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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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