DOC, MY PACEMAKER IS KILLING ME!
Emerson said, “Things are in the saddle, and ride mankind.” Never truer that when you have a computer riding herd on your heart. Pacemakers, also known as implanted defibrillators, have until now presumably been dangerous only in the vicinity of those ubiquitous hotdog-heaters and popcorn-poppers known as microwave ovens. Who would have suspected that the very same microwave could broadcast a TV signal, ruin a meal, or kill a retiree, depending on how you aimed it?
Well, revolt of the machines it may not be, but these Guidant pacemakers apparently on occasion get all cranked up and pace you right into the grave, or do other funny things. The origin of the defect — crappy sealer that lets moisture into the computer. Wish you'd told me that before you stuck it in my chest, Doc.
Here's what the NYT says:
[quote="Peggy Peck, Senior Editor, MedPage Today“]
FDA Took Months to Issue Safety Alert on Guidant Heart Devices
September 12, 2005
WASHINGTON, Sept. 12-The FDA knew as early as last February that Guidant implantable cardioverter-defibrillators (ICDs) were malfunctioning, but the agency waited months before issuing a public safety alert about the devices.
Although Guidant informed the FDA of problems in February, the FDA didn't issue a safety alert until June — an alert that was the first in a series of alerts concerning Guidant ICDs. The FDA's delay, which was detailed in a New York Times article today, will be publicly examined Friday during a special day-long meeting of heart specialists and government officials here.
The FDA was simply following current guidelines for device safety. The FDA has no specific requirement to go public with information about malfunctioning devices to either physicians or patients.
Although manufacturers are required to report malfunctions to the FDA, the information is treated as confidential, and the agency discloses malfunctions on a case-by-case basis.
Last month, leaders of the Heart Rhythm Society -- which convened Friday's meeting — and the FDA's own Circulatory System Medical Devices Advisory Panel recommended a number of changes to the FDA's medical device malfunction notification process, aimed at avoiding similar delays.
Writing in the Aug. 24 issue of the Journal of the American Medical Association, William H. Maisel M.D., M.P.H., of Brigham and Women's Hospital in Boston, who chairs the FDA's Circulatory System Medical Devices Advisory Panel, wrote that the policy should be changed to allow for direct notification of patients who have defective devices.
Moreover, when a device is recalled, the FDA requires the manufacturer to notify physicians but does not require device makers to notify patients. This Dr. Maisel found unacceptable. By contrast, he noted, when an automobile recall takes place, the car's owner — not the dealer who sold the car — is notified.
Patients are ”knowledgeable, informed and proactive, and they have the right to know about malfunctions or potential defects affecting their implantable device,“ he wrote. Dr. Maisel said that physicians should be notified, perhaps even before the patient is notified, but direct patient notification is a long overdue fix.
Moreover, when a manufacturer learns of a device malfunction, the maker should be required to publicly report the malfunction. Currently the manufacturers are required to tell the FDA about any malfunction that ”causes or could cause significant injury," but there is no hard and fast requirement to inform either physicians or the general public.
Guidant has been doing damage control since June when it announced that it was recalling 38,000 potentially flawed implanted heart defibrillators. The recalled models are the Prizm 2 DR, the Contak Renewal and Contak Renewal 2, the Ventak Prizm AVT, Vitality AVT, Renewal 3 AVT and Renewal 4 AVT ICDs.
A week after issuing that recall, Guidant issued a second ICD recall this time for its Contak Renewal 3 and 4, Renewal 3 and 4 AVT, and Renewal RF models.
Guidant has also faced problems with its pacemaker, and in mid-July it issued a recall of nine older pacemakers citing problems that could lead to pacing failure.
The devices, manufactured from Nov. 25, 1997, to Oct. 26, 2000 are:
PULSAR MAX
PULSAR
DISCOVERY
MERIDIAN
PULSAR MAX II
DISCOVERY II
VIRTUS PLUS II
INTELIS II
CONTAK TR
http://www.medpagetoday.com/ProductAlert/DevicesandVaccines/tb/1714
[/quote]
By THOMAS M. BURTON Staff Reporter of THE WALL STREET JOURNAL
October 26, 2005; Page B4
Medtronic Inc., St. Jude Medical Inc. and Guidant Corp., leading makers of medical devices, said they received Justice Department subpoenas inquiring into sales practices in the heart-defibrillator and pacemaker industry.
