. Or, knowing about the flaw, they cannot rest easy.
Some people who get ICDs may never again have a sudden cardiac arrest event,
so the device isn't called upon.
Less likely to replace them are patients at low risk of cardiac arrest and
who have the ICD because they've had heart attacks or have congestive heart
failure.
Heart attacks occur when vessels get blocked and blood doesn't flow to the
heart. In congestive heart failure, the heart pumps inefficiently. Either
can put patients at risk for cardiac arrest, a heart-rhythm disturbance that
prevents the heart from operating properly.
Patients who are older, chronically ill or diabetic are less suitable for
replacement because of higher infection risks, Vatterott says.
He expects more patients to confront such decisions in the future.
Guidant's decision not to tell doctors sooner about problems with the Ventak
Prizm 2 DR Model 1861 has spurred calls for guidelines for when companies
tell doctors about ICD malfunctions. As a result, doctors and patients might
know about flaws that they wouldn't have in the past.
Also, the number of people with ICDs is rapidly expanding. More than 300,000
a year are already implanted ‹ about half in the USA ‹ and Medicare recently
expanded the type of heart patients it will cover to get ICDs.
Yet Eric Prystowsky, director of the ICD unit at St. Vincent Hospital in
Indianapolis and a Guidant consultant, fears the headlines about ICDs may
still scare away potential patients. He's had one ICD candidate decline
because he had the false impression that they don't work, the doctor says.
Bartley and Fleischman would be first in line to convince the patient
otherwise. Both volunteer for WomenHeart, an organization devoted to
educating women about heart disease.
Both know they are at high risk of death and see their ICDs raising their
chances of living longer.
And both accept that no human-made device is perfect.
³But it's better than the one God gave me,² Fleischman says.
© Copyright 2005 USA TODAY, a division of Gannett Co. Inc.
While Pacemaker Failures Fall, Defibrillator Malfunctions Rise
By THOMAS M. BURTON
Staff Reporter of THE WALL STREET JOURNAL
September 16, 2005;
Malfunctions have been increasing in heart defibrillators and decreasing in
cardiac pacemakers, according to Food and Drug Administration research to be
made public today.
The research, conducted by FDA consultant and Harvard medical professor
William H. Maisel along with doctors from the federal agency, comes at a
moment of controversy for defibrillators, which are implanted to steady
erratic heartbeats as well as jump-start those in cardiac arrest. In recent
months, both Guidant Corp. and Medtronic Inc. have recalled defibrillators
because of rare defects in the devices.
The research concluded that malfunctions requiring the surgical replacement
of defibrillators increased from 7.9 per 1,000 devices in 1998 to 38.6 in
2001, before falling to the mid-20s by 2002, the last year examined. The
research, which surveys in part manufacturers' reports to the FDA, is
scheduled to be made public today at a hearing in Washington, D.C., on
medical-device safety. The conference is jointly sponsored by the FDA and
the Heart Rhythm Society, which represents electrophysiologists,
cardiologists who specialize in heart-rhythm aberrations.
Dr. Maisel and colleagues also found that over 12 years, from 1990 to 2002,
31 patients died because their defibrillators malfunctioned and 30 died
because their pacemakers didn't work.
These malfunctions are the focus of the hearing, and could lead the FDA to
change its practices regarding what sorts of malfunctions need to be
disclosed, and when, to doctors and patients. Pacemakers, which use
low-level electricity to speed up sluggish hearts, have been around for
decades. Defibrillators, which use a massive dose of electrical current to
jolt a heart out of cardiac arrest, are more recent and have become
increasingly complex.
Dr. Maisel and FDA officials underscored that malfunctions of the devices
are extremely rare, given the numbers of them that have been implanted in
patients. More than 2.25 million pacemakers and more than 415,000
defibrillators were surgically implanted in U.S. patients between 1990 and
2002. "It's important to take these findings in the context of lives saved,"
Dr. Maisel said in an interview. "You're talking about hundreds of thousands
of lives that are saved by these devices."
