Thursday, November 26, 2015

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A few weeks ago "pink Viagra", more properly known as Addyi, got a green light from the FDA. The drug purports to treat “hypoactive sexual desire disorder” in women. The day after the approval, Sprout Pharmaceuticals, a small company with the patent, was sold for US$1 billion in cash to Valeant Pharmaceuticals International. Valeant obviously thought it had a winner. 

It turns out that it has backed the wrong horse. In the first few weeks, only 227 prescriptions have been filled. “I thought there was going to be this huge onslaught,” the director of the Women’s Health Clinic at the Mayo Clinic told Bloomberg Business

Addyi has a lot of drawbacks; it has potentially deadly side effects, women can't drink alcohol while using it; it costs US$780 a month; and it must be taken daily. But the biggest problem might be that Valeant believed Sprout's canny public relations campaign which promoted sex as "a basic human right" and one of the FDA's "priority areas of unmet medical need". Perhaps women are more interested in commitment than a Viagra they can call their own. 

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Michael Cook
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This week in BioEdge

2015-11-16 10:37 PM
CRISPR-mania in China
by Xavier Symons | Nov 21, 2015
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tags: China, CRISPR, genethics

The new CRISPR as a technology only really came into the public spotlight last year. But already dozens, if not hundreds, of Chinese research hubs are using the technique on a range of animals.

CRISPR research is being supported in China via grants from the National Natural Science Foundation of China, Ministry of Agriculture, Ministry of Science and Technology as well as provincial governments.

In the past year alone, numerous articles have been published in leading journals documenting the use of CRISPR by Chinese scientists to create genetically enhanced goats, sheep, pigs, monkeys and dogs, among other mammals. In a September edition of Nature’s Scientific Reports, for example, geneticists Xiaolong Wang and Yulin Chen from Northwest A&F University published the results of study into enhancing goat muscle and hair growth. In early-stage goat embryos the researchers had successfully deleted two genes which suppress both hair and muscle growth. The result was 10 kids exhibiting both larger muscles and longer fur. So far,  no other abnormalities have appeared. 

And the Chinese genomics BGI recently announced that their institute will be selling ‘micropigs’ as pets. The institute originally created the micropigs as models for human disease, by applying a gene-editing technique to a small breed of pig known as Bama

“[CRISPR research] is a priority area for the Chinese Academy of Sciences,” Minhua Hu, a geneticist at the Guangzhou General Pharmaceutical Research Institute, told the Scientific AmericanA colleague, Liangxue Lai of the Guangzhou Institutes of Biomedicine and Health, added that “China’s government has allocated a lot of financial support in genetically modified animals in both [the] agriculture field [and the] biomedicine field.”

Not everyone in the country is sold on the new technology, said Yaofeng Zhao of China’s State Key Laboratory of Agrobiotechnology. In an interview with Nature he said:

“I think there are different viewpoints on gene modification. Even in China there are different viewpoints on this issue. Some people in the general public, they are scared. But for most academics, I think most scientists support this kind of research—we need to do something for the future”.

Zhoa doubts whether the whole population is ready for genetically modified animals:

“If you want to use modified animals in agriculture, you must consider the public opinion—Can they accept this? Even if the technology is quite safe, it depends on many factors if you want to commercialize this kind of animal in agriculture.”

In a recent opinion piece in the New York Times, Elizabeth Alter, assistant professor of biology at City University of New York, stressed the general need for regulation in the use of CRISPR. 

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Medicos a ‘military target’ in Syria
by Xavier Symons | Nov 21, 2015
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tags: Syria, war, war crimes

The war in Syria has taken a massive toll on the country’s healthcare system – 95% of doctors have fled, been detained or killed in the besieged eastern city of Aleppo.

A new report released by Physicians for Human Rights (PHR) this month gives detailed insight into the grave effects of the war on Aleppo medicos. Some of the more striking findings of the report include:

- The ratio of physicians to Aleppo residents is eight times less than what it was in 2010. Currently there is one doctor for every 7,000 residents, compared to one doctor for every 800 residents in 2010.

- Only 10 hospitals – 30% of the 33 functioning hospitals in 2010 – were functioning as of August 2015.

