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MAPTalk-Digest Wednesday, December 29 2004 Volume 04 : Number 227

001 Fw: MAP: Re: DPFWI: FDA approves new drug for severe pain
    From: Thomas J Hillgardner <>
002 Re: FDA approves new drug for severe pain
    From: "SHeath(DPFFLorida)" <>
003 Re: MAP: Re: DPFWI: FDA approves new drug for severe pain
    From: "D.H. Michon" <>
004 Re: MAP: Re: DPFWI: FDA approves new drug for severe pain
    From: Thomas J Hillgardner <>


----------------------------------------------------------------------

Subj: 001 Fw: MAP: Re: DPFWI: FDA approves new drug for severe pain
From: Thomas J Hillgardner <>
Date: Tue, 28 Dec 2004 23:17:40 -0500

"Side effects may include dizziness, drowsiness and altered mental
status, with patients confused at times."  Yeah, but is it good with a
couple of beers?  Or how much can you get for a few tabs of Prialt
(ziconotide) on the street downtown near the methadone clinic?  This is
going to solve the drug problem?  As with most pain relievers, if you
build it, they will come.  I wonder how much is an overdose quantity? 
Its pretty funny how both the Elan Pharmaceuticals spokesperson and the
FDA doc were like "there is no other drugs for pain relief after
morphine."  Talk about living in an altered state of consciousness!

My perspective never is mainstream, but I would like to think that the
recent FDA debacle with the Cox-2 inhibitors really has to make the words
of the D.C. drug warriors - that marijuana is not safe - ring hollow to
even the most unquestioning lout.  The plain vanilla truth is that
20-year longitudinal studies on every conceivable side effect are what is
required to assure the public that a substance is "safe."  This is never
done for any substance.  Instead, limited studies are required and there
is a monitoring program under federal law requiring health practitioners
to report all events of severe adverse reactions to the administration of
any FDA-approved drug.  And where there are billions of dollars to be
made selling hope and with the public clamoring for medical
breakthroughs, the FDA does not require an applicant to demonstrate that
a drug is safe before allowing it on the market.  An applicant need only
show that it appeared safe in clinical trials.  It is the media that has
led the American public to believe that FDA approval = safe.  Nothing is
ever safe or secure in the real world where there are risks inherent in
going out or staying at home.

There is even one medication that is advertised on TV that when they get
to the side effects disclaimer, there is a mention of rare reports of
death.  And the government is concerned that marijuana is not safe.

Thomas J. Hillgardner, Esq.
82-63 170th Street
Jamaica, New York 11432-2035
(718) 657-0606


- --------- Forwarded message ----------
From: "D.H. Michon" <>
To: <>, <>, <>
Date: Tue, 28 Dec 2004 21:21:38 -0600
Subject: MAP: Re: DPFWI: FDA approves new drug for severe pain
Message-ID: <000b01c4ed55$832ffda0$a1f5bc42@yourlk4rlmsu41>
References: <00c901c4ed2e$2e65f990$5922fea9@your74e0cdbdb2>

I think this derives from the "anything but opioids" thinking the WOD has

infused govermental creatures with for a long time. Witness the Vioxx, 
Celebrex, etc. revelations. Those drugs were pushed not because they are 
great pain relievers but because they are "non-narcotic." The same holds 
with this new class of drugs: they claim there are people who are not
helped 
by morphine but ignore the fact that heroin would definitely do the job 
(and, if it didn't, there are plenty of choices in "The Bentley
Compounds" 
famous for fentanyl and etorphine). Not only do they ignore this obvious 
fact but they appear willing to let the patient accrue severe risk  from 
this new drug despite what happened with the Cox2 inhibitors like Vioxx.
Oh, 
and ya can't just increase the dose, that's too sensible, that's what Dr 
Hurwitz did. It's crazy and it's fueled by the Drug War.
- ----- Original Message ----- 
From: "G F Storck" <>
To: "DPFWI" <>
Sent: Tuesday, December 28, 2004 4:40 PM
Subject: DPFWI: FDA approves new drug for severe pain

