Thursday, 30 June 2005

Princess Health and A New Format. Princessiccia

Princess Health and A New Format. Princessiccia

We had to change the graphic format of Health Care Renewal. Blogger still has been not come up with a solution of the formatting problems that resulted from their latest soft-ware updates. One such problem put a huge amount of white-space at the top of our blog.
The new format is not perfect, but should be readable, and no longer is dominated by looming white-space.
Princess Health and  A New Format.Princessiccia

Princess Health and A New Format.Princessiccia

We had to change the graphic format of Health Care Renewal. Blogger still has been not come up with a solution of the formatting problems that resulted from their latest soft-ware updates. One such problem put a huge amount of white-space at the top of our blog.
The new format is not perfect, but should be readable, and no longer is dominated by looming white-space.

Tuesday, 28 June 2005

Princess Health and A Former Rhode Island Legislator Pleads Guilty to Selling His Office to Local Health Care Organizations. Princessiccia

Princess Health and A Former Rhode Island Legislator Pleads Guilty to Selling His Office to Local Health Care Organizations. Princessiccia

Back to a big, and increasingly messy local story... former RI state senator John A. Celona has agreed to plead guilty to federal charges, according to the Providence Journal. Federal prosecutors stated that Celona and "other persons" created a "scheme ... to defraud the State of Rhode Island and its citizens of their intangible right to his honest services and to have those services performed free from deceit, favoritism, bias, conflict of interest and self-enrichment." Celona was previously indicted on similar charges in a state court action. The charges to which Celona has now admitted include:
  1. Accepting over $260,000 from Roger Williams Medical Center, (at the recommendation of its Chief Executive Officer (CEO), Robert A. Urciuoli, according to the newspaper,) channeled through its subsidiary assisted living center, to: influence cities to increase their ambulance transports to the hospital; oppose legislation that would have required the hospital to make payments in lieu of taxes; back legislation to extend a moratorium on construction of new nursing facilities; influence other law-makers to oppose formation of a Cancer Council that would have been lead by former Roger Williams Medical Center medical staff members who had feuded with Urciuoli; pressure a company to pay its debt to the hospital; and pressure another to make a favorable contract with the hospital.
  2. Accepting $45,000, and free travel to a golf tournament from CVS to: oppose pharmacy choice legislation; favor legislation that would permit electronic prescription of brand-name drugs; and opposing legislation to allow drug re-importation from Canada.
  3. Accepting over $13,000 from Rhode Island Blue Cross to: support a bill allowing insurance companies to design affordable benefit plans; support a bill changing health insurance plan parameters for small business; and oppose a bill requiring health insurers to cover prosthetic devices and modifying limits on their investments.
According to the news article, investigations of the roles of Roger Williams Medical Center, CVS, and Rhode Island Blue Cross in this are on-going.
This single case illustrates that mismanagement is not limited to particular types of health care organizations, and that problems at one organization may easily get tangled up with problems in others.
It also illustrates the wide-ranging effects of mismanagement and corruption.
Princess Health and  A Former Rhode Island Legislator Pleads Guilty to Selling His Office to Local Health Care Organizations.Princessiccia

Princess Health and A Former Rhode Island Legislator Pleads Guilty to Selling His Office to Local Health Care Organizations.Princessiccia

Back to a big, and increasingly messy local story... former RI state senator John A. Celona has agreed to plead guilty to federal charges, according to the Providence Journal. Federal prosecutors stated that Celona and "other persons" created a "scheme ... to defraud the State of Rhode Island and its citizens of their intangible right to his honest services and to have those services performed free from deceit, favoritism, bias, conflict of interest and self-enrichment." Celona was previously indicted on similar charges in a state court action. The charges to which Celona has now admitted include:
  1. Accepting over $260,000 from Roger Williams Medical Center, (at the recommendation of its Chief Executive Officer (CEO), Robert A. Urciuoli, according to the newspaper,) channeled through its subsidiary assisted living center, to: influence cities to increase their ambulance transports to the hospital; oppose legislation that would have required the hospital to make payments in lieu of taxes; back legislation to extend a moratorium on construction of new nursing facilities; influence other law-makers to oppose formation of a Cancer Council that would have been lead by former Roger Williams Medical Center medical staff members who had feuded with Urciuoli; pressure a company to pay its debt to the hospital; and pressure another to make a favorable contract with the hospital.
  2. Accepting $45,000, and free travel to a golf tournament from CVS to: oppose pharmacy choice legislation; favor legislation that would permit electronic prescription of brand-name drugs; and opposing legislation to allow drug re-importation from Canada.
  3. Accepting over $13,000 from Rhode Island Blue Cross to: support a bill allowing insurance companies to design affordable benefit plans; support a bill changing health insurance plan parameters for small business; and oppose a bill requiring health insurers to cover prosthetic devices and modifying limits on their investments.
According to the news article, investigations of the roles of Roger Williams Medical Center, CVS, and Rhode Island Blue Cross in this are on-going.
This single case illustrates that mismanagement is not limited to particular types of health care organizations, and that problems at one organization may easily get tangled up with problems in others.
It also illustrates the wide-ranging effects of mismanagement and corruption.
Princess Health and Guidant Executives Sued for Securities Fraud. Princessiccia

Princess Health and Guidant Executives Sued for Securities Fraud. Princessiccia

Those hits just keep on coming for Guidant Corp. The Indianapolis Star reported that Guidant and six of its top executives were named as defendants in a securities fraud lawsuit. The suit charges that the executives "concealed long-standing, life-threatening defects" in its products to prop up its stock price prior to the company's proposed merger with Johnson & Johnson. The suit alleges that the six executives, including Guidant Chief Executive Officer (CEO) Ronald W. Dollens, sold Guidant stock worth $39.5 million this year prior to the publication of the first news article by the NY Times about problems with Guidant's implantable cardiac defibrillators (ICDs).
Princess Health and  Guidant Executives Sued for Securities Fraud.Princessiccia

Princess Health and Guidant Executives Sued for Securities Fraud.Princessiccia

Those hits just keep on coming for Guidant Corp. The Indianapolis Star reported that Guidant and six of its top executives were named as defendants in a securities fraud lawsuit. The suit charges that the executives "concealed long-standing, life-threatening defects" in its products to prop up its stock price prior to the company's proposed merger with Johnson & Johnson. The suit alleges that the six executives, including Guidant Chief Executive Officer (CEO) Ronald W. Dollens, sold Guidant stock worth $39.5 million this year prior to the publication of the first news article by the NY Times about problems with Guidant's implantable cardiac defibrillators (ICDs).
Princess Health and Another Health Care Executive Pleads Guilty. Princessiccia

Princess Health and Another Health Care Executive Pleads Guilty. Princessiccia

The Charlotte Observer reported that David M. Hurley, the former Chief Operating Officer (COO) of aaiPharma Inc, agreed to plead guilty of conspiring to commit fraud. In 2003, federal prosecutors charged that Hurley made false ledger entries to overstate sales reports, revenues and earnings. In May, aaiPharma filed for bankruptcy.
An accompanying report noted that investigators are getting busier and busier with health fraud cases. In North Carolina, recoveries from health care fraud went from $2.2 million in 2000, to $18.3 million in 2004, and so far in 2005, the figure is $28 million. The reporter noted, "experts say health care fraud accounts for only a small portion of total health-care spending, but the truth is we don't know how much fraud is taking place."
Readers of Health Care Renewal may conclude that more broadly, conflicts of interest and corruption may add considerably to health care spending, while decreasing access, degrading quality, and demoralizing health care professionals.
Princess Health and  Another Health Care Executive Pleads Guilty.Princessiccia

Princess Health and Another Health Care Executive Pleads Guilty.Princessiccia

The Charlotte Observer reported that David M. Hurley, the former Chief Operating Officer (COO) of aaiPharma Inc, agreed to plead guilty of conspiring to commit fraud. In 2003, federal prosecutors charged that Hurley made false ledger entries to overstate sales reports, revenues and earnings. In May, aaiPharma filed for bankruptcy.
An accompanying report noted that investigators are getting busier and busier with health fraud cases. In North Carolina, recoveries from health care fraud went from $2.2 million in 2000, to $18.3 million in 2004, and so far in 2005, the figure is $28 million. The reporter noted, "experts say health care fraud accounts for only a small portion of total health-care spending, but the truth is we don't know how much fraud is taking place."
Readers of Health Care Renewal may conclude that more broadly, conflicts of interest and corruption may add considerably to health care spending, while decreasing access, degrading quality, and demoralizing health care professionals.

