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I recently attended an online marketing summit in Boston, and the buzzword throughout many of the sessions was “social media,” which, by Wikipedia’s definition, “describes the online technologies and practices that people use to share content, opinions, insights, experiences, perspectives, and media themselves.” Social media is also referred to as “Web 2.0” or “user-generated content” (UGC) and can exist in many forms (see below).

continues to educate, inform, and entertain our physician audience on all things technology, social media must be part of the conversation. 

, first out of the gate to target the physician crowd with social networking, has signed up 20,000 physicians for its free service and seems to be gaining a foothold in the industry with its 

. But what about the other players out there? You can find a list of social networking sites for docs from 

. Check them out and see which one best suits your interest.

But still, what about social media as it relates to a more targeted audience, specifically, you, the physician? It’s creating new discussions and technology within the public sector, but do you care? Do you visit the sites? Do you participate in the discussions? To help us gauge your perceptions of social media, 

 (join the party). The results suggest that, for the most part, you all know what social media is but don’t really care about it too much. In fact, 66% said social media was either somewhat unimportant or very unimportant to their practice, and more than half of the respondents (56%) said they didn’t regularly visit any social networking sites.

Although the results aren’t too surprising to me, I think it’s important to understand the implications of social media being “unimportant” to physicians. Yes, blogging, podcasting, social networking, etc. may be unimportant when it comes to growing your practice, but have you considered the importance of social media to your patients? Do you know where patients are going to talk about their conditions? How are they using social media/news sites? Who is blogging, and who is listening? Sites like E

 have opened up Web 2.0 channels that allow patients/caregivers who want to educate themselves about their conditions to do more than just read static content. Now they can actually create content themselves and communicate with other like-minded folks.

Staying current with this type of UGC enables physicians to keep their finger on the pulse of what their patients are discussing. It is also extremely valuable for pharmaceutical companies who are beginning to see the exodus from BRAND.COM to patient-site-created-by-patient sites. For more on the medical blogosphere and all things related to social media, check out 

the musings of our columnist Fard Johnmar

Social media will soon be too important for physicians to ignore, because presently, more than 160 million consumers use the Internet to learn more about their health conditions/problems, according to 

. These “cyberchondriacs,” as Harris has dubbed them, are driving the conversation with their physicians, with 58% saying they have discussed this information with their doctors at least once in the last year. They’re acting on your advice, too—more than half (55%) search for health information based on discussions with their doctors.

Like it or not, social media is here to stay. If you’re not participating now, you soon will be. I suggest finding ways to get involved, whether it’s joining a community of physicians/HCPs from the list below, downloading a few podcasts, or reading/posting some articles on Digg/Del.icio.us. You don’t need to be an everyday blogger like the aforementioned Dr. Karuturi or 

, just try to remind yourself to read them once in a while and comment.

And then there are conferences like the upcoming 

 in San Francisco this September 20, which

will quickly get you up to speed and involved with the movers and shakers of the industry. While you’re there, look for 

Articles

I recently attended an online marketing summit in Boston, and the buzzword throughout many of the sessions was social media, which, by Wikipedia's definition, describes the online technologies...

Social Media: Let the Games Begin

Recent columns on registering a domain name and building a website generated a larger-than-usual volume of reader feedback. I am truly gratified to get your e-mails; please keep them coming. In this month’s column, I’ll address the issues people wrote about most often: 1) hosting a website, 2) the Apple Macintosh, and 3) Web development tools.

Website hosting requires two basic components. The first is a Web server that accepts HTTP requests from Web

browsers (eg, Internet Explorer, Netscape, and Firefox) and serves them back Web pages of HTML documents and linked objects such as images. The second component is connectivity (or bandwidth) for transmitting all those millions of bits of data per second.

Two basic options exist for website hosting; choosing the right one depends on your level of technical know-how and website requirements. If you are comfortable with technology and want to have total ownership of your site, consider setting up a Web server on a dedicated computer in your office. One of the most popular servers is the Apache HTTP Server, which uses free open source software and can run on most computers. For more information, visit the 

. The biggest problem with do-it-yourself Web hosting is the need for high-speed Internet connectivity. Depending on how much traffic your website generates, you might need a T1 (aka DS1 or Digital Signal 1) connection, which can cost hundreds of dollars per month. Most small- and medium-size medical practices cannot justify that kind of expense for a website. If you have a large practice, you might already have a T1 line installed, but you still need to consider how the added Web server traffic will affect performance for regular office users, and whether you need to upgrade to a fatter T3 pipeline.

