[Ip-health] PACHA Resolution

[Jordan]

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[ Picked text/plain from multipart/alternative ]

>From PRNewswire:

Statement by Abner Mason, Founder of AIDS Responsibility Project, on the Un=
animous Passage by the Presidential Advisory Council on HIV/AIDS of a Resol=
ution Ensuring Only Drugs Proven to be Safe and Effective Are Bought for Af=
ricans
Wednesday April 21, 5:48 pm ET

LOS ANGELES, April 21 /PRNewswire/ -- Abner Mason, founder and executive di=
rector of AIDS Responsibility Project (ARP), today praised a Presidential a=
dvisory committee for passing a resolution (see below) in favor of buying o=
nly the highest-quality HIV/AIDS drugs for poor Africans.
Recently, the 34 members of the Presidential Advisory Council on HIV/AIDS (=
PACHA) unanimously passed the resolution that would ensure antiretroviral t=
herapies purchased for Africans with U.S. federal funds are verifiably safe=
 and effective. The resolution will now go to Health and Human Services Sec=
retary Tommy Thompson next month, and, if approved, would reach the Preside=
nt's desk by early summer.
"I am pleased that every member of this committee stands behind giving Afri=
cans what they deserve -- the same standard of care we would insist on for =
Americans. U.S. taxpayers should be sure their money is buying the best tre=
atments for Africans. Ineffective drugs will promote resistant strains of H=
IV, and we must be certain that our decisions do not perpetuate the pandemi=
c. Buying unproven treatments for Africans with American dollars, as some a=
re currently advocating, would be a mistake. For AIDS, the maxim must be, '=
First, verify,'" said Mason, a member of the PACHA and author of the resolu=
tion.
President Bush, through the Emergency Plan for AIDS Relief (PEPFAR), has co=
mmitted $15 billion over 5 years to provide drugs to 2 million people infec=
ted with HIV in 14 African and Caribbean nations.
The resolution states that PEPFAR funds must purchase only drugs that "meet=
 comparable standards for safety, quality and effectiveness as would be nec=
essary for drug approval in the United States or any other country with dru=
g approval standards of comparable scientific rigor."
The committee also voted in favor of establishing an "outside technical adv=
isory panel to advise the [administration] on clinical outcomes, quality st=
andards and diagnostic and drug treatment guidelines" for triple-combinatio=
n therapies.
Such drugs, also known as fixed dose combinations, are manufactured by two =
Indian generic companies, and have not been subject to FDA approval or equi=
valent stringent regulatory agency review in Europe, Japan, Australia, Cana=
da or New Zealand. Those countries act as referral agencies for developing =
countries that may lack sufficient expertise or resources for rigorous prod=
uct reviews.
ARP was founded in 2003 to educate key policy makers and the general public=
 to the unique needs of traditionally underserved HIV/AIDS-affected populat=
ions and to develop strategies and solutions to overcome barriers to treatm=
ent.
In 2002, Mason was appointed to serve as a member of the PACHA, where he is=
 chairman of the International Subcommittee. The PACHA provides advice, inf=
ormation and recommendations to the President and the Secretary of Health a=
nd Human Services regarding policies to promote the effective prevention, t=
reatment and research and care of HIV disease and AIDS in the U.S. and arou=
nd the world.
    International Subcommittee Resolution #2:    Ensuring the Safety, Quali=
ty and Effectiveness of Drugs Procured by the     President's Emergency Pla=
n for AIDS Relief Funds

Whereas, the President's Emergency Plan for AIDS Relief (PEPFAR) has as its=
 major goal the implementation of a plan to provide lifesaving drug treatme=
nt to 2 million people infected with HIV in the 14 targeted countries; and
Whereas, the Office of the Global AIDS Coordinator has been given the respo=
nsibility and authority to fund the purchase of drugs, and to determine wha=
t drugs will be procured either directly or indirectly with Emergency Plan =
funds; and
Whereas, the people of Africa and the Caribbean who will receive drugs proc=
ured directly or indirectly with Emergency Plan funds deserve drugs that me=
et a high standard for safety, quality and effectiveness; and
Whereas, even with the best of intentions, allowing a compromised standard =
of drug safety, quality and effectiveness for Emergency Plan drug procureme=
nts will allow, if not ultimately encourage a lower standard of care for Af=
rican and Caribbean drug recipients; and
Whereas, FDA approved ARV drugs and their generic equivalents have demonstr=
ated their capacity to effectively manage HIV disease; and
Whereas, poor quality, counterfeit, mismeasured, or ineffective drugs can s=
peed development of resistant virus, sicken or harm patients or simply fail=
 to help them, thus jeopardizing the success of the Emergency Plan,
Be it resolved, that the Presidential Advisory Council on HIV/AIDS recommen=
ds that the President direct the Office of the Global AIDS Coordinator to r=
equire that any drug procured directly or indirectly with Emergency Plan fu=
nds must meet comparable standards for safety, quality and effectiveness as=
 would be necessary for drug approval in the United States or any other cou=
ntry with drug approval standards of comparable scientific rigor; and
In addition, the Office of the Global AIDS Coordinator should be directed t=
o create an outside technical advisory panel to advise the Office on clinic=
al outcomes, quality standards and diagnostic and drug treatment guidelines=
, and
Be it further resolved, that PACHA recommends that the Secretary of HHS tak=
e all necessary steps to expedite clinical trials on new drugs and formulat=
ions, including fixed dose combinations (FDC's) that hold promise for simpl=
ifying treatment regimens, decreasing treatment costs, and thereby expandin=
g safe effective treatment.
UNANIMOUSLY APPROVED.

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Source: AIDS Responsibility Project




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