THE NGO OBSERVER News

REPORT ON REPUBLIC OF GEORGIA

 Dilyana Gaytandzhieva writes from Tbilisi, Sept. 12, 2018

“Georgians used as laboratory rabbits by GILEAD in Hep-C trial drug test in a poor developing nation”

http://dilyana.bg/us-diplomats-involved-in-trafficking-of-human-blood-and-pathogens-for-secret-military-program/

The biggest shareholder in Gilead is the former US Minister of Defense Donald Rumsfeld.

UPDATE SEPT 2020

"In 2020 Gilead donated a new experimental drug for use on Georgian patients – Sofosbuvir-velpatasvir, a generic version of Gilead’s Epclusa for the treatment of hepatitis C patients manufactured in India. The Indian generic drug has not been registered in Georgia yet. However, this unregistered drug has been imported in Georgia on the grounds of “a special state interest with the consent of the Ministry of Health”.
Despite the patient deaths and treatment cancellations in the Hepatitis C elimination project, Georgian health officials have gone further and invited Gilead to launch another clinical trial on 100 patients about the safety of Remdesvir (another Gilead experimental drug against COVID-19).

Not only have local health officials offered US drug giant Gilead to test its experimental COVID-19 medicine freely in Georgia but they have also exempted US diplomats from quarantine inspection upon arrival to the country at the request of the US Embassy to Tbilisi."
http://armswatch.com/georgia-cover-up-of-deaths-in-3-3-billion-pharmaceutical-project-documents/

ECO HEALTH ALLIANCE in Nation of Georgia LUGAR CENTER. ECO HEALTH ALLIANCE is a vast global NGO started by super TV personality Gerald Durrell, whose partners include: US Army DTRA; USAID; BOOZ ALLEN defense consultants; Johnson & Johnson; Colgate Palmolive; Boehringer Ingelheim; WHO; Bill & Melinda Gates; Bloomberg School; Johns Hopkins; CDC; NIH. In 2017 the US Defense Threat Reduction Agency (DTRA) launched a $6.5 million project on bats and coronaviruses in Western Asia (Georgia, Armenia, Azerbaijan, Turkey and Jordan) with the LUGAR CENTER being the local laboratory for this genetic research. The duration of the program is 5 years and has been implemented by the non-profit US organisation Eco Health Alliance. ECO HEALTH ALLIANCE--The project’s objectives are: 1. Capture and non-lethally sample 5,000 bats in 5-year period (2017-2022) 2. Collect 20,000 samples (i.e. oral, rectal swabs and/or feces, and blood) and screen for coronaviruses using consensus PCR at regional labs in Georgia and Jordan. According to the project presentation, ECO HEALTH ALLIANCE already sampled 270 bats of 9 species in three Western Asian countries: 90 individual bats in Turkey (Aug 2018), Georgia (Sept 2018), and Jordan (Oct 2018) and Georgian scientists sampling a bat for coronavirus research in 2018. Coincidentally, the same Pentagon contractor tasked with the US DoD bat-research program – ECO HEALTH ALLIANCE, USA, also collected bats and isolated coronaviruses along with Chinese scientists at the Wuhan Institute of Virology. ECO HEALTH ALLIANCE received a $3.7 million grant from the US National Institutes of Health (NIH) to collect and study coronaviruses in bats in China from 2014 to 2019. http://armswatch.com/new-data-leak-from-the-pentagon-biolaboratory-in-georgia/

R.I.P. Kevin Zeese, suddenly died recently of quick heart attack at 64.... legendary lawyer activist USA .... "fracture Police Solidarity, rather than Defund them" was one of his many postulates .... go to hour/minute/second 1:09:55 to hear his brilliant answer to the question "How do we deal with provocateurs who are Fed Agents infiltrated into our activist/protest movements who are if not infiltrators, then informants, or BOTH?" He starts out by responding that as many as 1 out of 6 protestors and members of "movements" are such federal plants agitating as provocateurs. This includes BLM and Antifa today, and also western NGO protests in Tbilisi. https://www.youtube.com/watch?v=RPQoQPJuO7Y&t=3533s

COVID-19 vaccine coming 2020 from DoD/FDA friendly GILEAD?
GILEAD HISTORY IN A ‘CAPSULE’

On July 11, 2014, the U.S. Senate Committee on Finance investigated GILEAD's Sovaldi Hep-C treatment high price ($1,000 per pill; $84,000 for the full 12-week regimen). Senators wrote to GILEAD CEO John C. Martin asking Gilead to justify the price for this drug. The committee hearings did not result in new law, but in 2014 and 2015, due mostly to mandated by law discounts, Sovaldi was sold well below the list price. For poorer countries, especially nation of Georgia, Gilead dispensed “free” national test trial treatments & licensed multiple companies to produce generic versions of Sovaldi, for example, in India, a pill's price was as low as about $4.00 (compared to its US price tag of $1,000 per pill). GILEAD had recruited Donald Rumsfeld to join the GILEAD board of directors in 1988, followed by board of directors member  George P. Shultz, (U.S. Treasury Secretary Shultz supported the Nixon shock--which sought to revive the ailing economy in part by abolishing the gold standard--and presided over the end of the Bretton Woods system).  However in January 1997, Donald Rumsfeld, a GILEAD board member since 1988, was appointed Chairman of GILEAD.  He later left the Board in January 2001 when appointed U.S.  Secretary of Defense at the start of George W. Bush's first term as President. On July 16, 2012, the FDA approved Gilead's prophylactic Truvada for prevention of HIV infection (it was already approved for treatment of HIV). The FDA has historically been very generous and helpful to Gilead which has aroused plenty of controversy. Gilead had intentionally withheld results of clinical trials demonstrating TAF’s relative safety and efficacy and shelved TAF-based therapies until 2010, when the FDA had approved Gilead’s application to patent TAF.

