ADELPHI, Md. — A federal advisory panel voted narrowly on Tuesday to recommend a ban on Percocet and Vicodin, two of the most popular prescription painkillers in the world, because of their effects on the liver.
The two drugs combine a narcotic with acetaminophen, the ingredient found in popular over-the-counter products like Tylenol and Excedrin. High doses of acetaminophen are a leading cause of liver damage, and the panel noted that patients who take Percocet and Vicodin for long periods often need higher and higher doses to achieve the same effect.
Acetaminophen is combined with different narcotics in at least seven other prescription drugs, and all of these combination pills will be banned if the Food and Drug Administration heeds the advice of its experts. Vicodin and its generic equivalents alone are prescribed more than 100 million times a year in the United States.
Laureen Cassidy, a spokeswoman for Abbott Laboratories, which makes Vicodin, said, “The F.D.A. will make a final determination and Abbott will follow the agency’s guidance.”
The agency is not required to follow the recommendations of its advisory panels, but it usually does.
The panel’s 20-17 vote to recommend a ban on the combination drugs was one of 11 it took at a meeting called to advise the F.D.A. on problems arising from the extraordinary popularity of acetaminophen. In 2005, American consumers bought 28 billion doses of products containing the ingredient.
While the medicine is effective in treating headaches and reducing fevers, even recommended doses can cause liver damage in some people. And more than 400 people die and 42,000 are hospitalized every year in the United States from overdoses.
In hopes of reducing some of these accidents, the committee voted 24 to 13 to recommend that the F.D.A. reduce the highest allowed dose of acetaminophen in over-the-counter pills like Tylenol to 325 milligrams, from 500. And members voted 21 to 16 to reduce the maximum daily dosage to less than 4,000 milligrams.
But they voted 20 to 17 against limiting the number of pills allowed in each bottle, with members saying such a limit would probably have little effect and could hurt rural and poor patients. Bottles of 1,000 pills are often sold at discount chains.
“We have no data to show that people who overdose shop at Costco,” said Dr. Edward Covington, a panel member from the Cleveland Clinic Foundation.
Dr. Lewis S. Nelson, a toxicologist from the New York University School of Medicine who served as the panel’s acting chairman, said experts had been warning of the dangers of combination painkillers like Percocet, which is made by Endo Pharmaceuticals, and Vicodin for years.
Still, the recommendation is likely to come as a shock to many patients, who may be unaware of the dangers of high doses of acetaminophen — even if they know the drugs contain the ingredient.
Some doctors already avoid prescribing pills that combine acetaminophen with narcotics like oxycodone (found in Percocet) and hydrocodone (in Vicodin).
“It ties the doctor’s hands when you put the two drugs together,” said Dr. Scott M. Fishman, a professor of anesthesiology at the University of California, Davis, and a former president of the American Academy of Pain Medicine. “There’s no reason you can’t get the same effect by using them separately.”
Dr. Fisher said the combinations were prescribed so often for the sake of convenience, but added, “When you’re using controlled substances, you want to err on the side of safety rather than convenience.”
Still, some doctors predicted that the recommendation would put extra burdens on physicians and patients.
“More people will be suffering from pain,” said Dr. Sean Mackey, chief of pain management at Stanford University Medical School. “More people will be seeing their doctors more frequently and running up health care costs.”
In a statement, Johnson & Johnson, Tylenol’s maker, said it “strongly disagrees” with the proposed restrictions on acetaminophen, adding that they would be likely to “lead to more serious adverse events as consumers shift to other over-the-counter products,” like Advil and aspirin.
Linda A. Suydam, president of the Consumer Healthcare Products Association, said the committee had ignored studies showing that doses sold by her members — two pills of 500 milligrams, up to four times a day — were safe. “I think this is a very effective dose and one needed for individuals who experience chronic pain,” she said.
The committee also turned its attention to over-the-counter children’s medicines containing acetaminophen, voting 36 to 1 to limit them to a single formulation. Right now the liquids are sold in two different concentrations, leading to confusion among doctors and parents.
“I don’t think it’s safe to have two formulations out there,” said Dr. Nelson, the acting chairman.
The members were divided over which formula to recommend, the concentrated or the less concentrated one. F.D.A. officials suggested that they would likely settle on the less concentrated formula so that if parents make a mistake, they would be less likely to overdose.
Acetaminophen is included in a vast array of over-the-counter cough and cold products, including Nyquil, Excedrin and many others. A small share of accidental poisonings result when people take two or more of these combination products without understanding the risk.
The F.D.A. asked the committee whether it should ban combination products that include acetaminophen. The vote was 24 to 13 against such a ban, with many members saying consumers saw the products as valuable.
“Based on the data provided, the combination O.T.C. medications really contributed very little to overall poisonings,” said Dr. Osemwota A. Omoigui, a panel member from the Los Angeles Pain Clinic.
A 2005 study found that most poisonings resulted from patients’ taking Vicodin and similar products that combine a narcotic with acetaminophen.
“I think this is the one place where we can engineer in safety,” said Dr. Judith M. Kramer, a panel member and an associate professor of medicine from Duke University Medical Center who voted to ban the combination prescription medicines. “We’re here because there are inadvertent overdoses that are fatal, and this is our one opportunity to have a big impact.”
Consumers need to be better educated about the risks of popular medicines, most panel members agreed.
“If you keep track of what you’re taking, none of this is an issue for you,” Dr. Jan Engle, a panel member and head of the Department of Pharmacy Practice at the University of Illinois in Chicago, said in an interview after the meeting.
Donald G. McNeil Jr. contributed reporting from New York.
i'm always for personal choice, but i think this was a good move indeed. I
recall the "NSAIDS wreck your liver" scare back in 1995, a few weeks into it the
NY DAILY NEWS published a half-page interview with the discoverer of
acetaminophen. He said he told his bosses it was "intrinsically hepatotoxic" and
that he suggested "no more than 500 325mg doses in a lifetime". the article went
on to describe the grim 1st place acetaminophen holds in drug-overdose
statistics.
i've told many people of that article over the years, including people who abuse
Vicodin and Percocet specifically... pretty much NO ONE was aware of the risks.
not even most doctors, although my orthopedist told me a couple of weeks ago
that his clinic advises patients to avoid more than 3 grams a day and no more
than 7 days at a time.
