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Congress has opportunity to greatly improve pandemic strategy

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Joel Hirschhorn
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If precision medicine is the future of medicine, then its application to pandemics generally, and COVID-19 in particular, may yet prove to be highly significant. But its role so far has been limited. Precision medicine must consider more than just genetics. It requires an integrative "omic" approach that must collect information from multiple sources - beyond just genes - and at scales ranging from molecules to society.

The situation becomes yet more complicated for infectious diseases. Viruses and bacteria have their own genomes that interact in complex ways with the cells in the people they infect. The genome of SARS-CoV-2 underlying COVID-19 has been extensively sequenced. Its mutations are identified and traced worldwide, helping epidemiologists understand the spread of the virus. However, the interactions between SARS-CoV-2 RNA and human DNA, and the effect on people of the virus's mutations, remain unknown.

... there is an opportunity to begin gathering the kinds of data that would allow for a more comprehensive precision medicine approach - one that is fully aware of the complex interactions between genomes and social behavior.

The NIH has said: "The National Institutes of Health's All of Us Research Program has announced a significant increase in the COVID-19 data available in its precision medicine database, adding survey responses from more than 37,000 additional participants, and virus-related diagnosis and treatment data from the nearly 215,000 participant electronic health records (EHRs) that are currently available.

The specialty germane to a personalized-pandemic strategy is called pharmacogenomics. It is the study of the role of the genome in drug response. It combines pharmacology and genomics to discover how the genetic makeup of an individual affects their response to drugs, including vaccines.

It deals with the influence of acquired and inherited genetic variation on drug response in patients by correlating genetic factors of an individual with drug or vaccine absorption, distribution, metabolism and elimination. It deals with the effects of multiple genes on drug and vaccine response.

The central goal of pharmacogenomics is to develop rational means to optimize drug therapy, including vaccination, with respect to the patients' genotype, to ensure maximum efficiency with minimal adverse effects.

By using pharmacogenomics, the goal is that pharmaceutical drug treatments, including vaccination, can replace or at least complement what is dubbed as the "one-drug-fits-all" approach. Pharmacogenomics also attempts to eliminate the trial-and-error method of prescribing, allowing physicians to take into consideration their patient's genes, the functionality of these genes, and how this may affect the efficacy of the patient's current or future treatments (and where applicable, provide an explanation for the failure of past treatments).

An August 2020 journal article was titled "Pharmacogenomics of COVID-19 therapies." Here are its optimistic views and findings:

Pharmacogenomics may allow individualization of these drugs thereby improving efficacy and safety... Pharmacogenomics may help clinicians to choose proper first-line agents and initial dosing that would be most likely achieve adequate drug exposure among critically ill patients; those who cannot afford a failure of ineffective therapy. It is also important to minimize the risks of toxicity because COVID-19 particularly affects those with comorbidities on other drug therapies... We found evidence that several genetic variants may alter the pharmacokinetics of hydroxychloroquine, azithromycin, ribavirin, lopinavir/ritonavir and possibly tocilizumab, which hypothetically may affect clinical response and toxicity in the treatment of COVID-19... These data support the collection of DNA samples for pharmacogenomic studies of the hundreds of currently ongoing clinical trials of COVID-19 therapies. One of the biggest success stories in the field of pharmacogenomics was for a drug used to treat another, highly lethal, infectious disease: abacavir for HIV... In an acute illness such as COVID-19, pharmacogenetics would only be useful if the genetic test results were already available (i.e., pre-emptive pharmacogenetic testing) or rapidly available (i.e., point-of-care genetic testing)... In the face of unprecedented challenges posed by the COVID-19 pandemic, collaborative efforts among the medical communities are more important than ever to improve the efficacy of these treatments and ensure safety. Some large national COVID-19 trials are evaluating pharmacogenomics, which will inform the role of pharmacogenomics markers for future clinical use.

A July 2020 NPR show was titled "Research On Personalized Medicine May Help COVID-19 Treatments." This was deemed newsworthy:

The nationwide All of Us Research Program aims to tailor medical treatments of all kinds, including treatments that may be developed for the new coronavirus. So far more than 271,000 people nationwide have signed up to share data with the initiative. All of Us started under President Barack Obama in 2018 and involves institutions across the country.

"This is an exciting opportunity for our participants to have a direct impact on COVID-19 research, watching how their participation in this historic effort is truly making a difference," said Dr. Elizabeth Burnside. "This focused initiative could be especially important for members of communities that are often underrepresented in health research and who may question the overall and personal benefit of research participation."

In sum, there was legitimate medical interest early in the pandemic to use personalized medicine, in which drugs and drug combinations are optimized for individuals or certain population demographics. The central goal is minimization of drug and vaccine toxicities and adverse reactions and deaths.

But one thing is now clear. The personalized approach to managing the COVID pandemic has not been aggressively pursued by public health agencies. They have placed their resources and hopes with mass vaccination, both encouraged, coerced, and increasingly mandated. The hope that we can vaccinate ourselves out of this pandemic has lost credibility.

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Joel S. Hirschhorn is the author of Pandemic Blunder: Fauci and Public Health Blocked Early Home COVID Treatment, Delusional Democracy - Fixing the Republic Without Overthrowing the Government and several other books, as well as hundreds of (more...)
 

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