A Great New Drug for Heart Disease!*
A Great New Drug for Heart Disease!*
A thought experiment to understand how Cardiology views diet...
Imagine we have a drug.
We think it's good for heart disease. 1
We run an RCT, and more people die taking the drug. 2
So we think something might have been wrong, we run another RCT. 3
More people die taking the drug.
But, but... Another RCT. More people die taking the drug. 4
Maybe it needs more 'power'. We'll run another RCT. Run by the biggest proponent of the drug, the scientist who proposed the hypothesis. 5
Bigger, better.
More people die taking the drug.
This is rather embarrassing at this point.
So we bury the results, we don't report them for 16 years, and play it down. 6
In the meanwhile, someone from outside, a European, does a trial that shows a lower level of the drug reduces deaths! 7
We ignore that part. 8
We ignore that the we knew that the bigger the effect the drug had, the more people died. 9
We never even approach the FDA for approval, with a series of failures like this, would they ever approve it?
But we continue to prescribe the drug. 10
We make it nearly mandatory. Every man, woman, and child in the country gets the drug, by law. 11
This is the story of seed oils and heart disease.
“The medicinal properties of linoleic acid were first reported in the United States in the 1960s indicating its usefulness in lowering serum cholesterol levels...” 12
They continue to ignore the negative evidence. 2015:
“Prior to lipid-lowering drugs, physicians prescribed their patients daily doses of sunflower, safflower, and soybean oils, which are high in [linoleic acid] [24]. Two studies examined the daily intake of [linoleic acid] as a cholesterol reducing agent and for long-term CVD risk reduction. Both studies concluded a 12–18 % drop in serum cholesterol levels and a decreased risk of cardiac events over time in the experimental groups [25, 26].” 13
Note they cherry-pick the studies to include favorable results, ignoring those above.
Cardiologists prescribe seed oils as a drug.
Why isn't it regulated like a drug?
Why don’t cardiologists face consequences for prescribing this harmful drug for decades?
“The Federal Drug Administration announced late last week that a fish-oil-derived medication, Vascepa, had been approved to prevent heart attacks, strokes and death in people who are at high cardiovascular risk.”
“FDA approves omega-3 fish-oil medication Vascepa to reduce risk of death in people with high cholesterol” 14
*This isn’t quite an April Fool’s joke, but it’s close. Sadly it’s all true.
References
1961: “A diet moderate in calories and fat (about 23-35 per cent of total calories from fat) may be helpful for these coronary-prone persons. Substitution of poly-unsaturated for a substantial part of the saturated fat in the diet may also be a valuable addition to this program.”
Page, I. H., Allen, E. V., Chamberlain, F. L., Keys, A., Stamler, J., & Stare, F. J. (1961). Dietary Fat and Its Relation to Heart Attacks and Strokes. Circulation, 23(1), 133–136. https://doi.org/10.1161/01.CIR.23.1.133
1965: “The patients receiving the key treatment (corn oil) fared worse than those in the other two groups: two years from the start of treatment infarction or death had occurred in one quarter more of the corn-oil than of the control group.”
Rose, G. A., Thomson, W. B., & Williams, R. T. (1965). Corn Oil in Treatment of Ischaemic Heart Disease. British Medical Journal, 1(5449), 1531–1533. https://doi.org/10.1136/bmj.1.5449.1531
1966: “Out of the 814 experimental group subjects, there have been 18 known deaths from causes other than coronary heart disease among individuals who had not experienced a new coronary event. This is in comparison to six such deaths out of the 463 individuals in the control group. All but two of these 24 deaths were in the 50-59 age group. The rates for these deaths in the 50-59 age group were 689 per 100,000 person-years in the experimental group, and 666 per 100,000 in the control group.”
Christakis, G., Rinzler, S. H., Archer, M., Winslow, G., Jampel, S., Stephenson, J., Friedman, G., Fein, H., Kraus, A., & James, G. (1966). The Anti-Coronary Club. A Dietary Approach to the Prevention of Coronary Heart Disease—A Seven-Year Report. American Journal of Public Health and the Nations Health, 56(2), 299–314.
1969: “All mortality data, subdivided into several predefined categories, are presented in table 27. As cited earlier, 70 deaths in the control group were attributed to acute atherosclerotic events, either as the sole or a major contributory cause of death, compared with 48 such deaths in the experimental group. However, deaths attributed to nonatherosclerotic cause, as well as deaths of uncertain cause, were more numerous in the experimental group than among the control subjects (table 27), so that total mortality was nearly identical.”
Dayton, S., Pearce, M. L., Hashimoto, S., Dixon, W. J., & Tomiyasu, U. (1969). A Controlled Clinical Trial of a Diet High in Unsaturated Fat in Preventing Complications of Atherosclerosis. Circulation, 40(1s2), II–1. https://doi.org/10.1161/01.CIR.40.1S2.II-1
1964: “The so-called "feasibility test" is now underway in five different cities: Baltimore, Dr. B. M. Baker; Boston, Dr. F. J. Stare; Chicago, Dr. J. Stamler; Minneapolis, Dr. A. Keys; and Oakland, Dr. L. W. Kinsell. In addition, a study of a group of hospitalized patients is being conducted by Dr. I. D. Frantz, Jr., of the University of Minnesota.”
Page, I. H. (1964). Editorial: The National Diet-Heart Study. Circulation, 29(1), 4–5. https://doi.org/10.1161/01.CIR.29.1.4
1989: “Although this study did not show a statistically significant reduction in cardiovascular events or total deaths from the treatment diet, the authors suspect that it might have shown such a reduction if the period of treatment had been longer in persons in the age range likely to benefit.”
