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| <b> Death by Medicine - Appendix<br> Gary Null PhD, Carolyn Dean MD ND, Martin Feldman MD, Debora Rasio MD, Dorothy Smith PhD </b>
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| <td <h1>Death
|
| by Medicine - Appendix</h1></td>
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|
|
| <p>OFFICE OF TECHNOLOGY ASSESSMENT (OTA)<br>
|
| Health Care Technology and Its Assessment in Eight Countries,
|
| 1995.</p>
|
| <p><b>General Facts</b></p>
|
| <blockquote>
|
| <p>1. In 1990 life expectancy in the U.S. was 71.8 years for
|
| men and 78.8 for women, among the lowest of the developed
|
| countries.</p>
|
| <p>2. The 1990 infant mortality rate was 9.2 per 1,000 live
|
| births. This was in the bottom half of the distribution
|
| among all developed countries. (OTA comments on the frustration
|
| of poor statistics and high healthcare spending.)</p>
|
| <p>3. Health status is correlated with socioeconomic status.</p>
|
| <p>4. Healthcare is not universal.</p>
|
| <p>5. Healthcare is based on the free market system with no
|
| fixed budget or limitations on expansion.</p>
|
| <p>6. Healthcare accounts for 14% of the U.S. GNP, which was
|
| over $800 billion in 1993.</p>
|
| <p>7. The federal government does no central planning. It
|
| is the major purchaser of health care for older people and
|
| some poor people.</p>
|
| <p>8. Americans have a lower level of satisfaction with their
|
| healthcare system than people in other developed countries.</p>
|
| <p>9. U.S. medicine specializes in expensive medical technology.
|
| Some major U.S. cities have more MRI scanners than most
|
| countries.</p>
|
| <p>10. Huge public and private investment in medical research
|
| and pharmaceutical development drives this "technological
|
| arms race."</p>
|
| <p>11. Any efforts to restrain technological developments
|
| in healthcare are opposed by policy makers concerned about
|
| negative impacts on medical-technology industries.</p>
|
| </blockquote>
|
| <p><b>Hospitals</b></p>
|
| <blockquote>
|
| <p>12. In 1990 there were: 5,480 acute-care hospitals, 880
|
| specialty hospitals (psychiatric, long-term care, rehab)
|
| and 340 federal hospitals (military, vets and Native Americans)
|
| providing 2.7 hospitals per 100,000 population.</p>
|
| <p>13. In 1990 the average length of stay for an annual 33
|
| million admissions was 9.2 days. Bed occupancy rate was
|
| 66%. Lengths of stay were shorter and admission rates lower
|
| than other countries.</p>
|
| <p>14. In 1990 there were 615,000 physicians, 2.4 per 1,000;
|
| 33% were primary care (family medicine, internal medicine,
|
| and pediatrics) and 67% were specialists.</p>
|
| <p>15. In 1991 government-run healthcare spending was $81
|
| billion.</p>
|
| <p>16. Total healthcare spending was $752 billion in 1991,
|
| an increase from $70 billion in 1950. Spending grew five-fold
|
| per capita.</p>
|
| <p>17. Reasons for increased healthcare spending:</p>
|
| <blockquote>
|
| <p>a. The high cost of defensive medicine, with an escalation
|
| in services solely to avoid malpractice litigation.</p>
|
| <p>b. U.S. healthcare based on defensive medicine costs
|
| nearly $45 billion per year, or about 5% of total healthcare
|
| spending, according to one source.</p>
|
| <p>c. The availability and use of new medical technologies
|
| have contributed the most to increased healthcare spending,
|
| argue many analysts. OTA admits that these costs are impossible
|
| to quantify.</p>
|
| </blockquote>
|
| <p>18. The reasons government attempts to control healthcare
|
| costs have failed:</p>
|
| <blockquote>
|
| <p>a. Market incentive and profit-motive involvement in
|
| the financing and organization of healthcare including
|
| private insurance, hospital system, physician services,
|
| and drug and medical device industries.</p>
|
| <p>b. Expansion is the goal of free enterprise.</p>
|
| </blockquote>
|
| </blockquote>
|
| <p><b>Health-Related Research and Development</b></p>
|
| <blockquote>
|
| <p>19. The U.S. spends more than any other country on R &
|
| D.</p>
|
| <p>20. $9.2 billion was spent in 1989 by the federal government;
|
| U.S. industries spent an additional $9.4 billion.</p>
|
| <p>21. There was a 50% rise in total national R & D expenditures
|
| between 1983 and 1992.</p>
|
| <p>22. NIH receives about half of the government funding.</p>
|
| <p>23. NIH spent more on basic research ($4.1 billion in 1989)
|
| than for clinical trials of medical treatments on humans
|
| ($519 million in 1989).</p>
|
| <p>24. Most of the trials evaluate new cancer treatment protocols
|
| and new treatments for complications of AIDS and do not
|
| study existing treatments, even though the effectiveness
|
| of many of them is unknown and questioned.</p>
|
