October 29, 2005

Pharamaceutical FUD (PHUD)

Category: Politics — @ 6:14 am

A few weeks ago I, one stormy night, I went to the theatre to see Serenity. I can’t say I am a huge Joss Whedon fan because, well I have never watched a Buffy Episode in my life. But a number of the Firefly episodes landed on my computer and even since I became hooked. I liked the characters and a sci-fi with a Western twist added an extra layer of grit to an already compelling plot.

The night I went to see the movie, I was working on a conference paper on psychiatry and the pharmaceutical industry. As is typical with me, I felt a little guilty that I was slumped in a big cushy movie theatre chair, stuffing myself with popcorn, and not hunched over my computer. So when the movie turned to the issue of pharmaceuticals, my guilt vanished as I felt this movie was part and parcel on my paper: the nature of public critique and debate over the authority psychiatric pharmaceuticals.

For those who have seen the movie, the reference to the dangers of some current psychiatric pharmaceuticals was quite obvious. At the end of the movie, the crew of Serenity finds themselves on some remote planet, past the really icky and creepy reevers. There they find a deserted planet. But actually on closer inspection, it is deserted only because it is filled with dead people. They discover some video projected computer program that reveals everyone has died of extreme apathy and complacency, which was a result of a drug, Pax that was, if I remember correctly, put in the water. People were so chilled out on the stuff, they basically stopped doing everything and died. But if Pax killed people by transforming them as totally passionless, one class of folks, however, reacted quite differently to Pax. They became insanely violent and like to eat people: yes the reevers.

The reference to Paxil is far from subtle. The drug has been mired in controversy in the last number of years. In fact, so much so, that among other lawsuits, investors alsosued claiming that Glaxo concealed the suicide risks Paxil carries.

This comes at the heels of other revelations that Big Pharma has concealed important data, the most famous being the cardiac dangers of a class of painkillers like Vioxx. To me, it seemed due to these events, there is a more critical stance toward pharma, and that perhaps the FDA would be a little more stringent in overseeing the drug approval process.

Apparently not.

So this article from the Washington Post
U.S. Alters Test Policy On Psychiatric Drugs: FDA Won’t Require 6-Month Studies
, actually came as a great surprise. And if you don’t believe me, read the article yourself: the logic is often backwards and filled with FUD. The Pharma version of FUD (PHUD) is served straight up in the article:

They also warned that the policy would cause drug companies to scale back on developing new drugs because of the potential increase in expense and risk.

Now I don’t toe a Scientology-like position where all psychiatric drugs are evil. There is a place for them, and there is a need to develop better drugs, especially given the side-efffects of so man y of them But what is clear, given these drugs, many of which are used on younger and younger kids, more caution and regulation would seem like the more prudent thing to do.

The article is included below:

By Shankar Vedantam
Washington Post Staff Writer
Wednesday, October 26, 2005; A03

The government will back down from a plan to require long-term studies of new psychiatric drugs before allowing them on the market, regulators said yesterday.

The reversal of the recently adopted policy came after a panel of experts unanimously recommended against requiring such studies as a condition of approval. While such studies are needed, the experts said, delaying decisions on new medications would hurt patients.

The panel’s vote came after it heard a barrage of complaints from industry executives, academic researchers and patient advocates. All the critics predicted that the policy would lead to delays in bringing new drugs to market while providing little new information that may not apply to most patients. They also warned that the policy would cause drug companies to scale back on developing new drugs because of the potential increase in expense and risk.

The new plan, which the Food and Drug Administration had begun to implement over the past six months, called for companies to conduct studies for as long as half a year before seeking approval of new drugs. Like many other medications, psychiatric drugs are typically approved on the basis of positive results from two short-term studies, each of which may last only eight weeks.

Because physicians routinely prescribe psychiatric drugs for much longer periods, the FDA had started demanding longer-term data, as do regulators in the European Union, said Thomas P. Laughren, director of FDA’s Division of Psychiatry Products. After the emphatic rejection by the panel yesterday, Laughren said regulators will “back off.”

