Science Policy

Over at the Nature News blog, there’s a great summary of the ways that last night’s State of the Union address by President Obama tackled issues near to scientists’ hearts. Several of these points are particularly relevant for medical researchers. For instance, the post says:

- Obama urged lawmakers not to “gut” US investments in basic research, arguing among other things that “the discoveries taking place in our federally-financed labs and universities could lead to new treatments that kill cancer cells but leave healthy ones untouched” and create lightweight vests that protect police and soldiers from “any bullet.”

- Calling on Congress to “stop expelling responsible young people who want to staff our labs,” the president argued that a path to citizenship should be created for foreign students who come here to study subjects like business, science and engineering. “Send me a law that gives them the chance to earn their citizenship. I will sign it right away.”

The entire post – which also addresses such areas of science as green technology and high-tech manufacturing – is a worthwhile read. A video of the president’s speech is available here in case you missed it.

Previously: Obama reaffirms commitment to health reform – but does Congress care?
Photo by The White House

I guess you could say that the Stanford Biodesign Program “wrote the book” on how to teach medical technology innovation to multidisciplinary teams. The U.S. Food and Drug Administration recently acknowledged the effectiveness of this training program by signing a “memorandum of understanding” with Stanford, which I discuss in today’s Inside Stanford Medicine.

The agreement lays the groundwork for the FDA and Stanford to collaborate on a number of initiatives, including educational outreach, cross-training of scientific personnel, and the development of new biostatistical methods for more accurately evaluating the safety of emerging medical technologies.

The biodesign program, which is in its 11th year, trains teams of doctors, engineers and business students — in an intensive one-year program — to identify a medical need, develop an invention to fill it, create a business plan, navigate the regulatory process, then present their inventions to venture capitalists. Since its inception, the program has led to more than 200 patents and 24 start-up companies.

Previously: Stanford Biodesign Program releases video series on the FDA system, FDA walks line between innovation and safety, Stanford physician-entrepreneur discusses need to change FDA approval process, and New biomedical device textbook gets early praise

A few years ago, Tom Rando, MD, PhD, found that if the circulatory systems of a young and an old mouse were connected, something in the blood of the young mouse seemed to rejuvenate the old mouse’s liver and muscle. And something in the old mouse’s blood seemed to age the young mouse’s equivalent organs and tissues. Rando taught Tony Wyss-Coray, PhD, the mouse-hookup technique, and last year the latter showed that factors in blood can similarly influence the robustness of stem cells in the brain, too. (This was the subject of a recent Stanford Medicine article.)

Meanwhile, Howard Chang, MD, PhD, and one or two other investigators in the research-osphere were showing the world that a whole lot of the DNA in each of our cells codes for not proteins but RNA molecules whose job it is to fire up or shut down the genes that do code for protein production. (For more, see this.)

In a just-out review article in the journal Cell, Rando and Chang raise the possibility of getting old cells to act younger. And not just any old cells, but the “adult” stem cells that reside in most if not all of our various tissues.

Most of us are more familiar with these cells’ more publicized relatives, embryonic stem cells (eSCs). These superstars are famous for being able to perform two tricks. They can multiply indefinitely in a dish, and they can differentiate into any of the 200-odd cell types in our body. That’s good and it’s bad. Good, because they offer the promise of regenerative medicine: essentially, differentiating eSCs into the needed cell types and infusing them to rejuvenate worn-out or defective tissue. Bad, because on their way to becoming the right kind of cells, they could go wrong instead, and become tumors.

Unlike eSCs, tissue-resident cells already know what they want to be when they grow up: They want to be whatever type of cell within that particular tissue that happens to be in short supply. In other words, these adult stem cells are already committed to a given lineage. A nerve stem cell’s not going to surprise you by turning into a fat stem cell.

Rando and Chang’s review, and this Q-and-A session I conducted with Rando the other day, explore the prospects for restoring aging tissues’ tiring stem cells to more-youthful activity levels. It might be possible to kickstart them with bloodborne factors isolated through experiments of the type I mentioned above – or, better, with pharmaceutical compounds that mimic the actions of those factors.

I feel younger already.

