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

[Ann-Marie Sevcsik]

http://www.huffingtonpost.com/lisa-conte/why-a-gates-foundation-gi_b_437888=
.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 going=
 away anytime soon. For me, the area of greatest concern is the Haitians' l=
ack of access to clean drinking water. The repercussions go far beyond imme=
diate enteric infections like life-threatening cholera, severe diarrhea (th=
e No. 1 killer of children under age 5), and dehydration, also posing long-=
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 destructi=
on."

A potential tool in the armament against the devastation of dehydration is =
crofelemer, a pharmaceutical product derived from the knowledge of shamans,=
 or healers, in the South American rain forests. The existing go-to formula=
, Oral Rehydration Solution (ORS), does indeed replenish depleted bodies an=
d save lives, and should always be given to children and patients with seve=
re disease in the case of dehydration. ORS does not slow or stop water loss=
. A complementary approach, crofelemer, according to data presented at scie=
ntific conferences, decreases fluid loss, and shortens the duration of diar=
rhea in both the mildest and most severe of cases, including cholera and ch=
ronic diarrhea in immuno-compromised patients.

Crofelemer has been in discovery and development as a pharmaceutical produc=
t for nearly 20 years. A targeted product launch for adult indications in s=
everal countries is 12 to 24 months away, pending final studies and regulat=
ory approval. Its pharmaceutical developer is committed to providing global=
 access--all countries, all populations and all channels of distribution, r=
egardless of social or economic status--to the ultimately approved product.

Enter angst: The development of crofelemer could have already been complete=
, including an investigation into its use in pediatric populations in combi=
nation with ORS (and zinc, another beneficial intervention). As I watch new=
scasts of the destruction in Haiti, images flash through my mind of all tho=
se who have hindered the investigation into crofelemer's promise, and there=
by the possibility of making a life-saving medicine available in crises lik=
e the one in Haiti.

Here's the story: In 2001, the investigation of crofelemer for pediatric po=
pulations was the subject of a potential grant from the Bill & Melinda Gate=
s Foundation, under which the developer--which had initiated the partnershi=
p in an effort to ensure that the product would be available to those most =
in need--would donate crofelemer to resource-constrained areas of the world=
. The developer was told that the grant would have to go through a nonprofi=
t organization for tax reasons, so it chose the San Francisco-based Institu=
te for OneWorld Health (iOWH) because of its focus on childhood disease and=
 its interest in funding activities not otherwise pursued by the pharmaceut=
ical industry.

Almost three years and hundreds of thousands of dollars in legal fees later=
, terms were agreed upon and a contract was drawn up for a grant totaling t=
ens of millions of dollars. Near the end of 2003, the Gates Foundation info=
rmed iOWH and the developer of its desire to move money for the crofelemer =
project--more generalized to its novel mechanism of action to address water=
 loss, termed a CFTR-inhibitor project--to iOWH by Dec. 31 for tax purposes=
. The foundation sought assurances from the developer and iOWH that the con=
tract was ready to be signed. In good faith, it was. The money moved to iOW=
H. Then, in a surprise year-end move, iOWH informed the developer that it w=
as tired of living off Gates Foundation grants and wanted some private mark=
et compensation. This meant that in addition to donating crofelemer for ped=
iatric purposes, the developer would have to compromise its intellectual pr=
operty position to provide private market return to iOWH in order to access=
 the crofelemer-designated grant funds. Shortly thereafter, the principals =
at iOWH went on vacation.

A leading academic investigator called the actions of iOWH "unethical, even=
 for a for-profit company (which iOWH is not). In 25 years on the faculty a=
t [a leading academic institution] and dealing with multiple companies and =
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 succes=
sful collaboration at that point in time, yet leaving the door open for fut=
ure discussions about efficiently bringing crofelemer to pediatric populati=
ons, should it meet regulatory approval. iOWH kept the grant money and did =
not inform the Gates Foundation of the breakdown of the potential alliance =
for several months.