Criticism of the plan was voiced in all 15 presentations made at the panel meeting yesterday, prompting the chairman of the advisory panel, University of Florida psychiatrist Wayne Goodman, to implore his fellow scientists to mount an argument in favor of the requirement, if only to play “devil’s advocate.” But all the panelists agreed with the academic researchers, patient advocates and industry executives from Merck and Co., Wyeth Pharmaceuticals, Eli Lilly & Co. and other companies in stressing that the new federal requirement would have adverse consequences.

In the real world, as many as half of all psychiatric patients switch medications after three months of treatment, and as many as 70 percent switch after six months, said David Michelson, executive director for neuroscience medical research at Eli Lilly, which makes Prozac and other psychiatric drugs.

Asking companies to conduct trials that show that medications work for six months or longer will lead to trials that focus on the small subset of patients who do well for such long periods, rather than on the majority that do not, Michelson and others said.

As a result, added Gary Sachs, a Harvard University researcher who testified at the meeting, such data will be of little help to clinicians in the real world who usually have to deal with less predictable cases.

“I believe the public interest is not served by this requirement, and it could cause a lot more harm and confusion than benefit,” Sachs told the panel. “It would be telling someone with a heart attack that we have a drug that we know works, but we can’t give it because we don’t yet know whether it would prevent further heart attacks.”

Sachs and other experts said “effectiveness studies” that can guide clinicians about which drug to try first, and when patients should stop taking a medication, are very valuable — but their complex design and requirements mean they are best conducted at public expense by research institutions such as the National Institute of Mental Health.

While that institute does fund such studies, Sachs said, “their commitment to do that is substantially less than we would wish.”

October 25, 2005

Shifting Bits in NYC

Category: Uncategorized — @ 5:25 pm

Last weekend was chock full of geeky events, mostly because there were many out of towners visiting NYC, which made me migrate there for the weekend. The highlights were: hanging with Seth my ex-SF roommate at the Software Freedom Law Center inaugural party, seeing some eggplant folks from Vermont, hanging with debianites and seeing some live shows. Particularily good and unusual was the 8 bit music show at the tank. The best performance was given by Bit Shifter. Check out some of his electrifying music dominated sounds of video games here

October 20, 2005

Delocate this

Category: Politics — @ 10:02 am

Forgot to mention that in CA I had the pleasure to meet the person, “xtine,” behind this handy net tool: the delocator

October 19, 2005

Inter-galactic travels

Category: Research,Travel — @ 9:38 am

Flying across the country during a nearly nation-wide cloudless day is nothing but striking. The first coast, for me being the east coast, is packed with human presence, nestled in green and this past weekend, was drenched in water. Then much of the country in the middle is sparse and the dramatic landscapes—the jutting Rockies covered in white, the hollow but topographically reddish-brownish Grand Canyon—makes them selves heard, and loudly. By the time you reach the other coast (if you fly into Los Angeles, like I did at least), human signs are in full swing again, notably in the form of concrete. Flying into LAX has its own peculiarities. If one did not know that wafting brown translucent film was pollution, one might think it was some natural and pleasant outgrowth of the brown hills that edge the city.

I left CA 2.5 years ago and went for my first visit this past weekend. I went to give a talk at the BioArt and Public Sphere Conference at UC Irvine. First I stopped in LA for a weekend of family fun since I had not seen my brother and his children in way too many years.

In the last year I have been on a self-imposed conference hiatus. Being they entail signigicant prep work, travel, and once there a lot of attention, they can act as a string of interruptions that last year I could not afford as I had to finish my dissertation. But now, I am back on the conference circuit, in part to present finished work and in part to present emergent, embryonic work in need of some serious shaping up.

So I felt particularly lucky to be invited to speak on my new project on psychiatric survivors as it really forced me, in the last weeks, to jump in to a whole set of new materials. The project went from a formless entity, residing primarily in the deep and inaccessible (even to me) recesses of my brain, into a formed substance that will hopefully, over time, become something more substantial.

