The following article was written by the ladies who put together the benzo petition which is now on the docket of the FDA in the US; they are all former moderators of the Yahoo benzo group. It answers questions and concerns all of us in the US and abroad may have about this petition and why we should even care about it. Read their story of what motivated this project. If you have felt your comments won’t make a difference, or you have questions about this petition, your concerns will be challenged here.
“WHY SHOULD ANYONE BOTHER SUPPORTING THE FDA BENZO PETITION?”
A LITTLE HISTORY:
The petition currently on the docket of the FDA requesting changes in benzodiazepine prescribing guidelines got its start several years back when Emily Robin “Frustrated at the ignorance from the doctors I saw with debilitating withdrawal symptoms, from short term Klonopin use, caused me to research benzo drug labels, it was in doing that I saw some inconsistencies and room for improvements. These inconsistencies were serious in terms of duration of safe drug usage, physical dependency onset and withdrawal healing duration. In searching the FDA website and phone conversations with people at the FDA I learned that citizens can formally petition the FDA and request specific changes or actions, and this is what started me on this journey.”
FOLLOWING IN THE FOOTSTEPS OF SUCCESS:
At about this same time, a member of a benzo group, Diane, gave Emily a copy of an actual Citizen Petition which had been sent in to the FDA requesting that trans fat data be disclosed on all food labels in the US. The group that did that petition was successful in getting what they requested of the FDA--we now have trans fat information on the majority of our food items purchased in the US, and that is the direct result of the Citizen Petition process. The success of that petition was due to a group of people caring about an issue enough to submit their requests to the FDA in the form of a Citizen Petition, and having both the scientific data and support of individual citizens to back up their requests.
Emily now had a concrete example of an effective citizen petition from which to work and created the initial benzo petition as she was able, while at the same time working through her own withdrawal off Klonopin. She was also actively moderating on the old Yahoo benzo group and simultaneously dealing with the issues we all do in benzo withdrawal such as jobs, etc.
JOINING FORCES:
Emily and Shirley Dahl met on the old benzo group when Shirley was helping with moderating during her very long withdrawal off Ativan. When she read the petition written by Emily based on the format of the trans fat petition, it was like an epiphany--she felt compelled to offer her help from her background in medical records and medical editing in order to enhance and expand upon the petition. Years ago she had been involved in writing a successful bill to change educational laws and guidelines in her home state to allow parents to homeschool their children. From that past experience in seeing a grass roots effort succeed, she knew it was possible for individuals to bring about some radical changes by combining their voices into a powerful collective voice. From the first day she saw the initial petition she knew it was a very important piece of work that simply had to get before the FDA in a way that would capture their attention and their hearts. “Our collective voices and stories of the suffering benzo’s are causing have to be heard by the FDA” and this was a way to accomplish that. Finding out there is actually a way for an average citizen to be heard by the FDA and stop the benzo problem on the front end by changing prescribing habits of doctors, versus picking up the pieces of shattered lives after the damage has been done, was very intriguing. This was a huge undertaking by Emily, and was a project most worthy of jumping in on and lending a hand to.”
“I saw this as an opportunity to channel my own extreme frustration at the medical community, due to my benzo experience and watching how doctors prescribe through my work, into something productive for others, while at the same time being therapeutic for me—it gave meaning to the previous three years of hell I had been going through—my thought was that maybe something good could actually come out of all of this. Just like so many others, I had experienced the unfathomable depths benzo withdrawal can take one to; it’s like a dark curtain descends on us. Through the lens of my personal beliefs, I had such a strong sense that the heart of God himself is very broken over the benzo issue for those who are being harmed (and even dying). I know it sounds very cliché, but I truly felt that I had been brought back from the edge of my own health crisis (brain tumor/brain surgery and subsequent benzo withdrawal) for a reason. It literally breaks my heart to know that at this very moment there are those feeling the same way I did (physically, psychologically, and spiritually). My hope is that this petition will allow the FDA to see the human side of this issue, and by educating the FDA it will ultimately put a stop at the source to the harm being done to so many. We simply have to speak out on this and try to do everything in our power to make the FDA aware of how destructive these medications are.”
Anthea Young, with her background in research writing and teaching, and being the co-owner of the benzo group, then took what was now version two of the petition and brought needed structure and clarity to it, while adding her own touches; this yielded version three.