- There are only 80 physicians working in Aleppo (approximately 5% of Aleppo’s pre-war physician population).

- To date, the Syrian government has launched 45 attacks on health facilities in eastern Aleppo city. Most hospitals still functioning in Aleppo have been attacked repeatedly, one up to seven times.  

Donna McKay, PHR’s executive director, is stunned by the total disregard for the rules of war in the Syrian conflict. 

“Typically in a war zone, hospitals are clearly marked and even provide their coordinates to the parties to the conflict as a safety precaution. But in the perverse logic of the Syrian conflict, those working in the medical field are actually forced to hide their identities and their facilities in the desperate hope that this will provide some measure of protection against attacks that have become shockingly commonplace.”

Dr. Michele Heisler, a PHR board member who and one of the report’s investigators, says the government is deliberately undermining healthcare in cities like Aleppo.

“The Syrian government is using attacks on Aleppo’s health care system as a weapon of war. The systematic targeting of hospitals is the biggest impediment to providing health care in Syria.”

The PHR report is just one of a litany of recent publications documenting the systematic targeting of battlefield hospitals in conflict zones around the world.  Numerous attacks on hospitals have also been made in Afghanistan, Gaza and Yemen.

Earlier this month BioEdge reported on the targeting of an MSF hospital by a US special forces in the Afghan town of Kunduz.  

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The case for banning smoking
by Xavier Symons | Nov 21, 2015
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tags: liberalism, paternalism, public health, smoking

Liberalism has led to legalization of many practices hitherto outlawed in Western societies. But to what extent can it used to justify the restriction of certain liberties? Can it, for example, justify banning cigarettes?

Kalle Grill (University of Umea, in Sweden,) and Kristin Voight (McGill) think the answer is yes. In an article published this week in the Journal of Medical Ethics, they argue that the health benefits of banning smoking outweigh the drawbacks of restricting on personal freedom. 

According to Grill and Voight, there are numerous considerations that count strongly in favor of outlawing the sale and smoking of cigarettes:

“As far as the current generation is concerned, then, four factors speak in favour of a ban: first, very large benefits in aggregate well-being. Second, reduced inequality in well-being because the benefits accrue largely to the disadvantaged. Third, improvements in internal autonomy for those who would prefer not to smoke. Fourth, respect for the autonomy of that proportion of the smoking population who want a ban (the evidence we cited suggests that this is about a third).”

Grill and Voight consider at some length the argument that banning cigarettes would place a significant constraint on the freedom of those who wish to smoke (despite the risk of health problems). According to these two ethicists, the immense benefits for public health that come with banning cigarettes far outweigh the drawbacks of limiting the freedom of a small minority of smokers in society.

“We accept that a ban would interfere with some (reasonably) autonomous choices as well as restrict individual freedom, but these negative implications are far outweighed by the well-being gains a ban would imply for both current and future generations…

“If we consider all the people who will be born in this present century, it is hard to see how prevention of the more than one billion expected premature deaths and the substantial individual suffering that comes with it could be outweighed by respect for the choice of some present (and some future would-be) smokers and concern for the restrictions on freedom involved.”

We would be interested to hear what our readers think about this issue. Grill and Voight put forward cogent arguments, but are they sufficient to justify such extensive state paternalism? 

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Some things never change
by Xavier Symons | Nov 21, 2015
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tags: China, human rights, organ donation

Hopes for a reform in China’s organ donation practices have faded, with revelations that the Chinese government is simply "reclassifying" organs obtained from executed prisoners.

Since the faux-announcement of an end to organ donation from prisoners in January, the state-controlled Chinese media has repeatedly suggested that the government is disguising inmates’ organs as "altruistic donations" from free citizens.

As early as January, the People’s Daily was reporting that prisoner’s would still be allowed to donate their organs “to atone for their crimes”. The head of China’s organ donation committee, D. Huang Jiefu, said he was confident these ‘voluntary’ donations would prevent any shortfall as a result of the new policy.

In March, Dr. Huang told The Beijing Times, “Once the organs from death-row prisoners who have voluntarily donated are included in our national distribution system, they are counted as voluntary citizen donations.”

According to Huige Li, a Chinese-born doctor at the University of Mainz, the government has merely performed an administrative trick. “They just reclassified prisoners as citizens”, he said.

