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Scans and Scams: Direct-to-Consumer Marketing of Unnecessary Screening Tests

Scans and Scams: Direct-to-Consumer Marketing of Unnecessary Screening Tests. Martin Donohoe. Outline. Evidence-based screening Appropriate and unnecessary testing Risks of unnecessary testing Unnecessary testing and luxury care Recognizing health scams Current pseudoscience / anti-science

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Scans and Scams: Direct-to-Consumer Marketing of Unnecessary Screening Tests

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  1. Scans and Scams:Direct-to-Consumer Marketing of Unnecessary Screening Tests Martin Donohoe

  2. Outline • Evidence-based screening • Appropriate and unnecessary testing • Risks of unnecessary testing • Unnecessary testing and luxury care • Recognizing health scams • Current pseudoscience / anti-science • Conclusions and Suggestions

  3. Criteria for Evidence-Based Screening • Disease reasonably common, significantly affects duration and/or quality of life • Existence of acceptable, effective treatment(s) • Asymptomatic period during which detection and treatment can improve outcome • Treatment during asymptomatic period superior to treatment once symptoms appear • Test safe, affordable, adequate sensitivity and specificity

  4. Evidence-Based Screening: Examples • Pap smears • Mammography • Decreases death rate from breast cancer by 20% • Blood pressure monitoring (age>21) • Cholesterol tests (ages 35-65) • Oral glucose tolerance testing during pregnancy

  5. Cost-Saving Interventions • Some immunizations • One time colonoscopy • Condom distribution • Safety belt laws • Hip protectors for elderly women at risk for falls • Streetlights • HIV testing of donated blood

  6. Low Cost/QALY Interventions • Most immunizations • Pap/HPV screening • Screening for DM2 and DM retinopathy • Smoking cessation education

  7. Low Cost/QALY Interventions • Air bags in autos • Restrictions on cell phone use in cars • Publicly-accessible automated external defibrillators • Suicide prevention programs

  8. Underuse of Appropriate Screening Tests • Cancer screening rates inadequate: • Breast cancer: 72% • Cervical cancer: 83% • Colorectal cancer: 59% • Underuse greater in non-whites, low SES pts, un-/under-insured • Underuse linked to adverse outcomes: • E.g., advanced stage at time of diagnosis of breast cancer and lower survival rates among African-Americans

  9. Unnecessary Testing • Early radiography for non-specific LBP • Annual EKGs on low risk patients without symptoms • Pre-op CXRs on patients with unremarkable H and Ps • Brain imaging with simple syncope and normal neurological exam • Too frequent colonoscopies • See Choosing Wisely (ABIM Foundation)

  10. Unnecessary Testing • Routine fetal ultrasonography • Tom Cruise/Katie Holmes personal US machine (cost $15,000 - $200,000) for daily use • Vertebrate data suggest prolonged and frequent use of fetal US can cause fetal anomalies • FDA: “unapproved use of a medical device” • May also violate state laws and regulations

  11. Diagnostic Yield: Utility and Reimbursement • Diagnostic yield • History = 75% • Physical exam = 10-15% • Testing = 10% • US reimbursement system financially incentivizes in reverse order

  12. Overuse of Diagnostic Testing • Patients report higher satisfaction with care when x-rayed and/or scanned • But symptoms may not decrease • Patients overestimate benefits of testing • Physicians eager to please

  13. Wasteful Healthcare Spending • Estimated cost of excessive labs and radiographic procedures = $200 billion to $250 billion • Defensive medicine accounts for estimated 1/5 CT scans; inaccessibility of prior studies another 1/5 • Physicians paid per procedure order more procedures than physicians paid on capitation basis

  14. Wasteful Healthcare Spending • Oncologists reimbursed for administering chemotherapy administer more (and more expensive) agents • Estimated $800 billion (1/3 of all healthcare spending) wasted in unnecessary diagnostic tests, procedures and extra days in the hospital • EHRs lead to increased testing

  15. Unnecessary Procedures

  16. Full Body CT Scans • Popularity increased after Oprah Winfrey underwent testing in 2001 • Self-referral body imaging centers • 161 in 2003, up from 88 in 2001 • Highly profitable

  17. Full Body CT Scans • Typical costs for full body CT scans $1000-$2000 • 2004 survey of 500 Americans • 85% would choose a full-body CT scan over $1000 cash • 2005 study: • 86% of patients had at least one abnormality • Mean = 3 abnormal findings per patient

