Healthwatch: Vytorin
dgh
FDA announces review of Vytorin.
It might be taken off the market.
dgh
I am kind of sorry to see it go -- I really liked the commercials on
TV.
- - - -
DGH
This was really posted by me, although the profile suggests otherwise.
J.D. Baldwin
In the previous article, dgh <mach...@gmail.com> wrote:
> FDA announces review of Vytorin.
>
> It might be taken off the market.
I think the end result of the review is more likely to be about
labelling than about whether it can continue to be marketed.
--
_+_ From the catapult of |If anyone disagrees with any statement I make, I
_|70|___:)=}- J.D. Baldwin |am quite prepared not only to retract it, but also
\ / bal...@panix.com|to deny under oath that I ever made it. -T. Lehrer
***~~~~-----------------------------------------------------------------------
brigid nelson
> In the previous article, dgh <mach...@gmail.com> wrote:
>> FDA announces review of Vytorin.
>>
>> It might be taken off the market.
>
> I think the end result of the review is more likely to be about
> labelling than about whether it can continue to be marketed.
extend a patent? The one where they tried to cook the books on the study?
There's been a bit of coverage of it here:
http://junkfoodscience.blogspot.com/2008/01/not-losing-sight-of-real-issue-on.html
b
J.D. Baldwin
In the previous article, brigid nelson <irja...@comcast.net> wrote:
> Isn't Vytorin the drug that was made up of two drugs in order to
> extend a patent?
This is getting to be a common tactic ... except the trick here is
that Vytorin is a combination of an out-of-patent drug with a still-
patented one. Another trick is to change the delivery formulation, as
with Ambien CR. There's a lot of question as to how this trick is
going to hold up in court. Even patents that seem sound -- Google on
"Lipitor" plus "Ranbaxy" -- can be called into question if you put
enough lawyers on the case.
> The one where they tried to cook the books on the study?
I'm not aware of those allegations. It happens.
> There's been a bit of coverage of it here:
>
> http://junkfoodscience.blogspot.com/2008/01/not-losing-sight-of-real-issue-on.html
That article raises some interesting points. I think the whole
cholesterol scare is starting to unravel. I have "high" cholesterol
myself -- not horrible, but it was in the low 200s since I was first
tested in my 20's, and hasn't changed much since. My "ratio" is also
just in the range that's considered a risk, even though I get a *lot*
of exercise and my eating habits aren't that bad. I'm not very
interested in going on statins until I see a hell of a lot harder link
between cholesterol levels like mine and heart disease. That link
isn't here and doesn't look like it's going to arrive anytime soon.
brigid nelson
>>
>> http://junkfoodscience.blogspot.com/2008/01/not-losing-sight-of-real-issue-on.html
>
> That article raises some interesting points. I think the whole
> cholesterol scare is starting to unravel. I have "high" cholesterol
> myself -- not horrible, but it was in the low 200s since I was first
> tested in my 20's, and hasn't changed much since. My "ratio" is also
> just in the range that's considered a risk, even though I get a *lot*
> of exercise and my eating habits aren't that bad. I'm not very
> interested in going on statins until I see a hell of a lot harder link
> between cholesterol levels like mine and heart disease. That link
> isn't here and doesn't look like it's going to arrive anytime soon.
A lot of people find that taking statins makes them feel like crap. Yet
doctors continue to recommend them for a problem that might not even be.
There's altogether too much follow the leader and not enough bothering
to educate one's self. The more I read, the more frustrated I get, it's
getting to the point where I don't even want to talk to my daughter's
renal dietitian - she says some pretty egregious things about sugar
metabolism and yet I have to trust her dietary recommendations.
It does look like there might be some light at the end of the tunnel. I
read this the other day:
Primary Article Source: “A Call for Higher Standards of Evidence for
Dietary Guidelines” by Paul R. Marantz, MD, MPH, Elizabeth D. Bird, AB,
and Michael H. Alderman, MD. American Journal of Preventive Medicine,
Volume 34, Issue 3 (March 2008) published by Elsevier.
From : www.Eurekalert.com Jan 31, 2008
Government dietary guidelines, unintended consequences and public policy
San Diego, January 30, 2008 – In the years following the government
promotion of a low-fat diet, obesity in America has reached almost
epidemic levels. Were the federal guidelines a direct cause, a catalyst
for unintended consequences or merely a well-meaning but unimportant
factor" In a study published in the March 2008 issue of the American
Journal of Preventive Medicine, Paul R Marantz, MD, MPH, Elizabeth Bird,
AB, and Michael H Alderman, MD, all from the Albert Einstein College of
Medicine, suggest that the government issued these recommendations based
on limited scientific data and assumed that no harm would result, but
the evidence now suggests otherwise. They caution that without proper
studies, such guidelines may be harmful.
