A SHAPE board member responds to critical editorial

In response to a CardioBrief editorial posted earlier this week that was highly critical of SHAPE, I received a letter from a lawyer who is  a member of SHAPE’s board of directors. Although I disagree with her views, her position is worthy of respect. With her permission I have posted her letter, followed by my own response.

Dear Mr. Husten:

Someone forwarded to me your latest blog about SHAPE and the upcoming Peggy Fleming event in Houston, and I just had to respond.   I understand that you have written some very fair things about SHAPE in the past, but your current posting is personally very distressing to me.

I have been a Member of SHAPE’s all-volunteer board for about three years.  I first got involved with SHAPE in 2005 after my husband of 25 years died of sudden cardiac arrest in April 2004.  He was 49 years old and a lifetime nonsmoker.  He had a happy sunny personality and a 34 inch waist that he maintained by carefully watching his diet and exercising.  He had a family history of heart disease and somewhat high cholesterol (total 250), which was being closely managed by his family doctor with high doses of Lipitor.  Most importantly for me, he was the love of my life and the devoted father to our two teenaged sons.

An autopsy after his death revealed that he had three blocked coronary arteries–one 90% blocked, one 80% blocked and one 40% blocked.  He had never experienced any chest pain or shortness of breath, and he had just received a clean bill of health from his doctor 10 days before he died.  After delving onto the medical literature, I learned about non-invasive coronary calcium screening, and I am convinced that, had such a screening test been prescribed for him (and he did ask his doctor for such a test in 2001 and was refused), he would still be alive today.

When I discovered the SHAPE Report and the SHAPE non-profit organization in the course of my research and read about the very eminent doctors who had loaned their expertise and good names to the endeavor of spreading the word about the importance of non-invasive screening for coronary calcium deposits, I volunteered to help in any way that I could.  Since 2005, I have held two modestly successful golf fundraisers for SHAPE in memory of my late husband.

Lest you think that I am some naive grieving person who has been “taken in,” please know that I am a very prominent attorney in Baltimore who knows how to do her research and who considers herself to be a pretty good judge of character.  Given my personal situation,  I was very disturbed to read your latest blog in which you describe the SHAPE Board, in so many words, as a group of self-serving shysters.

I have had the pleasure of working with all the distinguished doctors and other laypeople on the SHAPE Board for several years now, and I can tell you for a fact that not a single one has personally profited at the expense of SHAPE.  Not by one penny.  I would never allow myself to be associated with the group if that were the case.

Far from being self-interested, I have personally witnessed the doctors on the SHAPE Board  volunteering long hours to write papers, deliver lectures to other doctors, monitor on-going research studies, offer free blood pressure and cholesterol checks to the public, raise money, and do whatever else it takes to try to save the lives of tens of thousands of people who die every year from heart disease–many of whom, like my late husband, have no warning that they are a ticking time bomb.  Sure, we have a doctor on our Board who is in the screening business, but SHAPE is very clear that we do not advocate as a group for any one particular type of screening–we support and encourage any type of non-invasive coronary calcium screening for the “at risk” population of middle- aged man and women.

And I am sorry that you find our website “cheesy.”   I guess having a cheesy website is the fate of all non-profits that have a very limited budget and a volunteer, non-professional staff.  Unfortunately, we can’t afford to hire professional web designers who make five or six figure annual incomes.   Perhaps you know someone who will volunteer to upgrade our website for free?

I am also sorry that you dislike the fact that Kaneka, a vitamin supplement manufacturer,  is a small sponsor of the upcoming luncheon we are giving in honor of Peggy Fleming’s campaign against heart disease.  I have recently attended several American Heart Association fundraisers, and I see huge sponsorships of those events by Big Pharma, major hospitals with cardiology centers, and medical equipment sales outfits.   Do you also blog against these sponsored AHA events on grounds of conflict of interest?  In order for any non-profit to raise money, it must have at least some kind of sponsorship support from the business community–that’s a fact of life.

The bottom line is that I respect your right to engage in good investigative journalism and to protect the public from fraud, but I think you have crossed the line in your latest attack on SHAPE.   I felt personally assaulted by it, and I don’t deserve that kind of treatment after all that my family and I have suffered over the last five years and after all the good we have tried to do since our own personal tragedy to save the lives of others.

I invite you to meet with me or any of the other SHAPE Board members and to discover for yourself what dedicated, altruistic individuals we all are.  No exceptions.  All we want to do is to save lives.  Please take a closer, fairer look at us.   Please give us the benefit of the doubt until proven unworthy.

Thank you for giving me this opportunity to set the record straight, as I see it, from a perspective that is up close and very, very personal.

