Chewing the Fat: Starting a Discussion of Ethical Issues in the Life-long Drug Treatments of Obese Children

The medical significance of obesity in children is found in the extract below from the Perspective section of the September 25, 2008 issue of the New England Journal of Medicine and available as a free full article titled
“Storm over Statins — The Controversy Surrounding Pharmacologic Treatment of Children” by Sarah de Ferranti, M.D., M.P.H., and David S. Ludwig, M.D., Ph.D.

During the past 25 years, the prevalence of pediatric obesity has tripled; in some minority-group populations, the majority of adolescents are overweight or obese. Recent research suggests that increasing body weight in childhood, even within the range considered normal, is strongly associated with the risk of cardiovascular disease in adulthood. Case reports have identified renal failure requiring dialysis, limb amputation, and death before 30 years of age among persons who developed type 2 diabetes during adolescence. Because of such effects, some experts have predicted that life expectancy will decrease in the United States for the first time in more than a century unless something is done about childhood obesity.

As you will read in the article, the American Academy of Pediatrics has released a revised recommendation for the management of elevated cholesterol in children based on evidence that hardening of the arteries begins in childhood and the treatment with statin drugs which lower the cholesterol in adults may reduce the chances that the child will later develop coronary artery disease or other diseases of the arteries. It is suggested by the recommendations that screening for fats in the blood begin at age 2 and drug therapy for elevated LDL (“bad cholesterol”) may begin in 8 year old children. This would be in addition to attempt to prevent or reduce childhood obesity through control of diet and exercise. The “storm” and the ethics regarding the recommendation is related first to the unknown harm on normal physiologic development in children when cholesterol levels are reduced. Is starting a medication in a child with its physiologic consequences unknown ethical? Also a "slippery slope" may begin so that other cardiovascular and metabolic medications given to adults will be started in children as preventatives for heart disease, hypertension and diabetes. Slippery slopes raise ethical concerns about laxity regarding further unknown harms with these medications. Remember, controlled research studies are far less common in children than in adults. Another ethical concern relates to whether pharmaceutical companies can rid themselves of their conflict of interest when they are evaluating the role of these drugs for use in prevention of the adult disease. After all, starting a life-long medication in childhood has a better financial outcome for the company than starting the drugs only when the child becomes an adult.

In addition, open to discussion is who is responsible for obesity in children? Simply genetics, the parents, the schools, society in general? Should the professional guidelines for treatment of obese children with drugs trump the need for the parents and others to attend to the proper nutritional and activity factors to prevent childhood obesity and its consequences? ..Maurice.

A Call for Help

I wonder if the visitors here have any idea what it is like to run a bioethics blog such as mine. I would like to give you an example of the experiences I receive as moderator. I have had many other similar experiences where a visitor has written me about their burdens and want my help to resolve some issue. Do I know if these writers are expressing a true issue in their lives or just "pulling my leg" so to speak? I don't but then should I just ignore their requests? I received the following e-mail from a female visitor today.

Doktor Mo

I realize this is probably your screen name, perhaps not, but I am searching for a way to end life peacefully.

It is my choice. Can you direct me to the right places to go for assistance.

Thank you

I wrote back the following:

You are asking a question that is impossible to answer with the absence of any information about the reasons for your "choice". What I also don't know is what you mean by "peacefully" as compared with other ways that life ends. Does "peacefully" mean without pain? without emotional suffering? quickly? In many terminal diseases such as end stage liver or kidney disease one might look at that kind of dying as peaceful since there is a gradual but persistent loss of awareness until death occurs. My understanding about what you mean by "peacefully" might help me understand why you have made a choice to presumably end your life. ..Maurice.

As a member of the human community how would you respond to this person's request, if you would respond? Do yout think my response was what you might have written? If not, would you have written more, written less? Or not even respond? Any suggestions? ..Maurice.

