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Medical Forum / General / Cardiology / December 2004

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Gout from Lipitor damage? NAPROXEN increases heart attack risk. BEWARE

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Sharon Hope - 22 Dec 2004 02:03 GMT
The FDA warned today that NAPROXEN increases heart attack risk. The radio
news story said it was "an arthritis drug." (Gout is considered a form of
arthritis)

I called my husband from work to verify the drug that the rheumatologist
prescribed for the gout that he gets every time he overworks his
Lipitor-damaged muscles.

Sure enough, it was NAPROXEN.

I warned him not to take it any more, and he asked me, "How many Lipitor
users develop gout? They need to be warned."

So here it is, folks, the FDA warning issued today on NAPROXEN:

http://www.fda.gov/bbs/topics/news/2004/NEW01148.html

FDA Statement
FOR IMMEDIATE RELEASE
Statement
Dec. 20, 2004
Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA

FDA Statement on Naproxen
The FDA today released the following statement on NIH halting a clinical
trial involving non-steroidal anti-inflammatory drugs in patients at risk of
developing Alzheimer's Disease:

The Food and Drug Administration (FDA) is working with the National
Institutes of Health to review the available scientific information on
naproxen following the decision of the National Institute on Aging to halt a
clinical trial studying non-steroidal anti-inflammatory drugs in patients at
risk of developing Alzheimer's disease. Preliminary information from the
study showed some evidence of increased risk of cardiovascular events, when
compared to placebo, to patients taking naproxen.

In the meantime, FDA advises patients who are currently taking
over-the-counter naproxen products to carefully follow the instructions on
the label. Patients should not exceed the recommended doses for naproxen
(220 milligrams twice daily) and should not take naproxen for longer than
ten days unless a physician directs otherwise. Patients with questions about
naproxen should consult their physicians.

Naproxen was first sold as a prescription drug under the trade name Naprosyn
in 1976. FDA approved its use as an over-the-counter drug in 1994.

####
listener - 22 Dec 2004 03:42 GMT
> The FDA warned today that NAPROXEN increases heart attack risk.

They did nothing of the sort. Many doctors are confused and upset about
the NIH stopping the study. Many doctors have expressed dismay that the
NIH and FDA are overreacting to something that is just not understood at
this time. BUT LO AND BEHOLD, YOU, Sharon Hope are issuing your
"BEWARE!" warning throughout the land!! THE END IS NEAR!

I'll tell ya, this really gets me steamed. It's so reckless and
irresponsible. You should be ashamed.

L.


> So here it is, folks, the FDA warning issued today on NAPROXEN:
>
[quoted text clipped - 34 lines]
>
> ####
Sharon Hope - 22 Dec 2004 05:27 GMT
The quote is directly from the FDA website.

No embellishment, just a complete copy of what the FDA said.

Unless your post was a (failed) attempt at humor, your comments should be
directed to the FDA.

Per the FDA: "Preliminary information from the study showed some evidence
of increased risk of
cardiovascular events, when compared to placebo, to patients taking
naproxen."

get that?  INCREASED RISK OF CARDIOVASCULAR EVENTS

>> The FDA warned today that NAPROXEN increases heart attack risk.
>
[quoted text clipped - 38 lines]
>>
>> ####
listener - 22 Dec 2004 13:53 GMT
Nice creative snipping.

No, my reply was anything *but* humor. The key words in that quote might
be "Preliminary" and "some". One of the issues may be very long-term use
at high dosages.

I suggest you wait for more definitve information before you begin your
drumbeat.

L.

> The quote is directly from the FDA website.
>
[quoted text clipped - 53 lines]
>>>
>>> ####
Sharon Hope - 23 Dec 2004 03:43 GMT
No attempt was claimed to provide definitive information.

The simple post was to alert people who read this board to the fact that the
FDA has issued a warning on this drug.  Simple, verifiable - go to the link
to read it directly from the FDA site.

Although it is not a cardio drug, it was relaed to cardio by the FDA, and I
have first-hand knowledge that it is prescribed for people who have Lipitor
damage that causes gout.  Thus the smc readership need to know.

You can fill up all the computer buffers in the world listing all the things
this post was NOT and still miss some from the list.  If that is your chosen
way to occupy your time, proceed.  Consider it my holida gift to you.

Be aware, however, that listing all the things that this post was never
meant to be, though perhaps entertaining to you, is not something most
people are in need of - they can think for themselves - so please just
consider it personal therapy, and enjoy carrying on with your rants,
posturing and innuendo!  Happy holidays enjoying your favorite hobby!

> Nice creative snipping.
>
[quoted text clipped - 64 lines]
>>>>
>>>> ####
listener - 23 Dec 2004 04:28 GMT
> No attempt was claimed to provide definitive information.
>
> The simple post was to alert people who read this board to the fact
> that the FDA has issued a warning on this drug.  Simple, verifiable -
> go to the link to read it directly from the FDA site.

It would be very hard for anyone NOT to have heard about this since it
was on tv, online and in print quite a bit in the last few days. Sharon
Hope: self-appointed newsgroup early warning system.

> Although it is not a cardio drug, it was relaed to cardio by the FDA,
> and I have first-hand knowledge that it is prescribed for people who
[quoted text clipped - 12 lines]
> with your rants, posturing and innuendo!  Happy holidays enjoying your
> favorite hobby!

Sarcasm will get you nowhere.

L.
Sharon Hope - 23 Dec 2004 06:15 GMT
They may have heard about it as an arthritis drug.  None of the reports I
read or heard mentioned that

1) Lipitor/statins can induce gout
2) Gout, a form of arthritis, may be treated with one of these drugs,
Naproxen or Celebrex
3) The increased heart risk is of concern to anyone, but particularly to
those who might be taking a statin precisely to lower that risk

Please provide the links that included this associated information - on tv,
online or in print

