![[personal profile]](https://www.dreamwidth.org/img/silk/identity/user.png){kind=small}
May. 13th, 2007
October 20-28, 2005 posts
May. 13th, 2007 10:15 pmFriday, 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
Tuesday, December 20, 2005
News:
Micronutrients helpful for heart failure patientsec 07 (Reuters Health) - Micronutrient supplementation improves heart function and quality-of-life in elderly patients with chronic heart failure, according to a report from investigators in Germany and the UK.
"The vitamin story has been confused with studies examining the response to single vitamin supplements in relatively low-risk patients," Dr. Klaus K. A. Witte from Castle Hill Hospital, Cottingham, told Reuters Health.
On the other hand, "CHF patients are at higher risk and might have multiple deficiencies. Replacing just one micronutrient might expose deficiency elsewhere (the vitamin E and C interaction, for example), so a combination is important," Witte explained.
He and his and colleagues investigated the effects of long-term multiple micronutrient supplementation in 32 patients older than age 70 years with stable heart failure.
After an average of 295 days, the patients who had been assigned to get micronutrient supplements experienced significant improvements in cardiac pumping ability, the team reports in the European Heart Journal.
Also, patients taking micronutrients had an increase in their quality-of-life score, whereas the participants who had been given placebo supplements had a decrease in their quality-of-life score.
The differences in overall quality-of-life score were mainly due to improvements in scores for breathlessness on exertion, quality of sleep, and daytime concentration among the patients taking micronutrients.
"At present there are few supplements that include the constituents we used," Witte said. "I would generally recommend a combined multivitamin supplement along with zinc, copper, and selenium. I also feel strongly that a high dose Coenzyme-Q10 is important. Most currently available supplements do not have enough Co-Q10."
SOURCE: European Heart Journal, November 2005.
Sunday, December 18, 2005
Top Ten List: Ten Reasons Why CHF is Not the Worst Thing That Could Happen
10. No chemotherapy, radiation, dialysis, or daily injections.
9. You get to use handicapped parking spaces at the mall.
8. Perfect excuse for getting out of parties you'd rather not go to in the first place.
7. Lots of chances to lecture people endlessly when they say "you don't LOOK disabled"
6. ICD support groups serve free dinner at quarterly meetings.
5. Get to take part in medical studies and maybe even get paid for them.
4. Take naps in mid-afternoon even if you're under 65.
3. Improve your on-line research skills hunting for low-sodium products.
2. Takes your mind off worrying about getting Alzheimer's when you get old.
And the number one reason why CHF INTWTTCH:
1. Cardiologists' waiting rooms have such great magazines!
10. No chemotherapy, radiation, dialysis, or daily injections.
9. You get to use handicapped parking spaces at the mall.
8. Perfect excuse for getting out of parties you'd rather not go to in the first place.
7. Lots of chances to lecture people endlessly when they say "you don't LOOK disabled"
6. ICD support groups serve free dinner at quarterly meetings.
5. Get to take part in medical studies and maybe even get paid for them.
4. Take naps in mid-afternoon even if you're under 65.
3. Improve your on-line research skills hunting for low-sodium products.
2. Takes your mind off worrying about getting Alzheimer's when you get old.
And the number one reason why CHF INTWTTCH:
1. Cardiologists' waiting rooms have such great magazines!
It's the beginning of the holiday season! That means, for many people, FOOD.
And all those parties. Snacks and alcohol - what do we do about them?
First off, if you want to be sure there's something at a party that you can eat, bring something yourself; a bowl of my fruit salad with ginger dressing will work nicely. I can't seem to find the old post from a couple of years ago where I put this, so I'll re-print it below.
Eggnog is pretty much off limits. High in fat, higher in sodium than you'd think for a sweet beverage, and often has alcohol in it. A little alcohol will not hurt you, but eggnog can pack a surprising amount in it, with all the sugar disguising the alcohol content. So just say no to eggnog. You'll see "lite" varieties in the supermarket; these are lower in fat and cholesterol, but not any lower in sodium, and they tend to taste like vaguely rum-flavored thin milkshakes - worse, if they have artificial sweeteners in them. So they're not worth bothering with.
If you want to have a festive beverage that's very holidayish, consider mulled apple cider - there are thousands of recipes out there on the web. One way to make the making of mulled cider easier: instead of using cheesecloth balls to hold the spices (who even owns cheesecloth any more? How many of us would know where to find any if we wanted some? [The answer to that is: fabric stores.]}, use wire mesh tea balls. A large tea ball will hold the spices and brown sugar and allow the brown sugar to dissolve out into the cider just as cheesecloth would. And it's then washable and re-usable for your pot of tea.
Other beverages include sparkling cider - Martinelli's makes a non-alcoholic sparkling apple cider, as well as apple-cranberry and a couple other varieties. A chilled bottle or two of this with a festive bow is as welcome a hostess gift as wine, and drinkable by all. I served sparkling cider with Thanksgiving dinner, and everyone enjoyed it; we never even got around to opening the wine.
