Heartfelt with Dr Melissa Walton-Shirley

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The Bale/Doneen method of heart attack and stroke prevention: So you have a better idea?

Mar 3, 2011 09:09 EST

Las Vegas was the perfect setting for a two-day boot camp on heart attack and stroke prevention. The Sin City venue, the site of the largest of four annual Bale/Doneen method courses, epitomizes the veritable crap-shoot-of-a-journey that every patient embarks on after a heart attack or stroke. The indictment of "usual care" is that any number of brand-new stents or freshly plumbed bypass grafts will do nothing to prevent a second heart attack in two-thirds of patients. "The recidivism for this illness is deplorable," said Dr Bradley F Bale, explaining why he as a family practitioner joined Amy Doneen, RNP, to make up a dynamic duo whose mission in life is to combat vascular disease. Over 60 participants, a mix of interventionalists, general cardiologists, endocrinologists, primary-care physicians, CV surgeons, RNPs, and dentists journeyed to Nevada in pursuit of the missing pieces in the prevention and "aftercare" of ACS and other vascular syndromes. Bale and Doneen are dynamic evangelists of their approach, and it appears their number of followers is growing.

The "paradigm" for event prevention is based upon a simple cartoon. The "cat in a gutter," crouched below ground level, ready to leap out and attack unsuspecting birds, is frequently referred to throughout the course. The "cat" is representative of atheroma, deemed stable unless it becomes "inflamed." The "gutter" is the blood vessel endothelium. As long as the gutter is "cool," the cat doesn't "leap out," but if the gutter heats up due to "inflammation," then the patient develops ACS or stroke. Evidence of atheroma in any branch of the vascular tree--ie, an abnormal calcium score, peripheral vascular disease, erectile dysfunction, an abnormal stress exam, vascular calcification on chest X-ray or on a mammogram--is considered an indication of a "cat in the gutter." The "fire" in the gutter floor is fueled by glucose intolerance and insulin resistance in 70% of victims of vascular events, a fact rarely explored by patients or acknowledged by practitioners. Other maladies, such as psoriasis, rheumatoid arthritis, gum disease, or smoke exposure, are also triggers that can make a vessel "come in hot," a phrase often used by Bale to describe vulnerable plaque. The paradigm suggests that 75 g of glucola with a one-hour and a two-hour finger-stick test during the course of a hospital admission would direct traffic to the right path toward cooling off the vessel in the majority of patients. 

The most remarkable aspect of the Bale-Doneen program is that Amy and Brad guarantee their work, something I've never seen cardiologists do. If the patient experiences a heart attack or stroke while being compliant with their plan, the patient will get their money back for any out-of-pocket costs. They assert that they have had only two patients to experience "an event" in nine years in over 500 cohorts. What is more amazing is that they claim to understand why their two patients did poorly. One of them was referred back to her primary-care physician with her biomarkers in good stead. A year later, she experienced a heart attack. When Bale called to follow up, she confessed that her family doctor, citing her excellent lipid profile and apparent good health, stopped all of her medications. The other patient developed a severe tooth abscess, which was enough to fuel the archenemy of any vascular prevention plan: inflammation.

The Bale/Doneen method relies upon abnormal Berkeley panels, myeloperoxidase (MPO) levels, PLAC tests, carotid intima media thickness (IMT), and abnormal triglyceride/HDL ratios of >5 to guide treatment strategies, among other indicators. Most of these are uncommon entities found in the everyday grind of general cardiology practice but are mainstays of this paradigm. They micromanage their patients' biomarkers based on major trial outcomes and subset analyses. They also refer patients for more conventional testing such as echo and risk stratification. Their method does not ignore the benefit of percutaneous intervention or bypass grafting when necessary. One of Bale's patients developed "new ischemia" on a stress exam recently and underwent an elective PCI but instead of just bolstering up plaque with metal, they investigated why the patient's status changed. They are on the hunt for smoldering inflammation and once it is identified, appropriate treatments will be implemented, secondary-prevention cocktails adjusted, and the "cooling" of his vessels documented by waning inflammatory markers.

For those who criticize the Bale-Doneen method as "undocumented and unproven," they cite "evidence" from a major trial for every single recommendation. The ever-popular "just get them on a statin--any statin" approach, they believe, is largely incorrect. They do not use atorvastatin, especially in women and insulin resistant patients, citing subset analyses from ASCOT, WOSCOPS, CARE and PROVE-IT to support their penchant for pravastatin--that it "prevents diabetes." They favor carvedilol over metoprolol and other beta blockers because of COMET, stating, "The science is there," and their concerns that metoprolol increases NT-proBNP and promotes insulin resistance. They utilize ramipril because "you really can't beat the HOPE trial." They throw tons of sustained-release niacin at folks because of HATS, with Bale pointing out, "It's hard to prove statistical significance in 160 patients, but they did it!" They monitor their patients every three months for changes in inflammatory milieu in order to champion the opportunity for their patients to live well even in the face of severe vascular disease, and they insist it works.

On my return flight to Nashville, I saw the magnificent Grand Canyon unfold beneath me. Large furrows and breaks punctuated the earth's topography. Shades of pale yellow, gray, and red told the story of billions of years of daily assaults on its architecture, in much the same way our patients' endothelium is being etched on a minute-by-minute basis. A picture of a freshly ruptured plaque, black and shiny like caviar sitting within a freshly sectioned postmortem vessel, came to mind. It occurred to me that to simply lay a scaffolding over the vessel wall or build a bridge across it does nothing to stop the ongoing destruction any more than it would have affected the creation of this huge elongate crater in our earth's mantle . . . but to understand it, find the fire or the entities that are creating the furrows in our vessels . . . ah . . . that's the key. This paradigm has taken up the challenge of doing just that, and I think I should utilize this new information as a navigation tool for primary and secondary prevention. I will need to reexamine the thousands of slides presented during this course; otherwise, that small diploma tucked in my overhead compartment proudly declaring I completed the Bale/Doneen course will be worth no more than the paper it's written on. Perhaps it could help nearly all of my patients who have a two in three chance of having a second heart attack or stroke. At this point, I don't really have a better idea. Do you?

Disclosure: Melissa’s fees for the Bale/Doneen course were waived by the course organizers.








Your comments
The Bale/Doneen method of heart attack and stroke prevention: So you have a better idea?
# 1 of 104
March 3, 2011 01:47 (EST)
Brittany Bale Woodcock, RN

As I was on a relaxing run today my father’s words ran with me.  He taught me that daily exercise is one way to help me beat my Insulin Resistance and never become Diabetic. My father, Dr. Bradley Bale, diagnosed me with Insulin Resistance almost a decade ago.  As cardiology RN at Vanderbilt University I work on a daily basis with ACS patients.  My passion is educating our patients about Insulin Resistance, how it can be diagnosed, treated and maybe even save them from having yet another heart attack!  I agree with Dr. Walton-shirley, Dr. Bale and Amy Doneen, RNP, that the Oral Glucose Tolerance test should be utilized when a patient is admitted to the hospital for ACS.  Due to the shortened inpatient stays for ACS patients I believe that education on Insulin Resistance can be done before discharge and the Oral Glucose Tolerance Test done at the follow up visit.  I am currently working to get this protocol established at Vanderbilt as it should be in every hospital.  My involvement at Vanderbilt is just one example of how the work done by Dr. Bradley Bale and Amy Doneen, RNP is affecting many lives.    

# 2 of 104
March 3, 2011 02:20 (EST)
Spencer Penhart

Fantastic blog entry, Dr. Walton-Shirley.  I have had the privilege of knowing Amy Doneen and Dr. Bale for several years, and their highly-unique paradigm for treating CVD.  Their clinical trial knowledge is truly elite.  More importantly, their passion for patients is unmatched (ask Amy sometime about her patient who had her first CVD event prior to becoming Amy's patient, and had to start collecting aluminum cans for recycling to supplement her income because that first CVD event bankrupted her.  Things like that are the source of Amy & Dr. Bale's motivation).

With all the discussion around Healthcare Reform and improving "Quality", I hear a whole lot about cost reduction, but precious little about improving patient outcomes.  The Bale-Doneen method gets documented results, and any practitioner who is willing to guarantee his/her work is nothing short of amazing.  Dr. Bale and Amy show us what is possible when we are willing to take our commitment to patients to the highest levels.

 Thanks again for this great blog piece!

# 3 of 104
March 3, 2011 04:00 (EST)
Susan Barnes,RN

As a former office nurse for Dr. Bale and wife of one of his patients, I appreciate your article highlighting the Bale/Doneen Method.  Professionally, I had the wonderful experience of being a part of educating and empowering patients seeking to prevent heart attack, stroke and diabetes.  On a personal level, my husband first saw Dr. Bale in 2008 at the age of 49. After a comprehensive exam and testing mentioned in your article, we were shocked to learn that Greg was insulin resistant and had soft plaque in his carotid arteries.  The individualized treatment plan and follow-up targeted the causes of the problem and he continues to be event free: the best evidence of all!

In my present position as a Heart Failure Quality Improvement Specialist, I am directly exposed to the devastating effects of heart disease. I am hopeful that more effort and resources will be directed toward prevention of chronic diseases and their complications.

# 4 of 104
March 3, 2011 08:19 (EST)
Camille King
I am a patient of Dr. Bale and Amy.  I had a heart attack in July 2004.  In February 2004 I had blood work done.  My family physician said that I had a 1% chance of having a heart attack in 10 years.  That sounded like pretty good odds....right?  Five months later, I came very close dying.  After my heart attack I struggled to find answers from my cardiologist and family physician as to why this happened after they told me my risk was so minimal.  Luckily, I found Dr. Bale and Amy.  They ran the Berkley Tests and the two hour glucose test.  They found the root cause of my heart disease and they had a treatment plan to keep me from ever having another event.  Almost seven years later, my disease is under control.  The fire in my veins is now cold.  Standard medical care is a crap shoot, two in three chance of a repeat event.  Bale/Doneen is a sure thing, especially if you are gambling with your life!
# 5 of 104
March 3, 2011 09:40 (EST)
Michelle Beidelschies, PhD

This was a really fantastic article Dr. Walton-Shirley! Dr. Bale and N.P. Doneen are truly at the forefront of heart disease prevention.  I share their belief that our best means of prevention lie in education and early detection.  In working with them, I've been able to see the amazing impact of improved patient management that focuses on reducing inflammation levels and subsequently the development of heart disease and adverse cardiac events.

As the Medical Science Liaison for Cleveland HeartLab, I have talked with patients that have experienced a heart attack or stroke, and they are sometimes shocked to know that they are indeed preventable.  Likewise, some practitioners are intrigued by the advanced testing that is currently available, especially the MPO test which can identify vulnerable plaque and risk for heart attack.  

Thank you to Dr. Bale and N.P. Doneen for helping practitioners focus on preventing heart attacks/strokes rather than responding to their devestating effects!

 

# 6 of 104
March 4, 2011 02:37 (EST)
Joseph Ence

Dr. Melissa Walton-Shirley is EXACTLY correct.  The presentation that Brad and Amy provide, outlines science that cardiovascular disease can not only be identified early ANd largely prevented.  It takes teamwork between the medical provider and the patient to make this happen.  

I've been following this 'preventionist' type of medicine for years and its nice that doctors (especially aggressive and passionate ones) are understanding the disease that is the #1 killer in our society is manageable.  The current medical system we have is broken.  Cardiac stents don't extend lives, they are just rearrainging the deck chairs on the titanic. Attacking the disease at its functional core is the only way to cool off the inflamed arteries and get the body to heal itself. 

This educational system that Amy and Brad provide is growing stronger every day.  The physicains they attract at these events are the cream of the crop.  These docs are engaged, attentive and hungry to really make a difference.  What better disease to first attack than the biggest killer? 

# 7 of 104
March 4, 2011 07:09 (EST)
Mitch Finnie, MD
Amen.  I attended a Bale-Doneen seminar in September 2010 and the care I provide to my patients improved exponentially.  Not many physicians are "in the Bale-Doneen" camp, but I am hoping to change that trend.  The truth that acute MIs are 100% preventable is a Huge paradigm shift that will eventually change medicine for all.
# 8 of 104
March 4, 2011 01:30 (EST)
Rakesh Patel MD
I started routinely getting 2 hour glucose tolerance tests on patients over 6 years ago that I suspected were at risk for having diabetes. (The scary thing is that it is now, more normal to have an abnormal test than a normal one in my practice!) The problem: if they were pre-diabetic , what do you do? We knew these patients are at greater risk or CVD. Conventional wisdom was to encourage lifestyle changes. Maybe if you were more aggressive you started metformin (TZD and/or GLP-1 agonist if you really wanted to be aggressive).

 The main problem is that patients typically just do not respond to a number on a lab. This is the elegance of Brad/Amy’s approach. It ties all the loose ends together in a coherent package starting with educating the patient and looking for disease. Once that patient “buys in”, it motivates the patient to make the lifestyle changes they need to do and stay compliant with their medication. Definitely a “game changer” as Brad and Amy would say, in the way I practice medicine.

# 9 of 104
March 4, 2011 03:49 (EST)
Art Sands MD

Agree with the above letters - attended a lecture by Dr Bale and have discussed cases with Amy Doneen - following their recomendations I have had only one c-v event in my practice in the last 6-8 years- he was a patient that had a mildly  elevated LDL but a nl vessel age and no plaque on his IMT - in retrospect, should have looked closer with more advanced  testing - we use CIMT extensively now and it is a superb way to follow treatment and is also a very powerful tool to get patients to comply.

We use a fair amount of IR Niacin instead of Niaspan - no hepatic side effects and the dose can be up  to a gram tid or qid - Rugby Pharmaceuticals via http://anda.andanet.com/index.html - $10 for 1000 500mg tabs. I think Niaspan is more tolerable and taking meds three times a day requires good compliance but if I stress the tremendous benefits of niacin, have them take aspirin before a meal and then take the niacin immediately after  80+% learn to tolerate the IR niacin - can easily get their tot chol/HDL ratio under 2.5 (can't beat the price).

 Also, focus a lot on exercise, weight and stress reduction.

# 10 of 104
March 4, 2011 06:02 (EST)
CJ McConnell
Try Quercetin 500-2000 mg before niacin,.. we only used Alka-Seltzer [aqueous 325 mg ASA], preceded by 3 TB applesauce, which works great [compiance issue,.. was FORGETTING THE ASPIRIN !!],.. now quercetin beats all of that,.. much easier as well,.. supptresses the flush better than ASA.
# 11 of 104
March 4, 2011 06:39 (EST)
whufs
Nice love fest - so nobody here sees the irony of two individuals making money touting an unconventional approach to primary and secondary prevention of coronary disease endpoints all the while citing various studies without subjecting their basic premise (I guess glucose tolerance tests, niacin and a bunch of tests that our college does not recommend) to - wait for it - scientific study.  I guess we will just take their word for it.  Come on people if this represents an advance in the treatment of coronary disease then it should be tested and verified in a clinical study or refuted - until then it is nothing aside from the word of two individuals without any evidence of scientific truth.  Personal affirmation, word of mouth and proclamation of success is not what the practice of medicine is based on but it sells a lot of herbal remedies, fish oil, vitamin D etc.  My better idea is to conduct scientific evaluation of the theory before promoting a treatment strategy - it's called the scientific method - develop a hypothesis, design a trial which includes or excludes a null hypothesis and preferably replicate it in a second trial.  Only after that can something be accepted as fact.  There was a drug called laetrile that used to work so well for cancer that people traveled to Mexico to get it.  Five years ago the anti-oxident crowd insisted on putting everyone on Vit E and C and then folate.  Recent trials have questioned whether tight control of type 2 diabetes has any impact on coronary endpoints but we are to believe that glucose intolerance should be documented on every patient with a coronary event so we can treat something that in its fully developed state doesn't make a difference.  Choosing pravastatin as a preferred statin is in conflict with the majority of data correlating with potency and dose of statin and prognosis favoring crestor and lipitor versus less potent agents.  And finally the new wave of data looking at inflammation as monitored by CRP measurements is raising the possibility that Dr. Ridiker may be excessively influenced to promote a test he profits from and no treatment of inflammation has been shown to influence prognosis.  I think there is every reason to be skeptical.
# 12 of 104
March 4, 2011 07:06 (EST)
marcy Zwelling, MD

The irony of the comments by Whufs is that the Dale and Boneen method IS about scientific methodology ... Not only have they evaluated studies with a fine tooth comb, they do have studies that are ready for publication and their results are incredible.

