Wednesday, May 31, 2006

 
AIDS is not really "slowing down"

After 16 years of activism I get a little tired of these snapshots of the AIDS Pandemic that mislead people and give a false impression of the infectious disease picture.

The “numbers” these articles are quoting change all the time, week to week. And as with most statistics, these “numbers” are not necessarily accurate. There are many factors given too much or too little weight, as well as downright errors and short-sighted research criteria.

Americans are infamous for over-simplifying, trying to make issues look black & white when there are many shades of gray. The truth is the Infectious Disease Pandemic is much more complex and challenging, and much worse than our anemic mass-media has been telling you. If we weren’t so distracted we would know that Bird Flu is mostly bullshit, fed to us by George W. Bush. How much do you think Bush knows about illnesses and medicine?

If you really want to understand what’s going on, do research on the following: TB, Malaria, Hepatitis C (HCV) and MRSA – and Multi-Drug Resistant (MDR) strains of all these infectious illnesses. The picture is much more complex and much more serious than most people understand.

But infectious illnesses are scary, and we are infamous for ignoring that which scares us.

Friday, May 26, 2006

 
Researchers surprised to find no link between marijuana, lung cancer -
Study's findings apply even to heavy pot smokers:
Marc Kaufman, Washington Post
Friday, May 26, 2006

The largest study of its kind has unexpectedly concluded that smoking marijuana, even regularly and heavily, does not lead to lung cancer.

The new findings "were against our expectations," said Dr. Donald Tashkin, a UCLA pulmonologist who has studied marijuana for 30 years.

"We hypothesized that there would be a positive association between marijuana use and lung cancer and that the association would be more positive with heavier use," he said. "What we found instead was no association at all, and even a suggestion of some protective effect."

Federal health and drug enforcement officials have widely used Tashkin's previous work on marijuana to make the case that the drug is dangerous. Tashkin said that while he still believes marijuana is potentially harmful, its cancer-causing effects appear to be of less concern than previously thought.

Earlier work established that marijuana does contain cancer-causing chemicals as potentially harmful as those in tobacco, he said. However, marijuana also contains the chemical THC, which he said may kill aging cells and keep them from becoming cancerous.

Tashkin's study, funded by the National Institutes of Health's National Institute on Drug Abuse, involved 1,200 people in Los Angeles who had lung, neck or head cancer and an additional 1,040 people without cancer matched by age, sex and neighborhood.

They were all asked about their lifetime use of marijuana, tobacco and alcohol. The heaviest marijuana smokers had lit up more than 22,000 times, while moderately heavy usage was defined as smoking 11,000 to 22,000 marijuana cigarettes. Tashkin found that even the very heavy marijuana smokers showed no increased incidence of the three cancers studied.

"This is the largest case-control study ever done, and everyone had to fill out a very extensive questionnaire about marijuana use," he said. "Bias can creep into any research, but we controlled for as many confounding factors as we could, and so I believe these results have real meaning."

Tashkin's group at the David Geffen School of Medicine at UCLA had hypothesized that marijuana would raise the risk of cancer on the basis of earlier small human studies, lab studies of animals and the fact that marijuana users inhale more deeply and generally hold smoke in their lungs longer than tobacco smokers -- exposing them to the dangerous chemicals for a longer time. In addition, Tashkin said, previous studies found that marijuana tar has 50 percent higher concentrations of chemicals linked to cancer than tobacco cigarette tar.

While no association between marijuana smoking and cancer was found, the study findings, presented to the American Thoracic Society International Conference this week, did find a 20-fold increase in lung cancer among people who smoked two or more packs of cigarettes a day.

The study was limited to people younger than 60 because those older than that were generally not exposed to marijuana use in their youth, when it is most frequently tried.

Page A - 2
URL: http://sfgate.com/cgi-bin/article.cgi?file=/c/a/2006/05/26/MNGAKJ2S481.DTL

©2006 San Francisco Chronicle

Thursday, May 25, 2006

 
Elevating the Qaulity of Discourse:

I love web logs. They are a natural extension of the World Wide Web (WWW) as a communication medium. There are some brilliant political and/or sociological blogs by people who might never get a job at a “mainstream” paper, or even get their views published as independent journalists. They are intelligent, insightful and thought provoking. Often they call attention to something the mass media fails to tell us.

