An Open Letter to Dr. Andrew Kolodny

https://ramblingsoapbox.com/2018/06/26/an-open-letter-to-dr-andrew-kolodny/amp/

Update 6/27/18: I am overwhelmed by the positive responses I have received for this letter. I would ask that readers also take a look at all the articles and references cited in this piece, and share those as well. Those references go into much, much more detail and research than I have had space or time for here. Thank you all so much for reading and sharing, I believe we will make a difference and win this fight for our lives! #wearehere

See also: A Rock and a Hard Place, The Truth About the Opioid Crisis, and Strangulation on Medicine

Dear Dr. Kolodny,

I am one of millions of chronic pain patients in the United States who has been continually and increasingly oppressed over the past few years by progressively invasive and prohibitive laws at the state and federal levels concerning the delicate relationship between doctors and patients, particularly when it comes to a certain class of drugs, i.e. opiates.

Ever since my very real, physical condition began about 4 years ago, my family and I have been disoriented again and again by a lack of what might be termed, “help,” from doctors. We have discovered a very confused medical community, corruption, and a growing collection of laws being passed so fast and furiously hardly anyone seems to know just what is going on.

This has resulted in doctors leaving my city, doctors outright refusing to accept chronic pain patients (or, if they do accept these patients, refusing to treat them with medications that suit the patient best) or new patients, and unprecedented referrals to pain management clinics and psychiatrists. I have a detailed post planned addressing the pain management clinics, but the psychiatrist referrals were more baffling to me. My local psychiatrists even refused me as a patient about a year ago because, “we don’t see chronic pain patients.” That made sense to me as I don’t suffer from mental illness, still my providers insisted I must be mistaken.

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Down the Rabbit Hole

I began researching you and your career last night out of curiosity. I wanted to answer the question, “Who is this Dr. A. Kolodny, that everyone from journalists to policy makers and bloggers keep quoting as an “expert on opiates”?” And I found out. You, sir, are a psychiatrist and board-certified addiction specialist-turned policy maker (1) and buprenorphine (Suboxone) “evangelist” (2).

Your first private clinic was a Suboxone clinic in New York City, established sometime around 2003-2005, and it appears you (and/or other health officials) felt stymied by the federal limit at the time of just 30 patients for such clinics (put in place to stem corruption), because said health officials have been in the background, quietly working away at this very limit which was amended in 2006 (called DATA), to allow 100* patients after 1 year, and is now up in the House for being overturned altogether, along with expanding legal prescribers to nurses and other non-doctor medical staff. And look what has happened as a result:

Health officials, concerned about restricted access, lobbied alongside Reckitt Benckiser for the patient cap to be raised. “Why should we bind a healer’s hands from helping as many as he or she could?” Senator Hatch said, getting an amendment passed in 2006 that allowed doctors, on request, to go from 30 to 100 patients after a year.

The stage was set for more patients, prescriptions and problems. “It’s when the limit was raised from 30 that doctors started to get commercial about it,” said Dr. Art Van Zee, whose buprenorphine program at a federally funded community health center in rural Virginia is surrounded by for-profit clinics where doctors charge $100 for weekly visits, pulling in, he estimated, about $500,000 a year.

“They are not savvy about addiction medicine, don’t follow patients very closely, don’t do urine testing and overprescribe,” he said. “That’s how buprenorphine became a street drug in our area.” https://www.nytimes.com/2013/11/17/health/in-demand-in-clinics-and-on-the-street-bupe-can-be-savior-or-menace.html (4)

“In the early days of Suboxone, with Reckitt Benckiser barely marketing its own drug, Dr. Kolodny, then a New York City health official, crisscrossed the city with colleagues to spread the word about the new medication, entice public hospitals to try it with $10,000 rewards and urge doctors to get certified.”

https://www.nytimes.com/2013/11/17/health/in-demand-in-clinics-and-on-the-street-bupe-can-be-savior-or-menace.html (4)

Since at least 2005, you have been marketing buprenorphine as if you had a personal stake in the drug, to government institutions and agencies including prisons, public hospitals, and rehabilitation facilities (2). In the fall of 2013, you were appointed Chief Medical Officer (5), of the largest chain of non-profit detox/rehab facilities in the USA (cited for questionable practices and abuse from at least 2012-2015) (6) called Phoenix House, which received $131 million in June 2013 (7), championing the use of MAT, or “Medication Assisted Treatment”. I wonder which drug Phoenix House used?

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Hang ‘Em High?

Since you often cite the United States vs. Purdue Pharma (2007) settlement in your interviews and writings, perhaps you saw an opportunity to expand the use of buprenorphine by targeting and demeaning chronic pain patients as mere “addicts”.
It was odd to me in researching that incident, in the official “Purdue Guilty Plea” document (8), the very words they were condemned for, claiming OxyContin to be “less addictive” and “less subject to abuse and diversion” (8), appear to be the exact words you use time and again when describing the benefits of buprenorphine (2).