St. Jude, of St. Paul, Minn., and Guidant, of Indianapolis, both said that a broad subpoena was issued by the U.S. Attorney's Office in Boston, and that it deals with defibrillators, pacemakers, ”lead“ wires and related products. Medtronic said the subpoena it received, also from the U.S. attorney in Boston, specified that federal authorities are inquiring into ”provision of benefit, if any, to anyone in a position to recommend purchases of“ defibrillators, pacemakers and related devices. The Minneapolis company said authorities also inquired about company training materials for its salespeople relating to federal antikickback laws.
Guidant said it also received a separate subpoena from the U.S. Attorney's Office in Minneapolis about two of its defibrillator products, which have suffered malfunctions in rare instances.
While the precise focus of the inquiry couldn't be learned, there has been considerable debate lately among cardiologists about sales practices in the industry, including payments to doctors for filling out surveys and participating in postmarketing studies called ”registries.“
In the case of St. Jude, the company has used such surveys in its marketing and has paid $2,000 each to individual doctors over two years for their participation and data collection in a registry called the ACT study. This study focuses on already marketed defibrillators and pacemaker devices for congestive-heart failure. A St. Jude spokeswoman previously said that the company intends to see that medical-journal articles are published as a result of the study.
Guidant has generated controversy in recent weeks for offering money to doctors to fill out surveys to describe potential improvements the company could make in its heart products, said several doctors who are on the company's medical advisory board. Eric N. Prystowsky, an Indianapolis heart-rhythm specialist and member of the advisory board, was quoted in The Wall Street Journal last month [Sept.]as criticizing Guidant for offering $100 per survey to doctors, who then could fill out numerous surveys and get paid for each one. Dr. Prystowsky said at the time that he advised Guidant ”to drop it.“
Medtronic also makes payments for such ”postmarketing surveys," but has said the payments to doctors go indirectly through survey companies so doctors don't know the source of the money.
Write to Thomas M. Burton at tom.burton@wsj.com1
URL for this article:
http://online.wsj.com/article/SB113029531404379682.html
[/quote]
Well, revolt of the machines it may not be, but these Guidant pacemakers apparently on occasion get all cranked up and pace you right into the grave, or do other funny things. The origin of the defect — crappy sealer that lets moisture into the computer. Wish you'd told me that before you stuck it in my chest, Doc.
Here's what the NYT says:
July 19, 2005
Pacemakers by Guidant Have Flaw
By BARRY MEIER
The Guidant Corporation, already embroiled in controversy over recalls of heart devices, alerted doctors yesterday that nine of its older pacemaker models were prone to failing. Some patients might need to have the units replaced, the company said.
The alert covers 28,000 pacemakers made from November 1997 to October 2000 and still implanted in patients. Guidant said that a component used to seal the pacemakers could degrade, allowing moisture to build up and causing the devices to fail. Such failure could cause “serious health complications” in some patients, the company said. The flaw may have contributed to one patient's death, though that is not clear.
The pacemaker alert follows Guidant's recalls in recent weeks of tens of thousands of implantable heart defibrillators. Guidant's long delays in notifying doctors about problems with some of those devices have thrown a spotlight on the issue of when and how device makers alert physicians and patients to product flaws. It has also raised questions about how the Food and Drug Administration discloses safety data it collects about medical devices.
Late yesterday, Senator Charles E. Grassley, Republican of Iowa and chairman of the Senate Finance Committee, signaled his interest in reviewing issues surrounding the recent Guidant recalls.
In a letter to the F.D.A. commissioner, Dr. Lester M. Crawford, Mr. Grassley requested that the agency provide him with five years of annual reports filed by Guidant for the defibrillators and pacemakers that were the subject of recent company alerts or recalls. The Senate Finance Committee has previously investigated the agency's handling of several drugs, including Vioxx.