> Typical FDA double standard. The same logic has been applied to
cannabis, 
> but I guess that patient population isn't important enough for federal 
> bureaucrats. -- GS
>
> 
>
> There are side effects, and the FDA was including a "black box" warning
- --  
> the government's strongest warning short of a ban. Side effects may 
> include dizziness, drowsiness and altered mental status, with patients 
> confused at times.
>
> Despite the side effects, the drug was approved because there are no
other 
> options for these patients and the benefits outweighed the risks, said
Dr. 
> Robert Meyer, director of the FDA's Office of Drug Evaluation II.
>
> "Because this is such an important patient population where they have
such 
> pain and they have so few options we felt this drug does offer some
real 
> gains," he said.
>
> 
> ----------------
> FDA approves new drug for severe pain
> - LAURA MECKLER, Associated Press Writer
> Tuesday, December 28, 2004
>
> (12-28) 13:42 PST WASHINGTON (AP) --
>
> The government approved a drug Tuesday that offers a new way of
fighting 
> severe pain -- an option for patients who no longer benefit from
morphine 
> and other traditional pain medications.
>
> It's the first in a new class of drugs that selectively blocks the
nerve 
> channels responsible for transmitting pain signals. It will be marketed
as 
> Prialt and should be available by the end of January.
>
> "When you've taken all the kinds of pain medication that there is and
you 
> still have pain, that is a very frightening situation," said Dr. Lars 
> Ekman, president of research and development for the drug's
Ireland-based 
> manufacturer, Elan. "When you have that kind of pain, there is nowhere
to 
> go."
>
> The drug is part of a new class known as N-type calcium channel
blockers. 
> It is known chemically as ziconotide.
>
> Morphine is the standard treatment for severe pain from cancer, AIDS, 
> amputations and other significant illnesses, but its effects eventually

> wear off and the dosage must be increased. At some point, many patients

> switch from taking medication by mouth or by injection to a
microinfusion 
> pump implanted under the skin that delivers drugs directly into the
fluid 
> surrounding the spinal cord.
>
> Ekman said about 35,000 to 50,000 Americans have these pumps now. The
Food 
> and Drug Administration approved Prialt for patients who are already
using 
> these pumps but not getting effective relief from them or who cannot 
> tolerate the available treatments.
>
> This is the first new drug in 20 years to treat pain using such a pump.
>
> Prialt has been studied in patients with cancer, AIDS and other chronic

> pain, such as back pain. More than 1,200 patients took part in three 
> clinical trials.
>
> There are side effects, and the FDA was including a "black box" warning
- --  
> the government's strongest warning short of a ban. Side effects may 
> include dizziness, drowsiness and altered mental status, with patients 
> confused at times.
>
> Despite the side effects, the drug was approved because there are no
other 
> options for these patients and the benefits outweighed the risks, said
Dr. 
> Robert Meyer, director of the FDA's Office of Drug Evaluation II.
>
> "Because this is such an important patient population where they have
such 
> pain and they have so few options we felt this drug does offer some
real 
> gains," he said.
>
> Patients with a history of psychoses should not receive it, and all
others 
> should be monitored for signs of cognitive impairment, he said.
>
> The idea for the drug came from a snail called the Conus magus that
lives 
> in the South Pacific, which paralyzes its victims with venom after 
> capturing them, the company said. Researchers set out learning how to 
> develop a drug based on this venom and eventually copied the amino acid

> sequence.
>
> Elan would not say how much it plans to charge for the drug. On the
Net:
>
> FDA: www.fda.gov
>
> Elan: www.elan.com
>
> URL: 
>
http://sfgate.com/cgi-bin/article.cgi?file=/news/archive/2004/12/28/na
nal1642EST0612.DTL
> 2004 Associated Press 

------------------------------

Subj: 002 Re: FDA approves new drug for severe pain
From: "SHeath(DPFFLorida)" <>
Date: Tue, 28 Dec 2004 23:44:52 -0500

At 11:17 PM 12/28/04, Tom Hillgardner wrote:
>There is even one medication that is advertised on TV that when they get
>to the side effects disclaimer, there is a mention of rare reports of
>death.  And the government is concerned that marijuana is not safe.
>
>T

Steve: No drug in the current pharmacopia is held to the standard 
Prohibitionists insist must be applied to cannabis.

Much like the mantras recited when we discuss Regulation in preference to 
Prohibition.

"There will still be teens who can get drug ?, so your plan of Regulation 
is not worthy"

Whenever the adjectives 'safe' or 'risky' are presented, the first response 
should always be, "Compared to what?"

Marijuana use is Risky.

Compared to what?

Drug ? is Safe.

Compared to what?

Only then is valid discussion possible.

