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Perspective |

A Tale of Two Conferences FREE

Susan Molchan, MD1
[+] Author Affiliations
1Private psychiatry practice, Bethesda, Maryland
JAMA Intern Med. 2014;174(6):856-857. doi:10.1001/jamainternmed.2014.748.
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Published online

“Why are you here?” That was often the first question among fellow attendees as we met each other at a recent conference. It seemed perfectly reasonable at the time, but later I realized I had never attended a meeting where that question had arisen. Many of us circulate through the same set of specialty meetings each year. This conference, called From Avoidable Care to Right Care, was different. The 300 people who attended came from many walks of life and, though mostly from the United States, many countries. All were interested in addressing the inefficiencies and injustices in our health care system behemoth, especially with regard to the personal and societal costs of misuse and overuse of medical tests and treatments. We were, I suppose, a community of the concerned.

The awakening to the harms of overdiagnosis and overtreatment has been spreading through many forums including Less Is More in JAMA Internal Medicine and Too Much Medicine in BMJ. The Lown Institute sponsored the Right Care conference. The aspiration for medicine of physician and humanitarian Bernard Lown, MD, is as follows: “Do as much as possible for the patient, and as little as possible to the patient [emphasis added].”1

From the window of the welcome reception of the Right Care conference, I could see the Boston Convention and Exhibition Center flooded in light. It was at that site just a few months earlier that I had attended the Alzheimer’s Association’s International Conference (AAIC), the world’s largest conference on Alzheimer disease (AD). As a scientist at the National Institutes of Health, I had attended the AAIC regularly for years, and like most medical conferences, it had bristled with signs and banners emblazoned with the names and logos of sponsors and exhibitors, a pharmacopeia of color and gloss.

One session at the most recent AAIC starkly epitomized what looks to be evolving into the latest campaign for overdiagnosis. The US Food and Drug Administration (FDA) had approved the first drug/tracer to light up amyloid, for use with positron emission tomographic (PET) scans, the year before. Many people were promoting the scans (price tag $3000-$4000) despite the lack of evidence that they did anything for patients. “The scan does not establish a diagnosis of Alzheimer’s disease (AD) or other cognitive disorder,”2 the label specifies; it is used as part of a diagnostic evaluation.

One of the problems with amyloid PET scans is that they can glow just as brightly in someone with a normal brain as in someone with dementia. About 30% of elderly brains with no symptoms of dementia light up.3,4

Medical imaging today is astonishing (I had conducted PET research and practiced nuclear medicine): computer screens marching with oval after oval of a brain that can be zoomed and spun, sliced and coalesced again into a 3-dimensional cortex, the shades and colors of lighted pixels like World of Warcraft in a skull, reconnaissance missions in the crusade against AD. It is a wonderful research tool.

Its clinical utility, however, is a different story. Following FDA approval of a test, choosing wisely, as in deciding under what circumstances taxpayers should pay for yet another test, falls to the Centers for Medicare & Medicaid Services (CMS). Because of a lack of evidence for an effect on treatment plan or health outcomes, CMS denied the latest pharmaceutical company application for coverage of amyloid PET scans but proposed covering a limited number of scans that were part of research studies or that might help differentiate AD from frontotemporal dementia in difficult cases. A JAMA Internal Medicine editor, Robert Steinbrook, MD, sums up the CMS recommendation in this way: “This approach serves the public interest. It would be irresponsible for the CMS to cover amyloid PET imaging without adequate evidence about its role in AD or other neurodegenerative diseases.“5(p135)

At the “late-breaking, special” session concerning the CMS decision at the AAIC, no one needed to question why most in attendance were there; it was a familiar cast of characters: pharmaceutical and imaging company executives and staff members, lobbyists, staff members from the Alzheimer’s Association and other advocacy foundations, and academics, many of whom were funded by pharmaceutical companies as consultants and/or for research support. Speakers such as Gail Rodriguez, PhD, president of the Medical Imaging and Technology Alliance, extended heartfelt thanks to their partners in indignation against CMS officials whose “anti-moral ruling,” according to Michael Devous, PhD, served as “disincentive to provide new technology to advance patient care.”6 (Dr Devous is professor of radiology at University of Texas Southwestern Medical Center and has stated financial interests with developers of both primary amyloid imaging drugs, Lilly, and GE Healthcare.) Cooler heads (with less directly connected wallets) suggested that CMS was asking the right questions about the economics of health care and treating with appropriate seriousness the question of outcomes. Some of the group concluded that CMS must be further educated on the benefits of brain amyloid imaging coverage.7 Proposed strategies included applying pressure on CMS officials through members of Congress and senior officials at the Department of Health and Human Services, igniting a grassroots campaign, and finally conducting studies to collect evidence on outcomes.

