Re: Comparisons of effects of statins

[Guest guest]

At 10:16 AM 1/12/2004 -0500, you wrote:

Am J Cardiol. 2004 Jan

1;93(1):31-9.

Related

Articles,

Links

Comparisons of effects of statins (atorvastatin, fluvastatin, lovastatin, pravastatin, and simvastatin) on fasting and postprandial lipoproteins in patients with coronary heart disease versus control subjects.

Schaefer EJ, McNamara JR, Tayler T, Daly JA, Gleason JL, Seman LJ, Ferrari A, stein JJ.

Atherosclerosis Research Laboratory, Lipid and Heart Disease Prevention Clinic, Department of Medicine, Tufts-New England Medical Center, Tufts University School of Medicine, Boston, Massachusetts, USA

This may be a perfectly valid study. And for people with HIV, only a few statins can be used during ARV therapy anyway, atorvastatin being one. But I just don't entirely trust it yet, first of all. And second of all, I think there are other, better methods to control LDL/TG problems that could be tried and should be clinically evaluated.

Part of my distrust stems from recent concerns outlined below. And this just sounds SO much like another one of those. And god knows how much funding Tufts gets from Glaxo.

M.

***

Montgomery SA, Dunner DL, Dunbar GC.

Reduction of suicidal thoughts with paroxetine in comparison with

reference antidepressants and placebo.

Eur Neuropsychopharmacol. 1995 Mar;5(1):5-13.

PMID: 7613102 [PubMed - indexed for MEDLINE]

<URL:http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve & db=PubMed & list_uids=7613102 & dopt=Abstract>

In this study it was concluded that antidepressant paroxetine (Paxil, Seroxat)

reduced suicides. According to the study there were 2.8 times fewer suicides

in the paroxetine-treated group compared with active control and 5.6 times

fewer compared with placebo, calculated by patient year of exposure.

A few years later the family of Wyoming resident Schell, 60, sued GSK

in federal court after Schell shot his wife, daughter, granddaughter and then

himself to death in 1998 after two days on Paxil.

The original raw data is usually the sponsor's property, and drug companies

sponsoring trials don't give this data to other for analysis. In this case,

however, Dr. Healy of the University of Wales Department of

Psychological Medicine got access to this data by court decision. The result

of Healy's analysis differed from GSK's one. He argued GSK's internal records

demonstrated that there is a substantially increased suicide risk for patients

put on Paxil. Jury agreed and awarded $6.4 million to the plaintiffs. Later

the warning about suicide risk has been put on the label for drug in UK, but

not in USA.

Later several neutral meta-analyses and review articles have concluded that

antidepressants (except for lithium) don't reduce suicides and may even

increase them. Below some of these studies:

Healy D, Whitaker C.

Antidepressants and suicide: risk-benefit conundrums.

J Psychiatry Neurosci. 2003 Sep;28(5):331-7.

<http://www.cma.ca/cma/staticContent/HTML/N0/l2/jpn/vol-28/issue-5/pdf/pg331.pdf>

<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve & db=PubMed & list_uids=14517576 & dopt=Abstract>

( <http://www.biopsychiatry.com/suicides-ssri.htm> )

Healy D.

Lines of evidence on the risks of suicide with selective serotonin

reuptake inhibitors.

Psychother Psychosom. 2003 Mar-Apr;72(2):71-9. Review

<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve & db=PubMed & list_uids=12601224 & dopt=Abstract>

Van Praag HM.s

A stubborn behaviour: the failure of to reduce suicide rates.

World J Biol Psychiatry. 2003 Oct;4(4):184-91

<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve & db=PubMed & list_uids=14608590 & dopt=Abstract>

van Praag HM.

Why has the antidepressant era not shown a significant drop in suicide

rates?

Crisis. 2002;23(2):77-82.

<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve & db=PubMed & list_uids=12500893 & dopt=Abstract>

( <http://www.biopsychiatry.com/suicide.html> )

Khan A, Khan S, Kolts R, Brown WA.

Suicide rates in clinical trials of SSRIs, other antidepressants, and

placebo: analysis of FDA reports.