| <p>25. The NIH in 1990 had just begun to do meta-analysis
|
| and cost-effectiveness analysis.</p>
|
| </blockquote>
|
| <p><b>Pharmaceutical and Medical Device Industry</b></p>
|
| <blockquote>
|
| <p>26. About two-thirds of the industry's $9.4 billion budget
|
| went to drug research; the remaining one-third was spent
|
| by device manufacturers.</p>
|
| <p>27. In addition to R & D, the medical industry spent
|
| 24% of total sales on promoting their products and only
|
| 15% of total sales on development.</p>
|
| <p>28. Total marketing expenses in 1990 were over $5 billion.</p>
|
| <p>29. Many products provide no benefit over existing products.</p>
|
| <p>30. Public and private healthcare consumers buy these products.</p>
|
| <p>31. If healthcare spending is perceived as a problem, a
|
| highly profitable drug industry exacerbates the problem.</p>
|
| </blockquote>
|
| <p><b>Controlling Health Care Technology</b></p>
|
| <blockquote>
|
| <p>32. The FDA ensures the safety and efficacy of drugs, biologics,
|
| and medical devices.</p>
|
| <p>33. The FDA does not consider costs of therapy.</p>
|
| <p>34. The FDA does not consider the effectiveness of a therapy.</p>
|
| <p>35. The FDA does not compare a product to currently marketed
|
| products</p>
|
| <p>36. The FDA does not consider non-drug alternatives for
|
| a given clinical problem.</p>
|
| <p>37. Drug development costs $200 million to bring a new
|
| drug to market. AIDS-drug interest groups forced new regulations
|
| that speed up the approval process.</p>
|
| <p>38. Such drugs should be subject to greater post-marketing
|
| surveillance requirements. But as of 1995 these provisions
|
| had not yet come into play.</p>
|
| <p>39. Many argue that reductions in the pre-approval testing
|
| of drugs opens the possibility of significant undiscovered
|
| toxicities.</p>
|
| </blockquote>
|
| <p><b>Health Care Technology Assessment</b></p>
|
| <blockquote>
|
| <p>40. Failure to evaluate technology was a focus of a 1978
|
| report from OTA with examples of many common medical practices
|
| supported by limited published data. (10-20%)</p>
|
| <p>41. In 1978 congress created the National Center for Health
|
| Care Technology (NCHCT) to advise Medicare and Medicaid.</p>
|
| <p>42. With an annual budget of $4 million NCHCT published
|
| three broad assessments of high-priority technologies and
|
| made about 75 coverage recommendations to Medicare.</p>
|
| <p>43. NCHCT was put out of business by Congress in 1981-a
|
| political casualty. The medical profession opposed it from
|
| the beginning. The AMA testified before Congress in 1981
|
| that "clinical policy analysis and judgments are better
|
| made-and are being responsibly made-within the medical profession.
|
| Assessing risks and costs, as well as benefits, has been
|
| central to the exercise of good medical judgment for decades."</p>
|
| <p>44. The medical device lobby also opposed government oversight
|
| by NCHCT.</p>
|
| </blockquote>
|
| <p><b>Examples of Lack of Proper Management of HealthCare</b></p>
|
| <p><b>1. Treatments for Coronary Artery Disease</b></p>
|
| <blockquote>
|
| <p>45. Since the early 1970's the number of coronary artery-bypass
|
| surgeries (CABGS) has risen rapidly without government regulation
|
| and without clinical trials.</p>
|
| <p>46. Angioplasty for single vessel disease was introduced
|
| in 1978. The first published trial of angioplasty versus
|
| medical treatment was in 1992.</p>
|
| <p>47. Angioplasty did not cut down on the number of CABGS
|
| as was promoted.</p>
|
| <p>48. Both procedures increase in number every year as the
|
| patient population grows older and sicker.</p>
|
| <p>49. Rates of use are higher in white patients, in private
|
| insurance patients, and there is great variation in different
|
| geographic regions. Such facts imply that use of these procedures
|
| is based on non-clinical factors.</p>
|
| <p>50. At the time of this report, 1995, the NIH consensus
|
| program had not assessed CABGS since 1980 and had never
|
| assessed angioplasty.</p>
|
| <p>51. RAND researchers evaluated CABGS in New York in 1990.
|
| They reviewed 1,300 procedures and found 2% were inappropriate,
|
| 90% appropriate, and 7% uncertain. For 1,300 angioplasties,
|
| 4% were inappropriate and 38% uncertain. Using RAND methodologies
|
| a panel of British physicians rated twice as many procedures
|
| "inappropriate" as did a U.S. panel rating the
|
| same clinical cases. The New York numbers are in question
|
| because New York State limits the number of surgery centers,
|
| and the per-capita supply of cardiac surgeons in New York
|
| is about one-half the national average.</p>
|
| <p>52. The estimated five-year cost is $33,000 for angioplasty
|
| and $40,000 for CABGS. So, angioplasty did not lower costs.