Kolodny reminds his colleagues of the drug’s advantages. He stresses that bupe in the form of Suboxone is safe and almost impossible to abuse, a huge selling point at many of the clinics they will visit. Suboxone has a second active ingredient in the mix, he explains, an anti-overdose drug called naloxone.

It does nothing if you take bupe as directed. But if you sniff bupe or inject it or otherwise try to pack enough into your bloodstream to get high, the naloxone acts like a chemical booby trap, erasing the effects of any opiate, bupe included, and bringing on sweaty, nauseating withdrawal. “That’s the last time you’ll do it,” Kolodny says dryly. https://www.wired.com/2005/04/bupe/

In 2016, your organization, PROP (Physicians for Responsible Opiot Prescribing), got the ear of the CDC and helped to write the now-infamous, misinformed, and rushed guidelines for prescribing opiates. While these guidelines were fairly general in nature, they have been used as a springboard for countless pieces of state legislation and DEA investigations, which has, in turn, led to the above-mentioned abuse and abandonment of chronic pain patients and doctors, as well as opiate shortages in hospitals and ERs (The DEA, in an attempt to prevent diversion of opiates to the black market, has cut production by an incredible 45% in the past 2 years). I imagine that suits you just fine, since you have publicly stated you believe opiates should be discontinued for all but the dying and post-major surgery “for a few days” (https://www.ket.org/opioids/inside-opioid-addiction-10-questions-with-dr-andrew-kolodny/), and that “more treatment” is needed (https://www.vox.com/science-and-health/2017/8/3/16079772/opioid-epidemic-drug-overdoses), i.e. MAT/Suboxone clinics like Phoenix House.

You have hailed local municipalities and states in their further pursuit of legal action against American Big Pharma, the companies who make such things as Vicodin and Percocet, but not Suboxone/buprenorphine (which is also an opiate), which is made by an overseas company, Reckitt Benckiser, or Naloxone (Narcan), which is produced in a nasal spray exclusively by Amphastar Pharmaceuticals (10), a relatively new company founded in California in 1996 (11),  whose stock (and Narcan prices) has been rising quite a bit, lately (12, 13). Are you truly against the use of opioids, or just the ones that help pain?

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The Opioid Epidemic!

Although your policies, based on inaccurate data (14-15) https://www.acsh.org/news/2017/10/12/opioid-epidemic-6-charts-designed-deceive-you-11935 (15), and http://www.mdmag.com/journals/pain-management/2012/october-november-2012/just-how-responsible-is-prop, have been wildly ineffective at stopping heroin/fentanyl overdoses; although you are not a pharmacologist, opiate researcher, pain doctor, pain patient, surgeon, or even general practitioner; although you ran a private clinic for a short time in 2005 (as far as I’ve been able to learn) that dispensed buprenorphine/Suboxone, you have, for the majority of your career as far as I can tell, been a policy-maker and not directly involved with addiction patients or chronic pain patients whom you recently claimed were simply addicts who needed compassion and “treatment” (and, presumably, Suboxone).

“Many Americans are truly convinced that opioids are helping them. They can’t get out of the bed without them.”

“Policy makers were told by industry-funded pain organizations not to penalize pain patients because of drug abusers. We realized that this wasn’t true. We don’t have these two distinct groups, one for pain patients and the other for drug abusers.” https://www.kolmac.com/2015/12/qa-dr-andrew-kolodny-chief-medical-officer-phoenix-house/ (15a)

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If You’re Not For Us, You’re Against Us

You are cited and quoted in an impressive number of articles and interviews as a compassionate person who wants to see people and their families heal from the devastation of addiction, which is why it surprised me to find quotes from you that didn’t seem, well, “nice.”

It is the FDA’s role to vigilantly regulate the approval, labeling, and promotion of  pharmaceutical products, not that of counties or municipalities. County and municipal lawyers are inadequately qualified to make or enforce federal drug policy, and these lawsuits serve as a vehicle for local governments to seek revenue  through ill-informed measures under the guise of drug abuse prevention. In a May 30,2014, interview with   FDA Week, a CLAAD spokesman voiced these positions and expressed concern that these lawsuits are part of “a trend that will distract us from the real meaningful approaches to reducing prescription drug abuse.”

After reading the interview, Dr. Andrew Kolodny, president of Physicians for Responsible Opioid Prescribing (PROP)and Chief Medical Officer of Phoenix House,  contacted CLAAD via telephone to condemn its comments. During this conversation, Kolodny threatened that the Internal Revenue Service would revoke CLAAD’s tax-exempt status when alerted to the comments, which he believes conflict with CLAAD’s charitable mission.  CLAAD takes these false allegations and threats very seriously, and  responded in a letter which is publicly available for view on our website.

