The Telegraph‘s article below, about clinical trials performed on homeless people and descriptions of  ambulance medics found guilty of killing their patients for commissions from funeral companies, reinforces the need for person-centered bioethics training for healthcare professionals - an aim of Bioethics International. —

Three Polish doctors and six nurses are facing criminal prosecution after a number of homeless people died following medical trials for a vaccine to the H5N1 bird-flu virus.

21 people died after being given the vaccine The medical staff, from the northern town of Grudziadz, are being investigated over medical trials on as many as 350 homeless and poor people last year, which prosecutors say involved an untried vaccine to the highly-contagious virus.

Authorities claim that the alleged victims received £1-2 to be tested with what they thought was a conventional flu vaccine but, according to investigators, was actually an anti bird-flu drug.

The director of a Grudziadz homeless centre, Mieczyslaw Waclawski, told a Polish newspaper that last year, 21 people from his centre died, a figure well above the average of about eight.

Although authorities have yet to prove a direct link between the deaths and the activities of the medical staff, Poland’s health minister, Ewa Kopacz, has said that the doctors and nurses involved should not return to their profession. “It is in the interests of all doctors that those who are responsible for this are punished,” the minister added. 

Investigators are also probing the possibility that the medical staff may have also have deceived the pharmaceutical companies that commissioned the trials. The suspects said that the all those involved knew that the trial involved an anti-H5N1 drug and willingly participated.

The news of the investigation will come as another blow to the reputation of Poland’s beleaguered and poverty-stricken national health service. In 2002, a number of ambulance medics were found guilty of killing their patients for commissions from funeral companies. 

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Newswise — Nearly one in 10 obstetricians in a new study has considered giving up obstetric practice because of the emotional toll of stillbirths and infant deaths.

Three-quarters of the 804 obstetricians who responded to a survey by researchers at the University of Michigan Health System reported that the experience took a large emotional toll on them personally.

“Our survey reveals that perinatal death has a profound effect on obstetricians, and 8 percent had considered giving up obstetrics because of the emotional difficulty of caring for patients with perinatal death,” says lead author Katherine Gold, M.D., MSW, of U-M’s Department of Family Medicine and Department of Obstetrics and Gynecology.

“We know that stillbirth and infant death are traumatic events for families; this study suggests that they are also traumatic for the physician.”

The study appears in the July issue of the journal Obstetrics & Gynecology.

Approximately 15 percent of pregnancies end in early losses (before 20 weeks gestation). In the United States, 1.3 percent of pregnancies end in either stillbirth (losses after 20 weeks but before delivery) or infant death (deaths in the first year of life, most of which occur in the first week). On average, the typical obstetrician performing 140 deliveries a year could encounter nearly two dozen women with a miscarriage and one to two with stillbirth or infant death, the study says.

“Obstetricians want to see a healthy baby. When a fetus or baby dies, the loss can be devastating for the physician,” Gold notes. “Half of the time, the medical cause of a stillbirth is unknown, but physicians still may struggle with feelings of guilt or self-blame.

“When a fetus or baby dies, we focus on the family’s needs, but obstetricians are often struggling with their own emotions too.”

The threat of lawsuits also weighs heavily on physicians. Stillbirths are the number two reason for lawsuits against obstetricians in the United States, preceded only by allegations involving births with adverse neurologic outcomes. In the study, 43 percent of obstetricians who responded said they had worried about disciplinary or legal action due to a perinatal death with no identified cause.

Improved physician training would help obstetricians, according to a majority of the study’s respondents. Physicians who said they’d had adequate bereavement training were less likely to report that they had considered giving up obstetric practice because of the emotional difficulty of perinatal death, the study notes. Physicians who perceived their own training as adequate were less likely to worry about disciplinary or legal action when cause of death was unknown.

“As physicians, we get a lot of training in medicine but little in death and bereavement. Sudden and unexpected losses can be terribly difficult both for families and for the physicians involved in caring for the family,” Gold says. “This study shows that stillbirths and infant deaths can have profound and persistent effects on obstetricians. We need to find ways to help both families and physicians cope with these devastating events.”

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[NYT] Regulators are cracking down on companies that sell genetic tests directly to consumers, threatening to crimp the growth of one of the hottest sectors of the biotechnology industry.

The California Department of Public Health sent “cease and desist” letters to 13 genetic testing companies two weeks ago, telling them they could not solicit business from state residents. The companies include the early leaders in the field — 23andMe, Navigenics and deCode Genetics — which are trying to carve out a new business of offering personal genetic information for use in health and lifestyle planning.

The California action follows efforts by New York State, which has sent letters to 31 genetic testing companies since November, saying they need licenses to solicit DNA specimens from the state’s residents.

Pressure is also mounting for the federal government to take more action. A report in April by a federal advisory committee said there were significant gaps in the oversight of genetic tests that could lead to patient harm. The Department of Health and Human Services will hold a two-day public meeting July 7 and 8 to discuss regulation of personal genetic information services.

The Federal Trade Commission, meanwhile, has started investigations into possibly deceptive advertising or marketing of genetic tests, according to an agency official who spoke at a June 12 meeting convened by Senator Gordon Smith. The senator, an Oregon Republican, has been prodding federal agencies to take a stronger stance in overseeing genetic tests sold to consumers.

Yet the move to regulate the tests is raising many issues. What are the standards for proving a genetic test is valid? Must a doctor always be involved in ordering such tests to protect patients, or is that an attempt by doctors to protect their turf?

Some of the companies say people have a right to know the information in their genes and to guide their own health care.

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