An insider from the world of civil liberties defense through pro-bono legal activism offers his opinions;
On October 6th, the United States Department of Justice, through its arm of the Drug Enforcement Agency will take a major step in what it considers to be its war on drugs. The US Government is viewed, publically and privately, as the loser in this century-old war. This time, the DOJ has finally fired a shot that contains a lethal payload. Though other major regulatory pharmaceutical changes have seen adoption in the years gone by, we have rarely seen one that will have this immediate, negative effect. I am referring to the rescheduling of Hydrocodone Combination Products (HCP’s) from a class III medication to a class II medication.
For those unaware of the nuances of the chemicals and their effects that I will discuss, just substitute “Vicodin” in your mind when you see the term HCP. I am comfortable in assuming that all readers who frequent this website have an idea of what Vicodin-type products are all about. I am neither qualified nor interested in trying to present a scientific argument here. A simple internet search can answer most of your questions.
Further, for an in depth presentation of the new rules as well as DEA responses from content presented during the Discussion Period, please visit this link.
A quick summary in non-technical language:
The DEA has moved Vicodin from a class of drugs that were relatively easily to prescribe to patients suffering mild to moderate pain. Professionals ranging from Dentists, Pas, Nurse Practitioners and LTC Registered Nurses have been able to facilitate the dispensing of these products with relative ease. This has resulted in millions of patients getting relief from acute and chronic pain without having to turn to Schedule II formulations that include oxycontin – often dubbed “Hillbilly Heroin”. Rightfully so, products like oxycontin have been Class II (CII) because of the potential for abuse and injury. To put a different perspective on this, Cocaine is also a CII drug. Therefore, the same medication your dentist gave you after that root canal now legally falls under the same governance as Cocaine. The red tape and requirements to procure this prescription for your tooth pain are now equal to the absolute strongest, LEGAL, narcotics known to man.
Are you starting to see some problems here? If not, read on:
The requirements to prescribe and dispense CII drugs are deeply restrictive. On the morning of the fast approaching October 6th, masses of heath care professionals and pharmaceutical employees will no longer be allowed involvement in the delivery of HCP’s. Doctors and nurses will no longer be able to call your pharmacy to prescribe or refill HCP’s. Qualified Doctor’s staff will no longer be able to e-file these prescriptions. HCP’s will require hand written prescriptions with the Doctor’s signature for every prescription filled. The “refills allowed” spot on the bottom of the prescription will always be zero after October 6th. Patients will need to be seen by their Doctor every 30 days (no telemed, phone calls etc) if they need another month of Vicodin.
Many readers at this point probably think this is not such a bad thing, and maybe it is a very good thing! After all, we know there are many people addicted to HCP’s and the goal here is to break that addiction since using HCP’s is illegal without being under medical care. However, an in-depth look at the consequences of this regulation needs examination before one can responsibly declare this a good OR bad thing. We need to discuss this as a nation if we are concerned with personal liberty. Instead of discussion, we are seeing the dismissal of this regulatory change as a non-event. The right sees it as a positive step that will have no deleterious effect on their lives. More frightening, there is dismissal occurring by a supposedly educated group of libertarians that also are users or addicts of HCP’s. Many in this group have declared this an “uneventful enactment” of regulation.
There is an interesting thread I stumbled across on a Reddit sub forum dealing with Internet black-markets catering in illicit drug sales. It is authored titled “Hydrocodone getting rescheduled- How will it effect us?”
Of particular interest to me was the comment of one of the subreddit Moderators, an admitted HCP user:
… “It is unlikely to really make any difference
Norco being bumped up one level puts it in the same category as Percocet. The differences are small –” …
Actually, despite the Ostrich reasoning of head in sand as displayed by similar users, the reality is that the differences are enormous. While I have no idea how much it will affect black market pricing, I suspect it will have an enormous effect on the streets so I suspect the darkmarket issues to be identical.
Ironically, the adverse effects will occur mostly due to another point made in the same post where the Moderator is arguing the relevance of the change is nothing of concern. This same moderator goes on to say:
… “refills aren’t allowed to be written on the original script, and it will require a paper script handed to the pharmacist in states that currently allow for e-script or call-in for schedule III-IV meds.” …
This statement is fact. However, as opposed to supportive evidence that the change will be “no big deal”, this statement is the key that, on October 6th, will open Pandora’s Box.
