Science Meets Religion: The follow up

An update: Perhaps not coincidentally, moments after I got the press release I mentioned in my previous post, I got a second press release announcing the results of a multi-institutional study (of more than 1800 heart bypass patients), which failed to prove that prayers have healing power. A group of Catholics and Protestants did the study's praying -- they received the names of patients, and specific prayers to say for them immediately before surgery and for two weeks post-op.

In contrast to Sauvage's study, this study was "never intended to address the existence of God or the presence or absence of intelligent design in the universe." They were simply looking at the healing power of prayer (though, as they pointed out, it is difficult to distinguish "study prayer" from the "background prayer" of family and friends). As reported by Reuters, the results were perplexing: "some of the patients who knew they were being prayed for did worse than others who were only told they might be prayed for -- though those who did the study said they could not explain why."

Surely Sauvage knows why ... they should text him and ask.

Science Meets The Bio-Cosmic Druid

This morning, I got a press release I find disturbing. It claims that a recent research project has succeeded in, "Proving for the first time the existence of a higher power by scientific means." Here's what it says:

"Catharsis, the non-profit California corporation inspired by the work of Philip Sauvage, begins ground-breaking, scientific tests worldwide, on victims of severe fire burns from flaming cars and homes, wildfires and terrorist bombings, to prove, once and for all, the existence of a 'higher reality.'" Here's the protocol: "Sauvage requires four details of the victims within 30 minutes of them being severely burned – name, date of birth, place of birth, and a photo taken on a mobile phone – all of which must be texted to his team on (0041) 78686-1842 ... Results are immediate, clearly observable, absolutely incontrovertible, and quickly reproducible in hundreds of cases."

The man behind this, Philip Sauvage, is a palentologist with a cult-like following who claims to be able to heal people of pretty much anything -- AIDS, cancer, cystic fibrosis, Alzheimer's -- through prayer. Sauvage's titles include "criminologist, paleontologist, Father of Subliminal Influentiality [a.k.a. subliminal mind control], Chairman of Scientific Skeptics Board, Author and Bio-Cosmic Justice Enforcer." He was deported to France, where he was charged with defrauding followers whose conditions worsened after his "treatments." Sauvage is also a Druid. Here's a taste of how he explains himself in his memoir: "I grew up inside an immemorial 'super-shamanistic' tribe (the very real thing), whose 'powers' and 'wisdom' date back to the dawn of your Neolithic age. My clan has been serving the Earth, the Forests, the Animals and our ethnos without interruption or adulteration since then." You get the point.

Seeing this kind of stuff masquerading as science bothers me, and I hate to encourage them by posting this (apparently by doing so, I'm helping to advance the study: "The broader the media alert," his press release says, "the better and faster the test results come in"), but I couldn't help myself: The story of this guy Sauvage is so weirdly fascinating. Perhaps we should all test his abillities by texting our information to the cell phone number in his press release (see above) ...

Tips on Freelancing and Getting Published

People often contact me asking for advice on getting published, breaking in as a freelancer, coming up with story ideas, you name it. I've often told myself I'd come up with a FAQ page, or maybe even write a short book on the topic, but I've never had time. So I'm very pleased to say that Elaine Vitone, an MFA student in the University of Pittsburgh's nonfiction writing program (where I went to grad school, and where I was a visiting teacher last semester) has taken several handouts I wrote, combined them with a lengthy phone interview she did with me, and turned them into a great sort of Conversation With Rebecca Skloot. The document will be available soon as part of a guidebook for writing students in Pitt's graduate program. I'm posting it here with hopes that it will provide useful information for those who contact me seeking tips. Many thanks to Elaine for putting it together.

More on Fake Blood and Research Ethics

A few days ago, I posted about some sketchy ethical practices in a clinical trial that's been testing fake blood without people's consent in 18 states. Well, it looks like things may get more interesting with that soon: Senator Charles Grassley has called on the FDA to tell the public (a) what's happening with this study and (b) how potential benefits of this blood substitute could outweigh the risks ... He called the trial unethical and said it never should have been approved. Grassley is accusing the FDA of disregarding their responsibility to "protect the public health," and saying the burden of opting-out shouldn't be on the public. "Equally outrageous," he said, "is the FDA's apparent failure to ensure that communities are fully aware of the risks, benefits, and nature of this experiment." I'm eager to hear their response.

For more information on all of this, see two publications from the ever-impressive American Journal of Bioethics -- their recent open letter to IRBs and their piece about race and Polyheme launched the media coverage of this issue and finally brought these questions to the public's attention. Bravo to them.

