‘Frankenfish’ far less scary than fast food

By Art Caplan [cross-posted from his NBCNews Vitals column]

Two big events recently took place in the world of food: The Food and Drug Administration decreed that genetically engineered salmon wouldn’t harm the environment and McDonald’s announced that its McRib sandwich is back on the menu.

The FDA’s announcement paves the way for the first approval of a genetically engineered animal for humans to eat – and it was met with a good deal of highly critical wailing and groaning by Consumer’s Union, National Geographic and many other advocacy groups who are wary of genetically engineered food.

The McRib’s return was greeted with a few snickers by late night comedians and overwhelmingly happy faces on the millions of Americans who eat at one of the 13,000 McDonald’s restaurants from Maine to Hawaii every day. This, as my grandmother would have said in Yiddish, is “fakakta”—completely screwy.

If you like salmon, and I do, should you worry much about the safety of eating genetically engineered salmon?  No. The FDA said it could not find any valid scientific reason to prohibit the sale of the fish.

If you like the McRib, and I do, should you worry a lot about eating it?  Oh yeah.

Keep reading…

2012 Global Congress on Intellectual Property and the Public Interest

By Adriana Benedict

The 2012 Global Congress on Intellectual Property and the Public Interest has just come to a close in Rio de Janeiro, Brazil.  The conference brought together global leaders in intellectual property-related fields like access to medicines, access to knowledge, internet freedom, innovation and development, and open educational resources.  I was invited to participate in the various sessions concerning access to medicines, which focused on two sides of this global health challenge.

The first part of the access discussions focused on best practices and threats in the use of TRIPS flexibilities in developing countries.  Participants emphasized the need to look beyond the usual focus on compulsory licenses to set new priorities for understanding and leveraging less-developed flexibilities such as patentability criteria, patent opposition mechanisms and parallel importation.  An important overarching theme in these discussions was reframing flexibilities as rights, as they carry the same legal status as the intellectual property rights which make them necessary.

The other side of the discussions focused on innovation and research and development (R&D) for the developing world, primarily through recent advances by the WHO CEWG report in promoting a binding convention in this realm.  At the forefront of these proposals is the notion that incentives for innovation should be de-linked from product prices in order to address the needs of the developing world.  Participants emphasized that, moving forward, advocates should be careful to ensure that public and institutional debates on alternative R&D models do not narrow their focus from neglected populations to neglected diseases.

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Special issue in the Journal of Philosophy & Technology on evolution, genetic engineering, and human enhancement

By Yu-Chi Lyra Kuo

A special issue published this month by the Journal of Philosophy & Technology features a collection of articles discussing evolution, genetic engineering, and human enhancement. Recent years have seen a rapidly expanding variety of approaches to exploring the normativity of human enhancement, by philosophers, bioethicists, physicians, and biologists. The articles in this special issue largely focus on the question: how can evolution and aetiological teleology inform biological ethics and theories of human enhancement?

For a separate collection of articles discussing the ethics of human enhancement from the perspective of the physician-patient relationship, see this special issue by the American Journal of Bioethics, published approximately a year ago.

Happy reading, and happy holidays! ~YK

Twitter Round-Up (12/9-12/15)

By Casey Thomson
This week’s round-up looks at the problems of substandard drug prevalence abroad, NIH’s possible push for an anonymous grant-awarding process, and the Liverpool Care Pathway investigation. Check it out below!
  • Dan Vorhaus (@genomicslawyer) included a link to a report on the recent launch of Personal Genome Launch Canada. The post includes links to help navigate the content and learn more about the intricacies of this project. (12/9)
  • Frank Pasquale (@FrankPasquale) shared a post on the benefits and detriments of raising the age of Medicare eligibility from age 65 to 67 – an idea that has recently gained sway in the political arena. The author ultimately concludes that the move would only be a matter of cost shifting rather than cost saving, and thus harm the disenfranchised 65-66 year-olds that would front the cost. (12/10)
  • Frank Pasquale (@FrankPasquale) also included this article on Dr. Oz’s wrongful diagnosis on organics. While concerns about finances must indeed be taken into consideration when families decide what foods to purchase, families must also be concerned about the presence of pesticides in their food. Organic food, while more expensive, avoids this health hazard. (12/10)
  • Frank Pasquale (@FrankPasquale) additionally linked to this report on the preponderance of substandard (and oftentimes, consequentially lethal) drugs particularly in emerging markets. Efforts to crackdown on substandard drugs have thus far focused largely on counterfeit drugs, rather than those that are the result of “shoddy manufacturing and handling…or deliberate corner cutting,” which constitute an arguably much greater public health threat. (12/10)
  • Daniel Goldberg (@prof_goldberg) shared this post on the prevalence of worthless clinical practice guidelines. The article notes the need to distinguish the guidelines that meet much of the Institute of Medicine (IOM) quality criteria from the rest. (12/10)
  • Alex Smith (@AlexSmithMD) linked to a blog post on advance care planning and the gap between the needs of the healthcare system and those of patients. Currently, much of the paperwork required for advance directives is given without providing families and patients concrete skills needed for both identifying their desires and communicating such desires to direct their own medical care. This article calls for refocusing on providing direct patient empowerment in addition to the existing efforts to improve clinician communication in order to facilitate the ability of advance care planning to reflect the patient’s wishes. (12/11)
  • Michelle Meyer (@MichelleNMeyer) retweeted an article about the NIH’s consideration of introducing anonymity into the grant-awarding process in order to alleviate some of the concerns with bias that have long-plagued the agency. (12/12)
  • Dan Vorhaus (@genomicslawyer) also posted a report on BGI, a world-leading DNA sequencing organization based in China, and their commercial expansion efforts into the healthcare, agriculture, and aquaculture sectors. The question of whether BGI is more a research institute or commercial enterprise comes into question in the article. (12/12)
  • Stephen Latham (@StephenLatham) included a link to his own blog post on the recently renewed controversy concerning the Liverpool Care Pathway for the Dying Patient (LCP), particularly as to whether patients put on the LCP had a discussion with their care providers prior to the decision and whether hospitals were wrongly putting patients on the pathway. The talk of scandal sparked an independent investigation into the LCP; Latham’s article expressed his hope for thoroughness in the investigation and for serious consideration on how to renew the LCP effectively. (12/12)
  • Arthur Caplan (@ArthurCaplan) posted a link concerning the implications of 23andMe, a personalized genomics company, and their launch of the $99 genetic test in the hopes of inspiring greater numbers to get tested. The article’s author reflects on how the real benefit will likely not be immediate for individuals, but will rather depend on the chance that greater data will lead to more breakthroughs in understanding the human genome. (12/14)

