The Statin Effects Study

[SusieO]

I was part of the University of California San Diego statin effects study and they have finally come out with their first newsletter!

********
The Statin Effects Study
*Newsletter | May 17, 2007 | Volume 1 | Issue 1 *http://medicine.ucsd.edu/ses

*Thank you so much to all of you who have kindly contributed your time and experience to help advance understanding of possible statin effects!*

So far we have received over 4112 reports, and we couldn't be more grateful!

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*We have learned a great deal that helps us to help those who contact us:*

* Many adverse effects (*AEs*) are dose-related -- and recur with
high probability if an equivalent or higher potency statin is given
* Time to recurrence of symptoms is generally shorter (for muscle
AEs) than time to first onset
* The most commonly-reported AEs are: muscle, cognition (including
memory), neuropathy (sensory changes such as numbness, tingling,
or burning), and irritability
* Others may include, but are not limited to: other
mood/personality/psychiatric changes, violent
nightmares/thoughts/sometimes actions, gastrointestinal and liver
problems, shortness of breath, changes in temperature regulation
(including sweats), weight changes (e.g. weight gain), breast
enlargement, dry skin, rashes, erectile dysfunction, and blood
pressure changes
* Other effects statins may cause based on the literature are
protein in the urine, as well as kidney and heart effects
* It is possible that not all reported effects are directly related
to the drug

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*We are working to disseminate the results:*

* Published and presented findings to doctors
* Reports in the media about this work to increase awareness in
patients and doctors (We have found the reporting is NOT always
accurate)
* We recently had an American Heart Association (AHA) abstract
accepted and published, entitled "Do Low Dose Statins Affect
Cognition - Results of the UCSD Statin Study."

Here is the full list of articles we've published thus far:

_Articles published from the UCSD Statin Study:_

* "Do Low Dose Statins Affect Cognition? Results of the UCSD Statin
Study" (AHA Abstract)
* "Statins lower blood pressure: Results of the UCSD Statin Study"
(AHA Abstract)
* "Study Design. The UCSD Statin Study: A randomized controlled
trial assessing the impact of statins on noncardiac endpoints"
(Control Clin Trials)
* "Conceptual Foundations of the UCSD Statin Study: A Randomized
Control Trial Assessing the Impact of Statins on Cognition,
Behavior, and Biochemistry" (Arch Intern Med)

_Articles published from or related to the UCSD Statin Effects Study:_

* "Physician Response to Patient Reports of Drug Adverse Effects:
Implications for Patient-Targeted Adverse Effect Surveillance"
(Drug Safety - in press, article not yet available)
* "Letter to the Editor: Risk Factors for Rhabdomyolysis with
Simvastatin and Atorvastatin" (Drug Safety)
* "Implications of statin adverse effects in the elderly" (Expert
Opin Drug Saf)
* "Lack of Physician Response Toward Perceived Statin Adverse
Effects" (AHA Abstract)
* "Low and Lowered Cholesterol and Total Mortality" (J Am Coll Cardiol)
* Severe irritability associated with statin cholesterol-lowering
drugs" (Q J Med)
* Statin Adverse Effects: Implications for the Elderly" (Geriatric
Times)
* "Clinical Characteristics of 1053 Patients with Statin-Associated
Muscle Complaints" (Arterioscler Thromb Vasc Biol)
* "Statin Associated [Muscle] Adverse Events" (AHA Abstract)
* "Low cholesterol and violent crime" (J Psychiatric Res)
* "Low cholesterol and violence: Is there a connection?" (Ann
Intern Med)

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*
Some of our ongoing side projects include:*

* Examining the cognitive effects in more detail (Marce Evans has
done a terrific job)
* Looking at recovery from statin adverse effects (Dr. Beatrice
Golomb and Marvin Hanashiro)
* Examining reports of how doctors respond when patients bring up
possible AEs (published abstract available upon request)
* Our web-based survey; we have had over 3,000 entries so far and
counting!
* A validation and a test-retest reliability study - the purpose is
to improve acceptance of our questionnaires in the research community

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*Some of our future plans include:*

* A proxy survey, that can be filled out by family members
* Examining subjective benefits as well as adverse effects of statins
* Conducting tests to clarify the mechanisms by which statins cause
problems
* Assessing treatments that may help protect against problems
* Continued efforts to publish what we are finding

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*Acknowledgements:*

We gratefully thank all who have contributed to this effort!

