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DEA Letter Sparks Fears About Intimidation of Buprenorphine Docs
October 1, 2009

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News Feature
By Bob Curley

A recent letter from the Drug Enforcement Administration (DEA) to doctors certified to prescribe buprenorphine sparked concerns about intimidation and a perceived attempt to suppress the number of physicians prescribing the anti-opiate medication -- an impression that the Obama administration moved quickly to dispel.

The July 24 letter was addressed to individual healthcare providers who had received waivers from the Drug Addiction Treatment Act (DATA) in order to prescribe Subutex and Suboxone, both buprenorphine-based drugs that are used as an alternative to methadone maintenance.

DEA Miami Field Office diversion manager Barbara A. McGrath wrote that waiver recipients are "subject to inspection" by the DEA and that the agency was developing plans "to include inspections of DATA-waiver practitioners." About 18,000 physicians currently are authorized to prescribe buprenorphine.

"To accurately plan for and properly allocate resources effectively and efficiently, we are attempting to discern whether the DATA-waived portion of your medical practice will need to be inspected," according to McGrath, who advised recipients of the letter who don't want to prescribe the drug can exit the program by filling out an attached form. "Once DEA receives and processes your request, we can remove your name from the list of those medical practices scheduled for inspection," McGrath wrote.

The letter then goes on to require that physicians who want to continue prescribing or dispensing buprenorphine for treatment of opioid addiction complete a questionnaire and prepare for an inspection visit by having a variety of documents on hand, including DEA forms, their state license, treatment documentation, and their CSAT certification and waiver letter.

Objectively, the letter could be read as a simple administrative missive aimed at determining which doctors are subject to inspection under the DATA law. But given DEA's reputation among some doctors for choosing heavy-handed enforcement over patient needs -- along with a perceived hostility toward buprenorphine and other opiate-replacement therapies -- the letter resulted in an immediate outcry from recipients.

"Clearly these letters suggest to physicians that if they don't want a DEA inspection they can just opt out of prescribing Suboxone," said Richard Saitz, M.D., a board-certified addiction medicine specialist and professor at the Boston University School of Medicine, who received one of the DEA letters at his home address. Saitz said that the letters may have led some doctors to conclude that "it is the last straw and not worth it to them to put up with all of the challenges one needs to surmount to prescribe buprenorphine."

Charles O'Keeffe, a professor at Virginia Commonwealth University School of Medicine and an epidemiology and community health expert at the school's Institute for Drug and Alcohol Studies, noted that the majority of letter recipients were family practitioners and internal-medicine specialists who "went to the trouble to take the courses and get certified to prescribe" -- in other words, just the kind of providers that buprenorphine backers are hoping will embrace the drug as a way to treat addiction in office-based practices rather than clinical settings.

"Overall, the feeling was that it was inappropriate to single out these physicians," who may be especially vulnerable to feeling pressured by the DEA, said O'Keeffe.

Tom McLellan, deputy director of the Office of National Drug Control Policy (ONDCP), said the field's reaction was understandable, and that the Obama administration is working on a followup letter that will explicitly encourage physicians to become certified to prescribe buprenorphine.

"If you didn't know where the (DEA) letters came from it could be interpreted as a purely administrative document," said McLellan. "The problem is if you get a letter from the IRS or the DEA, it evokes strong emotional reactions."

McLellan told Join Together that acting DEA administrator Michelle Leonhardt "understood immediately" how the letter could have been misinterpreted. "She repeatedly assured me that neither she nor the DEA are against buprenorphine or are trying to discourage the use of buprenorphine," said McLellan. "They are merely trying to carry out their regulatory responsibilities."

"Let's cut DEA some slack on this," McLellan continued. "The field has to understand that this is not your father's ONDCP or DEA -- we're trying to work together to increase the appropriate availability of buprenorphine."

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COMMENTS ON THIS ARTICLE:

Posted by clark brittain d.o. on 02 Oct 09 09:17 AM EDT
i took the course, got certified, but have yet to prescribe.... now will not even think of it... no one deserves this scrutiny and it is further evidence that this administration is continuing the 'war on people' masquerading as a war on drugs...

Posted by Cindy Warren, Addiction Counselor on 02 Oct 09 09:17 AM EDT
Thank goodness this has been clarified. I have enough difficulty trying to find physicians who will become certified and then to find certified physicians that will do the Suboxone program correctly. If my Suboxone certified physicians give up due to heavy hand tactics, many patients will continue to fall victim to Rx opiate drug dependence. I love to see and work with the success stories. Thanks again for the clarification.

