Mayor Rahm Emanuel today announced a breakthrough agreement with Pfizer, Inc., that will commit the company to strict standards for the marketing and promotion of prescription opioids, a class of highly addictive narcotic painkillers, to treat common, chronic pain conditions, such as back pain and arthritis.

In June 2014, the City of Chicago filed a lawsuit against five pharmaceutical manufacturers for misrepresenting the benefits of opioids and concealing the serious health risks associated with these drugs. Pfizer, which was not named in the suit, has cooperated with the City’s investigation and litigation, providing documents and other evidence relevant to the City’s claims against other manufacturers of opioids. As the agreement notes, the City has not found, and does not suggest, that Pfizer has engaged in any misconduct in its marketing of opioids.

“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 Mayor Emanuel. “The use of these drugs has led to a dramatic rise in drug addiction, overdose and diversion in communities across the nation, including in Chicago. Pfizer’s cooperation is proof that companies can act responsibly. We will continue our fight to force other companies to end their irresponsible practices and be held accountable for their deceptive actions that cause serious damage to individuals, families and neighborhoods and has helped fuel the heroin epidemic in Chicago.”

As part of the agreement, Pfizer has committed to fairly and accurately disclose the risks of opioids in its promotional activities and external communications, including through its sales representatives who promote drugs directly to doctors. Specifically, the company will:

• Disclose the risk of addiction to opioids, even when used as directed.
• Disclose that there are no adequate and well-controlled studies of the use of these products longer than 12 weeks. (This is especially important since opioids are frequently prescribed for long-term pain conditions.)
• Not promote opioids for any off-label or unapproved uses.
• Include information on opioid addiction and abuse in connection with its promotional efforts and communications, whether under the Pfizer brand or not.
• Maintain and promote a non-marketing website.
• Upon request, and to the extent it is educating prescribers about opioids, fund continuing medical education programs aimed at increasing prescribers' awareness of the risks of opioid addiction and abuse and helping prescribers identify signs of opioid addiction and abuse.

“Pfizer’s cooperation significantly assists the City’s litigation, and the company’s willingness to set a standard for others in the industry is a testament to their understanding of this critical public health issue,” said Chicago Corporation Counsel Stephen Patton. “We filed and continue to pursue our legal action against Purdue Pharma and other drug companies to stop these companies from deceptively and unlawfully marketing opioids and to hold these companies responsible for the harm their deception has caused.”

The Chicago Department of Public Health (CDPH) will work with Pfizer, which also has committed to assist the City in educational efforts regarding opioids and the proper disposal of unused opioid prescriptions.

“Opioids have caused a public health epidemic that has affected patients, their families and entire communities, and education is key to preventing other forms of abuse,” said CDPH Commissioner Julie Morita, M.D. “We look forward to working with Pfizer to help keep residents of Chicago fully informed about the risks associated with the use of these painkillers.”

Consistent with the City's allegation that drug companies deceptively promoted opioids through prominent doctors, professional societies, and patient advocacy groups that were trusted and appeared objective, Pfizer also agreed that it will:

• Ensure that third party materials that are approved, disseminated, edited or otherwise directed by Pfizer fairly and accurately describe the risks and benefits of opioids;
• Not support organizations and individuals that make inaccurate or unbalanced claims about the risks and benefits of opioids; and
• Not distribute or promote treatment guidelines concerning opioids that are not fair and balanced.

Chicago was the first city to file suit against leading opioid manufacturers alleging that these firms knowingly and aggressively marketed these drugs as rarely addictive, while touting benefits that lacked scientific support in order to boost profits. Their efforts to increase the sale of these drugs have been successful, as the sale of opioids quadrupled between 1999 and 2010. In fact, enough prescription painkillers were prescribed in 2010 to medicate every American adult around the clock for one month.
In addition to the general, deceptive promotion of opioids to treat chronic pain, the drug companies named in the lawsuit specifically target their marketing to the elderly and veterans, with false promises that opioids were unlikely to be addictive and would help improve their function and quality of life. These actions have often led to catastrophic results.

A 2008 investigation reported that 87 percent of all opioids dispensed were to patients using them to treat chronic pain on a long-term basis, even though there is no scientific evidence supporting the long-term use of these drugs for non-cancer chronic pain.

The City’s Health Insurance Plan has reimbursed claims for approximately $12.3 million on these drugs between 2008 and 2015. The increase in misuse and abuse of these drugs is also generating additional health care costs. For example, estimates of visits to emergency rooms in Chicago due to the misuse and abuse of prescription painkillers have been steadily increasing, with a significant increase of 65 percent between 2004 and 2011. In 2015, there were 84 fatal overdoses in Chicago due to prescription opioid painkillers.

Many patients who receive a valid prescription for an opioid painkiller become addicted to these powerful drugs. Even law abiding citizens who are prescribed these painkillers can become addicted, and some may turn to heroin because it produces the same high but is cheaper and easier to access. A recent study found that heroin use among those who misuse or abuse opioid painkillers has increased, with most reporting abuse or misuse of these drugs before starting heroin.

By dramatically increasing the market for opioids, the drug companies have also created a supply of drugs that are diverted to people to whom they are not prescribed. In fact, more than three out of four people who misuse prescription painkillers use drugs prescribed to someone else.

The City is not seeking to ban these drugs. Instead, the lawsuit seeks to end deceptive marketing so that patients and physicians are able to make informed decisions about when and how to use these highly addictive drugs.

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