Note: The Director's response may be accessed at the end of our letter to him.

www.fairfoundation.org

5/31/2006

Elias A. Zerhouni, M.D.
Director, National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892

Cc: President George W. Bush; Members of the Senate and House Subcommittees on Labor, Health and Human Services, Education and Related Agencies

RE: Fair and Equitable Research Allocations

Dear Dr. Zerhouni,

HIV/AIDS researchers and prevention advocates have made great success against this illness in the USA with deaths continuing to plummet. For example,
deaths in California’s newly infected patients have fallen 98 percent (from 1992-2005 as of 3/31/06)[1] to 211 and this success is being repeated throughout
America, yet the NIH is still spending ten percent of the disease research budget on this one illness.

Such favoritism for HIV/AIDS has resulted in disproportionately low research allocations for all non-AIDS illnesses, including the sixteen[2] that kill a million more
than HIV disease in this country annually.

For example, in comparison to the CDC’s estimate of 15,798 HIV/AIDS deaths, cardiovascular disease kills 930,000, diabetes kills more than AIDS and breast
cancer combined, and COPD kills nine times as many as HIV disease, yet, the NIH is spending $3,040 on each AIDS patient in research versus $37, $50, and $5
on the above mentioned illnesses respectively.[3] (The actual number of HIV/AIDS deaths as reported to us by the Departments of Health in all fifty states and
DC is 11,919.[4])

In addition, many dozens of HIV organizations have communicated to Senators Specter and Harkin that “Hepatitis C-related liver disease is now the leading
cause of death among people with HIV/AIDS” [in the USA].[5] Indeed, although the mortality for HCV is comparable to that for HIV/AIDS and HCV’s morbidity is
a 4+ multiple of HIV/AIDS in the USA, only $25 is spent in research on each hepatitis C patient. This is unfair for the millions of mono-infected hepatitis C
patients and for the estimated 400,000 HCV/HIV co-infected patients.

While the above statistics are associated with diseases that cause great mortality, it should also be noted that orphan disease research funding of $1.18
billion for over 6,000 diseases is, on average, only $200,000 per illness, which illustrates well that orphan disease funding is also insufficient.

Regardless if the funding comparison is measured utilizing “allocation per patient,” “allocation per death” or “total allocation per disease,” the great success
against AIDS has resulted in its funding now being disproportionate. It should also be noted that hundreds of millions of dollars are raised for HIV/AIDS research
by celebrities and non-profit organizations (amfAR, [The Bill and Melinda Gates Foundation] etc.) while similar efforts do not exist for many other diseases.

In response to our previous communications to your office in which we offered objections to the favoritism afforded HIV/AIDS in research allocations, we have
received replies from an Associate Budget Director, Susan Quantius, and from Lana R. Skirboll, Ph.D., Director, Office of Science Policy. Below is a summary of
their points and our responses; however we would like to point out that Ms. Skirboll’s footnotes reference facts from 1999. Clearly, dramatic progress and
positive events have transpired since then regarding HIV disease.

· (Skirboll and Quantius) “I emphasize that disease burden includes more than a count of the number of deaths during a single year. NIH must also consider the incidence, severity, and economic costs of a disease as it judges the burden of a specific disorder, or we would never study chronic, non-life threatening conditions such as blindness, deafness, or arthritis.”

o FAIR: We agree. Our recommended NIH Allocation Factors[6] mirror yours and include incidence, severity, and economic costs of a disease, but from our inception we have added anther to your list: if a disease is an orphan disease it shall receive additional funding.

· (Skirboll and Quantius) “As you have repeatedly focused your premise t on (sic) the statement that "allocations are grossly biased towards AIDS" compared to other diseases, I would like to address that issue directly.” “You have chosen to use only deaths of Americans to determine your equation. To do so ignores the critical fact that AIDS is a global public health crisis that has already killed more than 22 million people around the world…”

1. FAIR: The key to global AIDS is well known, already exists and is the same solution that has dropped deaths in California’s newly infected patients 98 percent. It was well stated by Dr. Fauci stated many months ago when he was asked on CNN “What is the solution for global AIDS?” He did not say “more research;” he did say, “Prevention.” In President Clinton’s and CNN Medical Correspondent Gupta’s TV special, “The End of AIDS,” they and many eminent HIV advocates pointed out that the solution to global AIDS is primarily preventive education, providing the existing medications (HAART) and setting up infrastructures to deliver both. Research was rarely mentioned except in reference to vaccines, which I’ll discuss below. FAIR supports increased global efforts to provide prevention education, HAART and to establish health infrastructures to accomplish their distribution as well as the ABC health policies (Abstinence, Be faithful, and use a Condom) as advocated by Presidents Bush and Clinton.

