WASHINGTON — As legislation to address the opioid epidemic gains momentum, drug makers, insurers, and other interest groups are engaging in a concerted drive to tailor the bills to their liking.

The effort, in some cases, has resulted in lawmakers softening, or entirely backing off, some of their most far-reaching proposals.

Members of Congress have advanced dozens of bipartisan bills that advocates say are needed, commonsense steps to address the public health crisis. Later this month, the House is likely to consider legislation that would speed approvals for non-opioid painkillers, strengthen drug enforcement programs, improve care for children impacted by addiction, strive to reduce prescription levels, and improve prescription monitoring programs.

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But not all of the proposals have gone unopposed. The pharmaceutical trade group PhRMA, the American Medical Association, and a major drug distributor are among a handful of players maneuvering to shape the legislation, according to a review of lobbying disclosures by STAT and interviews with Capitol Hill aides, lawmakers, and lobbyists.

“This is the big time, and the price of working on major legislation is that insurance companies and pharmaceutical companies get involved,” said Andrew Kessler, a longtime advocate on addiction treatment issues who represents a number of behavioral health associations and treatment providers. “We’ve got work to do, they’ve got work to do, and let’s hope we’re better than they are.”

The push from Congress comes after a year of the White House and Congress promising action to address the crisis. And any legislation will almost certainly mean a surge in funding to health care providers and others, ensuring the bills are high on the radars of drug makers, drug distributors, insurers, and physician groups.

In four cases, outlined below, the ambitions of some lawmakers to staunch the opioid crisis may be colliding with the reality of other interests on Capitol Hill.

Widening access to addiction treatment

One of the most contentious issues is how far Congress should go in expanding access to any particular addiction treatment, resurfacing concerns that lawmakers could be playing favorites.

One of the treatments backed by the strongest scientific evidence involves the drug buprenorphine. Under the law, doctors must be licensed to prescribe it and face a cap on how many patients they can treat to ensure that it is used safely. (The medication itself can be addictive.)

A bill sponsored by Rep. Paul Tonko (D-N.Y.) would increase those caps and allow nurse practitioners and physician assistants to continue to prescribe the drug. But the proposal has languished in the House Energy and Commerce Committee, which has assembled an opioids package that the House is expected to consider soon.

It is one of few proposals with bipartisan support to be left out so far.

“Every single American public health expert who has spoken out and testified on this issue has said we need broader access to buprenorphine to address the opioid epidemic,” Tonko said. “We introduced a bipartisan bill to solve that problem, but we seem to be hitting roadblocks every step of the way. Each organization that has spoken out against our bill has a stake in preserving the status quo.”

According to federal disclosures, representatives of PhRMA and the drug maker GlaxoSmithKline lobbied on the Tonko proposal. PhRMA told STAT it had not taken a position on the legislation. A spokeswoman for GSK said the company had likely been asked for input by a congressional office, meaning it was required to list the bill in its disclosures.

Democratic aides and some lobbyists said in interviews that they were also concerned about the influence of Alkermes, a drug company that manufactures Vivitrol, a non-opioid treatment widely seen as an alternative to buprenorphine.

The day after Tonko’s bill was defeated, the congressman’s office received an unsolicited call from Alkermes staff asserting that the company had not been responsible for killing the proposal, according to his office. Indeed, an Alkermes spokeswoman said the company had not lobbied on Tonko’s bill, and its lobbying disclosures make no specific mention of it.

But negotiations on the bill had been delegated to Rep. Larry Bucshon (R-Ind.), who has received more in campaign contributions from Alkermes in the current cycle than any other lawmaker: $8,000 for a House race that is not seen as competitive. While the company has contributed in small increments to other members, large contributions have also gone to the committee’s chairman, vice chairman, and former chairman.

Alkermes employs two lobbyists who previously worked for key committee members. Bucshon also authored a bill in 2015 that would have placed new requirements on physicians wishing to prescribe buprenorpine.

A Bucshon spokesman brushed aside the concerns about the campaign contributions, saying the congressman’s opposition to the bill stemmed entirely from concerns about “adequate training” for those licensed to prescribe the drug.

The Alkermes spokeswoman, Jennifer Snyder, said in an email that “impliedly or expressly connecting Congressman Bucshon’s actions on this particular bill to Alkermes — based on Alkermes’ historical campaign contributions — is not factually accurate and is misleading,” and that the company is one of many to have contributed to Bucshon’s campaigns.

Asked about Tonko’s proposal, GOP committee aides pointed to the Drug Enforcement Administration as a reason the bill had not advanced. The DEA had initially opposed the Tonko legislation because of concerns that wider access to buprenorphine increased the risk it could be used illicitly.