Sunday, 26 June 2005

Princess Health and Now Stuck Switches for Guidant. Princessiccia

Princess Health and Now Stuck Switches for Guidant. Princessiccia

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

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

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

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.

Friday, 24 June 2005

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

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

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

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.

Thursday, 23 June 2005

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

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."
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

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."
Princess Health and Waxman Summarizes the Marketing of Vioxx. Princessiccia

Princess Health and Waxman Summarizes the Marketing of Vioxx. Princessiccia

The current issue of the New England Journal of Medicine also continues the journal's new skeptical approach to the business practices of the pharmaceutical industry with a second perspectives article, by Congressman Harvey Waxman, that reviews the results of his committee's investigation of the marketing of Vioxx. (Waxman JA. The lesson of Vioxx - drug safety and sales. N Engl J Med 2005; 352: 2576-2578.) (The most recent of the many Health Care Renewal posts on Vioxx is here.)
Waxman summarized techniques Merck used to try to minimize the cardiovascular adverse effects of Vioxx in its marketing efforts to physicians. Techniques included:
  • Avoiding discussion of a specific study, the VIGOR study, which showed that Vioxx increased cardiovascular events
  • Distributing outdated data from weaker studies that had not shown cardiovascular adverse effects, on a "Cardiovascular Card"
  • Identifying speakers for "educational events" who would be "favorable" to Merck products
  • Using "subliminal selling techniques" beyond intellectual persuasion.
Most strikingly, Waxman noted "Merck's marketing practices may be less aggressive and more ethical than those of many of its competitors."
My comment is that this suggests that the pharmaceutical industry ought to inject big doses of ethics and transparency into its marketing. But a quick scan of Health Care Renewal would also suggest that many large health care organizations, not just pharmaceutical manufacturers, could use similar injections of ethics and transparency into their business practices.
Princess Health and  Waxman Summarizes the Marketing of Vioxx.Princessiccia

Princess Health and Waxman Summarizes the Marketing of Vioxx.Princessiccia

The current issue of the New England Journal of Medicine also continues the journal's new skeptical approach to the business practices of the pharmaceutical industry with a second perspectives article, by Congressman Harvey Waxman, that reviews the results of his committee's investigation of the marketing of Vioxx. (Waxman JA. The lesson of Vioxx - drug safety and sales. N Engl J Med 2005; 352: 2576-2578.) (The most recent of the many Health Care Renewal posts on Vioxx is here.)
Waxman summarized techniques Merck used to try to minimize the cardiovascular adverse effects of Vioxx in its marketing efforts to physicians. Techniques included:
  • Avoiding discussion of a specific study, the VIGOR study, which showed that Vioxx increased cardiovascular events
  • Distributing outdated data from weaker studies that had not shown cardiovascular adverse effects, on a "Cardiovascular Card"
  • Identifying speakers for "educational events" who would be "favorable" to Merck products
  • Using "subliminal selling techniques" beyond intellectual persuasion.
Most strikingly, Waxman noted "Merck's marketing practices may be less aggressive and more ethical than those of many of its competitors."
My comment is that this suggests that the pharmaceutical industry ought to inject big doses of ethics and transparency into its marketing. But a quick scan of Health Care Renewal would also suggest that many large health care organizations, not just pharmaceutical manufacturers, could use similar injections of ethics and transparency into their business practices.
Princess Health and "Crying All the Way to the Bank" Revisited: Pfizer's Trials of Torcetapib-Atorvastatin. Princessiccia

Princess Health and "Crying All the Way to the Bank" Revisited: Pfizer's Trials of Torcetapib-Atorvastatin. Princessiccia

The current issue of the New England Journal of Medicine continues the journal's recent skeptical approach to the business practices of pharmaceutical companies. A perspectives article (Avorn J. Torcetrapib and atorvastatin - should marketing drive the research agenda? N Engl J Med 2005; 352: 2573-2576) reviews Pfizer's trials of a new drug that may boost HDL ("good") cholesterol, torcetrapib, but only in fixed combination with Pfizer's block-buster "statin," Lipitor (atorvastatin).
Since the US Food and Drug Administration (FDA) has approved this approach, should the trials be succesful, Pfizer would be allowed to market the new torcetrapib-atorvastatin combination as a brand-name drug beyond 2010, when its patent on Lipitor runs out. The FDA approval also would allow Pfizer to avoid the risk of anti-trust litigation, which otherwise might have been engendered by it offering a drug only when "bundled" with another of its products.
The trials would not result in any information about how torcetrapib performs alone, or in combination with a statin other than atorvastatin. Physicians would not have the options of prescribing torcetrapib alone, in combination with generic atorvastatin, or in combination with another statin. Thus this approach would limit scientific data available to physicians and researchers, and would limit therapeutic options for patients.
We previously posted about this issue here, based on a March New York Times article.
Avorn commented,
  • "the current trial design may not optimally meet the scientific needs of prescribers, the clinical needs of patients, the economic needs of payers, or the regulatory needs of policymakers. But they superbly meet the business needs of the sponsore - to create new knowledge in a way that will protect the market share of the largest drug company's most important product."
Therefore, he concluded, "the torcetrapib story suggests that we have become too dependent on manufacturers as the predominant source of our scientific knowledge about the effects of medication." He thus advocates having the National Institutes of Health (NIH) start supporting "public-interest" drug trials "fairly comparing competing therapies (especially costly new ones) with clinically realistic alternatives."
Maybe now that the NIH has strict conflict-of-interest rules, and top NIH officials are no longer allowed to get lucrative consulting contracts with pharmaceutical companies, (see post here), this idea will get more welcome reception there.
Princess Health and  "Crying All the Way to the Bank" Revisited: Pfizer's Trials of Torcetapib-Atorvastatin.Princessiccia

Princess Health and "Crying All the Way to the Bank" Revisited: Pfizer's Trials of Torcetapib-Atorvastatin.Princessiccia

The current issue of the New England Journal of Medicine continues the journal's recent skeptical approach to the business practices of pharmaceutical companies. A perspectives article (Avorn J. Torcetrapib and atorvastatin - should marketing drive the research agenda? N Engl J Med 2005; 352: 2573-2576) reviews Pfizer's trials of a new drug that may boost HDL ("good") cholesterol, torcetrapib, but only in fixed combination with Pfizer's block-buster "statin," Lipitor (atorvastatin).
Since the US Food and Drug Administration (FDA) has approved this approach, should the trials be succesful, Pfizer would be allowed to market the new torcetrapib-atorvastatin combination as a brand-name drug beyond 2010, when its patent on Lipitor runs out. The FDA approval also would allow Pfizer to avoid the risk of anti-trust litigation, which otherwise might have been engendered by it offering a drug only when "bundled" with another of its products.
The trials would not result in any information about how torcetrapib performs alone, or in combination with a statin other than atorvastatin. Physicians would not have the options of prescribing torcetrapib alone, in combination with generic atorvastatin, or in combination with another statin. Thus this approach would limit scientific data available to physicians and researchers, and would limit therapeutic options for patients.
We previously posted about this issue here, based on a March New York Times article.
Avorn commented,
  • "the current trial design may not optimally meet the scientific needs of prescribers, the clinical needs of patients, the economic needs of payers, or the regulatory needs of policymakers. But they superbly meet the business needs of the sponsore - to create new knowledge in a way that will protect the market share of the largest drug company's most important product."
Therefore, he concluded, "the torcetrapib story suggests that we have become too dependent on manufacturers as the predominant source of our scientific knowledge about the effects of medication." He thus advocates having the National Institutes of Health (NIH) start supporting "public-interest" drug trials "fairly comparing competing therapies (especially costly new ones) with clinically realistic alternatives."
Maybe now that the NIH has strict conflict-of-interest rules, and top NIH officials are no longer allowed to get lucrative consulting contracts with pharmaceutical companies, (see post here), this idea will get more welcome reception there.