“If it bleeds it leads:”

So let’s talk about the mass media for a moment. The editors at the Washington Post and Fox News exhort their reporters to cause an emotional reaction with every single story, mostly a negative one. Fear and Anger. They really don’t care about their readers or they would not cause this needless negativity just to sell their product. They hire people with questionable journalistic backgrounds who have axes to grind, people who care nothing about integrity or honesty.

I believe people are tired of negativity, shouting and being whipped into a frenzy. I believe there will be a backlash against the mass media outlets in the near future. Personally, I would love to see AOL Time Warner, The Washington Post, Fox News and their ilk pushed out of business – but I’m not holding my breath waiting for that to happen. At the most they may be forced to retool, fire a few of their worst, and change the way they present the news. It may be a pipe dream but stranger things have happened. When you put out all that negativity it will eventually come back to haunt you. Such is the nature of karma.

Reaction and discussion:

As it has been pointed out to me by some very astute friends and colleagues, even at the founding of this country (America) people in the public eye behaved badly. Argument became personal attack and character assassination. In our modern era, this form of discourse was refined by the Reagan Administration. Instead of forming a valid counter-argument it became standard to go after your opponent. Character assassination and repetition of your lie were became answer to a reasoned argumentative response.

And the problem has only grown worse. We are at a point where most people don’t even know how to form a reasoned argument. They go by what they see in the public sphere. Reaction has replaced response. Discussion becomes verbal violence. If I scream louder than you I “win.” Derogatory labels shut down the discussion.

I’ve heard people who disagree with Bill O’Rielly (Fox News) on air are told to leave the studio before the show ends because he may physically attack them backstage. These are the type of men we give a national platform to, awful people get the biggest voice. Everything from politics to financial investing have to be presented in this “screaming head” format. It’s disgusting, distasteful and arrogant. Yet we pander to it, encourage it and support it. This is one of the major reasons I don’t watch live TV very much.

Raising the quality of discourse:

The only way to combat this disturbing trend is to raise the quality of discourse, to stop watching these awful people until their shows are cancelled from lack of interest. I don’t care where you’re coming from, extremism is ugly from the Left or the Right. Open hostility and arrogance is abhorrent. It should not be an acceptable form of behavior in any forum.

But it starts on the street level. It starts with us. We need to respect each other and engage in reasoned, logical argument. If you have no factual basis for your argument sit down and be quiet. Screaming and attacking others won’t make you right, it never has and it never will. Once the dust settles you will just appear as ignorant and ugly as men like O’Rielly. If you state your beliefs people can choose to agree or disagree with you. That is enough. As desirable as it is you cannot force your beliefs on another person. You may get someone to agree with you just to quiet you down but in the long-term you accomplish nothing.

I don’t have to agree with you. We all have the right to our beliefs and opinions. That is the beauty of democracy. True freedom gives us the right to live as we choose, but we can only be as free as we allow others to be, without prejudice or vindictiveness. The WWW gives everyone the chance to express themselves and be heard.

Freedom of religion only works if everyone is free to practice their beliefs, or not to. I value your right to believe whatever you choose, but not to push your beliefs on me. If I want to be part of your belief system I can make that choice for myself.

And if you wish to engage in discourse you should be civil. If people don’t share your beliefs that is their right. It doesn’t make them any less or more human than you. Topics like religion and politics can be provocative and passionate, so being sensitive to others is pivotal.

Labels are traps:

There is a commonly held belief that we need to have a discussion on race and the past, present and future of the civil rights movement. But people who don’t wish to be challenged will call others racist, “Uncle Tom,” or “Oreo,” (black on the outside, white on the inside.) And people who are afraid of being labeled will engage in a type of insidious “politically correct” speech that accomplishes nothing. Labels are a way of shutting the other guy down and it’s an underhanded and dirty trick. When you label others you get labeled in the process and nothing changes. Nobody likes being attacked so it’s easier to throw up one’s hands and simply walk away.

Disagreement is cool but labels are not. If you want to know what the other person’s motives are you need to ask them without rancor or accusation. While it may be human nature to apply labels to things it’s best kept as an internal process.