· (Skirboll) Your "proration" in that regard [prorating research dollars based on mortality] is problematic both in the numerator and denominator.”

o FAIR: We agree. FAIR does not support the theory of “Proration” anymore, thus our name has changed from our early days as ProrateNIH to The FAIR Foundation. One of your allocation factors, that our recommended policies mirror, is “mortality.” However, we believe there should be a slight emphasis on mortality to prevent inverted situations whereby a disease that is killing relatively few accumulates excessively large research allocations. HIV/AIDS receiving one-half billion more than CVD when the latter kills almost a million more annually in the USA is just one example of this.

· (Skirboll and Quantius) “The transmissible nature of HIV makes it radically different from non-transmissible disease such as heart disease and cancer.”

o FAIR: If one is going to use the “infectious” argument, one should use it uniformly. As stated above, many dozens of HIV organizations have communicated to Senators Specter and Harkin that “HCV-related liver disease is now the leading cause of death among people with HIV/AIDS” in the USA, yet funding is only $25 per HCV patient versus $3,040 per HIV patient. The flu (influenza) kills twice as many as HIV every year, yet only $199 million is spent on the flu versus $2.8 billion on HIV. A disease like HIV being communicable does not justify disproportionate funding. Patient with diabetes, Parkinson’s, Alzheimer’s, orphan diseases, etc. should not be penalized because their illness is acquired congenitally or by environmental factors. The NIH places an inordinate emphasis on whether a disease is infectious, and this is especially true with its funding for HIV disease.

· (Skirboll and Quantius) “AIDS research is actually basic science, which has been determined to be related to AIDS, but it may, in fact, benefit a myriad of other disease research areas.” “It may be of interest to you that development of combination therapy for HIV infection stimulated interest in utilizing combination therapy to treat hepatitis C virus (HCV) infection. Pegylated interferon, initially tested on HIV-infected patients with Kaposi's sarcoma, later was shown to be effective for the treatment of HCV infection. “

o FAIR: Note their statement—the funding for basic science is “…related to AIDS” and it “may” benefit other illnesses. The basis science referred to here has AIDS as its basis, not the many non-AIDS diseases that it may help. AIDS activists use that argument to me regularly, “Don’t complain about AIDS receiving billions more than other diseases because AIDS research may help those illnesses some day.” Indeed, HIV research helped produce lamivudine for HBV and Peg-interferon for HCV. Those researchers deserve great credit for these achievements. However; all non-AIDS patients, including those with the sixteen diseases that kill a million more than HIV/AIDS here in the USA, want the NIH studying their disease in a fair and equitable manner, no more and no less. It is not fair to ask a patient with a non-AIDS illness to wait for the ancillary results of AIDS research. The HIV researcher is not studying HIV to find a solution to Alzheimer’s—if it does, well fine—but his/her goal is to advance the drug achievements against HIV/AIDS. Give the Alzheimer’s researcher appropriate funding because he wants the Nobel Prize for achieving the solution for Alzheimer’s, not HIV.

· (Skirboll and Quantius) “It has been declared a threat to our national security….”

o FAIR: We would be most grateful for your providing examples of our national security being threatened by HIV/AIDS.

