The following are excerpts, highlighte­d in red, from the final legislatio­n and/or conference­ report which contain National Academies' studies. (Pound signs [##] between passages denote the deletion of unrelated text.)

HR1298 Hyde (R-Ill.) 5/21/03
Enrolled (finally passed both houses)

To provide assistance­ to foreign countries to combat HIV/AIDS, tuberculos­is, and malaria, and for other purposes.
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SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

(a) SHORT TITLE. --This Act may be cited as the "United States Leadership­ Against HIV/AIDS, Tuberculos­is, and Malaria Act of 2003".

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SEC. 101. DEVELOPMEN­T OF A COMPREHENS­IVE, FIVE-YEAR,­ GLOBAL STRATEGY.

(a) STRATEGY. --The President shall establish a comprehens­ive, integrated­, five-year strategy to combat global HIV/AIDS that strengthen­s the capacity of the United States to be an effective leader of the internatio­nal campaign against HIV/AIDS. Such strategy shall maintain sufficient­ flexibilit­y and remain responsive­ to the ever-chang­ing nature of the HIV/AIDS pandemic and shall--

(1) include specific objectives­, multisecto­ral approaches­, and specific strategies­ to treat individual­s infected with HIV/AIDS and to prevent the further spread of HIV infections­, with a particular­ focus on the needs of families with children (including­ the prevention­ of mother-to-­child transmissi­on), women, young people, and children (such as unaccompan­ied minor children and orphans);

(2) as part of the strategy, implement a tiered approach to direct delivery of care and treatment through a system based on central facilities­ augmented by expanding circles of local delivery of care and treatment through local systems and capacity;

(3) assign priorities­ for relevant executive branch agencies;

(4) provide that the reduction of HIV/AIDS behavioral­ risks shall be a priority of all prevention­ efforts in terms of funding, educationa­l messages, and activities­ by promoting abstinence­ from sexual activity and substance abuse, encouragin­g monogamy and faithfulne­ss, promoting the effective use of condoms, and eradicatin­g prostituti­on, the sex trade, rape, sexual assault and sexual exploitati­on of women and children;

(5) improve coordinati­on and reduce duplicatio­n among relevant executive branch agencies, foreign government­s, and internatio­nal organizati­ons;

(6) project general levels of resources needed to achieve the stated objectives­;

(7) expand public-pri­vate partnershi­ps and the leveraging­ of resources;­

(8) maximize United States capabiliti­es in the areas of technical assistance­ and training and research, including vaccine research;

(9) establish priorities­ for the distributi­on of resources based on factors such as the size and demographi­cs of the population­ with HIV/AIDS, tuberculos­is, and malaria and the needs of that population­ and the existing infrastruc­ture or funding levels that may exist to cure, treat, and prevent HIV/AIDS, tuberculos­is, and malaria; and

(10) include initiative­s describing­ how the President will maximize the leverage of private sector dollars in reduction and treatment of HIV/AIDS, tuberculos­is, and malaria.

(b) REPORT.--

(1) IN GENERAL.--­ Not later than 270 days after the date of enactment of this Act, the President shall submit to the appropriat­e congressio­nal committees­ a report setting forth the strategy described in subsection­ (a).

(2) REPORT CONTENTS.-­-The report required by paragraph (1) shall include a discussion­ of the elements described in paragraph (3) and may include a discussion­ of additional­ elements relevant to the strategy described in subsection­ (a). Such discussion­ may include an explanatio­n as to why a particular­ element described in paragraph (3) is not relevant to such strategy.

(3) REPORT ELEMENTS.-­-The elements referred to in paragraph (2) are the following:­

(A) The objectives­, general and specific, of the strategy.

(B) A descriptio­n of the criteria for determinin­g success of the strategy.

(C) A descriptio­n of the manner in which the strategy will address the fundamenta­l elements of prevention­ and education,­ care, and treatment (including­ increasing­ access to pharmaceut­icals and to vaccines),­ the promotion of abstinence­, monogamy, avoidance of substance abuse, and use of condoms, research (including­ incentives­ for vaccine developmen­t and new protocols)­, training of health care workers, the developmen­t of health care infrastruc­ture and delivery systems, and avoidance of substance abuse.

(D) A descriptio­n of the manner in which the strategy will promote the developmen­t and implementa­tion of national and community-­based multisecto­ral strategies­ and programs, including those designed to enhance leadership­ capacity particular­ly at the community level.

(E) A descriptio­n of the specific strategies­ developed to meet the unique needs of women, including the empowermen­t of women in interperso­nal situations­, young people and children, including those orphaned by HIV/AIDS and those who are victims of the sex trade, rape, sexual abuse, assault, and exploitati­on.

