Sunday, April 30, 2006

Critical Mass: My Other Blog Life

About a week ago, I launched Critical Mass, the blog of the National Book Critics Circle, where I'm on the board of directors. It's been a serious labor of love, so I'm excited to see it alive and thriving (we're already getting thousands of hits a day). I'll be posting at Critical Mass with a team of other bloggers, all fellow NBCC board members -- we're all professional writers, critics and book review editors, and judges of the yearly NBCC awards. Critical Mass will feature publishing and criticism news and commentary, noteworthy book reviews, tips, useful products, and anything else that catches our attention.

I won't be posting any less here -- I'll just be posting there too, as will several great writers. So check it out, spread the word (and look at how cute our new mascot is!) ...


Vet Clinic Faked Dog's Death

Not long ago, a couple in Allentown, PA took their German shepherd Annie to the vet for euthanasia -- the dog was two years old and severely epileptic. But instead of putting Annie down, the vet faked her death, then found her a new home. Annie's owners found out and sued:
"Dana and Gary Ganyer said they cried while watching what they thought was the death of Annie ... But Annie was not euthanized ... Instead, the lawsuit says, the dog was given a sedative to make it appear she was dead. The clinic then gave Annie to a new owner, Gene Rizzo of northeast Philadelphia, who cared for the dog until he had her euthanized Nov. 2, the lawsuit says. "When I heard she was still alive I literally screamed and went into hysterics," Dana Ganyer said. The lawsuit, which seeks unspecified damages, accuses Mill Pond Veterinary Clinic, Mill Pond Kennels and three of its employees of fraud, negligence and defamation" (AP).
I completely understand the temptation to fake a dog's death. I was a veterinary technician for more than ten years -- I worked in regular clinics, emergency rooms and animal morgues. I've euthanized many many animals. In most cases, this was actually a beautiful thing -- a peaceful end to suffering. But every once in a while, people turn to euthanasia for wrong reasons ... the dog is too much work, it sheds too much, they don't have time for it. When that happened, we'd try to convince owners not to do it. If we had kennels in the clinic, we'd take it and find it a home. If we didn't have kennels, we'd call an animal rescue group to take it. If the owner insisted on euthanasia, we simply refused to do it. No vet I worked for would ever fake a dogs death, but we talked about doing it every time.

This case doesn't actually sound like wrongful euthanasia: "On June 30, the Ganyers received a call from the former clinic employee, who told them Annie was still alive, and a few days later they drove to Rizzo's home. According to the Ganyers, Annie could barely walk and was ''bloated, her coat was grey, her eyes bulged and it appeared she had hip ataxia, all side effects of phenobarbital.'' A few days later, she lapsed into a coma after a seizure and was actually euthanized. It's hard to fathom how this vet could have thought keeping this dog alive was the right thing to do under any circumstances.

This isn't the only case of its kind: A similar lawsuit was filed in March by woman whose vet agreed to euthanize and cremate her cat, but didn't. I'm not surprised to hear that vets are doing this -- I've always assumed this happened, but few cases have actually been documented. To me, this doesn't mean it isn't happening, it just means some vets get away with it (and when it's wrongful euthanasia, it's hard not to say, more power to them).


Friday, April 28, 2006

A Sad Day for Science Writers: Laura Van Dam's Obituary

Laura Van Dam was amazing; a tireless advocate of science writing and science writers, a brilliant woman -- she died this week after fighting lymphoma for years. This is a huge loss to science writing, and the many people like me who counted her as a friend. I just visited the website for the National Association of Science Writers -- which Laura was president of until her death. NASW members have posted incredible comments about Laura that really show the amazing impact she's had ... so many wonderful writers and reporters (Laurie Garrett, Joe Palca, Deborah Blum, Natalie Angier, Robin Marantz Henig, and on and on) credit Laura for encouraging -- and in some cases discovering -- them and their work. As do I. Laura and I spent many hours talking about my articles and my book over the years: She encouraged me when I hit hard spots, pushed me to write the best book I could, believed in it and me even when others didn't. The tragedy of young death robbing everyone of such a bright future applies to Laura in spades.

Her approach to the end was amazing and thoughtful. About two months ago, she called me to talk about her death. She hoped it wouldn't come for a few more years, because she desperately wanted to see her son off to college. Laura's own mother died after Laura went away to school; she knew that would probably be easier for him than the alternative. But she also knew the end might happen sooner than that. We talked for almost two hours about life and death, about living with brain damage (my father has written quite a bit about his own experience with brain damage, and Laura's illness caused extensive brain damage). All I can say is, Laura was one amazing woman many many people will miss -- those who knew her will miss her energy, her excitement and brilliance. Those who didn't know her will miss everything she did behind the scenes for the science writers of the world.

