W

ASHINGTON — Jessica Hulsey Nickel had only just begun to speak at a House hearing last month when a man in the back corner of the committee room stood, unfurling a paper banner and shouting toward the witness stand.

“I would like to know how much money the Addiction Policy Forum has received from the pharmaceutical industry,” yelled Randy Anderson, a well-known addiction treatment and recovery advocate in Minneapolis. “We’ve asked the question and no one will tell us. I figured I’d fly here today and ask.”

A congressman tried to gavel Anderson quiet. Committee aides scurried to fetch police. Nickel — the target of Anderson’s protests and Addiction Policy Forum’s president and CEO — ignored the interruption and continued with her testimony about legislation that would reshape federal laws regulating addiction treatment. When the hearing finished two hours later, no one besides Anderson had raised questions about potential conflicts of interest.

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Despite Anderson’s difficulty in getting her attention, Nickel’s three-year-old nonprofit is increasingly in the spotlight, both for its high-profile advocacy work and its close ties with drug makers. The vast majority of the group’s funding comes from pharmaceutical companies, some of whose executives sit on its advisory board. Overshadowed by APF’s funding sources, however, is a more striking connection: Until last fall, Nickel was concurrently working as a lobbyist for Alkermes, the maker of a drug used to treat opioid addiction, while heading the nonprofit.

In interviews with STAT, Nickel brushed off concerns about her work with Alkermes and her group’s multimillion-dollar partnership with PhRMA, the drug industry lobbying group, calling those reservations “an old way of thinking.”

“We need to be collaborating with industry, companies that have R&D budgets,” Nickel said. “The folks that cure diseases need to be at the table with us, so I stand by this partnership. I stand by the decision.”

Increased attention to the epidemic, however, has created an undeniable business opportunity for many drug companies. A spending bill passed earlier this year added $3 billion in funding for initiatives specific to the opioid crisis. Budget caps allow for many more billions to be spent in 2020 — a significant chunk of which is destined to fund medications used to treat opioid use disorder. The bills Nickel testified about before the Energy and Commerce Committee are likely to authorize much of this spending.

With Capitol Hill purse strings newly loosened, the companies that make medications critical for treatment of opioid use disorder — many of which fund APF — are positioned to earn millions as treatment is expanded. Those coming changes have heightened the fears of advocates wary of APF, which declined to specify dollar amounts for the funding it has received from industry partners.

“Transparency and accountability are paramount, and we have to hold our leaders to higher standards,” said Jesse Heffernan, a recovery advocate based in Wisconsin.

Heffernan, the former national empowerment and outreach coordinator at the advocacy group Faces & Voices of Recovery, has also been in early-stage discussions with Sen. Tammy Baldwin (D-Wis.) about pharmaceutical industry influence more broadly.

“When we have leaders like those from many national organizations like APF being tied to any kind of pharmaceutical money,” Heffernan said, “we need them to step up and talk about it.”

Political connections

Whatever legislation Congress passes to deal with the opioid crisis — key Republicans in the House hope for a vote prior to Memorial Day — much of the law is likely to focus on access to medication-assisted treatment.

The draft legislation now before Congress includes a provision requiring many providers of addiction treatment receiving federal grants to ensure access to all FDA-approved forms of medication-assisted treatment for opioid use disorder.

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Methadone, among the oldest, is the cheapest of the four. A second form of MAT, buprenorphine, has a number of manufacturers. Only one company, Alkermes, makes an increasingly popular third option — Vivitrol. A fourth MAT option comes from Indivior, an injectable form of buprenorphine that is also long-acting. Braeburn makes another injectable buprenorphine product it hopes will receive FDA approval shortly.

Alkermes is among the original funders of the Addiction Policy Forum, while Indivior and Braeburn are also listed as APF sponsors. The multiyear partnership with PhRMA is worth “tens of millions,” the trade association said. Each of the group’s industry partners said it had made the contributions without restrictions.

And from 2014 to 2017, Nickel is listed by name in $760,000 worth of lobbying disclosures for work on behalf of Alkermes through a separate consulting firm.

Nickel, who lost her father to opioid use disorder at an early age and whose mother passed away after years in recovery, said her group’s relationships with drug companies have proven valuable in APF’s fight to wind down the current opioid epidemic. Already, the group has used industry money to implement ambitious projects that advocates say could make life easier for individuals seeking treatment and their families.

APF is mapping addiction treatment and recovery resources in each of the nation’s roughly 3,000 counties; orchestrating yearly events on Capitol Hill for families impacted by substance use disorders; and took a lead role in planning a drug development event later this month alongside the Food and Drug Administration and National Institutes of Health.

