Heart health consultation with Dr. Joe D. Goldstrich

I'd like to start an occasional series of blog posts on The Heart Scan Blog in which I review studies relevant to the whole heart scan score reversal experience.

In a previous post, Don't be satisfied with "deceleration,"I discussed the BELLES Trial (Beyond Endorsed Lipid Lowering with EBT Scanning (BELLES)), in which either atorvastatin (Lipitor), 80 mg, or pravastatin (Pravachol),40 mg, was given to 615 women. Both groups showed an average of 15% annual plaque growth, regardless of which agent was taken and regardless of the amount of LDL cholesterol reduction.

I cited another study in which 471 participants received either Lipitor, 80 mg, or Lipitor, 10 mg. The rate of annual score increase was 25-27%, regardless of drug dose or LDL lowering.

Here's yet another study, a small German experience in 66 patients, with a curious design and using the now-defunct statin drug, cerivastatin (Bayccol, pulled in 2001, nearly simultaneous with the publication of this study, due to greater risk of muscle damage, particularly when used in combination with gemfibrozil). Achenbach et al in Influence of lipid-lowering therapy on the progression of coronary artery calcification: A prospective evaluation reported on this trial in which all participants underwent heart scanning to obtain a heart scan score; no treatment was initiated based on the score. A second scan was obtained after the no treatment period, followed by treatment with cerivastatin, 0.3 mg per day. A third scan was finally obtained.

In year one without treatment, the average increase in heart scan scores was 25%. In year two with cerivastatin, the average increase in heart scan score was 8.8%. In 32 participants who achieved LDL<100 mg/dl on the drug, there was an average modest reduction in heart scan scores of 3.7% (i.e., -3.7%).

Now, that was eye-opening. Why did this small study achieve such startlingly different results from the other two studies that showed relentless progression despite even high doses of Lipitor? That remains unanswered. Was cerivastatin unique among statins? Did the unique two-phase trial design somehow change the outcome by triggering participants to change lifestyle habits after their first scan (since most exhibited an increase in score; they were not "blinded" to their scores). Those questions will remain unanswered, since the drug has been made unavailable. This smal l study had actually been intended to be larger, but was prematurely terminated because of cerivastatin's withdrawal.

This experience is unique, as you can see, compared to the two other studies. But it was also smaller. The results are also different than what I have seen in day-to-day practice when I've seen people treated with statin drugs alone (not cerivastatin, of course): rarely do heart scan scores stop increasing. While slowing does usually occur (18-24% per year rates of annual score increase are very common in people who do nothing but take a statin drug and make modest lifestyle changes), I have personally seen only two people stop their score with this strategy alone. Nobody has ever dropped their score taking a statin alone, in my experience.

You can also see the nature of clinical studies: single or limited interventions instituted in order to control for unexpected or complex effects. If three different treatments are used, then what desirable or undesirable effects, or lack of an effect, is due to which treatment agent?

My experience is that no single treatment stops or reduces heart scan scores. It requires a more rational effort that includes 1) identification of all causes of coronary plaque (e.g., low HDL, high triglycerides, Lp(a), small LDL, deficiency of vitamin D, etc, none of which are substantially affected by statin drugs), and 2) correction of all causes. That simple concept has served us well.

Does chelation work?

It's a question I get asked fairly frequently. Although I have never performed chelation, IV or oral, and therefore have no direct experience, my concerns for this purported therapy have included:

1) The concept of extracting calcium from atherosclerotic plaque by removing it first from the blood is absurd. Early chelationists believed that this was the means by which EDTA might reverse coronary atherosclerosis. However, removing calcium from blood would more likely lead to osteoporosis or calcium extraction from bone, since bone is a more ready repository for calcium. Blood calcium levels are also tightly and narrowly controlled; any significant reduction in calcium ("hypocalcemia") can be life-threatening. And, indeed, there have been deaths from hypocalcemia in people receiving chelation.

