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  10:31:00 PM

Have some American homeless become lab rats?

The web magazine Medium features a searing examination of the US clinical trials industry. The headline of the first part, written by bioethicist Carl Elliott, says it all: “The Best-Selling, Billion-Dollar Pills Tested on Homeless People: How the destitute and the mentally ill are being used as human lab rats”.

Elliott begins his investigation in Philadelphia, which has a large homeless population and a number of medical schools and pharmaceutical companies. He says that companies run clinical trials for drugs, even dangerous drugs, cheaper and faster than universities. This leads to questionable ethical practices. 

“Pharmaceutical companies now typically outsource clinical studies to contract research organizations like South Coast, which run trials faster and at lower cost than universities do. Their job is simply to follow the instructions of their sponsors. This formula is working: The contract research industry has grown steadily since the early 1990s and may now generate over $100 billion in annual income, according to the Tufts Center for the Study of Drug Development. At the top of the heap are corporations like Quintiles, which has 28,000 employees and operates in about 100 countries. At the other end are private physicians and small companies like South Coast, which are often based in strip malls or suburban office parks.”

These companies pay participants. for the destitute and mentally ill, it is money for jam. “The main ethical issues here, of course, are the competence and judgment of the prospective subjects,” writes Elliott. While compensation is not coercive, the poor can barely resist the temptation.

Elliott has been a harsh critic of fellow bioethicists for years, regarding many of them as shills for Big Pharma. He writes:

“None of the bioethicists or review board managers I spoke to were willing to publicly defend paying mentally ill homeless subjects to take part in clinical trials, although most did not seem especially surprised to hear that the practice was occurring. But some prominent bioethicists do not see homelessness as a barrier to research.”

The article is confronting and provocative. It’s well worth reading. 

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  9:18:00 PM

Warsaw hospital head sacked for refusing to refer for abortion

Dr Bogdan Chazan  

The director of a hospital in Warsaw has been dismissed because he refused to refer a woman for an abortion. The case has become a cause celebre in Poland, leading to protests from the Catholic clergy and internet petitions.

Dr Bogdan Chazan was approached in April by a woman who wanted an abortion because the baby she was carrying was badly deformed. He refused, citing “a conflict of conscience” and instead of referring her to another doctor who would do the abortion, he suggested that the child be cared for  in a hospice when it was born.

As a result Hanna Gronkiewicz-Waltz, the mayor of Warsaw, fired Dr Chazan last month. She said that he did not have the right to refuse to refer and the he had not informed the woman about her options for getting a termination. Under Polish law, abortions can be performed until the 25th week of pregnancy if the life of the mother or child is at risk, or in cases of incest or rape.

“Today’s decision is the start of an attack on the conscience of doctors and people in management positions in the health service, it is a violation of their conscience,” Prof Chazan told the media. “Abiding by the laws of nature, and first and foremost by the law that prohibits killing a person, will probably become a reason for eliminating these people from management positions.”

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  8:53:00 PM

US hospital settles for US$190 million over violation of patient privacy

The prestigious Johns Hopkins Hospital in Baltimore has agreed to pay US$190 million in compensation to 7,000 victims of a gynaecologist who secretly photographed pelvic examinations.

Dr Nikita A. Levy, a gynecologist and obstetrician for Johns Hopkins Community Medicine in Baltimore, was dismissed in February 2013 after a female colleague noticed that he wore a pen around his neck which was really a concealed camera. He committed suicide shortly afterwards.

The FBI concluded that Levy had not shared his photos or uploaded them to the internet. The lawyer for the class action suit, Jonathan Schochor, disagrees. “I think there’s overwhelming probability” that the images were shared, he told the New York Times. The lawsuit charged Johns Hopkins with invasion of privacy, emotional distress and negligence in its oversight of Dr Levy.

Many of Levy’s patients are very distressed. “There’s been a huge, devastating result to this whole thing,” Mr Schochor said. “Many have had changes in their ability to focus, problems with sleeplessness. Some have had changes in their relationships with spouses and significant others.” Some patients, he said, have lost trust in the medical system and now refuse to go to doctors or take their children.

“Words cannot describe how deeply sorry we are for all this has affected,” two top officials of Johns Hopkins wrote to former patients last year. “We are terribly sorry this has happened and for the distress you must be feeling… Protecting patients’ dignity and privacy is part of the core values that we instill in our patient safety procedures.”