Posted by NAABT.org on 02 Oct 09 09:26 AM EDT
I don’t understand the DEAs priorities. Why are the expelling scarce resources inspecting buprenorphine physicians when so many people are dying of the truly dangerous drugs? This has prompted some physicians to drop their buprenorphine practice altogether leaving patients with no where to go in some areas. www.TreatmentMatch.org is still connecting 84% of patients with prescribing physicians but 16% are going untreated. In 7 years we’ve only been able to get 3% of US physicians to become certified to prescribe buprenorphine (While 100% can prescribe the drugs people become addicted to ).The last thing we need is another reason for doctors not to prescribe buprenorphine. We urge the DEA to focus on the drugs that negatively impact public heath not the lifesaving treatments and those who provide it. NAABT

Posted by George Clarke on 02 Oct 09 10:19 AM EDT
Has anyone pointed out the self limiting factor of Buprenorphine and the safety factor added to make Suboxone to the DEA? They must know about this. Looks like they are fireing a shot across the bow to maintain their integrity and would not do anything about it anyway unless a real problem showed up.

Posted by Melody on 02 Oct 09 11:26 AM EDT
Why aren't they carrying out there responsibilities on the hundreds of 1000's doctors who prescribe the very opiates which are killing people daily, instead of singling out the ones who are trying to curb the ever increasing opiate addiction population. I think their priorities are a little backwards.

Posted by NAABT.org on 02 Oct 09 11:57 AM EDT
The DEA cannot possibly accomplish anything positive from this policing action. It will not encourage physicians to become certified and treat addiction, only discourage them by adding one more inconvenience to the process of saving lives of addicted patients. The end result of this DEA action will be more people unable to get treatment, thus more people dying of overdoses. NAABT

Posted by Diane on 02 Oct 09 01:18 PM EDT
This policy is not only overhanded, but it is unnecessary. This drug is intended to help people who are already addicts. It does not create addicts, nor is it a substance that is typically abused or sold on the black market. It not only attacks doctors who are trying to help addicts, it attacks the addicts themselves by once again curtailing their access to legitimate and beneficial drug tx.

Posted by Steve Coulter, MD on 02 Oct 09 01:43 PM EDT
The DEA is following the law, but devoting limited resources to this bit of the law is counter-productive. Licensed physicians can prescribe far, far more dangerous and addictive substances with little or no oversight. When morphine, OxyContin, Percocet and the like can be prescribed without limit, discouraging physicians from treating people who need buprenorphine is insane. Fortunately, buprenorphine should become a generic drug this month. What's needed is federal reform of the DATA law to return medical practice standards to state authorities, as it is for essentially all other prescribing. Some smart lobbying could get this included in the health reform bill, perhaps.

Posted by robert newman on 02 Oct 09 06:03 PM EDT
are you sure the letter REQUIRES physicians to complete and submit the survey? I don't have mine in front of me, but don't recall such a requirement. Can you confirm or correct? thanks much

Posted by Alan Wartenberg MD on 02 Oct 09 09:56 PM EDT
The DEA is doing no such thing. There is no requirement within the regulations of a particular number of physicians who would be surveyed. Resources are scare, and the docs who are major league suppliers of Oxycontin, oxycodone and hydrocodone are the Gorillas in the room, with buprenorphine providers being the rhesus monkeys. It is shameful that the DEA has taken this action, and I find it even more reprehensible that McClellan feels that he has to be the team player. Shame on them!

Posted by Barry Schecter on 02 Oct 09 10:35 PM EDT
Isn't it time that we realized that the "War on Drugs" has cost the American People over one trillion dollars. Has drug use significantly decreased? Has supply decreased? Of course not. Yet, I have formerly been director of a methadone Treatment Center, and had a modicum of success, yet I work with a physician, and we operate a suboxone treatment program out of a family care center. We have nearly 100 people right now that will write letters on how this has changed their lives. One of the added benefits is that many of our opiate addicted patients, have also lost the desire to drink alcohol. When will there ever be a cohesive drug policy? Man has wanted to change their feelings since biblical times, why doesn't the DEA figure that out? Why do they police and scare the legitimate helpers? Probably because they are easier targets than the cartels. But then again, if we ended prohibition, what would the DEA do? What would the whole drug industry do? Perhaps they would have to get real productive jobs, instead, they make life awful for people with a chronic, brain disease. The numbers of people addicted has not changed, no matter what laws we enact. Where is the humanity in this country? What gave people the right to trample the Bill of Rights, The Constitution? Why, I would really like to know the purpose of discouraging those willing to help? It is difficult enough for the patients, the physicians, the staff, the whole system. Please, I urge you to look at LEAP.CC

Posted by Rita-Substance Abuse Counselor on 04 Oct 09 10:42 AM EDT
Our office did receive the letter and how I and the doctor read it was as such: That the DEA is wanting to make sure that the buprenorphine that is being prescribed is being done in the correct way. So as we do not have yet another drug out on the streets that is being bought and used, abused etc. Which is what needs to happen. Suboxone already has a street value. Half the people I have induced have already "tried" so they say. And, 3/4 did not even "try" it in the proper way. IE: Took it as one would a regular pill, snorted it. Heck, there are those out there that crush it up with a hydrodcodone and snort it and swear it gives a better "high". It is a tool. Along with counseling and support it s a miracle pill that is helping many, many opiate addicts. The doctors prescribing just needs the proper protocol in place. I do hope that it isn't taken away from those who are certified to prescribe it and I hope this does NOT stop other physicians from getting certified to do so. Just call the makers of Suboxone and they will send you out a liasion to help you start the process, and set up your program.