More recently, chelationists have argued that removal of heavy metals like lead and mercury are responsible for the purported benefits of chelation. And, indeed, blood levels of these heavy metals can be reduced by chelation. That alone may be a benefit. But to then make the leap to say that it also regresses atherosclerotic plaque by the same mechanism has no basis in science.

2) Practitioners associated with chelation tend to be shady. I have seen homeopathic therapies (among THE most ridiculous of concepts), "energy balance" therapies, desiccated organ extracts ("applied kinesiology"), and a variety of other fringe treatments offered by practitioners offering chelation. This doesn't necessarily mean, of course, that chelation is also fringe or suspect, but it tends to be offered by practitioners who engage in generally unscientific, unfounded practices.

The few people I've seen go through multiple courses of chelation (usually 30 or so infusions) have shown no impact on heart scan scores or any other measure of heart disease.

In response to the many questions I receive on chelation, I had been answering that, if we would simply wait for the publication of the NIH-sponsored trial of IV chelation therapy, perhaps we'd know once and for all.

However, in a lengthy criticism, four expert authors argue that the TACT trial to assess chelation study is doomed to failure for an entire list of reasons and should therefore be abandoned. The discussion is available on Medscape Cardiology. (Free sign-in required.)

Why the NIH Trial to Assess Chelation Therapy (TACT) Should Be Abandoned
We investigated the social and the scientific histories of chelation therapy beginning in the 1950s. We examined TACT protocols and consent forms, which, in response to Freedom of Information Act (FOIA) requests, the NIH provided to us with curious redactions. We examined the existing RCTs and the numerous case series cited by the TACT protocols. We examined evidence for risks, including information that is not in the standard medical literature. We examined various hypotheses that advocates have offered to explain how chelation "works."

We present our findings in 4 parts. First, we provide a brief history of the use of disodium EDTA as a treatment for CAD. Next, we describe the origin and nature of the TACT. Next, we discuss the evidence for chelation as a treatment for CAD and for atherosclerosis in general, and place it in the context of other proposed treatments that have been ineffective after an initial period of enthusiasm. Finally, we discuss the risks. For each topic, we contrast our findings with relevant statements in the TACT literature, to the extent that such statements exist.

Among the highlights:

--Since the mid-1970s, court documents and newspapers have reported at least 30 deaths associated with IV disodium EDTA, most of it administered by ACAM members.

--Early chelation investigators had chosen the disodium salt of EDTA, reasoning that if it could remove calcium from atherosclerotic plaques, it might shrink them. That notion was soon demonstrated to be invalid. It has largely been replaced by a "toxic heavy metals" antioxidant hypothesis, which is based on the potential for metal ions to produce free radical damage. Chelationists now cite "removing heavy metals" as the basis for their claim that chelation is effective for approximately 70 conditions, ranging from schizophrenia and autism to cancer. This provides them with numerous reasons to ignore any trial that finds chelation ineffective for CAD.

--Biochemical literature, either not cited or misrepresented in the TACT protocols, has demonstrated that the heavy metals hypothesis is implausible. Antithetically, it also demonstrates that the chelation mixture used in the TACT has pro-oxidant effects in vitro.

--In our opinion, TACT literature -- including 2 versions of the protocol, the consent form, information posted on the NCCAM Web site, and 2 editorials co-authored by the PI -- has misrepresented chelation, its risks, and the facts of the study. It has exaggerated the value of supportive case series, not only by ignoring evidence of bias and incompetence, but by misrepresenting citations and reporting erroneous data. It has minimized the dangers, both by understatements and by omissions of specific, published complications. It has not acknowledged the deaths mentioned above. It has repeatedly conflated disodium EDTA and a different drug, calcium-sodium EDTA.

--The TACT includes nearly 100 "chelation site" co-investigators who, in our opinion, are unsuitable to care for human subjects or to report trial data. Most espouse implausible health claims while denigrating proven methods; several have been disciplined, for substandard practices, by state medical boards; several have been involved in insurance fraud; at least 3 are convicted felons. Several were members of the ACAM or GLACM IRBs mentioned above. Few appear to have real expertise, required by TACT literature, in treating patients with CAD or in conducting clinical trials. Most continue to promote chelation while the TACT is in progress, contrary to good science, to human studies ethics, and to US Federal Code.

