Dr. Anil Potti, a Duke cancer researcher, was suspended last week after his claim to have been a Rhodes scholar could not be confirmed. Duke also halted enrollment in three clinical trials that Potti lead. The trials used gene-based test results of drug sensitivity to predict cancer patients’ responses to chemotherapy drugs.

Potti and colleagues at Duke also did the statistical analysis for a report published in the Lancet Oncology three years ago. The report was based on results from a clinical trial involving breast cancer patients. The published report was titled, “Validation of gene signatures that predict the response of breast cancer to neoadjuvant chemotherapy.”

The report, which had 19 co-authors, was an important step toward personalized medicine.

But the Lancet Oncology today expressed concern over errors that two of the report’s authors detected in the statistical analysis by Potti and his Duke colleagues.

Here it is: S0140673610701856

The Lancet investigation goes way beyond potentially false claims of one Duke researcher being a Rhodes scholar. Questions of research methods and errors reach beyond one possibly rogue researcher and potentially put patients’ lives at risk.

A few recent reminders that we are frail, vulnerable beings in a world dominated by microbes both good and evil: Listeria-laced pre-packaged spinach was found in an Elizabeth City store; a boil-water advisory was issued in Smithfield after a test showed coliform contamination (thankfully, a false alarm—there was no E. coli); and a flight to Charlotte turned around after someone inexplicably brought spoiled meat on board and maggots fell from the overhead bin.

Last month, NC State University researcher Dr. Ben Chapman and colleagues published some alarming findings about unsafe food handling in commercial kitchens. The team placed cameras unobtrusively around eight kitchens for seven weeks and then analyzed the footage. They counted an average of one cross-contamination event per food handler per hour. A cross-contamination event puts raw or contaminated foods in contact with ready-to eat items, like cutting a piece of raw chicken and then using the same knife to cut a sandwich in half before serving.

Eww.

With practices like that, it’s no wonder that the majority of food poisoning outbreaks are attributed to meals prepared outside the home. But until this study, practices in commercial kitchens were understood mostly from self-reporting and periodic inspections, leading to a rosier view of what goes on in them than what the videos revealed.

The research team suggests ways food-preparation kitchens can improve their track record by posting food safety infosheets around the kitchen, installing more hand sanitizer dispensers, reducing time-pressure on cooks during peak hours, and making cultural changes in the way food safety training and enforcement is done. But kitchen culture is hard to change, and measures like encouraging workers to stay home when they’re ill aren’t particularly popular with managers who fear abuse of paid sick days, as Chapman observed in a recent post on the strangely addictive food safety blog Barfblog.

Bad behavior by professional chefs doesn’t let us home cooks off the hook, either. My grandmother has used nothing stronger than vinegar to clean everything from chicken leaks to the cat’s flea medicine off the kitchen counter for years, and though I love her to pieces, that’s really not okay. As the CDC preaches, we still need to clean, separate, cook, and chill our food, and keep washing our hands.

More than one in four Americans gets ill each year because of some foodborne illness, says the CDC, landing around 300,000 in the hospital and resulting in 5,000 deaths annually.

And it peaks right now—in the dog (or should that be “contaminated hot dog”) days of summer.

One reason is that bacteria are more active and multiply faster when it’s warm. Another is that people tend to let down their defenses when grilling, camping, or spending a day at the beach, washing their hands, food and utensils less frequently than they would at home in the kitchen.

Now’s the time to be even more vigilant. If you want to remind yourself of all those food safety rules that your grandmother probably didn’t teach you (if she’s like mine), foodsafety.gov has a bunch of resources, including a smart phone app for recall notices.

Of course, food and water contamination doesn’t just come from unsafe practices in home and commercial kitchens. Often, the baddies get into our food somewhere along the vast, complicated supply chain. For more on the broader issues contributing to foodborne illness, stay tuned for the Sigma Xi annual meeting in November, themed “Food Safety and Security: Science and Policy.”

I suspect whoever caters that event will take a little extra care in the kitchen.

Anne Frances Johnson is a freelance science writer and grad student at UNC. www.annefjohnson.com.

Dan Vorhaus

Dan Vorhaus is a lawyer with Robinson Bradshaw and Hinson in Charlotte, N.C. where a portion of his practice comprises the growing field of personal genomics law. Given the interest in personal genomics in the Triangle, I thought I’d create an expanded version of the short question-and-answer interview I did with him for an up-coming issue of the Sci-Tech section in the Charlotte Observer and the Raleigh News and Observer (be on the lookout for that next Monday in print and online), and post it here. Vorhaus also authors the Genomics Law Report, a blog about the legal side of personal genomics, and he will be giving testimony to the Food and Drug Administration in the near future as the agency attempts to sort out particulars of how it plans to regulate genomic diagnostic testing.

How did you become interested in concentrating on personal genomics as an area of the law?
I have a master’s in bioethics; I did that degree before I went to law school. So as I started thinking about the areas of law and policy that were most interesting to me, that was clearly one of them. And it seemed like there was a tremendous opportunity for a field that is developing and emerging and creating all sorts of new and exciting legal issues. And it’s something that I’ve always had an interest in the underlying science and technology, and I was fortunate enough in law school to start working with some real pioneers in the field, specifically George Church in the personal genome field. Everything sort of built from there. Now, it’s how I make my living, it’s my career. And I love it. It’s something new and fascinating every single day and I can’t get enough of it.

