It’s official: the FDA saw fit to get Zohydro approved. As we have shared before, Zohydro is an opiate painkiller based on hydrocodone, except the vast majority (of not bribed) experts agree this is an awful decision.
Approximately 40 healthcare, consumer, and addiction treatment organizations are urging the FDA to reconsider their approval for the drug, which is set to be available in pharmacies as of March.
The primary argument for reconsidering, according to these groups, is that the number of prescription opiate deaths has skyrocketed, and the need for yet another that serves roughly the same function is of minimal use versus the problems it causes.
One doctor and president of Physicians for Responsible Opiate Prescribing said, “It will kill people as soon as it hits the streets.”
That is in addition to the 29 state attorneys general who petitioned the FDA to reconsider their decision in December, as well as the members of Congress who petitioned the same position back in November.
In as little as 11 years, the death rate from prescription opiates more than quadrupled, according to the CDC.
“[Zohydro] is somewhere in the neighborhood of five times more potent than what we are dealing with now…I’m five times more concerned, based solely on potency,” said one ER doctor not associated with the latest wave of petitions.
Although the makers claim the drug will be given only to a select few groups that would require such a medication, most experts acknowledge that the scope of patients will expand to other groups, just as previous prescription opioids have in the past.
Part of that is because the drug companies have to recoup the loses incurred in the development and testing phases of releasing a new drug to market. Ultimately they have to make more than it costs, and the costs are astronomically high.
In fact, it seems the only organizations in favor of this new drug going to market are the makers and the organizations they directly fund.
So, why is the FDA going ahead with approval of this medication when so many qualified groups and individuals are saying it is a horrible idea that flies in the face of everything the FDA is supposed to embody?
That is a very good question. It seems the FDA is even aware of this danger, claiming back in October that they “… ha[ve] become increasingly concerned about the abuse and misuse of opioid products, which have sadly reached epidemic proportions in certain parts of the United States,” including a recommendation to reclassify hydrocodone (the sole ingredient of Zohydro) from the current Schedule III drug to the more stringent Schedule II.
So, we have a regulatory agency, tasked with keeping consumers safe, acknowledging an epidemic in opioid deaths and recommending stricter regulations, being petitioned by doctors, treatment centers, attorney generals, Congressmen, and other healthcare groups; and said agency goes in the exact opposite direction of all these groups and their own recommendations to approve a new dangerous pain pill which already contain the same active ingredient at lower, less dangerous levels for the exact same purpose.
Do you think the FDA made a mistake getting Zohydro approved? What do you think is motivating the FDA? Let us know in the comments below!