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October
25
  2:56:00 PM

Drug tests in East Germany get “conceded pass”

Respect for informed consent is not regarded as one of the greatest virtues of East German medicine in the 1980s. Elite athletes in East Germany (GDR) were routinely given drugs to enhance their performance, even to the point of endangering their health. With such scandals in mind, no one was surprised when reports surfaced in the German media last year that the GDR had leased out patients as guinea pigs to Western pharmaceutical firms to support its failing health care system.

However, researchers at the Institute for the History and Ethics of Medicine, in Erlangen, Germany, have concluded that these sensational claims were “tendentious” and “distorted”. In an article in the Journal of Medical Ethics they say the GDR attempted to conduct trials according to international ethical standards and that there was no evidence to suggest the trials systematically and intentionally damaged patients.

Nonetheless, the surviving records do not exonerate the GDR authorities. The trials were conducted without the knowledge of the public and although GDR legislation stipulated that patients had to consent to the trials, there is no evidence that patients were systematically informed. Many different drugs were tested, including, chemotherapeutic agents, insulin, heparin, anti-depressants, anti-allergy drugs, toothpastes and cardiovascular drugs.

Some documents suggest that some of the trials were carried out without patients having a comprehensive understanding of what the trial involved. It is also unclear whether the patients knew that they were participating in trials and were aware of all the risks.

But even if the patients did not benefit, the companies and the government did. The companies were able to test new drugs legally, while at the same time opening up new markets in the Eastern Bloc and getting test results faster and more cheaply than they could elsewhere. The government appears to have earned DM16.5 million from 220 trials between 1983 and 1990 involving more than 14,000 patients and 68 Western companies, mainly from West Germany, Austria and Switzerland.

What accounts for the ethical shortcomings of the GDR health system? The researchers say:

“… the GDR ideology required the subordination of the individual to the interests of the collective, a basic precept of Marxism. Therefore, the rights of the individual were not always fully taken into account. This goes against traditional medical ethics where patient autonomy is the primary concern. In the GDR, decisions were often made for purely ideological reasons. State politics followed a socialist collective code of ethics and ethical freedom was non-existent, a fact that even formerly loyal GDR ethicists openly admit today. Medical employees, doctors and scientists were expected to subordinate their interests to prioritise tasks of importance to society. A truly independent medical opinion was not wanted.”
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November
02
  12:05:00 AM

A sceptical look at synthetic biology

Here's a sceptical look at a controversial subject: synthetic life (or synthetic biology). It's already a multi-billion dollar industry which has immense social and environmental implications. "Governments don’t yet know how to assess synthetically modified organisms for safety and so most are supposedly being kept contained, but now a new wave of SynBio organisms are being developed that are intended for environmental release," says one of the organisers of SynBioWatch, the lobby group which produced the video below: 

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October
25
  5:18:00 PM

British right-to-die campaigner starves herself to death

A leading right-to-die campaigner in Britain has starved herself to death. Jean Davies, 86, passed away on October 1, five weeks after she stopped taking food and two weeks after she stopped taking water. She did not have a terminal illness. She was afraid that the other alternative, a drug overdose, would not work and she wanted to die at home, not in Switzerland, where assisted suicide is legal. 

Ms Davies was president of the World Federation of Right to Die Societies from 1990 to 1992 and had been the chair of the Voluntary Euthanasia Society UK (which has been renamed Dignity in Dying).

The process took much longer than she expected. “She hadn’t realised that it would take her so long to die after she stopped drinking,” he daughter told the media. “She thought it might take three days. It took a fortnight.” Before dying her mother gave a long interview to the Sunday Times. “It is hell. I can’t tell you how hard it is,” she complained. “You wouldn’t decide this unless you thought your life was going to be so bad. It is intolerable.”

Why did Ms Davies persevere with her choice? "I think it occurred to her after she started her course of action that it was something which could attract attention," he daughter commented. "She sought publicity after her decision."

Reactions to Ms Davies’s showmanship varied. Dr Peter Saunders, of Care Not Killing, described it as “a subtle form of emotional blackmail aimed at softening opposition to a change in the law to allow assisted suicide or euthanasia.” He went on to say that “There are good reasons for keeping the law as it is. Any change in the law to allow assisted suicide or euthanasia would place pressure on vulnerable people to end their lives for fear of being a financial, emotional or care burden upon others. This would especially affect people who are disabled, elderly, sick or depressed.”

Pavan Dhaliwal, of the British Humanist Association, said it was an “immensely brave decision”. “It is our moral duty as a society to give assistance to mentally competent adults who are suffering incurably, permanently incapacitated, and have made a clear and informed decision to end their life but are unable to do so independently,” she said. 

