Update: U.S. Embassy in Georgia: "No clinical trials have ever been held at the Lugar Center"
The United States Embassy in Georgia provided Polygraph.info with the following comment.
"Lugar Center’s mission is to contribute to the protection of citizens from biological threats, promote public and animal health through infectious disease detection, epidemiological surveillance and research for the benefit of Georgia, the Caucasus region and the global community. No clinical trials have ever been held at the Lugar Center. The medications used in Georgia to treat and cure hepatitis C have been approved by the United States Food and Drug Administration, as well as the European Medicines Agency, for the treatment of hepatitis C infection in humans, and they do not need any additional testing. These certificates of approval are recognized by markets both in Georgia and around the world. The role of the Centers for Disease Control and Prevention (CDC) at the Lugar Center is to provide technical assistance in the areas of public health laboratory capacity building and quality assurance. The CDC’s role within the Hepatitis C Elimination Program in Georgia is to provide technical support to the Ministry of Labor, Health and Social Affairs for data analysis to monitor progress towards HCV Elimination," Christopher A. Davenport, Press and Information Attaché at the U.S. Embassy Tbilisi wrote to Polygraph.info via email.
Neither the Centers for Disease Control and Prevention (CDC) nor the Walter Reed Army Institute of Research (WRAIR) conduct any of the testing or analysis for the hepatitis C program. That work is conducted solely by the NCDC.
Over the last few years, Georgia’s Central Public Health Reference Laboratory -- the so-called “Lugar Lab” – has repeatedly been attacked by some Moscow insiders and politicians. The attacks usually begin a bombshell “revelation” that is instantly picked up by the Kremlin-controlled media, which report an “outbreak of pandemic diseases” or “leakage of pathogens.” Polygraph.info debunked such claims last October.
The latest such “revelation” came during a September 11 press briefing by former Georgian state security minister Igor Giorgadze, who claimed that the Lugar Lab performed secret experiments on humans.
“A preliminary examination of only a portion of the documents – and there are … thousands of pages delivered to me from my friends in Georgia – shows that behinds the walls of the Lugar Laboratory, biologists of the U.S. military-medical group in Georgia and private contractors under federal contract with the … Defense Threat Reduction Agency indeed could have performed on secret experiments on residents of Georgia,” Giorgadze told Russian media during the briefing in Moscow.
A top Georgian official told Polygraph.info that the information disseminated by the Russian media is a stupid rumor and that no experiments on humans are performed at the Lugar Lab. In his opinion, this is an attempt to discredit Georgia’s successful program to eradicate hepatitis C.
The documents revealed by Giorgadze and posted online under the heading “Experiments on People,” show medical logs of treatment of patients suffering from advance stages of the hepatitis C virus. According to the logs, 73 people died after receiving treatment over the course of nine months in 2015-2016.
According to the U.S. National Institute for Health, hepatitis C is an inflammation of the liver characterized by jaundice, liver enlargement, abdominal and gastric discomfort, abnormal liver function, and other symptoms, leading to the liver failure.
NIH says hepatitis has numerous causes, including excessive alcohol consumption, infection by certain bacteria, and viruses contracted through drug abuse (needle sharing).
“Since May 2015, an unprecedented program is being implemented in Georgia for the elimination of hepatitis C. It involves screening the adult population of the country and includes treating patients with an active infection with modern antiviral medicines such as Sofosbuvir, and a combination of Sofosbuvir and Ledipasvir,” said Amiran Gamkrelidze, the director general of Georgia’s National Center for Disease Control and Public Health (NCDC).
He added that the project is a shining example of collaboration between the public, private and international sectors, and that Russia “wants to discredit it” due to the involvement of U.S. foundations and institutions.
The anti-hepatitis C program Georgia is a joint project of the Georgian government, the U.S. Centers for Disease Control and Prevention and the American pharmaceutical company Gilead. The implementation of the project is monitored by the Technical Advisory Group (TAG), consisting of leading international scientists and public health specialists, according to Gamkrelidze.
As part of an attempt to discredit the anti-hepatitis C effort, Moscow has charged that the Lugar Lab, one of many Georgian institutions involved in this program, is a secret U.S. military facility that is developing biological weapons FOR USE against the local population in Georgia and against Russia’s national interests.
