Death by Medicine (Appendix)

OFFICE OF TECHNOLOGY ASSESSMENT (OTA)

Health Care Technology and Its Assessment in Eight Countries, 1995.

1. In 1990, US life expectancy was 71.8 years for men and 78.8 years for women, among the lowest rates in the developed countries.
2. The 1990 US infant mortality rate in the US was 9.2 per 1,000 live births, in the bottom half of the distribution among all developed countries.
3. Health status is correlated with socioeconomic status.
4. Health care is not universal.
5. Health care is based on the free market system with no fixed budget or limitations on expansion.
6. Health care accounts for 14% of the US GNP ($800 billion in 1993).
7. The federal government does no central planning, though it is the major purchaser of health care for older people and some poor people.
8. Americans are less satisfied with their health care system than people in other developed countries.
9. US medicine specializes in expensive medical technology; some large US cities have more magnetic resonance image (MRI) scanners than most countries.
10. Huge public and private investments in medical research and pharmaceutical development drive this “technological arms race.”
11. Any efforts to restrain technological developments in health care are opposed by policymakers concerned about negative impacts on medical-technology industries.

1. In 1990, the US had 5,480 acute-care hospitals, 880 specialty (psychiatric, long-term care, and rehabilitation) hospitals, and 340 federal (military, veterans, and Native American) hospitals, or 2.7 hospitals per 100,000 population.
2. In 1990, the average length of stay for 33 million admissions was 9.2 days. The bed occupancy rate was 66%. Lengths of stay were shorter and admission rates lower than other countries.
3. In 1990, the US had 615,000 physicians, or 2.4 per 1,000 population; 33% were primary care (family medicine, internal medicine, and pediatrics) and 67% were specialists.
4. In 1991, government-run health care spending totaled $81 billion.
5. Total US health care spending rose to $752 billion in 1991 from $70 billion in 1950. Spending grew five-fold per capita.
6. Reasons for increased healthcare spending include:
   1. The high cost of defensive medicine, with an escalation in services solely to avoid malpractice litigation.
   2. US health care based on defensive medicine costs nearly $45 billion per year, or about 5% of total health care spending, according to one source.
   3. The availability and use of new medical technologies have contributed the most to increased health care spending, argue many analysts. These costs are impossible to quantify.
7. The reasons government attempts to control health care costs have failed include:
   1. Market incentive and profit-motive involvement in the financing and organization of health care, including private insurers, hospital systems, physicians, and the drug and medical-device industries.
   2. Expansion is the goal of free enterprise.

Health-Related Research and Development

1. The US spends more than any other country on health-related R&D.
2. In 1989, the federal government spent $9.2 billion on R&D, while private industry spent an additional $9.4 billion.
3. Total US R&D expenditures rose 50% from 1983 to 1992.
4. NIH receives about half of US government R&D funding.
5. NIH spent more on basic research ($4.1 billion in 1989) than for clinical trials of medical treatments on humans ($519 million in 1989).
6. Most of the clinical trials evaluate new treatment protocols for cancer and complications of AIDS, and do not study existing treatments, even though their effectiveness is in many cases unknown and questionable.
7. In 1990, the NIH had just begun to do meta-analysis and cost-effectiveness analysis.

1. About two-thirds of the industry's $9.4 billion budget went to drug research; device manufacturers spent the remaining one-third.
2. In addition to R&D, the medical industry spent 24% of total sales on promoting their products and 15% of total sales on development.
3. Total marketing expenses in 1990 were over $5 billion.
4. Many products provide no benefit over existing products.
5. Public and private health care consumers buy these products.
6. If health care spending is perceived as a problem, a highly profitable drug industry exacerbates the problem.

1. The FDA ensures the safety and efficacy of drugs, biologics, and medical devices.
2. The FDA does not consider costs of therapy.
3. The FDA does not consider the effectiveness of a therapy.
4. The FDA does not compare a product to currently marketed products
5. The FDA does not consider nondrug alternatives for a given clinical problem.
6. It costs $200 million in development costs to bring a new drug to market. AIDS-drug interest groups forced new regulations that speed up the approval process.
7. Such drugs should be subject to greater post-marketing surveillance requirements. As of 1995, these provisions had not yet come into play.
8. Many argue that reductions in the pre-approval testing of drugs open the possibility of significant undiscovered toxicities.