Note: As mentioned in previous posts, retweeting should not be considered as an endorsement of or agreement with the content of the original tweet.

Save the Date: Health Law Year in P/Review, Friday 2/1/13

Friday, February 1, 2013
1:00-5:00pm
Wasserstein Hall 2036, Milstein East C, Harvard Law School

Health Law Year in P/Review
Please save the date for an upcoming panel on several recent developments and developments to come in the world of health law. This event is co-sponsored with the New England Journal of Medicine. Presentations and speakers will include:

Upcoming event: Lecture on Hormonally Active Pollutants by Joan Ruderman

Tuesday, 5pm

Sheerr Room, Fay House

10 Garden Street, Cambridge, MA

Joan Ruderman will be giving a talk titled, “Hormonally Active Pollutants: What Are They, What Can They Do, and How Do We Know They’re Out There?” Here is a summary of her talk:

Over the past few decades, an increasing number of chemicals that were designed for one purpose have now been found to have the surprising, additional ability to mimic hormones like estrogen. Examples of such chemicals, often called environmental estrogens, include certain pesticides, plasticizers, detergents, and compounds added to personal care products. There is growing concern that everyday exposures to these chemicals, and to others yet to be discovered, are contributing to increases in reproductive abnormalities, infertility, and estrogen-dependent cancers in both males and females. Previously identified environmental estrogens show little structural similarity to estrogen, making it impossible to predict simply on the basis of structure alone which other chemicals may also be estrogenic. Transgenic zebrafish embryos can play a unique role in screening chemicals that mimic estrogen.

The website for this lecture series can be found here. Hope to see you there! ~YK

Google, Whole Foods, and … Big Pharma?

By Nadia N. Sawicki

Google’s informal corporate slogan is “Don’t be evil.”  Whole Foods is a Fortune 500 company with a net revenue of 10 billion dollar that prides itself on a commitment to social responsibility.  Both companies have pledged to do long-term good in the world, even at the expense of short-term gains, and both are wildly successful.

If corporations can be profitable as a result of their commitments to social justice and corporate ethics, why can’t this doctrine be extended to the pharmaceutical industry?  Someday, a company called GoodPharma might reach the Fortune 500 on the basis of a pledge to improve access to medicine, conduct international research trials in accordance with the highest standards of research ethics, engage in research on orphan diseases, publish negative research findings, promptly report information about adverse effects, and generally act as a model for ethical industry practices.  If this business model hasn’t been explored, it should be.

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Twitter Round-Up (11/25-12/1)

By Casey Thomson

From policy adoption at the federal level to debate over the health concerns of political figures, this week’s round-up focuses largely on the news for bioethics and health law in the realm of politics.