Past Contributors -

* John McGraw, without whom this project would not be here (he
labored on this for several years, and with Dr. Golomb as an
inaugural member - he has gone on to graduate school in
anthropology and cognitive science at UCSD and we are very proud)
* Rosemay Remigio-Baker and Heather Dunn (short term project directors)
* Talina Konotchick - Congratulations on acceptance to a graduate
program in biological oceanography at UC Scripps Institution of
Oceanography
* Karen Kordas, MD - Worked on cognitive effects database
* Tram Dang - Talented programmer who initiated the web effort
* Elaine Yang - Congratulations on matriculation to medical school
* Tara Kane - Congratulations on completion of graduate school
* Karen Friery - Contributed to development of the web-based effort
* Sonia Gupta - Helped look at biochemical pathways affected by statins

Ongoing involvement -

* Michael Criqui, MD, MPH
* Advisory Board members
* Marvin Hanashiro
* Marce Evans
* Virginia Chan
* Edwin Kwon
* Janis Ritchie and Diana King, who have provided ongoing help
* We also thank the Robert Wood Johnson Foundation for partial
support through a Generalist Physician Faculty Scholar Award to
Dr. Golomb

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*We warmly thank those of you who have donated money to this effort; we could not support the costs of the work without your help. We are truly
grateful!*

Contributions have been critical to covering the costs of this work, and permitting us to respond to people who have questions or problems.
Unlike most who do research pertaining to statins, we do not solicit or accept money from the pharmaceutical industry for this work. We believe this is vital to permitting an unbiased evaluation that includes risks as well as benefits of statin use. Your contribution, if you wish to make one, will truly make a difference.

If you wish to contribute a donation, a check can be made to "UC San Diego Foundation, Fund #3923." Any amount would be welcome and appreciated!

Address to:

UCSD Statin Effects Study
9500 Gilman Drive, Dept. 0995
La Jolla, CA 92093-0995

We deeply appreciate your help in this effort!

------------------------------------------------------------------------
*
**Thanks to all of you who have let others with possible problems know about us!*

If you have any questions, comments, or updates on how you are, do not hesitate to contact us at statinstudy@ucsd.edu or (858) 558-4950 ext.
215. Furthermore, if you know of someone else who may have experienced benefits or adverse effects on statins, we would be grateful if you might be willing to provide them with our contact information and let them know that their input can be of great help to us!

*ONCE AGAIN, THANKS TO ALL OF YOU FOR YOUR KIND HELP! THE INFORMATION YOU HAVE PROVIDED IS INVALUABLE AND HELPS US TO HELP OTHERS!*

[JL]

Strange how this study seems to side step anything having to do
with congestive heart failure side effects brought on by CoQ10 depletion.
Seems that they are trying so hard to make statins look good. Wonder why? :roll:

[Brian C.]

All together now, WHITEWASH!!!!

Brian.

[catspajamas]

Considering my experience with the UCSD statin staff that is studying the effects of statins I think they are trying very hard to prove that our adverse side effects actually come from the drugs...They seem very sincere in their research...and I suppose they have to be very very careful when it comes to publishing their results...You wouldn't want them to be otherwise...We need the proof...beyond question.....A rep from the drug company did admit to me that during the trials, 1 in 10,000 people experienced some or all of the side effects you see listed on the literature that comes with your prescription....Considering the millions of people in the world...1 in 10,000 people is a lot of people....We are just the tip of the iceberg......I had a old 95 yr old neighbor that was healthy as a horse...She didn't take any meds, even balked at a aspirin at her age...She said"....."If the doctors don't kill you, the meds they order will".....Smart lady......(have a good day)

[Brian C.]

