Shifting Goalposts in Pharma's Medicine May Put You in Direct Harm's Way
#34 2024 The Rowen Report
Dear Subsscriber,
The following was forwarded to me today in one of my discussion groups. It is on point and highly relevant. Please read and you will see from this wise physician, who published this in the Chicago Tribune, the mantra of Pharma to place people at unknown risk of a serious disease (Alzheimer’s) to a high risk of toxicity from expensive patented drugs when most will never need the drug to begin with.
This is akin to Pharma inventing all kinds of diseases to capture a market where they are not needed hardly at all – pediatrics. Or Pharma continuing to push ways to redefine “high cholesterol” so all of us will “need” their poison statins, when a cholesterol of 220-240 has the lowest mortality rate. Or redefining healthy hemoglobin A1c, so that we are all diabetic.
I agree, this is horrifying. I will have one more comment after you read his piece.
To Your Excellent Health,
Robert Jay Rowen, MD
BY ANAND KUMAR. Published in Chicago Tribune:
When I turned 60, my primary care physician said something profound: “There is no reason for someone to wake up in this day and age and find that they have advanced colon cancer.” It was a nudge in the right direction.
Early detection and early intervention have been medicine’s mantra for the past several decades. Medical societies recommend colonoscopy and mammograms, for example, to individuals who are at minimal risk. This is based on the presumption that the biological processes that lead to the disease begin years, if not decades, before the disease becomes manifest. Detecting the disease in its “preclinical” state will result in early treatment that will prolong and improve the quality of life.
In the case of Alzheimer’s disease, some of the biological processes responsible for the condition are also presumed to begin two to three decades before the early symptoms of the disease first appear.
Despite the multiple risk factors involved, two proteins found in the brains of Alzheimer’s disease patients — beta amyloid and tau — have dominated the interest of researchers, federal funding and pharmaceutical research support. Academic researchers, pharmaceutical companies, advocacy groups and branches of federal government have formed a team that argues for a central role for these proteins beyond what the objective scientific evidence currently supports.
A recent conference in Amsterdam, dominated by researchers with strong ties to the pharmaceutical industry, recommended updated criteria for the diagnosis of Alzheimer’s disease. Should these recommendations be actualized, individuals with no cognitive or behavioral symptoms will be diagnosed as having Stage 1 of Alzheimer’s disease if they test positive for amyloid. Cognitive abnormalities that can be documented will be required for a diagnosis only in the more advanced stages of the disease. If these criteria are more broadly adopted, many cognitively and behaviorally normal individuals in their 40s and 50s will be diagnosed as having the disease based on an amyloid test alone. This sets the stage for placing them on expensive medications with modest therapeutic effects but serious side effects for a disease that many do not have and may never get.
Amyloid and tau are considered biomarkers for the disease — laboratory-based measures that are useful in diagnosing the disease, monitoring its progression and studying the impact of treatment. Levels of amyloid and tau can be detected using specialized brain scans; studies of cerebrospinal fluid, which cover the brain and spinal cord; and, more recently, blood tests.
But here is the critical caveat: Not all patients who have elevated levels of amyloid and tau will develop Alzheimer’s disease, and not all patients with a clinical picture consistent with the disease have elevated levels of amyloid and tau. In other words, these tests are not definitive by themselves and need strong clinical corroboration, and it is the totality of the picture — clinical presentation plus relevant testing — that is needed to confirm the diagnosis. There is evidence to suggest that a high proportion of patients in their 50s, 60s and 70s will test positive but will never develop the disease. The amyloid tests are not comparable to colonoscopies and mammograms in which a pathological report is used to corroborate imaging abnormalities before any intervention is made.
Further, in the case of Alzheimer’s, amyloid and tau serve as therapeutic targets for drug development. Over the past few decades, such efforts have disproportionately focused on compounds that reduce the levels of both proteins in the brain. The evidence that amyloid-lowering drugs have a meaningful impact in Alzheimer’s disease is modest, at best.
There are good and bad medical practices. This one is horrifying. The combination of an amyloid test, possibly just a blood test, and research demonstrating that the disease starts much earlier than the clinical presentation has shifted the discussion in favor of premature diagnosis, poorly applied public health principles and the potential use of expensive drugs with serious side effects in young normal adults. Labeling healthy individuals who have an abnormal blood test as having Alzheimer’s disease is scientifically unsound and ethically suspect, especially considering that many of them will never develop the disease. Neuroprotective agents should unambiguously protect neurons and be given only to individuals whose neurons need protection.
