Friday, October 28, 2005
Two articles related to heart failure:
Heart drug therapy complex, costly for elderly
Oct 20 (Reuters Health) - Because elderly patients with heart failure are faced with ever more complex and expensive medication regimens, more effort should go into optimizing their treatment, according to a new report.
"Physicians should be aware of the drug regimens they are expecting their patients to take," Dr. Frederick A. Masoudi from Denver Health Medical Center, Colorado told Reuters Health. "They should consider the number of drugs they prescribe, the complexity of these regimens, and what their patients must pay to obtain them."
Masoudi and colleagues studied patterns of medication prescriptions for older Medicare beneficiaries hospitalized with heart failure between 1998 and 2001.
Between 1998-1999 and 2000-2001, the average number of chronic medications prescribed for these patients increased from 6.8 to 7.5, and the mean daily number of doses increased from 10.1 to 11.1, the investigators report in the Archives of Internal Medicine.
The average estimated annual cost of these regimens increased by 22 percent between the two periods, the report indicates, from $3,142 to $3,823.
Substantial increases were seen between the two periods in prescriptions for beta-blockers, statins, and potassium-sparing diuretics, the results indicate. The most substantial change in prescriptions was for proton-pump inhibitors, which increased from 14.4 percent of the population to 22.3 percent.
Black patients received significantly fewer medicines than white patients, the investigators report, and patients under care of a cardiologist or a board-certified physician were treated with more medications at a higher cost.
"Clinicians should routinely review their patients' regimens and consider the justification for each drug, and every effort should be made to simplify wherever possible, with the goal of achieving drug regimens for every patient that are as simple and affordable as possible," Masoudi said.
"This study highlights, among other things, the importance of efforts to make drugs affordable for elderly persons," Masoudi concluded. "The inability to pay for medications is a central cause of non-adherence, which in turn renders any drug regimen useless."
SOURCE: Archives of Internal Medicine, October 10, 2005.
reprinted from Heart Center Online
October 20, 2005
Repeated Defect in Heart Devices Exposes a History of Problems
By BARRY MEIER
It was March in the high desert West but the day felt more like early summer
- warm, bright and breezy - as the young couple rode out on rented mountain
bikes along a trail that ran through the majestic red rock canyons outside
Moab, Utah.
The two college students met only a few months earlier, in late 2004. But
the couple, Jessica Lemieux and Joshua Oukrop, had talked in recent days
about their lives together and marriage. "I told him he had met his match,"
Ms. Lemieux recalled. "That I had started finishing his sentences for him."
It was one of the last things she told him. From behind, where Mr. Oukrop
was riding, she heard him call out, "Hold on, I need to..." When she turned,
he was already falling backward, the bike tumbling on top of him. She pulled
off his helmet. He gasped once, and then he stopped breathing.
Mr. Oukrop, a 21-year-old student who suffered from a genetic heart disease,
died of sudden cardiac arrest even though a medical device known as a
defibrillator had been implanted in his chest to protect him from
potentially fatal heart rhythms.
His death set off a series of events that would expose flaws in how
producers of critical heart devices disclose defects to doctors and
patients. It also would reveal that the Food and Drug Administration's
oversight of the fast-growing heart device industry is, at best, loose.
Those disclosures have resulted in calls for change in how and when
companies and the F.D.A. alert doctors about malfunctions and, in turn, what
physicians tell patients.
Two months after Mr. Oukrop's death, the Guidant Corporation, the country's
second-biggest maker of heart defibrillators, acknowledged that it had not
told doctors for three years that one model had short-circuited in about two
dozen cases, including the one involving him.
Guidant, which has said it did nothing wrong, has characterized the
student's death as a tragic event. But it turns out that the same type of
electrical defect that destroyed Mr. Oukrop's defibrillator also caused
another heart device from Guidant to malfunction.
Short circuits involving that device, an advanced pacemaker that also
contains a defibrillator, have been associated with the deaths of three
patients. Guidant said recently that it was aware of 49 short-circuit
reports involving both devices, out of a total of 42,000 units produced, a
malfunction rate that the company has characterized as low.
The devices' problems may be linked to Guidant's use of an insulating
material that in some cases can deteriorate if exposed to moisture like body
fluids.
Another device maker, Medtronic Inc., said it had stopped using the
material, called polyimide (poly-IM-ed), in the 1990's when it changed how
all its devices were made. Another company, St. Jude Medical, said it used
polyimide only inside the sealed part of its heart devices, where the
material was shielded from moisture.