It sounds like the bioethics degree had a big influence on you.
It did, although I already had this interest before, that was what caused me to pursue the bioethics degree. And I knew I was going to law school. I kind of applied those two things simultaneously. So, they have kind of worked together simultaneously. And I decided kind of early on that I was more interested in pursuing the law than some of the pure policy or philosophy or ethical issues behind a lot of these technologies. I think there is a real need… One thing you find with the law is that new areas tend to lag in new areas of technology and new areas of social development. And that is certainly true in the areas of personal genomics, personalized medicine, there is a long way for the law to go to catch up to where science and technology already are. And they continue to press on ahead. And the law continues to play catch up. So it seems that there is a real opportunity to be involved in helping to lay the legal framework for what I think will be important and meaningful technologies and services in people lives for years and decades to come.

That formalizes what I had suspected, with some of the things I’ve read about the Myriad ruling and the FDA announcing its intent to regulate direct-to-consumer genomic testing, it does seem that these formal regulations and policies are lagging behind the business practices.
That’s right. Both the examples you gave, the Myriad litigation — and really, the state of biotechnology patents more broadly – and the FDA and Congress’s involvement in genetic testing, especially consumer genetic testing, both of those are areas where there is a lot of uncertainty right now whether the law today is doing as good a job as it could be as far as protecting individuals and enabling commerce, and really striking the right balance between allowing the science and the technology to press forward while making sure that we have the right protections in place for people using these technologies. That is always going to be a tension in this area, I don’t ever foresee that dissipating; but that does not mean that we should work any less hard to get that balance as close as we can as quickly as we can.

You’ve posted about the Myriad gene patent litigation, in which a federal judge invalidated patents that Myriad held for human genes, BRCA-1 and BRCA-2, which are used to test for the likelihood of developing breast cancer. What was the most unusual thing about this ruling, because it seems to have caused quite a splash?
You’re right, it does cause a splash, but I would say the splash that it caused is probably greater than its legal significance, at least for right now. It’s important to keep in mind that this was a district court ruling, so without getting to much into the weeds, there is a long way to go with this litigation before it gets to the point where it will really impact the commercial landscape, before it really impacts what people feel comfortable doing in laboratories – whether it is research laboratories or commercial laboratories – it needs to .. It’s already been appealed to the federal circuit, which is the federal appeals court that hears patent cases. And it’s quite possible that from there it will go to the Supreme Court, and we’re talking at least another year. Perhaps two. Maybe even three more years before we get a final resolution in this case. The reason I think it garnered so much attention is because it really struck a nerve – and going back to this idea of law not always keeping up with where science is – it really struck a nerve when people heard that there were companies out there that held patents on human genes. And we are talking about isolated human genes, genes outside the body, no one owns you, but it is the case that some companies have patents on genes, and they have the ability if they want – and Myriad has done this because of the way patents work – they grant the patent holders monopoly rights, they have the ability to keep other people from doing tests to analyze those genes, to sequence those genes, to ask what does this mean, in the case of BRCA, for the susceptibility of a woman’s or a man’s, risk of getting breast cancer. And I think that struck a nerve with a lot of people.

It’s not the only sort of development with this area… [Other reports] have gone to the Secretary of Health and Human Services that looked at these issues and looked at the gene patent landscape and said this is a problem, this is impeding our ability to do the type of diagnostic or clinical work that we need to do, to advance the state of science and technology. There is another supreme court case that will likely come out on Monday, that also may be significant as far as the extent of biotech patents, in terms of how far they can reach. And it all goes back to this question of trying to strike the right balance. In the case of patents, we’re trying to strike the right balance of information disclosure and getting these technologies out there and allowing people to benefit from them, and preserving the commercial incentive to investments. That is how our legal system works, we build up this body of law over years and decades – in this case, patenting of human genes which reaches back to a 1980s Supreme Court case, probably even further, and it built up incrementally. And science does not work that way, it moves much faster. It was only 10 years ago that we published the first draft of the human genome sequence, and now, 10 years later, we are routinely sequencing whole genomes, let alone individual genes. And so, again, it’s that pace of technological innovation and scientific advancement that is much faster than we have the ability to move in the legal realm. So that causes a conflict in cases like Myriad where now everyone has to sit down and ask, do we have the right balance here? Should genes be patentable? Is this where we want to be? I think there is plenty of debate about that. It may be something that litigation solves, or maybe Congress steps in, or maybe there are people out there working on industry private solutions to work things out without having to wait on the courts to solve it.

One thing that confused me about this, is the idea of patenting human genes. In the case of Myriad, one of the things I was wondering was why do they have to patent a human gene? Why can’t they just patent their test? That seems like a more level playing field.
You’re right, that would be a more level playing field, and I think the simple answer is that if you are going to invest a lot of money into developing a test and researching an association between a gene a certain disease, and then figuring out the corresponding test, you may not want a level playing field. You may want to do all the testing, and that is what Myriad does. I should mention, there are other companies out there that have patents on human genes, and they have a patent that allows them to have exclusive rights to practice that patent. So, to conduct a test, or even to examine the gene, if the patent is one the gene itself; but they license out that patent or set of patents. Myriad, for example, I think has several dozen patents with almost two hundred claims, so we’re not talking about one or two patents, they have a whole suite of patents, that protects this business they’ve built around diagnostic testing for breast cancer, but there are other companies out there that have similar patents that do license them out to other people, and they say, here you can use this technology, you can use this gene that we’ve patented, there is going to be some sort of commercial terms with that, you’ll pay us some sort of royalty, or some kind of fee based on tests that you do, but you can get in the game too and essentially provide the same sort of service that we are providing.

