FDA spokesperson Karen Riley stated to the press:

” … regulators are expected to take as long as six months to consider the repercussions for patients, said spokeswoman Karen Riley.”

and

“Changing dosing recommendations on Tylenol would take years, said the FDA’s Riley, and the agency is well aware of the concerns of people who rely on Percocet and Vicodin.”

and

“I think you’ll find that this will be a measured response you don’t want to have unintended consequences,” she said, adding that labeling changes would be an option that could happen relatively quickly.”

http://www.columbusdispatch.com/live/content/local_news/stories/2009/07/20/WHATNOW.ART_ART_07-20-09_A1_FHEHA9F.html?sid=101

“A new national media study among 589 physicians revealed that the majority of physicians (82%) do not believe that drugs containing acetaminophen should be pulled off the market.”
http://sev.prnewswire.com/null/20090720/NY4906620072009-1.html
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What you say regarding (Schedule II) oxycodone is true enough, indeed. Roxane does presently offer oxycodone (only), as does Purdue’s Oxycontin.

Nevertheless, in the case of hydrocodone, federal law requires that it (both) be: offered in a dosage less than 15mg; *and, as well* be combined along with some other medicinal agent, in order to fall under Schedule III (as opposed to Schedule II). See (DEA #9806) at:
http://www.usdoj.gov/dea/pubs/scheduling.html

With NSAIDs (other than acetaminophen) known to cause even more gastric disturbances and potential damage, it’s hard to imagine what might be substituted for acetaminophen as the “other medicinal agent”. Further, the FDA policy would require prolonged “efficacy studies” to be concluded before such a product could be supplied.

I concur with you that ethanol (well known to cause some liver cell damage upon ingestion in any dosage amount) has (and will continue) to cause far more physiological damages than any direct physiological impacts of opiate/opioid use. Yet, our society’s efforts in the early 20th century to prohibit it were not only ineffective – they were counterproductive and far more damaging, themselves (in terms of health, safety, criminal activity, etc.) …

Indeed, we live in a strange world of inverted values and sensibilities. Perhaps the United State’s (rather unique and demonstrably fruitless) efforts to allow the State to decide what competent adults ought – or ought not – ingest in the course of peaceful private activities is a failed agenda that (in the final analysis) benefits only the culture of “life-coaches”, medical “supervisors”, law enforcement agencies, and the (more and more privatized) prison system. Around one half of the (unparalleled in any other society) 2 million people incarcerated in the United States are in prison for drug crimes.

Again, I ask the question, “exactly *whose* best interests are being served here?” … And, is it those citizens who are (ostensibly, allegedly) said to be the rightful beneficiaries of such social policies (for whose benefit and safety those policies were – allegedly – instituted)?
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The funny thing is that Alcohol has destroyed more lives through addiction and killing people and nobody has done nothing to remove that from the market, this just continues to anger me so it is time to go

In my post directly above, I (individually) opined:

” … the actual analgesic effect of the (typically, 325mg or 500mg of) acetaminophen – relative to the net analgesic effect of (even the minimal cases of) 5mg dosages of the opiods hydrocodone and oxycodone – makes *little or no* objectively substantiated measurable difference, anyway!”

Where it comes to the effectiveness of such complexing (of acetaminophen with opioids) and *chronic* pain – sure enough (according to the FDA themselves):

” ANALGESIC EFFICACY IN CHRONIC PAIN

The analgesic effects of the opioid/APAP combination in patients with chronic pain have
been much less studied. There were no factorial design studies identified in the literature
to assess the analgesic superiority of opioid/APAP combination over the individual
components in any chronic pain patient population. Randomized controlled studies of
opioids for chronic pain in the literature mostly focus on opioid single-entity products
other than opioid/APAP combination and only a few studies included a treatment arm of
opioid/APAP combination products. Most of these studies were discussed in published
systematic reviews in 200426 and 200527 or meta-analyses in 200628 and 200729. However,
the evidence level from these studies to support opioids for management of chronic pain
is ‘Limited’, as concluded in the Opioid Guidelines in the Management of Chronic Non-
Cancer Pain1. ”

Source: from (PDF page 80 of 100) at:
http://www.regulations.gov/fdmspublic/ContentViewer?objectId=09000064809d138c&disposition=attachment&contentType=pdf