Conclusion:

We need to call people on their incivility in a civil manner. The best way to elevate discourse is to always take the high road, even if the other guy (or gal) does not. We need to turn off the TV when the “screaming heads” come on, and write to the sponsors of those programs, telling them how we feel and boycotting their products until they move their support elsewhere. I fully support the ongoing boycotts against Fox News and other media outlets that focus on negativity and rage, but that’s just me, (and millions of other people who are tired of this stuff.)

Then we take responsibility for how we talk and behave, and make it clear we expect the same of others. A person who does not respect the boundaries and/or the feelings of others should be removed from the discourse until they can control themselves. We need to teach kids it’s not okay to behave in a rude manner. It’s not okay to violate the boundaries of others and treat them with disrespect, yet we tolerate this behavior all the time. Tolerance of inappropriate behavior is approval of that behavior.

Kindness and Respect have to be our constant watchwords. We are capable of this and it’s time we upheld these standards. Saying; “it can’t be done” is an excuse, not a valid reason. It can and should be done, every single time.

Tuesday, May 23, 2006

 
Fogbound needs a new editor:

http://community.livejournal.com/fogboundwrite/


Our original editor has walked away from the idea of helping other artists without being paid, and that is in direct violation of our charter. Fogbound is about helping self-publishing writers succeed without seeking to profit directly from their work.

Any editor who agrees to work with Fogbound may offer their editing services as a separate enterprise, but our purpose is to advise and consult without trying to make a buck, to help grow the community.

Unfortunately, there are people on the fringe of any artistic community that seek to profit from the work of others. As artists we are keenly aware of the fact that we don’t make a lot of money from our art. If profit-seeking were our motive there would be no art. But some seek even to take a bite out of the meager income our work may garner.

Fogbound is about helping and integrity. As founder I will never allow the group to be used or do anything that betrays the trust of our authors. As you can tell, this is a bit of a sore point with me.

If you are a talented editor who wishes to make a difference in our community, we would love to have you on board! Any work that goes through us is approved by all members of the group, which currently is comprised of our Graphic and Web Director (Charlie Hale) and myself. My area is marketing and promotion, and I run the day-to-day aspects of our group. Any editor who joins us would have an equal voice.

We already have two authors interested in what we have to offer, and there is a group of artists and community leaders who are following our birth and growth. I believe Fogbound has an exciting future, and if you’re a editor who wants to make a difference in the community I hope you will join us.

Interested editors should email me at: phil@valdemar.net

Sincerely, Phil Alden

Monday, May 22, 2006

 
It's going to be an interesting summer:

"I wrote the following document in 2004 when it became clear to me that AT&T, at the behest of the National Security Agency, had illegally installed secret computer gear designed to spy on internet traffic. At the time I thought this was an outgrowth of the notorious Total Information Awareness program, which was attacked by defenders of civil liberties. But now it's been revealed by The New York Times that the spying program is vastly bigger and was directly authorized by President Bush, as he himself has now admitted, in flagrant violation of specific statutes and constitutional protections for civil liberties. I am presenting this information to facilitate the dismantling of this dangerous Orwellian project."

Former AT&T technician Mark Klein
May 22, 2006

Sunday, May 21, 2006

 
Open Letter to the CDC about Hepatitis C (HCV) testing:


May 21, 2006

Centers for Disease Control and Prevention
Public Inquiries/MASO
Mailstop E11
1600 Clifton Road
Atlanta, GA 30333

Re: Widespread testing for Hepatitis C, (HCV)

Greetings:

As a long-time activist, freelance journalist and community volunteer, I fully support your call for widespread HIV testing. In fact, I don’t think it goes far enough. HIV testing should be as automatic as any other type of diagnostic. The more routine the less the stigma. Still, I applaud you for making this move.

But HCV is even more widespread than HIV, as you folks well know. I believe HCV testing should be as routine as HIV testing, if not more so.

But with both, counseling both before and after are integral in helping people get through the process. Many hospitals and clinics are dropping the counseling component due to cost and time constraints. If the federal government does not provide the resources for the entire process we do people a terrible disfavor.

Your goals are admirable, but HCV testing should be an additional component to HIV testing and routine diagnostic procedures. I hope you will consider this in future policy decisions.

