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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


Evidence shows that many poor people of Georgia were not given the full GILEAD anti-Hep-C vaccination treatment due to their inability to pay processing and administrative fees not included in the free drugs donated by GILEAD. Details are given below in a recent Jan 10 2020 detailed report of "lost patients" and "no returns" and also there are many questions why those who died were cut out of the statistics as if they were not part of the 'success' study, and also various cirrhosis liver test subjects who responded poorly to the treatment plan were deleted from the final results stats also.

Just a few days after this report the Georgian government announced they would throw away into the trash $200 million dollars of drug supply from GILEAD, without any reasonable explanation, which has incurred the attention of the opposition parties in the government to seek corruption and financial fraud charges of officials absconding with money and/or valuable drugs caches given by many foreign governments and agencies for this 5-year long program.

GILEAD conducted a similar program in Egypt which seems to have received more kudos in the press.

Recent reports from Vietnam confirm the conclusion that such "free" drug trial programs in a poor or semi-poor nation do not address well those afflicted with the disease who cannot afford the many small administrative and test exam results fees.

MAJOR MEDICAL RESULTS OF GEORGIAN FIVE YEAR TREATMENT PROGRAM BELOW.....

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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

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.


https://jam-news.net/georgia-throws-out-hepatitis-c-medications-worth-200-mln/

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”.


***


https://jam-news.net/georgia-throws-out-hepatitis-c-medications-worth-200-mln/

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

JamNews, January 12, 2020

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

BMC Infectious Diseases Published: 10 January 2020

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.

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

 

 

PLoS One. 2019; 14(4): e0216123.

Published online 2019 Apr 29. doi10.1371/journal.pone.0216123

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.

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Early 2016 TRANSPARENCY INTERNATIONAL report: "According to the Partnership Fund website, on December 24, 2015, “the Partnership Fund and an Austrian company Humanity Holding GmbH 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.





 

Key DEAL Players Backgrounds & JOB EXPERIENCES of MAIN PLAYERS

Who Attended This HISTORIC MEEETING between the GAHSC TEAM and the GEORGIAN PRIME MINISTER and HEALTH MINISTER on April 6th 2015



‘MST au Quotidien’ book [still in print] by Author: Dr Jean-Elie Malkin and Dr Bruno Halioua
Dr. Jean Elie Malkin of UNAIDS " I don’t see any reason why adapting ALL the procurement regulations for pharmaceuticals in Georgia according to EU rules wouldn’t work, [...] there are very high-level experts in our team who work for European pharmaceutics, and who used to work with [...] a European drug agency in London, and who will supervise, monitor and work very closely with those in charge at the Ministry [of Health]. They will help to reshape and redefine the Georgian regulations to make this specific component of pharmaceutics closer to European standards" said UN global AIDS administrator Dr. Jean Elie Malkin as he addressed the Georgian media after the April 6, 2015 signing of the national agreement, with a third party business he helped bring to life, a very new small consulting agency named GAHSC.

http://www.sudoc.abes.fr/DB=2.1/SRCH?IKT=12&TRM=071391150
Book on STD treatment in french language.

Brief bibliographic description: Specification Title: Publisher: GlaxoWellcome 1997
place of publication: GlaxoWellcome
Books ISBN code: ISBN 10: 2910657116 / ISBN 13: 9782910657116

Pulished by GlaxoWellcome Pharmaceutical Company

IMEDA Global Medical Alliance in the news [Dr. Malkin’s former global team affiliated with Kadris and Franck Droin and UNAIDS third party arrangements], from report in the news magazine L’Express, France:

Ukraine in Nigeria EXPOSED... http://www.lexpress.fr/actualite/politique/les-chers-rapports-du-docteur-kouchner_739931.html