Now that effective medicines have been discovered, there are new arguments for the NIAID keeping its large funding for HIV disease or even accelerating it
according to Dr. Fauci:[7]

1. “..many AIDS victims are young” (by Dr. Fauci[8]),

2. Women are greatly affected by HIV/AIDS,” and,

3. To produce a vaccine (by Dr. Fauci[9]).

FAIR’s responses to these arguments follow:

1. The CDC’s 2004 Surveillance Report reports the number of deaths in children in the USA under the age of 13 to be eighteen and the number of deaths from ages thirteen to nineteen to be 48.[10] Sandra Burchett, M.D., M.Sc., an infectious disease specialist at Children's Hospital in Boston and an associate in pediatrics at Harvard Medical School states what is commonly accepted as fact now, "Children who are diagnosed with HIV infection early and receive treatment for HIV can live not just better, but truly healthy, normal lives." Furthermore, in the CNN special President Clinton stated, “No one who has it [AIDS] has to die.” Regarding the severity of global AIDS on children, we have addressed that issue earlier.

2. The number of deaths in American women from heart disease, lung disease, breast cancer, colon-rectal cancer and AIDS is 267,000, 68,510, 40,410, 27,951 and 4,138 respectively.[11] Clearly, HIV disease is not the most urgent threat to woman when existing treatment is provided. Again, regarding the severity of global AIDS on women, we have addressed that issue earlier.

3. FAIR would like a vaccine for HIV and many other illnesses, but before large sums of NIAID funding are allotted for that purpose, we should endeavor to find better treatments for other illnesses that have not achieved the basic goal of effective therapy. Furthermore, if a vaccine is developed for HIV, then what is it? It will be yet another preventive policy and billions more will be needed to pay for this new preventive policy when we don’t have the funding now to provide medicines and develop health infrastructures in Sub-Saharan Africa. As stated above, we already have the preventive and pharmaceutical solutions to HIV disease.

An unrecognized factor negatively impacting all non-AIDS diseases is the “compounding effect” of present NIH policy. The present funding total of each
disease may be viewed as their “principal balance” for this analogy. If the President were to announce a 2 percent increase in NIH funding that was to be
applied relatively equally, the increase in AIDS funding will be approximately $59 million whereas non-AIDS illnesses with a lower “principal balance” or NIH
allocation would receive very small amounts. For example, prostate cancer will receive only $7.5 million and Parkinson’s disease $4.6 million, yet together they
kill three times the number from HIV disease in the USA annually. Each year the growth of the principle balance result from the compounding-interest effect
increases the disproportionate funding for AIDS to an even greater degree—simply because it had a greater balance to begin with, not because it’s threat has
increased without effective solutions. Consequently, the gap in funding between AIDS and all other diseases grows larger.

We join with you and the Ad Hoc Group for Medical Research Funding in urging more overall funding for bio-medical research. However, with the budgetary
limitations resulting from our government’s commitment in Iraq and to restoring the areas ravaged by hurricanes Katrina and Rita, necessary increases for
disease research funding are not being realized as in the five year period when your predecessor, Dr. Varmus, had his budget doubled. As with the common
citizen whose budget is pinched, it is appropriate now to reallocate funding, in this case, to reallocate some of the AIDS research dollars to other illnesses.

In the years of our communicating with you, the FAIR Foundation (FAIR is an acronym for “Fair Allocations In Research) has grown. We now have thousands of
members and supporters in all fifty states and the District of Columbia who want the success of AIDS advocates and researchers recognized with a
corresponding change in the allocation priorities of the NIH. I have given seventy-five presentations[12] in the Senate and House Office Buildings to the
Legislative Health Aides working for Congresspersons, including most on the Appropriations Subcommittees. I found a receptive audience that was surprised by
the magnitude of your success against HIV in the USA. In each I called for a corresponding re-distribution of a portion of HIV research funding to other
illnesses.

Our Board members include two gay citizens, Philip Rugo, a past HCV sufferer who has benefited from HIV research by using Peg-interferon and Ribavirin
successfully, and Ray Hill. Ray was one of this country’s most strident AIDS activists for almost two decades; however he now joins with Philip and our Board
in representing our supporters throughout the USA who are making a nationwide, clarion call for change. As a result of the great success against HIV disease
in the USA, Ray has switched his advocacy to HCV since it is impacting the co-infected HCV/HIV and prison communities so forcefully.