Wednesday, 22 June 2005

Princess Health and Secrecy and Censorship. Princessiccia

Princess Health and Secrecy and Censorship. Princessiccia

On June 6 I wrote a post entitled "Secrecy," and concluded "we should cultivate transparency and openness in health care. It is hard to conceive of legitimate reasons to keep hospitals' prices, contracts between medical schools and research sponsors, and contracts between doctors and managed care organizations secret. On the other hand, it is easy to think of how such secrecy could hide unethical business practices, and potentially even abuse of patients and corruption.It is time to end this secrecy. "
Since then, in the last 16 days, the following stories about secrecy have appeared on Health Care Renewal:
  • Louis Sherwood, A top Merck executive, now retired was accused of trying to intimidate physicians and researchers who had publicly questioned the safety of Merck's Cox-2 inhibitor Vioxx, now withdrawn from the market, or whether data about Vioxx was being withheld. (See post here.)
  • A Pfizer executive who had spoken out publicly in favor of drug re-importation charged that the company shut down his cell phone and email. (See post here.)
  • After Guidant found out that one of its models of implantable cardiac defibrillators (ICDs) had a defect that may cause them to fail, it kept the flaws a secret until the company found out that the NY Times was writing an article about the problem. (See post here.) It similarly concealed flaws in two other models of ICDs. Finally, it shippped old ICDs with the inventory out of inventory without notifying their recipients that the company had started making improved version without the flaw. (See posts here and here.)
  • CIGNA threatened a physician author with legal action because he published a satirical piece in a humor magazine. The threat was based on a provision in CIGNA's contract with the physician's hospital that forbade "disparaging" language. (See post here.)
  • Kaiser-Permanente sued a former employee for revealing in a blog that the managed care organization had posted real patient data on a web-site being used to develop an electronic medical record. (See post here.)
  • Eli Lilly filed one of its sales representatives after he published a book detailing his exploits prior to working for Lilly as a "slacker" sales representative for Pfizer. (See post here.)
These posts demonstrate that the urge to censor seems to be widespread in health care. The would-be censors noted above included pharmaceutical companies, a device company, a for-profit managed care organization, and a not-for-profit managed care organization. They sought to censor expression critical of their products and practices ranging from outcomes data, through academic and popular opinion, to satire. Their means of censorship ranged from simply keeping information to themselves, to threats, threats of law-suits, and law-suits filed.
These 16 days demonstrated the continuing threats against transparency and openness in health care. They also demonstrate that many threats come from leaders of large health care organizations who don't like information that puts them in a bad light made public. Yet how will we improve health care without access to information about what is going wrong, and opinions about what do to improve things?
Princess Health and  Secrecy and Censorship.Princessiccia

Princess Health and Secrecy and Censorship.Princessiccia

On June 6 I wrote a post entitled "Secrecy," and concluded "we should cultivate transparency and openness in health care. It is hard to conceive of legitimate reasons to keep hospitals' prices, contracts between medical schools and research sponsors, and contracts between doctors and managed care organizations secret. On the other hand, it is easy to think of how such secrecy could hide unethical business practices, and potentially even abuse of patients and corruption.It is time to end this secrecy. "
Since then, in the last 16 days, the following stories about secrecy have appeared on Health Care Renewal:
  • Louis Sherwood, A top Merck executive, now retired was accused of trying to intimidate physicians and researchers who had publicly questioned the safety of Merck's Cox-2 inhibitor Vioxx, now withdrawn from the market, or whether data about Vioxx was being withheld. (See post here.)
  • A Pfizer executive who had spoken out publicly in favor of drug re-importation charged that the company shut down his cell phone and email. (See post here.)
  • After Guidant found out that one of its models of implantable cardiac defibrillators (ICDs) had a defect that may cause them to fail, it kept the flaws a secret until the company found out that the NY Times was writing an article about the problem. (See post here.) It similarly concealed flaws in two other models of ICDs. Finally, it shippped old ICDs with the inventory out of inventory without notifying their recipients that the company had started making improved version without the flaw. (See posts here and here.)
  • CIGNA threatened a physician author with legal action because he published a satirical piece in a humor magazine. The threat was based on a provision in CIGNA's contract with the physician's hospital that forbade "disparaging" language. (See post here.)
  • Kaiser-Permanente sued a former employee for revealing in a blog that the managed care organization had posted real patient data on a web-site being used to develop an electronic medical record. (See post here.)
  • Eli Lilly filed one of its sales representatives after he published a book detailing his exploits prior to working for Lilly as a "slacker" sales representative for Pfizer. (See post here.)
These posts demonstrate that the urge to censor seems to be widespread in health care. The would-be censors noted above included pharmaceutical companies, a device company, a for-profit managed care organization, and a not-for-profit managed care organization. They sought to censor expression critical of their products and practices ranging from outcomes data, through academic and popular opinion, to satire. Their means of censorship ranged from simply keeping information to themselves, to threats, threats of law-suits, and law-suits filed.
These 16 days demonstrated the continuing threats against transparency and openness in health care. They also demonstrate that many threats come from leaders of large health care organizations who don't like information that puts them in a bad light made public. Yet how will we improve health care without access to information about what is going wrong, and opinions about what do to improve things?

Tuesday, 21 June 2005

Princess Health and Tales of Sales Reps. Princessiccia

Princess Health and Tales of Sales Reps. Princessiccia

Two recent news stories about how pharmaceutical companies' sales representatives market to physicians provided some interesting information....
The Philadelphia Inquirer noted that Wyeth has joined GlaxoSmithKline, AstraZeneca, and Pfizer in laying off sales representatives. A pharmaceutical sales consultant remarked, "this may be related to the issue of public trust. What we'ver realized is that we've probably gone too far." On measure of the distance traveled is the figure the Inquirer cited for the number of sales representatives working in the US prior to the lay-offs, over 100, 000, or approximately one for every seven physicians (see this post for numbers of physicians in the US versus numbers of managers). More striking was the statement that "a succesful sales representative can earn $150,000 to $200,000 a year, including a car and other perks. That's more than many primary care physicians make (see this post on physicians' compensation.)
Meanwhile, a reporter for the Los Angeles Times interviewed Jamie Reidy, the author of Hard Sell, described as a "slacker's tale," about Reidy's life as a sales representative for Pfizer. Reidy said, "I was the kid who didn't become a doctor because I almost failed high school chemistry. I was trained for six weeks and considered qualified to tell doctors which drugs to prescribe. Scary, isn't it?"
At the end, this becomes another story about the perils of blowing the whistle about the management of large health care organizations. Reidy had left Pfizer, and was working in the oncology division of Eli Lilly, advancing to a trainer of other sales representatives, until his book came out. Then Lilly fired him.
Princess Health and  Tales of Sales Reps.Princessiccia

Princess Health and Tales of Sales Reps.Princessiccia

Two recent news stories about how pharmaceutical companies' sales representatives market to physicians provided some interesting information....
The Philadelphia Inquirer noted that Wyeth has joined GlaxoSmithKline, AstraZeneca, and Pfizer in laying off sales representatives. A pharmaceutical sales consultant remarked, "this may be related to the issue of public trust. What we'ver realized is that we've probably gone too far." On measure of the distance traveled is the figure the Inquirer cited for the number of sales representatives working in the US prior to the lay-offs, over 100, 000, or approximately one for every seven physicians (see this post for numbers of physicians in the US versus numbers of managers). More striking was the statement that "a succesful sales representative can earn $150,000 to $200,000 a year, including a car and other perks. That's more than many primary care physicians make (see this post on physicians' compensation.)
Meanwhile, a reporter for the Los Angeles Times interviewed Jamie Reidy, the author of Hard Sell, described as a "slacker's tale," about Reidy's life as a sales representative for Pfizer. Reidy said, "I was the kid who didn't become a doctor because I almost failed high school chemistry. I was trained for six weeks and considered qualified to tell doctors which drugs to prescribe. Scary, isn't it?"
At the end, this becomes another story about the perils of blowing the whistle about the management of large health care organizations. Reidy had left Pfizer, and was working in the oncology division of Eli Lilly, advancing to a trainer of other sales representatives, until his book came out. Then Lilly fired him.
Princess Health and A Cautionary Tale About Health Care IT in the Real World. Princessiccia

Princess Health and A Cautionary Tale About Health Care IT in the Real World. Princessiccia

