True to form, Dr. John Cannell has published yet another wonderfully insightful Vitamin D Newsletter.
One item caught my eye, a response to a question about the Marshall Protocol. I, like Dr. Cannell, was inundated with questions about this so-called protocol, which amounts to little more than the unfounded speculations of a non-physician, actually someone not even involved in health care.
In all honesty, I blew the whole issue off after I read Dr. Marshall's rants. They smack of pure quackery, though from somebody who clearly has a command of scientific lingo. To Dr. Cannell's credit, he took the time and effort to construct a rational response in the latest issue of the newsletter. I reproduce his response here:
Dear Dr. Cannell:
I understand Dr. Marshall conducted a study and found vitamin D is bad for you. What kind of study did he do?
Mary, Minneapolis, Minnesota
Dear Mary:
I have been inundated with letters asking about Professor Marshall's recent "discovery." Some have written that to say they have stopped their vitamin D and are going to avoid the sun in order to begin the "Marshall protocol." The immediate cause of this angst is two publications, a press article in Science Daily about Professor Marshall's "study" (which is no study but simply an opinion) in BioEssays. Dr. Trevor Marshall has two degrees, both in electrical engineering. Before I begin, I want to again remind you that I am a psychiatrist who works at a state mental hospital. In my duty to full disclosure, I must say that I have known a lot of psychiatrists in my life and a few electrical engineers. If I knew nothing else of a disagreement between two people but their professions, I would believe the electrical engineer, not the psychiatrist.
In reading his two articles, Dr. Marshall's main hypotheses are simple. (1) Vitamin D from sunlight is different than vitamin D from supplements. (2) Vitamin D is immunosuppressive and the low blood levels of vitamin D found in many chronic diseases are the result of the disease and not the cause. (3) Taking vitamin D will harm you, that is, vitamin D will make many diseases worse, not better. If you read his blog, you discover that the essence of the Marshall protocol is: "An angiotensin II receptor blocker medication, Benicar, is taken, and sunlight, bright lights and foods and supplements with vitamin D are diligently avoided. This enables the body's immune system, with the help of small doses of antibiotics, to destroy the intracellular bacteria. It can take approximately one to three years to destroy all the bacteria." That is, Dr. Marshall has his "patients" become very vitamin D deficient.
Again, Dr. Marshall conducted no experiment and published no study. He wrote an essay. He presented no evidence for his first hypothesis (sunlight's vitamin D is different than supplements). From all that we know, cholecalciferol is cholecalciferol, regardless if it is made in the skin or put in the mouth. His second hypothesis is certainly possible and that is why all scientists who do association studies warn readers that they don't know what is causing what. Certainly, when low levels of vitamin D are found in certain disease states, it is possible that the low levels are the result, and not the cause, of the disease. Take patients with severe dementia bedridden in a nursing home. At least some of their low 25(OH)D levels are likely the result of confinement and lack of outdoor activity. However, did dementia cause the low vitamin D levels or did low 25 (OH)D contribute to the dementia? One way to look at that question is to look at early dementia, before the patient is placed in a nursing home. On the first day an older patient walks into a neurology clinic, before being confined to a nursing home, what is the relationship between vitamin D levels and dementia? The answer is clear, the lower your 25(OH)D levels the worse your cognition.
Wilkins CH, Sheline YI, Roe CM, Birge SJ, Morris JC. Vitamin D deficiency is associated with low mood and worse cognitive performance in older adults. Am J Geriatr Psychiatry. 2006 Dec;14(12):1032-40.
Przybelski RJ, Binkley NC. Is vitamin D important for preserving cognition? A positive correlation of serum 25-hydroxyvitamin D concentration with cognitive function. Arch Biochem Biophys. 2007 Apr 15;460(2):202-5. Epub 2007 Jan 8.
These studies suggest that the low 25(OH)D levels are contributing to the dementia but do not prove it. Only a randomized controlled trial will definitively answer the question, a trial that has not been done. So you will have to decide if vitamin D is good for your brain or not. Dr. Marshall seems to be saying demented patients should lower their 25(OH)D levels. Keep in mind, an entire chapter in Feldman's textbook is devoted to the ill effects low vitamin D levels have on brain function.
Brachet P, et al. Vitamin D, a neuroactive hormone: from brain development to pathological disorders. In Feldman D., Pike JW, Glorieux FH, eds. Vitamin D. San Diego : Elsevier, 2005.
