Guest post: Health care reform and nursing homes

November 30th, 2009 by David E. Williams of the Health business blog

This is a guest post by Denise Tyler, PhD, an Investigator in the Center for Gerontology & Health Care Research at Brown University.  She is the project manager for the Shaping Long-Term Care in America Project, a five-year, $10 million project funded by the National Institute on Aging that aims to improve nursing home care in the US by examining how market factors and state policies affect the quality of care delivered in the country’s 15,000+ nursing homes.

Millions of Americans live in nursing homes and millions more receive short-term care from one after a hospital stay.  But the current health care reform debate has largely ignored nursing home care.

This is due, in part, to a lack of data about how and why that care is given.

As we move ahead with health care reform, we must understand how nursing homes are being utilized, what kinds of patients live in them, and what the outcomes are for the people who rely on them for care.

This matters because health care reform will likely be paid for in large part, by reductions in current health care spending.  And the majority of these reductions will come from the Medicare program and nursing homes will likely be the target of these spending reductions.

Until now, there has been no resource for accessing information about nursing homes and those they care for.  A new Web site that provides this information for the first time, www.LTCfocUS.org, has been developed by the Center for Gerontology and Healthcare Research at Brown University.

LTCfocUS.org hosts data regarding the health and status of nursing home residents, characteristics of care facilities, and state policies relevant to long term care services and financing.  The Web site allows policy makers and researchers to trace clear relationships between state policies and local market forces and the quality of nursing home care. What’s more, www.LTCfocUS.org also provides information gathered from a variety of sources, which makes it useful to answer research and policy relevant questions that could not previously have been answered.  For example, the Web site can be used to determine which nursing homes are providing greater proportions of Medicare services or examine the growth in Medicare services in nursing homes over time.

The Web site contains data about nursing home resident health, with specific information covering areas including incontinence, or the number of patients who are on anti-depressants or have high blood pressure.  Users can also learn about the size of nursing home facilities, whether they are for profit or non-profit or affiliated with a chain. Do you want to know how full these facilities are? Our Web site can also help with this information.

The system now in place can also inform about local market condition and competition, the Medicare Managed Care market penetration rate, and state policies regarding Medicaid spending on nursing homes.

In addition, because the Web site provides several years of data, it is possible to examine trends over time and determine how changes in nursing home policy or financing have affected nursing homes and their residents from year to year.  This information will be important for deciding which policies and financing schemes improve care and save money, some of the primary goals of healthcare reform.

Why is this information necessary? It matters in the bigger picture, for both health care and health care reform.

Health care reform will spur many changes and it is critical that these changes be evidence-based, and not dependent on politics. LTCfocUS.org is a new resource that will be vital to building this evidence base regarding nursing home care.


Posted in Announcements, Policy and politics | 3 Comments »

Happy Thanksgiving

November 25th, 2009 by David E. Williams of the Health business blog

Enjoying the Thanksgiving break with family this week.


Posted in Announcements | 1 Comment »

Malpractice defense: Hysterectomy Leading to Vesicovaginal Fistula

November 24th, 2009 by David E. Williams of the Health business blog

In addition to my consulting work and writing the Health Business Blog, I’m chairman of the board of Advanced Practice Strategies, a medical risk management firm that provides litigation support for malpractice defense and an eLearning curriculum focused on enhancing patient safety. Here’s the Advanced Practice Strategies case of the month.

For previous examples see Fetal assessment and response Stroke after lung surgeryCoronary artery disease vs. medication administration and tPA administration leads to brain hemorrhage.

Illustrated Verdict by APS
Every month APS’s Demonstrative Evidence Group shares case examples from our archives to show how a visual strategy can support the defense effort. We hope that it is of value in your practice as you develop your defense strategies on behalf of health care providers. Please feel free to forward it to colleagues or clients.

About Us
APS is a leading provider of demonstrative evidence for the defense of medical malpractice claims. Our team of medical illustrators consults with defense teams to educate the lay jury audience about the complexities of medical care. We do this by developing a visual strategy with expert witnesses including high-quality case-specific medical illustrations, x-ray enhancements, and multimedia presentations. To learn more, e-mail us or call 877.APS.4500.

