Personalized, precise care

The ABCs of Biotech for Christians - Seventeenth in a series - P is for Pharmacogenetics

We hear about the Human Genome. Is there only one? Do all humans have the same one?

Clarification: The human genome is the complete set of nucleic acid sequences for humans, encoded as DNA within the 23 chromosome pairs in cell nuclei and in a small DNA molecule found within individual mitochondria. But each person’s genome is unique.

Pharmacogenomics, also called Pharmacogenetics, is the study of how genes affect a person’s response to drugs. “This relatively new field combines pharmacology (the science of drugs) and genomics (the study of genes and their functions) to develop effective, safe medications and doses that will be tailored to a person’s genetic makeup.” It is part of the field of precision medicine, which aims to treat each patient individually. (ref)

Because of the variation in human genomes, tailoring a drug to an individual can be an expensive project. However, progress in this special area of biotech is being made to lessen the individual expense. Identification of genetics variations that are associated with disease susceptibility and drug responses among individuals (“markers”)1 are being researched, and there have been some discoveries for specific therapies like warfarin, taken by many for blood coagulation.

Efforts to validate pharmacogenomics based algorithms for warfarin dosing have shown that such algorithms can improve the accuracy of dose prediction. However, converting theoretical benefit into validated clinical benefit has proven difficult… (ref)

This statement describes a difficulty with pharmacogenetics; it is hard to prove that the money spent on development is well spent, which brings us to a brief list of the challenges to the quest.

  • Evidence. There is not a weight of evidence that patient outcomes are significantly affected by individual therapies made possible through pharmacogenetics.
  • Reimbursement. The need for payment approved by insurance companies.
  • Integration into the electronic health record. (Not enough fields for the data, I guess.)

That last one seems funny but must be a real problem for those who have to make it all work. (ref)

A wonderful friend who sits near me at church, was recently diagnosed with pancreatic cancer. After trying some health supplements, he chose to have chemotherapy at one of the Cancer Centers of America that offers the pharmacogenomic approach to treatment. This hospital is not very near his home, but the doctor in his hometown was brutally negative in his prognosis, and it drove him and his wife away.

Hope is a critical element of illness. Without it, there is no point in trying to get well. Any doctor can at least say, “Let’s all pray. God is still a God of miracles.” A true statement.

My friends experienced the warmest of receptions at CTCA and a hope for the future. Its website gives easy-to-understand explanations about the drug therapies given for pancreatic cancer (and other ones), so that a person can figure out what is going on when they get a treatment or take a pill. Some of these medicines are listed in the FDA’s table of biomarkers, showing that they have been studied for individual or groups with similar profile for genomic efficacy. (ref)

CTCA also advertises that they participate in clinical trials to offer patients innovative treatment options. The local doctor could have said that if a treatment were not to help, he knew of other avenues.

Back to the topic of Pharmacogenomics: the major criticism seems to be its cost to benefit ratio.

None of us can know if we will be faced with a decision to pursue an expensive route that could hold more promise than the one-size-fits-all offer. I am glad that my church has provided as much assistance as possible for our couple with this tremendous need.

It comes to my mind that individual support for human suffering and need is perfectly carried out by the body of Christ in the local church. The member whose intimate identity is known finds help in the arms of the Lord through his people. This is the most precisely perfect care that is possible to have.

1 The Food and Drug Administration (FDA) monitors drug safety in the United States. It now includes pharmacogenomic information on the labels of around 200 medications. https://www.fda.gov/Drugs/ScienceResearch/ucm572698.htm This information can help doctors tailor drug prescriptions for individual patients by providing guidance on dose, possible side effects, or differences in effectiveness for people with certain gene variants.

To A Mouse in 2018

The ABCs of Biotech for Christians - Fourteenth in a series - M is for Mice

As early as the 16th century the lowly mouse was used in scientific experiments. Today, approximately 95 percent of all laboratory animals are mice and rats. This video (only a minute) explains why mice are so useful in biotech research.

PETA says there are 100 million mice and rats used in lab experiments each year in the USA. A certain number of these are cloned, but that may not make you feel happier for the mice.

Mice… “are remarkable tools.”