In his letter, Senator Grassley also asked agency officials to explain why they did not routinely make public such reports, which are filed annually by heart device makers for each defibrillator and pacemaker they make. An article last month in The New York Times highlighted how those annual reports contain far more detailed product-safety and performance data about heart devices than companies routinely provide to doctors. However, the F.D.A. treats the reports as confidential.
In its alert yesterday, Guidant said that doctors should consider replacing the affected pacemakers in patients who depend on the device for survival or to prevent serious health consequences. That category roughly ranges from 20 percent to 40 percent of pacemaker patients, two doctors said.
Because of their age, most of the pacemakers at issue will need to be replaced soon anyway, since their batteries are nearly drained. The company said that it would pay for the replacements.
While both pacemakers and defibrillators are implanted under the skin, they serve different purposes. A pacemaker regulates a heart that is beating too fast or too slowly. A defibrillator emits an electrical shock intended to interrupt a chaotic and deadly type of heart rhythm.
Guidant's recent spate of recalls, including the one announced yesterday, is likely to play a role in discussions of second-quarter earnings results due this week from both Guidant and Johnson & Johnson, which agreed in December to buy Guidant for $25.4 billion.
Today, Wall Street analysts are expected to ask Johnson & Johnson executives, when they discuss the company's earnings, if Guidant's recent problems might affect the timing or price of Johnson & Johnson's planned acquisition.
Asked for comment yesterday, a spokesman for Johnson & Johnson, which is based in New Brunswick, N.J., referred to a statement made in mid-June in which the company said it would close the Guidant deal this quarter, though it added that it viewed Guidant's product problems as “serious matters.”
The deal is valued at $76 a share to Guidant holders. But in recent weeks, the value of Guidant's stock has fluctuated sharply as investors have speculated on whether the deal's price will be revised. Yesterday, Guidant shares fell $2.10 to close at $67.31 a share, down 3 percent.
On Thursday, Guidant is set to announce second-quarter results. Those results will provide the first look at whether the company has suffered financial damage as a result of its recent recalls.
Analysts are split about how the steady beat of bad news from Guidant will affect its market share in the long term.
Guidant has been under scrutiny since late May when it was disclosed that the company failed to notify doctors for three years that an electrical defect in one defibrillator model could cause it to short-circuit when needed to save a patient's life. The company continued to sell units with the potential electrical flaw even after it began producing improved versions of the same model in which the problem had been fixed.
The F.D.A. is investigating how Guidant handled reviews of its products' dangers. Since late May, the company has issued alerts or recalled 11 models of defibrillators.
Yesterday, an F.D.A. spokeswoman said the agency was aware that Guidant had issued the pacemaker alert to doctors and that it was evaluating the matter. Guidant said it expected the F.D.A. to designate the alert as a recall, a formal classification that involves the type of physician notification that Guidant is already making.
A recall does not mean that a device should be removed. Instead, patients are typically advised to discuss with their doctors the risk posed by a device compared with the risk posed by the surgical procedure needed to replace it.
Several doctors said yesterday that they would probably recommend that pacemaker-dependent patients have the units replaced.
“To me, that is the conservative move,” said Dr. Eric N. Prystowsky, a heart specialist in Indianapolis who is also a medical adviser to Guidant. Nine older pacemaker models are involved. They are the Pulsar Max, the Pulsar, the Discovery, the Meridian, the Pulsar Max II, the Discovery II, the Virtus Plus II, the Intellis II and the Contak TR. The company said that the units, which are of an earlier design, have not been implanted for the last four years.
Guidant said it had identified 69 devices that may have had the seal problem, out of some 78,000 devices in which that component was used. Currently, about 28,000 of those units are still implanted in patients, with 18,000 of them in the United States.
In 20 known cases, the problem caused pacemakers to fail, and in 5 such instances, patients blacked out, apparently because of inadequate blood flow. In two other instances, the flaw may have caused a pacemaker to keep pacing at a high rate.
