If you just consider a single disease state, type 2 diabetes, there are over 100 different medication names to choose from and these medications come from ten different classes of drugs. The list is growing all the time. That brings up an important point for me. I remember in my training many years ago having this thought. There must be a right way to do this. All treatments cannot be equally beneficial. I asked my professors about it, and they said, “No, there is no best way. There are many ways to treat diabetes and as you face each new patient, you just pick one based on the needs of that patient.” That never made sense to me. It still doesn’t, and there are more and more people who agree with me. There is a way to settle the question and that involves comparing what happens to patients when they use a particular approach. It is all about the data. As you can see in the slide above, the way you treat diabetes makes a huge difference.
Some leaders in our current medical system don’t agree with me. When I tried to use the term “optimal medical therapy” (OMT) in a recent letter to the editor at the New England Journal of Medicine, they told me that I could not use that language. They would not allow me to use the term “optimal medical therapy” and substituted instead “appropriate medical therapy” which is not the same thing at all. Appropriate means “suitable, compatible, or fitting.” Optimal means “best or most effective.” Their objection was “optimal as compared with what and according to whom? What does it even mean?” Defining and promoting the idea of best or most effective medical therapy has been to focus of my entire professional life.
As I said, there are over 100 medications that are approved to treat type 2 diabetes. Any of those drugs is appropriate to lower the sugar, and that is the way most medical professionals think about diabetes. But we have proof that thinking does not work. The largest, NIH sponsored study of patients with type 2 diabetes, the ACCORD trial, tested that thinking. My team had 180 patients in that trial. I am very familiar with it. More intensive treatment of high blood pressure, and high cholesterol did not lower cardiovascular events or death compared to less intensive therapy. More intensive therapy to lower blood sugar killed more people. The cholesterol study compared statin alone vs statin plus fenofibrate. The blood pressure and sugar arms of the study could use any drug approved for the purpose. That would be “appropriate care” and that did not work.
The ACCORD study was terminated early in 2008. There was another study, the Steno 2 trial, with the same objective, targets, and methodology as ACCORD published, and it provided massive benefit to high-risk patients with type 2 diabetes. It was reported that same year after 13 years of follow-up, and this was an optimal medical therapy trial. The investigators had aggressive targets for blood pressure, cholesterol, and sugar control just like ACCORD, but they also specified that specific drugs should be used to achieve those targets. Instead of more people dying, fewer people died with optimal medical therapy. Compared with usual, appropriate care, the patients on OMT had one fourth as many heart attacks, one fifth as many strokes, and one sixth as many people went on to dialysis.
Treatment in Steno 2 was very specific. All obese diabetics received metformin for their glucose, statins for their cholesterol, and specific medications for blood pressure. “As mentioned, all patients were prescribed an ACE inhibitor or an angiotensin II–receptor antagonist because of the presence of microalbuminuria. If a patient had hypertension, thiazides, calcium-channel blockers, and beta-blockers were added as needed.” ACE inhibitors, statins, and metformin all reduce cardiovascular complications more than other medications that achieve the same risk factor control. There are better ways to treat diabetes and other cardiometabolic conditions. The data here supports that.
The New England Journal of Medicine may be the most influential journal in all of medicine, but other influential bodies don’t share their view. The National Academy of Medicine advises the government and other major institutions on healthcare policy. They recognize that chronic diseases cause most death, disability, and costs and that our system does a very poor job in dealing with those conditions. They don’t sugar coat it. “Between the health care we have and the care we could have lies not just a gap, but a chasm.” We are not even close to where we need to be! But they did not stop there, they produced an entire book, a road map to better care. They identified fifteen chronic diseases to focus on and they made very specific recommendations about how to treat them. “Stakeholders should develop evidence-based care processes consistent with best practices.” That sounds like optimal medical therapy to me.
Great Britain has followed that advice, and they live longer for half the money. Here is their guidance for the management of stable heart artery disease. “Offer people optimal drug treatment for the initial management of stable angina. Optimal drug treatment consists of one or two anti-anginal drugs as necessary plus drugs for secondary prevention of cardiovascular disease. Consider revascularisation (coronary artery bypass graft [CABG] or percutaneous coronary intervention [PCI]) for people with stable angina whose symptoms are not satisfactorily controlled with optimal medical treatment.” An entire country understands what OMT is.
I understand why so many Americans are upset with our institutions and don’t trust them. Just a very few people control what gets published in medical journals. We need extensive changes in the way we manage chronic diseases in this country and that is why I write on Substack. Here, I am free to tell the story as I understand it, and I hope that you find it valuable. Where you get your medical information makes a difference.
Bill, your struggle proves how corrupt the legacy medical racket truly is. The monopolist 19th-Centruy backward, dumpster-fire allopathic medicine, I called a "late-stage-sickness-seeking-profitteering- kabuki-dance-theatric" sponsored by the medical industrial complex, is not merit-based, but instead driven by the greed of a few on the top of the food chain. Their decision-making is not "patient-centered" at all. I found this out in the 1990's. I walked away in 1998 to create a permanent solution: Premier Heart's Multifunction Cardiogram technology platform to usher in the new era or Med. 3.0, where a merit-based and patient-centric healthcare delivery system is the goal.
The bottomline, the broken legacy system is rotten to its core. Time to replace it.