JoAnne Zawitoski

CardioBrief responds:

It is impossible not to be sympathetic to anyone in JoAnne’s position, and I empathize with her situation and history. I disagree, however, with the notion that an individual situation, no matter how tragic, necessarily provides a privileged perspective that somehow trumps all other concerns, or necessarily offers special insight. We don’t allow the victims of crimes to be judge and jury, and we can’t allow the innocent victims of a disease to decide public health policy, though of course we are all obligated to try to understand and consider their situation (this should not be an exercise in callous thought, though undoubtedly some will think it so).

In particular, in the context of SHAPE,  I don’t believe that an end or goal that almost everyone will agree upon– preventing heart attacks– justifies the means of taking any action necessary to achieve that goal. Just because preventing heart attacks is a worthy goal doesn’t mean that state legislatures should be making medical decisions, or that a self-selected group should be issuing guidelines outside the usual channels.

By allying itself with a snake oil company like Kaneka, and a medical practice like a “rejuvenation center” whose existence represents the complete contradiction of the altruism that an organization like SHAPE purports to represent, it seems to me that SHAPE hurts rather than helps its stated goal.

One word about CoQ10: in a followup letter to me, JoAnne noted, correctly, that there are a number of clinical trials that are investigating CoQ10, and there are many legitimate researchers and physicians who believe that it may have a real role to play in medical practice. But the point is that until the evidence is firm, and until the ratio of benefit and risk is known more precisely (and if there is real benefit then there is always real risk too), a substance like CoQ10 should not be used outside a clinical trial and should certainly not be promoted for its health benefits by dubious companies. CoQ10 may or may not be snake oil, but those who sell it to gullible and desperate consumers are snake oil salesmen.

In her followup letter to me, JoAnne also wrote that the SHAPE program is justified because it does “no harm” and would “save many lives each year.” This goes to the core of the issue. The fact is, every procedure and intervention is associated with costs and potential harmful effects. Even if one could imagine a diagnostic procedure that cost nothing and had no side effects like radiation, we would still be faced with the problem of false positives. Massive screening programs will inevitably lead to an explosion of interventions and procedures, and these will be costly, and some of them will certainly have a less than ideal outcome. Of course we all would have liked to have saved JoAnne’s husband, but the final cost must be determined not by raw emotion, but by carefully considered public health policy.

The day may come, and perhaps even soon, when widespread screening becomes acceptable policy. The American Heart Association and other legitimate organizations have made clear that they are hard at work evaluating and considering these type of issues. People who are genuinely interested in preventing heart attacks would do much better to offer their support to an organization like the AHA than to an organization like SHAPE.


  1. Marilyn Mann says

    A couple of thoughts:

    “An autopsy after his death revealed that he had three blocked coronary arteries–one 90% blocked, one 80% blocked and one 40% blocked. He had never experienced any chest pain or shortness of breath, and he had just received a clean bill of health from his doctor 10 days before he died. After delving onto the medical literature, I learned about non-invasive coronary calcium screening, and I am convinced that, had such a screening test been prescribed for him (and he did ask his doctor for such a test in 2001 and was refused), he would still be alive today.”

    The main purpose of calcium scanning is to identify people who are asymptomatic but at high risk so their risk factors can be treated. In her husband’s case, he was *already* being treated with “high doses of Lipitor,” according to Ms. Zawitoski. In addition, she states that he had a healthy lifestyle. Therefore, it is unclear to me why she thinks a calcium scan would have changed anything. If he was not already at the maximum dose of Lipitor then his doctor might have suggested increasing the dose, which would have lowered his risk slightly. I can’t help wondering if she thinks his life could have been saved through some invasive procedure such as stenting or bypass surgery. Correct me if I am wrong, Larry, but I don’t think there is evidence that that is the case. Most heart attacks occur throughout unstable plaque in nonoccluded arteries breaking off.

    I personally am not prepared to say that no one should undergo a coronary artery calcium scan. I think it is an option someone could choose after weighing the risks and benefits. But that is quite different from advocating mass screening as outlined in the SHAPE guidelines.

    As a lawyer, I am particularly disturbed by the following:

    “The bottom line is that I respect your right to engage in good investigative journalism and to protect the public from fraud, but I think you have crossed the line in your latest attack on SHAPE. I felt personally assaulted by it, and I don’t deserve that kind of treatment after all that my family and I have suffered over the last five years and after all the good we have tried to do since our own personal tragedy to save the lives of others.”

    She thinks by expressing your opinion you have “crossed the line”??!! Wake up and smell the coffee, lady! If you put yourself out there advocating controversial positions then you have to be prepared to take the heat. If she feels “personally assaulted” by that then she should not be doing what she is doing. All you did was disagree with her. The part about being a “very prominent attorney” in Baltimore made me laugh. Prominent attorney??!! Who cares!! That is pretty rich. I deal with “prominent attorneys” every day, and I am not at all impressed by them. Unbelievable arrogance! LOL.

