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Avandia News
Glaxo's Avandia Risks Prompt Doctors to Switch Drugs
By John Lauerman and Elizabeth Lopatto
May 23, 2007 - (Bloomberg) -- Boston doctor Annaswamy Raji
says she was so alarmed by a study linking GlaxoSmithKline
Plc's drug Avandia to heart disease that she immediately advised
a diabetes patient to stop taking the medicine.
Research released May 21 by the New England Journal of Medicine
provided evidence that Avandia raises the chance of a heart
attack by as much as 43 percent. London-based Glaxo shares
dropped for a third day, bringing the week's decline to 8.4
percent. The data caused U.S. lawmakers to question the government's
drug-safety monitoring.
Some doctors say the risks uncovered in the study are outweighed
by the drug's benefits. Patients should continue taking Avandia,
the world's top-selling oral diabetes treatment with $3 billion
in revenue last year, until Glaxo or U.S. regulators provide
more guidance, they say. Meanwhile, some doctors, insurance
companies and hospitals say they are reconsidering the use
of Avandia.
Raji took an 83-year-old man off the drug because he ``is
at a higher risk for heart disease and heart attack,'' said
the Boston physician, an endocrinologist at Harvard Medical
School and Brigham and Women's Hospital, in a telephone interview
yesterday. "Given the new information and until more
data is available, I recommended that he stop this medication.''
Raji said her hospital is reviewing its use of Avandia. Other
doctors said they were getting questions about its safety
from patients.
Patient Panic
"We figured we had about 30 calls from last night until
this morning,'' said Farida Khan, chief of endocrinology at
New York Methodist Hospital, who works in a practice with
two other specialists. "There are more messages in our
offices that we haven't picked up yet.''
Glaxo shares fell 27 pence, or 2 percent, to 1,344 pence
in London. They may reach their worst week since January 2003.
The stock is little changed this year, trailing the 600 member
Dow Jones Stoxx Index, which has risen 8.2 percent.
While the study findings raise some concern and indicate
the need for more clear data, there is no need for alarm,
according to an editorial released today by the Lancet, a
prominent medical journal that published one of the largest
studies on Avandia.
Doctors, patients and regulators can safely wait for the
results of a pivotal trial, dubbed Record, that is specifically
looking at heart risks among patients taking Avandia, known
chemically as rosiglitazone, the editors said.
"To avoid unnecessary panic among patients, a calmer
and more considered approach to the safety of rosiglitazone
is needed,'' they wrote. "It would be premature to over
interpret a meta-analysis that the authors and NEJM editorialists
all acknowledge contains important weaknesses.''
Of the 21 million people in the U.S. who have diabetes, two-thirds
will die from either heart disease or a stroke, according
to the American Diabetes Association. Doctors are trying to
determine what to do about the 1 million who take Avandia
after the study became public this week.
Talking to Doctors
"Our immediate concern is that patients aren't unduly
alarmed by the reporting of the data,'' said Philip Thomson,
a Glaxo spokesman, in a telephone interview. ``We are making
every effort to communicate with physicians and patients our
strong belief that Avandia is a highly effective treatment
for type 2 diabetes.''
The findings raise concerns similar to those faced by Merck
& Co. after the 2004 withdrawal of the painkiller Vioxx,
responsible for $2.5 billion in annual sales. Results from
a cancer study linked the drug to heart disease. The studies
included in the analysis of Avandia similarly weren't intended
to establish the product's effects on the heart.
Cleveland Clinic cardiologist Steven Nissen analyzed data
from 42 studies involving 15,560 patients who took the drug
and 12,283 patients who were given other medications or a
placebo. Patients getting Avandia were 64 percent more likely
to die from cardiovascular causes, though those findings could
have resulted from chance, the researchers said.
There were 158 heart attacks and 61 deaths from cardiovascular
causes among the patients in the studies, which generally
lasted from six months to a year. John Buse, a diabetes specialist
at the University of North Carolina School of Medicine in
Chapel Hill, said he needs more information before switching
patients to other drugs.
"It's an extremely well-done version of this kind of
study,'' Buse said. "It's possible that it's wrong.''
Takeda's Actos
Glaxo has declined to release more data on Avandia that might
clarify its effects on the heart, Buse said. In the meantime,
most patients can probably continue taking Avandia for at
least three months, or until a clearer picture emerges.
The European Medicines Agency advised patients today that
they should continue taking the medicine and speak with their
physicians at their next regular visit. Product information
on the risk of cardiac events related to the drug was updated
last year, the regulator said.
Other research indicates Actos, sold by Japan's Takeda Pharmaceutical
Co., lowers blood sugar in the same way as Avandia and cuts
levels of blood fats such as cholesterol that raise the risk
of heart disease.
If the findings of this week's New England Journal report
turn out to be related to fluid retention or weight gain,
it may have consequences for rival treatments of the same
type as Avandia. Those drugs are known as thiazolidinediones,
or TZDs.
