EXTENDED REMARKS

Submitted June 30, 2009,

by

Betts Tully

In addition to speaking before the REMS hearing board, both on May 5 & May 26,27, the following remarks are submitted for the board to consider:

Unlike the usual chronic pain patients you have heard from, who appear to be connected to pain organizations, which are heavily funded by pharmaceutical companies, I think I represent a significant population of patients, who feel the medical community and the regulatory agencies have let them down over the last 15 years.  Patients, suffering, as I have,  with an unwanted, unwarranted condition, called “legal and medically prescribed addiction”.  Patients, who simply went to their doctor for treatment for chronic pain and ended up with the added disease of addiction and all the devastation that comes with that.  Some received death.  Patients, who now struggle with the shame and disgust of being forced to deal with the physical and pharmacological effects of long-term narcotics, which in many cases has now overshadowed their original pain complaint.  Patients, who never dreamed they would one day end up in a detox clinic.

I want to make it unquestionably clear that I am absolutely in favor of using APPROPRIATE opioids for APPROPRIATE pain syndromes.  As a chronic pain patient, who is likely to need additional surgeries on my spine, I want to have appropriate and adequate pain relief given by trained pain management specialists or practitioners, available to me when I will need it.  My comments in no way indicate a desire to take away the much needed pain relief suffered by intractable pain for appropriate candidates for pain medication.

Before I tell you of my personal experience, I must say that I find it inconcievable how the very agencies, which are in place to protect us, have been the very agencies, who have contributed most heavily to what is now considered to be a national crisis in the management of pain and proliferation of prescription opiate use.  Agencies, both governmental and medical, that have contributed by neglect and non-action in the face of escalating death and addiction every year since 1996.  When I read the transcripts of the scores of meetings and hearings held on risk evaluation and mitigation, held by the FDA, it is unequivacably clear to me that this entire situation was for-warned, and the inadequacies in the systems were well known and documented.  Discussions held in 2003 clearly showed that evidence based scientific studies and trained practitioners, were NOT in place prior to allowing a mass influx of Schedule II drugs on the market.  The FDA was well aware of the lack of training among practitioners, which was desperately needed to insure the safety of the public from inappropriate use of opioids to manage pain.  To make things worse, fraudulent claims were allowed to penetrate the medical field, which ultimately contributed heavily to aggressive and  inappropriate pain management practices.  Those facts are hard to swallow for the average person, who counts on our governing agencies to protect us.

Some key factors of my personal experience as a chronic pain patient on opioid therapy:

• I am a legitimate chronic pain patient, who has never resorted to illegal means to provide me with opiates for pain, nor have I ever “doctor shopped”. 
• My etiology for treatment is degenerative disc disease, 2 back surgeries and lower back pain.
• In 2001, a so-called pain specialist took me from 6-8 Norco per day to 280mg’s of Oxycontin in addition to 10 Norco per day, for low back pain.  Over a 6 month period.  My instructions for taking OxyContin was as follows: Take 5 pills in morn. 5 in aft. And 4 at bedtime.  Kind of like the way heroin users take their drug any time they feel the need.
• He also, after realizing that I was horribly addicted and out of control, abandoned me, refusing to call back other doctors, who were willing to help me with this OxyContin “problem”.
• OxyContin took me from a productive, successful person to a person roaming my house in a stupor.  I lost my job, my house, my marriage, and my life as I once knew it.
• In my naievete, I continued to believe in the claims doctors made concerning the appropriate use of opioids for pain, and over the next 6 years attended 3 pain clinics.  All of these doctors did little more than issue prescriptions for opiates every 30 days and bill my insurance for seeing me to do that once a month.
• Although I instinctively knew to demand never to be put back on OxyContin, I was put on various doses ranging from 60 to 120 mgs of the following narcotics: Kadian, MS Contin, Duragesic patch, MSIR, Avinza.  I can tell you that none of them did the damage that OxyContin did to me. 
• Within these years, my worst suffering came with the longing for my life to return as I once knew it.  I became severely addicted to OxyContin, but after much research on my own I learned that I was also in the vicious cycle of dependancy/addiction to other pain narcotics given to me by my doctors.  It’s called hypo-analgesia.
• Last September, after asking my pain management doctor 3 times over 3 years that I wanted to get off these drugs, with no response, I independantly reduced my amount to 0 (zero).  I am today, although in a certain amount of daily pain, narcotic free.

I believe it is better to know nothing, than to believe something that is not true.  I trusted my doctor to tell me everything I should know about about the subject of pain management and medications.  Here is what I allowed him to tell me:

• Not to worry about addiction, even if there was a family history.
• Less than 1% of chronic pain patients become addicted. 
• Pain patients on opiates only become “dependant” , not “addicted”
• As long as I took my prescription “as directed”, I would have “no problem”
• Opiates allowed patients to live normal, productive lives
• Pain patients could spend the rest of their lives on narcotics, without adverse effects
• Escalating pain could be reduced by higher doses, and that most doctors “under-prescribe” pain

It’s better to know nothing, than to know something that isn’t true.   Had I known what I know today about narcotic therapy, I would not have let this happen to me.  This is what I know today:

·         The catalyst for the above medical statements comes from “junk science”, which was funded by pharmaceutical manufacturers, targeted at medical practitioners to change their prescribing patterns and to have captive the entire market of moderate pain patients.  Notice I left out severe pain patients.  There was not enough money in that target group to justify any marketing efforts.

