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.
Forget it, Jake. It's Libertopia.
Tabarrok & co. simply hate the idea of something like FDA. So everything they write is rife with factual errors and simple reasoning failures before you even get to the conscious bias. They are utterly reliable suckers for a story like this if the "mood affiliation" points the right direction.
Economics as practiced by these people is something closer to theology. Granted, a hard-working, Jesuit-vibes "rational" theology, but still theology.
It has been on the market for a long time so from the POV of safety i am sure it's a good drug. From the POV of efficacy it would join a lot fo other stuff we have like supplements that either dont do anything or have very small effects. I am fine with reciprocity for a drug like this but it wont materially affect the nation's health.
Steve
"Supplements" aren't regulated as drugs, thanks to Orin Hatch (R-Herbalife) and the multi-billion-dollar supplements industry. There only needs to be evidence of safety, not efficacy, for supplements.
I am intrigued by the "junk like Mucinex" part. Usually when I see this, it is commenting that there are no good, recent studies establishing its efficacy: exactly the reason ambroxol is not authorized. And of course the reason there are no studies is that there is no economic incentive for pharma to perform these studies on something out of patent. And by way of anecdatum, in my personal experience, Mucinex works fabulously well. I will feel like an elephant is sitting on my chest, then I take a Mucinex and in a minute or two I can breath just fine. It may be that it doesn't work for everyone, but that doesn't make it junk. Or it may be the placebo effect, to which I reply Hurrah for the placebo effect! Or it may be that my chest was about the clear up anyway, every single time. Yeah, right.
Mr. Tabarrok should not write about Europe's cold medicines if he has never had a cold in Europe. Somebody misled him about the effectiveness of this drug. My experience has been that cold medications they sell there are considerably less effective than the ones we have in the US.
I looked up Ambroxol on Wikipedia. It appears to be more or less what you get from Mucinex except it also can relieve sore throat so it has that going for it maybe.
Cold cures and the reasons for the nonexistence thereof are topics that are impenetrably opaque to some people.
I keep wondering if we don’t already have great cures for cancer and the cold. They’re just buried in the catacombs of big pharma, who makes way more money treating than curing.
A doctor told me big pharma owns many (many !!) research labs, especially those in universities. Aspiring researchers get a fully equipped modern lab, full salary and benefits and considerable latitude in his/her methods. Oh, just one thing - ALL findings belong to big pharma who will forward those finding for testing/evaluation. So far, for colds and cancer, findings come back- “Aw shucks, it just didn’t work out in the testing” which pharma has zero obligation to share with the researcher. When your research is ready for verification- they own it, they verify it.
Again, a grassy knoll cynicism, right up there with the 100 mpg carburetor , but I find it . . . ‘surprising’ that in all these years, we can’t find a cure for the cold or cancer, but pharma has gone to great lengths to corner the research lab market.
No data to back this up, so I’d be curious if anyone can verify the doc’s allegation that big pharma does indeed own most of our research labs. If they do, given the financial motivation , I’ll take the knoll.