Adventures in Ethics and Science

You may recall my examination earlier this month of a paper by Johnson and Stricker published in the Journal of Medical Ethics. In my view, it was not a terribly well-argued or coherent example of a paper on medical ethics. Now, judging from an eLetter to the journal from Anne Gershon, the president of the Infectious Diseases Society of America (IDSA), there is reason to question the factual accuracy of that paper, too. The Johnson and Stricker paper promised an exploration of ethical issues around an antitrust investigation launched by the Connecticut Attorney General examining the IDSA’s process for developing guidelines for Lyme disease. In particular, Johnson and Stricker suggested that conflicts of interest led the IDSA panel to improperly exclude “chronic” Lyme disease from their disease definition and treatment guidelines.

It’s true that IDSA has a horse in this race. However, as I noted in my earlier post, so do Johnson and Stricker. And unlike Johnson and Stricker, IDSA president Gershon seems to have a good handle on how to frame coherent and persuasive arguments.

From Gershon’s eLetter:

This article is riddled with inaccuracies and misleading information. The article is the latest salvo from a small but vocal group of physicians and patients who attribute a wide range of vague symptoms to what they call “chronic” Lyme disease. To treat “chronic” Lyme infection, this self-described “Lyme-literate” group promotes the use of long-term antibiotics – often delivered intravenously for months or even years. The cost of this treatment must be borne by patients themselves, leading a discerning person to question the authors’ interest in the real reason why they want the treatment guidelines changed.

Blinded, randomized controlled trials show that long-term antibiotic treatment is not effective for any condition described as “chronic Lyme” – a condition that currently has no consistent diagnostic markers. Far worse, this treatment has been shown to be extremely risky, potentially leading to fatal infections, serious drug reactions and fostering development of life-threatening drug-resistant superbugs. That this group continues to use its assaults on the IDSA and its Lyme disease guidelines as a platform to promote a not only unproven but expensive and potentially dangerous therapy is, we believe, clearly unethical.

Central to medical ethics is the welfare of the patient. The patient has expectations of the health care provider based on the health care provider’s specialized knowledge. Accordingly, the health care provider has an obligation to ensure that his or her treatment of the patient is guided by the best available knowledge. As a professional community, physicians recognize that the best knowledge comes from blinded, randomized controlled trials. Thus, they have a duty to take account of such knowledge in their efforts to help their patients and to avoid causing them harm.

Gershon suggests that setting aside this duty to be guided by the recognized body of medical knowledge in favor of the “physician autonomy” Johnson and Stricker seem to prioritize is unethical.

Gershon continues:

[T]he authors seem intentionally to confuse Lyme disease – a proven and highly treatable illness – with “chronic” Lyme infection, an unproven condition that a small group of doctors may provide as a “diagnosis” for patients with vague but often serious symptoms. There is no solid evidence of the existence of “chronic” Lyme infection. Although we do not doubt that there are patients who initially were treated for Lyme disease infection and subsequently have ongoing, vague symptoms, we are concerned these patients likely are suffering from a different or new illness and are receiving potentially dangerous “treatment” rather than being evaluated, properly diagnosed, and treated appropriately.

This nicely illustrates one of the other harms that may come from misdiagnosis or mischaracterization of an illness. Not only is the patient subjected to a treatments that, from the best data the medical community has, cannot be expected to work and can be expected to cause harm, but the patient’s actual condition is not recognized, thus preventing the patient from getting treatment that might actually help.

There is a harm of commission (in giving the patient an inappropriate and potentially harmful treatment) and a harm of omission (in failing to identify the treatment the patient really needs).

As to Johnson and Stricker’s charge that the IDSA panel cherry-picked the medical literature to support its preexisting conclusions, Gershon writes:

The IDSA Lyme disease guideline panel spent months scouring all of the Lyme disease research. Specific studies were not “selectively ignored,” but in fact stringently reviewed along with all of the other research. Based on widely accepted principles of evidence-based medicine, some studies were determined to lack scientific rigor, and were therefore not used as a basis for treatment guidelines.

Unless we accept Johnson and Stricker’s suggestion that physician autonomy is the good that should be prioritized above all others, it seems completely appropriate that the expert knowledge that informs treatment decisions be knowledge that meets the methodological standards recognized by the medical community — in other words, that the guiding knowledge be recognized as knowledge by the community, rather than as claims that haven’t been sufficiently tested or proven.