"Why Most Published Research Findings Are False”

“Why Most Published Research Findings Are False”. This is the title of an article by John P. A. Ioannidis writing in the August 30 2005 issue of PLoS Medicine

The Summary of the article is as follows:

There is increasing concern that most current published research findings are false. The probability that a research claim is true may depend on study power and bias, the number of other studies on the same question, and, importantly, the ratio of true to no relationships among the relationships probed in each scientific field. In this framework, a research finding is less likely to be true when the studies conducted in a field are smaller; when effect sizes are smaller; when there is a greater number and lesser preselection of tested relationships; where there is greater flexibility in designs, definitions, outcomes, and analytical modes; when there is greater financial and other interest and prejudice; and when more teams are involved in a scientific field in chase of statistical significance. Simulations show that for most study designs and settings, it is more likely for a research claim to be false than true. Moreover, for many current scientific fields, claimed research findings may often be simply accurate measures of the prevailing bias. In this essay, I discuss the implications of these problems for the conduct and interpretation of research.

There has been a general increase in computer literacy by the public. It is essential that the public also develop some literacy in the subject of medical research. Medical research conclusions appear virtually every day in one or another news media resource to which the public has access. Some studies are described in terms of warnings and some in terms of miracle discoveries. Many should not be taken at their media face value, though I suspect most of public would fully believe what they are told. I think that is because most of the public is not aware of what could make the results of a research project valid or non-valid. That is why it is essential that the public become more educated in what goes on in medical research. The public would then be skeptical and want to learn more about the topic rather than passively accept the news bite that they read or hear.

I find nothing wrong in the public being skeptical. These days we accept too much from government, politicians, scientists, “experts” and the news media without scratching our heads and asking “is what they are telling me really true?” And, unfortunately, even some scientists and/or the companies or institutions for which they work fail to be as skeptical about a research result as they should when the research project is faultily designed and carried out or there is some personal or financial conflict of interest present. A little research literacy by the public will go a long way. Become a bit more literate in this subject by clicking on the web link above and reading the article. ..Maurice.

Just Who Are We Medical Bloggers? An Answer

"Examining the Medical Blogosphere: An Online Survey of Medical Bloggers" by Ivor Kovic, MD; Ileana Lulic, MD; Gordana Brumini, PhD representing Rijeka University School of Medicine including the Department of Medical Informatics of the Rijeka University School of Medicine, Croatia has been published in the Journal of Medical Internet Research

Here is the Abstract of the article but go to the link above to read the full article. I look at medical blogging as not only to tell the visitors something of value but to also to "listen" to the visitors, since their comments may be equally valuable to us bloggers of medical issues. I know they have been valuable for me. With regard to my view of the role of medical bloggers and their blogs and an example of what values can be obtained, you might want to go to my thread “Medical Blogs: Who are They Good For?:My Answer on AMA News” where I reproduced the article I wrote and was published in the September 2008 issue of the American Medical Association News. ..Maurice.

ABSTRACT

Background: Blogs are the major contributors to the large increase of new websites created each year. Most blogs allow readers to leave comments and, in this way, generate both conversation and encourage collaboration. Despite their popularity, however, little is known about blogs or their creators.

Objectives: To contribute to a better understanding of the medical blogosphere by investigating the characteristics of medical bloggers and their blogs, including bloggers’ Internet and blogging habits, their motivations for blogging, and whether or not they follow practices associated with journalism.

Methods: We approached 197 medical bloggers of English-language medical blogs which provided direct contact information, with posts published within the past month. The survey included 37 items designed to evaluate data about Internet and blogging habits, blog characteristics, blogging motivations, and, finally, the demographic data of bloggers.

Pearson’s Chi-Square test was used to assess the significance of an association between 2 categorical variables. Spearman’s rank correlation coefficient was utilized to reveal the relationship between participants’ ages, as well as the number of maintained blogs, and their motivation for blogging. The Mann-Whitney U test was employed to reveal relationships between practices associated with journalism and participants’ characteristics like gender and pseudonym use.