Of course, the people involved in the study are genuine, good people.
However, they do have to be exceedingly circumspect and not publish anything that may significantly affect demand for statin products.
The threat of withdrawn funding, loss of tenure and damage to career prospects ensures that published findings are always harmless to powerful interests.

Brian.

[Ray Holder]

The drug rep's figure of 1 in 10,000 stde effects may only be of those recorded in the trial reports. Two trials, the BHF/MRC and the TNT are reported to have given statins to the participants for a period of up to 2 or 3 months before counting started. The BHF/MRC had 30,000 taking part when statins began to be handed out. On the official day 1 of the trial, only 20,000 were left, most of the others declined to continue, no reasons were collected. Quite a large number of early side effects swept under the mat, and a good figure for the trial outcome !!!!

Some truly "evidence based medicine", we are led to believe !!!

Ray

[tex62]

The UCSD study group refused to accept money from the drug companies to fund their study, unlike many of the other large studies.

JL: Dr. Golomb the leader of the study has published information about how statins can lead to heart failure. See *http://www.cmellc.com/geriatrictimes/g040618.html This was one of the articles listed under “Articles published from or related to the UCSD Statin Effects Studyâ€

[Brian C.]

No doubt about it, Dr Beatrice Golomb is indeed one of the "good guys"!

*http://www.medicine.ucsd.edu/faculty/golomb/

I hope she gets the Full Professorship she deserves.
Given her association with RAND Corp and her Congressional appearances re "Gulf War Syndrome" she is undoubtedly the biggest hitter we have in the cause.

Lets see how this unfolds.

Brian.

[SusieO]

For those who are skeptical or have questions why not write to them and ask about your concerns?

I feel like this study could be the break we all need to have doctors listen to us when we say our problems are from taking a statin and to then give us some type of testing i.e. muscle biopsy to see exactly what is wrong. I feel quite certain there is no cure for those of us who have been off the drug for years and still have problems.

I would also like to see statins taken off the market so no one else has to be harmed by them. If I can't be "fixed" at least give me it in paper showing I have statin damage from taking Lipitor and don't keep telling me "I am not sure what is wrong with you but take this pill."

I have tried (on and off) taking the many supplements and have yet to see any type of improvement in my own situation. The cost in my opinion to purchase them would be well worth it if they truly brought one back to good health, but for my own personal situation it has not done that. Some of you have gotten better and I am so thankful for that - but don't knock those of us who just can't see where it has helped at all (as a matter of fact some of the supplements i.e. CoQ10 actually gave me awful migraines).

When I took part in the study I was NOT on Lipitor - I had all ready stopped. They got in touch with me a second time to ask more questions about other meds I had tried i.e. Lopid, Cinnamon Capsules and Niacin and did I get the same side effects and so forth.

To say this is a "whitewash" or anything else negative is really not giving these folks a chance. This is only the first newsletter and I found it to be quite positive for someone suffering, like me, and my family feels the same way.

[Brian C.]

Sorry to have upset you Susie like you I truly hope that the San Diego study has not been in vain.
However I am a suspicious old dog and the more I learn about how the World works the more suspicious I become.
There is such an eye-wateringly HUGE amount of money being made from statins that a great deal of effort is made to avoid what is termed "market disruption", i.e. contra evidence has been systematically sidelined and buried in the noise of pro-statin studies since Merck first marketed their Mercavor statin and brought research into Coenzyme Q10 to an abrupt halt (they had a new diuretic to bring to market for the treatment of heart failure, i.e. cardiomyopathy).

I would say don't cling on to the hope of a wholesale Damascene conversion in the medical community but take charge of your own health and pass on what you learn here to those you love and others you come into contact with.

Education is our only defence in a wicked World.

By the way Susie, in encouragement I can share that after 6 weeks off Lipitor my energy is returning to something near normal for a chap in his 7th decade

Brian.