Or, Myriad is a good example. They did not actually patent this themselves, they licensed this from the University of Utah. And so it is interesting because one of the reasons why Myriad was swept up in this litigation is because there are thousands of genes that are patented, Myriad only has patents on a handful, but the reason they became a target in this litigation is partly due t otheir practice of not licensing out their IP, their intellectual property, and not giving people a chance to conduct or to develop competing gene tests. But that is the prerogative of a patent-holder. You have the right to exclude everybody else from practicing your patented invention. You can wave that right, in the form of a license, out to other people, if you want, but you don’t have to. So that is why there is this big question over what should be patentable. The technical discussion centers around section 101 of the Patent Act which defines what is patentable subject matter. And the question is, are genes patentable subject matter, or are they what is considered to be a product of nature?

Is it that things in the natural world can’t be patented?
Well, it doesn’t specifically say that in the Patent Act, but that is the way it has developed in the case law over time. The 1980 case that I referred to earlier … said that what is patentable is anything under the sun made by man. And there is this products of nature doctrine, and it says, well the Supreme Court says, that something that is a product of nature can’t be patented. And then the question is, what is a product of nature? And Myriad argues, in this case, that this is not a product of nature because you are taking genes, which occur naturally in the body, and you are separating them out, you are isolating them, you are doing things to them technically that make them no longer products of nature. And in the technical sense, that is correct because genes do not naturally occur in laboratories. But what Judge Sweet ruled is that what is fundamentally important in these genes, what really makes them significant, is the information that they carry. And that is the same whether you are talking about a BRCA gene in your body, in my body, or in Myriad’s laboratory. The information content is the same, and that is what is significant, so they are products of nature and they can not be patented. Whether that ruling stands up, remains to be seen. There is quite a good chance that it won’t.

That’s an interesting interpretation.
And it’s one that people share. I think it resonates quite strongly with people at a gut level. But again, there are limits to how that can be implemented by law in courts. Congress of course has the ability to change the law. As has happened in many, many cases, if Congress does not like a law they have the ability to go out and change the law.

The Food and Drug Administration is constricting regulations for direct-to-consumer genetic testing services offered by companies that scan a person’s genome and offer analysis for health risks or ancestry. What are the FDA’s specific concerns?
It’s interesting… since the whole Walgreens-Pathways thing blew up about five or six weeks ago now, they went after five or six companies. They’ve taken a step back and said, you know, we think we need to regulate all genetic testing. It’s important to remember that most genetic testing is not what is known as DTC [direct to consumer] or commercial or consumer genetic testing. Most of it occurs in a clinical context, done in clinical laboratories, and that is the vast majority of genetic testing on the market right now. Now, the concerns they raise about taking a risk-based approach to regulation, and specifically they are concerned about the safety and efficacy of these tests. So, making sure that the tests are accurate, making sure that – accurate in the sense that when you test for X, you actually get X – that’s what’s called analytical validity.

And then also what is known as clinical validity, which is making sure that the association or the link reported by the tests so that if you do have X, that means you have an increased risk of getting breast cancer, is actually a valid one. And in an area of science that is so new and so changing, that is something that can be difficult to show. Or it may be controversial. So there is a lot of recorded genetic associations that require confirmation, maybe they need more traditional studies to confirm the results, and some studies that have disproved associations, so that is a concern too.

Then there is a third problem which is what is known as clinical utility which is that even if you measure the association correctly and it does mean what you say it does, so you have X, you’ve actually measured X accurately and it does mean that you have an increased risk of disease Y, then clinical utility asks, Can I do anything with this? Can I take this to my doctor and can he start me on a new medication, or tell me that if I lose 15 pounds, then I can prevent myself from developing condition Y. That’s the clinical utility prong, and there is a lot of disagreement there about whether that is something the FDA should really be concerned with, or if that is something that should be left up to individuals. And there are varying definitions as to what constituted clinical utility. Alzheimers is a good example. There aren’t many drugs on the market right now that can be used to reverse the effects of Alzheimers, or be used as a preventative measure for preventing Alzhiemers.

But there are a lot of lifestyle changes that have some evidence that they might help. And there are lot of people that argue that for me, clinical utility means just knowing. If I want to know, then I should be able to know because then I can engage in family planning. I might decide to take an earlier retirement. I might do other things differently. There is going to be a big public meeting July 19 and 20 in DC where I will be at the FDA to talk about some of these issue and give them feedback as they start writing regulations. And of course, in addition to the FDA, the House of Representatives, Congressman Waxman’s committee, have gotten involved with writing letters and they appear to be gearing up to hold hearings and maybe do something in this area. I heard recently that Senator Hatch has a bill out that would address genetic tests and specifically create a new division within the FDA to address those. There is another bill on the House side, I think,… that would also wade into this area. So there are a number of different pathways on the table right now for how the regulation of genetic tests may develop. It’s a bit of a scramble right now.

Even though you said that direct-to consumer genomic tests are a small slice of the genomic testing pie, what legal concerns do consumers need to be aware of when using personal genomic testing?
Well, it is a small… let me back up by saying that consumer genetic testing is a small slice of the overall genetic testing pie, but diagnostics — and that includes an increasingly large percentage of what we think about when we talk about personalized health care – and there are some people that believe that within the not-to-distant future, it’s going to be diagnostics riving therapeutics, so drugs and pharmaceuticals, and not the other way around. Right now, you’ve got these big diagnostic companies, and you’ve got big pharmaceutical companies, but that may flip. We are really looking at, I think, a shift coming down the road. There are some questions associated with consumer tests. A lot of the issues are similar to just the issues associated with learning about genetic information in any context. You want to know that you understand… what information you will find out, if it will be useful to you.