  18. Full Body CT Scans are Opposed by • FDA • AMA • ACR • ACC • ACS • AHA • Many other professional organizations

  19. Marketing Scans • Companies market in areas of higher SES • Prey on fear of heart disease and cancer, and on the natural desire to detect health problems early in hopes of achieving a cure, or at least avoiding potentially disfiguring or toxic therapies • Some companies offering SPECT brain scans to diagnose and manage neuropsychiatric problems (including to children)

  20. Changes in Radiologic Imaging1996-2010 • Radiography: 1.2% annual increase • Angiography/flouroscopy: 1.3% annual increase • Nuclear medicine: 3% annual decrease • Ultrasonography: 3.9% annual increase • Use doubled • CT scans: 7.8 annual increase • Use quadrupled • Decreases noted in 2012

  21. Radiologic Imaging in the U.S.2010 • 265 CT scans / 1,000 people • 100 MRIs / 1,000 people

  22. Radiologic Imaging is Expensive • 75 million CT scans ordered in 2009 • Over 3-fold increase c/w 1995 • Down to 68 million in 2012 • Number of preventable duplicates very low per one study • Overall Medicare imaging costs more than doubled from 2000-2006 (to $14 billion) • 2009 costs down to $12 billion

  23. Benefits of Diagnostic CT scans • Decreased cancer mortality • Decreases in exploratory surgeries • Decreased time to triage of patients, especially trauma patients

  24. ?Value of Radiologic Imaging? • CT/MRI ordered in 6% of ER visits in 1998; 15% in 2007 • Most common reasons = flank pain, AP, HA • CT scans solely for HA rarely influence management or outcome (CA risk from scan approximately 1/20,000 • However, no change in percent of patients admitted to hospital or to ICU over same period • 33% show incidental findings (most of which are not reported to patients)

  25. ?Value of Radiologic Imaging? • Use of CT for dizziness in ER up from 10% of visits (1995) to 25% of visits (2004) without increase in CNS diagnoses • One study found ¼ of CT and MRI studies at one academic institution unnecessary

  26. ?Value of Radiologic Imaging? • 1/3 of the 4.25 million CT scans performed each year on children felt to be unnecessary • Will result in est. 4,870 cancers • ¼ pediatric patients with isolated headache gets at least one head CT (minimal yield, dangerous)

  27. Radiologic Imaging is Expensive • U.S. physicians order 7 times more CT scans than UK doctors (3X French doctors, 2X German doctors) • US has almost twice the number of MRI machines per capita than any other country • Many CT/MRI/other scans ordered because of defensive medicine • Radiology benefits managers

  28. Radiologic Imaging is Profitable • 1/6 physician practices owns advanced imaging equipment (CT and/or MRI) • “medical arms race” • Cardiologists/vascular surgeons earn 36%/19% of their Medicare revenue from in-office imaging • Installation of CT scanners in US cardiology practices tripled between 2006 and 2008

  29. Radiologic Imaging is Profitable • Screening CT coronary angiography now a Medicare covered benefit in all 50 states • Device manufacturers strong lobby • Medicare to cut fees for CT coronary scans significantly between 2010 and 2014

  30. Radiologic Imaging is Profitable • Ownership of scanners by physicians growing dramatically • FDA now requires physicians to declare ownership of imaging devices/facilities to patients • Physicians who self-refer for scans conduct twice as many imaging procedures

  31. Radiologic Imaging is Profitable • Orthopedic surgeons with a financial interest in an MRI scanner have 86% higher rate of negative scans • 2011: CO fined Heart Check America $3.2 million for conducting coronary CT scans on patients without appropriate physician referrals

  32. Radiologic Imaging is Expensive • Texas state law requires health insurers to cover costs of screening CT coronary angiograms and carotid ultrasounds • ACC supported, AHA did not take a stand • Based on SHAPE guidelines sponsored by Pfizer (not peer-reviewed) • Florida considering similar law

  33. Average Whole Body Radiation Exposure in U.S. in mSv (1 mSv = 100 mREM) • 1980: 3.6 • 2007: 6.7 • Worker exposure (mSv/yr over background): • Airline pilot and crew = 3.1 • Nuclear power plant worker = 1.9 • Astronaut on space station = 72

