Bioethics News and Events

IUCB: Sound Ethics: Biobanks & Pediatric Research: http://bit.ly/dinzYI

Sun, 07 Feb 2010 11:25 GMT

IUCB: Sound Ethics: Biobanks & Pediatric Research: http://bit.ly/dinzYI

IUCB: DTC Fetal Sex Prediction Tests: the US is Not Immune to Sex Selection: In January, Dutch researchers published a s... http://bit.ly/9ijxFY

Wed, 03 Feb 2010 03:41 GMT

IUCB: DTC Fetal Sex Prediction Tests: the US is Not Immune to Sex Selection: In January, Dutch researchers published a s... http://bit.ly/9ijxFY

Direct-to-Consumer Fetal Sex Prediction Tests: the US is Not Immune to Sex Selection

Tue, 02 Feb 2010 10:15 GMT

In January, Dutch researchers published a study relating to a new method for screening maternal blood to determine fetal sex as early as seven weeks after conception. Although this test reports 100% accuracy, other direct-to-consumer (DTC) fetal sex prediction tests that advertise online offer similar tests with unregulated accuracy.

Recently, these tests have come under increased scrutiny based on the possibility that consumers both in the US and abroad may purchase the tests as a means obtaining information about fetal sex as the first step in seeking a sex selection abortion. Unlike an ultrasound (performed at 18-20 weeks in the second trimester), these DTC tests advertise the ability to predict fetal sex between 5-10 weeks in the first trimester. This offers parents an opportunity to determine fetal sex and make corresponding planning decisions to produce a child of a specific sex that may have been previously unaffordable (through means such as preimplantation genetic diagnosis or sperm selection) or inaccessible (second trimester sex selection abortions).

Three main countries- China, India, and Korea- are often used as examples of countries with socio-cultural environments that contribute to male child bias in attitude and action. Literature contains extensive discussion on how and why socio-cultural attitudes have traditionally, and still to a large extent, continue to favor male children and perpetuate extensive gender discrimination within the respective countries. The magnitude of bias is reflected in the skewed population ratios such as the 50 million “missing” females that should otherwise exist in the Chinese population. These deeply entrenched reasons for male bias and the pervasiveness of these attitudes means that even despite legal steps to explicitly limit or prohibit sex selection abortions, for decades both parents and practitioners have ignored laws designed to prevent this practice in each respective country.

In recognition of this issue, some DTC fetal sex prediction companies specify that they do not sell the product to consumers in China and or India. However, some companies have not issued such restrictions, and consumers in India or China can locate these products by a simple internet search. In India, scholar and activist Dr. Sabu George filed a lawsuit against Google and Yahoo seeking to enforce an Indian law against advertising products that reveal fetal sex. While the search engines have pulled some advertisements, internet searches still provide links to the DTC fetal sex prediction company websites.

The potential of using fetal sex prediction tests as a means of sex selection is not only a problematic issue limited to other countries. Both attitudinal research and recent litigation suggests that some parents in the US may use these tests for sex selection purposes.

Despite a notion that the general US population does not possess a preference for a child of a specific sex, statistics suggest this assumption may not be correct. Numerous studies demonstrate that members of the US population do possess attitudinal bias favoring male children, either as only children or first born. Some parents not only hold this male child bias, but are also willing to translate these attitudes into practice to achieve the desired outcome.

Another lawsuit against the Baby Gender Mentor product, Duffy et al. v. Acu-Gen Biolabs et al., also confirms these attitudes exist within the US population. Plaintiffs allege the tests were inaccurate and falsely predicted their baby’s sex, which caused them emotional distress and had a “devastating effect.” One plaintiff asserts that the incorrect test results contributed to the demise of her marriage because her husband wanted a boy, while another plaintiff upon learning the results “struggled, needlessly, with whether to keep [the pregnancy.]”

Granted, vast socio-cultural differences exist between counties such as India, China, and the US that could lead to less devastating population wide outcomes. However, does this mean we should be less concerned that only a small percentage of the population may use these tests for sex selection purposes? What can we learn from these countries when formulating our policy relating to how these tests can or cannot be used?

--Katherine Drabiak-Syed

IUCB: Research Ethics News Digest - January 2010: http://bit.ly/bQS5tF

Tue, 02 Feb 2010 07:51 GMT

IUCB: Research Ethics News Digest - January 2010: http://bit.ly/bQS5tF

IUCB: RT @nprfreshair: An interesting discussion about bioethics and the economics of medical research on today's @nprfreshair.

Tue, 02 Feb 2010 03:31 GMT

IUCB: RT @nprfreshair: An interesting discussion about bioethics and the economics of medical research on today's @nprfreshair.