There have always been concerns about somebody else getting ahold of that information and somebody else using that against you. That’s one reason we passed the information non-discrimination act in 2008, to prevent employers and health insurers from using that information. But, that doesn’t mean that other people can not potentially get access to that information and use it against you. That could be your friends, or your co-workers or your family workers.

One thing you hear happening is non-paternity as a result of genetic testing, so you go get tested and your father gets tested and you find out, wait a second, our DNA doesn’t match. I think it’s something like a 10 percent non-paternity rate in this country, which is pretty high compared to what the known rate of non-paternity is. So there is a lot of those cases out there that I think are probably unknown to the family. So you can find out information that might be upsetting to you, or that might be surprising to you. You can also find out information that might be very useful, or interesting to you. That is a balance that everybody needs to sort of strike for themselves and think carefully about. So there are privacy concerns, discrimination concerns. The accuracy of the information… you have to be prepared that it’s not always accurate. There is clinical genetic testing and consumer genetic testing.

Have you tested your genome?
I have. I’ve had myself genotyped by 23AndMe, which is one of the companies that is in the middle of all this. Probably one of the most prominent companies. I paid for it myself. I did not want a conflict of interest because they have gien away a number of reduced cost or low-cost kits and I did not want to have any conflict there. And I think that is all I’ll say about that, because I’m going to be talking publicly about that in the not-too-distant future.

U.S. Rep. Dick Gephardt

He carried a to-do list with him that he plans to take to Congress and the Obama Administration.

Changing the way the Food and Drug Administration regulates the development of new medicines,  making the research and development tax credit for companies permanent and establishing a federal office to spearhead public-private partnerships between universities, the National Institutes of Health and R&D companies were among the suggestions on the list.

“It needs to be the new space program in my view,” Gephardt told about 100 people at the packed Capital City Club in Raleigh. 

Gov. Beverly Perdue, mayors and economic development officials from across the state attended the event, which was meant as a first step to build grassroots support for Gephardt’s to-do list.

At stake is the global leadership position the U.S. built in the past 30 years in discovering new medical treatments, improving quality of life and advancing health care, according to a report the Battelle Technology Partnership Practice released June 10. The Council for American Medical Innovation, or CAMI, an advocacy group Gephardt chairs, commissioned the report.

Experts, investors and bright minds from industry, universities and foundations whose brains the Battelle researchers picked, pinpointed several risk factors that the U.S. is in danger of losing its medical innovation edge.

Among those factors is the declining number of novel medicines that have come to market in the past decade. Between 2005 and 2008, the FDA approved on average 19 per year compared to an average 31 per year during the 1990s. A nearly 29 percent decline in venture capital that set emerging biomedical companies back during the recession was also troublesome. So were the science scores among 12th graders, which declined almost 3 percent from 1996 to 2005.

Health care and research to find new treatments have long been among Gephardt’s interests. What caught his attention was a novel triple cancer therapy that saved his son’s life nearly 40 years ago, he said. Gephardt supported a form of universal health care and helped double the NIH’s budget to support basic research to about $30 billion in 2003.

The unprecedented increase in NIH funding several years ago and a $10 billion boost the NIH received in stimulus funds last year benefited research institutions across the Triangle, including Duke University, RTI International and the University of North Carolina.

But Gephardt’s agenda to spur medical innovation and create more R&D jobs in the U.S. will face a Congress and a White House trying to gain control over a ballooning federal deficit. Gephardt didn’t think the NIH’s budget will be cut, but he acknowledged the belt-tightening mood in Washington by saying that his to-do list isn’t a “big ticket item. Yes,” he added, “this costs money, but the payoff is enormous.”

For most of us, our neurons remain malleable throughout our lives, giving us the opportunity for lifelong learning (though it does get harder with age). But for those afflicted with the rare genetic disease Angelman syndrome, the synapses are almost completely incapable of being remodeled. By the time children with Angelman syndrome are toddlers, their synapses have largely lost their plasticity, hardening like concrete into rigid structures that can no longer easily relay new information.

The result is quite tragic – children whose bodies grow and age normally but whose brains are locked forever in the state of a two year old. But there is also reason to hope, as tremendous progress has been made in the understanding of Angelman syndrome, say many of the researchers, clinicians, and parents in attendance at a recent conference on the disorder. The 2010 Angelman Treatment and Research Institute Scientific Symposium, held at the Carolina Inn in Chapel Hill on June 15 and 16, showcased the current research on the genetic disease, with efforts tapping into the latest technological tools from mouse models, brain imaging, stem cells, proteomics and gene therapy.

“Over the span of the conferences I have attended, I really feel like I can see the gap getting smaller between the cellular molecular finding and its clinical applications,” said Heather Adams, a neuropsychologist from Massachusetts who specializes in kids with cognitive impairment. She also has a daughter with Angelman syndrome.

Angelman syndrome is a rare intellectual disorder that affects about one out of every 15,000 people. It is often placed on the autism spectrum because of the shared language difficulties and inappropriate social behavior. The language impairment in people with Angelman syndrome is much more severe than in those with autism – in fact, most of them never speak a single word. And whereas individuals with autism might shun social interaction, those with Angelman are quite social.

“One of the very endearing things about these individuals is they have a very happy demeanor,” said one of the conference’s organizers, Ben Philpot, an Associate Professor in Cell and Molecular Physiology at the University of North Carolina. “They are often said to have inappropriate laughter, but I think that they just find more things in life funny than we do.”

