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

[Mike Gretes]

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_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' lack of access to clean drinking
> water. The repercussions go far beyond immediate enteric infections
> like life-threatening cholera, severe diarrhea (the 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 destruction."
>
> 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 and save lives, and
> should always be given to children and patients with severe disease
> in the case of dehydration. ORS does not slow or stop water loss. A
> complementary approach, crofelemer, according to data presented at
> scientific conferences, decreases fluid loss, and shortens the
> duration of diarrhea 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
> product for nearly 20 years. A targeted product launch for adult
> indications in several countries is 12 to 24 months away, pending
> final studies and regulatory approval. Its pharmaceutical developer
> is committed to providing global access--all countries, all
> populations and all channels of distribution, regardless 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 combination 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 thereby 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 Gates Foundation, under which the developer--which
> had initiated the partnership 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 nonprofit
> organization for tax reasons, so it chose the San Francisco-based
> Institute for OneWorld Health (iOWH) because of its focus on
> childhood disease and its interest in funding activities not
> otherwise pursued by the pharmaceutical 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 tens of millions of dollars. Near the end of 2003,
> the Gates Foundation informed 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
> 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 it was tired of living off Gates Foundation grants
> and wanted some private market 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 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 at [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 successful collaboration
> at that point in time, yet leaving the door open for future
> discussions about efficiently bringing crofelemer to pediatric
> populations, 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 innovation in the pharmaceutical business model, partnering
> with local companies and allying with relief efforts to ensure
> sustainable development of crofelemer and its ultimate availability
> to the global health community upon regulatory approval, independent
> of eleemosynary agendas. Investors with great vision supported this
> effort for social change in the pharmaceutical industry, venturing
> beyond their traditional comfort zones, and top international
> experts in the field of diarrhea research participated in the
> investigation of crofelemer.
>
> So what happened to the grant money? iOWH spent almost four years
> seeking early-stage technology that met the CFTR inhibitor
> definition criteria for the cash that was presumably sitting in its
> bank account, several times issuing PR announcements about its
> "campaign to jump-start research on diseases 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
> overcome."* iOWH's pronouncements confused global health experts,
> who pointed to the presentation of clinical data on crofelemer at
> scientific conferences 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
> subsequent to safety and efficacy testing and approval in adults.
> Over the years--most recently one day after the earthquake in Haiti--
> the developer of crofelemer 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
> approaches 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 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 expedited an efficient
> deployment of resources to direct future drug development efforts,
> as President Clinton noted during the 2009 Clinton Global Initiative
> conference, which highlighted a commitment to global access to
> crofelemer. It's frustrating, and ironic, that the important shared
> focus of the Gates Foundation and iOWH--mitigating diarrhea in
> children, particularly with the novel mechanism CFTR inhibitor--has
> hindered this investigation and delayed the potential introduction
> of such a product to the global health community.
>
> With great gifts comes great responsibility. No doubt, the Gates
> Foundation is a profound gift to global health, accounting for 80
> percent of NGO funding these days. A Gates grantee recently told me
> that when, due to the recession, 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 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 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 Data 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
> Health, 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
> regards 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
> programme 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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