The number of dead in the wake of the substandard medicines disaster in Pakistan continues to rise with approximately 140 patients killed. Another 50 are not expected to survive. The product involved was isosorbide mononitrate tablets, commonly used in heart failure and angina, which was provided free by the Punjab Institute for Cardiology to patients too poor to obtain their own drugs. Drug samples were analysed by the London School of Pharmacy, who discovered heavy contamination with pyrimethamine, an anti-malarial. There was no institution within Pakistan capable of performing the analysis, startling considering they manage to run a nuclear weapons programme.
Pyrimethamine is associated with blood dyscrasias such as leucopaenia, agranulocytosis, and thrombocytopenia even when used correctly due to its interference with folic acid metabolism. Acute overdosage also causes convulsions, tachycardia, respiratory depression, and circulatory collapse. In a cohort of ill cardiac patients it is unsurprising that deaths have occurred. Pyrimethamine’s half life of 4 days isn’t particularly helpful either, especially considering the patients would have been likely to be dosing themselves with 1 tablet twice a day.
On the regulatory front, there is some good news. The current lack of a regulator in Pakistan is no longer politically acceptable. There have been calls for a centralised regulatory authority, regional monitoring centres, as well as the development of clinical pharmacy services within hospitals. Sadly, the Pro-Vice Chancellor of the Dow University of Health Sciences couldn’t stop himself from saying “the element of conspiracy to damage the reputation and exports of Pakistani medicines could not be ruled out”, continuing the proud tradition of blaming foreign interests for Pakistan’s self-inflicted wounds.
Any regulator has a major job to do, and it is not clear that the Pakistan state is capable of creating such an institution. The Pakistan government is riddled with corruption, there are massive cost pressures, and the pharmaceutical industry appears to be run by non-expert profiteers willing to employ illiterate staff and child labour. How the pyrimethamine got into the tablets is as yet unknown, but it could even come down to the tablets being manufactured by people unable to read the labels on the containers of drugs.
In perhaps one of the most macabre turns in the whole debacle, the Pakistan Pharmaceuticals Manufacturers Association (PPMA) is compensating the families of the dead by offering each family two jobs within the pharmaceutical industry. They are to be given jobs to match their qualifications, so if they can read they may be considered over-qualified.
As if there wasn’t enough problems in the pharmaceutical industry in Pakistan, a factory exploded yesterday. Around 100 people are thought to be trapped in the building, with only a handful of women and children rescued. There is no effective health and safety for the workers, never mind the customers for their products.