Princess Health and Now Stuck Switches for Guidant. Princessiccia

Princess Health and Now Stuck Switches for Guidant. Princessiccia

Guidant ICD manufacturing problems

Gusty 13:20 Add Comment

The NY Times reported yet another problem with implantable cardiac defibrillators (ICDs) made by Guidant. This time it was a magnetic switch that could become stuck in the "off" position. Apparently, this flaw is not so serious as previous ones (see most recent post here), because it can be fixed without removing the devices. A Guidant consultant suggested that the problem affects about 6000 devices. The models affected were the Contak Renewal 3, Contak Renewal 4, Contak Renewal 3 AVT, Contak Renewal 4 AVT, and Renewal RF. The company "urged doctors ... to stop implanting" the device, but "did not say how it planned to fix the problem, when it expected to do so, or how it would fix units already implanted in patients," according to the Times. Also, "Guidant declined a request to interview its chief executive, Ronald W. Dollens."
Again, one would have hoped that the company could have done better with quality control, given that each of these devices cost about $25,000.

Princess Health and Now Stuck Switches for Guidant.Princessiccia

Princess Health and Now Stuck Switches for Guidant.Princessiccia

Guidant ICD manufacturing problems

Gusty 13:20 Add Comment

The NY Times reported yet another problem with implantable cardiac defibrillators (ICDs) made by Guidant. This time it was a magnetic switch that could become stuck in the "off" position. Apparently, this flaw is not so serious as previous ones (see most recent post here), because it can be fixed without removing the devices. A Guidant consultant suggested that the problem affects about 6000 devices. The models affected were the Contak Renewal 3, Contak Renewal 4, Contak Renewal 3 AVT, Contak Renewal 4 AVT, and Renewal RF. The company "urged doctors ... to stop implanting" the device, but "did not say how it planned to fix the problem, when it expected to do so, or how it would fix units already implanted in patients," according to the Times. Also, "Guidant declined a request to interview its chief executive, Ronald W. Dollens."
Again, one would have hoped that the company could have done better with quality control, given that each of these devices cost about $25,000.

Princess Health and Boston Scientific Settles Case of Defective Stent Systems. Princessiccia

Princess Health and Boston Scientific Settles Case of Defective Stent Systems. Princessiccia

Boston Scientific coronary artery stents legal settlements manufacturing problems

Gusty 13:02 Add Comment

The Boston Globe reported that Boston Scientific has settled a suit brought by the US Department of Justice that alleged "a failure by Boston Scientific to take the most appropriate steps in a timely manner to ensure that the devices it was distributing to hospitals nationwide performed properly," per US Attorney Michael J. Sullivan.
Boston Scientific began shipping Nir coronary artery stent systems on August 12, 1998. Coronary artery stents are small devices, often shaped like springs, or wire mesh cylinders, used to hold coronary arteries open. According to the Globe, within five days, Boston Scientific got reports that the balloons attached to the stent catheters were failing when inflated to pressures lower than they were designed to handle. In a September 12, 1998 conference with US Food and Drug Administration (FDA) officials, one said that the FDA was "very uncomfortable" with continuing stent shipments." However, Boston Scientific continued shipping the stents until October 5, 1998, and then began a voluntary recall. The FDA finally received 25 complaints that injuries were caused by failed stent balloons.
The settlement called for Boston Scientific to pay $74 million. Department of Justice officials chose that amount since it significantly exceeded the $61 million revenue the company received from the 34,589 Nir stent systems it sold (i.e., $1764 per system.)
This case, which took almost seven years to resolve, could be compared with the recent case of problems with Guidant implantable coronary defibrillators (ICDs). (See most recent of many posts on Guidant here.) In both cases, the companies appeared to delay notification of device defects, leading to more potentially defective devices to be shipped and implanted in patients. In both cases, the devices seem relatively expensive compared to the complexity of their engineering and manufacturing. (For example, the stents mentioned above are again simple metal devices shaped link springs or mesh cylinders, and the accompanying system consists mainly of a plastic catheter with an inflatable balloon at its tip, sold for, as noted above, more than $1700.) Given how much money the companies charge for these devices, one would think they would be able to afford exemplary quality control, and a system to rapidly notify physicians who implant the devices of any potential problems.

Princess Health and Boston Scientific Settles Case of Defective Stent Systems.Princessiccia

Princess Health and Boston Scientific Settles Case of Defective Stent Systems.Princessiccia

Boston Scientific coronary artery stents legal settlements manufacturing problems

Gusty 13:02 Add Comment

The Boston Globe reported that Boston Scientific has settled a suit brought by the US Department of Justice that alleged "a failure by Boston Scientific to take the most appropriate steps in a timely manner to ensure that the devices it was distributing to hospitals nationwide performed properly," per US Attorney Michael J. Sullivan.
Boston Scientific began shipping Nir coronary artery stent systems on August 12, 1998. Coronary artery stents are small devices, often shaped like springs, or wire mesh cylinders, used to hold coronary arteries open. According to the Globe, within five days, Boston Scientific got reports that the balloons attached to the stent catheters were failing when inflated to pressures lower than they were designed to handle. In a September 12, 1998 conference with US Food and Drug Administration (FDA) officials, one said that the FDA was "very uncomfortable" with continuing stent shipments." However, Boston Scientific continued shipping the stents until October 5, 1998, and then began a voluntary recall. The FDA finally received 25 complaints that injuries were caused by failed stent balloons.
The settlement called for Boston Scientific to pay $74 million. Department of Justice officials chose that amount since it significantly exceeded the $61 million revenue the company received from the 34,589 Nir stent systems it sold (i.e., $1764 per system.)
This case, which took almost seven years to resolve, could be compared with the recent case of problems with Guidant implantable coronary defibrillators (ICDs). (See most recent of many posts on Guidant here.) In both cases, the companies appeared to delay notification of device defects, leading to more potentially defective devices to be shipped and implanted in patients. In both cases, the devices seem relatively expensive compared to the complexity of their engineering and manufacturing. (For example, the stents mentioned above are again simple metal devices shaped link springs or mesh cylinders, and the accompanying system consists mainly of a plastic catheter with an inflatable balloon at its tip, sold for, as noted above, more than $1700.) Given how much money the companies charge for these devices, one would think they would be able to afford exemplary quality control, and a system to rapidly notify physicians who implant the devices of any potential problems.

