New Podcast Tackles Drug Pricing, Market Power, and More

About 24 percent of adults report difficulty in affording prescription drugs, including 9 percent who report it is “very difficult” to afford them and 15 percent who report it is “somewhat difficult.” Approximately 11 percent of adults reported rationing high-priced drugs in 2017.

Recently, @Arnold_Ventures launched a new podcast, “Deep Dive with Laura Arnold,” that tackles the issue of drug prices. In its debut episode, podcast host Laura Arnold sits down with David Mitchell, founder of Patients for Affordable Drugs, who began his fight for drug pricing reform after a devastating diagnosis of an incurable blood cancer. The cost of his medicine each year: $325,000. They discuss a broken system built to serve those who make money — not those who depend on it for their health.

“Our mission is to improve people’s lives by fixing broken systems,” Arnold says. “We view drug pricing as a broken system, and not just from a theoretical perspective, but from a human perspective. We see this as a crisis in our nation. People can’t afford their drugs, and the consequences for all of us, both personally and from a societal perspective, are dire.”

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American Opioid Litigation: A Conversation with Professor Elizabeth Chamblee Burch

Professor Elizabeth Chamblee Burch

In my last post about recent developments in American aggregate opioid litigation, I teased about a future segment documenting a fantastic conversation with Professor Elizabeth Chamblee Burch. This post delivers that promise. Professor Burch is Fuller E. Callaway Chair of Law at the University of Georgia School of Law and an expert in complex litigation, mass torts, multidistrict litigation, and civil procedure.

Readers can access her impressive scholarly contributions on these topics here.

As Professor Burch elucidates in her research, the United States civil justice system has witnessed the waning of class certification cases and, concomitantly, the rise of multidistrict litigation (MDL) to resolve high-stakes, aggregate civil disputes.

This trend includes the massive national multidistrict litigation currently pending in the United States District Court for the Northern District of Ohio (Opioid MDL). Unlike class certification litigation, which is governed by Federal Rule of Civil Procedure 23, the MDL process is subject to the 1968 Multidistrict Litigation ActRead More

The Funding Effect: How Drug Manufacturers Design Clinical Trials to Produce Favorable Results

By Ryan J. Duplechin

Many consumers are unaware that the U.S. Food and Drug Administration (“FDA”) does not test drugs in the approval process. Instead, drug manufacturers test their drugs and submit their own results to the FDA for review. Hoping to convince the FDA and investors of the safety and effectiveness of their new drug, manufacturers go to great lengths to report positive results in clinical trials. Read More

Recent Developments in Opioid Litigation: A Re-Cap, Visual Aid, and Summary of Outstanding Inquiries

Media reports suffered no shortage of hot takes concerning opioid “arch-villain” Purdue Pharma’s agreement to pay $270 million to settle its OxyContin lawsuit in Oklahoma. The highlights of that settlement include Purdue’s payment of $102.5 million to fund a new Center for Addiction Studies and Treatment at Oklahoma State University, $60 million for attorney’s fees and litigation expenses, $20 million worth of drugs to treat opioid use disorder, and $12.5 million to cover the opioid-related costs incurred by Oklahoma’s local governments. Members of the Sackler family, who were not named as defendants in the litigation, also agreed to contribute an additional $75 million to Oklahoma over a five-year period.

A noteworthy concentration of the media coverage dedicated to Purdue’s Oklahoma settlement has involved speculation regarding its potential impact on the numerous outstanding opioid cases in other states as well as the myriad federal cases aggregated in the opioid multidistrict litigation (Opioid MDL) before the United States District Court for the Northern District of Ohio. The New York Times, for example, was quick to claim that the Oklahoma resolution “could jolt other settlement talks with [Purdue], including those in a consolidated collection of 1600 cases overseen” in the Opioid MDL. The Wall Street Journal similarly reported that “Purdue Pharma LP has forged the first deal to resolve more than 1,600 lawsuits blaming the OxyContin maker for fueling the opioid crisis, a move that could lay the groundwork for the resolution of the rest of the litigation.”

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New HarvardX Course on the FDA and Prescription Drugs

Interested in learning more about pharmaceutical policy? Curious about the role of the FDA in ensure safe and effective drugs reach the market? Wondering why drug prices are so high in the US? Readers of my prior posts may enjoy learning more about these topics!

