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September 5, 2010)
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Health tourists travel
the world and spend thousands, but their hopes of being cured are li
by Denis Campbell
5 September 2010
For the past decade stem
cells have sparked huge excitement among scientists, dramatic media coverage
about breakthroughs that could mean a cure for some of the nastiest diseases,
and hope – sometimes desperate – among patients that the reality will match
the hype. That has fuelled a booming trade in stem cell tourism – people
heading to clinics abroad and forking out large sums for what are called stem
cell treatments but which are unlikely to work and possibly do harm.
It is, as some of the
"I've made some very
strong comments which could potentially land me in court, but people still go to
these clinics," said Professor Peter Coffey, director of the London Project
to Cure Blindness at University College London. There are now several hundred
clinics around the world which claim to have turned the potential of stem cells
into effective treatments. They lure those suffering from diabetes, multiple
sclerosis, heart failure, Parkinson's disease, autism, HIV, eye problems, spinal
cord injuries and much else besides.
Several thousand people
from around the world so far are estimated to have spent up to £20,000 or more
in such places. Yet while stem cells could transform medicine, there is as yet
scant actual proof of their efficacy. But still the tourists come.
The fact that scientists
believe it is likely to be 15 to 20 years before the continuing worldwide flurry
of trials and tests results in reliable treatments has not stopped clinics from
offering exactly that already. Strong regulation means there are no such places
in the
In 2008 the Multiple
Sclerosis Society warned sufferers not to be taken in by Integrated BioSciences,
a company registered in the Turks & Caicos Islands, which had offices in the
People's willingness to
trust their savings and their health to such clinics recently prompted the
International Society for Stem Cell Research to launch a website to educate
patients about the risks involved. Anyone thinking about going would be well adv
guardian.co.uk ©
Guardian News and Media Limited 2010
-- Product Would Be The
Second Complete, Fixed-Dose Antiretroviral Regimen --
The MAA will be reviewed
by the Committee for Medicinal Products for Human Use (CHMP). Review of the MAA
will be conducted by the EMA under the centralized licensing procedure, which,
when finalized, provides one marketing authorization in all 27 member states of
the European Union. An MAA for TMC278 also is being submitted today by Tibotec
to the EMA for review.
"The important role
of complete, fixed-dose HIV treatment regimens is well established in
The regulatory
application for the fixed-dose combination is supported by 48-week data from two
Phase III double-blind, randomized studies (ECHO and THRIVE) evaluating the
safety and efficacy of TMC278 in treatment-naive HIV-1 infected adults and a
bioequivalence study conducted by Gilead, which demonstrated that the
formulation of the fixed-dose combination of Truvada and TMC278 achieved the
same levels of medication in the blood as the component products dosed
simultaneously. ECHO (Efficacy Comparison in treatment-naive HIV-infected
subjects Of TMC278 and Efavirenz) evaluated TMC278 (25 mg) combined with a
fixed-dose background regimen consisting of emtricitabine (200 mg) and tenofovir
disoproxil fumarate (245 mg). THRIVE (TMC278 against HIV, in a once-daily
RegImen Versus Efavirenz), evaluated once-daily TMC278 (25 mg) compared to
once-daily efavirenz (600 mg) combined with an investigator-selected background
regimen consisting of two nucleoside reverse transcriptase inhibitors (abacavir
and lamivudine, or emtricitabine and tenofovir disoproxil fumarate, or
zidovudine and lamivudine).
About TMC278 and the
Fixed-Dose Combination
TMC278 (rilpivirine (as
hydrochloride)) is an investigational non-nucleoside reverse transcriptase
inhibitor being developed by Tibotec Pharmaceuticals. Tibotec submitted a New
Drug Application for
The investigational
once-daily single-tablet regimen of Truvada/TMC278 contains 200 mg of
emtricitabine and 245 mg of tenofovir disoproxil (as fumarate), both nucleoside
reverse transcriptase inhibitors, and 25 mg of rilpivirine (as hydrochloride), a
non-nucleoside reverse transcriptase inhibitor.
The fixed-dose
single-tablet combination of Truvada/TMC278 is an investigational product and
the safety and efficacy have not yet been established.
Additional Important
Information About Truvada
Truvada is a fixed-dose
combination tablet containing 200 mg of emtricitabine (Emtriva(R)) and 245 mg of
tenofovir disoproxil (as fumarate) (Viread(R)). In the European Union, Truvada
is indicated in combination with other antiretroviral agents (such as
non-nucleoside reverse transcriptase inhibitors or protease inhibitors) for the
treatment of HIV-1 infection in adults.
Truvada should not be
administered concomitantly with other medicinal products containing
emtricitabine, tenofovir disoproxil (as fumarate) or other cytidine analogs such
as lamivudine and zalcitabine. Truvada should not be administered with a third
nucleoside analogue.
Emtricitabine and
tenofovir are principally eliminated by the kidneys. Renal impairment, including
cases of acute renal failure and Fanconi syndrome (renal tubular injury with
severe hypophosphatemia), has been reported in association with the use of
Viread. It is recommended that creatinine clearance be calculated in all
patients prior to initiating therapy with Truvada and renal function monitored
every 4 weeks for the first year and every three months thereafter.
In patients at risk of
renal impairment, consideration should be given to more frequent monitoring of
renal function.
Dosing interval
adjustment and close monitoring of renal function are recommended in all
patients with creatinine clearance 30-49 ml/min. Truvada should be avoided with
concurrent or recent use of a nephrotoxic agent.