I'm especially worried about drug abusers using these pills willy-nilly, they
actually think the opiate within is the bigger risk.
Vicodin/Percocet and their variants were and are a deeply flawed approach to
drug abuse and dependence. Pharma companies mixed them up with the express idea
that pairing acetaminophen with various opiates would limit their abuse
potential by *making abusers feel sick via acetaminophen overdose*. The fact
that many opiate abusers will brag about taking 16 Vicodins at a time during a
drinking binge (Artie Lang from the Howard Stern Show among them) is proof of
the grim failure of that approach.
Ban them.
Jeton
--- In PozHealth@yahoogroups.com, PoWeRTX@... wrote:
>
> Panel Recommends Ban on 2 Popular Painkillers
>
> NY Times
> By GARDINER HARRIS
> Published: June 30, 2009
>
> ADELPHI, Md. â€" A federal advisory panel voted narrowly on Tuesday to
recommend a ban on Percocet and Vicodin, two of the most popular prescription
painkillers in the world, because of their effects on the liver.
>
After hearing all kinds of this scary stuff -- that acetaminophen will destroy
my liver, I find that I have been on NORCO for over a year because of shoulder
surgery, an Achilles tendon tear and heal injuries. The final surgery to fix my
Achilles tendon happens in August, then I will be very happy to NOT talk to a
doctor for a long time and to gradually wean myself off NORCO.
I have been taking 1 and 1/2 to 2 NORCO, which is 10 mg of hydrocodone with 325
mg of acetaminophen per tablet about 4 times a day, getting about 2,000 mg of
acetaminophen per day because I average between 6 and 7 NORCO tablet per day. I
was very skeptical when my doctor told me he had hundreds of patients who took
painkillers that added up to as much as 4,000 mg of acetaminophen per day for
long periods, with no significant liver toxicity. I DO take 1,500 mg of NAC,
which is the antidote for liver toxicity from acetaminophen, per day, and other
supplements that support liver health. How much do they protect me? Who knows.
Well, reporting in, my recent blood tests showed no elevations of AST and ALT or
GGT. While AST and ALT are multi-function tests and do not only read the liver,
GGT is specific to the liver. My GGT measured 20, which is low-mid normal - the
top of normal is 65. MY blood tests say that I am not experiencing any
significant liver toxicity.
I drink alcohol to the tune of 2 to 3 good drinks per night, pretty much every
night. I never drink to get drunk - I don't like being out of control -- only to
relax a little. I've heard that alcohol and acetaminophen could quickly cause
liver failure -- how scary. I've heard this from well-known PhD researchers.
This is a hypothesis on their parts -- not based on the experience my doctor
has, watching the blood tests of hundreds of patients. It is misguided and wrong
on other part, based on my experience.
This scare on acetaminophen, based on my experience is complete bullshit. This
is what my doctor said based on him watching hundreds of patients over dozens of
years.
Just another powergrab by conservative liars who want to control more people's
lives and control the use of painkillers and drugs, in general.
People who are in pain should be given whatever they really need to make life
livable. And moralistic jerks should get their powergrabbing hands out of
people's personal lives. This is exactly the same issue as medical marijuana.
NORCO has helped me live normally, without a lot of pain. I have had the option
to advance to oxycodone/oxycontin, and tried it and didn't like it. It made me
feel dumb and dull. The next day I was very crabby -- and could tell oxycodone
could easily create an addiction syndrome.
I still have 15 tablets that I don't use.
I have friends who have drug addiction problems who can't believe I could refuse
to take oxycodone, but I do just fine with the weaker painkiller, NORCO, with
its hydrocodone and want no part in going to anything more addictive. I have
weaned myself off hydrocodone after hernia surgery 10 years ago, know how to do
it and can do it again.
Goddess, protect is from paternalistic asshole powergrabbers and the FDA who is
in cahoots with them!
Michael Mooney
www.michaelmooney.net
www.medibolics.com
--- In PozHealth@yahoogroups.com, "jetonxxx" <jeton@...> wrote:
>
> i'm always for personal choice, but i think this was a good move indeed. I
recall the "NSAIDS wreck your liver" scare back in 1995, a few weeks into it the
NY DAILY NEWS published a half-page interview with the discoverer of
acetaminophen. He said he told his bosses it was "intrinsically hepatotoxic" and
that he suggested "no more than 500 325mg doses in a lifetime". the article went
on to describe the grim 1st place acetaminophen holds in drug-overdose
statistics.
>
> i've told many people of that article over the years, including people who
abuse Vicodin and Percocet specifically... pretty much NO ONE was aware of the
risks. not even most doctors, although my orthopedist told me a couple of weeks
ago that his clinic advises patients to avoid more than 3 grams a day and no
more than 7 days at a time.
>
> I'm especially worried about drug abusers using these pills willy-nilly, they
actually think the opiate within is the bigger risk.
> Vicodin/Percocet and their variants were and are a deeply flawed approach to
drug abuse and dependence. Pharma companies mixed them up with the express idea
that pairing acetaminophen with various opiates would limit their abuse
potential by *making abusers feel sick via acetaminophen overdose*. The fact
that many opiate abusers will brag about taking 16 Vicodins at a time during a
drinking binge (Artie Lang from the Howard Stern Show among them) is proof of
the grim failure of that approach.
>
> Ban them.
>
> Jeton
>
>
> --- In PozHealth@yahoogroups.com, PoWeRTX@ wrote:
> >
> > Panel Recommends Ban on 2 Popular Painkillers
> >
> > NY Times
> > By GARDINER HARRIS
> > Published: June 30, 2009
> >
> > ADELPHI, Md. â€" A federal advisory panel voted narrowly on Tuesday to
recommend a ban on Percocet and Vicodin, two of the most popular prescription
painkillers in the world, because of their effects on the liver.
