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In the News: Professional Ethics Report Fall 2016

Mandatory DNA Testing in Kuwait
by Katie Kraska

The Kuwaiti government recently announced the retraction of a law that would require DNA information for all citizens, residents, and visitors to be documented and held in a nationwide database. Recent discussions suggest that the database will now be limited to criminal offenders. [1]

The law (no. 78/2015) was approved July of last year following a terrorist attack at a Shiite mosque, which killed 27 people and was claimed by the Saudi affiliate of the Islamic State. [2] The Kuwaiti national assembly cited security reasons when first approving the USD $400 million project, arguing that it would reduce crime, dissuade terrorism, and identify bodies after natural disasters. [3, 4] The government maintained that the database would be secure, names would be replaced with barcodes, and the information would only be accessible by subpoena.

Many were concerned that the database could be misused by the government. Kuwait has strict immigration laws, requiring citizenship applicants to trace their lineage back to the early 20th century. Experts doubt that DNA could actually confirm or negate such claims, but many feared this evidence would be used to strip their citizenship or deny citizenship applications in the future. [5] Others worried that the database could support allegations of infidelity – a severely punishable crime in the country, particularly for women.

DNA databases are common in other countries, and international courts have ruled that there is nothing principally wrong with the practice if the collection and retention of samples are “extensively regulated, narrow in scope, and proportionate to meeting a legitimate security goal.” [6] This is why DNA databases are generally reserved for criminal offenders or as electively provided information – situations where an individual’s right to privacy has been in some way forfeited by unlawful action or willingly provided for service or medical research.

Kuwait is not the first country to cause controversy over the handling of a DNA database. In 2008, the European Court of Human Rights ruled that indefinitely retaining DNA samples of individuals who were never convicted of a crime violated a respect for privacy. The United Kingdom was ordered to destroy the DNA information of more than 1.7 million people. [7]

Members of the international community spoke out against Kuwait’s mandatory DNA sampling on similar grounds: bolstering the nation’s security does not proportionately justify the violation of personal privacy. “Many measures could potentially be useful in protecting against terrorist attacks, but potential usefulness is not enough to justify a massive infringement on human rights,” said Sarah Leah Whitson, the Middle East director of Human Rights Watch, on the organization’s website. [6]

Speaking out against the government or its members is a crime in Kuwait, but growing discontent among citizens, residents, and the international community may have contributed to the law’s revocation. [8] Kuwaiti lawyers challenged the law by arguing it violates the privacy afforded to citizens and residents in their constitution, as well as international human rights treaties ratified by the country.[9] The Constitutional Court will hear the case on December 21, 2016. [10]

Fabricated Chinese Clinical Trials
by Michelle Barretta

A one-year investigation led by the Chinese Food and Drug Administration (CFDA) concluded that 80% of clinical trial data for new drugs had been fabricated [1, 2]. The investigation revealed “fraudulent practice” and a “breach of duty by supervision departments and malpractice by pharmaceutical companies, intermediary agents and medical staff.” [1] The data from 1,622 clinical trials of new pharmaceutical drugs awaiting approval for mass production were examined, and it was determined that the data were incomplete, untraceable or did not meet regulatory requirements. [1, 2] In addition, the CFDA report stated that some pharmaceutical companies were suspected of deliberately concealing findings of any drug side-effects. [1]

According to the Economic Information Daily, industry insiders were not surprised by the investigation’s findings, citing issues with China’s generic drug industry. [1,2] The newspaper reported that the industry has been plagued with quality problems, and that many “new” drugs being developed are simply mixtures of existing drugs. [1] As a result, the industry has resorted to tampering with clinical trial data in order to meet quality standards [1]. Healthcare professional Luo Liang told Radio Free Asia (RFA) that China’s domestic industry has struggled to make a profit with the current regulations and standards that are in place. [1,2]. Mr. Luo stated that, “the domestic market for Western pharmaceuticals in China is either confined to very straightforward generic products that have been around for a long time… or revolves around joint-venture pharmaceutical manufacture with foreign companies. Either that, or Chinese pharmaceutical factories get hold of the formula for certain drugs whose patents have expired. There are no new drugs in development in the same way that there are overseas.” [1, 2]

A physician in the northern city of Xian, Dr. Zhang, believes that it is not the lack of regulations that is causing a problem, it is the failure to implement them. He stated, “there are national standards for clinical trials in the development of Western pharmaceuticals…but I don’t know what happened here.” [1].

Problems regarding public safety are not limited to the pharmaceutical industry. [1] Rights activist Mai Ke told RFA that there is an all-pervasive culture of counterfeit products produced in China. [1] “It’s not just the medicines. In China, everything is fake, and if there’s a profit in pharmaceuticals, then someone’s going to fake them too,” he said. In addition, Mr. Mai explained that the problem has extended to traditional Chinese medicines also used across the healthcare system. [1] He states that, “it’s just hard to regulate the fakes with traditional medicines than it is with Western pharmaceuticals, which have strict manufacturing guidelines.” [1]

Mr. Luo believes that the underdevelopment of academic ethics in China has led to an acceptance of manipulated data. [1] He does not think the results of the CFDA investigation are overstated, and says that, “if you compare Western pharmaceuticals manufactured overseas with those manufactured in China, there is a huge difference in the ingredients; the quality of the China-made drugs is appalling.” [1]

[1] /clinical-fakes-09272016141438.html

Pope Cites Science, Scientists as Solutions to World Problems
by Katie Kraska

In an address to a meeting of the Pontifical Academy of Sciences in November, 2016, Pope Francis called on scientists to offer leadership and collaborative solutions to the world’s most pressing issues, like food and water security, renewable energy, climate change, and artificial intelligence.

“Never before has there been such a clear need for science to be at the service of a new global ecological equilibrium,” he said. “…[I]t falls to scientists, who work free of political, economic, or ideological interests, to develop a cultural model which can face the crisis of climate change and its social consequences, so that the vast potential of productivity will not be reserved for the few.”[1]

The Pope was critical of the international community’s consistent disregard for scientific evidence and demonstrated obedience to fiscal and political concerns over the common good.  He expressed the need for a new normative system where people are stewards of and cooperators in life and biodiversity, as well as social justice. He went on to say that if such a shift does not occur, our current “techno-economic” paradigm will cause irrevocable harm to the environment, democracy, justice, and freedom.

The Pontifical Academy of Sciences is an independent entity within the Holy See, comprised of non-sectarian members who focus predominantly on how science and technology relate to global problems, the developing world, policy, bioethics, and epistemology. [2]

The Pope concluded with words of encouragement and mobilization for scientists: “Combined with moral values, the plan for sustainable and integral development is well positioned to offer all scientists, in particular those who profess belief, a powerful impetus for research.” [1]

[1] 11/28/pope_francis_address_to_pontifical_academy_of_sc iences/1275273
[2] about/history.html