Terra Sigillata

From Monday’s issue of The Press in York, England:

A breast cancer patient from York says she is “disgusted” by a shortage of the drug she and hundreds of other women rely on to reduce the risk of the disease returning.

Mother-of-two Marion Barclay, 45, said the situation became so serious last Friday, she faced the prospect of missing her daily dose of Arimidex tablets.

Marion Barclay Arimidex.jpgThis story is one of several reports on sporadic, worldwide shortages of Arimidex®, the brand of anastrozole sold by AstraZeneca. Anastrozole is a competitive inhibitor of the cytochrome P450 monooxygenase isozyme known as CYP19 or aromatase. Aromatase catalyzes the conversion of testosterone to 17β-estradiol and its inhibition is critical to the long-term management of estrogen receptor-positive breast cancers.

However, the off-label use of anastrozole for men with testosterone deficiency, or hypogonadism, has been a topic discussed at ScienceBlogs since self-help guru James Ray was found in possession of the drug when his Sedona resort room was searched following the deaths of three people in the infamous sweat lodge incident.

Related to this story, a commenter recently criticized endocrinologists in a thread at White Coat Underground saying that:

That is why they don’t know how to use aromatase inhibitors, such as Arimidex (anastrozole), stating it is “only for female breast cancer patients. So why are there between 100 and 1,000 times more men than women on it? Astra Zeneca is laughing all the way to the bank.

This is a peculiar statement because AstraZeneca can only promote the drug in the US for FDA-approved indications. Of course, with their patent on the drug expiring in June 2010 it would not be a surprise if they were seeking approval for a new indication: use in TRT. Indeed, small studies have shown that anastrozole may be effective in managing gynecomastia caused by testosterone conversion to estradiol in men receiving testosterone replacement therapy.

But if “between 100 and 1,000 times more men than women” are currently taking anastrozole, where would that data come from and why would it be publicly available?

And if true, could the alleged masses of men taking anastrozole for testosterone deficiency be indirectly responsible for women with breast cancer facing shortages of a drug essential for their survival?

Photo credit: The Press (York, UK)

Comments

  1. #1 chemgeek
    February 10, 2010

    “100 and 1,000 times”

    A range of an order of magnitude makes me highly skeptical that this is based on real data or at least reliable data.

    It may be true, but it sounds dubious to me.

  2. #2 phisrow
    February 10, 2010

    Would there be anything about this drug’s production process that would make it unusually difficult/slow to ramp up?

    If the patent is expiring soon, and the manufacturer is running a “nudge, nudge, wink, wink, you didn’t hear it from me” market expansion campaign, you would think that they would want to have enough of the stuff on hand, since their margins will certainly decline once the generics show up.

    Some sort of production disruption? The sneaky off-label campaign work faster than expected? All that BPA and inactivity even worse for men than generally known?

  3. #3 Girlyman
    February 10, 2010

    Interesting question. But drug shortages in the UK don’t appear to be limited to Arimidex.

  4. #4 aron
    February 11, 2010

    The patent for it is up in june 2010(COULD HAVE MENTIONED THAT)= Generic= Low prices.
    You also ignorantly say it is only useful for women. Children with growth disorders take this stuff too cause it slows epiphyseal closure.

    I highly doubt that men use so much anastrozole that women cant get it. BLAME the pharma companies and their doctors for the redicolous prices they charge and prescribing this to men. There are plenty of other drugs to raise testosterone and reduce estrogen in men.

    Please go write some more uniformed articles.
    p.s. excuse my 5 year old spelling abilities.

  5. #5 k2 incense
    February 16, 2010

    ^^^^

    Don’t blame the pharm companies. Blame the users.

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    May 6, 2010

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  7. If this story is true, it’s a shame because there are a lot of natural ways to boost testosterone rather than using prescription drugs.

    First of all your diet and exercise can have a great deal of effect on testosterone levels and my guess is that these drug users aren’t living the healthiest lifestyle.

    Also there are various natural herbs that may help boost testosterone as well.