Critics who categorically dispute the motives of organizations like CLAAD and its diverse coalition members are, at best, narrowly focused. Their zealotry reveals their otherwise undisclosed health insurance industry bias.  At worst, they endanger the lives of people who live with pain and other conditions that can require controlled substances by stifling access to quality care. http://paindr.com/claad-and-phoenix-house-square-off/ (16)

Anyone who questions your authority, expertise, policies, or the efficacy of your pet drug, buprenorphine, is loudly dismissed by you as uneducated (17), addicted (15a), or corrupt (15a, 18), regardless of how closely they actually work with addicts and pain patients (17).

But Dr. Kolodny, I have nothing left to lose — your policies and attitudes have directly impacted my health, my freedom, my ability to be a parent, my work, my hobbies, my family, my finances, my friends, and my personhood. I have no problem announcing to the public, as loudly as I can, “The Emperor is not wearing any clothes!”

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Citations

(1) http://www.cecentral.com/search/faculty/136145

(2) https://www.wired.com/2005/04/bupe/

(5) https://www.phoenixhouse.org/news-and-views/news-and-events/phoenix-house-appoints-dr-andrew-kolodny-as-chief-medical-officer/

(4) https://www.nytimes.com/2013/11/17/health/in-demand-in-clinics-and-on-the-street-bupe-can-be-savior-or-menace.html

(6) https://www.reuters.com/investigates/special-report/usa-rehab-phoenixhouse/

(7) http://www.phoenixhouse.org/wp-content/uploads/2014/06/2013-Financial-Report.pdf

(8) https://assets.documentcloud.org/documents/4378824/Purdue-Guilty-Plea-Copy.pdf

(9)

(10) https://www.npr.org/sections/health-shots/2015/09/10/439219409/naloxone-price-soars-key-weapon-against-heroin-overdoses

(11) http://www.amphastar.com/about-us.html

(12) https://www.equities.com/news/naloxone-stocks-who-s-really-winning-the-battle-against-the-opioid-epidemic

(13) https://thinkprogress.org/pharmaceutical-company-with-monopoly-on-lifesaving-treatment-jacks-up-prices-3883e95f88c7/

(14) https://medium.com/@stmartin/neat-plausible-and-generally-wrong-a-response-to-the-cdc-recommendations-for-chronic-opioid-use-5c9d9d319f71

https://www.ket.org/opioids/inside-opioid-addiction-10-questions-with-dr-andrew-kolodny/

(15) https://www.acsh.org/news/2017/10/12/opioid-epidemic-6-charts-designed-deceive-you-11935

(15a) https://www.kolmac.com/2015/12/qa-dr-andrew-kolodny-chief-medical-officer-phoenix-house/

https://abcnews.go.com/Health/deaths-drug-overdoses-continue-rise-us-blacks-hispanics/story?id=54094943

(16) http://paindr.com/claad-and-phoenix-house-square-off/

(17) https://www.nytimes.com/2016/05/29/opinion/sunday/addicted-to-a-treatment-for-addiction.html

(18) https://www.kolmac.com/2015/12/qa-dr-andrew-kolodny-chief-medical-officer-phoenix-house/

https://www.vox.com/science-and-health/2017/8/3/16079772/opioid-epidemic-drug-overdoses

https://www.cdc.gov/drugoverdose/prescribing/guideline.html

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Further Resources

https://www.cdc.gov/drugoverdose/prescribing/guideline.html

https://www.bendbulletin.com/topics/5342867-151/opioid-crisis-pain-patients-pushed-to-the-brink

http://www.mdmag.com/journals/pain-management/2012/october-november-2012/just-how-responsible-is-prop

http://nationalpainreport.com/cdc-does-not-comply-with-federal-law-8828305.html

https://www.chronicle.com/article/To-Counter-Opioid-Crisis-NIH/240219

https://www.painnewsnetwork.org/stories/2016/8/11/prop-ends-affiliation-with-phoenix-house

https://www.drugabuse.gov/publications/research-reports/relationship-between-prescription-drug-abuse-heroin-use/introduction

Filed under: General Problems | 10 Comments »

“We have been told directly per company policy and multiple emails that in cases where we refuse to fill controls we are to cite “professional judgment” and are absolutely not supposed to give any more details than that. We wouldn’t want to get sued for being ‘defamatory’ toward a prescriber, of course. This is mainly in situations where we feel the doctor is basically running a pill mill or has other unethical practices though. In general we try to explain dosing issues and the need to call an office when things seem legitimate”

“Was told by ohio board investigator that we cannot be specific with the patient as to why we are refusing. We can only tell them we are not comfortable filling the prescription, and that their doctor can call and discuss with us. He said that when we start explaining why we are refusing to fill it is deemed as “practicing medicine.”

