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Back with my journey over the years……
When I joined I was informed that the company was going into Anti-TB segment. Two and three drug combinations had been introduced already and had been gaining popularity at a fast pace. Ciba was the first to bring Rifampicin + INH. They were followed by Lepetit. Lederle came up with Ethambutol + INH. After the success of two drug combination, Lederle introduced three drug combination (Rifampicin +INH + Ethambutol).
Compliance to treatment had been a major, persisting issue in TB patients worldwide. The non-compliance arose from three major factors. One, the treatment was long; one year or more. Initially, the patient had to take three or four drugs for four to six months. After that, the drugs were reduced to two or three. It is very human to get tired with such a long treatment; so, patients dropped. Two, the ATT drugs had side effects, liver damage, eyesight issues and so on. The patients complained but had no other choice. When they felt difficult, they dropped. Third factor was cost. Rifampicin was most expensive, INH was cheapest, and Ethambutol was in between. TB is disease of the poor. When they could not afford, they dropped out. Another finding was that many patients kept taking only one drug, mostly INH, due to economic reasons. This was leading to treatment failures, relapses and emergence of drug resistance.
Pakistan had a large ATT market with a fair growth. Combination drugs had higher growth. That is what the data showed, hence the decision to enter ATT market with combination drugs.
I was visiting Karachi and I met Professor Nadeem Rizvi of JPMC. He knew me well. I told him we were coming into ATT segment. His immediate question was; with which drugs? I told him about combinations. He sighed and explained the situation. He said that the Chest Society, the representative body of chest physicians did not approve or support combinations because of serious concerns about bioavailability of combined drugs given in a single tablet. It was not proved that giving these separately and in a fixed dose combination (FDC) gave similar drug absorption. He said they would not support us. I was jolted. I asked him why the combinations were selling? He said these were given mostly by the non-specialists who probably did not fully understand the implications. The specialists by and large were not recommending combinations.
It was a major finding. I planned and visited Professors in Multan, Lahore and Peshawar. They all said the same thing. It meant we had a major problem at hand. I came back and presented my findings with the management. They were also jolted. They said the marketing had recommended it on the basis of IMS data which clearly showed good growth trend for combinations. And it was decided to launch only the combinations; no single drugs.
We deferred the launch, assigned the product development to develop single drugs and applied registrations. The entire launch was negatively affected.
Another fact which became visible meanwhile was that the ATT market was rapidly changing. Shortly after, the South African study endorsed that the drug absorption was not significantly affected when given in a single tablet. The acceptance of combinations started, albeit hesitantly. The entire ATT market changed. We started on a wrong foot and remained out-of-sync in this market. What could have been a big opportunity, became a big baggage.
Such is the fallout of following the data, if done without exploring and analyzing the full perspective. This is not the only case. Marketing people have been falling in this trap and probably shall keep doing so……