Basking in the glow of having finished my final paper for our bioethics class, I wonder what I will be wondering about this time next week without an assigned dilemma to consider.
For me, the stem cell debate, the genetics debate, the euthanasia debate, etc. all come together very concretely in the issue of health care worker’s ‘conscience clause’. I borrow from the Washington Post article linked below to describe some examples.
“In Chicago, an ambulance driver refused to transport a patient for an abortion. In California, fertility specialists rebuffed a gay woman seeking artificial insemination. In Texas, a pharmacist turned away a rape victim seeking the morning-after pill.”
Is it right for health care workers to refuse to do thing that violate their own moral and religious values? Or do healers have an ethical and professional responsibility to put patients first?
The heck if I know.
But I will be thinking on it. ... sort of like a never-ending Thursday night discussion.
http://www.washingtonpost.com/wp-dyn/content/article/2006/07/15/AR2006071500846.html
PJM
Friday, December 12, 2008
Elective surgery with a side of nan
You can now get an all-expense paid trip for yourself and a companion to travel to India and get that procedure taken care of.
http://www.nytimes.com/2008/11/21/health/21abroad.html?_r=1
One of the many any issues that occur to me regarding international ‘medical tourism’ is how this impacts informed consent issues. A search for ‘medical tourism’ turned up the two following medical travel agencies. These are not providers or insurers. From what I can see, you sign your consent in the foreign country after consultation with the foreign doctor.
I wonder if this consent would hold up in the United States? After traveling thousands of miles for the purpose of a surgical procedure, isn’t an individual somewhat captive and under some duress and ‘forced’ to sign a consent? Or is traveling thousands of miles to get a elective surgical procedure a form of consent in and of itself? I have always been focused on health care in the United States and would like to know more about how ethical practices are handled in situations like this.
http://www.medicaltourismsolutions.com/procedures/sample_packages.htm
http://www.medpathgroup.com/
http://www.nytimes.com/2008/11/21/health/21abroad.html?_r=1
One of the many any issues that occur to me regarding international ‘medical tourism’ is how this impacts informed consent issues. A search for ‘medical tourism’ turned up the two following medical travel agencies. These are not providers or insurers. From what I can see, you sign your consent in the foreign country after consultation with the foreign doctor.
I wonder if this consent would hold up in the United States? After traveling thousands of miles for the purpose of a surgical procedure, isn’t an individual somewhat captive and under some duress and ‘forced’ to sign a consent? Or is traveling thousands of miles to get a elective surgical procedure a form of consent in and of itself? I have always been focused on health care in the United States and would like to know more about how ethical practices are handled in situations like this.
http://www.medicaltourismsolutions.com/procedures/sample_packages.htm
http://www.medpathgroup.com/
Thursday, December 11, 2008
Declaration of Helsinki Abandoned
Earlier this year the FDA made a decision that would replace the Declaration of Helsinki (DOH), a system put in place in the 1970s by the U.S. and several other countries to govern drug trials on humans, with a system called Good Clinical Practice (GCP). http://www.thenation.com/doc/20080602/shah In charge of this new system is the International Conference on Harmonization which consists of drug regulators and pharmaceutical representatives from the U.S., EU and Japan. Instead of the standards set in place by DOH, which outlined principles emphasizing that “extreme care must be taken in making use of a placebo-controlled trial” where proven therapies exist, this new system practically allows pharmaceutical companies to dictate their own ethical rules in conducting experiments.
Though the DOH wasn’t a perfect system either, as it had undergone numerous revisions and had been characterized as being too vague, it was much less biased than the system in place now. The significance of this change is that the FDA will now permit pharmaceutical companies to conduct clinical trials in which the control group could be treated with placebos. Instead of old treatments being tested against new treatments, this change allows new treatments to be tested against placebos. This is a departure from the DOH which restricted the use of placebos ensuring that the patients would not be denied already proven life saving treatments. The argument for using placebo groups in less developed countries rests on the justification that those patients wouldn’t have access to traditional treatments anyway, so the placebo experiments are merely testing the new treatment against the existing “standard of care”—meaning no treatment.
It’s obviously unfair that trials which would never be conducted in the U.S. are being conducted elsewhere, but what worse is that this new system approved by the FDA allows pharmaceutical companies to conduct trials on their own terms. At least the provisions by the DOH provided that patients would obtain access to the study drug after the trials ended and that the communities in which the drugs were tested would likely receive benefits from the research—but the GCP does away with these restrictions.
