Biotechnology Healthcare - June 2008 - (Page 19) PERSONALIZED MEDICINE eases, though, are associated with multiple genes, and stance, was developed in an unheard of 25 months from the each gene implicated in a disease may exhibit one or more start of clinical studies. variations and may produce one or more proteins — each of which interacts with other proteins, other DNA, or WHY IT MATTERS TO YOU other RNA from the other 24,999 genes in the human One sign that personalized medicine has attained a cergenome. The biochemical relationships get very complex, tain cachet, at least among early adopters, is the launch in very quickly. 2007 of three Web-based, direct-to-consumer ventures that Despite all that, astounding progress is being made in will sequence your genome, advise you about your genetic coming up with personalized fixes when something in our risk for certain diseases, tell you about your genetic ancomplex biological organism goes haywire. They’re not cestry, and provide updates on future discoveries — all for yet perfect, but personalized drugs certainly beat what just under $1,000. came before. Just ask Rob Roy. At the same time, success The entertainment value of comparing genomes and stories like imatinib and dasatinib can make for irrational what they mean seems to be a big part of the sales pitch for exuberance about personalized medicine. these products — maybe because there isn’t much else con“There’s a misperception that eventually all drugs are sumers can do with their sequenced genomes right now. In going to be personalized drugs, and that we’ll have pera few years, though, we may be admiring these entrepresonalized medicines for every disease,” says Kaitin. “Acneurs for their vision. Perhaps we will all have our genomes tually, it’s highly unlikely that we’ll have only personalsequenced and allow physicians to use it to craft the most ized medicines because, very often, the economics won’t effective prevention or treatment strategy for us. support their development or use.” “I don’t think these start-ups are indicative of a general “For certain indications,” he continues, “generalized acceptance of having your sequences done,” says Kaitin. medicines may be the most cost-effective method of treat“It’s going to take a lot of education and experience for the ment. For example, if everybody in the world who has a public to feel comfortable with these products.” headache can be adequately treated with either ibuprofen That’s where BIOTECHNOLOGY HEALTHCARE comes in. or acetaminophen, then it would make no medical or comThe aim of this column is not to sequence your genome or mercial sense to develop a personalized headache meditell you about your ancestors. We want to keep you incine and the accompanying diagnostic screen to identify formed about this still immature — but already real and relthose individuals who will respond to it.” evant approach — to achieving optimal health, quality of His point is one of several that payers and employers life, and productivity. And we’ll do it for less than $1,000. think about when deciding whether to pay for pricey new Not a week passes without word of a new gene exprespersonalized medicines. It’s a tough call, especially when sion test, molecular imaging agent, protein signature, drug, trying to ascertain long-term benefit for diseases whose or other advancement that can alert you to diseases to natural history can span years. One explanation for the big which you may be susceptible, suggest ways to prevent them, zero in on the root cause, ensure response to a drug, price tags is the fact that molecular diagnostic tests reduce and monitor your progress back to wellness. the market for that drug. Ergo, unit prices have to go up In this column, we’ll look at some of these advances, into make up the difference and pay for the additional retroduce you to the people who make them happen, and exsearch and development costs of the companion diagnosplain why it matters to you. Ultimately, personalized medtic. icine will make a difference in your members, your Personalized medicine poses other challenges to the staemployees, and your own life. Those who are positioned tus quo, as all disruptive technologies do. For example, if to take advantage of what personalized medicine has to it takes approximately 10 years to develop a drug and 2 offer will be ahead of the game. years for a companion test, one can imagine that a drug maker might be reluctant to make the R&D investment Bob Carlson, MHA, writes exclusively about healthcare. He with no guarantee that a suitable diagnostic will be forthlives near Zionsville, Ind. coming. The diagnostics people may have similar worries about allocating resources before an approved drug is in hand. Looking ahead Because it starts with specific therapeutic targets and works with patients Personalized Medicine columns in BIOTECHNOLOGY HEALTHCARE selected on the basis of some bio• Testing for warfarin metabolism marker, personalized medicine pro• Direct-to-consumer genetic testing mises at least the possibility of a less • Tobacco addiction biomarkers and benefit design issues costly and a faster path from drug discovery to approval. Dasatinib, for inMAY/JUNE 2008 · BIOTECHNOLOGY HEALTHCARE 19
For optimal viewing of this digital publication, please enable JavaScript and then refresh the page. If you would like to try to load the digital publication without using Flash Player detection, please click here.