A far more common and sensible approach is to use a turnkey Web hosting service; this eliminates the hassle and security risks associated with hosting a site yourself. Th ere are literally thousands of companies that offer Web hosting and a wide variety of options such as dedicated servers, increased storage and bandwidth capacity, and heavy-duty tools. If you have a simple, five-page website with no e-commerce activity and fewer than 1,000 visitors a month, you could easily get away with using one of the free hosting plans offered by some of the biggest names on the Internet, including EarthLink, Yahoo, and Tripod.

If you need more features and functionality, you may want to go with a dedicated Web hosting company. 

American Academy of Family Physicians website

. This has been adequate for my needs, as few of my patients use the Internet. My EHR business (

, because it has a robust control panel, easy editing and e-mail setup, and other useful features. My consumer website (

) gets a ton of traffic (up to 1 million visitors a month) and requires a lot of bandwidth, so I use 

 for their ability to quickly scale and allow more bandwidth as the traffic waxes and wanes.

When researching technology companies and the services they offer, I find that tech websites, such as 

, provide the best summaries of the costs and benefits of the various options. A few readers asked me about the Apple Macintosh computer. Personally, I think the Macintosh is the most elegant, sophisticated, and easy-to-use personal computer on the planet. I have two Macs at home, and my kids prefer them as well. So, why don’t I use one in my practice? Simply put, I have too many third-party applications that run on Windows. Although the new Intel-chip Mac can run Windows software quite well if you install 

, that’s still one more step to get it up and running compared to a PC.

Apple’s iWeb tool features hundreds of website templates, enabling you to easily build your own site, with no HTML required, and publish your website with a single click. A basic, one-year subscription, which includes domain name and hosting, costs $99.95. In the column on building websites, I neglected to mention the sophisticated development tools that can make it easier and faster to design, develop, and maintain websites and Web applications. I prefer 

Dreamweaver offers the option of working in a visual layout interface or a streamlined coding environment, appealing to both designers and developers. It also integrates with other popular Adobe software programs such as Photoshop, Illustrator, and Flash. See you next month, when we’ll take a look at how to fi nd good tech help.

Dr. Bertman is Physician Editor-in-Chief of 

. He is also a Clinical Assistant Professor of Family Medicine at Brown University and president of AmazingCharts.com, a leading developer of Electronic Health Record software. He also is the founder and president of AfraidToAsk.com, a consumer website focusing on personal medical topics. He is in private practice in Hope Valley, RI.

Recent columns on registering a domain name and building a website generated a larger-than-usual volume of reader feedback.

Hosting a Website (and Other Reader Feedback)

How do you bring healthcare technology into your practice?

We try never to be infatuated with technologies in search of an application, but instead look for technologic solutions to the clinical problems that we have. Some solutions are very simple; for example, most EMRs have computer screens with refresh rates that make them very difficult to read. The screens are also at eye level, rather than the level at which you read paper charts. For practitioners who wear glasses or are otherwise visually challenged, looking up at a computer screen with a refresh rate that fatigues the eye is particularly difficult. The solution we implemented was to put a printer in every office, giving the physicians the opportunity to share print information (like laboratory results) with patients, and to print documents that they can then use to assemble information, rethink it, and put it back into the electronic record current to the patient’s needs.

What other technologies do you utilize in your daily practice?

We have an electronic portal for reporting of physician practices. We’ve developed a site so that doctors can look at certain preventive services that we think are important, and which the US Public Health Services thinks are important. We currently display nine measures, and each doctor can look at his or her panel of patients and identify those who need immunizations or are outside of a certain reference range. We also have processes in place for the entire group that enable us to target the population that needs a particular preventive service, so that the individual physician doesn’t have to.

The portal also helps physicians with time-limited board certification to demonstrate a practice improvement project every 10 years. The quality data enabled me to take the information we have compiled over the last couple of years and submit it to my board, saying “look at what we’ve done with our immunization, colonoscopy, and mammography rates that are 1) good for patients, and 2) fulfill the requirements that you say are important.” Instead of creating something de novo to accomplish the task, these are ongoing activities with easily retrievable data about my patients and my practice.

