Patient Modesty: Volume 53

                                                                                                                                       

The matter of how patients can get their physical modesty issues known, acknowledged and satisfied by the medical system seems to be a repetitive consideration on this blog thread and continues with no final conclusion. With regard to this issue, I thought to add to the conversation or perhaps even throwing in a "monkey wrench", so to speak, by putting up the graphic for this Volume which displays a known expression  thought to be a solution but then, on second thought, it might not be considered acceptable by some of my visitors. Instead they may say "we must change what we can get!" Ah! That will make the solution more complex. So what is the answer? Continue the discussion and maybe an answer will find consensus. ..Maurice.

p.s.- For those visitors who would like to access the recent conversation of my thread on this issue,
click on this link to Volume 52.

Graphic: Created by me with ArtRage and Picasa 3.

NOTICE: AS OF TODAY APRIL 29 2013 "PATIENT MODESTY: VOLUME 53" WILL BE CLOSED FOR FURTHER COMMENTS. YOU CAN CONTINUE POSTING COMMENTS ON VOLUME 54.

Challenging Your Autonomy: Others Telling You What Not to Eat

It is all about what has been called the "precautionary principle" which as defined in Wikipedia (where you can read all about it): "The precautionary principle or precautionary approach states if an action or policy has a suspected risk of causing harm to the public or to the environment, in the absence of scientific consensus that the action or policy is harmful, the burden of proof that it is not harmful falls on those taking an act. This principle allows policy makers to make discretionary decisions in situations where there is the possibility of harm from taking a particular course or making a certain decision when extensive scientific knowledge on the matter is lacking. The principle implies that there is a social responsibility to protect the public from exposure to harm, when scientific investigation has found a plausible risk. These protections can be relaxed only if further scientific findings emerge that provide sound evidence that no harm will result.In some legal systems, as in the law of the European Union, the application of the precautionary principle has been made a statutory requirement."

Do you want your government to order you or, if not, pressure you, what to eat and what not to eat and all based on the application of the "precautionary principle"?

I found an excellent discussion of this issue in The New York Review of Books review by Cass R. Sunstein who reviews the book"Against Autonomy: Judging Coercive Paternalism" written by Sarah Conly. The review starts out with the introduction "In the United States, as in many other countries, obesity is a serious problem. New York Mayor Michael Bloomberg wants to do something about it. Influenced by many experts, he believes that soda is a contributing factor to increasing obesity rates and that large portion sizes are making the problem worse. In 2012, he proposed to ban the sale of sweetened drinks in containers larger than sixteen ounces at restaurants, delis, theaters, stadiums, and food courts. The New York City Board of Health approved the ban."

Sunnstein then compares the views of John Steward Mill's well-known essay "On Liberty" ("Mill insisted that as a general rule, government cannot legitimately coerce people if its only goal is to protect people from themselves. Mill contended that the only purpose for which power can be rightfully exercised over any member of a civilized community, against his will, is to prevent harm to others. His own good, either physical or mental, is not a sufficient warrant. He cannot rightfully be compelled to do or forbear because it will be better for him to do so, because it will make him happier, because, in the opinion of others, to do so would be wise, or even right.") with that of Conly.

Her view, as introduced by Sunstein is "Sarah Conly’s illuminating book Against Autonomy provides such a discussion. Her starting point is that in light of the recent findings, we should be able to agree that Mill was quite wrong about the competence of human beings as choosers. 'We are too fat, we are too much in debt, and we save too little for the future.' With that claim in mind, Conly insists that coercion should not be ruled out of bounds. She wants to go far beyond nudges. In her view, the appropriate government response to human errors depends not on high-level abstractions about the value of choice, but on pragmatic judgments about the costs and benefits of paternalistic interventions. Even when there is only harm to self, she thinks that government may and indeed must act paternalistically so long as the benefits justify the costs."

Please go to the New York Review of Books and read the entire review and then return to post here your views of whether John Steward Mill is right or the view held by the author Sarah Conly or some alternate view that you hold. ..Maurice.

GIF Graphic: From Tumblr, John Locke

"Innovative Treatment" vs Research: Which is It?

The following original article which I wrote and was published today at the bioethics.net website is reproduced here with permission.  I will put some additional comments as an Addendum at the end of the copy. ..Maurice.
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February 19, 2013 12:30 pm

“INNOVATIVE TREATMENT” VS RESEARCH: WHICH IS IT?

Maurice Bernstein, M.D.

When does a doctor’s treatment of a patient become medical or surgical research? If what the doctor does is a standard and accepted method of therapy using proven medications or surgical techniques and represents nothing novel then at first glance what is occurring cannot be designated as research or can it? Ah! But here is where the issue of “innovative treatment” versus “medical/surgical research” become clouded. The United States government has set a standard regarding what activities by physicians could be called research and what could not based upon the April 19,1979 Belmont Report summarizing a governmental commissions conclusions and set the ethical standards for the ethics of research. The standard of what is research is summarized in the IRB Handbook (1993)

if there is a clear intent before treating the patient to use systematically collected data that would not ordinarily be collected in the course of clinical practice in reporting and publishing a case study. Treating with a research intent should be distinguished from the use of innovative treatment practices.