And then there's tea. Chai tea is a rich, spicy tea. It can be served sweetened or un; with milk or without. And there's decaf versions, if you are supposed to limit your caffeine intake. I also served chai at Thanksgiving - I made a huge pot of decaf chai, we sweetened it with Splenda, and drank it with dessert and afterward. One of my sisters-in-law is pregnant, so she really appreciated the non-alcoholic options. You can find decaf chais in various supermarket brands, such as Celestial Seasonings, or some good whole-leaf chais from on-line vendors, such as Plymouth Tea.
Finally, alcohol itself: a teeny tiny bit will not hurt most of us. I take 9 pills a day, including 5 that say on the label not to drink any alcohol. I have discovered, though, that I can handle 1/4 of a serving of alcohol without any ill effects. So I can allow myself a couple of gulps of beer or hard cider, or the bottom of a wine glass of white wine or champagne, or a bottle-cap-ful of Bailey's or other liquer poured over ice cream or into hot cocoa. I don't do it that often, but I can do it. Check with your doctor, and see if he or she goes into screaming fits at the idea, or instead says "yeah, you can have a sip of that as long as you don't drink a whole glass." Once you have that permission, though, don't overdo it!!
Festive Fruit Salad
suitable for bringing to parties or serving to company
1 banana
1 box of strawberries (more is OK- if you want to get a quart box instead of a pint box, that's fine)
1 large (quart) container of cubes of melon - most supermarkets have these, cubed honeydew and cantaloupe, sometimes watermelon too
1 can mandarin orange slices in juice
1 can pineapple chunks in juice
2 kiwi fruits (melon and kiwi are even higher in potassium than bananas!!)
several pieces of candied ginger
Use a bowl with a liquid-tight lid, such as Tupperware, to make this salad in.
1. Open the 2 cans and drain the juices into a separate bowl. Put the fruit in the bowl you're making the salad in.
2. Dice up the candied ginger into teeny pieces. Put it in the juices to steep. You can add a little bit of sugar to this if you want, but not too much!
3. Chop the banana into bite-sized chunks. Halve the strawberries. Cut the melon cubes, which are usually pretty large, into bite-size chunks. Put them in the salad bowl, and toss a couple of teaspoons of the fruit juice with them to keep everything fresh - the vitamin C (ascorbic acid) in the juice will do that.
4. Peel one kiwi, slice it in half, and then slice into thin slices to toss with the rest of the fruit. (You'll use the other kiwi at the end.)
5. Pour the rest of the fruit juice/ginger mix over the tossed fruit, and stir thoroughly. Cover, stick in the refrigerator, and let sit for at least 2 hours, and preferably more. At least once, more often if you think about it, tip the bowl around to stir up the ginger-juice so the fruit at the top gets to marinate in it.
6. Just before serving or setting off to the party, peel the other kiwi fruit and cut into thin circles. Toss the salad one last time, then place these kiwi circles decoratively on top - arrange them in a pattern, or cut snowflake shapes out of them first, or something decorative. Cover the bowl again until the minute you're ready to serve it or to put it on the buffet table at the party you're attending.
And all those parties. Snacks and alcohol - what do we do about them?
First off, if you want to be sure there's something at a party that you can eat, bring something yourself; a bowl of my fruit salad with ginger dressing will work nicely. I can't seem to find the old post from a couple of years ago where I put this, so I'll re-print it below.
Eggnog is pretty much off limits. High in fat, higher in sodium than you'd think for a sweet beverage, and often has alcohol in it. A little alcohol will not hurt you, but eggnog can pack a surprising amount in it, with all the sugar disguising the alcohol content. So just say no to eggnog. You'll see "lite" varieties in the supermarket; these are lower in fat and cholesterol, but not any lower in sodium, and they tend to taste like vaguely rum-flavored thin milkshakes - worse, if they have artificial sweeteners in them. So they're not worth bothering with.
If you want to have a festive beverage that's very holidayish, consider mulled apple cider - there are thousands of recipes out there on the web. One way to make the making of mulled cider easier: instead of using cheesecloth balls to hold the spices (who even owns cheesecloth any more? How many of us would know where to find any if we wanted some? [The answer to that is: fabric stores.]}, use wire mesh tea balls. A large tea ball will hold the spices and brown sugar and allow the brown sugar to dissolve out into the cider just as cheesecloth would. And it's then washable and re-usable for your pot of tea.
Other beverages include sparkling cider - Martinelli's makes a non-alcoholic sparkling apple cider, as well as apple-cranberry and a couple other varieties. A chilled bottle or two of this with a festive bow is as welcome a hostess gift as wine, and drinkable by all. I served sparkling cider with Thanksgiving dinner, and everyone enjoyed it; we never even got around to opening the wine.
And then there's tea. Chai tea is a rich, spicy tea. It can be served sweetened or un; with milk or without. And there's decaf versions, if you are supposed to limit your caffeine intake. I also served chai at Thanksgiving - I made a huge pot of decaf chai, we sweetened it with Splenda, and drank it with dessert and afterward. One of my sisters-in-law is pregnant, so she really appreciated the non-alcoholic options. You can find decaf chais in various supermarket brands, such as Celestial Seasonings, or some good whole-leaf chais from on-line vendors, such as Plymouth Tea.