• The state and federal regulatory systems, and more importantly, the medical institutions that were in place in the late ‘90’s were not sufficient nor adequately prepared for the massive assault of false and misleading information
• The general population of practicing licensed physicians holding narcotic prescribing priveleges were/are undertrained (less than 12 hours of narcotic education and/or pain management training) .  They are heavily reliant on the pharmaceutical claims, as well as the assumed review of the FDA for information on how to treat pain and use opiates.
• The science required to truly study and organize the benefits & risks of opiate therapy was not in place at the time this disaster began.  It is only now emerging to stem the proliferation and inappropriate use of these legal drugs
• The wasted energy and focus on the “criminal” element to explain the death and addiction that began to take place in 2000 only served to cost thousands of more medically – connected deaths and addictions.  The attention given to recreational “abuse” of prescription opioids left thousands of legitimate chronic pain patients in severe exposure to inadequate treatment.
• The FDA has held scores of public and private hearings on the subject of the death and addiction which began to emerge in early 1999, following a mass increase in the prescribing patterns of opioids to the public.  In reading those transcripts, it is perfectly clear that the FDA was advised and understood that there was not sufficient data (studies) available that was needed to understand the effects of prescribing schedule II drugs for moderate chronic pain.  In addition, discussions took place which reflected the FDA’s awarness of the central problem, which was the lack of training  of physicians, who held a license to prescribe narcotics, as well as a  lack of training in pain management practices.

As a citizen of the United States am I supposed to believe that the FDA didn’t know this was and is happening?  Am I supposed to believe that after scores of hearings, not only among this government body, but congressional and state investigations not to mention DEA, GOA, etc. that none of the findings of those bodies can effect the FDA’s rationale to allow the continuation of this broken system, and defective drug products like OxyContin?  Was the unsubstantiated undertreatment of pain that was claimed by questionable sources a good enough reason to create the never before seen death and addiction caused by inappropriate use (by both doctor and patients) of prescription opioids?  How did the desire to more aggressively treat dying cancer patients with pain medications extend to overmedicating practices in the treatment of lower back pain?

You are the top governing body that is given authorization to regulate and PROTECT the public from the harm of certain drugs.  THAT IS YOUR AUTHORITY & MANDATE.  When these other agencies, as well harmed members of the public came to you with alarming facts and figures, why did you not respond?   You allowed the release of inordinate and unprecendented numbers of strong narcotics to enter the public, and as the number of death and addiction rose, you did virtuallly nothing to contain it.  Over and over the FDA continued to respond with little more than repeating the pharmaceutical mantra “we don’t want to take away pain releif for those patients suffering debilitating diseases”.  Do you think addiction is not “debilitating”?  Death is debilitating.  What you knew or should have known, prior to authorizing strong narcotics for the relief of moderate pain to any practitioner holding a license to prescribe, is astounding to me.  The FDA’s hearings/discussions in 2003 reflect all of the inadequacies of a system to contain a growing public threat, yet here we are in 2009 holding ANOTHER risk evaluation and mitigation hearing.

 If I had known what was going to happen to me or the thousands of people who have suffereed under this totally inadequate system, do you think I (or anyone else), would have signed up for “opiate” therapy? 

Perhaps the FDA would like to count me as only one “lone” voice.  I am not alone.  Thousands of patients have been harmed by this misinformation and lack of action.  Instead of directing you to the “pain” orgainizations that will speak to you in this hearing about their completely unfounded fears of not receiving adequate pain relief, I can direct you to the  thousands of “real pain patients”, who are all over the internet pain patient forums and discussion groups, talking about how they struggle with the realities of that word “dependancy”, which in reality is nothing more than a cover word for addiction.  Or how they feel confused, if not abandoned by the doctors, who now refuse to give them their narcotics as liberally as they had.  Or the ones that are flat out abandoned.  Or the ones, who, after admitting to themselves that they are in fact “addicted”,  have been through the excrutiating experience of detox, in or out of a hospital setting. 

Many of these people are inappropriately and over prescribed.  They are under the old delusions that were propagated by the pharmaceutical companies.  The lies, which keep them in  the never-ending merry-go-round of physical dependance/addiction to opiates.  In other words, they are in the same type of denial any addict on the street deals with daily.   And they don’t have enough competant doctors to turn to for help.

And why aren’t they here?  Simple.   Like me, for 8 years, they are doped up, more incapacitated than they ever were with their original pain problem.  But the most attributable reason they are not here, is because this is a shameful and embarassing situation for most people to be found in.  Certainly difficult, if not impossible for most folks to speak about publicly.  A fact the pharmaceutical companies can count on for the silence among the damaged patients.  Worst, they have no agency or medical support to help them out of the hole they are in.