Princess Health and An Australian Survey of Threats to Research Integrity. Princessiccia

Princess Health and An Australian Survey of Threats to Research Integrity. Princessiccia

manipulating clinical research suppression of medical research surveys

Gusty 07:48 Add Comment

Another important article on threats to the integrity of clinical research has appeared in the Medical Journal of Australia. (Henry DA et al. Medical specialists and pharmaceutical industry-sponsored research: a survey of the Australian experience. Med J Aust 2005; 182: 557-560.)
The authors sent a survey to 5000 Australian specialists, excluding general practitioners, but also surgeons and anesthesologists, and obtained a 39% response rate. 388 specialists (41% of respondents) had done pharmaceutical industry sponsored research. Of these,

• 100 (25.7% of those engaging in research) reported that the first draft of a research report was written by pharmaceutical company or contract research organization personnel
• 55 (14.2%) reported a delay in presentation or publication of key study findings
• 41 (10.6%) reported failure to publish key findings
• 22 (5.7%) reported editing of the report to make the drug appear better than was justified by the study results
• 18 (4.6%) reported concealment of relevant findings.

This study suggests that manipulation and suppression of research results in favor of commercial research sponsors' products is an international pheonomenon, and one that involves not only academic researchers but those in private practice.
An accompanying editorial (Gotzsche PC. Research integrity and pharmaceutical industry sponsorship. Med J Aust 2005; 182: 549-550) suggested that "testing drugs in patients" should be "a public enterprise." It asked, "who would buy a washing machine that is five or 10 times more expensive than other washing machines just because its manufacturer has compared it with other machines and claims that it is the best?"
Thanks to Sue Pelletier's Capsules blog for the tip.

Princess Health and An Australian Survey of Threats to Research Integrity.Princessiccia

Princess Health and An Australian Survey of Threats to Research Integrity.Princessiccia

manipulating clinical research suppression of medical research surveys

Gusty 07:48 Add Comment

Another important article on threats to the integrity of clinical research has appeared in the Medical Journal of Australia. (Henry DA et al. Medical specialists and pharmaceutical industry-sponsored research: a survey of the Australian experience. Med J Aust 2005; 182: 557-560.)
The authors sent a survey to 5000 Australian specialists, excluding general practitioners, but also surgeons and anesthesologists, and obtained a 39% response rate. 388 specialists (41% of respondents) had done pharmaceutical industry sponsored research. Of these,

• 100 (25.7% of those engaging in research) reported that the first draft of a research report was written by pharmaceutical company or contract research organization personnel
• 55 (14.2%) reported a delay in presentation or publication of key study findings
• 41 (10.6%) reported failure to publish key findings
• 22 (5.7%) reported editing of the report to make the drug appear better than was justified by the study results
• 18 (4.6%) reported concealment of relevant findings.

This study suggests that manipulation and suppression of research results in favor of commercial research sponsors' products is an international pheonomenon, and one that involves not only academic researchers but those in private practice.
An accompanying editorial (Gotzsche PC. Research integrity and pharmaceutical industry sponsorship. Med J Aust 2005; 182: 549-550) suggested that "testing drugs in patients" should be "a public enterprise." It asked, "who would buy a washing machine that is five or 10 times more expensive than other washing machines just because its manufacturer has compared it with other machines and claims that it is the best?"
Thanks to Sue Pelletier's Capsules blog for the tip.

Princess Health and Two Massachusetts Hospitals to Offer Discounts Off "List Prices" for Uninsured Patients. Princessiccia

Princess Health and Two Massachusetts Hospitals to Offer Discounts Off "List Prices" for Uninsured Patients. Princessiccia

health care prices Partners Healthcare UMass Memorial Health Care

Gusty 13:44 Add Comment

Two Massachusetts hospital systems will begin offering discounts off "list prices" for uninsured patients, according to the Boston Globe. The systems are Partners HealthCare and UMass Memorial Health Care. The article noted that most hospitals do not routinely give such patients discounts. These two hospitals' policies are "among the first formal, publicized policies in Massachusetts that guarantee discounts to a broad group of patients and don't depend on patients requesting a markdown," according to the Globe.
Not emphasized in this article was how high "list prices" are at most hospitals. For example, see previous posts here, here and here.
This actions by Partners and UMass are a great first step, but the article does underline who widespread the practice of charging uninsured patients full freight has become. Susan Sherry, of Community Catalyst, asserted that many hospitals are either not offering discounts or are keeping them secret (see the report by the Access Project here). She did applaud the actions by Partners and UMass, "this is kind of out there in terms of national leadership. They're doing much more than hospitals in other parts of the country."