• Paul Allard

Companion Diagnostics: Has Big Pharma Really Bought In?

It seems that the drug industry should be viewed as “Angels” and “Demons”. There can be no denying that people live longer today and prescription medications, prescribed by well-trained physicians, play a significant role in longevity. For anyone contemplating the role of the pharmaceutical industry in human health, consider what might happen if the flow of drugs – both over the counter and ethical drugs – were shut off tomorrow. How many would die? And how long would it take to see the effects? And how much would the quality of life decrease for millions of prescription and OTC drug users?

But there is another side to the pharma coin. Patients have been harmed and lives have been cut short as a result of side effects of medications. Many new medications have astronomical costs, and there have been examples of the same kinds of corporate greed that we have seen with financial and other industries. As people, it is our natural bias to focus on the negative, and ignore the millions of lives saved every day, not only by ground breaking new discoveries, but by old standby drugs like beta blockers and aspirin. As a result, pharmaceutical companies today are often viewed negatively by the American people. In fact, in a recent Gallup Poll the Pharma industry ranked 24th out of 25 industries with only the Federal Government ranking lower. In these moments these companies are often not celebrated as they should be.

So knowing that drug companies offer a very human portrait of what the world really is, good and bad, do they really embrace companion diagnostics? An IVD (in vitro diagnostic)companion diagnostic device is an in vitro diagnostic device that provides information that is essential for the safe and effective use of a corresponding therapeutic product. These tests are essential to the development and implementation of personalized medicine. A model of medicine that accounts for the differences from person to person, according to their genetic variation, disease presentation, and predictability of whether a drug will work in a person or not. Personalized medicine through companion diagnostics is the key to providing the highest level of care to patients.

However, from a business standpoint, it reduces the number of patients that are eligible for a given therapy. Which does in fact reduce drug sales. The FDA has taken on the role of enforcing accountability of Pharma companies by requiring them to use companion diagnostics when a drug therapy requires a blood test, to determine patient eligibility for a therapy. However, is government regulation enough for a Big Business to do what’s best for the people they are tasked with helping?

Or, are complimentary diagnostics the escape hatch to avoid losing sales? Again, how can we work together to put patients first from enrollment into clinical studies, to routine medical practice, and beyond? Will millennials willingness to sacrifice financial gain, and interest in a less stress life, be the push that is needed to move personalized medicine to the forefront of healthcare?

Coming Soon: The difference between complimentary and companion diagnostics.

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