Not all generic drugs are made alike

With the very important matter of EpiPen price gouging in the news, this is a story of my experience with generics, and hopefully a cautionary tale. It has caused me to pause and first think about what I’m going to use a generic drug for, before using it.

About 1 in 20 people over 12 years, or 5% of this population in the US suffer from hypothyroidism, i.e., their thyroid gland doesn’t make enough thyroid hormone; and 1 in 2000 children are born with congenital hypothyroidism. To keep it short for this article, here’s a thumbnail sketch about the thyroid gland. It sits somewhere close to the top third of your neck, and secretes T3, T4 and calcitonin. This piece is about T3 (triiodothyronine)and T4 (thyroxine), commonly referred to as thyroid hormones. A blood test to check for levels of T3 and T4 determines whether a person suffers from hypothyroidism, and in the US, all infants are tested for this at birth because thyroid hormones influence the development of almost every organ. Luckily, there is a simple fix for this in most cases — if you are deficient in these hormones you will be prescribed levothyroxine; according to some sources, this is the second most commonly prescribed medication in the US. There are multiple manufacturers of this drug and perhaps the best known is Abbott Laboratories — they manufacture Synthroid. According to the FDA website, there are at least eight other manufacturers of the drug.

Also according to the FDA site, “ All generic drugs approved by FDA have the same high quality, strength, purity and stability as brand-name drugs. And, the generic manufacturing, packaging, and testing sites must pass the same quality standards as those of brand name drugs.” In other words, a 25 microgram tablet of levothyroxine from any of the nine manufacturers should be indistinguishable from one made by any of the other manufacturers, in terms of its ability to ameliorate the symptoms of hypothyroidism. But there’s many a slip ‘twixt the cup and the lip, as the old proverb goes! Several years ago, we decided to substitute generic levothyroxine for Synthroid that was prescribed for my son. Assuming that the generic was of the “same high quality, strength, purity and stability as” Synthroid, we saw no reason for concern. Wrong! The generic wreaked havoc on his system, and we had to quickly recheck his thyroid hormone levels before his endocrinologist could adjust his dose. With a dose of 25 micrograms — one-hundredth the weight of a single mustard seed — there’s little room for error, it would seem!

While generics help keep costs down for an already financially beleaguered patient, it behooves the FDA to put in place checks to ensure that generics are indeed identical to the original in efficacy.

Because of how drugs are dispensed in the US, consumers rely on the compliance of pharmacies when it comes to storing large opened bottles from which aliquots are dispensed to multiple patients. The moment a drug bottle’s seal is broken, the contents are exposed to the atmosphere. This means the drug has the potential to slowly deteriorate over time, thus reducing the actual effective amount ingested by the patient. Add to this the fact that the patient takes her little box of pills home and opens them every day, exposing them to the atmosphere and potentially further reducing the effective amount in the pill.

All this may sound unnecessarily fussy, but if ones medication is for something critical then it’s not fussy, it’s prudent. If it’s a generic to deal with a headache, then I can personally accept small errors; but if it’s a generic to deal with something critical, I now exercise a lot more caution. This despite FDA assurances that, “All generic drugs approved by FDA have the same high quality, strength, purity and stability as brand-name drugs. And, the generic manufacturing, packaging, and testing sites must pass the same quality standards as those of brand name drugs.”