Until then, keep up the good work!


Sincerely, Phillip T. Alden

Saturday, May 20, 2006

 
May 20, 2006

An open letter to Senator Liz Figueroa:

Liz Figueroa
43801 Mission Blvd., No.103
Fremont, CA 94539

You placed a large billboard in my neighborhood, (along highway 101,) stating; “Jackie Speir wants to take away your health care.” As a freelance journalist, activist and volunteer, I object to this constant negativity during political campaigns, and when I speak to civic groups I tell them the following:

Americans are tired of the politics of fear and negativity. We are tired of being afraid and angry, and tired of a media that consistently feeds this dark side of human emotion. There is a backlash that is growing against media outlets and politicians that prey upon our emotional state. In the following months you will hear about this more and more, and those who have not learned this lesson will find themselves increasingly isolated and rejected.

I urge you to speak out against the politics of negativity. It’s not enough to change your vote, (or worse, to not vote at all.) Vote for the candidate that takes the high road by all means, but also take time to write a letter or email to the negative candidate. Let them know why they lost your support.

And talk with your friends and fellow voters. Post an entry to your web log. When we share our disgust with the politics of fear and negativity we change the way the game is played.

Take down your negative billboards, Senator Figueroa, and stop pandering to the worst aspects of human nature. You will only earn the enmity of voters and community leaders, you will lose our votes and you will lose elections.

Sincerely, Phillip T. Alden

Friday, May 19, 2006

 
ALERT!!! Support Indian People Living with HIV/AIDS in Opposition to Gilead's Patent of Tenofovir


***INTERNATIONAL ACTION ALERT***


Support Indian People Living with HIV/AIDS in Opposition to Gilead's Patent


Application:


Take action today: Tell the government of India to reject the patent application by Gilead for a key AIDS drug, tenofovir, because it is not patentable under Indian law.


Background: On May 9 2006, the Indian Network for People Living with HIV/AIDS (INP+) and the Delhi Network of Positive People filed an opposition at the Delhi Patent Office to Gilead's patent request for a key AIDS drug: tenofovir disoproxil fumarate (TDF). (Gilead's brand name for TDF is Viread.)


TDF is a crucial AIDS drug that is urgently needed in the developing world, particularly for people who have become resistant to older drugs and need second-line HIV treatment at an affordable price. A patent monopoly on TDF in India would prevent generic competition, blocking access and keeping prices high in India, sub-Saharan Africa and throughout the developing world. Future generic production of fixed-dose combination pills containing TDF would also also be blocked.


TDF is not patentable in India--TDF consists of a salt (fumaric acid) formed out of a known compound (tenofovir disoproxil). The process of forming a salt out of an existing compound is common practice within the pharmaceutical industry. TDF does not meet the standard for patentability under Indian law, which states that "new forms of a known substance" such as a salt, which does not increase the efficacy of the known substance, are not inventions, and are therefore not patentable.


Now that the opposition has been filed, the Government of India needs to feel pressure from around the world, particularly from people living with HIV/AIDS in countries that desperately need access to generic TDF.


Upcoming events, like the UN General Assembly Special Session (UNGASS) AIDS Review May 31-June 2 in New York are key opportunities to send a message to the Government of India and the international community that Gilead's frivolous patent application must be rejected--TDF is not patentable in India.


Take action today: Call, fax and e mail Indian government representatives and tell them India should NOT grant a patent on TDF.


1. Ms K. Sujatha Rao
Director General, National AIDS Control Organization
Ministry of Health & Family Welfare
Government of India
9th Floor, Chandralok Building
36, Janpath
New Delhi 110001
India
email: sujatharao@yahoo.com
asdg@nacoindia.org
tel: +91 11 233 25331
fax: +91 11 2372 1746


2. Dr. Manmohan Singh
Prime Minister
The Prime Minister's Office
South Block, Raisina Hill,
New Delhi 110 011
tel: 91 11 230 12312
fax: 91 11 230 19545 / 91 11 230 16857


Key messages:


Tell Ms Sujatha Rao and Prime Minister Monmohan Singh's offices:


Who you are and where you are calling from, particularly if you are in a country that imports generic AIDS drugs from India;


