HONOLULU, April 23 - Women over age 65 who took vitamin D had nearly
one-third less risk of dying from heart disease as women who did not
take the supplements, according to research presented today at the
American Heart Association's Asia Pacific Scientific Forum meeting
today.
Vitamin D and calcium are part of the standard therapy for the bone-
thinning disease osteoporosis.
"Low blood levels of certain forms of vitamin D have been associated
with increased risk of heart attacks, but to my knowledge no one has
studied whether vitamin D supplements affect the risk of heart disease
events," says Paul D. Varosy, M.D., a fellow in cardiology and
medicine at the University of California at San Francisco and the San
Francisco VA Medical Center.
"Because previous investigators have established a possible
association between blood levels of vitamin D and heart disease, and
because taking a simple multivitamin tablet is inexpensive, safe and
common, especially among older adults, we thought it would make sense
to address our question," he says.
The researchers studied 9,704 women ages 65 and older enrolled in the
Study of Osteoporotic Fractures. The subjects included 4,272 women who
reported current use of vitamin D supplements. Varosy says the
researchers did not ask for details on the type or amount of vitamin D
taken, but they think that most of the women got the standard
recommended daily dose of 400 international units contained in
multivitamin tablets.
During an average follow-up period of nearly 11 years, 420 of the
women died of coronary heart disease (CHD). Women who used vitamin D
supplements had 31 percent less risk of heart disease death as those
who did not take the supplements. The use of calcium supplements did
not affect those results. Researchers controlled for possible factors
that could alter the results, such as heart disease risk factors,
calcium supplement use, self-reported health status, education and
behaviors such as exercise and smoking.
"In short, the benefits we observed seemed due to vitamin D and not
due to calcium," Varosy says. He says that vitamin D, which is both a
hormone and a vitamin, is one of the most important regulators of
calcium absorption in the body.
Atherosclerosis, the accumulation of cholesterol and fat in the walls
of arteries, is often associated with calcification, the buildup of
the mineral calcium in the arteries.
"A lot of evidence suggests that calcification in the arteries is very
similar to the calcification process that occurs in bone," he says.
Earlier studies had suggested that low blood levels of vitamin D might
play a role in the calcification that may contribute to heart disease.
In addition, co-author Warren S. Browner, M.D., was among the first to
observe that women with osteoporosis are more likely to die of
cardiovascular diseases than women without osteoporosis.
http://www.americanheart.org/presenter.jhtml?identifier=3002267
Thanks Vince
>Vitamin D gets an A+ for treating heart disease
In an observational study, not a randomized trial.
--
Jim Chinnis Warrenton, Virginia, USA
Correct, Jim.
Hopefully, you did not overeat over Thanksgiving :-)
It seems one of the anti-christian Sermo physicians have come out of
their very dark cave to see if you are for real though it is unlikely
we will see a doffing of the AOL bedsheet.
Fwiw, you were not the case that I reported sans PHI on Sermo because
that particular case is indeed one of our cardiac patients and
included the following set of EKGs...
http://HeartMDPhD.com/gifs/Sermo_AFIB2.JPG
http://HeartMDPhD.com/gifs/Sermo_AFIB3.JPG
http://HeartMDPhD.com/gifs/Sermo_AFIB4.JPG
The pathological untruthfulness of the anonymous Sermo physician does
not bode well for the future of Sermo. Now imagine the pharmaceutical
industry being guided by untruthful physicians such as these
(shudder). Marilyn has quite a keen sense of detecting dens of
corruption.
Be hungry... be healthy... be hungrier... be blessed:
http://TheWellnessFoundation.com/BeHealthy
Prayerfully in the infinite power and might of the Holy Spirit,
Andrew <><
--
Andrew B. Chung, MD/PhD
Lawful steward of http://EmoryCardiology.com
Bondservant to the KING of kings and LORD of lords.
A good study is a good study a corrupted study even a randomized
trail is corrupted. Evidently studies funded by the drug industry are
even randomized trails are offen corrupted. A BMJ piece
http://www.bmj.com/cgi/content/abstract/326/7400/1167
"BMJ 2003;326:1167-1170 (31 May), doi:10.1136/bmj.326.7400.1167
Paper
Pharmaceutical industry sponsorship and research outcome and quality:
systematic review
Joel Lexchin, associate professor1, Lisa A Bero, professor2, Benjamin
Djulbegovic, associate professor3, Otavio Clark, chief of clinical
oncology section4 .......
