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Are traditional drug approval protocols meaningful today?

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drug approval protocols

FDA

A cheap spit-test that reveals the secrets of your genome, used by hundreds of thousands of people worldwide has been stopped by the FDA.

FDA warning letter
On November 22^nd 2013 the FDA sent a warning letter to 23andMe, a privately held personal genetic-testing firm based in Mountain View, California to, "immediately discontinue" providing its saliva collection kit and Personal Genome Service, because it had failed to provide adequate information to support the claims made in the company's marketing.

23andMe is so named because of the 23 pairs of chromosomes in a normal human cell. Founded in 2006, the Company is a Silicon Valley favourite led by Ann Wojcicki, wife of Sergey Brin, one of Google's founders. It has raised more than US$100 million from backers that include Google, Genentech and Yuri Milner, a billionaire investor in Facebook and Twitter.

Taking more control of your health
Nature took four billion years to develop the code that determines our life. The Human Genome Project, that ended a decade ago, initiated a medical revolution. In 2003 sequencing an individual genome cost between US$10 and US$50 million. Since then the costs have plummeted towards US$1,000, allowing science and medicine to identify genes with disease causing mutations. In 2008 23andMe's US$99 personal genome test kit was named by Time Magazine as the "invention of the year".

Since 2007, 23andMe has invited some 500,000 "genotyped consumers" to spit into a tube, send it back to the company and thus discover whether they might be prone to a long list of diseases, from diabetes to Alzheimer's or be carries of inherited conditions that significantly raises their propensity of developing certain cancers. Results from 23andMe's test enables people to take more control over their own health.

Changing paradigm of medicine
In the past year 23andMe hired Andy Page, a former president of Gilt Groupe, a shopping website, as its own president and launched a national television campaign with a goal of doubling the number of people who use its test.

23andMe's mass marketing could help to change the cultural paradigm of medicine. The more people get tested, the more they'll ask their doctors about results and the more doctors will have to start incorporating personalised genomics into their practices. But the FDA is not concerned about these benefits; there only concern is that someone theoretically might get hurt.

Regulation has a role in protecting consumers from inaccurate testing and misleading information. However, if medical innovation is to benefit millions of patients, should regulators bear the burden of demonstrating that services, such as 23andMe, do more harm than good?

Takeaways
Regulations that govern medicine were developed during medicines battle with infectious epidemics when nobody could even read the molecular scale that controls health and disease today.

Drugs then were designed on hunches, and the safe and effective use of drugs depended on gathering statistical information about how they affect high level medical symptoms. Regulators assumed broad areas of biochemical uniformity, conflated differences and steered medicine to whole populations, which led to a one-size-fits-all regulatory system.

Such a system can't deal with diseases rooted in complex molecular diversity of human bodies. Today, regulators are ill equipped to deal with big data that drives molecular medicine and they are reluctant to embrace private practice and the statistical methods of the digital age.

Does current regulatory policy stifle innovation and suppress investment in medicine that can provide better health at lower cost?

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Are traditional drug approval protocols meaningful today?

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