It’s well known that lack of consent is common in poorer countries, but under this new system, there will be far less oversight on pharmaceutical companies than there was previously. I wouldn’t be surprised if many of these patients were coerced into these experiments due to lack of any alternative treatments. The lack of informed consent combined with coercion leads me to consider that much of what’s going on bears resemblance to the crimes perpetrated by those found guilty in the Nuremburg Trials.
Though the DOH wasn’t a perfect system either, as it had undergone numerous revisions and had been characterized as being too vague, it was much less biased than the system in place now. The significance of this change is that the FDA will now permit pharmaceutical companies to conduct clinical trials in which the control group could be treated with placebos. Instead of old treatments being tested against new treatments, this change allows new treatments to be tested against placebos. This is a departure from the DOH which restricted the use of placebos ensuring that the patients would not be denied already proven life saving treatments. The argument for using placebo groups in less developed countries rests on the justification that those patients wouldn’t have access to traditional treatments anyway, so the placebo experiments are merely testing the new treatment against the existing “standard of care”—meaning no treatment.
It’s obviously unfair that trials which would never be conducted in the U.S. are being conducted elsewhere, but what worse is that this new system approved by the FDA allows pharmaceutical companies to conduct trials on their own terms. At least the provisions by the DOH provided that patients would obtain access to the study drug after the trials ended and that the communities in which the drugs were tested would likely receive benefits from the research—but the GCP does away with these restrictions.
It’s well known that lack of consent is common in poorer countries, but under this new system, there will be far less oversight on pharmaceutical companies than there was previously. I wouldn’t be surprised if many of these patients were coerced into these experiments due to lack of any alternative treatments. The lack of informed consent combined with coercion leads me to consider that much of what’s going on bears resemblance to the crimes perpetrated by those found guilty in the Nuremburg Trials.
Placebo Effect
A nationwide survey this year suggested that as many as half of U.S. doctors prescribe a fake treatment — or placebo — at least once a month.
That sounds.. relatively harmless to me. Studies have shown repeatedly that placebos are effective in treating health complaints with a strong psychological component, such as pain, depression, constipation and erectile dysfunction. As long as the pill that I am given is having its desired effect (i.e. reducing the itching on the rash I want to go away, calming my anxiety, etc.), then I have no problems with not knowing that there is actually no real "medicine" in the harmless pill.
However, the survey ALSO found that most doctors who prescribed placebos actually were using real drugs not proven effective in treating patients' complaints. These "impure placebos," such as antibiotics and sedatives, could be doing more harm than good.
And THAT.. is when it becomes frightening. It's one thing if I am being prescribed harmless "sugar pills" which do nothing but alleviate the mental component of my "illness", and thereafter alter some physical effects as well. It's entirely a different stories when I am unknowingly putting actual drugs with actual effects (and possible side effects) into my body without full disclosure by the physician. That to me is a very scary thought, borderlining on malpractice.
Article found at: http://www.usatoday.com/news/health/2008-12-10-placebo_N.htm?loc=interstitialskip
That sounds.. relatively harmless to me. Studies have shown repeatedly that placebos are effective in treating health complaints with a strong psychological component, such as pain, depression, constipation and erectile dysfunction. As long as the pill that I am given is having its desired effect (i.e. reducing the itching on the rash I want to go away, calming my anxiety, etc.), then I have no problems with not knowing that there is actually no real "medicine" in the harmless pill.
However, the survey ALSO found that most doctors who prescribed placebos actually were using real drugs not proven effective in treating patients' complaints. These "impure placebos," such as antibiotics and sedatives, could be doing more harm than good.
And THAT.. is when it becomes frightening. It's one thing if I am being prescribed harmless "sugar pills" which do nothing but alleviate the mental component of my "illness", and thereafter alter some physical effects as well. It's entirely a different stories when I am unknowingly putting actual drugs with actual effects (and possible side effects) into my body without full disclosure by the physician. That to me is a very scary thought, borderlining on malpractice.
Article found at: http://www.usatoday.com/news/health/2008-12-10-placebo_N.htm?loc=interstitialskip
Practical Ethics
I thought you might be interested in playing a game called 'practical ethics'. Once a month or so, AHA poses a fictitious ethical dilemma to its magazine readers. First, you read the question. Then take a minute to think about what you would do. Then you compare your thinking to two opposing responses from hospital CEOs.
