Looks like the “powers to be” believe that very very many people suffering from chronic pain – over the this year and next – will be cut off their medically necessary pain medications, die from under/untreated pain compromising their underlying comorbidity issues or just chose a “death of desperation ” (Suicide).  Since our Founding Fathers did not define what the  “pursuit of happiness” encompassed, so our bureaucrats – using their own moral compass – have apparently decided that treatment of chronic pain is not part of our RIGHTS to be engaged into the pursuit of happiness.

To me, the timing of this proposed cuts in quotas is not accidental, starting this weekend all 435 members of the House and 1/3 of the Senate will be in full blown re-election mode.  Not much will get done between now and Jan, 2021 when the new Congress starts.

How many times have members of the community made phone calls, sent emails/letters, signed petitions, responded to proposed changes during public comment period and has anyone seen how any of those actions has impacted a positive change toward those in the community or if all the comments made actually made in changes in the original proposal ?

I remember a bill passed by Congress that would attempt to restrict the availability of opiates to treat pain and ONLY ONE in the Senate and a HANDFUL- or so – in the House VOTED AGAINST IT…  Probably the only time in the last several years that Congress has acted in a nearly unanimously bipartisan manner toward any bill/proposed law.   That would suggest that no matter if your representatives in Congress is a Democrat or a Republican… they could care less about how much you suffering you are dealing with. They obviously DON’T FEEL YOUR PAIN !

Could this be DEA’s reaction to some states trying to pass laws that would try to allow chronic pain pts a better access to pain management meds ?  If there is fewer doses of opiates available at the local pharmacy…  Does it really make any difference how many Rxs for opiates are written ?

Businesses spend 9+million/day on lobbying Congress… because they are successful in getting Congress to change directions in a way that benefits those businesses.  But it would seem that those in the community believe that their votes and their opinions will impact the member of Congress to see things their way..  Since the expiration of the Decade of Pain Law expired in 2009 and was not renewed… nothing has went in the direction that those in the community would like to see it happen.

I refer you to Einstein’s definition of INSANITY 

DEA Submits Proposed Quotas for 2021

https://www.deachronicles.com/2020/09/deas-submits-proposed-quotas-for-2021/

DEA rolled out its proposed aggregate production quotas for 2021 earlier this week, the same day, in fact, that it proposed adjustments to its 2020 quotas. Let’s start off by looking at the Big Five, at least as far as the SUPPORT Act is concerned: fentanyl, oxycodone, hydrocodone, oxymorphone, and hydromorphone.

Here is a snapshot:

Drug	Proposed 2021 Quota (g)	Vs. Original 2020 Quota	Vs. Adjusted 2020 Quota
Fentanyl	666,249	-18%	-29%
Oxycodone	57,110,032	-15.5%	-13%
Hydrocodone	30,821,224	-12%	-9%
Oxymorphone	28,204,371	+15%	No Change
Hydromorphone	2,827,940	-7.5%	-19.5%

As you can see, with the exception of oxymorphone, the proposed quotas are down significantly for the Big Five, from both the original 2020 quotas and the adjustments we saw both in April and yesterday.

Some of the reduction may be explained by DEA’s April adjustments, which were largely in response to the coronavirus pandemic. DEA increased the quotas for particular substances related to the treatment of the virus, including fentanyl, oxymorphone, and hydromorphone.

Now, under the SUPPORT Act, when arriving at the aggregate production quota, DEA must estimate the amount of diversion of any “covered controlled substance,” (i.e., the Big Five.) So how does DEA arrive at these diversion estimates? Well, under the SUPPORT Act, when analyzing diversion rates, DEA is charged with acting “in consultation” with HHS to determine “rates of overdose deaths and abuse and overall public health impact related to the covered controlled substance…” (DEA may also consult any other source it deems reliable.) DEA did not find most of the consultations particularly helpful apparently, finding both the CDC information on the rates of overdose deaths and the CMS information on rates of overprescribing either incomplete or unreliable for estimating diversion.

DEA fared better with the FDA apparently, but even here there was a wrinkle. FDA is responsible for providing “estimates and predictions of legitimate medical needs” for controlled substances in a calendar year. Quite an estimate it was too. FDA’s predicted level of medical need was “expected to decline on average 36.52 percent for calendar year 2021.” Wow. That said, “FDA’s predicted level of medical need for the United States was calculated by FDA at the beginning of the Coronavirus . . . pandemic and, therefore, did not take into account changes in usage that are necessary to treat patients who require schedule II controlled substances.”

I should note here, however, that DEA did “consider FDA’s concerns” over potential shortages in ADHD medications (amphetamine, methylphenidate, and lisdexamfetamine) when calculating its quotas for these controlled substances. But DEA also indicated that it “has grown increasingly concerned over the misuse of prescription stimulants among young adults and the demand for methamphetamine in the U.S.” This concern is leading DEA to “closely” monitor “trends in licit stimulant use.” The numbers indicate DEA largely held steady on the quotas for these stimulants.

Finally, DEA mentions that nine states’ attorneys general submitted PDMP data in response to a DEA request. “The data that DEA received varied in its form and content,” however, “and was ultimately determined to be inapplicable at the national level.”

So, for the most part and as DEA has historically done, DEA used its own internal reports to arrive at its diversion numbers for the Big Five. And, given the FDA’s whopping prediction about the decrease in medical need, the quota decreases may not be so dramatic as they might have been.  The historic and ongoing conflict between DEA’s assessment of the legitimate medical needs of the United States versus FDA’s assessment does not seem to be abating.  It will be interesting to see what, if anything, Congress will have to say about this.

Filed under: General Problems