[e-drug] Guidelines for donations: other dimensions needed

["Joana Ramos" <joaninha@comcast.net>]

E-DRUG: Guidelines for donations: other dimensions needed 
--------------------------------------------------

To this discussion, I'd add a comment about how the existence of the  IGDD has been used relative to the Novartis donation program  for the cancer drug Glivec.  You may recall that in  mid- 2001, when Glivec (imatinib mesylate) was first approved by the FDA in the US, Novartis CEO Vasella publicly announced that no patient  in  need of the drug would be denied it for financial reasons, and he announced the creation of both US and international donation programs. This was the first time that there has been a broad donation of a cancer drug. 

Glivec was unique in both being  novel drug which had delivered astonishingly results in 
trials, as well as a  drug for which a global, exorbitant price  was set.

Desperate patients took Vasella at his word, but access to the donation program has been anything but easy.  What  has transpired since, especially at the international level, has been the subject of various media reports.  The reality has been that there are  no universal income 
guidelines for getting the drug donated ( e.g.  it can theoretically be had  for uninsured patients in the USA earning under $43,000 US,  but in China, only  for those with incomes under $2400 US annual incomes)  despite its universal price of  approximately $30,000 US annually for the basic minimum dose. Patients are  thought to need to take the drug 
for the rest of their lives.  

The numerous  hurdles and inconsistencies in the donation program were the subject of a NY Times report in  June of 2003. ( The article is:  S. Strom et M. Flesicher-Black, Company's 
Pledge to Donate a Cancer Drug is Falling Short & Question on Choice of Foundation for Drug Program, New York Times, 5 June 2003. 
Accessible at: 
www.cptech.org/ip/health/gleevec/ 
<http://www.cptech.org/ip/health/gleevec/>)

The reason I mention  this is that not infrequently over the course of the  past 4 years that I have observed the Glivec situation, those seeking donations who experienced any manner of difficulties, were reminded by the program administrator that the GIPAP ( Glivec International Patient Assistance Program) must abide by IGDD  standards and regulations. Never  mind that the IGDD  did not, and were never meant, to apply to the donation of drugs directly to individuals.   The GIPAP website, at www.gipap.org , states:

 'The GIPAP model is designed to provide the drug to individual patients, as opposed to typical donation programmes that deliver drugs through hospitals or other third party distribution organizations. The  Max Foundation administers GIPAP on behalf of Novartis. As the  administrator, The Max Foundation is responsible for registering qualified patients according to specific medical and financial requirements provided by Novartis. These requirements are in  accordance with World Health Organization (WHO) guidelines, which 
provide global guidance on charitable donation programmes.'


And never mind how many patients anywhere are actually able to get this medicine by any route, the manufacturer can and does make much of the fact that it offers a donation program.

Joana Ramos, MSW
Cancer Resources & Advocacy
Seattle, WA  USA
206-229-2420
http://ramoslink.info/
Joana Ramos <joaninha@comcast.net>