Sundheds- og Forebyggelsesudvalget 2013-14
SUU Alm.del Bilag 323

The Coalition for Diagnostic Rights:

United for Ethical Management of Diagnostic Uncertaintywww.diagnosticrights.orgDiane O’Leary, PhD10107-3 Windstream Dr.Columbia, MD 21044diagnosticrights@gmail.comComments to Hearing for Funktionelle Lidelser19 March 2014I am a philosopher working in medical ethics, the Executive Director of the Coalitionethics,for Diagnostic Rights in the US. We are an organization with an international mission:to end the practice of mistakenly denying medical care to the ill based on recklessdiagnosis of any version of “it’s all in your head”. (That can include all varieties ofsomatoform disorder, functional disorders, somatic symptom disorder, bodily distressfunctionalsyndrome, bodily distress disorder, pervasive arousal withdrawal syndrome, etc.)The number of patients and patient groups asking for our assistance is hundreds oftimes larger than any number we cou possibly directly manage – because this problemcouldis an international epidemic. In that context we are gravely concerned about theapproach to diagnostic uncertainty currently in force in Denmark. We believe theprotocols of Professor Per Fink and The Research Clinic for Functional Disorders andPsychosomatics to be medically reckless to the point of negligence, and we call upon theDanish government to rectify this unethical state of affairs.****
1. There are distinct advantages t any diagnostic approach that can streamlinetoprotocols for management of patients with medically unexplained symptoms. Thesepatients absorb roughly 50% of a general practitioner’s day and very often lead to largeexpenditures that yield no diagnostic or treatment insights. Given current financialstrains on any national health service, diagnostic innovations that can reduceunnecessary expenditures for such a massive portion of the patient population are veryappealing.The Research Clinic for Functional Disorders works centrally with the concept of“bodily distress syndrome and that concept is a candidate to replace “somatoformyndrome”,
disorders” in the upcoming edition of the ICD. Aside from its appeal as a Danishinnovation, it carries substantial financial appeal for every national health service. BDScompetes with “bodily distress disorder”, an approach with considerably less financialpizzazz, but great ease of use.When considering the merits of a concept like BDS it’s important to keep in mind thecontext of heated international debate about how to replace the longstanding concept ofsomatoform disorder. Any psychiatrist who’s developed a genuine contender has alifetime investment in winning that spot in ICD-11. National investment in theresearch that makes a new concept like BDS possible is often made in hopes of financialreward as well. These sorts of pressures can make it very difficult for all partiesinvolved to take an objective look at the risks posed by a newly developed approach.****
2. The most important facts about any candidate to replace somatoform disorder arethose that clarify the size of the patient population affected by it. Materials onfunctional disorders in the BDS package focus on the 50% of the GP’s patient rosterwith “bothersome” unexplained symptoms – and fail to mention immense populations ofmedical patients whose genuine suffering is systematically ignored by BDS protocols.45% of autoimmune disease patients in the US report having been wronglydenied medical care on the basis of mistaken somatoform diagnosis, according tothe American Autoimmune-Related Disease Association. That’s 22 millionpatients mistakenly denied needed medical care in just that one category. Thisfigure is nearly double the total number who have cancer, according to the CDC.Research shows 1/100 US teens suffer from the autonomic disorder known as“POTS”, according to the National Dysautonomia Research Foundation, yetsurveys show POTS patients have an 85% likelihood of being refused medicalcare in error based on mistaken diagnosis of “it’s all in your head”. These kindsof figures are common for poorly understood disorders.There are roughly 30 million rare disease patients in the US according to theNIH, and 30 million in Europe, according to Eurodis – rare disease is far fromrare. In this US this figure is equivalent to the number swept up in the“epidemic” of diabetes, according to the CDC.These figures tell us the average doctor in the US and in Europe sees a bareminimum of 2 patients on every working day with rare diseases whether sheknows it or not.There are roughly 7000 rare diseases on the current roster according to Eurodis,so those 2 rare disease patients each day are statistically likely to suffer fromailments their doctors have never seen or heard of before.
