Lethal substandard drugs: an increasing danger in emerging markets

Article Highlights

  • Substandard drugs can increase population-level resistance to cures more than fake drugs with no real ingredients

    Tweet This

  • Only 87 per cent of products made by WHO unapproved manufacturers have the correct active pharmaceutical ingredient

    Tweet This

  • The President’s Malaria Initiative is the only donor program that self-polices drug quality

    Tweet This

  • Demanding better drug surveillance would send a message to the Global Fund that substandard drugs are problematic

    Tweet This

Subscribe to AEI's health emails
Articles and events on health policy. Published approximately twice a month.

First Name:
Last Name:
Email:
Zip Code:

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.

"Substandards may well be worse than deliberately counterfeited drugs containing no active ingredient."-Roger Bate
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.

The President’s Malaria Initiative: An Example Worth Following

If a donor procures millions of treatments, even if only a few percent of those products fail – such as the three percent of WHO-certified drugs that failed our quality testing — it means that hundreds, maybe thousands of patients are treated with poor quality medicines. In our research of donors’ regulatory practices, we discovered that the U.S. President’s Malaria Initiative (PMI) is the only donor program that effectively self-polices when it comes to drug quality. According to PMI, it “subjects every batch of every drug…procured with malaria funds to various analytical quality testing…” As a result it finds occasional poor quality products and has periodically returned products with quality issues to the manufacturer based on this testing.

That’s a sharp contrast with other governments and multilateral donors like the Global Fund to Fight AIDS, TB and Malaria, which outsources the job of assuring drug quality throughout the supply chain to the principal recipients of its grants. This is usually a government agency in the target country. This simply doesn’t do enough to ensure that only good quality medicines are being procured and distributed with Global Fund resources. It is unclear, for example, how often quality control testing is actually being performed by donors. It should be a priority for the incoming Executive Director of the Global Fund, Mark Dybul, to improve oversight of procured medicine quality.

Indeed, if we’re going to make progress, donors need to copy the PMI and conduct pre-shipment testing of every batch of drugs provided to poor countries. If the US Government’s flagship malaria program insists on such quality control measures, should not all donor agencies receiving taxpayer dollars do likewise? In our research we suggest implementing the following policy: Any manufacturer found with failing batches of drugs on more than three occasions in a year, will not be eligible for tendering in the following year.

The U.S. should also make pre-shipment batch testing and post-market surveillance a condition of all drug-related aid, especially for the Global Fund. While the 2013 budget for PMI is the same as in previous years, the Global Fund will see its budget increase, whereas on performance the reverse should be the case. Because the U.S. is the leading donor to the Global Fund by far, demanding better drug surveillance would send a clear message both to the organization’s new management and to other donor governments: it is time to take the global fight against substandard medicines seriously.

Roger Bate is a scholar at the American Enterprise Institute.

Also Visit
AEIdeas Blog The American Magazine
About the Author

 

Roger
Bate

What's new on AEI

Four years of Dodd-Frank damage
image Dodd-Frank, financial institutions, and public opinion
image Time for an Anwar Sadat moment in the Middle East
image Freedom of the skies at risk
AEI on Facebook
Events Calendar
  • 21
    MON
  • 22
    TUE
  • 23
    WED
  • 24
    THU
  • 25
    FRI
Monday, July 21, 2014 | 9:15 a.m. – 11:30 a.m.
Closing the gaps in health outcomes: Alternative paths forward

Please join us for a broader exploration of targeted interventions that provide real promise for reducing health disparities, limiting or delaying the onset of chronic health conditions, and improving the performance of the US health care system.

Event Registration is Closed
Monday, July 21, 2014 | 4:00 p.m. – 5:30 p.m.
Comprehending comprehensive universities

Join us for a panel discussion that seeks to comprehend the comprehensives and to determine the role these schools play in the nation’s college completion agenda.

Event Registration is Closed
Tuesday, July 22, 2014 | 8:50 a.m. – 12:00 p.m.
Who governs the Internet? A conversation on securing the multistakeholder process

Please join AEI’s Center for Internet, Communications, and Technology Policy for a conference to address key steps we can take, as members of the global community, to maintain a free Internet.

Event Registration is Closed
Thursday, July 24, 2014 | 9:00 a.m. – 10:00 a.m.
Expanding opportunity in America: A conversation with House Budget Committee Chairman Paul Ryan

Please join us as House Budget Committee Chairman Paul Ryan (R-WI) unveils a new set of policy reforms aimed at reducing poverty and increasing upward mobility throughout America.

Thursday, July 24, 2014 | 6:00 p.m. – 7:15 p.m.
Is it time to end the Export-Import Bank?

We welcome you to join us at AEI as POLITICO’s Ben White moderates a lively debate between Tim Carney, one of the bank’s fiercest critics, and Tony Fratto, one of the agency’s staunchest defenders.

No events scheduled this day.
No events scheduled this day.
No events scheduled this day.
No events scheduled this day.
No events scheduled this day.