Anti-addiction activists ask top FDA official to resign

Several groups of anti-addiction activists are asking the Food and Drug Administration’s head official to step down. They believe her actions and others’ actions have contributed to the mass painkiller epidemic wreaking havoc on the nation, CBS News reported.

A poor decision

A letter was sent to the administration on Sept. 24 asking agency leader Dr. Margaret Hamburg to step down. The FDA has been surrounded by controversy since October 2013, when it approved a potent painkiller called Zohydro despite being advised otherwise by medical experts.

Zohydro is an extended-release, pure form of hydrocodone. It is the first drug of its kind legally sold on the U.S. market. Hamburg defended the drug’s approval, stating it addressed a medical need. Other drugs such as Vicodin have combined acetaminophen with hydrocodone in the past, but medical researchers discovered that can cause liver damage.

The letter is the first formal request for new leadership at the FDA because of the issue.

“We are especially frustrated by the FDA’s continued approval of new, dangerous, high-dose opioid analgesics that are fueling high rates of addiction and overdose deaths,” stated the letter, which is addressed to Health and Human Services Secretary Sylvia Burwell. Burwell supervises the FDA and other health agencies.

One of the groups against the FDA is the Physicians for Responsible Opioid Prescribing. The 900-member advocacy group asked the FDA last year to significantly restrict opioid use in a petition. The FDA rejected the petition.

A spokeswoman for Burwell stated that her focus is on resolving the opioid crisis.

“Secretary Burwell appreciates hearing from stakeholders on the important issue of prescription opioid abuse, and looks forward to responding to their letter,” spokeswoman Tait Sye said in a statement.

An ongoing problem

Overdose-related deaths from opiates is becoming a concerning issue nationally. In the past 20 years, overdoses have more than tripled, according to 2011 data from the U.S. Centers for Disease Control and Prevention. The organization stated that approximately 100 people die each day because of an opioid overdose. The CDC recently asked doctors to only prescribe them to patients with severe pain, such as those in end-of-life care. However, often patients are given painkillers for minor conditions, such as back pain or arthritis.

Supporting a dangerous cause

Hamburg has been a large promoter of painkillers, believing that many Americans deal with chronic pain. The letter stated that Hamburg and the FDA are ignorant of the CDC’s and other organizations’ efforts to fight opioid abuse.

“Dr. Hamburg’s support for using opioids to treat chronic non-cancer pain is squarely at odds with efforts by the CDC to discourage this widespread practice,” the letter stated.

Others, such as FDA spokeswoman Erica Jefferson, argue Hamburg is focused on the issue at hand.

“Preventing prescription opioid abuse and ensuring that patients have access to appropriate treatments for pain are both top public health priorities for the FDA,” Jefferson said in a statement.

Members of Congress from several states have created bills that ban Zohydro. Attorney generals have also spoken out asking the FDA to revoke the drug or change its formulation to prevent abuse. Lawmakers in many states that have dealt with the most widespread opioid problems have also criticized the FDA.

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