[Ip-health] Huffington Post: Why a Gates Foundation Gift Was Not Enough for Haiti's Children

Thu Feb 4 00:20:23 2010

I've heard from someone at iOWH that here a response is being planned from =
them and possibly the Gates Foundation now that Davos media is dying down.

There have been massive management changes at iOWH, with almost all origina=
l senior staff having left, a big down-sizing of the organization at one po=
int, and with Victoria Hale now having recently started another non-profit:=
 http://www.medicines360.org/index.html.

Let's see how they respond as anything else is speculative, unless someone =
knows of other related things published?

On Feb 3, 2010, at 7:00 PM, Mike Gretes wrote:

> Interesting - good to note, however, there should be a declared conflict =
of interest: author Lisa Conte is Founder and CEO of Napo Pharmaceuticals, =
developer of crofelemer.
>
> http://www.napopharma.com/ir/lisa_conte.html
> http://www.napopharma.com/products/index.html
>
> Anyone know the extent/effects of the management change at iOWH?
>
> ____
> Mike Gretes
> Universities Allied for Essential Medicines
>
> On 2010-01-31, at 21:56, Ann-Marie Sevcsik wrote:
>
>> http://www.huffingtonpost.com/lisa-conte/why-a-gates-foundation-gi_b_437=
888.html
>>
>> Why a Gates Foundation Gift Was Not Enough for Haiti's Children
>> The post-earthquake horror in Haiti and the nation's desperate need for =
aid, as we learn from Presidents George W. Bush and Bill Clinton, is not go=
ing away anytime soon. For me, the area of greatest concern is the Haitians=
' lack of access to clean drinking water. The repercussions go far beyond i=
mmediate enteric infections like life-threatening cholera, severe diarrhea =
(the No. 1 killer of children under age 5), and dehydration, also posing lo=
ng-term threats to the physical health, cognition and human rights of Haiti=
's people. Before the quake, 47 percent of Haiti's residents had no access =
to clean water, while two-thirds lived without adequate sanitation. I heard=
 a leading refugee coordinator call this situation a "weapon of mass destru=
ction."
>>
>> A potential tool in the armament against the devastation of dehydration =
is crofelemer, a pharmaceutical product derived from the knowledge of shama=
ns, or healers, in the South American rain forests. The existing go-to form=
ula, Oral Rehydration Solution (ORS), does indeed replenish depleted bodies=
 and save lives, and should always be given to children and patients with s=
evere disease in the case of dehydration. ORS does not slow or stop water l=
oss. A complementary approach, crofelemer, according to data presented at s=
cientific conferences, decreases fluid loss, and shortens the duration of d=
iarrhea in both the mildest and most severe of cases, including cholera and=
 chronic diarrhea in immuno-compromised patients.
>>
>> Crofelemer has been in discovery and development as a pharmaceutical pro=
duct for nearly 20 years. A targeted product launch for adult indications i=
n several countries is 12 to 24 months away, pending final studies and regu=
latory approval. Its pharmaceutical developer is committed to providing glo=
bal access--all countries, all populations and all channels of distribution=
, regardless of social or economic status--to the ultimately approved produ=
ct.
>>
>> Enter angst: The development of crofelemer could have already been compl=
ete, including an investigation into its use in pediatric populations in co=
mbination with ORS (and zinc, another beneficial intervention). As I watch =
newscasts of the destruction in Haiti, images flash through my mind of all =
those who have hindered the investigation into crofelemer's promise, and th=
ereby the possibility of making a life-saving medicine available in crises =
like the one in Haiti.
>>
>> Here's the story: In 2001, the investigation of crofelemer for pediatric=
 populations was the subject of a potential grant from the Bill & Melinda G=
ates Foundation, under which the developer--which had initiated the partner=
ship in an effort to ensure that the product would be available to those mo=
st in need--would donate crofelemer to resource-constrained areas of the wo=
rld. The developer was told that the grant would have to go through a nonpr=
ofit organization for tax reasons, so it chose the San Francisco-based Inst=
itute for OneWorld Health (iOWH) because of its focus on childhood disease =
and its interest in funding activities not otherwise pursued by the pharmac=
eutical industry.
>>
>> Almost three years and hundreds of thousands of dollars in legal fees la=
ter, terms were agreed upon and a contract was drawn up for a grant totalin=
g tens of millions of dollars. Near the end of 2003, the Gates Foundation i=
nformed iOWH and the developer of its desire to move money for the crofelem=
er project--more generalized to its novel mechanism of action to address wa=
ter loss, termed a CFTR-inhibitor project--to iOWH by Dec. 31 for tax purpo=
ses. The foundation sought assurances from the developer and iOWH that the =
contract was ready to be signed. In good faith, it was. The money moved to =
iOWH. Then, in a surprise year-end move, iOWH informed the developer that i=
t was tired of living off Gates Foundation grants and wanted some private m=
arket compensation. This meant that in addition to donating crofelemer for =
pediatric purposes, the developer would have to compromise its intellectual=
 property position to provide private market return to iOWH in order to acc=
ess the crofelemer-designated grant funds. Shortly thereafter, the principa=
ls at iOWH went on vacation.
>>
>> A leading academic investigator called the actions of iOWH "unethical, e=
ven for a for-profit company (which iOWH is not). In 25 years on the facult=