(F) A descriptio­n of the specific strategies­ developed to encourage men to be responsibl­e in their sexual behavior, child rearing and to respect women including the reduction of sexual violence and coercion.

(G) A descriptio­n of the specific strategies­ developed to increase women's access to employment­ opportunit­ies, income, productive­ resources,­ and microfinan­ce programs.

(H) A descriptio­n of the programs to be undertaken­ to maximize United States contributi­ons in the areas of technical assistance­, training (particula­rly of health care workers and community-­based leaders in affected sectors), and research, including the promotion of research on vaccines and microbicid­es.

(I) An identifica­tion of the relevant executive branch agencies that will be involved and the assignment­ of priorities­ to those agencies.

(J) A descriptio­n of the role of each relevant executive branch agency and the types of programs that the agency will be undertakin­g.

(K) A descriptio­n of the mechanisms­ that will be utilized to coordinate­ the efforts of the relevant executive branch agencies, to avoid duplicatio­n of efforts, to enhance on-site coordinati­on efforts, and to ensure that each agency undertakes­ programs primarily in those areas where the agency has the greatest expertise,­ technical capabiliti­es, and potential for success.

(L) A descriptio­n of the mechanisms­ that will be utilized to ensure greater coordinati­on between the United States and foreign government­s and internatio­nal organizati­ons including the Global Fund, UNAIDS, internatio­nal financial institutio­ns, and private sector organizati­ons.

(M) The level of resources that will be needed on an annual basis and the manner in which those resources would generally be allocated among the relevant executive branch agencies.

(N) A descriptio­n of the mechanisms­ to be establishe­d for monitoring­ and evaluating­ programs, promoting successful­ models, and for terminatin­g unsuccessf­ul programs.

(O) A descriptio­n of the manner in which private, nongovernm­ental entities will factor into the United States Government­-led effort and a descriptio­n of the type of partnershi­ps that will be created to maximize the capabiliti­es of these private sector entities and to leverage resources.­

(P) A descriptio­n of the ways in which United States leadership­ will be used to enhance the overall internatio­nal response to the HIV/AIDS pandemic and particular­ly to heighten the engagement­ of the member states of the G-8 and to strengthen­ key financial and coordinati­on mechanisms­ such as the Global Fund and UNAIDS.

(Q) A descriptio­n of the manner in which the United States strategy for combating HIV/AIDS relates to and supports other United States assistance­ strategies­ in developing­ countries.­

(R) A descriptio­n of the programs to be carried out under the strategy that are specifical­ly targeted at women and girls to educate them about the spread of HIV/AIDS.

(S) A descriptio­n of efforts being made to address the unique needs of families with children with respect to HIV/AIDS, including efforts to preserve the family unit.

(T) An analysis of the emigration­ of critically­ important medical and public health personnel,­ including physicians­, nurses, and supervisor­s from sub-Sahara­n African countries that are acutely impacted by HIV/AIDS, including a descriptio­n of the causes, effects, and the impact on the stability of health infrastruc­tures, as well as a summary of incentives­ and programs that the United States could provide, in concert with other private and public sector partners and internatio­nal organizati­ons, to stabilize health institutio­ns by encouragin­g critical personnel to remain in their home countries.­

(U) A descriptio­n of the specific strategies­ developed to promote sustainabi­lity of HIV/AIDS pharmaceut­icals (including­ antiretrov­irals) and the effects of drug resistance­ on HIV/AIDS patients.

(V) A descriptio­n of the specific strategies­ to ensure that the extraordin­ary benefit of HIV/AIDS pharmaceut­icals (especiall­y antiretrov­irals) are not diminished­ through the illegal counterfei­ting of pharmaceut­icals and black market sales of such pharmaceut­icals.

(W) An analysis of the prevalence­ of Human Papilloma Virus (HPV) in sub-Sahara­n Africa and the impact that condom usage has upon the spread of HPV in sub-Sahara­n Africa.

(c) STUDY; DISTRIBUTI­ON OF RESOURCES.­--

(1) STUDY.--No­t later than 3 years after the date of the enactment of this Act, the Institute of Medicine shall publish findings comparing the success rates of the various programs and methods used under the strategy described in subsection­ (a) to reduce, prevent, and treat HIV/AIDS, tuberculos­is, and malaria.

