Dusting Off The Cobwebs

Yes, it's true:  Culture Dish is still alive under all the dust and cobwebs that have accumulated since my last post.  The good news:  My book, The Immortal Life of Henrietta Lacks, is finished and headed toward publication (which is why Culture Dish went on hiatus), and I'll be back to blogging soon.  I'll also be launching a new website at rebeccaskloot.com as well as giving Culture Dish a serious makeover.  First step:  It's moving to ScienceBlogs.  Stay tuned for more information, including a link to the new blog location once it's up and running ...

Bush Pushes Genetic Privacy Legislation

Here's a newsflash I never thought I'd hear: Yesterday, with Frances Collins by his side, Bush began lobbying for Congress to pass the long-stalled Genetic Privacy Bill, which could help protect patients from genetic discrimination. This bill, in one form or another, has been in the works for about a decade, but has repeatedly been pushed aside over fears that it might inhibit research and industry. I'm very interested to see the version of the bill they're working with now, how it's changed since its last incarnation, and whether/how it will protect patients against insurance and other discrimination. If it does, passing it would be a huge step forward for the world of tissue research, one patients rights advocates have been fighting for endlessly.

Tsunami Victims Selling Their Kidneys Instead of Fish

Police in India have found still more evidence of a black market in human organs: kidneys being sold illegally by fishermen and their families whose villages, boats, and incomes were destroyed by the 2004 tsunami. The AP reports on what one police officer describes as "a big racket":

"Community leaders in Eranavoor village, just north of Chennai, admitted that about 100 people, mostly women, have sold their kidneys for 40,000-60,000 rupees ($900-$1,350) since the December 26, 2004, disaster." Including: "Thilakavathy Agatheesh, 30, who said she sold a kidney in May 2005 for 40,000 rupees in the hope of setting up a small restaurant -- only to see her alcoholic former fisherman husband waste the money." She told the AP, "I used to earn some money selling fish, but now the post-surgery stomach cramps prevent me from going to work." Which has to make you wonder: Who's removing those organs? Do they know what they're doing? Are they competent surgeons (doubtful)?

I recently did a lengthy Q&A with Amy Friedman (which will appear in the next issue of Proto Magazine). Not long ago, Friedman published a controversial editorial (co-written with her father; they're both kidney experts) titled, "Payment for Living Organ Donation Should be Legalized." Her argument: Living organ donations could solve the massive organ shortage. People are going to sell their organs whether we like it or not, so instead of having a growing and very dangerous black market, we should have a legal market that's closely regulated, where quality is controlled and operations are performed by quality physicians.

Friedman is certainly not alone in her efforts. Just check out Organselling.com. And Gregory Pence, bioethicist and author of "Re-Creating Medicine," which includes a chapter called "Re-Creating Organ Donation." Though plenty of people disagree with him, he's been arguing his position for a long time. He says: "The question is not whether any risk of harm exists from commercialization -- it does -- but whether such risk justifies the sacrifice of thousands of dying patients. It doesn't."

Study Shows Patients Have Issues With Tissue Research

In my ongoing coverage of all things human tissue related, I came across this article about a recent study examining public attitudes toward tissue banks: "Tissue banking raises cloning fears." Interestingly, there was absolutely no coverage of this study in the U.S., where tissue research is a huge issue. The study, conducted by the Centre for Values, Ethics and the Law in Medicine at the University of Sydney, shows that Australians have many concerns over how their tissues are being used.

They're worried, for one, that scientists could clone them using stored tissue samples. There are many reasons people should question how their tissues are being used in research, but at this point, fear of being cloned isn't one of them (cloning humans isn't possible yet). But the study also found that people were opposed to tissues from their diagnostic samples -- like biopsies and blood tests -- being used "as a source of stem cells or by drug companies." to develop products. That is a very current and real issue worldwide: In the US, most people have their tissues in storage at this point, and the laws surrounding their use are unsettled and confused.

According to lead researcher Bronwen Morrell, this study shows exactly what I reported in my recent New York Times Magazine article: People want some level of control over how their tissues are being used in research and whether they'll be commercialized; they also want laws laying out requirements for consent, because at the very least, they want to know what's being done with their tissues.