Previously:Old blood + young brain = old brain, Old blood makes young brains act older, and vice versa, New job description for RNA, oldest professional biomolecule
Photo by jikatu

In a fascinating Science Progress blog entry, Jonathan Moreno takes a stock of how America is performing in terms of its investment in the life sciences. He writes:

So how is the country doing in biotech investment? A fascinating and richly detailed new industry report from Jones Lang Lasalle allows us to reach two salient conclusions: first, the United States is holding its own as the global leader; and second, since the 2007 downturn, industry clusters in China, India, and Singapore have displaced traditional powers Ireland, Italy, Germany, and Spain in direct pharmaceutical investment.

This result confirms the narrative we hear in so many fields these days about the turn toward Asia, and well justifies the Obama administration’s reassertion of American interests as a Pacific power.

As you saw in the block quote, Moreno’s entry summarizes a report (.pdf) from Jones Lang Lasalle, a financial and investment services firm. It also identifies several “clusters” in which, with the right funding and policies, biotechnology might begin to flourish.

Will a deadly pandemic rule the fall box office?  That’s the question posed by Steven Soderbergh’s blockbuster film, Contagion, which opens nationwide on Friday.

The story is simple: It’s an action/thriller centered on the threat posed by a deadly disease, and on the international team of doctors contracted by the CDC to deal with the outbreak. The actors are stellar: Matt Damon, Kate Winslet, Jude Law, Marion Cotillard, Lawrence Fishburne and Gwyneth Paltrow. And the director, Soderbergh: one of Hollywood’s best and brightest. But does Contagion get the science right?  (Hollywood usually fails in that respect.)

Last Sunday, I read a New York Times article that described the technical team of scientists who served as advisors to the screenwriter, director and actors. Shortly after, I spoke with one of them, Ian Lipkin, MD, director of the Center for Infection and Immunity at Columbia University’s Mailman School of Public Health, for a 1:2:1 podcast.

During our conversation Lipkin described how he prepped two of the actors for their roles in one of Columbia’s research labs, how the film’s soundmen gathered the authentic thumping noises that ooze from machines scattered throughout Lipkin’s research space and how he cajoled a reluctant Soderbergh to reshoot a scene to get it technically correct. He also told me that he hopes the audience will walk away from the film with a greater respect for scientists, along with a deeper understanding of what it takes to protect the nation’s health and how important it is to invest in scientific research and in government agencies such as the National Institutes of Health and the Centers for Disease Control.

Later, when I wrote to Lipkin to thank him for taking time to do the podcast, he replied: “Let’s persuade more kids to go into the hard sciences and engineering and educate those who don’t.”  Hopefully, this marriage between Hollywood and science just might resonate.

There’s a Q&A with Mahendra Rao, MD, PhD, the first director of the NIH Intramural Center for Regenerative Medicine,  over at Spoonful of Medicine today. Rao took the reins of the new, $52-million, seven-year center last month, and he had some something interesting things to say about his new place of employment:

Are you worried that the new center’s efforts could be derailed given the recent litigation surrounding the NIH’s stem cell policy?

I have to admit that was one of concerns when I took the job. The problem is that there’s no way to predict the future. But there’s a commitment from the NIH that this [new center] will be at least a five- to seven-year experiment. Maybe in two years’ time policies will change or the Supreme Court will rule differently, but we will still have a path to get things done.

What sets the regenerative medicine center apart from other academic institutes dedicated to stem cell technologies?

Neither in size nor in scientific quality could one say that this center is any different from some of the other more established centers. However, there are two crucial differences. One, this is a government center, and the government’s mandate is different than that at any other center. So, that’s a really important distinction. The second thing is that the center doesn’t function in isolation. It’s what’s around it that makes it very useful, and what’s around it is a whole lot of infrastructure and investment that’s gone in to building up a way to take things from the bench to the bedside. There are two really important pieces to that in the NIH Chemical Genomics Center and the NIH Clinical Center. Both of them are widely recognized, state of the art, best in class type of centers.

Previously: After the lawsuit, what’s next for stem cell research?

With the tenth anniversary of the 9/11 attacks approaching, numerous media are reporting on how the country has changed since that infamous Tuesday morning. In today’s Scientific American, Eugenie Samuel Reich takes a look at the tragedy’s effect on research:

Scientists and science policy experts say the federal government’s response to terrorist events in 2001, both the September attacks and the anthrax letters in October, have had a profound effect on U.S. research in areas as diverse as forensics, biodefense, infectious diseases, public health, cyber security, geology and infrastructure, energy, and nuclear weapons. Even the social sciences have been affected by the emergence of “terrorism studies” and the new emphasis on the threat in the field of risk analysis.

