Urine test for diagnosing statin myopathy?

[peter s]

Came across this tonight.
*http://www.wipo.int/pctdb/en/wo.jsp?IA=WO2003079026&DISPLAY=DESC

[cjbrooksjc]

Peter: V. interesting post. Amazing and frustrating that it is dated July 2003 - over five years ago!
Brooks

[Cat Mom2]

Makes you wonder if...

1- The test itself wasn't any good and they discovered it wasn't.....OR

2- Big Pharma heard about is and squashed it


6 years and no one has heard a word about this? In 2003 (or prior to) they did that study on those 4 people and proved it WAS statin related, yet, doctors still say it isn't the statins?

How come all the proof gets burried and nobody want to listen to it or look at it, yet believe every new great lie that comes out about it?

[peter s]

I believe the doctor who applied for this patent is the same person who did the pioneering study referred to in the prior post on the 4 patients with normal CK levels with statin-induced myopathy/myalgia. Indeed it may be the same patients he is discussing in the body of the patent application. The encouraging news, if there is any, is that the observed weakness and biopsy abnormalities in that small sample of patients reversed over time after cessation of the statin.

[peter s]

Statin-Associated Myopathy with Normal Creatine Kinase Levels
Paul S. Phillips, MD; Richard H. Haas, MD; Sergei Bannykh, MD, PhD; Stephanie Hathaway, RN; Nancy L. Gray, RN; Bruce J. Kimura, MD; Georgirene D. Vladutiu, PhD; John D.F. England, MD, the Scripps Mercy Clinical Research Center*

1 October 2002 | Volume 137 Issue 7 | Pages 581-585


Background: Muscle symptoms in patients who are treated with statins and have normal creatine kinase levels are not well understood.

Objective: To report biopsy-confirmed myopathy and normal creatine kinase levels associated with statin use.

Design: Case reports from preliminary analysis of an ongoing clinical trial.

Setting: Clinical research center in a community hospital.

Patients: Four patients with muscle symptoms that developed during statin therapy and reversed during placebo use.

Measurements: 1] Patients' ability to identify blinded statin therapy and 2) standard measures of functional capacity and muscle strength.

Results: All four patients repeatedly distinguished blinded statin therapy from placebo. Strength testing confirmed weakness during statin therapy that reversed during placebo use. Muscle biopsies showed evidence of mitochondrial dysfunction, including abnormally increased lipid stores, fibers that did not stain for cytochrome oxidase activity, and ragged red fibers. These findings reversed in the three patients who had repeated biopsy when they were not receiving statins. Creatine kinase levels were normal in all four patients despite the presence of significant myopathy.

Conclusion: Some patients who develop muscle symptoms while receiving statin therapy have demonstrable weakness and histopathologic findings of myopathy despite normal serum creatine kinase levels.

[peter s]

Apparently Dr. Phillips tried to expand his research, but the study was not completed.

*http://clinicaltrials.gov/ct2/show/NCT00127335

[Dee]

Dr. Phillips used to have a website with statin information called "imposter trial".

I can no longer locate that site, but back in Oct of 2004, I corresponded with Dr. Phillips when I had my muscle biopsy. My sample was sent to a California Neuromuscular Lab and I tried to donate a sample to Dr. Phillips for his studies, since he was also in California. Unfortunately the sample had not been properly preserved for his purposes (dry ice packed).

There has been a few people over the years that I have met (online) that have gone to see Dr. Phillips. I think he does a test that measures Co2 exchange in the lungs, as that can be a sign of statin damage and causes shortness of breath. He also does muscle biopsies to assess statin damage. I didn't pursue seeing him because there was nothing he could do, other than say you likely have statin damage, and I already know that.

The only thing I could find relating to the Imposter Trials is this:

*http://clinicaltrials.gov/ct2/show/NCT00127335

Here is another study that Dr. Phillips was involved in:

*http://focus.hms.harvard.edu/2008/011108/medicine.shtml

During our correspondence in 2004, Dr. Phillips sent 2 new studies to pass along to my doctor. They are:

"Statin-Associated Myopathy Is Associated With Impaired Oxidation of Fatty Acids"

AND

"Statin myotoxicity is associated with changes in the cardiopulmonary function"

I have those on PDF files if anyone wants a copy zap me an email at fjh@netins.net

[Dee]

Sorry Peter, that first link is a duplicate of the one you posted.

[Dee]

I did find the Imposter Trial website in archived form, thanks to the Stopped Our Statins group.

http://web.archive.org/web/20070423141625/http://www.impostertrial.com/

[peter s]

The web archive is a wonderful resource.

I am kinda surprised Dr. Phillips says this:
The vast majority of patients receiving statin therapy tolerate it without any side effect. Statins have been shown to be safer than aspirin in studies of over 80,000 patients. There is some evidence that patients with heart and vascular conditions who stop their statin therapy abruptly may be at increased risk of having medical problems. Statins save lives by reducing cholesterol and decreasing the complications of atherosclerosis. They also seem to have benefits beyond cholesterol lowering such as in reducing inflammation. A list of the other potential benefits is available on the virtues of statins page.

