GSK responds to NEJM

GlaxoSmithKline PLC
21 May 2007



              GlaxoSmithKline Responds to NEJM Article on Avandia



London (21st May 2007) - GlaxoSmithKline plc (NYSE:GSK) today issued the
following response to an article in the New England Journal of Medicine (NEJM)
on Avandia(R) (rosiglitazone maleate), a widely used and highly effective
treatment for type 2 diabetes:



GSK strongly disagrees with the conclusions reached in the NEJM article, which
are based on incomplete evidence and a methodology that the author admits has
significant limitations.



The NEJM paper is based on an analysis of summary information that combines a
number of studies - a meta-analysis - which is not the most rigorous way to
reach definite conclusions about adverse events. Each study is designed
differently and looks at unique questions: for example, individual studies vary
in size and length, in the type of patients who participated, and in the
outcomes they investigate.  The data compiled from these varied studies is
complex and can be conflicting.



Importantly, the editorial in the NEJM states: "A few events either way might
have changed the findings for myocardial infarction or for death from
cardiovascular causes.  In this setting, the possibility that the findings were
due to chance cannot be excluded.  In their discussion, the authors properly
emphasize the fragility of their findings."



In contrast to a meta-analysis, the most scientifically rigorous way to examine
the safety and benefits of a medicine is to conduct large scale, long-term
clinical trials in patients with the disease. Several trials of this type have
been ongoing for many years.  To date concerns regarding patient safety have not
been identified by the independent Safety Monitoring Boards for these trials.
Several trials have completed and the results published.  For example, GSK's
long-term, landmark study 'ADOPT' (A Diabetes Outcome Progression Trial) -  one
of the longest clinical trials in people with type 2 diabetes to date - directly
compared both the safety and effectiveness of Avandia with other oral
anti-diabetic medicines in over 4,300 patients studied for up to 6 years.



Data from ADOPT showed that the overall risk of serious, cardiovascular events
(CV death, myocardial infarction, and stroke, or MACE endpoint) for patients on
Avandia was comparable to metformin and sulfonylurea (glyburide) - two of the
most commonly used medicines to treat type 2 diabetes.  ADOPT showed comparable
rates of cardiovascular deaths:  Avandia - 5 reports out of 1,456 patients, or
0.34%; metformin - 4 out of 1,454, or 0.28%; and glyburide - 8 out of 1,441 or
0.56%.   The ADOPT clinical trial did show a small increase in reports of
myocardial infarction among the Avandia-treated group (Avandia: 24 out of 1,456
or 1.65%) vs metformin (20 out of 1,454 or 1.38%) vs glyburide (14 out of 1,441
or 0.97%); however, the number of events is too small to reach a reliable
conclusion about the role any of the medicines may have played in this finding.
 Importantly, ADOPT also demonstrated that Avandia was superior to metformin and
sulfonylurea regarding long-term control of blood sugar over five years, which
is a key goal in managing diabetes to avoid the long-term complications of the
disease.



In another long-term study, DREAM - which followed over 5,200 patients at high
risk of developing of type 2 diabetes for a period of three to five years -
Avandia monotherapy showed no increase in cardiovascular risk when compared to
placebo.



Furthermore, in 2000, GSK initiated RECORD - a large, long-term clinical trial
in people with diabetes- which has been prospectively designed to look at
cardiovascular outcomes.  The independent Safety Monitoring Boards responsible
for overseeing the safety of this trial monitors patients closely, and in its
regular operations has not found any safety risk that would interrupt
continuation of the study.



In addition, in a comprehensive analysis of patients in a US managed care
database of more than 33,000 people with diabetes - performed by independent
investigators - there was no difference in ischemic cardiovascular events
(including myocardial infarction) among patients taking Avandia-containing
regimens versus other oral anti-diabetic medicines.



The totality of the data show that Avandia has a comparable cardiovascular
profile to other oral anti-diabetic medicines. GSK stands firmly behind the
safety of Avandia when used appropriately, and we believe its significant
benefits continue to outweigh any treatment risks.



Because Avandia has been shown to control blood sugar for longer than other
standard oral anti-diabetic medicines, it is an important treatment option for
physicians who often need to prescribe two or three medicines to help their
patients maintain their blood sugar levels.  Type 2 diabetes is chronic,
relentlessly progressive and life threatening; yet, two-thirds of diabetic
patients suffer with uncontrolled disease. If left uncontrolled, diabetes can
lead to heart disease, and is the leading cause of blindness, kidney disease and
non-traumatic amputations in the US.



GSK has consistently shared its data on Avandia from meta-analyses and
controlled studies with the FDA and other regulatory agencies. Data is also
posted publicly on the company's Clinical Trial Register. We continue to work
closely with regulatory authorities and physicians to keep them fully informed
so they can make the best decisions for patients based on both the safety and
benefit of the medicine.



GlaxoSmithKline - one of the world's leading research-based pharmaceutical and
healthcare companies - is committed to improving the quality of human life by
enabling people to do more, feel better and live longer.  For company
information, visit GlaxoSmithKline on the World Wide Web at www.gsk.com.





Simon Bicknell

Company Secretary

21st May 2007



Cautionary statement regarding forward-looking statements 

Under the safe harbor provisions of the U.S. Private Securities Litigation
Reform Act of 1995, the company cautions investors that any forward-looking
statements or projections made by the company, including those made in this
Announcement, are subject to risks and uncertainties that may cause actual
results to differ materially from those projected. Factors that may affect the
Group's operations are described under 'Risk Factors' in the 'Business Review'
in the company's Annual Report on Form 20-F for 2006.



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