Human Error #404
On
I just read an interesting paper in Molecular Psychiatry (1) which beautifully illustrates the increasing power of analytical medicine and, at the same time, the profound error and danger of the pharmaco-centric model.
The authors, who represent nine research centres scattered around the USA, propose a brave new medicine for our brave new world. They point out that the incidence of mood disorders is increasing (although they are not interested in why this should be), and have focussed their work on identifying blood-derived gene expression biomarkers for these conditions.
From an initial set of 26 gene expression products they arrived at 12 which predicted and tracked depression, hospitalisation and suicidality; and a further 2 which predicted and tracked mania and bipolar disorders. They then cross-referenced these biomarkers against the known molecular targets of anti-depressant and other drugs.
From the above, they developed a diagnostic/prescribing/prognostic panel for doctors. This user-friendly little App shows docs which patients are depressed, which are likely to become depressed, which are likely to become suicidal and/or to require hospitalisation, and which drugs to give each patient before, during and after their illness. Precision engineering of mood states, brought to you by the most ethical of industries.
What could go wrong?
In a time of growing political coercion, and as the age of representative democracy fades silently into an age of deeply corrupt (2, 3) corporatism (sold to us as ‘multi-stakeholderism’), everything. The current move towards medical fascism may have started with Covid, but that was just a straw in the prevailing wind.
King Lear jetted into DC in September to sign an executive order adding measles to the list of infections for which a person can be forced to self-isolate ‘in order to protect public health’ (4). If this also protects the profits of Black Rock, Vanguard and the great families who own them, squatting like venomous toads behind poor Joe’s twilight throne, well that’s just a happy accident. Will Ebola be next? Herpes? HIV? Flu?
For those with a functioning long-term memory, when a child was diagnosed with measles (or mumps, or rubella) back in the day, we used to organise sickness sleep-overs. We fell ill, 99.9% of us recovered in a few days and we all developed life-time immunity, for free. What a missed money-making opportunity that was!
The incidence of serious adverse effects to the MMR vaccine is an order of magnitude lower than the incidence of illness or death due to measles, yet is still high enough for vaccine producers to have found it necessary to purchase total legal immunity from our thoroughly compromised political systems. This immunity has been extended to the much more dangerous Covid ‘vaccines’.
In connection with Covid, the fact that the ‘proper warning given before use’ proviso is manifestly being ignored in the current vaccine mandates creates, at the very least, grounds for legal challenge (ie 5). Unfortunately, given wide-spread regulatory capture in the wake of 1992’s PDUFA, which incentivised the FDA to play nice with Big Pharma (6-12), the move towards mandatory medicine is unlikely to stop with Covid and measles.
For example, as the numbers of biomarkers rise into the thousands, I predict that anyone with biomarker evidence indicating a risk of depression (as in the Mol Psychiatr paper) will eventually be required to medicate not just for their own sake, but for the public good. It will be sold as preventing more Parklands or Columbines. Think of the children, take Soma. You will own nothing but you will be happy.
This strategy is not only dystopian, it is also profoundly ahistoric.
Diagnoses of depression have increased 1000% or more in the last 50 years (13, 14). Our genes have not changed during this period.
The biomarkers currently under consideration may be relevant in today’s dysnourished and metabolically compromised population, but they obviously had little meaning in earlier (ie pre-transitional) populations. They will therefore have little diagnostic or prognostic value in vestigial groups, in the traditional blue zones and in the nascent Zinzino blue zone.
Consider a single nutrient such as vitamin C. As vitamin C levels in a population fall over time, increasing numbers of genes come to be associated with scurvy. When ascorbate levels close in on zero, all genes become risk-denoting. If increasing amounts of ascorbate are added to the food chain these genes are progressively removed from the equation until only an isolated few remain.
Nature and nurture can be analysed separately, but they cannot be separated.
In short, this latest American attempt to medicalise our future (1) is yet another example of a sampling error that undermines a good deal of pharmaceutical research. Their findings are valid only in dysnourished, compromised and diseased communities, like ours, which are rife with clinical and pre-clinical NCD’s.
