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ASHINGTON — In a bland Northern Virginia office building nestled between a Costco and a freeway interchange, a dozen government scientists have spent the past year crunching numbers and making the following determination: In 2018, drug makers will be allowed to produce no more than 98,145 kilos of oxycodone, 38,047 kilos of morphine, and 1,342 kilos of fentanyl.

The precise limits are set as part of a little-known process in which, every year, the Drug Enforcement Administration regulates the volume of controlled substances that can be produced in the United States.

The process was started nearly five decades ago to ensure that drug makers produced enough medicines to avoid shortages. But in the midst of a national opioid epidemic, fresh scrutiny of the quota system has spread to Capitol Hill, where Democratic lawmakers are pressing the DEA to use it for another reason — to help stem supply.

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“It is clear that we need to reduce the amount of oxycodone and hydrocodone that DEA approves for manufacture each year and hold Big Pharma accountable for manufacturing a product that is leading to the deaths of hundreds of people every day,” said Sen. Edward Markey (Mass.), who has introduced a number of bills aimed at addressing the opioid crisis.

Rarely, however, has the quota system been used to eliminate or constrain supply for a class of drugs similar to opioids — created to fill a medical need but with consequences that, in at least some cases, have outweighed the medical benefits.

The lone historical exception is that of the sedative methaqualone, which was marketed until the early 1980s as Quaalude. The drug became so abused that it quickly fell out of favor with the medical community, and in conjunction with nose-diving prescription rates and manufacturer interest, the DEA began to lower the quota for methaqualone production in 1973. It hit zero in 1981.  

But opioids are not quite analogous. No medical group thinks they are without merit when properly distributed, and a substantial number of pain patients would suffer if denied access to them.

Many experts are not sure using the quota system as a tool to constrain supply is a sound idea — and instead believe the focus should be on reducing prescriptions.

The DEA could have considered tightening quotas to address the crisis more than a decade ago, “when we were clearly already in the middle of an opioid crisis and it was clear the prescribing of OxyContin was happening at a rate much greater than could be clinically needed,” said Andrew Kolodny, the co-director of the Opioid Policy Research Collaborative at Brandeis University.  

“Now,” he said, “I don’t think it makes any sense, because the prescribing peaked in 2011 and 2012.”

Still, some lawmakers say that the DEA has historically been too liberal in the setting of the quotas. In a letter to the agency’s acting administrator earlier this year, 16 Democratic senators noted that the agency allowed aggregate production quotas for oxycodone to increase thirty-nine-fold between 1993 and 2015, and quotas for fentanyl to increase twenty-five-fold.

“Further reductions are necessary,” wrote the senators, led by Sen. Dick Durbin, the chamber’s No. 2 Democrat.

Republicans have had little to say on the issue. And a Trump administration official, speaking on condition of anonymity, said the politicization of the quota system has created the potential for hospital shortages and access issues for pain patients who have legitimate medical needs.

Outside the United States, there are cautionary tales of government intervention in the supply of pharmaceutical drugs.

In Russia, for example, a heavy-handed regulatory system meant to guard against drug abuse has led to shortages, with highly publicized cases like that of a Russian naval officer with late-stage cancer who committed suicide after being unable to obtain sufficient pain medicine.

In Uganda, fear of a U.S.-style opioid crisis has left palliative care doctors without the necessary means to treat patients in their final, agonizing stage of life.

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In the United States, the quota system is used for all Schedule II drugs — those that are deemed to have legitimate medical uses but that carry high potential for abuse. It also applies to a select number of stimulants, as well as research-oriented production of Schedule I drugs like marijuana and GHB deemed to have no accepted medicinal value.

To set the quotas, the DEA says it relies on estimates of legitimate medical need from the Food and Drug Administration, prescription levels from the previous year, manufacturers’ forecasts, and other data. A spokesman said the agency uses a strict formula, and does not take into account business or other circumstantial considerations.

“If any part of the steps that are taken need to be changed, or people want them to be changed, Congress has to do that,” the spokesman, Melvin Patterson, told STAT.

