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Sep-19-2016 22:44printcomments

FDA - Opioids for Pediatric Patients - How could you get it so wrong?

"The FDA reached this life-threatening decision without regard for the lives of children..."

FDA angry official
An angry official of the FDA.
Photo: Marianne Skolek-Perez

(MYRTLE BEACH, S.C.) - Last Thursday and Friday I attended an FDA meeting of the Anesthetic and Analgesic Drug Products Advisory Committee, the Drug Safety and Risk Management Advisory Committee and the Pediatric Advisory Committee.

The purpose of the two-day meeting was to discuss prescription opioid analgesics for pediatric patients. The FDA experts and their egos were in plentiful supply as they fell over each other condoning opioids for pediatric patients.

Unfortunately the audience in the large auditorium was sparsely attended -- no Partnership for a Drug Free Kids and no advocacy organizations.

Joseph T. Rannazzisi Deputy Assistant Administrator (retired) Office of Diversion Control U.S. Drug Enforcement Administration (DEA) was with me on Friday morning for the FDA hearing.

The FDA has been under fire by industry since the Center for Disease Control (CDC) issued new guidelines in the prescribing of opioids. A link to the guidelines is shown here: www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm.

In these CDC guidelines, they specifically state: "According to the CDC, prescriptions and sales of opioids have more than quadrupled since 1999, with at least 40 people on average dying from an opioid overdose every day.

"Primary care physicians in outpatient settings prescribe more than half of all opioids used. Given the extent of the epidemic, federal health officials determined that more guidance was needed in this area of medicine."

The reasons for the new CDC guidelines are described as follows:

"Improving the way opioids are prescribed through clinical practice guidelines can ensure patients have access to safer, more effective chronic pain treatment while reducing the number of people who misuse, abuse, or overdose from these drugs."

It goes on to say that the guidelines are designed to improve the treatment "for patients 18 and older in primary care settings. Note the CDC emphasizes the guidelines for opioid prescribing is "for patients 18 and older in primary care settings."

So why would the FDA be conducting hearings on opioids for pediatric patients? What I witnessed at these two FDA hearings left me wondering if I truly knew the extent of the meaning of the word "corrupt."

I was already aware that the FDA functioned under the umbrella of impunity -- exemption from punishment or freedom from the injurious consequences of an action. That was quite evident when Purdue Pharma's blockbuster opioid named OxyContin was approved by the FDA for use in children as young as 11 years old. This approval was made without an Advisory Committee hearing.

Sharon Hertz, MD, Director of Anesthesia, Analgesia and Addiction Products advised that the FDA reached this life-threatening decision (without regard for the lives of children) after Purdue Pharma "supported an indication for patients 11 to 16 years old and provided prescribers with helpful information about the use of OxyContin in pediatric patients."

On Friday morning, at 8:30 a.m. the FDA held an "Open Public Hearing" for anyone who had prior approval from the FDA to speak. On Thursday, there was no list of speakers for the open public hearing -- it was to be available on Friday morning. Impunity reared its ugly head and no there was not a list of speakers on Friday morning for the public hearing.

There were four individuals in total -- one from Purdue Pharma, the maker of OxyContin. It is not difficult to figure out how they felt about opioids being prescribed to pediatric patients as young as newborns and infant.

One speaker delivered a classic line to the FDA panel of "experts". It was "How can you get it so wrong?" The photo in this article shows the anger on the face of one of the FDA officials on hearing that question.

Could this mean the FDA has already made up its mind and the pharmaceutical industry will once again profit financially over human life?

I found it ironic that the FDA was set up to protect the American people from dangerous drugs and as I looked around a very large auditorium, I did not see an American flag displayed. After some time, I realized the flag was displayed -- in a corner with a door closed over it with just a piece of the flag showing. Speaks volumes.

Next year I predict, there will be more rock concerts, marches, 501 non-profit organizations formed as the death toll mounts -- only it will now be in the deaths and addiction of pediatric patients. Wake up America!

Next week conflict of interests in FDA Advisory Committee members and their experts.

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This was the public advertising of the hearing held on September 15 and 16 at the FDA's headquarters:

Advisory Committee Meeting: Anesthetic and Analgesic , the Drug Safety and Risk Management Advisory Committee, and the Pediatric Advisory Committee Date: September 15, 2016, 8:00 am to 5:00 pm Date: September 16, 2016, 8:00 am to 5:00 pm Location: FDA White Oak Campus – 10903 New Hampshire Ave, Silver Spring, MD. 20993 Agenda: The purpose of this public advisory committee meeting is to discuss the appropriate development plans for establishing the safety and efficacy of prescription opioid analgesics for pediatric patients, including obtaining pharmacokinetic data and the use of extrapolation.

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Steve Solomon October 16, 2016 1:53 pm (Pacific time)

Nothing shocks me anymore. Haddox from Purdue Pharma is still on the FDA's Executive Committee, Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Network. Mallinckrodt Pharmaceuticals is another drug pusher engaged in manufacturing many pharmaceuticals that have serious addictive potentials, including opioids, stimulants, anti-anxieties, etc. Most egregious is recently released XARTEMIS XR, an extended release form of oxycodone hydrochloride, as well as many extended release products in the hydromorphone hcl category. They also manufacture the opioid METHADONE, a drug marketed as a "treatment" for opioid addiction. However, the addictive potential of this drug is such that they include the following warning: "Methadone hydrochloride tablets expose patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death". At the very minimum, I believe the director of the "Division of Anesthesia, Analgesia, and Addiction Products" of the FDA should be rotated annually and ALL extended release opioids should be banned. Great work...Marianne.


Kathy Huffman October 2, 2016 7:24 am (Pacific time)

You are such an inspiration to everyone! How can we assist you in your fight against the DEA? There are hundreds of thousands currently fighting the DEA's unjust ban on Kratom. My daughter successfully withdrew off of all harmful opiates and narcotics safley with Kratom.With this war on opoids we need to keep Kratom legal for all Americans. There is a huge audience now,fully awakened to the harm caused by the FDA,HHS,FDA any many other corrupt agencies.Let us join together and save ourselves.

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