Results: A total of 80 (42%) of 197 eligible participants responded. The majority of responding bloggers were white (75%), highly educated (71% with a Masters degree or doctorate), male (59%), residents of the United States (72%), between the ages of 30 and 49 (58%), and working in the healthcare industry (67%). Most of them were experienced bloggers, with 23% (18/80) blogging for 4 or more years, 38% (30/80) for 2 or 3 years, 32% (26/80) for about a year, and only 7% (6/80) for 6 months or less. Those who received attention from the news media numbered 66% (53/80). When it comes to best practices associated with journalism, the participants most frequently reported including links to original source of material and spending extra time verifying facts, while rarely seeking permission to post copyrighted material. Bloggers who have published a scientific paper were more likely to quote other people or media than those who have never published such a paper (U= 506.5, n1= 41, n2= 35, P= .016). Those blogging under their real name more often included links to original sources than those writing under a pseudonym (U= 446.5, n1= 58, n2= 19, P= .01). Major motivations for blogging were sharing practical knowledge or skills with others, influencing the way others think, and expressing oneself creatively.

Conclusions: Medical bloggers are highly educated and devoted blog writers, faithful to their sources and readers. Sharing practical knowledge and skills, as well as influencing the way other people think, were major motivations for blogging among our medical bloggers. Medical blogs are frequently picked up by mainstream media; thus, blogs are an important vehicle to influence medical and health policy.

Genetic Tests: Companies Selling the Test Directly to Consumers

Would you like to be tested for the GRK3 gene to know if you might get a bipolar psychiatric disorder? This gene variant at best is present in 15% of patients with bipolar disorder and 5% of all patients who do not have bipolar disorder. Psynomics advertises that for $399 they will test a sample of your saliva for the gene and then send a 6 page report to your doctor. How about any woman watching or reading the ad from Myriad Genetics, even if she had no family history, would she desire to spend $3,100 testing for the BRCA1 and BRCA2 hereditary breast and ovary cancer genes where less than 1% of the general public carry these genes and when, if present, carries a 50% to 85% lifetime risk of breast cancer and a 15% to 60% lifetime risk of ovarian cancer? (Notice that the risk estimates are rather wide.) And for the BRCA, the company will perform the genetic counseling to the woman. There is much controversy still about the ethics and value of direct to consumer (DTC) drug advertising which is monitored by the U.S. Food and Drug administration. Now here comes genetic testing offered by direct to consumer advertising where there is no governmental monitoring. And then, what is the personal and social implications of such advertised random testing? This entire subject and more is presented in the June 2008 issue of The American Journal of Bioethics which is not web accessible without subscription, but one of the authors, ethicist Arthur L. Caplan, presents his view of the BRCA cancer gene testing sales pitch on Bioethics.net.


The title of physician ethicist Howard Brody’s editorial in the Journal sets the context that the genetic testing companies are following the pharmaceutical companies’ line to promote their product “Ask Your Doctor If This Genetic Test is Right For You”

But that’s the point, most doctors are not specialists in genetics and not able to make a decision at this stage of knowledge what are the benefits vs the risks of performing genetic tests on healthy people, particularly the young. They also are not skilled in genetic counseling of their patients regarding the value or the interpretation of the results of the tests. So then it becomes the responsibility of the individual with the “help” of the gene testing company to decide whether the results are worth the costs, the emotional consequences, unnecessary medical procedures and treatments, the implication for families and the impact of disclosure of the results of the testing on the individual’s insurance and job.

If genetic testing companies find that broadcasting direct to consumer advertising is simply their right to freedom of speech (and make some money) and ignore the ethical and social consequences of what they are doing, they should be held accountable for the negative consequences and not shift the responsibilities to anyone else including the physicians of those readers and viewers to whom they advertise. ..Maurice.

Following the Signs: Standards of Medical Practice

Just as an automobile driver must follow the signs and not drive at any speed selected by the driver and must obey signs that demand caution and attention, physicians practicing medicine must also follow signs along the road of diagnosis and treatment. The signs represent the standards of medical practice which are supposed to guide the physician safely and effectively as he or she manages a patient. They represent what is currently acceptable. Examples of such standards currently would be how heart attack patients are diagnosed and treated, how death by neurologic criteria (so-called “brain death”) is established, how a case of suspected thrombophlebitis is worked up and treated and, in general what treatments are appropriate for what illnesses. If a physician fails to obey the standards and an accident occurs, as with a driver ignoring the red light, there may be legal consequences.

