announcements, air pollution, and abbott

1) there was a post up about performing abortions that i took down on advice from a good friend. if you're interested in reading it, please send me an email or IM - i'd love to hear people's comments. thank you to everyone who has read/commented/helped me process so far.

2) I won the Global Health Action Committee (GHAC) Chair election in absentia at the AMSA National Conference in DC this past weekend :) i've definitely missed AMSA and am really looking forward to working with next year's leadership (esp all the GHAC coordinators and all GHAC peeps) in advancing global health action and advocacy.

3) Due to fires in Burma, Laos, and Thailand (both forest and those set by farmers who burn rubbish and/or practice slash & burn techniques) , the air quality in Chiang Mai has deteriorated considerably with decreased visibility and increased smog. Apparently the carbon particles in the air are more than twice the acceptable limit. Public health officials have encouraged immuncompromised & elderly to stay indoors if possible. Chris and i recently joined the ranks of those wearing masks whenever we venture outside.

4) There is a media war right now in the Asia edition of the Wall Street Journal regarding Thailand's issuance of a compulsory license on Abbott's Kaletra (liponavir/ritonavir), a common second-line HIV/AIDS drug (also used first-line in the US) with tons of back-and-forth among those supporting vs those hating on Thailand. There was a super inflammatory editorial titled 'Bangkok's Drug War Goes Global' in the March 7th edition of WSJ-Asia, and then lots of letters following. In any case, here's some quick background with all acronyms explained:

The Thai MOPH (Ministry of Public Health) announced that they were issuing a compulsory license (CL) for this drug a few months ago. For those not familiar with intellectual property/patent issues, this means that Thailand is going to make its own generic version of Liponavir/ritonavir using GPO (government pharmaceutical organization) facilities. Compulsory licenses allow countries to either manufacture their own generic versions of drugs currently under patent or to import generic versions from a country who wishes to sell. The rationale behind issuing a compulsory license, which is perfectly legal under current WTO (World Trade Org) trade agreements (Article 31, TRIPS - Trade Related Aspects of Intellectual Property agreement) is to dramatically lower the cost of the drug so that it can be accessible to more people in that country. A compulsory license is used for a specified amount of time and a royalty is given to the patent owner (in this case, Abbott).

In 2005, Brazil also announced that they would issue a compulsory license for Kaletra and produce their own version of the drug. However, this never came to fruition because the Brazilian government and Abbott agreed on a special reduced price for a certain number of years in exchange for Brazil withdrawing its compulsory license. Thailand also entered negotiations with Abbott after the Kaletra CL was announced, but the Minister of Public Health determined that Abbott's offered reduced price was not sufficient enough and Thailand is going forward with the Kaletra CL (the government is currently in process of importing Kaletra from an Indian generic company, Hetero - I assume this is to cover until GPO can get its own production going).

Abbott is PISSED OFF about this and announced yesterday that it will:

1) Refuse to register any new pharmaceutical products in Thailand AND
2) Withdraw any pending applications for registration

until Thailand changes its position (basically, until Thailand withdraws its Kaletra CL).

This is UNPRECEDENTED and means that no new Abbott products will be allowed to enter the Thai market. One registration that is being pulled is the heat-stable version of Kaletra, rarely accessible in the Global South. The entry of this drug would be huge, as the current version of Kaletra requires refrigeration (which is obviously difficult in tropical settings/rural areas/areas without constant electricity). Abbott has previously been criticized for not registering or making this drug accessible in countries where it is likely needed the most. By pulling the registration for heat-stable Kaletra (among other drugs, including those to treat heart disease and other general conditions), Abbott is sending a strong message to the 580,000 people living with HIV/AIDS in Thailand - as well as to the other governments considering issuing compulsory licenses in the future.

As messed up as it seems, pharmaceutical companies have a total monopoly on where they choose to register their medicines. Registration (for US people) is the equivalent of submitting your drug to the FDA for approval. If you don't submit it to the FDA, it can obviously never be approved/sold in the US. Same goes for other countries. If Abbott refuses to register drugs in Thailand, those drugs CANNOT be approved/sold here which obviously restricts access for not only new HIV/AIDS second-line drugs, but all sorts of drugs in general. The Thai Network of People Living with AIDS (TNP+) protested in front of Abbott offices at 1 pm today. i really wish i was in Bangkok at times like these.

on a semi-work related front, the head of the ethics/regulatory compliance office at RIHES invited me to give a talk to all the study coordinators (heads) at RIHES about these same issues (compulsory licensing, TRIPS, etc). she's a good (american) friend here and has helped me with some of the IRB stuff i'm working on for my demographics study on women who receive abortions here. she noted that tons of people had recently been coming to her with questions and she didn't know so much about it, so she decided to bring in me instead.

i also submitted an abstract last month about these Kaletra CLs in Brazil and Thailand last month to the American Public Health Association national meeting, building on some of the preliminary research I did at the WHO this past summer. Guess all this IP knowledge does come in handy sometimes :)