> >
>
i also have experience with acetaminophen, having had a 105.5 fever for a week
in 1995, with highly elevated liver enzymes, with nothing to explain it besides
having taken 3 vicodins and and 3 medium-strong drinks. i wasn't taking NAC at
the time, and most people don't.
there's nothing to stop doctors from prescribing any of the various opiates
currently paired with acetaminophen separately, the problem is in commonly
pairing (and titrating) them together. You describe this as a "powergrab" but
don't show who is gaining power by this move, and how exactly. The point is that
pairing acetaminophen together with opiates in the first place was the actual
powergrab: pharma companies wanted to punish anyone taking 'too much' opiate by
giving them too much acetaminophen to MAKE them sick. here is Time Magazine's
latest article on this, and i'll reprint the last 2 paragraphs here:
***The members based their decision on the studies and data that were presented
to them during the two-day meeting. The vast majority of studies linking liver
failure to acetaminophen use involve prescription acetaminophen products, such
as Vicodin or Percocet; more than 60% of the acetaminophen-associated liver
problems occurred in patients using prescription medications, while only 10%
occurred in those using nonprescription pain remedies. "The recommendations of
the committee are not based on the logic of what we think is happening, but on
the data presented to the committee," says Kramer. "A much larger percent of
liver-failure cases associated with acetaminophen involved a prescription
acetaminophen product."
Members were also concerned about the pairing of narcotic agents such as
hydrocodone and oxycodone, both known to be addictive, with acetaminophen, which
is known to increase the risk of liver problems with higher and higher doses. If
patients become dependent on the narcotic, and continue taking prescription
painkillers, they are also more likely to suffer from liver toxicity associated
with the acetaminophen. "How can you mix a highly addictive drug with one that
can cause toxicity at high doses?" says Dr. William Lee, director of the
Clinical Center for Liver Diseases at the University of Texas Southwestern
Medical Center. Lee presented data to the committee on liver damage due to
acetaminophen overdose. "It's like putting poison in a candy." ****
Jeton
--- In PozHealth@yahoogroups.com, "Michael" <michael@...> wrote:
>
> After hearing all kinds of this scary stuff -- that acetaminophen will destroy
my liver, I find that I have been on NORCO for over a year because of shoulder
surgery, an Achilles tendon tear and heal injuries. The final surgery to fix my
Achilles tendon happens in August, then I will be very happy to NOT talk to a
doctor for a long time and to gradually wean myself off NORCO.
>
> I have been taking 1 and 1/2 to 2 NORCO, which is 10 mg of hydrocodone with
325 mg of acetaminophen per tablet about 4 times a day, getting about 2,000 mg
of acetaminophen per day because I average between 6 and 7 NORCO tablet per day.
I was very skeptical when my doctor told me he had hundreds of patients who took
painkillers that added up to as much as 4,000 mg of acetaminophen per day for
long periods, with no significant liver toxicity. I DO take 1,500 mg of NAC,
which is the antidote for liver toxicity from acetaminophen, per day, and other
supplements that support liver health. How much do they protect me? Who knows.
>
> Well, reporting in, my recent blood tests showed no elevations of AST and ALT
or GGT. While AST and ALT are multi-function tests and do not only read the
liver, GGT is specific to the liver. My GGT measured 20, which is low-mid normal
- the top of normal is 65. MY blood tests say that I am not experiencing any
significant liver toxicity.
>
> I drink alcohol to the tune of 2 to 3 good drinks per night, pretty much every
night. I never drink to get drunk - I don't like being out of control -- only to
relax a little. I've heard that alcohol and acetaminophen could quickly cause
liver failure -- how scary. I've heard this from well-known PhD researchers.
This is a hypothesis on their parts -- not based on the experience my doctor
has, watching the blood tests of hundreds of patients. It is misguided and wrong
on other part, based on my experience.
>
> This scare on acetaminophen, based on my experience is complete bullshit. This
is what my doctor said based on him watching hundreds of patients over dozens of
years.
>
> Just another powergrab by conservative liars who want to control more people's
lives and control the use of painkillers and drugs, in general.
>
> People who are in pain should be given whatever they really need to make life
livable. And moralistic jerks should get their powergrabbing hands out of
people's personal lives. This is exactly the same issue as medical marijuana.
>
> NORCO has helped me live normally, without a lot of pain. I have had the
option to advance to oxycodone/oxycontin, and tried it and didn't like it. It
made me feel dumb and dull. The next day I was very crabby -- and could tell
oxycodone could easily create an addiction syndrome.
>
> I still have 15 tablets that I don't use.
>
> I have friends who have drug addiction problems who can't believe I could
refuse to take oxycodone, but I do just fine with the weaker painkiller, NORCO,
with its hydrocodone and want no part in going to anything more addictive. I
have weaned myself off hydrocodone after hernia surgery 10 years ago, know how
to do it and can do it again.
>
> Goddess, protect is from paternalistic asshole powergrabbers and the FDA who
is in cahoots with them!
>
> Michael Mooney
> www.michaelmooney.net
> www.medibolics.com
>
> --- In PozHealth@yahoogroups.com, "jetonxxx" <jeton@> wrote:
> >
> > i'm always for personal choice, but i think this was a good move indeed.
I agree entirely. It's stupid to mix hydrocodone with acetaminophen. They should
be separate meds, to be prescribed as such.
This system is based on paternalism, which is, in general, not truly for the
common good, but biased because someone in power thinks they know best or have
higher moral ground.
Michael Mooney
--- In PozHealth@yahoogroups.com, "jetonxxx" <jeton@...> wrote:
>
> i also have experience with acetaminophen, having had a 105.5 fever for a week
in 1995, with highly elevated liver enzymes, with nothing to explain it besides
having taken 3 vicodins and and 3 medium-strong drinks. i wasn't taking NAC at
the time, and most people don't.
>
> there's nothing to stop doctors from prescribing any of the various opiates
currently paired with acetaminophen separately, the problem is in commonly
pairing (and titrating) them together. You describe this as a "powergrab" but
don't show who is gaining power by this move, and how exactly. The point is that
pairing acetaminophen together with opiates in the first place was the actual
powergrab: pharma companies wanted to punish anyone taking 'too much' opiate by
giving them too much acetaminophen to MAKE them sick. here is Time Magazine's
latest article on this, and i'll reprint the last 2 paragraphs here:
>
> http://www.time.com/time/health/article/0,8599,1908408,00.html?xid=rss-topstorie\
s
>
> ***The members based their decision on the studies and data that were
presented to them during the two-day meeting. The vast majority of studies
linking liver failure to acetaminophen use involve prescription acetaminophen
products, such as Vicodin or Percocet; more than 60% of the
acetaminophen-associated liver problems occurred in patients using prescription
medications, while only 10% occurred in those using nonprescription pain
remedies. "The recommendations of the committee are not based on the logic of
what we think is happening, but on the data presented to the committee," says
Kramer. "A much larger percent of liver-failure cases associated with
acetaminophen involved a prescription acetaminophen product."
