Cancer Alert Probed as Sanofi, Novo Diabetes Drugs Put to Test

http://www.bloomberg.com/apps/news?pid=20601124&sid=aD1wUkdkBFzc


Cancer Alert Probed as Sanofi, Novo Diabetes Drugs Put to test Sept. 30 (Bloomberg) --
Doctors will try to unravel possible ties between diabetes treatments
and cancer thisweek after studies indicated that medicines used by
millions of people may leave some vulnerable to tumors.

European scientists startled medical professionals and
patients in June when they reported in the Diabetologia
medical journal that Sanofi-Aventis SA?s Lantus, the
world?s biggest-selling insulin, may increase the risk of
cancer. U.S. regulators delayed a decision on Novo Nordisk
A/S?s liraglutide drug until the fourth quarter after cases
of thyroid cancer emerged in animal tests.

The cancer link casts a spotlight on glucose-lowering
therapies that have become standard care for people who
can?t control their blood sugar levels with healthy eating
or exercise, said Edwin Gale, a professor of diabetes at
the University of Bristol, England, and the editor of
Diabetologia. Doctors attending this year?s European
Association for the Study of Diabetes meeting in Vienna
will discuss whether they need to weigh more closely the
risks of such medicines when Sanofi and Bagsvaerd, Denmark-
based Novo Nordisk present information on the safety of
their long-acting insulins, Lantus and Levemir, on Oct. 1,
Gale said.

Dogma

?As a general rule, the dogma has been that anything that
lowers glucose is equivalent in terms of benefit,? said
Gale in an interview. ?That?s now being teased apart. We?ve
got a number of relatively equivalent glucose-lowering
therapies. In the future, we?re going to be asking hard
questions about what the other costs and benefits will be.?

Diabetes therapies metformin, Avandia and Actos may be
protective against malignancies, Gale said.

Sales of Lantus, a so-called long-acting analog also known
as insulin glargine, and Levemir are growing even after the
Sanofi product came under scrutiny in June when four
European studies published in the medical journal suggested
it may increase the risk of tumors.

Sanofi said Lantus is safe and the studies have
?significant, methodological limitations and shortcomings.?

Insulin analogs are tested for carcinogenicity because the
hormone has long been known to interact with insulin-like
growth factors in the body that play a role in cell growth.

Safety

?There will be data from the manufacturers of the long-
acting analogs, which are reassuring as far as they go,?
said Gale. ?The question will be if they are sufficiently
powered to answer the questions? about their safety and
possible ties to cancer, he said.

The U.S. Food and Drug Administration, in response to the
Diabetologia studies, in a statement on its Web site on
July 1 questioned whether a link between Lantus and cancer
exists. The reports examined one to three years of therapy,
less than what is generally necessary to evaluate a link
between cancer and drug exposure, the FDA said at the time.
Variances such as patient weight and the dose of Lantus,
also may have influenced the findings, it said.

Sanofi said in a statement yesterday that it has begun a
range of studies in Europe and North America to explore in
more depth the cancer risk posed by human insulin and newer
medicines like Lantus, which works for 24 hours, reducing
the peaks in glucose levels throughout the day.

Consensus

?While there is a consensus among leading scientists around
the world regarding the difficulties of developing
conclusive evidence, Sanofi-Aventis is committed to
exploring this matter in depth,? the French drugmaker said.

Treatment for the more-than 200 million diabetics worldwide
is designed to help the body convert blood sugar into
energy. The drugs are taken for life, as the body gradually
produces less of the hormone insulin that naturally
controls blood glucose or sugar levels.

The number of people with diabetes worldwide is expected to
rise to 350 million in the next two decades, according to
Sanofi.

Sanofi is urging doctors to introduce insulin, often
regarded as a treatment of last resort, earlier in the
onset of diabetes amid evidence it may slow the progression
of the disease.

Type 2 diabetes, the most common type, typically develops
in overweight, sedentary adults. Most people with this form
of diabetes are overweight or obese, a condition that is
also tied to cancer. Obesity may have caused 124,050 newly
diagnosed tumors last year in Europe, according to research
released last week.

Canceled Project

Novo Nordisk canceled one of its insulin research projects
almost two decades ago after it triggered tumors in female
rats, Chief Science Officer Mads Krogsgaard Thomsen said.
Since then, the company has made sure its drugs bind to
cells in the same manner as insulin and don?t encourage
cell growth or division, he said. While the company?s data
show Levemir is safe, the issue with new forms of insulin
remains, he said.

?There will clearly be more experts and physicians thinking
about this,? Thomsen said. ?It?s not going to go away.
Nobody can say at this point that there is decisive data.
Depending on what happens when the next epidemiological
analysis comes out, if that is purely clean, that?s good
news? for the long-acting insulins, he said in a telephone
interview. ?If it?s grey, then the worrisome findings won?t
go away.?

Protect

New information also is emerging about metformin, a
cornerstone of treatment for diabetes, and cancer. Gale
said there is evidence to suggest the pill, now available
in generic formulations, as well as newer drugs like
GlaxoSmithKline Plc?s Avandia and Takeda Pharmaceuticals
Co.?s Actos, known as glitazones, may protect patients
against cancer.

?The textbooks for diabetes will have a new chapter,? said
Viktor Jorgens, executive director of the EASD, in a
telephone interview. ?It may be that the life expectancy of
people with diabetes is longer now, and we observe things
we didn?t see before,? he said. ?Or, we simply didn?t look
at the whole matter closely enough.?


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