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March 2019 Newsletter

 

If you haven't registered for "Opioids: Conflicts and Controversies" Conference on June 13-14, 2019 here at Georgetown, you can register for it here. We look forward to seeing you there!
 

The PharmedOut team takes lunch seriously: here we are at the French Embassy cafe.
 


Community Action Forum:
Busting High Drug Prices

Our friends the Right Care Alliance are holding a Community Action Forum on March 16 in Silver Spring, MD with US Representative Jamie Raskin. Details here.

Industry's Voice, Pain Patient's Face

by Judy Butler

In February, chronic pain patient and advocate Cindy Steinberg testified at a Senate Health Committee hearing, “Managing Pain During the Opioid Crisis”. Steinberg, National Director of Policy and Advocacy for the U.S. Pain Foundation, presented herself as the voice of unheard chronic pain patients; what she didn’t mention was the financial support her national organization receives from opioid manufacturers.
 
Pain advocacy organizations argue that corporate funding does not influence their positions. If that’s true, why would Ms. Steinberg’s testimony so closely parallel the marketing messages of industry? We know about these messages from internal company documents excerpted in a legal complaint filed by the Massachusetts Attorney General against Purdue Pharma.
 
The parallels between Purdue’s messaging and Ms. Steinberg’s statements before the Senate committee are striking. Examples of specific messages follow (all emphases are mine).
 
Pain patients are not addicts and they need continued, unchallenged access to opioids:
 
Massachusetts complaint: In May [2008], staff sent the Sacklers more ideas about ways to promote Purdue’s opioids… deflect blame from Purdue’s addictive drugs by stigmatizing people who become addicted. “KEY MESSAGES THAT WORK” included this dangerous lie: “It’s not addiction, it’s abuse. It’s about personal responsibility.”        
 
Steinberg written testimony: A critical misunderstanding that pervades media coverage of opioids and pain is the conflation of two largely distinct populations—those with the disease of chronic pain and those with the disease of opioid use disorder.
 
Massachusetts complaint: [CEO] Stewart also planned for Purdue to continue to push under-treatment of pain as a major message. Finally, the plan highlighted that sales could be increased by falsely convincing doctors that they could and should prescribe more to patients deemed to have low risk of addiction and that patients who were at risk of addiction were really just illegal drug users
 
Steinberg written testimony: As a result of well-intentioned measures to contain the opioid crisis, such as restricting the supply of prescription opioids, intense regulatory scrutiny of physicians, the establishment of ceiling doses and day limits on the number of opioids that can be prescribed, legitimate chronic pain patients are being made to feel like criminals simply for seeking relief—many of whom have been on long-term stable doses of their medication for years.
 
The concept that chronic pain patients are somehow protected against addiction to opioids is simply not true, and the Massachusetts complaint alleges that the industry was well aware of this. An internal Purdue document states about addiction:
 
"This can happen to any-one – from a 50 year old woman with chronic lower back pain to an 18 year old boy with a sports injury, from the very wealthy to the very poor." [text box from internal Purdue document]
 
The truth is that anyone can become addicted, and long-term use has demonstrable negative adverse outcomes with little if any improvement in function. But you certainly won’t hear that from Ms. Steinberg, or the industry messages she promotes.

Joy's Favorite Article of the Month

This month I would like to recommend an article by Sean Dickson of The Pew Charitable Trusts titled Effect of Evergreened Reformulations on Medicaid Expenditures and Patient Access from 2008 to 2016. “Evergreening” is a classic pharma tactic to prolong the market exclusivity of a drug, and in doing so its profitability,  for as long as possible, which passes exorbitant (unnecessary) costs on to payers like Medicaid.

Dickson assessed drugs in the FDA Orange Book, the list the agency maintains of approved therapeutics, and identified 73 active ingredient groups as having evergreen reformulations; 50 of those had increased Medicaid expenditures that could be  to delayed generic market entry. He estimated that Medicaid could have reduced expenditures by $9.35 billion had there been generics available for these 50 product groups. Especially notable is that attention-deficit treatments like Adderall generated 64% of these evergreen-increased expenditures.

The author suggests policy alternatives that could eliminate the perverse incentives that allow pharma to evergreen their products and keep prices high.

Joy Eckert, MPH is passionate about peer-reviewed literature about pharmaceutical marketing and conflicts of interest. She tweets about health policy at @joyonarant.

March News Round-Up

(For more, follow @Pharmed_Out on Twitter!)

 

FDA chief Scott Gottlieb steps down after nearly 2 years
"Dr. Corfman, who later helped remove high-dose birth-control pills from the market when safer versions were available, and whom Ms. Magazine once named a “hero” for his efforts on behalf of women’s health, died Feb. 18 at a retirement home in Bowie, Md."

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