Regulation and drug safety

By AnthonyLast updated: Saturday, January 28, 2012 • Save & ShareLeave a Comment

Modern day drug safety in developed countries does not generally involve poor product quality. This isn’t to say problems don’t arise, the FDA and MHRA had to shut Chiron’s vaccine plant in Liverpool for some time. Followers of the MHRA Drug Alerts service will also be aware of the drug recalls associated with manufacturing problems or errors. This is a marker of good regulation. FDA and EU regulators inspect the manufacturers of pharmaceuticals both within their countries and also those external suppliers with product licences. This is one of the reasons that one should be wary of buying pharmaceutical products over the internet – you may be buying counterfeit or poor quality medicine.

Elsewhere regulation can be shaky . In Panama in 2006 over 300 people were killed by diethylene glycol laced cough mixture. The diethylene glycol had arrived labelled as harmless glycerine from the relative regulatory desert of the Chinese pharmaceutical sector. In China, there have been numerous problems linked to pharmaceuticals and baby milk. In 2007, the head of the Chinese FDA, Zheng Xiaoyu, was executed. Executing people every so often is seen as the solution rather than improved regulation.

A similar problem seems to have arisen in Pakistan, with over a hundred people suspected to have been killed by suspected contaminated heart drugs given to 46,000 patients. This BBC report suggests bone marrow suppression is the problem, although the particular drug involved is not known. Samples have been sent out of the country for testing, since Pakistan doesn’t have the ability to test the drugs. One news report cites the Director of a government Drug Testing Laboratory (DTL) blaming poor prescribing for the deaths, but the story also highlights the severe problems facing regulators in a border-line failed state:

He believed that deaths caused by the suspected drugs in Punjab were actually caused by the prescription as doctors prescribed high doses of cholesterol-lowering drugs to heart patients and this was responsible for the fatal reactions. However, he acknowledged that the actual reason could only be determined once the drugs had been analysed and autopsies carried on the deceased.

On the other hand, there was no change in the electricity supply situation at the lab. Power was disconnected a couple of months ago due to the non-payment of dues to the Karachi Electric Supply Company (KESC) and officials were relying on a small generator to power their equipment.

Staff of the DTL admitted that since directions had been given to analyse these medicines on a priority basis, they were planning to acquire an illegal electricity connection (Kunda) to complete the task.

Three owners of pharmaceutical companies have been arrested. Another BBC video report ends with a man stating “They should hang them publicly in the squares, like they do in Saudi Arabia.”  While the actual facts behind this case may take some time to find, the answer is not to find scapegoats to punish. Effective and open regulation is the answer, and for that you need effective and open government, not bodies hanging from lamp posts.

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