FDA’s Approval of New Painkiller Highlights U.S. Opioid Addiction

Source: http://www.flickr.com/photos/epsos/

Source: http://www.flickr.com/photos/epsos/

Painkiller addiction is a growing problem in the United States, and consumer advocacy groups fear rates of addition will only increase thanks to the U.S. Food and Drug Administration’s approval of Zohydro — a hydrocodone-based prescription drug that is the latest variant of painkillers called opioid analgesics.

Last October, the FDA approved the drug for “the management of pain severe enough to require daily, around-the-clock, long-term treatment and for which alternative treatment options are inadequate.” The drug will be available to patients in March. The agency also noted that in keeping with updated labeling requirements for opioid analgesics, Zohydro will be labeled with “stronger warnings” that will “more clearly describe the risks and safety concerns” associated with its class of extended-release and long-acting opioid analgesics. As a Schedule II drug, Zohydro, which is manufactured by San Diego-based Zogenix (NASDAQ:ZGNX), will only be dispensed through a physician’s written prescription with no refills.

Still, the warning labels are not protection enough, according to many consumer advocates. A coalition of more than 40 healthcare, consumer, and addiction treatment groups wrote to the FDA on February 26 asking the agency to revoke its approval of the medication. “On behalf of consumer safety organizations, healthcare agencies, addiction treatment providers, community-based drug and alcohol prevention programs, professional organizations, and other groups on the front-line of our nation’s opioid addiction epidemic, we ask you to put the public’s health ahead of industry interests,” wrote to FDA Commissioner Margaret A. Hamburg, M.D. “In the midst of a severe drug epidemic fueled by overprescribing of opioids, the very last thing the country needs is a new, dangerous, high-dose opioid.”

The signatories included G. Caleb Alexander, MD, of the Johns Hopkins Bloomberg School of Public Health; Samuel A. Ball, PhD, the president and chief executive of CASAColumbia; Daniel A. Busch, MD, of Northwestern University’s Feinberg School of Medicine; and, Michael A. Carome, MD, the Director of Washington D.C.-based Public Citizen’s Health Research Group. Plus, the commission maintained that if Zohydro was approved based on adherence to existing FDA policies, “then surely those policies require urgent revision.”

“Too many people have already become addicted to similar opioid medications, and too many lives have been lost,” continued the letter, whose authors stated that prescriptions for opioids have skyrocketed in the past 15 years. The United States accounts for 5 percent of the world’s population, but consumes more than 84 percent of the world’s entire oxycodone supply and more than 99 percent of its hydrocodone supply. According the U.S. Centers for Disease Control, the sharp increase in opioid use has led to a parallel jump in opioid addiction and overdoses deaths. In fact, since 1999, fatalities from opioid overdoses have grown exponentially, especially among middle-aged sufferers of chronic pain. As the letter claims, citing CDC data, opioid analgesic overdose deaths have risen by 415 percent in women and 265 percent in men between 1999 and 2010.

As the letter’s authors acknowledged in the opening lines of the document, that same concern — the addition of hundreds of thousands of medical and non-medical opioid users and overdose deaths — was voiced by members of the United States Congress and 29 state attorneys general. In late November, eight congress members wrote to Secretary of the Department of Health and Human Services Kathleen Sebelius, expressing their “grave concerns” regarding the approval of the “high-dose narcotic painkiller” Zohydro despite a “November 2012 internal FDA memo warning of the drug’s high likelihood for abuse.” Plus, in December 2012, the agency’s advisory board voted 11 to 2 against approval, citing concerns for the potential for addiction.

“Substance abuse is exacting a toll on America,” noted Democratic Representative James McGovern of Massachusetts, Democrat Representative Stephen Lynch of Massachusetts, Democrat Representative Nick Rahall of West Virginia, and their peers. “The Centers for disease Control and Prevention reported that there were 38,329 drug overdose deaths nationwide in 2010 and that prescription drugs were involved in early 60 percent of those deaths.” In addition, the National Institutes of Drug Abuse has estimated that the overall cost of substance abuse in the United States, including lost worker productivity and health and crime-related expenses, exceeds $600 billion annually, the congresspersons said. “On many levels, we simply cannot afford to move yet another highly addictive opioid into the mainstream and potentially onto Main Street.”

As Washington emergency room physician Stephen Anderson told CNN, Zohydro is “somewhere in the neighborhood of five times more potent than what we’re dealing with now.” He was not part of the commission that petitioned the FDA .

In conclusion, the congresspersons asked the FDA to postpone approval until after the Zohydro manufacturer added “the appropriate safety and abuse deterrent protections,” which the company was working on at the time of the letter was written.

However, both Zohydro manufacturer Zogenix and the FDA have argued the drug’s benefits outweigh the risks. “We do not expect the introduction of Zohydro ER (extended release) to increase the overall use of opioids,” Zogenic executive vice president and chief medical officer Dr. Brad Galer told CNN by email. “In fact, prescription data from the last five years shows that total use of ER opioids is constant and independent of new entrants to the market.” He explained that the drug company would center its commercial sales strategies on doctors that have had positive experience prescribing opioids so that only the appropriate patients would receive the drug. After all, some advocates for chronic pain patients argue that some people do in fact need Zohydro-type medication “to get pain relief in order to live a fulfilling life,” as founder and president of the U.S. Pain Foundation Paul Gileno told CNN. The organization receives some funding in unrestricted grants from the pharmaceutical industry.

The problem with Zogenix’s plan, according to Anderson, “is that it costs a lot of money bringing a drug through clinical trials and then bringing it to market. You have to anticipate [the drug company] being able to market and get its money back.” The doctor, who has served as the president of the Washington chapter of the American College of Emergency Physicians, sees the strategy as a “marketing ploy where eventually it’s ‘I’ve got bigger, I’ve got stronger, why don’t you prescribe this,’ and I’m terrified of that.”

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