The FDA (again), asks for comment on these issues.  As a formerly opiate prescribed chronic pain patient, whose life was forever altered by this so-called therapy, I offer you the following:

• This is not, nor has ever been a complicated issue.  The benefits do not outweigh the risks.  A medical examiner in 2002 stated that “it does not take a rocket scientist to connect the dots, where OxyContin is concerned, even if poly-drug use is involved, in these deaths.  The common element of OxyContin in all these deaths, speaks volumes”.   
• The scientific evidentiary basis for OxyContin, as well as aggressive narcotic prescribing practices for the treatment of moderate pain, is flawed if not outright junk science, designed to drive  profits only.  Real studies are needed for dangerous products before these drugs and new practices are unleashed on the public.
• The claim that severe and chronic pain is or was “undertreated” is unfounded and scientifically inaccurate.  Accepted scientific evidence, based on rigorous study has never been conducted. 
• Restricting certain dangerous drugs will NOT impede the demand for appropriate pain management.  Pain organizations that “fear” undertreatment of pain should not drive the work needed to resolve this crisis.  Especially those pain organizations, which are founded and heavily funded by pharmaceutical companies.  In fact, the aggressive and inappropriate application of opioids has done more damage for the available treatment of pain, than any original concerns for undertreatment.
• The regulatory agencies that effect the processing of narcotics to the public have the obligation/responsibility for oversight and protection for the public.  This is their mandate and MUST be exercised.  The system that delivers these drugs, which ultimately ends up in the public’s hands, is either broken or insufficient to accommodate this dangerous situation.
• The medical community needs to reverse the policies, practices adopted over the past 10 years in relation to aggressive and unacceptable pain management practices.  It needs to take responsibility for developing “best practices” based on “best science”, in addition to disseminating this information.  It certainly needs to stop blaming patients, after they have served as the source for a patient’s supply of narcotics.  The FDA and the DEA can serve to put in place an administration that demands, and/or requires proper training and qualifications for physicians wishing to treat pain with schedule II drugs.
• The first rule is “do no harm”.  Unfortunately, we are long past that.  Now the “harm” must stop.  Certainly OxyContin has not proven to be a “superior” or “unique” delivery of pain management.  It needs to be severely restricted and regulated, given it’s track record as a pain management tool.
• The FDA needs to do the JOB they were mandated to do.  All of the evidence that they have heard over the course of this public hearing, is no different than the many other hearings they have held on this regard over the past 10 years.    Only higher incidents in death and addiction has changed/increased.   

Risk evaluation and mitigation has been available to you long before this.  Now that the numbers of death and addiction are too great to ignore, you ask for input into what should be done.  Besides suggesting that you exercise the power given to you, this is what I suggest:

1. Take OxyContin off the market for general use, immediately.  It is a defective product. Every patient and prescribing doctor can testify to that and is supported in the millions of prescriptions that were and are being written for q8 hours, even though the manufacturer claims 12 hours of extended release.  The  practice of increasing the the daily amount is a major factor in the deaths and addictions it causes.  
2. Enlist all of the governing agencies as partners to coordinate  effective control of the distribution process of Schedule II and III drugs.
3. Restrict all schedule II drugs to trained pain and addiction management specialists and Oncology practitioners.
4. Discontinue the application process for new Schedule II and III narcotics, which allows for the drug company to submit their own research and support documentation (study’s).  Require an independent panel review for approval.  Only use independent research to support the use of opiates for pain for the general public.
5. Begin and establish scientific based medical research on opiate therapy independent of pharmaceutical input.
6. Provide or establish a registration and/or certification process for all practitioners, who wish to specialize in pain and pain therapy and who want to adopt opiate therapy as part of their practice.
7. Insure that severe pain of any disease or disability can be identified objectively, relevant to the need for strong opioids, and make the availability for those pain medications a readily accessible tool for appropriate and certified physicians, to treat the pain. 
8. Conduct a massive and effective effort to reach all physicians, who are currently treating pain with narcotics.  Provide evidence based information on the pharmachological and biological components involved in opiate therapy.  Additionally, include current data on medical incidence addiction and the detection of addictive behaviors that can be found in the patient/doctor/clinical setting. 
9. Mandate that all state’s have consistant and effective monitoring systems, which include all the oversight tools to insure that medical prescriptions for schedule II and III drugs are safely and appropriately administered.
10. RE-educate the public in particular the chronic and acute pain patient’s of the true risks involved in opiate therapy.  Inform these patients, as well, of the alternative therapy’s they should consider before agreeing to this option.  Include in this infomational campaign those who are in the grip of addiction, the places and reasons to receive assistance.

Who should pay for the massive reform desperately needed at this late stage?  Many people have already paid a much too high price, including myself.  The price of continuing to do little-to-nothing will only bring more death and devestation to thousands of American families.

This is a crisis of unmatched proportion; THIS IS NOT A DEBATE ANY MORE

Exercise the powers given you by the Federal government, paid for by taxpayers, and DO THE RIGHT THING.  Make the broad and sweeping changes that were needed ten years ago, NOW.  The FDA doesn’t need to “evaluate the risks” anymore.  The FDA needs to “mitigate” the damage that has and is taking place right now.