“Our corporate guidelines prohibit us from being specific such as not to cause a customer service issue. Our state has made it a felony to discuss controlled database findings with patients but made it mandatory for both MD and RPh to utilize it…yet here we are. A script that shouldn’t be filled, but I can’t be truthful with the patient as to why…talk about an enthical conundrum…”

“one of the big chains has a refusal policy in place, but you’re not allowed to tell the patient specifically why you’re refusing it, as that would be “disclosing proprietary company information.” This definitely has patients leaving without an understanding of why it’s not being filled. I can’t tell you how much I would love to be able to say “Because your prescriber is a lying sleezeball and I don’t want my name on anything associated with him.”

Filed under: General Problems | 6 Comments »

https://mobile.nytimes.com/2018/06/26/us/disgrunted-veteran-fire-atlanta.html#click=https://t.co/WmV4QjIAYY%3Chttps://urldefense.proofpoint.com/v2/url

Filed under: General Problems | 5 Comments »

VA Catches Heat Over Previously Unreported Suicide Numbers In New Report

www.disabledveterans.org/2018/06/26/va-catches-heat-over-previously-unreported-suicide-numbers-in-new-report/

The Department of Veterans Affairs has reportedly backed off its own suicide report after reporters noted its own data revealed no change in suicide numbers and that suicides among troops were higher than expected.

Military Times noted VA was displeased that reporters and readers noted statistical outcomes it did not want. This year, the agency included breakdowns between various groupings of suicides. One of those groups is of active duty troops showing higher suicides than previously reported.

For 2015, the new numbers were 1,400 deaths, which is 900 higher than previously reported. Over the four-year span reported, the number of unreported deaths is over 3,400.

RELATED: Veterans Twice As Likely To Commit Suicide

Now, VA is backing off the report saying the numbers led to a “misperception” about the suicide numbers leading to “confusion” about military suicides.

VA Bumbles Response

According to the Military Times article:

“In our report, VA did not differentiate deaths between active duty, current never federally activated Guard and Reserve, and discharged never federally activated Guard and Reserve,” said Dr. Keita Franklin, VA’s national director of suicide prevention.

“This difference in the report may have caused some confusion and led to the misperception that approximately 1,000 more current service members died by suicide than DoD reported in 2015.”

Franklin said including the breakdown in the report was designed to provide more information about the demographics of individuals who took their own lives. The updated report also contains new information on veterans’ era of service, ethnicity and comparison age groups in an effort to provide “more data points for us to look at.”

VA officials blamed the confusion on the troops’ suicide information on inconsistent definitions used in various agencies. Individuals who served in the guard or reserves and are considered “veterans” in census reports may not have been counted in the Defense Department statistics because of different mobilization authorities and state rules.

But the VA researchers are now emphasizing they have not found fault with official military suicide statistics, which have counted between 550 and 450 active-duty, guard and reserve suicides in each of the last five calendar years.

What Report Did Show

The report still shows veteran suicides are holding steady at 20 per day despite record spending on vendor programs supporting the agency’s goal to reduce suicides.

Tens of millions each year in spending on vendor projects to make suicide prevention programs look sexy has led to a zero decrease in suicide numbers. Imagine if VA spent that money on hiring psychologists to treat veterans?

Source: https://www.militarytimes.com/veterans/2018/06/25/va-backs-off-suicide-study-which-indicated-thousands-of-unreported-military-deaths/

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Arizona pharmacist under investigation after declining to fill abortion drug

https://www.catholicnewsagency.com/news/arizona-pharmacist-under-investigation-after-declining-to-fill-abortion-drug-83383

Filed under: General Problems | Leave a Comment »

Opioid bills could net millions for companies

‘For years, we got the scraps. And now we’re the big time,’ says an anti-addiction consultant.

https://www.politico.com/story/2018/06/22/house-opioid-bills-lobbying-637695

The House is touting passage of dozens of bills that could help combat the national opioid crisis — but a small handful of companies that have spent millions lobbying Congress could reap a windfall if any of the bills become law.

In a two-week legislative blitz, the House cleared several narrowly tailored measures that would spur sales for companies that have ramped up their influence game in Washington, according to a review of the more than five dozen bills up for votes.

Those poised to benefit include:

• Alkermes, which spent $1 million lobbying in part to support a bill to fund full-service centers where people can detox, receive medical care and start treatment — a setup that could boost the fortunes of its best-selling product, anti-addiction treatment Vivitrol, which has been held back by the need for patients to fully detox before taking the drug.