"Objective To investigate whether funding of drug studies by the
pharmaceutical industry is associated with outcomes that are
favourable to the funder and whether the methods of trials funded by
pharmaceutical companies differ from the methods in trials with other
sources of support. "..........
......Conclusion Systematic bias favours products which are made by
the company funding the research. Explanations include the selection
of an inappropriate comparator to the product being investigated and
publication bias. "
So a" systematic" biased RCT are the 'Gold Standart" Heck Jim a
piece came out about one of you favorite products statins in The NYT
Cardiologists Question Delay of Data on 2 Drugs "
http://www.nytimes.com/2007/11/21/business/21drug.html?th&emc=th
"Nearly two years after the medicines' makers, Merck and Schering-
Plough, completed a clinical trial of the drugs, they still have not
released the findings. The delay has led to a growing chorus of
complaints from cardiologists. And yesterday, the companies responded
by promising to publish a portion of the results next March -- but
not
the entire set of data.
Doctors say that decision is highly unusual and will do little to
quell concerns about the trial, as well as broader questions about
the
effectiveness of the drugs. .......
....Of particular concern in this case is that Merck and Schering-
Plough
said yesterday that they had changed the trial's "primary endpoint"
--
the main medical result being measured. The companies now say that
they will use only partial results to assess the trial's success in
deterring the formation of plaque that can cause artery blockages and
lead to heart attacks.......
.......But scientists generally assume that for a clinical trial to
be
valid, its goals must be defined before it begins and never changed
afterward. Otherwise, the people conducting the trial could change
their goals to conform to the data the trial has actually produced.
"This sounds highly unusual to me," said Dr. Bruce Psaty, a professor
of medicine and epidemiology at the University of Washington. "You
need to live with your primary endpoint."....."
Evidently these RCT are viewed not as objectly as on might asume the
ability to not publish negative results. Change endpoints to lets say
'get the right answer' calls into question the results of RCT .
Really a good study is a good study and a biased RCT is biased by
design .
Thanks Vince
> A good study is a good study a corrupted study even a randomized
> trail is corrupted.
Can someone explain to me what this means?
Truth is truth and a falsehood is still a falsehood even if random.
or
+ is + and a - is still a - even if depending on chance.
Bill
--
S Jersey USA Zone 5 Shade
http://www.ocutech.com/ High tech Vison aid
Too often, it means that the person wants to pick and choose which studies
to believe based on the results.
Gees Jim it really has more to do with the ability of the funding
source to distort results in a way that enhances profit . . the times
piece noted
'Another big drug maker, Pfizer, for example, was harshly criticized
in 2001 for reporting that its painkiller Celebrex caused fewer ulcers
than older drugs after six months of use. Pfizer's study had
originally been designed -- but failed -- to show that Celebrex caused
fewer ulcers after a full year of use.'
Find that one moment that shows a benefit even if you have to move the
goalpost to achive it. It has more to do with the ability to pick and
chose what RCT studies to show and which to bury. Mix that with profit
and you have studies that by design are biased ,
'Another big drug maker, Pfizer, for example, was harshly criticized
in 2001 for reporting that its painkiller Celebrex caused fewer ulcers
than older drugs after six months of use. Pfizer's study had
originally been designed -- but failed -- to show that Celebrex caused
fewer ulcers after a full year of use.'
Thanks Vince
Without a discerning heart, that is all folks can do, sadly.
>On Nov 26, 11:36 am, Jim Chinnis <jchin...@SPAMalum.mit.edu> wrote:
>> listener <liste...@nospam.net> wrote in part:
>>
>> >bigvince <Vince.Mirag...@gmail.com> wrote in news:890f76c3-abb6-4f77-bc2b-
>> >a447a5776...@g30g2000hsb.googlegroups.com:
>>
>> >> A good study is a good study a corrupted study even a randomized
>> >> trail is corrupted.
>>
>> >Can someone explain to me what this means?
>>
>> Too often, it means that the person wants to pick and choose which studies
>> to believe based on the results.
>> --
>> Jim Chinnis Warrenton, Virginia, USA
>
>Gees Jim it really has more to do with the ability of the funding
>source to distort results in a way that enhances profit . . the times
>piece noted
The main way to get results you want is to find observational studies that
support your position. The drug firms have whole departments that generate
such silly studies. So do most universities.
