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August 2018 Newsletter

Recent Project News

 
  • Same bad drug, new tricks. Former Project Manager Alycia Hogenmiller and Dr. Fugh-Berman wrote "Addyi Rises Again" for Bioethics Forum, explaining why friends still don't let friends take "female Viagra."
  • Dr. Fugh-Berman was quoted in Medical Marketing & Media commenting on pharmaceutical and device companies' contributions to CME activities increasing for the fourth consecutive year, a trend that has serious implications for what healthcare providers are learning—and whom they are learning it from. 
  • Dr. Fugh-Berman also spoke to the BMJ, commenting on FDA advisory committee members with financial conflicts of interest regarding drugs they are assessing.
  • The PharmedOut team attended the FDA's patient-focused drug development meeting for chronic pain and distributed literature on opioids. Dr. Fugh-Berman testified at the open public hearing.
Save the date for our upcoming conference, Opioids: Conflicts and Controversies, June 13-14, 2019 at Georgetown University Medical Center. Email sk1880@georgetown.edu.
 
L-R: Vi Nguyen, David Lim, Dan Paglia, Matt Dempsey, Adriane Fugh-Berman, Ben Goodwin, Megan Whiteman, Sophie Krensky

Joy's Favorite Article of the Month

This month I recommend the thorough investigative report Hidden conflicts? Pharma payments to FDA advisers after drug approvals spark ethical concerns by Chris Piller and Jia You published in Science Magazine. 

The authors examine payments from pharmaceutical manufacturers to physicians who voted on FDA advisory committees. They found that 66 of the 107 physicians examined (62%) accepted payments from the makers of drugs that the panels voted to approve. Forty of those physicians accepted more than $10,000 and seven accepted more than $1 million. 

This story also includes conflicted doctors trying to explain why their conflicts aren’t really conflicts, disappointing answers to FOIA requests, and graphics that show the flow of money from drug manufacturers to physicians. 

Joy Eckert is the Project Manager of DCRx and AccessRx at the George Washington University Milken Institute School of Public Health. She tweets about health policy at @joyonarant.

PharmedOut Fodder:
A Million Ways to Market A Pill

By Judy Butler

Consumers may believe that doctors are taught to choose treatments based on the best-available evidence and for which benefits outweigh harms. That’s the definition of rational prescribing. Yet rational prescribing is not a given because of something not covered in medical training—pharmaceutical company influence. Pharmaceutical companies profit through the sale of new, patented drugs, so they spend millions on marketing to shape the environment in which doctors write prescriptions.  

Take, for example, opioids. In 1990, the president of the industry-supported American Pain Society (APS) called for a new approach to pain, including expanded therapeutic opioid use; the APS argued that such use rarely results in addiction. APS went on to produce guidelines encouraging expanded opioid use and trumpet their slogan “Pain: The 5th Vital Sign”, adding the highly subjective concept to the four objectively quantifiable measures of temperature, blood pressure, respiration, and pulse. 

Policy changes followed: in 1998 the Federation of State Medical Boards issued a policy that physicians would not face regulatory action for prescribing large amounts of opioids; the same year, the Veterans Health Administration required all clinicians to ask about patients’ pain at each visit; and in 2001 the Joint Commission (JCAHO) issued management standards requiring its accredited health care facilities to measure pain and prioritize its treatment. One need only to look at Purdue Pharma’s 2001 OxyContin marketing report to confirm industry involvement in these policies: “corporate initiatives and partnering efforts were very successful with the Veterans Administration, American Pain Society, and JCAHO in an effort to make Pain: The 5th Vital Sign. This ‘call to action’ was an important promotional initiative for Purdue. In addition to building sales for OxyContin Tablets, it also positioned Purdue as the leader in pain management education.”  

By 2006, the government implemented a patient survey that would determine hospital reimbursement rates. Patients were asked, "How often did the hospital staff do everything they could to help with your pain?" thus leaving patients to assess their own treatment with possibly unrealistic expectations and without regard for rational prescribing.