• Indivior, an Alkermes rival that spent $180,000 largely in support of a bill that eases restrictions on certain controlled substances used in injectable anti-opioid treatments — a change that would make it easier for doctors to buy Indivior’s once-a-month injectable Sublocade.

• Pennsylvania drugmaker Braeburn Pharmaceuticals, which spent $100,000 lobbying and backed the same bill because it is developing a competing injectable.

• A group of drugmakers that produce non-opioid pain relief medications, including California-based Heron Therapeutics, which spent hundreds of thousands to lobby for legislative changes to create an additional Medicare payment for non-opioid pain drugs.

The measures come as part of a House package that anti-addiction advocates and even some lawmakers say will make only incremental progress toward fighting a public health crisis that’s killing an estimated 115 Americans per day.

“This is a very energetic effort to pretend we’re doing something significant,” said Rep. Peter Welch (D-Vt.), who supported the package but stressed the need to devote greater resources to the opioid fight. “By and large it’s better to do than not, but it falls way short of what is required.”

Yet as the epidemic morphs into a major campaign issue — and Congress runs out of time to pass other legislative packages — interest in the opioid effort has ballooned. Congress used February’s budget deal to authorize spending $6 billion over two years to address the crisis, prompting more than 300 companies and interest groups to flood Capitol Hill to lobby on opioids during the first three months of 2018, according to disclosure forms.

“When you hear they’re investing $3 billion in this in 2018 and $3 billion in 2019, everyone’s ears are going to perk up,” said Andrew Kessler, the founder of behavioral health consulting firm Slingshot Solutions. “For years, we got the scraps. And now we’re the big time.”

Alkermes, a big potential winner, has already attracted attention for its aggressive marketing tactics and Washington lobbying presence. Former HHS Secretary Tom Price toured the company’s Wilmington, Ohio, plant last year to tout Vivitrol — stirring controversy by belittling rival medication-assisted treatments that are more widely-used.

Alkermes spent $1 million lobbying Congress from January through March, focusing on a bipartisan bill from Reps. Brett Guthrie and Gene Green that directs millions of dollars to create full-service centers where people can detox, receive medical care and start treatment under the same roof. The proposal, passed last week in the first wave of House opioid votes, attempts to address the difficulty many patients face finding comprehensive treatment, the lawmakers said.

It also neatly addresses a chief problem holding back Alkermes’ best-selling product: While Vivitrol is one of just three FDA-approved drugs treating opioid addiction, it’s the only one that requires patients to fully detox before taking it.

That’s a major roadblock for doctors who are often unsure whether a patient has been in withdrawal for at least a week, and for patients desperate for immediate treatment, crimping Vivitrol’s market potential just as providers increasingly embrace medication-assisted treatment.

“The issue with Vivitrol is the fact that 25 percent of patients fail the detox component and therefore relapse, and is also one of the reasons why patients prefer Suboxone or Sublocade,” said Biren Amin, a pharmaceutical analyst for Jefferies LLC, referring to competing treatments. “Vivitrol growth [is] clearly impacted.”

By contrast, doctors in the recovery centers proposed by Guthrie and Green could closely monitor and manage patients’ progress, and then start treatment as soon as they’re fully detoxed.

The bill was one of only two opioid bills that Alkermes targeted in its lobbying, according to disclosure documents. Of the four main lobbyists for the company on the issue, one previously served as Guthrie’s deputy chief of staff. Another was Green’s former legislative director.

Both Guthrie and Green rejected any suggestion the bill was written to benefit Alkermes, pointing to its support from anti-addiction groups. The bill doesn’t mandate the recovery centers use one medication over another.

“We met with all the stakeholders,” Guthrie said. “We just think most people need access to all the [treatment] options.”

In a statement, Alkermes highlighted the legislation’s broad support, adding that it “is not about a particular form of treatment, but rather focuses on … comprehensive care.” The company said it has always supported using all FDA-approved medications for opioid dependence.

Though Alkermes ranked among the biggest-spending companies on opioid issues, it’s far from the only firm spending large sums to capture Congress’ attention.

“Whoever’s stuff is slick gets put to the top of the pile,” one longtime behavioral health lobbyist said of the corporate muscle that’s descended on Capitol Hill.

Indivior backed a bill from Rep. Ryan Costello that would ease restrictions on certain controlled substances used in injectable anti-opioid treatments — an arcane but important change that would effectively make it easier for doctors to buy Indivior’s once-a-month injectable Sublocade. Some view injectable treatments as preferable because they’re less likely to be diverted or misused.

The legislative tweak — which has already passed the Senate — is the only specific House opioid bill that Indivior listed in disclosures showing $180,000 spent on lobbying in the year’s first three months.

Braeburn Pharmaceuticals, which is developing a competing injectable anti-opioid treatment, spent $100,000 over that same period and also listed the Costello bill as the only provision in the House package it focused on.