Their child-like view of the world – and the detrimental ramifications of a brain that is unable to change — all stem from a defect in a single gene called UBE3A. If the gene is mutated or deleted, the result is Angelman syndrome. But if it is duplicated, it may result in one of the more classic forms of autism. And altering its function can also lead to tumors of the cervix, though in the cancer field the gene goes by the name E6AP. So studying this one gene and its effects on the plasticity of our brains could have far-reaching implications.

“The work related to synaptic plasticity in genetic syndromes is forming thrilling insights as far as how we reason and learn things,” said conference attendee William Snider, director of the UNC Neuroscience Center.

At the two-day conference, scientists from across the country presented their latest findings on the role of this infamous gene in disease. One of the invited speakers, Harvard’s Michael Greenberg, explained the findings he had recently published in the journal Cell on targets of UBE3A. The molecule’s main job is to mark other proteins to be broken down or destroyed, so if UBE3A is absent then certain proteins accumulate to inappropriately high levels, causing subtle but lasting damage to our brain cells.

“If we know what the targets are we may be able to produce therapies that can break them down when UBE3A is no longer able to do its job,” said Philpot.
Philpot’s own work has indicated that pharmacotherapeutics or behavioral modifications may be able to restore the brain’s plasticity. He is currently using funding from the NC Translational and Clinical Sciences Institute (NC TraCS) to search for new molecules to treat Angelman syndrome, an area that is understandably of intense interest for many in the field.

“As a scientist I say the progress that has been made so far is remarkable, but as a parent, I say it is not fast enough,” said Alina Szmant, a marine biologist from Wilmington who has a 31-year-old daughter, Selena, with Angelman Syndrome.

Mark Nespeca, a clinician at Children’s Hospital in San Diego who also attended the conference, says that the pace of research depends a lot on your perspective. Because he does not conduct research himself, conferences like this one help him keep up with the many advances that have occurred since he was in medical school.

“With the advances in technology today, people are talking about sequencing your entire genome for just a thousand dollars,” said Nespeca. “There may come a day when kids will be coming to us at two months of age newly diagnosed, and we can say is there something we can do to make a difference so you can walk, can talk, not have seizures. But for a parent dealing with this illness day in and day out, it must be hard to wait and hope for that day to come.”

Today, I asked Tom Linden from the UNC School of Journalism and Mass Communication to answer a few questions:

Welcome to A Blog Around The Clock. Tell us a little more about your career trajectory so far: interesting projects past and present?

My passion always has revolved around journalism. When as a scrawny 13-year-old, I failed to make the starting nine on my JV high school baseball team, I was devastated. Rather than wait for my body to catch up to my aspirations, I jumped into journalism, eventually becoming my high school newspaper’s sports editor and editor-in-chief. I loved words and stories and so continued on my writing path through college where I was a columnist and editor for the Yale Daily News. As a senior at Yale, I covered for the Los Angeles Times the pretrial hearings of several Black Panthers accused of murder in New Haven, Conn. After graduation I worked on the city desk of the Times.

After taking a year off to do research for a book (that never materialized), I suffered a case of writer’s block and decided to pursue a career that would give me tools to travel around the world and practice a new craft… medicine. Within weeks of registering for med school, I realized that the journalism bug never left me. I completed med school and a residency in adult and child psychiatry at the Menninger Foundation, then in Topeka, Kans., and started a private practice in which I subsidized what I would call my “journalism addiction.” I worked at a small local television station in the northern Sacramento Valley where I became the health reporter and eventually the 5 o’clock news anchor. In 1989 CNBC hired me to join their start-up cable news venture as both a medical and environmental reporter and a financial news anchor. For the next eight years I worked for a variety of television stations and networks, including the Financial News Network, KRON-TV (San Francisco), Fox-11 (Los Angeles) and Lifetime Medical Television. I also started anchoring Journal Watch Audio, produced by the Audio-Digest Foundation and the Massachusetts Medical Society. In 1995 I co-authored one of the first books on the medical Internet, Dr. Tom Linden’s Guide to Online Medicine. In 1997 the University of North Carolina at Chapel Hill hired me to start a medical journalism program in the School of Journalism and Mass Communication.

As part of our program in medical and science journalism, my students and I have produced a couple documentaries with an environmental focus and more than 25 feature stories for North Carolina Public Television. I also just authored a book, The New York Times Reader: Health and Medicine, published by CQ Press. The book is both a compendium of great stories from The Times and a how-to manual for aspiring medical and health writers.

For the future I’m interested in producing a sequel to our Environmental Heroes documentary and continuing to help educate medical and science journalists.

Would you, please, tell my readers a little bit more about yourself?

I grow most of my own vegetables and fruit from May through November. I’ve just planted seven fig trees that I cloned over the winter and have more starter tomatoes, peppers and eggplants than I know what to do with. I voraciously follow the news and love walking in the forests of North Carolina. My family loves to travel, but travel and maintaining a major garden (small farm) don’t always mesh. I also love to hear good music. In North Carolina there’s lots of it.

Where are you coming from (both geographically and philosophically)?

I was born in California and have lived on both coasts and on the Plains (Kansas) which is very oceanic if you live in the countryside. If I had unlimited resources, I would live by the sea. Philosophically, I am a skeptic and question just about everything.

What is your (scientific) background?

As I said above, I went to medical school and took the usual courses. Science used to intimidate me, but does no longer. I’ve learned more about medicine by reporting on it, than I did in the hours and days that I spent studying it.