Bernard Kouchner's activities were not only limited to the Francophone Africa. In April 2004, he wrote, on behalf of Imeda Global Medical Alliance consulting, and with intents on Warsaw, a report for an improvement of the Polish health system. In May, he oversaw a mission to Nigeria to study the possibility of privatizing the hospital in Abuja. In June, he co-wrote a 65-page report for the reform of the health system in Romania. In February 2005, he wrote a report in English on behalf of Ukraine to establish a program to fight against AIDS ... Gabon is not looking to spend any money! Three stages of financing 330 000 euros must be paid --to the liking of Imeda Global Medical Alliance consulting, studies whose aim is to lead to the creation of a health insurance system in Gabon, a first in Africa. In reality, Libreville pays Imeda four chunks, or 1,234,000 euros. In parallel with the commitments made to Imeda, Gabon signed another contract with Africa Steps: they agreed to pay 480,000 euros per year, paid in four installments as done when receiving other “studies”. For work in Gabon, Bernard Kouchner was surrounded by specialists, and some remain anonymous. But not the names of Drs Jean-Elie Malkin and Isabelle Stroebel, which appear on both reports to the Gabonese President Omar.”

 

 

Franck Droin, directeur général with Saham Finances

KADRIS Group – Franck DROIN, Président

IMEDA Global Medical Alliance – Jean-Elie MALKIN, Consultant senior

KADRIS Group – Aurélie CHOMPRET, Consultante

 

-        Franck DROIN, Président du groupe de conseil KADRIS ;

-        Docteur Jean-Elie MALKIN, Consultant senior, IMEDA Global Medical Alliance ;

 

Franck Droin and Laurent Grouas, both collaborators of the KPMG Peat Marwick group. Having accumulated experience in the health sector, the two men decided to found, several months later, Kadris Consultants, a company specialised in consultancy for the development of health and social protection solutions. Kadris is active in three main fields: health and contingency (private health insurance, retirement funds, insurance companies, federations, contingency coverage…); savings and retirement (idem); health and social welfare (hospitals, clinics, health centres and networks, local and territorial authorities…). “The activities that we carry out are extremely diverse, so the multidisciplinary backgrounds and expertise of the Kadris teams are a decided advantage,” underlines Laurent Grouas, Vice President of Kadris who employs insurance professionals as well as medical practitioners.

 

 [2000), Franck DROIN is the head of a company aptly named (Kaïssa) for innovative strategies and services in the fields of health and social protection. Kaissa also developing a particular skill for health problems in Russian society.

 

 

Franck Droin

A graduate of the Ecole Centrale de Lille, Franck Droin

     1993 Consultant at KPMG.

     1999 Co-founder and CEO of Almerysa subsidiary services of France Telecom in health.

     Founded in 2001 Kadris, a consulting firm specializing in health.

     2013 Chairman and founder of Kaissa, consulting and services.

     2014 Director General Third stewardship Africa and Middle East Moroccan group Saham Finances.

¨   third party stewardship

¨   Third party stewardship, not to be seen as being mostly a shopping center

¨   Saham Finances and Cegedim Activ and Colina company

 

--Some energy companies are setting up private insurance systems, favoring direct access to health care provision. The activity of third-management, playing a role of articulation between these companies and the provision of care, will take on its full meaning in this country

--stewardship incorporates the notion of trusted third party. Patients or users of a health system should be reassured that there will be no misuse of their personal information. Most models that develop and agree that transparency must demonstrate the ability to manage this information, obviously with respect for the law and informed patient consent.

--accelerate the development of its health-management activities of third parties.

--After buying the Pan African insurer Colina in 2011, Saham Finances is now present in twenty countries of the continent. Health insurance is growing strongly and is even in some countries in the first place in the non-life insurance. The needs are enormous. The request comes at a time the middle class, or about 400 million people, but also companies investing in Africa. We must not forget that Africa will house a quarter of the world population in 2050.

-- the market is difficult to tackle. Health insurance is still seen as a loss leader that can meet the demand of businesses to other types of insurance.

--The difficulty in countries marked by weak public solidarity protection systems is how to provide quality service at an affordable cost. In this context, the third-management is a major challenge. In France, several platforms health involved in the areas of third-party payment and management of health professional networks.