Jan 10, 2020:

click here for all you ever wanted to ask about GILEAD but were afraid to ask...Sept 19, 2017 YALE SCHOOL OF MEDICINE-- "Gilead continues to refuse to systematically share the data most critical for scientists, showing its leadership has little regard for the public and no genuine commitment to transparency in clinical research"

Gilead Sciences Israel Ltd. 4 HaHarash St, Lobby E 14th floor, Hod Hasharon Business Park Israel –

Why GILEAD needs to widely distribute Harvoni & Sovaldi HepC treatment in 3rd World countries like Georgia, Egypt, (India, Mongolia too) very cheaply or for free – involves questions in USA over its FDA approval for which many experts and regulators question the transparency of its swift approval – conversely, for their drug treatment of Hepatitis C (HCV) Gilead said it would also launch its own branded Sovaldi in India at a price of $300 a month. The very same drug costs $84,000 for a 12-week course in the United States. https://www.reuters.com/article/us-gilead-sciences-fda/health-groups-sue-fda-for-gilead-hepatitis-c-drug-trial-data-idUSKCN0P92IZ20150629   “Health groups sue FDA for Gilead hepatitis C drug trial data”,  Jonathan Stempel, REUTERS & Health News,   June 29, 2015

Conclusions drawn from latest data relating to GILEAD free drugs trial across full nation of Georgia to treat HVC/HepC viral epidemic in the small nation legendary for its dirty hospital needles and careless dentists who had spread the virus until recent reforms--only Egypt is more afflicted with HepC infection density per population

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https://bmcinfectdis.biomedcentral.com/articles/10.1186/s12879-019-4741-5

Tsertsvadze, T., Gamkrelidze, A., Nasrullah, M. et al. Treatment outcomes of patients with chronic hepatitis C receiving sofosbuvir-based combination therapy within national hepatitis C elimination program in the country of Georgia. BMC Infect Dis 20, 30 (2020) doi:10.1186/s12879-019-4741-5 https://rdcu.be/b0ie3

• Received 17 April 2019
• Accepted 27 December 2019
• Published 10 January 2020
• DOI https://doi.org/10.1186/s12879-019-4741-5

We report latest available outcomes of SOF-based treatment regimens in patients with chronic HCV infection in the country of Georgia. Initially, DAA treatment was exclusively SOF based and included ribavirin (RBV) with or without pegylated interferon, depending on the HCV genotype, per national guidelines. From February 2016, more effective, interferon free DAA combination - sofosbuvir and ledipasvir (SOF/LDV) was introduced, and treatment regimens were revised. Most patients, 2838 (55.9%) were age 45–60 years, 4381 (86.3%) were males, and from Tbilisi the capital, or with many contacts there, many of them developing nation middle class. Of the 7342 patients who initiated treatment with SOF-based regimens, 5079 patients were tested for SVR. Total SVR rate was 82.1% in per-protocol analysis and 74.5% in mITT analysis. The lowest response rate was observed among genotype 1 patients (69.5%), intermediate response rate was achieved in genotype 2 patients (81.4%), while the highest response rate was among genotype 3 patients (91.8%). Overall, SOF/RBV regimens achieved lower response rates than Interferon supplemented IFN/SOF/RBV regimen (72.1% vs 91.3%, P < 0.0001).

Georgia’s real world experience resulted in high overall response rates given that most patients had severe liver damage. Our results provide clear evidence that SOF plus INTERFERON IFN and RBV for 12 weeks can be considered a treatment option for eligible patients with all three HCV genotypes. With introduction of next generation expensive GILEAD type DAAs, significantly improved response rates are expected, paving the way for Georgia to one day achieve HCV elimination goals, even for the poorest of villagers and not just the lower middle and middle classes of Tbilisi.

Our study has several limitations. First, data from patients in whom prior treatment had failed, was not collected. Second, liver fibrosis was assessed by multiple noninvasive indices, each of which have limitations on accuracy [20,21,22]. The national treatment database, which captures information on all hepatitis C patients enrolled in the program, provides accurate treatment related information on a national level. However it does not contain detailed information on some variables, including comorbidities (diabetes mellitus, kidney failure, extrahepatic manifestations etc.) as well as nature of deaths, adverse events and reasons of self-discontinuation. Also data available in the national system has limited ability to answer questions as to why people are lost to follow-up along the continuum of care. Significant number of patients who were lost to follow-up after treatment completion is a serious challenge of the treatment program. Despite notable progress of the Georgia HCV elimination program, challenges to Georgia achieving the national targets for HCV elimination by 2020 remain. With the introduction of next generation DAAs, replacement of IFN-based regimens by IFN-free regimens and significantly improved response rates are expected, paving the way for Georgia to achieve the goal of HCV elimination.

Treatment outcomes of patients with chronic hepatitis C receiving sofosbuvir-based combination therapy within national hepatitis C elimination program in the country of Georgia

In conclusion, in this large cohort study, a combination of SOF and weight-based RBV with or without IFN (Interferon) appeared to be an effective regimen to treat chronic HCV-infected patients, especially for HCV Genotype 2 and 3 patients. SOF formed the foundation of the HCV elimination program in Georgia. Cure rates in patients without cirrhosis were high, which are comparable with those reported in clinical trials. However, consistent with previous studies, the presence of liver cirrhosis were associated with lower SVR12 rates. Our results provide clear evidence that SOF plus IFN and RBV for 12 weeks can be considered a treatment option for eligible patients with all three HCV genotypes. With the introduction of next generation DAAs, replacement of IFN-based regimens by IFN-free regimens and significantly improved response rates are expected, paving the way for Georgia to achieve the goal of HCV elimination.

In our study response rates among patients with HCV genotype 2 were lower than reported in clinical trials and real-life studies which showed high efficacy of SOF plus RBV combination treatment among HCV genotype 2 patients including those with cirrhosis and/or treatment experience [8, 12,13,14,15]. Lower efficacy of treatment in genotype 2 patients may have been associated with a reported high prevalence of HCV recombinant form 2 k/1b among Georgian HCV genotype 2 patients [16]; these patients do not respond well to standard treatment for genotype 2 and regimens used for genotype 1 seem to be more effective [17]. Therefore there is a need for reassessing existing modalities for the management of HCV genotype 2 infection, especially in areas with high prevalence of HCV recombinant form 2 k/1b [18].

We observed high cure rates in HCV genotype 3 patients that are one of the most challenging subpopulations to treat [19]. Interferon-based regimens were superior to SOF/RBV alone. The results of clinical trials showed that HCV genotype 3 patients achieved higher SVR12 rates with a 12 week SOF and RBV in combination with IFN that patients who were treated with SOF and RBV alone [12].

