Alex Tabarrok links today to an old article by Robert Kuttner about a cure for the common cold:
Now unfolding is the next pharma outrage. I’ve written about a miracle cold and cough medication called ambroxol. It is far superior to junk like Mucinex and Robitussin.... Ambroxol, which is highly effective, has been available in Europe (and in most of the world) since the late 1970s as a generic. It costs about $5 a box.
You can’t get ambroxol in the U.S. because of the failure of the Food and Drug Administration to grant reciprocal recognition to generic medications approved by its European counterpart, the European Medicines Agency, when they have long been proven safe and effective.
I hate to step on a righteous rant, but:
- Ambroxol is not a miracle drug. In a recent report, the European authorities concluded that it has "modest but positive results."
- Ambroxol was originally tested in the '60s and '70s, when clinical studies were "considerably less standardised" than today.¹ It is now grandfathered in, but it would not be approved today based on the old studies.
- Reciprocity is probably a good idea, but it's not the FDA holding things up. It's the law. Until and unless Congress authorizes it, there's nothing the FDA can do.
In the meantime, you can always try to order it online from Canada. Except it's not approved there either. Hmmm. Mexico it is, I guess.
¹This is a polite way of saying they were crap:
The clinical studies performed during the development of bromhexine- and ambroxol-containing products between the 1950s and 1980s were considerably less standardised than would be necessary today, and would not completely fulfil contemporary requirements with regard to validated endpoints, statistical confirmation, or Good Clinical Practice (GCP). These constitute the majority of the available evidence.
....Often a large placebo effect is seen in studies investigating respiratory conditions, particularly in non-serious, self-limiting conditions.... It is acknowledged that most of the indications are supported by old studies presenting limitations and deficiencies. Some trials failed to show a significant difference between ambroxol or bromhexine and placebo and others only showed significant difference in some of the studied endpoints.... It is recognised also that the limitations and uncertainties attached to the dataset hinder the ability to draw robust conclusions on the efficacy.