I learned a lot from this post. Thanks, Philip.

Now, we have two political problems:

1. FDA shouldn't ban these painkillers combined with acetaminophen. I'm not sure
what organizations are against this, but we need to support them in stopping
this.

Even so, ideally, they'd make them separate drugs that are not combined with
acetaminophen. However, I was told that if hydrocodone was not combined with
acetaminophen, they would make it a schedule 2 drug, not a schedule 3. According
to Philip's post, doctors would be less likely to prescribe it if it were
schedule 2.

2. Nandrolone. A group of compounding pharmacists thinks that the way to help
keep nandrolone on the market is to make it a schedule 2, so that FDA thinks it
is controlled better. The post by Philip convinces me that this would be a
horrible thing to do because doctors would be MORE UNLIKELY to prescribe it.

We need to tell the pharmacists that we do NOT want them to petition for this.
I'm thinking we need to generate a letter to them stating this.

Michael Mooney
www.michaelmooney.net
www.medibolics.com

RE: [PozHealth] Re: Fw: NATAP: Ban Vicodin/Percocet-FDA Panel Recommends

I suffer from a congenital connective tissue disorder called Marfan syndrome.
This syndrome is caused by a faulty gene (FBN1) on the 15th chromosome pair, and
is autosomal dominant (if one parent has the syndrome, each child that the
parent brings into the world stands a 50% chance of presenting with this
syndrome). The fault in FBN1 causes this gene to code for a damaged version of
a key protein called fibrillin-1 (this protein is a key component of connective
tissue).

As a direct result of this genetic defect, my connective tissue (the "glue" that
holds the body together) is insufficiently elastic. This syndrome, if left
untreated, is highly lethal. As in so many patients who suffer from Marfan
syndrome, I have an ascending aortic aneurysm. In my case, the aneurysm is not
quite large enough to warrant the brutal surgery that may one day become
necessary – furthermore, the aneurysm has shown absolutely no indication of
increased size since I was first diagnosed as suffering from this condition back
in 1995. It appears that I may be one of the lucky patients who will never
require the surgery to which I allude above. This surgery involves replacement
of the aortic root and the aortic valve with a Dacron tube and artificial valves
– this procedure is highly effective, but requires that the patient take
warfarin sodium (Coumadin) for the rest of his or her life.

Currently, the standard of care consists of putting the patient on beta blockers
(e.g. metoprolol 100 mg twice daily) for life – beta blockers reduce both blood
pressure and heart rate. This in turn places less strain on the aneurysm,
lessening the chances of the aneurysm ever dissecting (slowly coming apart over
a period of hours) or rupturing (in which case the patient usually dies within
seconds). The standard of care also calls for regular echocardiograms with
complete visualization of the heart, or CT scans (an echocardiogram performed by
a talented radiologist is as good as a CT scan, and has the advantage of
enabling the radiologist to detect and measure any aortic valve incompetence
(which causes regurgitation of blood back into the heart)).

Recently, Dr. Harry Dietz (a world authority on Marfan syndrome and related
conditions) discovered that the faulty FBN1 gene also potentiates the action of
a hormone named Transforming Growth Factor beta (TGF-beta). This discovery has
completely revolutionized the treatment of Marfan syndrome. When TGF-beta is
overactive, the patient presents with symptoms such as unusual height (in my
case, 6'6"), unusually long arms and legs, a highly arched palate, a "crowded
mouth" (too many teeth for too small a mouth), a tendency for some joints to
dislocate spontaneously, and other problems that cannot be attributed to the bad
version of fibrillin-1 acting alone. Dr. Dietz theorized that drugs that block
the action of TGF-beta may arrest the condition. He therefore placed several
infants who had very severe cases of Marfan syndrome on a drug named losartan
(which inhibits the action of TGF-beta). This theory appears to be correct –
Dr. Dietz noted not just arrest of the syndrome in pediatric cases, but in
several cases, complete reversal of the aortic wall abnormalities that give rise
to the aortic aneurysms! In short, Dr. Dietz identified another factor in the
pathogenesis of Marfan syndrome – as a direct result of his work in pediatric
patients, and the successes he has documented in these patients, he is now
conducting a Phase III clinical trial involving adults, using losartan combined
with beta blockers, irbesartan combined with beta blockers, and beta blockers
alone. I decided not to wait for the results of this clinical trial, and my
doctor now prescribes losartan for me every month on a repeat prescription.

