Pharma firms, docs shed fat-loss pills over side effects

MUMBAI: With unhealthy lifestyles, the junk food culture and lack of physical activity becoming commonplace, you’d think obesity drugs would find takers among pharmaceutical companies. That however, isn’t the case.

Severe side effects make such drugs unattractive to both pharma players and doctors. While doctors are cutting down on prescribing obesity drugs to patients, multinational pharma players are abandoning the development of anti-obesity molecules. As per World Health Organisation (WHO) estimates, the number of obese adults globally could grow from 400 million now to 700 million by 2015.

In India, about 16% of the adult population is believed to be obese. Given these figures, the potential for such drugs is huge.

The global market for obesity drugs, estimated at a little over $1 billion now, is expected to grow rapidly in the future. But standing in the way are concerns over the side effects and the low success rate of these drugs.

Recently, French pharma giant Sanofi-Aventis cancelled the sales of its obesity drug Acomplia after European Medicines Agency, the European drugs regulator, suspended it due to side effects like severe depression and suicidal tendencies. Subsequently, Pfizer, the world’s largest drugmaker, abandoned its phase III trials of a similar anti-obesity molecule and Merck scratched its own experimental obesity medicine. The side effects seen in Sanofi’s Acomplia (generic name rimonabant) led to the other firms developing cold feet. In India, these global cases have caused a huge decline in prescriptions for obesity drugs. Yogesh Aggarwal, senior consultant (bariatric surgery) at Fortis Hospital, Noida, said in the last few weeks, prescription of obesity drugs has fallen 75%.

Phulrenu Chauhan, consultant endocrinologist at Hinduja Hospital, said that earlier, if 100 obese people were being given these drugs, the number is now 30. “We feel that the best mode of treatment is through changes in the lifestyle and diet,” Chauhan added.

Three obesity drugs — rimonabant (Acomplia), orlistat, and sibutramine — are available in the country. The Drugs Controller General of India (DCGI) recently withdrew the licences of 17 generic manufacturers of rimonabant, including Zydus Cadila, Sun Pharma, Ranbaxy, and Torrent Pharma, following the outcry over its side effects noticed in the EU. Orlistat is made by players like Ranbaxy, Torrent, Intas Pharmaceuticals and sibutramine by Sun Pharma, Torrent and Intas Pharma.

The sales of all the three drugs are declining, with the use of rimonabant being negligible. Rimonabant causes depression and suicidal tendencies, orlistat leads to patients losing control over their bowel movements, said Chauhan. Sibutramine is said to cause irregular heartbeats in some patients. A Ramachandran, president, India Diabetes Research Foundation, said, “Whenever a new drug comes out in the market, there is a lot of euphoria. The side effects come to the fore much later.”

Besides, the success of these drugs is limited. They can lower body weight by 5-10% only after a year of use, said S K Wangnoo, senior endocrinologist at Apollo Hospital. Experts also say that if the patients discontinue the drugs, they tend to gain back the lost weight.

Pharma analysts, however, are optimistic. Bhavin Shah, analyst from Dolat Capital Market, said, “Obesity is an emerging niche area in India. Glenmark, Suven Life Sciences, Cadila Healthcare, and Piramal Life Sciences have new chemical entities for
obesity in the pipeline.”