The Los Angeles Times reported another cautionary tale about the down-side of health care information technology (IT) in the real world. Apparently the Kaiser Permanente managed care organization, while testing electronic medical record (EMR) software, put up records of about 150 real patients on an unprotected web-site in 1999, and kept the web-site active until January 2005. Kaiser did not tell patients that their unprotected data had been available on the web for years until three months ago, according to the Times.
The problem first became public when a former Kaiser employee, Elisa D Cooper, posted about it, including links to the Kaiser web-site, on her blog. (I can't find her original blog, which may no longer be available on the web, but her current blog is here.) Kaiser then sued Cooper for invasion of privacy and breach of contract, even though, according to the San Francisco Examiner, she had been fired by Kaiser in 2003.
Beth Givens, the director of Privacy Rights Clearinghouse, commented that the incidents shows "just how vulnerable these systems can be." This is just one more case to think about the next time someone touts the EMR as the cure for all health care ills.
And it's also a reminder how large health care organizations, even ones with reputations as benign as Kaiser's is, at least out here in the East, react to whistle-blowers who publicly point out their managers' errors.
Princess Health and  A Cautionary Tale About Health Care IT in the Real World.Princessiccia

Princess Health and A Cautionary Tale About Health Care IT in the Real World.Princessiccia

The Los Angeles Times reported another cautionary tale about the down-side of health care information technology (IT) in the real world. Apparently the Kaiser Permanente managed care organization, while testing electronic medical record (EMR) software, put up records of about 150 real patients on an unprotected web-site in 1999, and kept the web-site active until January 2005. Kaiser did not tell patients that their unprotected data had been available on the web for years until three months ago, according to the Times.
The problem first became public when a former Kaiser employee, Elisa D Cooper, posted about it, including links to the Kaiser web-site, on her blog. (I can't find her original blog, which may no longer be available on the web, but her current blog is here.) Kaiser then sued Cooper for invasion of privacy and breach of contract, even though, according to the San Francisco Examiner, she had been fired by Kaiser in 2003.
Beth Givens, the director of Privacy Rights Clearinghouse, commented that the incidents shows "just how vulnerable these systems can be." This is just one more case to think about the next time someone touts the EMR as the cure for all health care ills.
And it's also a reminder how large health care organizations, even ones with reputations as benign as Kaiser's is, at least out here in the East, react to whistle-blowers who publicly point out their managers' errors.

Monday, 20 June 2005

Princess Health and CIGNA Can't Take a Joke. Princessiccia

Princess Health and CIGNA Can't Take a Joke. Princessiccia

The Associated Press reported (see the Washington Post version) that the Dr. Douglas Farrago, the physician who edits the humor magazine Placebo Journal was threatened with legal action for publishing a satirical piece on managed care. The parody was of a patient satisfaction survey, by the imaginary "SICKNA Healthcare" managed care organization, signed by "W. E. Sucque" from the "Medical Thievery and Health Policy Division."
After the piece was published, his employer, Sisters of Charity Health System, received a call from CIGNA Healthcare's lawyers demanding the Farrago "cease and desist." Apparently, CIGNA Healthcare's contract with the hospital system bars physicians from "any false or disparaging communications which could, or are likely to interfere with or otherwise damage any of CIGNA's existing or potential contractual relationships." CIGNA spokesperson Lindsay Shearer suggested that the complaint arose from offended CIGNA employees, "our employees work very hard to provide high quality service to our members, our clients, our providers. And when they see stuff like that it upset them."
Perhaps CIGNA really does have some employees who are easily offended. Perhaps they were educated at some of the insitutions of higher learning, so well documented by FIRE, where a slightly offensive remark is grounds for charges under the local "speech code." (See this link for examples.)
However, it was CIGNA's lawyers, not its line employees, who went after Dr. Farrago. So maybe the company's heavy-handed approach to suppressing free expression will generate more bad publicity for it than Farrago's parody could ever have done.
I agree with Farrago's take on this, "If my hospital, who has allowed me the freedom to be creative, gets bullied to fire me over this then it proves that HMOs are really running our health care system."
File this one under "intimidation and coercion," sub-category "attacks on free expression."
Princess Health and  CIGNA Can't Take a Joke.Princessiccia

Princess Health and CIGNA Can't Take a Joke.Princessiccia

The Associated Press reported (see the Washington Post version) that the Dr. Douglas Farrago, the physician who edits the humor magazine Placebo Journal was threatened with legal action for publishing a satirical piece on managed care. The parody was of a patient satisfaction survey, by the imaginary "SICKNA Healthcare" managed care organization, signed by "W. E. Sucque" from the "Medical Thievery and Health Policy Division."
After the piece was published, his employer, Sisters of Charity Health System, received a call from CIGNA Healthcare's lawyers demanding the Farrago "cease and desist." Apparently, CIGNA Healthcare's contract with the hospital system bars physicians from "any false or disparaging communications which could, or are likely to interfere with or otherwise damage any of CIGNA's existing or potential contractual relationships." CIGNA spokesperson Lindsay Shearer suggested that the complaint arose from offended CIGNA employees, "our employees work very hard to provide high quality service to our members, our clients, our providers. And when they see stuff like that it upset them."
Perhaps CIGNA really does have some employees who are easily offended. Perhaps they were educated at some of the insitutions of higher learning, so well documented by FIRE, where a slightly offensive remark is grounds for charges under the local "speech code." (See this link for examples.)
However, it was CIGNA's lawyers, not its line employees, who went after Dr. Farrago. So maybe the company's heavy-handed approach to suppressing free expression will generate more bad publicity for it than Farrago's parody could ever have done.
I agree with Farrago's take on this, "If my hospital, who has allowed me the freedom to be creative, gets bullied to fire me over this then it proves that HMOs are really running our health care system."
File this one under "intimidation and coercion," sub-category "attacks on free expression."
Princess Health and "We'll Manage It the Way We Damn Well Want". Princessiccia

Princess Health and "We'll Manage It the Way We Damn Well Want". Princessiccia

Phoebe Putney Health System is a health care system in Georgia, which boasts of "world-class medicine, hometown commitment." Its stated core values include "people come first," and "relationships are built on honesty and integrity."
Pheobe Putney was the subject of federal lawsuits, now dismissed, and state lawsuits alleging that it over-charged uninsured patients. It is one of the hospital systems that is now subject of congressional investigations of the not-for-profit status of hospitals and health systems. (See news article here.)
Now, the Atlanta Journal-Constitution has reported that top Phoebe Putney executives have run up lavish travel expenses for trips related to a for-profit subsidy. Pheobe Putney set up Grove Pointe Indemnity, based in the Cayman Islands, to provide the system with malpractice insurance. Top Phoebe Putney executives traveled to the Caymans, the Bahamas, and London, UK for Grove Pointe meetings. All travel was by private jet or first class on commercial airliners. Travel expenses included Cuban cigars, ($258 worth for one meal in London meeting), expensive beverages ($538 for one meal), and high-end accomodations (e.g., rooms at the Ritz in London, at 355 pounds sterling a night).
The Journal-Constitution asked Phoebe Putney Chief Financial Officer (CFO) Kerry Loudermilk about these expenses. Loudermilk first said what is lavish "is in the eye of the beholder." He responded to further questions about Grove Pointe, "We own it. We'll manage it the way we damn well want." A search of the GuideStar site for Pheobe Putney's 2002 Internal Revenue Service form 990 revealed that Grove Pointe had an income just under $2.5 million, and a total loss of just over $1.25 million in that year. Meanwhile, Loudermilk's total compensation was just under $3oo,ooo. He was one of eight executives who made more than $200,ooo. Three made over $300,000, and the system's CEO made nearly $600,000.
It will be interesting to see what the congressional investigation discovers about Phoebe Putney. Meanwhile, Loudermilk's response suggests that maybe the hired managers of this not-for-profit health care system feel a bit more ownership of it than they are entitled to. Although Pheobe Putney clearly owns Grove Pointe Indemnity, the managers of a not-for-profit do not own the organization. They should be running the organization in accord with its mission to benefit the public, which may not necessarily be the way they "damn well want." It's not clear that this job entitles them to smoke Cuban cigars on the health system's budget.
Princess Health and  "We'll Manage It the Way We Damn Well Want".Princessiccia