Our findings support use of a 12 week regimen of SOF plus RBV in combination with IFN as a treatment option for eligible HCV genotype 3 patients in settings, where new highly potent and well-tolerated DAAs against genotypes 2 and 3 are not available. Our results suggest the use of SOF/RBV combination for 24 weeks as an option for patients who cannot tolerate IFN.

After examining host and viral factors we found that presence of cirrhosis, and receiving IFN-free regimens were associated with lower SVR in a multivariable model. The low rates of response among cirrhotic patients is consistent with previous studies.

One strength of this study is the large number of patients as well as standardized treatment guidelines and standardized data collection. The diversity of our cohort with respect to sex, age, and genotype distribution makes our findings generalizable, reflecting reported real-world outcomes. Our study has several limitations. First, data from patients in whom prior treatment had failed, was not collected. Second, liver fibrosis was assessed by multiple noninvasive indices, each of which have limitations on accuracy [20,21,22]. The national treatment database, which captures information on all hepatitis C patients enrolled in the program, provides accurate treatment related information on a national level. However it does not contain detailed information on some variables, including comorbidities (diabetes mellitus, kidney failure, extrahepatic manifestations etc.) as well as nature of deaths, adverse events and reasons of self-discontinuation. Also data available in the national system has limited ability to answer questions as to why people are lost to follow-up along the continuum of care. Significant number of patients who were lost to follow-up after treatment completion is a serious challenge of the treatment program. However, in 2017 the program offered SVR assessment free of charge that would lead to reducing missing SVR data.. Despite notable progress of the Georgia HCV elimination program, challenges to Georgia achieving the national targets for HCV elimination by 2020 remain. Pangenotypic DAAs that are effective across the different genotypes of HCV introduced in late 2018 could have a substantial impact on improving access and simplifying diagnosis and treatment.

Why is Georgia throwing out GILEAD donated Hepatitis C medications worth $200 mln?

JamNews, January 12, 2020

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6488087/

PMCID: PMC6488087

PMID: 31034530

On the way to Hepatitis C elimination in the Republic of Georgia—Barriers …

We started with key informant interviews to guide the study instrument development and compare the study findings against health care planners’ and health care providers’ views. Forty PWID with various HCV testing and treatment experiences were recruited through the snowball method. The study found that along with structural factors such as political commitment, co-financing of diagnostic and monitoring tests, and friendly clinic environments, knowledge about HCV infection and elimination program benefits, and support from family and peers also play facilitating roles in accessing testing and treatment services. On the other hand, inability to co-pay for diagnostic tests, fear of side effects associated with treatment, poor knowledge about HCV infection, and lack of social support hampered testing and treatment practices among PWID. Findings from this study are important for increasing the effectiveness of this unique program that targets a population at high risk of HCV infection.

Pre-treatment diagnostics, treatment monitoring, and post-treatment laboratory tests were covered by the program and local governments with some co-financing required from patients. Since the beginning of the program implementation socially vulnerable patients and war veterans have been co-financed up to 70% by the program and up to 30% by local municipalities so they receive completely free testing services. As for the rest of the population, cost sharing for diagnostics, monitoring, and post-treatment tests across the years is presented in Table 1. Of the 40 drug addicts who were the PWIDs of this study, the respondents from the capital city frequently mentioned the contributions of CSOs in covering diagnostic test expenses. Tbilisi patients appeared to be in a better position due to significant contributions from the Mayor’s office that, at the time of the study since 2016 have been covering 60% of diagnostic and monitoring test costs in addition to the program co-financing of 30%. Respondents also admitted that they needed to pay some amount for clinical diagnostics and laboratory tests to monitor treatment outcomes.

SEPTEMBER 2018

Investigations have been currently launched regarding the GILEAD hepatic C Agreement with the Ministry of Health, as both a trial test and treatment given out, free of charge. When the “deal” was signed, it was agreed that 1,800,000 people would be screened in the next three years, but now “the program expired in April 2018 due to the ‘small number of patients’ ”

14:40 04-09-2018

InterPressNews was told by the State Security Service that the Anti-Corruption Agency had started an investigation on possible violations in the process of the distribution of medicines within the hepatitis C elimination program. In partnership with the American company Gilead, Georgia launched a large-scale Hepatitis C Elimination Program in 2015. The program aims to make Georgia a Hepatitis C-free country by 2020. However, to date, according to the Ministry data, slightly more than 50 000 patients have been registered in the hepatitis C elimination program, and more than 44,000 beneficiaries have completed this free GILEAD treatment.

The government and GILEAD since the signing of the Agreement three years ago, have now according to the Ministry of Health and Social Affairs of Georgia, they will pay only up to 70 percent of the costs of the testings for involvement in hepatitis C elimination program. Many poor people in Georgia cannot afford 144 GEL or more out of pocket for such a test. The cost for diagnosis is GEL 480 (USD 212), Sergeenko said after signing the agreement with the company in Tbilisi on April 21, 2015, and after the government covers its 70 percent, there will be 144 lari left for the patient to cover. He said each patient will have to cover only 144 out of the whole treatment which costs USD $100,000. "We will take the Georgia data to other countries around the world to really make the case that investment can fundamentally change the disease over time," Greg Alton, Gilead Head of Corporate affairs, said. Georgia has the world's third highest prevalence of hepatitis C, after Egypt and Mongolia, with nearly 7 percent of adults carrying the virus. It also has a wide range of Hep C viral variations and many different types of patients that are great for a free test trial study on humans.

