The convergence of several unique trends, including:

- personalization of medicine on an “n-of-1” basis,
- adaptive clinical design,
- globalization of health care training,
- compassionate use legislative initiatives for experimental therapies,
- wider acceptance of complementary medical technologies,
- the growth of international medical travel,
and
- the fact that we globally spend $7 trillion annually ($1 trillion spent on pharmaceutical products alone, with $200 billion of new R&D) and have an absence of curative interventions for any chronic degenerative diseases via traditionally regulated channels

has brought this DIY bio-genie “out of the bottle”

The “safety argument” has been obliterated by the system’s own actions.

Today there are literally hundreds of FDA approved products that can:

- prolong QT and/or Cause Torsades De Pointes resulting in sudden cardiac death;

- which are IARC Group 1 and 2 carcinogens;

- which have significant ”black boxed” SAE warnings;

- not to mention the 2+ million ADEs (100K+ fatalities annually in U.S. alone) which come from products that have gone through decades of human testing.

Animal models remain poorly predictive for humans, yet remain a mandatory cornerstone behind years and millions of dollars of early drug development activities. Penicillin kills guinea pigs and produces birth defects in rats, aspirin is poisonous to cats, cancer has been “cured in mice” thousands of times, and dozens of drugs found safe in animals are later withdrawn from market due to adverse drug events in humans.

Additionally, we continue to spend billions of dollars on traditional “gold standard”, population level clinical studies, despite the fact that they use definitions of disease that are excessively inclusive (based upon disease characterizations from literally decades ago), while at the same time are excessively exclusive of major segments of the patient populace.

What people have begun to understand is that it is pretty much all a big gamble, any way you slice it – so why not become an “n-of-1”?

One only needs to survey the landscape where such dynamics exist in “stealth mode” in current society to see where these concepts are already permeating our lives.

From a therapeutic perspective, current FDA initiatives regarding expanded access, off-label use, “animal rule only” development, and botanical drugs, as well as their public written position on personal importation, all highlight examples of various degrees of clinical, “let the patient beware” freedom that the agency is quietly willing to grant subjects today who seek out such products or who engage in related studies.

Further afield from pharmaceuticals, markets such as dietary supplements, cosmetics, processed ingredient foods/beverages, tobacco, legalized marijuana, and pesticide/herbicide usage, all technically represent large, uncontrolled clinical experiments on the general public, that we all are quite willing to accept today as personal choices.

It is an interesting new era.

Ira S Pastor
CEO
Bioquark Inc