DOYLESTOWN, Pa., June 23 /PRNewswire/ -- The Quigley Corporation said today that it intends to repeat a low-dosage zinc
gluconate glycine study originally conducted at the Cleveland Clinic
Foundation. The Company feels that the study to be published in the Journal
of the American Medical Association (JAMA) on June 24 did not follow the
research agreement or the protocol agreed to by The Quigley Corporation and
the Cleveland Clinic Foundation.
There were 129 protocol deviations involving at least 83 out of the 249
patients enrolled in that study, which can only be considered bad science.
"The purpose of the study was to identify whether a lower dosage would be
effective," said Company Chairman Guy J. Quigley. "The protocol violations
are so significant that no conclusion as to the effectiveness of zinc
gluconate glycine in a lower dosage in treating children can be determined.
Therefore, we intend to repeat the low-dosage study test at another medical
facility," he added.
The need to undertake a new study on a low-dosage zinc gluconate glycine
formulation is necessary because of the flaws in the Cleveland Clinic
Foundation children's study. The Quigley Corporation will not know whether a
lower dosage of zinc gluconate glycine will be effective until that study is
completed.
The original Cleveland Clinic Foundation study published in July of 1996
in the Annals of Internal Medicine relates to the 13.3 mg. zinc gluconate
glycine lozenge manufactured by The Quigley Corporation under the trade name
COLD-EEZE(R). This study showed that treatment with COLD-EEZE(R) resulted in
a 42% reduction in the duration and severity of the common cold symptoms.
COLD-EEZE(R) is widely and successfully used by children and adolescents on a
daily basis.
The low-dosage (10 mg. zinc gluconate glycine formulation) study to be
published in JAMA was performed by the Cleveland Clinic Foundation under Dr.
Michael L. Macknin. The study states that the lower-dosage zinc gluconate
glycine lozenge was not effective in treating common cold symptoms in children
and adolescents.
Certain statements in this press release are "forward-looking statements"
within the meaning of the Private Securities Litigation Reform Act of 1995 and
involve known and unknown risk, uncertainties and other factors that may cause
the Company's actual results, performance or achievements to be materially
different from the results, performance or achievements expressed or implied
by the forward-looking statement. Factors that impact such forward-looking
statements include, among others, changes in worldwide general economic
conditions, changes in interest rates, government regulations, and worldwide
competition.
The Quigley Corporation is the maker of COLD-EEZE(R), the only zinc
gluconate glycine (ZIGG(TM)) lozenge proven in two double blind studies to
reduce the duration and severity of the common cold symptoms.
For detailed information on the 129 protocol deviations, contact Karen
Goldman of INFOCUS, Inc. at 609-683-9055 x106.
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