While the criticism itself does not prove the point one way or another, as a clinical trial should, anyone contemplating chelation therapy would be well-advised to read the document first. Another reference: EDTA chelation therapy for cardiovascular disease: a systematic review.

The authors of the exhaustive discussion are:
Kimball C. Atwood IV, MD, Anesthesiologist, Newton-Wellesley Hospital, Newton, Massachusetts; Assistant Clinical Professor, Tufts University School of Medicine, Boston, Massachusetts; Associate Editor, Scientific Review of Alternative Medicine
Author's email: katwood@partners.org

Elizabeth Woeckner, AB, MA, President, CIRCARE (Citizens for Responsible Care and Research), Columbia, Maryland

Robert S. Baratz, MD, DDS, PhD, Medical Director, South Shore Health Center, Inc., Braintree, Massachusetts; Assistant Clinical Professor of Medicine, Boston University School of Medicine, Boston, Massachusetts; President, National Council Against Health Fraud, Inc.

Wallace I. Sampson, MD, Clinical Professor of Medicine (Emeritus), Stanford University, Stanford, California; Senior Attending Physician and formerly Chief of Medical Oncology, Santa Clara Valley Medical Center, San Jose, California; Editor-in-Chief, Scientific Review of Alternative Medicine

The authors provided the following disclosures:

Disclosure: Kimball C. Atwood IV, MD, has disclosed no relevant financial relationships in addition to his employment.

Disclosure: Elizabeth Woeckner, AB, MA, has disclosed that she has received compensation for consulting in civil litigation and professional disciplinary actions.

Disclosure: Robert S. Baratz, MD, DDS, PhD, has disclosed that he has been retained by state licensing boards, the Office of the US Attorney, and plaintiff counsel as an expert in disciplinary proceedings and litigation with regard to chelation therapy and associated matters. He is compensated only for his time and has no commercial interest in the outcome of the proceedings or litigation.

Disclosure: Wallace I. Sampson, MD, has disclosed no relevant financial relationships in addition to his employment.

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8/22/2010 10:10:15 AM |

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Jim Purdy
5/22/2010 3:30:00 PM |

QUOTE:
"... gram for gram, wheat increases blood sugar to a much greater degree than, say, chickpeas. "

Well, that ain't good.

David
5/22/2010 4:21:52 PM |

I've really enjoyed these last couple of posts about wheat. Very informative and accessible. Thanks for taking the time to make this kind of info available to the wider audience.

David

Anonymous
5/22/2010 5:12:17 PM |

fascinating

pjnoir
5/22/2010 8:48:14 PM |

WOW- a classic lose-lose. 25% remains in your colon, to become a bacteria feast and the rest (75%) increases blood sugar and insulin production to store it as a fat cell. hmmmmm, thank goodness for science, we may save ourselves.

Anonymous
5/22/2010 10:15:53 PM |

Dr. Davis,

While not on a directly related note, do you have any general feelings on moderate consumption of buckwheat as a carbohydrate source? From what I have read, this "pseudo" grain seems to be far less problematic than true grains. It would still not give most folks a license to consume it ad libitum, but I am curious if you'd consider this a decent choice in controlled amounts (with the actual amount varying by context and the overall health of the person in question).

-Dave Balon

Mike
5/22/2010 10:37:12 PM |

Excellent explaination, Dr Davis.

Anonymous
5/23/2010 1:55:46 AM |

I'm really enjoying your posts about wheat. Very interesting. Thanks

Paul
5/23/2010 1:59:40 AM |

Yet another study was just recently published showing a link between a high-carb diet and cancer:

Available Carbohydrates, Glycemic Load, and Pancreatic Cancer: Is There a Link?

