In the News

Maybe, like me, you read everything you could get your eyes on last week about the gene patenting case, and spent several days pondering the implications of the ruling by the Supreme Court that companies like Myriad Genetics can’t patent isolated human genes. Or, maybe you’re a busy person with not much time to dive deeply into the issue. If so, you might find today’s summary by the National Geographic - 7 Takeaways from Supreme Court’s Gene Patent Decision – a useful primer.

The article quotes Jake Sherkow, JD, and Hank Greely, JD, from the Stanford Center for the Law and Biosciences, who each provided comment on the case for us and other members of the media last week. I found point 2 – “Synthetic DNA is fair game” – to be particularly interesting, since it’s one of the first discussions of what the ruling allows, rather than prohibits:

While companies can no longer patent genes with the same sequences found in cells, the decision allows edited forms of genes not found in nature—known as complementary DNA, or cDNA—to be patented.

cDNA is not useful for diagnostic tests, but it is crucial for producing protein-based drugs, explained Robert Cook-Deegan, a professor of genome ethics, law, and policy at Duke University’s Institute for Genome Sciences and Policy.

“Those are the billion-dollar molecule patents,” Cook-Deegan said. “Biotech companies care a great deal about cDNA patents, and it should be reassuring to them that those patents are still fine.”

Hank Greely, a bioethicist and law professor at Stanford University, predicts cDNA patents will become even more valuable as scientists move beyond merely exploiting naturally occurring proteins.

“In the longer run, as we move into an era of synthetic biology, where we start trying to improve upon nature, then I think [cDNA patents] will be important,” Greely said.

Previously: A closer look at Supreme Court’s decision on gene patenting, Supreme Court rules on Myriad’s “gene patenting” case and Are genes patentable? A summary of the Supreme Court case

Wow, what a busy day for gene patenting discussions! This morning’s decision (.pdf) by the Supreme Court that isolated DNA is not patentable has sparked a wave of stories, press releases and announcements across the web. I thought I’d pull together some of the most useful information I’ve found today on the topic.

Twitter provided a forum for immediate responses to the ruling, my favorite of which was authored by NIH director Francis Collins, MD, PhD:

SC: “A naturally occurring DNA segment is a product of nature and is not patent eligible merely because it has been isolated” Woo Hoo!!!

— Francis S. Collins (@NIHDirector) June 13, 2013

(Collins later followed-up with a much more staid official statement, but I still love the “Woo hoo.”) The Twitter feed from the National Human Genome Research Institute was only a bit more restrained:

Huge news: Supreme Court decision says naturally occurring DNA is not patentable http://t.co/rhhtY2N4GI

Several Stanford experts weighed in as well, including Stanford law professor and bioethicist Hank Greely, JD, who had a slightly different reaction to the ruling:

Very 1st reaction w/o reading full opinion: cDNA exception won’t help Myriad or other test cos. Deeper reaction – the issue isn’t important.

— Hank Greely (@HankGreelyLSJU) June 13, 2013

Why unimportant? Only 1 “bad” company, patents expire, technology workarounds. On the other hand, Myriad has some strong “trade secrets.”

— Hank Greely (@HankGreelyLSJU) June 13, 2013

Geneticist Carlos Bustamante, PhD, also tweeted his thoughts about the issue of consumer choice (scroll down to read tweet series).

As the day wore on, it became apparent that those on both sides of the issue were claiming a victory of sorts. Myriad issued a positively worded release highlighting the Court’s decision to uphold the company’s cDNA patents. Stock in Myriad (and other biotechnology companies) initially jumped after the announcement, but ended the day down about 5.6 percent.

Two genetic testing companies (Ambry Genetics and Gene by Gene, Ltd) that I know of (there could well be more) jumped into the fray this afternoon with announcements that they will immediately begin offering BRCA1 and BRCA2 testing to patients at prices much lower than the $3,000 to $4,000 charged by Myriad. It remains to be seen, however, how much of an advantage Myriad’s proprietary database (used to interpret the sequence results and deliver risk estimates to patients) will confer to savvy patients who may choose to pay a premium for access to this cloistered information. Personally, I’m really interested in the effect the ruling will have on an end-around effort by researchers trying to reconstitute Myriad’s database by compiling individual patient’s reports from the company.

