Personal Genomics: A Participatory Activity

DNA ribbonLast week the GLR covered deCODEme’s announcement that it was offering existing customers of its main competitor, 23andMe, the opportunity to have their genomic data interpreted by deCODEme’s own service. For free.

Although somewhat surprising from a short-term commercial perspective, I generally liked the move by deCODE as a means to improve the company’s genomic data interpretation abilities. Here’s what I wrote at the time:

If interpretation proves to be one of the key differentiators between DTC genomics companies, as expected, deCODE (and other companies) should embrace opportunities to hone their interpretative platforms now, while the DTC commercial market remains relatively small.

As both Peter Aldhous of New Scientist and Daniel MacArthur of Genetic Future have pointed out, it appears that there is some honing to be done on deCODEme’s end. From ancestry confusion to interpretative errors in evaluating Alzheimer’s risk, deCODEme’s first attempt at genomic data migration has been an imperfect one. Would deCODEme have preferred a seamless launch to their 23andMe data migration service? Of course. But if the experiment now pays off in smoother data migration and interpretation for the company in 2010 and beyond, these first bumps in the road will soon be forgotten.


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Filed under Direct-to-Consumer Services, Genetic Testing/Screening, Genomic Sequencing, Genomics & Society

Follow-on Biologics: How Much Incentive Do We Need?

Drugs & MoneyAfter almost a full year of debate, a pathway for approving “follow-on biologics” or “biosimilars” continues to be a hot topic in Congress. We are all familiar with generic versions of brand-name drugs, and the federal regulatory scheme sets out well-defined shortcut procedures for approval of generics. Congress is now grappling with designing procedures for approval of generic versions of biological drugs. Although follow-on biologics are in some ways similar to generic drugs, the differences are crucial, and in fact the regulatory scheme for generic drugs does not work at all for biologics. Congress has its work cut out for it.

Biologics 101. In short, here is the problem: typical pharmaceutical drugs (“small molecule drugs”) are chemically synthesized, and once the brand-name manufacturer’s exclusive patent rights expire, generic manufacturers are free to obtain approvals under abbreviated procedures, Generic manufacturers are generally not required to submit preclinical (animal) and clinical (human) data along with these Abbreviated New Drug Applications (ANDAs), thereby avoiding the huge expenses associated with developing new pharmaceuticals. But this route is only open to the generic manufacturer if it can prove that the generic version of the drug contains an identical replica of the drug’s active ingredient. Under the Hatch-Waxman Act of 1984, the Food and Drug Administration (FDA) may approve a generic version of a drug if the generic contains the same active ingredient as the original, shows bioequivalence to the original, and is demonstrated to be manufactured according to appropriate practices. Once these are shown, the generic is allowed to piggyback on the designation of the original drug as safe and effective.


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Filed under Genomic Policymaking, Genomics & Medicine, International Developments, International News, Patents & IP, Pending Regulation

Genetic Discrimination Comes in Many Colors

Color-bind testAn email from a regular Genomics Law Report reader notes that we have been engaging unwittingly in genetic discrimination. Dr. Bob West is color-blind, and he points out that our treatment of hyperlinks—to date we have used red hyperlinks against black text in our posts, without any other markings to distinguish linked from ordinary text—creates a real problem for him.

Red-green color blindness, which is the most common form, is an X-linked genetic condition that affects an estimated 7-10% of men in the United States (because it is X-linked, it affects far fewer women). People with red-green color blindness have a difficult time distinguishing red from black characters, which made locating links on the GLR very difficult. To compensate, Dr. West was forced to print out the GLR columns (default print settings typically causes hyperlinks to become underlined, regardless of how they appear on screen) in order to identify the hyperlinks.

The GLR is responding. You will now notice that hyperlinks in the body of GLR columns, including this one, appear red and underlined (beige if you’ve previously visited the link), allowing readers two ways (color and style) to identify hyperlinks.

Remember to share your other comments and suggestions—from examples of inadvertent genetic discrimination to ideas for future columns—by contacting us. Thanks.

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Filed under General Interest, Genomics & Medicine, Genomics & Society

Weekly Twitter Roundup

Each week there are a number of stories and developments that, for one reason or another, don’t find their way into a full-length posting on the Genomics Law Report. Here’s a recap of what I was Tweeting this week @genomicslawyer:

Filed under General Interest

Is deCODEme Taking a Page from the 23andMe Playbook?

playbookDaniel MacArthur of Genetic Future provides coverage of the decision by direct-to-consumer (DTC) genomics service provider deCODEme to offer existing 23andMe customers the ability to upload their raw 23andMe data to the deCODEme service. For free.

MacArthur correctly notes that the value of the genome scans provided by companies such as 23andMe and deCODEme lies not in the actual creation of raw genetic data but in the interpretation of that data, and wonders why deCODEme has decided to give that away for free. Here’s MacArthur’s take:

So, why the free offer? I’m guessing deCODEme is gambling (quite reasonably) that offering free uploads will attract a non-trivial number of 23andMe customers over to deCODEme’s interface. That then provides the Icelanders with an opportunity to give people a fair trial of their own interface, and hopefully to impress them with the quality and accessibility of the data provided.

