The clinical trial team includes doctors, nurses, social workers, data entry technicians and other health care professionals (NWHRC 2005). They review a participant's health history and current medical intakes before the trial begins. They impart adequate information and instructions about the clinical trial, monitor each participant in the conduct of the trial and may contact the participant after the conduct of the trial.
Clinical trials or researches may also be open-label, placebo-controlled, double-blinded or randomized. They consist of four phases. Phase I establishes the maximum safe dosage; Phase II, its effectiveness; Phase III, its use on a broad population; and Phase IV, post-FDA insights on the effects of its long-term use (NWHRC).
From 1999 to 2000 alone, the Food and Drug Administration approved 73 new medications (NWHRC 2005). These included drugs for HIV, cancer, heart attack and Alzheimer's disease. As of 2000, Medicare covers many of the costs involved in participation in clinical trials or researches. The Institutional Review Board, in addition to the FDA, has to approve new drugs in case of oversight by the FDA. Participants in clinical trials can require more doctor visits and tests than if they did not take part. Researchers need to obtain detailed data on the progress of the treatment. From 1977 to 1993, the FDA prohibited women of child-bearing age from participating in early testing of most drugs to avoid birth defects. But today, they have been allowed again, as long as they are informed about the risks. When a particular drug proves exceptionally promising, the FDA puts it in "priority review" status. If accelerated scrutiny finds the drug suitable for treatment, it can be sent to market much sooner (NWHRC).
New medical devices, procedures and approaches to the treatment of diseases must also prove their worth (NWHRC 2005). Some studies seek to discover if a specific drug is better than surgery alone or earlier treatments can have better outcome. Health professionals who have doubts or questions about the diagnosis or treatment of a medical condition can settle them through the conduct of a clinical trial or research. Even the results of clinical tests must prove their mettle. They must provide "statistically significant" safety and/or effectiveness from mathematical analysis that they are highly likely to be true and not the mere product of chance. Clinical trials may be sponsored by government agencies, pharmaceutical or medical companies, individual physicians or health care institutions. These may be conducted in different locations or settings (NWHRC).
Issue 4: Rationing Health Care
Politicians and educators have not been too willing to confront the looming probability of the need to ration health care (Scott 2004). They refused to admit or even consider it in order to preserve the current health care system. But many healthcare policy leaders have been coming to terms with the dread. And the new Medicare bill signed into law by President Bush was a timely response to the dread. The NAIM was aimed at reviewing the costs of healthcare and limiting them when positive outcomes also seemed limited. It explored into a looming scenario when patients could be denied healthcare services, based on cost benefit analyses. The analyses could decide that the marginal benefit to the patient would not be worth its cost to the country. This would then call for rationing (Scott).
Section 1013, Title X of the NAIM charges the Health and Human Services Secretary to assess healthcare guidelines, reduce scientific uncertainty in healthcare delivery, allocate resources efficiently, and analyze financial effects of a change in incentives and allocation of resources on the healthcare marketplace (Scott 2004). The nation's growing budget deficit would bring the attention to social security and Medicare. The government cannot afford to continue paying benefits at the same level to those who demand them. There was need to either break the contract or revise it. If tax cuts were to be avoided now, future generations may not benefit from this social contract. President Bush endorsed the ideas of advisor Alan Greenspan to adjust healthcare in phases until younger generations could adapt to the circumstances. The forecast was that NAIM would cost the White House $139 billion more than expected. In addition, Medicare trustees found that Medicare would completely run out of funds by 2019. Successive studies have indicated that 30-35% of healthcare money has been misspent on unnecessary, ineffective and less than efficacious services (Scott).
Many of the perceived deficiencies of health care were likely to be issues other than excessive demand (Frankel 2000). These could include the public's unwillingness to accept the limits of effectiveness of health care and self-interest of professionals. Under-investment would be another. And the imbalance between demand and supply with the aging of the population, the appearance of new technology and the consequent increase in expectations would still be another. Rationing could be an approach to these problems. Rationing is aimed at regulating access to health care through measures intended to increase effectiveness, efficiency, equitability, ethicalness and benefits. The British view the ongoing debate on rationing as without scientific basis or rationale. The problem proposed is not in refutable form. The background data are drawn only from assertions, political analyses, and ethical debate. Assertions require data support. The discussion on rationing has been viewed as devoid of appropriate data. Moreover, every illustration of failure is considered evidence of something universal. Biases and claims of representativeness have been accepted as generalized facts. In turn, the persisting failure to satisfy the demands for a number of effective and high-volume procedures has been the cause of mismanagement in the main institution charged with health care. Today, a lot of the failure to meet demand is not necessary. When considering rationing, the inclination is to seek out and overrate the deficiencies involved or take recourse in the promised safety of "dilution." The common and unfounded interpretation has been that centers, which fail to satisfy health care demand, represent a global or universal pattern of failure (Frankel).
Issue 5: Organ Transplants
The United Network for Organ Sharing reported that over 80,000 people in the U.S. anxiously need organ transplants to save their lives and 17 of them die each while waiting and not obtaining what they need (USA Today 2003). Professor of health management would trace the problem to a faulty organ procurement system. There seemed to be trouble in identifying donors and obtaining their consent. The system needed a meaningful performance evaluation. In 1984, the National Organ Transplant Act established a system of nonprofit organ procurement organizations, which would serve the need without competing with one another. The objectives of the organizations were to educate the public about organ donation, provide clinical services to handle organ and tissue recovery, and deal with the donor families during the consent process. In charge of oversight were the Centers for Medicare and Medicaid Services. Observers noted that this function of the organization has been amiss and ineffective. These Centers tallied organ donors per million living residents within the area served by the organizations without considering the population's average age, ethnicity, religion and typical causes of death. These factors influenced the likelihood of the dying person's family to donate usable organs to the Centers. African-Americans would not be inclined to donate organs. This would mean that the Centers would not be able to gather donations in proportion to the population. And the elderly who typically had health problems would be similarly un-inclined (USA Today).
The Organ Procurement and Transplantation Network announced in 2004 that 27,000 Americans had received a solid organ transplant (Warren 2005). This was almost 6% more than the number of transplants performed the previous year. The number of donations from deceased persons had also increased by 11% also over the previous year's figure. In 2004, there were 7,150 deceased organ donors as compared with 6,457 in 2,003. This figure was the second highest yearly increase since the start of recording of such donations in 1987 (Warren).
According to this Network, there were 1,385 deceased donor transplants or 20,041 in 2004 as compared with 18,650 in 2003 (Warren 2005). This showed an increase of 7.4% in these two years. With this increase, deceased donations were more than those donated by live donors for the first time in four years. The margin between the two groups was, however, small. Live donations also increased by 6.966% in 2004 from 6,812 the previous year at a 2.3% increase. A major factor in the increase was attributed to the Gift of Life Initiative led by former HHS Secretary Tommy Thompson. The number of those awaiting transplants decreased to less than 6,000 for the first time in 6 years, according to the public announcement made by the Department of Health and Human Services. The Department's Organ Donation Breakthrough Collaborative was likewise credited for the increase. The increase was, however, shared by both participating and non-participating hospitals at16% and 9.4%, respectively, as compared to that of 2003 (Warren).
Part II - Ethics Committee Composition, Qualifications and…