Posted by Crash Test Addict on 05 Oct 09 01:44 PM EDT
This smacks of Gestapo tactics meant to worry physicians enough to drop Suboxone treatment for their patients, who BTW, usually don't have the money to afford the medication, and must rely on state medicaid and/or federal medicare plans to pay for the office visits and treatment. What better way to limit the prescribing of Suboxone than chasing most of the physicians off who would prescribe it, and at the same time save tons and tons of money in the process because now they are too worried about the DEA? The letter stinks to high hell, and the one designed to alleviate concerns, too little, too late. Physicians don't need yet another Big Brother in their lives. The aggravation just isn't worth it to them. Do you nuts up there in Washington have an ulterior motive to sabotage treatment for addicts because in your eyes they are worthless anyway? I wonder. Government has done far worse things to the public than that. Remember George back in the 60's who fed LSD to unsuspecting citizens courtesy of the CIA. What about irradiating black men's testicles? Ring a bell? Why don't you people in the DEA think before you act?

Posted by protected on 05 Oct 09 02:02 PM EDT
There are doctors that need to be monitored because of improper practices with Suboxone protocol.Also, More should be done to monitor the drugs that put people in need of Suboxone.

Posted by Sandra S. on 05 Oct 09 02:20 PM EDT
"a purely administrative document...the field has to understand that this is not your father's ONDCP or DEA--". Perhaps, and perhaps not. If, indeed, you don't want to discourage primary care doctors from providing buprenorphine treatment, use the tone that Purdue Pharma uses in letters to the DEA and legislators to make sure brand name Oxycontin is easily prescribed to Medicaid and Medicare patients in all states. Some doctors may be slow to believe in the new kinder, gentler, ONDCP and DEA, since the same people are doing the same work--change speaks louder in actions than in words, Mr. McLellan.

Posted by Kevin M. Passer, M.D. on 05 Oct 09 04:08 PM EDT
Suboxone is a life saving drug. The government should dispense it for free to anyone who wants it. No one should be deterred to prescribe it by this initiative by the DEA.

Posted by Brian McDonough on 05 Oct 09 05:01 PM EDT
I am currently studying for my CASAC-T & have been in treatment with people who have been on the Suboxone treatment plan & are drug-free & happy today. 'you don't fix what isn't broken!' The doctors are trained & know what they're doing. Go after the "doctor feel-good" & the other cronies...

Posted by Anonymous on 06 Oct 09 07:45 AM EDT
We have to realize criminalizing addicts DOES NOT WORK!!! I suggest the DEA send a letter to Suboxone docs on what they want us to do in terms of documentation and appropriate protocols. Mr. DEA man work with us docs not against us.

Posted by Janet on 07 Oct 09 04:29 PM EDT
I am so glad that DEA is finally cracking down on Suboxone. Our residential facility has stopped allowing people in who are on that drug because of misconduct wiht the drug. It is rampant. And the Medicaid Mills and private doctors who have deals with the pharmacies are making a fortune off of the drug. Not to mention, methadone is $12 a month and Suboxon runs between $150 to $550 a month. Who's making the money and why are all of the politicians supporting. Somebody is giving something to somebody and the American public and the drug addicts are getting screwed.

Posted by Submysavior on 08 Oct 09 03:49 AM EDT
This is the MOST ridiculous thing I have EVER heard..and JUST when I Thought the DEA couldnt possibly top THEMSELVES of all the foolish things they're before done!! \I personally am on Suboxone- and for ONCE in my miserable 10+ years of addiction to Hydrocodone, "Sub" has literally saved my LIFE. I no longer feel the need to chase my former "drug of choice" 24/7! Because the Suboxone ("Sub")fills the gap and keeps the craving/desperate need away!!! If the freakin' DEA IS successful at chasing away & making even MORE scarce the Sub doctors that ARE left...this will no doubt affect mine and other addict's 'life or death' Suboxone medication access!! At that point, I personally will have no choice but to either go back to opiates or end my own life. Because I will NOT go through the hellish withdrawals again that this wonder-drug is currently keeping me OUT of!