In one such case, that flaw may have contributed to a patient's death. However, because the unit was not returned to Guidant for inspection, the company said it was not clear if the death was related to the device or to the patient's health problems.
Copyright 2005 The New York Times Company
FDA had known about Guidant defibrillator faults
So the FDA knew about the problem all along, but kept it quiet. Patients need more information about the hardware they're carrying around in their bodies, and they need it as soon as possible. Helping Guidant perform “damage control” is not part of the FDA's mission. Rather it is to protect the public from shoddy merchandise passed off as state-of-the-art medical engineering. There is no excuse for these machines having leaky seals in the first place. But in a world where the space shuttle is riddled with safety hazards, and the City of New Orleans is allowed to drown as if it were a worthless swamp, perhaps it is not too surprising that the medical device cops are asleep at the switch, ready to wake up only at the sound of a train wreck.Christian Nordqvist
Editor - Medical News Today wrote:
FDA had known about Guidant defibrillator faults some months before issuing a safety alert
12 Sep 2005
According to records obtained by the NY Times, the FDA had known about the faults associated with the Guidant defibrillators for some months - the safety alert was issued last June, the FDA knew about the problems ever since February. As the FDA keeps manufacturers' information as ‘confidential', it did not immediately reveal this fact to the public.
The defibrillator in question is called the Ventak Prizm 2 DR. About one each month was short-circuiting. A young man died as a result of having one of these devices after the information was revealed to the agency, but before the safety alert was made public (after February, before June).
A defibrillator emits a series electric shocks, these make sure the heart does not have erratic rhythms. If the device does not work properly, the patient is at risk of dying.
Many health professionals and patient organisations are questioning the wisdom of holding information that can save patients' lives - just so that ‘confidentiality' can be maintained.
Some say it would bring the FDA to a halt if it had to reveal every bit of information to the public. The agency receives hundreds of reports from manufacturers. By law, in the USA, defibrillator manufacturers' have to send a report to the agency every year highlighting faults their devices may have. Doctors also get reports, but nowhere near as detailed as those received by the FDA. In the case of the Guidant defibrillator in question, doctors did not know until June, when the FDA issued the safety alert.
[quote="Peggy Peck, Senior Editor, MedPage Today“]
FDA Took Months to Issue Safety Alert on Guidant Heart Devices
September 12, 2005
WASHINGTON, Sept. 12-The FDA knew as early as last February that Guidant implantable cardioverter-defibrillators (ICDs) were malfunctioning, but the agency waited months before issuing a public safety alert about the devices.
Although Guidant informed the FDA of problems in February, the FDA didn't issue a safety alert until June — an alert that was the first in a series of alerts concerning Guidant ICDs. The FDA's delay, which was detailed in a New York Times article today, will be publicly examined Friday during a special day-long meeting of heart specialists and government officials here.
The FDA was simply following current guidelines for device safety. The FDA has no specific requirement to go public with information about malfunctioning devices to either physicians or patients.
Although manufacturers are required to report malfunctions to the FDA, the information is treated as confidential, and the agency discloses malfunctions on a case-by-case basis.
Last month, leaders of the Heart Rhythm Society -- which convened Friday's meeting — and the FDA's own Circulatory System Medical Devices Advisory Panel recommended a number of changes to the FDA's medical device malfunction notification process, aimed at avoiding similar delays.
Writing in the Aug. 24 issue of the Journal of the American Medical Association, William H. Maisel M.D., M.P.H., of Brigham and Women's Hospital in Boston, who chairs the FDA's Circulatory System Medical Devices Advisory Panel, wrote that the policy should be changed to allow for direct notification of patients who have defective devices.
Moreover, when a device is recalled, the FDA requires the manufacturer to notify physicians but does not require device makers to notify patients. This Dr. Maisel found unacceptable. By contrast, he noted, when an automobile recall takes place, the car's owner — not the dealer who sold the car — is notified.