Executives of Guidant, who declined to be interviewed for this article, have
said the company made all required reports to the F.D.A. about the devices,
including malfunction reports. The agency is investigating the company;
F.D.A. criminal investigators are involved in the inquiry.
Over the summer, Guidant, which is based in Indianapolis, issued recalls
affecting tens of thousands of defibrillators and pacemakers, including the
models that short-circuited.
These events have played out amid the backdrop of a high-stakes business
deal: Johnson & Johnson's announced in December 2004 that it would buy
Guidant for $25.4 billion. Johnson & Johnson's target was Guidant's crown
jewel: its heart device unit, which accounted last year for almost half of
Guidant's total sales of $3.8 billion.
As a result of Guidant's recent problems, however, that deal may be
renegotiated at a lower price or even unravel.
On Tuesday, Robert J. Darretta Jr., the vice chairman of Johnson & Johnson,
said the company was considering its alternatives under the merger
agreement. Yesterday, the chief executive of Guidant, Ronald W. Dollens,
responded, stating that his company believed that the "strategic rationale"
behind the deal had not changed.
Sounding the Alert
In May, two months after Joshua Oukrop's death, four Guidant executives
arrived at the Minneapolis Heart Institute, a cardiac center associated with
Abbott Northwestern Hospital, a short drive from the suburb where the
company's heart device division is based. There they met with one of Mr.
Oukrop's doctors, Barry J. Maron, to explain what they had learned about the
student's death and his defibrillator.
Dr. Maron was not just any cardiologist. In 2000, the 64-year-old physician
had published a landmark study that showed that defibrillators, long used in
adults with heart problems, could also save children and young adults like
Joshua Oukrop who were affected by a genetic disease, hypertrophic
cardiomyopathy, by interrupting the irregular heart rhythms the disease
causes.
Since then, Dr. Maron, a large man with soft, rumpled features, has traveled
the world like a medical missionary preaching greater use of the device and
reassuring parents that their children, if they got a defibrillator, could
lead normal lives.
While Joshua Oukrop's heart condition sidelined him from playing competitive
sports, he could pursue outdoor activities like hiking and biking after his
defibrillator was implanted in 2001.
Dr. Maron's world was shaken, however, back in March when a pathologist from
the medical examiner's office in Salt Lake City called to tell him about the
student's death. Nothing at the time suggested that the device had failed.
"I started to sweat bullets," he recalled recently. "I started thinking this
means that some of these kids can't be saved."
Soon, however, Dr. Maron would learn that it was not his research but
Guidant's device that had apparently failed Mr. Oukrop.
After a patient's death, it is rare for a defibrillator or pacemaker to be
inspected because patients are typically elderly and their deaths are
attributed to heart disease, rather than a device's malfunction. But Guidant
engineers discovered the student's device had short-circuited while trying
to send out a potentially life-saving jolt, though it was not clear when
that occurred.
At their meeting in May, Guidant officials explained to Dr. Maron that the
company knew of 25 other instances when the same model, the Prizm 2 DR, had
also short-circuited. They also said the company had fixed the problem in
April 2002, and that later units had not shorted.
The trouble was that many of those earlier units were still in patients.
Defibrillators can last five or six years before they must be replaced. The
company later acknowledged that it had sold older units out of inventory
after making an improved model.
Dr. Maron asked what the company planned to tell doctors. The medical
director of the cardiac unit, Dr. Joseph M. Smith, replied that Guidant did
not plan to tell them anything.
Dr. Smith said that Guidant was concerned, given the small number of
failures, that alerting physicians to the problem might cause them to remove
devices unnecessarily, or lead frightened patients to demand their removal.
The company believed that risks, like infection, associated with surgical
replacements outweighed the risks posed by the device, Dr. Smith said.
The meeting's tone remained cordial. But Dr. Maron had little doubt that
given Mr. Oukrop's age and condition, he would have replaced his device. Now
Dr. Smith was apparently saying that the company, even after Mr. Oukrop's
death, would keep making that choice for other physicians.
"I told him that it sounds to me that this is going to be the biggest
mistake that you are ever going to make," Dr. Maron said.
A few days later, the Guidant executives made a similar presentation to
another cardiologist at the Minneapolis heart institute, Dr. Robert G.
Hauser. If they were hoping for a more sympathetic hearing, they were wrong.
