Dr Douglas Kamerow, one of the BMJ’s Associate Editors, argued that when compared to branded ‘innovator’ drugs, generic equivalents were relatively untested, not as efficacious, contained different chemical formulations, and caused confusion for patients.

Commenting on the FDA’s generic legislation for the US market, Dr Kamerow said: ‘Although US generics must be proved to be bioequivalent to gain approval for sale by the FDA, bioequivalence is required only within 90% confidence intervals. This may be fine for most drugs, but some conditions may require drug levels with smaller variations. Full clinical trials are not required to approve generics – that’s why they are so inexpensive, after all – so true clinical equivalence is never tested.’

He added that for drug classes requiring careful titration and close tolerances, e.g. anticonvulsants, antifungals, and thyroid replacement drugs; therapeutic failures were more commonplace when generic equivalents were used.

Regarding the issue of patient confusion, Dr Kamerow argued that because pharmacists frequently changed their supplier for any particular generic product, it was common for different generic versions to be dispensed each time the prescription was filled. He added that this had a knock-on effect for patients, because when they discovered that their ‘yellow round pill’ was now ‘green and rectangular’, it could lead to increases in anxiety and decreases in adherence.

Dr Kamerow did acknowledge that generics were associated with undoubted savings, and cited the US Government’s Medicare Programme as saving US$33 billion in 2007 from generic prescribing alone. He also endorsed the use of generics whenever the desired healthcare outcome was easily clinically measureable, e.g. antihypertensives, analgesics, or anti-infectives.

Predictably, Dr Kamerow’s comments raised some immediate debate. In a rapid response to the journal, Dr Martin Kittel, a general practitioner in Berkshire, UK, stated: ‘I am quite astonished to read the author's views on branded drugs being the "saviour of the old lady" almost disregarding their astronomical cost. To me, these comments have an almost drug industry-led connotation. Is it morally justified for the taxpayer to pay 500–1000% more for a drug when it has a 5–10% benefit?’

The debate is set to continue.

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Reference

1. The pros and cons of generic drugs. BMJ. 2011 Jul 20;343:d4584.