Although the (formal) “public comment period” is stated by the FDA (in the following document) to have ended:
http://www.fda.gov/AdvisoryCommittees/Calendar/ucm143083.htm

… it is (nevertheless, and for what it may be worth) possible to post (anonymously, as we prefer it in the less-than-benign “Theraputic State”) comments relating to this matter at the FDA’s (… moderated) “blogsite” at:
http://fdatransparencyblog.fda.gov/comment-policy.html

Here is the particular docket entry and identifier for this issue taken up in the FDA’s recent June 29-30, 2009 meetings surrounding these matters of acetaminophen:
http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&o=09000064809d138c

Your actual blog entry itself can be entered at:
http://www.regulations.gov/search/index.jsp

(At least) there exists (if the FDA blog-site moderator(s) don’t nix your comments) a vehicle by which your input can (still) be publicly stated in a manner that (might even) be read by agency officials. Who knows – someone somewhere *might* actually take your opinions, and your thoughts, seriously … one/we can dream, anyway …

Cutting to the chase in these matters – eliminating the acetaminophen content, (and allowing patients to self-administer OTC acetaminophen) sounds like a “no-brainer”) as such complexing appears more to be an emotional and moral artifact (as opposed to demonstrably necessary or significant in terms of evidence-based science), anyway. Let us not ignore the essential truth of the fact that such complexing with acetaminophen (in the case of the opioids hydrocodone and oxycodone) is largely unnecessary, and arises largely out of emotion and moral orthodoxies – rather than demonstrable reality.

In a (simple) world, the manufacturers could easily dump the acetaminophen from their products in a matter of days. It is not necessary as a stabilizing or preservative element in the formulation of the medications, period.

Alternatively (and more practically), the per-dosage amounts of acetaminophen complexed within the existing (Schedule III) hydrocodone products could easily be dramatically reduce, in order to address the (cumulative) acetaminophen hepatic toxicity concern. It makes little sense to allow OTC sales of acetaminophen (which should rightly continue), while “hand-wringing” about current opioid medications that contain relatively small amounts of acetaminophen, anyway.

The unspoken likely truth is that much of the hepatic toxicity of acetaminophen (very likely) arises out of it’s concomitant use with our society’s “poison of choice” (ethanol, to which we choose not to demonize, having – wisely – come to our senses as to the futility of it’s prohibition).

In the *real* world (as we suffer it’s juggernauts of bulbous, bureaucratic nightmares) – real and substantive potential harm of these actions exists in terms of the collateral damage arising out of legal (as in the controlled substance scheduling status of hydrocodone resultantly changing as a result from Schedule III to Schedule II), as well as bureaucratic imbroglios:

[1] As in *long and protracted* FDA procedures to be satisfied in order to bring such a hydrocodone (only) product to market – as none reportedly currently exist for human consumption), likely also resulting in higher costs being charged (to patients and institutions alike) by “big-pharma” for such newer products; and

[2] The “chilling effect” upon physicians (and patients alike), due to the political and reputational issues arising out of the frequency and volume with which a physician prescribes the (more) tabooed Schedule II medications; and

[3] The corresponding limitations and requirements surrounding the prescription/dispensing of Schedule II medications, such as: requirements of hard-copy paper prescriptions (as opposed verbal specification); and requirements of a maximum 30-day (as opposed to a 90-day) supply being dispensed by pharmacists at any one time; and restrictions on the ability for pharmacies to deliver such Schedule II medications via mail/delivery services, etc.

Prescribing physicians are in the unique position to well know the practical problems and barriers that such actions by the FDA would create (and speak up …!) – whereas the vast majority of affected patients are likely to only realize the downsides of such a “new regime” post-facto (and a lot of good that will do them, eh?).

How about the idea of physicians advocating the patients’ interests (not to mention our own interests where it comes to the ability to provide adequate pain relief using hydrocodone in the future), and speaking-up (to their Employers, pharmacy boards, and the almighty FDA) *before* (as opposed to after) such harm may occur?