Patients are ”knowledgeable, informed and proactive, and they have the right to know about malfunctions or potential defects affecting their implantable device,“ he wrote. Dr. Maisel said that physicians should be notified, perhaps even before the patient is notified, but direct patient notification is a long overdue fix.
Moreover, when a manufacturer learns of a device malfunction, the maker should be required to publicly report the malfunction. Currently the manufacturers are required to tell the FDA about any malfunction that ”causes or could cause significant injury," but there is no hard and fast requirement to inform either physicians or the general public.
Guidant has been doing damage control since June when it announced that it was recalling 38,000 potentially flawed implanted heart defibrillators. The recalled models are the Prizm 2 DR, the Contak Renewal and Contak Renewal 2, the Ventak Prizm AVT, Vitality AVT, Renewal 3 AVT and Renewal 4 AVT ICDs.
A week after issuing that recall, Guidant issued a second ICD recall this time for its Contak Renewal 3 and 4, Renewal 3 and 4 AVT, and Renewal RF models.
Guidant has also faced problems with its pacemaker, and in mid-July it issued a recall of nine older pacemakers citing problems that could lead to pacing failure.
The devices, manufactured from Nov. 25, 1997, to Oct. 26, 2000 are:
PULSAR MAX
PULSAR
DISCOVERY
MERIDIAN
PULSAR MAX II
DISCOVERY II
VIRTUS PLUS II
INTELIS II
CONTAK TR
http://www.medpagetoday.com/ProductAlert/DevicesandVaccines/tb/1714
[/quote]
DEPT OF JUSTICE LOOKING FOR KICKBACKS
[quote="WSJ“]U.S. Seeks Data From Medtronic, St. Jude, GuidantBy THOMAS M. BURTON Staff Reporter of THE WALL STREET JOURNAL
October 26, 2005; Page B4
Medtronic Inc., St. Jude Medical Inc. and Guidant Corp., leading makers of medical devices, said they received Justice Department subpoenas inquiring into sales practices in the heart-defibrillator and pacemaker industry.
St. Jude, of St. Paul, Minn., and Guidant, of Indianapolis, both said that a broad subpoena was issued by the U.S. Attorney's Office in Boston, and that it deals with defibrillators, pacemakers, ”lead“ wires and related products. Medtronic said the subpoena it received, also from the U.S. attorney in Boston, specified that federal authorities are inquiring into ”provision of benefit, if any, to anyone in a position to recommend purchases of“ defibrillators, pacemakers and related devices. The Minneapolis company said authorities also inquired about company training materials for its salespeople relating to federal antikickback laws.
Guidant said it also received a separate subpoena from the U.S. Attorney's Office in Minneapolis about two of its defibrillator products, which have suffered malfunctions in rare instances.
While the precise focus of the inquiry couldn't be learned, there has been considerable debate lately among cardiologists about sales practices in the industry, including payments to doctors for filling out surveys and participating in postmarketing studies called ”registries.“
In the case of St. Jude, the company has used such surveys in its marketing and has paid $2,000 each to individual doctors over two years for their participation and data collection in a registry called the ACT study. This study focuses on already marketed defibrillators and pacemaker devices for congestive-heart failure. A St. Jude spokeswoman previously said that the company intends to see that medical-journal articles are published as a result of the study.
Guidant has generated controversy in recent weeks for offering money to doctors to fill out surveys to describe potential improvements the company could make in its heart products, said several doctors who are on the company's medical advisory board. Eric N. Prystowsky, an Indianapolis heart-rhythm specialist and member of the advisory board, was quoted in The Wall Street Journal last month [Sept.]as criticizing Guidant for offering $100 per survey to doctors, who then could fill out numerous surveys and get paid for each one. Dr. Prystowsky said at the time that he advised Guidant ”to drop it.“
Medtronic also makes payments for such ”postmarketing surveys," but has said the payments to doctors go indirectly through survey companies so doctors don't know the source of the money.
Write to Thomas M. Burton at tom.burton@wsj.com1
URL for this article:
http://online.wsj.com/article/SB113029531404379682.html
[/quote]