Class Problem?
"We know TZDs cause fluid retention,'' Steve Kahn, co-
author of an earlier trial called ADOPT, said in an interview
in December.
Other types of drugs offer diabetes patients possible options,
such as metformin, which slows the absorption of sugar; injections
of the hormone insulin; and sulfonylureas, which stimulate
the pancreas to make more insulin.
"Given the data that are available, the conservative
approach would be to change to another class of drugs,'' or
switch to Actos, said David Nathan, director of the diabetes
center at Massachusetts General Hospital in Boston. "In
the absence of other balancing data, doctors need to take
this seriously.''
U.S. medical experts are already urging lawmakers to require
companies to conduct longer studies of new drugs, even after
they are approved, and to make the results public to identify
risks as quickly as possible. The Avandia findings stemmed
from a lawsuit Glaxo settled with New York that required it
to make the results of its studies public. Not all companies
are similarly obligated.
"The health of the public would benefit from additional
revisions to the drug-safety legislation,'' particularly as
lawmakers work on a Food and Drug Administration revitalization
bill that would give the agency additional powers, said Bruce
Psaty, a cardiologist and drug safety expert from the University
of Washington, in an editorial that accompanied the study.
Medco, Massachusetts General
Medco Health Solutions Inc., the biggest U.S. manager of
drug benefits, based in Franklin Lakes, New Jersey, is considering
whether to add information on Avandia's possible heart-attack
risk to an alert system of potential side effects that it
sends to doctors.
Nathan said doctors at Massachusetts General will meet to
determine whether to make new recommendations for the drug.
Blue Cross and Blue Shield of Massachusetts will also review
whether the study warrants any action, said Chris Murphy,
a spokesman.
Other drugs to treat diabetes have side effects, North Carolina's
Buse said. High doses of insulin can drive blood sugar to
a low level, called hypoglycemia, which can lead to unconsciousness
and accidents. Sulfonylureas have also been associated with
heart disease in studies that haven't been confirmed. About
1 in 20 patients can't take metformin because of diarrhea,
bloating and other side effects.
"The message we've asked our staff to give patients
is to stay on Avandia,'' Buse said. ""If they're
nervous, they can come in to discuss their options. The only
bad decision they can make is to stop Avandia without talking
to us.''
To contact the reporter on this story: John Lauerman in Boston
at jlauerman@bloomberg.net ; Elizabeth Lopatto in New York
at elopatto@bloomberg.net.
Pharma May be Failing Diabetics But New Research Says Certain Foods Can Help
August 14, 2007 - SCOTTSDALE, Ariz.--(BUSINESS WIRE)--eFoodSafety.com (OTCBB:EFSF) – The warning alarm is sounding for over 15 million diabetics who use two of the most popular prescription diabetes drugs on the market today.
A new study published in the August issue of Diabetes Care reports that patients taking either of the prescribed diabetes drugs Avandia or Actos face twice the risk of developing heart failure compared to diabetics not taking the medications.
Both drugs are used by more than 3 million diabetic patients across the United States. A U.S. government review found Avandia to be the more harmful of the two, but a panel of outside experts recommended to the FDA that Avandia be kept on the market, with a stronger warning label.
Despite the FDA’s decision, many doctors are not writing any new Avandia prescriptions and some are even taking their patients off the drug. Medical experts say there are many nutritional changes that diabetics can make to lower their blood sugar levels naturally and that more research needs to be conducted on other options, besides prescription medication, to combat this growing epidemic.
Researchers from Bucks County Clinical Research in Philadelphia released a double-blind placebo study earlier this year to determine the effectiveness of a liquid whole food supplement called Cinnergen. The liquid supplement contains concentrations of cinnamon, blueberry leaf extract and cranberries, which have all been proven to regulate and stabilize blood sugar levels.
The majority of study participants were able to control their blood sugars with Cinnergen alone and did not experience any irregular sugar spikes throughout the day. Cinnergen is made by eFoodSafety.com (OTCBB:EFSF), and is available over-the-counter nationwide at retail locations including GNC, Vitamin Shoppe, CVS.com, Vitamin World and Kroger (for more locations or to purchase online, visit: http://www.cinnergen.com).
Doctors stress that diet and exercise are essential for diabetics and those trying to lower their risk of developing the disease. Over the past year, numerous studies have been published alerting diabetics to increased health risks associated with the disease:
* Diabetics are four times more likely to suffer in-hospital deaths from organ failure (Critical Care Journal, 7/07).
* Diabetics have a 27-percent greater risk of developing cancer, especially pancreatic and liver cancers (Archives of Internal Medicine, 7/06).
* Diabetics experience an increased risk of heart disease, equivalent to 15 years of aging (Lancet Journal, 7/07).
Contacts
For eFoodSafety.com, Scottsdale
Media Contact:
Pitch Inc.
Amy Summers, 727-848-1618 ext. 202
amy@pitchpublicity.com
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