Gershon’s letter presents more detailed responses to other claims Johnson and Stricker make about the IDSA and their Lyme disease guidelines. But these passages are enough for us to see her central idea, that their paper which purports to be about medical ethics seems itself to fall short of the central tenet of medical ethics, First, do no harm.

Comments

  1. #1 Kate
    May 26, 2009

    I do not have the expertise to comment on the validity of the chronic Lyme disease diagnosis. But I want to comment on another, related issue.

    I wonder if doctors have considered what drove those patients with “vague, serious symptoms” to seek the kinds of doctors who would give them the diagnosis of chronic Lyme disease? My mother’s multiple sclerosis symptoms were ignored for almost *twenty years* before she pushed hard enough to be taken seriously. My sister’s gluten intolerance, and my own, is not believed by doctors despite the evidence of a mother with an autoimmune disease and the presence of gluten autoantibodies in our systems. None of us were ever quite driven to doctors championing odd diagnoses, yet we certainly could have been.

    I have been told by some doctors that they don’t “believe in” gluten intolerance. But my symptoms disappeared once I stopped eating gluten. My experience has not always been that doctors follow evidence-based medicine, but whatever traditional diagnoses they learned in med school (they also learn some incorrect physiology that is thirty years out of date regarding, as one example, hypotheses regarding age at menarche).

    I don’t blame them, because the ridiculous amount of paperwork, the long hours they put in, etc, make it very difficult to keep up with the literature. And yet I do blame their attitude for driving desperate people to desperate measures, like months of IV antibiotics, if they finally meet someone who looks into their eyes and takes them seriously.

  2. #2 tobryant
    May 27, 2009

    Everyday I watch brilliant researchers struggle to present their work. I always remind my self that historically, many of America’s best scientists have never sounded coherent. As far as persuasive arguments, the truth is never persuasive. In fact the truth is rather agnostics. It simply is and this trait makes it harsh and a bit of a bully. “Coherent and persuasive” is the stuff of high dollar ads created by slick marketing agencies not found in truth or science.

    It is a shame that the good reputation of the IDSA has been sullied by a few corrupt panelists who wrote bias guidelines for the testing and treatment of Lyme disease. Historically this happens from time to time in the medical sciences and it almost always renders unfortunate results. But these few panelists are not a reflection on the IDSA unless the IDSA continues to embrace the 2006 guidelines.

  3. #3 MarkH
    May 27, 2009

    I have been told by some doctors that they don’t “believe in” gluten intolerance. But my symptoms disappeared once I stopped eating gluten. My experience has not always been that doctors follow evidence-based medicine, but whatever traditional diagnoses they learned in med school (they also learn some incorrect physiology that is thirty years out of date regarding, as one example, hypotheses regarding age at menarche).

    I assure you, gluten sensitivity is discussed in medical school and is a real diagnosis. However, there are physicians who have been misusing the diagnosis to try to explain things such as IBS and nonspecific bowel complaints without doing checking things like autoantibodies or performing a biopsy.

    Gluten sensitivity is real, but many physicians react with skepticism because it’s been misdiagnosed in so many people to give them some explanation for nonspecific GI symptoms. Even though there is a real syndrome, it’s used as a “dust-bin” diagnosis in which, frankly irresponsible, physicians chuck patients in order to give them some explanation for their complaints.

    Other diagnoses that are subject to this include fibromyalgia, chronic fatigue, chronic lyme, etc. While there are specific clinical criteria agreed upon by expert rheumatologists, these are bypassed by physicians who want to make their patients happy. As a result these diagnoses end up being occupied by every “difficult” patient, and subsequent physicians ultimately end up rolling their eyes when they hear it. It’s the diagnostic equivalent of giving patients antibiotics for a cold. They should know better, but they do it anyway.

    Next time tell a new physician you have antibody-confirmed gluten sensitivity, or biopsy-confirmed celiac sprue if that is indeed the case. That extra bit of information goes a long way to explain you haven’t been improperly labeled.

  4. #4 Kate
    June 3, 2009

    MarkH, I’m so glad to hear it’s being taught in med schools now; perhaps I’ve only spoken to docs who went to med school before this point. And I agree with the point you’re making about the dust-bin approach; most diagnoses with the word “syndrome” in them get used this way by at least some doctors.

    And I have told doctors about my antibody-confirmed gluten sensitivity and have received blank looks. I have yet to meet an MD who has any idea what I’m talking about or who “believes in” (I’m quoting, not my words) gluten intolerance. But I have now lived in the Northeast and Midwest, and have a hard time believing this is just happening in my neck of the woods.