Morrell also found that, when it came to the sticky issue of money, patients wanted to see profits funneled back into research, not into scientists' pockets (which is not standard practice now). Many said they trust the public sector more with their tissue than private companies: "As long as research was being done in a public hospital they would feel comfortable with that," she said. "But if it was a private company doing the research, especially drug companies, they wouldn't be that happy." This is interesting, in part because it indicates that the public isn't aware of how fuzzy the division between public hospitals and private companies can be these days.

The Immortal Dog?

Carl Zimmer has a great post over at The Loom about an incredible phenomena going on in dogs right now: Sticker's Sarcoma -- a tumor that's actually transmissible from dog-to-dog through licking and mating.

The amazing thing is this: A group of scientists just conducted a study to figure out what's going on with this tumor, and they found that all of these tumor cells -- regardless of which dog the tumor is from -- have the same genetic markers. Which means they all came from the same dog. Scientists have now traced this cancer back to its roots and found that it's most likely the remnant of one Asian dog or wolf who died 200 years ago, or more. A dog who has achieved an immortality similar to that of Henrietta Lacks, the woman I'm writing my book about.

Carl invoked Henrietta in his post, which does a great job explaining this phenomena and the paper just published on it:

"So here's the big question which the authors [of the scientific paper] don't tackle head on: what is this thing? Is it a medieval Chinese dog that has found immortality? If so, then it resembles HeLa cells, a line of cancer cells isolated from a woman named Henrietta Lacks who died in 1951. After her death, scientists have propagated her cells, and in that time they have adapted to their new ecological niche of Petri dishes, acquiring mutations that make it grow aggressively in the lab. One biologist even suggested that the cells should be consider a new species.

Scientists put Henrietta's cells into a petri dish to grow them in the 50s, and they're still alive today. The seriously freaky thing about this dog-thing is, no scientist took a sample from some dog and helped it live in culture. This whole thing happened naturally. Which is seriously freaky. Though this cancer isn't usually fatal -- it appears to vanish a few months after it appears -- this is yet another reminder that all those scientists of the 50s who were ridiculed for thinking viruses caused cancer were right. And they knew it: Decades ago, they actually injected HeLa cells into people to prove their point, and the result was similar to the dog cancer: small tumors grew, but soon vanished.

A Blow to the Fight Against Biological Patents: Labcorp V. Metabolite Dismissed

The other day, the Supreme Court dismissed a case I’ve been watching closely, which could have set some limits on how far patenting of genes and other bodily products will go in the future.

Several years ago, a company now called Metabolite patented the fact that an increased level of the amino acid homocysteine in your blood means you have a deficiency of certain B vitamins. So they own that diagnosis. Technically, if you test for, treat, research, write about or (in theory) even think about this disorder without paying a (steep) licensing fee to Metabolite, you're guilty of patent infringement (which I'm now guilty of for writing this).

Metabolite enforces their patent aggressively: A company called LabCorp developed a test for this deficiency and began offering it to doctors. So Metabolite sued them (in LabCorp v. Metabolite Laboratories) and won $7.8 million. LabCorp appealed right up to the Supreme Court, and quickly had scientists, patient advocacy groups, lawyers and ethicists fighting on their behalf with a flood of briefs. Their argument: Naturally occurring phenomena aren’t patentable; the relationship between homocysteine and B vitamins is as much a natural phenomena as gravity, therefore the patent should be invalidated. Sounds like a no-brainer. But it’s not, because there’s too much at stake.

For LabCorp, this is clearly about money – they don’t want to pay the $7.8 million, and they want to offer the test without paying future royalties. But for many others who wrote court briefs, this was their first big shot at limiting body-related patents – patents on diagnoses, proteins, even genes. Historically speaking, they had good reason to think they might win: Nearly a decade ago, patents on surgical procedures were common and strictly enforced, which meant if you went to the hospital with, say, a certain type of appendicitis and your doctor hadn't licensed the surgical procedure to fix it, he couldn't operate without risking a lawsuit. The practice of restrictive surgical patents stopped in the 90s because of a lawsuit similar to LabCorp v. Metabolite, where a court ruled that doctors weren't required to license surgical patents for treating patients.