Case Request
If you have an upcoming case in any of the following areas, please send us an e-mail and we’d be happy to show you some relevant examples of our work:
Bariatric/Gastric Bypass
Birth Injury & Defects
Brain Injuries
Cancers
Cosmetic Surgery
Delayed / Misdiagnosis
D ental Issues
Digestive Tract Issues
Emergency Room
Female Reproduction
Film Duplication/Digitizing
Film Enlargement
Heart Attack & Cardiac
Infection
Lasik Eye Surgery
Male Reproduction
Medication Issues
Spinal Cord Injuries
Surgical Issues
General Inquiries

I.V. Library
Click to view other editions:
Fetal Assessment / Response
Stroke After Lung Surgery
Shoulder Dystocia
Spleen Injury and Bleed
Cardiac Artery Disease
Gastric Bypass
tPA Infusion
Recurrent Hiatal Hernia
Hysterectomy / Fistula

Judgment for the Defense
Hysterectomy Leading to Vesicovaginal Fistula

http://www.aps-web.com/projectreview/IV/IV_1109web/2577m1_small.jpg

PLAINTIFF’S CLAIM:
The Plaintiff claimed that the Defendant was negligent in two respects: First, by bluntly dissecting during a total hysterectomy, thereby creating a vesicovaginal fistula through which urine leaked from the bladder into the vagina, and second, by failing to diagnose the existence of the fistula in a timely manner.

DEFENSE’S ARGUMENT:
This 36 year-old plaintiff underwent a hysterectomy because of abnormal vaginal bleeding and abdominal discomfort from a large, symptomatic 8–10 cm uterine fibroid. The patient’s anatomy was distorted by the mass, resulting in the cervix being pushed anteriorly into the base of the bladder.  This prevented normal visualization of the cervix on a speculum examination.

The manner in which the defendant performed the plaintiff’s hysterectomy—sharp dissection using scissors, as well as blunt dissection with her finger—was not only consistent with the standard of care but was (and still is) the method employed by many if not most gynecologists.

During the patient’s post-op hospitalization, there were no signs or symptoms that a vesicovaginal fistula had formed. The fistula presumably developed slowly, as evidenced by her symptoms only becoming apparent weeks after surgery. The physician theorized that the slow development stemmed from devascularization of the bladder wall, most likely resulting from a pelvic infection.

VISUAL STRATEGY:
APS worked with the attorneys and experts to develop a visual strategy that would help explain to the jury in detail that the procedures were performed appropriately:

We began by showing normal anatomy to orient the jury to the anatomical landmarks and surrounding structures.

We also illustrated the preoperative condition and how the fibroid mass in the uterus distorted the patient’s pelvic anatomy.

We created illustrations of the hysterectomy directly from the operative reports with the cooperation of the experts and defendants.

We created illustrations of the postoperative anatomy.

With illustrations we were able to explain that the vesicovaginal fistula was not diagnosed immediately after surgery because it formed over an extended period of time.

  1. We illustrated the pelvic infection, showing adhesions between the small bowel and the adnexa, along with the resultant thinning of the bladder wall.
  2. We created a board to show how necrosis weakened the bladder wall and progressed into a vesicovaginal fistula.
  3. We illustrated the vesicovaginal fistula based specifically on case documentation and expert review.

We concluded with a timeline that helped the jury visualize that the care given and the follow-up recommendations and treatments were all appropriate.

This combination of illustrations helped the defense successfully explain that:

  • The manner in which the defendant performed the plaintiff’s hysterectomy—sharp dissection using scissors, as well as blunt dissection with her finger—was not only consistent with the standard of care but was (and still is) the method employed by many if not most gynecologists.
  • The plaintiff did not have a vesicovaginal fistula during her postoperative hospitalization. The fistula developed slowly, becoming evident weeks later, presumably from devascularization of the bladder wall resulting from a pelvic infection. 