    Anyway, sorry to hijack the comments, just wanted to send some appreciation your way.

  5. #5 kent haydock
    June 7, 2009

    The two surveys conducted in Darien, CT in May at the Darien Library and at a meeting of the Darien Senior Men demonstrated conclusively (for the first time to our knowledge)that chronic Lyme disease exists in very distressing numbers in our stressed area. High levels of Lyme disease and closely-related over-abundant deer remain well documented by state scientists and medical authorities.

    We are not qualified to comment whether long-term treatment
    of Lyme is safer than no long-term treatment, however in 12 years of continued interviews at the grasroots level,I for one believe that treatment is better than non-treatment.
    We have reports of grave disabilities and even fatality, from chronic Lyme, but not of patients from receiving long-term treatment. Please remember it was persistant moms in Lyme, CT that brought recognition of Lyme disease here.

    Our point is mainly to confirm that chronic Lyme (which physicians here say can indeed compromise the immune system) does indeed exsist.In the name of goodness and mercy will qualified Epidemiologists please conduct further studies to at least confirm, or deny this contention?

    Kent Haydock 12-year Chair, Darien Deer Management Committee, and 5-year Public Education Chair of the Fairfield County Municipal Deer Managmn Alliance

  6. #6 Miguel Perez-Lizanp
    June 14, 2009

    Janet,

    Please do not write on topics you know absolutely nothing about.

    I spent about 2 years doing research for the antitrust investigation in the case by the Connecticut Attorney General against the IDSA Lyme disease guideline authors. Lyme certainly ranks as one of the most corrupted diseases in the history of medicine, courtesy of the IDSA Lyme authors… http://www.ct.gov/ag/cwp/view.asp?a=2795&q=414284

    You obviously did not look at Stricker/Johnson’s response to Gershon’s irresponsible letter with comments by responsible and knowledgeable doctors… http://jme.bmj.com/cgi/eletters/35/5/283#2445

    If you really want to learn more about Lyme disease and the corruption involved you should see the award-winning documentary “Under Our Skin” and Cure Unknown” by Pamela Weintraub.

    You really should retract the article you wrote. It contains harmful and incorrect information.

    Miguel Perez-Lizano
    http://lyme.kaiserpapers.org/#att

  7. #7 td
    July 6, 2009

    persistance of lyme in spite of treatment is well proven .. u r supporting here the lies of irresponsible evil minded people ..

  8. #8 ChronicLymie
    August 9, 2009

    Believe it: http://underourskin.com

    Chronic Fatigue Syndrome, Fibromyalgia, ADD, ADHD, Dyslexia, ALS, Parkinson’s, MS Alztheimer’s, Autism (+mercury exposure) = Undiagnosed Lyme

    B e l i e v e or your loved ones will suffer.

    Western Blot or Better is the only way, plus clinical evaluation. See a lyme Doctor pronto.

  9. #9 Joel Spinhirne
    September 18, 2009

    The original post was irresponsible and based on celebrity evaluation rather than facts.

    There are no clinical trials that add much to the knowledge of L. borreliosis. The IDSA and Gershon promote a theory at odds with any critical, logical examination of Borrelia infections.

    The IDSA’s science is startlingly bad and the IDSA guidelines for Lyme disease were developed to support a policy that is convenient for infectious disease doctors, manipulating and misrepresenting facts.

    It is the responsibility of scientists and even philosophers to correct the IDSA, not to support their nonsensical statements regarding Lyme disease.

    Take a look at the abysmal study Gershon refers to:

    Klempner study

  10. #10 Anon
    April 28, 2010

    “Unless we accept Johnson and Stricker’s suggestion that physician autonomy is the good that should be prioritized above all others, it seems completely appropriate that the expert knowledge that informs treatment decisions be knowledge that meets the methodological standards recognized by the medical community — in other words, that the guiding knowledge be recognized as knowledge by the community, rather than as claims that haven’t been sufficiently tested or proven.”

    Interesting false dichotomy. What you are suggesting sounds an awful lot like medicine by committee, an absolutely horrendous thought, but sadly becoming a reality more and more each day. Most of the really good medical work has been done and continues to be done by smart, independent and obsessed outliers (ie:Willy Burgdorfer) who could give a rat’s ass about what the medical community thinks. Your average mainstream doctor who gets their cook book from an insurance company is not one of these, and so they will never have a clue about lyme disease, unless of course they catch it, and likely not even then.

The site is currently under maintenance and will be back shortly. New comments have been disabled during this time, please check back soon.