The Alzheimer’s Association has referred to the scans as an “already FDA approved diagnostic tool,” asserting that earlier diagnosis leads to higher quality of life and enables “earlier access to appropriate treatments.”8 Other advocacy groups have chimed in, for example USAgainstAlzheimer’s: “CMS has stifled an important tool for establishing an early diagnosis in millions of patients.”9

Ironically, as the troops are being marshaled to target our cognitively impaired elderly patients with more scans, brightening the visions of blockbuster drug sales to our growing senior population, evidence is accumulating that dementia rates, that is “age-specific prevalence or incidence rates among people born later in the first half of the 20th century,”10(p2275) are dropping. Scientists from England presented some of the strongest data for this at the AAIC. In their prospective study, the British group found that the rate of dementia dropped a robust 24% over an approximately 20-year period.11 For years, clues from several different fields of research have pointed to the usual suspects as risk factors, including high blood pressure, diabetes, smoking, obesity, and physical inactivity.10,11 Eric Larson, MD, a leader in geriatric medicine and health services research, and his colleagues10 note that most dementias are a mix of AD and vascular and other degenerative conditions. The British study11 and others “illustrate the potential for deriving widespread public health benefits from such lifestyle interventions as improving educational opportunities in both early and later life, reducing vascular risk factors, and promoting greater physical activity.”10(p2277)

Impressive as scanning technologies are, positrons are unlikely to light the path to healthy brain aging, but the horizon is brightening with knowledge that we have right now. This is why I was there, at the Right Care conference.

ARTICLE INFORMATION

Corresponding Author: Susan Molchan, MD, 8723 Ridge Rd, Bethesda, MD 20817 (susan_molchan@verizon.net).

Published Online: April 7, 2014. doi:10.1001/jamainternmed.2014.748.

Conflict of Interest Disclosures: None reported.

The Lown Institute. About the Right Care Alliance. http://lowninstitute.org/right-care-alliance/. Accessed February 28, 2014.
Lilly USA LLC. Prescribing information for Amyvid (florbetapir F 18 injection). http://pi.lilly.com/us/amyvid-uspi.pdf. Accessed February 28, 2014.
Rowe  CC, Ellis  KA, Rimajova  M,  et al.  Amyloid imaging results from the Australian Imaging, Biomarkers and Lifestyle (AIBL) study of aging. Neurobiol Aging. 2010;31(8):1275-1283.
PubMed   |  Link to Article
Morris  JC, Roe  CM, Xiong  C,  et al.  APOE predicts amyloid-beta but not tau Alzheimer pathology in cognitively normal aging. Ann Neurol. 2010;67(1):122-131.
PubMed   |  Link to Article
Steinbrook  R.  The Centers for Medicare & Medicaid Services and amyloid-β positron emission tomography for Alzheimer disease. JAMA Intern Med. 2014;174(1):135.
PubMed   |  Link to Article
Alzheimer’s Disease and Brain Imaging Expert Writing Group. Letter to the Chief Medical Officer for the Centers for Medicare & Medicaid Services. http://www.snmmi.org/files/docs/Letter%20to%20CMS%20on%20Amyloid%20Imaging.pdf. Accessed February 28, 2014.
ALZFORUM Networking for a Cure. Coverage denial for amyloid scans riles Alzheimer’s community. http://www.alzforum.org/news/conference-coverage/coverage-denial-amyloid-scans-riles-alzheimers-community. Accessed February 28, 2014.
Alzheimer’s Association. Alzheimer’s Association to continue to advocate for coverage of diagnostic tool following CMS announcement.http://www.alz.org/news_and_events_coverage_of_diagnostic_tool.asp. Accessed February 20, 2104.
USAgainstAlzheimer’s. USAgainstAlzheimer’s disappointed with Medicare’s final decision to limit coverage of innovative diagnostic tool.http://www.usagainstalzheimers.org/press/usagainstalzheimer’s-disappointed-decision-limiting-innovative-diagnostic-tool-coverage. Accessed February 20, 2014.
Larson  EB, Yaffe  K, Langa  KM.  New insights into the dementia epidemic. N Engl J Med. 2013;369(24):2275-2277.
PubMed   |  Link to Article
Matthews  FE, Arthur  A, Barnes  LE,  et al; Medical Research Council Cognitive Function and Ageing Collaboration.  A two-decade comparison of prevalence of dementia in individuals aged 65 years and older from three geographical areas of England: results of the Cognitive Function and Ageing Study I and II. Lancet. 2013;382(9902):1405-1412.
PubMed   |  Link to Article