What is taking up the most of your time and passion these days?

Writing The New York Times Reader: Health & Medicine took most of my free time over the last year and a half. Now that the book has been published, I’m looking for a new project. I keep getting drawn to environmental issues since climate change and the destruction of the earth’s natural habitats loom as the biggest issues facing humankind. The challenge is to find stories that inspire action and not just induce fear.

What are your goals?

I’d like to see young people (i.e., everyone under the age of 30) do a better job of taking care of the planet than their parents and grandparents. I’d like to help them do that in any way that I can.

What aspect of science communication and/or particular use of the Web in science interests you the most?

Clearly the Web is the pipeline through which knowledge will travel over the next couple decades. I’m looking for ways to reach non-scientists with information that will both engage and inform them. As a television journalist, I see video as probably the most powerful tool to reach masses of people. The challenge is to how tell video stories in ways that both entertain and educate.

How does (if it does) blogging figure in your work? How about social networks, e.g., Twitter, FriendFeed and Facebook? Do you find all this online activity to be a net positive (or even a necessity) in what you do?

I have a blog, “Dr. Tom Linden’s Health Blog“, but am still trying to figure out what my blog voice is. I’ve taken a little hiatus in updating the blog during the course of writing my latest book, but hope to post more often in the days ahead. In tweeting a lot at a recent conference of the Assn. of Health Care Journalists, I got an appreciation for how much fun tweeting is.

Online activity is both a joy and a burden. I love staying connected with what’s happening around the world, but find it hard to control the beast. If you’re a journalist, you need to be comfortable with the entire toolkit.

When and how did you first discover science blogs? What are some of your favourites? Have you discovered any cool science blogs by the participants at the Conference?

David Kroll (Abel Pharmboy) and Anton Zuiker were my first science blogging mentors. I’m a fickle blogging reader and will follow a link at anything that piques my interest.

What was the best aspect of ScienceOnline2010 for you? Any suggestions for next year? Is there anything that happened at this Conference – a session, something someone said or did or wrote – that will change the way you think about science communication, or something that you will take with you to your job, blog-reading and blog-writing?

I love the networking that goes on at ScienceOnline. After each session I pore over the Web reading about the people I’ve just met. I liked Ivan Oransky’s suggestion in a previous Q&A about having full disclosure for all speakers and panel members at future conferences. Also, it would be nice to get back to the un-conference mode of the first few ScienceOnline meetings. Keep up the great work, Bora, David, Anton and everyone else who brings us this ScienceOnline gift every year.

It was so nice to see you again and thank you for the interview. I hope to see you again soon.

Cryptococcus gattii

In Africa, South America, Southeast Asia and Australia, crytococcus gattii infects eucalyptus trees and bothers people with compromised immune systems, such as HIV/AIDS patients and organ transplant recipients, who inhale its spores. But the strain that was first documented on Vancouver Island, Canada, a decade ago and has now spread to Seattle and Portland causes chest pain, fever, shortness of breath and weight loss in otherwise healthy people and has killed at least six of them.

In February 2007, the first North Carolina case, an otherwise healthy man, was treated at Duke University Medical Center, the Duke researchers reported in PLoS One. In a paper they published a week ago in PLoS Pathogen, the researchers wrote that the cryptococcus gattii strain in the Pacific Northwest was new, much more virulent and favored mammals.

The second Duke paper followed on the heels of a report on human health and climate change that was authored by a group of researchers from several federal agencies. Lead author of the report was Christopher J. Portier, the head of the environmental systems biology group at the National Institute of Environmental Health Sciences in Research Triangle Park.

“The purpose of this paper is to identify research critical for understanding the impact of climate change on human health so that we can both mitigate and adapt to the environmental effects of climate change in the healthiest and most effective way,” the report from the Interagency Working Group on Climate Change and Health read.

Filling research gaps in new diseases and well-known diseases that are coming back because of altered growing seasons, more rain in some areas and droughts in others, more violent storms and rising temperatures has been on researchers’ minds for years.

In the past decades, they have identified 30 new diseases, including hepatitis C, avian flu, HIV/AIDS and severe acute respiratory syndrome, or SARS, according to a 2004 report in Nature Medicine. Environmental changes are among the reasons for the emerging diseases. But researchers have also tracked a resurgence of previously documented diseases in new geographic areas, among them tuberculosis and cholera.

The report from the federal interagency working group zeroed in on the following research areas:

• More mold, dust, pollen and air pollution are likely to increase the prevalence of airway diseases such as asthma and respiratory allergies, which already affect about 50 million Americans.
• More information is needed on how climate change affects exposure to toxins and chemicals that might boost cancers, with about 500,000 deaths per year the second leading cause of death in the U.S.
• Heat waves and rising global temperatures could increase the number of heat-related illness and death. The 2003 heat wave in Europe, for example, caused about 35,000 deaths.
• Some birth defects linked to environmental causes have been steadily increasing.
• Exposure to biotoxins from ever more frequent, harmful algal blooms and chemicals from new batteries and compact fluorescent light bulbs could boost neurological and waterborne diseases.
• By 2050, about 200 million people are expected to be displaced by the effects of climate change. The population relocation and the changes in temperatures could cause a resurgence of diseases caused by insects, such as malaria and yellow fever, which were once rampant in parts of the U.S.

“Salamanders can regenerate. Why can’t we?,” Atala asked during a TEDMed talk last fall.

