send your complaints to Gilead Sciences Israel Ltd. 4 HaHarash St, Lobby E 14th floor, Hod Hasharon Business Park Israel
HARVONI (ledipasvir 90mg/sofosbuvir 400 mg tablets) is a once-daily single tablet treatment for chronic hepatitis C adult patients carrying the genotype 1 infection, who were not previously treated for the disease, with both cirrhotic and non-cirrhotic infections.
Prior to the availability of GILEAD’s sofosbuvir in 2014, when it was anointed as a BREAKTHROUGH THERAPY to the delight of lobbyists, (Breakthrough therapy is a United States Food and Drug Administration (FDA) misleading designation that expedites for-profit drug development that was created by Congress under Section 902 of the 9 July 2012 Food and Drug Administration Safety and Innovation Act. The FDA's "breakthrough therapy" designation is not intended to imply that a drug is actually a "breakthrough" or that there is high-quality evidence of treatment efficacy for a particular condition; rather, it allows the FDA to grant priority review to drug candidates if preliminary clinical trials indicate that the therapy may offer substantial treatment advantages over existing options for patients with serious or life-threatening diseases. The FDA has other mechanisms for expediting the review and approval process for promising drugs, including fast track designation, accelerated approval, and priority review). Before Sofosbuvir, hepatitis C treatments involved 6 to 12 months treatment with an interferon-based regimen that provided cure rates of 70% or less and was associated with severe side effects including anemia, depression, severe rash, nausea, diarrhea, and fatigue. As sofosbuvir clinical development progressed, physicians began to "warehouse" people in anticipation of its availability. Sofosbuvir's U.S. launch was the fastest of any new drug in history. Over 60,000 people were treated with sofosbuvir in its first 30 weeks on the U.S. market, about 5% of the U.S. infected population.
There is zero disclosure of Gilead’s Australia related party transactions with its parent company in Ireland – likely there are IP or service charges to Ireland – or with the ultimate parent company in the US. The accounts fail to provide a “true and fair” picture of Gilead’s financial position as required by accounting standards and the Corporations Act. Critics will note, however, that the original technology for GILEAD-Kite’s product, Axi-Cel, was developed at the National Institutes of Health on the taxpayer dime. It’s a narrative with which Gilead is familiar. In 2011, it bought another company, Pharmasset, for $11 billion. At the time, many investors gagged at the price. But the main drug from that deal became Sovaldi, a medicine that, in combination with others, can cure the liver virus hepatitis C. Gilead priced Sovaldi at $1,000 a pill, garnering criticism from patient advocates and Congress, but also generating $12 billion in their first year. University of Pittsburgh health policy wonk Walid Gellad boiled the coming criticism down to two words in a tweet: Sovaldi squared. But will this create added controversy, as happened with Sovaldi where Gilead cured a disease but was vilified for the price it charged?
After GILEAD snapped up Kite Pharma and moved more deeply into oncology, it’s little surprise that it has once again raided cancer specialist Roche/Genentech for its new CMO: Merdad Parsey, M.D., Ph.D., assumes the role at the start of Dec. 2019, coming from his stint as senior vice president of early clinical development in the Genentech Research and Early Development (aka gRED) group. While cancer was a focus for Parsey, other areas included inflammation and Gilead's original focus, infectious diseases.
Just over a year ago, Andrew Cheng, M.D., Ph.D., left Gilead just six months after being appointed CMO. Cheng’s swift exit kept the revolving door spinning at the top of Gilead, which lost its CEO, CMO, CSO and executive chairman over a nine-month window.
John Martin, Ph.D., began the period of change by stepping down as executive chairman last March. The following month, Norbert Bischofberger, Ph.D., vacated the CSO chair. Then in July, John Milligan, Ph.D., furthered the turnover by revealing he will step down as CEO of Gilead at the end of the year after 28 years at the company. In July of this year, and after nine years at Gilead and just over one year as CSO and R&D chief, John McHutchison, M.D., also said he was leaving the company. Robin Washington, the company’s longtime CFO, is also planning to retire next year.
Gilead CEO Daniel O’Day in a recent statement said, “Under John McHutchison’s, MD., guidance, the company was able to rapidly advance our hepatitis C portfolio, enabling therapies to reach people in need at an unprecedented pace, and he has continued to build on that work by helping the company expand its therapeutic areas of focus.” During his tenure at Gilead, McHutchison oversaw the development of five hepatitis drugs and also led the Big Pharma’s expansion into oncology with its blood cancer med Zydelig.
Gilead said Hutchison “decided” to leave the company but gave no other detail on his departure. And he’s not the only one leaving—Gilead announced on the same day that Chief Patient Officer Gregg Alton and human resources chief Katie Watson are also on their way out.
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”
When the FDA finally released a large amount of information on GILEAD and its approval of Sovaldi and Harvoni by the FDA, it withheld and redacted individual patient-level data (IPD), specifically the raw analyzable datasets critical for reanalysis of drug safety and efficacy by the scientific community, according to the groups. TAG and GHJP engaged in subsequent talks with Gilead to press the company on data sharing for Sovaldi and Harvoni, as well as other drugs it produces, but the talks were unsuccessful.
“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. We are deeply disappointed at Gilead’s stonewalling,” said Amy Kapczynski, a law professor at Yale and the GHJP’s co-director. “Gilead has refused to open its data to systematic independent scrutiny, though many others companies in the industry have begun to do this. These other companies recognize that transparency serves company interests, as well as those of patients and the public health.”
Other major pharmaceutical companies such as Johnson & Johnson and GlaxoSmithKline currently make such data available through third-party platforms that protect patient privacy through data-use agreements. While data sharing by other companies is voluntary, the process is also becoming a regulatory standard elsewhere in the world, with Canadian and European regulatory agencies committing to ensuring IPD access in some form. Such data sharing has been endorsed by leading scientific groups and agencies including the National Academies of Sciences and Engineering and Medicine.
“Our aim, as advocates and researchers, was always two-fold: to show that the FDA should release much more data to researchers than it typically does, and to press Gilead to join its peers in voluntarily making their data available to outside review and analysis,” said Gregg Gonsalves, assistant professor at the Yale School of Public Health and co-director of the GHJP. “We succeeded in our first goal. But when the FDA expressed the view that it could not turn over certain data sets without compromising patient privacy and commercial interests, we proposed a compromise: that Gilead follow what others have done, and work with a third-party to create a secure platform to share data or set one up themselves. They flatly refused, and refused even to create a timeline. In the end, Gilead told us they are not yet committed to any sort of systematic data-sharing with the research community. They’ve claimed that can only handle ‘bespoke,’ that is, one-off requests at this time.”
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."
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
For more on Gilead in Nation of Georgia, go to the NGO OBSERVER main web address here…read here HOW BIG PHARMA CREATED the U.S. TEA PARTY