both LasVegasDave and Flutters.
Posted on 12/15/2011 7:44:07 PM PST by EBH
Bedford-based company that makes drugs to treat cancer is under scrutiny ...
...Ben Venue Laboratories Inc. announced on Nov. 19 that it had shut down production, a move that exacerbated an already serious shortage of a critical drug to treat ovarian cancer.
The company does not know when it will resume production of the drug Doxil, but is working on correcting the problems as quickly as possible, Boehringer Ingelheim Corp. spokesman Jason Kurtz, said Thursday in an email. Boehringer Ingelheim owns Ben Venue.
Kurtz said the company was not prepared to address specific questions at this time, but will make more information available when it's appropriate.
"Our highest priority is the delivery of safe and effective products to patients," he said.
Pharmaceutical companies in the United States and Europe contract with Ben Venue to manufacture injectable drugs used in hospitals to treat cancer and other serious conditions. Ben Venue has more than 1,300 employees.
On Tuesday the European Medicines Agency -- whose role is similar to that of the U.S. Food and Drug Administration -- announced that it was recommending what it called a "precautionary recall" of six drugs manufactured at the Ben Venue facility in Bedford before the company shutdown.
Among the drugs targeted for the recall are those that treat viral eye infections in AIDS patients, and drugs to treat patients with myelodysplastic syndromes, a group of diseases that affect the bone marrow.
The EMA's recommendation is based on Ben Venue volunteering to temporarily suspend manufacturing and distributing drug products while it took time to undergo a thorough review of operations at its facility on Northfield Road.
An FDA report based on a visit to Ben Venue from Nov. 7 through Dec. 2 illuminated some of the issues,
(Excerpt) Read more at blog.cleveland.com ...
Over the summer physicians were warned of an impending shortage of Doxil and were urged not to start any new patients on the therapy.
"We have hundreds of patients on the wait list," Dr. Robert DeBernardo, a gynecological oncologist at University Hospitals Case Medical Center, said Thursday.
Ping FYI
Another example of government at work. The Taliban wants to take us back to the 14th century and Obama wants to take us to the 18th century. We have choices in November 2012.
Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.