Tuesday, June 28, 2011

Chemo Drug Shortages

Over the past few weeks I've been reading a number of articles on chemotherapy drug shortages. Here is just one video and article on the topic.

On June 16, 2011 Paclitaxel the generic brand of Taxol was put on the American Society of Health System Pharmacists current shortage list(ASHP). These drugs are manufactured in various milligram dosages from 6mg too 300 mg. The reasons given in the bulletin were:
Manufacturing shortage - Teva
Increased demand - APP
No reason - Bedford
There is no direct substitution for paclitaxel.

On June 23,2011 ASHP added carboplatin solution for injection to the list.
The reason for the shortage was given as:
Manufacturing shortage- Sandoz, Teva, Hospira
Discontinued manufacturing in May 2011- Bedford

These two chemotherapy drugs are the standard of care for women initially diagnosed with ovarian cancer and for many who recur. Paclitaxel is also used by women diagnosed with breast cancer and off label for other cancers.

From the ASCO in ACTION website I learned:

June 23, 2011

Drug Shortages Legislation Introduced in the House
This week, Representatives Tom Rooney (R-FL) and Diana DeGette (D-CO) introduced H.R. 2245, legislation that would amend the Federal Food, Drug, and Cosmetic Act to provide the Food and Drug Administration (FDA) with improved capacity to prevent drug shortages. As an important first step in addressing the complex issue of drug shortages, this bill is consistent with recommendations from the November 2010 Drug Shortages Summit co-convened by ASCO. The proposed legislation includes provisions that would expand FDA authority to require manufacturer notification of shortages and market withdrawals, and enhance communication among health care providers and stakeholders in the pharmaceutical supply chain about the nature and expected duration of shortages. ASCO and the Summit co-conveners provided input on this legislation and have sent letters to the sponsors thanking them for taking action on this issue and in support of the legislation.

I am happy that some action is being taken by Congress to address this issue that effects cancer patients throughout the country.
Carboplatin and Paclitaxel are just two drugs on this list. There are other chemotherapy drugs listed as well. Will lives be lost due to this drug shortage? How much worse will the impact be on patients treated at small chemo clinics?How many patients will have their treatment delayed or switched? What about Taxol? Why is there not a shortage of the name brand?

Let us hope that manufacturing rates increase in the near future.

Every Day is a Blessing!


ApopSal said...

Hi Dee and Women of Teal! I am a uterine cancer patient/ surviving after 12 months of treatment with taxol and carboplatin. I realize that my stage 4 metastatic cancer could still be ravaging my body without these treatments. How can we band together to put pressure both on pharmaceutical companies and congress to insure that production of these life saving drugs won't be limited by "functions of the market?" Clearly, the Bush promoted price controls were designed to save the Medicare/ medicaid system money: the unintended consequence - limited production - now threatens the lives of thousands. Thanks for your comments - check my blog - www.Apopsal@blogspot.com. Thanks - let's raise our voices together!

Anonymous said...

Thank you for this information. As a newly-diagnosed patient fighting ovarian cancer, I am incensed that the great majority of news outlets are not addressing an aspect of the taxol shortage: the additional costs associated with the substitution of taxotere. Because my second infusion will require taxotere as a result of the deliberate manufacturing shortage, I will require an injection of Neulasta, a drug that helps my body with diminished red blood cells. This drug, according to my oncologist's patient advocate staffer, will cost $7,000! If I were able to take taxol, my oncologist's drug of choice, I would need no Neulasta. Who's making money here?

Dee said...

Sorry to hear about your recent diagnosis . Having a drug shortage while being treated can only add to an already stressful situation.

You are correct that taxotere costs more and has a greater impact on blood counts than taxol. I took neulasta /neupogen when I had taxol ( I've never had taxotere).

There is an ongoing discussion of why some manfacturers stopped producing taxol but I am sure that profit margin might be one.
Good luck and thank you for commenting.