Where do these standards of medical practice come from and who enforces them? Interestingly, some standards may have arisen many years ago, derived from physician experience and hearsay leading to informal consensus as an accepted practice and never have been changed. Some standards, especially in modern times, have been based on clinical studies which provided evidence based conclusions. Some standards are set by professional organizations, often for their own sub-specialties in medicine or surgery. Some standards represent a consensus by society or laws set by legislation or by state medical boards. Insurance companies and health maintenance organizations also set standards of practice that they expect their patient’s physicians to follow. Also, there has been suggested that some standards may have been introduced by pharmaceutical and medical instrument companies for the company's financial interest but not necessarily in the interest of the doctor or the patient. Standards of medical practice also include not only those related to diagnosis and treatment but also ethical and professional behavior as set by physician associations such as the American Medical Association.

From a legal point of view, standards are not expected to be followed to the same extent everywhere. Some standards may be dependent on where the physician practices and what resources are available. A physician treating an acute stroke patient in a rural area away from medical centers may not be able to meet all the criteria set for treating a patient in a major city. Standards also may vary with the type of practice a physician is engaged. The standards for a general physician who has had no specialty training will be different than a physician with specialty training. Further the standards may be different between the various specialties. In fact, in court cases, it requires an expert witness who is familiar with the specific standards for the physician defendant to establish which standards were followed and which were not. Some standards may not be the same in all countries since the laws, resources and cultural settings may be different.

With regard to who enforces the standards of practice, beyond the courts, it is the various state medical licensure boards in the United States and the other similar organization in other countries. As with traffic signs, the physician must be able to defend his or her practice decision if the standards are not followed. ..Maurice.

GRAPHICS AND THEIR RELATION TO THE CONTEXT OF THE THREAD:
(Photographs taken by me in a neighborhood in Arroyo Grande, California 9-14-2008.)

END- Standards of practice which dictate that further attempts at curative therapy will be fruitless and that these attempts should be terminated but that comfort care should be continued.
SLOW- Standards of practice which dictate that there is valid concerns regarding the benefit vs risks of a procedure or treatment and that to continue to follow the same course should be carefully reconsidered.
STOP- Standards of practice which dictate that no value has been established for a procedure or treatment for the patient's condition (often requested by patient or family) and that it should not be further considered and if started should be stopped.

"Decay of American Culture" and Our Health Care System

Dr. Erich Loewy, physician-ethicist who has written to this blog several times in the past and who is very outspoken in expressing his beliefs has written another commentary which is an analysis of American culture and its consequences including its relation to medical care. Now, within the United States there is debate as to how to change the healthcare system to provide appropriate care to all but especially also to those who find no easy way to obtain and pay for their care. Some may find objections to what Dr. Loewy writes and, if so, their opposing views are certainly welcome on this blog. ..Maurice.

Several issues have been posted on Dr. Bernstein's superb discussion blog. I do believe that there are certain things they have in common. Dr. Bernstein, for example, brought up the problem of Islamic students who refuse to do some things on the grounds of their particular belief system which I do not think reflects the view of most Imams. I have had many students who were Muslim and never in about 40 years of teaching have ever had this type of problem. My best friend Manucher Mavendad unfortunately now dead used to frighten people in the lobby if by chance we came in through opposite door and he would say "you miserable Jew!!" and I would respond with "you filthy Arab"---by now our audience was certain that we would slay one another when we physically met. Instead of it we walked out together laughing. We were medical students--what do you expect.

I have watched over the years a decay in American culture (I fled here from the Nazis at age 11 in late 1938) which is frightening. I am told--I was not in the US than--that there was quite a bit of solidarity at the time of the Depression and people had and needed solidarity and mutual helpfulness. Over the years this country has become more and more obsessed with material values until today we have a lop-sided society.