What feedback have you received from patients about the portal?

One of the interesting things with quality reporting is that it really causes a practice to change, both for the physicians and patients. For example, if you’re going to target a population that has low mammography rates, you can identify those patients so that no matter when they come in, you can approach them for a mammogram. It takes a while for patients to adjust to such close scrutiny. But doctor and patient both get used to it once they can move beyond just acute care medicine.

Also, we have limits on the range we accept for diabetic control. When you tell a patient “your Hemoglobin A1c is 10.6 and this is not good for you and you’re making me look bad,” it’s amazing how they want to change to make the doctor—patient relationship work. They want to take care of themselves, and now you have this extra piece of information that says “both of us are suffering from you being out of control with your diabetes. I want to help you get back in control, and you can help me be a better doctor at the same time.”

What is the most significant recent development in healthcare technology for practicing physicians?

Electronic records that allow individual members of the healthcare team to work better together. For any office visit, three individuals at a minimum are seeing a patient, and each adds their own information to build the electronic record. Each has a set of criteria they have to follow to accomplish their tasks, and in this way, each provider is able to practice to their maximum licensure. When you’re able to do that, you’re providing the highest level of care in the most efficient and cost-effective way.

What technologies do you foresee having the greatest impact on physicians in the near future?

I still see the Web as being tremendously important. I was able to apply some of the principles I wrote about in the May 2007 

” as I went through my own board recertification in geriatrics. The knowledge-based modules are “open book,” and the most efficient reference source I could find to answer the questions that gave me trouble were Google, and Google Scholar. Google provides a far better search engine than the search engines we traditionally use in medicine. It got right to the data I needed. It is incredibly accurate, robust, and efficient. I think the medical literature search engines have a long way to go to catch up. 

This month's DocMVP is Eric G. Tangalos, MD.

DocMVP: Eric G. Tangalos, MD

Prominent among the many benefi ts touted by proponents of electronic health records (EHRs) is cost reduction. The installation of an EHR system, the argument goes, can decrease spending on materials, reduce the incidence of medical errors, and automate activities that would otherwise require paid staff employees to perform.

It is the last of these approaches that has engendered the most controversy. Often, eliminating the cost associated with employee activities means eliminating (ie, firing) employees. Although this idea may produce economically appealing results in theory, in practice, many physicians are reluctant to part with good employees in the name of economics alone. On the other hand, declining reimbursement and the ever-rising cost of doing business have many practitioners scrambling to save money wherever they can. Which brings us to our (literal) $100,000 question of the day: can technology replace your staff ? And our carefully considered, and definitive answer? It depends.

Before elaborating, it will be helpful to describe the specific ways in which EHRs and related technology can theoretically reduce labor-related costs. These points are probably somewhat familiar:

• Transcription: EHRs with built-in speech recognition functionality can allow automatic transcription, reducing or eliminating the cost associated with outside or in-house transcription services. Scott Irwin of the EHR provider NextGen (www.nextgen.com), who describes transcription as the “low-hanging fruit in the ROI world,” posits that a good electronic record system should be able to reduce transcription costs by 80% in one year and 100% in two.

• Coding, Billing, and Scheduling: Each of these processes can be automated, allowing staff ers to perform more important functions or to be eliminated altogether; if the average physician requires four assistants to handle these and similar tasks, suggests Irwin, an EHR system can reduce that number by one or more.

• Chart Maintenance: Reducing expenses associated with paper chart maintenance—which include the cost of the labor required to pull, file, copy, and maintain the integrity of hundreds of charts each day&mdash;is the Holy Grail of the EHR industry. It is in this area that technology has the greatest chance to make an immediate financial (and spatial) impact.

In Victoria, TX, a two-person asthma/allergy practice found itself in the market for a more efficient EHR when its previous provider, 

, decided to focus on Ob/Gyn practices. The practice installed an automated telephone system, eliminating the need for a front desk staffer to handle incoming calls. The practice also implemented a new electronic system that eliminated the need for constant handling of medical records and facilitated scheduling, billing/collections, and other tasks.

