This World: Bad Medicine

Short abstract

BBC 2, Tuesday 12 July at 9 pm

Rating: ★★★⋆

This piece of investigative journalism covered the massive worldwide trade in substandard drugs and the harm that these do. Nigeria was the focus, but I suspect that the programme could have been made about almost any developing country.

The context in which this scam flourishes is one of, firstly, widespread failure to contain major killers, most notably infectious diseases such as malaria, tuberculosis, and HIV; secondly, personal and national poverty; and thirdly, underdeveloped regulatory systems.

Figure 1.

Fake drugs: coming to a pharmacy near you?

Credit: BBC

Malaria and tuberculosis are both curable, and HIV can be contained by drugs, and people the world over have the right to expect standards of quality, efficacy, and safety. Tablets must contain the specified mass of the active ingredient, must not contain more than (defined) traces of contaminants, and must be bioavailable. Furthermore, the efficacy and safety of a drug must have been shown as part of rigorous clinical trials before the drug is launched. Legislation around these basic principles has evolved over the centuries but has most recently been enshrined by the International Conference on Harmonisation (www.ich.org), which has established internationally agreed standards for good manufacturing practice, good laboratory practice, and good clinical practice.

This World: Bad Medicine dealt mainly with good manufacturing practice but also ventured into the area of generic drugs fraudulently packaged with the proprietary details of multinational drug companies. It is expensive to develop new drugs, and development carries major financial risk, so multinationals protect their investments by protecting their patents. Once the patent lapses, generic companies can legally start to manufacture the drug but must, of course, prove drug quality and use their own packaging.

Some of the programme's examples were probably drugs of acceptable quality, masquerading as Pfizer or Merck products. Not so bad, you might think (except for Pfizer or Merck), but the programme revealed the temptation to include in drugs less and less of the expensive medicine, right down to straightforward frauds that contained no active drug at all. Obviously, such “placebos” carry grave risks (one of the tragic examples being a drug-free “adrenaline” used during cardiac arrest after surgery). But all substandard tablets carry some risks: therapeutic failure and the development of microbial resistance, as a result of underdosing, or toxicity, as a result of chemical or microbial contaminants.

The programme focused on Nigeria, as the victim, and on India, as the home of most of the offenders, and featured a large helping of undercover filming. For Nigeria one could have substituted most countries of sub-Saharan Africa beset with overwhelming health problems and chronically over-stretched budgets. Budgets are now stretched all the more because previously inexpensive drugs (such as chloroquine for malaria) have failed, and their recommended replacements (such as Coartem—a combination of artemether and lumefantrin) are much more expensive. This is fertile ground for hospitals to try to make savings by buying drugs from local suppliers (which seems to have been the case with the supply of “adrenaline” used so catastrophically after paediatric cardiac surgery). Gangsters, of course, are not difficult to find anywhere on this godforsaken planet, but the combination of massive profit and underdeveloped systems for government scrutiny makes African countries an obvious honeypot.

One aspect of drug use in Africa did not receive prominence in the programme, and it is worth stressing now. A drug might legally be “prescription only,” but in practice it will almost always be sold without prescription by small scale retail outlets. Thus drugs that ought to be used under close medical scrutiny are often available for use at home, without even a diagnosis in many cases: the opportunity for drugs to cause harm in Africa is alarming (Clinical Microbiology Reviews 2004;17: 612-37), even before aspects of quality are taken into account.

The programme was not forthcoming with many answers, but solutions are not difficult to see. People, wherever they are, should be using drugs that are guaranteed by robust national quality control systems in a setting of close regulatory scrutiny (including pharmacovigilance programmes, especially for new drugs). However, good quality drugs cost much more than substandard alternatives, while robust regulatory systems are extremely expensive and must sit on a foundation of accountable and transparent governance.

It is clear the programme makers did not really admire multinational drug companies any more than the counterfeiters did, but people need to accept that one cannot have it both ways. Generally, only multinational companies have the financial and technical resources to discover and develop new drugs (although it should be pointed out that the outstanding Indian company Ranbaxy has discovered and is developing a new antimalarial); and the consumer must cover the costs of this work, perhaps with help from international donors such as the Global Fund for AIDS, Tuberculosis, and Malaria.

Meanwhile, it would be an understatement to say that establishing decent governance in developing countries (surely the necessary foundation for so much) is a major challenge. The G8 nations say that they want to help countries to develop such systems: time will tell whether they mean it and whether they are up to the challenge.