Global Ethics – Medical Ethics – Hospital Ethics Committees – Research Ethics – Public Health

Archive for August, 2010

A recent study mapping the outsourcing of pharmaceutical pediatric research in developing countries has raised the concern of exploitation. The study performed by Duke investigators (Globalization of Pediatric Research: Analysis of Clinical Trials Completed for Pediatric Exclusivity) raises the concern that many of these trials are testing drugs that are unlikely to be reasonably available to the countries from where the research subjects are recruited. The study documented that more than one-third of the trials enrolled patients from a developing country and of these trials, more than one-third enrolled patients investigating cardiovascular and allergy/immunology diseases (e.g., atopic dermatitis and juvenile rheumatoid arthritis). To be sure, more than one-half of the trials involved studies of antiretroviral and antimalarial drugs, which address important health care needs of the developing countries. But a basic safeguard for the protection of potentially vulnerable populations is to test drugs first in populations that are less vulnerable, which would apply to the aforementioned cardiovascular and allergy/immunology diseases. Even if one wants to assume that parents gave volunatary informed consent for the enrollment of their children in research (a questionable reality), one needs to question the conclusions of institutional review boards (IRBs) that gave approval to the performance of these studies. Similar concerns have been raised in Chris MacDonald’s post on the Research Ethics Blog.

Investigators have found that patients with terminal lung cancer began receiving palliative care immediately at the time of diagnosis  were happier, more mobile,  in less pain as the end-of-life and ALSO:  lived nearly three months longer than those who did not receive palliative care.

The study was published in The New England Journal of Medicine and contrasts with the rhetoric about ‘death panels’ that surfaced during the debate on the Obama  Administration’s health care bill, thus casting doubt on the decision to strike end-of-life provisions from the health care overhaul passed last year.

In the three-year study performed at the Massachusetts General Hospital, 151 patients with advanced lung cancer were randomly assigned to get either oncology treatment alone or oncology treatment with palliative care — pain relief and other measures intended to improve a patient’s quality of life. They were followed until the end of 2009, by which time about 70 percent were dead.  Those getting palliative care from the start reported less depression and happier lives as measured on scales for pain, nausea, mobility, worry and other problems. Moreover, even though substantially fewer of them opted for aggressive chemotherapy as their illnesses worsened and many more chose to forgo cardiopulmonary resuscitation,  they  lived almost three months longer than the group getting standard care, who lived a median of nine months.

Palliative care is traditionally seen as an intervention only for those in their last weeks of life.  But, contrary to this opinion, the institution of palliative care makes sense from the beginning of an illness.

At the urging of consumer groups and key members of Congress, the Obama administration is rewriting new rules on medical privacy. The expressed concern is that the current rules do not adequately protect the rights of patients. The rules specify when doctors, hospitals and insurers must tell patients about the improper use or disclosure of information in their medical records. The concern, however, is under the current rules, health care providers and health insurance plans would have to notify patients of a privacy breach only if they found that the violation posed “a significant risk of financial, reputational or other harm to the individual.” But, how does a hospital or an insurance company know whether an improper disclosure will harm a person’s chances for promotion or endanger a victim of domestic abuse? The Privacy Rights Clearinghouse, a watchdog group, estimates that more than five million people have been affected by breaches of medical information in the last 18 months. Causes have included the loss of laptop computers and paper records, the posting of data on Web sites, and the curiosity of hospital employees snooping for medical information on celebrities and their colleagues. Interesting, despite the prospect of qualifying for a part of $27 billion in incentives from the federal government, a recent study published online in Health Affairs showed that only about 2% of hospitals had done enough to adopt the necessary elements of electronic medical records to qualify for these future financial incentives.

View from the Flamenco Hotel in Zemalek, Cairo, Egypt