Dr. Hauser's roots were in the device industry and they even intertwined
with Guidant's. For four years, starting in the late 1980's, he had been
president of Cardiac Pacemakers Inc., which was then part of Eli Lilly &
Company, the pharmaceutical company. In 1994, Lilly spun off Cardiac
Pacemakers and four other subsidiaries to form the company that became
Guidant.
More recently, Dr. Hauser, a wiry, dark-haired man of 66, had become an
industry watchdog, creating a database into which hospitals reported device
failures. In 2001, when he published an article about electrical failures in
some Guidant models, company executives had reacted much as they were doing
now with the Prizm 2 DR. They had said the problems were so rare they did
not affect overall product safety.
Dr. Smith, the Guidant official, suggested that Dr. Hauser and the company
collaborate on a medical journal article about the defibrillator. Later, Dr.
Hauser went into Dr. Maron's office.
The physicians were in a quandary. Guidant had disclosed its problem to
them. There was no way of knowing when the next device might fail. The next
step was theirs. Dr. Maron picked up the telephone and called a reporter.
A Second Device
In July, after Guidant had recalled the defibrillator and other heart
devices, the head of the company's cardiac implant unit, J. Frederick McCoy
Jr., made his views clear.
Company engineers, he explained in a newspaper interview, had promptly
identified and fixed the Prizm 2 DR's electrical defect in April 2002. He
added that Guidant saw no reason at the time to recall the model or stop
selling older units because so few had short-circuited.
"It is only with the benefit of hindsight that you can look back at 2002 and
ask the questions: Should we have notified? Should we have stopped
distribution?" Mr. McCoy said in that July interview with The Minneapolis
Star Tribune. "And the answers to those questions in 2002 was 'No' and 'No.'
"
But in December 2002, just a few months after fixing the Prizm 2 DR, Guidant
received F.D.A. approval to sell another heart device, one that would also
short-circuit. The unit was an advanced pacemaker plus a defibrillator
called the Contak Renewal. It is used in patients with congestive heart
failure.
The parallels between the flaws in the two devices would prove striking. So
would the actions of company officials. While Guidant, as it did with the
Prizm 2 DR, reported the Contak Renewal's failures to the F.D.A., it also
did not tell doctors about the failures until this June.
Both models shorted in a small number of cases because of deteriorating
wiring insulation, Guidant has said. And a link between those episodes may
be the insulator polyimide.
Guidant's two major competitors, Medtronic and St. Jude, have previously
used the material or are currently using it. But until recently, Guidant
used polyimide in a way that the two other companies do not - to coat
electrical wires in a component that sits atop the sealed part of a heart
device.
The component, called the header, is essentially a junction box connecting a
unit's computer and power supply with cables, or leads, that carry
electrical impulses to the heart.
However, body fluids can slowly seep into the header, which is not
hermetically sealed, and cause polyimide to deteriorate in some cases, said
two engineers who spoke on the condition of anonymity because they work for
other companies. In several cases, short circuits in the Guidant units
occurred about two years after implant, F.D.A. records show.
It was during the second half of last year - when secret talks between
Guidant and Johnson & Johnson were under way - that the device maker started
receiving reports from hospitals about short circuits in the Contak Renewal
as well as continuing problems with the Prizm 2 DR.
In a statement, Guidant said it had used polyimide with great success for
more than a decade in many company devices. The company said that problems
related to polyimide deterioration were limited to three models: the Prizm 2
DR, the Contak Renewal, and a related unit called the Contak Renewal 2. The
affected Contak Renewals were made before late August 2004, Guidant has
said.
"We have had no reports of shorting failures which inhibit therapy as a
result of polyimide degradation" in other company models, Guidant said in
its statement. It also said it used different connecting components in other
models.
Guidant executives like Mr. McCoy have insisted that their decisions about
when to disclose product defects were not affected by financial factors,
like the pending Johnson & Johnson deal. Guidant said that as with the Prizm
2 DR, the rate of failure of the Contak Renewal was not high enough to meet
the company's criteria for notifying doctors.
"At this company, the quality culture is absolutely apparent," Mr. McCoy
said in his July interview with the Minneapolis Star Tribune.
Others are skeptical. "I think J.& J. colored things," said Dr. Hauser of
Minneapolis.
Changes in Iowa
Whatever the case, the ripple effects of Guidant's recalls were felt
throughout the summer and fall in doctors' offices and medical centers
nationwide. One place was the University of Iowa Hospitals in Iowa City.