Finally (for now), for a general overview of the history of BRCA gene patenting and the field of genetic testing, check out this excellent article from Nova Next. I have a feeling I’m going to be reading it more than once as I (along with many experts in both law and biology) puzzle through the issues for these next few days and weeks.

Previously: A closer look at Supreme Court’s decision on gene patenting, Supreme Court rules on Myriad’s “gene patenting” case and Are genes patentable? A summary of the Supreme Court case

Alan Trounson, PhD, president of the California Institute for Regenerative Medicine, co-authored a comment piece published yesterday in Nature discussing the issues surrounding therapeutic human cloning. The comments were sparked by last month’s announcement by researchers at Oregon Health and Science University of the successful derivation of embryonic stem cells from cloned human embryos. Although problems with the original research article have since surfaced, the crux of the finding remains unchanged. The article explains:

This formidable technical feat is potentially a key step towards developing replacement tissues to treat disease. Media coverage of the paper has also rekindled long-standing controversies about human cloning, the use of human eggs and the destruction of human embryos. The achievement is a timely reminder that scientists must remain actively engaged in discussions about the ethics of using human embryos for research in cell biology and regenerative medicine.

The researchers used a technique called somatic cell nuclear transfer, or SCNT, to create the embryonic stem cells. In SCNT, the nucleus of a mature, donated human egg is replaced with the nucleus from a cell from another individual. The egg is then stimulated to divide and become an embryo carrying the genetic information from the donor nucleus. The process would conceivably allow researchers or clinicians to create unique embryonic stem cell lines to match individual patients and would avoid issues of immune rejection that could arise with non-genetically matched ES cells. But it’s also the first step in potentially cloning a human for reproductive purposes.

In the article, Trounson and his co-author, Martin Pera, PhD, from the University of Melbourne, urge caution and proactive consensus building to address the many complex ethical and biological issues surrounding this type of work. It’s a very interesting read. They conclude:

The potential benefits of stem-cell research are immense. Prospects for transformative treatments for conditions such as macular degeneration, type 1 diabetes or Parkinson’s disease are now on the horizon. But without first convincing governments, the public, and funding and regulatory bodies that all the possibilities have been thought through and evaluated, headline-catching results could create a backlash that unnecessarily delays the tremendous potential benefits of cell therapies.

Previously: Stem cell guidelines under fire and New York Stem Cell Foundation researchers create human stem cell lines from SCNT

This morning, the U.S. Supreme Court issued their anxiously awaited decision in the case of the Association for Molecular Pathology vs. Myriad Genetics, Inc. Often called the gene patenting case, the case raises the issue of whether companies like Salt Lake City-based Myriad Genetics, Inc. can patent genes, in this case, the BRCA1 and BRCA2 genes. Mutations in these genes confer a substantially higher risk of breast or ovarian cancer.

The Court ruled that naturally isolated DNA is not patentable, but that synthetic DNA (such as the cDNA for the BRCA1 and 2 genes) is patentable. The decision was unanimous. From the decision:

A naturally occurring DNA segment is a product of nature and not patent eligible merely becauseit has been isolated, but cDNA is patent eligible because it is not naturally occurring.

…

cDNA is not a “product of nature,” so it is patent eligible under §101. cDNA does not present the same obstacles to patentability as naturally occurring, isolated DNA segments. Its creation results in an exons-only molecule, which is not naturally occurring. Its order of the exons may be dictated by nature, but the lab technician unquestionably creates something new when introns are removed from a DNA sequence to make cDNA.

We’ll have a longer comment about the decision later today or tomorrow from Jacob Sherkow, JD, a fellow at Stanford Law School’s Center for Law and the Biosciences. Sherkow recently wrote a wonderful blog post for us summarizing the oral arguments in the case, which took place in April. And the SCOTUS blog carried a great, ‘made simple’ synopsis of the issue earlier this year for readers who want to quickly get up to speed.

The decision is likely to have far-reaching implications for the many other gene patents granted by the U.S. Patent and Trademark Office since the first gene (chorionic somatomammotropin) was patented by the University of California, Berkeley, in the early 1980s. The National Society of Genetic Counselors now estimate that around 20 percent of all human genes are patented.