The conference was one organized around one my favorite formats: an intimate one day affair and I would say incredibly unique in its inter-disciplinary nature. Ok, so most conferences fancy themselves interdisciplinary and, to some degree, they are: in attendance are sociologists, anthropologists, historians, crit lit folks and so on but we tend to reside in more or less the same galaxy, located perhaps on different planets. At this conference, being there were artists, engineers, biologists, activists, and the social sciency types, interdisciplinary functioned more along the lines of inter-galactic. It is not always an easy conversation to have because the distances between galaxies are much longer than between planets, but, lets face it: inter-galactice travel is a blast.

If you are interested in any of the talks, I think that the organizers are soon going to put up an archive of photos, video, and audio.

There were too many fascinating and important topics raised to discuss but here are some of the projects/talks that I found particularly interesting because I perhaps knew nothing about them until this weekend. First, if you don’t know about SymbioticA, well then learn a little about them as this project/lab/concept is probably one of the only fixed places with significant resources (as in a lab) where the intersection between bio-science and art is being created and sustained. Before this conference, there was another week long event BioTech Art Workshop Conducted by Symbiotica

One of the conference goals was to examone how to create a more participatory sphere between experts and non-experts in science via the avenue of art. Claire Pentecost, an artist based out of Chicago, raised this question pointedly. She explored the structural similarities between science and art in relation to the public (they are somewhat esoteric, inaccessible, etc) to problematize the idea that art is easily equipped to act a bridge that gets us toward greater accessibility. In other words, it is not just science that is esoteric, often, so is art. Along with raising that very difficult question that should be asked if such a bridge can ever be crossed, she also presented with the most vivaciousness and flair, which is I so appreciate since we sit for a full day of listening.

Sujatha Byravan also talked about The Council for Responsible Genetics, which has done some amazing work in its 20 + year existence. I was very happy to find out about their work and think that as bio-genetics and similar fields have a routine but perhaps unseen impact on our lives, their work becomes even more important.

Finally, Rachel Mayeri, a video artist and professor at Harvey Mudd, showed her video Stories from the Genome. Here is an excerpt from her website about it:

Part cloning experiment, part documentary, Stories from the Genome follows an unnamed CEO-geneticist whose company sequenced the Human Genome in 2003 – a genome that secretly was his own. Not satisfied with this feat, the scientist self-replicates, producing a colony of clone-scientists to save himself from Alzheimer’s. The animated video switches between misadventures in cloning, and a history of equally improbable theories of human development.

Stories from the Genome is based on the true life story of Craig Venter, who was the CEO of Celera Genomics in a race with an international consortium of scientists to decode the human genome. He did in fact use his own genetic material for the Human Genome Project, completed in 2001, despite much fanfare about the “diversity” of human populations it would represent. The video is intended to comment upon the dangers of short-sighted, self-interest in contemporary biotechnology and its appropriation for profit of human genetic information.

The video was stunning, in part because it was, peraps in some respects, an answer to the question that Claire raised. This video was not so esoteric, but incredibly accessible, however, not because it was simple or simplified the issue. It was accessible because it was a fun and funny interestinng story that could captivate, and thus take you along a short ride to explore the complicated issues and implications of genetic technologies. Combining weirdness, wonder, and humor, with a great dose of special effects, this video is well worth watching if you can get your hands on a copy.

October 18, 2005

Africa Source II

Category: Politics,Tech — @ 4:58 pm

If you are interested in or work on F/OSS, NGO’s and Africa, then this event, Africa Source2 may be for you. Over the years Tactical Tech have hosted these source camps, and from what I hear, with each passing event, they make sure the next one is even better.

Africa Source II -
Free and Open Source Software for Local Communities
Kalangala, Uganda – Jan 08-Jan 15, 2006
Please note that the deadline for sending in applications has been extended until October 24th, 2005.

We welcome applications from those working in Africa who are;
- campaigners, practitioners or project managers working within non-profits and interested in technology
- system administrators within NGOs, or acting as technical support to non-profits or community centres
- trainers and consultants to the non-profit sector, or those working in resource centres who are interested in technology

What is Africa Source II?
Africa Source II will be an eight day hands-on workshop aimed at building the technical skills of those working with and within NGOs on the continent. It will take place in one of the most beautiful parts of the Kalangala Island on Victoria Lake during the beginning of January 2006.
Africa Source II will focus on how technology, in particular Free and Open Source Software (FOSS) can be integrated into the project work of NGO’s. Over a hundred NGO Support Professionals and NGO Staff working at the local level across the region are expected at this meeting. Together with a handful of field leaders from Africa, Europe, North America and Asia, they will explore how technology can best serve the non-profit sector in Africa both in terms of access and content. I

We are still accepting applications! The deadline for sending in applications has been extended until October 24th, 2005.

