Sunday, January 22, 2012

Yes, we have no...Zofran?

Photo Credit

The issue of chemotherapy drug shortages has made the news a lot over the past 6 months or so, including an OpEd piece in the New York Times last August that pointed out that the situation is so bad that, in effect, cancer care is being rationed in the US.

How did this happen?

Well, the situation is quite complex, but much of what is going on was summarized beautifully by my colleague Michelle Hudspeth, Director of Pediatric Hematology/Oncology at Medical University of South Carolina (and graduate of our residency and fellowship programs), when she testified before Congress (her testimony is here).  Briefly, the problem can be traced, in part, to a rule by The Centers for Medicare and Medicaid Services (CMS) called the ASP + 6 Rule.  This rule limits what a private oncologist can charge for a chemotherapy drug to the Average Sale Price plus 6%. 

Why does that matter?  An article by the Director of the National Library of Medicine, and one in the New England Journal of Medicine, outlines the financial issues.  Because so many of the older chemotherapy drugs are available as generics and are consequently very inexpensive.  Consider the case of carboplatin.  A vial of carboplatin once sold for $125, but recently the cost has fallen to $3.50.  Add 6% to that, and you certainly don't recoup the cost of administering the drug in your office. Similarly, paclitaxel costs $312 per vial, while Abraxane (albumin-bound paclitaxel) costs $5,824 (all cost data come from this article in the New England Journal of Medicine).  There is almost no financial incentive to pharmaceutical companies to make generic chemotherapy drugs, nor is there a financial incentive to private oncology practices to use generics.

But this is just part of the problem.  There is currently a nationwide shortage of Doxil (liposomal doxorubicin), which is not a generic.  Why?  Through industry consolidation, there are fewer and fewer plants that manufacture these drugs, so when something happens at even a single plant, the entire market is affected.  Quality control issues at the only plant in the world that makes Doxil shut the plant down and with it, all drug production. 

So, it seems that industry consolidation, downward pressure on pricing of generics, as well as contamination, other quality control problems, and shortages of raw materials have conspired to create a perfect storm.

The consequences of these shortages go beyond just drug availability.  As the New York Times article discussed, and Dr. Hudspeth mentioned, medication errors are increasing as oncologists are forced to use less familiar drugs.  Research is affected, too. This article, published in the scientific journal Nature in October, discusses the effect of drug shortages on clinical trial enrollment.  Closer to home, the clinical trial I am running looking at Doxil and temsirolimus for sarcoma patients is on hold because Doxil is unavailable.  We haven't enrolled a new patient in months, and there is no end to the shortage in sight.

The shortages are not limited to chemotherapy drugs (which, of course, is evidence that the problem is not due to the inability of oncologists to make a profit giving drugs to patients).  Drugs for ADHD, the components for iv nutrition, anesthetics, and many others are affected.  In fact, on Friday I was told our hospital has only a 5 day supply of Zofran, the mainstay anti-nausea drug used for patients receiving chemotherapy. 

I sure hope they get more.  I'm not looking forward to giving chemotherapy without it.

Related Posts:
My Name is FDA, and I Approve of this Message
A Smarter War on Cancer
When Translational Research Really Translates


Mary said...

I shared this post with the Team Sarcoma Facebook group. When I was really sick after giving birth, zofran saved me! I was familiar with the drug name because I know so many young adults who have needed it while in treatment. I never had chemo, but I can only imagine how sick I would have been with it. It is hard to comprehend sarcoma specialists not having access to so many drugs that they need. Is there anything we can do? Would you be willing to write about this in ESUN??

Anonymous said...

I read the op-ed in the ny times when it was first written and wrote letters to my congressman and 2 senators, never having done so before. I got a personalized reply from one of the senators, which was encouraging, instead of the canned response from the other 2. And I can't imagine going through chemo without Zofran; the nausea was bad enough with it.

Hopefully this is solved soon!

Just the Tip said...

Coming from someone who has worked in pharmacy for 10 years and also happens to have an anaphylaxis reaction to phenergan, I think the only way to summarize this is that we're all doomed!

Kathleen B. said...

Get out the ginger snaps. This is truly sad. What about old timey drugs? Thorazine, compazine? Just wondering if they're effective.

Doctor David said...

Mary, thanks for sharing with the FB group. Unfortunately, I'm not sure that there's much that can be done at the grassroots level, other than perhaps making sure your Representatives and Senators are aware of the magnitude of the problem.

Kathleen, we are breaking out the old-timey drugs... but sadly many of those are also generic and are also in short supply. This morning on rounds I was told that the only anti-emetic we regularly use that is NOT in short supply is Ativan.

Elizabeth Munroz said...

Is this situation also the same in other countries? Or are we the only ones?

Kathleen B. said...

Oh my - Thanks Dr. David.

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