The government considered this distinction important because it would then separate physician activities carried out as a part of usual physician care of a patient from medical or surgical research. Such a distinction would then permit usual care to be free from government research oversight including institutional bodies known as IRBs (Institutional Research Boards).

For those readers unaware, IRB’s as described in Wikipedia:

An institutional review board (IRB), also known as an independent ethics committee or ethical review board, is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans. They often conduct some form of risk-benefit analysis in an attempt to determine whether or not research should be done. The number one priority of IRBs is to protect human subjects from physical or psychological harm. In the United States, the Food and Drug Administration (FDA) and Department of Health and Human Services (specifically Office for Human Research Protections) regulations have empowered IRBs to approve, require modifications in planned research prior to approval, or disapprove research. IRBs are responsible for critical oversight functions for research conducted on human subjects that are ‘scientific’, ‘ethical’, and ‘regulatory’.

It is apparent that an activity either being research or not being research can then involve or then not involve a host of governmental scrutiny and interference toward the physicians participating.

As you can read from the definition of research, the novelty of the treatment is not part of the criterion. The basic distinguishing characteristic that research is to be or is carried out is simply whether there was intent to collect data from that treatment and then formally present the data to others. It has nothing to do with whether the treatment was innovative or a standard medical or surgical practice. For example, a doctor finds through his or her reading or perhaps from a colleague that the off-label use of an established drug might be of value to a patient whom is not responding to the usual drugs prescribed.  Prescribing that drug without the intention to collect some patient data (such as an improvement in white blood cell count) in order to document the response as part of a communication of the value of the drug’s use to others by lecture or journal article would make this simply “innovative treatment” and not research. And the surgeon could be trying out on a patient a different approach in the procedure used to perform the operation and not documenting the apparent benefit or apparent complications of that procedure intentionally to be part of some formal presentation, then this could be considered only “innovative treatment” and not research.

Now, of course, the matter of informed consent by the patient would still apply and any complications from the off-label use of a drug or the non-standard operative procedure would still be the professional responsibility of the physician. But nevertheless, the government’s definition of research eliminates all the detailed disclosure requirements and safety precautions presumably part of the government’s  creation and utilization of IRBs.

So, what about the ethics of the separation of research from “innovative treatment”? Autonomy (the principle of self-determination by the patient) and Beneficence (the need to look toward doing good to the patient) should still be the paramount ethical principles in whichever activity is performed. I think that the following abstract from the American College of Obstetrics and Gynecology’s Ethics Guidelines sets the responsibilities of any physician who plans to veer away from common standards of practice as “innovative treatment” (whether medication, tests or procedures);

Innovations in medical practice are critical to the advancement of medicine. Good clinicians constantly adapt and modify their clinical approaches in ways they believe will benefit patients. Innovative practice frequently is approached very differently from formal research, which is governed by distinct ethical and regulatory frameworks. Although opinions differ on the distinction between research and innovative practice, the production of generalizable knowledge is one defining characteristic of research. Physicians considering innovative practice must disclose to patients the purpose, benefits, and risks of the proposed treatment, including risks not quantified but plausible. They should attempt an innovative procedure only when familiar with and skilled in its basic components. A clinician should share results, positive or negative, with colleagues and, when feasible, teach successful techniques and procedures to other physicians.  Practitioners should be wary of adopting innovative procedures or diagnostic tests on the basis of promotions and marketing when the value of the procedures or tests has not been proved. A practitioner should move an innovative practice into formal research if the innovation represents a significant departure from standard practice, if the innovation carries unknown or potentially significant risks, or if the practitioner’s goal is to use data from the innovation to produce generalizable knowledge. If there is any question whether innovative practices should be formalized as research, clinicians should seek advice from the relevant institutional review board.

My take: Though the separation between what is “innovative treatment” and research may still be a bit hazy for full satisfaction, to me it is how the physician, despite the government’s definition, behaves toward the patient defines the ethics to whichever activity is occurring and that is most important.
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Addendum:  I want to explain why I am concerned that the separation between "innovative treatment" and research is not as clear as I would like particularly for a professional action which could have far reaching effects in relation to its management, supervision and consequences.

 In the basic governmental document Code of Federal Regulations Title 45 Part 46 "Protection of Human Subjects", Section 46.102 (d) defines research as "Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. "

The IRB Guidebook then specifies research as "if there is a clear intent before treating the patient to use systematically collected data that would not ordinarily be collected in the course of clinical practice in reporting and publishing a case study" that it is "intent before treating" which is the defining criterion. It should be noted that this statement was an official IRB Guidebook answer  regarding the specific question: "Can treatment of a single patient constitute 'research'?" Since this definition is applied to a single patient, I assume that the definition applies to a dozen or hundreds of patients.  How is intent of the physician established and who decides  if not the physician him/herself?  And then what is "systematically collected data that would not ordinarily be collected in the course of clinical practice"?  I guess that is why defining what is research and what is not is really a matter of consensus.  What do you think?  ..Maurice.
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Medical "Curbside" Consultations:Are There Problems with It?