RESULT:
Arbitrator found in favor of the Defendant.

In Arbitration: “He found for the defense.  I would like to thank all of you for your invaluable work in making this a successful outcome for our client. ”
– Attorney Dennis R. Anti, Partner, Morrison Mahoney LLP., Springfield MA


Posted in Physicians | 2 Comments »

Tales of the Grim Reaper from Montreal

November 23rd, 2009 by David E. Williams of the Health business blog

I go to Canada fairly frequently. Whenever I’m in a social gathering and people find out I work in health care, they have something to say. It’s usually something good or bad about the US or Canadian health care system. Occasionally they ask for my view.

This weekend in Montreal I was speaking to an acquaintance (“Jim”) whose 87 year old father is in the hospital with advanced cancer. Jim told me that whenever he goes to the hospital doctors and other staff pressure him to sign papers indicating he does not want heroic measures. According to Jim the doctors feel his dad’s case is hopeless and want him to die soon.

Jim described his dad as a “young 87,” who was living on his own and driving until 2 months ago.

Jim said that the doctors frequently tell his father, “Do you realize how sick you are?” Jim is very angry about this and keeps telling the staff not to harangue his father with this profound insight. (His dad knows what’s going on but doesn’t want to hear about it constantly.) Meanwhile, Jim says his dad is receiving treatment and responding to it, which is a real nuisance from the hospital’s perspective.

Apparently the hospital wanted to discharge Jim’s dad, which Jim said was completely infeasible since his dad needs 24 hour care. So the hospital said they’d have to start charging Jim, figuring that would shake him loose for sure. But according to Jim, he surprised the hospital by agreeing to pay.

Jim’s take on this is that there should be a national policy in place that explicitly states under what circumstances care is to be given and in which cases it is to be withheld. That he could live with, he says, rather than being pressured at this difficult time and having his dad harrassed.

I don’t contend that this is an objective account. I was mainly trying to be a sympathetic listener, so didn’t really ask Jim to clarify his points. Still, it’s an interesting portrait.

At the same social gathering I ran into another Canadian who told me she was afraid to live in the States, where health care is such a problem, while in Canada everything is taken care of.

Interesting contrast.


Posted in Culture, International, Policy and politics | 2 Comments »

Podcast interview with Doctations CEO Dr. Louis Cornacchia (transcript)

November 20th, 2009 by David E. Williams of the Health business blog

This is the transcript of my recent podcast interview with the CEO of Doctations, Dr. Louis Cornacchia.

David Williams: This is David E. Williams, co-founder of MedPharma Partners and author of the Health Business Blog.  I’m speaking today with Dr. Louis Cornacchia, CEO and President of Doctations.  Dr. Cornacchia, thanks for your time today.

Dr. Louis Cornacchia: You’re welcome.

Williams: Tell me about Doctations.  What is it?

Dr. Cornacchia: Doctations is a software system.  It’s a suite of Google Apps-like applications using a standard web browser for doctors and their patients.  It contains the entire suite of functionalities that are found in any EMR/EHR and billing software.  Also it’s tied directly to web applications for patients, allowing  them to share space or Internet space with doctors in real time.

Williams: How would this be different from a typical application that might be set up in a physicians office?  Is it mainly the patient portal piece of it that makes it different?

Dr. Cornacchia: No, it’s the difference between having an intraoffice phone system versus a phone system that connects to the rest of the world.  It’s an Internet based system so it allows for clinical interactions, business interactions between physicians and both clinical and supportive interactions between doctors offices and patients.  So it’s really a whole new approach.  This isn’t an in-office client/server system.  This is a true network-based system that people can log onto today for free and actually start using a lot of the functionality without even paying a penny.

As physicians have gone on to do that, many have actually called and begun paying us a subscription fee per month specifically to gain the ability to add additional functionality to the software.  We have over twodozen partners that provide services such as real-time voice recognition and back end voice recognition tied to transcription. They’re all listed on our website.