Dr. Anthony Atala

Actually, we can and we do, he responded Tuesday during a presentation at Research Triangle Park headquarters, where he had traveled from Winston-Salem to talk at the TARDC luncheon. “It’s real,” he said.

The human body replaces bones every 10 years, skin every two weeks and intestinal tissue every six days. Regenerative medicine taps into the body’s ability to regrow tissue, expands on it and speeds it up in the laboratory.

The aim is to cure diseases with the help of spare parts the body doesn’t reject.

Researcher are already able to grow most tissues in the lab. Cartilage cells have been used to repair damaged knee ligaments since the mid-1990s. In 1999, Atala was the first to implant a laboratory-grown organ into a patient. The organ was a bladder.

Now researchers are working on skin, blood vessels and entire livers, kidneys and lungs. Within a decade or two, they may be able to make a whole heart, repair a damaged spinal cord or implant insulin-producing beta cells to erase diabetes.

A three-day forum the Wake Forest Institute of Regenerative Medicine held two weeks ago to bring together researchers, investors and companies developing products explored some of the promises and challenges in the field.

The promise of regenerative medicine is in the wealth of products moving through the regulatory pipeline. More than 50 research and development programs are under way to come up with products, Atala said at the forum. About 10 clinical trials testing products in patients have either started or are about to start and another 50 trials are scheduled over the next four years.

Challenges include making the products and convincing the health care system to pay for them.

At the TARDC luncheon Atala brought up one example to outline costs and benefits of regenerative medicine: About 90 percent of the patients on transplant lists are waiting for kidneys. While they’re on dialysis, they cost the U.S. health care system about $250,000 per year each. Kidneys grown in the lab would not only shorten the wait for a transplant but also lower costs for dialysis and for drugs that prevent rejection of tansplants.

How much is a lab-grown kidney worth, Atala asked. “$50,000? $100,000? $200,000?”

While regenerative medicine companies are giving this question a lot of thought, researchers in the labs are addressing challenges of making the products, such as growing enough tissue from a cell sample half the size of a postage stamp to cover an area the size of a football field in about 60 days.

The Wake Forest Institute of Regenerative Medicine uses five different approaches in the lab, Atala said. “We’re trying to see which strategy gets us there first.”

• In experiments to make whole livers, researchers have washed discarded organs with mild detergents to extract the liver cells. What remains is a collagen scaffold that looks like a liver and contains a vascular tree. Researchers then seed the scaffold with new liver cells or stem cells.
• To build whole hearts, researchers use a three-dimensional printer whose cartridge is filled with gel and cells rather than ink.
• An experiment that involved steers and cows used stacks of wavers seeded with kidney cells. Because an organ doesn’t fail until more than 90 percent of its function is gone, the tissue wafers promise to add enough functionality to a badly damaged kidney to keep a patient off dialysis.
• Researchers inject stem cells or the patient’s cells to regenerate tissue.
• In cases where tissue is needed that doesn’t grow in the lab, researchers use stem cells harvested from amniotic fluid.

Here’s Dr. Atala’s talk at TEDMed:

Click here to view the embedded video.

But the benefits of modern medicine go well beyond combat surgery.

Dr. Margaret Humphreys

Dr. Margaret Humphreys, a Duke University professor in the history of medicine and a fellow at the National Humanities Center in Research Triangle Park, issued a reminder Tuesday during a lecture at the N.C. Museum of History in Raleigh that germs bag a bigger punch than bullets.

“It wasn’t until World War I that more soldiers died from wounds than from disease,” Humphreys said during her lecture on the role malaria and yellow fever played during the Civil War.

Before the onset of modern medicine, infectious diseases had much influence on daily life, even during peaceful times. But it was during war, when food was scarce, sanitation was non-existent and many soldiers lived in close quarters away from home, that diseases brought on by viruses and parasites flourished.

The Bubonic plague ravaged parts of Europe during the Thirty Years War. Smallpox was a problem during the American Revolution. Typhus fever crippled Napoleon’s army. Yellow fever and malaria contributed to twice as many soldiers dying from disease than from wounds during the Civil War, Humphreys said, but malaria was of particular importance to the outcome of the war.

For much of the 1800s, Americans suspected bad smells had something to do with disease. They knew disinfectants made the odors go away and people who were exposed to them and didn’t die could become less vulnerable. But not until the 1880s did Louis Pasteur, a French chemist, raise the idea that microorganisms, or germs, existed and spread disease. It would take another two decades before mosquitos were identified as carriers of yellow fever and malaria.

Until then, “they don’t know about the mosquito,” said Humphreys. “Think poisonous air and bad smells” – and lots of them.

The first yellow fever epidemic broke out in Philadelphia in 1793 and several more followed in ports along the East and Gulf coasts during the next century. In 1862, an outbreak in Wilmington sickened about one-third of the town and killed 446 of the town’s 5,000 residents.

Yellow fever was feared, Humphreys said. About half of the severe cases ended in quick deaths from liver and kidney failure.

In 1864, Luke Blackburn, a physician and supporter of the Confederacy who would later become governor of Kentucky, tried to use dirty shirts and sheets from yellow fever patients in Bermuda in one of the earliest known cases of biological warfare. He packed the sheets and shirts in trunks with the intent to have them delivered to Northern cities, including one bound for President Lincoln’s White House.

There’s no record the trunks reached their destinations and it wouldn’t have mattered if they had. Even though Blackburn had much experience treating yellow fever in the American South, he had no idea the virus didn’t spread through personal contact.

Library of Congress map showing prevalence of malaria in 1870s.

