Durbin, Senators Send Letter to DEA Calling for Stricter Limits on Opioid Pills
Durbin, Senators Send Letter to DEA Calling for Stricter Limits on Opioid Pills
Do you know what happens at the end of death spiral if the person at the controls don’t know what the shit they are doing ? The chronic pain community is about to find out
ROCKFORD, IL –(ENEWSPF)–July 21, 2016. In a letter to the Drug Enforcement Administration (DEA), U.S. Senators Dick Durbin (D-IL) Sherrod Brown (D-OH), Edward Markey (D-MA), Amy Klobuchar (D-MN), Angus King (I-ME), and Joe Manchin (D-WV) called on the agency to use its power to more aggressively combat the opioid epidemic that is affecting communities across the country. With its existing quota-setting authority, the DEA effectively serves as a gatekeeper for how many opioids can be produced and sold in the United States every year. Durbin led the senators in urging the agency to keep addictive painkillers from flooding the U.S. market by setting lower quotas in the coming years.
“We agree and believe efforts to halt this widespread epidemic will not be successful unless we use every tool at our disposal. We urge DEA to utilize its existing quota setting authority, to the fullest extent possible, to combat this epidemic,” wrote the senators. “Fourteen billion opioid pills are now dispensed annually in the United States – enough for every adult American to have a bottle of pills. Certainly, the pharmaceutical industry is at fault for decades of misleading information about their products and the medical community bears responsibility for its role in over-prescribing these dangerous and addictive drugs, but we remain deeply troubled by the sheer volume of opioids available – volumes that are approved by DEA.”
For the past two decades, the DEA has approved ever-greater increases in opioid quotas, allowing production of oxycodone to increase 39-fold, hydrocodone to increase 12-fold, hydromorphone to increase 23-fold, and fentanyl to increase 25-fold.
The senators’ letter outlines changes the DEA should immediately adopt to improve the quota setting process, including: making the quotas that each drug company receives public; justifying the public health benefits of any opioid quota increase; and taking the opioid epidemic into consideration when setting quotas. Last month, Senator Durbin introduced the Addiction Prevention and Responsible Opioid Practices Act (A-PROP Act), which would mandate these changes in an effort to address opioid addiction before it starts.
The full text of the letter can be found below:
July 19, 2016
The Honorable Chuck Rosenberg
Acting Administrator
United States Drug Enforcement Administration
8701 Morrissette Drive
Springfield, VA 22152
Dear Acting Administrator Rosenberg:
Our nation is in the midst of a prescription opioid and heroin crisis that is destroying the lives of our friends, our neighbors, and our family members. In 2014, 28,647 people nationwide died from an opioid overdose. As you stated in announcing the 2016 National Heroin Threat Assessment Summary, “We tend to overuse words such as ‘unprecedented’ and ‘horrific,’ but the death and destruction connected to heroin and opioids is indeed unprecedented and horrific.” We agree and believe efforts to halt this widespread epidemic will not be successful unless we use every tool at our disposal. We urge the Drug Enforcement Administration (DEA) to utilize its existing quota setting authority, to the fullest extent possible, to combat this epidemic.
We have appreciated hearing about DEA’s efforts to combat the ongoing opioid crisis, including DEA’s “360 Strategy.” While this strategy lists demand reduction as a core focus, it appears primarily focused on the downstream dynamics of the problem, such as targeting the violent cartels and drug trafficking gangs responsible for perpetuating the opioid epidemic. These efforts, much like DEA take-back days, are critically important and should be commended. However, they do not go far enough. We believe DEA can and should be doing more.
