Drug regulators and sub-standard treatment

According to a Fortune piece by Katherine Eban entitled Dirty Medicine (May 15, 2013), “On May 13 (in the United States),Ranbaxy pleaded guilty to seven federal criminal counts of selling adulterated drugs with intent to defraud, failing to report that its drugs didn't meet specifications, and making intentionally false statements to the government. Ranbaxy agreed to pay $500 million in fines, forfeitures, and penalties – the most ever levied against a generic-drug company”.

When it comes to the production of pharmaceutical products, there is much more at stake than the lives of patients being exposed to poor quality drugs. It is essential to differentiate between fake and sub-standard drugs. Fake drugs are produced by criminals and there is often no attempt whatsoever to include active ingredients and if there is, it’s just enough to pass a basic test. Fake drugs not only fail to cure patients’ ailments, but also frequently contain chemicals that harm the patient. In contrast, sub-standard drugs, more often than not, are produced by legitimate drug manufacturers but these drugs are of poor quality. Sub-standard drugs that are made with either too little or too much active ingredient often deteriorate before a normal expiry date. While fake drugs may be highly detrimental to patients who consume them, sub-standard drugs are far more damaging because they increase the probability of resistance emerging to good quality drugs and have the potential to render an entire class of proven drugs useless.

There is worldwide concern about the increased prevalence of sub-standard drugs and their possible devastating long-term effect on our ability to control disease. Consider what is happening with anti-malarial treatments. Last year, the Lancet medical journal published a study conducted by the National Institutes of Health unit which found that 35 per cent of 2,300 malaria drug samples tested in sub-Saharan Africa were of “poor quality” – either fake, expired or badly made. This is devastating because,in the case of anti-malarial treatment, there are few effective drugs remaining.

The once highly successful malaria treatments, chloroquine and sulphadoxine pyrimethamine (SP),are seldom recommended for malaria cases because of the resistance to these drugs which has developed over time. And now, even the most highly effective treatment, a drug called artemisinin, which is based on the age-old Chinese herbal treatment derived from the Artemisia annua plant, is showing signs of reduced efficacy. To some extent, this increased resistance is due to the wily nature of the constantly evolving malaria parasite. A significant reason for the increased resistance, though, is the high prevalence of sub-standard treatments.

In the Pailin area of Cambodia, patients given artemisinin take twice as long as those elsewhere to be clear of the parasite – instead of the typical 48 hours, they take up to 84 hours and sometimes as many as 96 hours. It is in this area of Cambodia where the first signs of resistance to chloroquine and SP emerged. Countless people have died as a result of the wide-scale resistance to these once highly effective treatments. If resistance to artemisinin develops, the situation will be disastrous because we have no new effective alternatives and it is unlikely that a vaccine will be commercially available within the next five years, despite the dramatic progress that has been made.

The Ranbaxy case was one of outright fraud where the company knowingly sold sub-standard drugs around the world and deliberately deceived drug regulators by submitting false claims about its products. Because drug regulators rely on the information and data supplied by the companies themselves, the Ranbaxy case highlights the importance of the role of drug regulators in post-market surveillance. For a poor developing country such as South Africa, we need to conserve our scarce resources. Instead of reinventing the wheel, we should rely more on advanced country regulators for their expertise in assessing new drugs and focus our attention on ensuring that the drugs that are on the market are efficacious and do what they purport to do.

As more and more drugs from foreign countries come onto the South African market through both legitimate and illegitimate channels, if the MCC (or its proposed successor, the South African Health Products Regulatory Agency) attempts to continue to do business as usual – undertaking to do both the registration of drugs and monitoring the efficacy of drugs that are on the market – we are in for a devastating calamity. The MCC should not delay the registration of new good quality drugs that have been produced by internationally recognised companies and already approved by advanced country regulators.

Duplicating tests already conducted in advanced countries means the MCC is wasting time, money and jeopardising the health of South Africa’s citizens. The MCC should not be hampering the registration of genuine new drugs but rather focus its attention on ridding the market of fake and sub-standard medicines. An urgent priority for the Department of Health is to reform the MCC so that it no longer remains a self-serving bureaucracy but starts to allow South Africa’s citizens access to internationally recognised life-saving drugs.

A version of this article was first published in the July edition of the Medical Chronicle

AUTHOR: Jasson Urbach is an Economist and director of the Free Market Foundation Health Policy Unit.


HPU Feature Article / 11 July 2013


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