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”
https://medicine.yale.edu/news-article/15794/
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."
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
For
more on Gilead in Nation of Georgia, go to the NGO OBSERVER main web address
here… http://beaties_of_bulgaria.tripod.com/Tbilisi_National_Healthcare.html