I found this particularly interesting:

"The positive association for available carbohydrate intake was observed during the first 4 years of follow-up (HR(<2 years) = 2.60, 95% CI: 1.34, 5.06; HR(2-<4 years) = 1.94, 95% CI: 1.06, 3.55) but not subsequently (HR = 0.86, 95% CI: 0.52, 1.44); the opposite pattern was observed for total fat and saturated fat intake.

Another study:

Glycemic load, glycemic index, and pancreatic cancer risk in the Netherlands Cohort Study

Another study:

Dietary glycemic load and risk of colorectal cancer in the Women's Health Study

And another study:

Soft Drink and Juice Consumption and Risk of Pancreatic Cancer: The Singapore Chinese Health Study

Apolloswabbie
5/23/2010 3:27:45 PM |

Thank you Dr. D

Jill
5/24/2010 3:04:47 PM |

Dear Heart Scan Blog,

I am a student at the University of Rochester working on an internship project in conjunction with RateADrug.com to collect primary user data about side effects and benefits from commonly used treatments for Atherosclerosis & Arterial Disease. The goal is to build a large, public access database of unbiased, anecdotal data about Atherosclerosis & Arterial Disease treatments.

We want to let both patients and practitioners know about how they can participate in or benefit from the project. Users can add their experiences with a treatment and learn more about how the treatment is affecting them by taking a short, confidential survey. They can also use RateADrug to compare aggregate data for different Atherosclerosis & Arterial Disease treatments- both conventional and alternative (http://www.rateadrug.com/Atherosclerosis-and-Arterial-Disease-symptoms-feedback.aspx) - and forward the results of their own surveys to their doctors or family members.

Rateadrug is an independent data gathering and information website that does not accept funding or advertisement from drug companies.

Would it be possible for you to make this information available to your viewers so they can help us collect important data on Atherosclerosis & Arterial Disease treatments?

Thank you in advance. I'd be happy to speak with you if you have any questions or comments.

University of Rochester
www.RateADrug.com student intern
jillian@radpprep2.com

Dr. William Davis
5/24/2010 10:28:41 PM |

Hi, Paul--

Yes, indeed. The data relating high-carbohydrate intake with multiple forms of cancer is getting very scary.

Anonymous
5/25/2010 4:18:17 AM |

Wow, I am a long time fan of heartscanblog, but Paul's citation is the most misleading EVER. The authors found that carbs were associated with pancreatic cancer only in the FIRST FOUR years of follow-up, whereas fat and saturated fat were associated with pancreatic cancer during follow-up GREATER than four years. Since pancreatic cancer takes years to develop, the authors conclude that carbohydrates are NOT CAUSAL to pancreatic cancer - fat may be.

DrStrange
5/25/2010 2:43:32 PM |

"The data relating high-carbohydrate intake with multiple forms of cancer is getting very scary."

I would think at least in part from the higher blood sugars. Much less problematic w/ whole, intact grains (boiled vs ground into flour and refined (and then higher temp. baked or fried)!

discombobulated
5/25/2010 7:50:36 PM |

I love your blog. We have switched out diets to something much closer to what you recommend due to the fact that my husband's psoriasis gets so much better if he avoids wheat,potatoes, corn, refined sugars, and dairy. We figure it's better than using steroids for the problem. We also have one son who has been biopsied for celiac after is blood work and we were told he doesn't have the correct atrophy but does have a damaged intestine.

So we are committed to eating this way. But one thing I have wondered about is if you feel that carb blockers work for blocking starch. There are times when I would kill for a baked potato but try not to because it starts a negative cycle. And now I know that it's not so hot for my heart either.

This post made me wonder if there isn't some merit in them.

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5/26/2010 6:20:52 PM |

Thanks for discussing this.I thought whet is sort of better than the white bread for the diabetic and the heart patients.

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Mary Wier
7/10/2012 8:38:03 AM |

Bill and I found our Wheatbelly book and have been off gluten for 9 months, it was hard at first but we now
feel so different, Bill's blood sugar dropped 25 points, and we look at all our food so differently now!
The display of wheat rolls and pastry at our buffet looks more and more like hidden poison.
We are off sugar, too it is so tempting but our body says, Thank you Dr. Davis!