I thought I would share this question on patient privacy - that's a bit different than what we have been discussing, but I thought I would leave you with something a little less profound to grapple with - ethics in the trenches.
QUESTION:
Two members of your staff took photos with cell phone cameras of patients in the emergency room. The photos were later posted on the Internet on social networking sites. Since then, you’ve dismissed the employees who were responsible, and it appears that the patients were unrecognizable in the photos. Still, there is concern in your organization that this could happen again—and potentially lead to HIPAA violations—and some think you should ban staff from having cell phones outside of employee-only areas as a precautionary step. What should you do?
++++++++++++++++++++++++++++++++++++++++++++++
Doug Vinsel, CEO, Duke Raleigh (N.C.) Hospital
The action taken has to be balanced and proportionate to the problem at hand. Certainly the scenario described is one that creates the potential for institutional embarrassment and liability. The dismissal of the employees involved and the presumed apologies to the patients/families is appropriate. While the thought of banning cell phones outside of employee-only areas is an understandable reaction, it is, I believe, an overreaction and an impractical way to address the misconduct of two employees. Employee education around the proper use of cell phones should be a requirement for department managers to ensure staff understanding of appropriate usage. However, the vast majority of staff can be trusted to use cell phones appropriately and understand the consequences of not doing so. We want to build a culture of trust and treating one another and our patients respectfully. Establishing a ban on cell phones is contrary to those principles.
+++++++++++++++++++++++++++++++++++++++++++++++++++++
Anthony Spezia, CEO, Covenant Health, Knoxville, Tenn.
We absolutely support and wholeheartedly agree with the terminations of the two employees. This is a clear violation of our corporate compliance program, code of conduct and our standards of behavior. I would not place the ban on staff. Our values are incorporated into our strategic plan, are utilized in many internal and external communications and are all approved by the board of directors. This is not a matter of compliance; it is a matter of conviction, faith and trust. If our culture is to be strong, we must trust employees to do the right thing in clear cases where a situation is covered by our policies and standards. This is such a case, and we would not support banning cell phones solely for the purpose of enforcing an articulated policy. We would not violate our employees’ trust, nor would we diminish their commitment to act according to our norms by taking away their cell phones. Rather, we would trust them and our strong culture of accountability.
This article 1st appeared in the November 2008 issue of HHN Magazine.
____________________________________________________________________________________PJM
I thought I would share this question on patient privacy - that's a bit different than what we have been discussing, but I thought I would leave you with something a little less profound to grapple with - ethics in the trenches.
QUESTION:
Two members of your staff took photos with cell phone cameras of patients in the emergency room. The photos were later posted on the Internet on social networking sites. Since then, you’ve dismissed the employees who were responsible, and it appears that the patients were unrecognizable in the photos. Still, there is concern in your organization that this could happen again—and potentially lead to HIPAA violations—and some think you should ban staff from having cell phones outside of employee-only areas as a precautionary step. What should you do?
++++++++++++++++++++++++++++++++++++++++++++++
Doug Vinsel, CEO, Duke Raleigh (N.C.) Hospital
The action taken has to be balanced and proportionate to the problem at hand. Certainly the scenario described is one that creates the potential for institutional embarrassment and liability. The dismissal of the employees involved and the presumed apologies to the patients/families is appropriate. While the thought of banning cell phones outside of employee-only areas is an understandable reaction, it is, I believe, an overreaction and an impractical way to address the misconduct of two employees. Employee education around the proper use of cell phones should be a requirement for department managers to ensure staff understanding of appropriate usage. However, the vast majority of staff can be trusted to use cell phones appropriately and understand the consequences of not doing so. We want to build a culture of trust and treating one another and our patients respectfully. Establishing a ban on cell phones is contrary to those principles.
+++++++++++++++++++++++++++++++++++++++++++++++++++++
Anthony Spezia, CEO, Covenant Health, Knoxville, Tenn.
We absolutely support and wholeheartedly agree with the terminations of the two employees. This is a clear violation of our corporate compliance program, code of conduct and our standards of behavior. I would not place the ban on staff. Our values are incorporated into our strategic plan, are utilized in many internal and external communications and are all approved by the board of directors. This is not a matter of compliance; it is a matter of conviction, faith and trust. If our culture is to be strong, we must trust employees to do the right thing in clear cases where a situation is covered by our policies and standards. This is such a case, and we would not support banning cell phones solely for the purpose of enforcing an articulated policy. We would not violate our employees’ trust, nor would we diminish their commitment to act according to our norms by taking away their cell phones. Rather, we would trust them and our strong culture of accountability.
