by Morris Okumu, Pharmaceutical Society of Uganda
July 2012 started with the landmark news that GlaxoSmithKline (GSK) is to pay $3bn, the largest healthcare fraud settlement in US history. This settlement covers criminal fines and civil settlements with the US government regarding concerns about the promotion of three out of nine products of GSK, investigated over the period 1997-2004. Although governments and payers will be reimbursed, this sanction does not directly redress the harms that patients suffered: it makes no attempt to estimate the extent of damage, possible lives lost and all other intangibles. Fines are currently not big enough – the fines shouldn’t just recoup tainted profits, they should tackle the bottom line. This settlement raises key questions on the level of influence drug promotion has on prescribing patterns, treatment of opposing doctors, the consumer protection interest of pharma companies and the safety levels being taken care of by the Drug Regulatory Agencies (DRAs) especially in low- and middle-income countries (LMICs).
Marketing of medicines and technologies is typically characterized by a complex web of twists and competition – more often than not, the independence of doctors and pharmacists is washed away by gifts, holidays, etc. Careful analysis of this event in the US and past occurrences in other developed countries show that LMICs are just like any other jungle to master this trade of intrigue, and cut-throat market analysis. It is not uncommon to find wards, physician coats, dispensing rooms, and even services in health facilities openly or indirectly supported by a powerful pharma company under the auspice of product branding. It is more than critical to rethink whether the different “branding” strategies do not constitute a breach of ethical conduct by both the company and the health service provider. LMICs do not have sufficient funding to support minimum healthcare packages and the health workforce remains poorly remunerated. These forms of “good gestures” by the pharma industries turn out to be the perfect extra tonic to “better quality of service delivery.”
Drug regulators need greater power to deal with illegal drug promotion and non-disclosure of important clinical information. Illegal forms of promotion include, among others, marketing a product for the wrong purpose (say side-effect), hiding vital risks information, and touting unconfirmed and scientifically wrong claims of superiority. It is not uncommon for such practices to happen especially in situations where generic manufacturers have waded through difficult marketing paths in order to gain some form of market share and get to break-even level. Take the case of Cyproheptadine, which was marketed in East Africa for its side-effect of causing hunger and eventual weight gain, so many parents would ask for it over the counter, saying “I need that drug, mama, I am hungry.” Many other parents continue to get into such dilemma of what to do with a child that has no appetite.
Similarly, other countries should adopt procedures that allow their governments and payers to similarly impose fines and impose other penalties. This can only happen in countries where CEOs do not meet at a members-only club to discuss strategic options with key staff of the national DRA. Capacities of DRAs in LMICs remain very challenging, leading to a situation whereby almost anyone can enter and market their products. This case raises many questions, including:
- How are the DRAs in developing countries positioned to manage a situation of such magnitude without influence?
- Do our consumer protection agencies and watchdogs have a clear understanding of the level of harm this could cause especially in cases of medicines with narrow therapeutic windows?
- Isn’t it time to raise the bar for ethical practice in pharmaceutical products promotion?
This is probably the tip of the iceberg as we await many problems becoming unearthed at other companies.