The implications of LabCorp v. Metabolite could have been huge: If the court invalidated the patent, it would have called thousands of patents on medical tests and genes (worth potential billions) into question, because if a diagnosis gets ruled a natural phenomena, genes couldn't be far behind.

The court's only comment on dismissing the case was to say it shouldn’t have agreed to hear it in the first place. Which is odd. Three justices dissented, saying the court should decide the case because biotechnology patents (and similar patents in other businesses) are being granted too liberally and should be rolled back. They also said they would have invalidated the Metabolite patent.

Dismissing the case, the dissenting judges said, "threatens to leave the medical profession subject to the restrictions imposed by this individual patent and others of its kind," which could "raise the cost of health care while inhibiting its effective delivery."

Given my obsession with tissue research and consent issues, I can't help but point out that research participants probably had no idea this might happen: Hundreds of people donated the samples used to uncover this connection between homosysteine and B vitamins. Many gave spinal fluid samples (an invasive, painful procedure that isn't without risk), because they wanted to help people with this disorder get treatment. Their consent forms, like most, surely didn't say that Metabolite could use their samples to file for a patent that could actually restrict research and treatment for the disorder they were trying to help.

On The Road Again

I’m back at my West Virginia writing retreat putting finishing touches on my book, so my blog will be a little quiet for a while: I can get email on my Blackberry, but I don’t have internet access unless I drive into the nearby town and go online at Baristas or the local library (which is the whole point of being here – distraction free writing time!). I won’t be back in New York and posting regularly again until mid-August. But I will be posting periodically until then.

Big News on the Tissue Research Front: A Congressional Investigation Into Researchers Profiting Off Tissues Without Consent

Finally, Congress weighs in on the lax regulation of human tissue research, tissue ownership, and the practice of scientists profiting off tissues donated exclusively for research -- something I reported on at length in my recent New York Times Magazine story, Taking The Least of You (which I've been posting regular updates on here and here and here).

A Congressional report was released yesterday detailing an investigation they launched into NIH's practices after they found out that a scientist at NIH had been providing tissue samples (obtained with federal tax-dollars) to a pharmaceutical company and pocketing large profits in return:

"A senior government scientist pocketed hundreds of thousands of dollars as a drug company consultant in exchange for human tissue samples that cost the federal government millions to acquire, congressional investigators said yesterday ... the National Institutes of Health's Dr. Trey Sunderland ... chief of the geriatric psychiatry branch of the National Institute for Mental Health, sent Pfizer 3,200 tubes of spinal fluid and 388 tubes of plasma collected for Alzheimer's research.

The government spent $6.4 million to obtain the 3,500 samples that showed how Alzheimer's disease progressed in 538 subjects. Pfizer paid Sunderland $285,000 in consulting fees related to the samples, investigators said. In total, Pfizer paid him more than $600,000 from 1998 to 2004 for outside consulting and speaking fees."

This is nothing new -- there's a long history of scientists doing this sort of thing. As a Pfizer representative said, ``The payments over a six-year period were reasonable and customary for an expert of Dr. Sunderland's stature, and reflect the fair-market value of his consulting services." Perhaps, but it doesn't make it right.

The problem is that common practices outpaced regulation a long long time ago. Because they were established long before tissues became the huge commodity they are today, the regulations currently governing tissue research are minimal and don't address big ethical issues. As a result, the enormous tissue repositories scientists have built up over the decades aren't set up for regulation: There's no uniformity in the way tissues are collected, stored, consented, or monitored. It's a mess that isn't going to be easy to clean up.

``NIH tells us it has no centralized inventory system that could tell the NIH director how many vials of tissues are in freezers at a particular institute," said Representative Joe Barton, Republican of Texas and House Energy and Commerce Committee chairman . ``It would really be a shame if we find out that the National Institutes of Health has more control over its paper clips and trash cans than it has over its human tissue samples."

The committee's senior Democrat, Rep. John D. Dingell, said: "NIH lacks adequate controls for human tissue samples, human subject protection and the scientific conduct of many of its senior employees. Accountability must be restored to NIH's own research programs."