The inconvenient truth is that thanks to the modern diet and lifestyle, healthy populations no longer exist; and all clinical research today is overshadowed by this intractable yet unseen confounder. The majority of subjects in active and placebo arms of clinical trials have multiple nutritional and therefore metabolic, physiological and cytological imbalances. This must affect outcomes in both arms, and the risk of adverse effects also.
One way round this would be to include in every trial a sub-group of individuals with pre-transitional nutritional profiles, split between active and placebo arms. This would be extremely expensive, although the likely reduced risk of drug-related adverse effects in well-nourished individuals would generate better safety profiles and a better chance of provisional licensing.
An alternative might be to conduct all clinical trials in blue zones, although this raises the prospect that any findings might not be considered valid for wider use.
The third and best strategy would be to create a new generation of ultra-processed functional foods to re-establish pre-transitional nutrition among today’s huddled and intoxicated masses. This would provide better health for all, except the drug cartels.
There are additional and urgent socio-economic reasons to shift to a more cost-effective, nutritionally literate model of healthcare. Another Black Monday is pending, and the resulting depression will likely be the end of welfarism. Our politicians will prosper, thanks to inside trading (15), as will the deeply corrupt companies that own them (2), but the rest of us will not be so lucky.
If the food companies won’t step up you can find a DIY guide* to sustained and inexpensive drug-free health elsewhere on this site.
*‘Let Your Food be your PharmacoNutrition’.
Next week: Guess who’s not coming to dinner
References
- Le-Niculescu H, Roseberry K, Gill SS, Levey DF, Phalen PL, Mullen J, Williams A, Bhairo S, Voegtline T, Davis H, Shekhar A, Kurian SM, Niculescu AB. Precision medicine for mood disorders: objective assessment, risk prediction, pharmacogenomics, and repurposed drugs. Mol Psychiatry(2021).
- https://www.zerohedge.com/political/whistleblowers-torpedo-facebook-and-pfizer-whos-next
- BMJ Investigation. Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial. BMJ2021;375:n2635
- https://doi.org/10.1038/s41380-021-01061-w
- https://www.cnn.com/2021/09/17/politics/biden-measles-quarantinable-diseases/index.html
- Davis v. Wyeth Laboratories, Inc., 399 F.2d 121 (9th Cir. 1968).
- Kinch MS, Haynesworth A, Kinch SL, Hoyer D. An overview of FDA-approved new molecular entities: 1827-2013. Drug Discov Today. 2014 Aug;19(8):1033-9.
- Angelika B, Kalra BS, Khirasaria R. Trends in FDA drug approvals over last 2 decades: An observational study. J. Fam. Med. Primary Care. 9; 105–114 (2020).
- Darrow JJ, Avorn J, Kesselheim AS. FDA Approval and Regulation of Pharmaceuticals, 1983-2018. JAMA. 2020;323(2):164–176.
- 2018 Specialty Drug Trends. Health Economics 2019. https://www.healtheconomics.com/resource/2018-specialty-drug-trends
- Bradbury A. Increase In Drug Approvals. Priority Reviews Points To Bright Future For CMO Industry. Outsourced Pharma. 15 Oct. 2019.
- BioPlan Associates Notes Another Record Year For Drug Approvals From U.S. FDA; 35 Approvals In 2019. Biosimilar Development. 22 Jan. 2
- Horwitz AV. How an age of anxiety became an age of depression. Milbank Q. 2010 Mar;88(1):112-38.
- Lee S, Tsang A, Zhang MY, Huang YQ, He YL, Liu ZR, Shen YC, Kessler RC. Lifetime prevalence and inter-cohort variation in DSM-IV disorders in metropolitan China.Psychol Med. 2007;37:61–71.
- Jagolinzer AD, Larcker DF, Ormazabal G, Taylor DJ. Political Connections and the Informativeness of Insider Trades. J Finance 2020 75(4); DOI 1111/jofi.12899