Princess Health and Guidant's Short Circuit, Reloaded. Princessiccia

Princess Health and Guidant's Short Circuit, Reloaded. Princessiccia

Guidant ICD manufacturing problems

Gusty 06:02 Add Comment

The NY Times reported that after Guidant discovered a defect in its implantable cardiac defibrillator (ICD) that allowed the device to short-circuit and fail, it continued to ship ICDs with the defect even after it had started manufacturing redesigned devices without the flaw.
Our post about the discovery of the flaw is here.
Guidant's statement about the matter was, "After making these improvements, Guidant sold product manufactured before the improvements because the reliability data showed that the original PRIZM 2 DR, like the enhanced version, was a highly reliable life-saving device. Current data continues to support the reliability of the product."
The Times reported, "some doctors said they would be dismayed if the company allowed them to implant a device with a known flaw that had been corrected in other units."
As I said before, the decision about how to treat a patient's illness should be up to the doctor and patient, and be based on the best available data, as well as the patient's values. For a company to withold data relevant to the decision, which just happens to be unfavorable to the company's product, is plain wrong.

Princess Health and Guidant's Short Circuit, Reloaded.Princessiccia

Princess Health and Guidant's Short Circuit, Reloaded.Princessiccia

Guidant ICD manufacturing problems

Gusty 06:02 Add Comment

The NY Times reported that after Guidant discovered a defect in its implantable cardiac defibrillator (ICD) that allowed the device to short-circuit and fail, it continued to ship ICDs with the defect even after it had started manufacturing redesigned devices without the flaw.
Our post about the discovery of the flaw is here.
Guidant's statement about the matter was, "After making these improvements, Guidant sold product manufactured before the improvements because the reliability data showed that the original PRIZM 2 DR, like the enhanced version, was a highly reliable life-saving device. Current data continues to support the reliability of the product."
The Times reported, "some doctors said they would be dismayed if the company allowed them to implant a device with a known flaw that had been corrected in other units."
As I said before, the decision about how to treat a patient's illness should be up to the doctor and patient, and be based on the best available data, as well as the patient's values. For a company to withold data relevant to the decision, which just happens to be unfavorable to the company's product, is plain wrong.

Princess Health and CPOE cybernetic miracles not yet achieved. Princessiccia

Princess Health and CPOE cybernetic miracles not yet achieved. Princessiccia

Gusty 06:28 Add Comment

Lest hospital executives believe that computers are going to be a cure-all for all that ails medicine, here's another sobering report on computerized physician order entry (CPOE):

Medical errors kill nearly 100,000 American each year, with lethal drug interactions accounting for most of these deaths. Computerization -- which hospitals have been slow to embrace -- was supposed to eliminate most problems, but new research published Wednesday indicates that even the best computer system can�t save you from a doctor�s catastrophic screw-up. Harmful medication-related mishaps cropped up in a quarter of all patients at the Veterans Affairs Medical Center in Salt Lake City, one of the most high-tech hospitals in the country, according to a study published in Archives of Internal Medicine.

"If you were on an airplane and a quarter of the time it crashed, that would be a problem," said study co-author Dr. Jonathan Nebeker, a physician at the VA Medical Center.

Even though the hospital's computers were supposed to protect against dangerous drug interactions, illegible prescriptions and bedside mix-ups, nine of the 937 patients studied died as a result of medication problems, the study found.

As a medical informaticist, I have always been somewhat skeptical about the "syndrome of inappropriate confidence in computers" and related beliefs in "computational alchemy." While clinical IT progress in undeniable and must proceed, one must temper expectations about the technology to realistic levels. This is especially true for those involved in clinical operations. (Similar issues occur in the pharmaceutical R&D sector, as I have observed). We are still in an era when, paraphrasing Chuck Yeager, who shot down a faster German jet in his propeller-driven P51 Mustang, "it's the [person], not the machine."

This study also suggests that when implementing clinical IT, it best be done right by those with experience in both medicine and computing, because if it's done wrong, even worse problems can result.

