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Monday, August 15, 2011

Do you wonder about drug shortages?

The cancer literature is full of articles about shortages of the older (and less expensive) cancer drugs. Outrage even hit the pages of the venerable New York Times in early August, in the form of an editorial by Ezekiel J. Emanuel, MD - an oncologist and professor of medical ethics starting at the University of Pennsylvania in September 2011.

Emanual writes: "Only about 10 percent of the shortages can be attributed to a lack of raw materials and essential ingredients to manufacture the drugs. Most shortages appear instead to be the consequence of corporate decisions to cease production, or interruptions in production caused by money or quality problems, which manufacturers do not appear to be in a rush to fix...You don’t have to be a cynical capitalist to see that the long-term solution is to make the production of generic cancer drugs more profitable. Most of Europe, where brand-name drugs are cheaper than in the United States, while generics are slightly more expensive, has no shortage of these cancer drugs. "

But it's not only cancer drugs that are in short supply.

Simple things like magnesium sulfate (used to lower the blood pressure in eclampsia of pregnancy), Vitamin C in the intravenous form (currently available only at 4 times the price of a year ago), and amino acid solutions (used in cancer patients who are unable to maintain protein intake) are also difficult, if not impossible, to find.

We have switched to Magnesium chloride instead of Magnesium sulfate, because the latter is on "indefinite backorder". And now our suppliers tell us that Magnesium chloride is also becoming more difficult to find.

Emanual notes in his editorial that the newer chemotherapeutic pharmaceutical drugs are in plentiful supply. They don't work very well - they only prolong life by a short time, unlike some of the older drugs which were actually curative. But they are available - for a very expensive price. And insurance covers them.

What is wrong with this picture?

Is it possible that the profit margin in low enough on the generics, and the older drugs, and the chemicals that pharmaceutical companies simply decide not to manufacture them any more?

Is it possible that the Federal Drug Administration has such close ties with the pharmaceutical industry that it is inspecting the manufacturers of generic drugs more diligently than manufacturers of newer drugs still under patent protection?

Is it possible that the pharmaceutical companies have purchased a controlling interest in any of the manufacturers of generic drugs, to get them out of the market? I do note that Hospira appears to belong to Sanofi-Aventis. I have not been able to track down similar information about any of the other companies.

I don't know that we will ever get answers to these questions. But I do find it very curious that for months now we have been able to obtain the pharmaceutical version of leucovorin (used in cancer chemotherapy) but the generic version (at 1/10 th the price) has been unavailable since the fall of 2010.

Something is definitely wrong here. The big question is whether the wrongness is simple incompetence or actually deliberate...


  1. Something is wrong when corporations are allowed to buy up competitors and monopolize the market. This can lead to price fixing, strategically planned shortages, and even private regulation of materials; all in the name of profit for executives,major shareholders and to the detriment of the health of the consumer. I have coined a term,"ultra-capitalism" for when drive to profit at all cost infringes on rights of individuals for life, health, liberty and the pursuit of happiness.

  2. And unfortunately sometimes it appears to be one of our own who buys in to the "Big Pharma" mode. Dr. George Tidmarsh, a pediatric oncologist, is quoted in the New York Times on August 19th 2011 as saying “We have a meeting with the F.D.A. next week,” Dr. Tidmarsh said. “This unfolding tragedy must stop, and right now.” Dr. Tidmarsh was appointed Chief Science Officer and Head of Research and Development Operations of Spectrum Pharmaceuticals in June 2010. Spectrum is currently the sole supplier of any form of intravenous folic acid, crucial for treatment of cancer with 5-fluorouracil, a well known chemotherapeutic drug. Spectrum had its most profitable quarter ever earlier this year. The drug Fusilev®(a form a folic acid) is one of Spectrum's two drugs that have been FDA approved for treatment of cancer. Generic leucovorin (another form of folic acid) used to be available for $33 for a 10-pack of 100 mg vials. Fusilev® is still available, for a price of $191.44 per single 50 mg vial – a difference of about $360 for the same amount of leucovorin.


  3. It should be a crime to not have these WELL PROVEN drugs readily available. What happened to humanity! I understand wanting to make a profit but my GOD this is really really bad......
    Thanks for posting this Dr. Grout