How does a pharmaceutical company continue to release on the market medications that are not only highly addictive, but also dangerous?
They do it with some help from the FDA.
In December of 2012, the FDA voted 11 to 2 to reject the approval of Zohydro for use in the general population. Such vote came after the FDA reviewed Zohydro's medical trials and results and decided it was too dangerous and too addictive.
The drug maker, Zogenix, had been criticized for not placing enough emphasis on safety and efficacy.
Now, we need a little history to put this in perspective. In the past decade, a new wave of addiction was generated by the very common use of Vycodin and Oxycontin. The use of such drugs is believed to be implicated in the new surge in numbers of addicted people who have adopted heroin or other drugs as a substitute for the opiates.
The reason for the adoption of the lethal street opiate derivative, heroin, is that it became a consequence of a clampdown on the use of Vycodin and Oxycontin, by the Drug Enforcement Agency, which ordered the pharmaceutical companies to make the pills uncrushable, so that people would not pulverize them and inject them or snort them. Many of the deaths caused by Vycodin and Oxycontin use was due to this practice. However, it was a little too late. By then, the indiscriminate and many times, illegal, practice of prescribing Vycodin and Oxycontin so freely, had already created a very large number of addicts.
The fact that Vycodin and Oxycontin are highly addictive and that their use should not have been so pervasive and widespread, has been the subject of many articles and interviews.
When the pharmaceutical companies bowed to the DEA's request to make the pills uncrushable following the large number of deaths caused by the medications, pill mills were finally challenged. It is interesting to note, that the pharmaceutical companies changed the formulation of the drug only because the DEA asked them to, whereas no state where prescription laws were lax passed new legislation that made the prescription of the drug more difficult. Profits from the sale of the two opiates were enormous.
Two years after the change in the formulation of uncrushable Vycodin and Oxycontin, Zogenix submits papers to have Zohydro approved.
Let's examine Zohydro for a moment.
Zohydro is a combination of hydrocodone, the opiate in Vycodin, and Acetaminophen. Its potency is so high, that taking only two pills can kill an adult, and the mistaken assumption of one pill by a child causes death.
And there's one more thing: the pills are easily crushable.
So the FDA rightly declined to approve the drug. That's where the story should have ended, but it didn't.
The FDA, after appeal by the pharmaceutical company, reconsidered the application for the use of Zohydro and reversed its own decision, approving sale of the drug in the winter of last year.
Although the drug is now approved for use for patients that have extreme pain, and who are incapacitated or in long term care, and with prescription laws lax in some states - and plenty of shady doctors who were involved in pill mills before who could soon resume their lucrative business - the potential for abuse and death could be disatrous.
The problem with Zohydro is that it is a pure formulation of hydrocodone, and it is 10 times more powerful than its old incarnation, Vycodin.
Fortunately, there is now a discreet groundswell against the introduction of this new drug to market. A coalition of addiction, medical care and consumer advocate groups has submitted papers to the FDA asking it to reconsider its decision.
We are, as we speak, in the middle of one of the worst surges in drug addiction numbers of the past quarter century. It is not a secret that it was, and is, fueled by the overprescription and illegal prescription of opioids.
Why then, is this medication coming to market? Is there really a need for this medication even if is intended, to hear the pharmaceutical voices, only for a handful of terminal or critically ill patients?
The issue of course, is how many people will die from this drug. The answer should not be long in coming. The death potential of this drug is unprecedented. In the words of a doctor who heads an advocacy group, Physicians for Responsible Opioid Prescribing, the introduction of the drug "will kill people as soon as it's released."
In December alone, 29 state attorney generals have sent letters pleading with the FDA to reconsider. Even Congress has asked to review the decision.
But let's examine for a moment the FDA process. The process of examination of the drug trial results and other pertinent facts, prompted an 11 to 2 vote against approval of the drug. The decision at the time was done by the lower tier examiners and officials at the FDA.
The re-evaluation of the drug and its approval, were instead mandated by the upper tier of the Agency's officials. The reversal of the decision, therefore, was not a further examinaton by the people who are entrusted with the process and are qualified to reject or approve, but from higher ranking officials in the agency.
The CDC reports that in 1999, before the Oxycontin prescription boom, about 4,030 people died in that year from opioid abuse. That number had skyrocketed to 16,651 fatalities by 2010. That yearly figure is extremely high. Anyone who doubts that, should take a look at the statistics on mortality by the US government agency, and compare them, let's say, with deaths from automobile accidents.
The president of Zogenix, the producer of Zohydro, Dr Brad Galer, has retorted to criticism with: "We do not expect the introduction of Zohydro ER, to increase the overall use of opioids."
But there's a slight kink in his theory: many states have done nothing to pass legislation to curb prescription drug abuse. In this link, http://healthyamericans.org/report/109/reports/drugabuse2013 , there is a fair amount of information on the subject.
To boot, in Zogenix's own petition for approval, the so called stringent use guidelines clearly go out the window. A sample of the wording in the petition reveals that contrary to the company's assertion that the drug would be prescribed to an extremely narrow section of the population, the drug would be instead available to people such a "46 year old male with chronic back and leg pain....., a 52 year old female with metastatic breast cancer, and 32 year old woman with multiple orthopedic fractures."
However, in the past, Oxycontin and Vycodin were doled out freely for minor back pain, fibromyalgia - a condition that does not even have a clear diagnosis of cause - arthritis and countless other non critical conditions.
Even though the FDA said that it is proposing to move the new drug Zohydro from a schedule III drug to a schedule II, which has much more stringent dispensation requirements, there are many states where such classification has not stopped the prescription of addictive drugs, and the illegal prescription of the same.
Although labeling has been proposed to include stern warnings on the drug's potential problems and ill effects, unless the drug is made non crushable and issued for extremelay limited use, there is no reason the drug would not contribute to the already dire opioid addiction epidemic.
There is also no reason to believe that a pharmaceutical company would create a drug of such potency, spend a lot of money to bring it to fruition, and then only limit its use so narrowly that it defied the potential for recapturing R&D expenses. Such an effort could be justified for a drug to treat a very rare disease, but not pain. However, if the pharmaceutical company and the FDA and other parties clamp down tight on this drug, there might be the possibility that it will not contribute to further addiction problems.
But the question remains : Why? Why create such a lethal drug, when there are so many other alternatives already avaialable on the market for the treatment of pain? Why put on the market a prescription that if used in a household could so easily cause the death of a child? Why put out a drug with such potential in a crushable, extended release form?
Sources : The Chart/ Healthy Americans/Drug Free/CNN/FDA/NPR: 2.26.14