US Capitol Capsule: Move over Ebola! Fake drugs fight needs global attention, too
This article was originally published in Scrip
Much of the attention at the 2015 World Health Assembly (WHA) in Geneva, Switzerland later this month is expected to be focused on reforming the World Health Organization (WHO) and the failures by the international public health agency in responding to the ongoing Ebola epidemic in West Africa.
But in fixing what went wrong with Ebola, the lessons learned have implications for ensuring other areas of global health security, a group of experts said in a series of essays published last week in The Lancet.
Dr Lawrence Gostin, faculty director of the O'Neill Institute for National & Global Health Law at Georgetown University, who co-authored one of the essays, said, however, that actions to put global health security changes in place must be taken now while the Ebola epidemic "is fresh in our minds," otherwise, political momentum will fade, just like it did after the 2009 H1N1 influenza pandemic and the 2002-2003 outbreak of the severe acute respiratory syndrome.
"This is a critical moment," Dr Gostin told reporters during a 7 May media briefing ahead of the 18-26 May gathering of the WHA, which is the decision-making body for the WHO.
Among the global health security issues that's in desperate need of attention, Dr Gostin said, is the threat of substandard, spurious, falsely labeled, falsified and counterfeit (SSFFC) medical products.
"The fear of ineffective and unsafe treatments can spread contagiously, engendering distrust in the health system" – posing "formidable social, economic, and political challenges to health security," Dr Gostin and his co-authors declared, adding that "everyone is at risk" when SSFFCs enter the global supply chain.
SSFFCs, they said, "greatly undermine national and global capabilities to curb epidemic and endemic infectious diseases, as well as non-communicable diseases."
Populations will always face health security risks, Dr Gostin and his co-authors said.
"But the crucial point is that institutions must have the ability to regulate and bound those risks," they said. "The ubiquitous and highly profitable nature of the global trade in substandard and falsified drugs poses grave dangers, while eroding public confidence in governments and international institutions."
The WHO has estimated SSFFCs make up about 10% of global biopharmaceutical trade – although it's as high as 25% in low-income parts of the world, like Africa, where about 100,000 people die each year because of the fake or substandard medicines.
Dr Gostin and his colleagues said the disproportionate burden of SSFFCs in low-income countries is attributable, in part, to ineffective regulatory and criminal justice systems.
SSFFCs, they said, pose three overlapping risks that undermine human and global health security: hazardous ingredients, which cause poisoning or overdoses; lack of efficacy, so diseases progress; and subtherapeutic concentrations of active pharmaceutical ingredient, which can breed resistance, like with antimicrobials.
Beyond the human toll, substandard and falsified medicines pose substantial costs to national health systems – straining regulatory and law enforcement agencies and undermining the rule of law itself.
"Curtailing a problem of such global breadth needs mechanisms of action that span national boundaries, but remain largely within the regulatory powers of states," Dr Gostin and his colleagues said.
Sophisticated transnational criminal networks can produce illicit products that are very hard to differentiate from genuine products, Dr Gostin and his co-authors said.
"They are highly skilled at manufacturing, packaging, distributing, and selling unlawful products, while avoiding regulatory oversight or police detection," the scientists said.
They complained that "weak drug regulation and law enforcement at the national level combined with ineffective legal instruments and organizations at the international level enable traders in falsified drugs to prosper."
But George Karavetsos, the new director of the US FDA's Office of Criminal Investigations (OCI), said his agency of about 230 special agents has been working closely with other international law enforcement agencies, like Interpol, to stop those engaged in the illicit manufacture and trade of SSFFCs.
"The only way we are going to be effective in stopping these profiteers, these criminals, who have no regard for those who need these life-saving treatments," Mr Karavetsos told Scrip, is if the issue is viewed as a "global problem that needs to be addressed with global response."
But he noted that as egregious as the drug counterfeiters are, also to blame are healthcare professionals, clinics and pharmacies who engage in buying the SSFFCs, often online – whether knowingly or not – in trying to reduce their expenses and maximize their profits, with patients being the unwitting victims of tainted or ineffective products.
Mr Karavetsos, who took the reins of the FDA's OCI in January, said his agency has gone to great lengths to educate US healthcare providers about the dangers of buying products from unknown suppliers or over the Internet – creating a program in 2012, known as BeSafeRx, specifically to help inform and warn doctors and others about the risks of engaging in those activities.
He also pointed to some of the great successes achieved by the international law enforcement community in catching SSFFC criminals – specifically, Operation Pangea, which last year resulted in the confiscation of nine million fake and illicit medicines worth about $36m, the shutdown of 10,600 online pharmacies and the arrests of 237 people across 111 countries.
But Dr Gostin and his colleagues said more needs to be done to curtail SSFFCs – including new mechanisms of action that span national boundaries, but remain largely within the regulatory powers of states.
In addition, they pointed out that often substandard drugs enter the global supply chain because of failures by some companies to meet good manufacturing practices (GMP).
"Although large pharmaceutical companies have the funding and incentives to meet GMP, small market companies often do not," Dr Gostin and his co-authors said. "They need training and equipment to meet international standards, and governments need regulatory structures to assess and assure quality. Although states must invest in safe and effective drugs, many need international assistance to close glaring gaps in manufacturing and regulatory capacities."
The global stakes in SSFFCs are as high as they are because "the very legitimacy of national health systems and international organizations is at stake," Dr Gostin and his colleagues said.
"Substandard and falsified drugs have the potential to destabilize governments, affecting their functioning and credibility," they said.
SSFFCs pose a public health crisis not merely when epidemic disease spreads unabated or when treatment fails biologically, but also, and more enduringly, they said, when the public and civil society lose confidence in national and global governance – "a spiral of distrust caused by the failure to ensure a safe, effective supply of essential drugs and vaccines."
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NIH chief: Don't let moment pass for precision medicine
National Institutes of Health Director Dr Francis Collins on 5 May found himself once again on Capitol Hill explaining President Barack Obama's precision medicine proposal – declaring "the time is right for this ambitious initiative. "We have reached a remarkable inflection point in the potential of medical research and we should not let this moment pass," Dr Collins told members of the Senate Health, Education, Labor and Pensions Committee.
AcelRx puts Zalviso NDA resubmission on hold; shares slammed
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This and past US Capitol Capsule columns are available at http://www.scripintelligence.com/capitolcapsule/