The agency rescinded its opposition last week, according to multiple House offices.

Expanding DEA authority

In the Senate, the drug distributor AmerisourceBergen has waded into a debate about whether expanding the DEA’s authority would help interdict some suspicious drug shipments and ultimately help curb the opioid crisis.

A 2016 law had set a new threshold for the DEA before it could freeze drug shipments, mandating that the agency must demonstrate that a company’s actions represent “a substantial likelihood of an immediate threat.”

When the Washington Post and “60 Minutes” revisited the history of the legislation last year, and highlighted that it was authored by Rep. Tom Marino (R-Pa.), at the time President Trump’s nominee to be his drug czar, it set off a political firestorm in Washington. Marino withdrew from consideration, and lawmakers, mostly Democrats, quickly called for the law to be repealed.

Still, Sen. Claire McCaskill (D-Mo.), who introduced a bill last year to restore much of the agency’s discretion on suspicious shipments, has been unable to secure a Republican cosponsor.

In an interview, McCaskill said “pharma is working its magic” to prevent her bill from receiving a co-sponsor or a vote.

AmerisourceBergen, one of the country’s “Big Three” drug distributors, has lobbied on McCaskill’s bill in each of the last two quarters, according to lobbying disclosures.

The company denied directly opposing the bill, but any expanded authority for the DEA could increase the likelihood that drug distributors face increased scrutiny for drug shipments seen as suspicious.

“To the extent it can be proven there were any unintended consequences of the legislation, including lessened enforcement authority by DEA, we support parts of the law being re-evaluated,” the company said in a statement, emphasizing it supported the DEA taking “more steps — not fewer” to regulate opioids.

“The idea they came to the Hill in order to lobby offices in support of our legislation seems like a stretch,” said Drew Pusateri, a top aide to McCaskill on the Senate Homeland Security and Governmental Affairs Committee.

Several House Republicans have signed onto a bill to repeal the 2016 provisions, but it was not included in a broader package of bills that recently cleared the Energy and Commerce Committee, and McCaskill’s bill is not expected to receive a floor vote this year.

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Limiting first-time opioid prescriptions

As drug makers and insurers have worked behind the scenes on the opioids legislation, physician groups — most notably, the American Medical Association — have forcefully pushed back on proposals to limit first-time opioid prescriptions to three days.

The Centers for Disease Control and Prevention, in updated prescribing guidelines issued in 2016, said that three days or less of opioid treatment “will often be sufficient” and that “more than seven days will rarely be needed.” Addiction experts have also sought to curb the prescription of opioids.

But doctors groups have largely argued that any attempt by Congress to restrict opioids patients would represent an unwelcome intervention by the government in patient-doctor relationships and could deprive patients of medication they legitimately need.

“The CDC guidelines are voluntary and do not include a hard limit,” Dr. Patrice Harris, who chairs the AMA’s Opioid Task Force, said in a statement. “They were intentionally drafted with flexibility, and they were not intended to be codified. Congressional efforts to codify a strict limit on prescribing opioids are inconsistent with both the language and spirit of the guidelines.”

A PhRMA spokeswoman told STAT that the organization had not taken a position on the legislation proposing the stricter cap. The organization’s CEO, Stephen Ubl, endorsed seven-day limits on first-time prescriptions when testifying before a White House commission in 2017.

Providing mental health treatment

Experts have stressed the importance of providing treatment to those struggling with mental health and addiction, and advocates are hoping to bolster laws that enforce “mental health parity” — provisions that require insurers to offer mental health benefits on par with other benefits.

Labor Secretary Alex Acosta had previously expressed support for a proposal that would allow the department to fine insurers out of compliance with those laws — a proposal endorsed last year by the White House opioids commission.

“The Secretary of Labor testified he needs the ability to fine violators and to individually investigate insurers not just employers,” the panel wrote. “We agree with Secretary Acosta.”

Such efforts, however, have been aggressively opposed by the insurance lobby, which is fearful of broad federal authority being conferred to impose fines on specific insurers or plans.

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According to lobbyists and numerous Senate aides, Sens. Bill Cassidy (R-La.) and Chris Murphy (D-Conn.) had prepared legislation that would allow the Labor Department to fine insurers found to not be compliant with federal parity law. No such legislation has been unveiled, however, and the proposal fell short when Murphy introduced it as an amendment at a recent hearing.

A Cassidy spokesman forcefully pushed back on the suggestion that Cassidy had abandoned his support for the proposal, citing late-arriving guidance from the Labor Department and saying the senator remains open to the idea.