These policy changes occurred alongside an unprecedented effort by Purdue Pharma to market OxyContin (oxycodone), introduced in 1996. Hundreds of highly incentivized sales reps wooed doctors based on prescribing patterns discovered with sophisticated marketing data. The company funded and trained a speakers’ bureau for medical conferences and other events, treated doctors to pain symposia at resorts, ran ads in medical journals, sponsored web sites about chronic pain, and produced promotional videos. All these efforts were backed up with commercially-influenced medical literature citing physicians and research funded with undisclosed support from Purdue. The too-good-to-be-true message behind the marketing—here’s a safe, effective, “‘virtually’ non-addicting” drug that can treat long-lasting pain.

The consequences of the opioid industry misdeeds continue. Consider a July 2018 study finding that of opioid-naive patients reporting to an emergency room for an ankle sprain, 25% were prescribed opioids from 2011 to 2015. Rational prescribing? Definitely not—inexpensive NSAIDs treat ankle sprains most effectively and opioids are unlikely to have any clinical benefit. The researchers estimate that “more than 140,000 opioid tablets could have been prevented from entering the community if opioids had not been prescribed for our study sample.” Because large numbers of tablets are commonly left over after acute pain prescriptions and are poorly secured, it’s unclear how many of these tablets may have been diverted.

The study also found that while less than 5% of prescriptions were written above 225 morphine milligram equivalents (MMEs) per day, patients with these prescriptions were nearly five times more likely to transition to prolonged use than those with lesser dose prescriptions. The study authors note that without specificity about how many tablets and MMEs constitute a day’s supply, common 5- to 7-day supply limit policies aimed at safer opioid prescribing could be above 225 MMEs per day. 

It’s easy to see problems with misprescribing opioids and even easier to blame doctors for writing these prescriptions. It’s important to realize, however, the context in which these doctors’ decisions are made. The opioid industry flooded the environment with misinformation and distorted evidence reaping billions of dollars of profits along the way. These tactics continue, and not just with opioids. Is it any wonder doctors have difficulty with rational prescribing?

Check This Out!

 
The Bleeding Edge, out now on Netflix, is a new documentary exploring the medical device industry and how its rapid expansion has created a market full of potentially hazardous devices. It's a scathing look at a side of the industry that doesn't get as much press as pharma, and balances patient stories with expert perspectives.

Bonus: Dr. Fugh-Berman is in it (and has gotten press about her appearance in Forbes).

July News Round-Up

(For more, follow @Pharmed_Out on Twitter!)

Opioids

Post-Surgical Opioid Guidelines (Center for Opioid Research and Education)

Prescribing Opioids: How Many Are Too Many? By Julie Appleby (The New York Times)

Drug wholesalers sue New York over an opioid stewardship program by Ed Silverman (STAT News)

Dental Pain and Opioid Use: Latest Findings by Jane Koppelman (PEW)

Companies shipped 1.6 billion opioids to Missouri from 2012 to 2017, report says by Katie Zezima (The Washington Post)

Drug Firms Blame Opioid Crisis on Illicit Websites, Dealers by Jared S. Hopkins and Jef Feeley (Bloomberg)

Purdue Pharma justifies pushing Oxycontin by citing FDA rules it helped write by Jamie Satterfield (Knox News)

Court Documents Show How OxyContin’s Sales Team Pushed “Hope in a Bottle” by Julia Lurie (Mother Jones)

Big Pharma is quietly using nonprofits to push opioids by Paul D. Thacker (Los Angeles Times)

The growing case against IV Tylenol, once seen as a solution to the opioid crisis by Carolyn Y. Johnson (The Washington Post)

Hospital’s experiment in sedating patients without consent raises ethical concerns by Carolyn Y. Johnson (The Washington Post)

‘Turnaround Kid’ Is Tapped to Lead OxyContin Maker's Board by Jared S. Hopkins and Sonali Basak (Bloomberg)

Opioid addiction is plateauing. But the crisis isn’t over by Dylan Scott (Vox)

A simple electronic nudge can reduce opioid overprescribing by Keith Humphreys (The Washington Post)
 