The study you started a thread about is an excellent example of a
meaningless study. No one has any idea what the causal factors were relating
to heart disease in that study It resembles a lot of the observational
studies showing all sorts of new uses for statins.
Large, multi-center, repeated, prospective, randomized trials *can* be
biased or tinkered with by sponsors, but it's very hard. But any idiot can
find an observational study that shows exactly what they want to find.
But any idiot can
find an observational study that shows exactly what they want to find.
> --
> Jim Chinnis Warrenton, Virginia, USA
Not the Jim I know.
Bill who wants Jim to put a few pounds on. Just the opposite of
lighten up.
> Large, multi-center, repeated, prospective, randomized trials *can* be
> biased or tinkered with by sponsors, but it's very hard. But any idiot can
> find an observational study that shows exactly what they want to find.
> --
Heck just not accurate its easy to cook a study as noted . In the
times piece
'Another big drug maker, Pfizer, for example, was harshly criticized
in 2001 for reporting that its painkiller Celebrex caused fewer
ulcers
than older drugs after six months of use. Pfizer's study had
originally been designed -- but failed -- to show that Celebrex
caused
fewer ulcers after a full year of use.'
Does not look that difficult. Just make up the study as you go along
change the time . Change the endpoints as the time piece noted
"Of particular concern in this case is that Merck and Schering-
Plough
said yesterday that they had changed the trial's "primary endpoint"
"....
..........But scientists generally assume that for a clinical trial
to
be
valid, its goals must be defined before it begins and never changed
afterward. Otherwise, the people conducting the trial could change
their goals to conform to the data the trial has actually produced.
"This sounds highly unusual to me," said Dr. Bruce Psaty, a professor
of medicine and epidemiology at the University of Washington. "You
need to live with your primary endpoint."....."
Not in this RCT
Thanks Vince
>On Nov 26, 12:06 pm, Jim Chinnis <jchin...@SPAMalum.mit.edu> wrote:
>
>> Large, multi-center, repeated, prospective, randomized trials *can* be
>> biased or tinkered with by sponsors, but it's very hard. But any idiot can
>> find an observational study that shows exactly what they want to find.
>> --
>
>
>Heck just not accurate its easy to cook a study as noted . In the
>times piece
It's virtually impossible to cook multiple large prospective multi-center
randomized trials. And all credible trials these days need to have their
designs published in advance.
There is no observational trial that can determine cause. But it is possible
to do quality randomized trials that can. And it is not hard to see which
studies have credibility. The one you posted for discussion in this thread
has no credibility.
> Too often, it means that the person wants to pick and choose which
studies
> to believe based on the results.
"Without a discerning heart, that is all folks can do, sadly."
And with one clouded by the pagan "chi" it is what they do.
Valid research refuting in part and in whole fixations are ignored by
them sadly.
God bless.
Gees Jim the study we are talking about is that type of trail from the
times piece here
http://www.nytimes.com/2007/11/21/business/21drug.html?th&emc=th
Cardiologists Question Delay of Data on 2 Drugs
"Nearly two years after the medicines' makers, Merck and Schering-
Plough, completed a clinical trial of the drugs, they still have not
released the findings........
...The delay in publishing the Enhance results also raises broad
questions about whether the drug industry is sticking to its promises
to improve the disclosure of clinical trials. After sharp criticism
for failing to disclose trials that had negative results, drug makers
promised two years ago to publicly register clinical trials in advance
and promptly disclose their findings. But in practice they face few
penalties for failing to meet those promises.
Of particular concern in this case is that Merck and Schering-Plough
said yesterday that they had changed the trial's "primary endpoint" --
the main medical result being measured. ...."
The facts here do not support your statement.
> There is no observational trial that can determine cause. But it is possible
> to do quality randomized trials that can. And it is not hard to see which
> studies have credibility. The one you posted for discussion in this thread
> has no credibility.
> --
> Jim Chinnis Warrenton, Virginia, USA
In your opinion
Jim I reposted .The American Heart Association felt it had credibility
here the link http://www.americanheart.org/presenter.jhtml?identifier=3002267
"Vitamin D gets an A+ for treating heart disease
HONOLULU, April 23 - Women over age 65 who took vitamin D had nearly
one-third less risk of dying from heart disease as women who did not
take the supplements, according to research presented today at the
American Heart Association's Asia Pacific Scientific Forum meeting
today".....
........Co-authors include Kristine E. Ensrud, M.D., M.P.H.; Katie L.
