Monday, November 14, 2011

Money, Money, Money, Money . . . Money- More on the Doxil Shortage

"Some people got to have it."

J&J company, Janssen Products, LP, posted an update last week(on 11/9/11) about the Doxil shortage.  Unfortunately there is no indication that the shortage will end any time soon.  Janssen's president, as a cancer survivor himself, sympathizes with those of us affected by having our treatment plans interrupted or,  in my case, changed.  But, we are s#!t out of luck because Janssen chose to rely on one manufacturer to produce a drug which has no generic competition because it effectively still has patent protection in the US until 2014. (Doxil's patent expired in 2009 but J&J/Janssen still has the monopoly under the Orphan Drug Act as a reward for acquiring the company which produced a drug for a rare condition-one affecting fewer than 200,000 people).

According to Janssen,  this shortage has nothing to do with profit.  Here is Janssen's explanation:

Supply Management and Reason for the Current Shortage of DOXIL®

It is our practice to provide early warning of any shortage in supply of our medications so that prescribers, pharmacists and authorized distributors have as much lead time as possible to plan and source alternative treatment options where it may be appropriate. We alerted the U.S. Food and Drug Administration (FDA) and the healthcare community in June when we first determined that DOXIL® might be in short supply for a few weeks. When we learned that the shortage would be longer term, we quickly alerted healthcare professionals and directed them not to start new patients on DOXIL®. We have since continued to provide regular updates on the status of DOXIL® supply. 
The current short supply situation has been caused, in part, by unplanned downtime due to equipment failures at our independent specialty manufacturer. Some have challenged us, asking if our DOXIL® shortage is financially motivated in any way. We appreciate this opportunity to tell you that this is absolutely not the case. 
We are working closely with this supplier to restore uninterrupted access to DOXIL® as quickly as possible. Until that time, we expect product supply to remain intermittent over the next several months as this manufacturer works to return production capacity to the levels necessary to supply all patients in need. DOXIL® is complex to manufacture -- consisting of multi-step processes that require significant production times – which may add to the time it takes to bring us back up to full supply. (Italics added)
I still do not understand how equipment failures would lead to such a long time to restore production.  I am inclined to believe Ben Venue's original explanation to the WSJ in July  2011 that Ben Venue had made decisions to "prioritize" drug production  in response to a loss of production capacity and other production problems at their facility.  To me, this statement makes clear that Ben Venue decided to focus on manufacturing other more profitable drugs than Doxil when production problems arose, which is supported by Ben Venue's decision at about the same time to get out of the Doxil manufacturing business.  Given that  Janssen  had only this one manufacturer and no contingency plan when production stopped, I can only conclude that Janssen did not consider this drug sufficiently important (i.e. profitable), notwithstanding their protestations to the contrary and their orphan drug exclusivity status.

A recent article in the New England Journal of Medicine (The Shortage of Essential Chemotherapy Drugs in the United States,Mandy L. Gatesman, Pharm.D., and Thomas J. Smith, M.D.N Engl J Med 2011; 365:1653-1655 November 3, 2011)  also agrees that the drug shortages are first and foremost caused by profit motive:
The main cause of drug shortages is economic. If manufacturers don't make enough profit, they won't make generic drugs. There have been some manufacturing problems, but manufacturers are not required to report any reasons or timetable for discontinuing a product. Contamination and shortages of raw materials probably account for less than 10% of the shortages.
Janssen still has not told us much of anything about why the Doxil shortage happened and when it will be fixed.  To me, that is completely irresponsible and lamentable.  However, until the health care system in this country is not solely governed by the profit motive, we can expect no other result.

No comments: