Concerns about generic drugs
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Generic drugs undoubtedly represent significant progress in making medicine more affordable for more people, but problems arise when they’re labelled “copies”.
In France, a generic drug has been defined since 1996 as a “pharmaceutical speciality” that has the same active ingredients, the same form (tablet, vial, etc) and “bioequivalence” with its original counterpart, as demonstrated through “bio-availability” studies.
Bioequivalence studies demonstrate that the core active chemicals are delivered to the targeted organs and cells in a way similar to those of the original product and that the two treatments are “not different” from one another.
If the comparison shows a variation of 20 per cent or more, however, they are indeed different.
Most such studies involve single doses given to healthy volunteers so that the drug’s distribution within the body systems can be observed “cleanly”. How it works in people afflicted by disease, especially over long periods, is not examined.
It’s also important to note that not every medicine may be a candidate for generic substitution.
A medicine with a “narrow therapeutic index” is effective at a precise dosage, and even minor deviations render it quickly ineffective or toxic.
Anticoagulants, anti-diabetics, antiepileptics and numerous cardiac drugs prescribed in milligram amounts have this narrow therapeutic index.
In 2007, following a rise in epileptic seizures among people who’d switched to generic antiepileptic products, many European countries banned the substitution of such classes of medicine.
Having more than one generic product on the market creates another concern. All must be bioequivalent to the “original” but need not be bioequivalent to each other.
So switching from one generic to another can result in a significantly different amount of the active ingredients.
Such issues partly explain the continuing hesitancy among physicians to prescribe generics, despite the widespread belief that generics are “more or less” like the original.
The fact remains that generic drugs are cheaper, but considering the unresolved concerns, you and your doctor have to make the choice on a case-by-case basis.
Dr Gerard Lalande is the managing-director of CEOHealth, which provides medical referrals for expatriates and
customised executive medical checkups in Thailand. He can be contacted