It is true that in some diseases, high doses of vitamin D may be harmful. For example, in the early part of last century, the AMA specifically excluded pulmonary TB from the list of TB infections that ultraviolet light helps. They did so because many of the early pioneers of solariums reported that acutely high doses of sunlight caused some patients with severe pulmonary TB to bleed to death. Thus, these pioneers developed very conservative sun exposure regimes for pulmonary TB patients in which small areas of the skin were progressively exposed to longer and longer periods of sunlight. Using this method, sunlight helped pulmonary TB, often to the point of a cure. Furthermore, it is well known that sunlight can cause high blood calcium in patients with sarcoidosis. In fact, sarcoidosis is one of several granulomatous diseases with vitamin D hypersensitivity where the body loses its ability to regulate activated vitamin D production, causing hypercalcemia.
Cronin CC, et al. Precipitation of hypercalcaemia in sarcoidosis by foreign sun holidays: report of four cases. Postgrad Med J. 1990 Apr;66(774):307-9.
Furthermore, although medical science is not yet convinced, some common autoimmune diseases may have an infectious etiology. I recently spoke at length with a rheumatologist who suffers from swollen and painful joints whenever he sunbathes or takes high doses of vitamin D. As long as he limits his vitamin D input his joints are better. To the extent vitamin D upregulates naturally occurring antibiotics of innate immunity, sunlight or vitamin D supplements may cause the battlefield (the joints) to become hot spots. I know of no evidence this is the case but it is certainly possible.
However, If Dr. Marshall's principal hypothesis is correct, that low vitamin D levels are the result of disease, then he is saying that cancer causes low vitamin D levels, not the other way around. The problem is that Professor Joanne Lappe directly disproved that theory in a randomized controlled trial when she found that baseline vitamin D levels were strong and independent predictors of who would get cancer in the future. The lower your levels, the higher the risk. Furthermore, increasing baseline levels from 31 to 38 ng/ml reduced incident cancers by more than 60% over a four year period. Therefore, advising patients to become vitamin D deficient, as the Marshall protocol clearly does, will cause some patients to die from cancer.
Lappe JM, Travers-Gustafson D, Davies KM, Recker RR, Heaney RP. Vitamin D and calcium supplementation reduces cancer risk: results of a randomized trial. Am J Clin Nutr. 2007 Jun;85(6):1586-91.
I will not write again about Dr. Marshall's theories. No one in the vitamin D field takes him seriously. Personally, I admire anyone willing to swim against the tide and raise alternative theories. I have done the same with influenza and autism. However, I agree with the New York Times, An Oldie Vies for Nutrient of the Decade and Jane Brody's conclusion, "In the end, you will have to decide for yourself how much of this vital nutrient to consume each and every day and how to obtain it." I agree. You will have to decide for yourself.
The American Heart Association (AHA) was kind enough to send me an e-mail headlining the breaking news from the American College of Cardiology (ACC) meetings underway in Chicago:
ISAR-REACT 3 A Randomized, Double-Blind, Active-Controlled, Multi-Center Trial (ISAR-REACT 3) of Bivalirudin Versus Unfractionated Heparin in Troponin-Negative Patients Undergoing Percutaneous Coronary Interventions After Pre-Treatment With 600 mg of Clopidogrel
TRITON - TIMI 38 Stent Analysis Prasugrel Compared to Clopidogrel in Patients With Acute Coronary Syndromes Undergoing PCI With Stenting: The TRITON - TIMI 38 Stent Analysis
Percutaneous Coronary Interventions in Facilities without On-Site Cardiac Surgery (NCDR)
(And four other similar reports)
Let's meld the ACC headlines with the financial headlines:
July 2, 2007 The Medicines Company announces reacquisition of all marketing rights to bivalirudin, anticoagulant growing in use for coronary angioplasty and related procedures. 2008 sales anticipated to be in the $15-20 million range, to grow to $90-110 million, a growth rate of 50% per year.
November 20, 2007 Drug manufacturing giant, Eli Lilly, vies for a portion of the $5 billion (annual revenues) oral anti-platelet market, now occupied by Plavix, with its newer, but questionably better, agent, prasugrel.
Growth of the coronary angioplasty (percutaneous coronary intervention, or PCI) doesn't ordinarily make headlines, but the performance of specific companies within the industry does. Angioplasty and cardiac device maker (inc. the drug-coated stent, Taxus), Boston Scientific, for instance, announced record sales of $8.537 billion for 2007, an increase of $536 million. How to grow this market? We could always hope for more people with heart attacks or other unstable symptoms. Or, we could . . . increase the number of hospitals capable of PCI! Brilliant.