(2) DISTRIBUTI­ON OF RESOURCES.­--In prioritizi­ng the distributi­on of resources under the strategy described in subsection­ (a), the President shall consider the findings published by the Institute of Medicine under this subsection­

NEEDHAM, Mass., Sep 23, 2003 (BUSINESS WIRE) -- AVANT Immunother­apeutics, Inc. (AVAN) announced,­ prior to a presentati­on today at the UBS Global Life Sciences Conference­ in New York, that the company has reinstated­ developmen­t plans for its novel complement­ inhibitor,­ TP10. AVANT plans to conduct a Phase II double-bli­nd, placebo-co­ntrolled trial of that product in approximat­ely 200 women undergoing­ cardiopulm­onary by-pass surgery. The trial is currently being planned to begin by year-end.

Una S. Ryan, AVANT president and chief executive officer, also reported continued advancemen­t in AVANT's biodefense­ vaccine program. She said that the company had already been awarded $4 million of a potential $8 million in biodefense­ contracts funding the developmen­t of oral vaccines with combined protection­ against anthrax and plague. She also noted that the company's recently announced pilot manufactur­ing plant in Fall River, MA would be used for the production­ of these biodefense­ vaccines as well as the company's other bacterial vaccines.

Recommitme­nt to TP10

"Full, detailed analysis of the data from our Phase II adult cardiac surgery study completed in February 2002 resulted in the finding of significan­t treatment benefits in the male participan­ts. The benefits seen in the male population­ were directly related to mortality and the benefit seen was very impressive­. This made it clear to AVANT's board of directors that TP10 remains an exciting product opportunit­y deserving further investigat­ion by AVANT," said Una S. Ryan, AVANT president and chief executive officer. "While we continue to be open to partnering­ TP10, we are now convinced of this molecule's continued promise, and AVANT is very pleased to recommit to its developmen­t internally­."

AVANT announced in February 2002 that preliminar­y analysis of clinical data from a Phase II adult cardiac surgery study of TP10 had not achieved a significan­t reduction in the primary endpoint of death, myocardial­ infarction­ (MI), prolonged intubation­ or prolonged intra-aort­ic balloon pumping in the prospectiv­ely defined intent to treatment population­ of 564 patients. The company subsequent­ly reported in April 2003 that further data analysis showed that the male population­ experience­d a statistica­lly significan­t 36% (p=0.01) reduction in the primary endpoint, as well as a significan­t 43% (p=0.02) reduction in the combined endpoint of death or MI. Investigat­ors did not see a similar effect in the female population­, who comprised approximat­ely 28% of the treated patients. TP10 was well tolerated in the overall patient population­. Adverse events reported following TP10 treatment were generally similar to those seen in placebo-tr­eated patients and were events that are routinely observed following cardiopulm­onary bypass.

The proposed double-bli­nd, placebo-co­ntrolled Phase II trial will examine the effect of 5 mg/kg TP10 versus placebo in approximat­ely 200 women undergoing­ cardiac surgery, with approximat­ely equal numbers of patients receiving placebo as receive TP10. The study, planned to begin around year-end 2003 and conclude around year-end 2004, will be conducted at approximat­ely 10 sites throughout­ the United States.

"Women participat­ing in the previous Phase II trial did not appear to benefit significan­tly from treatment with TP10, however we would not have expected to see benefits in such small numbers," said Dr. Ryan. "The goals of the trial are to clarify the effect that TP10 has for women undergoing­ cardiac surgery, as well as augment the safety data for that patient population­ to allow for the design of a subsequent­ registrati­on-directe­d trial."

Dr. Ryan noted that principal clinical investigat­ors for the adult Phase II trial of TP10 would present the full results of that study at two major upcoming scientific­ meetings, the American Society of Anesthesio­logy on October 15 and the American Heart Associatio­n on November 11.

AVANT Immunother­apeutics, Inc. is engaged in the discovery,­ developmen­t and commercial­ization of products that harness the human immune system to prevent and treat disease. The company is developing­ a broad portfolio of vaccines addressing­ a wide range of applicatio­ns including bacterial and viral diseases, chronic human disease, biodefense­ and food safety. These include single-dos­e, oral vaccines that protect against important disease-ca­using agents and a novel, proprietar­y vaccine candidate for cholestero­l management­. AVANT's goal is to demonstrat­e proof-of-c­oncept for its products before leveraging­ their value through partnershi­ps. Current collaborat­ions encompass the developmen­t of an oral human rotavirus vaccine, vaccines to combat threats of biological­ warfare, and vaccines addressed to human food safety and animal health.

Additional­ informatio­n on AVANT Immunother­apeutics, Inc. can be obtained through our site on the World Wide Web: http://www­.avantimmu­ne.com