This is absolutely true, but it doesn't only apply to the NIH. This is essentially universal. There is no established system for monitoring the widespread use of tissues throughout science, and there must be. It has to be set up in a way that doesn't inhibit science, but does protect the public against having their tissues and tax dollars used in ways they haven't consented to (including -- but not limited to -- personal profits for reseserchers). This is something scientists and ethicists and policy makers have been arguing about for decades.

The NIH has issued a statement saying, "We agree we need to improve the tracking of tissue samples ... We are in the process of determining the best way of doing that now." I'll be interested to see what they come up with. A while ago, their cancer institute created the Office of Biorepositories and Biospecimens to establish uniformity in the way samples are collect, consented, stored, regulated and distributed. If it's applied to the whole of NIH instead of just the cancer institute, and if it gains any enforcement power, that could help sort this problem out. But at this point, all of their guidelines are voluntary -- researchers don't have to comply with any of them -- and they're not given to all NIH investigators.

Not surprisingly, the researchers at the center of this case aren't talking, and high up officials at NIH have recommended that Sunderland (the main researcher) be fired. Clearly, what he's done is ethically wrong, and a system needs to be put in place so this common practice stops. But this isn't just about Sunderland -- this is about the overall lack of regulation and guidelines in tissues research.

In working on my article and book about this issue, I've talked to countless researchers about the ethics of tissue research. On the whole, I'm absolutely convinced that most researchers want to use tissues ethically, and that they work very hard to follow the existing guidelines. But the guidelines are incomplete, often confusing and sometimes contradictory, so researchers are left to figure this out for themselves. Hopefully this investigation will help solve this problem, though if history tells us anything, it might not.

Time for the VA to Slow Down on Launching Their Biobank

For my ongoing follow up to my New York Times Magazine article: The Oregonian ran an editorial today saying that the Department of Veterans Affairs is about to launch a veterans' DNA bank without taking decades worth of patients rights debates into account or looking seriously at the well-known ethical issues involved in creating a bank like this (for more on these ethical issues, see my NY Times Magazine story). The VA wants to start collecting samples from veterans as early as this October -- it has an ethical advisory committee of 7 people with advanced degrees, an army dentist, and one disabled American Veteran. But it just signed them up last month. As the editorial says:

"The committee has a lot to discuss in just a few months. Little questions such as: If genetic research detects a hidden, undesirable trait, such as a predilection for alcoholism, can that information be shared with third parties? Should it be disclosed to the donor?

When future researchers study a tissue or blood sample, should they be able to trace it back to its donor?

If the agency sells a set of samples to a pharmaceutical company, which uses them to create a new drug, should donors be compensated?

Will donors really give informed consent to the use of their samples, since so much about the future research is unknown?

Can the Department of Veterans Affairs really guarantee privacy of the donors and security of the DNA specimens?

Many veterans have developed a healthy skepticism about the government that sent them to war. Those who have bumped into bureaucratic frustrations with the Department of Veterans Affairs -- and their names are legion -- are unlikely to believe that the same agency can effectively manage such a sensitive matter as DNA research ... a DNA repository of the blood and tissue of military veterans isn't something to be constructed hastily. The questions surrounding the matter are profoundly important, and the answers are by no means clear."

I'm very interested to see how this one unfolds ...

Another Tissue Ownership Update: The Catalona Ruling Documents

A few people have emailed asking where they can find the judge's ruling in the Catalona trial, so I thought I'd post links: You can find the Judge's opinion here, and the Judge's order here.

Since no one has put the patients' briefs online, I'm going to get an electronic version to post (my copy is the print version), so folks can read both sides of the case.

Tissue Ownership Update III: AP on Catalona

The AP just ran a story on the ruling. It cites the usual info, and includes a statement from William Catalona, who plans to appeal: "he regrets that Limbaugh made it 'a fairly narrow case of property law,' when a higher issue, 'patient autonomy' and the need to respect the wishes of research subjects, is at stake."