1. 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%).
2. In 1978, Congress created the National Center for Health Care Technology (NCHCT) to advise Medicare and Medicaid.
3. With an annual budget of $4 million, NCHCT published three broad assessments of high-priority technologies and made about 75 coverage recommendations to Medicare.
4. Congress disbanded NCHCT in 1981. 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.”
5. The medical device lobby also opposed government oversight by NCHCT.

Examples of Lack of Proper Management of HealthCare

Treatments for Coronary Artery Disease

1. Since the early 1970s, the number of coronary artery bypass surgeries (CABGS) has risen rapidly without government regulation or clinical trials.
2. Angioplasty for single vessel disease was introduced in 1978. The first published trial of angioplasty versus medical treatment was done in 1992.
3. Angioplasty did not reduce the number of CABGS, as was promoted.
4. Both procedures increase in number every year as the patient population grows older and sicker.
5. Rates of use are higher in white patients and private insurance patients, and vary greatly by geographic region, suggesting that use of these procedures is based on non-clinical factors.
6. As of 1995, the NIH consensus program had not assessed CABGS since 1980 and had never assessed angioplasty.
7. RAND researchers evaluated CABGS in New York in 1990. They reviewed 1,300 procedures and found 2% were inappropriate, 90% were appropriate, and 7% were 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 US 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 of the national average.
8. The estimated five-year cost is $33,000 for angioplasty and $40,000 for CABGS. Angioplasty did not lower costs, due to its high failure rates.

1. The first CT scanner in the US was installed at the Mayo Clinic in 1973. By 1992, the number of operational CT scanners in the US had grown to 6,060. By comparison, in 1993 there were 216 CT units in Canada .
2. There is little information available on how CT scans improve or affect patient outcomes
3. In some institutions, up to 90% of scans performed were negative.
4. Approval by the FDA was not required for CT scanners, nor was any evidence of safety or efficacy.

1. MRIs were introduced in Great Britain in 1978 and in the US in 1980. By 1988, there were 1,230 units and by 1992 between 2,800 and 3,000.
2. A definitive review published in 1994 found less than 30 studies of 5,000 that were prospective comparisons of diagnostic accuracy or therapeutic choice.
3. The American College of Physicians assessed MRI studies and rated 13 of 17 trials as “weak,” i.e., lacking data concerning therapeutic impact or patient outcomes.
4. The OTA concluded: “It is evident that hospitals, physician-entrepreneurs, and medical device manufacturers have approached MRI and CT as commodities with high-profit potential, and decision-making on the acquisition and use of these procedures has been highly influenced by this approach. Clinical evaluation, appropriate patient selection, and matching supply to legitimate demand might be viewed as secondary forces.”

1. Laparoscopic cholecystectomy was introduced at a professional surgical society meeting in late 1989. By 1992, 85% of all cholecystectomies were performed laparoscopically.
2. There was an associated increase of 30% in the number of cholecystectomies performed.
3. Because of the increased volume of gall bladder operations, their total cost increased 11.4% between 1988 and 1992, despite a 25.1% drop in the average cost per surgery.
4. The mortality rate for gall bladder surgeries did not decline as a result of the lower risk because so many more were performed.
5. When studies were finally done on completed cases, the results showed that laparoscopic cholecystectomy was associated with reduced inpatient duration, decreased pain, and a shorter period of restricted activity. But rates of bile duct and major vessel injury increased and it was suggested that these rates were worse for people with acute cholecystitis. No clinical trials had been done to clarify this issue.
6. Patient demand, fueled by substantial media attention, was a major force in promoting rapid adoption of these procedures.
7. The major manufacturer of laparoscopic equipment produced the video that introduced the procedure in 1989.
8. Doctors were given two-day training seminars before performing the surgery on patients.

1. In 1990, the US ranked 24th in infant mortality of 38 developed countries with a rate of 9.2 deaths per 1,000 live births.
2. US black infant mortality is 18.6 per 1,000 live births, compared to 8.8 for whites.

1. Mammography screening in women under 50 has always been a subject of debate.
2. In 1992, the Canadian National Breast Cancer Study of 50,000 women showed that mammography had no effect on mortality for women aged 40-50.
3. The National Cancer Institute (NCI) refused to change its recommendations on mammography.
4. The American Cancer Society decided to wait for more studies on mammography.
5. In December 1993, NCI announced that women over 50 should have routine screenings every one to two years but that younger women would derive no benefit from mammography.

Summary

1. The OTA concluded: “There are no mechanisms in place to limit dissemination of technologies regardless of their clinical value.”
   Shortly after the release of this report, the OTA was disbanded.