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Thursday, October 31, 2013

FDA Approves the New, Most Powerful Hydrocodone -- $Zohydro$

Even though a panel of experts assembled by the U.S. Food and Drug Administration (FDA) voted 11-2 against recommending approval of the painkiller Zohydro ER in December of 2012, the FDA went against the advice of their own monitors and approved the highly controversial drug Zohydro ER.
Zohydro contains the opioid hydrocodone.  Hydrocodone is the most frequently prescribed opiate, with more than 139 million prescriptions for hydrocodone-containing products in 2010.

Zohydro is the first pure hydrocodone drug sold in America -- a stronger form of hydrocodone because unlike some hydrocodone products such as Vicodin, it does not contain acetaminophen. In fact, Zohydro contains up to 10 times the amount of hydrocodone as Vicodin.

The United States is fighting a prescription drug health epidemic. Already, there are 23.5 million people in the United States who use hydrocodone for nonmedical purposes, according to the data from National Survey on Drug Use and Health in 2009. The numbers will  most certainly rise when a pure form of hydrocodone is legally available. The release of this new painkiller assures Zohydro will be abused by people addicted to other opioids, including oxycodone.

One doctor agrees. Dr. Lewis Nelson, a professor in the department of emergency medicine in the division of medical toxicology at NYU School of Medicine, in New York City said,"This product was specifically turned down by the FDA Advisory Committee due to the risks of misuse, abuse, overdose and death, particularly given the limited data supporting the benefits of this medication for chronic pain."

Nelson said, "Other similar products already exist that come in safer formulations. The new [risk-limiting] requirements will have an undefined impact on the safety of this very dangerous medication. This is not necessarily an improvement in existing therapy and will likely result in increased use and increased cost to patients with chronic pain."

 ("FDA Approves New Hydrocodone Painkiller Zohydro ER." October 25, 2013) 

Follow the Blood and Money Trails

You ask, "Why would a responsible American governmental body do this?"

Well, in their "wisdom," FDA officials said they approved the powerful painkiller by imposing certain restrictions. The FDA claimed Zogenix, the San Diego based drug manufacturer that manufactures the product, had met narrow targets for safety and efficacy.

Zohydro ER is classed as a "Schedule II" medication subject to the same type of control for OxyContin, methadone, fentanyl, Adderall and Ritalin. These drugs are major substances of abuse, and facts prove they are continuing to addict people in overwhelming numbers.

Despite Zohydro's potential for abuse, the FDA approved it. Under the new approval, the drug maker will have to conduct ongoing studies of Zohydro ER to assess the known serious risks of misuse, abuse, increased sensitivity to pain, addiction, overdose and death associated with long-term use beyond 12 weeks. These studies will also be required for other extended-release/long-acting (ER/LA) painkillers, the FDA said.

(Staff report. "FDA Panel Votes Against Recommending Zohydro for Approval.". December 10, 2012)

The FDA is is an agency of the United States Department of Health and Human Services full of deceit and turmoil. The love of money -- BIG MONEY -- has permanent residence in its headquarters.

It’s not unheard of for the FDA to ignore a recommendation of an advisory committee. In July, 2012, the FDA approved a plan to address prescription drug abuse by unveiling a risk evaluation and mitigation strategy (REMS) that calls for the voluntary education of doctors in opioid prescribing. An expert panel had recommended that pain education be mandatory. The FDA ignored the advice. Pain education is not mandatory for prescribers of deadly opioids. 

And, guess what? BIG MONEY and exclusive rights were at stake with approving Zohydro. Shares of Zogenix lost over half their value the week after the FDA panel voted against approval of Zohydro. However, Zogenix Inc. rose the most ever on increased investor expectations of U.S. regulatory approval. Zogenix climbed 40 percent to $1.69 in February, 2013, after jumping 55 percent for the largest intraday increase since the company first sold shares to the public in November 2010.

Zogenix, whose $38 million in 2011 revenue came from its migraine medicine Sumavel, has been counting on Zohydro to increase sales.

Zohydro uses Alkermes Plc (ALKS:US)’s drug delivery technology to provide extended release of the painkiller. Zogenix and Alkermes, based in Dublin, agreed November 2, 2012, that Alkermes would be the exclusive manufacturer and supplier to Zogenix of Zohydro.

February 27, 2013)
Yet, citizens should demand the FDA clear their eyes of dollar signs when the health of millions is at stake.
A recent CBS News report stated:

“Oxycodone is now the most-abused medicine in the U.S., with hydrocodone second, according to the Drug Enforcement Administration. The latest drug studies come as more pharmaceutical companies are getting into the $10 billion-a-year legal market for powerful yet highly addictive opioid narcotics.”

Americans love the white medicine. "It's like the wild West," said Peter Jackson, co-founder of Advocates for the Reform of Prescription Opioids. "The whole supply-side system is set up to perpetuate this massive unloading of opioid narcotics on the American public."

"You've got a person on your product for life, and a doctor's got a patient who's never going to miss an appointment, because if they did and they didn't get their prescription, they would feel very sick," said Andrew Kolodny, president of Physicians for Responsible Opioid Prescribing. "It's a terrific business model, and that's what these companies want to get in on."

The U.S. consumes 99 percent of the world's hydrocodone and 83 percent of its oxycodone, according to a 2008 study by the International Narcotics Control Board, CBS News added.

(Dave Masko. "Super Painkiller Zohydro Feared to be 2012's New Addiction."
med December 27, 2011)

Federal agencies that ignore recommendations from within; Big Pharma executives that have financial priorities; drug lobbyists that whisper into the ears of greedy politicians -- all of this presently exists in a nation that has sold its soul to pain relief, no matter the cost of human lives. 
The system is out of control causing a Brave New World of dependents who demand to be pain free. The FDA, Big Pharma, politicians "on the take," rogue doctors and pharmacists, and illegal drug dealers are more than happy to oblige. Welcome to Prescription Nation.
Due to Zohydro painkillers, I believe suffering will increase. Zohydro comes with its own painful realities.
Zohydro is here, and despite efforts to control it, I predict the following:
Hospitals will lose incredible amounts of money treating Zohydro overdose patients. 
* Abusers will rob pharmacies while injuring and killing their staffs to get the new prescription medication. 
* Thousands (millions?) of legitimate pain patients will become addicted to the powerful prescription painkiller Zohydro, in addition to the thousands (millions?) more who will abuse them illegally.
* Drug rehabilitation centers, already overcrowded, will be unable to treat increasing  numbers of individuals who become addicted to Zohydro painkillers.
* FDA officials will gain more and more confidence that "money talks" and become the "gods" that gladly grasp blood money and open the gates ever wider to the killing fields of prescription drug abuse.

* The societal gap between the perceived "throw-away's" of society and the "good people" will increase as more addiction ravages the poor and needy.
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