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Drug firm renews attempts at orphan drug trials

Drug firm renews attempts at orphan drug trials

REPRESENTATIVES of a self-described international "homeopathic medicine"

company have returned to Cambodia to seek government permission for controversial

clinical drug trials involving Cambodian orphans.

The Post has learned that representatives of Bahamas-based Hansi International Ltd

are in Phnom Penh consulting with Cambodian government officials and NGO representatives

regarding plans to test the company's "immune system enhancing" formula

on Cambodian orphans.

According to Nigel Goddard, Executive Director of Southeast Asian Outreach (SAO),

Hansi representatives had returned to Cambodia in recent days and were involved in

"low-profile discussions with high-ranking government officials" to seek

official support for their proposal.

Although Goddard spoke by phone with Hansi representatives on May 24 and is planning

a face-to-face meeting with them in the coming days, Hansi's head office denied any

involvement in Cambodia.

"We have no plans nor have we ever had plans to conduct a clinical trial in

Cambodia," Hansi's Dr D Green told the Post by email. Green further refused

to answer Post questions about the details of its immune formula pleading "time

constraints".

Hansi's initial announcement in February that it planned to subject up to 3,000 Cambodian

orphans to testing of a "herbal homeopathic preparation of primarily desert

and rain forest plants" was met with outrage by government officials and NGO

representatives who castigated the company for ignoring the government's Ethical

Guidelines for Health Research Involving Subjects.

Concern about the company's motives were heightened at the time by Hansi's admission

that cost considerations were a primary factor in the selection of Cambodian children

for the trials.

Goddard initially raised the alarm about Hansi's plans in February due to his concerns

that the company was prepared to ignore "proper ethical guidelines" for

research involving human subjects.

Goddard insisted at the time that "all trials ... be properly registered with

the Ministry of Health and other appropriate ministries and submit to a Cambodian

ethics review committee".

Hansi subsequently ceased negotiations with the government and its representatives

departed Cambodia.

In an interview with the Post on May 24, Goddard expressed cautious optimism that

his recent conversations with Hansi representatives in Phnom Penh indicated that

the company was now willing to follow international-standard ethical medical testing

protocols

"At this time I understand Hansi is following a clear line of [testing] protocol

which if they follow makes me less nervous [about the possible rights violations

of Cambodian orphans]," he said.

Goddard was unwilling to provide more details about the latest Hansi initiative for

fear of harming the company's current negotiations which he stressed "if done

properly, could result in positive benefits for Cambodia."

"If there's a lot of press coverage [of Hansi's drug testing proposal] it might

cause them to back out," Goddard said. "If they're going about it the right

way that would help Cambodia."

Minister of Health Hong Sun Huot told the Post that he was unaware of Hansi's most

recent proposal.

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