Taking pharma money is more the norm than the exception among nonprofits that work on addiction issues in Washington. Despite APF’s funders, Nickel insists the policy the group advocates for is determined by two factors: science, and the needs of the families it works with.

But APF is noteworthy for its close connections across Capitol Hill and federal agencies, which have allowed the group a central role in policy discussions.

In June, Nickel testified before a White House commission on combating the opioid crisis. In late 2017, APF invited stakeholders to a brainstorming session with APF and policy staffers for the House Energy and Commerce Committee, a key committee shaping opioid legislation, according to emails obtained by STAT. A committee spokeswoman denied such a meeting ever took place.

“We’ve been asked to submit ideas to House Leadership regarding suggestions for legislation to address addiction, like a CARA 2.0,” APF’s chief operating officer, Jay Ruais, wrote in the October email. APF confirmed to STAT in November that it was working with lawmakers from both parties on opioids legislation.

The group will honor House Majority Leader Kevin McCarthy (R-Calif.) at an awards dinner later this month. Nickel herself was a legislative aide to Sen. Rob Portman (R-Ohio) over a decade ago when he served in the House.

And most recently, APF has been jointly planning, with FDA and NIH, a patient-focused drug development event planned to take place April 17. The event will invite individuals and families impacted by substance use disorder to share their perspectives regarding what medicines have been useful and what is lacking in the current treatment landscape.

An FDA spokesman said the agency, after receiving a proposal from APF to run a patient-focused drug development event, liked the group’s idea so much that it decided to take the event over and run it internally, with logistical and outreach support from APF.

“Folks that say we shouldn’t be collaborating with the FDA or NIDA or NIH, or companies that make medicines for our disease space — I think those are folks that are stuck in an old way of thinking.”

Jessica Hulsey Nickel, Addiction Policy Forum president and CEO

APF has also reached into the federal research world for talent, hiring Maureen Boyle — formerly the chief of the science policy branch at the National Institute on Drug Abuse — as the group’s chief scientific officer in December.

“Folks that say we shouldn’t be collaborating with the FDA or NIDA or NIH, or companies that make medicines for our disease space — I think those are folks that are stuck in an old way of thinking,” Nickel said. “Those that can give us better medicines, better treatments, better pathways for our families, they need to be at the table with us.”

By and large, established voices in Nickel’s orbit agree.

“This is pretty labor-intensive, expensive stuff, and nobody else has done it,” said Sue Thau, a policy consultant for the Community Anti-Drug Coalitions of America and a member of APF’s board of directors. “That’s what [Nickel] is using the money for.”

Treading cautiously

Others are less convinced that the cost of collaborating with industry is worth the benefits.

“The practice of funding astroturf patient advocacy organizations is an industry-wide practice,” said Leo Beletsky, a public health and law professor at Northeastern University who focuses on drug policy. “This is no different, and certainly there is a huge business opportunity that Alkermes has happened upon here.”

After a New York Times report in February, the voices crying foul became louder. The story highlighted APF’s partnership with PhRMA and detailed a meeting Nickel attended at which industry lobbyists pushed Minnesota lawmakers to reject a proposed tax on prescription opioids.

“The pharmaceutical industry is now attempting to co-opt and otherwise influence individuals and families to take the pressure off a mounting onslaught of civil lawsuits and state opioid tax bills,” Facing Addiction, a national nonprofit geared toward addiction treatment and recovery advocacy, wrote on its website in February, directing readers to the Times report.

Still, addiction experts emphasize that medication-assisted treatment is a hugely valuable approach to help counter the opioid epidemic. And legislation that widens access to such medicines is, broadly, a good thing.

Some experts did question the requirement, in the draft legislation, that federally funded providers of substance use disorder treatment provide access to every FDA-approved drug on the market. That language has become common in legislation focused on addiction treatment, but has taken on added significance as new, expensive forms of MAT gain approval.

The cost of Vivitrol and of Indivior’s injectable drug are a large part of some advocates’ concern that compelling their presence in every addiction treatment setting could, in fact, pose a barrier to traditional and cheaper forms of medication.

“I’m in favor of requiring addiction treatment providers to offer the first-line treatments” of buprenorphine and methadone, said Dr. Andrew Kolodny, the co-director of Opioid Policy Research Collaborative at Brandeis University. “[But] if you make a provider do all or none, that’s making it harder for them to do what I think is essential.”

Spurring transparency

Because of APF and other groups’ connections to the drug industry, some advocates have hung their hopes on a pending bill from Sen. Claire McCaskill (D-Mo.) that could force more transparency. The bill would require any nonprofits receiving federal money — which APF does, in the form of grants from the Substance Abuse and Mental Health Services Administration — to disclose the value of all contributions from industry.