 

Franck Droin says in an interview: "In France it seems that we are just getting to know this side of things while in the US they’ve been operating like this for a long time: the insurer fully incorporates the health dimension. The insurer takes on the role of checking that the offer of healthcare services is consistent with the package of healthcare given, as well as carrying out the piloting of the healthcare services offered (as in the case of American Health Maintenance Organisations HMOs, for example). The mission and the activities of Kadris follow in the same vein. […] an oil rig based in Africa or Asia has every interest that the health and social situation around the exploitation sites is acceptable in order to protect its own personnel from health risks, social risks and any eventual security risks. […] We’ve also been carrying out a study in Burkina Faso for UNAIDS with the objective of seeing how efforts on the part of funding agencies can be better coordinated.”

 


 

 

Vincent Carew Executive Director, Middle East & Iraq

"Follow the Oil" says Vincent in his stentorian voice of expanding confidence in this unique video.

Vincent Carew, Executive Director at Cyril Sweett added "We are honoured to have been selected by KBZF to lead and deliver this charitable project on their behalf.

Vincent Carew BSc (Hons) MAPM MCIOB, Executive Director

 

Formerly worked on projects with GE General Electric—which specializes in many fields, Aerospace & Defense Industry & Healthcare

...

Vincent is an executive director at Cyril Sweett, the leading construction and property consultancy. Based out of its Abu Dhabi office, he is responsible for Sweett's growth strategy within the Middle East and North African business. When Vincent joined Cyril Sweett in the summer of 2008, the company had one office in Dubai representing its Middle East operation.

...

Despite the prevalent economic landscape, Vincent has been instrumental in working within the UAE and has since opened an office in Abu Dhabi and has led the business beyond the UAE into other GCC countries, the Levant and North Africa with offices now in Libya, Iraq, Saudi Arabia --KSA and projects in Oman, Morocco and Kazakhstan.

Vincent has extensive knowledge and insight on the real estate market across the public and private sectors, on government initiatives and policies and on market trends within the residential, commercial, mixed use, healthcare, transport and infrastructure sectors. His strategy, during this current global downturn, has focused on key growth sectors including healthcare and infrastructure and with his intuition and good market sense, he has identified new geographies for expansion.

 

 

Dr. Dan Oppenheim, CEO

Rabin Medical Center Inc., Tel Aviv

Rabin Medical Center (Hebrew: מרכז רפואי רבין‎) is a major hospital and medical center located in Petah Tikva,Israel

. It is owned and operated by Clalit Health Services, Israel's largest HMO  health maintenance organization. In January 1996, Beilinson Hospital and Hasharon Hospital were merged and renamed Rabin Medical Center. It has a capacity of 1,000 beds.

 

Dr. Dan Oppenheim, the chief administrator of the Rabin Medical Center (also known as Beilinson Hospital) and to the Health Ministry.

American Friends of Rabin Medical Center
www.afrmc.org

Although Beilinson and Golda HaSharon hospitals that now constitute the Rabin Medical Center were not well known in the United States prior to 1994 (a provision of its charter prohibited it from raising funds or promoting itself), since their merger, and the founding of AFRMC, thanks to the vision of Dr. Dan Oppenheim, Director General of Beilinson and the founder, Miriam Romm; Rabin Medical Center has created considerable excitement among those who have learned of its accomplishments.

 

 

Anna Aseieva, from Kiev Ukraine

Programme Director at Global Alliance for Health and Social Compact, a.outhwaite@gahsc.net [GAHSC]

 

Programme Director [currently] for

Global Alliance for Health and Social Compact GAHSC

Senior Project Manager

The Royal Marsden NHS Foundation Trust

November 2013 – October 2014 (1 year) London, United Kingdom

Senior Project Manager ECMCs

Cancer Research UK

September 2012 – November 2013 (1 year 3 months)London

The role is to build the 18 individual Experimental Cancer Clinical Research centres into a fully functioning network that would bring together laboratory and clinical patient-based research to speed up the development of new therapies and individualise patient treatment by evaluating new treatments and molecular markers for cancer.