Finally, alcohol itself: a teeny tiny bit will not hurt most of us. I take 9 pills a day, including 5 that say on the label not to drink any alcohol. I have discovered, though, that I can handle 1/4 of a serving of alcohol without any ill effects. So I can allow myself a couple of gulps of beer or hard cider, or the bottom of a wine glass of white wine or champagne, or a bottle-cap-ful of Bailey's or other liquer poured over ice cream or into hot cocoa. I don't do it that often, but I can do it. Check with your doctor, and see if he or she goes into screaming fits at the idea, or instead says "yeah, you can have a sip of that as long as you don't drink a whole glass." Once you have that permission, though, don't overdo it!!
Festive Fruit Salad
suitable for bringing to parties or serving to company
1 banana
1 box of strawberries (more is OK- if you want to get a quart box instead of a pint box, that's fine)
1 large (quart) container of cubes of melon - most supermarkets have these, cubed honeydew and cantaloupe, sometimes watermelon too
1 can mandarin orange slices in juice
1 can pineapple chunks in juice
2 kiwi fruits (melon and kiwi are even higher in potassium than bananas!!)
several pieces of candied ginger
Use a bowl with a liquid-tight lid, such as Tupperware, to make this salad in.
1. Open the 2 cans and drain the juices into a separate bowl. Put the fruit in the bowl you're making the salad in.
2. Dice up the candied ginger into teeny pieces. Put it in the juices to steep. You can add a little bit of sugar to this if you want, but not too much!
3. Chop the banana into bite-sized chunks. Halve the strawberries. Cut the melon cubes, which are usually pretty large, into bite-size chunks. Put them in the salad bowl, and toss a couple of teaspoons of the fruit juice with them to keep everything fresh - the vitamin C (ascorbic acid) in the juice will do that.
4. Peel one kiwi, slice it in half, and then slice into thin slices to toss with the rest of the fruit. (You'll use the other kiwi at the end.)
5. Pour the rest of the fruit juice/ginger mix over the tossed fruit, and stir thoroughly. Cover, stick in the refrigerator, and let sit for at least 2 hours, and preferably more. At least once, more often if you think about it, tip the bowl around to stir up the ginger-juice so the fruit at the top gets to marinate in it.
6. Just before serving or setting off to the party, peel the other kiwi fruit and cut into thin circles. Toss the salad one last time, then place these kiwi circles decoratively on top - arrange them in a pattern, or cut snowflake shapes out of them first, or something decorative. Cover the bowl again until the minute you're ready to serve it or to put it on the buffet table at the party you're attending.
December 28 2005 post
May. 13th, 2007 10:17 pmWednesday, December 28, 2005
Recently I had a MUGA scan done. This was because my most recent echo,a month ago, showed my EF as having fallen back down into the 15-20% range. Doc says that at low numbers like that, the echo isn't very accurate or precise; the MUGA is. I haven't heard the results yet - he's on vacation; I meet with him the day he gets back, Jan 9. Anyway, some of you have heard about MUGAs, and if you haven't, you can read more about them here:
http://heartdisease.about.com/cs/cardiactests/a/muga.htm
http://www.chfpatients.com/tests/muga.htm
Although those sites describe the test, they don't really. What they don't tell you is the "sit and wait" aspects. So here's what it's really like:
Arrive at lab in basement of building at 9 a.m., still 90% asleep. Sign in, sit and wait. After about 10 minutes, a tech gets around to you, and draws some blood, making jokes that you don't get since you're not really awake yet. Then you go back and sit in the waiting room for another 20 minutes, while they add the radioactive stuff to your blood. The stuff's called technetium, which they pronounce tek-NEE-shem. The waiting room has small chairs, cheap, with not much padding, and fewer and older magazines than a doctor's waiting room. So if you didn't bring your own reading material or knitting, you are in for more boredom than usual. They do, however, offer juice or coffee - in most cases, there is no reason why you cannot eat or drink before a MUGA, unlike many other lab tests and scans. So, if you don't have to fast, then one way to pass the waiting time is to bring your own coffee and donuts, or tea and toast, or whatever, for breakfast.
Then you go back in the blood-drawing room to have your blood re-injected into you. Then you go back out to the waiting room, and wait for another 20-25 minutes, for the radioactive blood to circulate enough. Pull out the knitting again, or the crossword puzzle, or your PDA. During this wait, the staff will probably also use the time to give you your "radioactive letter" - a note that says you've had this test done, so that if you have to go into a high-security area, you can explain why you happen to be radioactive. They recommend keeping it with you for 30 days.
Finally you get to go back to the machine. If you are wearing thin clothing, you probably get to keep it on; if you are wearing heavy clothing or clothing with metal on it - women's bras, shirts with snaps or metal buttons - you will probably be asked to undress to the waist. Then you lie down. The description at the web sites above says "you will be asked to hold very still." Actually, they don't count on you for that - what they do is stretch a thin rubber sheet over your thorax (chest) and right arm (your left arm rests above your head) and fasten it down, so that you are held firmly in place. It would take quite an effort to twitch, let alone move much, under there. Then the machine hums and the technician mutters at her computer and the background music plays, for about 15-20 minutes. (I dozed off, so I don't know the exact amount of time; it was at least 4 Christmas carols, though.) And that's it - when they let you up, you get to just leave, and wait to talk to your doctor about the results.