Peace from Clearwater, and oh yeah, it was 73 and sunny today.....heh

Steve

------------------------------

Subj: 003 Re: MAP: Re: DPFWI: FDA approves new drug for severe pain
From: "D.H. Michon" <>
Date: Wed, 29 Dec 2004 01:21:54 -0600

Thomas Hillgardner wrote: "Or how much can you get for a few tabs of Prialt 
(ziconotide) on the street downtown near the methadone clinic?"

As a methadone-maintained addict I take exception to the comment above, and 
on a drug law reform list no less! Having stated that, I realize it was 
written with tongue in cheek and presume no offence was intended. But Jesus 
H Christ! - we got enough stigma! - we don't need any more. Especially when 
the government itself issued a study that showed diverted methadone did not 
come from methadone clinics but from pill mills. To whit:
http://www.samhsa.gov/news/newsreleases/040206nr_deaths.htm
UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVISES
SUBTANCE ABUSE & MENTAL HEALTH SERVICES ADMINISTRATION

SAMHSA News Release
Date: February 6, 2004
Media Contact: Leah Young
Phone: 301-443-8956

Methadone Deaths Not Linked to Misuse of Methadone from Treatment Centers

Methadone-associated deaths are not being caused primarily by methadone 
diverted from methadone treatment programs, a panel of experts convened by 
the Substance Abuse and Mental Health Services Administration (SAMHSA), 
reported. The methadone report was released today by SAMHSA's Center for 
Substance Abuse Treatment Director, H. Westley Clark, M.D., J.D., M.P.H., at 
the Sixth International Conference on Pain and Chemical Dependency in New 
York City.

The consensus report, "Methadone-Associated Mortality, Report of a National 
Assessment," concludes that "although the data remain incomplete, National 
Assessment meeting participants concurred that methadone tablets and/or 
diskettes distributed through channels other than opioid treatment programs 
most likely are the central factor in methadone-associated mortality."

SAMHSA convened the panel to determine whether its methadone regulations 
were allowing diversion of methadone from clinics or whether the rise of 
methadone mentions in hospital emergency rooms and reports of deaths were 
due to methadone coming from other sources. Hospital emergency department 
visits involving methadone rose 176 percent from 1995 to 2002. The rise from 
2000 to 2002 was 50 percent, according to SAMHSA's Drug Abuse Warning 
Network. The panel of state and federal experts, researchers, 
epidemiologists, pathologists, toxicologists, medical examiners, coroners, 
pain management specialists, addiction medicine specialists and others was 
convened in May 2003

"The participants in the meeting reviewed data on methadone formulation, 
distribution, patterns of prescribing and dispensing, as well as relevant 
data on drug toxicology and drug-associated morbidity and mortality, before 
concluding that the cases of overdosing individuals were not generally 
linked to methadone derived from opioid treatment programs," SAMHSA 
Administrator Charles Curie said. "SAMHSA will continue to monitor the 
situation to insure that SAMHSA's supervision of opioid treatment programs 
is always in the public interest."

"The Office of National Drug Control Policy (ONDCP) is pleased that the 
consensus report findings demonstrate that the controls on methadone are 
working," Dr. Andrea Barthwell, Deputy Director for Demand Reduction at the 
White House Office of National Drug Control Policy, said. "We applaud the 
diligence that the providers of methadone have shown in keeping this a safe 
modality for the patients they serve and the communities in which they 
reside."

The panel based it conclusion that methadone is coming from other sources on 
data showing that the greatest growth in methadone distribution in recent 
years is associated with its use as a prescription analgesic prescribed for 
pain, primarily in solid tablet or diskette form, and not in the liquid 
formulations that are the mainstay of opioid treatment programs that treat 
patients with methadone for abuse of heroin or prescription pain killers.

"Methadone continues to be a safe, effective treatment for addiction to 
heroin or prescription painkillers," Dr. Clark said. "While deaths involving 
methadone increased, experiences in several states show that addiction 
treatment programs are not the culprits."

The expert panel learned that in North Carolina only four percent of the 
decedents were participating in addiction treatment at or near the time of 
death, and in Washington State use of multiple drugs was reported in 92 
percent of deaths involving methadone. In Texas, cases of overdose involving 
persons being treated in opioid treatment programs declined between 1999 and 
2002.

The experts noted that the increasing numbers of prescriptions for methadone 
are paralleling the increase in prescriptions for oxycodone, hydrocodone, 
and morphine, as physicians prescribe to ameliorate chronic pain.

The panel recommended creation of case definitions that would make a 
distinction between deaths caused by methadone and deaths in which methadone 
is a contributing factor or merely present. They want health care curricula 
to train health care professionals in both "the diagnosis and treatment of 
addiction and appropriate pharmacotherapies for pain."