> It would be very hard for anyone NOT to have heard about this since it
> was on tv, online and in print quite a bit in the last few days. Sharon
> Hope: self-appointed newsgroup early warning system.
zwalanga - 22 Dec 2004 06:09 GMT
> > The FDA warned today that NAPROXEN increases heart attack risk.
>
[quoted text clipped - 6 lines]
> I'll tell ya, this really gets me steamed. It's so reckless and
> irresponsible. You should be ashamed.

~~~~~~~~~~~~~~~~~~~~

Yes Listener. Physicians are expressing dismay.

"Shelve the Cox-2 inhibitors:" James Wright Therapeutics Initiative

http://tinyurl.com/5fchg

"Jim Wright, a pharmacology professor at the University of British
Columbia, said Health Canada should have required continued testing of
the drug after it hit the market.

"If that happened, we would have known this, the whole world would
have known this," Dr. Wright said in a telephone interview from
Vancouver. "Health Canada could easily have said, 'We'll put this
on the market, but only on the condition that this trial is done. And
at the end of that, they would decide whether they would continue to
license it.'"

Dr. Wright, managing director of the Therapeutics Initiative, a B.C.
based agency, said Health Canada should "shelve the cox-2 inhibitor
class of anti-inflammatory drugs" until further study is carried out
on the medication's possible dangers.

"Let's not be using the drugs while we're waiting to find out the
problem," he said. "Let's take the cautious approach."

Last week, Health Canada acknowledged that "there has been a lack of
published safety data regarding use for longer than one year of
selective cox-2 inhibitor" drugs, a new class of anti-inflammatory
medications."

~~~~~~~~~~~~~~~~~~~~`

"

> L.
>
[quoted text clipped - 15 lines]
> >
> > The Food and Drug Administration (FDA) is working with the National

> > Institutes of Health to review the available scientific information on
> > naproxen following the decision of the National Institute on Aging to
[quoted text clipped - 17 lines]
> >
> > ####
Dr. Andrew B. Chung, MD/PhD - 22 Dec 2004 05:11 GMT
> The FDA warned today that NAPROXEN increases heart attack risk. The radio
> news story said it was "an arthritis drug." (Gout is considered a form of
[quoted text clipped - 44 lines]
>
> ####

This concern would be extended to all NSAIDs similar to naproxen except
aspirin.

Hope the above information helps you.

Such is the work being done here for Christ's glory
(http://makeashorterlink.com/?U1E13130A).

Servant to the humblest person in the universe,

Andrew

--
Dr. Andrew B. Chung, MD/PhD
Board-Certified Cardiologist
http://www.heartmdphd.com/

**
Who is the humblest person in the universe?
http://makeashorterlink.com/?L26062048

What is all this about?
http://makeashorterlink.com/?K6F72510A

Is this spam?
http://makeashorterlink.com/?D13B21FF9
Don Kirkman - 24 Dec 2004 01:14 GMT
It seems to me I heard somewhere that Sharon Hope wrote in article
<CE4yd.269791$HA.187813@attbi_s01>:

>The FDA warned today that NAPROXEN increases heart attack risk. The radio
>news story said it was "an arthritis drug." (Gout is considered a form of
>arthritis)

>So here it is, folks, the FDA warning issued today on NAPROXEN:

>http://www.fda.gov/bbs/topics/news/2004/NEW01148.html

Sharon, please highlight the section of this report that warned of
increased heart attack risk from Naproxen.  I can't find it.

What I do find is that the FDA issued a statement that:
- they are working with NIH to review information
- they advise patients using OTC naproxen to follow the usage
recommendations of the manufacturer
- they advise patients using naproxen to consult with their doctors

I'm leaving the report intact so you can underline or highlight the
warning language.

>FDA Statement
>FOR IMMEDIATE RELEASE
>Statement
>Dec. 20, 2004
>Media Inquiries: 301-827-6242
>Consumer Inquiries: 888-INFO-FDA

>FDA Statement on Naproxen
>The FDA today released the following statement on NIH halting a clinical
>trial involving non-steroidal anti-inflammatory drugs in patients at risk of
>developing Alzheimer's Disease:

>The Food and Drug Administration (FDA) is working with the National
>Institutes of Health to review the available scientific information on
[quoted text clipped - 3 lines]
>study showed some evidence of increased risk of cardiovascular events, when
>compared to placebo, to patients taking naproxen.

>In the meantime, FDA advises patients who are currently taking
>over-the-counter naproxen products to carefully follow the instructions on
>the label. Patients should not exceed the recommended doses for naproxen
>(220 milligrams twice daily) and should not take naproxen for longer than
>ten days unless a physician directs otherwise. Patients with questions about
>naproxen should consult their physicians.

>Naproxen was first sold as a prescription drug under the trade name Naprosyn
>in 1976. FDA approved its use as an over-the-counter drug in 1994.
Signature

Don
donkirk@covad.net

listener - 24 Dec 2004 04:21 GMT
Don,

Didn't you see:

"Preliminary information from the study showed some evidence of increased
risk of cardiovascular events..."

There it is, clear as a bell. Right?

L.

> It seems to me I heard somewhere that Sharon Hope wrote in article
> <CE4yd.269791$HA.187813@attbi_s01>:
[quoted text clipped - 51 lines]
>>Naprosyn in 1976. FDA approved its use as an over-the-counter drug in
>>1994.
Sharon Hope - 24 Dec 2004 05:13 GMT
Synonymous, for example the study abstract
http://jama.ama-assn.org/cgi/content/abstract/286/8/954

JAMA, Vol. 286, No. 8, August 22, 2001,
Risk of Cardiovascular Events Associated With Selective COX-2 Inhibitors
Debabrata Mukherjee, MD; Steven E. Nissen, MD; Eric J. Topol, MD

JAMA. 2001;286:954-959.

Author Affiliations: Department of Cardiovascular Medicine, The Cleveland
Clinic Foundation, Cleveland, Ohio.

"cardiovascular event (myocardial infarction, stroke, and death) "

And , per NIH Medical Encyclopedia:
http://www.nlm.nih.gov/medlineplus/ency/article/000195.htm
Definition: A heart attack (myocardial infarction) occurs when an area of
heart muscle dies or is permanently damaged because of an inadequate supply
of oxygen to that area.

Thus the synonymous "cardiovascular event" ,  "myocardial infarction", and
the common vernacular "heart attack"

> It seems to me I heard somewhere that Sharon Hope wrote in article
> <CE4yd.269791$HA.187813@attbi_s01>:
[quoted text clipped - 54 lines]
>>Naprosyn
>>in 1976. FDA approved its use as an over-the-counter drug in 1994.
Don Kirkman - 24 Dec 2004 23:40 GMT
It seems to me I heard somewhere that Sharon Hope wrote in article
<mANyd.281110$HA.94857@attbi_s01>:

>Synonymous, for example the study abstract
>http://jama.ama-assn.org/cgi/content/abstract/286/8/954

>JAMA, Vol. 286, No. 8, August 22, 2001,
>Risk of Cardiovascular Events Associated With Selective COX-2 Inhibitors
>Debabrata Mukherjee, MD; Steven E. Nissen, MD; Eric J. Topol, MD

>JAMA. 2001;286:954-959.