This requirement of level two scheduling is what will drive street prices through the roof. Low demand and higher prices will be the impetus to this entire crisis.
The reason that oxycodone is priced exponentially higher than HCPs is not because of a correlative relationship to potency. It is because of the extreme difficulty in obtaining legitimate Rx quantities of oxycodone resulting from the C2 requirements that eliminate:
- Patients commonly walking in with prescriptions for Norco x 120 with three refills
- Most telemed Rx
- Virtually all ease of obtaining fraudulent paper that will work.
- Many pill-mill type operations and practices that do not want to face the increased felony levels associated with S2 vs. S3.
I would expect that the street prices would rise to nearly the level of all oxycodone products that are not tamper-proof. It is a big possibility that prices will rise to the very same levels as oxycodone and hydrpmorphone (Dilaudid e.g.). Some very educated minds also predict that both oxycodone and HCP’s will steadily rise simply because there is “no other game in town”. That creates monopolies just like the old Ma Bell phone companies. People would pay whatever the highest the market would bare because they were not willing to live without a phone. Sadly, the amount of people addicted on these substances who have already turned to the streets, will have similar price tolerance as those that were unwilling to give up their phone before deregulation.
We have many large issues we will soon face as a society. The Final Ruling causations and consequences are endless, but here are a few highlights:
- The 45-day effective period is completely unreasonable. Addicts will need more time to wean if they so choose, and patients getting Rx’s with 3 refills currently will need time to adjust to the monthly office visit requirement. This is an unfair burden to millions of HCP users.
- Because of (1) above, many street addicts that may have tried to wean faced with a more reasonable effective date, will instead turn to criminal acts to continue to feed their addiction. Some will be white-collar types that were able to satisfy their needs through the money they earned in their legitimate jobs. Those paychecks will no longer cover their habit. This could create a million+ felons that would have gone through their lives without ever committing a crime because they were always able to work as a means to pay for their habit.
- At the same time, those that society does not consider the most well behaved citizens, that were scoring HCP’s on the street funded by petty crime, will now have to move from misdemeanors and on to felonies. Since they will require exponentially higher funding, this is nearly inevitable. Many of us involved with crime and punishment are certain that these felonies will naturally include murders and aggravated assaults. This means it is not only the pain patients and those recreationally addicted to opiods affected by the Final Rule. Thousands of completely uninvolved, innocent citizens will now be in the path of peril. Put another way, the chance of your Granny being murdered for a Vicodin will no longer be statistically insignificant after October 6th.
- Hence, there will be the creation of a huge group of new victims that will correlate with the street price/mg. The higher it goes, the more Grannies die.
- Price increases are inevitable simply due to the extractor element – they need the base to make their more potent “brews”, and will absorb the increases. They will simply raise the prices on their final products already are priced in the stratosphere comparatively to their HCP counterpart, so increasing their prices will have less of a negative financial impact proportionally to their typical profits. In the extractor element, it is difficult to quantify the potential price pressures it will create, but discounting their effect is simply foolish. Even if considered only incremental in consequence, it is a certainty.
- Hundreds of thousands (maybe million+ ?, who knows?) pain patients will have to suffer horrible pain and/or opiate withdrawal sickness because the 45 day effective period does not leave nearly enough time for weaning according to the AMA. To decrease an HCP by 35%, a patient should wean for six or more months to do it safely and with dignity. Why the 35% you may ask? Easy, a patient that could not afford the costs of monthly visits will need to be on a commensurately 35% lower dose if their resources do not allow increased expenses in their lives. Do not be mistaken, the suffering population effected by inability to fulfill the monthly office visit requirements of S2’s is not your boardroom or country club user. It is your Granny. This creates disproportional suffering on the most fragile of our population.
- There will be a crisis in health care due to the rescheduling. Footnotes will reveal one day that this crisis was unnecessarily contrived since it will be the result of a government regulation and not the result of any “real” changes in the HCP situation. The burden this will placed on health care will be substantial and immediate. We are in a dire situation currently. Enactment of the AHCA has resulted in a critically significant shortage of health care workers trained at the PA level and above. As related to me by a D.O. friend who is also a provider,
“We can’t see all the patients now that need to be seen. There are not enough doctors and health care facilities in the US to satisfy the influx of new patients to general care. The rescheduling will require that millions of existing HCP users increase their appointment volume by 350%.
