>> Friday, March 28, 2014
I was linked to this, but I did NOT expound upon it at the time:
"Two members of the FDA’s controlled substance staff warned about the potential for abuse in materials presented to the advisory committee. “If approved and marketed, Zohydro ER will be abused, possibly at a rate greater than that of currently available hydrocodone combination products,” wrote medical officer Lori Love, MD, PhD, and pharmacologist James Tolliver, PhD."
But at least the makers are trying to make it harder to abuse (read that sarcastically):
"The company is also taking other actions to lower the risk of abuse, according to a statement supplied by Normart. These include locking pill bottle caps and an external “safe-use board” made up of experts in abuse, misuse, and diversion."
"According to the FDA-approved labeling, Zohydro is "for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternate treatment options are inadequate.” The manufacturer can’t market it for other uses, but doctors are free to prescribe it to any patient they deem appropriate."
Then I read the FDA's press release about it:
In their own press release, the FDA admits that complete safety testing is not in place but:
"The FDA is requiring postmarketing studies of Zohydro ER to assess the known serious risks of misuse, abuse, increased sensitivity to pain (hyperalgesia), addiction, overdose, and death associated with long term use beyond 12 weeks. These studies will also be required for other ER/LA opioid analgesics."
POSTMARKETING studies! Surely I read that wrong. According to so many opponents, the FDA never allows ANYTHING in this day and age, onto the market without complete studies. Huh. Curious.
But, the most frustrating thing in the first article, and only because we had heard over and over again about the safety of the CBD oil we want to try with Bug, is this exceptional statement:
"I firmly believe that the benefits of this product outweigh its risks," the FDA’s Bob Rappaport, MD, wrote in the summary review explaining why he approved Zohydro last October. Rappaport is director of the FDA's Division of Anesthesia, Analgesia, and Addiction Products. "Many patients in the U.S. suffer from untreated or poorly treated chronic pain. Further limiting access to potential treatments is not the answer when new treatments are critically needed.”
I once spoke about weighing the benefits and the risks whenever we give Bug a new medication. I explained that NO medications are harmless, even ibuprofen can be deadly. But there is NO such thing when it comes to this oil. Even if we look at its more psychoactive cousin, we see; a lack of motivation, psychosis in later life, and a few other side effects that DON'T SAY DEATH in the description. But this oil, this extract does NOT have that compound in it in abundance.
In fact, it has so little in it, one Doctor Representative said: 'That's trace! You can get more by brushing against it. I have no problem with this'. He then did a 180 in session and asked us to limit this to 'prevent' abuse. So...we are worried about abuse now? We saw him talking to members of the SMART Coalition of Utah County.
This same Coalition is now claiming to OWN HB105. Own as in: They made the changes to ensure that ONLY people with intractable epilepsy can have it. THEY made the changes to ensure that it has quantifiable and measurable standards (even though the Oil Manufacturers ALREADY DO THAT). They claim that THEY forced us to compromise to keep people safe from this dangerous oil...this oil that is SAFER THAN IBUPROFEN.
Why this rant? Because while they were spending ALL of their resources on this extract bill, while they were calling in people from outside of Utah to do presentations about houses being blown up while people are extracting from marijuana, while they were parading Gallup Poll's as legitimate research, while they were saying: Sorry about your children but we have to think about the children (NOT an exaggeration) they did NOT ONCE post about or take a stand against Zohydro.
NOT once and still haven't.Numerous Doctors have called for the FDA to pull Zohydro, but the SMART Coalition....didn't.
So I ask you: were we the best use of the 100K they get annually from the Federal Government: Trying to keep an oil with NO side effects from people? Or should they MAYBE have read about Zohydro and taken a stance on THAT.