Princess Health and "We'll Manage It the Way We Damn Well Want".Princessiccia

Phoebe Putney Health System is a health care system in Georgia, which boasts of "world-class medicine, hometown commitment." Its stated core values include "people come first," and "relationships are built on honesty and integrity."
Pheobe Putney was the subject of federal lawsuits, now dismissed, and state lawsuits alleging that it over-charged uninsured patients. It is one of the hospital systems that is now subject of congressional investigations of the not-for-profit status of hospitals and health systems. (See news article here.)
Now, the Atlanta Journal-Constitution has reported that top Phoebe Putney executives have run up lavish travel expenses for trips related to a for-profit subsidy. Pheobe Putney set up Grove Pointe Indemnity, based in the Cayman Islands, to provide the system with malpractice insurance. Top Phoebe Putney executives traveled to the Caymans, the Bahamas, and London, UK for Grove Pointe meetings. All travel was by private jet or first class on commercial airliners. Travel expenses included Cuban cigars, ($258 worth for one meal in London meeting), expensive beverages ($538 for one meal), and high-end accomodations (e.g., rooms at the Ritz in London, at 355 pounds sterling a night).
The Journal-Constitution asked Phoebe Putney Chief Financial Officer (CFO) Kerry Loudermilk about these expenses. Loudermilk first said what is lavish "is in the eye of the beholder." He responded to further questions about Grove Pointe, "We own it. We'll manage it the way we damn well want." A search of the GuideStar site for Pheobe Putney's 2002 Internal Revenue Service form 990 revealed that Grove Pointe had an income just under $2.5 million, and a total loss of just over $1.25 million in that year. Meanwhile, Loudermilk's total compensation was just under $3oo,ooo. He was one of eight executives who made more than $200,ooo. Three made over $300,000, and the system's CEO made nearly $600,000.
It will be interesting to see what the congressional investigation discovers about Phoebe Putney. Meanwhile, Loudermilk's response suggests that maybe the hired managers of this not-for-profit health care system feel a bit more ownership of it than they are entitled to. Although Pheobe Putney clearly owns Grove Pointe Indemnity, the managers of a not-for-profit do not own the organization. They should be running the organization in accord with its mission to benefit the public, which may not necessarily be the way they "damn well want." It's not clear that this job entitles them to smoke Cuban cigars on the health system's budget.
Princess Health and More Short Circuits for Guidant. Princessiccia

Princess Health and More Short Circuits for Guidant. Princessiccia

The NY Times reported yet more bad news from the Guidant Corporation. We had previously posted (here) how Guidant had delayed notifiying physicians and patients about the possibility that short-circuits could render one of its models of implantable cardiac defibrillators (ICD), the Prizm 2 DR Model 1861, useless, and then that Guidant had continued to ship the old version of this model from inventory after it had started making a new version less prone to this mode of failure (see post here). Now Guidant is launching a formal recall of 29,000 ICD devices. However, this recall includes two other models of Guidant combinded pacermaker and ICDs, the Contak Renewal and Contak Renewal 2, which Guidant had not previously identified as likely to short circuit. Furthermore, it appears that Guidant delayed notifying doctors and patients about the possibility that these models might fail until now, and that Guidant continued to ship older versions of these two models from inventory even after it began manufacturing newer versions that were designed not to short-circuit.
Again, to make the best possible decisions for individual patients, patients and physicians deserve to hear about problems with devices and drugs as soon as reliable information about them is available.
Princess Health and  More Short Circuits for Guidant.Princessiccia

Princess Health and More Short Circuits for Guidant.Princessiccia

The NY Times reported yet more bad news from the Guidant Corporation. We had previously posted (here) how Guidant had delayed notifiying physicians and patients about the possibility that short-circuits could render one of its models of implantable cardiac defibrillators (ICD), the Prizm 2 DR Model 1861, useless, and then that Guidant had continued to ship the old version of this model from inventory after it had started making a new version less prone to this mode of failure (see post here). Now Guidant is launching a formal recall of 29,000 ICD devices. However, this recall includes two other models of Guidant combinded pacermaker and ICDs, the Contak Renewal and Contak Renewal 2, which Guidant had not previously identified as likely to short circuit. Furthermore, it appears that Guidant delayed notifying doctors and patients about the possibility that these models might fail until now, and that Guidant continued to ship older versions of these two models from inventory even after it began manufacturing newer versions that were designed not to short-circuit.
Again, to make the best possible decisions for individual patients, patients and physicians deserve to hear about problems with devices and drugs as soon as reliable information about them is available.
Princess Health and "Naturopath" Takes the Fifth. Princessiccia

Princess Health and "Naturopath" Takes the Fifth. Princessiccia

The Providence Journal has followed-up on the story of local "naturopath" John E. Curran. (See our previous post here.) Curran requested an administrative hearing at the state Health Department about its suspension of his "natural healing" practice. At the hearing, Curran refused to answer every question put to him, pleading the Fifth Amendment. In particular, he would not answer questions about three diplomas that he allegedly purchased from a "bogus college," nor the $2650 check he used to pay for them; a blue coat he wore at his practice, with a badge that read, "John E. Curran, ND, MD, MPH, PhD'; documents that identified him as an ordained minister, "a fugitive-recovery agent," and a member of the press; and a New York City Police badge with his name on it. Eventually, Curran ended the hearing, and agreed to accept the suspension of his practice. The Journal reported that investigations of Curran by the US Food and Drug Administration, Internal Revenue Service, Postal Service, and Attorney's Office are still pending.
Although Curran may be an extreme example, a quick look at the web will reveal all sorts of complementary and alternative medicine (CAM) practitioners making exaggerated claims about the benefits of their services. Reputable medical schools have allied themselves with CAM institutions which claim they can treat depression with acupuncture, and increase longevity with herbs (see previous post here.) The extent that spending on unproven, useless, and even harmful CAM treatments contributes to rising health care costs remains unexplored.
Princess Health and  "Naturopath" Takes the Fifth.Princessiccia

Princess Health and "Naturopath" Takes the Fifth.Princessiccia

The Providence Journal has followed-up on the story of local "naturopath" John E. Curran. (See our previous post here.) Curran requested an administrative hearing at the state Health Department about its suspension of his "natural healing" practice. At the hearing, Curran refused to answer every question put to him, pleading the Fifth Amendment. In particular, he would not answer questions about three diplomas that he allegedly purchased from a "bogus college," nor the $2650 check he used to pay for them; a blue coat he wore at his practice, with a badge that read, "John E. Curran, ND, MD, MPH, PhD'; documents that identified him as an ordained minister, "a fugitive-recovery agent," and a member of the press; and a New York City Police badge with his name on it. Eventually, Curran ended the hearing, and agreed to accept the suspension of his practice. The Journal reported that investigations of Curran by the US Food and Drug Administration, Internal Revenue Service, Postal Service, and Attorney's Office are still pending.
Although Curran may be an extreme example, a quick look at the web will reveal all sorts of complementary and alternative medicine (CAM) practitioners making exaggerated claims about the benefits of their services. Reputable medical schools have allied themselves with CAM institutions which claim they can treat depression with acupuncture, and increase longevity with herbs (see previous post here.) The extent that spending on unproven, useless, and even harmful CAM treatments contributes to rising health care costs remains unexplored.

Friday, 17 June 2005

Princess Health and "Slippery As Oiled Pigs". Princessiccia

Princess Health and "Slippery As Oiled Pigs". Princessiccia

The Washington Post followed up on the case of the hospitals that employed used elevator hydraulic fluid rather than detergent to attempt to sterilize surgical instruments. The paper reported comments by the CEO of Duke University Health System, Dr. Victor Dzau. To explain why it took so long for administrators to figure out there was something wrong with the sterilization process, he noted that normally a lubricant is applied to surgical instruments to "make sure they don't develop rust and lock up during surgery." So, "it took us a while to figure out that this was beyond the normal level of oiliness."
Futhermore, Dzau discounted the potential health risks of the exposure, "while we understand that some patients have experience symptoms following their surgeries, everything we know would suggest that no causal connection has been established between any of the these patients outcomes and instruments exposed to the fluid in the presterilization process."
Meanwhile, this case has attracted considerable media attention, most not very flattering to Duke. A local commentator wrote in the News Observer, "what galls most is not the mistake, but the post-mistake arrogance of hospital officials. Hospital regulators accused them of ignoring clear, early distress signals being sent by staff members who knew the instruments weren't supposed to be as slippery as oiled pigs and leave a yellow residue."
Unfortunately, Dzau's remarks did not convince me otherwise. Surgical instruments are made of alloys that do not corrode easily, and its implausible that more than tiny amounts of oil are normally used in their sterilization. Although I am not a surgeon, I have seen plenty of sterilized instruments, and none of them were oily. Hence, if the instruments were really as "slippery as oiled pigs," anyone familiar with the operating room context should have identified this as a big problem.
Furthermore, Dzau's comment about causality is, while probably true, not helpful. The only way to establish that exposure to operating room instruments coated with used elevator hydraulic fluid causes particular health problems would be a controlled trial that randomized some patients to such an exposure. Such a controlled trial would clearly be unethical, and I am sure no previous trial has been done. Yet in the absence of such ultimate proof, it seems reasonable to assume that it is not a good for patients to expose them to surgical instruments washed with used hydraulic fluid.
A more productive approach would require investigating why adminstrators did not identify the oily instruments as a problem sooner.
Princess Health and  "Slippery As Oiled Pigs".Princessiccia