  34. Airport and Other Scanners • Previously used backscatter • Minimal exposure for most • Some concerns re quality and consistency of scanners • Scanners also used in prisons (10-50X radiation dose, but still very small)

  35. Airport and Other Scanners • Airport X-ray scanners banned in Europe (radiofrequency, or millimeter wave, scanners used instead) • U.S. airports have transitioned to mm wave scanners • use radio waves, so no ionizing radiation • higher false positive rate • TSA phasing out “virtual strip search” body scanners

  36. Airport and Other Scanners • Drive-by X-ray scanners being used in NYC at special events and during street patrols • See slide show on physician drug testing and privacy on phsj website for more details

  37. Radiation Dose to Entire Body in mSV (1 mSv = 100 mREM) – Sci Am 5/11 • Annual background radiation in U.S. = 3-4 • Airport scanner = 0.0001 • Domestic airline flight (5 hrs) = 0.0165 • Smoking (1ppd x 1 yr) = 0.36 (may be higher due to polonium)

  38. Radiation Dose to Entire Body in mSV (1 mSv = 100 mREM) • Extremity XR, bone density scan = 0.001 • Dental XR = 0.005 • CXR = 0.1 • Mammogram = 0.4 • Abdominal XR = 0.7

  39. Radiation Dose to Entire Body in mSV (1 mSv = 100 mREM) • Head CT = 2 • Chest CT = 7 • Low dose Chest CT = 1.5 • CTPA = 10-15 • V/Q scan = 2-2.5 • Pelvic CT = 10

  40. Radiation Dose to Entire Body in mSV (1 mSv = 100 mREM) • Diagnostic cardiac catheterization = 11.4 • PCI = 15 • Myocardial perfusion study = 16 • Whole body CT = 50 - 100 • Multiple scans common in patients with both acute and chronic conditions • E.g., MI patients undergo an average of 15 radiographic procedures, and 1/3 receives > 100 mSv

  41. Cancer Risk from Radiographic Imaging • Could cause up to 2% of cancer deaths within 2-3 decades • Projected 29,000 excess cancers due to the 72 million CT scans (necessary and unnecessary) performed in 2007 • For every 10 mSv exposure, cancer risk increased by 3% over 5 yrs • Compared with a 40 yr old pt, a 20 yr old has double and a 60 yr old has ½ the risk of CA from a single imaging test

  42. Cancer Risk from Radiographic Imaging • Skin, breasts, thyroid most vulnerable • Scans of children, serial scans carry higher risks • Average U.S. child undergoes 8 imaging procedures by age 18 (85% radiographs, 8% CT scans) • Childhood CT scans increase risk for leukemia and brain cancer

  43. Cancer Risk from Radiographic Imaging • Risk of CA from abdominal CT scan ranges from 1/300 to 1/2,000 – yet such scans can decrease admissions from ER by 18% • Estimates for CT coronary angiography lower, however many patients undergo multiple procedures • Thyroid shielding recommended for all CT and angiographic procedures

  44. Risks of Screening CT Scans • Physicians and general public unaware of amounts of radiation (and risks) involved • ?Adequacy of informed consent? • 1/3 of scans avoidable or could be replaced by ultrasounds or MRIs

  45. Other Risks of CT Scans • False positive findings: ¼ • Intravenous contrast-induced renal failure: 1/150 • 1/500 of these fatal • Intravenous contrast-induced severe allergic reaction: 1/5,000 (1/500 if history of asthma)

  46. Beware • Radiation doses from CT scanners may be highly variable between institutions and cases of faulty CT scanners delivering dangerous doses have been reported

  47. Medical Imaging and Radiation Exposure • 1980: Medical imaging responsible for 15% of U.S. radiation exposure • 2010: 50% (30% from cardiac imaging) • Defensive medicine, high tech approaches contribute • 1/270-4,000 women and 1/600-13,500 men will develop cancer from a single heart scan (vs. 1/3 lifetime risk of developing cancer)

  48. Medical Imaging and Radiation Exposure • 2010: FDA launches initiative to reduce unnecessary radiation from medical imaging • Studies suggest most CT radiation could be reduced 50% without loss of image utility • Newer machines deliver lower radiation doses without compromising image quality • Infant and child settings available

  49. Trauma Patients • Pan scans for trauma patients (head to pubic symphysis) expose patients to 20 mSv or more (double the amount that would can 1 future cancer in 1,000 40 yr old adults • More focused scans for trauma patients safe and effective

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