When two of the six staff members originally employed by the practice left, the practice’s efficiency had increased so dramatically post-EHR implementation that only one part-time employee was needed to replace them. This translated to an annual cost reduction of roughly $70,000. For more on this story, read Carolyn P. Hartley’s excellent article in the June 12, 2006 edition of 

 reported on the case of Spokane Internal Medicine, a nine-provider clinic in Washington state that handled nearly 600 patient charts per day. Three full-time equivalents (FTE) were required to manage the clinic’s chart room. Implementing an EHR allowed Spokane Internal Medicine to reassign these three FTE to other roles, and to eliminate extraneous FTE, reducing its FTE-to-provider ratio from 4.4:1 to 2.64:1.

In January 2004, Scott Barlow, MBA; Jeffrey Johnson, MD; and Jamie Steck, MBA, published an analysis titled “The Economic Effect of Implementing an EMR in an Outpatient Setting” in the 

Journal of Healthcare Information Management

. Barlow, et al. conducted a detailed study of conditions at the 

 (CUMC), a nine-location, 59-physician group, in the first year after the clinic adopted 

• Before installation of the TouchWorks system, 10.2 FTE were required to manage the estimated 100,000 charts CUMC handled each day. During the year—although the Clinic added thousands of new patients and doubled the number of physicians on staff &mdash; requests to the chart room fell by more than 35%. Th is allowed for the elimination of two FTE, with further reduction expected.

• By creating all new records electronically, the Clinic, with 20,000 new patients per year, would save $160,000/year in labor and supply costs for creating new paper charts.

• RNs and medical assistants working in the Clinic system were able to spend significantly less time (1.2 hours/day) handling paper records using TouchWorks.

Total cost of ownership (TCO) is a financial estimate of the direct and indirect costs associated with a particular piece of hardware or software.

In the case of EHRs, TCO includes the purchase price and maintenance fee, plus training expenses and lost productivity during training, minus any cost saved by the product. There can be little doubt that staff reductions and consequent savings reduce the TCO associated with EHR systems. An important point, as cost is often cited as a barrier to EHR adoption.

In a strongly worded 2006 assault on conventional EHR wisdom published in 

, Jaan Sidorov noted that for staff reduction-related savings to be realized, “staff employment would need to be completely terminated.” He points out that “anecdotes of healthcare systems... offering displaced workers other employment opportunities are commonplace enough to dilute these savings.” Consider: would your colleagues be willing to simply fire half their employees to save on salaries? Would you? For many physicians, this would seem to be the ultimate impersonal move, in a field that some have claimed has grown increasingly impersonal.

On the other hand, the ability of technology to reduce the need for paid administrative staff can be a tremendous boon to growing practices. Note that the CUMC was able to reduce FTE in spite of nearly doubling the size of the system. Similarly, 

 in Middletown, NY has been able to grow at a tremendous rate, in part because of its association with NextGen. Says Irwin, “They have gone from 20 to 120 doctors in just two years, because they only had to hire two or three FTE per doctor instead of four or five.” This ability to eliminate prospective employees instead of current ones can also prove useful for those practices in which workload begins to overwhelm existing staff; employees can be diverted from mundane tasks like file management to more important activities that might otherwise require additional help.

However, the automation of certain processes might lead to problems quite apart from cost. A computerized system that directs incoming phone calls may seem useful, but anyone who’s ever had to wait on the phone long enough to “Press 8 for Billing” will recognize the drawbacks. Computerized systems also tend to be inflexible; no matter how complex its algorithm, no automated system can ever apply judgment, creativity, or empathy to a situation. In an era in which patients feel increasingly alienated from their healthcare providers, this is a tremendously important problem, and one that will have to be solved before process automation becomes more common.

Sidorov goes a step further, arguing that “a considerable body of evidence suggests that widespread adoption of EHRs increases healthcare costs [in ambulatory care],” and could do likewise in the outpatient setting. In a response to Sidorov’s 

 takes issue with this characterization, suggesting that there is in fact a lack of good evidence in this area.

She maintains that what few reports are available deal with poorly implemented EHR systems, and thus do not reflect the true potential of this technology. 

 agrees, arguing that the data from the studies described by Sidorov were collected before EHRs became increasingly interactive. More interactive systems, it would seem, are more likely to be effective replacements for human actors.