Princess Health and "Slippery As Oiled Pigs".Princessiccia

The Washington Post followed up on the case of the hospitals that employed used elevator hydraulic fluid rather than detergent to attempt to sterilize surgical instruments. The paper reported comments by the CEO of Duke University Health System, Dr. Victor Dzau. To explain why it took so long for administrators to figure out there was something wrong with the sterilization process, he noted that normally a lubricant is applied to surgical instruments to "make sure they don't develop rust and lock up during surgery." So, "it took us a while to figure out that this was beyond the normal level of oiliness."
Futhermore, Dzau discounted the potential health risks of the exposure, "while we understand that some patients have experience symptoms following their surgeries, everything we know would suggest that no causal connection has been established between any of the these patients outcomes and instruments exposed to the fluid in the presterilization process."
Meanwhile, this case has attracted considerable media attention, most not very flattering to Duke. A local commentator wrote in the News Observer, "what galls most is not the mistake, but the post-mistake arrogance of hospital officials. Hospital regulators accused them of ignoring clear, early distress signals being sent by staff members who knew the instruments weren't supposed to be as slippery as oiled pigs and leave a yellow residue."
Unfortunately, Dzau's remarks did not convince me otherwise. Surgical instruments are made of alloys that do not corrode easily, and its implausible that more than tiny amounts of oil are normally used in their sterilization. Although I am not a surgeon, I have seen plenty of sterilized instruments, and none of them were oily. Hence, if the instruments were really as "slippery as oiled pigs," anyone familiar with the operating room context should have identified this as a big problem.
Furthermore, Dzau's comment about causality is, while probably true, not helpful. The only way to establish that exposure to operating room instruments coated with used elevator hydraulic fluid causes particular health problems would be a controlled trial that randomized some patients to such an exposure. Such a controlled trial would clearly be unethical, and I am sure no previous trial has been done. Yet in the absence of such ultimate proof, it seems reasonable to assume that it is not a good for patients to expose them to surgical instruments washed with used hydraulic fluid.
A more productive approach would require investigating why adminstrators did not identify the oily instruments as a problem sooner.
Princess Health and Michigan Politicians Covet Large Blue Cross Surpluses. Princessiccia

Princess Health and Michigan Politicians Covet Large Blue Cross Surpluses. Princessiccia

The Detroit News reported that the Chairwoman of the State Senate Appropriations Committee is calling on Blue Cross Blue Shield of Michigan to voluntarily contribute some of its large and growing surplus to help state health care programs, or face loss of its tax exemption.
Michigan Blue Cross now has a surplus of $2.24 billion. According to the News, that is 800 percent of the mandated minimum amount.
The article noted that in Pennsylvania, after state politicians noted large surpluses being piled up by in state Blue Cross insurers, the Governor reached an agreement with the plans that they would contribute some of their reserves to state health programs.
Michigan Blue Cross spokeswoman Helen Stojic countered, "we spend tens of millions of dollars already reinvesting in communities."
On the other hand, Tom Clay of the Citizens Research Council of Michigan, noted, "you could make the argument that if the Blues are building up a reserve, they're probably charging more for insurance than they need to."
In my humble opinion, leaders of both not-for-profit insurers like some Blue Cross plans, and not-for-profit hospitals and academic medical centers need to refocus on their missions, or risk rude encounters with politicians who can find other uses for the money these institutions have been accumulating.
Princess Health and  Michigan Politicians Covet Large Blue Cross Surpluses.Princessiccia

Princess Health and Michigan Politicians Covet Large Blue Cross Surpluses.Princessiccia

The Detroit News reported that the Chairwoman of the State Senate Appropriations Committee is calling on Blue Cross Blue Shield of Michigan to voluntarily contribute some of its large and growing surplus to help state health care programs, or face loss of its tax exemption.
Michigan Blue Cross now has a surplus of $2.24 billion. According to the News, that is 800 percent of the mandated minimum amount.
The article noted that in Pennsylvania, after state politicians noted large surpluses being piled up by in state Blue Cross insurers, the Governor reached an agreement with the plans that they would contribute some of their reserves to state health programs.
Michigan Blue Cross spokeswoman Helen Stojic countered, "we spend tens of millions of dollars already reinvesting in communities."
On the other hand, Tom Clay of the Citizens Research Council of Michigan, noted, "you could make the argument that if the Blues are building up a reserve, they're probably charging more for insurance than they need to."
In my humble opinion, leaders of both not-for-profit insurers like some Blue Cross plans, and not-for-profit hospitals and academic medical centers need to refocus on their missions, or risk rude encounters with politicians who can find other uses for the money these institutions have been accumulating.
Princess Health and Nursing Home Administrator Charged with Patient Neglect. Princessiccia

Princess Health and Nursing Home Administrator Charged with Patient Neglect. Princessiccia

Our local Providence Journal has been following a tragic story of the closing of a large local nursing home, after many reports of sub-standard care and financial difficulties. Today the paper reported that the former administrator of the nursing home, James D. Janetakos, has been charged by the state Attorney General with 11 counts of patient neglect, a felony.
Noteworthy is that this charge has usually been made against health care professionals, not managers. According to the Journal, "this is the first time in recent years that a top administrator has faced charges of patient neglect."
Law enforcement seems to be recognizing that mismanagement of health care organization may have serious effects on patient outcomes. I suspect many doctors, nurses, and other health professionals have know that intuitively for a while, but have rarely been in a position to act on that knowledge. And the concept seems still largely foreign to the health services research literature and in "health policy" circles, as best as I can tell (but I would love to be proven wrong on that, if anyone can do so.)
Princess Health and  Nursing Home Administrator Charged with Patient Neglect.Princessiccia

Princess Health and Nursing Home Administrator Charged with Patient Neglect.Princessiccia

Our local Providence Journal has been following a tragic story of the closing of a large local nursing home, after many reports of sub-standard care and financial difficulties. Today the paper reported that the former administrator of the nursing home, James D. Janetakos, has been charged by the state Attorney General with 11 counts of patient neglect, a felony.
Noteworthy is that this charge has usually been made against health care professionals, not managers. According to the Journal, "this is the first time in recent years that a top administrator has faced charges of patient neglect."
Law enforcement seems to be recognizing that mismanagement of health care organization may have serious effects on patient outcomes. I suspect many doctors, nurses, and other health professionals have know that intuitively for a while, but have rarely been in a position to act on that knowledge. And the concept seems still largely foreign to the health services research literature and in "health policy" circles, as best as I can tell (but I would love to be proven wrong on that, if anyone can do so.)
Princess Health and New Book on "Olivieri Affair". Princessiccia

Princess Health and New Book on "Olivieri Affair". Princessiccia

The NY Times reviewed a new book on what may be called the "Olivieri affair," one of the most notorious cases of research suppression from the late 1990's. The case, which involved allegations that the Canadian drug manufacturer Apotex attempted to suppress results of Olivieri's research which showed that the drug , defirapone, or L1, had unexpected adverse effects, was investigated by the Canadian Association of University Teachers, who issued an extensive report. The book, The Drug Trial, by Miriam Shuchman, apparently takes a revisionist approach, and is much more critical of Olivieri's role in the case than previously published reports. (See also this article on the book from MacLeans.) I haven't read the book so can't comment on its contents.
Princess Health and  New Book on "Olivieri Affair".Princessiccia

Princess Health and New Book on "Olivieri Affair".Princessiccia

The NY Times reviewed a new book on what may be called the "Olivieri affair," one of the most notorious cases of research suppression from the late 1990's. The case, which involved allegations that the Canadian drug manufacturer Apotex attempted to suppress results of Olivieri's research which showed that the drug , defirapone, or L1, had unexpected adverse effects, was investigated by the Canadian Association of University Teachers, who issued an extensive report. The book, The Drug Trial, by Miriam Shuchman, apparently takes a revisionist approach, and is much more critical of Olivieri's role in the case than previously published reports. (See also this article on the book from MacLeans.) I haven't read the book so can't comment on its contents.