>
> Members were also concerned about the pairing of narcotic agents such as
hydrocodone and oxycodone, both known to be addictive, with acetaminophen, which
is known to increase the risk of liver problems with higher and higher doses. If
patients become dependent on the narcotic, and continue taking prescription
painkillers, they are also more likely to suffer from liver toxicity associated
with the acetaminophen. "How can you mix a highly addictive drug with one that
can cause toxicity at high doses?" says Dr. William Lee, director of the
Clinical Center for Liver Diseases at the University of Texas Southwestern
Medical Center. Lee presented data to the committee on liver damage due to
acetaminophen overdose. "It's like putting poison in a candy." ****
>
> Jeton
>
> --- In PozHealth@yahoogroups.com, "Michael" <michael@> wrote:
> >
> > After hearing all kinds of this scary stuff -- that acetaminophen will
destroy my liver, I find that I have been on NORCO for over a year because of
shoulder surgery, an Achilles tendon tear and heal injuries. The final surgery
to fix my Achilles tendon happens in August, then I will be very happy to NOT
talk to a doctor for a long time and to gradually wean myself off NORCO.
> >
> > I have been taking 1 and 1/2 to 2 NORCO, which is 10 mg of hydrocodone with
325 mg of acetaminophen per tablet about 4 times a day, getting about 2,000 mg
of acetaminophen per day because I average between 6 and 7 NORCO tablet per day.
I was very skeptical when my doctor told me he had hundreds of patients who took
painkillers that added up to as much as 4,000 mg of acetaminophen per day for
long periods, with no significant liver toxicity. I DO take 1,500 mg of NAC,
which is the antidote for liver toxicity from acetaminophen, per day, and other
supplements that support liver health. How much do they protect me? Who knows.
> >
> > Well, reporting in, my recent blood tests showed no elevations of AST and
ALT or GGT. While AST and ALT are multi-function tests and do not only read the
liver, GGT is specific to the liver. My GGT measured 20, which is low-mid normal
- the top of normal is 65. MY blood tests say that I am not experiencing any
significant liver toxicity.
> >
> > I drink alcohol to the tune of 2 to 3 good drinks per night, pretty much
every night. I never drink to get drunk - I don't like being out of control --
only to relax a little. I've heard that alcohol and acetaminophen could quickly
cause liver failure -- how scary. I've heard this from well-known PhD
researchers. This is a hypothesis on their parts -- not based on the experience
my doctor has, watching the blood tests of hundreds of patients. It is misguided
and wrong on other part, based on my experience.
> >
> > This scare on acetaminophen, based on my experience is complete bullshit.
This is what my doctor said based on him watching hundreds of patients over
dozens of years.
> >
> > Just another powergrab by conservative liars who want to control more
people's lives and control the use of painkillers and drugs, in general.
> >
> > People who are in pain should be given whatever they really need to make
life livable. And moralistic jerks should get their powergrabbing hands out of
people's personal lives. This is exactly the same issue as medical marijuana.
> >
> > NORCO has helped me live normally, without a lot of pain. I have had the
option to advance to oxycodone/oxycontin, and tried it and didn't like it. It
made me feel dumb and dull. The next day I was very crabby -- and could tell
oxycodone could easily create an addiction syndrome.
> >
> > I still have 15 tablets that I don't use.
> >
> > I have friends who have drug addiction problems who can't believe I could
refuse to take oxycodone, but I do just fine with the weaker painkiller, NORCO,
with its hydrocodone and want no part in going to anything more addictive. I
have weaned myself off hydrocodone after hernia surgery 10 years ago, know how
to do it and can do it again.
> >
> > Goddess, protect is from paternalistic asshole powergrabbers and the FDA who
is in cahoots with them!
> >
> > Michael Mooney
> > www.michaelmooney.net
> > www.medibolics.com
> >
> > --- In PozHealth@yahoogroups.com, "jetonxxx" <jeton@> wrote:
> > >
> > > i'm always for personal choice, but i think this was a good move indeed.
>
> This scare on acetaminophen, based on my experience is complete
> bullshit....
>
> Just another powergrab by conservative liars who want to control more
> people's lives and control the use of painkillers and drugs, in
> general.
It's very popular these days to "conservative" bash (dog knows, I do my
share of it as well), but I wish Political Science 101, or even 99.5 was
taught more widely.
It's actually the trad *liberal* position to centralize government in
this fashion as well as expand its powers, expand the "nanny state," and
mandate this kind of control in people's lives. The trad *conservative*
position would be to make it all available, unregulated, and let people
make their own choices, informed or less so.
I agree, however, my "conservative-bashing" includes wolves-in-sheeps-clothing
like Henry Waxman, who never say a paternalistic law to control your behavior
because you're-too-stupid-to-do-it-yourself that he didn't champion.
Waxman's Answers
Drugs/steroids in sports! - Ban steroids from all uses.
Michael Jackson dies of painkillers. -Ban painkillers.
Vitamins compete with drugs, according to FDA in the federal register. -Make
vitamins into prescription-only items.
Yes, he's truly a control-your-life-conservative in liberal clothing.
Michael Mooney
www.michaelmooney.net
www.medibolics.com
--- In PozHealth@yahoogroups.com, Brian Mailman <bmailman@...> wrote:
>
> Michael wrote:
>
> > This scare on acetaminophen, based on my experience is complete
> > bullshit....
> >
> > Just another powergrab by conservative liars who want to control more
> > people's lives and control the use of painkillers and drugs, in
> > general.
>
> It's very popular these days to "conservative" bash (dog knows, I do my
> share of it as well), but I wish Political Science 101, or even 99.5 was
> taught more widely.
>
> It's actually the trad *liberal* position to centralize government in
> this fashion as well as expand its powers, expand the "nanny state," and
> mandate this kind of control in people's lives. The trad *conservative*
> position would be to make it all available, unregulated, and let people
> make their own choices, informed or less so.
>
> B/
>
No, I don't think you do, since you continue to misclassify. My point
is that classing someone(s) that disagree with you as "the other" is
simply the same dynamic as the conservatives you are bashing employ and
you should know which is which, anyway.