I was pushy enough to ask to see the technician's computer screen, and she ran a bit of the view for me. One can see one's heart clearly; what's surprising is how large and bright one's spleen is!!
Well, results when I get them will be posted here. Till then, Happy New Year!
keywords: MUGA, scan, EF
http://heartdisease.about.com/cs/cardiactests/a/muga.htm
http://www.chfpatients.com/tests/muga.htm
Although those sites describe the test, they don't really. What they don't tell you is the "sit and wait" aspects. So here's what it's really like:
Arrive at lab in basement of building at 9 a.m., still 90% asleep. Sign in, sit and wait. After about 10 minutes, a tech gets around to you, and draws some blood, making jokes that you don't get since you're not really awake yet. Then you go back and sit in the waiting room for another 20 minutes, while they add the radioactive stuff to your blood. The stuff's called technetium, which they pronounce tek-NEE-shem. The waiting room has small chairs, cheap, with not much padding, and fewer and older magazines than a doctor's waiting room. So if you didn't bring your own reading material or knitting, you are in for more boredom than usual. They do, however, offer juice or coffee - in most cases, there is no reason why you cannot eat or drink before a MUGA, unlike many other lab tests and scans. So, if you don't have to fast, then one way to pass the waiting time is to bring your own coffee and donuts, or tea and toast, or whatever, for breakfast.
Then you go back in the blood-drawing room to have your blood re-injected into you. Then you go back out to the waiting room, and wait for another 20-25 minutes, for the radioactive blood to circulate enough. Pull out the knitting again, or the crossword puzzle, or your PDA. During this wait, the staff will probably also use the time to give you your "radioactive letter" - a note that says you've had this test done, so that if you have to go into a high-security area, you can explain why you happen to be radioactive. They recommend keeping it with you for 30 days.
Finally you get to go back to the machine. If you are wearing thin clothing, you probably get to keep it on; if you are wearing heavy clothing or clothing with metal on it - women's bras, shirts with snaps or metal buttons - you will probably be asked to undress to the waist. Then you lie down. The description at the web sites above says "you will be asked to hold very still." Actually, they don't count on you for that - what they do is stretch a thin rubber sheet over your thorax (chest) and right arm (your left arm rests above your head) and fasten it down, so that you are held firmly in place. It would take quite an effort to twitch, let alone move much, under there. Then the machine hums and the technician mutters at her computer and the background music plays, for about 15-20 minutes. (I dozed off, so I don't know the exact amount of time; it was at least 4 Christmas carols, though.) And that's it - when they let you up, you get to just leave, and wait to talk to your doctor about the results.
I was pushy enough to ask to see the technician's computer screen, and she ran a bit of the view for me. One can see one's heart clearly; what's surprising is how large and bright one's spleen is!!
Well, results when I get them will be posted here. Till then, Happy New Year!
keywords: MUGA, scan, EF
A couple of articles about Guidant ICDs
Three new deaths associated with Guidant devices
Dec 15 (Reuters) - Guidant Corp has filed reports with the US Food and Drug Administration about three new deaths associated with short circuits in its heart devices, the New York Times reported on Wednesday.
Citing FDA records, the newspaper said the deaths occurred after Guidant recalled the heart devices in June.
Guidant has faced intense scrutiny in recent months over its failure to inform doctors about potential defects in some of its implantable devices used to manage abnormal heartbeats.
It eventually recalled some of its most lucrative implantable heart devices because of concerns about their safety. Sales have since resumed.
Including the new reports, number of deaths associated with the flaws has reached seven, the Times said. It said doctors and families of heart patients may be more likely to have the units checked for problems after a death because of the increased scrutiny on Guidant.
According to the report, Guidant said it "regularly communicates information about product performance to various stakeholders including physicians and regulatory bodies," and has recently been releasing more detailed information about product malfunctions.
In October, Guidant said it had received a Justice Department subpoena concerning some of those recalled heart devices, which regulate abnormal heart rhythm and protect against heart failure. Two other makers of heart devices also got subpoenas.
Guidant, which is the target of competing takeover offers from Johnson & Johnson and Boston Scientific Corp., was not immediately available for comment.
Publish Date: December 15, 2005
Heart Device's Export Blocked - FDA Questions Rhythm Stabilizers From One
Guidant Plant
By Marc Kaufman
Washington Post Staff Writer
Wednesday, December 28, 2005; A02
The Food and Drug Administration has told Guidant Corp., a maker of medical
devices, that it will not approve new contracts to export heart-rhythm
stabilizers made in its Minnesota plant until the company can prove that its
products are being properly made.
In a warning letter from the agency, the troubled company was also informed
that it had to make significant improvements in its manufacturing practices
before any additional company devices could be approved for sale.
Guidant acknowledged in a statement on its Web site that it received the
formal FDA warning Dec. 23, and that it outlined quality-control issues at
its St. Paul plant. The warning letter covered a broad range of
still-uncorrected problems first identified by the FDA during a September
inspection.
But, Guidant said in its statement that it has "taken a broad, thorough and
systemic review of its quality system and has made substantial steps toward
addressing all" of the FDA's concerns. The company has fulfilled 90 percent
of its upgrade commitments, the statement said.