    Marilyn Mann

  2. JoAnne Zawitoski says

    This is the last posting I will make on this website. I very much appreciate Mr. Husten’s publication of my response to his blog about SHAPE, which I allowed him to publish at HIS request. However, it is clear to me that far from generating any sympathy for my plight and some fairer understanding of what SHAPE is all about, I have only opened myself up to personal attack and derision, which is regrettable. Anyone who wants to know more about SHAPE and form their own objective opinions can visit our website or speak with any of our Board members, who include some of the most highly respected cardiologists and heart researchers in the country.

  3. Dear Marilyn and JoAnne,

    Can’t we all just get along? Perhaps we can leave out the personal aspects here and instead focus on some of the interesting issues raised in this discussion?

    In particular, I wonder if we could focus on Marilyn’s question about what a calcium scan would have achieved in her husband’s case? This is a fascinating question.

    JoAnne, what do you think a scan would have achieved in this case? Since he was asymptomatic and already on high doses of atorvastatin and had made the appropriate lifestyle changes, it’s hard to know what would have been possible in this case. A public policy that would support aggressive scans for people like this would inevitably result in a significant number of asymptomatic people undergoing interventional procedures.

    I would also be interested in hearing comments from cardiologists or other clinicians about this issue.

  4. James Ehrlich, MD says

    Dear Mr. Huston,

    As an expert in coronary plaque imaging, I am sorry to say that you share a very prevalent misconception about coronary calcium screening (you are in the company of lots of interventionally oriented cardiologists, much to the detriment of patients).

    Those of us who have published in the field recognize, that unlike stress tests, there are virtually NO false positive coronary scans. You are apparently defining coronary disease by significant obstruction (stenosis). Coronary calcium is virtually 100% sensitive and specific for ATHEROSCLEROSIS, the lesion of interest in PREVENTIVE CARDIOLOGY. In fact, the test is the most cost-effective first test in cardiology when the patient has atypical symptoms. We use the test to decide which individuals need more aggressive plaque stabilizing therapy and which majority of patients do NOT need intervention.

    So, those physicians who understand the procedure do LESS interventions and procedures as we now know that the majority of asymptomatics with mild to moderate disease have no significant stenosis and do not need expensive nuclear procedures or caths. And those people who have enough plaque to warrant further testing (provocative stress tests) at least are worth investigating further—as we already know they have lots of plaque.

    So, you are using a generality about screening tests without understanding the specifics in the case of atherosclerosis imaging detection—highly sensitive and specific for PLAQUE !!

    The fundamental issue that SHAPE is addressing is the FAILURE of conventional office based assessment to determine who is at high risk. The overwhelming majority of women <70 and men <60 will be considered at LOW (not even intermediate) Framingham risk the week prior to their devastating MI…and they would generally pass all the tests that are covered by insurance (stress, etc).

    If you want to understand this field fully, it would be worth your while to attend a SHAPE conference where world class preventive cardiologists present the data and a very compelling case for screening–given the current problem of unheralded MIs being rampant. Most people who get MIs can be identified by these techniques YEARS in advance—in time for effective plaque stabilizing therapy and aggressive risk factor modification

  5. Dr. Ehrlich,

    Without getting into the details of your response right now, I’d really like to know how the SHAPE guidelines would have changed the particular case we are discussing, that is, an asymptomatic middle aged male with hypercholestolemia already receiving high dose atorvastatin and receptive to lifestyle interventions.



  6. James Ehrlich, MD says

    Dear Larry,

    You bring up an interesting issue that is now being addressed at SHAPE and at every national lipid association conference—the concept of “residual risk”. The initial SHAPE conferences would not have contributed much to the care of a person with hypercholesterolemia who was being treated because the group focused on the large # of patients with few risk factors who would incorrectly be characterized as low risk and remain untreated.

    However,from an analysis of multiple lipid intervention trials (using statin monotherapy) where LDL was driven to <70, it is now clear that we are only taking care of 1/4-1/3 of the actual risk of a patient by getting LDL to a goal of 15% per year, he would be identified as being at 17 times the risk compared to those whose scans did not show rampant progression. In 2008, consensus documents have recommended that we should target apoB, non-HDL and LDL…not just LDL. So, this is an example of the kinds of discussions occurring at SHAPE in the past 2 years.

    So, the lessons learned from this individual’s death (and for Tim Russert and 1000s of others) is that we need to be far more sophisticated in management (e.g. quantify residual risk) and we cannot practice the way >90% of cardiologists practice—assume a patient is “under control” when a calculated LDL is <100 or <70.