And that’s the way it is, Friday, July 17, 2009 …
Goodnight Walter, Chet, and David, … and good luck!
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I watched one of the high-ranking FDA officials, when speaking publicly in an open meeting, make a “sublingual slip” when addressing the matter of the acetaminophen presently complexed together with (most of the) oxycodone and (reportedly all of the) hydrocodone analgesics, as an impact of the potential adoption of Proposal 5(b) in their June 29-30, 2009.

The FDA official was in the middle of such a related sentence when he said (something substantively equivalent in meaning to):

“… eliminating the opioids … … … excuse me, I meant to say, eliminating the acetaminophen … from …”.

In a separate video clip of the FDA post-decison press conference an FDA official confirms to the press that they have *not* (to that date) made *any* requests of the manufacturers of such opioid/acetaminophen analgesic products to volutarily “unbundle” the acetaminophen from the products. (That particular) FDA statement begins precisely 6 minutes into the video that can be viewed at:
http://www.youtube.com/watch?v=MDmBzHHsvbM

It begs the question whether the FDA’s potential actions under their “Option 5(b)” is an intentional way for them to ignore doing “with a scalpel” what they see a political opportunity to instead do “with a hammer”. The (effective) rescheduling of the potential implementation of “Option 5(b)” by the FDA – moving hydrocodone (from Schedule III as complexed with acetaminophen) to Schedule II (when administered on its own without such complexing) – has been previously identified, and commented upon within this same discussion thread.

Given that (hydrocodone only) products for human consumption reportedly do not presently exist on the pharmaceutical market, the time delays for even a (Schedule II) hydrocodone product to become available (in order to even be able to be prescribed) appear uncertain, and (by the FDA’s own written statements) potentially lengthly, complicated, and prohibitive).

Such a move on the part of the FDA would dramatically impact drug controls – without even having to persuade Congress to amend the Controlled Substances Act. And prescribing physicians know (better than most patients) that such an (effective) “rescheduling” would have detrimental consequences (for physicians and patients alike) where it come to prescribing/dispensing of opioid medications, adversely affecting the corresponding adequacy of pain treatment that those patients receive.

A *scientific* irony is that the actual analgesic effect of the (typically, 325mg or 500mg of) acetaminophen – relative to the net analgesic effect of (even the minimal cases of) 5mg dosages of the opiods hydrocodone and oxycodone – makes *little or no* objectively substantiated measurable difference, anyway! Please cite examples of published case studies if you disagree (where it comes to the moderate/severe levels of pain for which these opioids are indicated as a treatment).Thus, we must look to the realm of *emotion* (as opposed to demonstrable fact) for an explanation of “why?”.

As a result of the truth of the matter stated in the paragraph directly above, a *moral* irony is that this “complexing” (of acetaminophen within these products) has evolved and been sustained more out of a moral judgment using (phony) “numbers games” that exist far more as a “rhetorical placebo” than out of the result of demonstrable science-based reality.

Returning to the matter of scientific physiological findings where it comes to potential renal (in addition to hepatic) damages caused by the heavy daily usage of NSAIDs in patients. *Many* of those patients would not necessarily have to resort to such dangerously high NSAID dosing regimens were it not for the under-treatment by the medical profession of their moderate/severe chronic pain with opioids that arises out of the moral, political, legal, and reputational concerns and fears that physicians find themselves embroiled within as agents (of our own interests), of the State, and of our Employers.

Additionally, regimens that *combine* aspirin and acetaminophen (together, as well as when additionally combined with opiates/opioids) are widely suspected to be a significant factor in medication-caused renal damage.

The above tragic (and likely unnecessary) adverse impact – potentially contributing to a situation where roughly 1 in 7 adults are reported to be in some stage of chronic renal failure (CRF) – is, it seems, a boon for the sales of the 7-12 very profitable medications that are (typically) simultaneously prescribed to patients with end-stage renal disease (ESRD).

Tragic, cruel, inhumane, and malignant ironies here abound. Few would argue that the extraordinary and multifaceted costs (for patients, as well as taxpayers) surrounding hepatic and renal organ failure in patients are a necessary or worthwhile trade-off for the further perpetuation of baseless and (themselves, by far, *more*) toxic orthodoxies arising out of *moral* ideologies alone.

