November 17, 2005

In the press: pharma

Category: Pharma,Politics — @ 5:08 am

This week has seen a number of provocative articles in the mainstream press on the debates surrounding the blockbuster SSRI’s which made some pharma companies very rich in the last decade:

Fortune published Prozac Backlash, Trouble in Prozac Nation and the NY Times has published a piece on David Healy, the most famous academic whistleblower who was denied tenure because of his criticisms of such practices as ghostwriting as well as for uncovering the suicide risks that SSRIs carry.

update: There is also this fascinating piece from the NYTimes: Young, Assured, and Playing Pharmacist to Friends. This speaks to dramatic changes in prescription practices and knowledge due to direct to consumer advertising as well as knowledge sharing on the Internet. Below is a nice excerpt from the Times:

Direct-to-consumer drug advertising, approved by the Food and Drug Administration in 1997, has for most of their adult lives sent the message that pills offer a cure for any ill. Which ones to take, many advertisements suggest, is largely a matter of personal choice.

“If a person is having a problem in life, someone who is 42 might not know where to go – ‘Do I need acupuncture, do I need a new haircut, do I need to read Suze Orman?’ ” said Casey Greenfield, 32, a writer in Los Angeles, referring to the personal-finance guru. “Someone my age will be like, ‘Do I need to switch from Paxil to Prozac?’ ”

For Ms. Greenfield, who could recite the pros and cons of every selective serotonin reuptake inhibitor on the market by the time she graduated from college, years of watching doctors try to find the right drug cocktails for her and for assorted friends has not bolstered faith in their expertise.

November 15, 2005

Direct to Consumer Advertising

Category: Pharma,Uncategorized — @ 9:56 pm

The only two nations that allow direct to consumer pharmaceutical advertising are the United States and New Zealand. Apparently the US is now innovating on the concept, taking it to a whole new level:

This is the first time I have seen an ad of this nature, which was published in the New Yorker this week.

November 13, 2005

A possible DRM solution

Category: Politics,Tech — @ 6:03 pm

Recently I wrote about a DRM and Anthropology debacle asking for help for a fellow friend whose files are basically in limbo-land, totally stuck, in a format that can’t be converted. I asked for comments but, brilliantly, did not open the comments. So here is one useful one passed along by email:

Here is a small, not completely cheap box which can take the protection code off the digital audio, at least at some situations of usefulness in a digital chain.

http://www.m-audio.com/products/en_us/CO3-main.html

It could help your situation, I think. However, Sony, if you have been following the news recently, hires all sorts of incompetent people to design their DRM things.

So I think there is no way to find out for sure except to have someone pretty capable with digital audio try some things with your locked-out backups, probably just the other digital audio gear you have, and this box.

They may have to think a little to get it to work out, so find one person or more who like to be clever.

Good luck. And thanks for bringing this out…

update
And then I got this from Patrice R today, refering to the fact that many famous anthropologists lost thier data:

M.N. Srinivas “The Remembered Village” , I think the nicest case of lost date got
best book. And if I am not mistaken Fernand Braudel’s “La Mediterranee” is also the
result of lost data (FB in a German POW camp, MNS in an arson at Stanford)

The Left and Right Coast–Regulating Search

Category: Politics,Tech — @ 4:13 pm

So as part of my research and studies, I went from midwest, to west coast, and now I am back on the east where I used to live. While the midwest is home to one of the most prestigious law schools, there is very little activity related to technology, IP, and free speech issues–on academic or activist lines, at least in comparison to the other coasts.

On the west coast the activity was and still is overflowing but much of it was advocacy, policy related, or political in nature. Not to mention there are tons of grass roots initiatives related to this sort of stuff. Stanford law school and Boalt school of law however, guaranteed a consistent academic face.

Out on the east coast, I feel there is much less non-legal as well as perhaps legal (but I may be very wrong on that account) advocacy but the academic presence is very well developed, for example with seminar’s such as NYU’s Colloquium on Information Technology & Society and numerous conferences. One of the up and coming ones looks particiularly good,
Regulating Search: A Symposium on Search Engines, Law, and Public Policy. Certainly worth going to if you are around.

November 2, 2005

Anarchism and Christianity

Category: Politics — @ 5:50 pm

I am not sure when my friend Pedro has time to write this stuff but he apparently he doe. If you are interested in a critique of corporations, and the relation between anarchist ethics and Christianity, look no further. Pedro has written plenty on the subjects, neatly divided in three parts:

Anarchy as a Political and Ethical Option
Part II
Part III

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 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 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

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.

August 24, 2005

Go Debian Women

Category: Politics,Tech — @ 3:21 pm

I have been following Debian for years. For most of them, female presence has been uncomfortably sparse. But thanks to a recent effort ,led by some great ladies, to bring awareness to the existence of women and to encourage more to apply, there indeed has been an upsurge of developers and developers to be. Shows that some organization and visibility can go a far ways.