The State Security Service of Georgia has launched an investigation related to the GILEAD hepatic C drugs, which were expired in April of this year due to the small number of patients, - Minister of Health Davit Sergeenko said on Tuesday. The Minister of Labour, Health and Social Affairs of Georgia told reporters that the free GILEAD C hepatitis elimination program that: "No specific offense has been revealed yet, but an investigation is underway to conduct a triad - prevention, detection, reaction. This is a function of controlling bodies and we do not interfere in it", said Davit Sergeenko. "The international partners, the National Center for Disease Control GILEAD participate in the project, there is also an International Advisory Board, which meets twice a year and provides us with recommendations. One of the first recommendations in 2016, […] was that we had to treat a minimum 3500 patients per month in order to ensure that the planned elimination was implemented within the set terms. Our target was 3,500 patients per month…So we have calculations based on the number, recommended by the International Advisory Board and are taking the steps to be completed. Despite the monthly average target was 3,500 - we had just 1 000 [patients]. The order for the medicines is agreed with the International Advisory Board. In April, a certain amount of medicines was ordered for 3,500 patients per month and the flow was 1000 patients and the drugs given us had already been expired. It's bad, but the state did not suffer losses, because it is donation and they give us it free,” said Davit Sergeenko.

Hepatitis C screening programmes began in Georgia in 2015 and, by the end of April 2017, 43,989 individuals (29.3% of the estimated total population) had been diagnosed with HCV infection and registered with the elimination programme. A total of 33,673 individuals had initiated treatment with DAAs, and 24,273 individuals had achieved a sustained virological response (SVR), i.e. “were cured”.

PHOTO April 2015: Georgian Health Minister Davit Sergeenko signing long term Agreement with Dr. Jean Elie Malkin of UNAIDS ... who coordinated the Memorandum and Agreement document that was signed by the Government of Georgia with third party consultancy agency Global Alliance for Health and Social Compact [GAHSC], a small and totally new foreign consulting firm that is registered in England as a business, company number 09196046, in Somerset, UK.

THE NGO OBSERVER News

April 10, 2015, by Bryan Adrian

“Will Global Alliance working closely with GILEAD Somehow Bring Quality National Health Care to the Georgian People?”

GLOBAL FUND PARTNERS

A quick look at an attendance record shows that the vast majority of this panel that were present here in Tbilisi were at one time affiliated with UNAIDS or fellow colleagues of earlier UNAIDS and/or their Global Fund Partners, and that they were not on the permanent administrative staff of GAHSC. 

This groundbreaking long-term Agreement signed by the Ministry of Labor, Health and Social Affairs of the Government of Georgia, handing over their future into the hands of a small and unfamiliar newly registered alliance "consultancy group of foreign western experts," will shepherd the transitional government of Georgia into an exclusive EU business marriage agreement. A similar union was also anointed in the Ukraine over a year ago, with much fanfare and celebrations with Ukrainians expecting overnight successes. This long term Memorandum Agreement authorized a private EU small and elite steering committee, in their wisdom, to steer the national Georgian healthcare system and infrastructure reforms into the hands of a UNAIDS-endorsed, newly cobbled together, and virtually unknown EU/UK “expert” consultancy agency--the Global Alliance for Health & Service Compact [GAHSC], who were taken onboard by the Georgian Ministry of Labor, Health and Social Affairs, in the expectation of fulfilling to the letter of the EU laws all the very challenging and unfamiliar and confusing stipulations of the new TRADE AGREEMENT Georgia has made with the EU.

SIMILAR TO UKRAINE?

Already today, the new government of Ukraine which had themselves rushed into many similar memorandums of agreement with EU agencies, is no longer admired nor respected by many observers, for its fair and supportive pension plans and programs, nor for its helpful health plans and programs, nor for its jobs development programs, and not in any way today for its press and media and civil freedom policies and politics, ever since the Poroshenko government and his many Right Sector allies took command, gobbling down more and more extravagant IMF loans that will later burden the survivors of the civil war in that nation, into hopeless debt servitude. Not to mention the other additional debts to buy arms to escalate the civil war until the Russian speaking Ukrainians of Eastern Ukraine are dead or when the citizens of eastern Ukraine hand over all mining operations and industry to the new Kiev oligarchs, who would be very pleased if the East Ukrainians also got down on their knees begging to study Ukrainian as soon as possible.

A RENDEVOUS OF OLD FRIENDS?

Despite the meeting being publicized as a benediction between a small international consulting group called Global Alliance for Health and Social Compact’s [GAHSC] with the nation of Georgia Prime Minister Irakli Garibashvili and Health Minister Davit Sergeenko, it was for the most part a reunion of UNAIDS-WHO affiliated colleagues who already have managed assorted AIDS-sexual-blood transmitted disease prevention and treatment programs in parts of Africa and the Middle East and former CIS countries. please go to http://beaties_of_bulgaria.tripod.com/NGO-OBSERVER/GAHSC_STAFF.html for extensive notes on Dr. Malkin’s hand-picked crew and their past work and alliance experiences and histories.]  

The essential details of this "Memorandum" between the Georgian Minister of Health, and the Global Alliance for Health and Social Compact [GAHSC] seem to be invariably and conclusively "transparent" to the Ministers of Georgia, in Georgia ’s new and struggling Open Society, given the speed with which they signed this Agreement. 

Healthcare expert Jean Elie Malkin of UNAIDS,  Director for the UNAIDS Regional Support Team for Eastern Europe and Central Asia, according to local Georgian media reports, had appraised with flying colors, the transparency of their mutual forthcoming projects and reforms, before signing the Memorandum Agreement -- in addition to offering his own personal assurances and approval of the excellence of this GAHSC newly minted healthcare small consulting firm – in this historic Agreement Memorandum with the Georgian Minster of Labor, Health and Social Protection, David Sergeenko.  Mr. Sergeenko co-signed with a flourish of his pen, showing his strong confidence in this spanking new international consulting group, Global Alliance for Health and Social Compact [GAHSC], a consultancy firm with shoebox type offices in a few cities, most of them relatively close to Russian border regions.

“CHRISTOPHER DAVEY I PRESUME?”

Who are the GAHSC "experts" who are not yet listed on the official GAHSC website? http://gahsc.net/  [the only name given on their corporate stakeholders website is not even a full name but an email address for a.outhwaite@gahsc.net]. The Global Alliance for Health and Social Compact [GAHSC], is a consulting team that has been in business only about half a year, with a 24 year old newly appointed director whose name is listed as Christopher Davey and who was born in 1991 and who is a British national. Their consulting team-without-names  has signed a Memorandum with the Georgian Minister of Health David Sergeenko, endorsed by a regional director of UNAIDS, Dr. Jean Elie Malkin, using contractors/subcontractors that evidently are to be of Dr. Malkin’s own choice, and not Christopher Davey’s.  Let’s hope the ministers of Georgia are fully aware of the ramifications of this Agreement Memo and that the future proves to the world that their new western partners are responsible and sincere and successful in their engineering of the healthcare system in the emergent open society of Georgia, which is still in the process of vindicating itself as a proper EU western-style and fully western-indebted democracy. 