“When dietary guidelines were initially introduced in the late 1970s,
their population-based approach was especially attractive since it was
presumed to carry little risk,” says Dr. Marantz. “However, the message
delivered by these guidelines might actually have had a negative impact
on health, including our current obesity epidemic. The possibility that
these dietary guidelines might actually be endangering health is at the
core of our concern about the way guidelines are currently developed and
issued.”
Dr. Marantz and colleagues argue that if guidelines can alter behavior,
such alteration could have positive or negative effects. They cite how,
in 2000, the Dietary Guideline Advisory Committee suggested that the
recommendation to lower fat, advised in the 1995 guidelines, had perhaps
been ill-advised and might actually have some potential harm. The
committee noted concern that “the previous priority given to a ‘low-fat
intake’ may lead people to believe that, as long as fat intake is low,
the diet will be entirely healthful. This belief could engender an
overconsumption of total calories in the form of carbohydrates,
resulting in the adverse metabolic consequences of high carbohydrate
diets,” the committee wrote, while also noting that “an increasing
prevalence of obesity in the United States has corresponded roughly with
an absolute increase in carbohydrate consumption.”
Dr. Marantz and colleagues present data that support these trends;
however, they are careful to note that this temporal association does
not prove causation. Instead, says Dr. Marantz, “it raises the
possibility of a net harmful effect of seemingly innocuous dietary
advice. These dietary recommendations did not necessarily cause harm,
but there is a realistic possibility that they may have.”
In a commentary published in the same issue of the American Journal of
Preventive Medicine, Steven H. Woolf, MD, MPH, from Virginia
Commonwealth University and Marion Nestle, PhD, MPH, of New York
University, maintain that the guidelines are supported by decades of
research. While they agree with Dr. Marantz that people often compensate
for low-fat intake by consuming more calories, they disagree that the
guidelines were wrong to encourage low-fat diets. “The guidelines were
not the culprit,” said Dr. Woolf, who believes that the government was
right to share what was known about the dietary causes of disease.
Woolf and Nestle do not dispute that guidelines can have unintended
consequences. However, they write, “When the prevailing message fails to
achieve its intended aims or achieves the wrong ends, the solution is
not to abandon the enterprise but to reshape the message to achieve
desired outcomes.”
Continuing the dialog, Marantz, Bird and Alderman respond in a further
commentary, “When trying to mitigate potential harm from past guidelines
based on inadequate science, issuing ‘reshaped’ guidelines with
similarly inadequate science merely perpetuates past mistakes. It might
sometimes be best to avoid translating flaccid arguments into rigid
guidelines. Ultimately, this boils down to a difference in world view,
much like the distinction between clinicians guided by the therapeutic
imperative and those guided by the maxim ‘first do no harm.’ Of course,
when the evidence is clear, beneficial interventions are always favored,
and harmful interventions always shunned. It is when the data are
unclear that challenges arise.”
Marantz concludes, “As doctors, our first call is to do no harm. That’s
why we recommend that guidelines be generous in providing information,
but more cautious in giving direction. Any directions should be based on
the very highest standards of scientific evidence. After all, we expect
that much from pharmaceutical companies before they bring a new drug to
market.”
###
The article is “A Call for Higher Standards of Evidence for Dietary
Guidelines” by Paul R. Marantz, MD, MPH, Elizabeth D. Bird, AB, and
Michael H. Alderman, MD. The commentary is “Do Dietary Guidelines
Explain the Obesity Epidemic"” by Steven H. Woolf, MD, MPH, and Marion
Nestle, PhD, MPH, followed by the author’s response by Marantz, Bird and
Alderman. This exchange appears in the American Journal of Preventive
Medicine, Volume 34, Issue 3 (March 2008) published by Elsevier.
Aje RavenStar
"brigid nelson" <irja...@comcast.net> wrote in message
news:2NmdndVKF5gWJDna...@comcast.com...
<snip>
Dr. Melik: This morning for breakfast he requested something called "wheat
germ, organic honey and tiger's milk."
Dr. Aragon: [chuckling] Oh, yes. Those are the charmed substances that some
years ago were thought to contain life-preserving properties.
Dr. Melik: You mean there was no deep fat? No steak or cream pies or... hot
fudge?
Dr. Aragon: Those were thought to be unhealthy... precisely the opposite of
what we now know to be true.
Dr. Melik: Incredible.
-Sleeper, Woody Allen, 1973