[SusieO]

[quote="Brian C."] By the way Susie, in encouragement I can share that after 6 weeks off Lipitor my energy is returning to something near normal for a chap in his 7th decade :)

Brian.[/quote]


Brian that is great news!!! I hope that your improvement continues! :D

[Brian C.]

Thanks Susie

Isn't this forum great?

Brian.

[tex62]

As a word of encouragement to those who are still having side effects after being off statins for months, it took my husband almost a year to make a full recovery after getting off both Zocor and Tricor. Now that we are more informed, we know that he should NEVER have even been on statins. His triglycerides were somewhat high, but he's learned to control that with diet and NO drugs. Statin drugs reduced him from excellent health to a sufferer of torn cartiledges, carpal tunnel-like pain in both arms, muscles that cramped so badly that he couldn't sleep for more than a few hours, high blood pressure, and more.

After reading Dr. Graveline's book, my husband started taking 900 - 1100 mg. of CoQ10 daily and later added L-Carnitine. His recovery was apparant after that; however, there were days when there would be setbacks. After 8 - 9 months he had made a full recovery. What works for some people doesn't seem to work for others. It's been more than two years since he's been off statins and we feel very fortunate that he made a full recovery. Best wishes to each of you.

[cjbrooksjc]

UCSD Study: Tex62 is correct. The UCSD study refused Pharma funding and rely entirely on institutional (the school) and private funders. I am proud to say I am one of them, and I wish the best for the staff and their efforts there. I feel confident they are trying to be as open-minded and scientifically correct as possible so their findings can be supported by absolute fact. I only wish they could, even under those strict scientific constraints, publish more and publish more often.


Brooks

[Brian C.]

Brooks : I only wish they could, even under those strict scientific constraints, publish more and publish more often.


This is where the "market guardians" apply pressure to tone down, if not sideline, the report and accompanying studies. They are using stick and carrot in the time-honoured way I am sure.

It happens in physics, where the long-standing editor of a pair of distinguished journals has been recently ousted for publishing material undermining the Standard Model. Instrumental in the ousting has been a Nobel Prize winner.....

Way of the World John, way of the World :(

Brian.

[Brian C.]

For an example of how things are played in the public arena this is the story in the Pharmaceuticals section of todays' Daily Telegraph Business Section :

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

Garnier plays down diabetes drug fears

by Katherine Griffiths


Jean-Pierre Garnier, chief executive of GlaxoSmithKline, tried to calm fears about its diabetes drug, Avandia, after a critical report this week said it increased patient's risk of heart attacks.

Speaking at his penultimate Glaxo annual shareholder meeting before stepping down next May, Mr Garnier said:
"If you look at the entire picture you will see you can be confident about the safety profile of Avandia. I think it's an overreaction to a publication which was actually quite sensibly written"

Steven Nissen, one of America's leading scientists and chairman of cardiology at the Cleveland Clinic in Ohio, wrote an article in the New England Journal of Medicine that said Avandia could increase the risk of heart attacks by 43pc. [!]

Glaxo said it "strongly disagreed" with the findings.
The drug company's shares tumbled as analysts predicted it might have to strengthen Avandia's warning label in the US.
Doctors in Europe are already advised not to give the drug to patients with weak hearts.

Mr Garnier said he expected a short-term sales loss but predicted the drug would rebound once people digested all the available safety data.

copyright The Daily Telegraph, London 2007

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As we have seen with statins safety data can be made pretty indigestible.

Brian.

[Brian C.]

From today's NY Times :

*http://www.nytimes.com/2007/05/24/business/24drug.html?ei=5088&en=264b966f67f9573a&ex=1337659200&adxnnl=1&partner=rssnyt&emc=rss&adxnnlx=1180008256-KPwmNfwqlACpDxdioGy6Vg

No comment necessary.

Brian.

[cjbrooksjc]

Brian: Yes, there is always someone trying to poke a stick in the spokes of detractors. Much is at stake. As my Mother-in-Law would have said:

"Aye! The wee scunners!"

Regards,

Brooks

[Brian C.]

Och aye the noo :wink:

Brian