That in order to ensure the sustainability of AIDS programs in India and around the world, the TDF patent should NOT be granted; Gilead's patent application is frivolous and TDF is not patentable


Do not be mislead by a Gilead offer to do "voluntary licensing" of TDF to a generic Indian manufacturer: TDF is not patentable in India, so a promise of voluntary licensing is irrelevant, and an attempt to distract from the bottom line: the patent SHOULD NOT be granted


Their decision on whether or not to grant a patent on TDF will have an international impact on the availability and affordability of this key medicine


People living with HIV/AIDS and AIDS organizations are watching them closely, and call on them NOT to grant a patent for this critical drug. TDF does not meet the standard for patentability according to the India Patent Act; furthermore, on health grounds alone this patent should not be granted.


For more information: Below are briefing notes and a press statement from Medecins Sans Frontieres.


----------------BACKGROUND MATERIALS----------------


MSF Supports Opposition to Gilead's tenofovir Patent Application in India


Patenting Tenofovir Would Set Dangerous Precedent for Global Access to Newer Essential Drugs:


New Delhi/ Geneva, 10 May 2006 --- The medical humanitarian organization Medecins Sans Frontieres (MSF) is today expressing its support for Indian civil society groups in their battle against a patent application by Gilead Sciences for the key AIDS drug tenofovir. People living with HIV/AIDS in India opposed the patent application yesterday on the grounds that the drug consists of a previously known compound, and should not be considered an invention according to India's Patent Act.


If Gilead were granted this patent, generic production of tenofovir in India, where a generic version has been marketed since 2005, could be prevented until 2018, and any existing production would be in jeopardy. In addition, future generic production of fixed-dose combination pills containing tenofovir would also be blocked. Such combination drugs have had a major impact in helping scale up global AIDS treatment by simplifying it.


“Granting this patent would set a dangerous precedent. Limiting production of tenofovir and that of other newer essential drugs to a single company keeps prices high because generic competition is blocked,” said Ellen t Hoen, Director for Policy and Advocacy at MSF’s Campaign for Access to Essential Medicines.


Access to tenofovir in resource-poor settings is extremely limited. While Gilead, the patent-holder in most developed countries, has announced that it will offer the drug at a discount to 97 developing countries, the company has been extremely slow in making the drug available in these countries.


In MSF’s HIV treatment project in Khayelitsha, South Africa, where nearly 4,000 patients receive antiretroviral drugs, the difficulty in accessing tenofovir has resulted in only 40 patients with only the most urgent needs receiving the drug.


”We need tenofovir for more and more of our patients, but the supply from Gilead has simply been too unreliable, so we can't put more patients on it,” said Dr. Eric Goemaere of MSF in South Africa. “We have all been waiting impatiently to get tenofovir as a generic from India. Our project is a microcosm for what is to come elsewhere, and it is clear the world desperately needs more sources of this essential drug,” he added.


Tenofovir (tenofovir disoproxil fumarate TDF) is commonly prescribed as part of first-line antiretroviral treatment in the US and Europe. It is increasingly needed in resource-poor settings, both for patients starting treatment for the first time, because it leads to fewer side effects than other commonly used drugs, and for those patients who have been on therapy for several years. The latest World Health Organization (WHO) antiretroviral treatment guidelines recognize the importance of tenofovir for resource-limited settings, recommending its use in first and second-line regimens. But at the same time as tenofovir's importance is being underlined, access to it may be severely restricted.


The Indian Network for People Living with HIV/AIDS, represented by the Alternative Law Forum, Bangalore registered their opposition to the patent at the Delhi patent office yesterday. The public interest lawyers are arguing that forming a salt (fumaric acid) out of an existing compound (tenofovir disoproxil), is a common practice within the pharmaceutical industry, and should not be considered patentable under Indian law.


“For many of us living with HIV/AIDS, newer drugs like tenofovir offer new hope of continuing treatment. With patents interfering with our lives we have no choice but to oppose them,” said Loon Gangte, from the Delhi Network of Positive People, speaking at a press conference in Delhi.


