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Wednesday, June 26, 2013



HYPERTENSION DOESN'T NEED TO BE TREATED (A LOT OF IT ANYWAY):   In 1990 I reviewed all of the then available studies on the treatment of mild to moderate hypertension and was more than mildly surprised by the following observations:

  1. The trials showed a significant benefit in reducing both fatal and nonfatal stroke (40-44% reductions).
  2. The benefit for stroke reduction in middle-aged patients could be observed after only 4-6 weeks of treatment.
  3. No statistically significant benefit in the reduction of fatal or nonfatal MI was observed.
  4. There appeared to be no value in treating isolated mild to moderate hypertension in younger adults in the absence of risk factors.
  5. Treatment of mild to moderate hypertension was not cost-effective.

(I published the results of my review in J Am Board FP in 1993  May-Jun;6(3):243-54.) (1)

    This led me to the conclusion that pharmacological management of mild-to-moderate  hypertension should be directed only at those with elevated cardiac risk profiles. This, of course, meant that you would actually have to perform a cardiac risk assessment to determine global cardiac risk. Otherwise lifestyle measures are all that is needed for everyone else. My subsequent research into the effects of healthy lifestyles also supported this conclusion.(2)
        I have been alone in this opinion for most of my career, but now at last the Cochrane Collaboration has published a definite confirmation of this approach.(3) Their conclusions are likely to surprise you. The authors reviewed 11 RCTs and based their conclusions on only 4 qualified studies. These studies included 8,912 subjects who were treated for 4 to 5 years with antihypertensive drugs as compared to placebo. Active treatment with medication did not reduce total mortality. In 7,080 participants treated with antihypertensive drugs as compared to placebo did not reduce coronary heart disease, stroke, or total cardiovascular events.
        A follow-up editorial in JAMA explains how we came to be managing hypertension all wrong for over 20 years.(4) The author begins with a quotation from Julian Tudor Hart, the pioneer of screening for hypertension at the previous threshold of 160/100 mm Hg: "Why has it taken more than 30 years to reach this conclusion, when it was already evident from any careful and critical reading of the trials claimed originally to justify interventions in the diastolic range 90-100 mm Hg?"
        The effect of changing the disease definition was to create 13 million new hypertensive patients in the US. In that same year, more than 800 physicians, pharmacists, and scientists from 42 countries signed an open letter to the Director-General of the WHO complaining that these new guidelines 'would result in increased use of antihypertensive drugs, at great expense and for little benefit.' The editorial goes on to observe:

    "The following year, Getz and colleagues described the results of applying these European guidelines to the entire population of a county in Norway. The Nord-Trondelag Health Study provides BP and serum cholesterol level data for some 62,000 adults aged between 20 and 79 years in the period 1995 through 1997. When the European guidelines are applied, half the population are considered to be at risk by the early age of 24 years. By the age of 49 years, this proportion increases to 90%, and as much as 76% of the total adult population are found to be at 'increased risk.' Yet the current life expectancy at birth in Norway is 79 years for men and 83 years for women, making it one of the longest-living populations in history. In this context, the thresholds cannot be appropriate, and it is perhaps important to note that every one of the numerous authors of the European guidelines reported some degree of support from the pharmaceutical industry.
    "In 204, the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC7) sponsored by the US National Heart, Lung, and Blood Institute pushed the thresholds even lower, stating the prehypertensive individuals (systolic BP, 120-139 mm Hg, or diastolic BP, 80-89 mm Hg) require health-promoting lifestyle modifications to prevent the progressive rise in BP and cardiovascular disease. Nine of 10 members of the Executive Committee responsible for JNC7 record conflicts of interest relating to the receipt of payments from the pharmaceutical industry."

        It was after the publication of JNC 7 that I first began to suspect that the drug companies were deliberately leading us astray. I wrote extensively on my disagreements with JNC 7 in The Action Advisor for Primary Care, "You Should Read the JNC 7 Guidelines on Hypertension and Then Freely Deviate from Them As You Feel Appropriate for Your Practices".(5)

        The primary article above cites the guidance from the national Institute for Health and Care Excellence; according to this guideline drug treatment for hypertension should be offered to people aged younger than 80 years with stage 1 hypertension (BP < 160/100) only if they also have target organ damage, established cardiovascular disease, renal disease, diabetes, and/or a 10-year cardiovascular risk equivalent to 20% or greater. Dr. Heath concludes: "In view of the mounting evidence of both waste and harm, it is well time that we returned to the higher threshold of 160/100 mg Hg for the pharmaceutical treatment of hypertension in otherwise healthy people. The Eighth Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure provides a timely opportunity for achieving this, but, with the probably degree of industry entanglement, it seems a remote possibility. However, sooner or later the pharmaceutical treatment of mild hypertension seems likely to be consigned to what the novelist Amitav Ghosh has described as 'medicine's vast graveyard of discredited speculations.'"
COMMENT: Isn't the practice of medicine rather a marvel!?  Just don't say I didn't tell you so.