Previously: Are genes patentable? A summary of the Supreme Court case, At Stanford event, cancer advocate Susan Love talks about “A future with no breast cancer” and BRCA patients use Stanford-developed online tool to better understand treatment options
Photo by Mark Fischer

I just learned of a new Reuters blog, Cancer in Context, written by a reporter who was recently diagnosed with Stage 4 lung cancer. Debra Sherman has chosen to talk publicly about her experience (“There seems no reason to stop [writing health stories] now that my health is so compromised,” she wrote], and her aim for the blog is to use her journalistic skills to “report on the latest cancer research from the perspective of a patient.” I found her introductory post from earlier this month quite poignant:

As a Reuters journalist I have been writing about medical technology and healthcare for more than a decade. I’ve covered the major medical meetings, including the big one on cancer. I’ve written stories about new cancer drugs and treatments, about how many more survive the disease (true for breast, colon and some other forms, though not so much for lung cancer), and how a diagnosis can lead to bankruptcy, even for those with health insurance.

I wrote those stories objectively and never imagined any would ever apply to me.

Previously: A journalist opens up about her struggles with depression and anxiety and Fighting a stage IV cancer diagnosis

I’m kicking myself for not listening to it live, but today’s Science Friday on National Public Radio tackled, with the help of a couple of Stanford experts and their colleagues, a tough issue in genetic disclosure that I’ve written about here before. According to the description on the show’s website:

When doctors run out of clues on how to treat a cancer patient, they sometimes order a scan of all the patient’s genes. But such a test can turn up unexpected results, such as greater risk of another disease. When are doctors obligated to tell the patient what they know? And do patients have the right not to know?

Stanford bioethicist and law professor Hank Greely, JD, and genetic councilor Kelly Ormond joined two colleagues and host Ira Flatow in a half-hour discussion about just how much might be too much information for patients and doctors. And, although I haven’t listened yet (the audio of the discussion has just been posted), I can guess the punchline: There’s no black-and-white answer. Patients, researchers and clinicians alike (and, yes, even science writers!) are all stumbling into a brave new world in genetics and genomics that right now has more questions than answers. That’s why I’m excited to hear what Greely and his colleagues have to say.

An aside: I didn’t learn of the show ahead of time, but got wind of it via Twitter. As my colleague pointed out here earlier today, more and more scientists and science writers are using Twitter to stay connected and keep informed about events like conferences and media coverage in (nearly) real time. I certainly consider it one of my more valuable resources. If you’re interested in trying it out yourself, experiment with following organizations as well as people (the Science Friday radio show tweets its content each week as @SciFri, for example). But Greely, who tweets as @HankGreelyLSJU, has also been disclosing interesting tidbits about today’s show.

Previously: New recommendations for genetic disclosure released, When it comes to your genetic data, 23andMe’s Anne Wojciciki says: Just own it and Stanford neurologist discusses role of amyloid proteins in the nervous system on Science Friday

This evening, Dateline NBC will broadcast “Against All Odds,” a one-hour program devoted to the story of one family whose five children all have signs of the same heart disease, dilated cardiomyopathy. The Bingham family of North Powder, Oregon, first came to Lucile Packard Children’s Hospital in 2006, when their oldest daughter, Sierra, needed a heart transplant. A press release from Packard Children’s describes what happened after Sierra’s successful transplant:

“When Sierra received her heart transplant in 2006,” recalled dad Jason, “we thought that was the end of it.” But in spring 2012, Lindsey became sick with symptoms eerily similar to Sierra’s, and the Children’s Heart Center then discovered all the kids had developed heart issues over time. Lindsey was placed on the heart transplant list, and received a Berlin Heart bridge-to-transplant device on July 1, the same day brother Gage was implanted with a pacemaker. And after months of living in the hospital while the Berlin Heart kept her stabilized, when did Lindsey receive her donor heart? On Valentine’s Day of this year.