IUCB: The Lancet retracts Wakefield's MMR and Autism research - http://press.thelancet.com/wakefieldretraction.pdf

Tue, 02 Feb 2010 03:09 GMT

IUCB: The Lancet retracts Wakefield's MMR and Autism research - http://press.thelancet.com/wakefieldretraction.pdf

IUCB: Peter H. Schwartz. Autonomy and Consent in Biobanks.: http://bit.ly/9HbXjc

Mon, 01 Feb 2010 06:07 GMT

IUCB: Peter H. Schwartz. Autonomy and Consent in Biobanks.: http://bit.ly/9HbXjc

IUCB: Autism, MMR, Wakefield and the GMC: Research Ethics in the News: Thursday (January 28, 2010) the General Medical C... http://bit.ly/9eF0n7

Fri, 29 Jan 2010 12:09 GMT

IUCB: Autism, MMR, Wakefield and the GMC: Research Ethics in the News: Thursday (January 28, 2010) the General Medical C... http://bit.ly/9eF0n7

Autism, MMR, Wakefield and the GMC: Research Ethics in the News

Fri, 29 Jan 2010 11:24 GMT

Thursday (January 28, 2010) the General Medical Council (GMC), which registers doctors, promotes standards and provides ethical guidance to protect the public in the U.K., issued a long awaited report of a Fitness to Practise Panel Hearing [PDF - 349 KB]. The Hearing addressed the case of Andrew Jeremy Wakefield, John Angus Walker-Smith, and C. Professor Simon Harry Murch and their (primarily Wakefield's) pediatric research regarding a purported link between the MMR vaccine, autism and bowel disease. The GMC concluded the doctors are responsible for the unethical conduct of the clinical trial involving 12 pediatric patients. Some of the young children were subjected to unapproved and invasive tests, including spinal taps. In one case, a blood draw was conducted on children attending a birthday party for Wakefield's son; the party-goers were paid $8 for their trouble. Furthermore, Wakefield et al. published the results of this dubious research in The Lancet without mentioning the £50,000 he was paid to carry out the research on behalf of attorneys representing parents who believed the MMR vaccine harmed their children.

Exaggerating, perhaps, Brian Deer in The Sunday Times declares that The Lancet publication [1998 Feb 28;351(9103):637-41 | PubMed PMID 9500320] and the resulting media coverage triggered “the health scare of our time”. The groundless fear of MMR-induced autism led many parents to refuse vaccinations for their children. According to the U.K.'s Health Protection Agency, cases of measles have sharply increased in recent years.

In April the GMC will reconvene to determine if the doctors have committed serious professional misconduct; one or all of them may lose their right to practice medicine in the U.K. Wakefield, however, continues to have a vocal following of parents (some heckled at the hearing); he currently lives in the States and runs an autism clinic, Thoughtful House, in Austin, Texas.

Related News and Links:

MMR scare doctor ‘acted unethically', panel finds. Nick Triggle. BBC News. January 28, 2010.

British doctor rebuked over research linking vaccine and autism. Henry Chu. Los Angeles Times. January 29, 2010.

Fall of Andrew Wakefield, ‘dishonest’ doctor who started MMR scare. David Rose. The Times Online. January 29, 2010.

CDC, Vaccine Saftey: Measles, Mumps, and Rubella (MMR) Vaccine

Autism, MedlinePlus

Measles, MedlinePlus

Other Research Ethics News

Scrutiny emerges concerning conflicts of interest in veterinary literature. Jennifer Fiala. VIN News Service. January 26, 2010.

BMJ feature story peers into MIST controversy. Shelley Wood. HeartWire. January 26, 2010.

Corporate Backing for Research? Get Over It. John Tierney. The New York Times. January 25, 2010.

‘Guinea pigs’ also have rights. Kumudini Hettiarachchi. The Sunday Times (Sri Lanka). January 24, 2010.

Amphastar Pharmaceuticals files new appeal in FDA conflict-of-interest case. Andrew Zajac. Los Angeles Times. January 21, 2010.

A dubious practice, any way you slice it. Stuart Laidlaw. The Star (Toronto). January 15, 2010.

Chinese scientists dismissed after 70 suspect papers. Wu Ni. SciDev.Net. January 13, 2010.

Related: Publish or perish in China. Jane Qiu. Nature News (subscription required). January 12, 2010.

Draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: IRB Continuing Review After Clinical Investigation Approval; Availability. Food and Drug Administration, HHS. Federal Register: January 13, 2010 (Volume 75, Number 8 ).

- J.O.

IUCB: IU Data Privacy Day 2010 - January 28: http://bit.ly/bmNUlr

Wed, 27 Jan 2010 12:18 GMT

IUCB: IU Data Privacy Day 2010 - January 28: http://bit.ly/bmNUlr