I totally agree with what other ethicists have said. We who are employed by Universities (not only but perhaps even more so if these institutions are either state or receive state and federal funds) are employed to teach what we today believe the "truth" at the same time as saying that much of what we call "truth" today will probably be found to be wrong tomorrow. That we cannot know and we can only try to do three things: (1) Carefully teach the up-to date state of knowledge; (2) Serious thoughts of what are likely to be found to be problems tomorrow; and (3) Say that skepticism if not carried to a paralyzing extreme is healthy up to the point where it stops us from acting today because we may know better tomorrow.

The curriculum that was the framework of American Medical Education has been severely threatened by a paucity of state or federal funds and substituting for these grants from the Pharmaceutical Industry. In other words Pharma has essentially said "why should we do the research when we can "buy the University." It might have been thinkable if all medical schools for once got together to say to the federal and state governments: "we cannot run what we consider to be an excellent University without your funding us. We will not reduce or accommodate to the Pharmaceutical Industry because we feel quite certain that (for business reasons) they would swallow us. Having Pharma putting what they would have been ready to spend for grants into a common pool with no one knowing what came from where and having a board of people decide who gets what from the pot to me is thinkable.

I think that Capitalist greed (with its insistence of autonomous individualism as the highest good) will eventually undo us. I also think that these various things are made from the same cloth: support of industry; the growing number of poor, the old who throughout life worked hard at a rather menial job with a poor salary and who now (because they were poor their whole life) receives a totally inadequate social security; Medicaid and Medicare which are completely inadequate and co-payments which patients cannot afford and which makes their being insured a farce; a racist society covered by PC and a Democracy which lacks what John Dewey called the necessary underpinnings of political democracy. To whit: (1) Personal democracy; (2) Economic democracy and (3) Educational Democracy to which I would add Roosevelt's freedom from fear and freedom from want. We have in large and small things lost trust in our fellow man. This is a vicious circle: I think you do not trust me and therefore I do not trust you. This nation fails to understand solidarity and its rich possibilities for all of us.

The second paragraph of Jefferson's Declaration of Independence not only tells us in very few words what all people aspire to but also makes it clear that governments are instituted to protect these freedoms. If government fails to do this, the population has every right to get rid of that government which is more likely to preserve these rights and which is our (and not industries) servant. Indeed we not only have a right to do this we have a duty to act this way.

Hopefully such a change will be peaceful but with every day that passes I doubt it more. At the moment the population is too indolent and once they have been hit as individuals they complain but have lost all power. A revolt without knowing just what to put in place after they have succeeded chaos ensues and ultimately the need of the people to no longer live in chaos leads straight to the strong man.

We in medicine will, inevitably, be affected. Our current health-care system is the result for decades of an obstinate AMA which only wished the status quo. That, thank heavens, has changed. As citizens and as physicians we should, I believe, heavily participate in creating a health-care system were all have their needs taken care of.

Dr Erich H. Loewy
Professor of Medicine and Founding Chair of Bioethics (emeritus)
Associate in Philosophy
University of California, Davis

Muslim Culture and the Practice of Medicine: Issues of Teaching a Muslim Medical Student in the United States

I teach first and second year medical students how to relate to patients, take a medical history and perform the physical examination. My medical school, as do all medical schools in the United States accept students from all different cultures and religions. There are various issues involved in teaching students which arise and need to be resolved despite they have already been accepted to medical school and have begun their studies. I have recently been made aware of medical student issues that happen to be related to students of Muslim culture and religion. The issues do not arise with every Muslim student as far as I know but it has arisen and I really don’t know what the issues represent and how to deal with them yet meet my responsibility to develop a professionally competent physician.

