I learned about this pharmaceutical drug Doxil® from an ovarian cancer patient, Cary, who I met over the summer. We had conversed prior to meeting for some time as I was doing a promotion from our medical scrub site to help her organization, Teal Toes. She brings awareness, through Teal Toes, to ovarian cancer.
I recently asked Cary about this the Doxil® shortage. Cary learned that the company stopped making this drug through Facebook, rather than, more appropriately, from her own doctor. Someone posted that they were looking for the drug on her Teal Toes Facebook page. She explained that the drug was in short supply throughout the summer and that she could not find much information about it at all.
But this time it was not just a shortage.
The manufacturing company itself, Ben Venue* in Bedford Ohio, stopped manufacturing the drug Doxil® – a drug successful in helping cancer patients! Reasons given for halting the manufacturing process include contamination issues and a shortfall of quality process management.
Because Ben Venue is the sole supplier, officials warned doctors to monitor Doxil® users for adverse effects possibly related to contamination.
How can drug manufacturers fail to properly maintain equipment necessary for the manufacture of life saving medications?
It’s not as if they produce designer clothing or TV sets.
They produce pharmaceutical medications that save lives, or at the very least, extend lives.
I recently heard from Carey who told me she started on a Doxil treatment protocol in May 2011. She had this to say, “After 4 treatments, both my blood marker # (CA 125) had fallen significantly and CT showed some [tumor] shrinkage. Now that I have been off of it 4 months, my CA 125 is almost back up to what it was in May.”
A decreasing CA 125 level generally indicates that the tumor is responding to therapy, including chemotherapy, while a rising level indicates the tumor is not responding to therapy.
Because of test variation, small changes are usually not considered significant. Typically, physicians consider a doubling or halving of the previous value as important.
Because of the shortages in the U.S., some ovarian cancer patients have turned to other countries, such as Vietnam and Britain, for access to these types of medications. Patients overran a pharmaceutical plant in Cuba in May 2011 — patients looking for Vidatox®. More than 10,000 patients, some 3,500 of them foreigners, participated in trials for the drug with positive results in both improvement of quality of life and reducing tumor growth.*
How can cancer patients, their families, and friends make a difference and get Doxil®, and other lifesaving drugs, back into production in the United States?
Janssen Biotech, Inc. 800 Ridgeview Road, Horsham, PA 19044
Calls: 1-800-JANSSEN (1-800-526-7736)
Create YouTube Videos to Spread Awareness
Create Facebook Pages to Spread Awareness
Keep Yourself Informed
Check the constantly updated lists of drug shortages available online at U.S. Food and Drug Administration (www.fda.gov/drugs) and the American Society of Health-System Pharmacists (www.ashp.org/shortages). The ASHP list includes some meds that the FDA’s does not.
Estimated new cases and deaths from ovarian cancer in the United States in 2011 from the National Cancer Institute: New Cases: 21,990 / Deaths 15,460
Check out this YouTube video by: BeetMedicineTV – Elizabeth Poyner, MD, PhD Gynecologic Oncologist
Symptoms of Ovarian Cancer Include
Abdominal pressure, fullness, swelling or bloating
- Pelvic discomfort or pain
- Persistent indigestion, gas or nausea
- Changes in bowel habits, such as constipation
- Changes in bladder habits, including a frequent need to urinate
- Loss of appetite or quickly feeling full
- Increased abdominal girth or clothes fitting tighter around your waist
- A persistent lack of energy
- Low back pain
*Division of Johnson and Johnson – Janssen Division (Ben Venue is in Bedford, Ohio)
Photo credit: presstv dot ir, particularcuba dot wordpress dot com