>Author Affiliations: Department of Cardiovascular Medicine, The Cleveland
>Clinic Foundation, Cleveland, Ohio.

>"cardiovascular event (myocardial infarction, stroke, and death) "

>And , per NIH Medical Encyclopedia:
>http://www.nlm.nih.gov/medlineplus/ency/article/000195.htm
>Definition: A heart attack (myocardial infarction) occurs when an area of
>heart muscle dies or is permanently damaged because of an inadequate supply
>of oxygen to that area.

>Thus the synonymous "cardiovascular event" ,  "myocardial infarction", and
>the common vernacular "heart attack"

The definition of "heart attack" and its cognates is not at issue; you
said the FDA *warned* of additional risk of heart attack.  Where is that
warning to be found?
Signature

Don
donkirk@covad.net

Sharon Hope - 25 Dec 2004 02:08 GMT
The FDA advisory includes specific instructions to patients.  That quite
obviously constitutes a warning.   That is why the news media made it so
widely known.

You may split hairs with the FDA if you object to the words they chose, but
it is clear that the advisory is a warning.

> It seems to me I heard somewhere that Sharon Hope wrote in article
> <mANyd.281110$HA.94857@attbi_s01>:
[quoted text clipped - 26 lines]
> said the FDA *warned* of additional risk of heart attack.  Where is that
> warning to be found?
listener - 25 Dec 2004 15:23 GMT
> The FDA advisory includes specific instructions to patients.  That
> quite obviously constitutes a warning.   That is why the news media
> made it so widely known.
>
> You may split hairs with the FDA if you object to the words they
> chose, but it is clear that the advisory is a warning.

In some circles it's known as "critical thinking" which, apparently, when
you do it (to a degree) it's fine but when others do it you dismiss it,
ridicule it or ignore it.

Sophomoric L.

>> It seems to me I heard somewhere that Sharon Hope wrote in article
>> <mANyd.281110$HA.94857@attbi_s01>:
[quoted text clipped - 27 lines]
>> you said the FDA *warned* of additional risk of heart attack.  Where
>> is that warning to be found?
Don Kirkman - 25 Dec 2004 21:37 GMT
It seems to me I heard somewhere that Sharon Hope wrote in article
<gY3zd.237326$5K2.175138@attbi_s03>:

>The FDA advisory includes specific instructions to patients.  That quite
>obviously constitutes a warning.   That is why the news media made it so
>widely known.

>You may split hairs with the FDA if you object to the words they chose, but
>it is clear that the advisory is a warning.

Actually they did not use the words "warn[ing]" nor did they say
categorically that Naproxen "increases heart attack risk;" those are
your words that are being called into question.  An advisory is just
that, information about a possible event that a person with common sense
would watch out for; a warning is information about a clear and present
danger--don't you distinguish between a tornado advisory and a tornado
warning?  The weather service does.

[Balance snipped to save space; the full text is available in other
messages]
Signature

Don
donkirk@covad.net

Sharon Hope - 26 Dec 2004 04:39 GMT
Which is why I included the FDA wording with mine.  YMMV

> It seems to me I heard somewhere that Sharon Hope wrote in article
> <gY3zd.237326$5K2.175138@attbi_s03>:
[quoted text clipped - 17 lines]
> [Balance snipped to save space; the full text is available in other
> messages]
zwalanga - 25 Dec 2004 03:47 GMT
> It seems to me I heard somewhere that Sharon Hope wrote in article
> <mANyd.281110$HA.94857@attbi_s01>:
[quoted text clipped - 28 lines]
> Don
> donkirk@covad.net

This warning, couched as carefully as it has been, will most certainly
have been done to give away as little as possible,while still meeting
requisites for  legal disclaimer should some unfortunate soul(s) ever
decide Naproxen damage constitutes a class action. But having played
big game law, you knew that, didn't you Don.
Don Kirkman - 25 Dec 2004 21:37 GMT
It seems to me I heard somewhere that zwalanga wrote in article
<1103946428.336622.50320@z14g2000cwz.googlegroups.com>:

>> It seems to me I heard somewhere that Sharon Hope wrote in article
>> <mANyd.281110$HA.94857@attbi_s01>:

[...]

>> >Thus the synonymous "cardiovascular event" ,  "myocardial
>infarction", and
>> >the common vernacular "heart attack"

>> The definition of "heart attack" and its cognates is not at issue;
>you
>> said the FDA *warned* of additional risk of heart attack.  Where is
>that
>> warning to be found?

>This warning, couched as carefully as it has been, will most certainly
>have been done to give away as little as possible,while still meeting
>requisites for  legal disclaimer should some unfortunate soul(s) ever
>decide Naproxen damage constitutes a class action. But having played
>big game law, you knew that, didn't you Don.

Couched so carefully it can't be found, Zee.  A suggestion is not a
warning, either in law or in common sense.  And don't misinterpret what
I wrote early as my having "played big game law;" I specifically said I
am not a lawyer though I worked with and among lawyers and other justice
system folks for most of my career.
Signature

Don
donkirk@covad.net

zwalanga - 25 Dec 2004 22:16 GMT
> It seems to me I heard somewhere that zwalanga wrote in article
> <1103946428.336622.50320@z14g2000cwz.googlegroups.com>:
[quoted text clipped - 28 lines]
> Don
> donkirk@covad.net

I did not misinterpret what you did Don. ~Heh~ I know the difference.

I also know, and you know too, that this statement would be presented
as having been warning in a law suit undertaken on behalf of one
injured by naproxen. And it would be presented as such by the
defendents.

This advisory is a warning. Legally. And that is just why it was done.
So that in the event of law suits, pharma can say it warned. And then
legally, the burden bounces back to the injured. Whether or not a case
could be won or lost on this alone is moot.

This is warning. This is legal.

Split hairs all you like. Pharma warned. They're clear from here on for
anyone taking that medication NOW.
Sharon had it right.

Beware.

