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July 31, 2009

 

RE: Formal Petition
 

Dear Senator Grassley, Director Jaffe, Chairmen Obey and Inouye:

The undersigned, educational and medical authorities, organizations, advocates, patients, family, and friends; respectfully submit this formal petition. The HCV community is concerned that investments managed by the trans-NIH Institutes and Centers (ICs), may represent financial conflicts of interests through questionable grants and relevance to HCV disease study. We are submitting this petition for an investigation into HCV research investments and potential conflicts of interests; to include National Institute of Allergy & Infectious Diseases (NIAID) and Director, Anthony Fauci, MD., who has received questionable NIAID grants from the Institute's paltry $34 million HCV budget instead of the $1.3 billion HIV budget.  

The NIH has approved millions of dollars labeled as HCV research for HIV and other disease study, then subsequently report to congress as HCV specific investments. The primary beneficiaries of NIH HCV investments are not the many millions of patients solely infected with HCV, but rather only a few hundred thousand HIV patients who also have HCV.

HepCop points out that any suggested justification for funding HIV projects labeled as HCV investments, seems to be inconsistent with Dr. Fauci's own statement on CNN. He states; "...the scientific advancements that have been made in HIV (research) are breathtaking (with) highly effective drugs to suppress HIV to the point where what was a death sentence in the early eighties to now having patients who look and feel well, who are leading very productive, very gratifying lives..."
 

Examples of additional HCV bio-medical grants:

       Couples-Based HIV/STI Prevention for Injecting Drug Users in Kazakhstan

       Neurobehavioral Effects of HIV & Host Genetics in China

       Nutritional Status In HIV Hispanic Drug Abusers

       Risk Factors for HIV-1 infection Among Young Thai Men

       Drug Interactions in Substance Abusers with HIV Infection

       Hepatic Carcinogenesis Induced By Hepatitis B Virus Pres2 Mutant

       TLR Ligands In GBV-B

       Molecular Epidemiology of Chronic Liver Diseases

        Antiviral Role of APOBEC3 in HIV/HCV Coinfected Patients

Contrasting HIV patients, HCV patients cannot lead desired, gratifying, and productive lives when the majority of HCV investments favor other diseases. Researchers cannot achieve this goal without project investments that meet the priorities necessary for this change.

NIH will report to Congress, it made a $92.5 million investment in specific HCV research projects.
 
*Other Spending Research Totals:
     Non-Specific Research
     HBV/VH Research
     Chronic Liver Disease
     HIV Research

We petition for change in current guidelines that permit HCV research cited but without  benefit or advancement in the scope of HCV disease, to qualify as an investment reported to Congress and labeled as "specific" HCV research. The greater part of NIH HCV investments; do not advance research for prevention, vaccines, treatments, or cures for the majority afflicted.  The data is evident in the charts and documentation compiled from the NIH’s Research Online Reporting Tool (RePORT).  

A compelling example- NIH awarded one research project, totaling $156,104, for Cirrhosis.  Despite the fact, one in 2 men and 1 in 3 women will develop cirrhosis and suffer from many diseases and conditions that could diminish with research investments.

NIH is also spending less on HCV cures- Fewer than half the patients benefit any results from HCV treatments and the many side effects (some permanent, and directly associated with medications).
 

The HCV epidemic will generate trillions of dollars in health care related costs outpacing any other blood-borne viral disease.  Government's response suggest HCV patients, advocates and researchers, should be grateful that HIV funding supports any HCV research; while convincing Congress the additional funding awarded for HCV management research goals, are met with patient needs and not agendas. Clearly this is not the case.  

Thank you in advance for immediate attention to our petition and for future notification of actions taken to insure the community that HCV awards will not be monopolized and will serve the needs and majority of patients.

HepCop Organizational Contacts:

Cc:

Public health is generally defined as, “What we as a society do collectively, to assure the conditions for people to be healthy” (Baxter 2001).

See end of report for complete list of signatories]

Also available online http://hcvets.com/NIH/Petition.asp

*CDC reported "General Public" figures do not include Military related infections.

       Alter MJ, et al. The natural history of community-acquired hepatitis C in the United States. The Sentinel Counties Chronic Non-A, Non-B Hepatitis Study Team. N Engl J Med 1992;327:1899-905. - Data from the Third National Health and Nutrition Survey (1988-1994) estimate that there are approximately 3.9 million non-institutionalized, civilian Americans.

SCIENTIFICALLY DEFINED HIGH RISK GROUPS FOR HCV EXPOSURE

       6-10% or as many as 2.7 million Retired Military & Veterans (only a fraction identified)

       4% "Baby-boomers" Millions!

