Public Citizen Calls for New Vicodin Restrictions

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By: Irvin Jackson | Published: February 5th, 2013

The prominent consumer watchdog group Public Citizen is calling on federal drug regulators to restrict access to Vicodin and other hydrocodone-based painkillers. 

In a press release issued late last month, Public Citizen argued that hydrocodone painkillers are overprescribed in the United States. The press release came about the same time as the FDA’s Drug Safety and Risk Management Advisory Committee voted 19 to 10 to place hydrocodone in a more tightly regulated category of drugs.

The director of Public Citizen’s Health Research Group, Dr. Sidney Wolfe, testified at the advisory committee hearing, urging restrictions on the drug’s use.

“The United States is suffering from the world’s worst epidemic of prescription narcotic use, more than half of it being hydrocodone,” Wolfe said. “The reason: It can too easily be prescribed. Requiring doctors to see patients every three months to re-prescribe the drug would dramatically cut down on its misuse.”

According to Public Citizen, 99% of all hydrocodone in the world is manufactured and used in the United States. More than 2.6 billion doses of hydrocodone are taken by Americans every year, an average of eight doses per person, the group reports.

The advisory committee’s vote was to recommend that the FDA reclassify hydrocodone as a Schedule II controlled substance, which would group Vicodin with drugs like OxyContin. It would change and limit how doctors could prescribe hydrocodone to their patients. Public Citizen and Dr. Wolfe supported the measure.

The FDA is not required to follow the advisory committee’s recommendations, although it usually weighs those recommendations heavily in its final determinations.

Last year, the U.S. Centers for Disease Control and Prevention (CDC) declared that unintentional prescription drug overdose deaths had hit “epidemic” levels in the U.S.

Misuse and accidental overdoses of painkillers like OxyContin and morphine have driven the skyrocketing numbers, with opioid painkillers responsible for more deaths than cocaine and heroin combined since 2003.

In 2007, there were about 27,000 unintentional prescription drug overdose deaths in the United States, the CDC reported. Since 2008, prescription drug overdoses have accounted for more deaths than traffic accidents.

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There Is One Comment So Far • (Add Your Comments)

  1. Let me share that as a hydrocodone user of 20 yrs, a neuroscientist and patient advocate of 20 yrs & earlier supporter of Public Citizen, I am appalled at their role in restricting patient access to any drug, device, or medical treatment that has been proven to be safe. Widely, the problems I see in pain medicine misuse, are in the misunderstanding of & poor use of pain management practices. It is a medical specialty and I believe too few physicians truly understand how pain medicine should be used!

    There are many medical and other products that are safe when used as directed. But casting a restrictive new blanket policy over a class of otherwise safe medications because some physicians lack expertise in pain management, or because “the nation” is suffering a health & mental health crisis, is ludicrous!

    These new restrictions will only compromise the care of user patients, where some will seek to illegal and cross border means to obtain it at a much higher cost, AND where in the remainder, such as myself, there will be a compromise and deterioration of the care.

    I earlier worked on a shunt device safety issue with Public Citizen in 1996, and upon their urging petitioned (and later prevailed) FDA on widespread safety issues with CNS anti-siphon shunts. In the years since, I have repeatedly called on the FDA for new postmarket surveillance and other actions on behalf of the disorder, hydrocephalus, and CNS shunt technology, but my requests have fallen on deaf ears. My latest CNS shunt implanted last November, has already been recalled. I no longer have any relationship with Public Citizen, in part because they never took any interest in the widespread criminal failures in the field, and I felt they’d become too political. Their misguided activism in this hydrocodone bill only solidifies my concerns.

    Now my bigger concern is, WHAT’s NEXT? We already have massive problems with drugs, devices, and authorization of medical tests. How will this new philosophy, where a 3rd party group with no connection or standing in the care of a patient, champion new restrictions in patient care? This new bill is much bigger than hydrocodone. It’s about one’s access to quality of care, and one’s civil rights to health & happiness as protected under the Constitution! Staggering legislation!

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