TUBERCULOSIS IS A MUCH GREATER ISSUE HERE THAN AIDS -- AIDS: 4000 / TUBERCULOSIS: 7000 (estimated values)

To some observers this raises a few important questions, such as why the entire healthcare system of Georgia should be overseen and micromanaged by an inexperienced and unproven small consultancy firm, Global Alliance for Health and Social Compact [GAHSC], recommended and endorsed mostly or solely by a United Nations AIDS director. Georgia has a very low AIDS rate and has never been threatened --to this very day -- by a sudden AIDS outbreak or epidemic, nor do they have much of a drug addict subculture that could spread AIDS [unlike Ukraine and Russia]. In addition, Georgia is not a prostitution-friendly nation, its Orthodox Christian moral and traditional values may be the strictest of all Eastern Christian lands, on par with Muslim nations. On the other hand, hepatitis B and C and tuberculosis [TB] definitely need more examination in Georgia, two diseases which have high rates of transmission in Georgia and would require extensive sanitation training and hygiene education in local hospitals and clinics to improve prevention, more useful to Georgians than receiving further expensive drugs from EU nations -- even if they receive deep discounts for experimental Manufacturers Associations "free" drug trials. Georgians do not, nor do citizens of most other nations, need to be saddled and burdened with new super huge loans from World Bank/IMF, at this crossroads time of their proud and noble Georgian development.  It seems more and more the world is cheering on the success of the new Georgian government, and confident of their efforts to repair the damages and correct the misdemeanors and felonies of their former ruling government, which had been resoundingly voted out of office just a few short years ago.

NOT MUCH AIDS HERE IN A LAND OF MANY VIRGIN BRIDES

One written by a Belgian doctor, Dr. Jean-Louis Lamboray, who had once been Team Leader for UNAIDS from 1998-2004, and he had also been a Senior Public Health Specialist for The World Bank, from 1987-1988. He shocked the world and quit both UNAIDS and World Bank to run his own NGO founded in 2004, to better mitigate the spread of AIDS, at the local -- and not so much only the global level – which he saw as wasting valuable resources.

Dr. Jean-Louis Lamboray’s book, "What Makes Us Human" is available in French and Spanish and was scheduled to be available English by this date. http://www.bmj.com/content/329/7457/67.2 

If we can get Dr. Jean-Louis Lamboray to endorse the Global Alliance for Health and Social Compact [GAHSC] and to attest that they are a perfect partner for shepherding and steering Georgia into the EU golden heights of successful European healthcare policies and procedures, then I see no reason not to enthusiastically plunge ahead with this agreement and memorandum between GAHSC and the Georgian Ministry of Health. Who would not feel the same, about such an impartial and unaffiliated endorsement, as one coming from Dr. Lamboray?

As long as I have your attention, here is another highly recommended book related to this healthcare deal a few days ago with the Georgian Ministry of Health. It was written by Pierre Pean in 2009, titled "Le monde selon K.", in English known as, "The World According to K", a book about, among many other associated themes, the dizzying revolving door ties between former French Socialist turned Bush-Hugging-NeoConservative Bernard Kouchner, with Dr. Jean Elie Malkin, of IMEDA Global Medical Alliance, and with Marie Christine Danon, of Danomex and Africa Steps.

ONLY THE FUTURE WILL TELL IF PRESCRIPTION PRICES GO UP OR DOWN IN GEORGIA

It seems the most important outcome reported so far about this "memorandum" signed with an almost unknown "expert" consultancy team, Global Alliance for Health and Social Compact GAHSC, according to their official business registration [shown in this link] is that GAHSC is presided over by a 24 year old mystery company director just recently hired. GAHSC, whoever they will prove to make themselves out to be in the end, they most certainly put much emphasis today on quality control of modern and efficient “regulative systems" required for EU Trade Agreement of pharmacological products in Georgia.  We all know here in Georgia that more and more of the colossal GLOBAL PHARMA multinational corporations have already been swiftly moving into the Georgian pharmacy and healthcare market, pushing up the prices for what are now mandatory prescriptions, which until very recent new Georgian legislation, Georgians did not require a doctor’s prescription for many common and harmless drugs. Rich urban Tbilisi towns-people, as well as rural villagers out of work, must now go to a physician to get each medication they need, even for chronic illnesses, written out for them again and again, costing lots of money and the valuable time of doctors who could be diagnosing patients and not increasing their fatigue writing out bureaucratic prescription forms for the National Database to conform to new EU regulations.

THE TRAGIC STORY OF MARINA, mother of Natali Naskidashvili

Drug testing of experimental EU and U.S. drugs on poor Georgians has become more and more commonplace in Georgian clinics in the last few years [simply recall the abysmally underfunded Abastumani TB clinic and its poor internal heating and plumbing conditions and the rather carefree manner in which the patients inside are offered experimental drug testing by some European pharmaceutical companies offering free cutting edge treatments—Georgia has an estimated 7,000 diagnosed cases of TB today—in a country with a population of a little less than 4.5 million.] 

Click here for letter from a middle aged woman, Marina, mother of Natali Naskidashvili, in the Abastumani, Georgia, TB clinic, who was suffering at the time of her letter from the experimental drugs used in drug trials from EU companies, her letter in Georgian AND English [now she is dead] 

Marina’s letter from inside the Abastumani TB clinic in Georgia, about three years ago, expresses very dramatically her lamentations over being a test subject for experimental TB drugs from EU pharmaceutical companies testing their drugs on poor Georgians.

This may be the last chance for the Georgian government and the Georgian people to examine and re-evaluate their current choices for the future of their medical care on a national and local level.