“The practice there is unethical and should be changed to an ethical practice,” he said of China. “Administrative tricks don’t make it ethical.”

Dr. Torsten Trey executive director of Doctors Against Forced Organ Harvesting, fears that the practice of harvesting prisoners’ organs may never end.

‘‘Some sourcing pathways are altered,’’ Dr. Trey told the New York Times in an email. ‘‘Some previous channels are closed. Others are kept open.’’

Since ‘‘prisoners are under the control of the state, in contrast to free citizens who might enter an organ donation contract on the black market, we have to assume that — at least partially — policy makers, police, prison guards and military personnel are aware and backing the practice,’’ he said.

In a statement in the Beijing Times last year, Huang Jiefu alluded to the new organ procurement strategy:

‘‘Once organs from willing death-row prisoners are included in our national distribution system, they will be considered voluntary citizen donations, and the expression ‘death-row donations’ won’t exist any more.’’

Indeed, the rate of organ donation in China might have even increased. In 2014, about 1,700 people donated about 5,000 organs, Dr. Huang said. But in just the first two months of this year, 381 people donated 937 organs, he told The Beijing Morning News. That could translate to more than 2,300 donations this year. The figure did not include organs from living donors to family members.

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Belgian prisoners denied euthanasia
by | Nov 21, 2015
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tags: Belgium, euthanasia, prisoner euthanasia

Belgian serial rapist and murderer Frank Den Bleeken, who was serving a life sentence, sparked a controversy by asking for euthanasia in 2014. The government at first granted his request and the bureaucratic machine began whirring. However, it quickly backtracked and placed him in a specialised psychiatric unit where he could get better care.

In the wake of his highly-publicised request, 15 other prisoners have asked for euthanasia in Belgium on the grounds that they have unbearable psychological suffering. This week the head of the country’s euthanasia commission declared that they are not eligible. Dr Wim Distelmans told De Morgen that:

The unbearable suffering  that these prisoners describe is due in large part to the context (ie, prison) and is not the result of an incurable disease … We have advised the interested parties that they are not within the framework and conditions provided by law.

However, this may not be the end of the story. De Morgen reported that better psychiatric treatment would be made available to some or all of the 15 prisoners at the Sint-Kamillus university psychiatric center in Bierbeek. "If the patients maintain their request for euthanasia, then we'll reconsider," Dr Distelmans said.

After the apparently unstoppable expansion of euthanasia requests, Belgium may be applying the brakes, possibly in response to adverse international publicity. Apart from denying euthanasia to the prisoners, a prominent euthanasia doctor, Dr Mark Van Der Hoey, was recently charged with breaking the law after he was filmed euthanasing a patient in an Australian documentary. It was the first time since euthanasia was legalised in Belgium that a doctor has been charged, let alone convicted.  

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Drug companies flunk transparency test
by | Nov 21, 2015
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tags: clinical trials, drug testing, transparency

Only two-thirds of clinical trials for new drugs were disclosed in 2012, according to a new study in BMJ Open by Bioethics International, a non-profit group. In addition, almost half of all reviewed drugs had at least one undisclosed Phase 2 or 3 trial. This lack of transparency breaches legal and ethical standards.

Three of ten companies reviewed in the study—GlaxoSmithKline, Johnson & Johnson, and Pfizer—publicly disclosed all clinical trial results for at least one of their reviewed drugs. But the lowest scoring company, Gilead, disclosed 21% of the trial results for its HIV medicine Stribild. Sanofi's multiple sclerosis drug Aubagio also ranked low for publicly available information.

Incomplete disclosure of clinical trial results impacts the ability of healthcare decision-makers, including physicians, prescription guideline writers, payers and formulary committees, to evaluate the appropriate use of a drug effectively.

Bioethics International has also launched a Good Pharma Scorecard, to independently rank biopharmaceutical companies and new drugs based on key ethics, human rights, and public health criteria, beginning with R&D and clinical trial transparency. The organization plans to release these rankings annually.

"A critical issue facing the biopharmaceutical industry today is the loss of public trust," said Jennifer E. Miller, president of Bioethics International and assistant professor of medical at NYU Langone Medical Center. "Only 17 years ago, the pharmaceutical industry was among the most admired business sector in the world, and today only 12 percent of Americans believe that pharmaceutical companies are honest and ethical.”