Frantz, I. D., Dawson, E. A., Ashman, P. L., Gatewood, L. C., Bartsch, G. E., Kuba, K., & Brewer, E. R. (1989). Test of effect of lipid lowering by diet on cardiovascular risk. The Minnesota Coronary Survey. Arteriosclerosis (Dallas, Tex.), 9(1), 129–135. https://doi.org/10.1161/01.atv.9.1.129
1994: “Overall mortality was 20 in the control, 8 in the experimental group, an adjusted risk ratio of 0.30 (95% Cl 0.11-0.82, p=0.02).”
de Lorgeril, M., Renaud, S., Mamelle, N., Salen, P., Martin, J. L., Monjaud, I., Guidollet, J., Touboul, P., & Delaye, J. (1994). Mediterranean alpha-linolenic acid-rich diet in secondary prevention of coronary heart disease. Lancet (London, England), 343(8911), 1454–1459. https://doi.org/10.1016/s0140-6736(94)92580-1
2001: “Moreover, these subjects consumed less linoleic acid (3.6% versus 5.3% kcal) and more oleic acid (12.9% versus 10.8% kcal), !-linolenic acid (0.84% versus 0.29% kcal), and dietary fiber.”
“The unprecedented reduction in coronary recurrence rates, despite the fact that lipid/lipoprotein risk factors were comparable, clearly points to other important risk factor modifications as major influences in the development of CVD.”
“Although the authors propose that alpha-linolenic acid plays an independent role in lowering CVD risk, other dietary differences between the experimental and control groups could account for the observed effects.”
Kris-Etherton, P. M., Eckel, R. H., Howard, B. V., Jeor, S. C. S., & Bazzarre, T. L. (2001). AHA Science Advisory: Lyon Diet Heart Study. Benefits of a Mediterranean-style, National Cholesterol Education Program/American Heart Association Step I Dietary Pattern on Cardiovascular Disease. Circulation, 103(13), 1823–1825. https://doi.org/10.1161/01.CIR.103.13.1823
2016: “This finding that greater lowering of serum cholesterol was associated with a higher rather than a lower risk of death in the MCE does not provide support for the traditional diet-heart hypothesis.”
Ramsden, C. E., Zamora, D., Majchrzak-Hong, S., Faurot, K. R., Broste, S. K., Frantz, R. P., Davis, J. M., Ringel, A., Suchindran, C. M., & Hibbeln, J. R. (2016). Re-evaluation of the traditional diet-heart hypothesis: Analysis of recovered data from Minnesota Coronary Experiment (1968-73). BMJ, 353. https://doi.org/10.1136/bmj.i1246
2017: “In summary, randomized controlled trials that lowered intake of dietary saturated fat and replaced it with polyunsaturated vegetable oil reduced CVD by ≈30%, similar to the reduction achieved by statin treatment.”
Sacks Frank M., Lichtenstein Alice H., Wu Jason H.Y., Appel Lawrence J., Creager Mark A., Kris-Etherton Penny M., Miller Michael, Rimm Eric B., Rudel Lawrence L., Robinson Jennifer G., Stone Neil J., & Van Horn Linda V. (2017). Dietary Fats and Cardiovascular Disease: A Presidential Advisory From the American Heart Association. Circulation, 136(3), e1–e23. https://doi.org/10.1161/CIR.0000000000000510
2020: “Strategies to shift intake include cooking with vegetable oil in place of fats high in saturated fat, including butter, shortening, lard, or coconut oil.”
U.S. Department of Agriculture, U.S. Department of Health and Human Services, Perdue, S., & Azar II, A. M. (2020). Dietary Guidelines for Americans, 2020-2025. U.S. Department of Agriculture. https://www.dietaryguidelines.gov/resources/2020-2025-dietary-guidelines-online-materials
Singh, V., & Nimbkar, N. (2016). Chapter 7—Safflower. In S. K. Gupta (Ed.), Breeding Oilseed Crops for Sustainable Production (pp. 149–167). Academic Press. https://doi.org/10.1016/B978-0-12-801309-0.00007-0
Vaughan, R. A., Garrison, R. L., Stamatikos, A. D., Kang, M., Cooper, J. A., & Paton, C. M. (2015). A High Linoleic Acid Diet does not Induce Inflammation in Mouse Liver or Adipose Tissue. Lipids, 50(11), 1115–1122. https://doi.org/10.1007/s11745-015-4072-2
Chance, B. (2019, December 16). FDA approves omega-3 fish-oil medication Vascepa to reduce risk of death in people with high cholesterol [News]. ABC News. https://abcnews.go.com/Health/fda-approves-omega-fish-oil-medication-vascepa-reduce/story?id=67748996
Yes, in the early 1980s as a middle aged man at risk of heart problems a GP recommended replacing any saturated fats with polyunsaturated oils, which I did for some years including using that margarine with plant sterols ‘proven to reduce cholesterol’. Then I read the label and starting researching what was going on. I assumed this was a one off mistake at the time, now I know this lack of proper understanding is pervasive.
My brain hurts. I feel like a conspiracy theorist all the time these days with available information on the internet, but your references are persuasive, Tucker. (Have been for about 10 years) Besides, why do we want to eat something requiring a factory full of hydraulic presses, hexane solvents, and nickel catalysts to produce a product that is even tolerable to eat??!! I’ll take my meat and dairy fat all day, everyday. Thank you!!