Memorable quote reminiscent of earlier quotes made before by other UNAIDS high officials about Chilean and Haitian and South African UNAIDS program implementations:

“So, we will support, with our Georgian counterparts, this momentum in order to move Georgia close to the European standards on health. Moving to the European standards means to give the population of Georgia access to quality care, but also to affordable care, in order to decrease the overall cost of health, and do this in a transparent way,” stated Dr. Malkin of UNAIDS, who also has been heard dozens of times in his recent visit to Tbilisi saying “health is a human right”.

In closing, let me make one last comment. The slam-dunk signing of this Agreement could just possibly be the magical silver bullet to kill the ugly beast of creaky former CIS former Soviet Republics style medical and healthcare education and protocols -- at times still medieval in Georgia. Yet for all the trusting and hopeful Georgian ministers, who evidently see mostly golden horizons and no serious nor harmful speed bumps on their new road to rapidly restructuring their entire healthcare system, advised almost entirely by these GAHSC AIDS-disease experienced western-oriented and global-minded consultants-for-hire cluster of experts, their trust may be naively and regrettably misplaced.  Paradoxically, the Georgian Ministry of Labor, Health and Social Affairs should very soberly look at the 'great successes' of the EU nations recently in economics, bank loan debts, harsh austerity programs, industrial output, greatly reduced social services, serious problems of illegal immigration overload, and the increasing numbers of enraged European protestors against the heightened and accelerated military NATO involvement of their EU nations inside the borders of distant third-party countries, which all combined, should somewhat erase the big smile of success on their currently post-Memorandum exultant Ministers faces. But there is hope and light at the end of this tunnel.

Why I Have Always Preferred MEDEA to JASON and his foreign ARGO-NAUT Consultants

 Don’t forget the old legend of Jason and the Argonauts, and Medea, who was in fact not a Greek but a Georgian woman, famed for her medical skills as much as Hippocrates, if not more. Perhaps this time in the history of Georgia, Medea should set the agenda and not be robbed by the western Argonauts who come bearing gifts. After all, many historians now concede that Medea, the Colchis-Georgian healer, pre-dated Hippocrates in the human discovery of effective early systematic medical treatments. She is the light.

THE NGO OBSERVER News

FACTS LEADING UP TO 2016 article above...

The major funding for Humanity Georgia Pharmaceutical supplies and production of Indian-based generic drugs comes from the PARTNERSHIP FUND [PF], created in 2011 by the Saakashvli government. They [PF] also own 100% of shares of Georgian state oil and gas and electro systems, except for Telasi Electric, of which they own 24.5%. 

JSC Partnership Fund (PF) is a state owned investment fund, established in 2011. PF acts as financial partner for private investors and provides mid to long-term financing. Fund provides Greenfield as well as Brownfield financing and acts as a "Sleeping Partner” with a predetermined, clear exit strategy. Moreover PF enables projects to attract senior financing from commercial sources or IFIs. 

Pfizer Pharmaceuticals is in disagreement that most of the staff of Humanity Georgia were once Pfizer employees, as has been claimed by some of the Georgian media.

Early 2016 TRANSPARENCY INTERNATIONAL report: "According to the Partnership Fund website, on December 24, 2015, “the Partnership Fund and an Austrian company Humanity HoldingGmbH are launching a new project with active participation by the Ministry of Labor, Health and Social Affairs of Georgia upon request from the Georgian government. The project aims at building a high-tech pharmaceutical factory in line with international standards located in Orkhevi, Tbilisi. Humanity Holding GmbH established a daughter company JSC Humanity Georgia that will run the project in Georgia. The agreement was signed between the Partnership Fund, Humanity Holding GmbH and project company Humanity Georgia. Humanity Holding GmbH and found that its managing director is Norbert Cuder. The company was registered in Vienna on March 9, 2015, about two months before Humanity Georgia’s registration in Georgia, with several other Cuder family members in key positions. It is clear that Humanity Holding GmbH is a new company that does not have any experience in this field. The company is wholly owned by another Austrian company ProjectH Holding GmbH, which is also managed by Norbert Cuder. The Austrian business registry lists Cuder as a managing director of five more companies, which raises a suspicion that Cuder may be a manager only by name, and that other individuals are actual managers behind these companies. Transparency International would also like to respond to media reports about Giorgi Saganelidze (nephew of the Partnership Fund CEO Davit Saganelidze) holding a senior management position in Humanity Georgia. Even though it is entirely possible for Giorgi Saganelidze to have high enough qualifications and have a successful career, his family ties still raise questions about a possible corruption deal. It is also unclear how Humanity Georgia plans to import and produce medications at a price lower than that of its competitors’ while retaining the required level of quality. Interestingly, the process around Humanity Georgia bears a resemblance with another case involving the Ministry of Health. On April 7, 2015, in order to make substantial adjustments to the universal healthcare program, and develop the national healthcare system the ministry used the simplified (direct) procurement procedure to sign a contract worth USD 300,000 with an inexperienced British company Global Alliance for Health and Social Compact Ltd. At the same time, a few days earlier, on March 18, 2015, Global Alliance received another government contract worth USD 300,000 from the Partnership Fund, also reached through the simplified procurement procedure. Based on the official information obtained by Transparency International Georgia at the time, it was impossible to say whether Global Alliance had enough experience and expertise to properly plan and carry out a comprehensive reform of the Georgian healthcare system. The circumstances described above suggest that by acting upon uncertain interests the government or its specific members are placing some companies in a privileged position at the expense of others. We believe that a detailed explanation must be offered for these decisions. There can be no doubt that these circumstances raise investor distrust and damage the business environment, negatively affecting the country's economy.

SCROLL DOWN NOW for Late Dec 2015 New York Times news on GILEAD Hepatitis C large population group test drug programs in Egypt, India, and Georgia! {Sovaldi and Harvoni national try-outs}.

A small vulnerable country like Georgia needs to team up with dozens of generic firms and practice competitive pricing CONSUMER-BASED CAPITALISM in order to serve the people of this struggling developing nation. 