Project Manager / Clinical Diabetes Audit

Royal College for Paediatrics and Child Health

April 2011 – September 2012 (1 year 6 months) London, United Kingdom

Project Coordinator / Workplace Health

St. Mary's University College

November 2009 – April 2011 (1 year 6 months) London, United Kingdom

Project Officer

United Nations

November 2005 – September 2008 (2 years 11 months)

Queen Mary, U. of London

Master of Science (MSc), Public Health

2008 – 2009


----------------------------


Caroline Mascret

Maitre de Conférences en Droit Pharmaceutique, Responsable Master Marketing Pharmaceutique, Avocate à la Cour

Following a traineeship with the Assessment department of the French Agency for the Safety of Drugs and Health Products (ANSM), Caroline Mascret started her career as Head of Regulatory Affairs for France and Europe for AFIPA, a professional association representing self-medication drugs manufacturers, in which capacity she sat on several committees and working parties of the French Agency for the Safety of Health Products (AFSSAPS): control of advertising and circulation of recommendations on the correct administration of drugs, advertising to the general public, authorization of advertisements for products presented as being beneficial for people's health (“Visa PP”), self-medication. She also represented French self-medication drugs manufacturers on the committees set up by the Association of the European Self-Medication Industry (AESGP) in Brussels and took part in various European Commission working parties on self-medication drugs and advertising (ex DG III). For instance, she represented France at the meetings that gave the first draft of the Community Code of Medicinal Products for Human Use in 2001 and then a revision in 2004.

 

Caroline Mascret--Master of Law in Pharmaceutical Conferences, Pharmaceutical Marketing Master, Lawyer at the Court Paris Area, France Pharmaceuticals

Current Full Member - Vice President from 2009 to 2012

Previous

Attorneys, Health Authority, AFIPA

She participated in the commission of the European Association of Specialty Grand Public (AESGP) in Brussels, as a representative of the French manufacturers of self-medication drugs

Lecturer in Pharmaceutical Law in 2007 from the University of Angers, and joined the Faculty of Chatenay Malabry (University Paris XI) in 2011, where she is responsible for the Master 2 Pharmaceutical Marketing.

 

Some of her publications:

 

The principle of free movement of goods applied to human drug as part of the marketing authorization procedure based on mutual recognition by Member States, Medicine and Law 2009, pp. 62-67

 

Authorization for the drug market: a new drug registration procedure implemented in national law, Small Posters of 25 February 2008, No. 40, pp.5-9

 

 

Peter Makara

http://context.reverso.net/traduction/francais-anglais/Le+Dr+Peter

Peter Makara Dr Peter Makara is a social scientist from Hungary, where he has pursued his interests in health promotion and education.

 

 

Dr Makara holds an MA in Economics and a PhD in Sociology. His professional career is evidence of a range of experiences that spans health and social science research, top management in a national civil service, and an involvement in international cooperation. Since 1968 he has worked in the field of lifestyles and health research. Between 1987 to 1999 he was the Director for the National Institute for Health Promotion in Budapest, Hungary, and vice-chairman of the Hungarian Public Health Research Society. Until June 2001 Dr Makara held the position of acting Regional Advisor for National Health Policies, at the WHO Regional Office for Europe.

 

2001 Peter Makara Coordinator COHRED, [currently an NGO based in Switzerland]

http://www.cohred.org/downloads/annual_reports/726.pdf

COHRED was faced with the necessity of changing its status from a UN-affiliated organisation to operating as an NGO under Swiss law. A further shift that has taken place in COHRED’s history is an internal one – Dr. Yvo Nuyens, COHRED’s coordinator who so effectively steered the organisation through its first years retired mid 2001, and was replaced by Dr. Peter Makara. Dr Makara’s fresh insight provided COHRED with the impetus to rethink strategies, review activities, and renew its commitment to linking equity to health and development.

 

COHRED is partners with The European and Developing Countries Clinical Trials Partnership (EDCTP) and with --Pfizer Pharmaceuticals, The World Bank Group, and WHO..

 

http://www.edctp.org/home/strategy/

EDCTP aims to support collaborative research that accelerates the clinical development of new or improved interventions to prevent or treat HIV/AIDS, tuberculosis, malaria and neglected infectious diseases prevalent in sub-Saharan Africa.

EDCTP’s second programme (2014-2024) supports all clinical trial phases (I-IV) including health services optimisation research. Research and regulatory capacity development remain integrated in the research funding strategy in order to strengthen the conditions for conducting clinical research in sub-Saharan Africa. The EDCTP programme will be executed through partnerships between European and African institutions and researchers in collaboration with the pharmaceutical industry and like-minded organisations.