Stone, Ph.D.; Ian R. Reid, M.D.; Teresa Hillier, M.D., M.S. and Steven
R. Cummings, M.D. Other participating institutions include: California
Pacific Medical Center Research Institute, San Francisco; Minneapolis
Veterans Affairs Medical Center and the University of Minnesota,
Minneapolis; University of Auckland Department of Medicine, Auckland,
New Zealand; and the Kaiser Center for Health Research Northwest/
Hawaii, Portland, Ore.
American Heart Association
Thanks Vince
>On Nov 26, 1:36 pm, Jim Chinnis <jchin...@SPAMalum.mit.edu> wrote:
>> bigvince <Vince.Mirag...@gmail.com> wrote in part:
>>
>> >On Nov 26, 12:06 pm, Jim Chinnis <jchin...@SPAMalum.mit.edu> wrote:
>>
>> >> Large, multi-center, repeated, prospective, randomized trials *can* be
>> >> biased or tinkered with by sponsors, but it's very hard. But any idiot can
>> >> find an observational study that shows exactly what they want to find.
>> >> --
>>
>> >Heck just not accurate its easy to cook a study as noted . In the
>> >times piece
>>
>> It's virtually impossible to cook multiple large prospective multi-center
>> randomized trials. And all credible trials these days need to have their
>> designs published in advance.
>
>Gees Jim the study we are talking about is that type of trail from the
>times piece here
Irrelevant news story follows, having nothing to do with the vitamin D study
of concern in this thread:
>http://www.nytimes.com/2007/11/21/business/21drug.html?th&emc=th
>Cardiologists Question Delay of Data on 2 Drugs
>
>"Nearly two years after the medicines' makers, Merck and Schering-
>Plough, completed a clinical trial of the drugs, they still have not
>released the findings........
>
>...The delay in publishing the Enhance results also raises broad
>questions about whether the drug industry is sticking to its promises
>to improve the disclosure of clinical trials. After sharp criticism
>for failing to disclose trials that had negative results, drug makers
>promised two years ago to publicly register clinical trials in advance
>and promptly disclose their findings. But in practice they face few
>penalties for failing to meet those promises.
>
>Of particular concern in this case is that Merck and Schering-Plough
>said yesterday that they had changed the trial's "primary endpoint" --
>the main medical result being measured. ...."
>
> The facts here do not support your statement.
They don't establish credibility for the observational study on vitamin D
certainly. They also undermine the credibility of an unrelated unfinished
study on Vytorin. I don't see the problem here. I'd like to focus on
meaningful data. The vitamin D study you posted is meaningless. So is the
Enhance trial, for different reasons (mostly that the properly published
design is being changed midstream--a fatal research flaw). It doesn't
exactly "cook" the data; it renders them uninterpretable.
>> There is no observational trial that can determine cause. But it is possible
>> to do quality randomized trials that can. And it is not hard to see which
>> studies have credibility. The one you posted for discussion in this thread
>> has no credibility.
>> --
>> Jim Chinnis Warrenton, Virginia, USA
> In your opinion
>
>Jim I reposted .The American Heart Association felt it had credibility
So what?
>here the link http://www.americanheart.org/presenter.jhtml?identifier=3002267
>
>"Vitamin D gets an A+ for treating heart disease
>
>
>
>HONOLULU, April 23 - Women over age 65 who took vitamin D had nearly
>one-third less risk of dying from heart disease as women who did not
>take the supplements, according to research presented today at the
>American Heart Association's Asia Pacific Scientific Forum meeting
>today".....
>........Co-authors include Kristine E. Ensrud, M.D., M.P.H.; Katie L.
>Stone, Ph.D.; Ian R. Reid, M.D.; Teresa Hillier, M.D., M.S. and Steven
>R. Cummings, M.D. Other participating institutions include: California
>Pacific Medical Center Research Institute, San Francisco; Minneapolis
>Veterans Affairs Medical Center and the University of Minnesota,
>Minneapolis; University of Auckland Department of Medicine, Auckland,
>New Zealand; and the Kaiser Center for Health Research Northwest/
>Hawaii, Portland, Ore.
>
>
>American Heart Association
>
> Thanks Vince
>x-no-archive: yes
>
>Jim Chinnis wrote:
>
>> It's virtually impossible to cook multiple large prospective multi-center
>> randomized trials. And all credible trials these days need to have their
>> designs published in advance.
