viernes, 23 de marzo de 2012

Malaria vaccine

 Very interesting article from (CNN) -- A malaria vaccine has eluded scientists for decades, but preliminary results from a phase 3 clinical trial in Africa are providing hope.
The data suggest that the vaccine, known as RTS,S, cuts the number of malaria cases in half.
Overall 15,000 children in seven African countries are participating in the trial, which represents the furthest that any malaria vaccine candidate has ever progressed.
The preliminary results, which were announced at a malaria forum hosted by the Bill and Melinda Gates Foundation in Seattle, covered 6,000 of the participating children, all aged between 5 and 17 months.
The developers, GlaxoSmithKline and the PATH Malaria Vaccine Initiative, which receives funding from the Bill and Melinda Gates Foundation, said it showed roughly a 50% reduction in malaria cases in a 12 month period following vaccination.
Results from a group of infants between 6 and 12 weeks old will be announced late next year.
"Scientists have been working to develop a malaria vaccine for 40 years, and these findings show that we are on track in the development of a vaccine for African children, those who need it most," said Dr. Mary Hamel of the U.S. Centers for Disease Control and Prevention, who is one of the principal investigators on the study.
The vaccine is designed specifically for children because their immune systems are still developing, making them the easiest prey for the parasitic disease. Youngsters under the age of 5 account for the vast majority of the 800,000 people who die of the condition each year.
Philip Ouma and his mother, Rosemary
Philip Ouma and his mother, Rosemary
This year, Global Health Frontline News visited trial sites in Kenya, where 2-year old Philip Ouma was getting a booster shot. He buried his head in his mother's chest as a plunger with an inch-long needle glided into his arm and deposited its contents.
Unlike many of the babies and toddlers in this vaccine trial, Philip didn't burst into tears or even make a sound.
His mother, Rosemary, enrolled him in the trial because her three other children had repeatedly been sickened by malaria, putting an enormous strain on the family.
Indeed, the entire community felt the strain in their part of western Kenya, where malaria accounts for one-third of all deaths among children.
To administer the trials, the Kenyan government joined with the CDC and the Walter Reed Army Institute of Research.
Dr. Louis Macareo, who directs Walter Reed's clinical trial center in Kombewa, says this vaccine is different because instead of attacking the parasite, it seeks to boost the immune system. "When you get malaria, it spawns off a cascade of events in your body where your body produces antibodies that fight against the malaria," he said. "What we try to duplicate with the vaccine is to stimulate the body's immune system to produce similar antibodies."
The developers of RTS,S say preliminary results suggest that the incidence of adverse effects of the vaccine are comparable to those found in children receiving other vaccines in this blind trial.
The CDC's Mary Hamel says there was some increased incidence of fever and associated seizures in the older age group during the seven days following the RTS,S vaccination, but they were rare and all the children recovered.
GlaxoSmithKline and the PATH Malaria Vaccine Initiative say side effects will be monitored over the next three years to develop a safety profile.
If approved for widespread use, RTS,S would be given in tandem with other childhood vaccines, enabling overstretched health systems to introduce it with little difficulty.
And it's hoped that implementation could be just around the corner. The vaccine's developers say a 30-month analysis of the vaccine's effectiveness will be complete by the end of 2014.
If the results remain positive, the World Health Organization says it could recommend the vaccine as early as 2015.
Kayla Laserson, the director of a CDC partnership with Kenya's main research institute, known as KEMRI, says implementation talks are already under way. "Certainly, the preparations for it are there to go straight from discovery that this is in fact efficacious, to policy, to implementation; all those conversations are happening, so everyone is ready."
While a 50% cut in prevalence would not be a silver bullet against malaria, it would be a significant milestone with the potential to save hundreds of thousands, if not millions, of young lives.
But malaria control experts stress that if this vaccine ever does go to market, it would need to work in tandem with other interventions.
"Such a vaccine would not replace proven malaria control interventions such as insecticide-treated bed nets," the CDC's Hamel said, "but could be an important addition to those interventions."
Andrew Witty, the CEO of GlaxoSmithKline says that if approved, his company does not intend to make a profit from this venture. GlaxoSmithKline, which says that it has spent $300 million dollars on the development of RTS'S, will provide the vaccine at 5% above the cost of production, and that the excess amount will be reinvested for research into the next malaria vaccine.
David Lindsay is the managing editor of Global Health Frontline News.

martes, 13 de marzo de 2012

Qu'est-ce qu'un médicament générique?

Un médicament générique est un médicament similaire à un médicament autorisé (molécule princeps)

Un médicament générique est un médicament similaire à un médicament autorisé (molécule princeps) depuis au moins 10 ans dans l'Union européenne, et qui profite de la chute du brevet du princeps pour être commercialisé.
Le médicament générique doit contenir la même quantité en principe actif et être de même forme pharmaceutique que le médicament original. Il ne peut pas avoir de nouvelles indications que la molécule princeps qu'il copie.
De même, sa notice scientifique ne peut être transformée qu'après modification de la notice de la molécule princeps. Un générique est donc conforme à la spécialité de référence, et présente les mêmes effets, même fabrication, même forme pharmaceutique. En revanche, le goût, la couleur, les excipients utilisés peuvent être différents.

Regulatory policy

Regulatory Policy. http://enzo-umpierrez.blogspot...
Under the regulatory point of view, countries
do not develop new legislation to address convergence. Instead, they
modify existing regulations or institute new regulations to address new
technologies. For example, in the United States, the Federal
Communications Commission (FCC) introduced regulatory modifications to
allow new technologies, such as power line communications (PLC).