Under the 2005 Indian Patents Act, anyone can submit comments in opposition of a patent before the patent office decides to grant or reject it. Cancer patients and generic drug manufacturers recently opposed a Novartis patent application for Gleevec (imatinib mesylate), an anti-cancer drug, on the grounds that the application claimed a new form of an old drug. The patent was subsequently rejected by the patent office.


MSF has been providing antiretroviral treatment to people living with HIV/AIDS since 2000. Over 60,000 patients currently receive ARVs through MSF worldwide.


----------------------------------------------------------------------------------------------------------


Briefing Note:


May 2006


Opposition to tenofovir patent application in India:


The Indian Network for People Living with HIV/AIDS (INP+), the Delhi Network:


of Positive People are opposing a patent application filed by Gilead Sciences in India on tenofovir disoproxil fumarate (TDF), a key AIDS drug. The organizations represent people living with HIV/AIDS in developing countries, and officially registered their pre-grant patent opposition at the Delhi patent office on May 9th 2006.


The Alternative Law Forum, Bangalore providing the legal support to INP+ argues that forming a salt (fumaric acid) out of an existing compound (tenofovir disoproxil), is common practice within the pharmaceutical industry, and should not be considered a new invention.


Medecins Sans Frontieres (MSF) supports Indian civil society groups in their legal battle of opposing the TDF patent application, as it wants to be able to access and use the drug in its HIV/ AIDS treatment projects around the world.


Tenofovir - A Crucial Drug for AIDS Treatment:


TDF is clearly emerging as an important option for patients starting AIDS treatment for the first time, and those who have been on antiretroviral treatment therapy (ART) for some time and require access to newer drugs due to occurrence of toxic effects or as they develop resistance to first-line drug regimens. Because there are fewer known side effects associated with the use of TDF in adults, it is commonly prescribed in the US and Europe, where the drug is widely available at a priced of over USD 5,000 per patient per year.


In its HIV/AIDS treatment projects in South Africa, MSF has been trying to access TDF, as patients who experience long-term side effects from other drugs need to be switched to a TDF-based regimen. MSF would like to be able to provide TDF to its patients who urgently require the drug.


The updated World Health Organization (WHO) ART guidelines for HIV/AIDS treatment in developing countries recognize the importance of TDF and recommend the drug for first and second-line regimens.It is ironic that at the same time as the WHO is underlining the importance of and recommending TDF, there is a risk that it may remain inaccessible to many patients in developing countries, if this patent were granted.


Very Limited Access to Gilead’s tenofovir in Developing Countries:


MSF has experienced serious difficulties in trying to access TDF in countries where it operates, due to the fact that the drug is not widely registered for use and marketed in developing countries. Gilead, the only producer of TDF until 2005, had announced greater availability of TDF in 2002 with a preferential price for low-income countries. So far Gilead has made limited progress in making the drug widely available.


Another barrier to TDFs use is its high cost in countries not eligible for the discounted price of $208 per patient per year. Gilead has made no offer to provide TDF at a discounted price to middle-income countries like Brazil, India, Thailand and China. In developed countries, Gilead's price for TDF is $ 5718 per patient per year.


If Tenofovir is Patented in India, Generic Production is at Risk:


Indian pharmaceutical companies have been working on developing generic versions of TDF. A generic version of TDF is already being marketed in India. Yet, if Gilead were granted a patent on TDF, such generic production of the drug in India would be likely to stop, making prospects of accessing generic versions of the drug worldwide slim, as many developing countries rely on Indian generics. A TDF patent in India would lead to Indian drug manufacturers having to withdraw their generic TDF from the market, and any other generic production of the drug would be effectively blocked until 2018.


In addition, a patent on TDF would further compromise ART in developing countries as it would act as a barrier for developing fixed-dose combinations, or FDCs, which combine two or three drugs in a single pill, such as TDF/3TC and EFV. Because FDCs significantly reduce pill burden and increase adherence to treatment, they have become the backbone of scaling up AIDS treatment in developing countries. A patent on any of the drugs comprising the FDC makes it impossible for a generic company to produce the


FDC. Despite the fact that antiretrovirals like lamivudine (3TC) and efavirenz (EFV) are not under patent in India, Gilead's patent on TDF would prevent Indian generic companies from developing this much-needed FDC.


