Holy Morphine!! Drug Showdown in Cody

How did I miss this?  Cody Labs in our own Cody, WY, makes pharmaceuticals for the generic drug market.  I suppose their priorities are market-driven, but they sure like to sell heavy-duty painkillers.

One of which is morphine sulfate, the drug of choice during the Civil War and my drug of choice after major hip surgery.  The doc weaned me after five days, otherwise I would still be on it, or dead.  Someone can stick a knife in your gut, you can be strapped to a chair with Rush Limbaugh blaring on, you can still feel pain but you just don’t care.  I still think BP’s Tony Hayward was on morphine when he appeared before the US Senate.  You might appear interested but YOU JUST DON’T CARE.

Guess what?  The FDA has not approved morphine sulfate for manufacture and public use, with one exception: it recently approved manufacture by the same company, Boehringer Ingelheim’s Roxane Labs, whose “pink Viagra” pill for women was recently deep-sixed.  (I could tease that “just don’t care” theme out in a totally different direction… but I won’t.)

I don’t know what has been going on at the FDA for the past 72 years since it was established in 1938 with the mission to protect the public from dangerous drugs and badly manufactured drugs.  Congress exempted drugs already in use in 1938 from regulation.  I’d like to see the lobbyists’ expense sheets related to that gaping loophole.  Morphine sulfate had been in use for centuries, and therefore was exempted from regulation.

Huh?  What about adulteration, dilution, fraud, contamination, dosage controls, purity, patient advice, doctor advice….. shouldn’t the FDA have been regulating those aspects of morphine sulfate manufacturing and use?

Well, second guess what?  The FDA came out of its VanWinkle slumber a few years ago and started sending letters to manufacturers, stating that morphine sulfate is not a drug which is approved and they better stop making it before the FDA goes beyond a nastygram letter.

One wonders why this did not happen in, say, 1938?  I’m pretty sure that everyone knew that morphine was powerful and addictive by 1938.

The FDA hit Cody Labs with the warning letter on March 30, 2009.  It stated:

“This letter is written in reference to your firm’s marketing of an unapproved new drug in violation of the Federal Food, Drug, and Cosmetic Act (the Act). Based on the information your firm submitted to FDA’s Drug Registration and Listing System, you manufacture the following prescription drug:

• Morphine Sulfate Solution Immediate Release 20mg/ml

“As labeled, the above product is a drug within the meaning of section 201(g)(1)(B) and (C) of the Act [21 U.S.C. §§ 321(g)(1)(B) and (C)] because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and because it is intended to affect the structure or function of the body. Further, this drug product as manufactured by your firm is a “new drug” within the meaning of section 201(p) of the Act [21 U.S.C. § 321(p)] because it is not generally recognized as safe and effective for its labeled uses.”

Wow!  A “new” drug?  It was generally recognized as safe and effective during the Civil War, World War I, a bunch of other wars, cancer treatment for decades and even after my hip surgery.

There is an erosion of confidence in the competence of government in this country.  There are some essential functions that we need government to do, like streets and sewers and clean water and crime prevention; safe drug manufacturing falls within these important responsibilities.  It makes for better civil order if we have confidence in how government fulfills its duties.  This kind of rote brain-dead regulation does not encourage confidence.

The Billings Gazette carried a story on July 25 stating that the FDA is now trying to shut down the Cody Labs facility, at a potential loss of  50 jobs, because it failed to beat the other manufacturer to be the first applicant for new approval.  Not because of an unclean plant, or adulteration, or bad quality control, or because the drug had been found to be dangerous.   FDA licensed a competitor to make the same drug.  Why can’t Cody Labs keep making it?   Because only the first applicant would get expedited approval; Cody Labs has to wait another six months.

BNET, a thoughtful internet business news service, has a story dated July 23 on this; BNET thinks the FDA is right and Cody Labs is wrong.  I don’t agree.  But, third guess what?  Wyoming Federal District Judge Alan B. Johnson agrees with the FDA.  Cody Labs will have to make something else for a while.

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  1. There is s-o-o-o-o-o-o-o much more to this story than can be reported on the record. And it will have to stay dark for a while yet. This FDA meddling is the minor part of it. And it is just that —bureaucratic befuddlement. Morphine is broad term for a lot of different opiate-based substances, but M. sulphate is a downright common form . That a particular flavor and dosage of it isn’t on the FDA’s ridiculously detailed manifests says more about them than it does about the drug itself or the countless millions of people who have beneftitted from it worldwide for many decades. You know what they say …if Aspirin were discovered today , it would never get approved by the FDA as anything less than Schedule 1.

    But neither does this excuse Cody Labs, and especially its founder and onetime CEO Ric Asherman , who still runs the shop more or less . A more arrogant man you will never find in the arbitrary quadrangle called Wyoming. Ex-Navy SEAL with a huge Type A+ personality and a man who does not like to be told what to do by anyone or anything. He actually believed he could ignore the FDA and M-SO4 was ” grandfathered” —Not! Among other male traits . Like divorcing your wife cold , along with her four kids, their fifth , and getting an internet blonde bride half his age from Russia that came with an accessory sister ( high maintenance required). All a matter of public record. IMHO, Asherman did a lot to create his most recent mess all by himself , if true to form.

    I’ve been driving by CL since Monday and have not noticed any drop off in employee cars parked there. They make a few other fun things there, too. The M-SO4 is maybe a third of their sales. It doesn’t look like they’ve pulled back much. Yet.

    Later this year the morphine situation will be resolved, if Cody Labs has any customers to return to. You do have to ask from which of the Poppy Republics does Cody Labs gets its raw material. My bet is Turkey , but Asherman may have other sources from his overseas adventure days.

  2. Hi. RT. Good comments. I am beginning to be overwhelmed at the total corruption of government and what happens with big money. I court in NY just ruled the other day that it is against the law to even talk with a group that is labeled “terrorist”. The lab in Cody could be labeled “terrorist” or you or me. I just have fear for the babies that will grow up in this warped situation.
    p.s. did you see my Chukars in the Wyoming Wildlife, June issue. Laney