The hypotheses that drive the Bale and Doneen methodology are 1) USE SCIENCE to drive your decisions  2) FULLY evaluate the patient  3) DON't just treat numbers  4) FIND the root cause of teh problem  5) EDUCATE, EDUCATE, EDUCATE the patient and their family  6) WORK with EACH patient as an INDIVIDUAL 7) DO NOT ASSUME ... check things yourself.

I'm sorry, Whufs, I don't know your name or I would address you respectfully by your name.  I don't believe Brad or Amy would find fault with your comments.  They would find fault with applying them to their method.

I would recommend you attend a conference. You will be overwhelmed with the science and the structure.  

Sadly, many of us don't read the literature as thoroughly as we should. Just one example is my reading of the ASCOT study.  IF you look at subgroups, you will find that females don't do well with Atorvastatin.  I was shocked that I missed that.  Then, looking at other data, it seems that indeed Atorvastatin is NOT the statin of first choice for women or diabetics.  That was part of the studying I did while at the Bale and Doneen conference.  That was science.

SO... don't throw stones until you have the facts.  Don't become the victim of your own negativism.

Thanks for taking the time to read this !

marcy Zwelling, MD FACEP 

# 13 of 104
March 4, 2011 07:21 (EST)
whufs
Read my comments again and understand I am not "throwing stones" at anyone - if there is merit to this approach it should become standard of care and I simply suggest that the merit be tested and the approach defined.  There is every reason to question subset analysis of individual trials if that finding has not been verified in another trial - by virtue of chance it is possible that subset analysis can be misleading.  Even in this circumstance although Dr. Walton has stated in prior posts that she does not receive renumeration from industry in this particular instance her course fees were waived by the sponsors.  Our entire profession is lessened if we accept anything less than the truth to be fact.
# 14 of 104
March 4, 2011 07:28 (EST)
Bradley Bale

Whufs, we would love to conduct a randomized double blind sudy pitching our method against the 'standard of care'.  We actually called for such a study when we presented our regression data in Rome, Italy at the International Symposium on Atherosclerosis severa years ago.  Please find the grant money for us.  We do appreciate your comments.

Bradley Bale

# 15 of 104
March 4, 2011 08:20 (EST)
whufs
Have you submitted a request to the NIH - it would seem to be a perfect fit - no industry dependence and a tremendous potential benefit to society.  The NIH evaluates such grants based on benefit and merit.  There should be a priority to investigate prevention strategies particularly with the hopeful projections accompanying the Affordable Care Act.  I think I have been misunderstood in these posts because I am an interventional cardiologist who spends more time dealing with secondary prevention then I would ever want or hope to spend in the cath lab but my training is to be a slave to fact that we represent to our patients as truth.  If there is a method that can be tested it should be tested and if it works it should be promoted - in that order.  I have not seen a randomized study published in a peer reviewed journal that details your methods and results and so I can neither criticize or recommend your approach.  
# 16 of 104
March 4, 2011 09:34 (EST)
Amy Doneen
Thank you for your interest in our efforts Dr. Whufs.  Yes, indeed we have had a conversation with the thought leaders at the NIH and we do intend to pursue funding for a formal trial that places our method for CV prevention against the standard of care.  Like you, we remain clinically grounded while synthesizing peer-reviewed evidence into our method.  The Bale/Doneen Method is grounded in a platform of disease identification and treatment rather than the current standard of care, which is a risk factor paradigm.  You voice your frustrations with the current standard of care lacking the ability to stop the recidivistic nature of atherosclerosis.  We have halted disease in our clinical settings, as have the many others who embrace our method.  We, along with the support of Texas Tech health Science University, have collected and analyzed eight years of data on hundreds of our patients.  Ambulatory research shines in the ability to demonstrate the value of “real life” scenarios and, at the same time, demands the call for a formal placebo prospective trial to test the Bale/Doneen Method.  We are pleased to realize that those who embrace our method of prevention have experienced the same atherosclerotic stabilizing results that we have witnessed in our practices. 
# 17 of 104
March 4, 2011 09:58 (EST)
whufs
At the risk of keeping the entire organization affixed to the keyboard I applaud efforts to publish and formally study your method.  Absent that it is a sales pitch - nothing more.
# 18 of 104
March 5, 2011 11:34 (EST)
David B. Wright, MD
I just got back from the Bale-Doneen Preceptorship course in Las Vegas--WOW!!!  I have been using the Berkeley Heart Lab testing for 3 years--and it revolutionized my ability to provide PROPER care for my patients.  I then attended the "short course" given by Brad and Amy in November 2010--DOUBLE WOW!!!  I was able to turn up my competency another couple of notches by using the Carotid Intima Media Thickness testing in addition to the refinements in my knowledge about using the Berkeley Test in an optimal fashion.  They encouraged everyone to attend their two day course---TRIPLE WOW!!!  I finally feel fully competent to incorporate the latest knowledge into my clinical practice for the ultimate benefit of the patients I have come to know and love over the past 26 years of private internal medicine practice.  I have been working towards this goal of TRUE PREVENTION for several years--I've already seen the benefit in my first week back when I uncovered insulin resistance in a patient admitted with a TIA and a normal fasting blood glucose--AHA--ROOT CAUSE discovered (he was already on statin, ACE, Plavix, niacin with a great Berkeley profile!!).  Many thanks to Brad and Amy for their tireless pursuit of excellence and passion for spreading this gospel of wellness!!  I can't wait for their book to come out.  I encourage ALL patients to educate their doctors about The Bale-Doneen Method!  
# 19 of 104
March 5, 2011 11:40 (EST)
David B. Wright MD
Can't find the 500-2000 Quercetin in on-line search--can you suggest website?  THanks!  David
# 20 of 104
March 5, 2011 11:44 (EST)
Judy Carroll

Thank you for having this very informative blog, I have enjoyed reading everything very much.  I would like to add my comments from a dental/periodontal perspective.  In my 21 years of periodontal therapy practice I dont think I've attending anything as "life changing" as Brad and Amy's course (with the exception of my first use of a periodontal endoscope/microscope).  Brad and Amy's standards have elevated my own, I cannot possibly go back to doing things the way I have been (which I thought was comprehensive).  I now realize I had barely scratched the surface, even though my standard of care in periodontics would be considered beyond optimal.  The two day course was a real eye opener and a huge paradigm shift for oral systemic approach.  I intend to take this information and run with it by utilizing interdisciplinary approach on every perio case I treat.  The mouth-body connection has finally been bridged thanks to Oral DNA Labs definitive diagnosis and the very definitive information - directing therapeutic treatment and outcomes, AND the Bale Doneen Method.  These cannot be separated.   The synergistic methodology of treating disease from the mouth to the arteries will create optimal health at whole new level.   I have posted Brad and Amy's info on dental forums and I think I may write up something for a dental journal soon.  I will be in attendance at the June Chicago meeting with bells on!  As to the comments about studies re the Bale Doneen Methods - I understand all too well how hard it is to get grant money for studies, or even finding anyone to study your protocol, but lets not lose sight of common sense and practical application with hundreds of case studies.  you cant argue with success.  Extraordinary claims may require extraordinary evidence, but abscence of evidence does not necessarily mean abscence of proof. 

Below is the letter I sent to Brad and Amy this morning:

Hi Brad and Amy,I am sorry for the length of this letter, but it all has to be said.  I sincerely want you to know that you have changed my life and the direction of my career (and thousands of lives as a result).  I thought I had passion before, its at an entirely new level now thanks to both of you. J I recently attending your two day course in Vegas, I was the one ranting about the pathetic “standard of care” in dentistry.  You have both opened my eyes even further, your course has changed my life…too many words and thoughts to express…thank you for being the passionate trail blazers you both are.  My entire family will be seeing Amy very soon – we live in the Seattle area. I have had some cutting edge ideas I would love to get your feedback on. My views about the pitiful periodontal diagnosis and treatment going on in this country (and around the globe) somewhat reflect your views about the standard of care in medicine.  I have created a non invasive periodontal practice focused on “optimal health”, I give my patients the time and energy they deserve to determine cause and not just treat the effect (as so many in my profession do).  I pioneered a non invasive treatment called RPE – Regenerative Periodontal Endoscopy…I have been providing this innovative service for over 10 years.   Adding the more definitive diagnostic/tx methodologies through Oral DNA Labs has been a tremendous adjunctive service, these tests not only allow me to measure success beyond direct clinical observation, they also “direct” treatment moving forward.  In addition, I require all of my clients to have comprehensive blood work to help determine etiology, I am looking for all the systemic issues contributing to their periodontal disease (deficiencies, glucose levels, immune function, etc)…what I realize after taking your course is that I was barely scratching the surface.  I want the total package I learned in the Bale Doneen Method.   I already have many clients to refer to you or one of your graduates.  I cannot honestly go back to doing this the way I was doing it after taking your course. So here is my idea:  I am thinking of an optimal oral systemic health business model (interdisciplinary approach) that incorporates my method in perio (a highly definitive, non invasive periodontal protocol) with the Bale Doneen Method in the same place.  One full service facility with one shared goal - optimal health from the gums to the rest of the body to save lives.  Please just think about what this would mean.  Optimal care at its best for those who want it, and plenty of people want it.  My practice is busy treating people flying in from all over the globe who want optimal care. They will travel thousands of miles.  But I cannot realistically give them “optimal care” without incorporating the Bale Doneen Method directly into the equation for total health.  The gums are connected to the body, and vice versa.   I cannot achieve long term periodontal health without systemic health.  This has to be a total package.I am eternally grateful to both of you. Judy Carroll, RDH, DirectorPerioPeak InnovationsPeriopeak.com
# 21 of 104
March 5, 2011 03:25 (EST)
Judy Carroll

well, I screwed up Carl Sagan's quote in my post above, so here it is again:

"Extraordinary claims require extraordinary evidence.  Absense of evidence is not evidence of absense."  

Someone has to be the hard working trail blazer, the rest (research) will fall into place, eventually. but who wants to wait while people die? Similarly, I am not waiting for my patients teeth to fall out while I wait for someone to study my methods. 

# 22 of 104
March 5, 2011 03:29 (EST)
Mark Oldendorf, MD, Chairman CIMT Council, Society of Atherosclerosis Imaging and Prevention
Having been actively involved in the pursuit of integrating imaging studies with the practice of preventive cardiovascular medicine for the past 5 years, it is encouraging to see the interest the Bale/Doneen method has attracted.  Every aspect of what they promote is the result of exhaustive research of the literature with logical conclusions drawn for patient management.  It is quite evident they have integrated all relevant disciplines into an approach that takes advantage of all that is known concerning preventing and reversing the atherosclerotic process.  That they are willing to teach others is commendable and humanitarian.  Their approach is, quite likely, a template for all future atherosclerosis prevention programs.  I am certain once their data goes head to head with "standard care" that the results will show a resounding benefit to their method.  We are very privileged to have Brad Bale and Amy Doneen giving key lectures at our Scientific Sessions next month in Bethesda, Maryland.  
# 23 of 104
March 5, 2011 04:48 (EST)
Melissa

Whufs,

I congratulate you for your healthy skepticism regarding both the method and my objectivity.  Let me explain that I am a full time  private practice cardiologist. Anytime I leave the practice, it's a money loser. I would be far more productive by staying  in my office though I believe I am a much better help to my patients if I can stay well informed as possible.  It takes great effort to maintain a balance. I left immediately after seeing patients Thurs. evening, missed Friday and Monday but added an extra two days of office in order to make up for my two week days of  absence.   I fell asleep during Cirque Beatles Love-with acrobats flying over our heads, music blaring and lights flashing... (though what I saw was fabulous and my falling asleep should be no reflection on their performance!!!) I am fully recovered now and hope to have time to sit down and enjoy the booklet of slides attendees were given as a course outline. It was such a break- neck pace that I'm sure I'll pick up even more pearls that I missed while there.  

    My only interest in this program was to understand and report on the science.  I feel no need to apologize because I was impressed. I share your concern that this method,  though makes perfect sense,  has not been tested with randomized controlled trials compared with usual care. I look forward to those outcomes,  however, we are such miserable failures at secondary prevention, I"m wiling to try avenues that subset analyses of major trials have suggested will work.   I also want to assure you that several interventionlists were in attendance because they want  the effort they put forth to improve angina by performing PCI on stable patients  and to save lives from STEMI is maintained for years to come . Surgeons attended as well for the same reasons. Ultimately, I hope we can help eradicate vulerable plaque.  ( I'm certain that's only a dream,  as the issue of compliance will never be resolved.)

Thanks for your posts.  I appreciate your participation here on the Heartwire as I do all of those who have constructive and helpful advice, criticism and commentary. We enjoy our readers here very much!! 

# 24 of 104
March 5, 2011 06:57 (EST)
Rainshadow
Okay, if you believe, I believe.  Tell me how I can start micro-managing by "biomarkers" so I can keep my blood vessels "cool."  My BP is slightly high (on meds and exercising) AND my BS index (A1C) is 7.4-- on both "Lantus" (slow-acting) and "Apidra" (fast-acting) insulins.
Thanx,
Rainshadow
# 25 of 104
March 5, 2011 08:03 (EST)
Graham Reedy MD SPORTS MEDICINE
# 26 of 104
March 5, 2011 09:30 (EST)
whufs
I am familiar with the economics of private practice.  I simply stated fact.  Any argument is bolstered by selective data but on surface is there any reason for you as a seasoned cardiologist to believe that a two hour glucose tolerance test would influence your practice of cardiology?  Really - you think that a family practice physician and an extender can read the literature better than I can? Sorry but it has to be said - conduct a study and I'll buy it otherwise its a trip to Vegas.  My personal experience is that very few individuals develop secondary events if they comply with recommended medical therapy for prevention of same.  You have a venue of communication that requires some degree of censure.
# 27 of 104
March 5, 2011 10:16 (EST)
Lisa Collier Cool

While whufs certainly has every right to ask probing questions, here's one I'd like to ask him or her: What scientific evidence you utilize when you started placing stents in patients as an interventional cardiologist? Certainly there were no double blind randomized trials at that time, and the COURAGE trial years later found the only advantage vs. medical management for most patients was quicker resolution of angina. I raise this point since it seems ironic to use such an aggressive intervention, presumably not for free, without the randomized trial you deem essential for a far less aggressive prevention strategy that might help people avoid stents in the first place. Just curious.

# 28 of 104
March 5, 2011 10:32 (EST)
whufs
For 21 years I have used PCI as an adjunct to medical therapy for palliation of angina as indicated by common sense and several trials prior to the publication of COURAGE (ironically named in my opinion).  I reject your implication that I perform procedures for income as I do not (it accounts for less than ten percent of my billing) and I challenge the notion that individuals with ADDITIONAL training in interventional cardiology somehow do not understand basic fundamentals of preventive therapy.  If you were a physician with any experience you would understand the notion of the scientific method to ensure that we are not selling snake oil to patients who trust us with their lives - it applies equally to your distrust of intervention to my uncertainty of an approach that has been untested and frankly does not make scientific sense.
# 29 of 104
March 5, 2011 10:46 (EST)
CJ McConnell
Testing,..
# 30 of 104
March 5, 2011 11:09 (EST)
CJ McConnell

RE: "If you were a physician with any experience you would understand the notion of the scientific method to ensure that we are not selling snake oil to patients who trust us with their lives - it applies equally to your distrust of intervention to my uncertainty of an approach that has been untested and frankly does not make scientific sense."

Hmmm,.. so let's just stick with 80 of atorvastatin & utilize interventions as 'preventative medicine'.

