Arpo takes aim at FDA over latest Rx madness

As companies like Abbott and Zogenix race to get their ER (extended release) hydrocodone products to market, regardless of the fact that the Obama administration has already referred to the over-prescription of narcotic pain medication as a national “epidemic”, one group is asking you to do something if you want to stand up and fight against the tyranny and lunacy that this issue now represents.

Advocates for the Reform of Prescription Opiods (ARPO) has initiated a letter writing campaign to voice their objection to the consideration and potential approval of new drug applications for pure hydrocodone products manufactured by companies like those mentioned above. The first letter was mailed Tuesday of this week to Dr. Margaret Hamburg, Commissioner of the FDA, and a list of those who were carbon copied is detailed below. ARPO is a Northern American organization consisting of “bereaved parents, siblings and spouses, families of those suffering through an addiction, pain patients, doctors, and citizen advocates working toward more balanced care for patients who suffer from chronic pain, without causing harm to them and to the general public.” Their mission is “to end the epidemic of death and addiction caused by prescription opioid drugs”, and more information about them can be found here http://www.rxreform.org/ .

According to ARPO President Peter Jackson, “The goal of this campaign is to compel the FDA not to entertain any new drug applications for the new ER hydrocodone formulations being developed. It makes NO sense for them to consider new opioid approvals when in the midst of an out-of-control epidemic.” Their letter to Dr. Hamburg addresses several “myths” that seem to drive the federal drug policy including the fact that as many as 35% of legitimate pain patients who are prescribed long term opiods may suffer a life long dependency disorder as a result as well as the fact that there is a mountain of evidence that points to inappropriate and unethical “treatment” of pain nationally. While the letter does include statistics on overdose deaths that result from these practices and abuses, it fails to come right out and say that people are dying as a direct result of some companies (and some doctor’s) avarice for bottom line profitability, and that the FDA should be ashamed of itself for even entertaining such applications in light of all that has occurred. Furthermore, this new formula of pure hydrocodone will repeat the tragedies that occurred with OxyContin, and may even make us long for the days when that was the only issue on the radar.

Consider also the fact that Opana was introduced in 2006. According to Endo pharmaceuticals, this new and more powerful medication “was developed in part to provide an alternative to patients who’ve developed a tolerance for a specific painkiller” (i.e. OxyContin). The company goes on to say that Opana is a “true” twice a day pain reliever and attempted to separate itself from oxycodone based OxyContin’s reputation for abuse due to the fact that Oxycontin is a 12-hour formula, thereby encouraging user to take more than prescribed. In actuality, oxymorphone based Opana is more of a sedative and provides a shorter euphoric high. This shorter high makes Opana extremely habit-forming since abusers require more of the drug to maintain the desired level of euphoria, thereby requiring it to be taken more often. It may also be noteworthy to mention the fact that Purdue once had a patent infringement suit filed against Endo which was later dropped.

This may very well be the height of ridiculousness and a prime example of how these manufacturers attempt to redirect attention away form the truth. The truth is this: Endo had their eyes fixed on the fact that OxyContin recorded $3 Billion in revenues for Purdue in its first six years and Opana is 2-3 times as strong. The truth is also that Endo has marketed this SAME product under the name Numorphin (referred to as “blues” in the 70’s). It was taken off the market in 1972 due to its high potential for abuse. In the aftermath of the OxyContin explosion, Endo has RE-RELEASED this product calling it Opana and our own FDA has allowed it to happen. Since its reintroduction, the death rate for Opana in FL alone has increased by more than 242% in one year (’08-’09). Because of its relative “newness”, local and even national overdose death statistics have been harder to come by to date.

Locally, Dr. Neil Capretto at Gateway Rehabilitation Center has been quoted saying “I’ve had patients call it Oxycontin on steroids” and “It just came out in the last two years, and it’s been skyrocketing on the streets in the last three to six months.” A purer, more potent form of hydrocodone (SuperVicodin?) will in all likelihood follow the same trajectory.

Not only did the FDA allow for Opana to be (re) released, but it did so at a time when the OxyContin problem was already under fire. 11 months later Purdue was being fined $634 Million for many claims the FDA had not approved. Does anyone else feel like their intelligence is being insulted a bit? Now we are poised to repeat history once again with the redevelopment of pure hydrocodone.

When is enough enough?

If you are ready to say ENOUGH, then write to the FDA, send copies to all who are listed below. If you are at your wit’s end with companies like Purdue, Endo Abbott, Zogenix, Watson, Mallinckrodt, Ivax and Boehringer Ingelheim and others profiting from the death and enslavement of Americans, send copies to your local legislature, state reps and senators. Let them know you are outraged by this “legal” drug dealing in you neighborhood doctor’s offices and pharmacies. Let them know it’s not okay to get people hooked on pain medication for profit. Let them know there is too much of this available to too many. Write today while you can stop the next wave of opiods from hitting the streets of your town, falling into the hands of your family and friends, driving up crime and healthcare costs, decimating families and destroying lives.

If you need more information, contact resources like these:

http://www.rxreform.org/about-us/mission-statement/

http://www.prescriptionaddictionradio.com/

http://www.oxyabusekills.com/oxymessageall.asp?dispoption=zge&pg=141

http://www.stoprxdrugabuse.org/

http://www.responsibleopioidprescribing.org/

If you aren’t outraged, you aren’t paying attention.

A good place to start sending your letters:

Margaret A. Hamburg, MD

Commissioner, U.S. Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993