Thursday, 16 June 2005

Princess Health and Canadian Health Care A Contradiction in Terms. Princessiccia

Princess Health and Canadian Health Care A Contradiction in Terms. Princessiccia

To all those still infatuated with Managed Care:

June 16, 2005
Canadian Health Care A Contradiction in Terms
By Steve Chapman


To critics of the American health care system, Shangri-La is not a fantasy but a shimmering reality, though it goes by another name: Canada. Any debate on health care eventually arrives at the point where one participant says, "We should have what Canadians have. Free care, universal access and low cost -- who could ask for more?"

Well, plenty of people could ask for more -- starting with the Supreme Court of Canada. Last week, ruling on a challenge to the health care in the province of Quebec, the court sent a clear message south: Don't believe the hype.

The program, said the court, has such serious flaws that it is violating constitutional rights and must be fundamentally changed. And the flaws, far from being unique to Quebec, are part of the basic structure of Canada's health care policy.

No one doubts that the American model has serious defects, particularly rising costs and lack of access to medical insurance. But anyone who thinks the Canadians have come up with a magical solution is doomed to disappointment.

The dirty secret of the system is that universal access is no guarantee of treatment. Sick Canadians spend months and even years on waiting lists for surgery and other procedures. In 1993, the average wait to see a specialist after getting a doctor's referral was nine weeks. Since then, according to the Fraser Institute of Vancouver, it's increased to 18 weeks.

The typical patient needing orthopedic surgery has time to get pregnant and deliver a baby before being called. The Supreme Court cited the testimony of one orthopedic surgeon that 95 percent of patients in Canada waited over a year for knee replacements -- with many of them in limbo for two years.

In some cases, the delay lasts longer than the person enduring it. Or as the Supreme Court put it: "Patients die as a result of waiting lists for public health care."

Not only does the government subject its citizens to painful and even fatal delays in the public system, it bars them from seeking alternatives in the private market. You see, it's illegal for private insurers to pay for services covered by the public system.

That policy is what forced the Supreme Court to order changes. "The prohibition on obtaining private health insurance," it declared, "is not constitutional where the public system fails to deliver reasonable services."

The program has created a gap between supply and demand that is wider than Hudson Bay. Its failings, however, go beyond that. The single-payer approach, for example, is often held up as the only way to simultaneously control costs and deliver quality care.

In fact, Canada has somehow managed to do neither.

After adjusting for the age of the population, the Fraser Institute compared 27 countries in the Organisation for Economic Co-operation and Development that guarantee universal access to health care. By some mysterious alchemy, Canada has proportionately fewer physicians than most of these nations but spends more on health care than any except Iceland.

It would be a dubious feat to control costs only by depriving people of treatment. But to forcibly deprive people of treatment while letting costs surge is no achievement at all.

Admirers of our good neighbor to the north say the United States pours money into all sorts of fancy equipment but doesn't get better results by such measures as life expectancy. But life expectancy is affected by multiple factors, including education, crime rates and diet -- with health care playing only a modest role. In those areas where modern medicine can make a big difference, the United States does very well.

Take breast cancer. In Britain, which is famous for its socialized system, close to half of all victims die of the disease, according to a recent Cato Institute study by John Goodman, head of the National Center for Policy Analysis. In Germany and France, almost one-third do. In Canada, the figure is 28 percent -- and here, it's 25 percent. Our mortality rate for prostate cancer is 67 percent lower than Britain's and 24 percent lower than Canada's.

The usual story we hear is that the health care system next door provides first-rate care to all, at low cost. The realities -- dangerous delays, bloated expenditures and mediocre results -- are not so appealing. American liberals may not welcome evidence that the single-payer model works far better in theory than in practice. But for that, they can blame Canada.
Princess Health and  Canadian Health Care A Contradiction in Terms.Princessiccia

Princess Health and Canadian Health Care A Contradiction in Terms.Princessiccia

To all those still infatuated with Managed Care:

June 16, 2005
Canadian Health Care A Contradiction in Terms
By Steve Chapman


To critics of the American health care system, Shangri-La is not a fantasy but a shimmering reality, though it goes by another name: Canada. Any debate on health care eventually arrives at the point where one participant says, "We should have what Canadians have. Free care, universal access and low cost -- who could ask for more?"

Well, plenty of people could ask for more -- starting with the Supreme Court of Canada. Last week, ruling on a challenge to the health care in the province of Quebec, the court sent a clear message south: Don't believe the hype.

The program, said the court, has such serious flaws that it is violating constitutional rights and must be fundamentally changed. And the flaws, far from being unique to Quebec, are part of the basic structure of Canada's health care policy.

No one doubts that the American model has serious defects, particularly rising costs and lack of access to medical insurance. But anyone who thinks the Canadians have come up with a magical solution is doomed to disappointment.

The dirty secret of the system is that universal access is no guarantee of treatment. Sick Canadians spend months and even years on waiting lists for surgery and other procedures. In 1993, the average wait to see a specialist after getting a doctor's referral was nine weeks. Since then, according to the Fraser Institute of Vancouver, it's increased to 18 weeks.

The typical patient needing orthopedic surgery has time to get pregnant and deliver a baby before being called. The Supreme Court cited the testimony of one orthopedic surgeon that 95 percent of patients in Canada waited over a year for knee replacements -- with many of them in limbo for two years.

In some cases, the delay lasts longer than the person enduring it. Or as the Supreme Court put it: "Patients die as a result of waiting lists for public health care."

Not only does the government subject its citizens to painful and even fatal delays in the public system, it bars them from seeking alternatives in the private market. You see, it's illegal for private insurers to pay for services covered by the public system.

That policy is what forced the Supreme Court to order changes. "The prohibition on obtaining private health insurance," it declared, "is not constitutional where the public system fails to deliver reasonable services."

The program has created a gap between supply and demand that is wider than Hudson Bay. Its failings, however, go beyond that. The single-payer approach, for example, is often held up as the only way to simultaneously control costs and deliver quality care.

In fact, Canada has somehow managed to do neither.

After adjusting for the age of the population, the Fraser Institute compared 27 countries in the Organisation for Economic Co-operation and Development that guarantee universal access to health care. By some mysterious alchemy, Canada has proportionately fewer physicians than most of these nations but spends more on health care than any except Iceland.

It would be a dubious feat to control costs only by depriving people of treatment. But to forcibly deprive people of treatment while letting costs surge is no achievement at all.

Admirers of our good neighbor to the north say the United States pours money into all sorts of fancy equipment but doesn't get better results by such measures as life expectancy. But life expectancy is affected by multiple factors, including education, crime rates and diet -- with health care playing only a modest role. In those areas where modern medicine can make a big difference, the United States does very well.

Take breast cancer. In Britain, which is famous for its socialized system, close to half of all victims die of the disease, according to a recent Cato Institute study by John Goodman, head of the National Center for Policy Analysis. In Germany and France, almost one-third do. In Canada, the figure is 28 percent -- and here, it's 25 percent. Our mortality rate for prostate cancer is 67 percent lower than Britain's and 24 percent lower than Canada's.

The usual story we hear is that the health care system next door provides first-rate care to all, at low cost. The realities -- dangerous delays, bloated expenditures and mediocre results -- are not so appealing. American liberals may not welcome evidence that the single-payer model works far better in theory than in practice. But for that, they can blame Canada.
Princess Health and Dispute at the American Society of Hypertension Over Industry Involvement. Princessiccia

Princess Health and Dispute at the American Society of Hypertension Over Industry Involvement. Princessiccia

The Boston Globe reported that a dispute has broken out at the American Society of Hypertension over the influence of pharmaceutical companies and conflicts of interest. Things have gotten pretty messy, so it's not easy for an outsider to tell what are at its roots.
There are two factions, one who "expresses wariness about industry participation and a newer faction that embraces it," according to the Globe.
In the first faction is Dr. John H. Laragh, a society cofounder and editor of the American Journal of Hypertension. In an email to the Society's membership, he charged that "the lines separating marketing from education have been fractured." Prof. Curt Furberg, former member of the Society's executive council, agreed that "the society is seen as a marketing tool by industry. There is a lot of money to go around."
Furthermore, Laragh said that industry involvement has increased at the society's annual meeting. This year, industry-sponsored sessions, instead of being isolated as "satellites," were "intertwined with the rest of the program." He noted that one society member, who also is a founding partner of a company that administers clinical trials under contract with the pharmaceutical industry, chaired a meeting to discuss the results of a trial that his company administered.
In the second faction is the President of the Society, Dr. Thomas Giles. He said that industry involvement is "part of a 'partnership' between physicians, corporations, and government and can be managed with appropriate disclosure rules, " according to the Globe. He noted that unrestricted educational grants from pharmaceutical companies, notably Novartis, AstraZeneca, and Pfizer, financed about $1.5 million of the Society's $4.4 million budget. He said, "we will not put ourselves in the position where were [sic] are going to function as the marketing arm for anyone."
Laragh has also acquired "enemies," who questioned his editorial salary ($229,000 in 2003), and whether he "engineered" his wife's new position as President-Elect of the Society.
Not a pretty picture, but I guess that more open discussion about the role of industry in scientific and clinical societies may do some good.
Princess Health and  Dispute at the American Society of Hypertension Over Industry Involvement.Princessiccia