"Every day, you didn't know what was going to happen," the facility's
director of cardiac electrophysiology, Dr. Brian Olshansky, recalled
recently. "You were getting calls from all kinds of people. There would be
another 'Dear Doctor' letter on my desk. Another patient calling. Another
person from an investment house wanting guidance."
In recent months, about a third of the patients at the Iowa medical center
with Prizm 2 DR's underwent replacement procedures. Physicians, in deciding
whether to replace a device, typically weigh surgical risks like infection
against factors like a patient's dependence on a device.
Initially, one patient, Angela Martin, did not make that cut. Ms. Martin had
received a Prizm 2 DR defibrillator in 2000 after collapsing from cardiac
arrest during a meeting at a Veterans Affairs hospital, where she worked as
an X-ray technician.
Her doctors believed that she was at low risk because her defibrillator had
never fired. At first, Ms. Martin said she was also content to wait a year
or so until the unit's battery drained and it would be replaced anyway.
But as the summer wore on, she read newspaper articles about additional
recalls. By August she had read enough and asked for a new device.
"I was getting nervous," said Ms. Martin, 43, who lives in West Liberty,
Iowa, a town about 20 miles east of Iowa City. "I said, 'Let's get this
done. I don't want a lot of ifs in the back of my head.' "
In recent weeks, the clinic's pace has returned to normal, said Dr.
Olshansky. Yesterday, Guidant announced that it had regained more than 80
percent of the market share it had lost as a result of the recalls.
But it will not regain all its lost ground at University of Iowa Hospitals.
Until recently, it largely used Guidant devices because the hospital, like
others, can get price discounts by dealing with a limited number of
manufacturers. That has changed.
Dr. Olshansky, who is heading a clinical trial sponsored by Guidant, said
the recalls had cost the hospital so much money in terms of expenses like
increased patient follow-up that officials decided it made more economic
sense to spread their risks. Now, the hospital is using devices made by all
three major manufacturers.
There was another factor behind the change, Dr. Olshansky added. He said he
liked Guidant's devices. But he simply got tired of trying to explain to
patients, after everything that had occurred, why he was giving them one.
"It was difficult to swallow," Dr. Olshansky said.
Copyright 2005 The New York Times Company
Heart drug therapy complex, costly for elderly
Oct 20 (Reuters Health) - Because elderly patients with heart failure are faced with ever more complex and expensive medication regimens, more effort should go into optimizing their treatment, according to a new report.
"Physicians should be aware of the drug regimens they are expecting their patients to take," Dr. Frederick A. Masoudi from Denver Health Medical Center, Colorado told Reuters Health. "They should consider the number of drugs they prescribe, the complexity of these regimens, and what their patients must pay to obtain them."
Masoudi and colleagues studied patterns of medication prescriptions for older Medicare beneficiaries hospitalized with heart failure between 1998 and 2001.
Between 1998-1999 and 2000-2001, the average number of chronic medications prescribed for these patients increased from 6.8 to 7.5, and the mean daily number of doses increased from 10.1 to 11.1, the investigators report in the Archives of Internal Medicine.
The average estimated annual cost of these regimens increased by 22 percent between the two periods, the report indicates, from $3,142 to $3,823.
Substantial increases were seen between the two periods in prescriptions for beta-blockers, statins, and potassium-sparing diuretics, the results indicate. The most substantial change in prescriptions was for proton-pump inhibitors, which increased from 14.4 percent of the population to 22.3 percent.
Black patients received significantly fewer medicines than white patients, the investigators report, and patients under care of a cardiologist or a board-certified physician were treated with more medications at a higher cost.
"Clinicians should routinely review their patients' regimens and consider the justification for each drug, and every effort should be made to simplify wherever possible, with the goal of achieving drug regimens for every patient that are as simple and affordable as possible," Masoudi said.
"This study highlights, among other things, the importance of efforts to make drugs affordable for elderly persons," Masoudi concluded. "The inability to pay for medications is a central cause of non-adherence, which in turn renders any drug regimen useless."
SOURCE: Archives of Internal Medicine, October 10, 2005.
reprinted from Heart Center Online
October 20, 2005
Repeated Defect in Heart Devices Exposes a History of Problems
By BARRY MEIER
It was March in the high desert West but the day felt more like early summer
- warm, bright and breezy - as the young couple rode out on rented mountain
bikes along a trail that ran through the majestic red rock canyons outside
Moab, Utah.