(A spokesman for the Food and Drug Administration, which sends information about past and projected prescription levels to the DEA each year to assist in the quota-setting process, declined to specify the source of the FDA’s data.)

The quota levels for aggregate opioid production in 2017 were lowered by about 25 percent, a move that may have helped to address political pressure to reduce the quota but had little impact on actual supply. The DEA acknowledged that the numbers appeared lower because the agency decided to eliminate a cushion it has previously included as a safeguard.

It represented “a quota that was built into the system to handle an emergency, a catastrophic event” but that was never used, said Joe Rannazzisi, who ran the DEA’s division of diversion control until 2015 and now consults with lawyers pursuing legal action against the opioid industry.

For 2018, the DEA has lowered the quota for opioids another 20 percent — a quota even Rannazzisi acknowledged is more likely to substantively reflect and impact prescription levels.

“Physicians, pharmacists, and patients must recognize the inherent risks of these powerful medications, especially for long-term use,” Chuck Rosenberg, then the DEA’s acting administrator, said in an August statement. “More states are mandating use of prescription drug monitoring programs, which is good, and that has prompted a decrease in opioid prescriptions.”

While the DEA is required to publish the aggregate quota amounts each year, it is prohibited from making public the individual quotas it awards to specific manufacturers.

That makes it difficult, Democratic congressional aides told STAT, for the public to connect the dots between manufacturers and the supply of narcotics they are responsible for on the market.

Markey has sponsored a bill that would require the DEA to release individual quota levels for manufacturers, in the hope that drug makers perceived to be contributing to the addiction crisis will become more responsible actors in the face of greater public awareness.

That could put manufacturers that obtain controlled substances for research purposes or compounding with other drugs at a competitive disadvantage. But Rannazzisi said that in most cases, the idea of forcing accountability through transparency is a sound one.

“I totally agree with that,” he said. “Mr. Markey, his theory is somewhat correct — I guess he’s looking at shaming manufacturers for how much [quota] they’re getting.”

Industry groups have not bothered to advocate against the measure — it is virtually certain to receive neither a hearing nor a vote in the Senate Judiciary Committee. But opposition, Democratic aides said, would be fierce if Democrats controlled either the House or Senate or if the bill appeared likely to become law.

Purdue Pharma, which manufactures and markets oxycodone as OxyContin, declined to comment on the Markey bill and the quota process in general. A spokeswoman for PhRMA, the drug industry lobby, said the group had not reviewed the bill or taken a position on it.

Regardless of what happens, there is consensus across industry groups and the expert community that the simplest way to reduce the supply of opioids over the long term is simply to reduce prescriptions. Already, changes to prescription practices nationwide have sapped some of the demand for the drugs.

Guidelines issued by the Centers for Disease Control and Prevention to encourage more responsible prescribing practices are also a focus. And policy staff across federal agencies agree those guidelines, coupled with a slew of state laws limiting prescription length and encouraging use of non-opioid painkillers, are the best bet when it comes to addressing the crisis.

Instead of reducing prescriptions by lowering quotas, Kolodny said, governments should work to lower quotas by reducing prescriptions. But the Pandora’s box was opened long ago.

“In 2002, there should have been a change in the way we have a quota or a cap, and a cap would have been a mechanism to prevent other pharma companies from putting other opioids on the market,” Kolodny said.

“The problem with new opioids getting approved is each time the opioids get approved, [manufacturers] have to recoup their investment,” he said. “The only way to do that is to get prescribers to prescribe your drug, which means a campaign to incentivize prescribing. Basically each new opioid is pouring fuel on the fire.”

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  • Kolondy,I don’t want your Suboxone.Chronic pain patients are not addicts.
    Rewrite the CDC guidelines,they were created in violation of federal law.
    STOP THE WAR ON CHRONIC PAIN PATIENTS ANDREW KOLONDY!

