Saturday, November 17, 2007

Not with a Bang...The Death of Personalized Medicine

Today I plan to discuss where this magical field of personalized medicine is headed. A few things have changed over the week, and I think that this may change what I was originally going to discuss. But all in all the likely paths of personalized medicine could be up to 8-fold. Some are less likely and are therefore not discussed here.

In order to really understand personalized medicine's future we must know 4 truths.

1. Genotyping is getting cheaper and cheaper. Less than a penny a base pair. So in turn genetic testing should get cheaper and cheaper. This is the idea of a 1000 USD whole-genome. Unfortunately some tests still remain in the thousands of dollars. Therefore, I assume (unless these companies are paying their workers millions), that there is some significant money being made here.

2. There is a lack of healthcare specialists trained in the field of genetics. In fact the healthcare system fails all of us when it comes to genetics education and understanding.

3. The alternative healthcare market is skyrocketing. Do-it-yourself (DIY) treatment with herbs, vitamins, and nutraceuticals is predicted to be a trillion dollar market in the next decade. As a corollary, because genetics is not well understood by the "standard" medical practitioner, many view this as an alternative healthcare style

4. Insurance reimbursement for even standard genetic tests and counseling is woeful. If you are with an insurer such as Empire BCBS coverage of a BRCA panel is limited only to those who have breast cancer, or those who have 3 family members with such cancers at frighteningly young ages. This is better than others, who flat out refuse to cover BRCA testing unless a letter of medical need is written(taking valuable time from genetics providers).

This leads me to the paths. I think the paths are reliant on 3 things

1. Legal issues such as GINA approval and legal requirements changing for genetic testing

2. Public opinion for genetic technology in medicine remaining favorable

3. Personalized Medicine not being oversold

Probable Path 1

GINA is passed and states continue to have strong laws regarding genetic testing .
In this environment of protection from discrimination, polls have already demonstrated that the public will continue to view genetics as good for medicine. Therefore there will be a market for personalized medicine services. Private and public investment will continue to fuel the machine. However,there will be significant legal challenges to non-medical providers offering genetic services. But, personalized medicine will thrive. Discovery will continue and the public will continue to be excited. Personalized medicine will start to be oversold and the public may go wary. We are already seeing these trends with companies such as Navigenics. If lawsuits should happen, and they will, private investors will back away from this potential landmine

Probable Path 2

GINA dies in the Senate and strong laws regarding genetic testing continue to be enforced.
In this environment the public will still continue to be wary about discrimination. Most will not see value in giving a company, not governed by HIPAA, their genomic information. This is the environment we currently are in. All of this investment in these genome sequencing companies can go awry if customers’ personal health information can be sold to marketers looking to personalize ads. In addition if the government wishes to investigate DTC companies, as it is currently doing in CT, private genome sequencing could be a fad like Z-Cavaricci’s. Cool to have for a little while,until you realize that they put you at risk of being ridiculed or discriminated against. Now smart ad people will tell you that it is worth the risk, they may even tell you “Why not have the data now? You can use it later, but why not buy it now? Everyone is doing it.” Until that first case of genome data showing up when your prospective employer googles you. I imagine that would be worse than those “party” photos you still have up on your MySpace site.

Probable Path 3

GINA is passed and laws relax on genetic testing
In this sweet spot for corporate testing we see the rise of consumer genomics. The public opinion views this technology as benign as pregnancy testing. This is a scenario where the movie GATTACA takes place. “Genetics as a tool for better living”. Fueled by investment the future of personalized medicine is strong. We will see sex selection, PGD for athletic abilities. Since employers cannot discriminate based on “genetics” we may see some lawsuits because of genetics being used as a surrogate for “abilities” Because of the lack of legal consumer protection, the overselling may end up killing the best parts of this field. The databases of genomic data for research will be overflowing as patients will have no fears. IRBs will not have to treat genetic data and differently and perhaps restrictions on genetic research will be reduced. Discovery could be enhanced in this environment. I can see why many PhDs would favor this scenario.

The Sherpa Says: There are many more paths mapped out in my mind. I, the Sherpa have envisioned this mountain for decades. This is my passion. My existence. Maybe you should ask your friendly neighborhood consumer genomics company if it's theirs too. One things for sure, overselling via the NYT, Forbes and 23andMe will kill any chance of personalized medicine being viewed as a credible, respectable, medical specialty. This could be the beginning of the end of personalized medicine!


Anonymous said...

"I see many paths..."

Vague warnings and mystic predictions provide little insight. A Sherpa that doesn't tell me what he sees isn't much of a guide.

Steve Murphy MD said...

I just gave you three of the paths. For more paths give me a call.

sarah said...

I recently came across your blog and have been reading along. I thought I would leave my first comment. I don't know what to say except that I have enjoyed reading. Nice blog. I will keep visiting this blog very often.