On The Line - A New Play

I'm very excited to say that my boyfriend David Prete and our good friends Joe Roland and John Zibell have just launched a website for their new and fabulous Off-Broadway play, On The Line, which will be at the historic Cherry Lane Theater this April. As they describe it, "The play explores what happens when three lifelong friends take on management, the union and ultimately each other when a strike wreaks havoc on their working class town. Along the way they have to negotiate mobs of angry first graders, bat wielding bartenders, no-neck coroporate shills, and the North American Free Trade Agreement."

It's being put on by Mike Nichols (academy award winning director of The Graduate, Angels in America, Closer, Spamalot) and produced by Bill Haber and Bob Boyette (producers of Spamalot and many other amazing things). So check out the website, go see the play ... it'll be amazing: www.onthelinetheplay.com

Fake Blood and Research Ethics

For some time now, I've been following the debate over clinical trials of a blood substitute called Polyheme, which was designed by a company called Northfield to use in trauma cases instead of human blood. To get this product out to market, it has to be tested on humans to see if it's safe and effective. The problem is, getting informed consent for that is impossible: When a person shows up hemorrhaging in an emergency room, they're in no condition to understand and consent to the potential risks of a study like this. But since the mid-90s, the FDA has allowed clinical trials of various things (including antidotes to potential biological warfare) without informed consent, if informed consent is "unfeasable" to get.

So, for the last two years -- without consent -- patients in emergency rooms around the country (including Chicago, Denver, San Diego) have been getting this blood substitute instead of real blood to test the product's effectiveness. Technically, patients can say they don't want this research done on them, but to do so they have to get and wear an opt-out bracelet, which tells people in emergency rooms that they want real blood instead. The problem is, if you want one of these bracelets, you have to know the study is happening before you go to the emergency room. Today, a Chicago Tribune article lays out some of the ethical concerns well:

"Medical ethicists and community leaders in some areas of the country where Northfield has been testing its product for the last year have said the process does not allow for enough community input. In some cases, ethicists have complained those running the trials have placed tiny legal ads in newspapers that resulted in town meetings attended by only a few people ... some critics of Northfield's trial have gone so far as to say the research protocol is racist because the testing is done in and around inner-city hospitals, and potential test subjects would have little way of knowing they could become part of a clinical trial. The San Diego Reader, a weekly newspaper, in July reported that Polyheme was being tested only on trauma patients too ill to consent in downtown San Diego and three minority neighborhoods.

In a January letter to Illinois congressional leaders, a Chicago-area surgeon involved in clinical trials, Dr. Raymond Pollak, compared Northfield's trial to the Tuskegee syphilis experiment--a 40-year clinical study in which African-American men with syphilis went untreated by government doctors. "The Tuskegee experiment ... is a painful reminder of the potential for the harm that can come from the unethical conduct of human experimental clinical trials," said Pollak, a former University of Illinois professor and current head of clinical trials at Edward Hospital in Naperville. "I believe that similar concerns have now emerged in regard to an ongoing clinical trial being conducted by Northfield Laboratories, with the tacit approval of the FDA.

The makers of Polyheme were, not surprisingly, unhappy about the recent bad press (They make a point in their press release to say that Polyheme is a promising treatment for people with sickle cell anemia, which African Americans suffer from disproportionatly -- surely an oblique (and inadequate) response to the accusations of racism and comparisons to Tuskegee?).

This case is disturbing on many levels. Of course, it's very important for science to advance, and for new therapeutics like this to be developed -- Polyheme could solve blood shortage problems and eliminate the need for blood-type-matching -- but we have endless historical examples illustrating precisely why this should only happen with full consent and disclosure to the public. There are ways to inform the communities surrounding the hospital so they (a) know this trial is happening, and (b) can exercise their legal right to opt-out if they don't want to participate (federal law mandates that all people be given that right). At this point, this doesn't seem to be happening. [It's also not clear that it will be enough if it does happen] This is precisely how we end up with Tuskegee-like problems in the first place. Which is why the researchers involved in this trial (and the FDA) should take the issue of consent very seriously and devise ways to move forward without violating people's right to not be used as research subjects.

[A side note: I've been off line lately because every waking moment (and most sleeping moments) have been consumed by a big story I just finished for the New York Times Magazine (it will be on the cover of the magazine in a few weeks -- I'll post more about it then). In the meantime, I have a huge backlog of things to post about ...]