Eurodis also reveals that a staggering 41% of rare disease patients in Europe aremisdiagnosed at least once.There are 290,000 people in Denmark with rare diseases, assuming levelsproportionate with population size in Europe. This is roughly equal to the entirepopulation of the city of Aarhaus. (Figures from 2009.)If you take the unusually large student population in Aarhaus and triple it, thatnumber will still fall short of the number of rare disease patients in Denmarkwho have been misdiagnosed.Medical misdiagnosis at least doubles the delay to accurate diagnosis of raredisease according to Eurodis, but psychiatric misdiagnosis – that is, misdiagnosiswith something like BDS – will cause much more severe delays to accuratediagnosis and treatment.Eurodis studies show that misdiagnosis with something like BDS will take anaverage 3-month diagnostic journey for Tuberous Sclerosis patients and turn itinto a 3-year journey. For patients with Crohn’s Disease unobstructed diagnosistakes 1 year, but misdiagnosis with BDS will transform that into 6 years ofuntreated suffering and harm. A mistaken diagnosis of BDS for an Ehlers-Danlos Syndrome patient triggers an unspeakable 7 additional years of severesuffering and irreversible harm.****
3. Prof. Fink’s approach to functional disorders at the Aarhaus clinic pays little attentionto the possibility of diagnostic error – in fact, one 2007 presentation by Professor Finkneglects even to mention it. The patient learns in the clinic’s guidebook that manypatients there have received one of more of these diagnoses:FibromyalgiaChonic fatigue syndrome (CFS)Irritable bowel syndrome (IBS)Chronic pain disorderSomatisation disorderMultiple chemical sensitivity (MCS)Whiplash associated disorder (WAD)
with the additions of PMS, tension headache and myalgic encephalomyelitis in otherpublications. “Most doctors do know the different diagnoses mentioned in the abovebox”, the guidebook explains, “but they are unaware that they can be viewed as onesingle illness . . . Today, we regard these as subtypes of BDS”, it reports, as if the world
medical community is in harmony on this point. With the right cocktail ofantidepressants, mental health therapy and exercise, apparently all of these problemscan be cured.If this sounds a bit like one of those magical “tonics” sold from covered wagons in theAmerican wild west, it is. Prof. Fink is indeed asserting – as if there simply is nodispute about it – that he has found one magical cure for everything from irritable bowelsyndrome to whiplash, from PMS to the disabling suffering of severe ME, and thatmagical cure is talk therapy, exercise and antidepressants.****
4. A sham of this kind can only be professionalized by expert use of terminology. In thiscase it’s the term “functional” that does all the work. Professor Fink treats the phrase“functional symptoms” as synonymous with “unexplained symptoms” in a 2007 paper,“Symptoms and Syndromes of Bodily Distress”, and he describes them as symptoms“defying the clinical picture of known, verifiable, conventionally defined diseases . . .unbacked by clinical or paraclinical findings”.Of course the obvious question here is this: what about symptoms of the many disorderson that list that are widely accepted as medical explained? On what basis should anydoctor accept the broad conclusion that all of these widely varied medical disorders havepsychiatric causes? More specifically, where is the medical research that refutes theenormous numbers of practicing physicians, research centers, medical journals andclinics devoted to understanding and treating, say, fibromyalgia, as a wholly medicalcondition – in this case one that’s made international headlines just this week withrobust new medical verification?On what basis should we conclude that as a psychiatrist Prof. Fink has the expertise torefute claims about irritable bowel syndrome from, say, an esteemed