Each year, DEA is responsible for setting annual quotas for manufacturers’ production of schedule I and II controlled substances, including opioids. In effect, DEA serves as a gatekeeper for how many opioids are allowed to be legally sold every year in the United States. Yet, for the past two decades, DEA has approved significant increases in the aggregate volume of opioids allowed to be produced for sale in the United States. Between 1993 and 2015, DEA allowed aggregate production quotas for oxycodone to increase 39-fold, hydrocodone to increase 12-fold, hydromorphone to increase 23-fold, and fentanyl to increase 25-fold. According to IMS Health, 14 billion opioid pills are now dispensed annually in the United States – enough for every adult American to have a bottle of pills. Certainly, the pharmaceutical industry is at fault for decades of misleading information about their products and the medical community bears responsibility for its role in over-prescribing these dangerous and addictive drugs, but we remain deeply troubled by the sheer volume of opioids available – volumes that are approved by DEA.
The Controlled Substances Act provides DEA with a number of authorities, which, if utilized fully, could help appropriately reduce the number of opioids available nationwide. First, when DEA, in a given year, approves a higher opioid quota than is ultimately used, DEA can and should lower the ensuing year’s quota accordingly if there is no other compelling need for the higher quota. Second, DEA has the authority to approve mid-year quota adjustments and thus could take a more judicious approach for initial opioid quota setting and allow for mid-year adjustments, if needed. Finally, when setting quotas, DEA’s authority states that “the Administrator shall consider changes in the currently accepted medical use in treatment with the class or the substances which are manufactured from it.” We believe the recent Centers for Disease Control and Prevention (CDC) Guideline for Prescribing Opioids for Chronic Pain constitutes a “change in the currently accepted medical use” of opioids and should be taken into consideration when setting future years’ opioid quotas.
The 2016 CDC Guidelines recommend dramatic changes in how opioids are prescribed for chronic care patients. For instance, the medical experts at the CDC recommend that patients receive immediate-release opioids instead of extended-release or long-lasting opioids; that patients receive the lowest effective dosage of opioids possible; and that patients receive opioids for the shortest possible effective duration. Taken together, these CDC recommendations clearly demonstrate that fewer opioids will be medically necessary in the coming years.
These new guidelines – coupled with recent opioid drug manufacturer settlements acknowledging both the addiction risks of these products and the insufficient research body about the effectiveness of opioids when used long term – provide grounds within the scope of DEA’s existing authority to take proactive steps to lower quotas.
In addition to the steps outlined above, we also strongly urge DEA to do the following:
- Remove, for schedule II opioids, the 25 percent across-the-board aggregate production quota increase that was implemented in 2013;
- Take into consideration the impact of the opioid manufacturing quotas on the downstream public health burden of opioid misuse and diversion;
- Make public the approved individual manufacturing quota for each manufacturer of schedule II opioids, including oxycodone, hydrocodone, oxymorphone, hydromorphone, and fentanyl;
- In years during which the approved opioid manufacturing quotas increase, provide public justification to explain why the public health benefits of increasing the quotas outweigh the consequences of having an increased volume of such substances available for sale and potential diversion in the United States; and
- Identify formal strategies to improve data collection from approved drug collection receptacles, mail-back programs, and take-back events on the volume and class of controlled substances that are collected and develop a plan to use this information to inform the quota-setting process in subsequent years.
Thank you for your commitment to finding a solution to the prescription opioid and heroin crisis. We look forward to working with you to address this epidemic and request that you outline any authorities DEA needs, but does not currently have, to address the quota-setting concerns and proposed changes outlined above. We appreciate your consideration and look forward to your response.
Sincerely,
Source: http://www.durbin.senate.gov
Filed under: General Problems
In 2015, the President tweeted: “Sales of powerful painkillers have skyrocketed. In 2012, enough prescriptions were written to give every American adult a bottle of pills.”
You will find this and other misleading statements are debunked on Page 6 of the Feb 2016 Research Report called: Negative Outcomes of unbalanced opioid policy supported by clinicians, politicians, and the media by Scholten & Henningfield :
” Bottles exist in many sizes, but the President’s message was based on a bottle size of only 7 to 10 pills!”