If you're an NASW member, I urge you to read the tributes to her on the NASW site. Her obituary and the many responses to it are there:

"An independent book editor, Laura spent many years as a senior editor with Houghton-Mifflin, where she specialized in books related to science, technology, medicine, and health. She worked with authors including Natalie Angier (Woman: An Intimate Geography), Daniel Schacter (The Seven Sins of Memory), J. Richard Gott (Time Travel Through Einstein's Universe), and Steve Olson (Mapping Human History, a National Book Award finalist) ... Laura served as a senior editor with the MIT publication Technology Review and as a newspaper reporter.

She is survived by her husband, Howard Saxner, and son, David Saxner. A memorial service is planned for Sunday, April 30, at 2 p.m. at the First Parish Unitarian Church, Harvard Square, Cambridge, Mass. Donations may be made in Laura's name to the Pappas Center for Neuro-Oncology c/o Massachusetts General Hospital, Development Office, 165 Cambridge St., Suite 600, Boston, MA 02114."

There's also a wonderful detailed obituary in the Boston Globe.

Happy travels, Laura ... we'll miss you.

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Wednesday, April 26, 2006

Big News For All Women of the World: HPV Vaccine May Prevent Cervical Cancer in Already-Infected Women

This is pretty stunning news ... so stunning, in fact, that I have nothing to say about it other than: Whoa! And hallelujah: For women infected with one of four cancer-causing strains of HPV, Merck's new vaccine appears to prevent 88% of all cervical cancer, 91% of all "external genital lesions" (aka: warts, cancerous and non), and 100% of all high-grade cervical pre-cancer and high-grade vulvar or vaginal pre-cancer.

This is huge news, since
cervical cancer kills millions of women each year. In what may be the greatest understatement of the year, Marc Steben, a doctor involved in the study, says: "These strong results against serious illness will definitely interest sexually active women."

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Moleskine Mania

Oh no!! I, like many writers (including, at one point, Hemingway) am addicted to Moleskine notebooks. I carry several at all times: One for story ideas, another for my to-do lists and calendar type things. Plus I have one next to my bed for writing thoughts in the middle of the night, and another on my desk for taking notes during phone conversations (even with my family -- it's a hazard of my profession). They're slick, not-too-expensive, perfectly sized, sturdy ... they've gained nearly cult status among writers (and everyone else, apparently).

The owner of the company that makes Moleskines, who is now 69 years old, just announced that he's put Moleskine up for sale. He said: "Moleskine is growing very quickly and it is becoming too big for us. We do not have the capacity to follow it through."

At this point, the Moleskine is so successful, surely someone will snatch it up. That someone just better not change a damn thing about those notebooks! Just the thought of that makes me want to pull a Bruce Chatwin -- when the company that produced Moleskines went bankrupt in the 80s, Chatwin, a travel writer, ran out and bought 100 of them. Right about now, I'm tempted to do the same. My only question is, Why just 100?

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Monday, April 24, 2006

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.

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Gay Talese: Writing is Hard

There was a great little profile of Gay Talese in the NYTimes yesterday -- it nails his personality better than any profile of him I've seen. Talese is considered one of the founders of creative nonfiction (or literary journalism or narrative nonfiction or whatever you want to call it), right up there with Joseph Mitchell, Tom Wolfe, Joan Didion, and others.

It's always good to be reminded that greats like Talese are just as tortured by writing as everybody else: It usually takes him 10 - 12 years to publish a book (which makes me right on track at year 9):
"Mr. Talese, who has compared writing both to passing a kidney stone and to 'driving a truck at night without headlights, losing your way along the road and spending a decade in a ditch,' is a painfully slow worker - a tinkerer and reviser, an obsessive typer and re-typer."
All I can say is: Me too. But Talese goes much further than me in that department: "He keeps track of his progress, or lack of it, with memos and exhortations to himself that he posts on white foam panels on the wall." Things like: ""GT, what other stories - and when are you going to get back into print!?????????" Or "Where am I going???" A long time ago, I blogged about his bizarre revision practices, which sometimes involve scraps of paper and binoculars.

Talese struggles with false starts, killed magazine stories, delusions about deadline ... things any writer can relate to. About writing books, the profile quotes him saying, "The funny thing is that I never think they're going to be difficult. The Times book I thought I could do in about six months and it took me years. And maybe I should have, but I never thought this one would be so hard." Amen.