“It’s impossible to have evidence-based medicine without the evidence,”  says Dr Miller, the lead author on the study. “People are worried that companies are hiding critical information about new medicines and vaccines -- their safety and efficacy information -- for the sake of profit.”

Professor Art Caplan, also, of NYU Langone Medical Center, said, "Transparency is a critical component of the ethical practice of medical research, and this ranking system has the potential to become a useful vehicle for change by outlining best practices and identifying areas that need improvement."

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A quiet revolution in organ transplant ethics
by | Nov 21, 2015
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tags: organ donation, organ transplants, transplant ethics

Earlier this week New York University Langone Medical Center announced the successful completion of the most extensive face transplant to date. It was performed on a volunteer firefighter from Mississippi who suffered a full face and scalp burn in 2001 when a roof collapsed on him during a rescue search.

It was a triumph of modern medicine, but it was also a reminder of the questions which swirl around transplant surgery. Organ transplants have always been regarded as life-saving interventions. Without a heart, lungs or kidneys patients die. But surgeons are now transplanting non-vital body parts, such as the face, uterus, voicebox, penis, ovary and fallopian tube, which require a fresh look at standards of medical ethics, according to bioethicist Art Caplan, of New York University Langone Medical Center. He writes in his column in Forbes magazine:

Unlike heart, liver, kidney and lung transplants, they are being done to enhance the quality of life or to palliate suffering. Some are being done not to save lives but to allow individuals to create new ones. These are manifestly ethical goals. But the shift away from saving lives to making them better involves a shift in the ethical thinking that has long formed the foundation of organ transplantation. They require doctors, patients, regulators and the rest of us to rethink the risk and benefit ratio represented by these new forms of transplant.

Powerful immosuppressive drugs are an integral part of any transplant. But these have side-effects, including organ failure, which shorten a patient’s life span. How ethical is it to increase a patient’s quality of life by shortening his quantity of life? 

Transplanting a face to allow a person to reenter society without stigma or scorn is a wondrous thing. Allowing a woman to bear a child in a society or state where gestational surrogacy is not even an option will find some eager to try. But the new world of transplant requires revisiting some old ways of ethical thinking to help grapple with an entirely new set of opportunities and challenges.

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Filling out euthanasia death certificates in Quebec
by | Nov 21, 2015
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tags: Canada, death certificates, euthanasia, Quebec

Physician-assisted suicide begins in Quebec on December 10. One of the overlooked consequences of this radical change to the law is how doctors will fill out death certificates. Although the immediate cause of death will be a lethal drug, doctors have been advised to list the cause of death as an underlying medical condition.

The Collège des médecins du Québec and pharmacy and nursing regulators have issued a Practice Guide directing Quebec physicians to falsify death certificates in euthanasia cases.

The physician must write as the immediate cause of death the disease or morbid condition which justified [the medical aid in dying] and caused the death. It is not a question of the manner of death (cardiac arrest), but of the disease, accident or complication that led to the death. The term medical aid in dying should not appear on this document.2

Since untruths are not normally part of medical practice, how does the practice guide justify this? It gives two reasons: first, that some patients may not want their families to know how they died, and second, that it protects families who don't know that their loved ones have been killed by physicians from some unspecified "harm."

Writing in the Protection of Conscience blog, Sean Murphy comments that this is bound to upset both Quebec physicians and families.

Many physicians, coroners and other health care workers may share these concerns, even if they don't have moral reservations about euthanasia. Indeed, euthanasia supporters may worry that mandating deceptive practices is counterproductive and inconsistent with the Practice Guide's expectation that physicians will apply "moral rigour" in processing euthanasia requests.

Others may be uncomfortable lying or dissembling to families about how their loved ones died, which would seem to be unavoidably associated with falsifying causes of death. They may be concerned that falsifying records and lying to families is likely to undermine the trust essential to the practice of medicine. And many people simply have moral or religious objections to falsifying documents, lying, dissembling and other forms of deception under any circumstances.