FunctionalGastrointestional Disorders Clinic at University of North Carolina? Their clinicbrochure directly contradicts Fink’s use of the term “functional” with this unequivocalstatement: “It is important to understand that these are not psychiatric disorders”. Howwould doctors at that UNC clinic – or the thousands like it across the globe – respondto the notion that their devoted work on medical IBS solutions is meaningless becauseProfessor Fink has declared “today we regard [IBS] as a subtype of a psychiatricdisorder”?The field of psychogenic medicine has done a great deal of research on the terminologythat makes patients with apparently somatoform symptoms more “compliant”, lesslikely to angrily insist that their suffering is truly physical. It turns out the term“functional” will pass for “genuinely medical” to the patient who doesn’t know anybetter, and the very wide range of professional interpretations of that term suit thecompliance project very well. For the patient who’s looking into Fink’s insistence thathis symptoms are “functional”, a quick Google search reveals countless facilities treating“functional” conditions with medical solutions. “How comforting!” the BDS patient will
exclaim! What he won’t see – and this is a cool calculation on the part of BDSproponents – is that at Prof. Fink’s clinic the term “functional” actually means“psychiatric”, even if it does mean “medical” elsewhere with greater frequency.****
5. To adequately assess the viability of Prof. Fink’s budget-conscious approach youmust get to the heart of the matter – research that proves not only that commonlyaccepted medical disorders like IBS, tension headache, PMS, whiplash and lower backpain are actually psychiatric disorders, but also that they’re one and the samepsychiatric disorder.Following that, you must locate proof that none of the “contentious disorders” likefibromyalgia, chronic fatigue syndrome, multiple chemical sensitivity disorder or evensomething as disabling as ME, couldpossiblyhave true medical causes. Keep in mindthat researchers announced new evidence this week of fibromyalgia’s medical origins,and keep disorders like Lupus in mind too, as serious and quite common diseases oncethought to have psychiatric causes.Next, you must read between the lines to determine what a patient with autoimmunedisease endures at the Aarhaus clinic, given that she’s got a 45% chance of having hermedical symptoms mistakenly construed as psychiatric in a standard medical setting.What happens to the 85% of teens with POTS who are routinely forced to sufferuntreated by doctors with much broader acceptance of the medically unknown thanProf. Fink can muster? What is an average day at the clinic like for the patient who’sbeen mistakenly diagnosed with BDS when she actually suffers from POTS or lupus?Finally, and this is the most important of these tasks because it so severely threatenssuch a massive portion of your population, you must consider the journey of a raredisease patient at the Clinic for Functional Disorders. Remember that there are asmany people with rare disease in Denmark as there are people in Aarhus, that 41% ofthem are misdiagnosed, and that those misdiagnosed with BDS face at least double thedelay to accurate diagnosis and treatment – with some, like those with MarfanSyndrome, suffering for an unnecessary 13 additional years.When these investigations yield startling results ask yourself, “Given the inhumanelevels of suffering caused by mistaken diagnosis of BDS, what checks and balances hasProf. Fink has built into this system to protect patients who are actually ill frommisdiagnosis?”The individual consequences of improper diagnosis include theworsening in clinical status, psychological damage often related tomedical denial of the undiagnosed disease and, in some cases, death.This is Eurodis clarifying the consequences of diagnostic delay for rare disease patientsin Europe.