Zee
Don Kirkman - 26 Dec 2004 08:43 GMT
It seems to me I heard somewhere that zwalanga wrote in article
<1104012962.659790.43240@c13g2000cwb.googlegroups.com>:

>> It seems to me I heard somewhere that zwalanga wrote in article
>> <1103946428.336622.50320@z14g2000cwz.googlegroups.com>:

>> >> It seems to me I heard somewhere that Sharon Hope wrote in article
>> >> <mANyd.281110$HA.94857@attbi_s01>:

>> [...]

>> >> >Thus the synonymous "cardiovascular event" ,  "myocardial
>> >infarction", and
>> >> >the common vernacular "heart attack"

>> >> The definition of "heart attack" and its cognates is not at issue;
>> >you
>> >> said the FDA *warned* of additional risk of heart attack.  Where
>is
>> >that
>> >> warning to be found?

>> >This warning, couched as carefully as it has been, will most
>certainly
[quoted text clipped - 4 lines]
>> >decide Naproxen damage constitutes a class action. But having played
>> >big game law, you knew that, didn't you Don.

>> Couched so carefully it can't be found, Zee.  A suggestion is not a
>> warning, either in law or in common sense.  And don't misinterpret
[quoted text clipped - 4 lines]
>justice
>> system folks for most of my career.

>I did not misinterpret what you did Don. ~Heh~ I know the difference.

<G>

>I also know, and you know too, that this statement would be presented
>as having been warning in a law suit undertaken on behalf of one
>injured by naproxen. And it would be presented as such by the
>defendents.

>This advisory is a warning. Legally. And that is just why it was done.
>So that in the event of law suits, pharma can say it warned. And then
>legally, the burden bounces back to the injured. Whether or not a case
>could be won or lost on this alone is moot.

>This is warning. This is legal.

Can you give me a case citation or a reference to legislation equating
advise with warning?  What legislature or what court deemed an advisory
to be a warning?

>Split hairs all you like. Pharma warned. They're clear from here on for
>anyone taking that medication NOW.
>Sharon had it right.

I'm not splitting hairs, I'm parsing English statements.
Signature

Don
donkirk@covad.net

zwalanga - 26 Dec 2004 14:10 GMT
> It seems to me I heard somewhere that zwalanga wrote in article
> <1104012962.659790.43240@c13g2000cwb.googlegroups.com>:
[quoted text clipped - 64 lines]
> Don
> donkirk@covad.net

If it wasn't perceived as a legal threat they wouldn't be doing this.
The next step will be a stronger "advisory" warning people, or an
"advisory" pulling the drug. The document is the advisory. What it is
doing is warning.

This is legal telling communications "say this".
And the reason they are doing it is legal.


Zee
William Wagner - 26 Dec 2004 15:14 GMT
> If it wasn't perceived as a legal threat they wouldn't be doing this.
> The next step will be a stronger "advisory" warning people, or an
[quoted text clipped - 6 lines]
>
> Zee

Found these two below.

Posted on Sat, Dec. 25, 2004

http://www.philly.com/mld/inquirer/news/nation/10496237.htm

No whistle-blower protection for many

Federal medical workers may be fired for reporting alleged wrongs, a
judge ruled in an NIH case.

By John Solomon

Associated Press

WASHINGTON - Thousands of federal doctors and medical researchers who
receive some of the highest salaries in government do not enjoy the same
protections to blow the whistle on wrongdoing as other civil servants, a
judge has ruled.

Administrative Judge Raphael Ben-Ami of the U.S. Merit Systems
Protection Board ruled recently that Dr. Jonathan Fishbein, a National
Institutes of Health specialist, could not seek the board's protection
from firing under the Whistleblower Protection Act.

Fishbein was hired by NIH in 2003 to help improve AIDS research
practices. He alleges he is being fired because he uncovered concerns
about sloppy research practices that might endanger patient safety.

NIH said that he was being fired for poor performance and described a
"disgruntled" employee who failed to make his two-year probation period.

Fishbein is a "Title 42" employee and is paid $178,000 a year, slightly
more than the $175,700 that members of President Bush's Cabinet receive.

Title 42 of the federal code allows the government to pay research and
medical experts as special consultants and give them salaries higher
than the civil servant maximums. The law is designed to help the
government compete against high-paying private industries.

NIH employs more than 3,959 Title 42 workers, and the Centers for
Disease Control and Prevention employs 200 to 300, according to the
Department of Health and Human Services.

Ben-Ami ruled Nov. 9 that Fishbein was not covered by the Whistleblower
Protection Act because he is a Title 42 employee and has "no appeal
rights" during his two-year probationary period.

"Title 42 appointments of special consultants are made without regard to
the civil service laws," and therefore they are not permitted to appeal
to the Merit Systems Protection Board under the whistle-blower law, he
ruled. "The board lacks authority to consider the appellants' claims of
discrimination or retaliation."

Fishbein's lawyers are appealing to the full board.

The whistle-blower law was passed more than a decade ago to strengthen
federal workers' protections when they raise allegations of federal
wrongdoing, giving them outlets such as the board and the U.S. Office of
Special Counsel to seek legal protection.

The National Whistleblower Center, based in Washington, is urging
Congress to fix what it called a "dangerous loophole."

"This is a major setback for drug safety," said Kris Kolesnik, the
center's executive director. "Many of these employees, such as Dr.
Fishbein, hold sensitive health- and safety-related positions. Without
protections, these employees will not blow the whistle."

The Associated Press reported last week that Fishbein was among several
NIH employees who raised concerns in 2002 about a study in Africa
involving the AIDS drug nevirapine.

Documents showed that the way the research was conducted violated
federal patient safety rules and suffered from record-keeping and
patient monitoring problems. But the study's general conclusion that the
drug could be used safely in single doses to protect babies from HIV was
upheld.

Steve Kohn, Fishbein's attorney, said federal agencies including NIH
have markedly increased their recruitment and hiring of employees under
Title 42 in recent years, leaving an entire class of workers without
whistle-blower protections.

Kohn said, "It's a game of cat and mouse, in which the real losers are
the American people."

????????????????????.

Perhaps of interest also.

Jurdy's Blog on Big Pharmaceutical NewsJurdy's Blog on Big
Pharmaceutical News

http://www.jurdy.net/

????????????????????.

Happy Holidays!