The experts surmise that current reports of methadone deaths involve one of 
three scenarios: illicitly obtained methadone used in excessive or 
repetitive doses in an attempt to achieve euphoric effects; methadone, 
either licitly or illicitly obtained, used in combination with other 
prescription medications, such as benzodiazepines (anti-anxiety 
medications), alcohol or other opioids; or an accumulation of methadone to 
harmful serum levels in the first few days of treatment for addiction or 
pain, before tolerance is developed.

SAMHSA, a public health agency within the U.S. Department of Health and 
Human Services, is the lead federal agency for improving the quality and 
availability of substance abuse prevention, addiction treatment and mental 
health services in the United States.

- ----- Original Message ----- 
From: "Thomas J Hillgardner" <>
To: <>
Sent: Tuesday, December 28, 2004 10:17 PM
Subject: Fw: MAP: Re: DPFWI: FDA approves new drug for severe pain

> "Side effects may include dizziness, drowsiness and altered mental
> status, with patients confused at times."  Yeah, but is it good with a
> couple of beers?  Or how much can you get for a few tabs of Prialt
> (ziconotide) on the street downtown near the methadone clinic?  This is
> going to solve the drug problem?  As with most pain relievers, if you
> build it, they will come.  I wonder how much is an overdose quantity?
> Its pretty funny how both the Elan Pharmaceuticals spokesperson and the
> FDA doc were like "there is no other drugs for pain relief after
> morphine."  Talk about living in an altered state of consciousness!
>
> My perspective never is mainstream, but I would like to think that the
> recent FDA debacle with the Cox-2 inhibitors really has to make the words
> of the D.C. drug warriors - that marijuana is not safe - ring hollow to
> even the most unquestioning lout.  The plain vanilla truth is that
> 20-year longitudinal studies on every conceivable side effect are what is
> required to assure the public that a substance is "safe."  This is never
> done for any substance.  Instead, limited studies are required and there
> is a monitoring program under federal law requiring health practitioners
> to report all events of severe adverse reactions to the administration of
> any FDA-approved drug.  And where there are billions of dollars to be
> made selling hope and with the public clamoring for medical
> breakthroughs, the FDA does not require an applicant to demonstrate that
> a drug is safe before allowing it on the market.  An applicant need only
> show that it appeared safe in clinical trials.  It is the media that has
> led the American public to believe that FDA approval = safe.  Nothing is
> ever safe or secure in the real world where there are risks inherent in
> going out or staying at home.
>
> There is even one medication that is advertised on TV that when they get
> to the side effects disclaimer, there is a mention of rare reports of
> death.  And the government is concerned that marijuana is not safe.
>
> Thomas J. Hillgardner, Esq.
> 82-63 170th Street
> Jamaica, New York 11432-2035
> (718) 657-0606
> 
>

------------------------------

Subj: 004 Re: MAP: Re: DPFWI: FDA approves new drug for severe pain
From: Thomas J Hillgardner <>
Date: Wed, 29 Dec 2004 09:21:12 -0500

No offense intended!  But like anything in life, not every person
maintained on methadone is dedicated to staying clean.  I pass two
methadone clinics on the frequent walk I take from my house to the Long
Island Rail Road station in Jamaica.  At one of them there frequently
appears to be purveyors of other narcotics and pain killers in the
vicinity.  There is stigma and then there is reality.  I cannot tell you
whether it is the clinic customers that are hawking "supplies" or other
folks who perceive that as a good market place location.  (In fairness,
it is also one block from the welfare office (a different stigma) and the
LIRR (no stigma)).  But it is a fact that someone is frequently selling
drugs on the street near that location.

Also, isn't that SAMSHA study using the same faulty reasoning to reach
its conclusion that deaths from methadone overdose are not caused by
methadone diverted from clinics as it uses to support its conclusions
that the increased potency of marijuana has led to an increase in
emergency room admissions?  Isn't it irrational to conclude from
"mentions" in the DAWN studies that the named drug "caused" the hospital
admission?  Just like with marijuana, perhaps the increase in mentions
may be due to an increase in the number of users.  Does anybody have the
stats on the number of persons enrolled in methadone programs for
comparison to the DAWN mentions?  Even the SAMSHA folks admitted that
their "data remain[ed] incomplete."  Yet they sure had enough paper on
hand to put out a press release trumpeting their conclusion from their
incomplete data set.