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    .”The CCSVI treatments despite the short-term improvements in many cases, showed the correctness of the road to be followed. In many cases the improvements remained and they were not “placebo” effects. They proved that Dr. Schelling was right. Unfortunately these CCSVI treatments were performed by inappropriate specialists, who had no idea of the blood system in the brain and of the nervous system. These times are now over.
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    Justice will not be served until those who are unaffected are as outraged as those who are.- Benjamin Franklin

  • This entire situation makes me sick!! I am just so darn tired of anti-opioid zealots and their unsubstantiated PROPaganda and claims that prescription narcotics were the lone cause for the uptick in OD’s and abuse in general!

    If it were really that simple things would have gotten much better by now and not a whole lot worse for everyone concerned.

    They’ve been cutting back RX’s for years now! My dose began getting reduced around early 2013! It wasn’t medically justified either. My doc said he was preparing me for what was coming.

    There are too many intervening variables that aren’t being considered! Or, maybe they’re being conveniently left out?? Maybe, their consideration was just too much work?

    Narcotic abuse has been a perpetual issue that has had plenty of time and resources to be properly explored and remedied! But, rather than learn from other countries that have had tremendous success the US & Canada waited for things to become exponentially worse and then rather work through it logically, compassionately or humanely they pulled what they usually do and reacted in a drastic and ubiquitously harmful manner. Even when the so-called unintended consequences were realized they fully ignored them and placed emphasis on the unintended aspect so that in hindsight they could say: loops! Oh well, too late and besides it has done ‘some’ good. So, rather than work to abate the harm they are just steamrolling ahead! Total BS!

    What has the government done about the real crisis of heroin … other than ensuring its production by having US soldiers guard Afghanistan poppy fields?

    Way to go gov! CIP’s (esp. vets), are committing suicide daily and at a higher than ever rate! And addicts have gone from using safer pharmaceuticals to Fentanyl laced with heroin! Good grief! The fact that they’ve made matters worse couldn’t be any more apparent! If it were a snake it’d have bitten ’em all by now!

    Most of us involved and/or effected by the draconian application of the perverted intentions of the CDC, Kolodny and their merry band of nitwits know and have seen the real data, have seen their claims uncovered and denounced by industry experts for the cherry picked pseudoscience it is, and we know their PROPaganda campaign rests squarely on personal bias that amounts to an utter disregard for an individual’s constitutional rights! YES! Proper and adequate pain relief is a human right!

    They have salted bits of half truths with just enough plausibility that every scared witless, soulless, first do no harm to one’s self, spineless physician has been able to chomp onto one bit or another to justify totally abandoning their long time and well documented patients! Sure bet they sleep just fine at night having convinced themselves that they’re actually doing no harm while they wash down that salty bite size mediaspeak or rather “governmentspeak” snack with a tall glass of denial.

    What REALLY and SERIOUSLY concerns me and keeps me awake at night other than my own waaaay under treated CIP is that these A**hats still believe that too many prescriptions are still being written!!!

    SAY WHAT!?? Seriously!??

    What about all the good, decent, and honest people that have already lost their medications entirely!??

    With this sort of CRAZY in play these poor folks will probably never get their lives back! Physicians are still being told that there are too many scripts being written and they’re all too aware of the DEA’s attacks on legit practitioners. So, tell me, what physician is going to call attention to their practice by giving back much needed relief to those who’ve already been entirely abandoned!? It makes me sick! It needs to stop!

    Historically, chronic pain both malignant and nonmalignant had been severely under treated. There was a call to address this serious issue. Sooooo… doctors began to write more prescriptions. Duh! There is one variable that’s been conveniently left out of the equation! And hey, how about the fact that more and more baby boomers have reached an age where their bodies are broken from decades of manual labor? I’m sure that’s played a role in the increase of RX’s for pain. There’s too many factors being left out.

    Unfortunately, Purdue Pharma, looking to recoup their R&D for OxyContin, went a bit overboard with their advertising campaign. But, their greed and the physicians that apparently forgot everything they were taught about narcotics and somehow let themselves believe big pharma had altruistic motives and that they’d made some sort of magical coating that rendered a narcotic safe for the first time in … well, ever… Does NOT Negate the very real fact that narcotic therapy for chronic intractable pain is still the best option for many people to live some sort of a semblance of a quality life once all other options have been exhausted!!