In addition, a good number of those who object to euthanasia who are not directly involved in lethally injecting a patient will almost certainly consider participation in deception to involve  unacceptable complicity in killing, even if it occurs after the fact.

This is not an unreasonable position. The killing of thousands of hospital patients in Nazi Germany involved extensive falsification of death certificates by physicians, supervised and assisted by state functionaries. Their goal was to convince families that loved ones who had been lethally injected or gassed had died from natural causes. Few would now say that those involved in what Robert J. Lifton called a "bureaucracy of medical deception" were not morally implicated in the deaths of those patients.  

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Sociologist opposes ban on Indian commercial surrogacy
by | Nov 21, 2015
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tags: commercial surrogacy, India, surrogate motherhood

Dr Nayna Patel (centre) and her "house of surrogates", in Gujarat   

There is always a flip side to an argument, even if you are talking about “baby farms” of surrogate mothers in India. Sharmila Rudrappa, a sociologist at the University of Texas at Austin, has written a book, Discounted Life: The Price of Global Surrogacy in India,  about the experience of surrogate mothers in Bangalore. In an interview with The Times of India, she criticised moves to decommercialise surrogacy.

This ban is certainly going to dent the earnings of surrogate mothers, but it's not going to be that large. But what's worse is the Centre is looking to ban commercial surrogacy altogether. It wants to institute only altruistic surrogacy , where no money will be exchanged. Look, the cat is out of the bag -the businesses are set, doctors have invested in equipment, networks are established.

To think that you can turn the clock back and go back to altruistic surrogacy is downright ridiculous. The Centre has no interest in regulating surrogacy, and helping surrogate mothers achieve a life of dignity. Now, they are expected to gift their labour and hardship. There may be no contracts. Rich families can coerce or compel their poorer relatives, or maids to engage in "altruistic" surrogacy for them. Under these conditions, exploitation of surrogate mothers will deepen. 

She does not believe that women are necessarily exploited:

The women I met know that surrogacy is risky but still pursue surrogacy because life has become expensive in Bengaluru. None of the women I met was from rural areas. They were all Bengaluru residents, or came from the outskirts. And none of them was desperately poor; they came from multi-income families. They believed that the wages from surrogacy could pull them out of economic uncertainty . 

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Charlie Sheen’s reluctant bioethics script
by | Nov 21, 2015
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tags: medical privacy, privacy

The real lives of Hollywood stars often have just as much bioethical interest as their movies. This week Charlie Sheen, a popular actor in film and television with a colourful personal life, admitted that he was HIV positive on the Today show. He was diagnosed about four years ago and the disease is under control.

But this is not just another ho-hum personal tragedy. Apart from his self-destructive drug and alcohol abuse, compulsive promiscuity is part of Sheen’s public image and questions were immediately raised about whether he had infected one of his wives or many sex partners without informing them of his HIV status. Knowingly infecting a partner is a criminal offence in California. Prosecution is rare because a high bar has been set for the standard of proof but Sheen could be sued civilly for negligence, emotional distress or sexual battery.

The 50-year-old actor went public to protect himself against blackmailers who had extorted US$4 million from him over the past four years. “I release myself from this prison today,” he said.  “I have paid those people — not that many — but enough to where it has depleted the future. Enough to bring it into the millions.”

The bioethical take-away? The extreme importance of protecting medical record privacy.

According to the Washington Post, “opportunistic criminals are beginning to resort to similar schemes targeted at anyone who might potentially be hurt or embarrassed if others had access to information about their mental illness, nose job, abortion, or the fact that they're going through bottles of Viagra”.

Now that doctors and health care institutions are digitising all of their medical records, hackers are having a field day. The WaPo says:  

The Identity Theft Report Center reported in January that breaches in the medical/health care industry topped its list of breaches in 2014 with 42.5 percent of the 783 incidents they tracked. The 333 medical/health care incidents affected 8,277,991 records and took place at small health care clinics as well as a diverse group of large organizations, including Novo Nordisk, Tennessee's State Insurance Plan, Touchstone Medical Imaging, the University of California Davis Health System and the Kaiser Foundation Health Plan of Colorado.

Charlie Sheen’s tormenters obtained their information the old-fashioned way and few people are as rich or famous as he is. But his admission is an example of the down side of integrating medicine and information technology. 

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