AIDS Treatment Budgets are Likely to be Affected if TDF is Patented


Developing countries scaling up AIDS treatment programs under the WHO 3 by 5:


Initiative will be seriously affected. Currently 1.3 million people living with HIV/AIDS (PLHA) are accessing treatment under the 3 by 5 Initiative. In India, the National AIDS Control Organisation (NACO) provides 20,000 PLHAs with antiretroviral therapy. Unavailability of ARV drugs included in the WHO ART treatment guidelines for resource poor settings may impact the political will of developing countries to provide HIV/AIDS treatment.


The international medical humanitarian agency MSF began providing HIV/AIDS treatment in 2000 and is currently providing it to over 60,000 patients in nearly 30 countries including Thailand, South Africa and India. MSF hopes to source TDF from India in the near future, as Indian manufacturers are the source of 84% of antiretrovirals MSF uses in its AIDS treatment projects across the globe.


BACKGROUND ON INDIAN PATENT ACT AND PRE-GRANT OPPOSITIONS:


Indian Patents: One Year On:


About this time last year, the Indian Parliament approved the country's new Patent Act, thereby allowing pharmaceutical products to be patented in India. This new law put some serious constraints on generic competition but also included some potentially important features such as "automatic licensing" and the possibility for anyone to object to a patent before it is granted.


Although the law was not passed until last year, from as early as 1995, companies could start filing patent applications for pharmaceuticals in India with the patent offices. The Indian patent office started to examine these thousands of patent applications last year after the revision of the Indian patent law. Many patent applications for antiretroviral drugs (ARVs) such as tenofovir (tenofovir disoproxil fumarate TDF) and Combivir (zidovudine/lamivudine, or AZT/3TC) are waiting to be approved or rejected.


First Patent Granted in India in March 2006:


On March 3rd 2006, Roche announced it was "becoming the first pharmaceutical company in India to receive a product patent under the new patent regime". The patent was granted on peginterferon alfa-2a (Pegasys), a new generation hepatitis C therapy.


Because no generic versions of this product are being manufactured yet, any generic competition will be impossible until the new patents term runs out in 2017 unless the Indian government grants a compulsory license to another pharmaceutical company. Thus, this drug will only be available as a Roche product at about $5,000 per six-month treatment course, a price that obviously rules out the use of this drug in developing country settings.


Not all Patent Applications Lead to Patents:


Not all patent applications are valid. Many of the applications do not claim real inventions and therefore should not deserve a patent. Many patent applications are for a new use of old drugs, or simply for derivatives of old drugs or combinations of old drugs. The Indian Patent Act, if rigorously interpreted, provides several grounds for rejecting a patent, for instance if the pharmaceutical substance claimed is only a new form of a known substance.


Gleevec Patent Application was Rejected


On January 25th 2006, the Indian patent office rejected Novartis' patent application for its anti-cancer drug imatinib mesylate (Gleevac) on the grounds that the application claims a new form of a known substance (Novartis’ patent application was related to a particular crystal form of the salt of imatinib mesylate). The rejection was a major victory for the


Cancer Patient Aid Association of India and some Indian generic companies, which had both submitted a pre-grant opposition to the patent office. The rejection of the Gleevac patent gives reason for optimism.


Essential Drug Patents in the "mailbox" Waiting for Examination:


One of the next on the list for examination by the Indian Patent Office is Gilead’s patent for tenofovir disoproxil fumarate (Viread), as the patent application was filed with the Delhi Patent office in 1998. The Lawyers Collective, in collaboration with the Alternative Law Forum, is currently drawing up an extensive list of drugs based on medical needs and for which patent applications are pending in India.


What is the Pre-Grant Opposition System?


Due to the volume of patent applications, patent examiners often miss information related to the patent application under consideration about it being just an improvement of an old drug and not a new chemical entity. If attention is brought to information that shows that the patent application is for a derivative or a new use of a known drug, the possibility of invalid patents being granted is reduced. Opposing patent applications in the case of ARV drugs is feasible, as research has indicated that most of the patent claims for patent protection are for known pharmaceutical substances like polymorphs, salts, and combinations.


Anyone can bring such information to the attention of the patent controller through the pre-grant opposition process (as provided under Section 25 of the Indian Patents Act), and generic companies have already filed a number of pre-grant oppositions. In addition to companies, patient groups (INP+ and other state networks) and public interest organisations are also working to oppose patent applications for essential drugs.