Interestingly every item in the Bale-Donnen Method is better substantiated than any interventional measure. Unfamiliarity with the data is expected,.. as most of this is not routinely presented by highly funded industry concerns. Interestingly,.. >90% of the data that supports their methos IS,.. NIH funded. Additionally, the Insulin Resistance that underlies the majority of patients is almost NEVER addressed when patients are discharged post-procedure. That's "state of the art" ? If anything is Snake-Oil,.. it is interventions on patients who have stable/asymptomatic CAD. The pharmacologic choices in the BD method are almost ideally individualized to each patient. And they are laready suggested as options in the guidelines. The fact that >75% are on niacin and the majority are on insulin sensitzers is a reflection of what the majority display phenotypically,.. but tragically in the mainstream population,.. these are rarely screened for the same: PPG, sd-LDL, low HDL2[b], LpPLA2, TG-rich remnants, etc. Treating a calc-LDL & calling it a day serves industry,.. not the patient. The 1st year our diabetologist started advanced lipid testing & shifting to more specific statin selection and ESPECIALLY maximizing the % of patients on niacin,.. his cardiology referral dropped >60%. The FP/PCP has only seen 1 MI in a 5 year period,... it has been another 2 years since we hit that milestone. A vascular-related admission in his practice is RARE after 7 years of this method.

" If you were a physician with any experience you would understand the notion of the scientific method,.."

Actually,.. the scientific method IS being used here every day. We compared our outcomes to a large MCO data base: ~90% lower across the board. Not published of course,.. but we are more than comfortable our patients are not being exposed to risk. I can't say the same when they used to be sent to the CV-surgical units at the 2 local heart centers.

My friends like to call me Mac,.. what's your name ?

# 31 of 104
March 5, 2011 11:32 (EST)
whufs
CJ McConnell why are you so angry - we are supposed to have healthy skepticism because it serves our patients.  If the science is sound I am suggesting it be studied so it can be incorporated in the mainstream.  The Bale/Doneen "method" is advertising that the disease complex of atherosclerosis can be cured (or at least halted) and if true it represents what I consider the greatest discovery in cardiovascular medicine to date!  Why are you so defensive about publishing the specifics in a treatment trial and subjecting it to the rigor of science - or are you that confident that you know the truth absent proof.  I'll ignore your offensive comments that are undeserved but I am curious why you felt them necessary.
# 32 of 104
March 5, 2011 11:43 (EST)
Lisa Collier Cool

Interesting, Wfufs, that unlikely everyone else who posted here, you don't choose to put your name so we can look up your credentials and publications, if any, and decide whom we'd rather believe--someone who operates on "common sense" by sticking stents in people long before a randomized double blind clinical trial was conducted or someone whose prevention method is grounded in peer-reviewed studies published in leading journals like JAMA and NEJM. 

To me, operating on "common sense" doesn't sound like the "scientific method" at work, especially, when as you point out, people are trusting you with their lives. I fail to see the logic of this or why your credibility is somehow enhanced because you derive less than 10 percent of your income from stent procedures. However, if you're doing anything specific in your practice to prevent the need for stents, bypasses and other interventional procedures, then I applaud you for that and would like to know the details, so we can compare your prevention strategy and its rationale with that of Dr. Bale and N.P. Doneen.

Lisa 

 

# 33 of 104
March 6, 2011 12:06 (EST)
CJ McConnell

Melissa & anyone else,..

We are starting to see even better compliance with the quercetin pre-dosing prior to niacin vs. our old "stand-by" Alka-Seltzer & applesauce. Dunbar @ U of Penn/Phila. is testing quercetin between 500-200 mg. So,.. we have been starting @ 500 vs. the 200 mg we used in the past. The papers from TC Theoharides @ Tufts got our interest piqued & I think this may prove to be a superior method of compliance vs. 325 mg ASA as an aspirin or as Alka-Setzer. NO aspirin "baggage". The downstream benefit [potentiallly] of the prostaglandin metabolite as a ligand for PPAR-Gamma,.. can still be accessed by d/c quercetin after 90 days,.. once the patients' tolerability has maximized. It seems a rather 'benign' way to help patients get up to dose more successfully with niacin,.. and yet still reap ALL the plethora of benefits from the niacin.

Interestingly,.. this is just starting to be recognized in nephrology,.. as niacin, even Rx-niacin,.. is a GREAT phosphate reducers [sodium/phosphate transporter in the most proximal duodenum] even rivaling current [Pi] binders/chelators used in CKD & it is ideally suited for their IR-based dyslipidemia, ADMA, low-adiponectin, etc. Niacin continues to be a great "shotgun" for mutiple risk 'targets'. It is VERY cost effective as well.

Mc

# 34 of 104
March 6, 2011 12:28 (EST)
whufs
Well Lisa I am employed and my employer may not agree with my comments so I choose not to disclose my identity.  What have I posted that is offensive and why do you presume that I am practicing irrationally?  Read all of my comments and reflect on the fact that I have simply asked that the specific assertions be subjected to study so we may all benefit.  I would suggest to you that cardiologists trained in intervention may also have an intense interest in prevention.  Also as you know numerous trials have been done that prove that intervention assists in symptom control for individuals with coronary disease as well as improving prognosis in acute myocardial infarction so your statement "sticking stents in people long before a randomized double blind clinical trial" should be reconsidered in fairness.  I cannot compare my effectiveness in secondary prevention to that of the Bale/Doneen method because I am following the recommendations of the American College of Cardiology and it has not been studied or proved inferior to any other approach to date - oh wait I guess that has been my point throughout. Would it not be more valuable to society to publish this approach and subject it to scientific rigor and then incorporate it as standard of care if it is superior to the current recommendations or is it better to presume it works and pass it along through weekend seminars?
# 35 of 104
March 6, 2011 12:56 (EST)
Lisa Collier Cool

I'm still waiting for an explanation of why your using "common sense" is the "scientific method," and someone else basing a prevention method on peer-reviewed studies in JAMA and NEJM and teaching it to other healthcare providers in an American Academy of Family Medicine-accredited CME course is "snake oil," and to learn even one specific thing you're doing in your anonymous practice to prevent the need for the stents, bypasses, etc. that bring in nearly 10 percent of your income. N.P Doneen has already stated that she and Dr. Bale have "along with the support of Texas Tech health Science University, have collected and analyzed eight years of data on hundreds of our patients." Dr. Bale's bio is online at: http://baledoneen.com/images/userfiles/file/Biographies/20100828202934_10_ABOUTBRADLEYBALEupdated8_28_10.pdf

and N.P. Doneen's bio is online at: http://baledoneen.com/images/userfiles/file/Biographies/20100828203627_10_ABOUTAMYDONEENupdated8_28_10.pdf

As you'll see, they have given more than 1,200 presentations at leading medical conferences all over the world. Since I don't know who you are, it's impossible to see what credentials and publications, if any, you bring to this table. But as previously stated, if you are working to prevent heart disease and stroke in your practice, then I applaud that. It just seems to me that you're very quick to be judgmental and negative in this forum, with no indication that you've conducted any research on your result.

# 36 of 104
March 6, 2011 01:25 (EST)
whufs
As I stated I am a salaried cardiologist who does not profit from stent implantation.  I employ the recommendations of the American College of Cardiology for prevention of coronary endpoints.  I have stated nothing negative in any of the posts above unless you have an emotional or financial interest in the "Bale/Doneen method."  My credentials and publications are irrelevant to the comments made - one can read and understand without peer or societal recognition.  "Common sense" dictates that someone having refractory angina with a 90% stenosis benefits symptomatically from PCI - its called a cardiology fellowship I guess.  I detailed the scientific method in my first post if you have never been introduced to it.  Would access to my CV make any of this any clearer for you?  If you are so interested in the scientific application of the "Bale/Doneen method" then where is the clinical trial data that proves it superior to 80 mg of Lipitor?  I mean if this is so superior it should be easy to prove right?  So prove it and stop insulting professionals who require proof to provide best care practices to our patients.  If I stated that in my practice I have never seen a secondary endpoint in patients who adhered to my therapy wouldn't that require replication before you accepted it to be fact?  And finally if there is some magic discerned from careful analysis of subsets in multiple clinical trials why has it not been promoted by cardiologists who sub-specialise in preventive cardiology?
# 37 of 104
March 6, 2011 02:13 (EST)
Rakesh Patel MD
Quercetin has work well in our practice, in the same doses stated in the list
# 38 of 104
March 6, 2011 03:16 (EST)
H Fritz MD, RVT

To Whufs:  

Your logic that the because the ACCORD  trial failed to show exceptionally tight glucose control in Diabetics with established CAD events results in no reduction in CV endpoints necessarily means that post meal glucose has nothing to do with the atherosclerotic process merely reveals your lack of comprehension of the pathophysiology involved. 

Once atherosclerosis of diabetics  has progressed to the point of producing end organ damage such as MI or stroke, the pancreatic beta cells of most such people have burned out forcing one to rely on exogenous insulin for tight glucose control since the opportunity to benefit from the lifestyle effects of proper diet, weight control, exercise and oral meds have slipped into the past. 

Hence, to achieve tight glucose control you are left with an enormous risk of increasingly frequent hypoglycemic complications from exogenous insulin use which is the most likely explanation for why tight DM control was not found to reduce CV endpoints in Accord. 

To the contrary, if you discover the IR process at an early stage before beta cell burnout as occured, then the IR can be reversed or normalized and the entire disease process halted without undue risk from the preventive, non-invasive, intervention that has been proven to be effective.  Get it? 

Your assertions that the Bale-Doneen method is nothing short of snake oil advertising is irresponsible since you have not heard them present their facts.  Bale himself in these posts has acknowledge the need for clinical trials to test the applications of their interpretations of the clinical literature, and is merely sharing what he and Amy have found clinically useful in their practice.  You don't have to believe it.  But for most of us who have attended and objectively experienced the benefits of applying their methods even on ourselves, their approach seems to make a lot of sense and actually works.  Yes, it is certainly possible and likely that a non cardiologist may know more about preventing atherosclerois than a cardiologist who is so sure he knows it all and can't learn anything from anybody else.  It amuses me to hear you hide under the cover of the ACC which is continually updating and changing their CV preventive guidelines to the extent that they are now endorsing the clinical utility of CIMT, a test which you claim has been dismissed as having no value by the ACC.  It might be more profitable for you to spend a little more time catching up on the latest ACC literature below before you keep spouting out your unsubstantiated opinions.  J. Am. Coll. Cardiol. 2010;56;e50-e103; originally published online Nov 15, 2010;

J. Taylor, William S. Weintraub, and Nanette K. Wenger

Frederick G. Kushner, Michael S. Lauer, Leslee J. Shaw, Sidney C. Smith, Jr, Allen

J. Budoff, Zahi A. Fayad, Elyse Foster, Mark A. Hlatky, John McB. Hodgson,

Philip Greenland, Joseph S. Alpert, George A. Beller, Emelia J. Benjamin, Matthew

Cardiovascular Magnetic Resonance

Society of Cardiovascular Computed Tomography, and Society for

and Prevention, Society for Cardiovascular Angiography and Interventions,

American Society of Nuclear Cardiology, Society of Atherosclerosis Imaging

Developed in Collaboration With the American Society of Echocardiography,

Foundation/American Heart Association Task Force on Practice Guidelines

Asymptomatic Adults: A Report of the American College of Cardiology

2010 ACCF/AHA Guideline for Assessment of Cardiovascular Risk in

# 39 of 104
March 6, 2011 03:29 (EST)
constantin rusu

Supposing the long-awaited RCT proves them right (which I really wish it did); I'd still think twice before instituting the idea of "money back guarantee" (as a customer I would probably buy into, but as a patient I'd certainly be very reluctant).

No positive RCT, however well designed, should make us forget that a "definitive" answer, let alone a "guarantee", is something a doctor should always be cautious about. Otherwise what would make us better than Jerry Falwell and his promise of "rapture" for all his followers?

# 40 of 104
March 6, 2011 06:47 (EST)
whufs

To Dr Fritz,

Respectfully the first four paragraphs of your comment are unreferenced out of necessity. I agree with the statement that medications aimed at glycemic control may be counterproductive when cardiac endpoints are the major goal of same.  I have made no irresponsible comment throughout unless suggesting randomized trials of treatment paradigms is offensive to some.  I fully acknowledge that others may be in possession of knowledge that I am not acquainted with and I read avidly to try to correct that as best I can.  The statement "it is certainly possible and likely that a non cardiologist may know more about preventing atherosclerois than a cardiologist who is so sure he knows it all and can't learn anything from anybody else" is irresponsible - how is it likely that a family practitioner would be more familiar with management of atherosclerosis than a cardiologist who treats it every day - or is that just an insult aimed at me personally?  I am not "hiding" behind the ACC as it is our professional organization that creates best practice guidelines and establishes standard of care.  I am familiar with the reference above, personally know two of the authors and based on discussions I have had with them I don't think the type of early disease identification and particularly followup (ie. serial CIMTs or Coronary Ca+) that I guess you champion has found it into the recommendations for practice because of the lack of RCT.  Whether CIMT correlates with cardiac endpoints is controversial as studies are mixed.  The imaging guidelines mentioned above in no way comment on the Bale/Doneen principles - they are simply appropriate use criteria so again I am not sure why you are so angry at the possibility that I haven't read them - relax I have.  And I agree with the post above about making guarantees in medicine - if it is truly that good it should be easy to prove.  

# 41 of 104
March 6, 2011 09:12 (EST)
CJ McConnell
I believe Dr. Fritz was "spot on",.. as they say in the UK.
# 42 of 104
March 6, 2011 09:19 (EST)
Melissa

For what it's worth, the suspicion that glucose intolerance drives vulnerable plaque rupture is not  heresy. As I've stated previously, I first sat down to listen to a long talk about it in Europe several years ago. At that point, I had not yet met Bradley Bale. I came home and immediately started glucose testing everyone with early onset CAD.  The most astounding patient I tested was a small very thin male runner age 50, basketball coach who had a positive troponin- I and mild CAD with wall motion abnormality  by echo, non smoker without early family history.  I was astounded that his 2 hour GTT was 250.  I was just covering for my partner on the weekend and when he came back Monday, he too was suprised.  No doubt in my mind  this was the culprit as his lipids weren't all that bad either.  So...he got a diet and a cocktail of meds. He confessed that he could do better with his food choices and I believe his eyes were opened. Certainly mine were. I now diagnose 3-5 new cases of glucose intolerance during many weeks of the year, some of which are completely obvious (30 pounds of excess weight) and some not so obvious. The problem is that many physicians "undo" the progress I've made when I tell the patient they are at high risk of future vascular events.  Their physicians try to reassure them it's no big deal.....and it won't be until they come in with multivessel disease, renal failure, stroke and blindness 10 years later.  Then, everyone will get very concerned and we will get to spend 100,000 for bypass grafts and multiple stents.....which they absolutely WILL NEED to get them out of dutch. 

Later, Bradley posted here on the forum a few times. I had not yet made the connection between Bradley and his brother, Phillip with whom I've worked with in town for 20 years.(yes, a duh moment I confess--should have asked)  Phillip then gave me Bradley's number and I interviewed him for the first time.  That interview was a few years ago and about a year or two after I had heard Gabriel Stegg's lecture in either Stockholm or Barcelona that had already changed my life.  Oddly, I do remember that the talk was sponsored by Rimonobant folks, the drug that did not make it through our FDA for obesity.  Gabriel's talk was not a sales pitch, it was a talk on the metabolic syndrome and many of my patients owe their lives to him and  that talk.(I've told him so many times).  

I have spent nearly a decade of my life, along with my partner and a former associate  pushing primary PCI without surgery onsite in the state of Kentucky and have provided advice and phone/email support to numerous programs around Kentucky and Tennessee.   Petr Widimsky is one of my heroes (mapped the Czech republic to find the shortest route to a PCI). So I am not a metal hater.  I love metal and plumbing in those who missed out on or were not compliant with prevention measures.I have enormous respect for interventionalists and surgeons. I use them daily and until we finally were able to get a 2nd interventionalist at our hospital, for six years I've been dragging patients up from the ER to the cath lab, doing the urgent cath, placing IABP's and occasion temporary pacers when necessary. I get it. We are not at a point in medical history where we can afford to do without interventionalists and surgeons and won't be in my lifetime, maybe never. 