Drug Pricing

Trump promised drug makers would lower their prices, but not every company got the memo by Ed Silverman (STAT News)

Trump Fails at Lowering Drug Prices as Costs Keep Going Up by Robert Langreth, Cynthia Koons, and Jackie Gu (Bloomberg)

The Ratcheting Price Of The Pneumococcal Vaccine: What Gives? By Shefali Luthra (Kaiser Health News)

Pricing pledges from drug makers include plenty of fine print by Ed Silverman (STAT News)

 

Pharma Marketing/Industry

Addyi Rises Again by Alycia Hogenmiller and Adriane Fugh-Berman (The Hastings Center)

Hidden conflicts? by Charles Piller (Science)

Novartis handling of Cohen deal adds to its ‘ledger of corporate wrongdoing,’ critic charges by Ed Silverman (STAT News)

Mystery solved: Addiction medicine maker is secret funder of Kennedy-Gingrich group by David Armstrong (STAT News)

Signaling concern over industry funding, Congress presses for transparency at groups supporting NIH, CDC by Lev Facher (STAT News)

Overprescription in Urgent Care Clinics—The Fast and the Spurious by Michael A . Incze, Rita F. Redberg, Mitchell H. Katz (JAMA Network)

How Essential Oils Became the Cure for Our Age of Anxiety by Rachel Monroe (The New Yorker)

Bayer to stop sales of birth control device tied to injuries by Matthew Perrone and Lindsey Tanner (AP News)

Health Canada is ordered to provide clinical trial data on several medicines to a researcher by Ed Silverman (STAT News)

The truth about ‘breakthrough’ drugs by Carolyn Y. Johnson (The Washington Post)

How drugmakers sway states to profit off of Medicaid by Liz Essley Whyte, Joe Yerardi, Alison Fitzgerald Kodjak (The Center for Public Integrity)

These Pills Could Be Next U.S. Drug Epidemic, Public Health Officials Say by Christine Vestal (PEW)

Artificial hip maker demands retraction of a paper calling its research ‘grave fraudulence’ by Ivan Oransky and Adam Marcus (STAT News)

How Goop’s Haters Made Gwyneth Paltrow’s Company Worth $250 Million by Taffy Brodesser-Akner (The New York Times)

Purdue Pharma Edits Public Service Ad In Washington Post by Fred Schulte (Kaiser Health News)

Pfizer chastised for missing risks in pharma ad police's second letter of 2018 by Beth Snyder Bulik (FiercePharma)

Pharma's med-ed backing rises for fourth straight year by Carrie Gavit (MM&M)

 

Pharmacology/Other Medical Studies

Is Posthospital Syndrome a Result of Hospitalization-Induced Allostatic Overload? by Deena S. Goldwater, Kumar Dharmarajan, Bruce S. McEwen, Harlan M. Krumholz (Journal of Hospital Medicine)

Mortality among patients due to adverse drug reactions that lead to hospitalization: a meta-analysis by Tejas K. Patel, Parvati B. Patel (Springer)
 

Policy

Yes, Nurses Have ‘Physically Taxing’ Jobs. And a $20.8 Million Settlement by Tyler Pager (The New York Times)

In Conversation With… Gordon Schiff, MD (Patient Safety Network)

Want Reliable Medical Information? The Trump Administration Doesn’t by The Editorial Board (The New York Times)

Trump administration is shutting down practice-guidelines clearinghouse for doctors by Ivan Oransky and Adam Marcus (STAT News)

Reviving the FDA’s Authority to Publicly Explain Why New Drug Applications Are Approved or Rejected by Matthew Herder (JAMA Network)

U.S. effort to weaken an international breast-feeding resolution has a long history by Carolyn Y. Johnson and Amanda Erickson (The Washington Post)

Opposition to Breast-Feeding Resolution by U.S. Stuns World Health Officials by Andrew Jacobs (The New York Times)

Resolution 2881/18 (The Colombian Health Ministry)
 

Education

National Clinician Scholars Program

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