Indivior did not respond to specific questions about its lobbying effort, saying in a statement that “government policies impacting these treatments must adapt toensure patients have access to all evidence-based treatment options.”

Braeburn said the bill simply codifies prior understandings, and that it supports policies that open up access to all treatments for opioid use disorder.

A spokeperson for Costello said he supports medical innovation and expanding access to a variety of anti-opioid treatments, and noted the bill passed unanimously out of the Energy and Commerce Committee. The legislation wasn’t initially rolled into the House’s main opioid package, but could still be added or passed separately.

Other bills proposed in the House are more direct in the way they would help specific companies.

A small group of post-surgery pain drug makers, including Heron Therapeutics, stand to benefit from Rep. Scott Peters’ legislation creating an additional Medicare payment for certain non-opioid pain drugs.

Heron, which is developing a treatment that would qualify for the payment, spent $40,000 lobbying on rate-setting issues for post-surgical non-opioid drugs from January to March.

The company is headquartered in Peters’ district, and said in an email that it has discussed opioid and addiction policies with the California lawmaker. But it emphasized that none of its currently approved drugs would benefit from the proposal, and that drugs made by other companies could also qualify.

A spokesperson for Peters said he met with Heron employees and toured the company’s headquarters as part of his interest in promoting post-surgery opioid alternatives, but he also met with other groups and developed the bill’s language in coordination with federal health officials and other lawmakers.

A bipartisan effort led by Reps. John Shimkus (R-Ill.) and Raja Krishnamoorthi (D-Ill.), meanwhile, reverses deep cuts to reimbursements for select interventional pain management techniques.

That qualifies as a victory for the main trade group representing doctors who use non-opioid methods — including epidurals and other injections — to manage pain. In a celebratory blog post, the American Society of Interventional Pain Physicians said it turned to Congress to restore its pay levels after unsuccessfully lobbying federal health officials.

“The agency said heck no, we can’t touch it — it needs a legislative fix to be more specific in the intent of Congress,” Shimkus said about when he stepped in. He added that the higher pay rate is needed because those more invasive pain management techniques are often more expensive than prescribing opioids.

A spokesperson for Krishnamoorthi said the lawmaker’s interest stemmed from his support for non-opioid alternatives, and that he never personally met with ASIPP about the legislation. ASIPP’s PAC has donated the maximum $10,000 allowed for this election cycle to both support for the bill.

Behavioral health and anti-addiction advocates have largely shrugged off those narrow provisions, saying they’re a byproduct of a fast-moving, piecemeal effort to address a public health crisis.

Yet they also acknowledge it means crucial funds will be limited to select groups instead of the broader population.

That only heightens the importance of Congress continuing to pursue new proposals for curbing drug abuse, Slingshot Solutions‘ Kessler said.

“There’s a lot of good stuff in there,” he added. “However, there’s a lot to be very, very cautious of as well. And the reason is because as much attention as Congress is paying and as much money as they’re dedicating to it, we’re still not anywhere close to where we need to be.”

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CVS Exploits PBM Role, and Taxpayers Pay

https://www.wsj.com/articles/cvs-exploits-pbm-role-and-taxpayers-pay-1529956036

Recently, CVS accused the Journal (Letters, June 8) of mischaracterizing its pharmacy benefit manager (PBM) operation. Thomas Moriarty is right to contend that the PBM’s role “is to negotiate the best price possible for patients and clients,” but wrong to pretend that large PBMs are accomplishing that mission.

In Kentucky, lawmakers discovered that PBMs, including CVS, pocket over 40% of the state’s annual Medicaid spending on prescription drugs. In Arkansas’s Medicaid program, independent pharmacists received $909 for 20 tablets of Temozolomide. CVS’s PBM gave its pharmacies $4,000 for the same cancer medicine.

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Marine Veteran Files Lawsuit Against VA, Roe

https://www.greenevillesun.com/news/local_news/marine-veteran-files-lawsuit-against-va-roe/article_c465ebfa-b517-58e2-92e8-1bdf906be605.html

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10-04-08 DRAFT 2010 UPR: Human Rights Alert (Ngo) – The United States Human Rights Record – Allegations, Conclusions, Recommendations.

Human Rights Alert, NGO PO Box 526, La Verne, CA 91750 Fax: 323.488.9697; Email: jz12345@earthlink.net Blog: http://human-rights-alert.blogspot.com/ Scribd: http://www.scribd.com/Human_Rights_Alert

NINETY SIX PAGES LINK HERE TO LOAD

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http://www.cantonrep.com/news/20180624/cvs-cut-payments-to-community-pharmacies-after-aetna-merger

Some pharmacists question the timing of the reimbursement reductions and say they think it was no coincidence. They question whether CVS Caremark used that reduction to help raise $70 billion to merge with Aetna and create a health conglomerate that would include CVS Caremark, the nation’s No. 2 pharmacy-benefit manager; Aetna, the No. 3 health insurer; and CVS Pharmacy, the nation’s largest retail pharmacy chain.