Figures

Tables

References

The Lown Institute. About the Right Care Alliance. http://lowninstitute.org/right-care-alliance/. Accessed February 28, 2014.
Lilly USA LLC. Prescribing information for Amyvid (florbetapir F 18 injection). http://pi.lilly.com/us/amyvid-uspi.pdf. Accessed February 28, 2014.
Rowe  CC, Ellis  KA, Rimajova  M,  et al.  Amyloid imaging results from the Australian Imaging, Biomarkers and Lifestyle (AIBL) study of aging. Neurobiol Aging. 2010;31(8):1275-1283.
PubMed   |  Link to Article
Morris  JC, Roe  CM, Xiong  C,  et al.  APOE predicts amyloid-beta but not tau Alzheimer pathology in cognitively normal aging. Ann Neurol. 2010;67(1):122-131.
PubMed   |  Link to Article
Steinbrook  R.  The Centers for Medicare & Medicaid Services and amyloid-β positron emission tomography for Alzheimer disease. JAMA Intern Med. 2014;174(1):135.
PubMed   |  Link to Article
Alzheimer’s Disease and Brain Imaging Expert Writing Group. Letter to the Chief Medical Officer for the Centers for Medicare & Medicaid Services. http://www.snmmi.org/files/docs/Letter%20to%20CMS%20on%20Amyloid%20Imaging.pdf. Accessed February 28, 2014.
ALZFORUM Networking for a Cure. Coverage denial for amyloid scans riles Alzheimer’s community. http://www.alzforum.org/news/conference-coverage/coverage-denial-amyloid-scans-riles-alzheimers-community. Accessed February 28, 2014.
Alzheimer’s Association. Alzheimer’s Association to continue to advocate for coverage of diagnostic tool following CMS announcement.http://www.alz.org/news_and_events_coverage_of_diagnostic_tool.asp. Accessed February 20, 2104.
USAgainstAlzheimer’s. USAgainstAlzheimer’s disappointed with Medicare’s final decision to limit coverage of innovative diagnostic tool.http://www.usagainstalzheimers.org/press/usagainstalzheimer’s-disappointed-decision-limiting-innovative-diagnostic-tool-coverage. Accessed February 20, 2014.
Larson  EB, Yaffe  K, Langa  KM.  New insights into the dementia epidemic. N Engl J Med. 2013;369(24):2275-2277.
PubMed   |  Link to Article
Matthews  FE, Arthur  A, Barnes  LE,  et al; Medical Research Council Cognitive Function and Ageing Collaboration.  A two-decade comparison of prevalence of dementia in individuals aged 65 years and older from three geographical areas of England: results of the Cognitive Function and Ageing Study I and II. Lancet. 2013;382(9902):1405-1412.
PubMed   |  Link to Article

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Response from MITA
Posted on April 11, 2014
Gail M. Rodriguez, Ph.D.
Executive Director, Medical Imaging & Technology Alliance
Conflict of Interest: None Declared
Beta amyloid PET imaging is a ground-breaking diagnostic technology, and there is vigorous evidence to support its use in patients with suspected dementia or Alzheimer's Disease. The suggestion that industry is campaigning for overdiagnosis is irresponsible and counterproductive. Physician experts in these disease areas support the appropriate use of the technology, guided by physician-developed criteria from the Alzheimer's Association and the Society of Nuclear Medicine and Molecular Imaging. Given someone in our country develops Alzheimer's disease every 68 seconds, and by 2050, there is expected to be nearly a million new cases per year, we should all be working together on solutions to this widespread and costly problem. In direct costs alone, the price tag of Alzheimer's disease could be amplified to $1.2 trillion if the prevalence multiples as expected by the year 2050. The ability to be diagnosed appropriately and prescribed the most effective medications early on in the progression of a disease can improve treatment, survivability and quality of life.
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