Princess Health and Dispute at the American Society of Hypertension Over Industry Involvement.Princessiccia

The Boston Globe reported that a dispute has broken out at the American Society of Hypertension over the influence of pharmaceutical companies and conflicts of interest. Things have gotten pretty messy, so it's not easy for an outsider to tell what are at its roots.
There are two factions, one who "expresses wariness about industry participation and a newer faction that embraces it," according to the Globe.
In the first faction is Dr. John H. Laragh, a society cofounder and editor of the American Journal of Hypertension. In an email to the Society's membership, he charged that "the lines separating marketing from education have been fractured." Prof. Curt Furberg, former member of the Society's executive council, agreed that "the society is seen as a marketing tool by industry. There is a lot of money to go around."
Furthermore, Laragh said that industry involvement has increased at the society's annual meeting. This year, industry-sponsored sessions, instead of being isolated as "satellites," were "intertwined with the rest of the program." He noted that one society member, who also is a founding partner of a company that administers clinical trials under contract with the pharmaceutical industry, chaired a meeting to discuss the results of a trial that his company administered.
In the second faction is the President of the Society, Dr. Thomas Giles. He said that industry involvement is "part of a 'partnership' between physicians, corporations, and government and can be managed with appropriate disclosure rules, " according to the Globe. He noted that unrestricted educational grants from pharmaceutical companies, notably Novartis, AstraZeneca, and Pfizer, financed about $1.5 million of the Society's $4.4 million budget. He said, "we will not put ourselves in the position where were [sic] are going to function as the marketing arm for anyone."
Laragh has also acquired "enemies," who questioned his editorial salary ($229,000 in 2003), and whether he "engineered" his wife's new position as President-Elect of the Society.
Not a pretty picture, but I guess that more open discussion about the role of industry in scientific and clinical societies may do some good.
Princess Health and Deferred Prosecution for Bristol Myers Squibb for Fraud Charges. Princessiccia

Princess Health and Deferred Prosecution for Bristol Myers Squibb for Fraud Charges. Princessiccia

The NY Times reported that federal prosecutors will defer prosecution of Bristol Myers Squibb for alleged manipulation of inventory designed to artificially inflate sales. The company will return $300 million to stockholders; set up an endowed chair of business ethics at Seton Hall University Law School; remove its CEO, Peter R. Dolan, from his additional position as chairman of board; and allow a retired federal judge to continue monitoring company operations, and appoint an additional board member acceptable to him. If the company complies with all obligations to the government, the prosecutors will dismiss criminal complaints already filed without further prosecution.
Two former Bristol Myers Squibb executives, former chief financial officer Frederick S. Schiff, and Richard J. Lane, former head of worldwide medicines, were indicted on charges of conspiracy and securities fraud. Lawyers for both men declared their innocence.
The prosecutors stated that these events resulted from a "corporate culture at Bristol-Myers at the time that emphasized higher sales at all costs...." according to the Times.
Princess Health and  Deferred Prosecution for Bristol Myers Squibb for Fraud Charges.Princessiccia

Princess Health and Deferred Prosecution for Bristol Myers Squibb for Fraud Charges.Princessiccia

The NY Times reported that federal prosecutors will defer prosecution of Bristol Myers Squibb for alleged manipulation of inventory designed to artificially inflate sales. The company will return $300 million to stockholders; set up an endowed chair of business ethics at Seton Hall University Law School; remove its CEO, Peter R. Dolan, from his additional position as chairman of board; and allow a retired federal judge to continue monitoring company operations, and appoint an additional board member acceptable to him. If the company complies with all obligations to the government, the prosecutors will dismiss criminal complaints already filed without further prosecution.
Two former Bristol Myers Squibb executives, former chief financial officer Frederick S. Schiff, and Richard J. Lane, former head of worldwide medicines, were indicted on charges of conspiracy and securities fraud. Lawyers for both men declared their innocence.
The prosecutors stated that these events resulted from a "corporate culture at Bristol-Myers at the time that emphasized higher sales at all costs...." according to the Times.

Wednesday, 15 June 2005

Princess Health and A Not-For-Profit Hospital Sues a Former Donor. Princessiccia

Princess Health and A Not-For-Profit Hospital Sues a Former Donor. Princessiccia

The Boston Globe reported that the not-for-profit Massachusetts Eye & Ear Infirmary has sued a foundation for failure to deliver a pledged contribution. However, the pledge was apparently made to support a specific research program run by a doctor who has left the hospital, taking his research program with him. The Casey Foundation, run by Washington philanthropist Betty Brown Casey, had been funding work done by Dr. Steven Zeitels. After Zeitels and four other members of his team moved to Massachusetts General Hospital, the foundation asked Massachusetts Eye & Ear Infirmary to return any funds remaining in the grant. The hospital responded by suing the foundation for about half of the $2 million grant which it had not yet received, saying that the money was meant for the institution, not any particular researcher. Zeitels, however, said that the foundation had not meant to provide general funding for the hospital, but "was funding a specific program with unique investigators that was delineated both in the original proposal ... as well as scientific reports."
Suing a former donor seems to be a heavy-handed approach for a not-for-profit institution that presumably wants to receive money from other donors in the future. But it fits in with current US congressional concerns that some not-for-profit hospitals act more like for-profit corporations. (See our previous post here.)
Princess Health and  A Not-For-Profit Hospital Sues a Former Donor.Princessiccia

Princess Health and A Not-For-Profit Hospital Sues a Former Donor.Princessiccia

The Boston Globe reported that the not-for-profit Massachusetts Eye & Ear Infirmary has sued a foundation for failure to deliver a pledged contribution. However, the pledge was apparently made to support a specific research program run by a doctor who has left the hospital, taking his research program with him. The Casey Foundation, run by Washington philanthropist Betty Brown Casey, had been funding work done by Dr. Steven Zeitels. After Zeitels and four other members of his team moved to Massachusetts General Hospital, the foundation asked Massachusetts Eye & Ear Infirmary to return any funds remaining in the grant. The hospital responded by suing the foundation for about half of the $2 million grant which it had not yet received, saying that the money was meant for the institution, not any particular researcher. Zeitels, however, said that the foundation had not meant to provide general funding for the hospital, but "was funding a specific program with unique investigators that was delineated both in the original proposal ... as well as scientific reports."
Suing a former donor seems to be a heavy-handed approach for a not-for-profit institution that presumably wants to receive money from other donors in the future. But it fits in with current US congressional concerns that some not-for-profit hospitals act more like for-profit corporations. (See our previous post here.)
Princess Health and No Federal Standards for Reporting Flawed Medical Devices. Princessiccia

Princess Health and No Federal Standards for Reporting Flawed Medical Devices. Princessiccia

The NY Times reported about recent recalls of implanted cardiac devices. One important point the reporter made was that so far the US Food and Drug Administration (FDA) has no uniform standards for notification of physicians when problems are found with implantable devices. Currently, it is up to the device manufacturer to decide when to report problems. Apparently, it is acceptable for the manufacturer to "consider potential loss of business to competitors and legal liability" when making such decisions.
The results of this lack of standards include the decision by Guidant to delay reporting of short-circuits in one model of implantable cardiac defibrillator (ICD). (See previous post here.) Guidant had judged that replacing such defibrillators would "unnecessarily" expose patients to surgical risks. Thus, Guidant justified its decision to withhold information about the possibility of ICD failure, apparently based on a judgment that the reduction in possible benefit due to ICD failure was less important to patients than the risks of ICD replacement.
But by withholding information about ICD reliability, Guidant seemed to be substituting its judgments about how to balance benefits and harms for those made by patients and doctors. As Dr. Eric N. Prystowsky said, "You are not my father. You are not my mother. You are just a company selling products. You have to let me make these decisions."