That seems reasonable, and many 23andMe customers are likely already familiar with porting their raw genetic data to other interpretive tools – Promethease, for example – so perhaps this puts deCODE in front of a group of individuals who would not otherwise be in the market for a duplicative genome scan. (23andMe appears unconcerned by the prospect of a side-by-side comparison of its service with that of deCODEme.)
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Filed under Bioinformatics/IT, Direct-to-Consumer Services, General Interest, Genetic Testing/Screening, Genomic Sequencing, Genomics & Society, Industry News

Reproductive Genetic Screening: More Questions Than Answers

Lots of Babies

The Genomics Law Report has published a couple of guest commentaries recently dealing with genetic screening—a topic our own Adam Doerr also addressed in two posts this summer dealing with “wrongful life” claims brought against sperm banks by children with genetic diseases inherited from their donor fathers. Such claims are premised on the failure of the sperm bank to conduct genetic screening that could have detected the defective genes—thereby avoiding the conception of the child on whose behalf the wrongful life claim is brought.

In this post, I look at a recent gamete screening controversy—the revelation that a man fathered at least two dozen children, all but two through the donation of his sperm to a bank, despite having a potentially serious genetic defect—and examine numerous issues the story raises. Many relate to whose interests are valued the highest. Should the wellbeing of the children born of the process—the only people involved who have no say in the matter—come first, or does respect for the autonomy of the parents control? I do not attempt to answer the questions posed, but seek to encourage discussion with respect to the need for clearer policies and guidance in a number of these areas.


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Filed under Genetic Testing/Screening, Genomic Policymaking, Genomics & Medicine, International Developments, Legal & Regulatory

Protecting Your Brand Name on the Internet

Bench to Market (article)Twenty-four hundred years ago, in the scroll age, the marketing guru Socrates observed, “Regard your good name as the richest jewel you can possibly be possessed of.” In the intervening years, only the technology of communication has changed; the wisdom of protecting your brand name and the goodwill it carries is still valid. For many of today’s businesses that are built on innovative products or services, such as those provided by many of the readers of The Genomics Law Report, the Internet and its social media are the most important methods of communicating with potential customers and collaborators.

Brand protection on the Internet begins with selecting and registering a “domain name.” Domain names are akin to virtual street addresses on the Internet, where the registry or “top level domain” is the name of the street and the string to the left of the “.” in the domain name is the ‘second level domain name.” Thus, “genomicslawreport.com” is the unique address for our site, consisting of the second level domain “genomicslawreport” registered on the popular “com” street. Anyone in the world can find us and no one else publishing there. We have grown jaded about this technological marvel, but a consequence of the domain name system is that every business should want to be sure that it preemptively registers domain names that support its brand and take reasonable and prudent measures to assure that others do not unfairly profit from the goodwill residing in that brand by registering domain names that impersonate, mimic or denigrate the brand or that sell counterfeit products under the brand name.


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Filed under Badges, Bench to Market

What ELSI was New? Plenty.

What ELSI is new (article)From October 5 to December 8, 2009, the Genomics Law Report featured a series of thirty-six guest commentaries by industry, academic and thought leaders in the fields of genomics and personalized medicine. Entitled What ELSI is New?, the series, which we have organized into an e-book (pdf), asked each contributor to briefly respond to the following question: “What do you believe is the most important ethical, legal or social issue (ELSI) that must be addressed by the fields of genomics and/or personalized medicine?

For better or worse, that’s where the instructions ended. The invited contributors identified the ELSI of their choice and discussed (or not) their rationale for so selecting as they saw fit. In addition to refraining from substantive editing, we intentionally avoided coordinating commentaries. Although we encouraged independent submissions from a variety of contributors and deprived them of any advance knowledge of what others in the series would say, one of our hopes was that consensus would begin to form around certain key ethical, legal and social issues.

To some degree this occurred. In collecting the series for the convenience of readers who would like to have all of the contributions in one place (pdf), we have ultimately settled on six broad topic headings for the commentaries
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Filed under Direct-to-Consumer Services, General Interest, Genetic Testing/Screening, Genomic Policymaking, Genomic Sequencing, Genomics & Medicine, Genomics & Society, Informed Consent, Legal & Regulatory, Pending Regulation, Privacy, What ELSI is New?

Weekly Twitter Roundup

Each week there are a number of stories and developments that, for one reason or another, don’t find their way into a full-length posting on the Genomics Law Report. Here’s a recap of what I was Tweeting this week @genomicslawyer:

Filed under General Interest, Industry News

Protecting the Name

Bench to Market (article)A great invention deserves a great name. When the time comes to market your game-changer, you can be sure of two marketing realities: copiers will race to build similar products, and purchasers will reward the product they remember. These two truths lie behind the adoption of the trademark iPhone® to identify Apple Inc.’s unique combination of music player and smart telephone and to distinguish it from other, similar products that now are marketed by Palm, RIM and other competitors. Because consumers know to ask for an iPhone® device by name, iPhone symbolizes and sustains the considerable goodwill that attaches to this category-creating product. The inner electronics of the device have changed repeatedly since it was first introduced, but consumers still associate today’s product with the original and its goodwill because of the consistent use of this trademark.


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Filed under Badges, Bench to Market, Patents & IP