The intensive FDA inspection followed a series of recalls and warnings
issued for Guidant's heart defibrillators and pacemakers because of reported
malfunctions, some of them fatal. Federal and state officials are
investigating the company, which faces dozens of lawsuits over its recalls.
After the inspection, FDA officials said that the company did not properly
warn doctors about software problems that caused some pacemakers to
malfunction, that company quality control was ineffective at several levels,
and that record-keeping was poor.
FDA spokesman Jason Brodsky said that while Guidant remains out of
compliance with good manufacturing practices at the St. Paul plant, the
agency had no additional product warnings yesterday for patients and their
doctors.
"We're working with the company now to bring them into compliance," Brodsky
said. "There are significant manufacturing concerns, but we have no new
recommendations for use of the products."
Brodsky said that the FDA's refusal to issue new export certificates for the
plant or to approve new device applications is not a new regulatory action
but rather a consequence of the plant remaining out of good manufacturing
compliance.
In the warning letter to Guidant, Minneapolis District Director W. Charles
Becoat said that the company had submitted five letters since early
September outlining its plans to improve the St. Paul plant. Nonetheless, he
wrote, "You have failed to address all of the significant violations . . .
and will receive additional correspondence detailing the inadequacy of your
response."
The company's devices are implanted in cardiac patients and use electric
shocks to correct faltering heartbeats. While the problems of some implanted
defibrillators and pacemakers have tarnished the industry, agency and
industry officials say that failure rates remain low and the devices are
often lifesaving.
Guidant's manufacturing problems have emerged as two larger companies --
Johnson & Johnson Co. and Boston Scientific Corp. -- have negotiated to buy
the company. Johnson & Johnson reduced its offer by almost 20 percent after
the problems arose, and then Boston Scientific countered with an offer
similar to the initial one from Johnson & Johnson.
Guidant stock dropped by almost 3.5 percent yesterday on the New York Stock
Exchange. The decline was the biggest since the price fell almost 5 percent
last month after New York Attorney General Eliot L. Spitzer accused the
company of misleading doctors about a design flaw in its defibrillators.
© 2005 The Washington Post Company
(keywords: Guidant, ICD, defibrillator, pacemaker)
January 2006 posts
May. 13th, 2007 10:18 pmTuesday, January 24, 2006
This week's article:
'Statin' drug may be helpful in heart failure
Jan 20 (Reuters Health) - Treatment with Lipitor (atorvastatin), one of the popular cholesterol-lowering "statin" drugs, can help the heart pump better in patients with heart failure, according to a new report.
By contrast, findings from a much smaller study showed that aside from lowering cholesterol levels, Lipitor did not benefit patients with heart failure. Both reports are published in the Journal of the American College of Cardiology.
"Although the reasons for these discrepant findings are not known, the most logical explanation is that the (group in the second study) had relatively mild heart failure" and thus there was less chance for Lipitor to show a benefit, Dr. Douglas L. Mann and Dr. Kumudha Ramasubbu, from Baylor College of Medicine in Houston, note in a related editorial.
Still, the second study is important because it shows that cholesterol lowering can be achieved in these patients without any obvious side effects using high-dose statin therapy, the editorialists point out.
In the first study, Dr. Srikanth Sola, from Emory University in Atlanta, and colleagues assessed the outcomes of 108 heart failure patients who were randomly assigned to receive Lipitor (20 milligrams per day) or inactive "placebo" for 12 months.
A significant improvement in the heart's pumping ability was noted in the Lipitor group during the study period, whereas a drop was observed in the placebo group. In addition, use of the drug appeared to reduce inflammation.
In the second study, Dr. Barry E. Bleske, from the University of Michigan at Ann Arbor, and colleagues assessed the outcomes of 15 patients with heart failure who were treated with Lipitor (80 milligrams per day) or placebo for 12-weeks and then crossed over to the other treatment for another 12 weeks.
With the exception of a significant drop in LDL ("bad") cholesterol levels, Lipitor therapy produced no beneficial, or harmful, effects in this patient group.
At present, statins can be recommended to heart failure patients with known heart disease and elevated levels of LDL cholesterol, Mann and Ramasubbu note. The broader question of whether these drugs should be given to all patients with heart failure remains unanswered, but several ongoing trials are addressing this topic, they add.
SOURCE: Journal of the American College of Cardiology, January 17, 2006.
I just realized I hadn't ever mentioned the results of the MUGA scan. I saw my cardiologist last week to discuss them. The MUGA gives an exact number, instead of the range that an echo gives. My EF is, therefore, 21%.
And while I'm relatively asymptomatic compared to most people with EFs that low, he finds it frustrating that despite all the meds and my reasonable weight and all that, we haven't managed to improve that to at least 30%. So he's referred me to an electrophysiologist with Johns Hopkins, to be evaluated for going back in and implanting that third lead on the pacemaker. As I mentioned when I started this blog, the EP who did it couldn't get the third lead in; the vein at the back of my heart was too "tortuous." Anyway, that was nearly 3 years ago; since then, surgeons have become more experienced at laparascopic implantation, and also there's a possibility that the doctors at Johns Hopkins might just be better than the ones back in Austin... anyway, he's gonna look at me and see if it might be possible now to do that.
