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Jack Sisson's Life Ethics Blog

We must find new ways through many ethical issues, especially regarding bioethics, medical ethics, and criminal justice. Jack Sisson's 'Life Ethics' blog focuses on numerous areas of concern, including the philosophical and ethical dilemmas surrounding stem-cell research, abortion, medical research, and health care.

 


From Health Affairs Blog:

From fake Avastin to contaminated generic Lipitor, every month Americans are becoming more aware about the dangers of lethal products they might be unlucky enough to take. With attentive regulators and competent companies, most incidents of dangerous drugs in US pass without significant harm, but when tainted steroid injections were recently distributed to thousands of patients, 36 died and over 500 suffered painful conditions.

The tragedy for those Americans harmed is multiplied at least a thousand fold in the carnage wreaked in developing countries. Perhaps 100,000 people die every year from dangerous medicines and by most estimates the situation is deteriorating. To put it simply we are losing the global fight against bad medicines.

Efforts are being made by law enforcement officials.  Eighty-two million doses of counterfeit drugs in Africa were seized by numerous national authorities, comprising about $40 million worth of antimalarials, antibiotics, cough medicines, contraceptive pills, and fertility treatments.

Why Substandard Drugs Are Even Worse Than Counterfeits

The problem is that such crackdowns tend to focus on counterfeit drugs, deliberately falsified by criminal networks. Such efforts are obviously warranted, but probably a much greater public health threat, as the tainted steroid injections demonstrated, is substandard drugs that are the result of shoddy manufacturing and handling – or perhaps worse, deliberate corner-cutting.

In poor countries, an astonishing number of bad drugs reach patients through legitimate supply chains and even donor programs underwritten by U.S. and European taxpayers. Substandard drugs tend to have a suboptimal — but non-zero — dose of active pharmaceutical ingredient. Such low-dose products do not effectively treat individual patients, yet they are more likely to rapidly increase population-level resistance than fake drugs with no real ingredients. Resistance can even be spread to effective drugs, undermining entire product categories. As a result substandards may well be worse than deliberately counterfeited drugs containing no active ingredient.

Donor governments and U.N. agencies do take measures to ensure the quality of medicine they procure. Most governments or multilateral donors, for example, will only purchase for aid programs medicines that have been approved by a stringent regulatory authority — such as the U.S. Food and Drug Administration or its European equivalent — or by the World Health Organization (WHO). But this isn’t enough to safeguard patients against poor quality drugs.

As I’ve demonstrated through previous research, off-the-shelf drugs made by Chinese and, to a lesser extent, Indian manufacturers tend to perform inconsistently on quality tests. In one study, more than 15 percent of the Chinese drugs we collected that were approved by the WHO failed to include adequate amounts of active pharmaceutical ingredient.

Our latest paper, in Malaria World Journal, reinforces these findings. Over 97 per cent of products made by manufacturers approved by the WHO had the correct active pharmaceutical ingredient. Among manufacturers not approved by the WHO, the percentage drops to about 87 per cent.

Worse still, some of the drugs we tested had been bought through Western donor programs, funded by taxpayers, and steered through aid programs to African markets. Some of these drugs may have degraded through bad storage, but many were just badly manufactured, perhaps to cut corners to lower costs and increase profits. After all, once a manufacturer has obtained quality certification, it is relatively easy to sell the drug at a lower quality in countries with weak regulations.

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