SABINSA Corporation, the US based sister concern of Sami Labs
of Bangalore, has questioned what it described as the lack
of balance in a Journal of the American Medical Association
(JAMA) report giving results of research on the potential
cardiovascular benefits of the company's branded gum guggal
Line had last week carried extracts of the JAMA study results,
which, according to Dr. Muhammed Majeed, founder and Chief
Executive Officer of Sabinsa Corporation, "are an incomplete
representation of the overall safety and efficacy of documented
data". The JAMA study was co-funded by Sabinsa Corporation,
which holds the IND (investigational new drug) license No.
59, 712 relating to Gugulipid.
is an eight-week safety and preliminary efficacy study done
for the first time with Gugulipid on the American population
that we thought was of primary importance. Work on the same
IND is continuing at Our Lady of Mercy Medical Centre, Bronx,
New York, for a three-month duration to further evaluate efficacy,
" Dr. Majeed said in a detailed communication.
weeks is too short a period for some of Gugulipid's pharmacological
effects to reveal themselves.
all studies on products like this need to be done for three
months or more. "We will continue our efforts in clinical
documentation of this products as an efficacious cholesterol
management nutraceutical," Dr. Majeed said.
Sabinsa obtained US Patent No. 6,436991 for Gugulipid, which
works towards the nutritional/nutraceutical improvement of
has initiated a second IND study involving Gugulipid in the
US, scheduled to begin in the fall of 2003.
to Dr. Viladimir Badmaev, vice-president of Medical and Scientific
Affairs, Sabinsa, cardiovascular disease is currently seen
as a process where multiple lipid fractions, not just LDL,
play an important role.
there are known cholesterol-lowering drugs, which actually
increase LDL, while lowering other important lipids, such
recent considerations in therapy of high cholesterol include
indices of inflammation, e.g. C-reactive protein, as well
as levels of uric acid and lipoprotein (a).
history of gum guggal started in the 1960s when the gum began
to be systematically studies for its potential in the treatment
of elevated blood cholesterol.
profile, pre-clinical and clinical trials were done in the
country during the 1980s at the Central Drug Research Institute
(CDRI), Lucknow. There are nine published human clinical trials
evaluating the hypolipidemic effect of guggal extracts.
only five studies used a standardised guggal extract, out
of which only two were randomised and only one was placebo-controlled.
to Dr. Badmaev, the JAMA study did reaffirm the long history
of safe use of Gugulipid.
communicated to the Federal Drug Administration, in compliance
which the IND study protocol, were in keeping with what has
been previously documented slight skin rash in a low number
is undertaking further clinical study evaluating fractions
of Gugulipid to identify the potential skin sensitising components,
the only side-effect reports.
to Dr. Majeed, the task of improving a worthy and safe nutraceutical
such as Gugulipid was tedious, but ultimately rewarding.