Princess Health and CPOE cybernetic miracles not yet achieved.Princessiccia

Princess Health and CPOE cybernetic miracles not yet achieved.Princessiccia

Gusty 06:28 Add Comment

Lest hospital executives believe that computers are going to be a cure-all for all that ails medicine, here's another sobering report on computerized physician order entry (CPOE):

Medical errors kill nearly 100,000 American each year, with lethal drug interactions accounting for most of these deaths. Computerization -- which hospitals have been slow to embrace -- was supposed to eliminate most problems, but new research published Wednesday indicates that even the best computer system can�t save you from a doctor�s catastrophic screw-up. Harmful medication-related mishaps cropped up in a quarter of all patients at the Veterans Affairs Medical Center in Salt Lake City, one of the most high-tech hospitals in the country, according to a study published in Archives of Internal Medicine.

"If you were on an airplane and a quarter of the time it crashed, that would be a problem," said study co-author Dr. Jonathan Nebeker, a physician at the VA Medical Center.

Even though the hospital's computers were supposed to protect against dangerous drug interactions, illegible prescriptions and bedside mix-ups, nine of the 937 patients studied died as a result of medication problems, the study found.

As a medical informaticist, I have always been somewhat skeptical about the "syndrome of inappropriate confidence in computers" and related beliefs in "computational alchemy." While clinical IT progress in undeniable and must proceed, one must temper expectations about the technology to realistic levels. This is especially true for those involved in clinical operations. (Similar issues occur in the pharmaceutical R&D sector, as I have observed). We are still in an era when, paraphrasing Chuck Yeager, who shot down a faster German jet in his propeller-driven P51 Mustang, "it's the [person], not the machine."

This study also suggests that when implementing clinical IT, it best be done right by those with experience in both medicine and computing, because if it's done wrong, even worse problems can result.

Princess Health and More Accusations of Harsh Bill Collecting Tactics: Intermountain Health Care. Princessiccia

Princess Health and More Accusations of Harsh Bill Collecting Tactics: Intermountain Health Care. Princessiccia

health care prices hospitals Intermountain Health Care

Gusty 12:46 Add Comment

Intermountain Health Care (IHC, in Utah) is another large health care system that has been accused of employing harsh collection tactics against poor patients who don't pay their bills. Earlier this month it announced kinder, gentler collection processes. It is unclear if these were a response to charges heard in the state legislature last year that the system operates like a for-profit company, and threats that it then should be taxed like one. (See news articles here and here.)
Nonetheless, a state legislative tax force will be investigating IHC, prompted by "recurring perceptions of monopolistic practices, ... of heavy-handed collection practices." (News article here.)
Ironically, a tiny news item appearing early in May suggested that this apparently tough-minded organization could not prevent Ralph Jay Hansen, its former retirement account fund director, from embezzling $2.6 million between 1996 and 2004. (See article here.)

Princess Health and More Accusations of Harsh Bill Collecting Tactics: Intermountain Health Care.Princessiccia

Princess Health and More Accusations of Harsh Bill Collecting Tactics: Intermountain Health Care.Princessiccia

health care prices hospitals Intermountain Health Care

Gusty 12:46 Add Comment

Intermountain Health Care (IHC, in Utah) is another large health care system that has been accused of employing harsh collection tactics against poor patients who don't pay their bills. Earlier this month it announced kinder, gentler collection processes. It is unclear if these were a response to charges heard in the state legislature last year that the system operates like a for-profit company, and threats that it then should be taxed like one. (See news articles here and here.)
Nonetheless, a state legislative tax force will be investigating IHC, prompted by "recurring perceptions of monopolistic practices, ... of heavy-handed collection practices." (News article here.)
Ironically, a tiny news item appearing early in May suggested that this apparently tough-minded organization could not prevent Ralph Jay Hansen, its former retirement account fund director, from embezzling $2.6 million between 1996 and 2004. (See article here.)

Princess Health and Drug Studies Required by FDA Fast Track Process Never Completed. Princessiccia

Princess Health and Drug Studies Required by FDA Fast Track Process Never Completed. Princessiccia

FDA

Gusty 12:29 Add Comment

Help, help, there is so much going on I a can't keep up with it anymore....
The Los Angeles Times just revealed a report by the staff of US Rep. Edward J Markey (D-Mass) about the US Food and Drug Administration (FDA) fast-track drug approval process. This process, created in part as a response to demonstrations by AIDS activists in the late 1980's (see previous post here), allows rapid marketing of drugs after a limited number of studies, contingent on manufacturers' willingness to perform future studies.
Apparently, many of these studies are never finished.
Markey's report said that of 91 studies promised since 1992, 42, almost half, were not completed, and 21 were never started.
Markey is calling for new legislation to impose penalties on pharmaceutical companies that do not complete promised studies.