I state these facts to make the point that I didn't drink any Kool-aid and Dr. Bale and Amy aren't trying to be the Jim Jones of prevention.  They have pioneered a paradigm that helps make sense of all of the data that is NOT acknowledged by pharmaceutical companies and was not in the forefront of marketing. As the old saying goes, the devil is in the details and we need a trial to tease out the devil. I'm afraid, the leaving out of those details at major presentations and in major publications is the issue.  In the rush to present new data, I'm often wondering, "what about the subset of women, etc". and unfortunately I never hear from that data again sometimes.  

This course did not make some NEW REVELATION about the concept of IR (insulin resistance) being a driver of ACS and stroke, it presented me with evidence from many many trials as to what was likely  and what is not likely to be working in primary and secondary prevention based on  solid facts in major trials. I believe it emphasizes the importance of individualized care for individuals at risk. I have no more data to tell me HOW To titrate many medications than I do for choosing a cocktail of prevention meds.  I know the optimal dose of coreg is 6.25 mg bid for mortality benefit but should I really titrate it at 2 weeks, four weeks, or next week?  Patients are nothing more than unique human genomes so many of the most optimal specifics in the approach to their management will remain unkown, but when you have a KNOWN culprit with such a strong association with early death and morbidity with very little risk associated with it's treatment, it's worth a try.   Since we aren't getting it right 2 out of three times, I do think listening to this evidence is worth a try. 

Melissa 

# 43 of 104
March 6, 2011 10:50 (EST)
Ellie

I was part of the dental delegation at this conference. It was wonderful to have interaction with physicians and dialogue about the oral systemic inflammatory connection.

Dentistry is interesting because results of disease can be easily monitored by patients and health professionals. General health is not so visible and measurable.

For three decades there has been proof that cavities are a transmissible disease and that a simple, low cost method exists to interrupt this transmission, prevent disease and reverse cavities- without fillings.

This method is a public health measure in other countries but has remained virtually unknown in the U.S. while dental professionals wait for "more evidence".

With the advent of the internet, this healthy, simple method has been presented to the public. It has been employed by families to prevent and reverse disease. People have noticed positive changes and their health professionals have witnessed reversal of disease and spontaneous improvement in their patients' oral health.

Many dentists have been amazed that natural repair of cavities is possible- since the science of cariology, risk analysis and remineralization has never been part of the U.S. dental education system. Now dentistry must evolve and realize that brushing and flossing cannot be used to control a contagious, infectious salivary disease. 

My point is that while dentistry remains stuck looking for "more evidence" the 'standard of care" allows patients to suffer and require treatment. This new approach can prevent caries and drastically reduce the need for treatment.

Who wants to wait for their dentist to gather more studies while they have fillings, crowns and root canals? Some patients ( especially young children) die under sedation for dental treatments.

# 44 of 104
March 6, 2011 12:14 (EST)
Lisa Collier Cool

I'm glad that we're at least in agreement that prevention is important, wtfus. Certainly it would be valuable to have a randomized clinical trial of the Bale/Doneen Method, but realistically, with drug and device companies funding most clinical research, finding a sponsor would daunting, given that their method involves a multiplicity of approaches and NIH receives vastly more applications than it has resources to fund. But as you yourself have said in another context, there are time in medicine when it's common sense to take the information that is out there in the medical literature and put in into clinical practice. You felt 21 years ago that enough had been shown about stents to start using them even though the gold standard of proof hadn't been met with a randomized double blind clinical trial. So I don't really understand what you are so hostile to that being done with a method that involves non-invasive evidence-based treatments, unless in your mind, this is a turf war issue about non-cardiologists developing a method to prevent CVD. 

If you ask a question about anything in the method, I'm sure that Dr. Bale or N.P. Doneen would gladly post clinical references from leading journals showing why that works. So why attack with libelous terms like "snake oil" when you haven't attended the CME course or examined the evidence behind each facet of the method? To me that suggests your mind is closed to new ideas, making further discussion futile.

# 45 of 104
March 6, 2011 12:40 (EST)
H Fritz, MD, RVT

To Whufs:

Your claim to be familiar with the ACC referrence I provided demonstrates how superficial your absorption of the facts really is.  That guideline makes it clear that not even the widely promoted and ACC/AHA endorsed NCEP guidelines for preventive care in asymptomatic adults including the Framingham risk scoring system have been rigorously tested by RCT.  Your insistence on a RCT from disease-based ASCVD management, such as Bale/Doneen advocate, before we should give it another thought rings very hollow when your ACC itself readily admits that even their current "standard of preventive care" in asymptomatic adults is "only" their opinion and not to be treated as unquestionably correct conclusions substantiated by rigorous RCT. And may I remind you that the entire paradigm shift of peptic ulcer disease management some 30 yrs ago all resulted from a researcher thinking out of the box, bucking the stream of mainline card carrying gastroenterologists in their ivory tower organizations.  No one is this blog has advocated 'guaranteed" results.  Bale and Doneen however seem confident enough in their approach that they are willing to return any out of pocket expenses should CV events occur while under their care.  I don't consider that guaranteeing anything.  It is merely demonstration of a high degree of confidence in what they have found to be so much more effective than what you are doing or are willing to stand behind with your approach that lacks RCT evidence. I am not angry at anyone, not even you. I am however not willing to allow irresponsible statements from you in response to my comments to go un-answered. 

# 46 of 104
March 6, 2011 01:02 (EST)
whufs
Dr. Fritz as you know the utilization of clinical criteria to assess coronary risk is solely to address the likelihood of the development of a cardiac endpoint so that populations may be selected for primary prevention.  This has implications with regards to cost of treatment, patient education and individual decision making allowing a physician to at least provide a ballpark figure of what the chance of developing an endpoint is over a ten year period of time for free.  My understanding of statin based data is that endpoints are roughly halved in populations regardless of what the pretreatment risk is so a patient with a one percent ten year risk may not desire to take medications that someone with a ten percent risk would readily accept.  Having said that I am quite sure that I (like you) encourage treatment in even supposed low risk subsets based on the safety of treatment and the possibility that patients may not behave like the population study suggests they should.  The Framingham risk analysis has been well described and is a consistent easy to use tool.  Now if there are patients who are on the fence or additional investigation is needed to see if prophylactic treatment is wise then so be it and I employ coronary calcification screening when that situation occurs.  I think we still agree - I hope.  Now using your example of peptic ulcer disease and the association with H. Pylori I agree that it was years of subtle suggestion that finally was - you guessed it - subjected to the rigor of study to illustrate a new concept that changed the practice of medicine in that regard.  I still haven't said anything irresponsible or out of step with any of the posts above.
# 47 of 104
March 6, 2011 01:33 (EST)
whufs
Yes and if all of the additional testing and treatments recommended did not result in a substantial reduction in coronary endpoints in a clinical trial then the book you are promoting would be a pretty tough sell now wouldn't it?  When did I say I didn't believe in primary or secondary prevention and when did I suggest that stenting is a substitute for the aggressive medical treatment of atherosclerosis?  Go ahead point it out in any of the posts above you won't find it.  You made it up to create an argument to serve your purpose.  Which one of us here has a conflict of interest?  Turf war - really?  My query is what serial tests like CIMT, coronary calcification, glucose tolerance tests, MCOs, genetic testing etc add to standard treatment of atherosclerosis?  For the expense of those tests how much better (if at all) are outcomes?  These are standard questions that should be asked of any new treatment paradigm before it can be firmly recommended.  In the last two years there has been an entire awakening in the urologic community about over treatment of prostate cancer based on misapplication of a screening test (PSA) that was supposedly an advance but which was never adequately tested.  Having said that and in hopes of no hard feelings how can I pre order the book (I am serious I love to read new ideas).
# 48 of 104
March 6, 2011 02:06 (EST)
Judy Carroll
I was wondering how many physicians and specialists are exploring definitively what the patients status is re periodontal disease?  what objective info are you given, if any, when you do pursue this "player" in cardio, stroke, and diabetes?  and how does this fit into your own treatment protocol?  I would appreciate some feed back.  thank you.
# 49 of 104
March 6, 2011 02:22 (EST)
H Fritz MD, RVT

To Whufs:

Contrary to your declaration of innonence regarding irresponsible statements, your first post began with name calling of any who don't subscribe to your standards which are no more substantiated than those you are deploring.  We are unfortunately all too familiar with the poor results of utilizing the "officially endorsed" clinical criteria alone for coronary risk assessment, so no need to attempt to dodge my assertion that you are calling for playing by a double standard.  Ask any of your patients who have experienced their first coronary event whether the efforts of their health care providers who were responsible for identifying those at increased risk early enough to be able to at least inform them of how they might have prevented their event was "free" or without cost to them after they get your hefty bill for your stents which alone still have minimal impact on preventing future CV events.  It does no service to your patients to claim to be politically cost effective if their primary prevention efforts have overlooke them and if the only one to gain from so doing is you the fat cardiologist who is staying very busy stamping out fires that might have been prevented if they would have been willing to keep an open mind.  No one is unaware of the fact that the Framingham risk scoring system has been plenty well described and easy to use.  But that fact misses the whole point when the ability to prevent many events has again failed until the firemen like you arrive to ply your tools on those 50% of them who have not already died from sudden death.  Increasing evidence is accumulating that strongly suggests that employment of imaging tools beyond the FRS system on not just those whose risk score by FRS seems to be sitting on the fence.  No I don't agree with you about that, and neither do most of the other postings and neither does the accumulating medical literature.  I do however agree that ultimately a RCT is need to address this matter appropriately.  But until that is done, at least my patients are grateful to be alive and spared from the expense of yet another stent for which they are subjected to inceasingly risky and complex medical regimens which all might have been avoided if one were willing to keep an open.   

# 50 of 104
March 6, 2011 02:40 (EST)
Lisa Collier Cool

I see you've looked me up, whfus, and would have done the same with you were you not hiding behind a screen name as you make your jabs and insults. I am so impressed with Dr. Bale and N.P. Doneen's method, which I deem potentially lifesaving (based on interviews with their patients) that I am writing a book with them to bring this information to the public. As the winner of 18 awards for medical journalism, I have been writing about heart disease for America's leading magazines for more than 20 years, including most recently, a 31-page section on women and heart disease for Prevention magazine. Some of the articles from the section, which quoted Dr. Bale, Arthur Agaston, MD, and Marianne Legato, MD, among others, are online if you'd like to read it.

While the randomized double blind placebo controlled clinical trial is unquestionably the gold standard for scientific evidence, only a median of 11% of current practice recommendations of the ACC/AHA are based on level A evidence. Most are just expert opinion, according to this 2009 report in JAMA. It's ironic indeed that you are holding these 2 specialists in CVD prevention to a higher standard that than used for a median of 89% of the current practice guidelines of your own medical society! 

See 

Scientific Evidence Underlying the ACC/AHA Clinical Practice Guidelines

 

  • Pierluigi Tricoci, MD, MHS, PhD
  • Joseph M. Allen, MA
  • Judith M. Kramer, MD, MS
  • Robert M. Califf, MD
  • Sidney C. Smith, Jr, MD
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  •  http://jama.ama-assn.org/content/301/8/831.full
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    # 51 of 104
    March 6, 2011 02:53 (EST)
    whufs
    Again even when I agree with you I cannot appease you.  Why do you presuppose that because I have additional training in intervention that I must therefore not practice or agree with aggressive prevention strategies.  Your comment about the "fat cardiologist" tells me all I need to know - yeah I want people to develop CAD so I can put a stent in - that's pretty pathetic sir and I hope I afforded you a bit more respect than that as I try to address your comments medically not personally.  Representing the standard of care has usually not been castigated as it seems to be with certain practitioners on this site - did you think about the fact that I have consistently asked for proof that this is an improvement over the standard of care because I think that would be valuable for all of us to know.  Is my mind somehow closed because as Dr. Walton Shirley stated (not me) "I didn't drink the kool aid" without definitive proof?  You dislike interventional cardiologists and to the extent that my specialty has been soiled by individuals who have not practiced appropriately I do not entirely disagree - I know where you are coming from and you deserve an opinion but to lump all of us into that category is not fair.  With regards to the postings on this site have you taken a look at who they are - I have and I am not surprised to be feeling a little lonely here.  Cheers.
    # 52 of 104
    March 6, 2011 02:59 (EST)
    whufs
    You are all over their website.  You have every reason to have a bias.  You have attacked me and misrepresented statements I made and didn't make so I thought it was relevant.  Should I disclose my identity so you can personally attack me and my family - for what - asking for a clinical trial to address what is being represented as the cure of the most common lethal disease on the planet.  Sorry for using google but what is happening here is pretty obvious.
    # 53 of 104
    March 6, 2011 03:07 (EST)
    constantin rusu

    Since I've raised the "guarantee" question, I feel the need to intervene just to make sure I'm not misunderstood. It's perfectly all right (and desirable) to be confident in your own ideas. But when it comes to science, the confidence ought to be balanced by the intellectual honesty. 

    This refund policy, however valid the medical arguments, brings forth the  dangerous idea of  infallibility. Science never claimed to be infallible. If I was dr.Bale (or dr. Doneen) I'd be - on the contrary- worried if not a single CV event occurs during my care. 

    # 54 of 104
    March 6, 2011 05:25 (EST)
    whufs

    Ok  I must admit I’m getting a little punchy and as a representative of the scientific method and such things as cost benefit fully acknowledging that I do not make my living giving seminars or writing books let’s at least identify the participants particularly with regards to the comments regarding industry supported research:

     

    Dr. Bale and Amy Doneen RN profit from seminars promoting their “system” to the tune of $2500.00 per attendee (unless you provide free advertising).  They are in the process of publishing a book rather than sharing their discovery and subjecting it to scientific validation.  Their method which I fully admit I am not intimately familiar with utilizes many tests which are not covered by insurance (based on Dr. Walton-Shirley’s description) and my suspicion is that the institutes that they run are likely “cash only” operations meaning that by definition they have attracted a highly motivated clientele with means to participate in a concierge type practice model.  This population is not likely representative of the general public so comparing endpoints in that regard has a built in population bias.  If this treatment paradigm is the cure for atherosclerosis I would assert that there is a moral imperative as a physician to share it rather than selectively disseminate it for a fee.  Finally if all of this didn’t pan out in a randomized trial than there would be no cause to buy a book now would there?  I get it.

     

    Lisa Collier Cool is a literary agent who is promoting and apparently co-writing the book that Dr. Bale and Amy Doneen RN are publishing.  She has started a blog to promote it and the website has already advertised the presence of this article in theheart.org.  Thank you for your kind comments Lisa.  And thank you for not disclosing your conflict of interest as it makes my comments all the more relevant.

     

    Dr. Walton-Stanley works with or has a professional association with Dr. Bales’ brother and just received a $2500 course for free presumably for the free advertising her column would create for the book Dr. Bale and Amy Doneen are publishing and that Ms Cool is promoting as their literary agent.  Having said that I thought her summary was balanced and reasonable as are her posts in general – which is why I read them.

     

    Marcy Zwelling MD is an internist with a concierge practice in Southern Califormia – I suppose that’s the connection.

     

    CJ MCConnel MD and H Fritz MD are two internists with a special interest in preventative cardiology (my impression based on numerous posts from other blogs) – I have no qualms with them aside from their proclivity to assume they are more intelligent than those who try to respectfully disagree.

     

    Various relatives, former patients and the nurse who works in the office.