G
11/27/2007 3:21:00 AM |

Baychol ('gorilla'-statin when it came out) had a halogenated side group, which means biologically, this gave it 'super' powers.  Other drugs with halogens are also stronger as well (ie topical steroid Clobetasol). Unfortunately, Baychol also had 'super' strong side effects as well! including death from rhabodmyolysis (breakdown of muscle fibers which then leads to 'clogging up' the kidneys when the myoglobins are released into the blood stream, leading to multiple organ failure). Car accident, trauma and marathon runners can get the condition as well.
I like your scientific method of accurately assessing various dysfunctions of the lipoprotein patterns and correcting with modifications in various strategies (D3, B3, monounsaturated nut oils, etc). Tying this in with tracking the size of shrinking calcium deposits in plaque make a lot of sense (and of course backed up with data, like the one you just posted!)...

BTW, with erectile dysfunction associated with atherosclerosis, do you also see symptom reversal with the TYP plan? at what level of CAC reversal?  Do you see less use of Viagra later?
Do you have a cure for white hair too (* ha ha haaaa *)? Global warming?  Amazon de-forestation? You're so humble!
THANK YOU! G

Dr. Davis
11/27/2007 12:12:00 PM |

Hi, G--

As always, thanks for the insights.

Because 99% of the people who participate in the program begin with asymptomatic coronary plaque, it's not possible to say if symptoms are relieved. The occasional person who chooses this program but has anginal chest pain has indeed experienced complete elimination of symptoms.

Re: erectile dysfunction. Also, no systematic tracking, so I don't know. Also, I have to admit not purposefully looking for it in men well into the program. But a great thought! It would indeed make sense that restoration of endothelial function and erectile capacity would accompany plaque control and/regression.

Anonymous
11/27/2007 6:00:00 PM |

Geez Doc, I wish you would have put the last paragraph first on your Blog. I was just about to throw up my hands in despair and call in for a double cheese all meat pizza on wheat, thinking all was lost. I was greatly releived to see I might still make it a while with low dose(10mg)lipitor, 1500 Niacin, Aspirin, and 2000IU D3. With exercise & diet I have worked hard to get LDL,Trigs,LP(a) all in the 30,s. With HDL at 68 I now see hope...don't do that again please! Over&Out

Dr. Davis
11/27/2007 10:39:00 PM |

Well, my motivation for posting these occasional summaries of prior clinical studies is to provide, bit by bit, some of the rationale behind the Track Your Plaque program and to show why the simple-minded "take your statin and shut up" approach simply doesn't work.

G
11/28/2007 11:19:00 PM |

Theoretically, ED and peripheral vascular disease should regress ('cured' perhaps?) if sufficient plaque reversal occurred and original blood flow were restored... wouldn't you think?  ED is frequently common in T2DM and pre-CAD (I made that up) individuals.

I customarily ask about ED because I use it as a motivating 'factor' in my strategy to get individuals to comply with changes to improve T2DM (yes, I just gave all my secrets now!).  You'd be surprised how effective this strategy is (of course only men -- I use a diff one for females)! Often people will not make necessary changes for 'health' reasons as you know.  The justifications are typically everything-but!

You know, I can tell that you're not in the business of selling books, eh?  You're strength is as an innovator imparting knowledge/power...saving lives... preventing unnecessary tragedies...  (THANK YOU FOR ALL YOU DO!)  if you notice improvement in ED, I'd suggest you change your book title to... you know to reach greater target audiences! (well, you'll get the men then you'll have to trust they'll share with their partners)
'TYP -- Reverses ED and Heart Disease'
'Don't Live with ED or Coronary Heart Disease'
'Erectile Dysfunction can be erased, just like your CAD'
'Better in bed, greater longevity'

*ha haa haaa* i'm j/k... who is your marketing person?!! not very sexy or splashy... (pardon, if it is you!)

bobb
11/30/2007 6:05:00 AM |

Dr Davis,

Two years ago my calcium score was 145.  I am 58 and my score is 294!
I am very fit, work out 4 times a week with weights and cardio and have for years.  I take 80 mg of vitorin, fish oil, folic acid, nacin, and 2 baby asprin a day. My cholesterol is 142, Hdl 79, LDL 54 and triglycerides 47!  I am 5 9 and 165 lb.