In addition, families endure other consequences, including lifelongfeelings of guilt due to inappropriate behavior toward the affected personprior to diagnosis, or possible birth of additional affected siblings.Without diagnosis a patient’s medical or social needs may not receive dueattention and the patient may be considered a complainer who, as a resultprogressively loses confidence in medicine.****
6. There is bad reasoning at the root of Prof. Fink’s approach to functional disorders –failure to recognize the distinction between symptoms that “have not been explained”and symptoms that “cannot be explained”. The two might seem quite clearly distinct tothe average Joe (certainly if that Joe happens to be a scientist of any kind), but to thosein the field of psychogenic medicine this distinction is often elusive. The implication isthat a doctor’s diagnostic skill is so close to infallible that every symptom a doctor hasnot readily explained must have causes outside the range of medical expertise – that is,psychiatric causes. Given the extraordinary prevalence of rare disease, and theimpossibility of any doctor recognizing even a small portion of the 7000 rare diseases,this is a diagnostic approach that simply cannot be medically defended, no matter howmany bold and impressive statistics are built upon it.****
7. The surest sign of uncertainty is secrecy. The practice of medicine is a collaborativeendeavor because collaboration works as a filter against reckless and ill-conceived ideasabout patient care. On both the conceptual level and the level of clinical practice, opendebate is what keeps medicine honest, and patients safe.If Prof. Fink felt secure that his approach to that list of disorders could withstandmedical scrutiny, he would present it not to the patients he treats, but to the doctorswhose work he challenges. If he felt he had sufficient grounds for refuting the medicalbasis of fibromyalgia he would proceed to do so on the level of peer-reviewed medicaljournals, alongside research supporting the view that fibromyalgia requires medicaltreatment. As long as there remain doctors, researchers, clinics and publications on themedical origins of any disorder on Prof. Fink’s list, that means he has failed to convincethe medical community that medical treatment should be withheld – and if he’s failed toconvince them he certainly should fail to convince the Danish government.That same indefensible secrecy is evident on the level of patient care in the currentepidemic of forced inpatient mental health treatment for disputed disorders. JustinaPelletier was held on a psychiatric ward at Boston Children’s Hospital for fourteenmonths because doctors there insisted the teen’s longstanding diagnosis ofmitochondrial disorder was mistaken.
Experts in psychosomatic medicine just like Professor Fink were so certain hersymptoms had psychiatric causes that they alerted the state to remove the child fromher home so that inpatient treatment for somatoform disorder could be possible – thesame general treatments provided at Prof. Fink’s clinic. When after a year the girl’sphysical condition had clearly deteriorated, the Court was forced to rectify its error withopen reversal of its original decision. The Judge ordered the girl to be returned to heroriginal doctors for treatment of the disputed medical disorder. As the family nowprepares their lawsuits against the hospital and the state, the girl begins the very longrehabilitation effort that will make it possible for her to walk again, having lost thatskill when her medications were recklessly and mistakenly withdrawn.That atrocity occurred, like so many others across the globe, because doctors inpsychosomatic medicine flatly refused to collaborate with doctors currently treating thepatient medically. It is difficult to see any way to defend that secretive approach aspatient-protective because, again, if a psychosomatic diagnosis is firmly supported it willwithstand debate with doctors in favor of a medical approach. Refusal to collaborate cannever be a patient-protective choice. Secrecy of that kind is a sign that those standingfor psychosomatic diagnosis are afraid their footing will fail when they face a challenge.** **
8. In the end of the day, beyond all the statistics, beyond the medical and psychiatricdisputes, this is an ethical matter. Failure to recognize a disorder like BDS might resultin unnecessary medical tests and treatments, but failure to recognize a medical disorderhas consequences so dire that they overturn the very purpose of the practice ofmedicine. Both the Danish medical system and the Danish government have a duty torecognize that the potential harms of the current approach far outweigh its potentialbenefits – difficult as that fact may be for the financial bottom line.Every field has its blind spots, long lapses in vision caused by generations ofunconsidered professional habit, lapses no one in the field has ever been called upon toexamine or defend. In medicine that blind spot is diagnostic uncertainty. Any outsidercan peer in and see there what medical expertise now fails to see: patients with physicalsuffering have a right to medical treatment until proof exists to support an alternativeapproach. As things currently stand in Denmark the reverse is true for all the manymedical patients whose symptoms happen to pose diagnostic challenges. This state ofaffairs burdens your population with years of unnecessary suffering.Any diagnostic protocol that fails to take stock of the risk of error must be rejected, andthis one risks inhumane suffering with appalling frequency. When doctors fail to seesomething like this it is the job of government to make it clear.Respectfully,
Diane O’Leary, PhD