This report demonstrates how even this tweet by our President is only half true “120 Americans die every day from drug overdoses – most involving legal prescriptions drugs. October 21, 2015 )
People are dying but the statistics make no distinction between who is dying from heroin and mixing of various street drugs, and those who choose suicide over living a life tortured with pain. The truth is that LEGAL prescribed prescription drugs are RARELY IF EVER involved in overdoses. Where are the statistics pinpointing that link?
The President’s statement is completely untrue! As legitimate, legal prescribed prescription medicines only account for a minority of issues, as the addiction population within the pain patient community is LESS THAN 3%.
He says: “MOST overdoses involve legal prescription drugs”? No, they don’t. And the lack of distinction between the legal prescribed medicine use and illegally obtained use of the medicines for NON Medical use is disturbing because they lump them altogether as if the people who received prescribed opioid medications for pain are also “addicted”
We realize there is a “dependency” but the CDC, DEA and Surgeon General fail to make that distinction and now they lump everyone in the basket of “opiate dependency disorder” as if taking a medication for pain is a disorder. Do we call people who rely on blood pressure medication and insulin (which results in epidemic proportions compared to those dying from prescription pain medicine overdoses?
Consider that there are large discrepancies when it comes to figuring out what is killing Americans. Opioid related deaths seem to range anywhere from #10 to #22 depending on what chart you use to measure the statistics: (Legal and illegal) opioids deaths come in at #10 in “Drug War Facts” http://www.drugwarfacts.org/cms/Causes_of_Death
#20 in Real Time Deaths, http://www.romans322.com/daily-death-rate-statistics.php The first three on the chart are preventable in terms of lifestyle choices. cardiovascular disease, 796,494 cancer, 584,881: Chronic Lower Respiratory Disease 149,205.
Then it was updated in 2014: Total legal and illegal drug over doses still #10 with 47,055, now broken down into: Heroin overdose 10,574 Pharmaceutical opioid Analgesics: 18,893 That leaves 29,467 that doesn’t seem to be accounted for. Something is left unaccounted for.
It is actually very difficult to determine how many are actually dying from accidental overdose from opioids alone. Nevertheless, why is it that while prescribed opioid use is going down, heroin use is going up? It’s almost as if these new policies could turn a certain population of people who suffer from pain into addicts if they turn to the street and find heroin for relief and eventually become a statistic if they happen to get some that is laced with fentanyl or some other synthetic drug.
Wow…now I see why people are blaming the Democrats for this as they are the one’s signing this letter and i have to admit that Trump recently stated he will get rid of Drug Cartels which I’m told is “impossible as they will find another way in and the ONLY REAL SOLUTION IS TO MAKE EVERYTHING LEGAL and then regulate and control ” which is actually done in some other countries.
Please read my response to Steve’s question, What is an epidemic ? on his blog. https://www.pharmaciststeve.com/?p=16247 There is a 10 page scientific report by the Journal of Pain & Palliative Care Pharmacotherapy called: NEGATIVE OUTCOMES OF UNBALANCED OPIOID POLICY SUPPORTED BY CLINICIANS, POLITICIANS, AND THE MEDIA which I have posted the link to access: http://www.tandfonline.com/
I suggest people highlight key points and send to their congress people as I gave it to former governor Charlie Crist who is also running for Congress ) It’s long and complicated to understand the scientific language so I’m going to follow up with the excerpts from the report which you can also read on Steve’s blog .
If there is any hope for change, all we can do is write, tell our story and educate them how ALL DRUGS BUT ALCOHOL ARE included in these statistics that is being blamed for this “epidemic of prescription opiods”
I
f they don’t respond, we can only conclude there is truly another agenda such as the influence of Big Pharma for a new generation of drugs and the whole recovery industry which could be much like the Prison industry which is privatized and very lucrative. We may have to get a lawyer involved as apparently this happened in Russia and they got rid of all opiate medication and only the wealthy can get it now.