"During the ten long years I struggled with benzodiazepine problems, I came to the realization that something needed to be radically changed. The information about benzo’s and their problems was available but it wasn't in the hands of the right people. The medical profession wasn't aware of rational prescribing habits; they weren't aware of the problems of long term or even short term use, and when people got into trouble they had no idea how to fix it. It seemed to me that the doctors needed to be re-educated and my thoughts at the time were that there needed to be some national protocols developed around benzo’s, and these needed to be taught at medical schools. But how to make that happen I had no idea, so I was spending my time trying to save people from benzo’s one at a time. Then Emily asked if I would read the petition. When I saw what had been produced, I thought to myself - WOW - this is it - this is the mechanism that could educate not only the medical profession but everyone else as well. If the requests made in the petition were to happen, then we could stop the suffering and save countless lives. What else could I do but support such a wonderfully worthwhile idea. My contribution hasn't been huge compared with the hours that Emily and Shirley have put into this, but I have been extremely honoured to be involved - it has my complete support, and I hope that it will have yours too - together we can make a difference."
We were very fortunate in that Professor Heather Ashton joined our team by giving us her valuable insights; she reviewed this petition on several occasions, right up to the final version. Her assistance was deeply appreciated and an invaluable contribution. Dr. Ashton then honored us with her endorsement of this document, along with the other notable physicians who signed it.
A LONG HARD STRUGGLE:
By this time some hard decisions were made and it was decided we needed to revamp the whole thing as it was getting too complex, while retaining the good parts that had accumulated to date. Back to the drawing board we went—ugh! Yes—it has been a very long, tedious, and frustrating experience for all of us:). Finally, many months later after some amazing hurdles had been crossed, we had a final document.
It is really quite amazing that three people with very different personalities and approaches to things, who have never met each other face-to-face and live thousands of miles from each other, produced this document working on the Internet, all while being in different stages of our own benzo withdrawal and dealing with ‘life.’ The common thread driving us to hang in there and complete this mission is the desire to end this benzo nightmare and give a voice to all of you who are currently going through this and those who have suffered before us.
A TRUE GRASS ROOTS EFFORT:
Usually Citizen Petitions are filed by lawyers or large consumer groups—it is a rather unusual to have just a couple individuals file these petitions. Thus, the benzodiazepine Citizen Petition is in the truest sense of the word an international grass roots effort, as it was written by two US citizens and one New Zealand citizen simply because we care deeply about this issue and how it has, and is right now, impacting all of you. No lawyers have been involved in this process.
The many sources now available to those wanting to document the benzo experience, (such as Ray Nimmo’s site at www.benzo.org.uk , the work Anthea has put into her site and her surveys, the education we received through being involved in on-line benzo groups, the wonderful people who have stayed involved in the benzo issue through leading groups and other activities despite wanting to move on with their own lives, etc.) have all been essential elements for providing documentation to base this petition on. We are grateful for all the contributions these people have made which made this petition possible.
FOLLOWING IS SOME Q&A BASED ON QUESTIONS WE HAVE HEARD ABOUT THE PETITION:
1. WHAT DO YOU HOPE TO ACCOMPLISH?
We hope to change benzodiazepine prescribing guidelines so that all labels mention that benzo’s are only meant for 2-4 weeks use (so far Ativan is the only benzo that states this). We want all benzo labels to mention the issues of protracted withdrawal, as well as info on slow taper, and that this info needs to be in all pharmacy leaflets and at benzo manufacturer websites. We hope that it becomes widely known that benzo’s are only meant for 2-4 weeks use, and we hope this decreases the cases of people becoming physically dependent on benzo's and suffering withdrawal.
2. DO YOU REALLY THINK THE FDA WILL TAKE THE ACTION REQUESTED IN THIS PETITION?
We are very confident these requests will be enacted, assuming the FDA gets a true picture of the harm being done. If Ativan had not changed their label in 2007 to reveal that benzo’s are not recommended for over two to four weeks of use, and that withdrawal has been noted after one week of use when stopped abruptly, we would not feel as confident as we do that the FDA will enact our requests. Our requests are very logical in light of the changes made in 2007 to the Ativan label. Also, the scientific literature that has been published for many years clearly supports our position, and this was used as a foundation of our petition.
The only thing left that would help the FDA understand this issue is the magnitude of this problem, demonstrated to them with your personal stories and statements in support of this petition. Yes, it’s true we have a section giving a few personal accounts of benzo experiences in the petition already. But those cannot possibly have the impact that thousands upon thousands of first-hand stories to the FDA would have from the many people who have endured this hell. Along with our Citizen Petition, we sent the FDA a copy of the signature petition that has been on line for several years now, written by Cindy Samora. However, as those are not authenticated signatures, they are considered anecdotal. Direct, first-hand reports from all of you would be most beneficial.
3. WHY DIDNT YOU REQUEST THAT BENZO’S BE BANNED?
Even though we may all have preferred to see a petition requesting that benzo’s be banned or severely restricted, we took the approach we did as it is much more realistic to request that benzo drug labeling be changed to match Ativan’s which already states benzo’s should not normally be prescribed for over two to four weeks, and that withdrawal symptoms have been noted in as little as one week on the drug with abrupt discontinuation of the drug. We felt that approach was a bit of a ‘no-brainer’, as far as how the FDA might view our requests. We also added needed information that is not on the Ativan label, so that in the end the new labels for all benzo’s will give accurate and comprehensive information to patients and doctors. If these requests are enacted, it will have a very beneficial outcome on the benzo problem.
