Companion Diagnostics – Partnering for Personalized Medicine

Industry Insights from Paul Meade, M. Sc, MPH

When the Human Genome Project was finally completed with the mapping of the genetic sequences of our DNA, there were many predictions about how the face of medicine would change forever. We would finally figure out how to cure diseases linked to genetic aberrations, find ways to enhance our interaction with the environment, and develop medicines that are tailored to fit our unique genome. But a decade later, we are all aware of just how painfully slow progress has been to date. However, one area that is advancing steadily is the use of companion diagnostics.

Everyone was quick to point to Herceptin and the prototype example of a diagnostic test that was required to be use prior to prescribing this chemotherapeutic agent for women with breast cancer that over-expressed the HER2/neu gene. But now there are more examples of such companion diagnostics, and the list continues to grow.

What does all this mean for the future of medicine, and the interaction among the diagnostic and biopharmaceutical companies? When we can go to a physician’s office, be correctly diagnosed, and then given a medicine to take knowing in advance that we will have a high probability of responding, without suffering from annoying side effects, then we will have personalized medicine.

Does that mean that people will have their own “designer” drugs specific to their unique genome? No, of course not. But it does mean that based on your similarity to a known genetic type, or genotype, your response to the medicine will be highly predictable, and therefore “personalized” to your specific needs. Thus, many drugs introduced in the future will have a unique companion diagnostic that will inform a specific response, and the cost benefit of taking such a drug will increase tremendously. As the old saying goes, “the most expensive drug in the world is the one that doesn’t work!”

Does that mean that companion diagnostics will be forever married to new therapeutic agents? Not really. As our knowledge of population genetics expands, and our characterizing of many different genotypes increases, we will likely get to the point whereby known genotypes will be mapped to known therapeutic agents, and the need for each new product to have its own companion diagnostic will diminish with time. But until then, expect to be given both a test and a prescription when you are treated at your nearby physician’s office. The road from general to personalized medicine is a long one that will take a great deal of research. But once we get there, the administration of medicines will gain a huge leap forward in effectiveness and efficiency.

Ethics of Gene Therapy to Dominate Healthcare Landscape for Years to Come

Industry Insights from Paul Meade, M. Sc, MPH

During my recent studies for an ethics certificate, I encountered several ethical issues that stimulated my thinking about the future of healthcare.

I would like to address an ethical issue that I feel will dominate the healthcare landscape for the next several decades, in the area of genetics.

With the completion of the Human Genome Project and the mapping of mankind’s blueprint of life, we are beginning to gain a greater understanding of what makes us human. One logical extension of this “knowledge of life” is the ability to control or manipulate life itself. Gene therapy will give us the ability to not only modify our genetic predisposition to diseases, but also to enhance lifestyle abilities. No one would argue the ability to change one base-pair and eliminate Huntington’s disease from an unborn child, but how far is one willing to go to be taller, more athletic, have a gift of music, or become a genius. Who will decide what genetic alterations are acceptable to a society? And who will qualify to have such manipulations—only those that can afford to pay?

The ability to manipulate our genome is the ability to control human evolution itself. No more will we need to rely on random chance and Darwinian principles, such as natural selection–we will be able to control our own evolution. The future generations will undoubtedly be faced with ethical decisions unlike any have ever had to face before in the medical field. Who will develop guiding principles? Will there be a global standards, or country-specific directives? Whose decision will it be—the individual’s or that of society in general?

There have been fears of stem cell research, not for its promise to cure horrific diseases, but for its potential to be abused for frivolous causes. Will someone try to create a master race? Will someone create the perfect warriors and conquer other countries? Will someone create a race of highly intelligent humans who will attempt to dominate others?

Another aspect of controlled evolution might play out with regard to healthcare delivery. Who will receive special benefits of genetic manipulation? Will drug addicts have gene therapy to eliminate the gene that results in addictive traits? Will some people be deemed undesirable to receive healthcare because their respective genetic profiles are substandard?

One other ethical concern I have is the linkage between genotypic expression and phenotypic expression. While it might be somewhat possible to hide one’s genotype from public scrutiny, but once certain genotypes are linked to a phenotypic expression, then they becomes impossible to hide. The concern here would be one of overt discrimination and bias against certain groups based on the visible expression of their genotype. All of these ethical issues will confront the next few generations. Bioethics will certainly expand in the future.

Paul Meade is the founder and president of Thought Leader Select. He received a master of public health degree in the spring of 2010 from the Gillings School for Global Public Health at the University of North Carolina at Chapel Hill.  Meade also earned a certificate in ethics from the Gillings School’s Public Health Leadership Program.