Without getting too technical, I suffer from chronic pain. My back, knees, and
arms are badly damaged – phrases such as spur formation, levoscoliosis, annular
bulge, Schmorl's node formation, bone marrow signal changes, degenerative
changes, etc. jump out from the CT scan reports. My doctor in New York City
(where I lived and worked until about two years ago) treated the chronic pain
with OxyContin as the mainstay of my pain management regimen, and Norco 10 / 325
(hydrocodone 10 mg and acetaminophen 325 mg) for breakthrough pain.

I now live in the UK, where hydrocodone is not marketed – instead, I take
OxyNorm 10 mg and 20 mg capsules, and the UK equivalent of Tylenol #3 with
codeine (known as Co-codamol in the UK) for the treatment of breakthrough pain.
I continue to take OxyContin 160 mg twice daily as the mainstay of my pain
management strategy. I am therefore on OxyContin, OxyNorm, and Co-codamol for
pain management.

Yes – thank you, I am well aware of the fact that oxycodone (the active
ingredient in OxyContin and OxyNorm) is a very powerful opiate! A French study
concluded that, on a gram for gram basis, 100 mg of oxycodone packs the same
analgesic punch as about 150 mg of oral morphine (making oxycodone considerably
stronger than morphine); another study concluded that oxycodone is roughly
equianalgesic to diamorphine (heroin, which is a legal painkiller in the UK,
often used in the treatment of cancer pain and in palliative care contexts).
Yes, you read that correctly – heroin (known to doctors as diamorphine) is a
legal drug in the UK when dispensed by doctors who know what they are doing, and
oxycodone is roughly equianalgesic to diamorphine.

I am lucky in that I have developed tolerance to oxycodone unusually slowly.
Back in 1995, my daily dose of OxyContin was 80 mg twice daily. Now, 14 years
later, my daily dose of OxyContin is 160 mg twice daily. The development of
tolerance and the manifestation of withdrawal symptoms when an opiate or opioid
is abruptly discontinued are not indicative of addiction! It was accepted
wisdom for a long time that tolerance and withdrawal were indicia of addiction –
pain management specialists now know that physiological dependence on an opiate
or opioid is not the same as addiction. Addiction is diagnosed clinically in
terms of the behaviour of the patient and in terms of psychology: Does the
patient hoard drugs? Does the patient engage in deceptive techniques to acquire
drugs (e.g. "doctor-shopping")? Does the patient refuse to travel unless he can
bring his "stash" with him? Does he engage in drug-seeking behaviour? These
are now the issues that pain management specialists take into consideration when
determining whether nor not a patient is addicted.

The decision by the FDA advisory panel, if adopted by the FDA, could have tragic
consequences. It is now well established that doctors in the USA are notorious
for undertreating chronic pain for fear of their patients becoming "drug
addicts". The "war on drugs" has become enmeshed with the legitimate field of
pain management, to the extent that many doctors in the USA (about 25% of them)
don't even bother to order the triplicate prescription blanks required in order
to issue Schedule II prescriptions for drugs such as pure oxycodone, pure
codeine, pure morphine, etc. Pain management specialists have coined the phrase
"opiophobia" to describe the attitude of so many doctors who do not specialize
in pain management. Up until now, doctors in the USA have always been able to
fall back on Schedule III compound analgesics – e.g. Norco 10 / 325 (hydrocodone
mixed with APAP), Tylenol #3 with codeine, Vicoprofen (hydrocodone mixed with
ibuprofen), Darvocet (dextro-propoxyphene mixed with APAP), etc. Schedule III
prescriptions are not tracked to the same extent as Schedule II prescriptions,
and doctors may issue up to five refills on all Schedule III prescriptions,
whereas they may not issue any refills on Schedule II prescriptions. All
Schedule II prescriptions have to be written up on triplicate prescription
blanks, and a new prescription has to be written for each month's supply of the
medication in question. Given the well-documented tendency of doctors in the
USA to undertreat chronic pain, I foresee a great sadness as those doctors who
previously issued prescriptions for medications such as Norco, Vicodin, Tylenol
#3, etc. simply stop issuing prescriptions for opioid / opiate analgesics,
leaving their patients to suffer with NSAIDs and drugs such as acetaminophen and
aspirin.