Check out a free HarvardX online course, “The FDA and Prescription Drugs: Current Controversies in Context,” put together by Petrie-Flom Center affiliates Dr. Aaron Kesselheim, Dr. Ameet Sarpatwari, Dr. Jonathan Darrow, and many others, that is now open for enrollment. (Disclosure: I did not play any role in the development or making of the course, but I am serving as a teaching assistant/discussion moderator for the course). Read More

Close up on a pile of yellow pain pills

Addressing the Opioid Epidemic Starts with How We Treat Pain

As a nurse practitioner in a busy suburban emergency department, pain is my job. Pain is one of the most common reasons people come to an emergency department (ED). It could be abdominal pain, chest pain, back pain or even emotional pain, including depression or suicidal ideations. Pain is a driver for people seeking medical care. We have made pain into a vital sign, and we ask, “How would you rate your pain on a scale of 1 to 10?” a mandatory question for any patient who steps through our door.

This whole concept evolved circa 1987 when the Institute of Medicine urged healthcare providers to use a quantified measure for pain. It gained even more traction in 1990 when then president of the American Pain Society, Dr. Mitchell Max, called for improved means to assess and treat pain. The term “oligoanalgesia” gained popularity in the published literature, meaning that we weren’t giving enough pain medication to patients in the ED, in clinics or in any other healthcare setting. Healthcare providers responded. We asked about and we thought, more effectively treated pain to address this issue.

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close up of human eye

The Luxturna Debate: Why Ethics Needs a Seat at the Drug Pricing Table

By Clio Sophia Koller

Jack Hogan can now ride his bike home at dusk after an afternoon of playing with his friends. Is that childhood rite-of-passage worth $850,000?

Recently, the Health Policy and Bioethics Consortium convened by Harvard Medical School’s Center for Bioethics and the Program on Regulation, Therapeutics, and Law (PORTAL) at Brigham and Women’s Hospital met to discuss the implications of Spark Therapeutics’ new gene therapy treatment—along with its staggering price tag.

Luxturna, a novel therapy approved by the FDA last year, treats a rare form of inherited blindness known as retinitis pigmentosa. The therapeutic agent targets the RPE65 gene, associated with the disorder, and is shown to improve vision in a population with progressive vision-loss and an inability to see in dim light. Read More

hand reaching for blue pills

Should Non-opioid Analgesics have “Opioid Sparing” as a Label Claim?

Most meetings of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) are held to review a New Drug Application (NDA), usually for a novel opioid preparation. But, on November 15, the AADPAC discussed the concept and implications of “opioid sparing” as a potential product label claim for a non-opioid type of medication.

Although trends in outpatient opioid prescriptions appear to be heading in an encouraging direction (see figure below), the demonstration that a non-opioid medication could further decrease the overall use of opioids for acute pain has obvious implications for the amount of opioids prescribed and taken by patients who undergo painful surgical procedures. This will also decrease exposure in the community where prescribed opioids may become diverted for recreational use.

In recent years, some across-the-board measures (e.g. state laws that limit the duration of prescribed opioids) have attempted to reduce opioid prescribing, but as the FDA emphasized in their presentation at the meeting, these “one size fits all” strategies will not account for individual patient variation, and may lead to inadequate pain treatment in some patients. Read More

a stethoscope tied around a dollar bill, with a bottle of pills nearby

Drug Pricing Controls and the Power of Familiar Ideas

Eight in ten Americans think that prescription drug prices are unreasonable, according to a March 2018 Kaiser poll. That same poll found that more Americans considered passing legislation to lower drug pricing to be a top priority than passing legislation to improve infrastructure or to address the prescription painkiller epidemic, among other things.

Effectively addressing drug pricing is a complex task that will require the diligent efforts of many actors. On October 24, the Petrie-Flom Center held a full day’s programming to this important and timely topic. What I want to state here is a simple point—namely, that the very discussion of potential solutions can play a role in turning creative innovations into implementable solutions.

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Commentary: Do We Really Need a New, More Powerful Opioid?

The FDA’s Analgesic and Anesthetic Drug Advisory Committee (AADPAC), of which I am a member, met October 12 to discuss a controversial New Drug Application (NDA) for a powerful opioid called sufentanil, manufactured by AcelRx.

Like fentanyl, sufentanil is a short-acting synthetic opioid, but approximately 5 to 10 times more potent. In the midst of the current opioid crisis, why would anyone think that the availability of another powerful opioid is a good idea?

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