Friday, January 04, 2013

The Seedy, Greedy Underbelly of U.S. Drug Channels

Happy new year! Let’s kick off 2013 with a look at newly-uncovered unethical behavior by physicians and pharmacists.

In late December, the FDA sent warning letters to 350 (yes, 3-5-0) physician practices that knowingly purchased gray market Botox, which turned out to be counterfeit. The next day, the LA Times profiled two independent pharmacy owners that profited on the prescription opioid abuse.

Taken together, these stories illustrate why manufacturers need to keep a close eye on channels to the patient. Greed is not always good. Too bad that these providers didn't know which shoulder to follow.

DIRTY DOCS

Remember the foolish oncology doctors who saved a few pennies by buying counterfeit Avastin from an unauthorized Canadian supplier? See Greedy Physicians Invite Fake Avastin Into the Supply Chain.

Well, it turns out that the same supplier also sold fake Botox, which at least 350 (!) physician practices bought. Just before Christmas, the Food and Drug Administration (FDA) sent a letter to these medical practices, writing:
“The U.S. Food and Drug Administration (FDA) has received information indicating that your medical practice has received medications from a foreign supplier owned and operated by Canada Drugs, known as Quality Specialty Products (QSP), A+ Health Supplies, QP Medical, Bridgewater Medical, or Clinical Care. Most, if not all, of the products sold and distributed by these suppliers, including versions of Botox®, have not been approved by FDA.” (Click here to read the FDA’s letter.)
One of the practice managers told the Wall Street Journal: "I was assured it was the same product, but it was just less expensive.” How reassuring. Click here to see the FDA’s list of the unethical docs who put profits before patients. Hopefully, no one you know made the list.

Seriously?!? As happens so often, gray market diversion created the opportunity for counterfeit drugs to enter the legitimate and secure supply chain. The willfully-clueless medical practices purchased from a non-authorized distributor, which had illegally imported the product from a non-authorized source. What did they expect?

Believe it or not, there are still anti-pharma crazies who want to INCREASE the availability of drugs from Canada. Just be thankful that Senator Byron Dorgan retired!

SLIMY PHARMACISTS

The day after the FDA’s announcement, the L.A. Times published a disturbing profile of independent pharmacy owners who profited handsomely from prescription painkillers. See Rogue pharmacists fuel addiction.

For instance, Pacifica Pharmacy of Huntington Beach filled nearly twice as many of those prescriptions as did nearby Walgreens, CVS and Sav-On pharmacies combined. Click here to read the California Board of Pharmacy (BoP) case against Pacifica Pharmacy. Scary stuff.

As I have long argued, the DEA has mistakenly targeted wholesalers and manufacturers because the DEA can't stop the real criminals—the patients abusing prescription drugs, the physicians running “pill mills,” and the pharmacies dealing these drugs.

Alas, it doesn’t look like the California Board can get the job done, either. NACDS data shows about 5,700 retail pharmacies in California. And according to the LA Times article:
  • "California's 42,000 pharmacists filled 318 million prescriptions last year."
  • "The task of identifying careless or corrupt pharmacists and initiating disciplinary action falls to 37 investigators for the California Board of Pharmacy."
Let’s see, that’s about one investigator for every:
  • 154 pharmacies
  • 1,135 pharmacists
  • 8.6 million prescriptions
Virginia Herold, the agency's executive director, said: "We work really hard. But there's a limit to what we can do." Gee, I’m sure the CA BoP will have no problem managing the implementation of e- pedigree. I feel safer already!

3 comments:

  1. Adam,
    The point of this column and its details are very much on the mark. when I covered the Botox news (http://www.pharmaceuticalcommerce.com/index.php?pg=latest_news&articleid=26711&keyword=Botox-FDA-unapproved-importation-QSP-Avastin-e-pedigree), I was shocked first at the scale of doc offices involved (350!) and second at how quietly this news was received. BTW, Allergan, makers of Botox, told me that they do direct distribution (plus some specialty distributors), so it's supposed to be a closely controlled network. Botox is a temperature-controlled product; who wants to bet how well its storage and shipping was handled by the unauthorized distributor?

    I'm certainly willing to give pharmacists, and state boards of pharmacy, the benefit of the doubt regarding maintaining proper distribution practices, but there appears to be a gaping hole in the overall system here (pertaining to unauthorized distribution and specialty distribution to doc offices). Nevertheless, when FDA had its mid-December publlic hearing on the NECC drug compounding scandal, state BoPs unformly asserted that they could manage the necessary pharmacy oversight (see NCPA's review of the meeting here: http://www.ncpanet.org/pdf/leg/dec12/fda_public_meeting_121912.pdf

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  2. Adam,
    Wow!  Even the University of Southwest Texas Medical Center buys drugs illegally according to the FDA's list.  What kind of lesson is that?Dirk.

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  3. Adam,

    Re: fake Botox, look at the consequences from nearly ten years ago:

    http://www.people.com/people/archive/article/0,,20146391,00.html
    http://abcnews.go.com/GMA/OnCall/story?id=3183605&page=1

    Thanks for calling attention to the issue.

    Mark

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