The two college students met only a few months earlier, in late 2004. But
the couple, Jessica Lemieux and Joshua Oukrop, had talked in recent days
about their lives together and marriage. "I told him he had met his match,"
Ms. Lemieux recalled. "That I had started finishing his sentences for him."
It was one of the last things she told him. From behind, where Mr. Oukrop
was riding, she heard him call out, "Hold on, I need to..." When she turned,
he was already falling backward, the bike tumbling on top of him. She pulled
off his helmet. He gasped once, and then he stopped breathing.
Mr. Oukrop, a 21-year-old student who suffered from a genetic heart disease,
died of sudden cardiac arrest even though a medical device known as a
defibrillator had been implanted in his chest to protect him from
potentially fatal heart rhythms.
His death set off a series of events that would expose flaws in how
producers of critical heart devices disclose defects to doctors and
patients. It also would reveal that the Food and Drug Administration's
oversight of the fast-growing heart device industry is, at best, loose.
Those disclosures have resulted in calls for change in how and when
companies and the F.D.A. alert doctors about malfunctions and, in turn, what
physicians tell patients.
Two months after Mr. Oukrop's death, the Guidant Corporation, the country's
second-biggest maker of heart defibrillators, acknowledged that it had not
told doctors for three years that one model had short-circuited in about two
dozen cases, including the one involving him.
Guidant, which has said it did nothing wrong, has characterized the
student's death as a tragic event. But it turns out that the same type of
electrical defect that destroyed Mr. Oukrop's defibrillator also caused
another heart device from Guidant to malfunction.
Short circuits involving that device, an advanced pacemaker that also
contains a defibrillator, have been associated with the deaths of three
patients. Guidant said recently that it was aware of 49 short-circuit
reports involving both devices, out of a total of 42,000 units produced, a
malfunction rate that the company has characterized as low.
The devices' problems may be linked to Guidant's use of an insulating
material that in some cases can deteriorate if exposed to moisture like body
fluids.
Another device maker, Medtronic Inc., said it had stopped using the
material, called polyimide (poly-IM-ed), in the 1990's when it changed how
all its devices were made. Another company, St. Jude Medical, said it used
polyimide only inside the sealed part of its heart devices, where the
material was shielded from moisture.
Executives of Guidant, who declined to be interviewed for this article, have
said the company made all required reports to the F.D.A. about the devices,
including malfunction reports. The agency is investigating the company;
F.D.A. criminal investigators are involved in the inquiry.
Over the summer, Guidant, which is based in Indianapolis, issued recalls
affecting tens of thousands of defibrillators and pacemakers, including the
models that short-circuited.
These events have played out amid the backdrop of a high-stakes business
deal: Johnson & Johnson's announced in December 2004 that it would buy
Guidant for $25.4 billion. Johnson & Johnson's target was Guidant's crown
jewel: its heart device unit, which accounted last year for almost half of
Guidant's total sales of $3.8 billion.
As a result of Guidant's recent problems, however, that deal may be
renegotiated at a lower price or even unravel.
On Tuesday, Robert J. Darretta Jr., the vice chairman of Johnson & Johnson,
said the company was considering its alternatives under the merger
agreement. Yesterday, the chief executive of Guidant, Ronald W. Dollens,
responded, stating that his company believed that the "strategic rationale"
behind the deal had not changed.
Sounding the Alert
In May, two months after Joshua Oukrop's death, four Guidant executives
arrived at the Minneapolis Heart Institute, a cardiac center associated with
Abbott Northwestern Hospital, a short drive from the suburb where the
company's heart device division is based. There they met with one of Mr.
Oukrop's doctors, Barry J. Maron, to explain what they had learned about the
student's death and his defibrillator.
Dr. Maron was not just any cardiologist. In 2000, the 64-year-old physician
had published a landmark study that showed that defibrillators, long used in
adults with heart problems, could also save children and young adults like
Joshua Oukrop who were affected by a genetic disease, hypertrophic
cardiomyopathy, by interrupting the irregular heart rhythms the disease
causes.
Since then, Dr. Maron, a large man with soft, rumpled features, has traveled
the world like a medical missionary preaching greater use of the device and
reassuring parents that their children, if they got a defibrillator, could
lead normal lives.
While Joshua Oukrop's heart condition sidelined him from playing competitive
sports, he could pursue outdoor activities like hiking and biking after his
defibrillator was implanted in 2001.
