By Michael F, GSK Social Media on August 27, 2010 10:31 AM
a publication aimed at those who conduct clinical trials, recently published an
interesting look at myriad factors driving increased interest by the
bio-pharmaceutical industry in researching and developing orphan drugshttp://www.ecliniqua.com/2010/08/16/orphan-drug.html.
the factors cited are financial incentives, unmet medical needs, advances in
science, and unusual regulatory flexbility.The piece points out that, while activity in this field is picking up,
much remains to be done.For instance,
GSK's Marc Dunoyer, who heads up our rare diseases unit, told eCliniqua that
there are 8,000 rare diseases and as few as 10% have approved treatments.And although the FDA told eCliniqua that nearly
40% of all new drugs now approved by the agency are orphan drugs, reportedly only
359 orphan drugs for 150 rare diseases have been approved in total.
address this, the National Organization for Rare Disorders, academia, industry
and regulators are working to find ways to overcome obstacles that are slowing
efforts to help those who suffer from rare diseases.We're hopeful these efforts will accelerate
the availability of more treatments for rare diseases.
By Peggy, GSK Vaccine Scientific policy on August 25, 2010 3:47 PM
combination of inspiration, hope and heartache accurately describes the last 30
years of my career of treating pediatric infectious disease and working to develop
vaccines that help prevent them.Vaccines
have helped us come a long way in the battle against debilitating diseases,
such as polio, smallpox, rubella and diphtheria. Still, epidemics of
vaccine-preventable diseases erupt, sweeping through areas, spreading illness
and claiming lives.
now the state of California is dealing with an epidemic of pertussis, or
whooping cough.The number of cases of
whooping cough reported so far this year in California is more than five times greater
than during the same period last year.Sadly,
seven infants there have died from whooping cough since the beginning of this
may think that this is not a serious disease, but nobody wants it.Adolescents and adults can experience a
severe cough, the complications of which can lead to vomiting and broken
ribs.Babies younger than a year are
most vulnerable to complications. For them, the disease can be fatal.
can help prevent whooping cough, but only if people get vaccinated.Whooping cough is one of the many diseases
that children are vaccinated against as part of the routine childhood
immunizations.By ensuring that children
get their recommended shots, we can help protect them from whooping cough.
five to ten years after completion of the childhood vaccination series,
immunity to whooping cough can wear off. That's why a booster shot is routinely
recommended adolescents and adults.The
booster shot is called a Tdap vaccine, and it helps protect adults and
adolescents against tetanus, diphtheria and pertussis.In my opinion, there are two things we can do
to make even great gains in the battle against many infectious diseases. First,
healthcare providers can make checking vaccinations records a routine for
adults, not just children.Second,
adults can ask their healthcare provider about the vaccinations that they need.
I read about the whooping cough epidemic in California, an all too familiar
sense of sadness took hold of me. Yet, I rally, knowing that there is still
work to do.I am inspired by the vision of
a day when vaccines are available--and used--to help protect people of all ages
I recently recorded a podcast
with GlaxoSmithKline (GSK), the global pharmaceutical company,
and their success story of implementing a PC power management initiative that
is expected to cut energy costs by ~$1 million per year.
While these savings alone should impress any IT executive - especially IT
infrastructure and operations professionals who manage PCs - what I found so
unique about their story came through my conversation with Matt Bartow,
business analyst in GSK's research and development IT organisation, who led
this initiative. In particular, GSK is a great example of how "empowering"
staff to innovate can industrialise IT operations leading to significant cost
To ensure the project was a success, GSK enacted a two week
pilot of these new settings on a diverse group of 550 volunteers with different
working habits from different countries and lines of business. To refine the
power settings, users were surveyed to understand if productivity, application
use, or any other working behavior was impacted.
This trial run also helped GSK develop their green IT baselineto assess their financial and environmental savings
potential - which turned out to be significant. When implemented across GSK's
92,000 PCs globally, these more aggressive PC power management settings are
expected to save close to $1 million in energy costs each year, and a reduction
in carbon emissions equivalent to taking 1,012 passenger vehicles off the road.
By Mary Anne, GSK Communications on August 23, 2010 5:21 PM
August 20, we blogged
about our July 28 communications with clinical trial investigators in TIDE, a
prospective, cardiovascular outcome study comparing Avandia
(rosiglitazone) to Actos (pioglitazone) as mandated by the U.S. Food and
Drug Administration (FDA). That July 28 communication summarized the
two-day FDA Advisory Committee meeting (July 13-14) on the cardiovascular
safety of Avandia. There is an update from FDA regarding the TIDE trial which
we felt should be shared for the sake of transparency.
the post was published, GSK has received a request from the FDA that the
company inform the TIDE Steering Committee to "re-issue a letter" for trial
participants that was sent prior to GSK's July 28, 2010 summary for
investigators, Institutional Review Boards and Ethics Commitees involved
in the TIDE trial.
wrote GSK that the July 16 letter to trial participants did "not accurately capture
the results on all the voting questions posed to the advisory committee panel
at this meeting. There is an overemphasis on the mortality findings that
appears to dismiss the risk of ischemic cardiovascular events, particularly
between rosiglitazone and pioglitazone. Consequently, this information
does not fully inform participants of the potential risks of the different
treatments in the TIDE trial."
By Mary Anne, GSK Communications on August 20, 2010 12:46 PM
facts are left unclear in the New York
entitled "Glaxo Memo on Avandia Questioned."