     

     

    I do not apologize for being a critical thinker or aggressively questioning new assertions – in my opinion it is what continues to make medicine fun.  In reviewing my posts I would like to apologize for the “snake oil” comment – it may be interpreted as an intent to defraud and that was not my intention – I simply was equating assertions without testing to a distant time when that was the norm.  That being said utilizing subset analysis and selected findings from various studies to prove efficacy of a treatment approach is the basis for hypothesis testing but does not substitute for same – that was my point from the initial post and if that has been lost in the subsequent replies than I would simply assert it once more.   I do apologize to my fellow physicians if anything I have stated was personally offensive – I am simply representing a viewpoint ingrained in me by training which has served me well for many years.

    # 55 of 104
    March 6, 2011 07:31 (EST)
    Bradley Bale
    Whufs, I am not sure who you are, but my guess is you did not write the book How to Win Friends and Influence People.
    # 56 of 104
    March 6, 2011 08:46 (EST)
    whufs
    Correct.  Manipulating others with intellect seems nefarious - not something that appeals to me.  Do you agree?
    # 57 of 104
    March 6, 2011 08:54 (EST)
    Melissa

    Oh my,.......I hadn't checked in again until the late afternoon and the board has been busy!

    I would like to insist that everyone here remain civil and refrain from personal attacks.  I would like to add that at no time was I aware  there was to be a book until the last day of the meeting.  Also, my blogs are not an advertisement but rather a commentary. When I do write, there is never a guarantee to anyone as to what I will write or even IF I will write something.

    I will be reading the slides for weeks to come I'm sure!!!

    Thanks for all your posts. Whufs, do not feel so alone. I think your reaction is typical of folks who hear about this approach for the first time. I'm sure we all appreciate your dedication to your profession and thanks for your saying I was balanced.)

    Appreciate all of you for reading.

    Melissa 

    # 58 of 104
    March 6, 2011 08:58 (EST)
    Judy Carroll

    I was recently accused of selling "snake oil" with my periodontal methods on an international forum for periodontal/dental professionals.  I know this game well.  I have compiled 100's of case studies over 10 years in periodontal endoscopy tx, real results with real people facing huge problems, they all still have their teeth...a method I cannot get anyone to study...let alone RCT's.  so I understand the dilemma of "pioneering humanitarian work" which goes against the institution and conventional methods accepted by main stream "sheep", and yet all aspects of my protocol are well published.  whufs, you need to realized that there are "powers that be", such as big pharma, who control the research, dont be one of the sheep.  your education is almost your downfall, as it is with the many of the periodontists who critisize my protocol - which is not rocket science, and yet my results speak for themselves. I feel this has parallels to the Bale Doneen method.  open your mind and let go of the rigid "scientific method", which may be tainted in the end by greed.  money can buy results, as Amy and Brad demonstrated, and as I have seen big pharma do in dentistry. I am trying to get my patients off the "perio-merry-go-round", and I see Brad and Amy doing the same for the "heart attack-stroke-diabetes-merry-go-round".   

    # 59 of 104
    March 6, 2011 09:04 (EST)
    whufs
    Now I am a sheep - from a dentist no less - I guess I am not capable of understanding the effect of industry without going to - uhhh dental school.  Please.
    # 60 of 104
    March 6, 2011 09:25 (EST)
    Judy Carroll
    ha, ha...nope, not a dentist, that would be the last thing I would study or pursue...I am a periodontal therapist, yes, a "registered dental hygienist" who created a whole new niche with advanced endoscope techniques...I have no "important" credentials after my name (to you)...and yet I pioneered endoscopic bone regeneration for hopeless teeth.  go figure.  maybe you shouldnt get so caught up in credentials.  I was trying to point out the obvious, which seems to have flown right over your head, as is the case with over-educated periodontists in my field...a dying profession. you may want to take note.
    # 61 of 104
    March 6, 2011 09:48 (EST)
    whufs
    I do apologize if I have offended you as I have absolutely no idea about the dental profession much less periodontics - and how am I a sheep again - I missed that - just because I require proof of treatment to suggest we represent a standard of care based on same.  I think you inferred that I was somehow naive about the effect of industry as it relates to published data which I guess is covered in dental hygiene school.  And with regards to credentials in none of my arguments have I suggested that that is a prerequisite to original thought.  I congratulate you for your success and your contribution to oral health.
    # 62 of 104
    March 6, 2011 09:54 (EST)
    Judy Carroll

    nevermind.  I realize if your views on dentists is so low my comments would certainly be beneath you. I never should have taken the bait by being defensive in my post. if you knew the obvious about the possible tainted published literature I didnt read into it.  I just see too many professionals sitting on the sidelines criticizing people trying to create better methods, which is a "safer place to be" than challenging the accepted standards.

    # 63 of 104
    March 6, 2011 09:56 (EST)
    Judy Carroll
    thanks for the response. :)
    # 64 of 104
    March 7, 2011 02:04 (EST)
    Lisa Collier Cool

    Whfus, if your research on medical topics is comparable to that you did on my bio, then I truly fear for your patients since almost everything you wrote about me is wrong, even though my bio is very easy to find online. Although you describe me as a "literary agent," I last worked in that field in 1984, so your information is more than 2 decades out of date. I have never "started a blog" about the Bale/Doneen Method, an assertion you have apparently invented out of thin air. Two weeks ago, I was hired as a "health expert" to blog on the Yahoo health page with my Day in Health blog. Posts to date have NOT covered the Bale/Doneen Method. Instead, I have written about Rare Disease Day, the discovery of a possible target for treatment of aggressive prostate cancer, pulmonary embolism. and weight loss surgery. Anyone who is interested can easily verify this by visiting the blog: 

    http://health.yahoo.net/experts/dayinhealth

    Also, I have no idea where you came up with the notion that I have "advertised" Melissa's post on theheart.org on my website, www.lisacolliercool.com. There is absolutely NO mention of it there or on the Yahoo blog, which does include a bio of me listing my various books, including the new one I'm working on with the 2 specialists, without any reference to theheart.org whatsoever. You seem to have an unfortunate tendency to go off half-cocked and then end up misfiring, so I suggest that the next time you post, you try doing more careful research beforehand, to avoid looking silly.

    # 65 of 104
    March 7, 2011 03:00 (EST)
    CJ McConnell

    When will this storm blow over ?

    Maybe being a willow makes more sense than being the oak,...

    # 66 of 104
    March 7, 2011 06:48 (EST)
    sfukmd

    New Health Blog by Lisa Collier Cool

    March 1, 2011 at 2:48pmPosted in General News

    The Bale/Doneen Method is proud to announce a new blog by Lisa Collier Cool, co-author of the forthcoming Bale/Doneen Method book (Beat the Heart Attack Gene with Bradley Bale, MD and Amy Doneen, ARNP).

    This is from the Bale Donnen web site.  My apologies for stating incorrectly that your blog was established to promote the book but that was where I got that - my intent was to understand the vitriol directed by you against me and when I discovered the association I must admit I lost interest in further specifics.  You are co-authoring a book that I was indirectly criticizing and in response to fairly innocuous comments suggesting that formal randomized trials would be appropriate you then proceeded to make the following assertions:

       In your first post three misfires in rapid succession.  When I first started placing stents in 1994 (that's when they became available) they were FDA approved based on definitive trial evidence showing superiority to balloon angioplasty.  A scientific truth established through large trials and never refuted.  The comment about the irony involved in the naming of the COURAGE trial is that there were at least five published trials prior to that which arrived at the same conclusion - for a thoughtful cardiologist with a proclivity to read the literature (although I guess others have questioned that) this trial added little to what was already known - it assists with angina control at the expense of a small increase in early complications.  That you would accuse me of placing stents inappropriately without data would then also be incorrect but perhaps my subtlety hid that so I point it out know.  You then make the snide comment "presumably not for free" and we all understand your insinuation however insulting but I know you write books and articles for free so the real accusation is that I was placing stents that were not indicated for financial gain - thank you for that.

       Your second post ruminates about "common sense" and again misstating that I was placing stents prior to a randomized trial.  The common sense was the training afforded by a cardiology fellowship and the general knowledge attained with the certification, practicing in accord with best clinical data/recommendations and again your snide comment about deriving less than ten percent of my income is noted.  The latter issue is addressed above.  Your insinuation that an interventional cardiologist would not institute preventative therapy is also noted and is incorrect.

       Your third comment adds little.  I have no idea what the last sentence means.  Do you mean that if I don't have self reported prevention outcome data than I can't comment on the scientific method or suggest that a treatment trial be conducted - kind of like dueling banjos in Deliverance?

       Your fourth comment I largely agree with - no kidding.  Aside from the "turf war" comment which is ridiculous for those of us already overwhelmed.  I understand that it would be difficult to compare a "method" with standard of care but think of the conceptual model here and the questions raised by Bale and Donnen - is treatment of insulin resistance the key to preventing vascular endpoints or is it simply a marker, are Berkeley panels and following CIMT worth the expense and how much additional benefit is conferred, how much better is this versus statins plus niacin alone - many more questions come to mind well worthy of study but remember there has never been a change in the standard of care absent investigation and frankly single center studies have a long history of disappointment so self reporting outcomes absent randomization and multi-center involvement will always be open to critique.  Hardly a closed mind in my opinion.

       Your fifth comment underscores the entire point of my posts and I agree with the notion that much of what we do is tenuous scientifically and often based on "expert" opinion and as you point out those "experts" are invariably subject to commercial interests that may impede objectivity whether it be industry involvement, "institutes" or profiting from a book.  The solution is a randomized trial and where have we heard that before?

       Your final comment I have addressed.  There are two comments that I have made that I regret.  The first was the "snake oil" reference because it can have a double meaning which I had not thought of when I posted it.  I did not intend the interpretation of an intent to defraud.  I was referring to the times before the Exner Report and the FDA when medicine was not regulated and anyone could claim anything and hence "snake oil" sold for profit.  We learned that our entire profession is diminished if we do not adhere to a method to best ensure truth and that lesson is no less relevant today.  The second comment "she has started a blog to promote it" as you pointed out is incorrect not because I cannot conduct proper research but because the undisclosed conflict of interest is established by the fact that you are writing the book and my interest had pretty much been satisfied at that point.

       I hope that you look at all my posts and understand that despite the various insults directed at me I have tried to objectively maintain the simple stance that however good a story this makes it will not gain traction to supplant standard care without a randomized clinical trial - and if this is a cure for atherosclerosis not verified and not disseminated that would be a loss for all.  Finally I promise I will read the book - a good physician is a skeptic who knows by virtue of the profession that he is often wrong but still strives to get it right.

     

    # 67 of 104
    March 8, 2011 04:05 (EST)
    Rakesh Patel MD

    As a family physician who probably does not know as much as a cardiologist at treating atherosclerosis, i feel compelled to throw my 2 cents in, at the risk of being flamed (which i know i will).

     A soon to be published article in the Clinical Journal of Lipidology (2011)5, 105-113, discusses the case of discordance regarding LDL-P vs LDL-C in assessing Atherosclerotic risk. It shows nicely looking at data from MESA that increased particle number (higher LDL-P) is a better predictor than LDL-C when they are discordant and that CIMT is worse in this patient population (LDL-P>LDL-C) along with increased incidence of CV events. The main point is that who are the patients that have small ldl particles (hi LDL-P) that are TG rich/CE poor? The IR patient. Ding! How do screen for that patient, 2 hour gtt, ding ding. These patients have these particle abnomalities long before any blood glucose problem occurs. Many of these patients can slip thru if not being adequately screened. Yes put them on a statin. But the problem is that most monotherapy statin trials at best gives you a 37% relative risk reduction in events (4S, WOSCOPS, CARE, HPS, LIPID, AFCAPS). In these trials when you tease low hdl patients (read IR) it's worse. 60-70% of the risk is laeft on the table.

    So is it really a stretch that IR is the driving force. Are we really in a chicken or the or situation here. Is that not why DM patients are now considered disease risk equivalent for CAD. It is a continuum and can be arbitrary at times (just look at cut points for diagnosis for DM II in Europe vs the USA)

     My whole point here is that that the method that Brad and Amy relate is not a so far fetched idea from Mars. It is grounded in sound medical evidence. Has there "method" been put thru a RCT trial, no. Can I connect the dots (read common sense), yes. Am i am going to wait 5-10 years for a trial to be on the table and let patients at risk continue to have events, no.  What is the risk of applying the method, not a lot. Is it so out of the box to RX TLC, asa 81, a statin and a RAAS agent, absolutely not (and very cheap at that) then add niacin and a tzd if needed. My math tells me from an out of patient out of pocket cost, it would be about $10000 over 25 years. Whats the cost of ACS, $125000(?), the cost of outpatient PCI, $50000 (?)(not including lost wages and productivity)? Let alone there 2nd or 3rd procedure.

     Whufs, i certainly understand your initial question, and no one on this board can give you a satisfactory answer, because what you are looking for has not been done.  But there are certainly enough smoking guns to at least look before you dismiss it. Again, I am just a family doc, so what do I know ;-)

     Lastly, whufs, if you want to take the BD Method course, i would gladly split your fee. Next one is in Baltimore, i think you would be surprised.

    Bring on the flames 

    Disclosures: I speak for Big Pharma (in bed with everyone, beholden to none) and i am in a traditional practice taking all insurance including medicare and medicaid (read: i practice in the real world). 

    # 68 of 104
    March 8, 2011 05:07 (EST)
    H Fritz MD RVT

    Regarding whufs claim that RCT were the traction factor that led to the major paridigm shift of Peptic Ulcer Disease treatment, quite to the contrary, by the time the resistance to even consider the new idea by the skeptics of the day had delayed progress as a result of repeated rebuffs, insults and rejections,  Marshall and Warrens "new" bacterial etiology theory, became so conclusively established that it was unethical to conduct a RCT, so none was ever done.  Just wondering whether the increasing evidence from many fronts demonstrating that it is definitely possible to reverse and prevent atherosclerotic events may become so well established by those persistent ones willing to think out side the box, that despite the resistance of the die hard skeptics, a RCT may very well have become unethical to perform.  Just wondering.  History has a way of repeating itself. 

      

    # 69 of 104
    March 8, 2011 06:04 (EST)
    whufs

     

    Dr. Fritz,

       I disagree - a casual 5 second google search to a standard textbook of gastroenterology suggests that several RCTs were done and solidified the then controversial notion linking bacterial infection to recidivist peptic ulcer disease.  I have included the link below.  It would have been a shame if we were still allowed to question it twenty five years later but we cannot because it was proven in the appropriate manner (ie. RCT).  Fully agree that there was a strong headwind prior to the definitive RCTs and that innovative thinking based on biopsy findings led to a change in thinking.

    http://books.google.com/books?id=WSP6wdD_8MEC&pg=PA106&lpg=PA106&dq=H+pylori,+ulcers&source=vrt&ots=wK4JjU0--A&sig=e4PoFlacYzlanqlJK_fjslZuFQM&hl=en&ei=SAZ2TcU7it2BB5_YuMwF&sa=X&oi=book_result&ct=result&resnum=14&ved=0CIUBEOgBMA0#v=onepage&q=H%20pylori%2C%20ulcers&f=false

       Can you imagine a clinical trial formulated in the early eighties comparing serial nuclear stress testing and revascularization based on same vs observational therapy with appropriate and equal preventative medical therapy in both groups - and when that study showed no difference in death or q wave infarction and increased cost, repeat procedures, increased NQ/peri-procedural MI in the aggressive screening group - what number of nuclear stress tests, cathetrizations and revascularizations would have been averted over the ensuing twenty years?  It was felt to be unethical to not look for progressive disease, presumed to be the standard of care in many training programs and resulted in an evaluation/treatment paradigm that still cannot be excised (see Dr. Topol's recent comments on this site).  Ms Cool in a comment above cited an assertion that 89% of our treatment recommendations are not vigorously supported by trial data and I just think that we should not add to it.

     

    # 70 of 104
    March 8, 2011 06:35 (EST)
    whufs

    No flames for you!  You make a cogent and well articulated case for performing RCT.  I think you misunderstand the question that I would address and please allow me to explain.

