Dr. Marty Makary’s ‘Blind Spots’ Book Is At Odds With Established Findings

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The man currently being considered for the FDA Commissioner spot has a lot of advice in his most recent book, but studies contradict several major topics.

Marty Makary is well-known for writing informal autobiographical books critiquing medical practice in America. Given that he is poised to lead the FDA, it should concern people that his book, Blind Spots: When Medicine Gets It Wrong, and What It Means for Our Health, has some serious biased presentation of data inaccuracies. How can Dr. Makary claim he is qualified to run the FDA when he presents controversial data in such a biased style?

Blood pressure

In Blind Spots, Makary rhetorically asks: “Can we lower high blood pressure by improving sleep quality and reducing stress instead of throwing antihypertensive medications at people?”

While that sounds like a good idea to someone who doesn’t know any better, it leaves something out. According to the NIH, essential hypertension makes up 95% of hypertension cases and has no modifiable cause (i.e., it’s not sleep or stress-related, it’s genetic). In other words, it exists in people who already get plenty of sleep and are at a good weight, et cetera. That is fundamental knowledge known by medical students and non-degreed ancillary healthcare workers. To the extent Makary implies otherwise, he’s just wrong.

YouTube screen grab.

Cosmetic Breast Implants

Blind Spots promotes using silicone and other breast implants for cosmetic surgery. Makary states in his book chapter titled “Silicone Valley” that “…evidence was never presented that silicone breast implants caused any woman to suffer lupus, cancer, or another condition” (emphasis added). That is a statement so outrageously wrong that suggests that he never actually reviewed the data, and/or raises the possibility that Makary’s book or chapter was ghostwritten by a nonscientist.

Here are the actual facts: The largest ever study performed (nearly 100,000 patients) at the University of Texas showed that silicone breast implants are associated with a higher risk of certain autoimmune disorders, as well as stillbirth, scleroderma and melanoma.

Other adverse effects reported include connective tissue disease, which includes lupus, rheumatoid arthritis, severe muscle and joint pain, weakness, cognitive difficulties and fatigue as part of a constellation of symptoms referred to as “breast implant illness.”

Makary never addresses these substantial risks for his readers, nor the fact that the FDA, which Trump has selected him to lead, has multiple dedicated webpages warning Americans about the legitimate and significant risks of silicone and other breast implants. That’s the real sin, as it appears that Makary is wholeheartedly endorsing an obviously dangerous product to his uneducated readers.

Estrogen and Hormone Replacement Therapy

After dismissing long-standing and clearly established cosmetic breast implant risks, Dr. Makary takes a hard, heavily biased stance supporting Hormone Replacement Therapy (HRT), while fully ignoring arguments opposing that practice. Despite the well-published dangers, Makary promotes HRT not just to reduce symptoms of menopause, but to also to delay the onset of Alzheimer’s disease; prevent cardiovascular disease and heart attacks; and reduce colon cancer risk.

Thus, Markary writes that “women taking estrogen have a 35% lower incidence of Alzheimer’s.” Makary then references a 40-year-old survey review of 8,877 women in a southern California retirement community who died between 1981 and 1992.

In that study, researchers examined death records and found a mere 248 mentioning Alzheimer’s or other forms of dementia, with about 35% more mentions in women who had not taken HRT compared to the group that had. Obviously, neither the methodology nor the small patient sampling could every be considered conclusive or compelling enough to make a recommendation to patients.

Additionally, observational findings are never a substitute for a double-blind controlled study, which is the scientific and medical standard for obtaining conclusive findings. Makary’s cited observational questionnaire study also relies way too much on elderly patients with supposed memory/cognitive problems to accurately self-report and comprehend questionnaires.

On top of that, this sort of observational study would have dozens (at least) of unmeasured and unidentified confounding health variables even if they were reported accurately. Still, Makary casually cites it in his book to his readers as if it were fully proven fact, despite his cited findings being nowhere near conclusive. In fact, even the above linked study’s authors state in their paper that their findings are not conclusive.

To further support his one-sided argument for HRT, Makary cites another observation study, the Nurse’s Health Study from 1991, updated in 2000, to claim that HRT reduces the risk of heart disease. The Nurse’s Health Study documented the self-reported health habits, treatments, and outcomes of over 70,000 nurses over two decades.

While it’s possible that nurses are more accurate self-reporters, the study is still observational. Nevertheless, Makary declares “heart disease is the leading cause of death in American women. HRT reduces that risk by about 50%,” despite that study’s findings contradicting many other HRT studies.

In contrast, a randomized controlled clinical trial (superior to observational study data), found that there were no cardiovascular benefits to women taking HRT. In fact, it showed the exact opposite—that HRT significantly increased the risk of stroke and blood clots along with the overall incidence of heart disease. Although that finding was just below the 95% confidence interval for significance, it was still very clinically significant.

Makary’s Book Contradicts Established Cochrane Findings on HRT

The Cochrane Collaboration is an international, not-for-profit organization that aims to help people make well-informed decisions about health care by preparing, maintaining and promoting the accessibility of systematic reviews of the effects of health-care interventions. Cochrane systematic reviews are prepared according to predefined, explicit methodology, and published in The Cochrane Library. Cochrane is considered one of the most highly credible sources of healthcare information.

The Cochrane reviews are well-regarded as exhaustive clinical and scientific reviews of all data, and Makary’s book makes clear that he’s familiar with and respects the Cochrane reviews…yet he ignores them.

A decade ago, the Cochrane’s review wrote “[Our] results showed no evidence that [HRT] therapy provides any protective effects against death from any cause, and specifically death from cardiovascular disease, non-fatal heart attacks or angina, either in healthy women or women with pre-existing heart disease. Instead, the findings showed a small increased risk of stroke for post-menopausal women.” (Emphases added)

Makary’s “Blind Spots” has a ‘blind spot’ for Cochrane’s exhaustive analyses. Makary ignores all risks and changes the argument, stating that HRT presents no risk of cancer—even though several of the latest analyses of available data examining over 27,000 women showed the opposite is true.

“In the Women’s Health Initiative estrogen plus progestin trial…mean follow-up of eight (8) years, breast cancer incidence was increased.” These studies also found that the breast cancer risk declined following discontinuing HRT.

Cholesterol and Heart Disease

Makary’s claims regarding heart disease are also questionable. He dismisses generally accepted and scientifically proven causes of heart disease, as well as preventative measures such as regulating cholesterol and fat intake, despite data dating back over half a century showing that people who have high cholesterol and have had a prior heart attack greatly benefit from drugs that modulate cholesterol and vascular function.

According to Dr. Makary, patients should dismiss the five-decade-standing recommendations to avoid cholesterol-laden and high-fat foods. In other words, he dismisses cholesterol intake as a factor in heart disease. It’s an unscientific stance for any physician to take, let alone one who will be leading food regulation and have a prominent role preventing the obesity epidemic in America.

I also question Markary’s evaluations of home childbirth, a subject on which he has zero clinical trial experience, zero government experience, zero and large-scale leadership experience. His stances on everything else the FDA regulates, including food, devices, biologics, tobacco, cosmetics, veterinary products, radiation-emitting devices, concern me, too. There are also valid questions about Makary’s entire history regarding mRNA shots for COVID.

When it comes to blind spots in the practice of medicine, Makary seems to have no shortage of his own. Given the position to which he’s about to be elevated, his history should concern all Americans, yet he will likely be approved by senators who don’t know any better.

While America is winning with Trump and MAGA appointees, we will lose with Martin Makary as FDA commissioner.

Benjamin Rushe is a pseudonym.