All the same, it is clear that physicians looking to EHRs as simply a way to save money are likely to be disappointed. “The practices that receive benefits are those that consciously work to obtain the benefits by changing their operations to take advantage of the new technology,” says Duke. “It is not sufficient to simply implement an electronic record; a practice must redesign the way it operates and train the staff to be able to function in this new environment.” In short, the goal is (or should be) to reform healthcare by improving management of cost and quality, including, but not limited to, the cost of labor and the quality of the work it produces.

Frank Ferrara is a freelance writer and former 

Prominent among the many benefits touted by proponents of electronic health records (EHRs) is cost reduction. 

The Price of Progress: Can Technology Replace Your Staff?

Currently available pharmaceutical therapies for many chronic illnesses leave much to be desired. Although considerable progress in therapeutics has been made in recent years, available treatments usually do not provide a definitive cure. The goal of current therapy is usually more modest—symptom relief or delay in disease progression.

Many of today’s drugs are also often quite expensive and often must be taken over a long period of time. Therapy with currently available medications is often hit-or-miss, because we cannot accurately predict a patient’s response to a drug or if side effects will occur. Thus, selection of a therapeutic agent for an individual patient is usually marked by a frequently time-consuming and expensive process of trial and error. Often, the first drug chosen is not effective or is not tolerated due to side effects.

All medications approved for marketing by the FDA have been shown, through well-controlled randomized studies, to be statistically effective for large groups of test subjects. However, these drugs are often not effective for some individuals in these groups. Absent or incomplete efficacy in individual patients is very common among major drug classes. The cost of this failure to effectively treat is very high.

Due to recent advances in several fields of biomedical research, we will soon be able to identify those patients for whom a drug will be effective. We are on the threshold of major breakthroughs in individualized patient care as a result of new and anticipated advances in molecular biology, genomics, pharmacogenetics, biomarkers, and other biomedical disciplines.

Key to these changes is our growing understanding of the genetic factors that underlie disease and patients’ responses to medications. Pharmacogenomics blends pharmacology with genomic science to study how drug response is influenced by inherited variations in genes and the proteins they produce. Pharmacogenetics is expected to have a profound effect on the individualized treatment of complex, multigene disorders. Recent advances in genomic research have enabled new strategies to determine how individual genetic differences may be responsible for variability in response to drug treatment.

Ongoing studies are finding links between a patient’s specific genotype and the likelihood that a specific agent will be effective or that an adverse effect will occur. Subtle variations in genes can affect expression of specific protein targets, such as receptors, transporters, and cell signaling pathways, all of which play an important role in response to medications. Future therapies will often be based on the identification of which molecular pathway is disrupted in a given patient. This emphasis on diagnostics represents a sea change in the focus of the healthcare industry from a clinical definition of disease and diagnosis to a molecular definition of diagnosis and predisposition.

A major limitation of current therapeutics is the relatively small number of known “drugable targets” at the molecular level. It is anticipated that advances in genomics will greatly expand the amount of targets. The number of targets “hit” by all drug substances marketed today is only about 200, but the number of potential targets for small molecule drugs is estimated to be about 3,000. Therapies that impact biological activity at these targets will greatly expand our therapeutic armamentarium with agents that are selective for the disease process, with limited side effects.

These advances will usher in a new era of effective and truly personalized treatment for major diseases. The considerable “noise” that now exists, in the form of non-response to treatment and adverse drug effects, will be reduced as therapies are channeled to patients for whom they will be safest and most effective, improving

Studies of twins and blood relatives have shown that genetic factors are important determinants of the normal variability of drug effects. For example, genetic variations appear to underlie differences in the effectiveness of the beta-agonist albuterol used in the treatment of asthma. Different haplotypes (groups of genetic variations) are associated with patients’ varying responses to the medication.

Haplotype 4 is associated with depressed responsiveness and haplotype 2 with increased responsiveness to this agent. Similarly, there is considerable variation in clinical response to antipsychotic agents. For example, the response rate for clozapine varies between 30% and 60%, a diff erence believed to reflect variation in genes governing neurotransmitter-receptor-drug relations. An optimal combination of six specific gene variations (across multiple genes) has been associated with a maximal (77%) success rate with clozapine. Other antipsychotic agents may be relatively more effective in patients with other gene-variation combinations.