We should be saying, “WHY?”, and *not* accepting the patent fallacy that it is in the best interests of pain patients to risk permanent (renal as well as hepatic) damage so that moral ideologues will rest easier – knowing that people who experience chronic moderate/severe pain are risking the physiological health of their major organs (thus, their very mortality) in order that the members of a bogus (and morally, not physiologically, based) cult of drug-avoidance will experience an ongoing sense of “well-being” (about the scriptures and strictures controlling the lives of persons *other than themselves*, it is noted).

Yet, (little or) no “free market” in such patient advocacy on the part of physicians exists – as the State, with the assent and assistance of our private for-profit health care system, proffers only dis-incentives and penalties (both real and imagined) for those who (rightly) might question such misplaced and detrimental (endemically) “moral orthodoxy” – engendered and sustained without significant rational basis in pharmacological fact – and in the midst of finding that high usage amounts of NSAIDs are (themselves) far more detrimental on a *toxicological* basis …

On balance, and in the historical retrospect, we may find that the primary net effect of the War on Drugs was to endanger and denigrate the physiological health of our society, via a pantheon of (albeit perhaps once previously unintended and unrecognized) tragic consequences.

Could (and should) we as a medical profession as well as a society not (honestly and substantively) ask the question, “who’s interests are *really* being served”, here? And (honestly), at what level of hierarchy on this “ladder of controls” exists the (ostensibly being served) patients’ best interests?
.

Patients, on the other hand, would appear (even to the lowliest members of your medical “team”) be likely to be labeled as “phobic” (as they like to write) regarding your potential future ability to consume certain specifically identified (Schedule II or Schedule III) opiates/opioids.

I would not expect more than duly raised eyebrows, and the potential birth of an immediate and lasting suspicion as to your level of knowledge and interest in such lofty matters as the adequate relief of your pain under the wise and all-powerful benevolent hands of the “Theraputic State”.

Such subjectively originated and duly recorded judgments on the part of any member of your “health-care-team” may well find their way into your medical records – to be shared with insurance companies, your employers, etc., for the rest of your days, (essentially) completely outside your ability as an individual to question, modify, or appeal.

In Newspeak – “War is Peace; Freedom is Slavery; Ignorance is Strength”, to the result that “insincerity” becomes the adversary and nemesis of “clear language”.

Trust your own first-hand knowledge and intuition first and foremost, knowing that your physicians exist only one-rung upwards from yours on the labyrinthine and hollow Ziggurat of Babylon.

For instance (did you know) that (if) you have health insurance through any kind of “group” plan (such as one’s employer, whether insured or self-insured), neither YOU the insured patient, or your representatives (outside of subpoena under ongoing court proceedings) possess any right whatsoever (in any state in the nation that I know of) to view the actual text (and the terms and conditions set forth within) of the formal written contract between the “Provider” of the insurance policy and the “Owner” of the insurance policy (that “Owner” being the “group organization”, and NOT the individual patient).

The specious for-profit-insurance driven nightmare of duplicities on the part of physicians and patients alike, (all cowering under threat of ostracization from our peers) that has correspondingly evolved in our society today has/will make patients (and perhaps, some physicians) later cringe in regret for so (naively) trusting in faceless and secretive organizations run by attorneys and actuarials (to the ultimate detriment of physicians and patients alike).

“We call first truths those we discover after all the others.”
-Albert Camus

One (truly) needs dual degrees in medicine and law to see to it that one’s own life as a patient proceeds, grows frail, and one day dies in a manner freely chosen by the competent, informed, and autonomous individuals that many of us would like to believe that we should bear a inaliable human right to be!
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“And people think that there comments will count on this mannor.”

Maybe, maybe *not*, Anom.

Nearly half a million doctors and patients prescribing and filling prescriptions for hydrocodone formulations every single working day have a direct interest in the matter.

It’s true that the FDA’s “public comment” time window has passed. It is not *necessarily* true that the FDA has deaf ears to millions of people (patients, physicians, and medical institutions) making their thoughts known via the Press …

Take a look at what the FDA back-tracked on recently regarding eliminating opioid medications in just a few months ago (April of 2009) at:

http://www.associatedcontent.com/article/1649765/fda_reverses_decision_on_opoid_availability.html?cat=5#comments

“Power never concedes without a demand, it never has and it never will.”
-Fredrick Douglas
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