This is a record payout for cases involving a doctor’s violation of privacy, but it is not extraordinary. In 2012 there were two gigantic settlements. A lawsuit over a Delaware paediatrician who recorded assaults on hundreds of children led to a $120 million payout and a Connecticut hospital settled for about $50 million after an endocrinologist used a medical study as a pretence to take obscene photographs of children.

Patient modesty and privacy are vital in the doctor-patient relationship. Scandals like this could scupper the use of Google Glass in a medical setting.

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  5:24:00 PM

Top physician dies after treating Ebola patients

The most senior Sierra Leone doctor helping to fight the Ebola epidemic has died after contracting the virus from patients. Dr. Sheikh Umar Khan was a virologist in charge of a hospital unit treating Ebola patients in Kenema – a major city in the most effected area of the country. Dr. Khan was credited with treating over 100 patients since the outbreak began in February.

He passed away on Sunday in a Doctors without Borders clinic, just a few days after being diagnosed.

"It is a big and irreparable loss to Sierra Leone as he was the only specialist the country had in viral haemorrhagic fevers," Chief Medical Officer Dr. Brimba Kargbo said on Tuesday.

Dr. Khan was aware of the risks he was taking, but continued to work with Ebola patients. He has been hailed by Sierra Leoneans as a national hero. 

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  4:57:00 PM

Savulescu on changing the world - literally

Academics advocating geoengineering usually encounter strong resistance, and sometimes ridicule, amongst their peers. Many say you risk creating problems worse than the ones you are trying to solve.

In a recent Practical Ethics post, Oxford bioethicist Julian Savulescu defended the notion, suggesting that it could be the only way to combat climate change.  

By genengineering, Savulescu is referring to large-scale interventions by which we can alter the structure of the environment, making it more conducive to human inhabitation. He used as an example the introduction of ants, iron sulphide, and artificial trees to combat global warming.

Savulescu suggests that genengineering is already occurring in the form of massive carbon omissions. Insofar as it is already happening we shouldn’t be concerned to engage in large-scale geoengineering to bring the world back to normal.

He also challenges the claim that the ‘natural’ climate is the best. We should rely less on assessing how things naturally are, and more on deciding how they should be:

“We cannot avoid asking and answering the question: what is a good human life? Likewise, we cannot avoid the ethical question: what is a good climate?”

Savulescu argues for a kind of long-term genengineering, as this will have less immediate negative effects (if any):

“We should prefer interventions that slowly modify climate over generations, rather than rapid interventions that carry risk within a single generation, if we wish to adopt a person-affecting precautionary approach.”

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  4:35:00 PM

Bioethicists defend ‘manipulative’ Facebook study

After the flurry of criticism for the now infamous Facebook ‘social contagion’ study, bioethicists are defending its authors.

The paper, co-authored by a data manager from Facebook and two researchers from Cornell, examined how users’ emotions changed when confronted with manipulated newsfeeds. Based on carefully written algorithm, researchers omitted certain ‘positive’ and ‘negative’ posts from users’ feeds when they logged on to the website (read the abstract here).

The experiment was conducted without the direct consent of its 310,000 participants.

The study has been variously labelled “terrifying”, “scandalous” and “cruel”.

In a column in Nature, a number of prominent bioethicists challenge these criticisms.

The authors argued that the study was no different from Facebook’s usual practice:

“It is true that Facebook altered its algorithm for the study, but it does that all the time, and this alteration was not known at the time to increase risk to anyone involved.”

They were divided on the question of informed consent:

“Some [of us] think that the procedures were consistent with users’ reasonable expectations of Facebook and that no explicit consent was required. Others argue that the research imposed little or no incremental risk and that informed consent might have biased the results; in those circumstances, ethical guidelines, such as the US regulations for research involving humans, permits researchers to forgo or at least substantially alter the elements of informed consent.”

They are concerned about the impact of intense criticism on further research:

“The extreme response to this study, some of which seems to have been made without full understanding of what it entailed or what legal and ethical standards require, could result in such research being done in secret or not at all.”

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  4:16:00 PM

Woman loses baby in tragic mishap

An Indian woman has lost her unborn baby after doctors accidentally administered an abortion drug. The woman, from the Rajouri district in Northern India, was attending a private hospital for a routine check-up when the incident occurred.

According to the woman’s husband, a senior gynaecologist had prescribed an IV glucose drip. Junior medical staff mistakened the woman for another patient and instead administered an abortifacient.