The story cites David Korn, senior vice president of the Association of American Medical Colleges, making an analogy I wanted to include in my story, but it was cut for space: He sees tissue collections as research libraries. "If, at any time, book donors or their heirs could walk into the library and take out volumes, it would be awfully hard to maintain a library of any scholarship value." Korn always does an excellent job of showing why this issue is complex from both sides.

It is possible to maintain a top-of-the-line tissue library while getting consent -- the National Cancer Institute is on their way to becoming the model for doing so.

Tissue Ownership Update, II: More on Catalona

I'm getting a lot of requests for continued follow up on my NYTimes Magazine article and my last two posts (here and here), so I'll write as things happen. There will be plenty, since several news organizations are starting to cover the decision.

In a news story today Lori Andrews, director of the IIT Institute for Science, Law and Technology, raises a key point: The judge ruled that Washington University owned the samples in part because the consent forms were printed on Washington University letterhead, despite the fact that those forms said the patients were giving the tissues to Catalona [or in some cases, Catalona and his colleagues]. She calls the ruling, "a big setback for patients' rights," because it means universities can use samples for research "even over patients' objections. "

Washington University suggests that if patients control their tissues, it will have "horrible implications," because donors could refuse to donate to certain recipients. This is something the judge mentioned in his ruling. He said:

"Allowing [a research participant] to choose who can have the sample, where the sample will be storied, and/or how the sample can be used is tantamount to a blood donor being able to dictate that his/her blood can only be transfused into a person of a certain ethnic background, or a donated kidney being transplanted only into a woman or man."

I find that absurd: Giving patients the right to determine what's done with their tissues and which scientist does research on them does not equal discrimination and determining who receives the benefit of that research. Preventing patients from controling their tissues doesn't change the fact that someone decides who gets the sample, how its stored and used, and who benefits from it -- it just leaves those decisions to scientists, universities and biotech companies instead of patients. And there's no evidence that they'll make better decisions about tissues use than patients who, on the whole, want to see medicine advance (in fact, there's plenty of evidence that patient involvement can help advance science, just look at Ted Slavin, or the story of Sharon Terry -- how and why she became a co-patent holder on the gene found in her childrens' tissues, and the positive impact that had on research).

But regardless, at this point people have the right, legally and ethically, to determine who gets their tissues and organs (just read The National Organ Transplant Act). I'm extremely sensitive to the issue of race and medicine (I am writing a book that deals with it). But this feels like a case of playing the discrimination card inappropriately: By this judge's logic, if I want to give my kidney to my mother, and I sign a form saying so on Washington University letter head, then Washington University owns my kidney, doesn't have to give it to my mother, and I'm wrong for trying to give it to her? That's crazy talk.

Tissue Ownership Update: William Catalona v. Washington University, the ruling

This just in: Judge Rules People Don't Own Their Tissues (again). In my last post, I described my story in this week's New York Times Magazine about tissue ownership and promised an update, so here it is: [Please note: Before reading further, you should read my article, otherwise this post won't make much sense, because it follows up on the story's final section and assumes readers of this post have read the entire story.]

In the story, among other things, I wrote about the potentially landmark court case between Washington University and Dr. William Catalona, which questioned whether patients can control the use of their tissues in research, and whether they retain any property rights in their excised body parts. (The case where Washington University claimed ownership of 6,000 tissue samples from patients who asked that their samples be removed from the university's prostate cancer bank, which is worth millions of dollars). After more than a year of deliberating, the judge finally ruled on Friday (4/14/06), which was interesting timing for me, since my article had already gone to press for publication the next day. It was too late to include his ruling in my story, where I would have covered it in detail and given experts the chance to comment on it. Since I couldn't do that, please pardon the long post while I'll give some details here as a follow-up:

Judge Stephen Limbaugh ruled in favor of Washington University on all counts saying, "Washington University owns all biological materials, including but not limited to blood, tissue, and DNA samples, in the GU Repository." (The GU Repository stands for Genito-Urinary Repository, otherwise known as the prostate collection.) "Neither Dr. William Catalona nor any research participant," he wrote, "... has any ownership or proprietary interest in the biological samples."