> however, my "conservative-bashing" includes wolves-in-sheeps-clothing
> like Henry Waxman, who never say a paternalistic law to control your
> behavior because you're-too-stupid-to-do-it-yourself that he didn't
> champion.
Which is a trad "liberal" position. To have an agency or bureau
control, (e.g., expanded governmental control) things that individuals
in a Jeffersonian model can and should control for themselves.
> Waxman's Answers Drugs/steroids in sports! - Ban steroids from all
> uses. Michael Jackson dies of painkillers. -Ban painkillers. Vitamins
> compete with drugs, according to FDA in the federal register. -Make
> vitamins into prescription-only items.
Those are not trad conservative positions, as I said. You're describing
aspects of the nanny state. What the conservatives wish is a smaller
government with less regulation (Bush, Rove, and Co. are an extreme
aberration). As you seem to do.
I don't suppose this is a good time to make the announcement about Henry
Waxman's new book in which he details his life-long crusade to protect the
American public.
At least, it was news to me. I nearly fell over in the bookstore.
Ironic or just downright funny?
Sanford
Sanford M. Gross, OD, FAAO
Associate Professor
Illinois College of Optometry
3241 South Michigan Ave
Chicago, Illinois 60616
>>> Brian Mailman <bmailman@...> 7/6/2009 1:01 AM >>>
Michael wrote:
> I agree,
No, I don't think you do, since you continue to misclassify. My point
is that classing someone(s) that disagree with you as "the other" is
simply the same dynamic as the conservatives you are bashing employ and
you should know which is which, anyway.
> however, my "conservative-bashing" includes wolves-in-sheeps-clothing
> like Henry Waxman, who never say a paternalistic law to control your
> behavior because you're-too-stupid-to-do-it-yourself that he didn't
> champion.
Which is a trad "liberal" position. To have an agency or bureau
control, (e.g., expanded governmental control) things that individuals
in a Jeffersonian model can and should control for themselves.
> Waxman's Answers Drugs/steroids in sports! - Ban steroids from all
> uses. Michael Jackson dies of painkillers. -Ban painkillers. Vitamins
> compete with drugs, according to FDA in the federal register. -Make
> vitamins into prescription-only items.
Those are not trad conservative positions, as I said. You're describing
aspects of the nanny state. What the conservatives wish is a smaller
government with less regulation (Bush, Rove, and Co. are an extreme
aberration). As you seem to do.
No Joe. It's interesting...his tome on his idealism.
In 1993 APLA took me to meet Waxman in his office to "discuss" technical matters
that he didn't seen to understand about complementary medicine for HIV. He was
actively roadblocking things related to this.
He was duplicitous. As soon as APLA's committee head signaled me to ask the real
questions, he ducked and dodged and almost lost his sheepskin to show the wolf
under it. He's married into the medical/pharma/insurance industry, lock, stock
and $$ and that's why he is NOT supporting Obama's public health care option.
I engaged him one more time at a public meeting in Santa Monica. Same MO.
He may think he's working to protect Americans, but his means to that end
includes deception and acting with a lack of the kind of moral code I think our
President has.
All Democrats who oppose the public health care option should be forced to
consider that they might be voted out of office.
Michael Mooney
www.michaelmooney.net
www.medibolics.com
--- In PozHealth@yahoogroups.com, "Sanford Gross" <SGross@...> wrote:
>
> Hey Guys;
>
> I don't suppose this is a good time to make the announcement about Henry
Waxman's new book in which he details his life-long crusade to protect the
American public.
>
> At least, it was news to me. I nearly fell over in the bookstore.
>
> Ironic or just downright funny?
>
> Sanford
>
> Sanford M. Gross, OD, FAAO
> Associate Professor
> Illinois College of Optometry
> 3241 South Michigan Ave
> Chicago, Illinois 60616
>
> >>> Brian Mailman <bmailman@...> 7/6/2009 1:01 AM >>>
> Michael wrote:
> > I agree,
>
> No, I don't think you do, since you continue to misclassify. My point
> is that classing someone(s) that disagree with you as "the other" is
> simply the same dynamic as the conservatives you are bashing employ and
> you should know which is which, anyway.
>
> > however, my "conservative-bashing" includes wolves-in-sheeps-clothing
> > like Henry Waxman, who never say a paternalistic law to control your
> > behavior because you're-too-stupid-to-do-it-yourself that he didn't
> > champion.
>
> Which is a trad "liberal" position. To have an agency or bureau
> control, (e.g., expanded governmental control) things that individuals
> in a Jeffersonian model can and should control for themselves.
>
> > Waxman's Answers Drugs/steroids in sports! - Ban steroids from all
> > uses. Michael Jackson dies of painkillers. -Ban painkillers. Vitamins
> > compete with drugs, according to FDA in the federal register. -Make
> > vitamins into prescription-only items.
>
> Those are not trad conservative positions, as I said. You're describing
> aspects of the nanny state. What the conservatives wish is a smaller
> government with less regulation (Bush, Rove, and Co. are an extreme
> aberration). As you seem to do.
>
> B/
>
A true conservative wants government to stay out of controlling people's lives -
I agree with them. Real liberals want to regulate some things to REALLY protect
and really take care of the public. I agree with that.
I agree with socialists related to health care and education.
Politically I am completely independent.
You mistake what I am "bashing."
The difference between my "bashing" and the way the current Refucklicans bash is
that I don't make things up that aren't true while making some kind of attempt
at character assassination or exaggerating the importance of odd trivia to
distract from the real issues. No, you're wrong. I do agree with you. And I
don't want small government when it comes to protecting the public from
industrial vampires. I want strong regulations that actually protect the
well-being of all the people, while giving the people full freedom to be
themselves.
Michael Mooney
--- In PozHealth@yahoogroups.com, Brian Mailman <bmailman@...> wrote:
>
> Michael wrote:
> > I agree,
>
> No, I don't think you do, since you continue to misclassify. My point
> is that classing someone(s) that disagree with you as "the other" is
> simply the same dynamic as the conservatives you are bashing employ and
> you should know which is which, anyway.