Bill

Signature

Zone 5 S Jersey USA Shade
Serious Vision Problems like Starghart?s ?
--> http://www.ocutech.com/

Don Kirkman - 26 Dec 2004 22:54 GMT
It seems to me I heard somewhere that zwalanga wrote in article
<1104070239.572380.231860@z14g2000cwz.googlegroups.com>:

I don't want to drag this out, but . . .

>> It seems to me I heard somewhere that zwalanga wrote in article
>> <1104012962.659790.43240@c13g2000cwb.googlegroups.com>:

>> >> It seems to me I heard somewhere that zwalanga wrote in article
>> >> <1103946428.336622.50320@z14g2000cwz.googlegroups.com>:

[. . .]

Zee wrote:

>> >> >This warning, couched as carefully as it has been, will most
>> >certainly
[quoted text clipped - 5 lines]
>played
>> >> >big game law, you knew that, didn't you Don.

I wrote:

>> >> Couched so carefully it can't be found, Zee.  A suggestion is not
>a
>> >> warning, either in law or in common sense.
[...]

>> >I also know, and you know too, that this statement would be
>presented
>> >as having been warning in a law suit undertaken on behalf of one
>> >injured by naproxen. And it would be presented as such by the
>> >defendents.

>> >This advisory is a warning. Legally. And that is just why it was
>done.
[quoted text clipped - 5 lines]
>>
>> >This is warning. This is legal.

>> Can you give me a case citation or a reference to legislation
>equating
>> advise with warning?  What legislature or what court deemed an
>advisory
>> to be a warning?

>If it wasn't perceived as a legal threat they wouldn't be doing this.
>The next step will be a stronger "advisory" warning people, or an
>"advisory" pulling the drug. The document is the advisory. What it is
>doing is warning.

>This is legal telling communications "say this".
>And the reason they are doing it is legal.

I think I see the problem now.  You're not talking about a warning to
the users but to the company itself:  "legal telling communications 'say
this.'  But Sharon wasn't talking in those terms at all, she was talking
about the FDA warning users about cardiac risk.
Signature

Don
donkirk@covad.net

zwalanga - 26 Dec 2004 23:39 GMT
The FDA does not write the advisory/warning. Pharma does. In this case,
Pfizer. Pfizer's legal department and Pfizer's communications
department sit down and write this. Legal tells communications what
must be said and not, it goes through many drafts. But none of them are
done by the FDA (or Health Canada).

The FDA then publishes the warning. But it has not authored it, and any
summaries or precis of this warning though written by the FDA would
have to be veted through Pfizer's legal and communications again.

Sorry. At the very least it is an advisory that warns. Semantics. But
hey, I can riff on this as long as you like. Part of my linguistic
rehab. Zee

> It seems to me I heard somewhere that zwalanga wrote in article
> <1104070239.572380.231860@z14g2000cwz.googlegroups.com>:
[quoted text clipped - 62 lines]
> this.'  But Sharon wasn't talking in those terms at all, she was talking
> about the FDA warning users about cardiac risk.
Hawki63 - 24 Dec 2004 23:58 GMT
>Subject: Re: Gout from Lipitor damage? NAPROXEN increases heart attack risk.
>BEWARE
>From: "Sharon Hope" shope@anet.net
>Date: 12/23/2004 9:13 PM Pacific Standard Time
>Message-id: <mANyd.281110$HA.94857@attbi_s01>

>Risk of Cardiovascular Events Associated With Selective COX-2 Inhibitors

except that Naproxen is NOT a Cox II

please read the potential adverse effects of ....say...aspirin...

bleeding will be number one...does that mean that aspirin is BAD....course
not..

also please list ANY pill,,potion..supplement or herb that has NOOOOO potential
adverse effects/..

cannot be done..any substance ingested has potential adverse effects...

one must weigh the risks to the benefits..

which you and others refuse to do...

you harp only on the risks..

sorry..

hawki.....
zwalanga - 25 Dec 2004 00:25 GMT
> >Subject: Re: Gout from Lipitor damage? NAPROXEN increases heart attack risk.
> >BEWARE
[quoted text clipped - 25 lines]
>
> hawki.....

Speaking of things others refuse to do Hawki..how about diet and
exercise to control diabetes 2, obesity and cholesterol levels instead
of taking the high tech road?
Don't give me no whine about that knee.

Zee
Hawki63 - 25 Dec 2004 18:54 GMT
>Subject: Re: Gout from Lipitor damage? NAPROXEN increases heart attack risk.
>BEWARE
>From: "zwalanga" zwalanga@yahoo.com
>Date: 12/24/2004 4:25 PM Pacific Standard Time
>Message-id: <1103934340.468640.54960@c13g2000cwb.googlegroups.com>

>Speaking of things others refuse to do Hawki..how about diet and
>exercise to control diabetes 2, obesity and cholesterol levels instead
>of taking the high tech road?
>Don't give me no whine about that

>knee.

why Zee...how nice of you...

actually it is NOT only "that knee"...but also a degenerative tendon on the
opposite ankle...that I have been nursing for the past two years..

this holiday season with its increased walking,,shopping...etc..made it
perfectly clear that surgery is the only answer..this time ...BIG surgery...as
I need a "tendon transplant"..actually the surgery is not that bad...but two
surgeons warn me that the rehab can take 6-12 months!!!

please do not lecture me on "walking" as a cure for my lipid problems...as I
can barely get around my house..

and calling it a "whine" only demonstrates how little you know about orthopedic
infirmities..

and BTW I do NOT have diabetes!!!

and BTW...with all your walking etc...are your lipids much lower than 500 yet??
hawki.....
zwalanga - 25 Dec 2004 20:16 GMT
> >Subject: Re: Gout from Lipitor damage? NAPROXEN increases heart attack risk.
> >BEWARE
[quoted text clipped - 29 lines]
> and BTW...with all your walking etc...are your lipids much lower than 500 yet??
> hawki.....

Why Hawki how nice of you....to respond to a woman watching her husband
live 1/4 of the life he might have, live through daily excrutiating
pain, see her retirement income and savings depleted, business lost,
wonder if next they will lose their home, see her children and
grandchildren cry over this different father and grandfather...and be
so callously and easily sarcastic to her. On the eve of a day she
celebrates.

I have a back fused in two places with metal brackets and screws as
long as your longest finger, and lived through one of the screws moving
and damaging my spinal nerves further. The implants weren't done
lightly. I greatly disabled an in excruciating pain daily before I
consented, but not until I had lost control of bowel and bladder.