This article 1st appeared in the November 2008 issue of HHN Magazine.
____________________________________________________________________________________PJM
No More Stretchmarks
http://www.commondreams.org/views02/0117-05.htm
This is article on the advancing medical technology of artificial wombs. Although it was of signifigant value in my final paper, I was unable to find evidence of any more research being done in this area.
Roe v Wade needs to be reevaluated and challenged with this new technology in mind. In 1973, abortion via surgical method was the only option. Since the 1990's we have many many herbal and chemical abortive options readily and cheaply available.
This is article on the advancing medical technology of artificial wombs. Although it was of signifigant value in my final paper, I was unable to find evidence of any more research being done in this area.
Roe v Wade needs to be reevaluated and challenged with this new technology in mind. In 1973, abortion via surgical method was the only option. Since the 1990's we have many many herbal and chemical abortive options readily and cheaply available.
TO Die Early
To Die Early
Persons that are considered mentally ill tend to die early. The question is why? Depending on the individuals mental illness they are granted surrogate or guardians that play a major role in their finances, property management if owned, and medical decision. So what are the contributing factors? The Association of State Mental Health Program Directors conducted research and determined that people that are severe mentally ill die 25years earlier than the general population. Therefore, the journey began to decide why this occurs. The illnesses that are prevalent are diabetes, obesity, and cigarette smoking. The diseases are all treatable and preventable. The socioeconomic factor does play a role for person without money do not always have access to healthcare and one could only image how hard it is to receive care when it is determined that you are mentally ill. The article pointed out that person who are mentally ill tend to substandard medical because physicians do not take their concerns seriously. Smoking was cited as the leading cause of death and in some psychiatry hospitals patients are used as reinforcement if behaved well the reward was a cigarette and if your actions were deemed deplorable a cigarette was denied. Obesity is contributed to medication and the adverse effects. As well the general public has an issue with obesity. If people are in a controlled area then why is exercise not included in their daily regimen. Not too compare state mental facilities to jail yet, in jail exercise is considered necessary for their quality life So is a person that is mentally disable, does their life lack quality. There are many changes that are occurring in that are require the standard of medical care for patients in a clinical setting. For example, the patient’s weight, fasting blood glucose test, and carefully reviewing the patient’s medical history. The issue I have are the standards that are set because the standards are the normal standard of care that each patient should receive. SO why was the standard so different for mentally ill patients.
KIRK
Article title: Why Do the Mentally Ill Die Younger?
http://www.time.com/time/health/article/0,8599,1863220,00.html
Persons that are considered mentally ill tend to die early. The question is why? Depending on the individuals mental illness they are granted surrogate or guardians that play a major role in their finances, property management if owned, and medical decision. So what are the contributing factors? The Association of State Mental Health Program Directors conducted research and determined that people that are severe mentally ill die 25years earlier than the general population. Therefore, the journey began to decide why this occurs. The illnesses that are prevalent are diabetes, obesity, and cigarette smoking. The diseases are all treatable and preventable. The socioeconomic factor does play a role for person without money do not always have access to healthcare and one could only image how hard it is to receive care when it is determined that you are mentally ill. The article pointed out that person who are mentally ill tend to substandard medical because physicians do not take their concerns seriously. Smoking was cited as the leading cause of death and in some psychiatry hospitals patients are used as reinforcement if behaved well the reward was a cigarette and if your actions were deemed deplorable a cigarette was denied. Obesity is contributed to medication and the adverse effects. As well the general public has an issue with obesity. If people are in a controlled area then why is exercise not included in their daily regimen. Not too compare state mental facilities to jail yet, in jail exercise is considered necessary for their quality life So is a person that is mentally disable, does their life lack quality. There are many changes that are occurring in that are require the standard of medical care for patients in a clinical setting. For example, the patient’s weight, fasting blood glucose test, and carefully reviewing the patient’s medical history. The issue I have are the standards that are set because the standards are the normal standard of care that each patient should receive. SO why was the standard so different for mentally ill patients.
KIRK
Article title: Why Do the Mentally Ill Die Younger?
http://www.time.com/time/health/article/0,8599,1863220,00.html
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