    Is aggressive "blind" therapy with lifestyle modification, weight loss, exercise, diet, statin/niacin, BP control with ACE, ASA and traditional treatment of diabetes inferior to "directed therapy" using Berkeley biomarkers, two hour glucose tolerance tests etc. and treating to endpoints individually (admittedly with many of the same armaments)?  That is what I think the question is and from this one would likely get subset data about the role of insulin sensitizers for pre-diabetes (which sounds like the only unconventional issue to my eye).  It does not sound like a difficult trial to envision and it may or may not translate well to the "real world" where begging patients with established CAD to take their statin is often the practical hurdle.  Is this important to know?  In my opinion yes and until it is done I am not comfortable accepting comments made on the Bale web site that his program is the equivalent of an A student while current evidence based recommendations are a C student (intellectually his sophistication and grasp of vascular biology yes but superiority clinically not yet).  That thought process in my opinion puts the cart before the horse and may lead to untoward consequences (see my nuclear stress reference to Dr. Fritz).

    I fully agree with aggressive therapy - my question is whether we should be creating "abnormal biomarkers" as a new disease alongside say HTN.  The "pre-hypertension" diagnosis fell apart in an RCT.  Rate control in afib - notion disputed by RCT.  Mucomist - you guessed it RCT.  That being said it makes physiologic sense so it should be tested unlike other markers of risk (uric acid, TSH, ferritin) where the same cannot be said.  There need not be a delay in implementing such strategies (a little nervous about TZDs I must admit) but why not study it so that proven strategies can be presented to third party payers and patients alike. 

    # 71 of 104
    March 8, 2011 12:52 (EST)
    H Fritz MD RVT
    Whufs, you are definitely correct on this one.  Embarassingly, my earlier cursory google search ended too quickly.  I respectfully appreciate the correction.  As far as possible I try not be closed minded to innovative thinking while not discarding currently accepted guidelines and conclusions which are usually based on the best level of evidence available - be  they RCT or not. 
    # 72 of 104
    March 8, 2011 01:01 (EST)
    Lisa Collier Cool

    No need to apologize for using google, whfus, but it would have been gracious to apologize for using it incorrectly and posting a bio of me that wrong in virtually every detail from my profession to the subject matter of my blog and the content of my website. Probably at this point, we should agree to disagree re the Bale/Doneen Method. 

    Re my statement about the evidence or lack of it backing ACC/AHA practice recommendations, this isn't my opinion or interpretation, but the actual findings a 2009 JAMA study. Below is a verbatim quote from the study, which is online here:

    http://jama.ama-assn.org/content/301/8/831.full 

     

    Scientific Evidence Underlying the ACC/AHA Clinical Practice Guidelines

    >Considering the 16 current guidelines reporting levels of evidence, only 314 recommendations of 2711 total are classified as level of evidence A (median, 11%), whereas 1246 (median, 48%) are level of evidence C. Level of evidence significantly varies across categories of guidelines (disease, intervention, or diagnostic) and across individual guidelines. <

    If you disagree with these findings, then your debate should be with the authors of that study, not me, since I am simply citing what they reported in one of the world's leading peer-reviewed medical journals.

    Lisa 

     

     

    # 73 of 104
    March 8, 2011 01:02 (EST)
    whufs
    No big deal - I was a medical resident at the time and the smartest guy I have ever met a GI attending who was hosting journal club reviewed a study addressing this and made the comment that "some things turn out to be uncomfortably true" - that after mocking the concept on several occasions in morning report no less!  Be well.
    # 74 of 104
    March 8, 2011 01:57 (EST)
    whufs

    We agree (thank god).  I have apologized and explained the former.  I agree that too much of what we represent to patients as standard of care is understudied and often turns out to be incorrect when subjected to same - have no qualms with the findings of the study you cite - we should try to better.  I would hope that you understand that that finding is not likely to be specific for the ACC/AHA - I am quite sure it applies to all disciplines but the ACC quite rightly has been on the forefront of best practice recommendations and in order to do that with any integrity the level of certainty of the evidence used in the recommendations has been stratified by the quality of the information available.  In most instances the quality of the science is suboptimal and in those instances the treatment recommendations are necessarily less confident.  Many things defy scrutiny or simply cannot be tested but treatment strategies usually fall into the category where outcome analysis is possible and desirable and with regards to the question at hand I have given examples above.  Simply stated we should be trying to reduce that number (89%!) not add to it.

    # 75 of 104
    March 8, 2011 05:13 (EST)
    Tom Blue

    As the Executive Director of the American Academy of Private Physicians (www.aapp.org), I have attended the Bale/Doneen preceptorship five times and am consistenly amazed by the incredible depth of information dispensed by Brad and Amy in a short two days. Even more incredible is the magnitude of the effort that is clearly required for them to stay so current with the never-ending flow of research related to this topic.

    As the national professional association for private (concierge) physicians, we are bombarded with  medical innovations in search of early physician adopters. Many are quite impressive.

    I have yet to see one with more potential to change the world of medicine, the careers of physicians committed to disease prevention, and the lives of millions of patients than the Bale/Doneen Method. If you have not yet attended one of their preceptorships, register immediately for the upcoming one in May.

    Tom Blue

    # 76 of 104
    March 9, 2011 12:46 (EST)
    C. McGee

    I commend Dr. Walton-Shirley for taking the time to invest in the work of Dr. Bale and N.P. Amy Doneen.  Many physicians seem to be all too easily satisfied with cleaning out or bypassing "the plumbing" and even prescribing "standard" medications without giving a second thought to preventing the origin of the cause. 

    It is unacceptable in a day and time where there is solid scientific evidence showing otherwise.  

    It is "the right thing to do" - not only for the patient but also for a health care system struggling to stay afloat with the standard (blindfolded) way of practicing.  We need to wake up and take responsibility for own on health proactively, leading the way for less knowledgeable patients to follow.  We must hold ourselves accountable for the prevention of the diseases that contribute to unnecessary hardships and losses for individuals, and collectively for our country.  We can do this!  The science is there.

     Thank you Dr. Bale and N.P. Doneen.  Keep up the excellent work!

    # 77 of 104
    March 9, 2011 06:35 (EST)
    pefstratiou
    I could not agree more with whufs. If that method really achieves the claimed results it would eliminate coronary artery disease as number one killer. Without definite proof from a RCT it is just too good to be true.
    # 78 of 104
    March 9, 2011 07:21 (EST)
    Joe Turnbow, M.D.

    I met Brad Bale and Amy Doneen several years ago.  The first thing I ever heard him say was, "The Standard of Care for cardiovascular disease will get your patient killed."  I was very skeptical and even upset at first.  But he proved his point to me.  In September, 2007 I was privileged to be able to attend a (then) 5 day preceptorship with Brad and Amy learning the Bale/Doneen method.  I was so impressed and fascinated with the knowledge they had accumulated and put into a practical method that can be used clinically that I ended up selling my Urgent Care Center and opened a Heart Attack and Stroke prevention practice.  I do not have a randomized clinical trial, but I can tell you that in the six years I have been using the Bale/Doneen method not one of the patients who has followed my advice has had a heart attack, stroke, stent or bypass.  So far it is too good to be true.

                              Joe Turnbow, M.D.

                              Heart Attack Prevention Strategies, PC

                               Boulder, Colorado

    # 79 of 104
    March 9, 2011 07:49 (EST)
    whufs

    Brother where have you been - I feel like I walked into the wrong restroom.  So here we go.

    C. McGee with all respect let me reply: 

    "Many physicians seem to be all too easily satisfied with cleaning out or bypassing "the plumbing" and even prescribing "standard" medications without giving a second thought to preventing the origin of the cause."

    That is unsubstantiated propaganda non-sense that as a well meaning cardiologist I find insulting. 

     

    "It is unacceptable in a day and time where there is solid scientific evidence showing otherwise."

    Well if the data is so convincing then will third party payers reimburse patients for the expense? Oh wait there is NO published data just claims and assertions that the data exists.

     

     "It is "the right thing to do" - not only for the patient but also for a health care system struggling to stay afloat with the standard (blindfolded) way of practicing.  We need to wake up and take responsibility for own on health proactively, leading the way for less knowledgeable patients to follow. "

    Yes you know more than your physician and the societies that establish treatment recommendations and quite frankly recognize that such thinking requires the VA and Medicare and Medicaid to agree to finance that approach because it is cost effective - oh goodness I don't think we even ventured there before.  I frankly cannot imagine a less knowledgeable patient then one that is deceived by a good unproven story.

     

    "We must hold ourselves accountable for the prevention of the diseases that contribute to unnecessary hardships and losses for individuals, and collectively for our country.  We can do this!  The science is there. "

    No it's not.  Not until you take equal risk, equal motivated populations and compare the Bale/Doneen approach to standard therapy can you comment on a scientific truth.

     

    Okay now say bad things about me because there is no logical retort to the argument.

    pefstration - thank you. 

     

    # 80 of 104
    March 9, 2011 08:04 (EST)
    whufs

    "Heart Attack Prevention Strategies, PC"

    How stupid do you think we are - your corporation is named to attract "business" - my god is anybody awake out there?  Are your methods fully covered by third party payers?  Aside from your word is there any evidence that what you purport to be true is true?  You cannot prove or document anything but it was financially lucrative enough to give up the practice of medicine to pursue this.  You know what - I hate to get up in the middle of the night to attend to some poor soul in his time of need - until I get there and then I remember why I went into this to begin with.  Why I am alone on this thread is embarrassing.  Sorry but just because you have a concierge practice doesn't mean you can make things up and demean those of us who practice the standard of care as evaluated by the experts in our specialty.  CJ McConnell teach me to be a willow because I just don't have it in me.

    # 81 of 104
    March 9, 2011 09:01 (EST)
    Drummer55

    My sympathies,..

    EZ to understand how Jesus got nailed to the cross,..

    Passion for prevention seems to a language only understood in primary care,..

    Somebody out there help me understand this hostility,..

    # 82 of 104
    March 9, 2011 09:35 (EST)
    whufs

    Okay - Jesus was nailed to the cross like a couple thousand years ago.  I don't pretend to understand it (I am Roman Catholic Gr K-8 educated) and hope that you are not equating a scientific argument to a religious prosecution.

    Passion for prevention is shared by us all.  Having said that you know that third party payers require evidence to reimburse you and your patients for services based on evidence and cost effectiveness.  So it is necessary to prove a treatment paradigm is both effective and cost efficient - anything less is naive.

    There is only hostility when passion is in conflict with truth otherwise we are yelling about the same thing.

    So to appease all interested parties the truth should be sought absent passion and hostility.  In this instance it is a randomized controlled clinical trial so that all individuals may benefit not just those fortunate enough to be able to afford concierge style practice patterns.  I think Jesus would have liked that.  (disclaimer: I don't pretend to speak for Jesus)

    # 83 of 104
    March 9, 2011 10:49 (EST)
    Melissa Walton-Shirley

    No need for the disclaimer. Jesus probably ate the mediterranean diet and took care of his temple, so he practiced his own kind of primary prevention I'm certain. : )

    Great discussion everyone. Hope you enjoy the forthcoming posts from the program.

    Melissa

    # 84 of 104
    March 10, 2011 01:40 (EST)
    cobble
    This is a tough crowd.  Melissa, I don't think the fellow you mentioned lived long enough to experience CV disease.   It is always difficult to question/challenge the status quo.  I think guidelines by nature are quite conservative.  I do agree with RCT evidence however and would strongly encourage such in regard to the 'method'.  Whufs I think your comments are cogent and appreciated.  It is difficult to be the outsider on this blog.  ARB's have underperformed expectations even though they impact the RAAS system.  Much of the LDLc, LDLp discordance marketed commercially comes from the error associated with FLDLc and labs.  Much of the 'method' has strong support based on science, some requires faith.  I think we are all working toward a common goal however and that is identifying disease early and trying to minimize as much risk and untoward events as possible.  
    # 85 of 104
    March 10, 2011 03:25 (EST)
    Camille King
    I find it slightly amusing that one person that keeps posting on this blog keeps pointing out that Dr. Bale and N.P. Doneen and others using the Bale/Doneen Method are all about the money.  My heart attack cost my insurance company approximately  $30K back in 2004, I can only imagine that the price tag for this has gone up considerably since 2004.    MY cost of prevention via Dr. Bale and N.P. Doneen is approximately $2-3K per year, insurance does not pick up this tab.  It would seem by looking at the dollars involved, there is more money being made on intervention than prevention.  There is even more money involved when you factor in that 2 of 3 patients have a repeat event (statistically).  I do not believe that either of the doctors specializing in prevention or the doctors specializing in intervention are operating on a non-profit basis.  So why would a doctor specializing in intervention have concern that another doctor specializing in prevention be profiting from the Bale/Doneen method?  Especially when you consider that doctors using the Bale/Doneen method have such a high sucess rate in patients NOT having another cardiac event.  Isn't the medical practice supposed to be centered around what is best for the patient?
    # 86 of 104
    March 10, 2011 05:16 (EST)
    whufs
    Ms King for my education can you provide me the reference for the "statistically 2 out of 3 patients have another cardiac event" (or anyone for that matter).  Is this any event (readmission for non-cardiac chest pain included) and over what period of time - it seems like an awfully high number and I can guarantee that has not been my personal experience so I am intellectually curious from where the assertion arises - it is not something I would teach a cardiology fellow to expect employing appropriate secondary prevention measures.  Secondly can you reference the occurence/recurrence rate and the population from where it is derived for the Bale/Doneen method versus that of a similar population utilizing standard recommendations for primary or secondary prevention (these are necessarily two different risk groups).  I have looked at the website and I do not see any publications in peer reviewed literature that address that question.  With regards to concierge medicine it raises a whole specter of societal questions and in my opinion exposes a schizophrenic attitude among our population who in general favor a public option/single payer which would not cover innovative (potentially ground breaking, potentially no more effective than standard care) approaches without definitive proof of efficacy (based on the National Health Service model in Britain).  Although for you paying 2-3k/yr out of pocket is not a great hardship I daily hear my patients lament being in the "doughnut hole" so I don't have the option of pursuing this strategy until such time that traditional insurers agree to cover it - so until a randomized controlled trial is done this "method" is proclaimed an unparalleled success which until tested will only be available for those who can pay out of pocket.  I am a doctor with additional training in intervention who spends most of his time practicing general cardiology for a salary and I can guarantee that if you look at a current bill for acute infarction with intervention you will find a hospital bill of $20k and the interventionalist who saved your life was paid ~$700.00 (at least in my area).  I do not care who profits from what aside from the medical implications as discussed throughout this blog but I would assert that if this is near cure of the most morbid disease on our continent than there is a moral imperative to publish it, test it, prove it and require it be available to all via third party payers.  Instead from what I can tell there is a budding industry in "Heart Attack Prevention Strategy" centers available to those with private funds and seemingly without specific oversight with the proclamation that this is definitively better than the care provided by your cardiologist.  So excuse me if I would like some data before I accept that I am an average student (I believe Dr. Bale considers us a C student on his site) by necessity or tell me what I can say to my deprived patients to make them feel better about getting "substandard care" because they can't afford anything more.  Finally this method purports to be the cure for the most lethal disease in our country and the NIH won't fund a study and somehow I am a lone "negative skeptic."  The answer to your last question is "yes" - for all.
    # 87 of 104
    March 10, 2011 08:14 (EST)
    whufs
    Ms King and all others - I am waiting.  Although I appreciate the sympathy of "cobble" I find it simple to represent truth.  Has there been an argument that I have not refuted?
    # 88 of 104
    March 10, 2011 10:36 (EST)
    H Fritz MD RVT

    Whufs, you don't have the final truth on this issue because your position of utilizing the standard accepted guidelines alone is also lacking RCT evidence.  So, the jury is still out.  It is premature for either side to claim superiority.   

    # 89 of 104
    March 11, 2011 05:06 (EST)
    whufs

    "It is premature for either side to claim superiority."

     

    I agree - only one side is claiming superiority and cannot substantiate it.  If both are equal and one is far more expensive than one might wonder what and whose purpose it serves.

     

     

    # 90 of 104
    March 11, 2011 11:49 (EST)
    James Ehrlich, MD

    During the past several years in 4 cities, I have been involved in cardiac risk assessment for > 50,000 people. 

