Genuine Question: Should We Infer An Anti-Competitive Motive, When A Needed Vaccine For ~80,000 Oncology Patients Remains Subject To Stock-Outs, For... A Decade? [Cough. Merck.]

We've followed this for well-over eight long years -- the odd little vaccine that is part of certain bladder cancer treatments, as a first line (for up to 80,000 patients a year in the US). But the stuff has been supply-constrained. . . for the better part of a decade (how is that even. . . possible?).

Rather than offer wild-eyed conjecture at the head, I'll simply encourage the readership to read all of Fierce's very well thought out, longish update, on the state of the play, in the US at least:

. . .BCG, originally developed as a tuberculosis vaccine, is also a standard treatment for NMIBC, which accounts for about 80% of around 80,000 new bladder cancer diagnoses each year in the U.S.

The FDA has cleared Anktiva and BCG to treat patients with BCG-unresponsive NMIBC with carcinoma in situ. And ImmunityBio is evaluating the combo in BCG-unresponsive NMIBC with papillary tumors and perhaps more importantly in BCG-naïve NMIBC.

In the current indication, ImmunityBio will go toe to toe with Merck & Co.’s PD-1 megablockbuster Keytruda and Ferring Pharmaceuticals’ gene therapy Adstiladrin, both of which are administered by themselves without BCG. Ironically, Merck is currently the sole supplier of BCG in the U.S. . . .

Merck’s TICE BCG has been the lone BCG product in the U.S. since 2012, coming after Sanofi and another drugmaker ran into manufacturing problems. Sanofi officially pulled out of the market in 2016. Merck, which had before then not been the major supplier globally for BCG, was forced to pick up the slack. . . .

Now, were I a cynical sort of gent, and were we living in a prior epoch (prior to the required negotiated drug-pricing executive orders) I might have suggested that Merck historically (by designed indifference) kept a shorted- / shortish-supply chain on BCG to make other competitors' efforts at using it -- in more-lucrative oncology settings, as a combo therapy. . . more difficult. Note that Rahway claims (at least) that you presently can't get larger delivery quantities unless you've been ordering larger quantities since 2012 or so. [Yes, this is why I posted (again) on Mr. Shkreli immediately prior here.]

That all would have the effect of more or less "locking supplies in place", and keeping upstarts largely off the field in the US. In the EU, Japan and UK. . . that would likely be frowned upon, and may even violate the EU Competition Commission's rules. So, we will keep an eye on it. [It is not too great a stretch to say that Martin Shkreli nakedly did this, with Daraprim -- and thus earned a life-time FTC pharma industry ban. . . while, when much the same is accomplished. . . politely, with kid gloved large manufacturing facility cap ex, over a period of a half-decade, it is permissible in the US at least.]

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