October 6, 2005

Problems with gmail?

Category: Tech — @ 11:25 am

So I use gmail for about 1/2 of my mail but it is becoming clear to me that it gobbles, like a big fat hungry turkey, my outgoing mail. I know of a number of occasions when my mail went out but was never received. I have had, for example, my dad check his spam folder but it was not there either. So not that gmail was all that grand (though handy at times), I think the days of gmail are soon to be over.

How do we Deconstruct? We Construct

Category: Books/Articles,Ethics,Politics — @ 7:51 am

One of the truly great things about my postdoc is I am reading again. And reading a wide range of books and articles. Some of it is reading for our working groups (for example Jody Greene’s excellent, really excellent, work on the the relationship between liability and property established by copyright), other reading is on psychiatric survivors and then I am catching up on some theoretical stuff on politics, being that is the backbone of much of my work.

I just finished “Contingent Foundations” by Judith Butler, which is a concise and short piece touching on her signature topic: the nature of politics when you are anti-foundationalist and you confront the reality of discursive constraint. On the one hand, some of her work deeply resonates with me, for after all, I am not one to champion individuality along the lines of unhinged agency and am precisely interested in how political action manifests within a field of various constraints. What I like about Butler is that despite her penchant for deconstruction, she steers clear from the twin towers of cynicsm and nihilism and attempts to affirm a positive (if not positivist) and emancipatory politics. In her own words:

“… if feminism presupposes that “women” designates an undesignatable field of differences, one that cannot be totalized or summarized by a descriptive category, then the very term becomes a site of permanent openness and resignifiability.. To deconstruct the subject of feminism is not, then to censure its usage, but on the contrary, to release the term into a future of multiple signification, to emancipate it from the maternal or racialist ontologies to which it has been restricted and to give it play as a site where unanticipated meanings might come to bear. Paradoxically, it may be that only through releasing the category of women from a fixed referent that something like ‘agency’ becomes possible. For if the term permits resignification, if its referent is not fixed, then possibilities for new configurations of the term become possible.” (1992: 16).

On the other hand, despite a positive politics, I feel that the nature of political action in her work and many in her class, is left unspecified, and here I mean in a very pragmatic sense. How is it exactly do we “release the term into a future of multiple signification”?

I agree with her that categories, words, etc., the world of the discursive, is much more bloated than most language ideologies will let on. Resignification is possible, especially when we contest the universalisms that presuppose some of our cherished categories. Yet, sometimes you get the feeling that resignification is a simple act of language and will (just the thing she writes against) as opposed to requiring an engaged and difficult material practice by which new subjectivities and moralities can be born through building of alternative moralities. One must engage in a dialectic between a desire for alternatives that exists in an inchoate and imaginary plane, and its realization through the medium of intersubjective action. For it is through a material vehicle in which one can participate in the process of resignification and more importantly embody new meanings.

October 5, 2005

Producing Open Source Software

Category: Books/Articles,Hackers — @ 7:59 am

My friend Karl Fogel has recently published a book on free software projects that should be of interest to researchers and developers alike: Producing Open Source Software. Karl and I were feverishly writing our free software “stuff” at the same time, meeting up for dinner and late night deserts to take small breaks from what was an obsessive and compulsive time in our lives.

Karl is an excellent writer and has put a LOT of thought into this book, which gives to-be-project-leaders a serious heads up on how to go about organizing a project. Even if it is more of a “how to” book, it is ethnographic in the sense that he derives his data from, well, being a participant in free software development. And for those who like to pick apart the cultural and ethical world of F/OSS, well this is an excellent book to scour because of its normativity.

Truly he has thought of almost everything to cover, from the technologies that are imperative for development to the problem ofdifficult people

And true to his geek ethics, the book is free as in speech. So order it, or download it, or read it online; it is there for you to read and share!