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Chronicle of an Unforetold Death

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Chronicle of an Unforetold Death SPECIAL ARTICLE HEALTH CARE REFORM Chronicle of an Unforetold Death Neil A. Holtzman, MD, MPH riting in sorrow and anger, I express up front my potential conflict of interest in interpreting the facts surrounding the death of my wife, Barbara Starfield, W MD, MPH. Within hours after her sudden and unex- Barbara started taking low-dose aspi- pected death, I notified the dean of the rin after coronary insufficiency had been Johns Hopkins Bloomberg School of Pub- diagnosed 3 years before her death, and lic Health, on whose faculty she served, clopidogrel bisulfate (Plavix) after her right that Barbara had apparently died of a coro- main coronary artery had been stented nary occlusion. He relayed the news 6 months after the diagnosis. She reported around the world. Devoted to improving to the cardiologist that she bruised more effectiveness and equity in health care, easily while taking clopidogrel and bled Barbara received many tributes.1 longer following minor cuts. She had no Because she died while swimming alone, personal or family history of bleeding ten- an autopsy was required. The immediate dency or hypertension. cause of death was “pool drowning,” but the The autopsy findings and the official underlying condition, “cerebral hemor- lack of feedback prompted me to call at- rhage,” stunned me. The pathologist attrib- tention to deficiencies in medical care and uted the massive hemorrhage to cerebral clinical research in the United States amyloid angiopathy (CAA), listing “anti- (Table 1) reified by Barbara’s death and coagulation therapy” on the death certifi- how the deficiencies can be rectified. cate under “other significant conditions.” No Ironically, Barbara had written about all significant occlusion of any of her coro- of them. nary arteries was found. A scalp bruise ad- jacent to a larger bruise on her right tem- LACK OF COORDINATION OF CARE poralis muscle was observed, but no skull fractures. Patchy microhemorrhages were When patients die suddenly and unex- observed in the cerebral cortex. pectedly and are not in a health care fa- cility, no routine procedure is required for See also pages 1144 notifying their physicians, even if the pa- tient is autopsied. (Unfortunately, only 8% and 1145 of deaths were autopsied in the United Cerebral amyloid angiopathy is not rare States in 2007, and only 2% in Barbara’s 5 in the elderly, estimated to occur in 8.0% age group. ) Had I, as next of kin, not in- of those aged 75 to 84 years (Barbara’s age formed Barbara’s physicians, they would group) and 12.1% in those aged 85 years not have learned of her death until she and older.3 However, a large proportion missed her next appointment, if then. of patients in whom CAA is diagnosed post Barbara strongly believed that for com- mortem do not die of cerebral hemor- mon conditions, primary care physicians rhage.3 Nonfatal microhemorrhage asso- should have primary responsibility for 6 ciated with CAA can be detected by mag- management, coordinating care with spe- netic resonance imaging.4 cialists as needed. By amending the stan- dard death certificate to include the name Author Affiliation: Department of Pediatrics, The Johns Hopkins University of the decedent’s primary care physician School of Medicine, Baltimore, Maryland. and by requiring state departments of vi- ARCH INTERN MED/ VOL 172 (NO. 15), AUG 13/27, 2012 WWW.ARCHINTERNMED.COM 1174 ©2012 American Medical Association. All rights reserved. Downloaded From: http://archinte.jamanetwork.com/ by a Monash University Library User on 08/21/2012 tal statistics to notify the physician ming into the curved wall of the when the death certificate is filed, pool. Once she started to bleed, Table 1. Lessons From Barbara’s physicians will be made aware of clopidogrel drug regimen could have Death their patients’ deaths (and causes if made the bleeding worse. Patients Lack of coordination—providers are not the patient is autopsied). The pri- taking clopidogrel were signifi- notified of sudden and unexpected mary care physician should then be cantly more likely than patients tak- deaths responsible for notifying the spe- ing only aspirin to experience an in- Underreporting of possible adverse drug cialists involved in the patient’s care. crease in intracerebral hematoma events volume (P = .05) and possibly to Multimorbidity—best appreciated by UNDERREPORTING have twice the mortality rate (8 vs primary care physicians 14 Inadequacy of randomized controlled trials OF ADVERSE DRUG EVENTS 4 per 28 patients; P = .19). Potential bias in randomized controlled Greater awareness of the high fre- trials sponsored and supported by the In response to my request, Barba- quency of CAA in those aged 65 and pharmaceutical industry ra’s cardiologist submitted an ad- older might lead physicians caring verse drug event report to the US for