    So, we use imaging to find patients with “non-obstructive atherosclerosis” (which kills most of us and cannot be found by other tests) and it alllows us to set proper goals. We then use advanced lipids and other biomarkers to characterize the risk and determine combinations of therapy (fibrates, niaspan, statins, fish oil). Finally we use serial imaging, endothelial function tests and other ways discussed by SHAPE to MONITOR success of therapy and track progression of subclinical disease.

    Sadly, the AHA and its journal Circulation has been obstructionist and immoral in their stance on the early detection of our nation’s main killer as well described in an American Journal of Cardiology editorial (Hecht et al) called the “Deadly Double Standard” The expert consensus document on EBCT should have been published years ago…but outrageously, Joseph Loscalzo of Circulation used a flimsy excuse to block publication of those guidelines. So, i don’t think the AHA should be trusted when it comes to encouraging advances in atherosclerosis imaging methods.

    Finally, recall that there is a good reason we don’t see promotion of stress tests, angiograms and other highly reimbursable tests with lots of false positives—they are already covered by insurance and are highly profitable. Coronary calcium identifies the large population of patients who do not need those procedures—and that is a strong reason most cardiologists don’t WANT to understand its value.

  7. James Ehrlich, MD says

    Somehow, my last comment did not reproduce faithfully in one area…so let me clarify.

    When patients (especially those with cardiometabolic risk) have LDL driven to 15% progression of the calcium score is associated with very high risk regardless of the LDL level (and cannot be predicted by treating someone with statins to “goal”). Therefore, we need the sophisticated methods advocated by SHAPE in its recent conferences (serial scans, endothelial function, new biomarkers like Apo B, etc) to determine whether this patient (or someone like Russert) has been adequately taken care of by statin monotherapy.

    Preliminary studies have shown that combination therapy (when indicated) can achieve a 70-90% event reduction. So, the AHA and NCEP guidelines are far behind in advocating tests to detect true risk and exploring this issue of residual risk. At least the ACC and ADA have issued consensus documents suggesting the story is far more than statin therapy.

  8. James Ehrlich, MD says

    very weird. your website continues not to faithfully reproduce what i am saying. It keeps on combining 2 sentences and creating a nonsensical statement ( “When patients (especially those with cardiometabolic risk) have LDL driven to 15% progression of the calcium score is…”. i am trying to say that LDL driven to <70….and then separately mentioned that serial EBT scans with progression over 15% defines lack of control.

    Sorry i have to keep posting until your website reproduces what i am saying….very weird.

  9. Sheesh, Marilyn, as a person who (according to serial comments on other blogs) has family members who suffer from heterozygous familial hypercholesterolemia, it would seem like you would have just the smallest bit of compassion. While you note that you are an attorney, it is interesting that you no longer proudly state that you area an attorney in the Division of Investment Management at the Securities and Exchange Commission. Perhaps if you didn’t spend so much time trying to be the first to comment on various healthcare related blogs and finding new and interesting ways to attack widows, you and your peers would have been able to follow up on the hundreds of people who tipped you that Bernie Madoff was a crook.

  10. Marilyn Mann says

    John Do,

    I do have compassion for Ms. Zawitoski. I’m sorry if I seemed like I didn’t. After all, members of my husband’s family have died of heart disease or are at risk of heart disease. My mother-in-law had a heart attack just a few weeks ago. My husband’s uncle died of a heart attack at 40 and his grandfather died of a heart attack at 35. However, no one is arguing that heart disease, including fatal heart disease, is not a bad thing. The question is, what do we do about it? Ms. Zawitoski is entitled to her opinion. However, she seems to be saying that Larry is NOT entitled to his. How else to interpret her statement that his editorial “crossed the line”?

    I am puzzled as to why you think I am hiding the fact that I am an attorney in the Division of Investment Management at the SEC. This information is freely available on the internet and on Gooznews.com at the following link:


    I do think that having gone to law school and/or having family members with heart disease does not, in and of itself, give you any special expertise with respect to health policy issues, including issues related to heart disease. Nor does it mean that your opinions should not be criticized. I also think that Larry should be free to express his opinion on his blog in any way he feels is appropriate. His editorial was not a personal attack against anyone, including Ms. Zawitoski. I am sorry that she interpreted it that way.


  11. Shelton Thomas, MD says

    I suspect the calcium score of the decease man that is discussed would have place him in the upper quartile for his age. Per the SHAPE reccomendations, this would have lead to a functional test ie a stress test that would have identified flow limiting blockage that could have been treated effectively. Like any screening test, the data generated has to be used appropriately.


  1. […] In March of this year, when the bill was introduced, SHAPE initially claimed that the bill had been endorsed by the AHA, but this claim was denied by the AHA after CardioBrief asked them to comment. (You can read our editorial about this episode and the ensuing controversy.) […]

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