In fact, this medical and research center is actually working to improve Georgian people’s health.
“The Lugar Center is a high-level lab diagnostic facility for various infectious diseases, which also includes the hepatitis C diagnostics, and serves as an external control and referral lab for other labs throughout the country that are involved in eradicating the virus,” Gamkrelidze said. “Consequently, the Lugar Center has nothing to do with treating people, as was voiced in Giorgadze’s briefing and in the presented documentation. There are currently 32 medical facilities throughout the country that provide treatment for hepatitis C.”
In its section on alcohol and hepatitis C, NIH relates that while with many patients a diseased liver is able to regenerate its tissue and retain its function, severe hepatitis may progress to scarring of the liver tissue and to such conditions as fibrosis, cirrhosis, liver cancer and chronic liver dysfunction.
If treated late, such conditions are usually fatal.
Gamkrelidze confirmed that in the first stage of the program in Georgia (2015– first half of 2016), treatment was provided to patients with a high degree of liver damage. “Regardless of decompensated cirrhosis, severe fibrosis, ascites and other complications, the patients were given the opportunity of treatment within the program to be able to defeat the virus. Since July 2016, all limitations on a patient’s condition have been canceled, due to which all patients have the opportunity to receive treatment.”
NCDC found that while most of the treated patients were cured, a number of patients died during the implementation of the program. “This was associated with various degrees of liver damage and various complications and concomitant diseases that are quite common in patients with severe hepatitis C. It is notable that from the very beginning of the program, the rate of patients who died due to various reasons has nothing to do with the medicines used,” Gamkrelidze explained.
As Giorgadze’s documentation shows, 73 people died while in the treatment program during nine months in 2015- 2016. It shows that the Lugar Center treated them with Sovaldi and Ribavarin, which are U.S. and EU approved oral medications used for treatment of chronic hepatitis C.
This is confirmed by the published materials. For example, all the cases under the column headed “reason for taking” (these medications) listed ”chronic hepatitis C.”
In April 2017, the U.S. Food and Drug Administration approved use of Sovaldi for pediatric patients, meaning children aged 12 to 17. The FDA previously approved this medication to treat hepatitis C in adults.
The FDA’s medication guide also approves Ribavirin, which is sold under different brand names, including Copegus and Rebetol.
Ribavirin and Sovaldi are also approved by the European Medicines Agency.
Worldwide, around 400,000 persons die from liver diseases related to hepatitis C annually. Georgia, a country with a population of 3.7 million, has long been affected by hepatitis C and, thanks to the efforts made in the last ten years, the country is on the forefront of the fight against this disease.
The prevalence of hepatitis C is blamed for the collapse of the country’s health system in the 1990s.The low quality of health services, unsafe drug injection practices (including the widespread practice of needle sharing among people who inject drugs) and low infection control and blood safety in health facilities continued into 2000s.
All these factors contributed to the spread of hepatitis C in the general population.
In 2015, the World Health Organization admitted that significant challenges in the fight against hepatitis C remain, including the asymptomatic, chronic nature of the virus, which has resulted in delayed diagnosis and transmission among hard-to-reach regions. To address these challenges, the Georgian government adopted a long-term strategy for 2016–2020 aimed at the total elimination of the disease in the country.
According to the national population survey conducted by the NCDC and the U.S. Centers for Disease Control and Prevention during May-August, 2015, 5.4 percent of Georgia’s 3.7 million population -- 150,300 adults -- have been hepatitis C positive. The successful implementation of the program in Georgia resulted in 24,481 out of 36,012 patients getting rid of the infection in 2015-2017.
The so-called Lugar Lab, officially called the Center for Public Health Research, is located in Tbilisi and named after former U.S. Senator Richard Lugar. It became operational in 2013. The Center is part of Georgia’s National Center for Disease Control (NCDC) system, within the Ministry of Labor, Health and Social Affairs. The U.S. Defense Threat Reduction Agency (DTRA) funded the Center under the 1991 Nunn-Lugar Cooperative Threat Reduction Program, which was designed to dismantle Cold War-era weapons of mass destruction and convert such capabilities to exclusively peaceful scientific research.