The money behind this push for procedures is staggering. It drives enormous marketing efforts, pays Washington lobbyists, pays for many nice dinners and trips for doctors who engage in the system, and pays for very costly research.
And the AHA and ACC are kind enough to let us know about these great pieces of news.
Have you ever wondered to what degree health care is driven by a profit motive?
A doctor advises you to undergo a procedure. Is that advice motivated solely by concern for your health and welfare? Or, does the generous financial compensation peculiar to procedures bias your doctor’s decision?
The billboard on the highway advertises a hospital heart program. Is it meant to raise awareness of lifesaving services? Or, is it the same as an ad for a casino or hotel chain, a marketing tool for generating business?
At one time or another, we’ve probably all shared a suspicion that healthcare is occasionally motivated by money: over-priced prescription drugs, hospitals charging higher prices to the uninsured, the three-minute doctor’s visit for $200. Direct-to-consumer drug advertising has brought aggressive drug sales tactics front and center to the public’s attention. “Ask your doctor about . . .” is the mantra of countless 30-second spots appearing several times an hour on national television. Direct-to-consumer drug advertising has provided the American public with a $4.5 billion reminder that there’s money to be made in the world of prescription drugs (U.S. Government Accountability Office). And there’s certainly a load of money to be made. A 2003 Harvard and Massachusetts Institute of Technology study showed that, of every dollar spent on consumer drug advertising, $4.20 was recovered through increased sales (Impact of Direct-to-Consumer Advertising on Prescription Drug Spending; Henry J Kaiser Family Foundation). A $53,000 ad run three times during the Oprah Winfrey Show is money well invested for a drug manufacturer.
The knotty issue of medical errors has recently captured attention. Unintentional medical errors—-nurses administering the wrong medication, doctor misdiagnoses or amputating the wrong leg, unrecognized medication interactions—-are an estimated $29 billion headache. Former Secretary of Health and Human Services, Tommy Thompson, reported that up to 98,000 lives are lost every year as a result of errors in healthcare delivery.
No doubt, these are all enormous problems that plague our healthcare system.
But I am going to make the case for a much larger problem. The magnitude of this problem dwarfs that of medical errors. It’s not an issue of neglect, nor is it committed in error. It is built on intentionally committed acts, systematically conducted on a massive scale, and sustained by the participation of many. It is a plague of unprecedented proportions on the health care system. It requires the willing participation of parties at multiple levels, from lone medical practitioners, to hospitals, to multi-billion dollar medical device and drug manufacturers, even to institutions like the FDA and American Heart Association.
The problem is the bizarre situation that has evolved in health care for the heart. I specify health care for the heart, not heart disease, because actual disease is not always part of the equation. Astonishingly, much of the inflated cost of heart care is based on the feared specter of heart disease, the implied threat of heart disease, the possibility, sometimes vanishingly remote, of heart disease based on some harbinger of risk. Sometimes the disease itself is nowhere in sight. The system thrives on a culture of fear, an open ticket to over-testing and profligate spending. Ads cleverly admonish you to “Do it for your family”. Nuclear stress testing alone generates $18 billion of costs. Yet this test is normal in 80% of people tested. Worse, the 20% of “abnormal” stress test results are not always indicative of genuine disease, they are “false positive,” and are a big part of the reason that 30% of heart catheterizations fail to show disease. “My arteries checked out okay!” relieved patients will declare?-but there may have been no reason to have pursued a costly test like catheterization in the first place. But the system makes far better sense when you understand that nuclear stress tests and heart catheterizations are the bread and butter of cardiologists and hospitals, and the ticket to more financially rewarding procedures.
This approach evolved in the 1960s, when coronary heart disease itself was impossibly difficult to diagnose until a catastrophe like heart attack declared itself. But in the 21st century, coronary heart disease is easily, inexpensively, and safely detectable, decades before heart attack risk looms over your life. Yet murky, risk-based tests like stress tests and cholesterol testing continue to dominate the practice of “heart disease detection” in real-life practice.
Make no mistake: This problem is huge. The cardiovascular health care system has mushroomed into a gargantuan profit-generating mechanism, far larger than is required to deliver essential heart care. In 2003, over $431.8 billion was spent in the U.S. on cardiovascular health care, $151.6 of this on coronary disease alone (American Heart Association, Heart Disease and Stroke Statistics—2007 Update). The U.S. Department of Health and Human Services projects that total health care spending will double to $3.6 trillion by 2014, consuming 18.7 percent of the nation's economy, much of the increase due to expanding cardiovascular costs.
