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Diabetes study increases death risk | |
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HEALTH TIPS WEEKLY - Thursday, February 7, 2008
"News That Keeps You Healthy"
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FDA acts against unapproved colchicine
WASHINGTON, -- The U.S. Food and Drug Administration said it
will take action against companies marketing unapproved in-
jectable colchicine, a drug used to treat gout. Colchicine
is a highly toxic drug that can easily be administered in
excessive doses, especially when given intravenously, the
FDA said, noting there's only a narrow margin between an
effective dose of the drug and a toxic, perhaps even fatal,
dose. Officials said they had received 50 reports of adverse
events associated with the use of intravenous colchicine,
including 23 deaths. "Today's action supports our ongoing
efforts to end the marketing of unapproved drugs with ser-
ious health risks," said Dr. Janet Woodcock, the FDA's dep-
uty commissioner for scientific and medical programs. "It is
a priority that these products be removed from the market."
The FDA warned individuals and companies making the products
to cease their activities within 30 days and stop shipping
the product within 180 days or face regulatory action.
Thereafter, all injectable colchicine drug products must
have FDA approval to be manufactured or shipped interstate.
The FDA said its action announced Thursday does not affect
colchicine products that are dispensed in tablet form and
are frequently used to prevent gout attacks.
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Gene's role identified in brain cancer
BOSTON, -- U.S. medical scientists have identified a gene
that either fights the development of the brain cancer tumor
glioblastoma or helps the tumor advance. Researchers led by
Associate Professor Azad Bonni of the Harvard Medical School
said scientists have long assumed the gene, STAT3, only acts
as a tumor inducer, and have been developing therapeutics
that inhibit STAT3. But the study's findings that the gene,
depending upon the tumor's genetic makeup, might actually
fight tumor growth means current therapies could do more
harm than good in some cases. The findings, therefore, might
change the way researchers approach not only glioblastoma,
but other types of cancers as well. Bonni said. "This dis-
covery lays the foundation for a more tailored therapeutic
intervention," said Bonni. "And that's really important. You
can't just go blindly treating people by inhibiting STAT3."
The study, which included researchers at the Dana Farber
Cancer Institute, appears online in the journal Genes and
Development and will be reported in the journal's Feb. 15
print issue.
Aggressive diabetes regimen disappointing
WASHINGTON, -- Part of a U.S. study of diabetes has been
halted because aggressively reducing blood sugar appears to
increase the risk of death, officials said Wednesday. The
increased fatalities from heart attack and stroke also un-
dercut a major assumption researchers had made about diab-
etes, that getting blood sugar levels close to normal would
improve diabetics' health, The Washington Post reported.
"It's profoundly disappointing," Richard Kahn, chief scient-
ific and medical officer for the American Diabetes Associat-
ion, told the newspaper. "This presents a real dilemma to
patients and their physicians. How intensive should treat-
ment be? We just don't know." The study, sponsored by the
National Heart, Lung and Blood Institute, involved 10,251
people with type 2 diabetes in the United States and Canada.
Half were put on a diet, exercise and drug regimen aimed at
reducing blood sugar levels to those of the average diabe-
tic, while the other half were treated more aggressively to
cut their levels close to normal. Half the excess deaths
were from heart disease.
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AIDS researchers look for new vaccine
BOSTON, -- AIDS researchers meeting in Boston said they are
starting basically from scratch in the search for a vaccine
to protect against the immune disease. The San Francisco
Chronicle said the failure of a Merck vaccine study that
left some volunteers susceptible to HIV has led to calls for
a pause in new clinical trials. Dr. Tony Fauci, head of the
National Institute of Allergy and Infectious Diseases, has
agreed to convene a meeting of leaders in the vaccine field
to rethink strategy, the newspaper said. Speaking at the
15th annual Conference on Retroviruses and Opportunistic
Infections Tuesday in Boston, Harvard researcher Ronald Des-
rosiers said current vaccine research trials were basically
useless. "There is no rational basis for believing that any
of the products in the pipeline have any reasonable hope of
being effective," said Desrosiers. Desrosiers said the res-
earch community needs to accept that HIV is the "undisputed
champion" among viruses in its ability to mutate resistant
strains, the newspaper said.
Diabetes study increases death risk
CHAPEL HILL, N.C., -- Experts have ended part of a study
which aimed to lessen diabetics' heart disease risk after
they found it increased death risks, a report said. The nat-
ional study intended to lessen heart disease by reducing
blood sugar to regular levels, Raleigh (N.C.) News & Obser-
ver reported Wednesday. One study leader at the Diabetes
Care Center at the University of North Carolina Hospitals
said they are immediately ending that element of the study.
In the study, 257 Type 2 diabetes patients who were subjec-
ted to intensive blood-sugar reduction treatment died. Only
203 patients, who received standard blood glucose treatment,
died in a control group, the newspaper said. The information
translates to three more fatalities per 1,000 patients in
the intensive therapy group. Two other parts of the study of
10,251 people that reportedly aim to lessen blood pressure
and cholesterol will carry on until June 2009, when the
study is over.
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Proteins may protect against infections
BUFFALO, N.Y., -- U.S. scientists said certain proteins
appear to have the potential to enhance the production of
antibodies against a multitude of infectious agents. Univer-
sity of Buffalo Professor Terry Connell developed the LT-IIa
and LT-IIb enterotoxins and their respective mutant proteins
as mucosal adjuvants, or "boosters," that can enhance the
potency of existing and future vaccines. "Almost every bact-
erium and virus that attacks us doesn't bore through the
skin," said Connell. "These infectious agents enter by colo-
nizing the mucosal surfaces on the eye, sinuses, mouth, gut
lining, lungs and genital tract." The scientists used a
mouse model to determine the nasal passage is the best muc-
osal surface on which to apply LT-IIa and LT-IIb. Mixing a
very small amount of LT-IIa or LT-IIb with an existing ant-
igen and dripping the mixture into a mouse's nose subsequen-
tly produced a strong antigen-specific immune response in
the nasal passages, as well as in saliva, the urogenital
tract and the bloodstream, their research showed. In cont-
rast, immunization with only the antigen generates a much
lower level antigen-specific immune response. Connell and
colleagues published five papers last year describing their
advances and might begin human trials in about a year.
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