At the drug-receptor level, variations in genes controlling dopamine receptors have been associated with patterns of response to antipsychotics. Some variants are associated with a better response to typical antipsychotics, others with a better response to atypical agents. Several gene variants controlling serotonin receptors may influence the effectiveness of antipsychotic agents in schizophrenia’s negative symptoms (blunted affect, social withdrawal); other variants have been linked to drug effectiveness in positive symptoms (delusions, hallucinations). A dopaminereceptor variant has been implicated in susceptibility to tardive dyskenesia.Weight gain induced by atypical antipsychotics is associated with genetic factors, but the genes involved can differ among agents.

In addition, some gene variants are associated with less weight gain in response to a given agent, even with those

atypicals in which weight gain is often pronounced.

Examples abound of known genetic factors that influence cancer drug response. If detected, they can actually be used to predetermine how well a drug will work for an individual patient.

• The Oncotype DX 21-gene assay quantifi es the expression of 21 genes linked to the likelihood of breast cancer recurrence and the effectiveness of certain types of chemo- and hormonal therapy.

• A multigene assay can predict the recurrence of breast cancer in patients treated with tamoxifen. Gene expression analysis can be combined with an algorithm for calculating risk for distant recurrence of breast cancer.

• Polymorphisms in the HER2 receptor gene have been found to determine whether a patient with metastatic breast cancer will respond to treatment with Herceptin (trastuzumab).

• A test for the BRCA 1, 2 genes guides surveillance and preventive treatment based on susceptibility risk for breast and ovarian cancer.

• The BCR-ABL and c-KIT detect genetic mutations in the tyrosine kinase receptor that are correlated with the efficacy of Gleevec (imatinib mesylate) in chronic myelogenous leukemia (and also in gastrointestinal stromal tumors).

• The thiopurine S-methyltransferase (TPMT) assay guides dosage adjustment of Purinethol (mercaptopurine) in treatment of acute lymphoblastic leukemia. Patients with inherited little or no TPMT activity are at increased risk for severe toxicity from conventional doses of this drug.

• Genetic analysis can be used to assess clinical response to therapy for follicular lymphoma with the monoclonal antibody Bexxar (tositumomab). Analysis of a genetic rearrangement in the BCL2 gene demonstrated a molecular association with clinical response and disease progression.

The p16/CDKN2A genetic test guides surveillance and preventive treatment based on susceptibility risk for this cancer.

Iressa (gefitinib) is a genome-based drug for lung cancer that blocks the epidermal growth factor (EGF) receptor kinase. This agent almost failed FDA approval because of low response rate in clinical trials. But some subjects did respond dramatically. In particular, persons in Japan have a higher response rate than US patients. A mutation has been found in a gene encoding the receptor for EGF that is associated with drug response. Japanese people are more likely to carry this mutation than US patients and are three times more likely to respond to treatment with Iressa.

The UGT1A1 marker detects variations in the UGT1A1 gene in colon cancer that influence the ability to break down Camptosar® (irinotecan), which can lead to increased blood levels of the drug and a higher risk of side effects.

An estimated two million people develop serious side eff ects from adverse drug reactions (ADRs), and more than 100,000 hospitalized individuals die from ADRs each year in the US,13 resulting in enormous costs to society—the cost of drug-related morbidity and mortality in 2000 exceeded $177 billion.

ADRs often result from variations in the genes that regulate the enzymes involved in drug metabolism. Variations in these genes can result in slower or faster drug metabolism. Gene mutations can result in the production of an enzyme with reduced function, or no enzyme may be produced at all. Depending on whether a person has zero, one, or two normal copies of a gene, he or she may be a poor, intermediate, or rapid metabolizer. The fewer normal copies a person has, the poorer the metabolism and hence higher blood levels of the drug. This, in turn, may result in greater effectiveness or, more likely, greater side effects.

Among 27 drugs frequently cited in adverse drug reaction studies, 59% are metabolized by at least one enzyme with a variant genetic allele known to cause poor metabolism. Identifying persons having such alleles prior to drug administration may result in a clinically important reduction in adverse outcomes. Genetic tests are available to detect variants in the cytochrome P450 series genes that commonly regulate drug metabolism. Testing for genetic variations and metabolic status prior to drug treatment would allow accurate selection of dosages, thereby reducing costly drug interactions and toxic responses.