In the end, when it came to property rights, the judge didn't do anything new: He simply went along with the Moore and Greenberg rulings (explained in my story), which said, "the property right in blood and tissue samples ... evaporates once the sample is voluntarily given to a third party," regardless of whether you've been informed about what your tissue will be used for. So nothing changes there: You don't own or control your tissues once they're removed from your body, unless you (like Ted Slavin) negotiate terms on the front end.

At points, the Catalona ruling is a bit circular: The judge said that having possession of something can establish ownership, and since Washington University had possession of these tissues samples (though patients asked for them to be transferred elsewhere and W.U. refused), they were acting as owners, and therefore they own it. Which is what the patients were disputing in the first place. The patients argued several other points, including that they didn't want their tissues and DNA distributed to scientists for research they didn't consent to. But the judge discounted all patient testimony saying, "these gentlemen all had a deep personal connection to Dr. Catalona, and believed that they owed their lives to him. " Because of this, he called their testimony "suspect."

The judge pointed to several ambiguities in the case: The consent forms didn't say whether patients gave their tissues to Catalona exclusively. They did said patients could withdraw from the research at any time, but didn't say what that meant regarding tissues. The judge wrote, "There is nothing stated in the governing federal regulations which equates a right to discontinue participation with a right to control the disposition and use of the excised biological materials." Contract law says that in the case of ambiguities in written agreements (like consent forms), the ambiguity goes against the writer of the contract -- if you don't specify it in the form, you don't get it. But that's not how this judge ruled. Instead, he said, "The Court finds that the right to discontinue participation in a research project means nothing more than that the [research participant] has chosen not to provide any more biological materials ... Nothing more can or should be read into this right." In other words, you can't ask scientists to stop doing research on your tissue. This ruling could have a far-reaching impact, since it's the first to define the federal right to withdraw in terms of tissue research. (See story for details).

In the end, the judge surprisingly discounted all arguments regarding the consent forms, calling these tissues a "gift," and saying -- in a disturbing statement -- that "the existence of the informed consent forms is inconsequential." He didn't mention one important thing: The law says if there is consent in writing, you must honor it, which means those forms aren't "inconsequential" at all.

In a statement that parrots the Moore ruling, this judge said, "Medical research can only advance if access to these materials to the scientific community is not thwarted by private agendas. If left unregulated and to the whims of a [research participant], these highly-prized biological materials would become nothing more than chattel going to the highest bidder. It would no longer be a question of the importance of the research protocol to public health, but rather who can pay the most." This is ironic, given that many experts argue (and several studies have supported this) that access to these materials is already being "thwarted by private agendas" in an area of science where materials are no longer shared freely because of a focus on proprietary information and profits instead of public health. People have been arguing for years that profits and competition in science have created precisely the situation this judge says he hopes to prevent. The one thing he's done is cut patients off from having a say in this -- these patients weren't after profits of any kind. They wanted their tissues used for the research they intended it for -- the university was the party raising the issue of profits.

I'm very interested to see what happens from here -- many interesting debates will follow, and an appeal. This case isn't over, so the saga continues ...

I'll be live on the air discussing my story and the Catalona ruling tomorrow on NPR affiliate KPCC in Los Angeles from 11:00 to 11:40 (west coast time). So tune in.

Who owns your tissues? What are they being used for? And how come you don't know?

My article about the little-known world of tissue research ("Taking the Least of You"), is on the cover of this Sunday's New York Times Magazine. Be sure to pick up an actual copy so you can see Marcel Dzama's incredible artwork illustrating it (left). In the meantime, you can read it online. (After this story went to press, there was an interesting development in one of the cases I cover -- check back Sunday for a detailed post updating the story.)

The gist: Today, most Americans have their tissues on file somewhere. These tissues come from routine medical tests, operations, clincal trials and research donations -- they're often used in research without our knowledge, and can be worth vast sums of money. Some experts believe this violates people's rights, skews how tissues are used in research, and jacks up the cost of drugs and diagnostics (patients supply the tissues and tax dollars that make the research possible, they don't share in profits, then pay steep fees for the products derived from their contributions). But at this point, the law isn't clear on whether you have the right to own or control your tissues. When they're part of your body, they're clearly yours. Once they're excised, things get murky.