 

http://hpe4.anamai.moph.go.th/hpe/data/mission/StrengthHealthSystem_orginal.pdf

WHO European Office for Investment for Health and Development, WHO Regional Office for Europe, supported the production process. Invaluable comments on this brief were also received from Enis Baris, Gauden Galea, Bosse Petersson, David McQueen, David Pattison, Eero Lahtinen, Jaffar Hussein Saeed, Marilyn Rice, Peter Makara, Tatjana Buzeti, and Mihály Kökény. This document is based on a number of WHO documents and reports published by the European Regional Office. As such, acknowledgments should be given to the WHO/EURO staff involved in the production of the WHO/EURO 2009 Report Millennium Development Goals in the WHO European Region (WHO Regional Office for Europe, 2009a).

 

 

 

Mr. Yuriy Subbotin, UNAIDS Project Manager, UN in Ukraine, Kiev

http://www.un.org.ua/en/information-centre/news/504-2005-11-16

subbotiny@unaids.org.ua


 

 

HIV has spread rapidly in the Black Sea coastal areas of Odessa and the Crimean Peninsula, where illegal drugs are more easily available. Yuri Subbotin, the World Health Organization WHO representative in Ukraine, 1997, said people also are ignorant about how AIDS is transmitted. Most of the new cases were registered among intravenous drug users, who often contract the virus when using ''poppy straw,'' a popular opium derivative sold by the dose in used syringes. 

 

On  22 October 2008, the Norwegian Crown Princess began her day by meeting with Ukrainian students of Scandinavian languages at the Scandinavian Gymnasium in Kiev.  Dr Yuriy Subbotin, Leadership and Advocacy Adviser at UNAIDS Ukraine, described the HIV epidemic and emphasized the importance of young people’s involvement in prevention efforts. In her speech, the Crown Princess warned that “drug use and unsafe sex make young people particularly at risk”. 

http://www.royalcourt.no/nyhet.html?tid=73889&sek=26939

 

Projects completed with GAVI, the Swiss & Washington DC Lobby Street district headquarters for the Global Alliance for Vaccines! Roll up your shirt sleeve and get injected, again and again...... you will never regret it and never look back.

 

USAID

 

Eliot Pearlman, Senior Health Advisor

WHO

 

Subbotin Yuriy V., Head, WHO Bureau for Coordination and Liaison with Ukraine

 

Partners with USAID-SUPPORTED HEALTH INFORMATION SYSTEMS IN THE UKRAINE

 

 

 

Andrei Mecineanu – World Health Organization, Country Office, Moldova

 

 

Andrei Mecineanu, Program Coordinator Center for Health Policies and Studies, Moldova

 

Andrei Mecineanu

 

Date of birth September 16, 1982, MDA Comrat

Citizenship. Moldova

STUDIES

2010 – 2012 State University of Medicine and Pharmacy "Nicolae Testemitanu"

Doctoral Studies, Social Medicine and Management Specialty

Chisinau, Moldova

2007 – 2010 State University of Medicine and Pharmacy "Nicolae Testemitanu"

Faculty Residency, Specialty Neonatology Chisinau, Moldova

2002 - 2007

State University of Medicine and Pharmacy "Nicolae Testemitanu"

Faculty Medicine

Chisinau, Moldova

2001 - 2002

University of Medicine and Pharmacy "Iuliu Haţieganu"

Faculty Medicine

Cluj-Napoca, Romania

INTERNSHIP

2012

World Bank Institute

International Seminar "Universal Health Coverage Advancing"

Paris, France

2012

World Health Organization WHO, Country Office Moldova

Seminar on "Health System Strengthening and Sustainable Financing for

Moldova "

Chisinau, Moldova

2008

European Institute of Political Studies

Chisinau, Moldova

2008

International Centre for Democratic Transition

Budapest, Hungary

Areas

Scientific Interest

Health Management, Public Health

2012 - present

State University of Medicine and Pharmacy "Nicolae Testemitanu"