I will share it here if it’s okay with Steve because it might even be more relevant to this thread. The document has two pages of references to back up what we are talking about here: ……………..https://www.pharmaciststeve.com/?p=16247
Here is my letter to all these idiots.
Dear Senator.
I am writing you to let you know that your continued discrimination and specific targeting of pain sufferers is not going unnoticed by the Chronic Pain Community. In regards to your latest attack against people in pain who use opiates inorder to have any sort of quality of life, we accuse you of crimes against humanity. Making people needlessly suffer by restricting or blocking access to the only medications that ease the intensity of Chronic Pain without providing a viable substitute is not only unethical, but has been determined by NATO and the WHO to be against International Law. Your letter to the DEA calling for stricter restrictions on prescribing of opiates only proves that your refusal to listen to both sides of the science is either that you are in bed with the PROP industry, or you are just to ignorant to realize that the science you have been fed is less than half of the truth. So, after your term is up and your wondering why you were voted out of office, I Suggest you to sit down and re-read this letter and think about how big of a difference at the polls 116 million Chronic Pain Suffers can make when it comes to a re-election campaign. We have not only made it our commitment, but we have made it our top priority that you never serve another term in public office.
I’ve had enough of ignorant politicians playing God with my healthcare. I have EDS and scoliosis and will always be in pain 24/7 because of those diseases and other comorbidities that come with them. The only way I and many other people with chronic illnesses can support ourselves and our families is because we take opiates which reduce (never eliminates completely) our pain.
If they would actually do some research they would find the studies used for death rates lumped in heroin overdoses which has nothing to do with Drs prescribing opiates. Overdose cases from fentnyl is also not he fentynl patches pain patients receive. Street drugs are not our meds. So why are they being included?
Have you stopped to even consider what your well intended but completely misguided laws will do to us? The chronically ill medically necessary pain patients?
You would rather force us to look to the streets for more dangerous and illegal drugs so we can fill your privatized prisons? Instead of being seen monthly by our pain management doctors that are their to actually manage our pain and medications?
There has been no alternative offered to us that actually works. In many cases no warning either.
There needs to be a voice for the chronically ill pain patients to fight for us. Where are the people who know these new laws are bullshit? It’s just a way for the DEA to claim a false victory because they are failing to keep real illegal drugs off the street. A way to feed the privatized prison system funding their greed. None of this is about us; about the people who really need this medication to be productive citizens, to do simple tasks like house cleaning or taking a shower.
Shame on all of you.
I thought I just looked at the Calendar and it said: January 16, 1920. So 100 years later, Al Capone and the rights of a free people still don’t matter to our own Government! That’s right, they stopped teaching history and our government officials have so much denial and addiction to power they can’t see beyond their selfish ideologies. Pain will kill you just as dead as anything else! So all of us chronic pain patients and our families thank you from the bottom of our hearts for the miserable life and death you are so callously bestowing upon us! Just remember, an estimated 116 million adults experience chronic pain. That’s a lot of votes Dummies!
Steve: actually in the last Presidential election there was only a 126 million votes cast and 106 million eligible voters – DIDN’T VOTE.. and there was 5 million votes between winner and loser..
I’m having a hard time following your numbers. In 2014 we had a population of 318 million . I assume you mean we have 106 million registered voters; so how do you get 126 million votes cast? I was told by a volunteer at the last election that they were told that morning that only 8% of the population votes . That’s only about 25 million people voting (25,440,000) a tragedy considering that’s the main topic of conversation on the news every night and with everyone with such a hot opinion, why are people so apathetic? People shouldn’t complain if they aren’t going to get involved whether by voting or by writing letters, signing petitions and participating one way or another.
There was 126 million votes in the last Presidential election.. .and a estimated 106 million eligible voters that DID NOT VOTE.. there is a reported USA population of 320 million +/-… so that would suggest that there are 232 million adults > 18 y/o abt 70% of the population are adults.