If he judges that it's not, then we have to decide whether it's worth it to do a limited thoracotomy, cracking open a couple ribs to get at the heart - much less invasive and quicker recovery than cracking the sternum for open-heart, but a lot more trouble than laparascopic surgery, and it would actually require a couple of nights in the hospital and a couple of weeks of recovery time. And not playing a large saxophone that hangs from around my neck for a couple of months. So I'd have to think about that. Maybe wait until the summer, after the 4th of July concerts are over!
And while I'm relatively asymptomatic compared to most people with EFs that low, he finds it frustrating that despite all the meds and my reasonable weight and all that, we haven't managed to improve that to at least 30%. So he's referred me to an electrophysiologist with Johns Hopkins, to be evaluated for going back in and implanting that third lead on the pacemaker. As I mentioned when I started this blog, the EP who did it couldn't get the third lead in; the vein at the back of my heart was too "tortuous." Anyway, that was nearly 3 years ago; since then, surgeons have become more experienced at laparascopic implantation, and also there's a possibility that the doctors at Johns Hopkins might just be better than the ones back in Austin... anyway, he's gonna look at me and see if it might be possible now to do that.
If he judges that it's not, then we have to decide whether it's worth it to do a limited thoracotomy, cracking open a couple ribs to get at the heart - much less invasive and quicker recovery than cracking the sternum for open-heart, but a lot more trouble than laparascopic surgery, and it would actually require a couple of nights in the hospital and a couple of weeks of recovery time. And not playing a large saxophone that hangs from around my neck for a couple of months. So I'd have to think about that. Maybe wait until the summer, after the 4th of July concerts are over!
A short article from New Scientist, 14 January 2006:
Implantable defibrillators have saved countless lives by applying electric shicks to jump-start failing hearts. But these devices have one serious flaw: they often go off when they are not needed, giving unsuspecting and perfectly healthy recipients the fright of their lives. [BunRab's 2 cents worth: if they were perfectly healthy, they wouldn't have implanted defibrillators, would they now.] "People often don't realise just what unpleasant and flawed devices standard defibrillators are," says Andrew Grace... For this reason, he has been working with Cameron Health of an Clemente, CA, to develop a defibrillator that may spell an end to unnecessary shocks by more thoroughly assessing electrical activity in the heart.
Standard defibrillators are connected to the heart via wires, and judge how well the organ iz functioning by monitoring the small area of tissue that is usually the origin of rhythm disturbances. However, electrical anaomalies in this area are not always morrored elsewhere in the heart, and are therefore not always significant. But defibrillators still kick in and give the heart an unnecessary shock.
The new device scans the whole heart in the same way as an ECG, and will only provide a shock if it picks up a major, organ-wide irregularity. Like an ECG it uses sensor electrodes and magnets to pick up the electric fields generated by electrical activity in the heart muscle.
As well as avoiding false alarms, the device is less invaive than standard defibrillators as it is not attached to the heart itself but fits on the chest just under skin. This makes fitting it simpler and safer.
There's a couple paragraphs more, but that's the gist of it. What I get from this is that it's ONLY a defibrillator, not a pacemaker; it wouldn't be used for anyone who needs a pacemaker as well as an ICD, and doesn't therefore apply to anyone who is getting bi-ventricular pacing out of their device.
Plus, I'd have to say I haven't heard of any noticeable number of people getting unnecessary shocks; I've met many people with the ICD/pacemaker devices, and most have *never* had their ICD shock them. Let alone unnecessarily. So I'm not convinces that this was as big a problem as the developer of the new device is making out. However, others' experience may vary. Certainly, for people who need only an ICD, smaller and easier would be better. I wonder, though, whether it eats up more battery power monitoring more of the heart? Would that mean more frequent, if less invasive, surgery?
This week's news article:
Resistance training OK for heart failure patients
Dec 27 (Reuters Health) - Contrary to qualms about deleterious effects on the heart, people with chronic heart failure can safely undertake a resistance training program, Australian researchers report. In fact, such training appears to have a beneficial effect on how strongly the heart is able to pump blood.
Resistance training has been shown to improve the functional ability of people with chronic heart failure to perform activities of daily living, and to improve their overall quality of life. However, there have been concerns that it may accelerate the remodeling process that affects the main pumping chamber of the heart -- the left ventricle -- when chronic heart failure sets in.
To investigate, Dr. Itamar Levinger, from Victoria University of Technology in Melbourne, and colleagues used ultrasound to assess the structure and function of the left ventricles of eight men with heart failure who participated in an 8-week resistance training program and seven similar men who did not.
The investigators' findings appear in the International Journal of Cardiology. The resistance training did not appear to have a significant effect on left ventricle measurements, the report indicates.
Yet, the patients who undertook the resistance training showed significant increases in the amount of blood the heart was able to pump with each beat, compared with the non-training group.
"Since resistance training improves functional ability and quality of life of patients with chronic heart failure without causing a reduction in left ventricular contractile function or structure it is recommended to add this training regime to the regular exercise rehabilitation programs of these patients," Levinger's team concludes.
SOURCE: International Journal of Cardiology, November 2, 2005.