A quick look at the list of Nobel prizes for medicine confirms their contribution: discovery of sulphonamides in 1939; penicillin, 1945; yellow fever vaccine, 1951; polio vaccine, 1954; cellular origin of retroviral oncogenes, 1989; HIV-Aids virus, 2008; not to mention prions in 1997. Each time mice played a key part. In the 1980s nearly one-in-three Nobel prizes for medicine were awarded to work on mice. …In genetics, cancer, immune response, embryonic and nervous systems and infectious diseases … in short in most fields, mice are valuable…

Alongside the success stories are accounts of expensive failures. (ibid) After all, mice are not human, so to view them as replicating aspects of our physiology in drawing conclusions for medicine and therapies does have limitations.

To overcome these, mice are altered to allow biotech researchers to better try out models for cures or to better understand the disease or anomaly under review. There are various ways to alter a mouse:

  • Breeding can enhance a particular trait for study
  • Mouse DNA can be modified to edit out a section or gene so that the mouse can be examined for its response to a drug based on its lack of a certain gene. Or, specific DNA can be activated for testing.
  • Mice can be genetically modified by introducing a gene in the germ stage (petri dish) of its reproduction so that it is “transgenic” and expresses human genes. Thus, it has become a new kind of creature. It is no longer a mouse.

Last week a number of news stories reported that the US FDA has signed a contract to purchase fresh human baby parts from aborted fetuses so that they can be transplanted into mice for research projects. The FDA notice stated, “Fresh human tissues are required for implantation into severely immune-compromised mice to create chimeric animals that have a human immune system.”

The slope is slippery. Three summers ago a national scandal erupted with videos published one week at a time beginning in July by the Center for Medical Progress (CMP), proving that Planned Parenthood (PP) contracted with biotech companies to supply body parts from aborted babies for research needs. The parts were sold for $50 to $100 or ?, who knows. This was presented by PP as money for necessary expenses in procuring the “tissue.” PP technicians were paid a bonus for intact specimens. It is against the law to sell or acquire human body parts for profit. (PP’s net assets in 2017 were $1.6 billion.)

legal rules for sales of human body parts

The public was stunned. Political action was demanded and some legislators sought answers from PP. The CMP videos proved that abortions were being performed to retain the integrity of certain organs, though this changed the procedure described in advance to the woman.

The method of suctioning out the fetus that destroyed recognizable parts was changed to removal by other means to retain the liver or thymus, for example. The women were asked to sign off on the plan to use their baby's body parts but were not remunerated. In other words, the money they pay for abortion helps to pay for the research done by biotech companies in need of fresh human tissue. The biotech investors no doubt really appreciate their generous contribution.

It would seem that all of the difficult undercover work of the CMP was for nought.

Robert Burns’ To A Mouse comes to mind, only quoting the final two stanzas:

…But Mouse, you are not alone,
In proving foresight may be vain:
The best laid schemes of mice and men
Go often askew,
And leave us nothing but grief and pain,
For promised joy!

Still you are blessed, compared with me!
The present only touches you:
But oh! I backward cast my eye,
On prospects dreary!
And forward, though I cannot see,
I guess and fear!

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...and every living creature that moveth, which the waters brought forth abundantly, after their kind, and every winged fowl after his kind ... the living creature after his kind, cattle, and creeping thing, and beast of the earth after his kind ...the beast of the earth after his kind, and cattle after their kind, and every thing that creepeth upon the earth after his kind: and God saw that it was good. -Genesis 1

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Flesh and Bone and The Protestant Conscience is an e-book on Amazon.com. It is 99¢ and in the Amazon lending library as well. The book description follows.

Would you let your conscience be your guide?

Does God care if the skin and bone of the dead are passed along to the living for medical uses? Is organ donation OK with God? Should you sign a Living Will?

Did you know that dead organ donors are often anesthetized before their organs are removed? Do you know the current definition of death? The conscience cannot function without facts.

As we ponder the ethics of in vitro fertilization, stem cell research and man-made chimeras, our thoughts trail off. How then should we live? (Ez 33:10)

How should a Christian think about euthanasia by starvation when doctors and the state attorney general all agree it is time to withhold feeding from a brain injured patient? Some things are family matters, but someday it may be our family.

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It offers a special focus on the doctrine of the Resurrection that is related to such decisions. Sunday School classes and Bible Study groups could use this book to facilitate discussion about the issues covered.