On March 30th 2006, The Indian Network for People Living with HIV/AIDS (INP+), the Manipur Network of Positive People (MNP+), represented by the Lawyers’ Collective HIV/AIDS Unit officially submitted their opposition to a patent application filed in the Kolkata patent office by GlaxoSmithKline (GSK) for Combivir, a fixed-dose combination of two essential AIDS drugs zidovudine/lamivudine. The opposition is based on technical and health grounds. Clearly concerned that the granting of such a patent will increase the burden on developing countries already struggling to treat patients, INP+ objected to the Combivir patent application on the ground that it does not claim a new invention but instead simply the combination of two existing drugs.


Wednesday, May 17, 2006

 
Welcome to my public blog!

This is the place where I will cross-post articles I write and web log entries of an editorial nature.

 
Anyone who knows me knows I’m not some kind of anti-drug crusader. Normally I say that people have the right to poison their bodies any way they choose. I don’t like to see anyone destroying their minds or bodies with addictive substances but it’s a free world.

But my feeling on this changes when it comes to Crystal Methamphetamine, (also known as “Crystal Meth” or simply “Crystal.”) When Erik and I were in New Zealand nearly everything was refreshing about their society except when the conversation turned to Crystal. This chemical is causing destruction in every corner of the planet and people everywhere are concerned about its spread and use.

But there is a vicious dynamic in the gay community I call “The Crystal Crucible.” This dynamic involves sex, Crystal, Viagra and Poppers. Hank Wilson, a dear friend and tireless activist was the first guy to discover, (with the help of a local physician,) the fatal link between Viagra, Poppers, and cardiac arrest. When we meet our discussion always turns on these three substances.

“The Crystal Crucible” involves taking these drugs in combination to literally fuck all night. Crystal keeps one awake. Viagra fights limp dick caused by Crystal, (also known as “Crystal Dick.”) Poppers, (amyl nitrate,) increase the sensation of orgasm. As if this were not bad enough, add alcohol and other substances like Ecstasy and you have a powerful chemical mix.

Young gay men fall into this pattern of behavior and place themselves upon The Crucible. Like their heterosexual counterparts, they have no concept of what they are doing to their minds and bodies. They use these drugs to dance the night away and have sex for hours on end, additionally putting themselves at risk for exposure to HIV and other infectious diseases.

But the truly frightening part comes after they come down from the Crucible. Here’s a conversation I have heard too many times:

“My brain is damaged from the Crystal and I can tell. All the time.”

“My doctor says it’s permanent.”

Then I usually hear a story about another victim of the Crucible who took his own life rather than live with permanent, irreversible brain damage. The horror of the Crystal Crucible is something that is hard to understand until you see the effects afterwards. The hardest thing to do is to keep from weeping when I hear these men speak.

I wish I could tell you this is a rare occurrence, but it’s not. Crystal is destroying the minds of thousands of young gay men, and by extension, everyone else who uses Crystal Meth around the world. This is not the kind of drug addiction/abuse one can recover from and the damage it causes drives suicide rates.

And Crystal is not all that new to our landscape. It appeared in the 80s but its use was short-lived because it drove people into the ground so quickly it scared addicts.

That fear is gone today. Crystal is in every group, in every community, in every country in the world. It is literally spreading like wildfire through rural communities, damaging brains and destroying lives. The effects of Crystal use in large cities is hidden by factors in the environment, but that will not last. This is not just a “backwoods” problem.

People are free to make their own decisions, make their own mistakes. But the Crystal Crucible is too costly a mistake for us to turn a blind eye and leave it to free will. In the 80s AIDS was killing my community, today Crystal is the killer.

“Crystal causes permanent, irreversible brain damage.”

This is the message we need repeat like a mantra until everyone hears it. It’s our job to look out for our brothers and sisters, not only in the GLBT community but in the world at large. The sooner we get people to stop using Crystal the less brain damage they will suffer. And maybe we can save thousands of young men and women, gay and straight.

“Crystal causes permanent, irreversible brain damage.”

Pass it along, repeat it publicly – often.

This matters.

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