Coadministration of
Truvada and didanosine is not recommended. Co-administration of tenofovir
disoproxil fumarate and didanosine results in a 40-60 percent increase in
systemic exposure to didanosine that may increase the risk of didanosine-related
adverse reactions. Rare cases of pancreatitis and lactic acidosis, sometimes
fatal, have been reported. Patients on atazanavir/ritonavir and lopinavir/ritonavir
plus Truvada should be monitored for tenofovir-associated adverse events and
Truvada should be discontinued if these occur.
Decreases in bone mineral
density (BMD) at the lumbar spine and hip have been seen with the use of Viread.
The effect on long-term bone health and future fracture risk is unknown. If bone
abnormalities are suspected then appropriate consultation should be obtained.
Cases of osteomalacia (associated with proximal renal tubulopathy and which may
contribute to fractures) have been reported in association with the use of
Viread.
Changes in body fat have
been observed in patients taking anti-HIV medicines. Immune Reconstitution
Syndrome has been reported in patients treated with combination therapy,
including Viread and Emtriva, and may necessitate further evaluation and
treatment.
Most common adverse
reactions (incidence greater-than or equal to 10 percent) are hypophosphatemia,
dizziness, headache, diarrhea, nausea, vomiting, elevated creatine kinase,
asthenia and rash.
The parent compound of
Viread was discovered through a collaborative research effort between Dr.
Antonin Holy, Institute for Organic Chemistry and Biochemistry,
For complete prescribing
information for Truvada, visit the EMA website.
About
Gilead Sciences is a
biopharmaceutical company that discovers, develops and commercializes innovative
therapeutics in areas of unmet medical need. The company's mission is to advance
the care of patients suffering from life-threatening diseases worldwide.
Headquartered in
Forward-Looking Statement
This press release
includes forward-looking statements, within the meaning of the Private
Securities Litigation Reform Act of 1995, which are subject to risks,
uncertainties and other factors, including risks related to
02 Sep 2010
HIV-infected children receiving highly active antiretroviral therapy (HAART) may
require revaccination to maintain immunity against preventable diseases. There
remains no standard or official recommendation on revaccination of children
receiving HAART, an effective intervention in reducing morbidity and mortality
in HIV-infected children. Researchers at the Johns Hopkins Bloomberg School of
Public Health reviewed published data to assess these children's immune
responses to vaccines and found that most children treated with HAART remained
susceptible to vaccine-preventable diseases, but responded well to
revaccination. Their review was published in the September issue of the Lancet
Infectious Diseases.
"Most children on HAART responded to revaccination, although immune
reconstitution was not sufficient to ensure long-term immunity for some
children," said William Moss, MD, MPH, senior author of the review and an
associate professor with the
Researchers reviewed 38 published studies to establish whether children infected
with HIV on HAART have protective immunity to vaccine-preventable diseases and
to assess short-term and long-term immune responses to vaccination of children
given HAART. Short-term was defined as less than or equal to 3 months, and
long-term was defined as greater than 3 months. They found that starting HAART
in infancy, before receipt of routine childhood vaccines, might preserve
immunity to vaccine-preventable diseases. Currently, the World Health
Organization (WHO) recommends giving most routine childhood vaccines to children
infected with HIV, but does not make recommendations on revaccination.
"Continued efforts are needed to identify and treat HIV-infected children
at younger ages and at earlier stages of disease," said Catherine Sutcliffe,
PhD, lead author of the review and a research associate with the
"Do children infected with HIV receiving HAART need to be
revaccinated?" was written by Catherine Sutcliffe and William Moss.
This review was supported by the Canadian Institutes of Health Research and the
National Institute of Allergy and Infectious Diseases.
(AFP) – 2 September,
2010
The test -- remarkable
not only for its ease-of-use and accuracy, but its cost-effectiveness -- works
on the molecular level, identifying genetic markers for the illness in the
saliva of test subjects.
Researchers said the
result is a far quicker diagnosis than when using traditional testing methods.
"Early, rapid and
accurate detection of TB, including identification of drug-resistant strains, is
critical to effectively treating the disease, reducing secondary resistance,
stopping further transmission and saving lives," said Giorgio Roscigno,
chief executive officer of the Foundation for Innovative New Diagnostics (FIND),
one of the funders of the research.
The milestone, he said,
can "help save the millions of lives needlessly lost to TB every
year."
The test not only detects
the presence of TB, but also identifies whether it is the strain of the disease
that is resistant to rifampin -- a frontline medication used to treat the
illness.
Of 1,730 patients
suspected to have drug resistant TB, the test was able to correctly identify 98
percent.
"The need for
accurate and rapid detection of tuberculosis for the growing at-risk populations
in the developing world has been well-documented," said John Bishop,
Cepheid, the company which developed the molecular diagnostic exam.
Experts say a speedy
diagnosis of TB, particularly the drug-resistant variant, is especially vital in
sub-Saharan Africa and
Existing tests to
diagnose TB generally take weeks before results are available -- a critically
important window of time for patients with compromised immune systems who need
may need immediate treatment.
The study's authors said
that undetected and untreated, 90 percent of these patients die within months of
first contracting tuberculosis, underscoring the need for quick detection and
treatment.
TB remains one of the
major causes of disability and death worldwide, with an estimated 1.8 million
deaths in 2008 and an increasing incidence of drug-resistant disease.