Personalized medicine

It appears that the completely archaic notion of mass-produced drugs for the average patient is about to change (1). The manufacturers paid lip service to personalized medicine for nearly a century and it was clear that their heart or business models were never in it. The normal function may have done as much damage to humanity as nuclear weapons, for those who adhere to it blindly believe in averages and standard deviations based on a manufactured construct. The only redeeming quality of humans is that they are different and diverse. As the men in power separate the weak from the wealthy, the struggling from those who never struggled, the golfers from those who cannot afford a club, the academics from practitioners, the atheists from the religious, the North from the South, the West from the East, they miss an important point - every human on Earth is different, regardless of the visible features they exhibit or where they originate from.

The design of clinical trials seems to fail this basic notion. Pushing humans through protocols like cattle through a food manufacturing company is not the best way to discover drugs. It is certainly the best way to reduce costs and to prove to the regulators that something important has been done. In the process, they left large underserved populations in the lurch and pumped those who take the medicine with a dose that is suboptimal. Emerging technologies are immensely capable to figure out who will benefit from a drug and who will not and at what quantity. It is time statisticians left the industry as their contributions do more harm than good, not unlike the insurance industry, clinging to actuarial tables.

Now, available technology can titrate every individual to the optimal dose and we do not need, "population statistics," to approve or to disapprove drugs. If the regulators do not return to school to learn what has been happening, they will continue to make bad decisions.

(1) Digitization of multistep organic synthesis in reactionware for on-demand pharmaceuticals

Philip J. Kitson, Guillaume Marie, Jean-Patrick Francoia, Sergey S. Zalesskiy, Ralph C. Sigerson, Jennifer S. Mathieson, Leroy Cronin*

The dawn of non-invasive diagnostics

Recent news that a single blood test could provide the diagnosis of eight common cancers with 99% specificity (1) is a constant reminder that medicine is still stuck in archaic and invasive procedures to detect, diagnose and treat ailments. With a high concentration of human resources in provider settings, medicine has been slow in embracing emerging technologies and ideas, outside the domain. And this attitude is shared across the healthcare value chain including manufacturers, payers, and regulators.

It is unfortunate. Granted, Biology still remains to be the arena where humans could not progress exponentially. Their brains, with millions of years of deterministic training, have been well specialized to dominate engineering and chemistry. However, they could not understand the marvelous machines assembled by nature from a single cell organism to somewhat more complex humans, with any level of precision. Nature has had time to perfect designs of such beauty and humans, ever curious, have been trying to walk up to the cup of knowledge. But it has not been. Fossils indicate attempts at brain surgery many hundreds of thousands of years ago and despite higher structural knowledge, we have not advanced sufficiently to a differentiable plateau. In most simpler fields, we have demonstrably shown that humans are the weak links in decision processes - from transportation, energy, manufacturing and even, finance.

It is a conundrum. We are stuck - great strides in deterministic sciences do not translate into domains of high uncertainty and diversity. And, those who practice in these complex domains seem to have their blindfolds on as if they have nothing more to learn.  Diagnostics could provide the impetus to move higher - serum and stool harbor such information content, it is a shame we have not figured it out.

(1) Detection and localization of surgically resectable cancers with a multi-analyte blood test

1.        Joshua D. Cohen1,2,3,4,5, Lu Li6, Yuxuan Wang1,2,3,4, Christopher Thoburn3, Bahman Afsari7, Ludmila Danilova7, Christopher Douville1,2,3,4, Ammar A. Javed8, Fay Wong1,2,3,4, Austin Mattox1,2,3,4, Ralph. H. Hruban3,4,9, Christopher L. Wolfgang8, Michael G. Goggins3,4,9,10,11, Marco Dal Molin4, Tian-Li Wang3,9, Richard Roden3,9, Alison P. Klein3,4,12, Janine Ptak1,2,3,4, Lisa Dobbyn1,2,3,4, Joy Schaefer1,2,3,4, Natalie Silliman1,2,3,4, Maria Popoli1,2,3,4, Joshua T. Vogelstein13, James D. Browne14, Robert E. Schoen15,16, Randall E. Brand15, Jeanne Tie17,18,19,20, Peter Gibbs17,18,19,20, Hui-Li Wong17, Aaron S. Mansfield21, Jin Jen22, Samir M. Hanash23, Massimo Falconi24, Peter J. Allen25, Shibin Zhou1,3,4, Chetan Bettegowda1,2,3,4, Luis Diaz1,3,4, Cristian Tomasetti3,6,7,*, Kenneth W. Kinzler1,3,4,*, Bert Vogelstein1,2,3,4,*, Anne Marie Lennon3,4,8,10,11,*, Nickolas Papadopoulos1,3,4,*