…

Some of the post-9/11 changes have entailed increased regulation. Jerry Jaax, a veterinarian and infectious disease researcher who oversees research compliance at Kansas State University in Manhattan, Kans., says that many biomedical fields have been swamped by such new regulations or increased enforcement of pre-9/11 regulations in a bid to prevent researchers and the materials they handle from becoming security threats. He says federal rules on select agents—pathogens that require special facilities and handling—and on imports and exports of biological samples and materials, have slowed the ability of scientists to do research important to public and agricultural health. “Some say we’re regulating away our ability to do this kind of research and I think there’s some truth to that,” he says.

Erin Prosser at Scientific American Blogs writes that consumers who debate the nutritional values of organic versus conventionally grown fruits and vegetables may be missing the point:

So for now, I say whether you choose the organic bag of apples or the conventionally grown ones really doesn’t make a big difference. As long as you’re choosing any bag of apples over a bag of Doritos, you’re on the right track.

This rings especially true for those who might have access to corner stores and supermarkets that vend conventionally grown produce, but not organic products.

Previously: Organic vs. natural: Tips for parents who want to go green, “Natural” or not, chicken nuggets are high in fat, sodium and People equate “organic” with “healthy,” risking poor food choices
Photo by karimian

One week ago, a federal judge threw out a lawsuit against government funding for human embryonic stem cell research. But, as Nature’s Meredith Wadman is reporting, the field remains vulnerable:

…[R. Alta Charo, JD] who studies law and bio­ethics at the University of Wisconsin–Madison] notes that the current US Congress is so politically divided it is unlikely to enact a law either explicitly permitting or explicitly prohibiting government funding for the research. But, she says, “nothing in this decision and nothing in the Dickey–Wicker amendment” stops a new president from quashing research simply by refusing to fund it. [Stanford's Hank Greely, JD] says that the best way to protect the research “is to get some real medical progress with stem cells” to prove the worth of the field.

This may prove difficult in the short-term though, as the field took a hit from the funding threat:

Although NIH approval of new stem-cell lines has resumed, and even accelerated (see ‘Bouncing back’), some say that it will take years to recover from the impact of the shutdown. Scientists who left the field in the interim might never return.

“Things have changed permanently. It’s not just going to go back to the way it was — not immediately,” says Meri Firpo, who researches stem-cell therapies at the University of Minnesota Stem Cell Institute in Minneapolis.

Previously: Stanford law professor on embryonic stem cell ruling, Judge Lamberth dismisses stem cell lawsuit, Stem cell funding injunction overturned by federal court and NIH intramural human embryonic stem cell research halted

I wrote yesterday about the dismissal of the lawsuit against federal funding for human embryonic stem cell research. Now Stanford law professor and bioethicist Hank Greely, JD, has an in-depth look at the case and what could come next:

I thought this was a graceful, gracious, and fully professional opinion by Judge Lamberth.  The poor man had been been reserved twice by the DC Circuit, in different directions.  He did not attempt to play games with the latest Circuit decision and follow its letter while avoiding its intent.  While making it clear that he thought he had been right, he did what a judge is a supposed to do in applying the law in light of his position in the judiciary hierarchy.

As a former scientist and science writer, it’s really fascinating to view the legal side of how court cases like these work. I’m learning a lot about the judicial process. And it appears my education isn’t over yet, according to Greely, who asks:

So now what?

The plaintiffs could do four things:

1.   Ask Judge Lamberth to reconsider his decision:   Good luck with that.

2.  Appeal to the DC Circuit:  I think this is likely.

3.  Ask the US Supreme Court to take the case directly:  Good luck with that, too – the Court does that very rarely and only in real emergencies.

4  Quit:  I doubt it.

It looks like an appeal could drag out this process even longer–as detailed in Greely’s post. But I can’t leave you this time without also calling attention to a related post today on Science Progress by Jonathan Moreno:

Stepping back from this legal meandering, the larger importance of this incident lies in the fact that only research on biology has been subject to such a challenge. Even at the fever pitch of our culture wars, no advocates have thought to bring suit against the federal government for funding, say, geological studies that confirmed that the earth is more than 6,000 years old. Indeed, from the infamous Scopes “monkey” trial to present-day creationism lawsuits, biology (in particular, the teaching of evolution) has been the wedge into literal readings of the Biblical period of creation. The fact is that modern biology is threatening in ways that the physical sciences are not, a challenge for a country that is both founded on the promise of science and needs science to sustain its leadership role in the 21st century.

