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SKEPTOID BLOG:

The FDA is Pushing a Big Pharma Agenda to Get Our Kids High

by Eric Hall

August 22, 2015

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Donate Outrage media is a big contributor to thescientific illiteracyof the general public. While it is true scientists have to do a better job of communicating science, the media needs to do a better job of balancing views and clicks with being intellectually honest.

One of my recent outrage-generating discoveries was a site calledTheAnti-Media. Giving the appearance of going against the grain or shunning the authority of "the mainstream" or the government is cool, so right there they can generate clicks. A recent article titled "The FDA Just Approved OxyContin to Be Prescribed to Children" talks about the outrage of "over-medicating" children and how dare the FDA give the OK for this, but yet limit access to marijuana. I won't go into the marijuana dichotomy in this post, but for more on that you can look at other posts on Skeptoid,such as this one by Stephen Propatier,andone I recently wrote.

Some people who linked the article on social media called the move "outrageous," "child abuse," made comments as to this is why the world is getting worse or simply asked, "Seriously?" The problem is they failed to understand the context under which this FDA guidance was released. It was actually done to provide doctors more guidance on when to use OxyContin and at what doses.

Before I discuss what the FDA did, let me pre-address some comments here. Yes, the FDA isn't perfect and has problems. The FDA could do a better job of communicating information. Yes, it is possible there are some corrupt people in the FDA, like in any organization. It doesn't mean everyone in the FDA is out to shill or to make money at the expense of the life and health of other people. I will not address conspiracy nonsense.

The FDA is working on providing better public communications on their decisions. One way they are doing this is throughCenter for Drug Evaluation and Research (CDER) conversations. They did one of these conversations with Dr. Sharon Hertz, M.D., the FDA's Director of the Division of Anesthesia, Analgesia, and Addiction Products,under the CDER. Her conversation concernedthe research in pediatric use of opioid medicines.

Dr. Hertz starts the conversation with this statement:
Thankfully, not many children experience the types of cancer pain, extensive trauma or surgeries that require long-term pain management. However, few pain management products have specific information in their label about their safety and effectiveness in pediatric patients. This even includes several new pain medications that have been approved for use in adults. To manage pain in pediatric patients, physicians often have to rely on their own experience to interpret and translate adult data into dosing information for pediatric patients.
In other words, OxyContin isn't being studied as medicine for kids to treat aches and pains. It is already being used to treat children with severe pain, such as caused by severe accidents, cancer, or major surgery for birth defects. And the FDA is attempting to understand more about dosage for children in order to make its use as a palliative safer and more effective. To not attempt to manage that level of pain, in my opinion, would be where the child abuse case could be made.

The outrage article then goes through the usual dance of pointing out opiate deaths while pointing out the lack of deaths with marijuana use. It feels like because the author sees marijuana as cool, he would much rather give the kids an uncontrolled dose from a joint than a more carefully monitored dose as prescribed by a doctor. I pointed out in some comments on social media that while I agree the FDA should look into the marijuana-deriveddrugs to add to doctors' pain-management toolbox, it doesn't meanmarijuana poses no risks. The popular marijuana oils have as many as 200 active compounds, and the dosing is not as exact. There arestudieswhichpoint outsomepotential harms, especially in teenage patients.

TheAnti-Mediapost has a sub-title asking, "Are we the only ones who think prescribing OxyContin to 11-year-olds is a bad idea?" Way to fire up the minions! Give the kids pot, not real medical advice! They use this question to lead to a conspiratorialtone of the FDA simply wanting to give more business to "big pharma." When Dr. Hertz was asked about the motivation for the FDA's action, she said:
First, I must stress that this program was not intended to expand or otherwise change the pattern of use of extended-release opioids in pediatric patients.Prior to this action, doctors had to rely on adult clinical data to shape their decision-making in treating pediatric patients. This program was intended to fill a knowledge gap and provide experienced health care practitioners with the specific information they need to use OxyContin safely in pediatric patients.
TheAnti-Mediapost gets worse as, towards the end, they basically recommend usingpsychedelic mushrooms to treat pain, rather thanprescribed medicine, applying thenaturalistic fallacyto justify such use.

It is awesome to see how medical experts are getting better at making decisions on gathering data and looking for what's best for patients. While we should all make sure tobe as informed as possiblebefore making medical decisions, we shouldn't be outraged when evidence doesn't fit our personal narrative. Instead, we should be happy there is now more guidance on how to help kids who already have things pretty tough.

by Eric Hall

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