Diabetes drug in the midst of cancer survey controversy

A diabetes drug that is in use in Kenya may increase the risk of cancer, according to a study conducted on 300,000 patients under insulin-treatment.

The European Association for the Study of Diabetes (EASD), which released details of four studies from its journal Diabetologia online, said the findings were “far from conclusive, but they do indicate the need for further investigation of this issue.”

The new research was released after mounting speculation that damaging data was about to be published over a cancer link with Sanofi’s modern long-acting insulin analog, sinking the French drug maker’s share price by 12.3 per cent in two days.

Lantus, which sold ¤2.45 billion in 2008, is a key driver for Sanofi as top drugs like Plavix and Lovenox face the threat of generic competition.

Analysts have been expecting sales to grow strongly for the next five years.

In Nairobi , a statement sent to the newsrooms by Cheryl Barretto, Head of Operations, Eastern Africa Sanofi-Aventis, said the finding are not final and shows “no definitive conclusions can be drawn regarding a possible causal relationship between lantus (insulin glargine) use and the occurrence of malignancies.”

A German study of 127,031 diabetics on insulin found malignancies were more common in patients treated with Lantus, also known as glargine, than in those prescribed a comparable dose of old-style human insulin.

“Our study does, however, arouse an urgent suspicion which should have consequences for the treatment of patients,” said Peter Sawicki, director of Germany’s Institute for Quality and Efficiency in Health Care and co-author of the study.

In Kenya, the drug is mainly used to treat children, according to an official of Kenya Diabetes Management& Information Centre, James Mwangi.

Mr Mwangi told Business Daily that Lantus is particularly popular with children since it is only injected once every day as opposed to other types which require two doses. He said he was not aware of the new findings.

Following that original German study, further research was carried out using three other large patient databases in Sweden, Scotland and the UK.

In the Swedish study, involving 114,841 insulin-treated patients, those on Lantus alone were almost twice as likely to be diagnosed with breast cancer.

The 49,197 patients in Scotland also showed similar tendencies although the difference did not reach statistical significance. The UK study — the smallest of the four, involving 10,067 patients -- found no link.

The EASD said patients should not stop treatment but the organization added they could consider using a long-acting human insulin or a mixture of long- and short-acting human insulin twice a day instead of once-daily Lantus.

The EASD said it had already communicated the latest study results to the European Medicines Agency and had started discussions with Sanofi as to how further studies might be conducted to get to the bottom of the issue.