| NEW YORK, June 12
NEW YORK, June 12 Global drugmakers said on
Wednesday they would cooperate with an independent review to
address concerns of a potential link between widely used
diabetes medicines and pancreatic cancer and other safety
The American Diabetes Association (ADA) this week called for
a new evaluation of clinical data on drugs used to control blood
sugar for patients with type 2 diabetes. They include Merck &
Co's $4 billion a year Januvia franchise, Novo Nordisk's
Victoza, and Byetta and Onglyza from Bristol-Myers
Squibb Co and AstraZeneca Plc, among others.
"People who are taking these medications, or who may
consider taking them, should have the benefit of all that is
currently known about their risks and advantages in order to
make the best possible decisions about their treatment," Dr.
Robert Ratner, ADA's chief scientific and medical officer, said
in a statement.
The medicines are called incretin mimetics because they
mimic hormones the body produces to stimulate release of
insulin, and are from classes of drugs known as GLP-1 receptor
agonists and DPP-4 inhibitors. GLP-1 drugs boost insulin
production by the pancreas and slow absorption of food. DPP-4
inhibitors block an enzyme the breaks down the GLP-1 peptide in
the gut, thereby increasing insulin production.
The U.S. Food and Drug Administration in March said it was
studying unconfirmed reports that the drugs cause inflammation
of the pancreas and pre-cancerous changes to cells in the
pancreas. European health regulators are also studying the
Around the same time, new concerns arose from a small study
conducted by a leading diabetes expert, Dr. Peter Butler, from
the University of California, Los Angeles.
Butler examined human pancreases from patients who had died
of causes unrelated to pancreatic disease and found more
pancreas lesions and one cancerous tumor in those who had taken
Januvia or Byetta compared with nondiabetics or diabetics who
had not taken those medicines.
More than 370 million people are living with diabetes
worldwide, with type 2 accounting for 90 percent to 95 percent
of the cases, according to the International Diabetes
Federation. Without significant lifestyle changes to curb
obesity and other causes of diabetes, that number could balloon
to as many as 552 million by 2030, the organization projected.
NO FIRM EVIDENCE OF RISK
Bristol-Myers and AstraZeneca issued a joint statement
expressing support for the ADA initiative. Merck said it is
committed to participating in the ADA effort, and is separately
conducting a 14,000-patient heart safety study of Januvia.
Danish drugmaker Novo Nordisk, in an emailed comment, said
its studies to assess safety signals of its $1.8 billion a year
Victoza do not reveal any evidence of increased risk of
pancreatitis or pancreatic cancer.
"As far as the ADA proposal is concerned, this is something
that I do support from a conceptual basis," said Alan Moses,
Novo's global chief medical officer, in a telephone interview.
"In principle, Novo Nordisk absolutely supports working with
the other companies, but the final details depend on what
specifically is being proposed," Moses said, adding "it all
depends on the credibility of the data that's being evaluated."
The safety concerns are being discussed on Wednesday and
Thursday at a workshop conducted by the National Institutes of
Health (NIH) and the National Institute of Diabetes and
Digestive and Kidney Diseases (NIDDK).
A document outlining the FDA's presentation at the workshop
was handed out at the meeting. Attendees quoted it as saying the
agency review of trial data on the drugs did not provide enough
evidence to say whether there is a link to pancreatitis, and
that long-term study would be required to determine any cancer
risk. A FDA spokeswoman could not immediately confirm the
contents of the document.
"The FDA basically appears to just be saying 'look, there
just isn't enough information here to make an informed
decision'," said Mark Schoenebaum, a drug industry analyst with
ISI Group who was attending to two-day NIH/NIDDK workshop.
"There are no conclusions at this point in time from the
meeting and I doubt very much there will be because the science
quite frankly is immature about the whole area of pancreatic
cancer," said Novo's Moses, who will address the workshop on
Thursday. "Everybody agrees that this is an incredibly complex
In an interview with Reuters earlier this week Peter Stein,
Merck vice president of clinical research for diabetes,
expressed full confidence in the safety of Januvia.
During the workshop, Merck said it will present data on the
safety profile of Januvia, known chemically as sitagliptin,
including an updated analysis of data from more than 14,000
patients from 25 randomized clinical trials.
Merck last month reported a surprising decline in first
quarter sales of Januvia, which has been the drugmaker's fastest
growing medicine since its 2006 approval. It was not clear if
increased competition, safety concerns or other factors led to
the 4 percent slip in quarterly sales to $884 million.