The woman was given the abortion drug despite telling doctors that she had merely come for her weekly glucose drip.

The woman went home, but returned to the hospital just an hour later, complaining of severe abdominal pain. Doctors told her that it was too late to save her baby.

"We have immediately registered a case and arrested the doctor, whose negligent act has caused this," said Rahul Malik, Superintendent of Police in South Jammu.

Indian authorities have suspended the license of the hospital whilst an investigation into the incident takes place. 

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  12:28:00 AM

Compassionate use: Putting drug regulations to the test

When should pharmaceutical companies give gravely ill patients access to experimental treatments? The above news segment offers an good summary of the issues involved in this vexed ethical dilemma. 

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  2:25:00 PM

Euthanasia could be option for poor, says Lithuanian health minister

The new Lithuanian Health Minister, Rimantė Šalaševičiūtė

Euthanasia might be needed for poor people who cannot access palliative care, the new Lithuanian Health Minister has suggested. Rimantė Šalaševičiūtė was sworn earlier this month, but already she has made waves by backing an open discussion of the legalisation of euthanasia.

Without making any specific proposals, she told local media that Lithuania was not a welfare state with palliative care available for all and that euthanasia might be an option for people who did not want to torment relatives with the spectacle of their suffering.  

The minister has also raised the idea of euthanasia for children. She noted that this option had been approved for Belgian children after a long public debate. It was an option which might be appropriate in Lithuania as well after public debate.

Ms Šalaševičiūtė will face an uphill battle in her campaign to introduce Lithuanians to euthanasia. Many doctors and the Catholic Church oppose it. Dr Andrius Narbekovas, who is both a priest and a doctor, and a member of the Health Ministry’s bioethics commission, told the media:

“The Ministry of Health should protect health and life, instead of looking for ways to take life away. It goes without saying that it is … profitable and cost effective … But a democratic society should very clearly understand that we have to take care of the sick, not kill them."
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  1:25:00 PM

Guantanamo nurse refuses to participate in force-feedings

A military medical professional at Guantanamo Bay recently refused to force-feed detainees after witnessing the suffering it caused detainees, according to the American branch of the prisoner lobby group Reprieve.  

The incident is thought to be the first case of 'conscientious objection' to force-feeding at Guantánamo since a mass hunger-strike began at the prison last year. Cleared Syrian Abu Wa’el Dhiab related the news on a phone call last week with his Reprieve lawyer, Cori Crider. Dhiab explained that a military nurse recently told him he would no longer participate in force-feedings, saying: “I have come to the decision that I refuse to participate in this criminal act.”  

A Department of Defense spokesperson confirmed this to the Miami Herald: “There was a recent instance of a medical provider not willing to carry out the enteral feeding of a detainee.” The nurse in question has apparently been assigned elsewhere; Mr. Dhiab said that after the man made his decision known, he never saw him again.

The nurse also related to Mr Dhiab the discrepancy between military descriptions of force-feeding and the reality: “before we came here, we were told a different story. The story we were told was completely the opposite of what I saw.” Other nurses have voiced their concern about the practice, according to Mr Dhiab, but said they had no power to object. Mr. Dhiab says he often heard comments to the effect of: “Listen, we have no choice. We are worried about our job, our rank.” 

Force-feeding has been ongoing at the prison since men started hunger striking in peaceful protest at their detention without charge or trial. Last year more than 100 men participated in a mass hunger strike at worsening conditions and indefinite detention after President Obama closed the office charged with closing the prison. That office has since reopened but 149 men, the majority of whom have been cleared for release, remain imprisoned. 

Cori Crider commented: “This is a historic stand by this nurse, who recognized the basic humanity of the detainees and the inhumanity of what he was being asked to do. He should be commended. He should also be permitted to continue to give medical care to prisoners on the base but exempted from a practice he rightly sees as a violation of medical ethics.”

And in a comment piece in The Guardian, she added:

"Since it isn't technically a disciplinary matter – and frankly, even if it were – the rest of the doctors and nurses at Gitmo ought to join their colleague’s boycott. They should return to first principle of medicine, which is patient autonomy. They should insist on using force-feeding only when absolutely necessary and in ways that minimize, not maximize, the suffering it causes – a compromise my client would accept. In so doing, they would have the support of the American medical community, which has already condemned force-feeding and urged health professionals not to participate."
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