Science in regulatory policy making: case studies
in the development of workplace smoking
Lisa A Bero, Theresa Montini, Katherine Bryan-Jones, Christina Mangurian

Regulatory Policy Committee Annual Report 2011:

Regulatory Policy Committee Annual Report 2011: Departments achieve year on
year improvement but number of regulatory proposals deemed ‘Not fit for
purpose’ remains unsatisfactory
The independent Regulatory Policy Committee (RPC), charged by government with
assessing the quality of analysis and evidence supporting government departments’
proposals to regulate, today publishes its Annual Report 2011 ‘Improving Regulation’.
The report shows that 72% of just under 600 Impact Assessments (IAs) reviewed were
judged to be ‘Fit for Purpose’, a significant improvement from the 56% recorded in 2010.
However, this leaves more than a quarter of all proposals judged ‘Not fit for Purpose.’
IAs, produced to support regulatory proposals, are scrutinised by the RPC to assess the
quality of the case made and to validate the government’s One-In, One-out system. An
RPC Opinion is produced rating each IA as Red, Amber or Green (RAG). A Red rating
declares the IA ‘Not Fit for Purpose’. This draws Ministers’ attention, in real time, to
significant concerns with the quality of analysis and evidence provided to support the
proposal, and informs their decisions. ‘Improving Regulation’ presents departmental
RAG performance and lists the IAs that have been reviewed alongside the rating
Chairman of the RPC Michael Gibbons said: “Across Whitehall, Departments have
worked hard to show a greater commitment to IAs and an improvement in their quality
with considerable year on year improvement in response to the independent challenge
presented by the RPC. This is a very significant step forward and provides evidence that
the scrutiny we provide is beginning to make a real difference. This would not of course
be possible without the highly visible and consistent commitment of Ministers to this
“But a quarter of IAs still fail to pass the RPC test and this is worryingly high.
Departments need to raise their game still further and we should all expect and work
towards 80%, ideally more, ‘Fit for Purpose’ RPC Opinions by the end of 2012.
Secondly, we are looking for a step change in the number of best practice ‘Green’
ratings, with only a third achieving this standard in 2011. Thirdly, renewed effort from
those Departments whose performance does not reflect the overall picture. We are also
looking for greater consideration of alternatives to regulation at consultation stage and
more robust cross-Whitehall evidence gathering.
“2011 has seen a significant rise in the quality of evidence and analysis supporting
regulatory proposals, essential to ensuring that the policymaking process delivers
effective outcomes. But there is room for more improvement and we will look for this in
2012 and beyond.”
The RPC also provides an independent review of the costs and benefits of measures
covered by the Government’s One-in, One-out rule, whereby departments must offset
any new regulatory cost on business with cuts to the cost of existing regulation.
Mr Gibbons continued: ”The Government’s One-in, One-out rule has undoubtedly put
pressure on Departments to strip away regulation. This challenge makes Departments review regulatory design and bring forward ‘Outs’ for the RPC to validate. The two most
common problems we find are 1) inaccurate forecasting of the cost and benefits to
business and 2) incorrect classification of what is an ‘In’ or an ‘Out’ and we will be
looking for improvements in these areas this year."
For further information please see
or contact Sue Youngman, Compass Rose & Co on 07768 283 162.
1. The RPC was set up in 2009 to provide independent scrutiny of the evidence
supporting proposed regulatory measures put forward by Government. In 2011 it
moved to commenting, for the first time in the UK, on evidence in real time,
before it was seen by ministers. It becomes an Advisory Non-Departmental
Public Body in April 2012.
2. The RPC does not comment on the Government’s policy objectives. It comments
on the analysis and evidence supporting new regulations.
3. The RPC is a group of independent experts, including businessmen, academics,
trade union and consumer representatives. The Committee is supported by a
secretariat of officials with a mixture of analytical, policymaking and economic
expertise. Further information on the Committee can be found on the RPC
4. Departments submit IAs accompanying regulatory proposals to the RPC, and an
RPC Opinion must be given before Ministers on the Reducing Regulation
Committee, the Cabinet sub-Committee set up to vet all new regulatory
proposals, will consider the proposal. Under the RPC’s traffic light system, if it is
‘Fit for Purpose,’ it is classified as either ‘Amber’ or ‘Green’. ‘Amber’ is used to
denote an IA with areas of concern that should be corrected but which is still ‘Fit
for Purpose’. If an IA is classified ‘Red’ it is ‘Not Fit for Purpose’ – the RPC has
major concerns over the quality of evidence and analysis.
5. The RPC’s Opinions inform the decisions that are taken by Ministers as to
whether they proceed or not with the proposal. If the Government proceeds with
a proposal despite the RPC assigning a ‘Red flag’ the Opinion is published on
the RPC website.
6. Each IA is tested against well-established standards for Government appraisal
set out in the Better Regulation Executive’s toolkit[1] and guidance for impact
assessments along with HM Treasury’s Green Book[2].
The RPC has previously published its seven recommendations for how to improve the
quality of IAs:
· Don’t presume regulation is the answer
· Take time & effort to consider all options
· Make sure you have substantive evidence
· Produce reliable estimates of the costs and benefits
· Assess non-monetary impacts thoroughly
· Explain and present results clearly
· Understand the real cost to business of regulation 1. The RPC has also been asked by ministers to provide a quality check of the
figures for the government’s ‘One in, one out’ policy. Under this policy each new
regulation which imposes a cost to business must be balanced by the removal of
existing regulation with at least as great a cost.
2. The RPC has been tasked with ensuring that the claimed costs and benefits of
regulatory proposals are more than just ‘claims’, and that the costs and benefits
to business have been identified and are a realistic and credible estimate of their
potential impacts.