Existing Problems

The Centralization of Modern Medicine

Traditional organizations have a strict hierarchy. Bureaucratic hurdles abound. As importantly, many traditional organizations tend to scale back an important factor that made them successful in the first place: research and development (R&D). In fact, a study in 2019 showed that these large pharmaceutical companies did not actually invent most of the drugs they sell. Indeed, it appears they have already reduced their investment in the discovery of new medicines.

This is because the development of precision medicine is currently centralized.

  • Most of the financial power, R&D, and actual development of precision drugs lies in the United States of America and the United Kingdom, partly as a result of an enhanced and globally competitive regulatory environment conducive to such developments. (3,4)

  • Within the US and the UK, most of the financial power lies in, and drug development is led by an “oligarchy” of very big and powerful companies. (5,6)

  • These big and powerful companies are de-facto monopolizing the precision medicine space. That’s because these institutions control most of the human genetic data that can be monetized within precision medicine.

As demonstrated by political oligarchies and their influence on a nation’s economy, monopolistic and centralized pharmaceutical companies equivalently lead to the stagnation of innovation; simultaneously widening the gap in providing precision medicine to underrepresented populations. Additionally, the middlemen in the process take a huge chunk of the profits when it comes to monetizing users’ genetic profiles; specifically, they can sell one individual’s genetic profile for thousands of dollars per record, with no consequential compensation to the rightful owner of that information.

The Lack of Representation in Medicine Research

Today, it’s clear that medicine is getting ever more precise, but certain populations stand to benefit more than others.

Research in medical genomics has focused mainly on individuals of European descent; leaving others such as Asians, Hispanics, and Africans,.. underrepresented in their access to the benefits derived from precision medicine.

In a new study (8), researchers analyzed over 20,000 clinical trials and found that over half of the clinical trials did not report race or ethnicity data and that the trial participants recruited were generally not representative. The representation of marginalized people based on their race or ethnicity continues to be poor but does show some signs of slow improvement. Only 43% of the trials reported data on race or ethnicity. Where data were reported, marginalized groups are taken as a whole — including, Black people, Hispanic/Latino people, Asian people, American Indian people, and “Other/Multi” — were underrepresented.

“About 71% of US adults use some form of sun protection when outdoors on a warm, sunny day – an increase of 3% from 2008.”

However, despite public health initiatives to increase the use of sunscreen, the benefits of this may only be seen by a select few members of the population. According to the largest study (9) (to date) in different racial and ethnic populations across the US, there was no evidence to support the association of UV exposure and melanoma incidence in black or Hispanic populations – studies assessing the association of UV radiation and melanoma exclude patients of darker skin types.

People of African, Latino or indigenous ancestry are underrepresented in many major genome studies, according to a new analysis (10), which notes that these minority groups make up less than 4 percent of the 35 million samples from 2,511 studies in the Genome-Wide Association Study (GWAS) Catalog. The continued under-representation of populations of mixed ancestry or of people whose ancestry is not European is a problem.

While there has been an improvement in the diversity of representation within medical research, it’s clear that the gap is still large and potentially consequential. That’s because the underrepresentation as mentioned above has already provided numerous examples of negative real-world clinical consequences. One example is the usage of Clopidogrel (Plavix), a standard first-line medication used to prevent heart attacks and strokes. Research has found that, due to genetic differences, individuals of East Asian descent have a higher risk of heart attacks or strokes when they take Plavix.

Despite facing worse health outcomes, marginalized populations are often left out of studies and clinical trials and miss the opportunity to participate in research on potentially life-saving treatments.

The Existing Barrier to Clinical Trials & Starting a Precision Medicine Initiative

The R&D process for new drugs is lengthy and costly, with a high risk of failure. Less than 12% of the candidate medicines that make it into phase I clinical trials are approved by the FDA. (11)

According to a report on clinical trial costs (12), the average cost of phases 1, 2, and 3 clinical trials across therapeutic areas are around $4, 13, and 20 million respectively. Pivotal (phase 3) studies for new drugs approved by the Food and Drug Administration (FDA) of the United States cost a median of $41,117 per patient.

A typical CRO clinical trial budget: Understanding the main cost sections. CROs may structure their budgets in different ways, proposing different rates. Nevertheless, clinical trial quotations normally include the following cost sections:

  • Regulatory affairs

  • Site identification and selection

  • Site contracting and payments

  • Site initiation and activation

  • Site management

  • Onsite monitoring

  • Drug safety management

  • Drug logistics

  • Biological sample logistics

  • Clinical supplies logistics

  • Medical writing

  • Site close-out

  • Project management

  • Study files/document management

  • Data management

  • Statistics

  • Quality control

  • Communication with central CRO/sponsor

  • Pass-through costs

According to a recent report by PhRMA (13), the Pharmaceutical Research and Manufacturers of America, it takes on average at least 10 years to bring a new medicine to market. Additionally, some studies have estimated that it takes between $2 billion to $3 billion on average to bring a new drug to market, other reports suggest the cost is much higher.

“If you look at total R&D spend over a period of time and divide it by the number of new drug products produced, the numbers quickly approach the $5 billion to $8 billion range.”

An often-used example of early success in precision medicine is targeted therapy for a small subset of patients affected by cystic fibrosis, a common genetic disorder that leads to premature disease and disability. However, the price tag of the drug can be around $300,000 per year per patient (14). Economic considerations can have major implications for differential access to such treatment for families, communities, and society at large.

Last updated