|
| This was because of high failure rates of angioplasty.</p>
|
| </blockquote>
|
| <p><b>2. Computed Tomography CT</b></p>
|
| <blockquote>
|
| <p>53. The first CT scanner in the U.S. was installed at the
|
| Mayo Clinic in 1973. In 1992 the number of operational CT
|
| scanners was 6,060. By comparison, in 1993 there were 216
|
| CT units in Canada.</p>
|
| <p>54. There is little information available on how CT scan
|
| improves or affects patient outcome.</p>
|
| <p>55. In some institutions up to 90% of scans performed were
|
| negative.</p>
|
| <p>56. Approval by the FDA was not required for CT scanners.
|
| No evidence of safety or efficacy was required.</p>
|
| </blockquote>
|
| <p><b>3. MRI</b></p>
|
| <blockquote>
|
| <p>57. The first MRI was introduced in 1978 in Great Britain;
|
| the first U.S. scanner in 1980. By 1988 there were 1,230
|
| units; by 1992 between 2,800 and 3,000.</p>
|
| <p>58. A definitive review published in 1994 found less than
|
| 30 studies out of 5,000 that were prospective comparisons
|
| of diagnostic accuracy or therapeutic choice.</p>
|
| <p>59. American College of Physicians assessed MRI studies
|
| and rated 13 out of 17 trials as "weak" - meaning
|
| the absence of any studies on therapeutic impact or patient
|
| outcomes.</p>
|
| <p>60. The OAT concludes that, "It is evident that hospitals,
|
| physician-entrepreneurs, and medical device manufacturers
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| have approached MRI and CT as commodities with high-profit
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| potential, and decision-making on the acquisition and use
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| of these procedures has been highly influenced by this approach.
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| Clinical evaluation, appropriate patient selection, and
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| matching supply to legitimate demand might be viewed as
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| secondary forces."</p>
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| </blockquote>
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| <p><b>4. Laparoscopic Surgery</b></p>
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| <blockquote>
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| <p>61. Laparoscopic cholecystectomy was introduced at a professional
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| surgical society meeting in late 1989. In 1992, five years
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| after introduction, 85% of all cholecystectomies were performed
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| laparoscopically.</p>
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| <p>62. There was an associated increase of 30% in the number
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| of cholecystectomies performed.</p>
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| <p>63. Because of the increased volume of gall bladder operations,
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| the total costs increased 11.4% between 1988 and 1992, in
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| spite of a 25.1% drop in the average cost per surgery.</p>
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| <p>64. The mortality rate for gall bladder surgeries also
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| did not decline as a result of the lower risk because so
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| many more were performed.</p>
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| <p>65. When studies were finally done on completed cases,
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| the results showed that laparoscopic cholecystectomy was
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| associated with reduced in-patient duration, decreased pain,
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| and shorter period of restricted activity. But there were
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| increased rates of bile duct and major vessel injuries and
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| a suggestion that these rates were worse for people with
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| acute cholecystitis. There were still no clinical trials
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| to clarify this issue.</p>
|
| <p>66. Patient demand, fueled by substantial media attention,
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| was a major force in promoting rapid adoption.</p>
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| <p>67. The video, which introduced the procedure in 1989,
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| was produced by the major manufacturer of laparoscopic equipment.</p>
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| <p>68. Doctors were given two-day training seminars before
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| performing the surgery on patients.<br>
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| Infant Mortality</p>
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| <p>69. In 1990 the U.S. ranked twenty-fourth in infant mortality
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| out of 38 developed countries with a rate of 9.2 deaths
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| per 1,000 live births.</p>
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| <p>70. U.S. black infant mortality is 18.6 per 1,000 live
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| births and 8.8 for whites.</p>
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| </blockquote>
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| <p><b>Screening for Breast Cancer</b></p>
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| <blockquote>
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| <p>71. There has always been a debate over mammography screening
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| in women under 50.</p>
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| <p>72. In 1992 the Canadian National Breast Cancer Study of
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| 50,000 women showed that mammography had no effect on mortality
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| for younger women, aged 40-50.</p>
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| <p>73. The National Cancer Institute (NCI) refused to change
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| its recommendations on mammography.</p>
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| <p>74. The American Cancer Society decided to wait for more
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| studies on mammography.</p>
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| <p>75. Then, in December 1993 NCI announced that women over
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| 50 should have routine screening every one to two years
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| but younger women would have no benefit from having mammography.</p>
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| </blockquote>
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| <p><b>Summary</b></p>
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| <blockquote>
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| <p>76. The OTA concluded that, "There are no mechanisms
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| in place to limit dissemination of technologies regardless
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| of their clinical value."</p>
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| </blockquote>
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| <p>Shortly after this report, the OTA was disbanded.</p>
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| </P> </font></p> </td> </tr> </table> </td> </tr> </table>
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| </table>
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| <td class="arial12"><font color="#000000"><b> Copyright © 2005: Taxus Pharma / Construction des Trois-Monts Inc.</b></font></td>
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