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October 2018 Newsletter


 

 Contraception and Naloxone
CME Now Available!


Check out the newly released DCRx modules, "Counseling Patients About Family Planning" and "Prescribing Naloxone in District of Columbia", accredited for a total of 2 CME/CPE hours. The module is free for DC healthcare providers and available for a nominal onetime fee for providers licensed elsewhere (the fee includes access to all other DCRx CME modules as well).

Access the DCRx learning center here

Recent Project News

 
  • In her most recent Bioethics Forum piece Dr. Fugh-Berman calls for medical journal editors checking authors' conflicts of interest and academic medical centers disclosing all researcher conflicts of interest: "Why should academic medical institutions that are supposed to be upholding principles of truth and transparency, keep disclosures secret?" She was also quoted on the topic in Fierce Healthcare's writeup of the Memorial Sloane-Kettering scandal, in which MSK's chief medical officer failed to disclose millions of dollars in drug company payments. 
  • Marketers or care providers? Dr. Fugh-Berman commented on the deceptive, unethical use of nurse "ambassadors" (actually employees of pharmaceutical companies or their vendors) to market Humira in the Los Angeles Times and STAT News
  • Dr. Fugh-Berman was quoted in Reuters and Business Insider on the targeting of individual patients with hemophilia by pharmaceutical companies (each patient controls market share for wildly expensive factor treatments).
How many pharma skeptics can you fit into one office?
There's no punchline, we're actually wondering.

Greater Decline in Opioid Prescribing After
CDC Guidelines Released

by Judy Butler

What happens when a government agency uses an unbiased, evidence-based approach to examine opioids for chronic pain? It finds no evidence of long-term benefits and extensive evidence of possible harms of opioids, recommends nonpharmacological and nonopioid pharmacological therapy for treatment of chronic pain, withstands an industry-funded assault, and reduces opioid prescribing.
 
That, in a nutshell, is the story of CDC’s Guideline for Prescribing Opioids for Chronic Pain, released in March 2016.
 
The Centers for Disease Control and Prevention (CDC), did not include any industry-funded participants in the process of drafting its guidelines. This stands in contrast to other federally-funded efforts addressing chronic pain and opioids: the National Institutes of Health, the Food and Drug Administration, and the Institute of Medicine all included industry-funded participants in their efforts. 
 
It’s no surprise that the draft CDC guideline was met unfavorably by the opioid industry, which remained behind the scenes. Working through surrogates with undisclosed funding, the industry mobilized forces against the publication of the guidelines. As reported by the Associated Press, many of those attacking the CDC guideline belong to the Pain Care Forum (PCF), a group founded by the chief lobbyist of OxyContin-maker Purdue Pharma and comprised primarily of drugmaker-funded members. For example, a letter from the Washington Legal Foundation (WLF) argued that the CDC broke the law by not disclosing its advisers’ identities and should redo the guidelines. Ironically, the WLF did not disclose that it received funds from Purdue.
 
The American Academy of Pain Management (now the Academy of Integrative Pain Management), another Purdue-funded PCF member, called for Congress to investigate the CDC. Pain patients mobilized to oppose the guidelines included representatives from the Interstitial Cystitis Association and other consumer advocacy group members of PCF, and also Purdue-funded groups including the Power of Pain Foundation (now iPain).
 
Although the CDC opened the guideline for comments and delayed its release to maximize public participation, the opioid industry failed to invalidate its conclusions. The CDC compiled and responded to all the comments derived from a constituent webinar and public comment, and stood behind the strength of its evidence-based guideline. The CDC's steadfastness paid off in public health benefits.
 
A recent study in the Annals of Internal Medicine demonstrates the substantial impact of the guideline on opioid prescribing rates. The study compared monthly opioid prescribing data prior to guideline release (January 2012 - February 2016) to post release (March 2016 - December 2017). The monthly drop in overall opioid prescribing rates increased from 23.48 per 100,000 to 56.74 per 100,000. For prescriptions higher than the upper limit of 90 morphine milligram equivalents (MME) per day recommended by the CDC, the monthly decline increased from 3.56 per 100,000 persons to 8 per 100,000.
 
The CDC guideline has also played an interesting role in opioid litigation. As part of a 2017 settlement with Santa Clara County, California, Pfizer agreed not to make any claims that conflicted with the CDC guideline nor support organizations and individuals that make such claims. Pain News Network (PNN) reported it will no longer receive Pfizer’s $10,000 annual grant for sponsorship of its newsletter. However, it’s unlikely that other opioid manufacturers would take similar steps, unless required to by litigation.
 
This is a success story that we should recognize and encourage. One can only imagine the impact that the federal government could have on opioid prescribing—and rational prescribing of other drugs—if all Federal actions had more evidence and fewer conflicts.

Joy's Favorite Article of the Month


The costs of drug development have long been debated among academics. This month I recommend an article that brings a new perspective to the costs of drugs, titled Estimated Costs of Pivotal Trials for Novel Therapeutic Agents Approved by the US Food and Drug Administration, 2015-2016 from JAMA Internal Medicine by Moore et al.

Pivotal trials are used to determine whether or not a drug is approved by the FDA. The authors identified 138 pivotal trials for 59 therapeutics that were approved in 2015 and 2016. They compared estimated costs of pivotal trials based on various trial characteristics including design, duration, enrollment, and endpoints. Although the authors found that trial costs varied widely, the most expensive trials were those with larger enrollment,  and non-inferiority trials. Estimated costs clustered between $12.2 million to $33.1 million. 

Other research claims that the cost to develop a drug is more than  $2 billion, but this study suggests that pivotal trials are not the main reason for development costs that high.

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.

September News Round-Up

(For more, follow @Pharmed_Out on Twitter!)

Dr. Fugh-Berman's piece on why academic institutions ought to disclose researchers' conflicts of interest
Opioids
A member of the family that owns Purdue Pharma — which is being sued by more than 1,000 jurisdictions for its alleged role in seeding the opioid crisis with its pain medication OxyContin...
Statins

Policy

What's in, what's out, and what's still on the table in the opioids package passed by the Senate

Industry Influence
Dr. José Baselga, the chief medical officer of Memorial Sloan Kettering Cancer Center, resigned on Thursday amid reports that he had failed to disclose millions of dollars...
Pharma Marketing
"'Imagine if you had the choice between the drug that comes with Florence Nightingale or the one that doesn’t,” [Dr. Fugh-Berman] said. “It’s a very potent marketing tool."
Drug Pricing
What began as a desperate search for life-extending medicine, cystinosis parents say, has become a story of corporations profiteering off their children.
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