  • Dan Vorhaus (@genomicslawyer) posted a feature on the history of gene patent litigation and implications for next-generation sequencing technologies. (11/26)  He also included a link summarizing key information on H.R.6118, newly passed in the House and Senate and now being presented to the President. Otherwise known as the Taking Essential Steps for Testing (TEST) Act 2012, the bill gives the Centers for Medicare and Medicaid Services (CMS) “greater flexibility in enforcing CLIA [Clinical Laboratory Improvement Amendments] proficiency testing violations” (as noted by Vorhaus). (11/26)
  • Daniel Goldberg (@prof_goldberg) included a post on the inequality in self-rated health as considered by gender. The study, done in Spain, found that females’ lower sense of self-rated health is a reflection of the higher burden of disease in women, and encouraged systems of health to reconsider the approach towards afflictions with lesser impact on mortality that are possibly receiving less attention than is deserved. (11/26)
  • Daniel Goldberg (@prof_goldberg) additionally included a report on the problems parents with disabilities are facing in terms of retaining (or even gaining) their right to be a parent. Such bias against parents, the article notes, may not recognize that ensuring essential support may be all that is needed to discourage problems or eradicate risks for the majority of cases. (11/26)
  • Frank Pasquale (@FrankPasquale) linked to a blog post on the recent protests by AIDS activists in the office of House Speaker John Boehner. The protesters, stripped naked in order to reveal the painted “AIDS Cuts Kill” written on their chests, were there to protest the possible cuts to HIV/AIDS program funding that may follow a fiscal cliff deal.  (11/28)
  • Arthur Caplan (@ArthurCaplan) featured his talk with Boston Public Radio on the fine line politicians must walk when balancing their struggle with a health crisis along with the responsibilities of being a public official. The recent health concerns facing Boston’s Mayor Thomas Menino served as inspiration for this discussion. (11/28)
  • Frank Pasquale (@FrankPasquale) added a news article detailing the recent speech made by principal deputy national coordinator David Muntz of HHS’ Office of the National Coordinator for Health Information Technology. Muntz, in addition to discussing the need to better incorporate technology for fostering stronger communication between patient and doctor, mentioned some striking statistics: “only 15% of patients have renewed a prescription online,” while “just 10% have a personal health record.” (11/29)
  • Arthur Caplan (@ArthurCaplan) posted a link to a new feature on concierge medicine, where appointments can be paid for solely through cash and not through insurance. While previously considered an option only for the rich, concierge medicine has possible implications for the greater body of patients: as the article noted, it may become a more viable option especially as threats of regulation and backlash in a doctor shortage encourage traditionally high-priced firms to backtrack. (11/29)
  • Arthur Caplan (@ArthurCaplan) also shared a video by Canadian comedian Rick Mercer on getting flu shots. (12/1)

Note: As mentioned in previous posts, retweeting should not be considered as an endorsement of or agreement with the content of the original tweet.

Myriad Updates: Clinical Data as Trade Secrets and a Pending Certiorari Decision

By Dan Vorhaus (Cross-Posted from Genomics Law Report)

Earlier this month, my colleagues John Conley, Robert Cook-Deegan, James Evans and I published a policy article in the European Journal of Human Genetics (EJHG) entitled “The next controversy in genetic testing: clinical data as trade secrets.”  The EJHG article is open access so you can read the entire article at the EJHG website, but here is the abstract:

Sole-source business models for genetic testing can create private databases containing information vital to interpreting the clinical significance of human genetic variations. But incomplete access to those databases threatens to impede the clinical interpretation of genomic medicine. National health systems and insurers, regulators, researchers, providers and patients all have a strong interest in ensuring broad access to information about the clinical significance of variants discovered through genetic testing. They can create incentives for sharing data and interpretive algorithms in several ways, including: promoting voluntary sharing; requiring laboratories to share as a condition of payment for or regulatory approval of laboratory services; establishing – and compelling participation in – resources that capture the information needed to interpret the data independent of company policies; and paying for sharing and interpretation in addition to paying for the test itself. US policies have failed to address the data-sharing issue. The entry of new and established firms into the European genetic testing market presents an opportunity to correct this failure.

In certain respects, this article is an expansion of a previous piece three of us wrote on the Genomics Law Report last year discussing Myriad Genetics’ response to the rise of whole-genome sequencing technologies in the context of diagnostic genetic testing. The current EJHG expands upon that discussion, while still using Myriad Genetics as a case study, particularly the company’s development of a proprietary database of DNA sequence variants (including variants of uncertain significance, or VUSs) and related clinical information pertaining to the breast cancer genes BRCA-1 and BRCA-2.

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DNA DTC: The Return of Direct to Consumer Whole Genome Sequencing

By Dan Vorhaus (Cross-Posted from Genomics Law Report)

This morning, Gene By Gene, Ltd. – better known as the parent company of the popular genetic genealogy provider Family Tree DNA – formally announced a corporate reorganization that includes the debut of a new division, DNA DTC. (Apparently the news was also announced earlier this month at the Family Tree DNA Conference, although the company waited until today to launch press releases.)

The announcement from Gene By Gene is newsworthy for several reasons, including:

1. The Return of True DTC Whole Genome and Whole Exome Sequencing. According to DNA DTC, the company offers a range of products “utilizing next generation sequencing including the entire exome (at 80x coverage) and the whole genome.” The company’s website, while fairly Spartan, appears to bear this out. Whole exomes ($695 at 80x coverage) and genomes ($5,495 at 30x coverage) are both listed as available products.

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