[The New York Observer had an interesting profile of him too, as does the LA Times]


Saturday, April 22, 2006

And Now For Something Completely Different: Man Survives 12 nails to the Head

The headline really says it all: This man shot 12 nails into his head in a suicide attempt and suffered no lasting damage. The brain is such an amazing and baffling organ. If I was a religious person, I'd say God was messing with this guy. Like, Go ahead, shoot another one ...

A bit of the story, from the AP:
"The man ... went to an Oregon hospital complaining of a headache. Doctors were surprised when they took X-rays and found the nails - six clustered between his right eye and ear, two below his right ear and four on the left side of his head ... He became short-tempered and hostile when OHSU staff asked him how the injury occurred ... The man at first told doctors he had had a "nail gun accident." It wasn't until later that the patient admitted he'd used meth and the injury was a suicide attempt ... Surgeons were able to remove the nails with needle-nosed pliers and a drill because the nail heads did not penetrate the skull."
Apparently, there's a study looking at this sort of thing: This man is the first to survive "intentionally fired so many foreign objects into the head," but nail gun injuries aren't unheard of: "Nail gun injuries are often accidental. But more than 65 percent of the time, a nail gun injury to the head is associated with an intentional discharge, a psychiatric disorder or both, the study said."


Tuesday, April 18, 2006

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.

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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.

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Monday, April 17, 2006

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.

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Sunday, April 16, 2006

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.

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Thursday, April 13, 2006

Pharma Funded Studies Show Funder's Drug to be Superior!

The folks over at the have a great post today reporting: "Stunning news to anyone without a brain: industry funding affects research." Check out their site for the full story.

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The Science and Business of DNA Diagnostic Testing

Andrew Pollack has an good story in today's New York Times that covers advances in DNA testing for diagnostic purposes -- it's becoming more and more widespread, and profitable (this is related to my cover story in this Sunday's NY Times Magazine). His story raises, once again, questions about patents, profits and science, and the impact this has on the cost and quality of the healthcare people get in exchange for their money and genetic samples (which this science depends on).

Some makers of these tests are making the argument that regulation of their products would "make it uneconomical to develop many tests, which have smaller sales than drugs. " But when there's this kind of money involved, and people are relying on these tests to decide whether they should bypass chemotherapy, somebody better make sure those tests actually do what they claim to do.

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Tuesday, April 11, 2006

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.)

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Monday, April 03, 2006

Doctors Vindicated Over Baby Experiment?

Eight years ago, two UK doctors were suspended from their posts for using an experimental treatment on babies in respiratory distress. Instead of intubating the infants (which is standard practice but can cause damage), they used something called Continuous Negative Extrathoracic Pressure (CNEP), which involved putting a box over the baby's chest to create a vacuum that helps the child expand it's lungs and draw in air. In 1998, two years after they published their research, the doctors became the focus of a governmental inquiry because parents complained that they hadn't consented to the use of experimental treatments on their children. The doctors were suspended, the investigation took years -- it uncovered problems with the trial, but the hospital challenged the parents' complaints, saying they couldn't prove they hadn't been told. Then the whole thing seemed to fade away ...

Now, according to an article in today's Independent, suddenly these doctors are "vindicated" because a study has shown that children treated with CNEP during respiratory distress do no worse -- and in some cases do better -- than children who are intubated: "Now aged 9 to 15, the children treated with CNEP had 'substantially higher' language and visual/spatial skills than those given conventional ventilation, the researchers say." The article quotes Professor Sir Alan Craft, president of the Royal College of Paediatrics, saying that this "'pioneering' research has been subjected to 'unprecedented scrutiny ... many lives have undoubtedly been saved by his research.'"

The fact that CNEP works is great news. But saying that this means the researchers are off the hook is risky logic that raises an old issue: The advance of medicine depends on doing research on humans. If you do unethical research that leads to useful results, does it excuse the research practices? Of course not. There was a huge debate about this surrounding the Tuskegee studies (pictured above) -- Tuskegee researchers uncovered a lot of potentially useful information about the clinical course of syphilis, but they did so at a terrible cost. When the trial ended and the ethical problems were uncovered, those results still existed -- some people believed the results shouldn't be cited in future syphilis research because of how the information was obtained. Others said that was silly -- we can't simply ignore the facts they uncovered. There's a huge literature on this. In the case of Tuskegee, no one talked about the researchers being vindicated because some of their results could be medically useful.

I'm not saying this CNEP study is another Tuskegee: I have no idea what really went on with this research, whether the doctors behaved ethically, or whether parent claims about lack of informed consent are accurate. I'm just sayin, it's dangerous to dismiss ethical issues because of scientific results. The only thing that settles ethical questions is further investigation into the research practices, not positive research results.