Publish Date: December 27, 2005
February 2006 posts
May. 13th, 2007 10:19 pmTuesday, February 21, 2006
The "Speed Bump"* comic in yesterday's paper was funny. There's a guy lying in a hospital bed, and a doctor talking to him: "We successfully replaced your pacemaker with an iPod, Mr. Wyatt... Now you can march to the beat of any damn drummer you want."
*it's a single-panel cartoon that runs in daily newspaper, by Dave Coverly.
*it's a single-panel cartoon that runs in daily newspaper, by Dave Coverly.
Monday, February 20, 2006
As predicted, Johns Hopkins has indeed phoned me twice since my last visit, to get my address and insurance info and mother's maiden name and first 10 digits of pi, in preparation for my surgery next month. Why can't they get their computers to talk to one another, instead of phoning me at 8:15 in the morning?
Friday, February 17, 2006
From an article a couple months ago in the Baltimore Sun, some medical websites. You've probably already found most of these, but if not, try them:
http://www.medlineplus.gov (NIH and National Library of Medicine)
http://www.healthfinder.gov (Dept. of Health & Human Services)
http://www.ahrq.gov (Agency for Healthcare Research and Quality - reportedly not very user-friendly)
http://www.pubmed.gov (National Library of Medicine)
http://www.consumerreportsmedicalguide.org (Consumer Reports; mostly free but some info requires a subscription)
http://www.healthratings.org (Consumer Reports' ratings of other medical websites)
http://www.mayoclinic.com
http://hms.harvard.edu (Aetna and Harvard Medical School)
http://www.pdrhealth.com (medicines)
http://www.safemedication.com (medicines, run by Amer. Soc. of Health System Pharmacists)
http://www.crbestbuydrugs.org (Consumer Reports again)
http://www.medlineplus.gov (NIH and National Library of Medicine)
http://www.healthfinder.gov (Dept. of Health & Human Services)
http://www.ahrq.gov (Agency for Healthcare Research and Quality - reportedly not very user-friendly)
http://www.pubmed.gov (National Library of Medicine)
http://www.consumerreportsmedicalguide.org (Consumer Reports; mostly free but some info requires a subscription)
http://www.healthratings.org (Consumer Reports' ratings of other medical websites)
http://www.mayoclinic.com
http://hms.harvard.edu (Aetna and Harvard Medical School)
http://www.pdrhealth.com (medicines)
http://www.safemedication.com (medicines, run by Amer. Soc. of Health System Pharmacists)
http://www.crbestbuydrugs.org (Consumer Reports again)
This week's news articles:
First, as the overweight, couch-potato, baby-boom generation starts edging into the "normal" age range where heart failure becomes more common, what a surprise! Heart failure rates increase! What is of note, regardless of age, here, is that survival rates are improving - finally! We were getting tired of those mortality statistics not budging, despite newer meds and newer surgeries. Finally, it appears, the cumulative effects of those things are having an effect on mortality.
Next, a reminder to us all that we should have our kidney function checked regularly.
First, as the overweight, couch-potato, baby-boom generation starts edging into the "normal" age range where heart failure becomes more common, what a surprise! Heart failure rates increase! What is of note, regardless of age, here, is that survival rates are improving - finally! We were getting tired of those mortality statistics not budging, despite newer meds and newer surgeries. Finally, it appears, the cumulative effects of those things are having an effect on mortality.
Heart failure increasing in older adults
Feb 08 (Reuters Health) - The rate of heart failure in the US among older adults increased from the 1970s to the 1990s, but survival rates have improved, new research shows. Both of these trends were more apparent in men than in women.
"Hospitalizations for heart failure have more than doubled between the two periods," Dr. William H. Baker, from the University of Rochester in New York, said in a statement. "Heart failure is the most common discharge diagnosis for men and women over age 65."
The findings, which appear in the American Heart Association's journal Circulation, are based on study of new cases of heart failure in the early 1970s and 1990s using data for more than 300,000 older adults enrolled in an HMO in Oregon or Washington.
From 1970 to 1974, a total of 387 patients were diagnosed with heart failure. The number of new cases from 1990 to 1994 was 1555. After accounting for age, a 14 percent increase in the rate of heart failure was observed between the two periods. As noted, this rise was greater in men than in women.
Deaths due to heart failure fell during the 20-year period by 33 percent for men and by 24 percent for women, the report indicates.
As to why survival did not improve as much in women, the researchers believe that it may be because older women have more additional diseases than men or because they are more physically frail.
"The increase in incidence and survival for heart failure suggests an accelerating rise in this disabling and costly disease that is of public health and clinical importance," Baker emphasized. "In the future, heart failure deserves the highest research priority into its precipitating factors and its management."
SOURCE: Circulation, online February 6, 2006.
Next, a reminder to us all that we should have our kidney function checked regularly.
Poor kidney function ups death risk in heart failure
Feb 07 (Reuters Health) - Impaired kidney function raises the risk of death and hospital admission in patients with chronic heart failure, even among those patients with fairly well preserved heart-pumping action, study findings suggest.
So-called "renal insufficiency" has been shown to increase the risk of death in chronic heart failure patients, but most studies have involved patients with markedly reduced left ventricular ejection fraction (LVEF) -- a measure of the heart's blood-pumping strength.