Monday, April 22, 2013





SOME MORE DATA ON CALCIUM AND HEART DISEASE: In a recent issue I wept over the US Preventive Services Task recent statement on routine calcium and vitamin D supplementation. They went on record as against it. My assertion is that they were woefully premature as conclusive data just aren't there yet. This question from a subscriber is an example of the kind of agony they have caused for primary care doctors:

    My name is Bob and I'm a Vit D prescriber. I feel powerless in the face of
the USPFTF's recommendations. I enjoyed your wry comments. But what about
those concerns about increased heart disease from Ca supplementation?
That's what I worry about.

Here's my response:

     "You ask a good question about calcium supplementation, and I have concerns as well. In making a decision in cases like this I revert back to a basic set of principles of medical evidence.

1. Never change practice based on 1 study or just 1 evidence review. I reviewed the USPSTF statement, and it poses as many questions as they had answers (mostly wrong, in my opinion). The USPSTF clearly acknowledges that we need more data. I don't understand why they changed such a common, appropriate practice overnight. I just don't think the data are there yet. But the issue has been raised, and I will continue to search for more data. [See below.]

2. Whenever we've been doing something for 50 years or so with no reason to be concerned about, I fundamentally mistrust the new study that says STOP doing it. The methodologies of all these studies vary greatly, their level of significance varies, and they are not really homogeneous, so it is difficult to put them into meta-analyses. 

3. Look at the big picture. During this same time (last 50 years), cardiovascular disease has clearly and markedly declined (despite all the calcium we were recommending). I have not seen any one of my patients die of calcium-induced heart disease. (How would I know?) The recommendation seeks to have us remove a reputed agent of heart disease that we cannot see at work. This can lead to a lot of superstitious medicine. If I am going to be superstitious, it is going to be in the direction of encouraging nutritional adequacy across the board.

4. Apply common sense:  We know that the diets that most Americans eat these days are highly flawed. Significant rates of deficiency have been shown for vitamin C, D, folate, B12, and iron. It is absolutely counter-intuitive not to tell patients to get the recommended minimum amounts of calcium and vitamin D. Calcium is a much studied nutrient. We have studies showing the supplementation leads to reduced rates of obesity, colon cancer, and osteoporosis. How come the adverse cardiovascular effect never showed up in those studies? What is to say that the new studies are better and more definitive than the older studies. My expectation is that newer studies will show the USPSTF position irrelevant. [One example appears below.]

Finally, what I dislike most about this USPSTF recommendation is that it just so flies in the face of primary care physicians who have made a concerted effort to do the right thing, as it was previously recommended. When they come out with a new, different recommendation, the data need to be definitive. The worst thing they could do is to leave us in a no-man's land, which is what they have done. When we in primary care feel this upset about an issue, sometimes we're right.

Let's wait and see how the data unfold. In the meantime keep prescribing the minimum RDA of calcium and vitamin D."

The saga will continue.