It is likely that payers will apply the principles of evidence-based medicine and pharmacoeconomic analysis to their coverage decisions regarding the new genetic technologies, just as they do for other medical services. Covered services must receive FDA approval and be supported by peer-reviewed evidence on performance and health outcomes. It would be expected that these new technologies demonstrate improved net health outcome, be at least as beneficial as established alternatives, and be cost effective.

Several studies indicate that molecular diagnostic testing might make healthcare more cost effective. A modeling study using insurance claims for asthma patients to determine the economic impact of a hypothetical diagnostic test used to predict drug response found that such a test would offset costs, provided that the test was sensitive and not overly expensive. An examination of genetic testing for TPMT deficiency, which can lead to severe adverse reactions to purine drugs, has confirmed the cost-effectiveness of such testing under certain conditions.

Recently, a model was published detailing the impact of applied genomics testing in cancer on cost savings in specific disease situations. The best-known example of genetic-diagnostic success is Herceptin, coupled with HER2/neu testing for breast cancer. Adoption has been successful despite a small market and concerns about value, because patients and providers were early demanders of this drug, which treats a life-threatening disease with few options and a poor prognosis. Despite the high costs of treatment, payers are covering the drug.

Testing CYP2C9 activity to prevent bleeding due to high blood levels of warfarin (see call-out) is predicted to prevent one major bleed for every 44 patients screened. At $135/assay, this would cost $6,000 (a neutral economic result), but patient outcome and quality of life would improve. A prospective trial at Harvard University is ongoing to test the clinical and economic outcomes of such testing in the real world.

The medical community is currently not prepared to meet the challenge of these new technologies and to utilize them in routine clinical practice. There are only 900 board-certified medical geneticists and only 2,000 board-certified genetic counselors in the US.

Seventy-two percent of physicians rate their knowledge of genetics as fair to poor; and 69% of physicians have had a genetic course in medical school but have not applied genetics to their practice. The genetic content in nursing school curricula actually declined from 10.5 hours in 1984 to just six hours in 1996. Clearly, physicians and allied healthcare professionals will have to work hard to stay abreast of developments in genetics-based medical technologies. The effort required will be considerable, but well worth it given the vast potential benefits in the form of improved outcomes, reduced side effects and adverse drug events, and cost savings.

Richard Levy, PhD, is a Senior Research Advisor for the National Pharmaceutical Council.

Personalized Warfarin Dosing: Predicting Dose Requirements and Preventing Toxicity

The oral anticoagulant warfarin is a top-20 drug in the United States, and the most widely used worldwide for the oral treatment and prevention of thromboembolic events, including atrial fibrillation and deep-vein thrombosis. Warfarin has a narrow therapeutic index and high risk of overdose or toxicity, and is among the top three drugs causing adverse drug events leading to emergency visits in older individuals.

Variability in response to warfarin is high; the daily therapeutic dose within a patient population can vary by more than an order of magnitude. Patients are all titrated to the same pharmacological endpoint—a two-to-threefold increase in their clotting time&mdash;but stable dosing can take many months to achieve and put patients at risk of excessive bleeding (if the initiating doses are too high) or ineffective clot control (if the doses are too low). It is important to quickly find the correct dose for an individual patient since the therapeutic window for this drug is small.

Non-genetic factors such as age, gender, body mass index, and drug history contribute up to 30% to warfarin dose variability, and these factors are generally taken into account when prescribing initial doses of the drug. Much of the remaining variability is associated with differences in cytochrome P450 metabolism (specifically CYP2C9) and to variation patterns in the VKORC1 gene that codes for an enzyme-controlling response to this agent.17 By combining patient clinical characteristics with knowledge of the CYP2C9 and VKORC1 genotypes, as much as 60% of the variability in warfarin dose requirements can now be explained

Currently available pharmaceutical therapies for many chronic illnesses leave much to be desired.

August 2007 | Oncology Live®

Social Media: Let the Games Begin

Hosting a Website (and Other Reader Feedback)

DocMVP: Eric G. Tangalos, MD

The Price of Progress: Can Technology Replace Your Staff?

The Inner Frontier: Exploring the Brave New World of Personalized Medicine