Am J Psychiatry. 2003 Apr;160(4):790-2.

<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve & db=PubMed & list_uids=12668373 & dopt=Abstract>

Khan A, Khan SR, Leventhal RM, Brown WA.

Symptom reduction and suicide risk in patients treated with placebo in

antidepressant clinical trials: a replication analysis of the Food and

Drug Administration Database.

Int J Neuropsychopharmacol. 2001 Jun;4(2):113-8.

<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve & db=PubMed & list_uids=11466159 & dopt=Abstract>

One of the authors of the 1995 Paxil study, Dr. Dunner of the University

of Washington's Department of Psychiatry has admitted that he had never seen

the original raw data, and that he mainly had " lent " his name against a hefty

fee.

In 2002 the English quality newspaper Guardian published the following article

about the medical ghostwriting and wrote in this context also about the 1995

Paxil study, the trial of the Schell shooting incident, and Dr. Dunner:

Scandal of scientists who take money for papers ghostwritten by drug

companies

Guardian, Thursday February 7, 2002

<http://www.guardian.co.uk/Archive/Article/0,4273,4351264,00.html>

A couple of citations:

" Scientists are accepting large sums of money from drug

companies to put their names to articles endorsing new

medicines that they have not written - a growing practice

that some fear is putting scientific integrity in jeopardy.

Ghostwriting has become widespread in such areas of

medicine as cardiology and psychiatry, where drugs play a

major role in treatment. Senior doctors, inevitably very

busy, have become willing to " author " papers written for

them by ghostwriters paid by drug companies.

Originally, ghostwriting was confined to medical journal

supplements sponsored by the industry, but it can now be

found in all the major journals in relevant fields. In some

cases, it is alleged, the scientists named as authors will

not have seen the raw data they are writing about - just

tables compiled by company employees. ... "

[...]

The responsibility of scientists for the content of their

papers takes on serious significance in the context of

court cases in the US, where relatives of people who killed

themselves and murdered others while on SSRIs (selective

serotonin reuptake inhibitors) - the class of drug to which

Prozac belongs - claimed the drugs were responsible.

According to Healy, a north Wales-based

psychopharmacologist who has given evidence for the

families, the companies have relied on articles apparently

authored by scientists who may in fact have not seen the

raw data.

Dr Healy, who had unprecedented access to the data that the

companies keep in their archives, said: " It may well be

that 50% of the articles on drugs in the major journals

across all areas of medicine are not written in a way that

the average person in the street expects them to be

authored. "

He cites the case brought last year against the former

Kline Beecham (now GlaxoKline) by relatives of

Schell. The court found that the company's best-

selling antidepressant, an SSRI called Seroxat, had caused

Schell to murder his wife, daughter and granddaughter and

commit suicide.

The company's defence was based on scientific papers which

analysed the results of trials comparing Seroxat with a

placebo and found there was no increased risk of suicide

for depressed people on Seroxat. But the raw data probably

does not support that, argues Dr Healy. Some of the placebo

suicides took place while patients were withdrawing from an

older drug. When the figures are readjusted without these,

he says, they show there is substantially increased risk of

suicide on Seroxat.

This raises the question of whether the eminent scientists

whose names were on the papers ever saw the raw data from

the trials - or saw only tables compiled by company

employees, he says. Dunner, a professor at the

University of Washington, who co-authored one of the papers

in 1995, admits he did not see the raw data. " I don't know

who saw it. I did not, " he said. " My role in the paper was

that the data were presented to us and we analysed it and

wrote it up and wrote references. "

His co-author Stuart Montgomery, then of St 's hospital

medical school in London, declined to answer calls and

emails from the Guardian. The third name on the paper is

that of Geoff Dunbar, a company employee.

The World Health Organisation has expressed concern about

the ties between industry and researchers. Quick,

director of essential drugs and medicines policy, wrote in

the latest WHO Bulletin: " If clinical trials become a

commercial venture in which self-interest overrules public

interest and desire overrules science, then the social

contract which allows research on human subjects in return

for medical advances is broken. " "

[Guest guest]

>>>This may be a perfectly valid study. And for people with HIV, only a few statins can be used during ARV therapy anyway, atorvastatin being one. But I just don't entirely trust it yet, first of all. And second of all, I think there are other, better methods to control LDL/TG problems that could be tried and should be clinically evaluated.