It happened in Ohio, New York, Iowa, Arkansas, New Jersey and possibly other states. Pharmacy middleman CVS Caremark suddenly cut the reimbursements it paid community pharmacies for drugs, some of them far below pharmacists’ costs for potentially life-saving medications.

Each of the cuts happened late last year or early this year — all within a few months of when CVS Health announced a merger with health insurer Aetna.

In a Columbus Dispatch review of data collected from 40 pharmacies, the numbers back up what lawmakers and critics said happened in the fourth quarter of 2017: CVS Caremark sharply reduced payments to pharmacies.

In the first quarter of 2017, CVS Caremark received $370,000 in taxpayer dollars from those transactions. In the fourth quarter of the same year, CVS Caremark’s portion was $522,000, according to the data. The data represent less than 1 percent of the $3 billion Medicaid paid for prescriptions in 2017. CVS Caremark handles the prescriptions for four of the state’s five managed care plans.

CVS Health, parent company of both CVS Caremark and CVS Pharmacy, reported a net revenue of $34.2 billion in the fourth quarter of 2017, according to its website. That is a $3 billion increase compared to the fourth quarter of 2016.

Timing questioned

Some pharmacists question the timing of the reimbursement reductions and say they think it was no coincidence. They question whether CVS Caremark used that spending reduction to help raise $70 billion to merge with Aetna and create a health conglomerate that would include CVS Caremark, the nation’s No. 2 pharmacy-benefit manager; Aetna, the No. 3 health insurer; and CVS Pharmacy, the nation’s largest retail pharmacy chain.

“Dramatically, within days (of the merger announcement), reimbursements for many mental health generics dropped through the floor; below anyone’s ability to buy the product and provide it to the patient,” New York Assemblyman John T. McDonald III said in a legislative hearing earlier this month.

CVS officials say emphatically there was no relationship between the reimbursement cuts and the proposed merger.

“That’s absolutely not true,” Mike DeAngelis, CVS’s senior director of corporate communication, said Tuesday when asked about questions raised by some pharmacists and lawmakers.

Last fall, CVS Caremark cut so deeply the reimbursements for Suboxone, an important drug in the fight against Ohio’s opioid epidemic, that some pharmacists said they were forced to stop stocking it. The Ohio Department of Medicaid intervened with CVS officials and the company quickly increased reimbursements.

Ohio Medicaid Director Barbara Sears on Wednesday said along with Suboxone, her department received complaints about big cuts in reimbursements for hundreds of other drugs.

At the same time, CVS was sending letters to pharmacies citing their likely financial woes stemming from declining reimbursements and offering to buy out its retail competitors.

Complaints dismissed

Complaints also came to the Ohio Department of Insurance, which provides some oversight to the actions of pharmacy benefit managers — companies that negotiate prices with drug companies, help decide which medications are covered by health insurance plans and set reimbursement rates to pharmacies.

The department received 40 complaints about CVS Caremark from independent and large-chain pharmacists in 2017, according to state records.

Of those, 35 were filed in the fourth quarter. In all but two instances, the state sided with CVS Caremark in the dispute.

Department of Insurance officials said they are enforcing the law as written, and the statute doesn’t allow them to address pharmacy benefit manager reimbursements.

“Our authority with respect to PBMs is very narrow, and we cannot take action if there is no violation of the law,” said Chris Brock, spokesman for the insurance department.

In two instances, the complaints were referred to the Ohio Department of Medicaid.

“CVS Caremark just seems to make up their own price,” said Joel Wolfe, a pharmacist for Dave’s Pharmacy in Cleveland, in his complaint. “When you call CVS Caremark … no one will tell you what is going on.”

One of Wolfe’s complaints was for the generic version of Suboxone.

“On 10/30/2017 we were paid $18.88. On 9/30/2017 we were paid $23.50 and on 10/31/2017 were paid $5.09,” Wolfe wrote.

The 40 pharmacies that provided data to The Dispatch showed the same wild swings in reimbursements for the same quantities of the drug.

In the first quarter of 2017, CVS Caremark was paying the pharmacies an average of $1.06 per pill less than what the PBM got from the state, according to the data from the 40 pharmacies.

In the fourth quarter, the pharmacy payments plummeted to $21.23 per pill below what Caremark was receiving from the state. In other words, from October-December, Caremark was taking in $21.23 for every pill sold to help troubled Ohioans overcome their opioid addiction.