Dr. Maron's world was shaken, however, back in March when a pathologist from
the medical examiner's office in Salt Lake City called to tell him about the
student's death. Nothing at the time suggested that the device had failed.
"I started to sweat bullets," he recalled recently. "I started thinking this
means that some of these kids can't be saved."
Soon, however, Dr. Maron would learn that it was not his research but
Guidant's device that had apparently failed Mr. Oukrop.
After a patient's death, it is rare for a defibrillator or pacemaker to be
inspected because patients are typically elderly and their deaths are
attributed to heart disease, rather than a device's malfunction. But Guidant
engineers discovered the student's device had short-circuited while trying
to send out a potentially life-saving jolt, though it was not clear when
that occurred.
At their meeting in May, Guidant officials explained to Dr. Maron that the
company knew of 25 other instances when the same model, the Prizm 2 DR, had
also short-circuited. They also said the company had fixed the problem in
April 2002, and that later units had not shorted.
The trouble was that many of those earlier units were still in patients.
Defibrillators can last five or six years before they must be replaced. The
company later acknowledged that it had sold older units out of inventory
after making an improved model.
Dr. Maron asked what the company planned to tell doctors. The medical
director of the cardiac unit, Dr. Joseph M. Smith, replied that Guidant did
not plan to tell them anything.
Dr. Smith said that Guidant was concerned, given the small number of
failures, that alerting physicians to the problem might cause them to remove
devices unnecessarily, or lead frightened patients to demand their removal.
The company believed that risks, like infection, associated with surgical
replacements outweighed the risks posed by the device, Dr. Smith said.
The meeting's tone remained cordial. But Dr. Maron had little doubt that
given Mr. Oukrop's age and condition, he would have replaced his device. Now
Dr. Smith was apparently saying that the company, even after Mr. Oukrop's
death, would keep making that choice for other physicians.
"I told him that it sounds to me that this is going to be the biggest
mistake that you are ever going to make," Dr. Maron said.
A few days later, the Guidant executives made a similar presentation to
another cardiologist at the Minneapolis heart institute, Dr. Robert G.
Hauser. If they were hoping for a more sympathetic hearing, they were wrong.
Dr. Hauser's roots were in the device industry and they even intertwined
with Guidant's. For four years, starting in the late 1980's, he had been
president of Cardiac Pacemakers Inc., which was then part of Eli Lilly &
Company, the pharmaceutical company. In 1994, Lilly spun off Cardiac
Pacemakers and four other subsidiaries to form the company that became
Guidant.
More recently, Dr. Hauser, a wiry, dark-haired man of 66, had become an
industry watchdog, creating a database into which hospitals reported device
failures. In 2001, when he published an article about electrical failures in
some Guidant models, company executives had reacted much as they were doing
now with the Prizm 2 DR. They had said the problems were so rare they did
not affect overall product safety.
Dr. Smith, the Guidant official, suggested that Dr. Hauser and the company
collaborate on a medical journal article about the defibrillator. Later, Dr.
Hauser went into Dr. Maron's office.
The physicians were in a quandary. Guidant had disclosed its problem to
them. There was no way of knowing when the next device might fail. The next
step was theirs. Dr. Maron picked up the telephone and called a reporter.
A Second Device
In July, after Guidant had recalled the defibrillator and other heart
devices, the head of the company's cardiac implant unit, J. Frederick McCoy
Jr., made his views clear.
Company engineers, he explained in a newspaper interview, had promptly
identified and fixed the Prizm 2 DR's electrical defect in April 2002. He
added that Guidant saw no reason at the time to recall the model or stop
selling older units because so few had short-circuited.
"It is only with the benefit of hindsight that you can look back at 2002 and
ask the questions: Should we have notified? Should we have stopped
distribution?" Mr. McCoy said in that July interview with The Minneapolis
Star Tribune. "And the answers to those questions in 2002 was 'No' and 'No.'
"
But in December 2002, just a few months after fixing the Prizm 2 DR, Guidant
received F.D.A. approval to sell another heart device, one that would also
short-circuit. The unit was an advanced pacemaker plus a defibrillator
called the Contak Renewal. It is used in patients with congestive heart
failure.
The parallels between the flaws in the two devices would prove striking. So
would the actions of company officials. While Guidant, as it did with the
Prizm 2 DR, reported the Contak Renewal's failures to the F.D.A., it also
did not tell doctors about the failures until this June.