     I have been fortunate to have met Brad Bale on several occasions and have always come away extremely impressed by his logic, his teaching capabilities and the fact that his expertise is driven by the literature.  He has been a pioneer in the early detection and aggressive prevention of CVD and concentrates on the triggers and underlying causes of the process (inflammation, insulin resistance, etc) with a very intelligent integration of imaging (CIMT), advanced lipids, conventional and emerging biomarkers.

    I am looking forward to an upcoming book on the Bale Doneen method written by Lisa Collier Cool, an individual who I have exchanged emails with in the past and came away very impressed with her passion, knowledge and capabilities.

     Keep up the great work, Brad, Amy and Lisa.  I applaud Dr. Walton-Shirley for allowing a larger audience to learn of this revolutionary and highly EFFECTIVE approach to CVD prevention.

     

     

    # 91 of 104
    March 11, 2011 01:26 (EST)
    H Fritz MD RVT
    Whufs: Fair enough; rightly so. It can't be overemphasized, however, that the current primary prevention "standard of care" is based on expert opinion, and not on RCT evidence.  Hence there is room for challenging the "standard of care".  Hopefully, this interchange will help us all to be intellectually honest in how we define our standards and what we claim regarding its effectiveness, both in terms of clinical outcomes and cost. I realize that is the message you have been advocating all along and commend you for it.   
    # 92 of 104
    March 11, 2011 01:35 (EST)
    Camille King

    "Perhaps it could help nearly all of my patients who have a two in three chance of having a second heart attack or stroke. " - Dr. Melissa Walton-Shirley stated this in her original blog. I believe that Dr. Bale and N.P. Doneen have also stated that they have only had two patients have a repeat event, and both went off the program. 

    Unless you have gone through the trauma of a cardiac event I do not think you can fully understand the scope of what has happened, both physically and mentally.  The worry of why the event happened in the first place, the worry of will you have another heart attack.  Dr. Bale and N.P. Doneen spent two hours with me on the first appointment, they explained what had happened and what we needed to to to prevent another event from happening.  They went over the blood tests that they would be running to determine specifically what had caused my heart attack to happen.  They explained to me why just 5 months earlier a doctor had told me I had a 1% chance of having a heart attack with in ten years, what data drew him to come to that conclusion and why in my case that data was flawed.  This information of such a minimal risk almost killed me.  Instead of going to the hospital I came very close to just going home while I was having my heart attack. The cardiologist that inserted my stent told me if I would have gone home, I would have died because too much time would have been lost.  Dr. Bale and N.P Doneen explained what my part in the treatment was and how important it is that we work together to control my disease.   I am now 7 years down the road and thankfully I have not had another heart attack.  I now have peace of mind.  All of my blood tests come back normal.  I don't wake up wondering if I will be okay, I know that I am taking my medicine, excercising, watching my diet and Dr. Bale and N.P Doneen are watching over me medically. 

    Conversely, when I have gone to the cardiologist's office, during my ten minute appointment I have been warned to remember my symptoms of a heart attack and if they happen again dial 911.   I have been asked to do a stress test, even when one week prior I completed a half marathon, with no issues.  I had one cardiologist ask me if I went to see him because I saw him on TV, he then proceeded to tell me about his TV experiences for the next ten minutes.  Seriously?  I got a bill for $400 for this appointment, my portion was $220.  As I was leaving the office the nurse gave me a slip to make an appointment for a stress test.  The doctor did not mention this to me.  

    I think that each individual needs to weigh their own risk and make their decisions accordingly.  I would encourage doctors to look at the Bale/Doneen method before dismissing it and see if it can help some of your patients.   In my case I was given the best information my general practitioner had at the time and it almost cost me my life. 

    # 93 of 104
    March 11, 2011 05:25 (EST)
    whufs

    Ms King,

       I do not know all the details of your case and I do understand what you nicely summarized.  You seem to have been poorly served by a member of my specialty and as you might imagine from the tenor of many of my posts I am not the most diplomatic and I assure you that includes colleagues who demean my profession.  Once you experienced a cardiac event your cardiologist would have been expected to institute aggressive preventative therapies, diagrammatically explain the vascular biology of acute coronary syndromes, enroll you in a cardiac rehabilitation program and ensure frequent followup so questions can be addressed as they arise.  Recommending a stress test in an asymptomatic patient who just completed a half marathon without chest pain and who previously had a clear anginal warning mechanism is of dubious value (see my post above) but I do not know all of the details that led to that recommendation.  What your risk assessment was prior to your infarction I cannot guess and your family physician may have been correct in assigning you low risk but even an individual with a 1/1000 risk has exactly that chance of having a 100% real heart attack (to the relief of the other 999 I suppose).  One thing I find helpful is to listen to absolutely opposing viewpoints and then go to the references to discover my own (sophist) truth.  In this case I would encourage members to google the writings of Maryanne Napoli at the Center for Medical Consumers with regards to statin based prevention strategies - not something I concur with just the converse argument with some cogent points.  I still don't know where the 2/3 repeat cardiac event number comes from aside from the fact that Dr Walton-Shirley said it presumably after hearing it at the course.  I would need to go to the reference article to put that in context because after 25 years in practice it is not a believable statistic on face.

       It sounds like Bale and Doneen have provided you an excellent service.  My medical arguments were never intended to represent them as anything but well meaning just unproven.  Much of the method is really standard of care - it is only some of the suppositions and unproven treatments that I take issue with as well as the followup testing which like stress testing is not of proven value.  

       Finally I would like to point out a couple of ironies for those who have responded in various ways.  First there are two wellness practitioners in my town who champion biomarker directed therapy and also recommend repeat CIMT and one even CT calcium followup.  I don't agree with all they do but they provide excellent lipid management and for my patients who desire that I freely refer to them and they refer patients to me.  In real life I am not nearly as hostile as you might believe.  Secondly isn't it at least "slightly amusing" that the hated interventional cardiologist took interest in a preventive cardiology blog and stirred up a bit of scientific banter - like I said "walking into the wrong restroom" turned out to be quite enjoyable.

       At this point the "negative skeptic", "fat cardiologist" who cannot read the literature will stop bleating like the "sheep" he is - I have some unnecessary stents I need to put in.  Cheers all. 

     

    # 94 of 104
    March 13, 2011 07:14 (EDT)
    Frank A. Snyder, MSc, MD

    Dear Whufs,

        I am enamored of your writing style, not to mention your disposition while trying to drain this swamp of alligators.  I respect the fact that you take the time to point out sources of your data.

    Wait for it......BUT!  I'm not sure how to take this particular sentence of yours:

    "how is it likely that a family practitioner would be more familiar with management of atherosclerosis than a cardiologist who treats it every day - or is that just an insult aimed at me personally?"

    Does it make a difference if it's an internist as opposed to family practice?  Further, I'm not sure you meant "management of atherosclerosis" or "prevention of atherosclerosis"?

    You may think these niggly little questions, but semantically they are different.  Management may meant invasive procedures or testing not available to primary care, whereas Prevention, at least for some of us internists is our livelihood.

    Why would we know more about prevention?  Primarily because cardiologists do not get involved with the disease process until it's in its final 5% of its life.  I wrote a paper 20 years ago, titled "The Jade Effect" (no...it's not a spy novel), addressing this as a problem with many specialists.  That the disease process is accumulating and ruminating for the first 95% of it's life, then the specialists take over.  This wouldn't be so bad except for 2 things:

    1) The specialists write the rules and regulations for the entire 100%, despite only being involved the last 5%.  (this is a little less true now with Steve Nissen's contributions with IVUS).

    2) By the time we send you a patient, you place their severity in a continuum that typically results in, "you're not sick...this guy in the CCU is SICK!"  Thus denigrating the effects of the primary care doc to warn the patient there is a problem to contend with.  (Not always, but it's so disheartening when it occurs...)

    Sadly, I think there are no RCT's to prove what I've just said, nor are they forthcoming. Your comment on how "Easy" it would be to do an RCT on B/D method is far more difficult than you imagine.  Plus if you were thrown in the study, you might skew the curve to make the study worthless since you also have not had a patient with an MI that followed your instructions.  I admire that probably out of a sense of hubris, since I can make the same statement.  I've done research since 1975 and practiced medicine since 1986. I am an editor for an international cardiovascular journal, and I am the CMO for a cardiovascular drug company.  I promise you the study would be quite expensive.

    Evidenced-base Medicine is there to bring the tardy of us to the 50% mark, and the adventurous of us from going overboard trying everything we read.  but the studies for pioglitazone are quite remarkable as long as you monitor for CHF. Data below:

     " ACTOS has a positive change on HDL cholesterol and triglyceridesACTOS may have a positive change on HDL (good) cholesterol and triglycerides (blood fats) without consistent changes in LDL (bad) cholesterol or total cholesterol in patients with type 2 diabetes. ACTOS has been shown to:
    • Increase HDL cholesterol.
    • Decrease triglycerides.
    • Have no consistent effect on LDL or total cholesterol.
    While ACTOS may provide some lipid benefits, ACTOS is not intended as a substitute for cholesterol medications. The effect of these lipid changes has not been determined.If you have high cholesterol, you should ask your doctor what steps you can take to lower it. These may include:
    • Changing eating habits to reduce intake of dietary saturated fat.
    • Being more physically active.
    • Maintaining your proper weight.
    Your doctor may also prescribe a cholesterol-lowering medication in addition to these healthy lifestyle habits. ACTOS is not intended as a substitute for cholesterol medications."   Off of "EMed TV":Lipid Lowering With Actos: What Does Research Show?In studies, Actos increased HDL cholesterol ("good" cholesterol) by 12.2 to 19.1 percent. It also decreased triglycerides by about 9 percent. The medication did increase LDL cholesterol ("bad" cholesterol) and total cholesterol, although people not taking Actos increased their LDL and total cholesterol by similar percentages.From Diabetes Care:doi: 10.2337/diacare.28.7.1547 Diabetes Care July 2005 vol. 28 no. 7 1547-1554

    A Comparison of Lipid and Glycemic Effects of Pioglitazone and Rosiglitazone in Patients With Type 2 Diabetes and Dyslipidemia

    1.       Ronald B. Goldberg, MD1, 2.       David M. Kendall, MD2, 3.       Mark A. Deeg, MD, PHD3, 4.       John B. Buse, MD, PHD4, 5.       Anthony J. Zagar, MS5, 6.       Jane A. Pinaire, PHD5, 7.       Meng H. Tan, MD5, 8.       Mehmood A. Khan, MD6, 9.       Alfonso T. Perez, MD7, 10.     Scott J. Jacober, DO5 and 11.     for the GLAI Study Investigators+ Author Affiliations
    1.       1Division of Endocrinology, Metabolism, and Diabetes, University of Miami School of Medicine, Miami, Florida
    2.       2International Diabetes Center, Park Nicollet Institute, Minneapolis, Minnesota
    3.       3Division of Endocrinology and Metabolism, Department of Veterans Affairs and the Indiana University School of Medicine, Indianapolis, Indiana
    4.       4Divisions of Endocrinology and of General Medicine, University of North Carolina School of Medicine, Chapel Hill, North Carolina
    5.       5Lilly Research Laboratories, Eli Lilly, Indianapolis, Indiana
    6.       6Takeda Pharmaceuticals North America, Lincolnshire, Illinois
    7.       7Takeda Global Research and Development Center, Lincolnshire, Illinois
    1.       Address correspondence and reprint requests to Scott J. Jacober, DO, Lilly Research Laboratories, A Division of Eli Lilly, Lilly Corporate Center, DC 5116, Indianapolis, IN 46285. E-mail: sjacober@lilly.com Next Section

    Abstract

    OBJECTIVE—Published reports suggest that pioglitazone and rosiglitazone have different effects on lipids in patients with type 2 diabetes. However, these previous studies were either retrospective chart reviews or clinical trials not rigorously controlled for concomitant glucose- and lipid-lowering therapies. This study examines the lipid and glycemic effects of pioglitazone and rosiglitazone. RESEARCH DESIGN AND METHODS—We enrolled subjects with a diagnosis of type 2 diabetes (treated with diet alone or oral monotherapy) and dyslipidemia (not treated with any lipid-lowering agents). After a 4-week placebo washout period, subjects randomly assigned to the pioglitazone arm (n = 400) were treated with 30 mg once daily for 12 weeks followed by 45 mg once daily for an additional 12 weeks, whereas subjects randomly assigned to rosiglitazone (n = 402) were treated with 4 mg once daily followed by 4 mg twice daily for the same intervals. RESULTS—Triglyceride levels were reduced by 51.9 ± 7.8 mg/dl with pioglitazone, but were increased by 13.1 ± 7.8 mg/dl with rosiglitazone (P < 0.001 between treatments). Additionally, the increase in HDL cholesterol was greater (5.2 ± 0.5 vs. 2.4 ± 0.5 mg/dl; P < 0.001) and the increase in LDL cholesterol was less (12.3 ± 1.6 vs. 21.3 ± 1.6 mg/dl; P < 0.001) for pioglitazone compared with rosiglitazone, respectively. LDL particle concentration was reduced with pioglitazone and increased with rosiglitazone (P < 0.001). LDL particle size increased more with pioglitazone (P = 0.005). CONCLUSIONSPioglitazone and rosiglitazone have significantly different effects on plasma lipids independent of glycemic control or concomitant lipid-lowering or other antihyperglycemic therapy. Pioglitazone compared with rosiglitazone is associated with significant improvements in triglycerides, HDL cholesterol, LDL particle concentration, and LDL particle size. From (Arteriosclerosis, Thrombosis, and Vascular Biology. 2006;26:182.):
    © 2006 American Heart Association, Inc.

    Atherosclerosis and Lipoproteins

    Effects of Pioglitazone on Lipoproteins, Inflammatory Markers, and Adipokines in Nondiabetic Patients with Metabolic Syndrome

    Philippe O. Szapary; LeAnne T. Bloedon; Frederick F. Samaha; Danielle Duffy; Megan L. Wolfe; Daniel Soffer; Muredach P. Reilly; Jesse Chittams; Daniel J. Rader From the Division of General Internal Medicine (P.O.S., L.T.B.), Institute for Translational Medicine and Therapeutics (P.O.S., L.T.B., M.L.W., D.J.R.), Division of Cardiovascular Medicine (F.S., M.P.R.), and Center for Clinical Epidemiology and Biostatistics (P.O.S., J.C., M.P.R.), University of Pennsylvania School of Medicine, Philadelphia, Pa. Current affiliation for P.O.S. is Wyeth Research, Collegeville, Pa. Correspondence to Daniel J. Rader, Institute for Translational Medicine and Therapeutics, University of Pennsylvania Medical Center, 654 BRBII/III Labs, 421 Curie Blvd, Philadelphia, PA 19104-6160. E-mail rader@mail.med.upenn.edu  

       Abstract

    Objective— The purpose of this research was to evaluate the short-term effects of pioglitazone (PIO) on high-density lipoprotein cholesterol (HDL-C) and other metabolic parameters in nondiabetic patients with metabolic syndrome (MetSyn).
    Methods and Results— Sixty nondiabetic adults with low HDL-C and MetSyn were randomized to PIO or matching placebo for 12 weeks. PIO increased HDL-C by 15% and 14% at 6 and 12 weeks, respectively, compared with placebo (P<0.001). Changes in HDL-C were correlated to changes in adiponectin (r=0.34; P=0.01) but not to changes in insulin resistance. PIO did not affect serum triglycerides or low-density lipoprotein (LDL) cholesterol concentrations but reduced the number of small LDL particles by 18% (P<0.001). PIO reduced median C-reactive protein levels by 31% (P<0.001) and mean resistin levels by 10% (P=0.02) while increasing mean serum levels of adiponectin by 111% (P<0.001) compared with placebo. PIO did not affect weight and modestly decreased insulin resistance. Conclusions— In nondiabetic patients with low HDL-C and MetSyn, PIO significantly raised HDL-C and favorably affected lipoprotein particle size, markers of inflammation, and adipokines without changes in triglycerides, LDL-C, or weight. These results suggest that PIO has direct effects on HDL, which may contribute to its antiatherogenic effects. We performed a detailed evaluation of the lipid effects of pioglitazone (PIO) in nondiabetic patients with metabolic syndrome. The primary finding was that PIO raised high-density lipoprotein cholesterol by 14% compared with placebo, without significant changes triglycerides or low-density lipoprotein cholesterol. Our results suggest that PIO may be useful as an antiatherosclerotic strategy in this nondiabetic population.  In:  Diabetes Technology & TherapeuticsLipid Response to Pioglitazone in Diabetic Patients: Clinical Observations from a Retrospective Chart Review

    To cite this article:
    Allen B. King, Dana U. Armstrong. Diabetes Technology & Therapeutics. June 2002, 4(2): 145-151. doi:10.1089/15209150260007354.