Mimi Hart, owner of Hart Pharmacy in Cincinnati, said CVS Caremark drastically cut the price of the generic for Antivert, an antihistamine used to treat motion sickness and dizziness. Hart said CVS Caremark paid her 54 cents per pill, when the cheapest she should find it from a wholesaler or manufacturer was 95 cents.

Other pharmacies complained of similarly large price swings for drugs that treat incontinence, seizures, ulcers and mental health.

“Wake up legislators,” said Rick Marlin, a pharmacist for 46 years and director of pharmacy for Allen’s Pharmacy in Youngstown. “PBMs are doing whatever they want, whenever they want.”

CVS Caremark’s response to pharmacists’ complaints often was the drug could be purchased at the lower price from drug wholesalers McKesson or Cardinal Health. The state accepted that argument when telling pharmacists why they agreed with CVS Caremark.

“What the state doesn’t seem to understand is that there are three major wholesalers, and normally a pharmacy only contracts with one of those three,” Marlin said. “So you can’t buy from the other ones, and we check with our colleagues that do have contracts with those other wholesales and they say there’s no way I can buy it at that price either.”

Widespread cuts

Antonio Ciaccia of the Ohio Pharmacists Association said he doesn’t know whether the reimbursement cuts were tied to the Aetna merger, but “there’s a lot of strange coincidences that are piling up.”

CVS officials said some pharmacies saw reimbursement cuts late last year, but most did not. However, if only a small number of them felt the reimbursement cuts, it was a very vocal one. Consider:

• In New York, Kathy Febraio, CEO of the state’s Pharmacists’ Society, said the CVS reimbursement cuts didn’t stop with the mental health drugs McDonald complained about. “It did not end there. It was very widespread,” she said. “If this went on, it was going to impact patients’ access to medications.”

• In New Jersey, Elise Barry, CEO of that state’s Pharmacists Association, said CVS reimbursement cuts initially were reported Oct. 25 — a day before they started in Ohio and New York. “It was somewhat coincidental,” she said of the fact that the cuts took place just as CVS was about to announce the Aetna merger. “We have suspicions about that.”

• In Arkansas, Scott Pace, CEO of that state’s Pharmacists’ Association, said in February during a news conference that “on Jan. 1, the health insurers and their pharmacy-benefit middlemen dramatically cut the reimbursements to the pharmacies that provide care around the state. These cuts resulted in many patients being turned away at the pharmacy counter. It was not because the pharmacists didn’t want to serve them, but because the insurance reimbursements simply didn’t cover the cost of the medication.”

Arkansas Attorney General Leslie Rutledge now is conducting an investigation into CVS Caremark’s reimbursement practices, saying they “hurt Arkansans in every community across the state.”

Company’s position

In a meeting with Dispatch reporters on Tuesday, four CVS executives said there was no conscious plan to cut reimbursements so the company could raise extra cash. Instead, they said the company’s reimbursements are determined by a secret algorithm that is based on a “maximum allowable cost” list for drugs.

“We don’t manipulate the algorithm,” DeAngelis said.

Michael D. Sargent, CVS Health’s senior director for regulatory and policy affairs, acknowledged some pharmacies suffered cuts, but he said it was because of the kinds of drugs they sold. He added most pharmacies didn’t experience the swift, deep cuts.

“Our sense was, based on the pricing changes that were made in the fourth quarter, that there was some variability based on drug mix,” he said. “But on the whole, pharmacies — chain and independent — were kind of in the middle and there weren’t these wide spikes or drops in reimbursements … across the board. We did see some some spikes and we made adjustments in the fourth quarter of 2018.”

The PBM’s ability to make such adjustments — despite what DeAngelis said about not manipulating the algorithm — raises suspicion by pharmacists. Those concerns stem from how the state allows PBM’s to cover their costs and make a profit: The middlemen keep the entire difference between what they get from the state and what they pay to pharmacies, a total of more than $223 million in the past year for CVS Caremark.

Since, as the CVS executives pointed out, much of what a pharmacy benefit manager receives from the state is fixed by contract (via managed-care companies hired by the state), the only significant variable is how much the PBMs choose to pay Ohio pharmacies.

CVS hit pharmacies from another direction on Friday by increasing transaction fees, charged each time a pharmacist checks a price or fills a prescription. The increase will generate an estimated $1.2 million for CVS annually.

The Ohio Medicaid analysis of CVS pricing released last week found no evidence of anti-competitive practices, but state officials said the analysis looked only at whether CVS was paying competitor pharmacies less than it was paying its own.

“We haven’t seen other factors that we ourselves would claim as anti-competitive behavior, but we are not ruling out the possibility that there is information we don’t have,” said Greg Moody, director of the Governor’s Office of Health Transformation. “If folks have evidence of anti-competitive behavior, of course we’d pay attention to that.”

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