Guidelines, Goalposts, and Genotypes

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  • 09/11/2013

Pierre Trudeau once said, “There's no place for the state in the bedrooms of the nation.“ But what’s the appropriate place for the state in our nation’s pharmacies and medicine chests – particularly for opioids?

Yesterday was the day to address that question.

First there was the FDA’s announcement of class-wide labeling changes and new post-market study requirements for extended-release and long-acting opioids.

Until now, the FDA had said the drugs were appropriate for the treatment of "moderate-to-severe" pain. The new drug label drops the word "moderate" and says it should be used only to manage "pain severe enough to require daily, around-the clock, long-term treatment." Additionally, FDA is adding a boxed warning on the risk of neonatal opioid withdrawal syndrome.

The agency said manufacturers must conduct one or more post-marketing studies to quantitatively estimate the risks of misuse, abuse, addiction, overdose and death associated with long-term use, as well as a clinical trial to evaluate the risk of developing increased sensitivity to pain with long-term use of extended-release and long-acting opioids. Companies also must conduct a study of "doctor/pharmacy shopping" -- a practice in which patients visit multiple doctors and pharmacies to obtain prescriptions -- and whether it is "suggestive of misuse, abuse and/or addiction." Per a report in BioCentury, “FDA said companies should work together on the post-marketing studies.”

Once the labeling changes are finalized, FDA said it will modify the classwide REMS for extended-release and long-acting opioids. The REMS, which the agency approved in 2012, requires companies to make educational programs available to prescribers at no or nominal cost but does not require prescribers to participate and does not include a prescriber registry.

The other big new was a Capital Hill conference on Personalized Medicine and Responsible Access to Pain Medication (sponsored by the Center for Medicine in the Public Interest – the think tank home of I was honored to chair the event.

Speakers included Bob Twillman of the American Academy of Pain Management, Cindy Steinberg of the US Pain Foundation, Stuart Kim of Mallinckrodt Pharmaceuticals, Steve Usdin of BioCentury, syndicated healthcare columnist Judy Foreman, and Professor Charles Inturrisi of Weill Cornell Medical Center.

The speakers and attendees rocked the Rayburn Building. Video of the event will soon be posted on the CMPI website.

I tried to set the tone with my opening comments:

Joshua Lederberg, the Nobel Prize Laureate once observed that the failure of regulatory, legal and political institutions to integrate scientific advances into risk selection and assessment was the most important barrier to improved public health.  

Lederberg noted that in the absence of such changes,  "the precedents affecting the long-term rationale of social policy will be set, not on the basis of well-debated principles, but on the accidents of the first advertised examples."

Policies and regulations that seek to limit risk are often shaped by the immediate fear of sensational events. This perspective is commonly called "The Precautionary Principle" which in various forms asserts that unless innovators can demonstrate that a new technology is risk free, it should be not allowed into the marketplace.  Moreover, any product that could possibly be dangerous at any level should be strictly and severely regulated. 

But precaution is not always safer than the alternatives.

Some current examples of precaution and the public health

·      The National Action Plan for Adverse Drug Event Prevention, just announced in a Sept. 4 Federal Register notice, outlines a comprehensive strategy to reduce AEDs for opioids. Much of the research actions called for by the plan seem designed to decrease prescribing. For instance, the plan calls for research by CDC, NIH and, public-private collaborations to look into adopting adjunctive and behavioral modalities to augment and reduce opioids use for chronic pain;

·      Upscheduling and the relabeling of medicines to treat depression, diabetes, chronic and acute pain;

·      And, finally, the role of tamper-resistant technologies in the appropriate management of pain medicines (both innovator and generic).

It’s also important to consider the DEA’s “Thug Regulation” strategy that results in a decline in appropriate patient access; an increase in regulatory time and cost and, ultimately, a decline in innovation.

The California Medical Association has received reports from physicians that Walgreens pharmacists are refusing to fill controlled substances prescriptions without additional information from the prescriber.

Per dictates from the DEA, Walgreen’s pharmacists are now demanding that physicians provide information on diagnosis, ICD-9 codes, expected length of therapy and previous medications tried and failed.

In other words, tighter restrictions for patients who really need the medications, more paperwork for physicians and a heavier workload for pharmacists. Abusers and criminals rarely follow regulations.

When you have a hammer, every problem looks like a nail. The DEA sees opioid abuse and seeks to minimize access to them. That’s a law enforcement solution. They mean well – but are behaving like a bull in a china shop

Arbitrarily limiting choice is not generally associated with the Scientific Method.

Should regulation be shaped by factors other than science or should advances in medicine and digital information be used to right-size regulation, reduce the excessive reductionism that leads to regulatory overreaction and promote resilience rather than ever increasing restrictions?

Consider the program recently instituted by CVS (and detailed in a recent New England Journal of Medicine Perspective piece) where, via the use of “Big Data” the chain pharmacy identified “outlier prescribers” and took appropriate and responsible actions.

The DEA’s attempt to deputize pharmacists on the one hand and the CVS program on the other raise some interesting questions:

·      What will the role of the 21st century pharmacist be in improving drug safety and medication adherence via more proactive (and remunerated) patient education?

·      How can pharmacists become better integrated (beyond Med Guides) into the FDA’s Safe Use of Medicines initiative?

·      When will pharmacy synchronization programs really kick into gear, and how will states help to jump-start these important initiatives?

To paraphrase the American political scientist Aaron Wildavsky, we at the Center for Medicine in the Public interest believe in a strategy of resilience based on experience. We must learn from adverse consequences in order to develop a capacity to advance the public health. Variability is the key to survival.



Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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