Those that can afford this frequency increase are going to be in for a massive shock when they call their PM center only to find out that they can no longer be accommodated. The rescheduling will force providers to cull up to 60% of their client base simply because there are not enough hours in a day. I do not think anyone did the math on this one. If they did, they get an F-!”
- The effective date leaves a woefully inadequate warning period for most of the patient pool. We need more time to educate all parties regarding the new requirements. Throughout the United States, at pharmacies, hospitals, treatment centers, and long-term care facilities face a critical need for more (highly) trained staff that extends beyond the shortages created by the ACA. For this regulation is to be implemented in a professional, safe manner, this staffing shortage cannot be ignored. The CII re-class represents a minimum, net-effective increase of 300% more patients. This will overwhelm all resources and capacity currently available. This is not only impossible to achieve in 45 days, but it is a dangerous game to play when handling the business of prescribing and filling powerful narcotics. Innocent people will be injured or killed due to staffing challenges.
- Sadly, especially with our government, Final Rule implementation is impossible to modify at this point. For every year it takes our fine regulators to impose a new regulation, it takes 4 years to UN-impose under the best of circumstances. As this crisis has not yet begun, there is no chance the DEA will realize the shortcomings of such a small effective window, much less be able to make corrective changes.
The only timely solution to avert this impending disaster would be an Act of Congress. I think most agree that would be a long shot even without being in an election cycle. Where does this leave us?
The sky is falling and this is not a drill!
We see this rare disaster straight in front of our faces. We have 45 days to avert this disaster, but the only people who can do anything have decided this disaster is but a tiny consequence of stamping out what they perceive to be a bigger problem. This rescheduling is yet another step backward in our fight to be free. The government has taken another huge step to regulate morality in the US. Mandates of this nature move us ever further from what the Framers intended. This regulatory rescheduling of a decades old classification is a farce. It is not based in sound health – in fact the consequences if the effect will result in the complete opposite. It is an overt assault of the Thought Police upon citizens least able to defend themselves.
This type assault closely follows the core tenets of the Stalin doctrine. It took sixty years and a guy with a massive birthmark on the top of his head to begin that unraveling. God help us if this type of governance is our future.
In fact, let me leave you with this thought that I could never possible convey as well as Justice Douglas did Sixty years ago.
In a prescient statement, Douglas summed up what we have to lose. He was addressing the amendment that the Founders deemed to be first on the list. It is the key to this entire “freedom concept” our country was supposedly founded upon. It is this liberty that the new DEA ruling most threatens.
“[t]he time may come when no one can be sure whether his words are being recorded for use at some future time; when everyone will fear that his most secret thoughts are no longer his own, but belong to the Government; when the most confidential and intimate conversations are always open to eager, prying ears.
When that time comes, privacy, and with it liberty, will be gone.
If a man’s privacy can be invaded at will, who can say he is free? If his every word is taken down and evaluated, or if he is afraid every word may be, who can say he enjoys freedom of speech? If his every association is known and recorded, if the conversations with his associates are purloined, who can say he enjoys freedom of association?
When such conditions obtain, our citizens will be afraid to utter any but the safest and most orthodox thoughts; afraid to associate with any but the most acceptable people. Freedom as the Constitution envisages it will have vanished.”
But wait, I would never leave you with such a bleak outlook!
I have great news!!
There is no reason to get depressed or have any fears. There is a very happy ending for the opiate dependent willing to make the effort.
I fully expect lower trends in price, with higher trending availability and potency of heroin.
So, what’s the big deal anyways if the profits flow away from evil, Western Pharmaceutical and US companies into the hands of Asian and African poppy farmers??
Cash seeding for Afghans, Yemenis, and Libyans has never caused any problems in the past, right?
Sleep well, my friends. Your government is protecting you.
A brief review of the Federal Register posting:
reveals the following stipulation;
This rule is not a major rule as defined by section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act (CRA)). This rule will not result in: an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign based companies in domestic and export markets. However, pursuant to the CRA, the DEA has submitted a copy of this final rule to both Houses of Congress and to the Comptroller General.
The DEA’s contention is that the change is so insignificant that does not warrant the protections afforded by the Congressional Review Act. This invalidates my comment suggesting an Act of Congress is required to avert this impending situation. I suppose an Executive Order from the President would work. What are the chances that a President in a constant battle to disavow the stereotypes associated with his race would step in and invalidate a restrictive drug law? I think the chances are as close to absolute zero as one could imagine.