Ans) Too often in developed countries, clinical research studies look only at the effects of therapy on surrogate values.
- For example, in COPD they emphasize FEV1 measurements, which do not correlate well with improved patient outcomes late in the disease. Often such therapies have high incidences of disabling side effects and are very expensive.
- Such studies frequently do not provide comparisons of different therapies or analysis of whether a particular benefit (e.g. fewer exacerbations) can be obtained with one less expensive drug or whether several drugs are needed to obtain the benefit. Such approaches that neglect patient cost and patient outcomes seem to be designed by drug regulatory agencies to facilitate approval of new, expensive, and unnecessary therapies.
- The ICC urges drug regulatory agencies worldwide to focus on patient outcomes rather than effects on surrogate variables. It recommends that better information and education for COPD patients would improve COPD outcomes more than research that doesn't consider patients' views.
COPD patients' right to support and understanding:
- During the first half of the twentieth century, primary care
medicine in its many forms predominated throughout the world. COPD
patients were part of their communities and their doctors provided
continuity and comprehensiveness of health care for them.
- However, since that time there has been a global increase in the prevalence of specialist physicians and a decrease in the number of primary care physicians to the point that in many countries COPD patients have lost their access to their own family doctor, and with that lost many of their rights to continuity and comprehensiveness of health care.
- Community support and participation in COPD patient organizations can help to provide COPD patients' right to support and understanding.
COPD patients' right to receive care and therapy that will benefit them:
- Withthe increase in specialty care, which often uses expensive high-tech methods, the expense of COPD patient care has increased substantially in most developed countries, with mean yearly COPD health care costs much greater today than in the past.
- The highest COPD care costs are in the United States, although many developed countries are also experiencing large health care cost increases.
- For patients without health insurance or unable to pay for care, their rights to therapy are seriously curtailed.
- This increase in cost is difficult to understand, because between the days of my medical residency in the 1970's and today there has been little change in the therapy for COPD, both in outpatient and inpatient care: smoking cessation, bronchodilators, corticosteroids, antibiotics, oxygen, and chest physiotherapy remain the foundation.
- Evidence has not shown that life expectancy, co-morbidities, or activity limitations have changed during this time.
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