In Crisis: Opioids, Pain, and Patients

While virtually every one of us knows of someone affected, the latest data on the opioid crisis from the CDC are startling. More than two million Americans are addicted to painkillers and nearly a half million people have died from overdoses of prescription narcotics since the year 2000.

The addiction and deaths happened in all classes and income levels, in men and women, blacks and whites, and in the Northeastern, Midwestern, and Southern regions of the U.S. So recently, in an amazing display of bipartisanship, Congress passed and the President signed the Comprehensive Addiction and Recovery Act (CARA) authorizing the federal government to award states grants for opioid-related initiatives on education, prevention, treatment, and recovery efforts.

It’s time for the pharma marketing industry to step up, lend its expertise, and become part of the solution. It’s not just about following regulations—it’s about self-regulation and professional responsibility.

In the midst of the CARA debates, Pfizer set an example in an agreement with the City of Chicago. Predictably, critics argued that Pfizer did no more than agree to follow the law to avoid addition to a false advertising lawsuit. The critics are at least half wrong.

Pfizer Goes A Step Further

Yes, Pfizer did agree to follow the law and Chicago agreed not to sue. But Pfizer promised to do much more, including adhering to an internal code of conduct that requires it to include serious opioid warnings in all of its medical education, communication, and marketing activities. It should be applauded—and others would do well to follow suit.

Among other things, Pfizer agreed to disclose in its marketing materials that narcotics carry a serious risk of addiction, even if used properly, and that there is no good evidence of effectiveness beyond 12 weeks of use.

The agreement also goes well beyond the law—it binds Pfizer to maintain an unbranded website to help HCPs become aware of the signs of opioid addiction, abuse and misuse, and to include such information in its materials for detailing and continuing medical education. And, while yes, that website already exists (www.rethinkopioids.com), it goes further, stressing opioids should not be first-line treatment for pain.

At the same time, Pfizer indirectly responded to a challenge by FDA Commissioner Dr. Robert Califf made during a May review of the FDA directed opioid REMS program. Dr. Califf then called for the industry to step up and do more than required by the FDA. Maybe Rahm Emanuel, the embattled Mayor of Chicago, said it best: “This landmark agreement is a big step in the right direction to help protect and educate the public about the true risks and benefits of highly potent and addictive painkillers.”

Meanwhile, Chicago continues to pursue a two-year old lawsuit against five other manufacturers alleging misleading opioid marketing. Pfizer was not named in that suit, and is a small player in the category with only its abuse deterrent formulation Embeda and its Troxyca pending approval at FDA. As critics have suggested, Pfizer may have its own competitive reasons for the agreement. So be it.

We are the professional communicators, the educators, and the storytellers who know how to make communication compelling and effective. It’s up to us to step up in the face of this public health crisis and do our part. It’s the right thing to do. In fact, policy makers and the public have a right to expect it from us.

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