[Dee]

I know what you mean, I feel the same way about some of his information.

If you look on the flow chart under the physicians link, you will see that he says that if you are'nt better 2 weeks after stopping the statin, to start taking it again, as statins were not the problem.

That has always irritated me, I KNOW he sees and hears from people that NEVER get better and it IS the statin.

He has done some great research and I think he continues to do so, but seriously he needs a reality check.

[peter s]

Keep in mind his protocol assumes a normal CK test.

[peter s]

Also keep in mind there may be an implicit assumption in his protocol that it applies to people who have recognized their symptoms and possible association with statins relatively early. He himself may not think the two week rule applies to people who have taken the drug for years.

[harley2ride]

I saw Dr. Phillips years ago. His impostertrial website was one of the first places available to get information on statin damage. We emailed back and forth a bit. I had the oxygen exchange test, and some other tests done with him. Back when nobody would admit it could be statin caused, he was telling everybody, that it very well could be..

[Dee]

Thanks Peter.

RE: Restarting the statin if no improvement in 2 weeks.

I can understand that thought process early in the statin game, but not now. He needs to update his protocol to reflect the various scenerios of statin adverse effects.

But since his site is no longer available by regular access, perhaps it is not misleading very many doctors at this time.

I take that particular advice (2 weeks off statins) personally, as that is exactly what I was told, and I am CERTAIN that Doctor was following Phillips advice.

After 2yrs. 8 months on Pravachol I was a mess, and still am as far as permanent muscle problems with weakness, lack of stamina, and general fatigue are concerned, and I took my last Pravachol pill almost 5 years ago.

Several other problems did eventually clear up, BUT nothing resolved in that 2 week time period. (I had over 20 new health problems develop while on Pravachol.)

Had I not taken it upon myself to investigate, what may have happened to me if I had followed that 2 week advice and restarted Pravachol because I wasn't "Better after 2 weeks"?

I am happy to see that there is ongoing research that is getting to the bottom of the mechanisms of statin damage. I just seems agonizingly slow when you are watching the best years of your life go by, and being so screwed up from a statin.

[Dee]

[quote="peter s"]Keep in mind his protocol assumes a normal CK test.[/quote]

My CK was 123, perfectly normal the last day I took a statin.

The muscle biopsy 6 months later showed non-regenerating nerve death and lipid deposits in the cells, indicating mitrochondrial disease.

[peter s]

Please understand I was only trying to speculate as to what he may have been thinking, not to defend what he says as gospel truth. Maybe he has modified his views since then, or maybe if you contacted him he would have some insight into your case?

Plus of course even if his advice was generally good, or applied to the vast majority of people, there are still going to be people for whom it is bad advice. Even in the case of a mostly benign drug, there will be certain people who cannot tolerate it or may even have a serious adverse reaction. The best we can hope for may be better screening protocols before prescribing.

[Dee]

I do understand where you are coming from. I just feel that statin victims can not afford to get rather sloppy general advice when so much is at stake.

I did contact Dr. Phillips way back in the fall of 2004 to question the 2 week protocol, can't remember if I ever heard back from him. (Did I mention the statin induced memory problems?....lol)

I guess the frustrating thing for me is that after all these years doctors in general still have their heads "buried where the sun don't shine", and there has been enough research now that they should be wide awake.

I find it disturbing that Doctors get their info on drugs from drug reps that regurgitate study information that goes thru this cycle:

Study funded by drug company that developed the med and stand to make billions (hello?) > published in peer reviewed medical journals (which by the way have questioned the bias factor of said studies) > waltz into doctors office handing out free samples and spouting biased trial and benefits information that downplays side effects and WAY over states benefits and QUOTE FROM SAID RELIABLE MEDICAL JOURNALS > Doctor thinking he has the lastest dependable info on a drug glady whips out the RX pad and prescribes away.

I cringe everytime I hear of someone being on a statin, as the research I've done on the clinical study statistics show when you look at absolute risk rather than the relative risk numbers (used to market statins)....there is little argument for them to even still be on the market, let alone maiming and killing people. I am convinced they are virtually worthless for their intended purpose > preventing heart attacks.

And it isn't just statins, it is every wonderous new drug that comes out.

I know, I have been on several that have been pulled from the market.

[peter s]

I fully share your despair at the lack of knowledge one typically finds, and the robotic reliance by most doctors on the "party line" -- the same party line that said with the same smug assurance that smoking did not cause cancer and that dental fillings were perfectly safe, among a thousand other egregious errors. It has been said that all truths go through three stages: first they are ridiculed, then they are violently opposed, and finally they are accepted as self-evident.

By the way, FWIW, not to downplay statin problems in the slightest, but I think psych drugs are an even bigger threat to society. I spent ten years addicted to the non-addicting drug klonopin, and have seen close family members tortured by anti-depressants.