McCaskill released a report in February about chronic pain advocacy groups that later proved to have been funded by pharmaceutical companies. As a follow-up to that report, she is planning legislation to force added transparency from pharmaceutical groups regarding their contributions to nonprofits.

In the meantime, some in the recovery sphere are treading cautiously. Lori Erion, the founding director of the Ohio-based group Families of Addicts, said she stopped working with APF’s state chapter there due to concerns about industry influence.

“I have no doubt the intentions of Addiction Policy Forum are good,” she told STAT. “However, I am concerned that advocating for the people could be skewed when the largest part of their funding comes from big pharma. I founded FOA Families of Addicts and know the funding struggles well that we face. For me, it’s a matter of integrity and doing what is best for the people. I wish APF the best.”

But hopes that the Addiction Policy Forum might cease to accept pharmaceutical money, or play a less central role in national advocacy, are unlikely to be realized, as their work forging partnerships with other national organizations and issuing grants to advocacy groups around the country continues.

“I think it’s foolish to think that some inexperienced and new activists are going to divide the recovery advocacy movement,” said Patty McCarthy Metcalf, the executive director of Faces & Voices of Recovery, a national treatment and recovery group that has partnered with APF.

“[Nickel has] never taken a position she doesn’t fully believe in,” Thau said. “She’d give the money back before she’d do that.”

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  • You mean the same way they tell chronic pain patients to suck it up, Dr. Dave.. we didnt ask for our illnesses either. But, its ok to deny us meds, or restrict the hell out of them to the point doctors wont even prescribe them anymore.

    • There is a HUGE difference between addiction and dependence
      I am dependant on my chemotherapy for my cancer but I am not addicted to it
      Some people who use pain meds specifically opioids, in general, get addicted to them. That means that their brains actually make a molecular biological change that makes it function differently than those who use the same pain meds but don’t get addicted
      I take pain meds for my cancer pain. I am NOT addicted I stop when I want to and accept the pain and when it gets too much I can turn it back on with no mental difference. I do NOT feel high I am not craving I am not altered in any fashion
      Now an addict, if even a slight drop in dosage is not supplied, will feel all of those symptoms and added to that will usually also require a greater amount of drug in order to feel the same sensation he/she felt a few months ago with lesser amounts
      This article has absolutely NOTHING to do with day2day opioid function or doses or prescribing or even sickness it is ONLY about the fact that an organization who is supposed to be working to help addicts get clean and or assistance is being funded by the same companies who are making the drugs, to begin with
      I have NO issue with that except she is refusing to divulge the details of the relationship
      I am 100% in support of PharmaCos taking some of their profits and running them back into the addiction process. Let’s face it the addict is way past using prescription drugs they have left the sublingual and novel lollipop narcotic in favor of street-level cocaine and heroin which is FAR cheaper
      So why not allow the PhamaCos to help this mess?
      Time readers stop using STAT for their own pulpits on every article and focus on the topics at hand
      This has nothing to do with denying drugs or liability or the like
      Read Reply on Point Repeat
      Dr. Dave

  • Buprenorphine is an agonist/antagonist which means it has narcotic and naloxone properties. I was involved in a study where it was utilized in a post op recovery room and the patients hated it. It made them feel nauseous and spaced out and didn’t relieve their pain well. Vivitrol is a pure antagonist like naloxone or narcan. It will totally block any pain med. It has no use at all in patients in pain. But I have seen addiction specialists force it on people with painful conditions just to see them suffer. These agonist/antagonists are really more for the purpose of torturing people than for any real purpose if the patients have pain issues. Addiction specialists are unfortunately not ethical practitioners if they are forcing chronic pain pts to be placed on agonist antagonist drugs. That is a sadistic treatment modality to force on a pt with pain issues. But I have seen this done simply because a practitioner wanted to exert their unethical will over a compliant pain patient.

  • DKR
    Did you actually read and critique the two studies you mentioned? YES there was a SLIGHT increase in physician use of the drugs supported by free lunches handout goods and other co,complimentary things given to docs by PharmaCos BUT the difference was minimal and the overall outcome was totally nullified once the audience we polled and reviewed after suggesting that they were going to be accounted for in a federal database
    Actually, since the two papers came out and the implementation of the database more and more docs go the other way TOTALLY. If I go to a seminar or CME paid for by a company I tend to pick the seminar apart to greater scrutiny and hold the speaker and the company to a higher standard to convince me to use their drug
    I agree with you 100% that ALL it takes if openness I care less if the agency creates protocols to support one drug over another based on their financial support the question is clinical is the options equal do the choice solve the addiction problem and is the cost equated between options?
    If two drugs are equipotent both approximately the same cost then I am FINE with making the drug from the sponsoring company SOP as opposed to other options
    When it all comes down to it the choice is based on the doctor on the case and unless/until we make us robots we still decide what is best for our patients
    Dr. Dave

    • Addicts won’t get clean until we give them EFFECTIVE ways to get clean!

