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The dark side of drug marketing

By Staff | Sep 26, 2016

The phrase heroin epidemic is now all too familiar. So too are the feelings associated with the news of yet another tragic overdose death. The frequency of local arrests for possession or sale of the lethal substance no longer surprise or shock. We understand the drug has a foothold in even the most bucolic of our communities.

But we are hardly alone.

The state and nation are grappling with the realities of this scourge and struggling to formulate appropriate solutions. Focusing efforts on law enforcement or treatment alone misses the vital need to also boost the effectiveness of the Federal Drug Administration to regulate and hold the drug industry responsible for its products and the way they are marketed.

There is incontrovertible evidence the pharmaceutical industry’s marketing of prescription opioid painkillers and the FDA’s failure to quickly step in and end inappropriate marketing practices are root causes of the current heroin and opioid addiction crisis killing Americans in alarming numbers. Connecticut can be proud that Sen. Richard Blumenthal, when he was the state’s attorney general and well before heroin and other opioid-related deaths surged, was among those who led a fight against Stamford-based Purdue Pharma’s marketing of the opioid painkiller OxyContin.

On behalf of Connecticut in 2001, he sued Purdue, contending the drug maker was marketing OxyContin for off-label uses, an illegal practice. The lawsuit argued Purdue advocated that physicians counsel patients to use OxyContin in ways not approved by the FDA, such as taking the drug every eight hours instead of the approved 12-hour intervals. Purdue in 2007 settled the case, paying Connecticut and 26 other states $19.5 million and agreeing to change its marketing. Connecticut received more than $700,000 in the settlement and used $100,000 of that amount to establish a state prescription drug-monitoring program.

Blumenthal’s subsequent 2008 lawsuit seeking to force the FDA to issue stronger warnings about OxyContin, unfortunately was unsuccessful.

It took several more years, an increasing body count of overdose deaths and conclusive statistical evidence of the connection between the boom in the number of opioid painkiller prescriptions and surging heroin use, for many in Washington to act. Finally, some serious discussion forced accountability for both the pharmaceutical industry and the FDA. In February 2016, the FDA called for a sweeping review of its opioid policies and in March released an action plan "to take concrete steps toward reducing the impact of opioid abuse on American families and communities."

Sen. Chris Murphy was quoted in an interview with the Morning Consult in March as saying, "We’ve clearly reached a tipping point on heroin and heroin overdoses that commands us to treat this issue with more seriousness. So it’s not like this issue hasn’t been around for a long time, but there clearly is a ferocity to the epidemic now."

While the recent FDA action demonstrates steps in the right direction, it’s distressing the problem of heroin and opioid addiction needed to reach a level of ferocity before getting Washington’s attention. The crisis requires more effective solutions and a multi-pronged attack from drug-makers and regulatory agencies, along with physicians, law enforcement officials and treatment facilities. And as federal officials and elected representatives grapple with dealing with what is, they have a responsibility to be proactive about considering how to control what is sure to be.

Researchers are constantly developing new drugs, offering doctors more tools to control pain and cure disease. But the addicted and those who prey on them will also develop new ways to abuse these drugs. Pharmaceutical marketing, and the FDA’s control of it, must be cognizant of mitigating this potential for abuse, rather than feeding it.

Now is the time for Washington officials to develop more effective monitoring systems and regulatory processes to protect consumers. Those controls must look to preventing future crises as much as solving the current one.

The Day (Conn.)
Sept. 18

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