These are all available because they are web services provided by corporations specializing in their specific niches and providing services to doctors to improve the workflow within the office, improve cashflow, and improve the ability for the physician to take care of their patients. For example, on the scheduling side, there is the ability to tie into a web service that allows for automated phone reminders to patients 48 hours before an office visit.  There is really nothing for a physician or an office staff to do other than schedule the patient and the phone calls are automated.  So as a true Internet creature the Doctations system can take advantage of all these basic Internet web services that have been available to the big guys for years and make them available to small offices or big offices alike.  It doesn’t make a difference.

Williams: How does this change the practice of medicine from the standpoint of the patient or the physician?  What are the sorts of things that can be enabled when somebody pulls all these web services together?

Dr. Cornacchia: Well that’s just the beginning. I don’t know if you’re familiar with what’s going on with Health 2.0.  We’re in the very early stages of forming companies based on web services for patients, services that will define whether or not a new symptom of a patient is related to a new medication they started, for example.  We’re seeing a large number of web 2.0 web services that are coming to us and asking to partner with us so they can provide services directly to patients through the same network system we’re using to help patients connect directly to the doctors.

Williams: As you say, we’re still at the early part of this. What are you seeing in terms of the typical profiles of your users?  What are they like?

Dr. Cornacchia: There is no typical profile.  That’s the most unusual part of this.  It isn’t as if it’s all 25 year old women or 35 year old men.  We see a full spectrum of people from the teens all the way up to the 70′s and 80′s using this.  It’s surprising to me because I actually expected that it would be more of the younger crowd who grew up with computers like we did.

I think that what’s happened is that the Internet world has just made it so clear to everyone, even those who are older than we are, that in fact the conveniences of using the web are so great that it’s worth the effort. The result is that you end up with services that are provided more efficiently and therefore more cost effectively than through standard bricks and mortar approaches.

Williams: Is there a benefits for a Doctations user if they want to interact with another physician that is also Doctations user?

Dr. Cornacchia: Well David, yes.  Just think of the implications of having a free version of the software available to everyone. Now collaboration can occur between doctors and referring physicians without the physician having to be a paying member.  But then what happens is the non-paying physician looks at the system and begins to realize it’s a full-fledged comprehensive system with task management and integrated billing. They can look at their own billing in real time and then interface with medical billers in their office or outsource. They begin to realize it’s a fully certified system that’s as good as any system they’ve ever seen.  It’s better because now it’s truly an Internet creature and so they end up with the best of both worlds.  So most doctors are saying: I’m coming with you.  We’ve had a lot of doctors moving in our direction just because doctors who are collaborating with doctors who are using our system suddenly realize this is a great way to go.

Williams: Obviously a lot of attention is being paid at the Federal level to the concept of meaningful use as part of the stimulus package and health care reform.  How does the stimulus package tie into what you’re doing at Doctations?

Dr. Cornacchia: We invented meaningful use ten years ago.  I’m a physician and I went to this not to become another EMR vendor, but to fix problems. As a physician and as somebody who has experienced health care from the patient’s side rather intimately, I can tell you very clearly that having a client/server system is a shadow of what an Internet based system can do.  So in meaningful use, it’s all about how can you achieve health care efficiencies without creating more work and at the same time building quality.  It actually turns out that it’s a common denominator for both, so building an Internet based system solves both problems. Meaningful use basically means an Internet based system.

Taking client/server systems that are in every office and tying them together is ultimately not a satisfactory answer because there are problems of synchronization. Unless each office is continually connected and continuously synchronized with some central database, there is a remote potential that there could be miss synchronization resulting in inappropriate or incorrect or incomplete information being looked at by a single physician.

It could result in a death because the wrong medication was prescribed and doctors didn’t know another medication was prescribed five hours earlier and had never been synchronized with the central system.  That approach has failed and I think that people are beginning to realize that that’s just not going to work.  In fact, what we visualized in 2001 and 2002 as the only real answer to these problems was right on.  It has to be Internet based.

