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Q&A: CEO of MD Network Discusses Navigenics Partnership to Use Genomics in Medical Care

Navigenics plans to use a nationwide network of physicians to try to integrate genomic information into personalized-medicine decision making. 
Under an agreement announced this week, Navigenics will provide its testing services to doctors in the MDVIP network, a collective of physicians spread across 25 states and Washington, DC, who practice preventative and personalized healthcare.
The Navigenics testing service will be used to identify an individual’s risk for developing conditions such as type 2 diabetes, cancer, heart attack, and celiac disease.
Personal genomics firms have recently received criticism and regulatory scrutiny for the lack of physician involvement in their direct-to-consumer screening services.
In June, Navigenics, 23andMe, and Decode Genetics' DecodeMe business unit were among 13 genetic-testing companies to receive warning letters from the California Department of Public Health. The letters ordered them to stop marketing their genetic tests to California residents without a state license and the involvement of a state-licensed physician [see PGx Reporter 06-25-2008].
The CDPH’s letters followed similar cease-and-desist orders the New York State Department of Health sent in April to 23 DTC genomics-services and genetic-testing companies.
Since these warnings were issued, Navigenics and 23andMe have been cleared for DTC personal genomics services in California. However, all along, Navigenics has maintained that not only does its service employ state-licensed physicians and genetic counselors, but that it’s screening service is not intended to make medical decisions.
Now, in partnering with MDVIP, a network of 280 doctors serving more than 100,000 patients, Navigenics is re-emphasizing the role of doctors in personal genomics.
“Working with their personal MDVIP physician and Navigenics’ board-certified genetic counselors, individuals can chart and implement a personalized wellness course to help decrease their overall risk, delay disease onset or prevent it altogether,” Navigenics and MDVIP said in a joint statement.
For six months before launching the initiative, Navigenics and MDVIP studied more than 40 clinical encounters to see how doctors and their patients integrated preventive genomics methodologies.
MDVIP CEO Edward Goldman said in a statement that patients involved in that study “overwhelmingly found the experience positive, they felt empowered rather than anxious, and they indicated a desire to change their lifestyles and more productively work with their physicians.”
Goldman spoke to Pharmacogenomics Reporter this week about the Navigenics alliance, and what MDVIP hopes to achieve with regard to personalized medicine. Below is an edited transcript of the interview.