>
> > however, my "conservative-bashing" includes wolves-in-sheeps-clothing
> > like Henry Waxman, who never say a paternalistic law to control your
> > behavior because you're-too-stupid-to-do-it-yourself that he didn't
> > champion.
>
> Which is a trad "liberal" position. To have an agency or bureau
> control, (e.g., expanded governmental control) things that individuals
> in a Jeffersonian model can and should control for themselves.
>
> > Waxman's Answers Drugs/steroids in sports! - Ban steroids from all
> > uses. Michael Jackson dies of painkillers. -Ban painkillers. Vitamins
> > compete with drugs, according to FDA in the federal register. -Make
> > vitamins into prescription-only items.
>
> Those are not trad conservative positions, as I said. You're describing
> aspects of the nanny state. What the conservatives wish is a smaller
> government with less regulation (Bush, Rove, and Co. are an extreme
> aberration). As you seem to do.
>
> B/
>
There's always Viprofen (narcotic with ibuprofen) and Empirin #3 (narcotic and aspirin) so it's not like there are no alternatives to using acetaminophen. My understanding is there is a synergy between the two ingredients. Together, they give better pain relief than only one or the other. I've avoided acetaminophen for years. It does nothing for me except make me feel slightly nauseated.
--- On Fri, 7/3/09, jetonxxx <jeton@...> wrote:
From: jetonxxx <jeton@...> Subject: [PozHealth] Re: NATAP: Ban Vicodin/Percocet-FDA Panel Recommends BULLSHIT To: PozHealth@yahoogroups.com Date: Friday, July 3, 2009, 10:48 AM
i also have experience with acetaminophen, having had a 105.5 fever for a week in 1995, with highly elevated liver enzymes, with nothing to explain it besides having taken 3 vicodins and and 3 medium-strong drinks. i wasn't taking NAC at the time, and most people don't.
Ah, I at first requested Vicoprofen to avoid acetaminophen, but because it is
kidney toxic, it raised my blood pressure A LOT. I'm not sure that it isn't more
kidney toxic than acetaminophen is liver toxic. Maybe someone who is a
pharmacologist here knows. I switched to Vicodin, then Norco -- which has less
acetaminophen per amount of hydrocodone for the most benign effect.
Michael Mooney
--- In PozHealth@yahoogroups.com, Flipper 501501 <flipper501501@...> wrote:
>
> There's always Viprofen (narcotic with ibuprofen) and Empirin #3 (narcotic and
aspirin) so it's not like there are no alternatives to using acetaminophen. My
understanding is there is a synergy between the two ingredients. Together, they
give better pain relief than only one or the other. I've avoided acetaminophen
for years. It does nothing for me except make me feel slightly nauseated.
>
> --- On Fri, 7/3/09, jetonxxx <jeton@...> wrote:
>
> From: jetonxxx <jeton@...>
> Subject: [PozHealth] Re: NATAP: Ban Vicodin/Percocet-FDA Panel Recommends
BULLSHIT
> To: PozHealth@yahoogroups.com
> Date: Friday, July 3, 2009, 10:48 AM
>
>
>
>
>
>
>
>
>
>
>
>
>
>
>
>
>
> i also have experience with acetaminophen, having had a 105.5 fever for
a week in 1995, with highly elevated liver enzymes, with nothing to explain it
besides having taken 3 vicodins and and 3 medium-strong drinks. i wasn't taking
NAC at the time, and most people don't.
>
"Acetaminophen, where it is known as paracetamol in Europe, I hear is often
sold with its antidote. NAC."
Is it? I never heard of that.
When properly used, paracetamol is quite stomach friendly, with the desired
effect.
And properly used means: staying within the recommended limit of 6 x 500 mg
a day.
Only over 15 x 500mg it is consired harmfull to the liver.
And indeed, in case of overdose, NAC is an antidote.
I consider acetaminophen/paracetamol much safer than NSAID's.
The use of NSAID's, even within their safetly limit, can give many side
efects.
Chronic use of NSAIS's in the Netherlands is always accompanied with proton
pump inhibitors to prevent gastric bleeding.
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.
For this being 2009, in some ways we've not come very far.
"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.
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.
The issue of opiophobia is inversely connected to the pairing of acetaminophen
and opiates...opiophobia is what coupled the two drug classes together in the
first place.
There is a patient-driven movement in the USA towards overcoming that doctors'
opiophobia, and many medical bodies are coming to support that movement.
decoupling acetaminophen and opiates makes that easier, because the combination
of the two is simply one of the biggest (or the biggest, depending on the
information source) causes of drug overdoses in the US.
ALL press coverage of the FDA panel decision has focused on the danger involved
being from acetaminophen, not from any opiate. This can only help the cause of
the pain-management movement, as even the most disconnected doctors learn that
the FDA is not as concerned with opiates as they feared. More so now that we
have a rational Executive in place.
I dont know what the over-the-counter drug market looks like in the UK, but here
in the US one can find acetaminophen everywhere and in almost everything.
However, as a result of opiophobia, overdoses and fatalities that should have
been attributed to (prescribed and non-prescribed) acetaminophen were attributed
to prescribed opiates instead.
As you yourself point out, opiates have an exceptionally wide therapeutic
range...but acetaminophen has an exceptionally narrow range. the horridly
paternalistic attitude that paired them together in the first place (expressly
to punish "unauthorized" opiate use) has destroyed tens or hundreds of thousands
of livers and lives pointlessly, and ironically exacerbated the opiophobia that
leaves many in needless agony.
decoupling them has been a long time coming, and will ultimately benefit
patients medically...and politically.
Jeton
********
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).
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.
"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.
I have given this issue a great deal of thought over the
course of the past few days, and I am grateful to those persons who have
complimented me, and for their kind remarks.I stand by the central argument that I
made in my earlier message – which is that banning drugs such as Norco (hydrocodone mixed with APAP), Vicodin
(hydrocodone mixed with APAP), Tylenol #3 with Codeine
(codeine mixed with APAP), Darvocet
(dextro-propoxyphene mixed with APAP), etc. will have tragic, and even lethal
consequences in the USA.I further believe that the consequences
of banning these compound medications in the UK would be very, very different
from the consequences of banning these compound medications in the USA.