Part of my distrust stems from recent concerns outlined below. And this just sounds SO much like another one of those. And god knows how much funding Tufts gets from Glaxo.<<<

I realize that whenever a study is funded by industry, there is always going to be some measure of skepticism about the results. But I honestly feel that Tufts is an institution with the highest ethical standards. I would trust them more than any other medical school to administer this type of study. They are also doing studies with fish oils, diet, nutrition etc.

By the way, I am on simvastatin (Zocor) which was the only statin shown to be just as effective as atorvastatin. I'll bet that Zocor is one of the statins that you would put on the list NOT to use during ARV therapy. I tried several other statins and they didn't work as well. Also, I'm on NNRTI instead of PIs - where I think the main concern is. I've tried many other therapies instead of statins. They didn't work for me. I continue to take Carnitor, fish oils, niacin, etc.

Glenn

[Guest guest]

Definitely!! Simvastatin is completely contraindicated when someone is

using ARV. Unless one took a really really low dose, about a 1000th the

current dose. I wonder, tho, if one COULD take such a very low dose, at

very low cost, and get the cholesterol lowering effect? The reason one

doesn't take it if I recall aright is because ARV shoots the simvastatin

level up a thousand times (with all the concomitant toxicities exacerbated

enormously).

M.

I'm on a normal 40 mg dose, which was actually bumped up from the 20 mg that I started at. Again, I think if you check you'll see that the contraindication is with Protease Inhibitors, not with all ARV in general.

Glenn

[Guest guest]

At 09:39 AM 1/15/2004 -0500, GetWell@... wrote:

>

>

> >>>This may be a perfectly valid study. And for people with HIV, only a

> few statins can be used during ARV therapy anyway, atorvastatin being

> one. But I just don't entirely trust it yet, first of all. And second of

> all, I think there are other, better methods to control LDL/TG problems

> that could be tried and should be clinically evaluated.

>

>Part of my distrust stems from recent concerns outlined below. And this

>just sounds SO much like another one of those. And god knows how much

>funding Tufts gets from Glaxo.<<<

>

>I realize that whenever a study is funded by industry, there is always

>going to be some measure of skepticism about the results. But I honestly

>feel that Tufts is an institution with the highest ethical standards. I

>would trust them more than any other medical school to administer this

>type of study. They are also doing studies with fish oils, diet, nutrition

>etc.

Oh--I think Tufts is a big place, like Harvard. Each does some GREAT work.

For a stellar example, Charlie Smigelski! He's a great guy and a good heart!

But not all the parts of the machine are necessarily in good shape. I'm

specifically think of the egregious, pharma-ass-licking study done by

DiMasi et al. that claimed bringing a drug brought to market costs $800

million. Horseshit.

>By the way, I am on simvastatin (Zocor) which was the only statin shown to

>be just as effective as atorvastatin. I'll bet that Zocor is one of the

>statins that you would put on the list NOT to use during ARV therapy. I

>tried several other statins and they didn't work as well. Also, I'm on

>NNRTI instead of PIs - where I think the main concern is. I've tried many

>other therapies instead of statins. They didn't work for me. I continue to

>take Carnitor, fish oils, niacin, etc.

Definitely!! Simvastatin is completely contraindicated when someone is

using ARV. Unless one took a really really low dose, about a 1000th the

current dose. I wonder, tho, if one COULD take such a very low dose, at

very low cost, and get the cholesterol lowering effect? The reason one

doesn't take it if I recall aright is because ARV shoots the simvastatin

level up a thousand times (with all the concomitant toxicities exacerbated

enormously).

M.

[Guest guest]

At 10:04 AM 1/15/2004 -0500, you wrote:

>snip....

>Definitely!! Simvastatin is completely contraindicated when someone is

>using ARV.

Clarification--specifically, protease inhibitors. A non-PI containing

regimen does not preclude use of a simvastatin as far as I know.

Thanks, Glenn, for pointing that out!

M.