    That’s another thing I am so sick and fricken tired of!!

    WHY do these zealots and government folk think that people that had already been put on high dose opioid therapy had not already tried everything under the sun!!??

    I mean, they have made it seem as if every single doctor had gone straight to pharmaceuticals!! Personally, I spent like 18 years managing my severe pain without daily opioid therapy!! I’d like to see one of them deal with mind blowing pain 24/7 for nearly 20 years and tell me they’d like to do another 20 w/out adequate relief! I’m betting the vast majority wouldn’t last a day!

    All in all this crazy and dangerous quota bologna is going to only hurt American citizens! Lord forbid we end up with a major catastrophic event and hospitals aren’t able to help everyone in need! Never mind that patients, who are expected to use one pharmacy (and must now due to e-scripts), will no doubt show up to pick up their medication only to be told it’s not in stock and it’ll take a week to get! Ahh, but alas I suppose this IS what they want! Force people into withdrawal and then hopefully to the ER because they cannot tolerate the symptoms where they’ll be treated to a lack of dignity, respect, compassion all while being forced to wait for at least eight hours to be told they can be only receive meds to help the symptoms of withdrawal and the heck with their pain!

    This is NOT my America!! This is NOT the country I was proud to be a part of. It’s something totally different. Maybe, just maybe these ARE “the latter days” – ??

    Sorry to ramble on and on like usual. But gosh, I’m so fed up with all the illogical and inhumane ploys! *SIGH*

    • Please pardon my typos. I thought I caught them all but I just saw a couple. Like, “loops” should have been “oops”. Ug! My auto spell check just did it again. It replaced oops with loops & I almost didn’t notice again.

      Anyway, aside from our government trying to cull the herd … I hope everyone has a happy, love filled, and joyful holiday season!! Sending prayers to one and all <3

  • What this Really boils down to you have a few olgarchys that have hedged against a pharmaceutical companies and used the DOJ,DEA, & meida to perpetuate this misconception of legal drug use with illegal regardless who it kill this government of ours doesn’t give a nickel f@*: about the disabled in this country.

  • When the DEA built a case against McKesson, a huge distributor of opioids, over many years and recommended criminal and civil prosecution they were rebuffed by prosecutors. Instead, McKesson paid a measly $150 million fine and had to reduce distribution in a few warehouses and submit to a monitor for a while.

    $150 million is not even a week’s profit – it’s pocket change and not a meaningful penalty. Those agents built a case but the political will to pursue criminal charges was zero. So, now, they’re being asked to lower quotas after prescribing already peaked 5 years ago. Brilliant.

    See: http://www.cbsnews.com/news/whistleblowers-dea-attorneys-went-easy-on-mckesson-the-countrys-largest-drug-distributor/

  • What about the people who can not stand a life of pain again. Maybe they considered ending their life before? Now it may be that they refuse to go back to a life of pain again and will consider this even more now since they have experienced a little relief. Maybe our government should take a long look at this . Obviously they have not !

  • The DEA has all ready made life for people like me and thousands of others with chronic pain lives more difficult which has lead to hunreds of suicides and thousands of doctors scared to death to treat anyone with chronic pain what a country we live in that treat the disabled like criminals it too bad no one will stand up for our rites.

  • I’ve been on opioid seance 1999 for a work related injury to my lower back. At the same time I got a hernia that got infected due to mesh and suechers 7 surgeries damaged my left groin and my leg put that with my back yes there is alot of pain I would no wish it on anyone . .But seance State and Gov. Has cut meds for people like myself and many others nation wide we suffer with little me they left us with . Don’t blame chronic pain patient like myself for others who sell there med just to make a buck they should be random drug test to catch the bad patients and stop putting real patients though he’ll with the lack and cuts on meds . a friend in pain James

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