4. ATIVAN HAS HURT A LOT OF PEOPLE—HOW COULD YOU HAVE THE AUDACITY TO RECOMMEND THE FDA FOLLOW THE ATIVAN LABEL?
We wholeheartedly agree that Ativan/lorazepam is a very problematic drug and has hurt many people (that is the drug Shirley tapered off of, so there is no lack of appreciation for the horrors of Ativan). However, the current labeling on Ativan after the changes were made do reveal a portion of the information that needs to be made available to all medical providers and patients alike, and the other benzo labels do not yet do so. So, using their label as a starting point and then improving on it (which is what our requests do) will help prevent the development of physical dependency to benzodiazepines.
5. WHAT’S IN IT FOR ME AND THOSE I CARE ABOUT IF THESE PROPOSALS ARE ENACTED BY THE FDA?
There will be a number of benefits to you if these proposals are adopted by the FDA:
- Knowledge. It will increase the awareness of doctor and patient alike on both the proper use and the dangers of benzodiazepine prescribing.
- Accountability. If correct information is made available to medical professionals from a respected source (FDA and pharmaceutical companies) and it is then ignored, this sets the scene for ensuring that doctors are held accountable for their prescribing habits, for disability payments due to harm, and eventually legal action.
- Validation. Having the correct information documented in a respected place would validate our experience in the eyes of our doctors, family, friends, and employers.
- Prevention of future problems. Until the correct information about benzodiazepines gets out into the hands of the people who need it (doctors and patients), this problem isn't going to get any better for the next generation of people--our children and grandchildren are at risk.
- Correct treatment. Without a way to get the correct information out into the hands of the people who need it, those who currently have a problem are going to continue to have difficulty getting the help they need to get benzodiazepine-free.
- You will have the personal satisfaction and pride of knowing you literally helped save lives and kept others from our own experience.
If the FDA makes the changes we request, then patients will have recourse when dealing with their doctors. All they would have to do is show their doctor a drug leaflet or drug label. These changes may legally help patients who are over-prescribed the drug after the drug label changes are made. People that are going through withdrawal and are being doubted by their doctors or family, can feel a sense of vindication if the changes get made.
6. WHY SHOULD THOSE OUTSIDE THE US BOTHER WITH SENDING THEIR COMMENTS TO THE FDA?
It is most definitely worthwhile for those outside the US to comment on the petition. Firstly, the FDA doesn't restrict comments to just those who live in the US; it allows and takes note of all comments from around the globe. Secondly, the US is a leader in medical ideas and protocols; if things don't change in America, then it is unlikely that things will change elsewhere, especially in the smaller countries around the world. Like it or not, we all now live in a global society, so what happens in one country affects other countries, both good and bad. Anthea, who is from New Zealand, has fully supported this petition.
7. IF THESE CHANGES ARE ENACTED, WILL IT MEAN I WON’T BE ABLE TO GET MY BENZO PRESCRIPTIONS FILLED FOR MY TAPER?
Absolutely not—this will not be a risk. We have heavily emphasized in the petition the importance of gradually tapering patients off these medications and that current protocols that rapidly pull patients off are extremely harmful. The recommendations in the petition to allow patients to taper at their own speed are mentioned throughout the petition. A patient is at more risk for this to occur now under the current labeling guidelines than they would be if our requests are enacted.
8. IF THESE PROPOSALS ARE ENACTED, WILL IT MEAN BENZO’S WON’T BE AVAILABLE FOR LEGITIMATE USES WHERE THEY CAN BE OF BENEFIT?
We can see no reason why these proposals would have that effect. What they would do is help prevent doctors from putting so many people on them in the first place. Doctors will still be able to prescribe as they see fit—we have not prevented them from making medical decisions. But accurate information on the risks of these drugs will now be widely known to both doctors and patients. The good of the many will now be a concern of our doctors. Special unique needs of patients (such as in the elderly or sick, or those who truly need benzo’s for various reasons), will be protected. Benzo’s have legitimate applications for things such as one time use before medical procedures, use for very short-term crisis sedation, etc., and doctors will not have their hands tied in any way by our proposals. We believe that when patients and doctors alike have full informed consent, the very best medical decisions will be made.
9. WHAT HAS THE RESPONSE RATE BEEN LIKE SO FAR?
To date, the response rate to the petition has been quite poor and rather disappointing (at last check only about 140 responses total). The various benzodiazepine support groups have memberships in the thousands and the benzodiazepine problem itself affects millions of people world wide, yet the comments on the petition are relatively few.