But Senate aides and multiple outside consultants who closely monitored or helped draft the policy said that at one point Murphy and Cassidy had planned to introduce a bill. And while Murphy stuck with his proposal in spite of aggressive insurer lobbying, they said, the proposal effectively died when they lost Cassidy’s support and GOP support with it.

America’s Health Insurance Plans, which represents insurers including Anthem, Blue Cross Blue Shield presences in several states, Cigna, and Kaiser Permanente, did not respond to request for comment on whether it had lobbied against the proposal.

A policy staffer for the ERISA Industry Committee (ERIC), which represents large employers on insurance policy, said the Labor Department had been unable to articulate why the ability to impose fines would prove helpful in enforcing parity law. Capitol Hill offices, he said, had also demonstrated a poor grasp of which mental health coverage gaps qualified as parity violations.

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  • Re buprenorphine vs. methadone, I think there is an important point to make. I’ve been a pharmacist for about 33 years, mostly in a state that has seen substantial mortality from opiates. In the early years of the epidemic in Utah, methadone was a major contributor to mortality. IMO buprenorphine is safer than methadone. Please don’t take a single study out of context. Look at all the data… like the increased mortality risk of methadone documented by the Utah State Department of Public Health, and also in Washington state. Also look at why experienced clinicians use methadone with a healthy dose of respect due to an extremely variable half-life and low ceiling for respiratory depression, which when used by inexperienced clinicians can kill patients. Methadone may be cheap compared to buprenorphine, but it would be extremely hard to convince me it is safer.

  • The main focus is on the small number compared to the 100,000 ppl who need opioid pain relief to live without their lives being overwhelmed by severe chronic pain who most have never had an issue with opioid abuse disorder.. Why are these humans ignored in these discussions EVERYDAY? This group have Never experienced a problem with opioids except when they’re denied the life are Newing medications that are the only thing they’ve tried that unable these patients to function in their private lives , think sleep once again without being overwhelmed by chronic severe pain interfering in the close to normal lives that once again feel love and give love so important to life!!!

  • I’m not arguing that the government, should be dictating treatment. I am saying that an unpleasant, cynical, and deliberate campaign on the part of Perdue Pharma spilled large amounts of their product into the general population and that we are still reaping the results. Sit down and read “The Family That Built an Empire of Pain” in the Oct. 30, 2017 issue of The New Yorker or simply googel “opioids perdue.” Of course, physicians should have a wide range of tools, chemical and behavioral, at their command, I don’t think anyone is arguing that, either. Intimating that the regulation of drugs and that appropriate protocols be developed for their use as analgesics is somehow the government taking control of things and harming patients is either naive or to be engaged in spreading the counter PR being produced by the industry – my opinion, anyway.

    • Yes you are so very correct Alex Pirie, so right. Nice to see an informed intelligent person. 60 Minutes Oct 15, 2017 and 60 Minutes June 17, 2018 both Episodes will tell the untold truth of Perdue and the Political influence that had to get Oxy approved and into the hands of any person that asked, even those that didn’t. It’s shameful and it’s sickening. When you actually look at what they claim to be doing to stem the deaths…they are doing absolutely nothing. Years to even begin to act…meanwhile people stack up like firewood in morgues. They want to allow the same drug makers that got us here to get us out…in other words reward them with more money and business. Shameful.

  • “…addiction is not a predictable result of opioid prescribing.” Of course not, nobody would argue with that. The fault, crime, really, was, and, to some extent still is, the excessive and illegal marketing of the oxy’s by Perdu Pharma and the over prescription by unwitting (usually) doctors – excessively documented in the courts and media (STAT, in particular, or the NYT today). Of course, opiates have a role, but handing them out like candy, writing repeated scripts without counselling patients on possible risks, and monitoring usage was an all too frequent path to addiction in my community. Things are changing slowly, but it has required, in many cases, legislative and judicial intervention, or threat thereof, to steer the course back to good medical practice as opposed to adding to the Sackler fortune. At discharge after a diagnosis in an ED for a kidney stone, I declined a prescription for oxycodone. “Oh, you must, you’ll need it,” the RN and an MD insisted. After some argument, I said, “Alright, I’ll take it, sell it on the street and support my children’s post secondary education.” I thought it was funnier, in a bitter kind of way, than they did. I survived quite well on a couple of days of an NSAID and lots of water. The sooner the obscene amounts of money (written off as business expense) spent on lobbying by the pharmaceutical/industrial complex and the grotesquely compelling media drug ads are curtailed, the better off we’ll all be. Hey, some of that money might be spent on research instead of depending on the NIH and our taxpayer dollars for basic scientific and developmental research – although, in reality, any money saved will probably go to buying back company stock, another “bitter pill” that the U.S. with it’s staggering medical costs and embarrassingly low standing in health outcomes is being compelled to swallow. No, to date myself, what’s good for General Bullmoose is NOT good for the USA.