Despite being close to broke, the developer was able to move forward with i=
nnovation in the pharmaceutical business model, partnering with local compa=
nies and allying with relief efforts to ensure sustainable development of c=
rofelemer and its ultimate availability to the global health community upon=
 regulatory approval, independent of eleemosynary agendas. Investors with g=
reat vision supported this effort for social change in the pharmaceutical i=
ndustry, venturing beyond their traditional comfort zones, and top internat=
ional experts in the field of diarrhea research participated in the investi=
gation of crofelemer.

So what happened to the grant money? iOWH spent almost four years seeking e=
arly-stage technology that met the CFTR inhibitor definition criteria for t=
he cash that was presumably sitting in its bank account, several times issu=
ing PR announcements about its "campaign to jump-start research on diseases=
 of the developing world that haven't been addressed by for-profit drug com=
panies," and professing it had "seized the initiative in recent years to cl=
ear logjams in the drug development process that the industry hasn't overco=
me."* iOWH's pronouncements confused global health experts, who pointed to =
the presentation of clinical data on crofelemer at scientific conferences t=
hroughout the years. In an interview with the San Francisco Chronicle in Ap=
ril 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 mi=
sleading message.

Normally, in the drug industry, a pediatric product is developed subsequent=
 to safety and efficacy testing and approval in adults. Over the years--mos=
t recently one day after the earthquake in Haiti--the developer of crofelem=
er 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 dis=
cussions, the developer was rebuked by both.

Crofelemer's first-in-class status is important to the pursuit of approache=
s to mitigate diarrhea and dehydration. In the best case, crofelemer would =
have already been successfully developed and would be distributed in Haiti =
today as the country struggles to organize sufficient infrastructure to hel=
p its people and, in particular, its children--the next generation. Even if=
 crofelemer had not lived up to its promise, that knowledge would have expe=
dited an efficient deployment of resources to direct future drug developmen=
t efforts, as President Clinton noted during the 2009 Clinton Global Initia=
tive conference, which highlighted a commitment to global access to crofele=
mer. It's frustrating, and ironic, that the important shared focus of the G=
ates Foundation and iOWH--mitigating diarrhea in children, particularly wit=
h the novel mechanism CFTR inhibitor--has hindered this investigation and d=
elayed the potential introduction of such a product to the global health co=
mmunity.

With great gifts comes great responsibility. No doubt, the Gates Foundation=
 is a profound gift to global health, accounting for 80 percent of NGO fund=
ing these days. A Gates grantee recently told me that when, due to the rece=
ssion, the foundation didn't increase its grant funding this past year, the=
 effects were felt thunderously by the NGO community. In many arenas of glo=
bal health, the foundation is the agenda.

The crisis in Haiti and the helplessness we all feel have moved me to write=
 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 at a=
ll costs, the most precious of which are the lives of children in places wi=
th little resources. Dear Mr. Gates, I hope you get this message.

Napo Pharmaceuticals, Inc., press releases: "Napo Gathers International Pan=
el on Global Health," Oct. 8, 2009; "Napo Announces Positive Clinical Data =
Indicating Crofelemer Could Effectively Treat Cholera," Sept. 22, 2008; "Na=
po 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 Bi=
ll & Melinda Gates Foundation, Jan. 16, 2008.
Letters from and to Ahvie Herskowitz, COO of Institute for OneWorld Health,=
 and Lisa Conte, CEO of Napo Pharmaceuticals, Inc., March/April, 2005
Wired News, "A Drug to Eradicate Diarrhea," Kristen Philipkoski, July 11, 2=
005.
Letter to the Editor of the San Francisco Chronicle from Conte in regards t=
o "OneWorld teams with Roche for diarrhea cure" by Bernadette Tansey on Apr=
il 17, 2008.
Email from Conte to Yamada, Jan. 2008
The Lancet, "The Bill & Melinda Gates Foundation's grant-making programme f=
or global health," D. McCoy, G. Kembhavi, J. Patel, A. Luintel, vol. 373, i=
ssue 9675, May 9-15, 2009, pp. 1645-1653.