From Johanna Ryan:
Last week, RxISK joined with forty-one other organizations from across the U.S. and Canada to urge the FDA to withdraw its approval for a new drug. Zohydro ER is actually not so “new” – it’s pure hydrocodone, a synthetic opiate which has been widely prescribed for many years in the U.S. However, Zohydro will contain up to ten times the hydrocodone available in tablets such as Vicodin or Lortab, which combine it with over-the-counter painkillers like acetaminophen.
First a lifeline then a noose
As we explained in Steve Rummler’s story last month, the United States (and increasingly Canada as well) are in the midst of a full-blown epidemic of prescription opioid addiction. This is largely a medically created epidemic, fueled by an industry-funded campaign to convince prescribers that these drugs were safe when used for “legitimate” chronic pain rather than to get high.
FDA: An equal opportunity regulator
The story of Zohydro’s approval contains some special twists. The FDA’s own scientific advisory panel in December 2012 voted 11-2 against licensing the drug. Ten months later, FDA officials then took the unusual step of overruling their own scientific panel. As one of those officials explained, they knew this drug “would contribute to the already critical public-health problem of prescription opioid abuse”, but they felt the FDA could not “punish this company and this drug because of the sins of the previous developers and their product.” In other words, if Purdue Pharma had gotten its shot at creating a public-health disaster with OxyContin, then Zogenix and Alkermes, who market and produce Zohydro, apparently deserved their chance as well.
Zogenix was also allowed to test Zohydro in modified trials using an “enriched enrollment” design which began by screening out subjects who did not respond to the drug or had adverse reactions. In effect, only the success stories were studied. It has since emerged that this strategy was hammered out in closed meetings with top FDA officials which drug company executives paid tens of thousands of dollars to attend.
When is enough, enough?
We’re happy to join with groups like Public Citizen and Physicians for Responsible Opioid Prescribing, and addiction treatment centers like Phoenix House and Hazelden. But the bulk of the people who have taken the lead here are grieving parents, recovering addicts and others who have personally borne the brunt of this disaster. Judy Rummler lost her son, Steve, to a problem that began with pills prescribed for a back injury, and ended in a fatal overdose. Ari Israel’s son Michael was given opioids to treat the pain of Crohn’s disease, only to develop an addiction that drove him to suicide. Amy Graves lost her little brother Josh to a single prescription pill. They know from experience that this is not a fight which pits “legitimate” patients against “drug abusers.” Both groups are victims here, and too often they’re the same people. Both deserve better than they’re getting from an increasingly profit-driven healthcare system.
The text of the Zohydro letter is below. Click here for a PDF version with a complete list of signers. And if you haven’t signed the petition on Change.org urging the FDA to withdraw Zohydro, please do it now.
February 26, 2014
Margaret A. Hamburg, M.D.
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
RE: New Drug Application NDA 202880, Zohydro ER
Dear Dr. Hamburg,
We are writing to echo concerns raised in letters written by Members of the United States Congress and by State Attorneys General regarding the Food and Drug Administration’s (FDA) approval of Zohydro, a high-dose, single-entity hydrocodone formulation. We join them in asking you to adopt the recommendation of the FDA-appointed scientific advisory panel, which voted 11-2 against approval of Zohydro.
On behalf of consumer safety organizations, health care 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. 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.
If your decision to approve Zohydro was based on adherence to existing FDA policies, then surely those polices require urgent revision. FDA must take into account recent history. After the release of similar high-dose opioid analgesics, thousands of lives were lost from overdose and hundreds of thousands of medical and non-medical users became addicted. We implore you to take these painful lessons into account.
Over the past 15 years, prescriptions for opioids have skyrocketed. The United States, with about 5% of the world’s population, is now consuming more than 84% of the world’s entire oxycodone supply and more than 99% of the hydrocodone supply. According to the United States Centers for Disease Control (CDC), the sharp increase in opioid prescribing has led to parallel increases in opioid addiction and overdose deaths. Since 1999, overdose deaths have skyrocketed, especially among middle-aged individuals prescribed opioids for chronic pain. Opioid analgesic overdose deaths have increased by 415% in women and 265% in men.
Zohydro’s maker has claimed that it is safer than existing hydrocodone products because it does not contain acetaminophen. Zohydro is not safer. It will contain up to 10 times more hydrocodone than Vicodin or Lortab. Someone unaccustomed to taking opioids could suffer a fatal overdose from just two capsules. A single capsule could be fatal if swallowed by a child. For patients unable to tolerate acetaminophen, many opioid formulations made without acetaminophen are already available. There is no need for another high-dose, single-entity opioid.
Too many people have already become addicted to similar opioid medications and too many lives have been lost. We urge you to exercise your authority and responsibility to protect the public’s health by keeping Zohydro off the market.
[Signed by 42 leading physicians, directors of addiction treatment centers and consumer/community activist groups combating the opioid epidemic in the U.S. and Canada, including RxISK.org. Click here for a copy of the letter in PDF format with complete list of signers.]
 United States hydrocodone and oxycodone consumption statistics as reported by the International Narcotics Control Board in 2012.
 CDC. Vital signs: Overdoses of prescription opioid pain relievers and other drugs among women—United States, 1999–2010. MMWR 2013; 62:537-542