y at [a leading academic institution] and dealing with multiple companies a=
nd collaborators, I have not been witness to such inappropriate behavior." =
The developer walked away from the situation, noting the worthy intentions =
of both parties, and citing the lack of a culture match to consummate a suc=
cessful collaboration at that point in time, yet leaving the door open for =
future discussions about efficiently bringing crofelemer to pediatric popul=
ations, should it meet regulatory approval. iOWH kept the grant money and d=
id not inform the Gates Foundation of the breakdown of the potential allian=
ce for several months.
>>
>> Despite being close to broke, the developer was able to move forward wit=
h innovation in the pharmaceutical business model, partnering with local co=
mpanies and allying with relief efforts to ensure sustainable development o=
f crofelemer and its ultimate availability to the global health community u=
pon regulatory approval, independent of eleemosynary agendas. Investors wit=
h great vision supported this effort for social change in the pharmaceutica=
l industry, venturing beyond their traditional comfort zones, and top inter=
national experts in the field of diarrhea research participated in the inve=
stigation of crofelemer.
>>
>> So what happened to the grant money? iOWH spent almost four years seekin=
g early-stage technology that met the CFTR inhibitor definition criteria fo=
r the cash that was presumably sitting in its bank account, several times i=
ssuing PR announcements about its "campaign to jump-start research on disea=
ses of the developing world that haven't been addressed by for-profit drug =
companies," and professing it had "seized the initiative in recent years to=
 clear logjams in the drug development process that the industry hasn't ove=
rcome."* iOWH's pronouncements confused global health experts, who pointed =
to the presentation of clinical data on crofelemer at scientific conference=
s throughout the years. In an interview with the San Francisco Chronicle in=
 April 2008, iOWH claimed it would bring a proof of concept CFTR inhibitor =
to the clinic in six and a half years. The Chronicle refused to correct the=
 misleading message.
>>
>> Normally, in the drug industry, a pediatric product is developed subsequ=
ent to safety and efficacy testing and approval in adults. Over the years--=
most recently one day after the earthquake in Haiti--the developer of crofe=
lemer reached out to both iOWH (the management of iOWH has changed) and to =
the Gates Foundation, proposing joint efforts to accelerate the development=
 of a pediatric crofelemer. To the astonishment of those who witnessed the =
discussions, the developer was rebuked by both.
>>
>> Crofelemer's first-in-class status is important to the pursuit of approa=
ches to mitigate diarrhea and dehydration. In the best case, crofelemer wou=
ld have already been successfully developed and would be distributed in Hai=
ti today as the country struggles to organize sufficient infrastructure to =
help its people and, in particular, its children--the next generation. Even=
 if crofelemer had not lived up to its promise, that knowledge would have e=
xpedited an efficient deployment of resources to direct future drug develop=
ment efforts, as President Clinton noted during the 2009 Clinton Global Ini=
tiative conference, which highlighted a commitment to global access to crof=
elemer. It's frustrating, and ironic, that the important shared focus of th=
e Gates Foundation and iOWH--mitigating diarrhea in children, particularly =
with the novel mechanism CFTR inhibitor--has hindered this investigation an=
d delayed the potential introduction of such a product to the global health=
 community.
>>
>> With great gifts comes great responsibility. No doubt, the Gates Foundat=
ion is a profound gift to global health, accounting for 80 percent of NGO f=
unding these days. A Gates grantee recently told me that when, due to the r=
ecession, the foundation didn't increase its grant funding this past year, =
the effects were felt thunderously by the NGO community. In many arenas of =
global health, the foundation is the agenda.
>>
>> The crisis in Haiti and the helplessness we all feel have moved me to wr=
ite to the Gates Foundation again, yet perhaps this time in a way in which =
the message won't get submerged by those with personal agendas to protect a=
t all costs, the most precious of which are the lives of children in places=
 with little resources. Dear Mr. Gates, I hope you get this message.
>>
>> Napo Pharmaceuticals, Inc., press releases: "Napo Gathers International =
Panel on Global Health," Oct. 8, 2009; "Napo Announces Positive Clinical Da=
ta Indicating Crofelemer Could Effectively Treat Cholera," Sept. 22, 2008; =
"Napo Announces Successful Clinical results in Phase 2 Study of Crofelemer =
in Acute Adult Infectious Diarrhoea," April 10, 2008
>> "Napo Pharmaceuticals," Stanford Graduate School of Business case study =
by Joshua Spitzer, May 18, 2006.
>> Letter to Tadataka Yamada, President of the Global Health Program at the=
 Bill & Melinda Gates Foundation, Jan. 16, 2008.
>> Letters from and to Ahvie Herskowitz, COO of Institute for OneWorld Heal=
th, and Lisa Conte, CEO of Napo Pharmaceuticals, Inc., March/April, 2005
>> Wired News, "A Drug to Eradicate Diarrhea," Kristen Philipkoski, July 11=
, 2005.
>> Letter to the Editor of the San Francisco Chronicle from Conte in regard=
s to "OneWorld teams with Roche for diarrhea cure" by Bernadette Tansey on =
April 17, 2008.
>> Email from Conte to Yamada, Jan. 2008
>> The Lancet, "The Bill & Melinda Gates Foundation's grant-making programm=
e for global health," D. McCoy, G. Kembhavi, J. Patel, A. Luintel, vol. 373=
, issue 9675, May 9-15, 2009, pp. 1645-1653.
>>
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