      The misconception is this is about obstinance and lack of willpower and sheer self-neglect. Nothing could be further from the facts.
      Facts: Addiction is an actual brain alteration that not everyone goes thru but for those who do the return path is much more difficult.
      Getting help is FAR more than motivational BS and meetings that Rah Rah the addict to magically self-correct and self-monitor until the brain starts to change back (never fully changes back in those who have true addiction hence why AA says “we are recovering alcoholics” NOT recovered or former)
      We in science and medicine need some OTHER way to return the body to pre-addiction status and to make the sensation to use go way as well as make the withdrawal much easier
      Like they say you never know until you walk a mile in their shoes
      I have never been an addict or even tried a street drug but I have worked with LOTS who have as well as being involved with drug interdiction for decades. What I KNOW is that this is NOT will power it is a disease
      NO different than telling someone to toughen up and stop their cancer before it spreads, or man up and stop the stroke bleed.

      Pretty nonsensical response huh?
      SAME exact issue when asking an addict to tough up and get help and stop drugging/drinking. They would if they could but since they can’t they don’t
      Dr. Dave

  • I have absolutely NO issue with accepting funds and or “partnering” with industry players BUT I think that the organizations need to be transparent as to how much the commercial players are contributing.

    I am 100% in favor of using the PhamaCo money to move closer to resolves. There is NO reason to assume that because they provide leadership and cash that also assumes that the organization is going to make bad societal decisions for economic reasons.
    If the organization is above board and is explaining the day2day operation and directions it is taking along with being fiscally accountable to everyone for its actions then the partnership can work very well

    This is NO different than the tens of thousands of physicians who on the various federal lists required when PharmaCos and or equipment manufacturers provide anything from lunch to free merchandise to CME tuition expenses etc

    It doesn’t ASSUME that the docs are then going to go back to their patients and treat them poorly because some PharmaCo gave up some cash in order to educate or inform on their product.

    Sure I get it that there are hundreds or thousands of paranoid scandalmongers who look at every potential as an assured absolute and who see conspiracy at every corner. That doesn’t imply they are correct. I still totally believe that we walked on the moon and that 911 was not a Hollywood hoax and there really was a plane in the side of the Pentagon.

    There will ALWAYS be bad people who use good intentions for bad outcomes or personal gain but to assume everyone will do that is wrong

    In this case, give the organization the benefit of the doubt until proven guilty that they will partner with big Pharma and together will reign in some of the deaths from opioids and narcotic uses

    Dr. Dave

    • Research shows that free lunches, etc by pharma companies directly to doctors in their offices influences their decisions and behavior. Majority of the doctors in the studies would believe that it didn’t influence their behavior. Yet their prescription writing proved that it did. This is ultimately what led to not only laws requiring transparency regarding all Pharma monies to doctors, even a $10 sandwich. Since those laws passed, the amount of money doctors receive from Pharma for such lunches and for speaking fees has reduced drastically as fewer docs do it.

      If APF and other organizations truly believe that the source of their funds does not influence their behavior, they should just have full transparency about their funding and let others draw their conclusions.

  • No where in any of these conversations do feel a focus on the killer, Fentenal. After you’ve legislated legit use of opioids for chronic pain out of use, fentenal will show up everywhere. Its already in cocaine. Tobacco, pot, alcohol are just a matter of time. There is a big problem but don’t throw the Baby out with the bathwater.

  • Lol that industry funding is acceptable in anti drug circles. These are the same people who shout over and over about the pharmaceutical companies that caused this so called crisis. VERY hypocritical of them.

  • Not sure what’s the point of this post is except to be decisive. Damn the opioid problem is the problem, ADP is actually doing something about it and you want to make an issue on who is writing the checks to fund great work ??!

    When the drug companies lawsuits are all settled and like the tobacco industry $25B is now available over 10 years to be spent in dealing with the problem they help create … What are we to do ? …Say “no thanks”….Keep your $25B …We will ask the tax payers to pay for solutions….

    Dude. Good is good …Who cares who is writing the check !!!

    My .02c

    Tim

    • I care who is writing the checks, especially when they are the ones who contributed to the deaths of our loved ones! Blood money in my eyes.

    • I don’t see it as blood money, but then I’ve zero family members who’ve gotten hooked either through scripts or recreational use.

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