    • Sorry, but addiction is not that simple. The substance is merely the main symptom of a very complex mental health disorder called addiction. The addict is attempting to self-medicate some underlying issue, whether its past or present trauma, mental health illness and/or disorder, emotional pain, hopelessness, poverty, etc.

      The consumption of alcohol is not the cause of alcoholism. The activity of eating is not the cause of food addiction. The mere act of gambling, sex or shopping does not cause addictions to those activities. Why on earth would one believe any differently about another substance?

      Most people who consume alcohol do so in a responsible manner and do not end up developing alcoholism. The same can be said of eating, gambling, sex and shopping. The majority of people who take part in any of these activities, even on a regular basis like eating, do so without developing an addiction.

      You’re extremely naive to believe that the unrestricted or loosely-restricted availability of potentially-addicting substances is a main factor in regards to addiction. If it was, then the majority of Americans and Europeans would be hardcore, hopeless alcoholics, as the majority of us have consumed (and even binged on) alcohol at least once in our lives.

      Furthermore, just because you did not require a prescription opioid for pain relief of a kidney stone, please don’t assume everyone else is the same. Contrary to popular belief, studies have shown that addiction is very rare in both the chronic pain community and among those who need relief from an acute illness or injury.

      For the most part, addiction occurs when the potentially-addictive substance is used for recreational purposes and very rare when used for legitimate medical purposes. The large majority of people, particularly those without the genetic predisposition to addiction, who do misuse a substance at least once in their lifetime do not end up developing an addiction.

      We can help provide more affordable treatment options to those who reach out for help without harming those who are chronically-ill with an incurable diseases, disorders and inoperable injuries that cause chronic or intermittent pain. Prohibition has never worked, as history has shown us over and over again. When a government excessively restricts or prohibits substances (or just about anything that can be bought and sold), the black market will gladly provide.

  • In case someone missed it, the opiod epidemic is the direct result of the prescription drug epidemic. Pharma on steroids was invented with direct to consumer marketing of prescription drugs in the 1990’s, followed by the pain clinics. This new chapter is not a game changer, unless different addictive drugs, more rehab centers, and more suffering for those who absolutely need them and can’t get them, is change.
    I am a chiropractor who sees the epidemic differently. A recent back pain case came through my door, who had been prescribed morphine for aprox. 7 years. While the back pain cleared within a few weeks, the horrific damage done by the morphine will take months if not a few years for recovery. This is one of the worst cases, but isolated it’s not. Since Direct to consumer advertising came into play, I figure aprox. 6 or 7 out of every 10 news patients I see are suffering in part or wholly from the side effects of various prescription drugs, including opiods.
    The only way I see this working for the better, and it will be a cold day in H—, is re-testing the chiropractic profession, and comparing results to the medical profession for pain management. Years ago, chiropractic outperformed medical care in Work Comp studies, but it didn’t fit the agenda of pharma, the insurance industry or the medical profession , so chiropractors were gradually pushed out.

    • Victor, you might want to examine the case made by Dr Nora Volkow, Director of the National Institute on Drug Abuse. Your knowledge of addiction is sadly out of date. Volkow and McLellan stated the following in the New England Journal of Medicine:

      “Unlike tolerance and physical dependence, addiction is not a predictable result of opioid prescribing. Addiction occurs in only a small percentage of persons who are exposed to opioids — even among those with pre-existing vulnerabilities… Older medical texts and several versions of the Diagnostic and Statistical Manual of Mental Disorders (DSM) either overemphasized the role of tolerance and physical dependence in the definition of addiction or equated these processes (DSM-III and DSM-IV). However, more recent studies have shown that the molecular mechanisms underlying addiction are distinct from those responsible for tolerance and physical dependence, in that they evolve much more slowly, last much longer, and disrupt multiple brain processes.”[i]

      [i] Nora D Volkow, MD and Thomas A McLellan, Ph.D., “Opioid Abuse in Chronic Pain — Misconceptions and Mitigation Strategies” . NEMJ 2016; 374:1253-1263 March 31, 2016]. http://www.nejm.org/doi/full/10.1056/NEJMra1507771

    • Wiley, I also recommend deep reading of a report circulated in draft in December 2017 by the Agency for Healthcare Research and Quality. Subject “Noninvasive, Nonpharmacological Treatment for Chronic Pain: A Systematic Review”. About 20 types of therapy were examined for five categories of pain including low back pain. Over 4500 clinical trials reports were recovered and subjected to a rigorous quality review. Only 245 reports survived that review, largely because most trials failed to follow up to confirm benefits lasting more than 30 days after conclusion of the trial.