The Dateline program chronicles many milestones of the year-plus the Binghams spent living at the Ronald McDonald House at Stanford for their kids’ treatment, including the moment Lindsey learned that a new heart was waiting for her, the Valentine’s Day transplant and the family’s recent reunion with their friends and family in Oregon. Tune in at 8 p.m. Eastern Time/7 p.m. Central Time and keep your box of tissues handy.

Previously: One family – and five children with the same serious heart disease, Pediatric patients on the Trick-or-Treat Trail
Photo by The Family Album Project

Science Insider took another look yesterday at the effects of the budget sequestration on research. After describing the potential harms of the NIH’s recently announced 5 percent budget cut - “part of a larger pattern of declining funding over the past decade” – reporter Jocelyn Kaiser points out another troubling aspect of sequestration:

NIH leaders say that the sequester’s most severe effect is the chilling message it sends to young scientists. In testimony last week, [NIH Director Francis Collins, MD, PhD,] quoted a former student who is finishing a Ph.D. at the Massachusetts Institute of Technology. She’s seen her role models struggle with funding. “I can’t erase the fear that this is my future,” Collins quoted her writing.

“We’re putting an entire generation of U.S. scientists at risk,” Collins warned. “If they go away, they won’t come back.”

Previously: Sequestration hits the NIH – fewer new grants, smaller budgets, NIH director polls Twitter for real-world responses to budget cutbacks and As budget sequester nears, a call for Congress to protect funding for scientific and medical research

I’ll admit that I often use the excuse of not having enough time to work out. Between the demands of work and raising two small kids, sometimes it really is difficult to drag myself to the gym. That’s why this piece on Well this morning grabbed my attention – a high-intensity workout in just seven minutes, and one that’s backed by science! Blogger Gretchen Reynolds writes:

…Sometimes you just want someone to lay out guidelines for how to put the newest fitness research into practice.

An article in the May-June issue of the American College of Sports Medicine’s Health & Fitness Journal does just that. In 12 exercises deploying only body weight, a chair and a wall, it fulfills the latest mandates for high-intensity effort, which essentially combines a long run and a visit to the weight room into about seven minutes of steady discomfort — all of it based on science.

“There’s very good evidence” that high-intensity interval training provides “many of the fitness benefits of prolonged endurance training but in much less time,” says Chris Jordan, the director of exercise physiology at the Human Performance Institute in Orlando, Fla., and co-author of the new article.

I’m ready to give this a try. If all I need are seven minutes, a chair and wall, then there’s really no room for excuses anymore.

Previously: Fitness research: A year in review, Is fitness level more important than body weight in boosting heart health, Study shows physically fit older adults have fewer age-related changes in their brains, Exercise may be effective in treating depression, Exercise may protect aging brain from memory loss following infection, injury, How physical activity influences health and Study shows how physical activity benefits seniors’ hearts
Photo by lululemon athletica

Man bites dog. As reported on the Wonkblog and elsewhere yesterday, a new analysis indicates that the rate of gun-induced homicide has plummeted by half over the past two decades.

Asked in a March Pew Research Center survey whether crimes involving guns have increased, held steady or been in remission since twenty years ago, more than half of all respondents said such crimes were on the rise.

Wrong. In 1993 – a year remembered by many of us through a Vaseline-coated lens of nostalgia – the gun-homicide rate in the United States was twice what it is today. The 49 percent drop since then is consistent with a general and steady, if unheralded, drop-off in rates of all violent crimes, as the federal Department of Justice’s Bureau of Justice Statistics confirms.

Actually, the rate of firearm-related homicides began a rapid ascent in the 1960s, peaked in the early 1990s, and has now returned to that of the early 1960s. (Gun-related suicides have also declined, but not as dramatically.)

These statistics do not bring back to life a single innocent person who has been killed, by guns or otherwise, in the past two decades. But they do provide some perspective in what has been an emotion-charged and too-often fact-challenged debate. As I’ve previously written, I fear that the debate leading to the Affordable Care Act – now proving famously tough to implement -a few years ago involved some misconceptions concerning the state of health care in the United States. People on both sides of the current debate on gun-control legislation would be well advised to get the facts straight.

Previously: U.S. health system’s sketchy WHO rating is bogus, says horse’s mouth and Rush to judgment regarding the state of U.S. health care?
Photo by ~Steve Z~