You have shown great courage as NIH Director. In your 2/2/05 speech to NIH employees explaining why it had become necessary for you to appropriately
impose, in your words, "drastic" restrictions[13] on stock ownership and other forms of outside income, scientists, physicians and other staffers stepped to the
microphones and railed against the new rules. A large group, the “Assembly of Scientists,” even threatened to sue, but you held your ground and would not
waiver from that which was necessary and appropriate. Announcing a partial re-distribution of HIV/AIDS funding may produce similar criticism, but we believe
that if there is one person who has the courage to acknowledge the great success of AIDS researchers and admit it is time for change at the NIH in this
matter, it is you.

I have listed the FAIR Foundation Board of Directors [as cosignatories] on the following pages for your review, and I thank you very much for your time and
consideration.

Sincerely,

Richard Darling, DDS
President and CEO

Each member of FAIR's Board of Directors with their signature was included with this letter.

Editor note: Two edits have been added since this was mailed to Dr. Zerhouni. They are enclosed in [ ] brackets.

[1] http://fairfoundation.org/quiz/quiz.htm

[2] http://www.fairfoundation.org/thesixteen.htm

[3] http://www.fairfoundation.org/factslinks.htm

[4] http://fairfoundation.org/states/hiv-aids_deaths_by_state.htm

[5] http://fairfoundation.org/specter_letter_hcv_in_aids_pts.pdf

[6] http://fairfoundation.org/factors.htm

[7] http://fairfoundation.org/fauci.htm

[8] Op. Cit. Note 7

[9] http://fairfoundation.org/news_letter/2006/03june/aids_vaccine.htm

[10] http://www.cdc.gov/hiv/topics/surveillance/resources/reports/2004report/table7.htm

[11] http://www.fairfoundation.org/news_letter/2005/january/womenandaids.htm

[12] http://fairfoundation.org/news_letter/2005/10oct/fair_travels.htm

[13] http://www.nih.gov/news/pr/aug2005/od-25.htm

Dr. Zerhouni's response dated 8/24/06 may be viewed here. In it the Director argues that HIV/AIDS is causing major, global national security issues and refers to the article “The National Security Implications of HIV/AIDS” by Harley Feldbaum, Kelley Lee, Preeti Patel, which you may read here. We find the article to be a biased report replete with speculative adjectives such as “might,” “may,” “could,” “if,” “likely to,” etc. which are epitomized by contradictory comments such as the following:

· “HIV/AIDS is severely affecting the armed forces of many countries. Accurate data on prevalence of HIV among soldiers is difficult to obtain because affected states either do not collect or do not want HIV prevalence data published.”

· Despite the lack of reliable data, there is evidence that the disease is affecting African militaries.

· The effect of HIV/AIDS on state stability is perhaps the least studied, yet also the most feared, potential impact of the disease on security. The US National Intelligence Council argues that high rates of HIV/ AIDS are “likely to have significant economic, social, political, and military implications” in certain countries. If these implications become severe, the AIDS epidemic could contribute to state instability.

· In the strategically important states of Russia, India, and China, HIV/AIDS may contribute to medium- to long-term risks of state and regional instability. However, far more evidence is needed to support such claims.

Yet, the article continues to make such claims, including stating that Russia denying 9,000 potential draftees from becoming soldiers due to HIV infection lends credence to their theory that national securities are at risk. The Russian army has 960,000 troops and at a national conference on narcotics held in November 2003, First Deputy Health Minister Gennady Onishchenko said that the number of drug addicts had increased by ten times over the past eight years and in 2003, 20 thousand conscriptees were released due to drug-abuse problems, of which 6.5% had tried heroin. See those facts on the Russian Army here. Clearly HIV is not the major problem in that army.

The article by Feldbaum, et al even ties in the 9/11/01 attack on New York City to their contentions by suggesting that “failing counties due to HIV” can and will be responsible for such attacks in the future. It also suggests that because some “Peacekeepers” have been accused of rape and spreading HIV, such behavior is sufficient enough, and grounds for, the argument that there is some such security risk from the disease.

Perhaps the underlying basis for such claims is exposed in a concluding statement which ties this "national security" argument to the desire for more power and funding: "Equally important is the ability of the health community to appropriately harness the political clout and resources of the security community.” Obviously, the "health community" that the authors refer to is actually that one owned by the HIV/AIDS community.