I spent six months in orthopaedic rehabiliation. I know a LOT about
orthopaedic rehab. Following that, still with nerve damage and
attendent disabilities both because of the screw moving and the failure
of the fusions to correct my spondylolisthesis and scoliosis, I
followed the 2 1/2 hour workout of my Everest summitting nephew.
Everyday: gym, weight lifting, treadmill, stretching, pool work,
swimming, running cross-country. At the peak of my physical ability, I
was started on statins.
Don't give me any whine about that knee.

Zee
Hawki63 - 26 Dec 2004 21:09 GMT
>Subject: Re: Gout from Lipitor damage? NAPROXEN increases heart attack risk.
>BEWARE
>From: "zwalanga" zwalanga@yahoo.com
>Date: 12/25/2004 12:16 PM Pacific Standard Time
>Message-id: <1104005785.594559.74170@f14g2000cwb.googlegroups.com>

>Why Hawki how nice of you....to respond to a woman watching her husband
>live 1/4 of the life he might have, live through daily excrutiating
>pain, see her retirement income and savings depleted, business lost,
>wonder if next they will lose their home, see her children and
>grandchildren cry over this

which all has nothing to do with your snipe at me for "whining"

>I spent six months in orthopaedic rehabiliation. I know a LOT about
>orthopaedic rehab. Following that, still with nerve damage and
>attendent disabilities both because of the screw moving and the failure
>of the fusions to correct my spondylolisthesis and scoliosis, I

>Don't give me any whine about that knee.

ie....one CANNOT walk for exercise with the injuries that I have..
and "running cross country"...surely you do NOT understand that problems in
different parts of one orthopedic structure mean different things...

if you can run cross country..you obviously do not need a tendon transplant in
your ankle..

not to mention that my other leg..as a result of a MVA 27 years ago..has 3 pins
in its ankle..no patella in its knee..

there is no comparision

one CAN walk etc with spinal problems

BTW...I also have had a spinal fusion..

.">Don't give me any whine about that knee.

if only that was the only source of my whine..

hawki.....
zwalanga - 26 Dec 2004 23:18 GMT
> >Subject: Re: Gout from Lipitor damage? NAPROXEN increases heart attack risk.
> >BEWARE
[quoted text clipped - 9 lines]
>
> which all has nothing to do with your snipe at me for "whining"

It was not a snipe actually, until you over-reacted with what then was
most definitely a lamo whine.

> >I spent six months in orthopaedic rehabiliation. I know a LOT about
> >orthopaedic rehab. Following that, still with nerve damage and
[quoted text clipped - 6 lines]
> and "running cross country"...surely you do NOT understand that problems in
> different parts of one orthopedic structure mean different things...

Why yes I do understand Hawki. I understand that a woman who can run
around the malls shopping could work out and exercise. But she gets
more strokes from whining. I also understand that statins cause
myopathy (weakness and atrophy) and tendonitis. So even if you had your
proclivities prior to taking statins (as did I) the statins are going
to make everything worse.

Did I mention my hip surgery?  Removal of the trocanteric bursa, and a
tie back on the tensor fascialata? All kinds of knee problems from
that. Then there's the right leg over one-half inch shorter than the
left, kinda plays fast and loose with my instrumented fusion (the
lumbar one).

> if you can run cross country..you obviously do not need a tendon transplant in
> your ankle..

I didn't get off the surgery guerney and start running cross country.
It took me two years, including six month of formal rehab. It was a lot
of tears, pain and determination.

And NO time spent shopping and running around the mall and making
excuses for myself.

> not to mention that my other leg..as a result of a MVA 27 years ago..has 3 pins
> in its ankle..no patella in its knee..
>
> there is no comparision

Sure there is. You are whining, long past injury, several months past
surgery and whining that you cannot do gym rehab, but you can run
around the mall.

> one CAN walk etc with spinal problems
>
> BTW...I also have had a spinal fusion..

Instrumented? Failed, with a bone fusion that snapped when you fell in
the hospital? And then the pedicle screw (one of eight) moved?

> .">Don't give me any whine about that knee.
>
> if only that was the only source of my whine..

You are welcome to my sympathy. But not your excuses.
Zee

> hawki.....
Hawki63 - 27 Dec 2004 08:26 GMT
>Subject: Re: Gout from Lipitor damage? NAPROXEN increases heart attack risk.
>BEWARE
>From: "zwalanga" zwalanga@yahoo.com
>Date: 12/26/2004 3:18 P.M. Pacific Standard Time
>Message-id: <1104103122.552592.305080@c13g2000cwb.googlegroups.com>

>Why yes I do understand Hawki. I understand that a woman who can run
>around the malls shopping could work out and exercise. But she gets
>more strokes from whining. I al

ya know...I have had more than enuf of your know it all yammerring

NOWHERE did I state that I was "running around malls shopping"...what I
mentioned was that even attempting to do usual holiday stuff has made it
perfectly clear that this ankle tendon transplant can no longer be put off...

HOW you misread that is beyond me...YOU are the one still continuing to ONLY
focus on a knee repair of a mere two months ago(??) ...which you call a
"whine"..

>I also understand that statins cause
>myopathy (weakness and atrophy) and tendonitis. So even if you had your
>proclivities prior to taking statins (as did I) the statins are going
>to make everything worse.

if you had half the knowledge you think you did...you would be dangerous...

I have been on statins for about a year....

I do NOT have tendonitis...nor "weakness"...what I have is a tendon that is
totally degenerated..."frayed like a rope" is how it was described to
me....this diagnosis preceded my statin therapy by more than a year...two
orthos explained that such degeneration (in my case) are the result of the 27
years of walking with a funny gait due to injuries to my OTHER leg...

so get off your "statins caused it" ...as you know nothing of the anatomy and
pathophysiology of my ankle...

>> if you can run cross country..you obviously do not need a tendon
>transplant in
>> your ankle..

which I do...NOW...whine?? you bet ya??

>And NO time spent shopping and running around the mall and making
>excuses for myself.

oh...f off you biddy

>Sure there is. You are whining, long past injury, several months past
>surgery and whining that you cannot do gym rehab, but you can

again....read the above..my "whine" is of TODAY....not of long past
injuries...it was YOU keeping score of who hurts the worst

>cannot do gym rehab, but you can run
>around the mall.

bullshit...

>> BTW...I also have had a spinal fusion..
>
>Instrumented? Failed, with a bone

no...I had a decent surgeon..