Less is known about the impact of kidney function on heart failure in the presence of preserved heart-pumping power.
To investigate, Dr. Hans L. Hillege, from the University of Groningen in the Netherlands and associates studied 2,680 heart patients -- 1087 of whom had an LVEF greater than 40 percent indicating preserved heart-pumping action.
At baseline, 36 percent of patients had poorly functioning kidneys. During a median follow-up of 34.4 months, 950 patients died of cardiovascular causes or were admitted to the hospital for heart failure, and there were 625 deaths from all causes.
The authors report that both poorly functioning kidneys and lower LVEF were significant independent predictors of worse outcomes.
"The strong independent effect of renal function in our analysis after adjustment for numerous cardiac risk factors shows that renal function is a valuable predictive variable in evaluating outcomes," the authors maintain, "even if it probably represents partly underlying atherosclerotic or hypertensive vascular disease."
SOURCE: Circulation, February 6, 2006.
Tuesday, February 14, 2006
Reading KateMonster's post reminds me to also be thankful to the doctor who diagnosed me. I had been taking drugs to treat asthma, which are directly harmful to hearts with cardiomyopathy, and the same thing could have happened to me. However, when my GP, frustrated with my nonresponsive "asthma," referred me to a pulmonologist, it took him about 5 minutes to correct the diagnosis - even though he was a lung specialist, not a heart specialist, he looked at my heart in the x-rays, not just the lungs, and listened to my heart as well as my lungs. He was so sure of the diagnosis that he wrote out a couple of the necessary prescriptions - Lasix and digoxin - right away, even as he wrote up a referral to a cardiologist. So thank you to him, and to his ready box of Kleenex and kind nurse. That was 3 years ago, and I'm still alive now. Yay!
Friday, February 03, 2006
On the first of Feb., I got to see an electrophysiologist at Johns Hopkins - one of the reasons we moved up here to Baltimore!!
My regular cardiologist over in Howard County had referred me, and this EP had an opening relatively soon in his schedule. I swear, the longest part of the whole deal was waiting in lines once I got to Johns Hopkins Outpatient Clinic. First you walk in the lobby and wait in a check-in line, to then be told that since you are new you have to go wait in another line to get a "history card" after which you are finally permitted to approach the elevators and go up to the correct floor, where you wait in line for a floor concierge to direct you to the correct wing, where you finally wait in line at the check-in desk for the group of doctors you are actually there to see. At each and every one of these stops, you wind up repeating your name, and your mother's maiden name, and the first 6 digits of pi, and... well, not quite that, but an awful lot of repetitive info - especially given that I had already given all this info during not one, but TWO phone calls the previous week.
Then I got to sit in a waiting area - there are several of them in the cardiology pod, each with at least one more person waiting than there are chairs. I did get a chair, however, and got some knitting done. I am finished with the first wrist-warmer made out of self-striping sock yarn for my friend Fade!! Yeeha!
And in other good news, Dr. Sinha is sure that he can indeed put the third lead in, so that I will have bi-V pacing finally, and he is quite convinced that he can persuade my insurance to pay for it. The fact that my EF is still only 21%, when after 3 years and all the medication and so forth they would expect it to improve to 30%, is prima facie evidence that something needs to be done.
So something will be done, on Thursday, March 2. I have to be there at 6:30 a.m. - I told him I would not even need a sedative, let alone anesthesia, at that hour. Anyway, I am sure they will phone at least once more to ask all the same questions over again about my name and medications and mother's maiden name and pi and the lost treasures of the Incas.
My regular cardiologist over in Howard County had referred me, and this EP had an opening relatively soon in his schedule. I swear, the longest part of the whole deal was waiting in lines once I got to Johns Hopkins Outpatient Clinic. First you walk in the lobby and wait in a check-in line, to then be told that since you are new you have to go wait in another line to get a "history card" after which you are finally permitted to approach the elevators and go up to the correct floor, where you wait in line for a floor concierge to direct you to the correct wing, where you finally wait in line at the check-in desk for the group of doctors you are actually there to see. At each and every one of these stops, you wind up repeating your name, and your mother's maiden name, and the first 6 digits of pi, and... well, not quite that, but an awful lot of repetitive info - especially given that I had already given all this info during not one, but TWO phone calls the previous week.
Then I got to sit in a waiting area - there are several of them in the cardiology pod, each with at least one more person waiting than there are chairs. I did get a chair, however, and got some knitting done. I am finished with the first wrist-warmer made out of self-striping sock yarn for my friend Fade!! Yeeha!
And in other good news, Dr. Sinha is sure that he can indeed put the third lead in, so that I will have bi-V pacing finally, and he is quite convinced that he can persuade my insurance to pay for it. The fact that my EF is still only 21%, when after 3 years and all the medication and so forth they would expect it to improve to 30%, is prima facie evidence that something needs to be done.
So something will be done, on Thursday, March 2. I have to be there at 6:30 a.m. - I told him I would not even need a sedative, let alone anesthesia, at that hour. Anyway, I am sure they will phone at least once more to ask all the same questions over again about my name and medications and mother's maiden name and pi and the lost treasures of the Incas.