      For manual adjustment of the spine in low back pain, the following was found:

      “Spinal manipulation was associated with slightly greater effects than sham manipulation, usual care, attention control, or a placebo intervention in short-term function (3 trials, pooled SMD -0.34, 95% CI -0.63 to -0.05, I2=61%) and intermediate-term function (3 trials, pooled SMD -0.40, 95% CI -0.69 to -0.11, I2=76%) (Strength of Evidence: Low).

       There was no difference between spinal manipulation versus sham manipulation, usual care, an attention control or a placebo intervention in short-term pain (3 trials, pooled difference -0.20 on a 0 to 10 scale, 95% CI -0.66 to 0.26, I2=58%), but manipulation was associated with slightly greater effects than controls on intermediate-term pain (3 trials, pooled difference -0.64, 95% CI -0.9

      =============End extract.

      What we learn from this compilation of trials is that chiropractic may have a role to play “at the margins” in moderate low back pain and perhaps neck pain. But AHRQ found that manual therapies of all kinds were almost exclusively used as adjuncts or additions to “usual therapy” — the nature of which, the trials failed to document or report precisely. Given that opioid analgesics and anti-inflammatory drugs are the primary “usual” therapies in low back and neck pain, it seems to me reasonable to conclude that manual therapies cannot now be regarded as reliable replacements or alternatives.

      Many financially self interested practitioners loudly proclaim the benefits of alternative medicine. But the AHRQ report would lead us to understand that there is very often less in these therapies than meets the casual eye.

  • Interesting article as usual government is looking for solutions after someone is addicted. More research is needed into prevention strategies, such as findings treatment that work, needed regulation of treatment programs, and finally research into the social, financial, genetic, and psychiatric predisposing factors. Decriminalizing drug abuse and treating as illness would be a big step forward. Putting users in jail makes no sense

    • Totally agree with Victor. Same old, same old, prevention is the key, but nobody makes big bucks off prevention. Vivitrol/buprenorphine both probably have a place in our materia medica, but huge amounts of time and dollars are being squandered on lobbying and campaign donations. Time to take the money out of politics and put it into getting out in front, but this would slide over into looking into the social determinants of health and no pharma CEO, board member, or stockholder wants to go there. Making money off addicting people (and, yes, they did, big time) and then off “un-addicting” them as they are now, a great business, lousy public health model.

  • Author sounds like chicken little! I’m glad cooler heads are starting to prevail regarding this supposed epidemic

  • Several points:

    It has now been proven beyond any reasonable contradiction that prescriptions of opioid pain relievers by doctors to their patients are unrelated to overdose deaths. The flood of fentanyl and other illegal drugs is so large that any contribution of prescription opioids get lost in the noise. Analysis of CDC OD and prescription data prove this observation.

    Second:
    Opioid pain reliever prescribing is at a 10 year low while overdose deaths continue to climb. Restriction of medical supply is causing shortages of hospital anesthetics needed in surgery. Yet the DEA proposes to further restrict opioid production for any classes of drugs believed to be “diverted”. Such restrictions compound an already failed policy which amounts to nothing less than an undeclared war against pain patients.

    Third:
    Recent signing into law of the VA Mission Act is guaranteed to outright KILL hundreds more Veterans by denying them effective pain management and driving them into disability and sometimes suicide. Section 131 of that law implements the VA’s “Opioid Safety Initiative” which denies opiod pain relievers to all Veterans in the VHA system. This section of the law must be repealed immediately. It is scientifically, morally, and ethically wrong, amounting to nothing less than torture for thousands of Vets.

    • I should correct my wording: the Opioid Safety Initiative mandates tapering down all Veterans to below 90 MME per day, but not cutting them off entirely. The effect won’t be much different: tens of thousands will be coerced into tapering to below their minimum therapeutic dose level. This is fundamentally irresponsible and abusive. There are no effective or useful alternatives to opioid analgesics for many Veterans with severe pain.

  • The more money Congress throws at addiction, the more scammers will profit at the expense of addicts struggling to recover. Strengthening enforcement of parity law is critical. The vast majority of addicts are self-medicating for mental illness symptoms of one sort or other. The consequent poverty derived from addiction also causes stress that compounds emotional problems while simultaneously restricting access to treatment.

    What is needed is a comprehensive bill. It looks like what we will get is a another safety net full of big holes.

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