       10% African American Men

       1 in 50 Hispanics

       40% Institutionalized, homeless and Immigrants

Fastest Growing HCV Prevalence- Among Women, Average Age 24 Yrs Old, From Low-Income Areas. Studies show drug use is not the contributing problem. Yet NIH spent most of HCV Harm Reductions resources on drug/alcohol abuse and HIV risk factors.

Acute HCV Infections Among Women

       39.2% African American

       31.9% Latino

       15.4% White 

       6.7% Asia or Pacific Islander  

       6.7% indicated other or mixed race/ethnicity

Our data incriminate previously unidentified risk factors for transmission of HCV. Such as reported in the  November 2006 Journal of Viral Hepatitis 13(11): 775-782. 15 independent risk factors for HCV. These include body modifications, sharing piercing jewelry, abortions, some dermatological procedures, outpatient injections, contact sports, beauty treatments, professional pedicure/manicure) and confirm those already recognized- hospitalization, endoscopic procedures, blood and kidney dialysis, acupuncture, reuse of medication vials, HCV positive health care workers failure to follow standard practices and not following manufacturer recommendations by the reuse of single use medical devices.

The largest public health patient notification for exposure to pathogens in the history of the USA occurred FY 2008. Public health sent in excess of 70,000, letters warning of possible HCV exposure from unsafe medical practices involving several Nevada clinics.[4]  The Southern Nevada Health District reported that 200 people are testing positive daily in public health departments. [5]  The impertinence for standard procedures is evident in the statement made by the former head of the CDC, Julia Louise Gerberding in response; "The outbreak of HCV may represent the tip of an iceberg” of safety problems at clinics around the country". [6]

According to the World Health Organization, "The only means of protection from the Hepatitis C virus are the implementation standard procedures." Nation-wide, from 2004-June 2009, hundreds of thousand medical exposures to HCV have occurred with an undetermined number of positive infections because of policy differences. Medical exposures surpass any other risk factor for HCV infections.[7]

The NIH HCV Prevention Strategy
Research Funding-National Institute on Drug Abuse

Total NIDA HCV Funding   $18,281,932

http://www.cdc.gov/HIV

In 1994, the CDC could not deny the failure of public health to report HCV infections. Eighty-five percent reported increases in the number of cases reported during the past 5 years. But it was discovered, because of the failure to report "acute" HCV infection, the data could only identify a true 12% increase in the disease incidence. [1]

Despite the flawed data the figures, NIDA used them to support a super-sized hepatitis C epidemic by injected drug users. Recent and very large urban health studies report actual drug related transmissions occurs 1/3 the rate NIDA projects.[2]

Scientists also raised questions concerning research integrity, during hearings held by a Committee on Government Reform and Oversight. Reports in subcommittee files from Department of Health and Human Services make noteworthy that the National Institute on Drug Abuse [NIDA] spent the most NIH resources and continues to spend the most resources on HCV research. Stating it may reflect an institutional bias within HHS that HCV is a disease of injection drug users. This bias may have worked against early recognition of HCV as a broader public health problem.[3]
 

The American Gastroenterological Assoc estimated HCV Health related costs:

       1998,  $693 million

       2002   $15 billion per year

       2010   $1 Trillion dollars
 

2005- HCV recognized as a Carcinogen-
First Viral Pathogen to receive this designation... (PDF- Hepatitis C Virus* Known to be a human carcinogen First Listed in the Eleventh Report on Carcinogens (2004) Carcinogenicity Hepatitis C virus (HCV) is known to ... ntp.niehs.nih.gov/ntp/roc/eleventh/profiles/s092uhpc.pdf - 01-27-2005)
 

Projected % Disease Increase Between 2005-2008

       Decompensation                    223%

       Liver related deaths                279%

       Liver transplantation               528%

       Extrahepatic Manifestations   793%

NIH spent less than $335,000 on "HCV" Clinical Trials…  The other 1.6 million allocated "In The Name OF HCV" benefits all liver disease.
 
Examples of IC HCV bio-medical grants:
5U01AT003566-03 BELLE, STEVEN $393,253  Phase I/II Trials of Silymarin for Chronic Liver Diseases Data Coordinating Cente  
5U01AT003560-03 FRIEDMAN , SAMUEL $273,536  A phase I/II randomized, placebo controlled trial of silymarin for hepatitis C .

The very essence of a free government consists in considering offices as public trusts, bestowed for the good of the country and not for the benefit of an individual. (John C. Calhoun) 

Sign the Petition- Office of Government Ethics to begin an immediate investigation into HCV research funding and potential conflicts of interests at the National Institutes of Health (NIH).  Download Petition- Printer Friendly Word Doc-