FDA mandated the TIDE trial, and the Agency asked GSK to write a summary of a
two-day Advisory Committee hearing (July 13-14) and the FDA's subsequent
notification to GSK that the TIDE trial was being placed on partial clinical
hold. The summary was directed to a very specific audience:investigators (the doctors doing the trials),
Institutional Review Boards and Ethics Committees that oversee the ongoing TIDE
clinical trial with Avandia.
the FDA asked: "Within one week, you must inform all investigators,
institutional review boards (IRBs) and ethic committees involved in the TIDE
trial of the new safety data/information presented at the FDA Advisory
Committee meeting held on July 13 and 14, 2010. Please also include
information regarding the deliberations, recommendations and voting from the
panel members regarding the specific questions posed at the meeting. This
information may be utilized by investigators and IRBs to update the informed
consent document for patients currently enrolled in the TIDE trial. In
addition, a written summary of this information/data should be submitted to
your IND file."
agreed the letter was important for investigators so that they could inform
patients in the TIDE trial about the Advisory Committee meeting. GSK then prepared the letter, which the chair
of the TIDE Steering Committee approved. The letter was not a general outreach
summary was to be brief (9.5 pages here) and sent quickly (sent within one
week). To provide some context, the transcripts of the meeting total 934 pages.
Written briefing materials for the committee had been posted by FDA online and
the GSK letter alerted investigators to the documents and provided a link to
available materials. Contrary to the NY Times report, the summary mailed by GSK
provided full detail on the questions posed to the Advisory Committee and the
vote on each.
summary outlined presentations by FDA agency personnel, GSK and others as well
as major discussion points. A brief summary--which is what was required--certainly
cannot cover the entirety of the briefings or hearing presentations but both
GSK and the chair of the TIDE steering committee agreed that the summary
reflected the science and data discussed at the advisory committee meeting. A
copy of the letter is available for public review.
By Michael M, GSK Communications on August 19, 2010 2:42 PM
we have in past natural disasters, GSK is working closely with partner
humanitarian organizations to assist in the response to the terrible floods in
Pakistan. And that includes our staff
who live and work in that country. The
note below was posted on our internal company website:
GSK steps up response for Pakistan flood
The situation in Pakistan is changing rapidly
as floods have swept down the country and even more rains are expected in the
coming weeks. As the needs are emerging, GSK Pakistan is stepping up its
response, working with a number of organizations in all flood-affected areas to
provide shelter, clean water, healthcare and food.
On August 18, GSK made a contribution of
£100,000 (roughly $150,000) to support agencies which are organizing food and
medicines distribution, including funds specifically earmarked for the World
Food Programme (WFP), the International Red Crescent (IRC) and medicines to the
provincial government agencies reaching some of the remotest areas.
Despite huge logistical challenges, GSK
Pakistan's medicines have been among the first to reach many marooned villages.
Our donated medicines have been distributed by a variety of relief aid agencies
such as the Abaseen Foundation, the first to reach 20,000 people in the remote
Swat valley, and International Medical Corps (IMC) which rapidly mobilized six
medical teams to the Khyber Pakhtunkhwa Province in the immediate
aftermath of the floods. With a temporary halt in the rains, people have
been able to make their way to the mobile clinics set up by IMC, which have
conducted over 6,000 health consultations, treating some of the most pressing
cases such as acute diarrhea, skin disease and acute respiratory
GSK Pakistan has also provided medicines to
several other relief agencies reaching areas further south. For example,
the Pakistan Medical Association (PMA), working in Sindh, where widespread
destruction has displaced an estimated 3.5 million people from their homes, and
also the Pakistan's National Health Emergency Preparedness and Response Centre
(HEPR) and The National Commission for Human Development (NCHD), which has
already reached over 80,000 patients in mobile medical camps in all the flood
In line with GSK's principles for
humanitarian support, we are continuing to evaluate the ongoing healthcare
needs and will provide further support at the request of the Ministry of Health
and local/international NGOs who are involved in the recovery efforts.
GSK Pakistan employees have been making
contributions in cash and in kind. A number of international appeals have been
launched. Employees can make a personal donation via the following
Medical Corps has been operating in Pakistan since 1984, providing
primary health care services and water/sanitation facilities to displaced
Pakistanis as well as to Afghan refugees in the frontier areas.
US-based employees can send
contributions to the American Red Cross, Box 37295, Washington, DC
20013, and earmark gifts for the Pakistan Floods Disaster.
By Michael M, GSK Communications on August 19, 2010 2:36 PM
Earlier this week we were delighted to announce the launch of a
major initiative in Washington, DC with Donovan McNabb and the Washington
Redskins. See below for more, or visit
the redskins website.
17, 2010, Washington, D.C. - The Washington Redskins
and GlaxoSmithKline (GSK) announced today they are teaming up with Redskins
quarterback and health advocate Donovan McNabb to help tackle the nation's
childhood obesity epidemic. As the newly appointed 2010 Redskins Health
Ambassador, McNabb will work side by side with Washington, D.C. youth to
demonstrate fun and easy ways to make exercise part of their daily lives.
Beating childhood obesity is a top priority on the local and national agenda,
gaining momentum through the Redskins' commitment to the Play 60 movement for
an active generation and first lady Michelle Obama's "Let's Move!"
campaign. D.C. has one of the highest childhood obesity rates in the
nation, which has long-term implications since obesity is linked to chronic
diseases like diabetes, heart disease and some forms of cancer.
"We can beat this! I'm so excited to teach
kids and their parents how exercising for 60 minutes a day will keep them
healthy and help prevent chronic diseases. Football has always motivated
me to stay active, fit and healthy, and I want to motivate kids to find an
activity that will help them do the same," said McNabb. "Seeing the
effect chronic disease has had on my father's life has pushed me to help kids
take up healthy habits and provide them with the right tools for a healthier
future. Like I tell my father - together, we can beat this."