Both models shorted in a small number of cases because of deteriorating
wiring insulation, Guidant has said. And a link between those episodes may
be the insulator polyimide.
Guidant's two major competitors, Medtronic and St. Jude, have previously
used the material or are currently using it. But until recently, Guidant
used polyimide in a way that the two other companies do not - to coat
electrical wires in a component that sits atop the sealed part of a heart
device.
The component, called the header, is essentially a junction box connecting a
unit's computer and power supply with cables, or leads, that carry
electrical impulses to the heart.
However, body fluids can slowly seep into the header, which is not
hermetically sealed, and cause polyimide to deteriorate in some cases, said
two engineers who spoke on the condition of anonymity because they work for
other companies. In several cases, short circuits in the Guidant units
occurred about two years after implant, F.D.A. records show.
It was during the second half of last year - when secret talks between
Guidant and Johnson & Johnson were under way - that the device maker started
receiving reports from hospitals about short circuits in the Contak Renewal
as well as continuing problems with the Prizm 2 DR.
In a statement, Guidant said it had used polyimide with great success for
more than a decade in many company devices. The company said that problems
related to polyimide deterioration were limited to three models: the Prizm 2
DR, the Contak Renewal, and a related unit called the Contak Renewal 2. The
affected Contak Renewals were made before late August 2004, Guidant has
said.
"We have had no reports of shorting failures which inhibit therapy as a
result of polyimide degradation" in other company models, Guidant said in
its statement. It also said it used different connecting components in other
models.
Guidant executives like Mr. McCoy have insisted that their decisions about
when to disclose product defects were not affected by financial factors,
like the pending Johnson & Johnson deal. Guidant said that as with the Prizm
2 DR, the rate of failure of the Contak Renewal was not high enough to meet
the company's criteria for notifying doctors.
"At this company, the quality culture is absolutely apparent," Mr. McCoy
said in his July interview with the Minneapolis Star Tribune.
Others are skeptical. "I think J.& J. colored things," said Dr. Hauser of
Minneapolis.
Changes in Iowa
Whatever the case, the ripple effects of Guidant's recalls were felt
throughout the summer and fall in doctors' offices and medical centers
nationwide. One place was the University of Iowa Hospitals in Iowa City.
"Every day, you didn't know what was going to happen," the facility's
director of cardiac electrophysiology, Dr. Brian Olshansky, recalled
recently. "You were getting calls from all kinds of people. There would be
another 'Dear Doctor' letter on my desk. Another patient calling. Another
person from an investment house wanting guidance."
In recent months, about a third of the patients at the Iowa medical center
with Prizm 2 DR's underwent replacement procedures. Physicians, in deciding
whether to replace a device, typically weigh surgical risks like infection
against factors like a patient's dependence on a device.
Initially, one patient, Angela Martin, did not make that cut. Ms. Martin had
received a Prizm 2 DR defibrillator in 2000 after collapsing from cardiac
arrest during a meeting at a Veterans Affairs hospital, where she worked as
an X-ray technician.
Her doctors believed that she was at low risk because her defibrillator had
never fired. At first, Ms. Martin said she was also content to wait a year
or so until the unit's battery drained and it would be replaced anyway.
But as the summer wore on, she read newspaper articles about additional
recalls. By August she had read enough and asked for a new device.
"I was getting nervous," said Ms. Martin, 43, who lives in West Liberty,
Iowa, a town about 20 miles east of Iowa City. "I said, 'Let's get this
done. I don't want a lot of ifs in the back of my head.' "
In recent weeks, the clinic's pace has returned to normal, said Dr.
Olshansky. Yesterday, Guidant announced that it had regained more than 80
percent of the market share it had lost as a result of the recalls.
But it will not regain all its lost ground at University of Iowa Hospitals.
Until recently, it largely used Guidant devices because the hospital, like
others, can get price discounts by dealing with a limited number of
manufacturers. That has changed.
Dr. Olshansky, who is heading a clinical trial sponsored by Guidant, said
the recalls had cost the hospital so much money in terms of expenses like
increased patient follow-up that officials decided it made more economic
sense to spread their risks. Now, the hospital is using devices made by all
three major manufacturers.
There was another factor behind the change, Dr. Olshansky added. He said he
liked Guidant's devices. But he simply got tired of trying to explain to
patients, after everything that had occurred, why he was giving them one.
"It was difficult to swallow," Dr. Olshansky said.
Copyright 2005 The New York Times Company