Thomas J. Hillgardner, Esq.
82-63 170th Street
Jamaica, New York 11432-2035
(718) 657-0606


On Wed, 29 Dec 2004 01:21:54 -0600 "D.H. Michon" <>
writes:
> Thomas Hillgardner wrote: "Or how much can you get for a few tabs of 
> Prialt 
> (ziconotide) on the street downtown near the methadone clinic?"
> 
> As a methadone-maintained addict I take exception to the comment 
> above, and 
> on a drug law reform list no less! Having stated that, I realize it 
> was 
> written with tongue in cheek and presume no offence was intended. 
> But Jesus 
> H Christ! - we got enough stigma! - we don't need any more. 
> Especially when 
> the government itself issued a study that showed diverted methadone 
> did not 
> come from methadone clinics but from pill mills. To whit:
> http://www.samhsa.gov/news/newsreleases/040206nr_deaths.htm
> UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVISES
> SUBTANCE ABUSE & MENTAL HEALTH SERVICES ADMINISTRATION
> 
> SAMHSA News Release
> Date: February 6, 2004
> Media Contact: Leah Young
> Phone: 301-443-8956
> 
> Methadone Deaths Not Linked to Misuse of Methadone from Treatment 
> Centers
> 
> Methadone-associated deaths are not being caused primarily by 
> methadone 
> diverted from methadone treatment programs, a panel of experts 
> convened by 
> the Substance Abuse and Mental Health Services Administration 
> (SAMHSA), 
> reported. The methadone report was released today by SAMHSA's Center 
> for 
> Substance Abuse Treatment Director, H. Westley Clark, M.D., J.D., 
> M.P.H., at 
> the Sixth International Conference on Pain and Chemical Dependency 
> in New 
> York City.
> 
> The consensus report, "Methadone-Associated Mortality, Report of a 
> National 
> Assessment," concludes that "although the data remain incomplete, 
> National 
> Assessment meeting participants concurred that methadone tablets 
> and/or 
> diskettes distributed through channels other than opioid treatment 
> programs 
> most likely are the central factor in methadone-associated 
> mortality."
> 
> SAMHSA convened the panel to determine whether its methadone 
> regulations 
> were allowing diversion of methadone from clinics or whether the 
> rise of 
> methadone mentions in hospital emergency rooms and reports of deaths 
> were 
> due to methadone coming from other sources. Hospital emergency 
> department 
> visits involving methadone rose 176 percent from 1995 to 2002. The 
> rise from 
> 2000 to 2002 was 50 percent, according to SAMHSA's Drug Abuse 
> Warning 
> Network. The panel of state and federal experts, researchers, 
> epidemiologists, pathologists, toxicologists, medical examiners, 
> coroners, 
> pain management specialists, addiction medicine specialists and 
> others was 
> convened in May 2003
> 
> "The participants in the meeting reviewed data on methadone 
> formulation, 
> distribution, patterns of prescribing and dispensing, as well as 
> relevant 
> data on drug toxicology and drug-associated morbidity and mortality, 
> before 
> concluding that the cases of overdosing individuals were not 
> generally 
> linked to methadone derived from opioid treatment programs," SAMHSA 
> 
> Administrator Charles Curie said. "SAMHSA will continue to monitor 
> the 
> situation to insure that SAMHSA's supervision of opioid treatment 
> programs 
> is always in the public interest."
> 
> "The Office of National Drug Control Policy (ONDCP) is pleased that 
> the 
> consensus report findings demonstrate that the controls on methadone 
> are 
> working," Dr. Andrea Barthwell, Deputy Director for Demand Reduction 
> at the 
> White House Office of National Drug Control Policy, said. "We 
> applaud the 
> diligence that the providers of methadone have shown in keeping this 
> a safe 
> modality for the patients they serve and the communities in which 
> they 
> reside."
> 
> The panel based it conclusion that methadone is coming from other 
> sources on 
> data showing that the greatest growth in methadone distribution in 
> recent 
> years is associated with its use as a prescription analgesic 
> prescribed for 
> pain, primarily in solid tablet or diskette form, and not in the 
> liquid 
> formulations that are the mainstay of opioid treatment programs that 
> treat 
> patients with methadone for abuse of heroin or prescription pain 
> killers.
> 
> "Methadone continues to be a safe, effective treatment for addiction 
> to 
> heroin or prescription painkillers," Dr. Clark said. "While deaths 
> involving 
> methadone increased, experiences in several states show that 
> addiction 
> treatment programs are not the culprits."
> 
> The expert panel learned that in North Carolina only four percent of 
> the 
