In a surprising move, Pfizer reached an agreement with the city of Chicago to follow a code of conduct for marketing opioids that officials hope will become standard practice for other companies.
The drug maker agreed last week to disclose in all promotional materials that opioids carry a risk of addiction and not to promote them for any unapproved uses. Moreover, Pfizer must make clear that there is insufficient research about the effectiveness of opioids if used beyond 12 weeks, a nod to concerns that the drugs are too often used on a long-term basis, which can lead to addiction.
The pact reflects an unusual development, however, because Pfizer agreed to cooperate with the city in a fight against several of its competitors. Two years ago, Chicago filed a lawsuit accusing five other drug makers of deceptively marketing opioids. Pfizer appears to have avoided being drawn into the litigation by providing city officials with documents and other evidence useful to the lawsuit.
Some industry watchers, meanwhile, said that the four-year agreement, which does not pertain to any other city or state, largely requires Pfizer to adhere to existing laws and regulations governing drug marketing. For this reason, they said the agreement breaks little new ground in the battle against inappropriate or overprescribing of opioids.
“They’re agreeing not to break the law? That’s nothing to celebrate,” said Dr. Andrew Kolodny, who heads Physicians for Responsible Opioid Prescribing, an education and advocacy group, and is also chief medical officer at Phoenix House, a nonprofit that runs drug abuse treatment and prevention programs.
A Pfizer spokeswoman acknowledged the company already follows the practices outlined in the agreement.
Nonetheless, the pact comes amid rising concerns over an epidemic of deaths and overdoses attributed to opioid painkillers. Every day, more than 40 Americans die from overdoses of opioid painkillers, according to federal health officials. And each year, 2 million people abuse or misuse the drugs. For these reasons, Chicago officials touted the deal as a significant effort with potential to curb the trend.
“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 highly addictive painkillers,” said Chicago Mayor Rahm Emanuel in a statement. Last year, there were 84 fatal overdoses in Chicago due to prescription opioid painkillers.
The city notes its health insurance plan has reimbursed claims for approximately $12.3 million for opioids between 2008 and 2015.
The pharmaceutical industry has regularly been blamed for contributing to the problem through misleading marketing and funding medical organizations that set guidelines for opioid use. In 2007, Purdue Pharma, which markets OxyContin, and three former executives paid a $600 million fine and pleaded guilty to criminal charges of misleading the public about the risks of addiction and abuse.
In the spring, a Kentucky judge ruled in a lawsuit brought by STAT that secret documents tied to the marketing of OxyContin must be released. Purdue is appealing that decision.
Pfizer, however, is a relatively small player. The company markets just one opioid called Embeda, but it is not a big seller, which may have lessened its exposure to the lawsuit, and it already carries a so-called Black Box warning about serious risks. A Pfizer spokeswoman noted that, as part of the agreement, which she described as voluntary, Chicago did not accuse the company of violating any laws and that the drug maker did not admit to any wrongdoing.
The pact also requires Pfizer to refrain from providing samples of any opioids to physician offices or funding any outside organizations that make illegal claims about the use of opioid painkillers. The company must also disclose details of any clinical trials for opioid drugs being developed and maintain a website disclosing its promotion of opioids.
“If Pfizer adheres to the agreement, hopefully it will help prevent dissemination of information that leads to overprescribing,” said Dr. Michael Carome, who heads Public Citizens’ Health Research Group. “Whether it will ultimately have a major impact remains to be seen. It appears to be a small step in the right direction.”
Pfizer may have another motive for entering into the agreement, according to Dr. Adriane Fugh-Berman, an associate professor at Georgetown University Medical Center, who runs Pharmed Out, a project that examines the influence drug makers have on the practice of medicine.
She noted that Pfizer is currently working with Eli Lilly to develop a different type of painkiller and hopes to win regulatory approval by 2018. The drug, which is an injectable, is currently in late-stage testing and would be used to treat osteoarthritis, chronic back pain, and cancer pain. Called tanezumab, it would have to be administered every eight weeks.
“It’s in Pfizer’s interest to highlight the addictive properties of opioids because they have a competing product under development,” she said. “When a company comes out slamming a particular class of drugs, it’s generally because they have a competitor in the wings. Think of this as prelaunch marketing, which can start long before the launch.”
My wife has pain from knee replacement arthritis all over but can’t seem to what she needs for pain what can you recommend even if it’s experimental
Pharmvet1 misunderstands the professor’s statement about “pre-launch marketing.” It is illegal to promote an unapproved medication, yes. But pharma engages in pre-launch disease state marketing all the time. Nothing illegal about educating providers or policymakers about the disease state or other context that happens to be connected to your future product’s benefits. Is the disease state not well-known (or even unknown)? Start running ads and seeding speakers at conferences to educate providers about the new diagnosis your future med will soon be approved for (example: opioid-induced constipation or “OIC”). Pre-launch marketing can also involve having sales reps start to denigrate aspects of their own medication when it’s about to go off-patent, and then when your new patent-protected formulation gets approved– surprise! It has benefits that solve the problems of the old (now generic) formulation! It will be _much_ safer, less sedating (or more sedating) or dissolve more evenly, or taste better, or work faster or longer, or be harder to divert…
I’ve seen a number of pre-launch marketing plans first-hand in my time in pharma sales.
I stand corrected but miss the goof old days of “coming attractions” type ads, with a website link:
. COMING SOON
. (when more isn’t enough)
The closing comment by the good Dr Fugh-Berman of Georgetown would seem to imply that big Pharma only does good for Big buck$ later. ‘Shocked, I am shocked that….’
I guess the good doctor is unaware that prelaunch marketing has been illegal for years, but why trifle with the truth when Pharmed Out speaks with impunity.
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