Global Alliance team under Dr. Jean-Elie Malkin and Dr. Bernard Kouchner [between the two they have more than just one or two Israeli ties] has accelerated and completely legitimized the GILEAD anti-Hepatitis C national experimental vaccination program in Georgia with their SOLVADI [sofosbuvir] treatment program/project. SOLVADI sofosbuvir must be taken with other complex drug treatments in order to be long term effective, and this does not seem to be the case in Georgia's experimental program. SOLVADI sofosbuvir had not been studied well in treatment experienced people with genotypes 1,4,5,6 and there are few data at all for genotypes 5 and 6. SOLVADI sofosbuvir works better for some people than for others. SOLVADI sofosbuvir is not effective if taken alone and this can lead to drug resistance. Will GILEAD's next generation Hep C treatment, HARVONI, be a much better improvement? 

GLOBAL HEALTHCARE POLITICS IN THE REPUBLIC OF GEORGIA

Ever since the highly publicized contract was signed in Spring of 2015, between Dr. Jean-Elie Malkin's Global Alliance for Health and Social Compact [GAHSC, aka "Global Alliance"] and the Ministry of Health of Georgia, there have been dizzying reshufflings of the staff members of GAHSC, also known as Global Alliance. Currently, the new board chairperson of Global Alliance is the controversial Dr. Bernard Kouchner, the short time Socialist of France who shifted gears and benefited greatly, to the surprise and disappointment of his colleagues, to the opposite politics of George Bush and Nicolas Sarkozy. Dr. Malkin was former senior consultant of Imeda Global Medical Alliance, which had numerous and profitable contracts in African nations.

In addition, for over 30 years, Doctors Without Borders and Dr. Bernard Kouchner have had acrimonious public disagreements and have not had good relations with each other. Doctors Without Borders and millionaire Bernard Kouchner, the current health consultant chairperson to the country of Georgia, have had unresolvable and irreconcilable differences for many decades, on such issues as, the right to intervene and the use of armed force for humanitarian reasons. Dr. Kouchner is in favor of playing power politics with military solutions within the organizational structures of humanitarian aid societies, whereas Doctors Without Borders stands up for an impartial humanitarian action, independent from all political, economic and religious powers.

Dr Kouchner, a former short term UN administrator for war torn Kosovo, has been labeled by the famous investigative journalist Pierre Pean in his book "The World According to K", as a hypocrite for earning large sums of money as a health consultant to governments in Congo-Brazzaville, Gabon and other regimes, while grooming his image as a human rights campaigner. http://www.theguardian.com/world/2009/feb/05/france-bernard-kouchner

The book gives details of two companies owned by associates of Dr Kouchner, Danomex and Africa Steps, which billed Gabon and Congo-Brazzaville E4.6million ($9million) for reports he wrote on their health insurance systems. http://www.washingtonpost.com/wp-dyn/content/article/2009/02/04/AR2009020403427.html

Dr Kouchner was working as a consultant at the time, between 2002 and 2007, but Pean claims he recovered unpaid debts from Gabon after May 2007. A third company was Imeda Global Medical Alliance, involved also in the health contracts of these African nations ruled by alleged dictators. http://investigationfin.canalblog.com/archives/2009/02/13/12519900.html

Imeda Global Medical Alliance was advised by senior consultant Dr. Jean-Elie Malkin, who is now president of Global Alliance healthcare consultants [GAHSC] in the Republic of Georgia, in which he just recently appointed Dr. Bernard Kouchner as his board chairperson of Global Alliance-GAHSC healthcare consultancy firm, whose main client is the Ministry of Health of the Republic of Georgia.

Late Dec 2015 New York Times news on GILEAD Hepatitis C large population group test drug programs in Egypt, India, and Georgia! {Sovaldi and Harvoni}.

Editor's note: The Indian generics industry emerged [in the last decade or two], and it now makes most of the world’s H.I.V. medicines — at less than $100 per patient per year. [Their] low generic prices prodded wealthy donor nations, who sold the same medicines for up to $86,000 per patient per year, to create programs like the Global Fund, to keep themselves on eye of the pyramid of the global market.

NYT article: By DONALD G. McNEIL Jr. DEC. 15, 2015 http://www.nytimes.com/2015/12/16/health/hepatitis-c-treatment-egypt.html

"Gilead Sciences, based in California, makes sofosbuvir, which since 2013 has been sold in the United States as Sovaldi for about $1,000 per one-a-day pill. A course of the drug, taken with ribavirin and often interferon, usually cures hepatitis C infection in 12 weeks. Sofosbuvir is an enormous blockbuster; in its first year on the market, the drug earned Gilead more than $10 billion. But for the past year, Gilead has sold the drug to the Egyptian government for about $10 a pill. The government distributes it to pharmacies across the country, where it is dispensed free to patients.

Gilead, due to its overpricing in USA and EU, was under some pressure to make the drug more widely available. […] But for the past year, Gilead has sold the drug to the Egyptian government for about $10 a pill. The government distributes it to pharmacies across the country, where it is dispensed free to patients. […] Gilead also allows 11 Indian and two Egyptian companies to make sofosbuvir under license and to sell it at any price they like, in return for a 7 percent royalty. Before sofosbuvir, the main hepatitis treatment plan was using two old drugs: interferon and ribavirin. The drugs are loaded with side effects and difficult to tolerate. Last year, Gilead Sciences, based in California, offered an alternative. The company makes sofosbuvir, which since 2013 has been sold in the United States as Sovaldi for about $1,000 per one-a-day pill. A course of the drug, taken with ribavirin, and often interferon, usually cures hepatitis C infection in 12 weeks. Sofosbuvir is an enormous blockbuster; in its first year on the market, the drug earned Gilead more than $10 billion. In return for selling sofosbuvir cheaply, Gilead asked that Egypt impose strict restrictions on every bottle to prevent the drug from being sold on the black market and undermining its business elsewhere. “If you can solve the hepatitis problem in Egypt, you are a hero,” he added. “The drug companies know that.”

GILEAD COO John Milligan

GILEAD Chairman, venture capitalist Michael Riordan, in his late 50s now.

From the corporate website: Gilead drew its strategic focus from its founder, Michael Riordan. Riordan, who started Gilead long ago when he was 29 years old. He earned his medical degrees from Johns HopkinsUniversity and Harvard. With his degrees in hand, Riordan entered the realm of venture capital finance, a seemingly incongruent career choice that proved indispensable to Gilead's financial well-being. Riordan spent a year working for Menlo Ventures, learning the vagaries of venture capitalism. As his success in finding funding for Gilead would reflect, Riordan proved to be an adept venture capitalist. By mid-1992, the company also was working on a program tied to DARPA, the clandestine U.S. Defense Department's Advanced Research Projects Agency. Mr. Riordan is in addition no stranger at all to important directors at NIH, SAIS, CFR, DARPA, Yale elite private societies, nor Beaufort 12 Holdings-Asia.