Most tragically, the system has grown through the exploitation of trust. The faith we have in doctors, hospitals, and the institutions and people associated with healthcare has been subverted into the service of profit. Many practitioners and institutions have chosen to operate under the guise of doing good but instead capitalize on the public’s willingness to accept as fact the need for a major heart procedure and all its associated costly trappings.
The New England Journal of Medicine just published a new analysis of the Multi-Ethnic Study of Atherosclerosis (MESA) database authored by Dr. Robert Detrano of University of California-Irvine.
As we would expect, the study confirmed the ability of heart scans and coronary calcium scoring to predict heart attack. This study is unique, hovever, in including Hispanics, Chinese Americans, and African Americans in its 6722 participants.
The analysis confirmed that coronary calcium scores yielded similar information, regardless of race. It confirmed that people with a zero heart scan score had a nearly zero risk of cardiovascular events; it also confirmed that higher scores (e.g., >300) yielded much greater risk over the 4 years of observation: 7.73-fold greater risk for people with scores 101-300; 9.67-fold greater for scores >300.
One of the media reports on the study can be viewed on HeartWire
To those of us who have used heart scans in thousands of people, the MESA results come as no surprise, having seen these phenomena played out every day in real life. Although similar results have been previously shown in a number of other smaller studies, Detrano's analysis of MESA does serve to further validate these concepts. It also serves to deliver the message more broadly into the mainstream media message.
No surprise whatsoever: Coronary calcium scores obtained through heart scans represent a measure of the disease--coronary atherosclerosis--itself. It is not a risk factor that may or may not be associated with development of coronary atherosclerosis. Thus, when heart scan scores are held up in comparison the cholesterol, LDL cholesterol, c-reactive protein, or any other risk measure, heart scan scores outshine all these measures by enormous margins as predictors of your future.
Want to know what your uncorrected heart disease future could be? Consult your heart scan score. Not your cholesterol panel.
Ideally, you get a heart scan and your doctor sits down with you and provides a rational, insightful discussion on what the results mean.
Is heart attack in your future? If so, when? Are blockages present? What is the role of other tests like stress tests and heart catheterizations? Do CT coronary angiograms add any important information? What is the role of cholesterol? Can diet or nutritional supplements impact on heart scan score?
But what happens if you are unable to get the answers you desire? What if you get brusque responses, or your doctor just doesn't know? Or what if there is a clear conflict of interest or the possibility of financially-tainted advice? ("You need a heart catheterization right away or you'll die of a heart attack!")
One example of this process was posted by a frustrated Member of Track Your Plaque who found that answers were virtually unobtainable from his/her doctors:
I underwent a heart scan a few weeks ago, based on a recommendation from a doctor. I assumed that, since I was paying for it, and I requested it, the results would be fully explained to me.
Late on a Friday afternoon, the radiologist who intrepreted it called me and said I would be receiving a report, and so would the doctor. I asked that she explain them to me. She said their policy was to give the report to the doctor and let him explain them. She did say I was in the 90th percentile for my age--and that 10% had a worse score. I asked where do we go from here, and she said, if you're not having symptoms, maybe lifestyle changes, but YOUR DOCTOR will let you know. I asked for a copy of the films and reports, and was told YOUR DOCTOR can request them. I called back a little later and she was gone. It was starting to sink in that I must have a terrible score. In the meantime, I did what I should have done before I went for the scan---looked up information on the internet, and read about calcium scoring. This website [Track Your Plaque] hadn't showed up in my Google search, so a lot of the information was useless.
I did manage to get the score of 186, with the breakdown per artery from someone at the clinic, but only after I insisted I paid for the test, I have a right to the information. 'Course having a score per artery didn't really help---what did it mean? ie: if a 72, how did that correlate to any blockages? Was it a big lump...or spread along the wall throughout the artery.
I had an appt. the following Tuesday with THE DOCTOR---a very busy doctor. After an hour and 1/2 wait in a crowded waiting room, I got to see him. We discussed briefly another issue, and he started walking out. I followed him out and said I wanted my full l5 minutes of time allotted in their scheduling, which seemed to irritate him.
I followed him into his office and said, WHAT ABOUT THE HEART SCAN? What do the numbers mean? He responded that he didn't know, he'd have to see the films, but don't worry--you're probably ok, and I should get a thallium stress test anyway. He said he couldn't intrepret the numbers, or give an opinion on where the plaque was or how it was configured.
I then went to the interventional cardiologist that afternoon and the thallium stress test was scheduled. I asked about the HEART SCAN, and again, no acknowledgment. I asked if he would get the films and explain the results, and again no acknowledment as he was walking out the door.