As a church-going, science-loving believer of evolution and biology (hey, we do exist!), I say Amen to that. But it’s a challenge that can be overcome. Right?

Previously: Judge Lamberth dismisses stem cell lawsuit, Stem cell funding injunction overturned by federal court and NIH intramural human embryonic stem cell research halted

This morning, U.S. district court judge Royce Lamberth dismissed a case that threatened to ban federal funding for all human embryonic stem cell research. At issue was the Dickey-Wicker amendment, which prohibits federal money from being used to destroy or harm a human embryo. Stem cell scientists have successfully argued in the past that using the money to support research on stem cell lines that had been derived with other sources of funding sidestepped that requirement; the two plaintiffs who brought the suit disagreed. They also argued that embryonic stem cell research unfairly diverted federal money from the study of adult human stem cells, which are not derived from embryos. From this morning’s Washington Post:

“This Court, following the D.C. Circuit’s reasoning and conclusions, must find that defendants reasonably interpreted the Dickey-Wicker Amendment to permit funding for human embryonic stem cell research because such research is not ‘research in which a human embryo or embryos are destroyed,’” Lamberth wrote.

We’ve written about this issue numerous times before (see below). But to quickly get up to speed, you may want to read an April blog entry from Amy Adams at the California Institute for Regenerative Medicine, which nicely summarizes the background of the case.

Previously: Stem cell funding injunction overturned by federal court, More on ongoing stem cell court case, Judge Lamberth’s stem cell opinion is disappointingly bad, Stanford stem cell expert weighs in on district court ruling

Nobel laureate and Stanford Professor Roger Kornberg, PhD, in an op-ed he co-wrote for the San Jose Mercury News:

NIH funding also is essential to continue educating and training our nation’s best scientists. It is the lifeline that draws and sustains many innovative and thoughtful young researchers. Without such opportunities, these young people could gravitate to nonscientific fields. The likely result: a U.S. workforce not educated sufficiently for the 21st century and a biomedical research and technology industry that is far less competitive in the global marketplace.

Previously: Report: NIH investments created $68 billion in economic activity last year

My colleague wrote yesterday about the two candidates for chair of the California Institute for Regenerative Medicine. The votes are in, and investment banker Jonathan Thomas, PhD, was selected. The New York Times’ Prescriptions has the story.

Previously: New chair to be selected for the California Institute for Regenerative Medicine

The governing board of the California Institute for Regenerative Medicine is scheduled to decide this evening between two candidates for chairman: bond financier Jonathan Thomas, PhD, and cardiologist and business man Frank Litvack, MD. Litvack was nominated by California State controller John Chiang, while Thomas was nominated by California treasurer Bill Lockyer, lieutenant governor Gavin Newson, and governor Jerry Brown.

The two men are very different in terms of both background and expectations as to what role the chair should play in CIRM’s overall governance and mission. Thomas feels the job would require a substantial time commitment and involvement in the day-to-day workings of the agency, whereas Litvack views the job as more of a supervisory position with less hands-on governing. The men are reportedly also seeking vastly different salaries–from about $137,000 for Litvack versus about $400,000 or more for Thomas.

I could list lots of links for background, but David Jensen of the California Stem Cell Report has already done that legwork for me by compiling a thorough reading list that includes links to statements from the candidates, recent news reports about the selection process and a memo from current chairman Robert Klein detailing his opinion as to the role of the chair in CIRM’s future. He also includes a link to a recent Nature report describing the ‘stark choice’ the agency faces with their vote tonight.

The meeting, which starts at 4 pm PST will be webcast to the public. Candidate statements are estimated to begin at around 5 pm. However, I’m thinking much of the juicy discussion will likely be reserved for the governing board’s closed session this evening. Le sigh. That won’t stop me from listening to the public portion of the meeting. If you care about the future of California’s stem cell agency, you should too.

Jonathan Moreno, PhD, makes the case for a “bioprogressive America,” in which the left and right join together to support the advance of human knowledge:

Since the nation’s founding, progress in the Enlightenment sense has been key to the idea of America. A corollary belief has been an exceptional level of investment in creating a political, legal, and financial environment that encouraged scientific innovation. Jefferson’s patent statute, for example, gives particular latitude to inventors, as the founders (who were themselves remarkably keen on natural philosophy and numbered several world-class thinkers), sought to make the new nation a welcoming home for the brightest and most creative minds.

Loved this entry.

Via Krista Conger