IT DIDN'T TAKE LONG: "DIETARY AND SUPPLEMENTAL CALCIUM INTAKE AND CARDIOVASCULAR DISEASE MORTALITY: THE NATIONAL INSTITUTES OF HEALTH--AARP DIET AND HEALTH STUDY": This was a prospective study from 1995 through 1996 in California, Florida, Louisiana, New Jersey, North Carolina, and Pennsylvania and the two metropolitan areas of Atlanta, Georgia, and Detroit, Michigan.(1) There were a total of 388,229 men and women aged 50 to 71 years included in the study. Dietary and supplemental calcium intake was assessed at baseline. Supplemental calcium intake included calcium from multivitamins and individual calcium supplements. During a mean of 12 years of follow-up, 7904 and 3874 cardiovascular deaths occurred in men and women, respectively. Supplements containing calcium were used by 51% of men and 70% of women. In men, supplemental calcium intake was associated with an elevated risk of CVD death (RR 1.20), more specifically with heart disease death (RR, 1.19), but not significantly with cerebrovascular disease death (RR, 1.14). In women, supplemental calcium intake was not associated with CVD death (RR, 1.06), heat disease death (1.05), or cerebrovascular disease death (1.08). Dietary calcium intake was unrelated to CVD death in either men or women. The authors conclude simply that more studies are needed. COMMENT: So what is all the fuss about? Most of the supplements we prescribe are to older women who do not appeared to be harmed at all by this.
AND, YES, VIRGINIA, COUNSELING ABOUT DIET IS GOOD FOR REDUCING CARDIOVASCULAR RISK:  Notwithstanding the misguided opinion of the USPSTF, the Cochrane Collaboration does indeed find dietary counseling to be a good thing.(2) These Cochrane collaborators analyzed randomized studies with no more than 20% loss to follow-up, which lasted at least 3 months, and involved healthy adults comparing dietary advice with no advice or minimal advice. Trials involving children, trials to reduce weight, and trials involving supplementation were excluded. The investigators found 42 trials with 52 intervention arms (comparisons) comparing dietary advice with no advice. There were 18,175 participants or clusters randomized. 29 of the 44 included trials were conducted in the US. Dietary advice reduced total serum cholesterol by 0.15 mmol/L and LDL cholesterol by 0.16 mmol/L after 3 to 24 months. Mean HDL cholesterol levels and triglyceride levels were unchanged. Dietary advice reduced blood pressure by 2.61 mm Hg systolic and 1.45 mm Hg diastolic and 24-hour urinary sodium excretion by 40.9 mmol after 3 to 36 months. Compared to no advice, dietary advice increased fruit and vegetable intake by 1.18 servings a day. Dietary fiber intake increased with advice by 6.5 g/day, while total dietary fat as a percentage of total energy intake fell by 4.48% with dietary advice, and saturated fat intake fell by 2.39%. The authors conclude: "Dietary advice appears to be effective in bringing about modest beneficial changes in diet and cardiovascular risk factors over approximately 12 months, but longer-term effects are not known." COMMENT: It should be no discouragement that the benefits are in relatively small percentages because we are talking about brief, simple interventions across the entire population. Just as every 1-2 mm Hg and 1-2 mg of cholesterol make a difference, so does every extra serving of fruits and vegetables. The goal is only 5. We can get there. It will make a difference!


Xiao Q et al. Dietary and supplemental calcium intake and cardiovascular disease mortality: The National Institutes of Health-AARP Diet and Health Study. JAMA Intern Med 2013; 173(8): 639-46.

Rees K et al. Dietary advice for reducing cardiovascular risk. Cochrane Database Syst Rev. 2013 Mar 28:3: CD002128. doi: 10.1002/14651858. CD002128.pub4. PMID: 23543514.

Thursday, April 4, 2013


THE BEST WHAT-NOT-TO-DO's IN MEDICINE:  We are at the threshold of a new era in medicine that really began with an article in Annals of Internal Medicine(1), which I reviewed in the Jan 12th issue of the Journal of the FP Revolution in 2012. This started a brand new movement in medicine which has now gained substantial momentum. A large number of generalist and specialist societies have now identified and endorse a core set of test, evaluations, and practices that no longer ought to be done. [Actually we should never have been doing them, but we're slow learners making progress.] Since they are posted in the Internet in obscure locations (2), many of us have never seen them. Therefore, I am going to just provide a graphic to illustrate each of them with no other commentary in this issue. Read 'em and learn 'em. They're great!

Here's the main point: There is almost universal consensus among medical experts (including myself) that the medical procedures listed below SHOULD NOT BE DONE. If your doctor is recommending any of them, ask him/her, "Why?"  Or, equally acceptable, just say NO!

