From Addiction to Zohydro

moneypharmaAddiction is a very serious and common problem in the United States, whether it relates to drugs, alcohol, or even trivial activities such as watching T.V or playing video games. Among these addictions listed, drug addiction continues to be one of the nation’s top concerns. Drug addiction is so prevalent in today’s society that everyone is bound to know someone, or at least know of someone with an addiction during his or her life. Addiction can have detrimental, often even fatal effects on the people who fall victim to its disastrous consequences and families are left to grieve in their absence.

Although a handful of healthcare professionals think the newest painkiller Zohydro will greatly improve the lives of chronic pain patients, a significantly larger amount of doctors along with advocacy groups firmly believe that the new drug will increase addiction rates. As a concerned citizen and someone who has witnessed a friend fall into the downward spiral into addiction, I believe that the release of Zohydro will increase the addiction rate, which will cause an increase to the death rate from drug abuse in America.

According to the National Institute on Drug Abuse (NIDA), the number of prescription medication abusers in 2010 was 8.76 million. Among the top three most abused prescription drugs in this category, painkillers ranked number one with 5.1 million users, followed by tranquilizers and stimulants. What’s even more staggering is that in a study conducted in 2012, an estimated 23.9 million Americans aged 12 or older had used an illicit drug or abused a psychotherapeutic medication (such as pain reliever, tranquilizer, or stimulant) in the past month. With the overwhelming increase of prescription drug abuse in a mere two years, it seems foolish and irresponsible that the FDA approved Zohydro for public use, yet it has been released to pharmaceutical companies over the last few weeks.

Founder and president of the U.S Pain Foundation, Paul Gileno, believes Zohydro’s release will not affect the addiction rates in the country despite its past with prescription medication abuse. “A person with pain is not a person who abuses medication,” Gileno stated during an interview with CNN. Gileno continued with saying, “A person with pain is a person suffering to get pain relief in order to live a fulfilling life.” While petitioning for the FDA’s approval last year, Zogenix representatives listed examples of patients who could benefit from Zohydro: “a 46-year old male with chronic back and leg pain who had two failed surgeries; a 52-year-old female with metastatic breast cancer experiencing diffuse pain; and a 32-year-old woman with multiple orthopedic fractures.” While many of these cases is reality for some people, healthcare professionals refuted that even chronic pain patients like these will develop a tolerance from the medication which could lead to an addiction. Dr. Brad Galer, who is the executive vice president and chief medical officer of Zogenix, assures the public that the company will target sales of Zohydro to a “select group of physicians who have good experience prescribing prescription narcotics, so that only an appropriate group of patients in chronic pain get the drug.” Zogenix claims that it “is committed to promoting the appropriate use of Zohydro through a comprehensive suite of voluntary initiatives, which include integrated educational resources for patients, prescribers and pharmacists, surveillance programs to identify misuse, abuse and diversion.” The statement also noted the risks of addiction, overdosing and death in the prescribing of the drug.

With the approval and release of Zohydro into America’s pharmacies, and in an effort to combat “misuse and abuse,” the FDA proposed new restrictions that would change regulations on opioids. Currently combination painkillers such as Vicodin and Percocet are listed as Schedule III drugs, and if this reclassification proposal is accepted, they will be labeled as Schedule II. This re-classifying would mean that patients would have to obtain a written prescription from a medical professional, rather than a prescription via telephone, to access the drugs. Refills would also be prohibited; patients would have to check in with the doctor to get another prescription. If the Drug Enforcement Administration approves the proposal, the FDA hopes that future drugs will be “properly prescribed and appropriately used by the patients who need them the most.” Zohydro is already classified as a Schedule II drug, another reason both the FDA and Zogenix are confident it will not contribute to the broader overdose problem. However drugs already classified as Schedule II, such as Adderall and Ritalin, are already prone to abuse among the population so the FDA’s proposed regulations might not necessarily eliminate the chance of misuse.

Despite the confidence the FDA and Zogenix have about Zohydro, one of the most controversial aspects of its approval is the fact that it is completely hydrocodone-based, making it much stronger than other painkillers. Painkillers such as Vicodin, Norco, and Lortab all contain additives such as aspirin and acetaminophen that not only can contribute to liver malfunction if consumed for a long period of time, but also they dilute the active ingredient of hydrocodone. Zohydro is said to be up to 10 times stronger than Vicodin, with its side effects lasting as long as 12 hours. This is a concern for the general public because it would be extremely easy for an accidental overdose to occur. Another issue the public has with Zohydro is that it is non-tamper resistant, unlike similar drugs in its class. Many of those opposed of the new drug believe that this will lead to crushing Zohydro into a powdered form, warranting users to either snort, smoke, or inject the drug into their system to obtain a quicker and more intense high. These ways of abusing the drug will increase the chances of addiction, overdose, and most certainly death.

According to Dr. Michael Carone, director of Public Citizen’s Health Research Group, “American has about 5 percent of the world’s population; we consume 99 percent of the world’s hydrocodone. That tells you that we have a problem managing the use of these drugs, that they’re over-prescribed by physicians and other health care providers… and part of this is driven by the pharmaceutical companies aggressively promoting their products through physicians.” In 2010, enough prescription painkillers were administered to medicate every American adult every 4 hours for 1 month according to the World Drug Report. This statistic along with Dr. Carone’s statement only feeds into the belief that Zohydro will definitely increase the addiction rate in the country since painkillers are easily accessible.

One of the most widespread drug addictions among the country is prescription pain medication, more specifically opioids. With this fact in mind, it causes one to wonder: Why would the Food and Drug Administration approve Zohydro, when U.S deaths from drug abuse have nearly tripled since 1990? What is even more interesting and controversial is the fact that the FDA approved Zohydro despite the 11-2 vote against its release by the FDA’s own scientific advisory panel. It makes one wonder whether there is something larger between the pharmaceutical companies and the FDA. With Zohydro available as a prescription medication, despite the regulations that will come with it, there is no doubt in my mind that it will lead to increased addiction rates. The rise in addiction could lead to more deaths across the nation and the FDA will have to face the horrible truth that the healthcare professionals and advocacy groups, who were in opposition to Zohydro’s release, were right the entire time. Will Zohydro’s benefits truly outweigh its deadly risks?







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