From Wikileaks, a US government cable on its involvement to shape Guatemala legislation on pharmaceutical IPR

August 28, 2011
From KEI staff review of Wikileaks cables (/wikileaks)

Among the many new cables released by Wikileaks is this gem, a detailed account of the U.S. government pressure on the Guatemala legislature to shape legislation on pharmaceutical test data IPR.

http://wikileaks.org/cable/2005/03/05GUATEMALA659.html

C O N F I D E N T I A L SECTION 01 OF 05 GUATEMALA 000659

SIPDIS

E.O. 12958: DECL: 03/11/2010
TAGS: ETRD KIPR PGOV PREL GT
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John LaMattian, former head of Pfizer R&D, says industry mergers have harmed R&D efforts

John L. LaMattina, the former President of Pfizer Global Research and Development, has just published an article in Nature that looks at the impact of drug company mergers and increased industry concentration on R&D. Among his conclusions: the “impact on the R&D of the organizations involved has been devastating.”

http://www.nature.com/nrd/journal/v10/n8/full/nrd3514.html

COMMENT

NATURE REVIEWS | DRUG DISCOVERY VOLUME 10 | AUGUST 2011 | 559

The impact of mergers on pharmaceutical R&D

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ADAP waiting lists continue to grow; 9,217 individuals on waiting lists, 64% are African American or Hispanic

The number of patients sitting on AIDS Drug Assistance Programs (ADAP) wait lists, denied the life-saving treatment they need, have risen dramatically over the past two years. ADAPs are critical in providing HIV/AIDS treatment to low-income, uninsured, or underinsured patients within the United States and its territories. As noted in an earlier KEI blog, in January 2010, 361 individuals were on ADAP waitlists; that number grew to 7,873 across eleven states as of May 5, 2011 (a 2100% increase over less than sixteen months).

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Approval, ownership, market structure, and placement on WHO EML for 100 new cancer NMEs on NCI alpha list

KEI research associate Paul Miano has written the following paper: Cancer: Approval, ownership, market structure, and placement on WHO Model Essential Medicines List, for 100 new molecular entities (NMEs) on the NCI alpha list of cancer drugs and vaccines. KEI Research Note 2011:1,

A full copy of the paper is available in PDF format here.

The following is from the introduction (sans footnotes, which are in the PDF version):

Introduction and Summary

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In the first 7 months of 2011, the FDA has approved 18 new molecular entity pharmaceutical drugs (and no biologic NMEs)

In the first seven months of 2011 (January 14 to July 20) , the US FDA has already approved 18 new molecular entity drugs. These are some notes on the approvals:

  • All of the NME products are considered pharmaceutical drugs, and received approval under FDA procedures for New Drug Applications (NDA).
  • Despite the trends indiciating shifts to biologic products from pharmaceutical drugs, none of the 2011 products introduced to date were biologics.
  • One third (6 of 18) received Priority review status. 12 of 18 received Standard review status.
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Federal Circuit decision in AMP v. USPTO results in three-way split in reasoning; 2-1 decision finds isolated DNA patentable

It has been estimated that 1 out of every 8 women in the United States will develop invasive breast cancer during her lifetime. Although a diagnostic test exists to identify mutations on the BRCA1 and BRCA2 human genes, two genes associated with breast and ovarian cancer, many women are not afforded the opportunity to have testing done because Myriad Genetics holds exclusive rights over these genes. Continue Reading

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WIPO General Assembly: Expectations loom over decisions on treaties for actors, reading disabled persons and genetic resources

The WIPO General Assembly meets from Monday, 26 September 2011 to Wednesday, 5 October 2011 and will take place at the International Conference Center Geneva (CICG), 17 rue de Varembé, 1211, Geneva.

The tentative schedule for 49th session of the WIPO General Assembly can be found here: http://www.wipo.int/edocs/mdocs/govbody/en/a_49/a_49_1_prov_2.pdf.

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