      Also very valuable for consumers are the consumer information sheets that accompany each one of these guidelines. There is a sample at the bottom of this page. The whole set can be found at this link:
        My favorites are (a Baker's Dozen):
  1. No routine pre-operative lab tests in average risk patients: not chest x-rays, ECGs, or chemistries or coagulation tests. Let's face it. Hospitals and surgicenters want these only for revenue production.
  2. No DEXA scanning for bone mineral density until age 65 in women, one-time only, and age 70 in men.
  3. No routine annual cholesterol panel in patients not on a special diet or drug therapy. [Note: This puts us at odds with many so-called expert guidelines that govern organizations like Kaiser, Community Health Centers, etc. Once every 5 years is enough for people without risk factors or disease.]
  4. Don't perform Pap smears on women younger than 21.
  5. Don't order HPV (human papilloma virus) testing on women younger than 30.
  6. Don't order carotid ultrasounds as screening for asymptomatic patients. [The corollary of this is, Don't auscultate for bruits (a harsh sound from irregular blood flow) on routine exams. A finding of a bruit will make your doctor really, really want to order an ultrasound. Don't let him/her! The USPSTF specifically 'recommends against' it because known harms exceed known benefits.
  7. Don't repeat colon cancer screening by any method (including stool blood testing) for 10 years after a negative colonoscopy in average-risk individuals.
  8. In the hospital don't order daily blood counts and chemistry panels in the face of clinical and lab stability.
  9. No echocardiograms or carotid ultrasounds for patients with simple syncope (faint).
  10. Don't order nuclear thyroid scans to evaluate thyroid nodules if thyroid function is normal.
  11. Don't prescribe cough and cold medications for children < 4 years of age. [Their parents can always do this, but physicians shouldn't be doing it.]
  12. Don't perform ultrasound testing for boys with undescended testicles. [This is a new one for me.]
  13. Don't order special testing for clotting disorders when patient presents with a first episode of a venous leg clot with a known cause (such as a recent fall, fracture, surgery, or other trauma). Don't re-image a venous leg clot in the absence of a clinical change.
    Go ahead and pick your own favorites from the lists below. [...and let your friends know!]

        The Choosing Wisely website also has nice accompany patient education handouts for consumers. A sample for GERD appears below.

parts per million of atmospheric carbon compatible with a familiar, sustainable planet Earth
1. Qaseem A et al. Appropriate use of screening and diagnostic tests to foster high-value, cost-conscious care. Ann Intern Med 2012; 156: 147-9. EDITORIAL: Laine C. High-value testing begins with a few simple questions. Ann Intern Med 2012; 156: 162-3.
2. The ABIM Choosing Wisely website:
Article retrieval tips: To find an article in PubMed simply enter the PMID number into the search field. Where a 'doi' heading is listed, you can insert the doi information into a Google search and retrieve the article.

Tuesday, March 12, 2013



THE USPSTF HAS JUST PUT CALCIUM AND VITAMIN D IN THE DOG HOUSE:  The USPSTF is taking abrupt action to stop this new menace--calcium and vitamin D supplementation--in its tracks.(1) Those of you who have been harmed by this pernicious combination should call 1-800-BAD-DRUG.
        Actually, we don't really know that these drugs are bad for us, it is just that there is 'insufficient evidence' to know that they're good for us, but let's not quibble. Specifically, we can say categorically that there is at present no good evidence that routine calcium and vitamin D supplementation for men or pre-menopausal women offers any benefit for the prevention of fractures. There may be other benefits but these are not discussed. The Task Force adds salt to the wound by stating 'current evidence is insufficient to assess the balance of the benefits and harms of daily supplementation with greater than 400 IU of vitamin D3 and greater than 1000 mg of calcium for the prevention of fractures in non-institutionalized postmenopausal women. For those who have ever had the misfortune to prescribe these, take 2 aspirin and call your lawyer. Finally, the emboldened USPSTF takes a strong stand ("recommends against") on daily supplementation with 400 IU or less of vitamin D3 and 1000 mg or less of calcium for the primary prevention of fractures in non-institutionalized postmenopausal women.
        The USPSTF also mentions some countervailing factors:
        1. They do recommend vitamin D supplementation (~800 IU/d) for the prevention of falls in community-dwelling adults aged 65 years and older who are at increased risk for falls because of a history or recent falls or vitamin D deficiency.
        2. A major meta-analysis of 31,022 adults over the age of 65 found that fractures may be reduced (by ~ 12%) for persons taking higher doses of vitamin  D (> 800 IU/d) among both institutionalized and community-dwelling adults.
        3. In fact, the USPSTF itself concluded in 2011 that combined vitamin D (300-1100 IU/d) and calcium supplementation (500 to 1200 mg/d), but not vitamin D supplementation alone, can reduce the fracture risk in older adults.
        4. The Institute of Medicine and World Health Organization have recommended standards for adequate daily intake of calcium and vitamin D as a part of overall health.