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October
25
  12:19:00 PM

Is conflict of interest a real problem for doctors?

In this YouTube video Aaron E. Carroll, a paediatrician at Indiana University School of Medicine and a blogger at The Incidental Economist, explains why it is important for doctors to be aware of potential conflicts of interest.

“This ‘magical thinking’ that somehow we, ourselves, are immune to what we are sure will influence others is why conflict of interest regulations exist in the first place. We simply cannot be accurate judges of what’s affecting us.”

An excellent introduction to an important topic. (For the related New York Times blog post, click here.)

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October
25
  11:07:00 AM

Bioethics consultancies: the way of the future?

Informal bioethics consulting has been common in many countries for decades. But ethicists in the US are attempting to formalise the practice, creating independent ‘ethics consulting’ services for healthcare professionals and scientists. 

Ethics committees such as institutional review boards (IRBs) tend to have a narrow focus and their guidance is often binding on healthcare professionals.

Ethical consulting services can provide important advice that goes beyond the jurisdiction of IRBs. They provide “an open space for talking about research ethics in a way that is not driven by the regulatory environment”, says Marion Danis, chief of the bioethics consultation service at NIH Clinical Center, a research hospital in Bethesda, Maryland. The can also provide valuable ‘second opinions’ to IRB’s, Danis said.

Benjamin Wilfond, director of the Treuman Katz Center for Pediatric Bioethics at Seattle Children's Hospital in Washington, has set up the Clinical Research Ethics Consultation Collaborative, a group of around 35 bioethicists who hope to keep improving the consultation service model, even without NIH support. 

“There's energy behind continuing what we started,” says Holly Taylor, a research ethicist at the Johns Hopkins Berman Institute of Bioethics in Baltimore, Maryland, and a member of the group.

University of Minnesota bioethicist Steven Miles is very enthusiastic about the initiatives. “For innovative research designs, you need some independent person to say, 'Well, let's step back and think about this not just from the standpoint of do the regulations permit it, but does it fulfil the spirit of what people want done with the public research enterprise?'.

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October
25
  10:08:00 AM

Should all Ebola volunteers be quarantined?

Hundreds of foreign healthcare workers have been shuttling in and out of Ebola-affected countries in West Africa. They are altruistic, generous and brave. Should they be burdened with a 21-day quarantine when they return even if they do not have any symptoms of the disease? If so, fewer might go at a time when Liberia, Sierra Leone and Guinea need all the help they can get.

An example of the case for strict quarantine measures in the United States is Dr Craig Spencer, a 33-year-old physician who returned to New York City after working in Guinea. He felt fine, boarded a subway, went bowling with his fiancée and friends, and used a taxi. Then he developed a fever, which turned out to be Ebola.

Irresponsible, says Howard Markel, a medical historian at the University of Michigan, in The New Republic, but characteristic of energetic young physicians. who have a “sense of invulnerability, the inability to be stricken with illness even in the face of an epidemic, and, most cogently, a disdain for following the very rules and medical advice we give to our patients everyday.”

New York and New Jersey have mandated a compulsory 21-day quarantine for medical workers returning from the worst-affected countries.

The case against these draconian measures is that they will deter people from volunteering. “We do want to ensure that whatever policies we put in place takes as the first priority the protection of the American public,” said White House press secretary Josh Earnest yesterday. “But at the same time, we don’t want to overly burden those individuals who are going to great lengths to try to serve their fellow man and stop this outbreak at the source, which ultimately is in the best interests of the American people.”

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October
25
  10:07:00 AM

Radical measures to prevent the spread of Ebola in hospitals

At least three US hospital systems are currently considering whether they withhold certain treatments from Ebola patients, in a bid to protect their doctors and nurses.  

The move comes after two nurses from Dallas were infected with the virus whilst treating a patient who had recently returned from West Africa.

Executives at University of Chicago Medicine are considering whether procedures such as inserting a breathing tube or putting a ventilator on a patient should be avoided due to the potential of exposure to the virus.  

“We have very little experience with [those procedures] except for Mr Thomas Duncan, who didn’t do well,” said Dr Emily Landon, a bioethicist and epidemiologist from the hospital. 

Pennsylvania’s Geisinger Health System is also considering whether certain ‘risky’ procedures could be avoided, as are managers from Intermountain Healthcare, which runs facilities in Utah. 

Geisinger is paying close attention to directives from the Centre for Disease Control and Prevention (CDC), and has set up an Ebola Response Team to deal with the new viral threat.