>
>That is SO not true, about not being able to cook them. It's not some
>nefarious conspiracy centrally driven, it's about he influences on each
>center's investigator of his income stream and future prospects. They
>all share similar influences without collusion. It's tacit
>understanding and pervasive influences of industry money coupled with a
>toothless and even complicit FDA.
You paint a really dismal picture, Susan: The researchers come up with
whatever results the sponsor wants, and the government is complicit. It's
amazing that we can do open heart surgeries, cure certain cancers, prevent
many heart attacks with aspirin or clopidogrel, cure many infectious
diseases with pills. How did we ever manage to find out how?
In any case, there is a level of quality associated with evidence from a
study. Ideally, you have multiple prospective randomized studies funded by
different organizations and run by different PIs. Replication is crucial.
At the very bottom of the credibility scale is an observational study such
as the one re vitamin D that is the subject of this thread. Most such
results are overturned when randomized trials are done.
I would agree with Jim's comments. The women who took vitamin D would
tend to be different from the women who didn't.
Marilyn
Any easy examples come to mind ?
Bill
And the nod by the AHA proves nothing. Especially given the nonsense
they've pushed in the past, IMO.
How would they differ ?
In Susan's world, all investigators who get paid and are offered more
work are corrupt. But, fortunately, for us, it's *not* a conspiracy!
LOL.
Marilyn
> x-no-archive: yes
>
> listener wrote:
>
>> In Susan's world, all investigators who get paid and are offered more
>> work are corrupt. But, fortunately, for us, it's *not* a conspiracy!
>>
>> LOL.
>
> You always bring such insight and intellectual rigor to any discussion.
>
> I don't recall your ever having made one single contribution here that
> wasn't a shill for industry or a personal dig at someone else.
>
> Susan
>
Why do you always respond to my insights with your brand of demeaning,
personal digs? It really is unbecoming.
I'm not making this stuff up. One minute, you're trashing the entire
research profession (because they, god forbid, get paid for what they do!)
and the next your dispensing medical advice without a license.
There's danger here. Between you an Vince, it's all-spin, all the time.
Many of the very differences you and JIm speculate occured where
controlled for from the original post .
'
"...Researchers controlled for possible factors
that could alter the results, such as heart disease risk factors,
calcium supplement use, self-reported health status, education and
behaviors such as exercise and smoking. ''
The primary difference would be they took vitamin d and had less
heart disease.
"During an average follow-up period of nearly 11 years, 420 of the
women died of coronary heart disease (CHD). Women who used vitamin D
supplements had 31 percent less risk of heart disease death as those
who did not take the supplements. The use of calcium supplements did
not affect those results. Researchers controlled for possible factors
that could alter the results, such as heart disease risk factors,
calcium supplement use, self-reported health status, education and
behaviors such as exercise and smoking. '
"In short, the benefits we observed seemed due to vitamin D and not
due to calcium," Varosy says. He says that vitamin D, which is both a
hormone and a vitamin, is one of the most important regulators of
calcium absorption in the body. ''........
No the assertion that you and Jim make that these women where
"different' in view of the fact that this study controlled for such
factors seems illogical.
Thanks Vince
A randomized interventional study with all the whistles will remove
the effect of an unobserved factor only if its influence on the two
other variables (heart disease and vit D) is through statistical
correlation. This takes care of confounding.
But that's not the only possible influence an unknown factor U can
have on the relation of heart disease (H) with with vit D.
If there are effects such that the value of H depends on joint values
of D and U, the interventional approach might be just as unreliable as
far as the inference about causality, direction and magnitude of the
effect is concerned.
Since the factor U is unknown, its average value (or the frequency,
pU) cannot be controlled, and can vary across populations. This can in
fact lead to a reversal of an observed effect of D on H in a
randomized study, for certain types of interactions.
As a consequence of this, a value pU can be determined such that the
effect of D on H will be zero in one randomized study, while at
different pU values it would either be positive or negative, in other
randomized studies of arbitrarily large size.
The forms of the joint effects permitting an effect reversal (in the
absence of correlation) are restrictive, so it is true that things can
go wrong more easily in an observational study. But randomized studies
are not immune to that.
>> A good study is a good study a corrupted study even a randomized
>> trail is corrupted.
>
>
> Can someone explain to me what this means?
In other words, you can tell the good studies from the bad
studies not by how they're run but by the results they get.
--
| Bogus as it might seem, people, this really is a deliverable |
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+--------------- D. C. Sessions <d...@lumbercartel.com> --------------+