Stacking The Deck http://www.investopedia.com/articles/markets/081114/how-gilead-sciences-became-big-name-biotech.asp

INVESTOPEDIA: With the progress from drug development to public availability being famously sluggish in the United States, Riordan preemptively lured some of the most powerful people in Washington to serve as Gilead board members and executives. They include former cabinet secretaries Carla Hills, George Shultz and Donald Rumsfeld. For whatever reasons, Gilead drugs make it to market relatively quickly. Which dovetails with the story of what is perhaps Gilead’s most famous creation, Tamiflu.In the mid-to-late 2000s, the fear of fatal contamination by “bird flu” swept much of the developed world. Even though bird flu cases were almost entirely restricted to rural parts of Southeast Asia, and numbered only in the dozens. Nevertheless, even with no reported cases in the United States, Tamiflu’s previous manufacturer sold tens of millions of doses to governments and non-governmental organizations. The United States Department of Health and Human Services authorized the purchase of $200 million worth of Tamiflu, in anticipation of an epidemic that still has yet to materialize. At the time, Gilead’s former chairman served as Secretary of Defense, sitting a chair or two away from the HHS Secretary.

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Hep C drug tourism has begun as patients seek Harvoni, Sovaldi overseas
When Gilead Sciences struck its hepatitis C supply deal with Indian generics makers, the terms were tight, with provisions designed to keep the knockoff pills in countries where Gilead allows cut-rate pricing. Some state health systems overseas require patients to show IDs to get their meds and present empty pill bottles for refills. More

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Recommended professional pharmaceutical trade articles by Eric Palmer

China rejects Gilead patent for hep C cure Sovaldi

http://www.fiercepharma.com/story/china-rejects-gilead-patent-hep-c-cure-sovaldi/2015-06-19

http://www.fiercepharmaasia.com/story/drug-approvals-hep-c-candidates-not-fast-enough-china/2015-12-18

China authorities could join the 20-year-old International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use that lets member countries rely on the results of trials conducted by other members to be used in deciding whether to approve a drug without duplicating the trials in China. China still has not joined and insists its lengthy process must be followed. India, with an equal population, was able to negotiate an agreement with Gilead to allow 9 generics makers to market Sovaldi at $900 per course in emerging markets, but Gilead excluded China as well as Brazil, Mexico and Thailand from the deal.

Aug 2015—GEORGIA--Nino Shubladze worked 10 years at the top of management for darling Saakashvili-enamored Rustavi-2 media network.  She left Rustavi-2 very very shortly after the covert recordings brouhaha last May, 2014.  Now she has just recently been appointed by Health Minister DavitSergeenko as top media and public relations issues advisor to the Georgian Health Ministry. Will she steer the Health Ministry of Georgia through the dangerous rapids' waters of western nations cut throat competition in the very lucrative field of Hep-C treatment? Gilead Sciences has made billions of dollars from its hepatitis C blockbuster drugSovaldi, and is now looking to give away the expensive treatment in some countries in an effort to eradicate the disease. Gilead is trying to raise funding by forming a coalition of governments and multinational agencies, as has been done with behemoth corporate global efforts to combat AIDS, tuberculosis and malaria, for a profit. The program will start by giving the $1,000-dollar-a-pill Sovaldi to 5,000 patients in the republic of Georgiathis year. Will things be so simple and free for Minister Sergeenko and his new media/PR guru, Nino Shubladze, a ten year player on the Saakashvili team, which has been diametrically opposed to everything in the new Georgian government's reforms? http://www.interpressnews.ge/en/politicss/70924-journalist-nino-shubladze-to-be-appointed-as-advisor-to-the-health-minister.html

June 19, 2015 | By Eric Palmer

http://www.fiercepharma.com/story/gilead-ready-take-cash-hep-c-superstars-and-buy-something/2015-05-01

China has upended a Gilead Sciences' patent on its pricey hep C drug Sovaldi, a move that health advocacy groups loudly applauded today. The patent overturned was not the only IP Gilead holds on Sovaldi, but when Gilead found itself in a similar position with China two years ago, it allowed discounted copies to be made.

 5 drugs approved last year by the FDA that the EvaluatePharma report says will have $1 billion or more in sales by 2019, are Gilead Sciences' ($GILD) hep C combo Harvoni.

May 1 2015: “GILEAD can influence Phase III hep C combo treatment and accelerate its product to possible FDA approval and generally in the treatment areas GILEAD in now raking in money hand over fist.” (sofosbuvir aka SOVALDI) -- PUBLISHER’S NOTE -- Sofosbuvir is used for the treatment of chronic hepatitis C, genotypes 1, 2, 3, and 4, IN COMBINATION with pegylated interferon and ribavirin, or withribavirin alone. It is also used in combination with the viral NS5a inhibitor ledipasvir in an interferon-free combination for the treatment of genotype 1 hepatitis C infection. Sofosbuvir is also used in HCV patients with an HIV coinfection. The treatment is based on a number of clinical trials, for example the ELECTRON trial which showed that a dual interferon-free regimen of sofosbuvir plus ribavirin produced a 24-week post-treatment sustained virological response (SVR24) rate of 100% for previously untreated patients with HCV genotypes 2 or 3. On October 10, 2014 the FDA approved the combination product ledipasvir 90 mg/sofosbuvir 400 mg called HARVONI.

http://beaties_of_bulgaria.tripod.com/NGO-OBSERVER/GAHSC_STAFF.html

Global & Related Key Concepts, "bands" & "threads" itemized below

CLICK HERE… http://beaties_of_bulgaria.tripod.com/NGO-OBSERVER/GAHSC_STAFF.html … for a short DOSSIER/CV on many of the KEY foreign PLAYERS at the Jean Elie Malkin of UNAIDS Memorandum Agreement Meeting & historic SIGNING with the Health Minister of GEORGIA