School of Public Health Management

Lecturer

Video of Memorandum Agreement meeting

 


https://www.facebook.com/GaribashviliOfficial/videos/835231506567927/

facts about GLOBAL ALLIANCE FOR HEALTH AND SOCIAL COMPACT LTD

Private Limited Company, Active – 09196046  Time in Business: less than 1 year

ID: 24759407/6

22 BILLET STREET TAUNTON SOMERSET TA1 3NG

 

GLOBAL ALLIANCE FOR HEALTH AND SOCIAL COMPACT LTD

22 BILLET STREET, TAUNTON, SOMERSET TA1 3NG
(88 companies also use this postcode)

Legal Information for GLOBAL ALLIANCE FOR HEALTH AND SOCIAL COMPACT LTD

Company Registration No.:

09196046

Incorporation Date:

30 Aug 2014 (7 Months old)

Financial Year End:

31 Aug

Capital:

£100.00 on 30 Aug 2014

 

Type of accounts

 

NO ACCOUNTS FILED

Company Number

09196046

Last checked on

26th February 2015

 

 

 

Company directors

CHRISTOPHER DAVEY Christopher Davey was born in 1991 and is a British national. Aged 24 this person currently holds 1 active appointment.

 

Ownership (Shareholders)

We have 1 shareholders for Global Alliance For Health And Social Compact Ltd, according to the latest Annual Return submitted on 30 August 2014.

Name of Shareholder

Shareholding

Ownership

Mr Christopher Davey

100 Ordinary £ 1.000000

100%

 

Company secretaries

PAIFANG NOMINEES (UK) LTD PAIFANG NOMINEES (UK) LTD

 

Company Description

GLOBAL ALLIANCE FOR HEALTH AND SOCIAL COMPACT LTD is a Private Limited Company registered in United Kingdom with the Company reg no 09196046. Its current trading status is "live". It was registered 2014-08-30. It has 1 director and 1 secretary.It can be contacted at 22 Billet Street, Taunton, Somerset, Ta1 3Ng, United Kingdom. They are currently rated NA and are considered to represent an average risk score. This information was last updated on the 8th September 2014.

 

http://cbw.ge/home/healthcare-experts-pm/ Local April 7, 2015 News Coverage of ===> Georgia’s Prime Minister Meets Health Care Experts

 


Georgian Health Minister Davit Sergeenko signing the long term contract with Dr. Jean Elie Malkin of UNAIDS, in the hopes of fulfilling the new and challenging and demanding healthcare and pharmaceutical requirements of the Trade Agreement with the EU


Despite the meeting being publicized as the small international consulting group Global Alliance for Health and Social Compact’s [GAHSC] meeting with the nation of Georgia’s Prime Minister Irakli Garibashvili and Health Minister Davit Sergeenko, it was for the most part a grand reunion of UNAIDS-WHO affiliated colleagues who have already managed AIDS-sexual-blood transmitted disease treatment and prevention programs in parts of Africa and the Middle East and former CIS countries.

 

Names of staff [either contracted or employed by GAHSC] who attended the Tbilisi meeting:

KEY Panel PLAYERS at a glance: Dr. Jean Elie Malkin of UNAIDS & formerly with IMEDA Global Medical Alliance; Anna Aseieva from Kiev Ukraine, Programme Director at Global Alliance for Health and Social Compact—GAHSC, and former Project Officer for UN; Caroline Mascret from French Pharmaceutical Marketing groups & agencies; Peter Makara formerly from Hungarian WHO; Yuriy Subbotin, former UNAIDS Project Manager & UN & WHO representative in Ukraine, Kiev; Franck Droin, President of French Kadris Group/ Kaïssa & former colleague of Jean Elie Malkin, of IMEDA Global Medical Alliance; Vincent Carew Executive Director, Middle East, & Iraq, for Cyril Sweett; Dr. Dan Oppenheim, CEO, Rabin Medical Center Inc., Tel Aviv, Israel, also prominent in AFRMC; Andrei Mecineanu – Program Coordinator Center for Health Policies and Studies, Moldova, seminars with WHO & World Bank.

If you want to contact THE NGO OBSERVER, please send your email to: maureensnowdden@gmail.com

 

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Bryan Adrian for THE NGO OBSERVER