This is so typical of the reactionary and backwards mentality that informs the
"war on drugs" – Americans have a shocking tendency to confuse the abuse of a
drug with its legitimate usage. The recent death of Michael Jackson has thrown
this issue into sharp relief – already, people are blaming OxyContin and
Demerol, instead of the dumb f—k who (allegedly) abused both of these drugs on a
daily basis. Those patients who suffer from chronic pain and who need
aggressive treatment with mu-agonist opioids and opiates may now end up paying
the price for the crass stupidity of people such as Michael Jackson and Rush
Limbaugh (after his abuse of OxyContin, people started blaming OxyContin itself
for his addiction, instead of blaming the gasbag who blackmailed his maid and
who shovelled these tablets into his system as though they were pistachio nuts).
After Sonny Bono skiid into a tree whilst high on Vicodin, his wife blamed the
Vicodin for his accident, not the idiot who took to the slopes in a semi-stupor.
Doctors in the USA are already afraid of falling victim to overzealous D.E.A.
bureaucrats, who are uninhibited by wisdom, knowledge, or clinical experience
and who substitute their own judgment for that of physicians who have studied
medicine for seven or eight years before being permitted to prescribe!

Yes – some people abuse compound analgesics, mix them with alcohol, and damage
their livers – but it is generally not sound public policy to throw away an
entire class of drugs to accommodate the stupidity and ignorance of those
patients who abuse such drugs!

The situation in the UK is precisely the reverse of that in the USA. Doctors in
the UK are entirely willing to prescribe powerful medications to those patients
who can document a legitimate medical need for such drugs. I had a good and
caring doctor in New York City, and therefore never suffered the effects of
opiophobia first-hand – but I heard of a doctor in Oregon who was disciplined
for treating a terminally ill cancer patient with acetaminophen alone, for fear
of turning that patient into a "drug addict" (the doctor was forced, as a
condition of retention of his license to practice, to work side-by-side with a
pain management specialist)! These are not isolated incidents in the USA.
These tragedies occur with tragic frequency. Fortunately, doctors in the UK
treat chronic pain seriously and have not confused the legitimate usage of
powerful opioids and opiates (including diamorphine!) with the abuse of such
medications. I doubt very much that the UK would follow the USA's example
should the FDA adopt the recommendation of its advisory panel – but even were
the UK to do so, I don't believe that UK doctors would stop issuing powerful
opioids / opiates – instead of prescribing drugs such as Co-codamol, they would
probably write separate prescriptions for codeine and APAP; instead of writing
prescriptions for Co-dydramol, they would probably write separate prescriptions
for dihydrocodeine and APAP.

Sadly, the FDA usually follows the recommendations of its advisory panel.
However, it does not have to do so, and there is still time to apply pressure on
the FDA (in the form of angry public comment) to put a stop to this madness
before it starts!

I very much hope that people will take this issue very, very seriously, and make
the necessary noise to derail this grotesque proposal.

Philip

From: PozHealth@yahoogroups.com [mailto:PozHealth@yahoogroups.com] On Behalf Of
John Barrow
Sent: 03 July 2009 15:59
To: PozHealth@yahoogroups.com
Subject: [PozHealth] Re: Fw: NATAP: Ban Vicodin/Percocet-FDA Panel Recommends

"So the "solution" in reaction to people who take too much Acetaminophen is to
propose banning Percocet (Oxycodone) and Vicodin? To me this is another
knee-jerk reaction void of common sense. These pain-killers are invaluable to
many people. What will be next, Aspirin? Too much Aspirin can erode the stomach
lining."

Gary,

The thought is that "uncoupling" the two might lead to safer usage of the
agents, separately. It would still be possible to combine the agents, but with
less convenience.

While NSAIDs have risks, Acetaminophen really has some safety problems,
especially when used with alcohol. A real issue is that acetaminophen is
present as an ingredient in so many other agents that unintentional overdose is
pretty easy.

I have never seen acetaminophen sold with NAC in the UK or France, where I have
worked.

JB