Given this I can not seem to stop the increases in calcium.  What else can I do.

Bill Blanchet is my Doctor!

Thanks!!

Dr. Davis
11/30/2007 12:38:00 PM |

Bobb--

Clearly you can get no more benefit out of squeezing more out of cholesterol values. I would propose that you and Dr. Blanchet (a refreshingly open-minded physician who I'm going to invite to become a panel member on Track Your Plaque) consider several issues:

1) Have all causes beyond cholesterol (HDL, LDL, etc.) been identified?

2) Have you addressed vitamin D? Vitamin D is a huge effect.

I would invite you to look at our website, www.trackyourplaque.com, for much more information. There is no 10 cent answer to your question. A comprehensive approach that corrects all causes is usually necessary.

Neelesh
12/8/2007 4:30:00 AM |

I accidentally bumped in to this study about the connection between vitamin D3 and ApoA-I, observing that ApoA-I levels are reduced by Vitamin D3.

http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=pubmed&dopt=AbstractPlus&list_uids=16236546

As far as I know, ApoA-I is a good lipoprotein.

I tried to find some more material on this topic, but to no avail.

Is this something that you have seen, Dr Davis?

Thanks!
-Neelesh
http://www.recoverytrail.com/blog/

Dr. Davis
12/8/2007 2:00:00 PM |

Hi, Neeleesh--

I don't know what to make of this study. It is clearly counter to what I am seeing in real live humans.

I see the total HDL and the large HDL subclass (richer in ApoA1) increase, often substantially. So I see the exact opposite.

My observations on this phenomena are informal. Formalizing this observation is part of a future research project.

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11/2/2010 8:22:46 PM |

Those questions will remain unanswered, since the drug has been made unavailable. This smal l study had actually been intended to be larger, but was prematurely terminated because of cerivastatin's withdrawal.

Rita.
5/19/2008 10:17:00 AM |

Vitamins A and K2 help the body put calcium where it belongs--in bones and teeth. Vit D helps in absorbtion but the other fat solubles assist in proper incorporation away from arteries and soft tissues.

Jeffrey Dach MD
5/19/2008 10:38:00 AM |

For a more balanced view of EDTA chelation for heart disease, see the Toledo Cardiologist, James C. Roberts MD FACC

Roberts is a practicing invasive cardiologist. He lectures extensively on his clinical success with Phosphatidylcholine(IV or in Liposomal Oral Format with EDTA): Reverse Cholesterol Transport and Metal Detoxification. A DVD of his lectures is available which describes considerable clinical success with oral EDTA.

Regarding the reference: "EDTA chelation therapy for cardiovascular disease: a systematic review". The authors of this hatchet job make their living by denouncing chelation therapy indicating political economic motivations. The alternate information presenting studies showing benefit was not presented. We find the same type of denouncement in the medical literature for all types of natural therapies including the recent meta-analysis showing that vitamins increase mortality:

Mortality in Randomized Trials of Antioxidant Supplements,Goran Bjelakovic, MD, JAMA 2007;297:842-857.

For more on this see:

My Vitamins Are Killing Me!

Jeffrey Dach MD

Anonymous
5/21/2008 9:56:00 PM |

Rita, how much K2 would you recommend someone take and as I believe there are a number of different subsets of K2 which one or brand would you recommend?

jpatti
6/4/2008 4:32:00 PM |

I think chelation is silly, but on the other hand, I'd rather be a subject in this study than in the one where they wanna do prophylactic bypasses on diabetics.

As for the K2 question, I recommend Twinlab D3/K2 dots. I don't believe anyone knows how much K2 is ideal yet, so I just dose them to my D3 serum levels and take the K2 that comes along with them.

kenneth
2/25/2011 5:14:57 PM |

chelationists=devils workers

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