Posted by Anonymous on 08 Oct 09 04:23 PM EDT
Personally, my answer would be to END THE WAR ON DRUGS! Make them readily available where people wont have to continually "doctor shop" - hoping to find a sympathetic doctor that might just have some mercy on those in pain and those that are in withdrawal!) THIS explains the forbidden "doctor shopping"! Of COURSE people are shopping for a less stingy doctor that will hopefully prescribe more freely!!!! DUH. I'll be if a lot of those that work for the DEA were in chronic pain or had ever experienced hellish withdrawal- that they would BACK OFF ON THE 'DRUG ON PEOPLE AND DOCTORS.'

Posted by Bernard J Bernacki DO, MPH on 10 Oct 09 12:43 PM EDT
Legitimate prescribers of these medications, those doing AND documenting the pre RX assessments and maintaining longitudinal office records AS REQUIRED, should have no problem with an inspection. In fact, I WELCOME the DEA effort to protect the addicted public from unscrupulous physicians who are using the buprenorphine program as another get rich quick scheme. We should be policing our own, not conplaining that the DEA has to protect the patients instad of US being more responsible!

Posted by ANONOMOUS RN on 14 Oct 09 03:45 PM EDT
I find it really disheartening to read some of these comments that contain wildly inaccurate horror stories about Suboxone and subsequent "crackdown" from the DEA, which has caused some MD's to just stop prescribing. Coming from a medical professional of 20 years who spent years dealing with an opiate addiction, Suboxone is the ultimate in a SAFE, WONDER DRUG that controls cravings and allows the opiate addict a chance to live a normal life. Regular daily use of Suboxone produces NO distinguishable "High" and believe me in saying "I know the feeling".... For the first years in my life, I function to full capacity each day, and without the worry of relapse. To knock such a revelation in treatment options for opiate addicts is really a crying SHAME!!!! Anyone serious about changing their life, should really consider such a remarkable and safe medication for maintenance or sustained abstinence from other opiates... MJ

Posted by Florence - Substance Abuse Counselor on 15 Oct 09 03:56 AM EDT
What is everyone afraid of? If you have a good program and follow the right protocol it should be no problem. As we know their are many people practicing medicine that are addicts themselves. If you are doing the right thing you wouldn't be threatened.

Posted by Amy Steinmetz on 22 Oct 09 03:40 PM EDT
So...this Suboxone issue...it is heated, almost as heated as methadone but I won't go there... What really needs to happen is that prescribing docs need to urine their caseloads and require group and/or individual therapy with someone like me who is both qualified and up to speed with behavior and addiction research, not to mention experience in the field

Posted by C Marlo Baird, MD, MPH on 26 Oct 09 07:19 AM EDT
My suggestio is for a 5 or 6 question survey regarding outcomes by Treatment site to be patterned after the Treatment Services Review that Dr. Tom McLlelan developed for individual outcome research. That way more useful information can be collected and built on over the next 1-2 years at a lower expense to the DEA. Dr. Tom McLellan or the Treatment Research Institute (Philadelphia) could coordinate the data and supply the site appropriate questions. That would be collaborative power (DEA & ONDCP) and provide statistical strength especially in regard to identifying populations at risk for adverse events and practices that are more effective in assisting recovery.(The good, bad, and ugly that accompanies largeer trials of medication use.) Michelle Leonhardt (DEA) would have data useful for SAMHSA, NIDA, CDC and individual states as well as treatment providers and patients.

Posted by Eric Wilhelm on 31 Oct 09 10:58 PM EDT
Miracle drug. Saved my life, And I expect that any practicioner that really cares will ensure proper practices are observed & will easily deliver @ inspection time.

Posted by SuboxDoc on 10 Nov 09 09:00 PM EST
The comment above by 'Amy Steinmetz' is problematic; The certification requirement for 'ability to do or refer for counseling' is appropriate; mandatory group or individual counseling as a requirement for treatment with buprenorphine helps fill the chairs for therapists like Steinmetz, but I would never refer a patient to a therapist with the attitude that ALL addicts require counseling. I have many patients who have done very well with buprenorphine without guidance from Steinmetz and other therapists. I have also worked to reverse the shame instilled by therapists who view all opiate addicts as people with profound character defects-- when many opiate addicts on buprenorphine do just fine, thank you very much. Not all 'counseling' is good for people, and not all addicts require counseling.

Posted by Anthony on 12 Nov 09 04:17 PM EST
Funny, it was easier for my doctor to get me addicted to oxycontin than it was to get presribed suboxone to get off them....Where is the sense in that? Oh wait, the govt wants me to be addicted...not to be clean...

Posted by SuboxCounselor on 17 Nov 09 03:45 PM EST
This sounds like the DEA wants to make this such a hassle for doctors that they will quit prescribing Suboxone. Why don't they have the same standards for pain clinics? Does the govt. want to keep people addicted?

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