Food and Drug Administration

Clearing the way for Personalised Medicine

Adrian Life Sciences & Pharma, Opinion and Analysis, US Economy 1 Comment


In “Ride the Wave”, Fred Rogers and Richard Lalich point to the huge potential of personalised medicine based on bio-information. Knowledge of the gentic make-up of an individual will soon allow us to cure many of the maladies that afflict us – and maybe even slow down the rate at which we age. As you will see, this will present great opportunities, but also some significant challenges.

At first, each person’s individual genome will be deciphered, then treatments will be tailored to his or her specific genetic composition – which means that medicine is at a crucial turning point. However, there is more involved here than simple overcoming technical hurdles.

Food and Drug Administration

Food and Drug Administration

Personal Implications

As Scientific American point out, the development of these technologies raises the spectre of a company such as 23andMe having our genetic code and the effective freedom to do with it as they wish. They state, “While the FDA concentrates on the question of whether 23andMe’s kit is a safe and effective medical device, it is failing to address the real issue: what 23andMe should be allowed to do with the data it collects”.

In the late 19th and early 20th centuries, mankind made huge medical advances. It was very successful, and it enabled us to live long enough that we now suffer from a range of different diseases than we did previously. Through our increased knowledge of genes, we can now treat many illnesses that is difficult to cure.

According to Peter Huber, a senior fellow at the Manhattan Institute for Policy Research, “Healthcare once mainly depended on killing germs. Now most drugs are used to tune people. [For example,] Lipitor tunes our artery-clogging cholesterol, [and] Plavix our blood-clotting platelets. Tomorrow’s regimens will be guided and adjusted using relevant biomarkers [that are] specific to individual patients.”

Oncologists now input a breast cancer patient’s genetic data into diagnostic algorithms to devise a drug treatment that is just for her.

However, against this backdrop, the FDA still operates approval processes that are of the mass drugs age. It is now concerned with avoiding risk than speeding up the benefits to patients. For example, drug treatments still depend on large scale trials with a focus on statistical correlations to demonstrate efficacy.

The result is an inevitable collision between patient welfare, and bureaucratic requirement. Many ailments become too costly to treat, so patients suffer. Ultimately, the patient, the pharmaceutical company and the economy pay the price. Whilst avoiding patient risk is obviously paramount, there is inherent risk involved in not treating patients – just as there are consequences to this on their wellbeing (which should be assessed alongside the side-effects of treatment).

Given these, the following should be considered as likely for the future:

  • First, a paradigm shift on the part of regulators will take place. In time, this shift is inevitable – there will be increased pressure form the industry and also from patient welfare organizations. The current dominant regulator obsession with side-effects is misplaced. For personalized medicine side-effects are indications that the treatment only works for some patients and not for others. The FDA will often refuse to approve a drug because it does not work for everyone – ignoring the subset of patients for whom it does work.
  • Second, we can expect a new approval system will be established, enabling the rapid deployment of personalized treatments – within the next ten years. Adaptive trials will enable patients and doctors to modify treatments along the way. Anonymized outcomes of individual trials would need to be reported to a central database for other researchers and doctors to access. Reforming the FDA, and Intellectual Property rights would reward those who develop new information faster and come up with new ways to distribute it widely at economically efficient prices.
  • Third, reforming the approval process for personalized medicine will help cut healthcare costs. Ever-cheaper advanced molecular medicines will displace the increasingly expensive and often ineffective hands-on care of doctors and hospitals.

More Information:

  1. Ride the Wave: How 12 Technologies will Change the World and Make You Rich, by Fred A. Rogers and Richard Lalich. Crucial Trends Press © 2013. All rights reserved.
  2. Nature, 5 January 2014, “Regulation: The FDA Is Overcautious on Consumer Genomics,” by Robert C. Green and Nita A. Farahany. © 2014 by Nature Publishing Group, a division of Macmillan Publishers Limited. All rights reserved.
  3. “The Cure in the Code: How 20th Century Law is Undermining 20th Century Medicine” by Peter W. Huber. Published by Basic Books © 2013 by Peter W. Huber. All rights reserved.
  4. Scientific American, 27 November 2013, “23andMe Is Terrifying, but Not for the Reasons the FDA Thinks”. All rights reserved.


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