Hydrocodone, on its own, is classified as a Schedule II
drug.Codeine,
on its own, is also classified as a Schedule II drug.Dextro-propoxyphene,
on its own, is also classified as a Schedule II drug.Dihydrocodeine,
on its own, is also classified as a Schedule II drug.What all of these drugs have in common,
besides their being scheduled as Schedule II drugs in the USA, is the fact that they are relatively
weak mu opioid agonists.The “gold standard” against
which all opiates and opioids are measured remains morphine,
despite the fact that there are many, many drugs currently available that are more
powerful than morphine on a milligram for milligram basis (examples include hydromorphone, oxycodone,
fentanyl, and oxymorphone).
There is a class of drugs, the members of which are very,
very widely prescribed throughout the world.It is now well-established that drugs in
this class are highly addictive psychologically, and mildly addictive physiologically.Despite the unequivocal nature of these
findings, and despite efforts on the part of both governments and physicians to
reduce the number of prescriptions written for these drugs, these drugs remain
extremely popular, and large pharmaceutical companies continue to work on
changing the molecular structures of these drugs in such a manner as to
maintain their efficacy whilst rendering them less likely to lead to physiological
addition.The drugs to which I
refer are known as the benzodiazepines
(BZDs), and members of this class of drugs include diazepam
(Valium), clonazepam (Klonopin), lorazepam (Ativan), temazepam (Restoril), flurazepam (Dalmane), oxazepam (Serax), triazolam (Halcion), and alprazolam (Xanax).Although only about 15 drugs from this
class are licensed for marketing in the USA, more than 80 BZDs have been
developed and sold in Western nations throughout the world.(I have compiled a list of BZDs and
their characteristics, and would be happy to circulate this list to any person
requesting it from me at philipchandler domain earthlink dot net.)
All of these drugs alleviate anxiety (are anxiolytic); many of them help people to fall asleep or to
remain asleep (are hypnotic); many
of these drugs cause retrograde amnesia (are amnestic)
(which is desirable when performing unpleasant and uncomfortable procedures,
e.g. colonoscopies); and many of these drugs function as muscle
relaxants.Notwithstanding the fact that these drugs are highly addictive
psychologically, and mildly addictive physiologically, they remain extremely
popular.Back in the early 1980s,
doctors started to appreciate the extent to which these drugs lead to
addiction, and legislatures around the world tightened up on the prescription
of these drugs.Nevertheless,
doctors continued to prescribe drugs from this class extensively.Although the BZDs unquestionably induce
tolerance (particularly to their hypnotic effects), many patients who take them
insist that they continue to function and to keep them calm years after they
were first prescribed for them.(In
the interests of full disclosure – I take lorazepam for panic attacks and
anxiety, and am profoundly grateful to the scientists who first figured out
that a combination of a benzene ring and a diazepine ring acted to potentiate
the effects of a neurotransmitter known as gamma-aminobutyric acid (GABA),
which relaxes and “calms down” the brain.)
The New YorkState legislature
demonstrated what can and does occur when politicians, uninhibited by wisdom,
knowledge, or experience, make medical decisions and impair the ability of
licensed medical professionals to make medical decisions about which the politicians
know absolutely nothing.Effective
January 1, 1990, all prescriptions for BZDs written in the State of New York had to be
written up on Schedule II prescription blanks.These prescription blanks are issued in
triplicate; the pharmacist retains one copy; the doctor retains one copy; and
one copy is sent to the state Department of Health.Although the BZDs remained Schedule IV
medications, for all practical purposes, they had become Schedule II medications.No prescriptions issued on Schedule II
prescription blanks may be refilled; a new prescription must be obtained each
time the old prescription runs out.The prescribing habits of all physicians are monitored by the state
Department of Health, where bureaucrats who know absolutely nothing about psychopharmacology
assume the role of monitors, logging and keeping track of the prescribing
habits of doctors who write out prescriptions for BZDs.
The results were both tragic and predictable.There was an immediate, sharp drop in
the number of prescriptions written for BZDs such as Xanax and Valium.New YorkState
took a huge leap backwards into the medical dark ages, as doctors up and down
the state dusted off old and relatively useless drugs with relatively narrow
therapeutic indices such as meprobamate and chloral hydrate, and prescribed
these dangerous old drugs (which the BZDs were intended
to replace!) for anxiety and insomnia respectively.There was also a corresponding, sharp
increase in the number of patients admitted to emergency rooms up and down the
state suffering from the effects of overdoses of these old, dangerous
remedies.Frustrated patients
continued to demand BZDs from their doctors, who were now no longer willing to
prescribe them, and many patients turned to the Internet to obtain these
drugs.“Prescription mills”
flourished all over the country.Eventually, even the most hardened doctors started to relax their rigid
postures, and started to issue prescriptions for BZDs on triplicate
prescription blanks, despite the risk they ran of being audited by the state
Department of Health.Fortunately
for both doctors and patients alike, the state Department of Health simply lacks
the manpower to intimidate every doctor who determines that the prescription of
BZDs is warranted in individual cases, and after several years during which it was
all but impossible for patients in the State of New York to obtain
prescriptions for drugs in this class, the forces of supply and demand slowly
went back to work.One BZD in
particular – alprazolam (Xanax) – was favoured by those doctors who
took the risk of prescribing drugs from this class once again.Upjohn Pharmaceuticals conducted a
highly successful marketing campaign for this particular BZD, which is now by
far and away the most heavily prescribed BZD in the State of New York.Ironically, alprazolam (Xanax) is also
amongst the most addictive of the BZDs, because of its relatively short
half-life (about 6 – 12 hours) and its very high potency (about 0.5 mg of
alprazolam has the anxiolytic effect of about 10 mg of diazepam).
So we already have a model of what would occur in the USA should an
entire class of drugs be subjected to tighter surveillance and regulation.Also, I take into consideration my personal
experience.I used to take
OxyContin 80 mg twice daily in the USA,
with Norco 10 /
325 prescribed for breakthrough pain.Upon arriving in the UK and presenting my medical records to a general
practitioner in the UK, she continued the OxyContin (in a much higher dose) and
instead of Norco 10 / 325, she prescribed OxyNorm 10 mg and OxyNorm 20 mg
capsules for breakthrough pain, with Co-codamol (equivalent to Tylenol with
Codeine #3 in the USA) only for
the more mild episodes of breakthrough pain.In other words, my UK physician had no fear of
prescribing a Schedule II controlled substance for the treatment of both
chronic pain and episodes of breakthrough
pain; she prescribed the Schedule III controlled substance only for the
alleviation of the more mild episodes of breakthrough pain.This represents an entirely different
and infinitely more merciful philosophy towards the treatment of chronic pain
than that which prevails in the USA.