What society needs are biomarker-based tests that are validated and standardized using objective population health concepts and guidelines in order to determine how specific and sensitive they really are in individuals without cognitive signs and symptoms. This step is critical to preclude over interpretation of laboratory test results in broader populations.
We also need drugs that are demonstrably effective on meaningful, real-world outcomes while remaining affordable and free of life-threatening side effects. Simply put, the risk and cost benefit analyses need to be reasonable and acceptable.
Academic researchers, advocacy groups and relevant branches of the federal government have a moral and ethical responsibility in this regard. After all,
they are the entities funding and advancing this agenda. The scientific bar should be very high before we diagnose healthy individuals with Alzheimer’s disease. The implications of this diagnosis must not be trivialized.
Inappropriately diagnosing and treating typical Americans with expensive drugs that promise to “prevent” Alzheimer’s disease does not constitute scientific progress. It is a slippery slope that will get more slippery over time.
The saying primum non nocere, or “first do no harm” — attributed to the ancient Greek doctor Hippocrates — is one of the promises that graduating medical students make as they begin their journey. Let us never forget that promise. Let us work to gain the public trust.
Dr. Anand Kumar is a professor and head of the department of psychiatry at the University of Illinois at Chicago and past president of the American Association for Geriatric Psychiatry.
Rowen note: Please look at his last paragraph regarding the saying from Hippocrates. Yes, that is the oath and promise I took/made upon my graduation from medical school. In today’s world, I understand that the Hippocratic oath has been dropped into an oath to “evidence based medicine”, aka the Pharma gods. Also, please know that while the proteins mention are found in the brains of those afflicted with Alzheimer’s, no one knows if they are primary causes or simply the body’s reaction to say an infective or other primary cause. If your blood pressure is high, is it because of a lack of a Pharma drug, or perhaps a missing nutrient or lifestyle? And we know that BP drugs are not without toxicity!
“I swear by Apollo the physician, and Asclepius, and Hygieia and Panacea and all the gods and goddesses as my witnesses, that, according to my ability and judgement, I will keep this Oath and this contract:
To hold him who taught me this art equally dear to me as my parents, to be a partner in life with him, and to fulfill his needs when required….
I will use those dietary regimens which will benefit my patients according to my greatest ability and judgement, and I will do no harm or injustice to them….
Into whatever homes I go I will enter for the benefit of the sick, avoiding any voluntary act of impropriety or corruption, including the seduction of women or men …”
– Original Hippocratic Oath
“We will not permit considerations of age, disease, disability, creed, ethnic origin, gender, nationality, political affiliation, race, sexual orientation, social standing, financial status, or any other factors to stand between the care we seek to provide and our patients. …
We will always be truthful. We will not blur, omit, or fabricate information relevant to our patients’ care or to the effectiveness of the team.”
— Yale School of Medicine Class of 2018 Physician’s Oath
“I will give to my teachers the respect and gratitude which is their due. I will impart to those who follow me the knowledge and experience that I have gained.
The wholeness of my patient will be my first consideration.
Acting as a good steward of the resources of society and of the talents granted me, I will endeavor to reflect God's mercy and compassion by caring for the lonely, the poor, the suffering, and those who are dying.
— Loma Linda University Physician’s Oath
Final Comment: It would appear the respecting sexual orientation (which we should do anyway out of natural respect for any individual), or respecting one’s teachers (even when they are bought and paid for my Pharma) has become more important than doing no harm, or emphasizing diet, as found in the original oath.
It varies. Likely averaging 5 mg daily.
I am 73. Most of my friends with ‘normal’ BP, my age, are low energy/low liveliness. My friends with higher BP are far more vital. They are more alive, and they do more things. I think the 120/80 paradigm for BP might be fine for young adults. But 140-150/90-95 is better for elderly. A doctor told me he is seeing massive increases in early dementia starting about 10 years ago. Around then they lowered the threshold for putting someone on BP medication. So…tossing something out…as we age some people’s tubes get clogged, maybe thin out etc. in order to pump blood everywhere, including the brain, we NEED higher blood pressure. Without it the brain becomes energy and oxygen starved. And you get dementia.