    Published in Volume: 4 Issue 2: July 5, 2004

    Full Text: • PDF for printing (109.5 KB) • PDF w/ links (158.9 KB)
    Allen B. King, MDDiabetes Care Center, Salinas, CaliforniaDana U. Armstrong, RDDiabetes Care Center, Salinas, CaliforniaThe objective of this study was to determine whether improvements in the lipid profile observed in controlled clinical trials with pioglitazone are seen in the clinical practice setting, and to ascertain the influence of concurrent statin treatment. Charts of 100 consecutive patients with type 2 diabetes (mean age 56.8 years) treated with pioglitazone (45 mg/day) for 2-4 months were retrospectively analyzed for changes in serum lipids, glycemic parameters, and body weight. Subanalyses were performed on the relationship of lipid changes to baseline lipid values and to concurrent statin therapy. Pioglitazone was associated with statistically significant (p < 0.001) changes from baseline in HbA1C (mean decrease 1.09%), body weight (mean increase 1.76 kg), HDL cholesterol (HDL-C) levels (mean increase 15.6%), and triglycerides (mean decrease 9.9%). There was an increase (+ 1.09%) in mean individual LDL-C levels from baseline values, but this change was not statistically significant. The greatest absolute and percentage improvements in HDL-C and triglycerides were observed in patients who had the greatest lipid abnormalities at baseline: in patients with baseline HDL-C < 35 mg/dL, mean individual HDL-C values increased by 31% (p < 0.001); in those with baseline triglycerides >399 mg/dL, triglyceride levels decreased by 46% (p < 0.001); and in patients with baseline LDL-C > 129 mg/dL, mean individual LDL-C values decreased by 10.6% (p < 0.001). Subgroup analysis showed similar beneficial changes in HDL-C and triglycerides in patients who were not receiving concurrent statin therapy (n = 48) as in those who were receiving statins (n = 49). This observational study demonstrated that significant improvements in HDL-C and triglyceride levels can be achieved with pioglitazone in the clinical practice setting. The greatest improvements occurred in patients with the worst baseline lipid levels, and benefits were seen regardless of whether patients were receiving concurrent statin therapy.     In addition, the following paper explains how pioglitazone augments niacin: Circulation. 2008;118:S_471.)
    © 2008 American Heart Association, Inc.

    Lipid Lowering: Combinations and New Agents

    Abstract 3705: Pioglitazone Augments Niacin-Induced Increases in Adiponectin in Non-Diabetics with Metabolic Syndrome and Low HDL

    Richard L Dunbar1; Ramprasad Gadi1; LeAnne T Bloedon1; Sushma Ramprasad1; Megan Wolfe1; Amanda Baer1; Daniel J Rader1; Frederick F Samaha2 1 Univ of Pennsylvania, Philadelphia, PA
    2 Philadelphia Veterans Administration Med Cntr, Philadelphia, PA
    Background Niacin and pioglitazone (PIO) increase HDL by uncertain mechanisms. Both increase adiponectin, whose effects on carbohydrate and fatty acid metabolism may benefit HDL indirectly. Little is known of the combined effects of the drugs on adiponectin and other adipokines. We hypothesized that PIO would complement changes in adipokines from niacin, and in turn, augment HDL. Methods In an open-label run-in, non-diabetics with low HDL titrated from 0 to 2 g extended-release niacin over 4 weeks, and were randomized to add PIO 30 mg or placebo in a double-blind manner. After 6 weeks, PIO was increased to 45 mg for another 6 weeks. We assessed changes in fasting adiponectin, resistin, complement C3 (the serum-detectable precursor of acylation stimulating protein), free fatty acids (FFA), hydroxy-butyrate (HBA), and triglycerides (TG), and their relationship to changes in HDL. Results Of 72 completers, 34 took niacin and placebo and 38 took niacin and PIO. The table shows absolute and relative change of each analyte from baseline to 16 weeks. Relative change in adiponectin was strongly correlated with change in HDL (Spearman’s rho +0.49, p<0.0001), as was change in TG (rho –0.50, p<0.0001); the other analytes had little influence. On multivariable regression, change in HDL was predicted by change in adiponectin (p=0.0001) and TG (p<0.0001), which remained significant on adjustment for changes in glucose and insulin. Conclusion: Pioglitazone augments niacin-induced changes in adiponectin and complement C3 thought to be favorable, and neutralizes niacin’s unfavorable increase in FFA. Adiponectin strongly predicted HDL after adjustment for TG. Since PIO had no independent effect on TG, we speculate that additional HDL-raising from PIO is mediated by the large increase in adiponectin. In summary, PIO enhances HDL-raising from niacin in proportion to increased adiponectin.

    But what can an internist do for the prevention of coronary events better than a cardiologist?  I don't know about the other internists, but I can tell you this one gave up teaching cardiologists because a number of them were resentful that an internists "could possibly know more" than they did on the causes and prevention of cardiac events. Thank God the majority were able to learn and teach me simultaneously.  Why would I know more than some?  Because I spend a minimum of 3-4 hours a day reading, and I collect data the same way I used to collect baseball cards in 1962.  So yes, Whufs, there might be one or two of us out there that just might be able to surprise you.

    I think your comments on looking for known markers as iron, uric acid et al are instructive.  Incidentally, combined with the MTHFR gene deficiency, iron and uric acid assum a more inflammatory and thus dangerous profile.  The research of a year ago proved that homocysteine levels aren't important directly.  What's important is the amount of working MTHFR enzyme availabe in the intima.

    Since 1993, I've been doing Glucose Tolerance Tests with C-Peptides.  So the concept is not new...why C-peptides?  Insulin has 3 variables that contribute to its levels, C-peptides have one...time.  A C-peptide is a more accurate measurement of insuin production than insulin itself is, (personal communication with Dr. Steve Garvey, Univ. of Alabama).  That way you can pick up insulin resistance BEFORE they have abnormal blood glucose.

    Thanks for providing enlightend entertainment...made my night!

    Melissa...that was fun reading all this...wish they were all this way!

                            Frank A. Snyder MD

     

     

    # 95 of 104
    March 13, 2011 09:27 (EDT)
    whufs

    "how is it likely that a family practitioner would be more familiar with management of atherosclerosis than a cardiologist who treats it every day - or is that just an insult aimed at me personally?"

    Perhaps uncalled for but I was feeling a bit frisky from comments made from a contributor that I think I quite likely agree with more than not.  For what its worth I am an Internist by training with an additional year of chief residency who only specialized because of what I perceived (I think correctly) as a particular desire of our culture to require same.  I have no doubt that you have greater knowledge in the information you referenced than I but it does give me an opportunity to expand my understanding and I will be reviewing your post the way I always do when I find I have not been exposed to science pertinent to my service to patients - I must admit it sounds a bit dry for a "balloon guy" though.  I think my point is we should learn from estrogen for women to prevent CAD, anti-oxidant nonsense, co Q10, folate, serial nuclear stress tests, PCI for stable CAD, mucomist, aggressive rate control in afib and the permanent pacers required to facilitate same - every time we make it up even with the best intentions...well I think you see my point.  Although I suspect we agree more than disagree I am not comfortable with extrapolation of physiology to clinical practice recommendations absent outcomes testing however expensive it might be - and frankly "expense" is a broad concept to society and I would refer you to the comments I made with regards to the nuclear scintigraphy paradigm with regards to stable coronary disease and what that has cost society.  I have made the societal/third party payer argument but I am not afraid to say that in an age of concierge practices there is an understandable desire to compete for patients, advertise superior approaches and at some point the slippery slope leads further away from proven treatments toward that which can be sold and advertised.  In the circumstance at hand I think it is quite likely that aggressive screening of an entire population would identify individuals not at high risk by Framingham criteria who may wisely be targeted for more aggressive primary prevention but what threshold exactly would that be and with what aggression of medical therapy would we pursue them and at what cost of followup and what if therapy in and of itself was harmful (Avandia does have a black box warning for increasing MI risk not decreasing it)?  I just think our profession requires the humility of restraint - we don't know everything and we can't make it up in the meantime - not as a standard of care and certainly not something that is superior to the aggregate best practice recommendations based on available data made by our professional societies.  Once that rubicon is crossed then no one should believe anything because that would be last guardian of truth - sophist (only what I know, only what I can prove).  Trust me it was a nightmare to be an intern and resident during my years in training programs but they are all good doctors and would be able to easily identify me from reading my comments here.  Thank you for the references - I have some reading to do.

    # 96 of 104
    March 13, 2011 10:45 (EDT)
    whufs
    It was the word "likely" I found curious - I wasn't sure whether it was just me or all cardiologists who were being targeted.  And I thought I was the alligator in the swamp.  Finally let's not get into the Actos versus Avandia thing - from what I have seen presented to the FDA it is hard to understand why the latter is not off the market and I thought the former was going to be subjected to a cardiac endpoint trial - which is a good thing.  Also I think it would be a useful trial to identify insulin resistance and do an RCT for primary prevention - again from what posters have asserted is that in the ACCORD trial it was "too late" but that doesn't seem to be the case for statins in secondary prevention so it should be proved not assumed.  
    # 97 of 104
    March 15, 2011 07:55 (EDT)
    Melissa

     

    These conversations are very important in order to drive change and should  center around what we can do to make our population safer and healthier and how to most efficiently get help to those who have fallen ill.  If our president would support prevention programs, drive a smoke free America campaign, promote mass BP screenings,  mount an intensive assault on obesity in children and adults, and map the shortest route from an ST Elevation MI to a PCI, our population would flourish with far less cardiovascular disease, and fewer expenditures for preventable disease. It's simply to look at our most expensive DRG-CHF and work backwards toward addressing all the drivers of this disease process.

    The byproducts of an agressive prevention movement would include the ability to provide our seniors with health care without the threat of a government shut down, give our teenagers a guarantee of a college education ( the gift that keeps on giving) and ultimately with less illness,  poverty, smoking and drug abuse our young children would be better cared for and nurtured which promotes productive and self supporting adults. (healthier, happier and ultimately less expensive adults as well!)

    Melissa  

    # 98 of 104
    March 16, 2011 08:23 (EDT)
    cobble
    Melissa, well said.  Prevention and appropriate interventions are crucial in addressing something which affects all families in this country.  Thanks
    # 99 of 104
    March 18, 2011 12:04 (EDT)
    Frank A. Snyder, MSc, MD

    Whufs...the cardiac endpoint studies are ongoing...if you believe in CIMT data, then pioglitazone has already beaen noted to delay same.  I DO NOT represent or speak for Takeda...it's just that 10 yrs of research on the drug has left me quite impressed.  Once again, the only caveats I see are weight gain and CHF...just choose your patients wilsely.  I'll try to go back through my 8 terabytes of hard drives and stick them on a disk for you...but I'm sure you'd enjoy the prospect of self-discovery as opposed to being spoon-fed information that just might ultimately lead to my conclusion.  God forbid that I should be biased.  But please...do your own research and read your own conclusions.  No...you're not the alligator...it just seemed that everyone around you was trying to take a bite out of your....umm...viewpoints...

    I was trying to let you know that I though you handled them well...

                                     Frank A. Snyder, MSc., MD

    # 100 of 104
    March 19, 2011 02:54 (EDT)
    Melissa

    Thanks Mike.

    The caveat to the success of the Bale/Doneen method to date goes to the issue of compliance.  Since less than 50% of patients who are included in "all comers" studies of compliance actually take their medications, I can project that the number of patients who would benefit from the Bale/Doneen program would be much better than what we perceive we get with standard care.  There has never been a magic pill or program that "fixes" the compliance issue.  I would like to see a randomized trial between highly selected patients  with usual care vs. the B/D method, then, a group of "all comer" patients divided into the B/D method vs. "usual" care.  That's when things would get really interesting.

    Melissa

    # 101 of 104
    May 15, 2011 02:15 (EDT)
    MCGDeveloper

    All the discussions have been illuminating, lively and educational! Thank you all! 

    # 102 of 104
    May 27, 2011 05:37 (EDT)
    whufs
    AIM High (for all you niacin proponents) is a sufficiently powered negative trial of the effects of long acting niacin on the reduction of MACE.  IMPROVE-IT will undoubtedly be a negative trial given it's size and the fact that it has not been concluded (the company has every reason financially to drag this out). Torcetab also a negative result with a potentially weak explanation for same.  Fenofibrate again of no benefit.  Tight control of AODM - again no benefit.  So without going to the course but digesting most of the elements from the responses above exactly what magic is being touted that has not already been tested and disproven?  Being a skeptic and requiring proof of concept should be a requirement for every practitioner of medicine however caustic and uncomfortable it may appear in print.  Promoting something as truth despite evidence to the contrary suggests a secondary motive which I think has been well delineated throughout this blog.  My basic question is whether biomarkers should be trusted as treatment surrogates in the prevention of cardiac endpoints - a question that carries enormous importance in terms of testing, serial testing and multiple drug treatment strategies apparently being offered in a concierge approach because third party payers do not participate.  I hope that we are all not so naive to continue to be surprised when something we assume to be true because it makes (even physiologic) sense turns out not to be true.  And any of us with even a modicum of statistical training understand the razor edge benefit of many therapies we promote which also means that not much manipulation would be required to change the conclusions reached by the study that defined the benefit.  So all of the posts above however condescending about the physiologic and "bench proven" benefits of various lipid reduction strategies can be tempered by the stark reality that all of these efforts can and should be tested in the population intended before being promoted as fact and certainly before being promoted as being superior to standard of care.
    # 103 of 104
    September 1, 2011 05:10 (EDT)
    Stroke Prevention

    Neurcumin™ is a unique nutritional supplement formulated by leading physician Nasser Razack, MD, former Director of Neurointervention at the University of Michigan. It contains both natural anti-oxidants and anti-inflammatory agents which protect the brain by reducing free radical damage and inflammation. These properties make Neurcumin™ an unprecedented and excellent neuroprotective agent. The ingredients contained in Neurcumin™ are not only all natural, but are more powerful than many over-the-counter or prescribed medications with little or no side effects
    # 104 of 104
    September 21, 2011 08:52 (EDT)
    BTBMD
    Nonsense advertising - there is no such thing as a "leading physician".  It is all about proven science but there are plenty of stupid people out there you can take advantage of - he is probably a leader" in doing that.

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    About Dr Melissa Walton-Shirley
    Dr Walton-Shirley performs invasive cardiology, nuclear cardiology, and stress echocardiography in a private practice in Glasgow, KY.

    Her chief medical interests are CHF/hypertrophic obstructive cardiomyopathy and the promotion of primary PCI for acute MI. Recently she played a significant role in helping to launch an ambitious pilot study of primary PCI in Kentucky, the Kentucky Primary Angioplasty Pilot Project. She has also participated in the TIMI 19, Duke-HF, NRMI, and CRUSADE trials and is proud to have been an advocate of the first smoke-free initiative in Kentucky (2011). She champions a smoke-free America.

    Dr Walton-Shirley received her undergraduate degree at the University of Kentucky and went to medical school and did her residency and fellowship at the University of Louisville. She is married with two daughters. Her interests include singing, writing poetry and songs, fitness, and, of course, theheart.org.