Yellow fever traveled on ships and mostly affected U.S. ports. Malaria came aboard European immigrants and African slaves and was widespread. A mild version, called vivax malaria, came from Europe and affected even areas with temperate climate. The more severe and deadly version, called  falciparum malaria, came from Africa and required the warm and humid climate of the American South.

During the Civil War, malaria raged in coastal North Carolina, the South Carolina Sea Islands, the Mississippi delta and on the James River peninsula in Virginia.

The combination of yellow fever outbreaks and falciparum malaria made the southern lowlands so dangerous, Confederates considered the diseases their secret weapons, Humphreys said. Southerners believed that “when the Yankees come down here, our very land will throw them out.”

But Union troops had two advantages that made a difference, particularly in battling malaria: Up to 10 percent were African-American and had at least partial immunity and the North had unrestricted access to quinine, a medicine that was regularly dispensed.

The blockade of Confederate sea ports limited the South’s access to quinine, especially after 1864, Humphreys said. Southern women smuggled the medicine in their hoop skirts and the South developed an alternative made from willow, poplar and dogwood bark and whiskey. But the “Southern quinine” didn’t work.

Also, the North brought along its own diseases, such as smallpox and measles, she said. And in the end, the Union suffered fewer deaths from disease than the Confederacy.

Fashioned after conferences that have sprung up in the past few years across the U.S. and in Europe, the three-day forum brought together researchers, investors and policymakers interested in regenerative medicine, tissue engineering and stem cells. It was the first such event organized by Wake Forest University’s Institute for Regenerative Medicine, which is headed by Dr. Anthony Atala, a urological surgeon who in 1999 was the first to implant a laboratory-grown organ into a patient.

Dr. Robert Lanza

The organ was a bladder. Now researchers are working on skin, blood vessels and entire livers. So, what’s next? How about a whole heart, or a kidney grown from a skin cell?

“I don’t think that’s science fiction,” said Dr. Robert Lanza, chief scientific officer of Advanced Cell Technology, a biotech company near Boston.

Buddy Ratner

Buddy Ratner, professor of chemical engineering and bioengineering at the University of Washington in Seattle, agreed. “In the next 10 years, regenerative medicine will revolutionize medicine,” Ratner said.

“The future will be ours to grab,” said Tim Bertram, but the Tengion executive added, “If the public isn’t demanding it, [development] will slow down.”

Tim Bertram

Lanza, Ratner and Bertram made the comments answering questions from science, health care and medical writers who attended the forum. Bertram’s words of caution reflected the difficulties some regenerative medicine companies faced after the recession dampened investors’ willingness to fund brave-new-world-type technologies.

Advanced Cell Technology has battled fund-raising problems for two years and its stock trades for pennies a share. Tengion, which is trying to bring some of Atala’s technologies to market, ran into regulatory hurdles and had to cut jobs last year. The Pennsylvania-based company, which has research and development operations in Winston-Salem, plans to raise up to $44 million in an initial public offering this week, according to Renaissance Capital.

Regenerative medicine takes a lot of inspiration from old-fashioned surgery. But where surgery tries to repair, regenerative medicine aims to replace or augment. The spare parts are built outside the body, with the patient’s own cells or with different types of stem cells.

Artificial materials play an important role in shaping the spare parts. So do different techniques to construct them.

Scaffold to grow an ear in a dish.

At Wake Forest’s Institute of Regenerative Medicine, researchers use scaffolds made from porous materials and seed them with cells to grow ears for soldiers who suffered head injuries. The same scaffolds can also be used to fashion toes or fingers. To make heart valves, pieces of blood vessel or skin, the researchers may use a three-dimensional printer whose cartridges are filled with cells and a gel instead of ink.

Kyle Binder, a doctoral student at the institute who pursues degrees to practice medicine and do research, is working on a mobile bioprinter that would allow doctors to print cells directly onto burn wounds or open wounds from foot ulcers, a complication from diabetes, and allow for new skin to grow without scarring.

The bioprinter is equipped with a laser scanner to map the wound, Binder said. Then, clusters of 10 to 500 cells are deposited rapidly across the wound layer after layer. The bioprinter can cover the upper front body of an adult in as little as half an hour and animal tests have shown that the wound heals in about two weeks, he said.

Dr. Anthony Atala

Researchers in regenerative medicine have been able to grow muscle, bone, cartilage and retinas and they’re working on lungs and kidneys, said Atala, who also spoke at the forum. All of these spare parts can be made from a patient’s own cells, which would eliminate drugs to block the body from rejecting transplants.

Nerve, liver, pancreatic and heart muscle cells are the only ones that researchers have not yet been able to coax into growing in the lab, Atala said. Different types of stem cells are used instead.

Researchers are also experimenting with manmade materials. Healionics, a spinoff of the University of Washington, is working with material that has long been used to make soft contact lenses. The material has tiny pores, which promote blood vessel growth and healing. Small pieces of the material have been used to regenerate skin and bone and tests are under way to use it as a heart muscle patch, said Ratner, who was instrumental in developing the technology.

Regenerative medicine promises to help patients waiting for organ transplants and to reduce the need for some costly medical procedures, such as kidney dialysis. Diseases that could be treated with regenerative medicine cost the U.S. health care system about $400 billion in 2004, Atala said.

But the health care insurance system will ultimately determine which spare parts will become available in the next 10 years, said Richard Caruso, founder of Integra, a New Jersey regenerative medicine company that develops and markets surgical implants and medical devices. Technologies for which insurance companies are willing to pay are the most likely to get developed.