Dr G. Kevin Donovan, director of the bioethics centre at Georgetown University, told hospitals to proceed with caution: “To have a blanket refusal to offer these procedures is not ethically acceptable”.

Dr Nancy Kass, a bioethicist at Johns Hopkins Bloomberg School of Public Health, said healthcare workers should not hesitate to perform a medically necessary procedure so long as they have robust personal protective gear.

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October
24
  5:37:00 PM

Assisted suicide debate intensifies in Scotland

British Anti-euthanasia group Care Not Killing (CNK) has launched a major online campaign intended to derail a new assisted-suicide (AS) bill being debated in the Scottish parliament.

The proposed legislation, due to be discussed by the parliamentary justice committee next Tuesday, would make assisted suicide legal for people as young as 16 who suffering from “a terminal or life shortening illness”. 

The bill was originally moved by Margo MacDonald, an MSP who died in April following a long battle with Parkinson’s disease. 

CNK’s online petition labels the proposed changes “unnecessary, unethical and uncontrollable”. Extant penalties, the petition states, “act as a strong deterrent to exploitation and abuse whilst giving prosecutorial discretion in hard cases.”

CNK spokesperson Dr Gordon MacDonald said that a change to the law would “place pressure on vulnerable people to end their lives for fear of being a financial, emotional or care burden upon others.”

Earlier in the year influential Scottish journalist Kevin McKenna wrote a scathing critique of the bill, criticising the “twisted morality” and “bizarre…deathly obsession” that underpinned it.  

Patrick Harvie MSP, and ardent supporter of the bill, accused CNK of providing a distorted picture of proposed changes:  “I hope that MSPs will judge this bill on its own merits before reaching their decision.” 

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October
24
  10:31:00 AM

Nasal cells allow paralyzed man to walk again

Scientists who developed a treatment to allow a paralysed man to walk again have spoken of the possibility of healing other debilitating nervous system conditions.  

Prof Geoffrey Raisman, of University College London’s Institute of Neurology, said the successful operation on paralysed fire-fighter Darek Fidyka opened the door to treating nervous system damage throughout the body.  

Thirty-eight-year-old Mr. Fidyka has regained feeling in his lower limbs after doctors transplanted olfactory ensheathing cells (OECs) from his nose into his spinal cord. OECs are what allow the sense of smell to return when nerve cells in the nose are damaged. A few months after the transplant, Fidyka’s thigh muscles began to grow, and two years on he can walk with the help of a Zimmer frame. 

The ability to trigger nervous system repair has massive implications, says Professor Raisman. “There’s no reason to restrict this to spinal cord. We have opened the door to a future which is terrifyingly large.”

John Haycock, a Professor of Bioengineering at the University of Sheffield, said: “It paves the way for cell-based therapies in conditions of the nervous system previously thought impossible to treat, not just spinal cord injuries but other conditions such as stroke. 

Some scientists are sceptical. “One case of a patient improving neurological impairment after spinal cord knife injury following nerve and olfactory cell transplantation is simply anecdotal and cannot represent any solid scientific evidence to elaborate upon”, said Dr Simone Di Giovanni, Chair in Restorative Neuroscience, Imperial College London.

But others say the technique is quite promising: “I think there’s good reason to be optimistic” wrote Dr Paul Zachary Myers of the University of Minnesota Morris. “It has to be a realistic hope — progress has been made. A cure does not exist. But that’s still some pretty good news.”

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October
18
  11:37:00 PM

Italian nurse may have killed 38 nursing home patients

A 42-year-old Italian nurse has been arrested over one death in a nursing home in the northern city of Lugo. But she is suspected of killing as many as 38 because they annoyed her. According to Italian media Daniela Poggioli even took selfies with some of the dead patients. “In all my professional years of seeing shocking photos, there have been few like these,” said Alessandro Mancini, the chief prosecutor of Ravenna.

The police investigation will be difficult, as the alleged method was an injection of potassium chloride, which is undetectable after a few days.

Some of Ms Poggioli’s colleagues suspected that something was wrong because so many patients were dying, far more above the average. She was also uncooperative and gave some patients laxatives just before the next shift to inconvenience other nurses. She also used to give patients sedatives to ensure that they would be quiet. 

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Drug tests in East Germany get “conceded pass”
25 Oct 2014
A sceptical look at synthetic biology
2 Nov 2014
British right-to-die campaigner starves herself to death
25 Oct 2014
Is conflict of interest a real problem for doctors?
25 Oct 2014
Bioethics consultancies: the way of the future?
25 Oct 2014

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