Tuesday, July 17, 2012

Drug Shortages Part 2- the Scramble Continues

'Drug Free Zone? Free Drug Zone?' photo (c) 2008, Byung Kyu Park - license: http://creativecommons.org/licenses/by-sa/2.0/
REPUBLISHING A POST FROM AUGUST 10, 2011 with New Postscript

 I have written about the nationwide shortage of Doxil, a drug used primarily to treat recurrent ovarian cancer.  In turns out that not only is there a Doxil shortage.  Three other mainline chemotherapies for ovarian cancer, carboplatin, cisplatin and taxol,  are in short supply.  I learned about the taxol shortage from a new friend on an ovarian cancer website.  Her clinic, not too far from where I live, has run out of taxol.  Luckily I get my infusions at a major medical center which still has a supply of these three drugs even though it does not have Doxil.

Doxil is available again for special cases, which unfortunately do not include me because I have not yet started treatment with Doxil.

Important Updates on DOXIL® Shortage (8/5/2011)
We remain committed to restoring the availability of DOXIL® (doxorubicin HCl liposome injection). A modest supply is now available through the DOXIL® C.A.R.E.S. (Creating Awareness & Reinforcing Education Support) Physician Access Program.
To help ensure that patients currently on DOXIL® receive the amount of DOXIL® necessary to continue their course of therapy, we have set up the DOXIL® C.A.R.E.S. Physician Access Program, a physician allocation process to obtain newly available DOXIL® supply.
As DOXIL® supply will remain intermittently available in the coming months, first priority will be given to patients currently on DOXIL®. We continue to recommend that no new patients start therapy with DOXIL® until adequate supply becomes available. (emphasis added)

So I could go for an indeterminate time not getting the drug that my oncologist says best increases my odds for a decent remission.  I am starting to feel the need to scramble myself.

According to the American Society of Health System Pharmacists, drug shortages currently affect about 200 medications in the United States, including antibiotics. The FDA reports record shortages for 2010 and projects more record shortages for 2011.  But the FDA has no power to require drug manufacturers to explain why there are shortages and effectively must beg the manufacturers to keep it informed.

The only real reason for these shortages is the economics for Big Pharma, which makes more money from new drugs, antidepressants and potency pills than generic chemotherapy drugs.  Dr. Ezekiel Emmanuel in the New York Times (August 7, 2011) explains:

Only the older but curative cancer drugs — drugs that can cost as little as $3 per dose — have become unavailable. Most of these drugs have no substitutes, but, crazy as it seems, in some cases these shortages are forcing doctors to use brand-name drugs at more than 100 times the cost. 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.

Senators Schumer and Klobucher have introduced billPreserving Access to Life-Saving Medications Act, which would require manufacturers to report shortages  and reasons for the shortages to the FDA. A similar bill has been introduced in the House.  See comparison of the two bills here.  Hearings are planned for the fall and hopefully manufacturers will become more accountable for their profit driven decisions about what drugs to produce.  I hope so.  My fellow cancer warriors and I cannot fight the good fight if the drugs aren't even available.

Postscript July 16, 2012   Drug shortages still continue but have become "old news", i.e, not news worth covering.  For example there are still shortages of Taxol (paclitaxel) which will cost patients more if taxotere (docetaxel) is substituted. And drugs shortages continue to grow as an international problem including shortages of drugs to treat leukemia and myeloma, as well as first line ovarian cancer treatment, cisplatin.  However, the issue is not covered anymore by main stream media and only finds its way into print in specialized medical publications. The bills I mention above never passed, although one part of the bills requiring six months notice of expected shortages to the FDA did pass in June 2012 as part of another bill.  Worst of all, we are starting to hear anecdotally about people dying from the Doxil shortage. Why doesn't the media care anymore???