Could you tell me a bit about MDVIP?
MDVIP is about nine years old right now. We started with the premise that 97 percent of all medical expenditures are for the treatment of illness and only 3 percent are for the prevention of illness. Moreover, many of the things that are called prevention are really the early detection of disease and not really true prevention. So, if I call mammograms, pap smears, [or] PSAs “prevention,” I’m not really preventing breast cancer or cervical cancer, I’m really picking it up at an early treatable stage. We did, however, believe that we could prevent disease, that we knew enough about risk factors and life style risk factors based on habits, on occupations on proclivities, to assess what was putting a patient at high risk, and predictably they would develop a disease that we could modify these risk factors and truly prevent the disease. So we were interested in early detection and in true prevention.
In order to do that, it required an intervention of about two-and-a-half hours per year, per patient. For every single patient to do the type of physical exam that Cleveland Clinic or Mayo Clinic does on every single patient in the practice, and at the same time to do out prevention program, which involves sophisticated health risk assessments, involves patient monitoring [and] monitoring devices. In order to accomplish that we were not able to do that in a standard practice that has 2,500 patients. In our model, we reduced the practice down to only 600 patients. And for those 600 patients, we have this early-detection prevention program, but we are also their primary care physician.
Due to the smaller practice, we can see patients the same day, and our minimum visits are a half hour. You contact the physician on your home phone, cell phone; or beeper; not through an answering service. We have an elaborate electronic platform that allows communication between doctor and patient, and allows the patient to receive wellness information through their own personalized wellness site, rather than a WebMD approach, which puts everything on the Web and you determine what you need.
Could you discuss the study you and Navigenics conducted?
We took three of our practices and a select number of patients, approximately 100 or less. And we ran the Navigenics test on them. We followed up with questionnaires. Our first interest was seeing how this information changed the primary interaction between the doctor and patient. On the doctor’s standpoint did it change how he or she approached the patient? We run a health risk assessment on each of our patients to assess lifestyle risk. The genetic risk is a complement to that. So, from the doctor’s standpoint, did this change how he or she monitored a patient’s disease? For instance, if someone has a lifestyle risk for diabetes and a genetic tendency for diabetes, does that mean the doctor’s surveillance of the patient is more frequent, more in-depth, is it different than for someone at low lifestyle risk or someone who didn’t have the genetic tendency, and did it alter the treatment pattern? Was the doctor more aggressive in terms of cholesterol control if someone had lifestyle risk factors for cardiac and coronary artery disease, as well as, genetic tendency toward heart attack?
On the patient standpoint, we were interested in if the knowledge was new for them, and based upon the knowledge if they changed compliance and made lifestyle changes. So, the study was really designed to assess what on a practical level is the result of genetic testing in a primary care setting, both for patient and for doctor.
What are the advantages of a doctor in the MDVIP network to sign up patients for Navigenics genetic-testing services? How is it different if an individual goes to Navigenics’ website directly?
Our doctors are in a position to assess the value of this additional piece of data, as opposed to a patient randomly selecting it. In random selection, there might be some patients who may be highly motivated and educated with regard to this. But there might be other patients who through lack of understanding and knowledge or through natural ennui that patients have may not sign up for it. In fact, those patients may be the ones that should sign up for it, because the genetic risk factor coupled on to their life style risk factor, coupled on to their lifestyle risk factor, really exposes them to a degree of risk that’s important to ascertain, rather than to allow randomness to dictate that decision. So, I think the fact that the physician is involved in the patient interaction and the patient decision-making, provides a much different experience and frame of reference, than patients reading an ad in the newspaper or going to a web site.
Is there a financial incentive for patients to sign up for Navigenics’ service through MDVIP?
I’m sure that there is. We’ve talked about a financial advantage, and I anticipate there would be one. But I can’t tell you at this point what that would be.
Is the partnership between MDVIP and Navigenics a result of the regulatory scrutiny that personal-genomics companies have faced?
I candidly don’t think it had to do with regulatory considerations. At least, certainly not on our side, and my perception is not on Navigenics’ side … As much as people would like to, I don’t think that you can take the physician out of healthcare. All of the direct-to-consumer initiatives may have their place, but the physician is essential. … In our pilot, when patients found out they had a lifetime risk and a genetic risk for an illness, 91 percent said that time of information would change the action and the seriousness with which they take their doctors’ original advice.
That’s very much different than a person responding out of direct-to-consumer marketing. The emphasis, the importance, the individuality, and the personalization, requires a medical consultant, mainly the physician to be able to tell the patient how important this information this is with in their health and with the probability of avoiding morbidity and mortality. So, the impetus to this was that we think the proper place this resides is not circumventing the physician, but definitely involving the physician as an important modality to add to patient understand and to add to a physician’s ability to advise and guide the patient to prevent the occurrence from happening, or pick up the occurrence at its earliest stage when it’s cost-effective and curative.
What is the structure of the partnership?
The first encounter of the patient will be with the physician. The physician will be in a position based upon the patient’s overall health to recommend or not recommend this test. If they recommend the test, then the patient and physician will talk about what this information means in the overall context of the patient’s healthcare and personalized situation. The genetic counselors will be supplied by Navigenics and utilized by MDVIP doctors on the basis of supplementing the information that the doctor has conveyed to the patient or asking them any other specialized information that a certified genetic counselor can answer.
Some believe that current reimbursement guidelines do not allow for the extra time it will take doctors to discus direct-to-consumer genetic screening. Are you working on a reimbursement strategy for your doctors in this regard?

Neither the physicians nor MDVIP has any profit incentive in this. What we’re interested in is good medicine. Our practices are perhaps a little different from the traditional practice, since we have a maximum of 600 or less patients. Each of our patients routinely has a visit of a half hour, and we usually average an hour-and-a-half and two hours for a comprehensive annual evaluations. Our physicians do have the time to counsel patients. In fact, the increased time that doctors and patients enjoy with one another and can focus on the preventative aspects of a patient’s health, is the reason for being in MDVIP. It’s what we do.

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