10. WHY DO YOU THINK THE MAJORITY OF BENZO VICTIMS HAVE NOT COMMENTED TO THE FDA?
We are not sure why this is, but are speculating it might be for the following reasons:
- Possibly people feel too sick to be bothered, and that is understandable given the nature of withdrawal and recovery. If you are too sick to comment to the FDA yourself, get someone else to do it for you, and at the same time get them to make a comment as well. We could more than triple numbers if we got family and friends to comment.
- Privacy may be another concern--people may be hesitant to share such personal details of their lives and think there might be repercussions if they put their stories out there. Right now there are about 38 viewable comments on the FDA site supporting the petition. People may not realize they can choose to have their comments kept private by selecting “Individual Consumer” in the drop down box in the comment section (see end of article for details). The majority of comments the FDA has received so far are private ones, so very few are in public view. No one has to know you commented. If people are feeling extremely hesitant to comment, they can even just use their first name; you don’t have to fully identify yourself to the FDA.
- Possibly we haven't made the commenting process easy enough to understand - if that is the case, PLEASE let us know - we are only too happy to walk you through it. We recently changed the directions just in case they were confusing to some. So if that was your experience, please try again. Remember, if you have trouble with the process, we are only too happy to be of assistance--just shoot us an email at the address below.
- People may think it is unlikely to make any difference—apathy, basically. People often assume in situations like this others will make the effort, and that their own small voice won’t change anything anyway. However, this is a very unique opportunity to stand up and be counted and actually make a difference—it really can happen. If you have not commented to the FDA so far, please don't let apathy be the reason you don't comment on it in the near future. This window of opportunity could close soon, and there is a real opportunity here (we wouldn’t have worked our ‘you-know-what-off’ if we didn’t think this was possible).
- Benzo sufferers may already feel victimized by the FDA and the pharmaceutical companies and want to stay as far away as possible from these entities. However, we believe the FDA is not something to be feared-people who work there are average citizens just like we are. There can be a lot of unfounded fear of government which makes people avoid taking action that could actually help their fellow citizens (who are their family and friends).
- Lastly, people may have concerns and questions about the petition that have not been addresses so far. If you have concerns about the petition that are keeping you from voicing your support to the FDA that have not been addressed, please communicate with us on this so we can clarify any obstacles you may have. Just send an email to: benzo_action@yahoo.com
11. HOW MUCH LONGER DO I HAVE TO SUBMIT MY COMMENTS?
The FDA gives no guarantees on how long the comment period will be available to the public, so, as the old saying goes, don’t put off until tomorrow …………. :) Just think, if this opportunity had presented itself several years back, the majority of us would likely have been spared the horrible experience of benzo withdrawal.
FINAL POINTS WE WOULD LIKE TO SHARE:
We want you to have your voices heard by the people who have the power to actually stop this benzo madness, but only you can join your voice with ours to create a powerful impact on the FDA—it can only be done by you sending in your comments. Reading the petition and agreeing with it (either in all or in part) is simply not enough. You have to take one additional very small step and voice your opinion. This is easy to do and only takes a few minutes. We may be a very diverse group of people, but we have the common thread of having suffered great harm from benzodiazepines and wanting this stopped. Given what we all have learned the hard way, we have a moral and civic responsibility to do the right thing and help prevent this harm in others, particularly when it requires very little from us to do so.
Let’s not let this unusual opportunity we have to bring an end to benzo dependency slip through our fingers. Whether you agree with the petition on every detail or not, please don’t miss the big picture and the potential we have to stop creating benzo victims if these measures are passed. Take a couple minutes right now while this is still fresh on your mind and send in your comments to the FDA—it is very easy. You can make your comments as short or long as you like—just follow the link below for more information.
Let’s all ban together from around the world and do our part to cause the FDA to put an end to the horror of benzo dependency!
To READ the petition or a short summary of it, and to COMMENT, go to: www.benzosupport.org (Scroll down to the bottom of the page and follow the links).
NOTE: We all deeply appreciate your taking the time to read this article. If you have more questions or comments, feel free to email us at: benzo_action@yahoo.com.
Just a note to let you all know that Alison Kellagher passed away this last Tuesday. If you didn't know her, you missed a gem. The news story is here: http://www.coloradodaily.com/cu-boulder/ci_15015300#axzz0nAWOCudS
Alison was a Moderator on the Benzo group for a time. She was a wonderful person who helped many people who were in withdrawal from benzos and other psych drugs and never, ever gave up pursuing her dreams. She wrote a bit of her story here:
http://www.benzosupport.org/alison.htm
I know everyone who loved her will miss her very much. She left behind a great husband, Bill, who stuck by her through thick and thin. She was truly special in many ways and I am thankful to have known her.