Some of the issues, occurring in Great Britain, are described in an article in the October 7 2007 issue of the UK TimesOnline an excerpt of which follows:

Some Muslim medical students are refusing to attend lectures or answer exam questions on alcohol-related or sexually transmitted diseases because they claim it offends their religious beliefs.
Some trainee doctors say learning to treat the diseases conflicts with their faith, which states that Muslims should not drink alcohol and rejects sexual promiscuity.
A small number of Muslim medical students have even refused to treat patients of the opposite sex. One male student was prepared to fail his final exams rather than carry out a basic examination of a female patient.
The religious objections by students have been confirmed by the British Medical Association (BMA) and General Medical Council (GMC), which both stressed that they did not approve of such actions

I am pleased to have visitors to my blog from all over the world including countries where there is a strong Muslim culture. I would most appreciate visitors from those countries to write here and educate me how medicine is practiced there in terms of for example, physical examination of patients of opposite gender. Is the body exposed in any way (if so, what way?) and what degree of touching (or what we call palpation) is carried out? Are there aspects of the history which are not allowed to be asked a patient? What are the standards of medical practice in Muslim countries? Are there special instructions that are given to medical students in those countries to be in keeping with the Muslim culture and religion? What do you think should be United States medical school teachers’ response to Muslim students’ requests for excluding asking certain questions or excluding examinations on certain genders? I truly look forward to learn. Please help me. ..Maurice.

Sleep: A Right, A Duty? Regulated by Law? Something to Medicalize?

Sleep, sleep, sleep. What do you know about both the physiologic but also the cultural aspects of sleep? To begin to learn about the “rights and duties of a sleeper”, go to the September 2008 issue of Virtual Mentor and read the piece by Robert Meadows.

Do we all have the right to sleep? Where should we be allowed to sleep? Are we responsible for our behavior and actions while we are asleep? Should who is in our bed when we sleep be regulated by laws? What are our responsibilities to others to obtain a good night’s sleep and awaken refreshed and ready to work? Must we wear specific clothing when we sleep? Does sleep have to be medicalized: that is, if someone has trouble getting to sleep or not able to sleep some specified number of hours, that this represents a medical disorder and that it should be treated as a disease with medications as indicated?

Read the above article and return with your comments about the “rights and duties of a sleeper”. ..Maurice.

Ethical Dilemmas:Playing Ethicist: Almost Anyone Can Do It

You don’t have to sell yourself as an ethicist in order to “play" an ethicist, suggesting answers to hypothetical cases. My view, previously expressed on this blog, is that most every awake and interested person has the capacity based on their own knowledge, experience and viewpoint, to play ethicist and make a significant contribution toward resolution of an ethical dilemma.

Just to demonstrate the validity of my view, I have created 4 potential ethical dilemmas and request my visitors to play ethicist pretending that you are faced with the issue and have the responsibility of talking to the doctor, patient or family member about what you would suggest as a solution to the dilemma. By the way, in attempting to solve an ethical dilemma, it is essential that the ethicist or “play ethicist” make sure that they have all the facts of the case needed to help resolve the dilemma. Without the necessary facts, one cannot generally make an ethical decision. Try these hypothetical cases out and then write and let me know your answers to the questions and your decisions. ..Maurice.


1. A 65 conscious man on a ventilator for life support tells the doctor, by writing a note, that he wants the ventilator turned off. The doctor knows that if she turns off the ventilator the patient will die in a few minutes. What further information would you need to know in order to advise the doctor whether what is requested by the patient is ethical and legal?

2. A baby born 6 days ago without a brain but with a brain stem that is allowing the baby to breathe and maintain blood pressure has developed pneumonia. The mother insists that the doctor treat the pneumonia. The father wants the doctor to allow the child to die. What would you recommend to the parents and the doctor?

3. Two children one age 5 and the other age 7 were born with a genetic disorder which limits their life to less than 15 years. The mother is again 2 months pregnant and asks the doctor for advice as to what to do. However, the doctor holds moral views and by religion is against abortion. What would you advise how the doctor should respond to the mother?

4. A father brings into the emergency room his 3 year old child for a bloody nose but is found by the doctor to have a fresh bruise on the left buttock and right shoulder. What facts should the doctor know before breaking patient confidentiality rules and report these findings to governmental authorities as suspected child abuse?