Scientists, ethicists and policy makers are in the midst of a heated debate over (a) whether scientists should have to ask permission to do research on your tissues or turn them into commercial products, (b) whether you should have any control over your tissues once they're removed from your body, and (c) whether you deserve a cut of the financial action in the form of payments or affordable heath care. My latest article tells the story of this debate -- of cells worth billions, of patients who've fought the system and won, others who've lost, and the important science that comes from all of it.

This story is part of a larger project: For nearly nine years, I've been working on a book about the history and ethics of cell and tissue culture research. It's called The Immortal Life of Henrietta Lacks, about the first human cell line ever grown in culture. Those cells (called HeLa) were taken from a woman named Henrietta Lacks in the 1950s without her knowledge. They became one of the most important tools in medicine, and are still used in laboratories around the world. Those cells have done wonders for science, but they've also had dramatic and troubling consequences for her family. You can read excerpts of their story on my website; the book will be published by Crown in 2007.

Scientists As Entrepreneurs: Your Tax Dollars at Work

As you'll see in the cover story I have coming out in this Sunday's New York Times Magazine, I spend a lot of time talking to researchers about the commercialization of science. Most downplay the role of the market in science and say it's rare that researchers start companies and turn profits. So I was very interested to see the results of the first study to actually look at the role of the market in science, which found "an astonishingly high rate of entrepreneurship."

"A study of university scientists who received financing from the U.S. National Cancer Institute ... found that the scientists generated patents at a rapid pace and started companies in surprisingly high numbers. The study, the authors say, suggests that the commercial payoff for the government's support for basic research and development in the life sciences is greater than was previously thought."

I'm all for commercialization of research results, because without it, biotech and pharmaceutical companies wouldn't turn research results into the therapeutics and diagnostics we need. But the cost of those products are becoming increasingly prohibitive. Especially given the fact that tax dollars fund much of the research. Which means the public is paying twice: Once to help fund the research, then again (at riduculous rates) to reap the benefit of that research when they go to the doctor. (The public also provides everything from DNA samples to drug test subjects to help make that research possible.) There's something problematic with that picture.

I've talked to Anna Barker, the deputy director of the National Cancer Institute, about this stuff in the past. In my eyes, she couldn't be more right when says this: "At the end of the day, without commercialization, these ideas don't find their way to people ... What we have to do is intelligently balance two considerations - to smooth the path to commercialization but also guard against conflicts of interest that could undermine science." (Disputes over patents, like the recent Metabolite case now in the Supreme Court, can tie up research materials and important research for decades.)

On Writing: Finishing My Book

As you may have guessed by the sudden increase in my blog postings, I've finally left the hills of West Virginia and returned to New York City. After months of sitting and typing (and sitting and typing and sitting and typing), I've traded my beautiful view of the Appalachian foothills for this beautiful view of Times Square. Because, 447 pages and 124,013 words after I began writing my book, I have finally finished it (well, a draft of it anyway).


The day before yesterday, I walked into my editor's office and handed her a manuscript that weighed 19.5 pounds and was roughly the size of a New York City phone book. As you can see from this picture, taken moments before I turned in the book, I was a bit dingy from the whole thing (and sleep-deprived: note the bags under my eyes), but ecstatic. I've been working on this book for seven years -- the relief of finally getting it out of my head and onto paper is unlike anything I've ever experienced. I half-expect if I climbed on my bathroom scale, I'd actually weigh about 75 pounds lighter from finally losing all 124,013 of those words. And with this sudden lightness, I've found motion.

