Obamacare, It’s for the Children. A Glimpse into the Future? Shortage and Rationing of Life-Saving Drugs

It begins with a cautionary tale regarding a shortage of the chemotherapy drug, cytarabine, which is “threatening the treatment of acute myeloid leukemia (AML) in children around the country.” Some hospitals are rationing supplies of cytarabine, while others turning away new patients, Thomas H. Maugh II reports in the Los Angeles Times.

Cytarabine, he continues, is a “key ingredient in the drug cocktails given to such children.” Of the estimated 43,000 new cases of leukemia diagnosed annually in the U.S., the American Cancer Society reports half of them are AML.

Louis J. DeGennaro, chief mission officer of the Leukemia & Lymphoma Society, told Bloomberg News, “Without it, most patients die. There’s really no substitute for cytarabine in those chemotherapy regimens.”

Maugh relates an ABC News poll of major U.S. hospitals, which found “many had to limit the number of patients receiving the drug, often rejecting new patients so that patients already in the system could complete their drug regimens. Others said they had been receiving referrals from community hospitals that were unable to obtain supplies of the drug.”

Cytarabine is “also used in the treatment of adults with acute lymphocytic leukemia, but it is apparently not as critical in such drug regimens and it is primarily adults that are being denied access to the drug now,” Maugh writes.

The shortage originated last year with problems “obtaining the drug’s main ingredient and preventing crystals of dried medicine from forming in vials,” Bloomberg reports.

Hospira Inc. of Lake Forest, Illinois, one of three U.S. manufacturers of cytarabine, “re-entered the market in March after fixing the crystallization issue and has made the manufacture of cytarabine a priority ahead of other products.” One of the other two companies, APP Pharmaceuticals of Schaumberg, Illinois, also “encountered difficulties toward the end of 2010 in obtaining the key ingredient in the manufacture of the drug,” Maugh writes. Both also experienced the crystallization problem.

As a result, the third company, Bedford Laboratories of Bedford, Ohio, experienced depletion of its stock.

As the shortage worsened, the FDA looked for a foreign source to import cytarabine and plans to use the import source for backup.

Major hospitals named in the ABC report as experiencing shortages include Johns Hopkins in Baltimore, Maryland; Nebraska Medical Center in Ohama; Massachusetts General Hospital and Tufts Medical Center in Boston; University Hospital in Cleveland, Ohio; Mayo Clinic in Rochester, Minnesota; and University of Chicago in Illinois. Other hospitals, including St. Jude’s Children’s Research Hospital in New York, have not had any problems in acquiring cytarabine.

The most recent status report on the FDA website, dated April 12, shows manufacturing delays for all three drug companies. Hospira is showing both a shortage and a manufacturing delay with the release of additional lots of 100mg/ml 20ml vials scheduled for April 11.

The Wall Street Journal reports April 15:

Hospira said in an April 11 letter to doctors that dried cytarabine on filling needles may have entered vials during manufacturing, which halted shipments for part of February. A Hospira spokesman said the problem has been resolved and that shipments resumed last month. The company is now working to increase production “ahead of other products” to address the shortage.

APP said in a March 15 letter to doctors that it hadn’t determined a “root cause” for the cytarabine crystals. APP had to recall one lot of cytarabine and also had to stop shipments.

In a statement Friday, APP said it would begin releasing “newly manufactured” cytarabine starting the week of April 18. APP appears to be the smallest cytarabine manufacturer of the three firms.

The WSJ also says, “Even if all goes as planned, doctors are concerned it will take weeks or months for the cytarabine shortage to resolve. Some pediatric leukemia specialists who are attending their annual medical society meeting in Baltimore kept a close eye on their email for news of cytarabine shipments.”

This is under the best of circumstances before other factors buried in the Obamacare bill are discovered. Recall, then-Speaker Pelosi famously said Congress had to pass the bill before we found out what’s in it.

If this cybaratine case is any example, children and many others will die when life-saving drugs become rationed or otherwise unavailable — and cybaratine is only one of many such drugs reported to be facing shortages.

Medscape Medical News reported in December 2010 that “current shortages are the worst that have ever been experienced; in hospital pharmacies, the shortage of intravenous agents is approaching a national crisis,” according to the American Society of Health System Pharmacists. There were 168 products in short supply, compared with 150 in 2008.

Just looking at cancer drugs alone that were listed in short supply we find “carboplatin, cisplatin, doxorubicin, etoposide, leucovorin, nitrogen mustard, and vincristine.”

Returning to the FDA’s list of drug shortages, production of cisplatin has been delayed since last September and APP is facing increased demand and releasing batches as they become available. Doxorubicin, which is produced by Bedford, has been experiencing increased demand since at least February. Doxorubicin is used in the treatment of patients with breast cancer, acute lymphocytic leukemia, and hepatocellular carcinoma. Etoposide, produced by both Bedford and APP, is facing increased demand and is being released when available by the former and is delayed by the latter. The same two producers are also involved in manufacturing delays for leucovorin. APP, however, which recently launched its leucovorin injection in response to the ongoing shortage, has its product on back order.

“In some of these cases, there are no equivalents, there are no work-arounds,” Michael Link, MD, president-elect of the American Society of Clinical Oncology, told Mediscape Medical News.

And, it’s not just cancer drugs that are in short supply. The same article points to the broad-spectrum antibiotic amikacin “often used in patients with low blood counts because of chemotherapy,” and propofol, a “short-acting anesthetic that is used for bone marrow aspirations and spinal taps in children with leukemia.”

The FDA reports amikacin, also manufactured by Bedford, is on back order and propofol, produced by Hospira and APP, is being released as soon as available. Another producer, Teva Pharmaceuticals, which manufactures many of the same drugs, has discontinued its propofol injection altogether.

Speaking at a Chicago fundraiser April 14, Obama claimed that, under the GOP “vision,” “we can’t invest in roads and bridges and broadband and high-speed rail. We would be a nation of potholes and our airports would be worse than places that we used to call the Third World but that are now investing in infrastructure.”

Perhaps someone should tell POTUS how bad the drug situation is.

In January 2011, a recent survey of health care professionals found an “unprecedented, and growing, shortage of critically important medications” was not only affecting patient care but also endangering patients’ lives.”

This drug shortage of such epic proportions — described as a deadly problem with no end in sight — was likened to that “often associated with third-world countries.”

Keep in mind, this is only the tip of the shortage iceberg. Google “drug shortages” online and you’ll find much, much more.

Americans are not going to care about high-speed rail and broadband in the wilds of Utah or prairies of Iowa if they don’t have life-saving drugs for themselves or their families.