This weekly column offers opinions on the latest pharmaceutical industry news.
At a meeting held last week to review the opioid epidemic, FDA Commissioner Dr. Robert Califf told the audience that “there’s a lot of sin to go around.” And among the sinners, he noted, are drug makers.
On the same day, coincidentally, one of those companies was given a chance to make amends.
In an unusual development, Pfizer signed a pact with the city of Chicago and agreed not to engage in the sort of marketing that helped fuel the epidemic in the first place. Chicago Mayor Rahm Emanuel boasted of a “landmark agreement” and a “big step” toward blunting the risks of these prescription painkillers, which were blamed for more than 14,000 deaths two years ago, according to federal health officials.
To be sure, any time a drug maker agrees to restrict or enhance its marketing in ways that benefit public safety is noteworthy, especially given the eye-popping fines that so many of these companies have paid over the past decade to settle charges of illegal marketing.
But this particular deal is unlikely to make much, if any, difference. In fact, for the moment, the only certain winner in this arrangement is Pfizer. And it’s a big win.
Here is the back story that prompts me to write this. The deal was reached as Chicago officials press a two-year-old lawsuit against five other drug makers — including Purdue Pharma and Johnson & Johnson — for allegedly misleading the public about the risks of opioids and causing a rise in city health care costs.
Pfizer, however, is not a party to the case. The drug maker is really a bit player in the opioid market. Its only product, known as Embeda, generated just $16.6 million in sales and some 28,200 prescriptions last year, according to the IMS Health research firm.
But for city officials, Pfizer serves a useful purpose.
Like all drug makers, Pfizer tracks what rivals are doing and this kind of marketing intelligence can help with a lawsuit. And so, as Chicago officials noted, Pfizer provided them with “documents and other evidence.” This may explain how the city was able to revise its lawsuit last November with fresh information about alleged wrongdoing.
In doing so, Pfizer may have broken from the pack and ratted on other drug makers — but they are competitors, after all. Meanwhile, the company avoided being pulled into the litigation.
In return, Pfizer made several promises.
These include agreeing not to promote its painkiller for unapproved uses or provide free samples to physicians. The company must disclose the risk of addiction in its materials and will fund programs to educate doctors about opioid risks. Pfizer will also note there is insufficient research to say opioids can be used longer than 12 weeks, a nod to concerns about long-term use that can lead to addiction.
All of these are all useful and important steps, but a Pfizer spokeswoman acknowledged the company already follows these practices. Certainly, the company should be doing so. If nothing else, it’s illegal to promote a prescription medicine for unapproved uses, and samples should not be distributed for controlled substances such as opioids.
“Pfizer looks good. They get a lot of public relations points,” said David Juurlink, a clinical pharmacologist at the Sunnybrook Health Sciences Centre in Toronto and a member of Physicians for Responsible Opioid Prescribing, a nonprofit that advocates for stricter prescribing. “But when you dissect the agreement, it won’t make any practical difference, unless they shared information with Chicago not in the public domain.”
Indeed, city officials may have received damning evidence that could help win their lawsuit, although this may not become clear until or unless the case goes to trial and documents become public. Clearly, this is what they are betting, especially because the US Senate is sitting on the results of a four-year-old probe into financial ties between drug makers and the medical organizations that set guidelines for opioid use.
Pfizer also agreed not to support patient or other outside groups that make inappropriate claims about opioids. But the company did not commit to ending support for organizations hat resisted new federal guidelines for reducing opioid prescribing.
Meanwhile, Pfizer may have smartly distinguished itself from the competition. Along with Eli Lilly, the company is developing an injectable drug that could be a safer alternative to opioids for chronic back or cancer pain. The plan is to seek regulatory approval in 2018 and, if that happens, Pfizer gets to pitch itself as a more forthright company.
For now, the extent to which the Pfizer information proves useful to Chicago officials remains unknown. And even if such information eventually surfaces, the city could still lose the lawsuit. By then, however, Pfizer will likely have been forgiven for any sins.