One thing you don't hear a lot about is how much writing actually hurts. Physically. I have been sitting in one place and typing for months. Years, really. But during this last push, I sat for months. I don't recommend this. Last night, I had a celebratory sushi dinner with my boyfriend and two of our friends, all of us writers, all of us finishing long book projects. To hear us whining about our writing related injuries was comical: My friend Mark rubbed his forearm between sips of champagne and asked if I could feel my fingers, because he couldn't feel his. They tingle, he said. Mine only tingle in the morning, I told him. David spent half the night standing next to the table because his back hurt too bad to sit; Marcela talked about how her body just shuts off, usually on Fridays, and she falls asleep no matter how much coffee she drinks. While we talked, I kept kicking my legs out from under the table with no warning because of hip cramps. At one point David had to massage Mark's back because of a spasm, I got in some weird yoga-like pose to stretch my hip, and suddenly we looked at each other like, Why are we sitting? So we ditched the table and the celebratory champagne and just walked. Which is all I've done since I turned in my book. I probably walked about six miles Friday, then another five or so yesterday. And I can't stop. Like I suddenly found water after being dehydrated for months. Which of course makes me think, Why am I sitting here typing? So on that note, I'm going for a walk.

On Writing: Country Roads, Take Me Home

So I’ve done it again, I’ve fled New York City for a hundred-year-old West Virginia farmhouse perched on an Appalachian foothill overlooking the Ohio River Valley. (The picture above is currently my favorite shot of the view from my writing desk.) There isn’t a phone line or internet connection in sight, which (aside from the beauty and the silence and the miles of open spaces where my dog can run and chase deer while I sit on the porch swing) is precisely why I’m here. That, and finishing my book. But those two things go hand-in-hand these days, because apparently I have to be miles from an Internet connection to actually spend an entire day writing.

I have no idea how this happened: At one point in my life, I'd get a few emails, I'd respond to a few emails, no big deal. Then a few turned in to lots which turned into hundreds, and now it’s just out of control. A friend of mine wrote an article for Time Out New York last summer about how electronic communication is ruining our ability to concentrate. The fact that he used my out-of-control-email-life as the lead to his story was probably not a good sign. A psychiatrist in London has actually done a clinical trial showing that email does more damage to a person’s concentration and IQ than smoking pot:

“emails … have an addictive, drug-like grip. Respondents' minds were all over the place as they faced new questions and challenges every time an email dropped into their inbox ... the effect ... was the equivalent, over a day, to the loss of a night's sleep.

"This is a very real and widespread phenomenon," said Glenn Wilson, a psychiatrist from King's College, London University, who carried out 80 clinical trials … The average IQ loss was measured at 10 points, more than double the four point mean fall found in studies of Cannabis users ... Dr Wilson and his colleagues found a compulsion to reply to each new message, leading to constant changes of direction which inevitably tired and slowed down the brain. In fact, it is a recipe for muddled thinking and poor performance."

I buy that completely: When I got to West Virginia almost two weeks ago, it took several days before I could just sit down and write without that weird nagging feeling like, There’s something else I should be doing right now … emails to read, emails to reply to. Writers don’t just sit and write anymore, do they? Of course they do. They just have to go to the middle of nowhere, miles away from any internet connection to do it.

A few weeks ago, during a conversation with an editor, I was talking about how hard it is to juggle a book, freelance writing, teaching, public appearances, and the many emails that result from it all. She very wisely said, “The key to life is focusing on what’s important, not what’s urgent.” The light bulb that sentence set off in my head was more like a carillon bell. This is the problem with email, and it’s the problem with writing books: An email comes in, someone asks a question, however small, and for some reason we feel we must respond within minutes, or at least days. That’s urgent. But it might not be as important as, say, the book you’ve spent the last eight years of your life trying to write. The book that may not be due in minutes or even days, but that is due in a month. I asked this editor where she came up with that brilliant phrase -- I figured she’d say something about it being a Buddhist meditation or something. But no. “A time management specialist came into the magazine,” she told me. “He sat down in my office and the first thing he said was, don’t check your email.” Then he gave her that line about the urgent and the important.

So why am I telling you this, aside from it being a good quote. I’m telling you this because, secretly, that's why I started this blog. It's my way of staying in touch with friends and family and the outside world while I'm off focusing on one very important thing: My book. It's my way of saying, please forgive me while I write my heart out and only go online a couple times a week. I hope everyone understands. Please, keep emailing me: I love reading them, and I promise I’ll respond. It just might take a little while.

On Writing: Driving at Night

My new favorite quote, from E.L. Doctorow:

"Writing a novel is like driving a car at night. You can see only as far as your headlights, but you can make the whole trip that way."

What more is there to say?