>You are welcome to my sympathy. But not your excuses.
>Zee

I do not want ...nor need ...either...

lots of luck with your lipids..

hawki.....
listener - 27 Dec 2004 13:12 GMT
>>Subject: Re: Gout from Lipitor damage? NAPROXEN increases heart attack
>>risk. BEWARE
[quoted text clipped - 73 lines]
>
> hawki.....

Next: She'll attribute your "obvious hostility" to your statin!

The only way to deal with zee's rude, arrogant, dismissive and
misinformed manner is to killfile her.

L.
Hawki63 - 27 Dec 2004 17:43 GMT
>Subject: Re: Gout from Lipitor damage? NAPROXEN increases heart attack risk.
>BEWARE
>From: listener listener@nospam.net
>Date: 12/27/2004 5:12 AM Pacific Standard Time
>Message-id: <Xns95CC53EADED77some1outthere@38.144.126.102>

snip

>The only way to deal with zee's rude, arrogant, dismissive and
>misinformed manner is to killfile her.
>
>L.

yes...you are correct...and I plan on doing just that from now on..

thanks
hawki.....
Hawki63 - 28 Dec 2004 00:16 GMT
>Subject: Re: Gout from Lipitor damage? NAPROXEN increases heart attack risk.
>BEWARE
>From: hawki63@aol.com  (Hawki63)
>Date: 12/27/2004 9:43 AM Pacific Standard Time
>Message-id: <20041227124302.06404.00002142@mb-m18.aol.com>

just returned from the orthopedist's.....with cast on left ankle up to
knee..for next 4 weeks..

hmmm...wonder if I am allowed to whine yet???

hawki.....
William Wagner - 28 Dec 2004 00:44 GMT
> >Subject: Re: Gout from Lipitor damage? NAPROXEN increases heart attack risk.
> >BEWARE
[quoted text clipped - 8 lines]
>
> hawki.....

Keep it elevated and complain of pain to your family members.  Or as my
adult children  say ....chill.  Hope it  goes well.

Bill

Signature

Zone 5 S Jersey USA Shade
Serious Vision Problems like Starghart?s ?
--> http://www.ocutech.com/

zwalanga - 28 Dec 2004 00:52 GMT
Your usual the-more-intervention-the-better choice. The wrong choice.
It can only lead to more intervention.

You will experience atrophy, weakening and predispose to more injury
both there and in the compensating joints ligaments and tendons.

A better choice would have been to start conisistent active rehab.
Several months or years ago.

Zee

> >Subject: Re: Gout from Lipitor damage? NAPROXEN increases heart attack risk.
> >BEWARE
[quoted text clipped - 8 lines]
>
> hawki....
Hawki63 - 28 Dec 2004 01:29 GMT
>Subject: Re: Gout from Lipitor damage? NAPROXEN increases heart attack risk.
>BEWARE
>From: "zwalanga" zwalanga@yahoo.com
>Date: 12/27/2004 4:52 PM Pacific Standard Time
>Message-id: <1104195147.837890.212240@z14g2000cwz.googlegroups.com>

>Your usual the-more-intervention-the-better choice. The wrong choice.
>It can only lead to more intervention.

You truly never cease to amaze me with your totally non educated solutions to
problems that need an education to evaluate

"the wrong choice??""  "will lead to more intervention??"""

actually the goal is relief of pain and inflammmation secondary to
immobilization..

>You will experience atrophy, weakening and predispose to more

>injury
>both there and in the compensating joints ligaments and tendons.

LOL LOL...how pathetic...

when you get board certified in ortho and can read MRI's...come around
again..in the meantime..your lack of knowledge of my problem is so laughable it
is laughable..

>A better choice would have been to start conisistent active rehab.
>Several months or years ago.

again....LOL LOL LOL

you are still assuming I have "tendonitis"...which I have told you I have not..

do yourself a favor and do some research on "ankle tendon transplant" et al....

and learn something about pathophysiology..

and shut the f... up...

ps....this injury CANNOT be made worse...and actually the cast is to HELP the
other structures gain some strength and mobility..

the tendon is shot...

but again....lecture to someone who has less brains than you..if such a person
reads this group..

lady...you are a pathetic wannabe non educated medical know nothing..

hawki.....
listener - 28 Dec 2004 01:52 GMT
>>Subject: Re: Gout from Lipitor damage? NAPROXEN increases heart attack
>>risk. BEWARE
[quoted text clipped - 5 lines]
>>injury
>>both there and in the compensating joints ligaments and tendons.

Wow. I imagine zee hunched over her crystal ball, massaging it lovingly,
intoning those words in a thick accent......(think female bela lugosi).

A hoot!

L.
Hawki63 - 28 Dec 2004 01:58 GMT
>Subject: Re: Gout from Lipitor damage? NAPROXEN increases heart attack risk.
>BEWARE
>From: listener listener@nospam.net
>Date: 12/27/2004 5:52 PM Pacific Standard Time
>Message-id: <Xns95CCD55E26882some1outthere@38.144.126.109>

>>You will experience atrophy, weakening and predispose to more
>>
>>>injury
>>>both there and in the compensating joints ligaments and tendons.

says Zee...not a specialist in any medical field...not even good at researching

>Wow. I imagine zee hunched over her crystal ball, massaging it lovingly,
>intoning those words in a thick accent......(think female bela lugosi).
>
>A hoot!

yeah....i thought so too...tho it is beyond the bend in ridiculousness that she
feels herself qualified to make such judgements...

as I told her...come back when she is board certified in ortho ...and maybe I
will stop feeling sorry for her need for ego boosting posts such as this///

hawki.....
zwalanga - 28 Dec 2004 02:11 GMT
You continue to think the more intervention you have the better. You do
not need a cast, you just need to quit running the mall.  Immobilize
yes, but there are better ways, and you will not find them at an
orthopaedic surgeons office. (He has probably already booked the
surgery this will hasten you toward).

You also did not need an MRI, partictularly since you are seeing such a
hot shot orthopod. Could he not have diagnosed this without uber
technology?

I am not assuming you are being treated for tendonitis. You might have
that, on top of anything else you have malpractised your way into,
thinking the more interventions you have the more real is your problem.