If you didn't already know, what is called in the medical profession "curbside consultations" are going on
every day and really no standards of practice have been set for this behavior. "Curbside Consultation" is simply a brief meeting between two doctors, perhaps in a hallway of a hospital or at the same dining table and one doctor is taking care of a puzzling case of a sick patient and asks the other doctor who isn't involved with the care of that patient to give some advice about what to do next in terms of workup, diagnosis or treatment. Often the requesting doctor is one in general medicine and the other is a specialist but may be just another general physician who has had a similar case. In this brief conversation, the requesting doctor will attempt to present some of the facts (history, physical findings and labs) that the doctor can recall and present in a few minutes or less and then will wait for advice and suggestions made by the "curbside consultant" doctor.The patient is usually unidentified and the case is usually unknown by the "consultant". This activity is considered and performed as a "professional courtesy", a friendly and perhaps expected professional communication between two doctors, in which the "consultant" is not providing the advice for any fee and has no intent to provide direct management to the patient under discussion and a consultation about which the patient is unaware and may not be told later. This is in contrast to a formal consultation where a referring physician informs the patient of the need for consultation and arranges an appointment with the consultant who may provide further diagnosis and advice and perhaps further management   of the patient.

One motivation for the curbside consultant to participate may be to be considered by the referring physician for later formal care. One motivation for the requesting physician to ask for a "curbside" would be get advice for no monetary charge to the patient. Occasionally, the requesting physician may repeat communication with the doctor who had made the "curbside" advice as a courteous followup report. However,the requesting doctor may be looking for addition advice. Repeated followup informal consults may not be appreciated by the consult doctor both out of concern for the proper care of the patient and for the consulting doctor's own financial interest.

As I have already mentioned, though this consultative action has great popularity in the medical profession and is considered a common and professionally accepted activity, the law and the ethics of "curbside consultations" is missing.This is unfortunate since this lack of rules can lead to malpractice actions taken upon the consulting doctor as well as the requesting doctor if serious problems in the patient's management occurs. In this regard, it is not clear whether the consulting physician's name should be noted in the patient's medical records. Laws defining malpractice issues in this form of consultation may vary from state to state in the United States. The threat of malpractice, may, particularly if large financial penalties of malpractice suits are decided, discourage such consultations and might impair a route of possible valuable transfer of medical advice. It also is unclear whether Federal HIPAA laws regarding privacy of the patient's history,identified by name or not, permit informing another individual who is not directly attending the patient for care or responsible for insurance payment. In addition, there is no consensus with regard to what the consulting physician's ethical responsibilities such as attention to doing a "good" and avoiding harm, are with regard to the unnamed patient. Or would all ethical responsibilities remain with the patient's own physician? Another issue is whether it is ethical for the patient's physician to carry out a consultation with another physician without necessarily providing the full medical history and without the patient's knowledge or permission, both of which might be considered ethically unprofessional. I suggest that in view of these uncertainties within a long establish and common professional activity, it is important that these questions should be answered from both the legal and ethical aspects so the requesting doctor and the "curbside consultant" and the patient will be aware of what are the limits of this practice.

My question to my visitors is with the information I have written about "curbside consultations", would you want your doctor, if he or she felt it was necessary, to request from another doctor such a consult? Or would you rather have a formally arranged appointment with the consultant? If you were aware that the "curbside" activity had already occurred in your case and without your prior knowledge, would you approve? Would you consider that the doctor who advised your physician in this manner had any personal or professional responsibility of what would actually happen in your care if so should be held responsible? ..Maurice.

Graphic: "At Curbside" photograph taken by me 2-10-2013.

Following Orders: Obedience to Authority Figures in Medicine

When your doctor urges you to do something said to benefit your health, do you obey? If not, why not? This blog thread is about how my visitors feel about following orders from those who might be considered as "authority figures in medicine". What follows is a series of questions, a sort of a survey.

What do you consider as an order? "Stop your smoking?" "Loose weight" Do you look at a prescription written for you as an order?

If you tend to avoid following orders, is it because you disbelieve the benefit, it is impractical to carry out the order or you believe in personal decisional autonomy and you refuse to follow health orders by others, particularly those who appear as authority? Would you first want to know if those giving you the order would or have followed it themselves?  How do you look at a doctor who is giving you not an order but giving you advice? Or how about a recommendation?  Do you consider advice differently than an order? If so, what do you see as a difference between recommendation or advice and an order from a personal point of view? Should recommendation or advice be more acceptable to you than an order? Would you consider following such advice based on the professional responsibilities of the authority? For example, would you be more likely to follow advice from a nurse or a pharmacist than from your physician? Or how about from the next door neighbor? Would the neighbor's personal medical experience represent to you an "authority"?

Do you look upon certain members of the news media who speak about health issues as authority? Would you consider following their advice on their subject? How about pharmaceutical company advertisements? Do you consider the ads as representing the advice of a medical authority? When the ad says for a product "talk to your doctor", would you be willing to do that?


A lot of questions but without answers from my visitors  there won't be much more to learn from this thread! So.. should I order your responses??  ..Maurice.

Graphic: My photograph of an exercise session, Santa Monica Beach, CA. Feb. 2013.