What I am trying to say is that, were I convinced that USA
doctors would switch to prescribing hydrocodone (or oxycodone, or codeine, or
dextro-propoxyphene, etc.) and APAP separately, I would probably be less
opposed to the proposed elimination of so many Schedule III drugs.Were I
convinced that the more enlightened UK approach would prevail, I would
probably see the sense in eliminating so many of the Schedule III drugs that
currently exist.Somebody remarked
that it was opiophobia itself that contributed to the development of so many
compound analgesics, in which such high doses of APAP are combined with
Schedule II drugs.If this is true,
however, it merely highlights the dangers that would accompany the elimination
of so many Schedule III compound analgesics – opiophobia has not
disappeared (although it is slowly being conquered) and shows no signs of disappearing
any time soon.The result would
almost certainly be a repeat of what occurred in the State of New York in the 1990s – but this time,
chronic pain (as opposed to anxiety) would be permitted to continue to ruin
countless lives.
(As an aside – the drug scheduling system permits the
above-mentioned Schedule II drugs (e.g. hydrocodone) to be sold and prescribed
under Schedule III provided they are mixed with as
little as 15 mg of APAP – this is not widely known!In other words, a compounding pharmacy
can create a combination of hydrocodone 10 mg and APAP 15 mg and distribute
this on a Schedule III prescription.I forget the ceiling dose of the Schedule II medication, but I do remember
reading that the lowest permissible dose of the APAP in a Schedule III compound
analgesic can be as low as 15 mg, which is virtually nothing!)
The extent to which opiophobia is still prevalent can be
assessed first-hand by going into any search engine and entering the search
string “Richard Paey” or the
search string “Howard Hurwitz”.The former was a patient, locked up by
the State of Florida not because he had trafficked in prescription painkillers
(the prosecution acknowledged that it has absolutely no evidence whatsoever
that Paey had ever trafficked in his painkillers, despite having placed him
under surveillance for several months, and further stipulated that it believed
his claims that he had consumed everything that had been prescribed for him –
however, he will still convicted of “trafficking” based solely on
the amount of painkiller prescriptions that he filled, despite the fact that he
had not “diverted” them or in any way abused them).The latter was a doctor, sentenced to a
prison term for prescribing “too many” painkillers to patients in
genuine need of pain relief.Paey
was ultimately granted an unconditional pardon, due to sustained pressure
applied to the governor by outraged sufferers of chronic pain.To the best of my knowledge, however, Hurwitz
remains in prison.A prominent pain
control doctor remains a much more juicy target for an
ambitious prosecutor than does a patient suffering from chronic pain due to an
automobile accident!
Such scenarios are utterly unthinkable in the UK.The National Health Service (NHS) has
been criticized by arrogant and ignorant people as being a form of “socialized
medicine”, and detractors enjoy recounting horror stories of people not
properly treated – but this system works infinitely better than the
patchwork quilt of coverage available only to the privileged employed in the USA.One of the reasons I very much doubt I will
ever return to the USA
is because I would have such difficulty obtaining adequate pain relief.
I hope that people will really grant this issue a great deal
of thought, and look to the lessons of recent New YorkState
history before blindly agreeing to the decision to eliminate so many Schedule
III drugs.
PHILIP
CHANDLER
From: PozHealth@yahoogroups.com
[mailto:PozHealth@yahoogroups.com] On Behalf
Of Michael Sent: 06 July 2009 11:13 To: PozHealth@yahoogroups.com Subject: [PozHealth] Re: Fw:
NATAP: Ban Vicodin/Percocet-FDA Panel Recommends
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.
"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.
I called Rich Degarmo at Degarmo's Compounding Pharmacy and relayed enough of
what you said that he agreed that his groups trying to get nandrolone made into
a schedule 2 was not a good idea and they will back off.
Thank you,
Michael Mooney
www.michaelmooney.net
www.medibolics.com
www.twitter.com/michaelkmooney
> 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.
Acetaminophen/paracetamol even at the current recommended dose can cause
liver toxicity in some people, especially if taken over several days.
People with chronic hep B or C may be at greater risk (though studies
are mixed). But most drugs can cause severe side effects in some people
-- doesn't mean they should all be banned.
A lot of acetaminophen overdoses are suicide attempts, so selling it
with NAC wouldn't help, since those people wouldn't take the antidote. I
wonder if you could co-formulate acetaminophen with NAC, since it's not
harmful and lots of people use it as a supplement?
Others boost their dose of Vicodin or Percocet to get more of the
narcotic (either because the longer they use it, the more they need to
control pain, or sometimes for recreational use), and end up getting too
much acetaminophen in the process. If they can sell the combo by
prescription without being Schedule II, I don't see why they can't sell
hydrocodone alone, and then people who also wanted acetaminophen could
take it separately.
It's only logical to sell hydrocodone alone, for full freedom to choose for the
doctor -- and the patient.
Michael Mooney
--- In PozHealth@yahoogroups.com, Liz Highleyman <liz@...> wrote:
>
> > 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.
>
> Acetaminophen/paracetamol even at the current recommended dose can cause
> liver toxicity in some people, especially if taken over several days.
> People with chronic hep B or C may be at greater risk (though studies
> are mixed). But most drugs can cause severe side effects in some people
> -- doesn't mean they should all be banned.
>
> A lot of acetaminophen overdoses are suicide attempts, so selling it
> with NAC wouldn't help, since those people wouldn't take the antidote. I
> wonder if you could co-formulate acetaminophen with NAC, since it's not
> harmful and lots of people use it as a supplement?
>
> Others boost their dose of Vicodin or Percocet to get more of the
> narcotic (either because the longer they use it, the more they need to
> control pain, or sometimes for recreational use), and end up getting too
> much acetaminophen in the process. If they can sell the combo by
> prescription without being Schedule II, I don't see why they can't sell
> hydrocodone alone, and then people who also wanted acetaminophen could
> take it separately.
>
> --
> Liz Highleyman
> Freelance journalist
> liz@...
> 415-305-0821
>