        I would suggest that this concern for overall health may be relevant for people in our business. Preventing falls isn't a bad thing either. Calling attention to dietary and nutritional factors in health could be construed by some as a good thing.
        The only harm that the USPSTF can dig up about supplementation is an increased risk of kidney stones (estimated number needed to harm (NNH) 1/273. Perhaps we can learn to live with this.
COMMENT: This recommendation statement is premature. When we have good authority to do something generally considered safe (e.g., IOM, WHO, and the former USPSTF) it should require some very solid evidence (not just a lack of it) to overturn established practice that could still be very health promoting despite the Task Force's cautions. A 1/273 risk of kidney stones does not rise to that level of evidence or harm. The problem with the USPSTF is increasingly that, as with Orwell's elephant, they find the evidence synthesis easier to do when inspecting only small pieces of the elephant. What we need our recommendations to be based on are some good whole-elephant outcomes.
        It its consumer-oriented report of the guidelines the USPSTF does offer this helpful aid to interpretation illustrating that their opinion should be just one of many that goes into a consumer decision about calcium and vitamin D supplementation.

        In the meantime, what do you do?
        1. Don't change current practice. There is not enough evidence to do so.
        2. At a minimum have a discussion with all patients aged 65 years or older about the prevention of falls and the possible prevention of fractures.
        3. Don't start using more alendronate (or other bisphosphonates) since benefit from these is only clear for the group of patients who have already had fragility fractures.
        4. Do temper your enthusiasm for screening for osteoporosis since it appears that we don't know what to do about it anymore.
        5. Do fall back on exercise as the main preventive measure. I would, of course, assert that we should be doing this anyway...BUT WAIT, THE USPSTF DOES NOT ENDORSE COUNSELING TO EXERCISE EITHER!(2)

SHOPPERS, IT'S SAFE TO GO NEAR THE EGGS AGAIN: Chicken eggs are high in cholesterol (about 200 mg each). It is common for providers and experts to caution against their consumption in persons for whom cholesterol is a clinical concern. We have a new meta-analysis of 17 prospective cohort studies in which egg consumption was measured with food-frequency questionnaires; patients were followed for 10 to 20 years of follow-up.(3) No associations between egg consumption and risk for either heart disease or stroke were observed. For the subgroup of diabetics, egg consumption increase the risk of heart disease (RR, 1.5) and lower the risk of stroke (RR, 0.80). COMMENT: Eat your eggs.

DIET DOES MATTERDespite the USPSTF's apparent opposition, interventions to promote a healthy diet (in this case, specifically a Mediterranean diet) have some significant benefits. We've all known about the substantial benefits of a Mediterranean diet for years. Here we have another confirmation.(3) Spanish investigators conducted a multicenter trial in which 7447 high-risk patients were randomly assigned to one of 3 interventions: (1) a Mediterranean diet supplemented with extra-virgin olive oil; (2) a Mediterranean diet supplemented with mixed nuts; or (3) a control diet. Participants received quarterly individual and group educational sessions and, depending on group assignment, free provision of extra-virgin olive oil, mixed nuts, or small non-food gifts. The primary end point was the rate of major cardiovascular events (MI, CVA, or death from CV causes). On the basis of the results of an interim analysis, the trial was stopped after a median follow-up of 4.8 years. The multivariable-adjusted hazard ratios were 0.70 and 0.72 for the group assigned to a Mediterranean diet with extra-virgin olive oil and the group assigned to a Mediterranean diet with nuts, respectively. COMMENT: This worked very nicely. How are you going to get patients to even try a nice health diet like this if you don't counsel them?  Tell me that, USPSTF!

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1. USPSTF. Vitamin D and calcium supplementation to prevent fractures in adults: Clinical summary of US Preventive Services Task Force Recommendation. Chung M et al for the USPSTF. Vitamin D with or without calcium supplementation for prevention of cancer and fractures: An updated meta-analysis for the USPSTF. Ann Intern Med 2011; 155: 827-38. Moyer VA for the USPSTF. Vitamin D and calcium supplementation to prevent fractures in adults: US Preventive services Task Force Recommendation Statement. Ann Intern Med 2013; Feb 26.

2. USPSTF.Behavioral Counseling to Promote a Healthful Diet and Physical Activity for Cardiovascular Disease Prevention in Adults.

3. Rong Y et al. Egg consumption and risk of coronary heart disease and stroke: Dose-response meta-analysis of prospective cohort studies. BMJ 2013 Jan 7; 346:e8539. (

4. Estruch R et al. Primary prevention of cardiovascular disease with a Mediterranean diet. N Engl J Med 2013 Feb 25. PMID: 23432189.