Dr. Maisel and FDA colleagues also looked at separate databases in Europe of
reports from doctors and hospitals about malfunctions of defibrillators. The
researchers reported a similar trend there -- increased malfunctions in
defibrillators in recent years. Reported malfunctions rose from 6.5 per
1,000 "person-years" in 1998 to 26.8 in 2001 before falling slightly in
2002. Dr. Maisel said the consistency of the trends suggests a true
incidence of more malfunctions rather than changes in the way doctors and
hospitals report them.
"This examination of the FDA data is very important, showing that the
pacemaker malfunction rate has actually gone down, but we appear to be
seeing a rise in the malfunction rate" for defibrillators, said Bram
Zuckerman, the FDA's chief of the cardiovascular device division, who also
participated in the research. For pacemakers, the number of replacements due
to malfunctions ranged from 1.4 per 1,000 to 9 per 1,000, and that number
has been declining in the past several years.
The meeting is part of a broader FDA initiative to forge closer
relationships with medical societies, in an effort to promote research using
agency data and get out the FDA's safety messages. FDA warnings about drugs
and devices are often missed or ignored by doctors. The agency plans to
revamp the rules that govern the so-called "Dear Doctor" letters sent to
physicians to inform them of side effects and other problems, and also make
them available digitally. Scott Gottlieb, the FDA's deputy commissioner for
medical and scientific affairs, said there now is pressure for the agency to
release information about safety concerns much earlier, even if the issue
hasn't come completely into focus.
Write to Thomas M. Burton at tom.burton@wsj.com Copyright © 2005 Dow Jones &
Company, Inc. All Rights Reserved
Study shows increase in defibrillator defects
By Steve Sternberg
USA TODAY
Heart specialists and federal regulators are joining forces in a broad
effort to improve the safety of implantable defibrillators and to restore
patient confidence in the devices.
A new study conducted by Harvard researchers and funded by the Food and Drug
Administration found that recalls by the leading makers of these
defibrillators indicate a steady increase in malfunctions that has gone
largely unnoticed by government regulators.
Since January, all of the leading manufacturers ‹ Guidant, Medtronic and St.
Jude Medical ‹ have issued safety alerts or recalls involving thousands of
defibrillators.
From 1990 to 2002, doctors implanted 2.25 million pacemakers and 416,000
defibrillators in patients across the USA. The study found malfunctions
occurred in 20 of every 1,000 defibrillators implanted. Device failures
caused 31 deaths, says study lead author William Maisel of Harvard Medical
School.
³In hindsight, the agency perhaps could have connected the dots sooner,²
says Bram Zuckerman, director of the FDA's cardiovascular device division
and a co-author of the study. ³The agency is very interested in evaluating
our current system and making sure we can implement changes that will make
it work better.²
Maisel notes, however, that in the same period, implanting 416,000
defibrillators in vulnerable heart patients saved about 30,000 lives. ³For
every 1,000 lives saved, there might be one death attributable to device
malfunction,² he says.
But Maisel sees a troubling trend. In the mid-1990s, doctors replaced 7.9 of
1,000 implanted defibrillators because of malfunctions. By 2001, the rate
rose to 38.6 per 1,000 implants. It fell slightly to 20.7 of every 1,000 by
2002. More than half of the malfunctions occurred in the study's last three
years.
The pacemaker replacement rate fell during the study to a low of 1.4 per
1,000 implants.
Unlike pacemakers, which regulate the heart's rhythm, defibrillators shock
the heart back to life. When defibrillators malfunction, they sometimes must
be removed and replaced, an operation that can lead to infection in 1% of
patients.
The recalls often force doctors and patients to weigh the risks of replacing
a potentially troublesome device against the risks of leaving it in place.
The Heart Rhythm Society met Friday with heart specialists, regulators and
device makers to consider safety issues and a strategy for dealing with
recalls.
© Copyright 2005 USA TODAY, a division of Gannett Co. Inc.
