Weekly Roundup: UK Insurance Genetics Moratorium Renewed & Breast Cancer Patents, Research in the News

With so many developments at the intersection of genomics and the law, there is often a variety of interesting stories that, for one reason or another, don’t find their way into a full-length posting on the Genomics Law Report. In this post we recap several recent key developments and, at bottom, round up all of the recent tweets from @genomicslawyer.

UK Insurers Continue Moratorium on Predictive Genetic Tests. In 2008 the United States passed the Genetic Information Nondiscrimination Act (GINA). Title I of GINA prohibits health insurers from using genetic information to deny coverage or to set premiums or payment rates. Title II of GINA addresses the use and misuse of genetic information by employers. In the United Kingdom, which provides universal health coverage through the government-funded National Health Service (NHS), discussion of genetic nondiscrimination has largely focused on the employment context (see, e.g., the 2009 report on Genomic Medicine from the House of Lords). To date, however, the United Kingdom has not enacted a formal prohibition on the use of genetic information by either employers or insurers.

Although the U.K. lacks a formal counterpart to GINA, in 2001 the Association of British Insurers (ABI) and the government’s Department of Health did establish a voluntary moratorium on the use of predictive genetic testing by insurers. According to the ABI:

The moratorium means the results of a predictive genetic test will not affect a consumer’s ability to take out any type of insurance other than life insurance over £500,000. Above this amount, insurers will not use adverse predictive genetic test results unless the test has been specifically approved by the Government. Only around 3% of all policies sold are above these limits. The only test that is approved is for Huntington’s Disease.

The moratorium was initially scheduled to expire in 2011. It was extended until 2014 in 2008 and, this past week, it was extended again, to 2017. The moratorium is scheduled to be revisited again in 2014.

Myriad Oral Argument. As regular GLR readers already know, the latest development in the Myriad gene patent litigation occurred on Monday. The Federal Circuit heard oral argument in the case, which will likely be the last public step before the three judge panel issues its opinion in several months. We’ve already discussed here at the GLR what we learned from the Myriad oral argument, but there has been excellent coverage of the case elsewhere as well. At the Pharmacogenomics Reporter, Turna Ray explored the somewhat confusing position Myriad took at oral argument with respect to the relationship between the company’s BRCA patents and whole-genome sequencing. In addition, the lead up to the oral argument also produced some interesting analyses, including at The Atlantic, where Andrew Cohen provided a play-by-play account of the events to date, and at Nature.com, where Shobita Parthasarathy focuses on how Myriad, regardless of its outcome, has produced “a more democratically engaged patent system.”

One other patent-related note: for those who are wondering what a government shutdown later today might mean for the US Patent Office, Patently-O has the answer. [Update: Nature also has an excellent high-level overview of how a shutdown will affect various government agencies, including the NIH and the FDA.]

Breast Cancer’s Complexity. Finally, a recent study from researchers at Washington University in St. Louis serves as a reminder that our knowledge of breast cancer, despite the ongoing litigation over the BRCA1 and BRCA2 genes, is still woefully incomplete. Scientists led by Matthew Ellis have sequenced the whole genomes of fifty patients’ breast cancer tumors along with matching DNA from the same patients’ healthy cells. They presented these results at the Annual Meeting of American Association for Cancer Research on April 2nd and revealed that most of the 1700 genetic mutations discovered were unique to individual patients’ tumors and only three occurred in 10% or more of the patients.

The sample was from patients in clinical trials of estrogen-lowering drugs known as aromatase inhibitors. Patients who are not responsive to such drugs have lower survival rates, but scientists do not know what causes these differences. One such association was for the breast cancer suppressor gene MAP3K1, which produces a protein that accelerates programmed cell death. MAP3K1 mutations were associated with the aromatase inhibitor-sensitive–more favorable–type of disease and were present in about 10% of the tumors. This result may be beneficial for pharmacogenomics research aimed at targeting particular types of breast cancers – similar to the research that led to the Genentech drug, Herceptin.

The next step will be to repeat the experiment with a much larger sample size (at 1,000 tumors), an indication of just how far we have to go when it comes to truly understanding how diverse cancers operate in equally diverse individuals.  Additional coverage is available from GenomeWeb and The Wall Street Journal.

Roundup of tweets from the intersection of genomics, personalized medicine and the law:

Filed under: General Interest, Genetic Testing/Screening, Genomic Policymaking, Genomics & Medicine, GINA, Industry News, International Developments, International News, Legal & Regulatory, Myriad Gene Patent Litigation, Patents & IP
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