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FDA Approves Zohydro

Well, the FDA did it again. Imagine Brittney Spears singing "Oops I did it again" about now. They have approved a new pain killer with no abuse resistant features. The reason for doing so...profits for the manufacturer and protecting the patent. You see, since they approved the "no abuse resistant" medication, that patent is protected from generic producers. They will make billions in profits while drug abusers kill themselves by overdosing. Then, in about five to seven years, the "abuse resistant" version will be approved thereby extending the patent on the name brand preventing generics.

All of this is in the name of profits for the pharmaceuticals. You want to know why our health care in America is screwed...drug companies desire to get every dime out of us while endangering the public.

Just wait, it won't be long before you see stories in the media about this "horrible" drug killing people. The company will release the abuse resistant version and will be hailed as saving American's from the ugly side of abuse. Keep in mind when you do see this happen that the GOVERNMENT and the same company allowed it to happen...all for profits.

Several Epidurals, L4-S1 360 ALIF, Numerous Facet Joint Injections, RFA x2


  • Wow it's really unfortunate to see somebody attempt to make this argument yet again. Do you think the DEA or government as a whole is gaining significant financial benefits and are therefore approving this formulation to help big pharma when they federal government is responsible for the absurdly significant costs of Medicare, emergency services due to overdose, etc? Yes, the government approved the abuse deterrent oxycontin formulation in 2010, but nobody seems to be discussing the fact that at the same time they REFUSED to allow brand name opana to release it's new formula and prevent genetics from going onto the market. This is because the FDA thoroughly looks into the new formulation in clinical trials and the abuse deterrence factor was negligible. If anything, the gvt would LOVE genetics to be available so their reimbursement costs would be lower. Your argument is ignorant and doesn't take into account every aspect of the topic at hand.
  • The government is not gaining financially...but the politicians who run the government are getting PAC funding from the pharmaceutical companies and they are gaining financially. Follow the money. Are you asserting that the DEA has anything to do with the approval process for a medication?

    Your assertion that the government would love "genetics" so their reimbursement rates would be lower is axiomatically incorrect as well. Your comment would only be valid if you were talking about government sponsored insurance. Since most people...or should I say it used to be that most people who had their own insurance doesn't rely on the government to cover their costs for prescriptions. I also feel pretty certain that the Office of Medicare under Health and Human Services doesn't consult with the FDA regarding drug costs in the approval process.

    By the way, if you think the FDA looks thoroughly into medications you would be most incorrect. If they spent time actually researching medications, then black box warnings wouldn't come out six months after they approve a medication.

    You seem a little on edge midnight11. It's not nice to call someone's thought's ignorant. We all have opinions, good or bad. Here is a lesson for you...when you spew hate you're only highlighting your own frailties.
    Several Epidurals, L4-S1 360 ALIF, Numerous Facet Joint Injections, RFA x2
  • midnight11mmidnight11 Posts: 8
    edited 11/15/2013 - 1:48 PM
    I'm not trying to say your opinion is ignorant itself, so I apologize if you read it that way. I am stating that all of these topics which can easily end up being repeated due to the current trend in doubting the duality between financial benefits alongside positive health care. I actually am stating that the DEA has a role in the approval process for CII meds given that the DEA determines how much active ingredient a manufacturer can receive a year for controlled subs. Also, in regard to the approval for reformulation, the FDA is forcing pharma companies to prove through much more extensive trials than those the medication originally submitted to be approved in order to demonstrate an actual significant reduction in the ability for the medication to be abused. Considering how much money was spend on the Opana reformulation, I don't think you can really argue that financial benefits to politicians are just going to result in any medication peddled as safer to be approved. The makers of Opana were made to look foolish next to OxyContins Purdue after they received the patent extension for their reformulation. Honestly, if we were talking about statins, I would agree that financial incentives and political influence are important to look at more closely. However, take a look at the company that developed Zohydro - they are a TINY company that has no blockbuster drug in their products and therefore I am doubtful they can really afford to influence politics at the level you're insinuating.
  • Its all about the money. And the politicians will be after it! . The FDA is government run....that alone should tell u of their ethics. And efficiency.
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