There are experts who could have helped you long ago, but they are not
surgeons, and you would have had to do the major work.
Nah. That  is not your style.
Hawki63 - 28 Dec 2004 03:21 GMT
>Subject: Re: Gout from Lipitor damage? NAPROXEN increases heart attack risk.
>BEWARE
>From: "zwalanga" zwalanga@yahoo.com
>Date: 12/27/2004 6:11 PM Pacific Standard Time
>Message-id: <1104199909.444966.242440@z14g2000cwz.googlegroups.com>

>You continue to think the more intervention you have the better

and you continue to amaze me with your idiocy..and total inability to read for
comprehension..perhaps they don't teach first graders that in Canada

how sad

>You do
>not need a cast, you just need to quit running the mall.  

please return to my inital post ...I never said I was "running the mall"

Immobilize??  for the two years since this was diagnosed?? or the 27 years
since the  injury that caused my uneven gait??  yeah right..

>mmobilize
>yes, but there are better ways, and you will not find them at an
>orthopaedic surgeons office.

oh pray tell..oh surgeon wannabe...what you see in that crazy crystal ball...

>You also did not need an MRI, partictularly since you are seeing such a
>hot shot orthopod. Could he not have diagnosed this without uber
>technology?

ahhh...again you demonstrate your total lack of knowledge in this area..

NO....only the "uber technology" would do..few mortal folks can see inside the
anatomy...

no swelling no redness..no inflammation...

oh but I suppose you figure xrays to diagnose fractures are passe as
well...what an idiot

>I am not assuming you are being treated for tendonitis. You might have
>that, on top of anything else you have malpractised your way into,
>thinking the more interventions you have the more real is your problem

look up tendonitis..and come back and post the signs and symptoms...

"more real is my problem??""'

yikes...asif I need verification...

but then...you think your "running around" will offset your lipids of over
500...you are a pathetic being...who likely will be caught in your own big
mouth sooner than later..

>There are experts who could have helped you long ago, but they are not
>surgeons, and you would have had to do the major work.
>Nah. That  is not your style.

oh how cute.......yep...PT and all that...yep...bet you plan on removing your
own cancerous organs as well...who needs experts??

when one has a brain the size of a pea..and an ego the size of an elephant..

hawki.....
zwalanga - 28 Dec 2004 00:58 GMT
And still you keep reading me. Y

You are flipping hilarious. Pay nospam a monthly fee so you can log on,
kill-file virtually everyone then proceed to read those same people and
respond to them through a third party. I have known five-year olds who
have grown out of that kind of rational.

You do need a nurse.

Zee

> >>Subject: Re: Gout from Lipitor damage? NAPROXEN increases heart attack
> >>risk. BEWARE
[quoted text clipped - 80 lines]
>
> L.
listener - 25 Dec 2004 20:22 GMT
>>Subject: Re: Gout from Lipitor damage? NAPROXEN increases heart attack
>>risk. BEWARE
[quoted text clipped - 31 lines]
> and BTW...with all your walking etc...are your lipids much lower than
> 500 yet?? hawki.....

Uh, oh...me thinks you're about to get an earful from zee (the victim).

L.
zwalanga - 25 Dec 2004 22:00 GMT
> >>Subject: Re: Gout from Lipitor damage? NAPROXEN increases heart attack
> >>risk. BEWARE
[quoted text clipped - 35 lines]
>
> L.

What do you call someone with minor heartbeat irregularities who refers
to himself as "Afibber" (finally he can call himself something)
swallows a truckload of medications to treat this big nothing, and
without heart disease, takes medications for that too. Then, he takes
medications to treat the adverse effects these unneeded medications
cause.

Hypochondriac...Wuss...Fool...
Victim?

Definitely.

Zee
Sharon Hope - 25 Dec 2004 02:03 GMT
Again, the post was a copy of what the FDA said, not me.  If the FDA's
statement is counter to your perceptions about risk, that is between you and
the FDA.

> >Subject: Re: Gout from Lipitor damage? NAPROXEN increases heart attack
> >risk.
[quoted text clipped - 27 lines]
>
> hawki.....
Frankie - 25 Dec 2004 21:53 GMT
Source: http://www.nih.gov/news/pr/dec2004/od-20.htm

The trial that started the chain of events:
Alzheimer's Disease Anti-Inflammatory Prevention Trial [ADAPT]
ADAPT was launched Jan 31, 2001, sponsored by NIA.

QUOTE: Data from the ADAPT trial indicated an apparent increase
in cardiovascular and cerebrovascular events among the participants
taking naproxen when compared with those on placebo. END QUOTE
*******************************************************************
Source: http://www.alz.org/news/04q4/122104.asp

QUOTE: The suspension came after data from the Alzheimer's
Disease Anti-Inflammatory Prevention Trial (ADAPT) linked
naproxen to an increased risk of "heart attack" and "stroke".

FDA officials called the situation with regard to NSAID safety
"confusing." The agency is in the process of reviewing all
available
data about the drugs and will hold a meeting in February to discuss
future regulatory implications. END QUOTE
*******************************************************************
"hold a meeting in Februrary" ????
What's wrong with now???
*******************************************************************
Source: http://www.nia.nih.gov/
I was shocked not to see any info at all as to the latest status of
the ADAPT Trials, as NIA sponsors this trial.
*******************************************************************
Naproxin Info
Source: http://www.drugs.com/naproxen.html
Who should not take naproxen?
·  Before taking this medication, tell your doctor if you
· have an allergy to aspirin or any other NSAIDs
· have an ulcer or bleeding in your stomach
· drink more than three alcoholic beverages a day
· have liver disease
· have kidney disease
· have a coagulation (bleeding) disorder
· have congestive heart failure
· have fluid retention
· have heart disease
· have high blood pressure
*******************************************************************
ADAPT
Source: http://clinicaltrials.gov/show/NCT00007189

ADAPT Trial Exclusion Criteria:

History of peptic ulcer disease with bleeding or obstruction.
Clinically significant liver or kidney disease.
History of hypersensitivity to aspirin, ibuprofen, celecoxib,
naproxen, or other NSAIDs.
Use of anti-coagulant medication.
Cognitive impairment or dementia.
Current alcohol abuse or dependence
*******************************************************************
My analysis of the info above....

Individuals that should not even take naproxin:
CHF, heart disease and high BP

YET, these individuals were not even considered in those
that should be excluded from the ADAPT trial. The only
exclusion pertained to "anti-coagulant medication".
Seems this trial was doomed from the onset.

Frankie
 
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