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Heritable modifications could have unintended and far-reaching consequences for human evolution, genetically (e.g. gene/environment interactions) and culturally (e.g. social Darwinism). Altering of gametocytes and embryos to generate inheritable changes in humans was defined to be responsible.
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Viral vectors carry the risks of toxicity, inflammatory responses, and gene control and targeting issues.
Some commonly occurring disorders, such as heart disease, high blood pressure, Alzheimer's disease, arthritis, and diabetes, are affected by variations in multiple genes, which complicate gene therapy.
Some therapies may breach the Weismann barrier (between soma and germ-line) protecting the testes, potentially modifying the germline, falling afoul of regulations in countries that prohibit the latter practice.
Alipogene tiparvovec or Glybera, e.g., at a cost of $1.6 million per patient, was reported in 2016 to be the world's most expensive drug.
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