After this lengthy saga.....MY QUESTION IS....since this is a test you can order yourself (literature at center made mention of the tests you can get without a doctors request)......WHO IS THEIR FIDUCIARY RESPONSIBILITY TO WHEN IT COMES TO EXPLAINING THE RESULTS?
I learned more on this website [Track Your Plaque], and the emailed book then I did dealing with two doctors and the center itself. Thinking back, there was nothing but a brochure on the test at the center. No "Track your Plaque" stuff.
Day 2 I called the scanning center and relayed my dilemma. I was put in touch with another radiologist--a very informative one, who appeared passionate about heart scans as a preventive test. He compared them to mammograms. He hadn't heard about the "Track Your Plaque" program but was going to check it out. He said people varied in their responses to the test results, as well as doctors/cardiologists as to the next step. (ie: lifestyle changes..the next test, etc). He seemed to feel blockages of more than 50% for many cardiologists would indicated angioplasty and stenting.
I'm going back to review the films with him later this week. He wasn't that concerned with the 101 reading on the right artery. The 72 on the left he had concerns with and indicated the CAT test [CT angiography] would offer more as far as how much was there, and approx. blockage, and could be a baseline to compare to in the future. He said some cardiologists would go right to angioplasty...some to a CAT which is more conservative...some might watch and encourage lifestyle changes. He said the Heart Scan doesn't show soft plaque. He also said the internist who referred me was one of only a few in the city that felt strongly about the heart scan---and probably used it to take further action via a referral, and just didn't have time to discuss it, with the way medicine is run these days.
This Member's frustrated post pretty much sums it up:
1) Doctors don't seem to have the time nor motivation to be bothered about offering advice that leads to prevention of disease.
2) The tendency is to always ask, "Are heart procedures necessary?", not "How did this happen?" or "What can we do about this to keep it from getting worse?" How about diet, supplements, and other tools to use at home?
The obvious uneasiness of the radiologist, the last physician this Member spoke with, can just as easily lead to boneheaded advice: Maybe getting a stent isn't such a bad idea. Maybe a CT angiogram is an absolute necessity.
I hear comments like this every day. It is the reason why I continue to plug away at this program and try to set things straight.
By the way, subscribers to our Track Your Plaque Newsletter just heard about our latest success story, Roy, who dropped his heart scan score over 500 points. If you are yet not a newsletter subscriber, click here.
In January, 2007, $11.6 billion (2006 net sales) cereal manufacturing giant General Mills rolled out three million boxes of Wheat Chex and Multi-Bran Chex, each boasting a picture of cardiologist, Dr. Nieca Goldberg's face on the box.
Dr. Goldberg has been a frequent national spokeswoman for the American Heart Association (AHA). In a media interview, American Heart Association President, Dr. Alice Jacobs, stated that she supports Dr. Goldberg's work with the General Mills’ products. "The AHA is always in favor of educating the public on how to make heart-healthy lifestyle choices." Dr. Jacobs added that the AHA doesn't consider Goldberg's appearance on the cereal boxes ‘an endorsement’ of the products. "The content on the box is basic heart health information," she said.
Putting images of someone like Dr. Goldberg on cereal boxes appeals to a certain audience, mothers worried about health in this instance. Manufacturers recognize that the perceptions of their food need to be created and nurtured.
Eerily reminiscent of tobacco company tactics of the 20th century? Recall the Brown and Williamson claim that Kool cigarettes keep the head clear and provide extra protection against colds? Lucky Strike, Chesterfield, and Camels all promoted the health benefits of cigarettes, including prominent endorsements by physicians.
How about Philip Morris’ ads for Virginia Slims cigarettes: "You've come a long way, baby"? Interestingly, food manufacturing behemoths Kraft and Nabisco were both majority-owned by Philip Morris, now renamed Altria.
Take a look at the composition of these two "heart healthy" breakfast cereals endorsed by Dr. Nieca Goldberg and the American Heart Association:
Products like this:
--Make people fat--abdominal fat (wheat belly) --Reduce HDL cholesterol --Raise triglycerides --Dramatically increase small LDL --Increase inflammatory responses --Increase blood pressure --Increase likelihood of diabetes
These products are sugar and sugar-equivalents with a little fiber thrown in and a lot of marketing propaganda, aided and abetted by the misguided antics of the American Heart Association and Dr. Goldberg. It's hard to believe that Dr. Goldberg would sell her soul on something so knuckleheaded for a moment of notoriety.
As I've often said, if a product bears the AHA Check Mark of approval, be sure not to buy it.