> decedents were participating in addiction treatment at or near the 
> time of 
> death, and in Washington State use of multiple drugs was reported in 
> 92 
> percent of deaths involving methadone. In Texas, cases of overdose 
> involving 
> persons being treated in opioid treatment programs declined between 
> 1999 and 
> 2002.
> 
> The experts noted that the increasing numbers of prescriptions for 
> methadone 
> are paralleling the increase in prescriptions for oxycodone, 
> hydrocodone, 
> and morphine, as physicians prescribe to ameliorate chronic pain.
> 
> The panel recommended creation of case definitions that would make a 
> 
> distinction between deaths caused by methadone and deaths in which 
> methadone 
> is a contributing factor or merely present. They want health care 
> curricula 
> to train health care professionals in both "the diagnosis and 
> treatment of 
> addiction and appropriate pharmacotherapies for pain."
> 
> The experts surmise that current reports of methadone deaths involve 
> one of 
> three scenarios: illicitly obtained methadone used in excessive or 
> repetitive doses in an attempt to achieve euphoric effects; 
> methadone, 
> either licitly or illicitly obtained, used in combination with other 
> 
> prescription medications, such as benzodiazepines (anti-anxiety 
> medications), alcohol or other opioids; or an accumulation of 
> methadone to 
> harmful serum levels in the first few days of treatment for 
> addiction or 
> pain, before tolerance is developed.
> 
> SAMHSA, a public health agency within the U.S. Department of Health 
> and 
> Human Services, is the lead federal agency for improving the quality 
> and 
> availability of substance abuse prevention, addiction treatment and 
> mental 
> health services in the United States.
> 
> ----- Original Message ----- 
> From: "Thomas J Hillgardner" <>
> To: <>
> Sent: Tuesday, December 28, 2004 10:17 PM
> Subject: Fw: MAP: Re: DPFWI: FDA approves new drug for severe pain
> 
> 
> > "Side effects may include dizziness, drowsiness and altered 
> mental
> > status, with patients confused at times."  Yeah, but is it good 
> with a
> > couple of beers?  Or how much can you get for a few tabs of 
> Prialt
> > (ziconotide) on the street downtown near the methadone clinic?  
> This is
> > going to solve the drug problem?  As with most pain relievers, if 
> you
> > build it, they will come.  I wonder how much is an overdose 
> quantity?
> > Its pretty funny how both the Elan Pharmaceuticals spokesperson 
> and the
> > FDA doc were like "there is no other drugs for pain relief after
> > morphine."  Talk about living in an altered state of 
> consciousness!
> >
> > My perspective never is mainstream, but I would like to think that 
> the
> > recent FDA debacle with the Cox-2 inhibitors really has to make 
> the words
> > of the D.C. drug warriors - that marijuana is not safe - ring 
> hollow to
> > even the most unquestioning lout.  The plain vanilla truth is 
> that
> > 20-year longitudinal studies on every conceivable side effect are 
> what is
> > required to assure the public that a substance is "safe."  This is 
> never
> > done for any substance.  Instead, limited studies are required and 
> there
> > is a monitoring program under federal law requiring health 
> practitioners
> > to report all events of severe adverse reactions to the 
> administration of
> > any FDA-approved drug.  And where there are billions of dollars to 
> be
> > made selling hope and with the public clamoring for medical
> > breakthroughs, the FDA does not require an applicant to 
> demonstrate that
> > a drug is safe before allowing it on the market.  An applicant 
> need only
> > show that it appeared safe in clinical trials.  It is the media 
> that has
> > led the American public to believe that FDA approval = safe.  
> Nothing is
> > ever safe or secure in the real world where there are risks 
> inherent in
> > going out or staying at home.
> >
> > There is even one medication that is advertised on TV that when 
> they get
> > to the side effects disclaimer, there is a mention of rare reports 
> of
> > death.  And the government is concerned that marijuana is not 
> safe.
> >
> > Thomas J. Hillgardner, Esq.
> > 82-63 170th Street
> > Jamaica, New York 11432-2035
> > (718) 657-0606
> > 
> >
> 
> 
> 

------------------------------

End of MAPTalk-Digest V04 #227
******************************

Mark Greer ()         ___ ___     _ _  _ _
Media Awareness Project              /' _ ` _ `\ /'_`)('_`\
P. O. Box 651                        | ( ) ( ) |( (_| || (_) )
Porterville, CA 93258                (_) (_) (_) \__,_)| ,__/
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