Who’s Hiding News of Bad Drugs?
Nick is a member of The Motley Fool Blog Network -- entries represent the personal opinion of the blogger and are not formally edited.
It is now commonplace to find stories of inferior, fake, or otherwise substandard pharmaceuticals. However, a couple of papers published this week are more interesting than most and could have far reaching implications for manufacturers of World Health Organization-approved malaria products, which include Novartis (NYSE: NVS), Sanofi (NYSE: SNY), Ipca (BSE:524494)(NSE:IPCALAB), Cipla (BSE:500087)(NSE:CIPLA), Ajanta (NSE:AJN) and Guilin (SZSE:002275).
Featuring scholars from American and African think tanks and health groups, the University of Ottawa, and the London School of Hygiene and Tropical Medicine (LSHTM), the authors of these papers have found that even drugs approved by the WHO failed quality control in small but important amounts. One of the studies, published in Research and Reports in Tropical Medicine, found that 7.7% of antimalarials approved by the WHO were seriously underdosed (far from the zero percent that is acceptable). Products are suppose to have between 90% and 110% of the active ingredients -- these researchers qualified those under 75% as seriously underdosed. Such an outcome could prove fatal to those taking the drugs, and could build resistance to an entire range of the best drugs. If the authors are correct (and if these are not just isolated incidents), then the findings are worrying.
The authors stress that the quality failing is not really the fault of the WHO. The WHO plays a pseudo-regulatory function, and monitors production plants in emerging markets and ensures that companies make reliable, quality products. It then approves those companies and the specific products analyzed. Unfortunately, the WHO does not have the budget or authority to monitor every specific product that routinely makes it to market. Patients rely on the local drug regulatory authorities in these locations to monitor products on the market and censure companies that fail to maintain standards.
Regrettably, most of these regulators – from the corrupt Indian regulator CDSCO to the largely inadequate regulators across Africa – are falling down on the job. Companies can get away with selling worse drug versions to poorly regulated markets, such as Angola or Ethiopia. The research suggests that this is a problem that needs to be addressed. The papers in RRTM are far from conclusive -- the sample sizes are not large, and it is quite possible that the results would not be replicated if sampling was larger and more systematic. Still, any company can make a mistake. Perhaps that is what the RRTM papers show, and there is no systemic fraud after all.
Yet, it seems that some people don’t want the story told, or at least don’t want anything to do with it.
The original version of the paper circulated to journalists prior to publication listed three scientists from the LSHTM as coauthors. In the final published version they are absent, merely acknowledged as having done the High Performance Liquid Chromatography (HPLC) analysis of the drugs. The lead author of the research, Roger Bate, author of Phake, played down the significance of this change in e-mail exchanges. Dr. Harparkash Kaur, the most senior of the chemists withdrawn from the paper, suggested I speak with the LSHTM press office. A few days later, after another e-mail prompt, the press office e-mailed me Dr. Kaur’s response saying, “Although I carried out laboratory analysis I did not feel it would be appropriate to take credit for the design and implementation of the study. I informed the lead author of my decision.”
Her explanation seems reasonable perhaps, but why the defensiveness when asked, and why leave the decision so late? (Nothing stirs interest more than evasiveness and buck passing.)
It should be noted that the LSHTM is part of an evaluation of the malaria drug subsidy program that supports production of the drugs bought by the researchers. It’s possible that LSHTM leadership was less than happy with its scientists for taking part in a separate independent evaluation, especially one that finds such damning results.
Lead author Bate did comment that it had been hard to find reviewers for the research. He had pulled the research from the Malaria Journal, since after nearly four months the editors had not been able to find reviewers. “It’s as though no one wanted to touch the results,” Bate added.
Read the reports here:
Nick Slepko has no position in any company mentioned here at the time of publication. The Motley Fool has no positions in the stocks mentioned above. Motley Fool newsletter services recommend Novartis. Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy. If you have questions about this post or the Fool’s blog network, click here for information.