elderly patients who are taking Food and Drug Administration antiplatelet drugs to be alert for tran- new drug’s safety (harm), as well as (FDA), stating that she was receiv- sient or increasing cognitive impair- its efficacy, in granting premarket ap- ing anticlotting medications that ment that might indicate microhem- proval. Important as they are, such might have contributed to her cere- orrhages and to follow up with a trials have limitations, as Barbara bral hemorrhage. The “report may thorough neurological evaluation pointed out.13 Problems of inad- be the critical action that prompts and magnetic resonance imaging if equate sample size, short duration, a modification in use or design of the indicated. Primary care physicians and comorbidity are exemplified by product, improves the understand- are better trained than cardiolo- the 2 RCTs on whose findings the ing of the safety profile of the drug gists to be on the lookout for cog- use of clopidogrel following the per- or device and leads to increased pa- nitive changes. cutaneous insertion of coronary ar- tient safety.”7 The FDA report form Multimorbidity gives reason to tery stents is based (Table 2). Both does not ask for patient identifica- question, as Barbara repeatedly did, studies were of short duration, either tion and cannot be used for mal- whether the emphasis on specialty 1 year15 or an average of 8 months16 practice litigation. care in the United States is mis- after stenting. The statistical signifi- Barbara lamented that adequate placed. “Specialty care for morbid- cance of both benefit and harm end care “is not realized when likely ad- ity that is not in the area of the phy- points is shown in Table 2. Only verse events are not systematically sician’s special competence,” Barbara with composite end points (eg, re- recorded and studied,”8(p65) which is wrote, “compromises quality of duced cardiovascular death and myo- often the case.9 She also noted that care.”13 Many of the studies on clopi- cardial infarction) is statistically sig- iatrogenic causes constitute the third dogrel following coronary stent nificant benefit attained. In one of leading cause of death in the United placement have been directed by car- these studies,15 a borderline associa- States.10 Oral antiplatelet agents are diologists and focus on the reduc- tion of clopidogrel with harm (ma- the third most frequent category of tion of atherothrombotic out- jor bleed; P = .07) was observed. drugs implicated in hospitaliza- comes, which may be high in the Despite the short follow-up pe- tions for adverse events in patients short term, rather than on bleed- riods and the slim statistical signifi- aged 65 years or older.11 ing, which is spread throughout the cance, many cardiologists have pre- The FDA should inform the pub- duration of drug treatment. scribed clopidogrel for longer than lic that anyone can file the agency’s As our population ages and mor- 1 year after a stenting procedure, as adverse event report. Penalties (fi- bidities accumulate, the United in Barbara’s case. nancial and criminal) should be im- States needs policies that redirect Since these studies were re- posed when a drug company with- American medicine to primary ported, several others have been con- holds information from the FDA on care physicians. By providing con- ducted, of which 4 are shown in aggregated adverse events of drugs tinuing care over time, primary care Table 2. Two of these were RCTs.17,20 that it manufactures. Postmarket physicians can practice person- The other 2 were population-based surveillance of new drugs should be focused as opposed to disease- registry studies of patients being expanded. Barbara and I urged more centered care.8 They can get to know treated in practice, not in clinical stringent enforcement of the FDA’s their patients as persons and be- trials.18,19 Three of the 4 had more rules for postmarket surveillance.12 come aware of their multiple mor- patients than the first 2. None of bidities, alert to the presence or pos- these later studies found a signifi- MULTIMORBIDITY sibility of disease and/or drug cant benefit of clopidogrel admin- interactions. istered for a duration of longer than Barbara, who emphasized the im- 6 or 12 months following coronary portance of multimorbidity,13 was THE LIMITED SCOPE artery stenting. Two showed a sig- caught in its web: CAA, discovered OF CLINICAL TRIALS nificant increase in major bleeds post mortem, could have increased (P = .007 in Tsai et al18 and P Ͻ .001 her risk of cerebral hemorrhage from The FDA relies on randomized con- in Valgimigli et al20) and another a head trauma, perhaps by her swim- trolled trials (RCTs) to establish a borderline increase.19 ARCH INTERN MED/ VOL 172 (NO. 15), AUG 13/27, 2012 WWW.ARCHINTERNMED.COM 1175 ©2012 American Medical Association. All rights reserved. Downloaded From: http://archinte.jamanetwork.com/ by a Monash University Library User on 08/21/2012 Table 2.
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