I know a lot of people have put a lot of work into client/server systems and I think that there is a way to incorporate such systems into this type of a network, but I think that it requires that certain central repositories of data become integrated at the code level. I don’t think it requires a tremendous amount of work but for the most part what we’re going to see is a migration into Internet systems in order to achieve true meaningful use, simply because the cost efficiencies of providing services to Internet architectures like Google apps and like Doctations are just so much more cost effective, so much less expensive. That alone is a decision maker, but then when you look at all the connectivity and collaboration and other options that then become available at the Internet level, there is just no other choice.

Williams: If a Doctations patient is in the hospital, are you able to have collaboration between the hospital and the ambulatory physicians or is that harder than doing it among ambulatory physicians?

Dr. Cornacchia: Connecting to hospital-based systems using collaborative-based modern technology built on a .net backbone is actually straightforward.  The cost of integrating systems like these are actually remarkably low.  The only variable that can’t be accounted for is the bureaucracy associated with achieving agreement to connect between the vendors and on behalf of the particular facility or hospital.  That’s the only unknown variable.

The actual technology costs of connecting these systems is almost trivial. You end up connecting to a whole backbone of people so the cost of connections in a cloud based system just makes it a much more viable option as opposed to trying to connect each and every client/server based system to a hospital system.  So there is the advantage of numbers.  On top of that, there is the reality that our interface is available as an add-on to an existing hospital system so that they can simply link it directly to the various portions of their hospital system and make our collaborative technology immediately available.

Williams: There are some other companies that have gotten on the Internet health care band wagon.  Maybe I’ll ask you to contrast yourself with a couple of those that are fairly prominent.  One is Practice Fusion that focuses on the EMR side and another is American Well that’s more focused on the clinical interactions.  How do you fit in with them?

Dr. Cornacchia: I think they’re both great companies and I think that they’re thinking in a similar direction and I think that’s great.  The more people moving in this direction the better.  I think that the EMR system in Practice Fusion is a good start.  I think that it’s a good basic SOAP based system.  Most physicians are familiar with and it’s reasonable.  I think that they have not gone through the certification process, in fact they have ridiculed it, which I think is wrong.

We went through the certification process and as a physician trying to achieve a vision it was a painful process because there are a lot of hoops you have to jump through to make that work.  In conclusion, they’re not inappropriate hoops.  They were hoops that are actually required for complicated workloads that are found in doctors’ offices and other clinical settings.  So what’s present in the certification project is actually laudable.  It’s very well thought out and I don’t think it’s biased at all. It’s a very well thought out set of requirements and I think it’s unwise to challenge that.  I think it’s unwise to contradict that whether or not there are vendors involved.

I know all the rest of the issues.  I don’t see it.  I don’t really believe that.  I think things probably happen that we don’t know about of course, but for the most part what we saw was legitimate requirements and criteria for a system that has to live in a very complex world for doctors and patients.

American Well deals with communications. If you take a communications system and it just exists out in its own place, separate from the actual software system used to run the office, both clinical processes and billing processes, it becomes a non-integrated separate process. We originally thought about moving in that direction, but what’s really required is one comprehensive Internet based system that then gets expanded and becomes the foundation for communications and collaborations.

There’s no reason why there should be one EMR approach, probably multiple EMR approaches.  So what we’ve built is a software platform for Internet health care that we make available to government agencies and universities at the source code level.

So the answer to your question is that they are both excellent companies and I think that they’re both moving the entire industry forward. They both have a lot to contribute and I think that they’re very much along the lines of functionalities that exist already in Doctations.

Williams: I’ve been speaking today with Dr. Louis Cornacchia.  He is President and CEO of Doctations.  Thank you very much for your time today.

Dr. Cornacchia: You’re welcome.  You’re very welcome.


Posted in e-health, Entrepreneurs, Physicians, Podcast | 1 Comment »

Why not lower the recommended mammogram age to 30? or 20?

November 19th, 2009 by David E. Williams of the Health business blog

The controversy over the recent mammogram screening recommendation from the United States Preventive Services Task Force (USPSTF) is quite interesting. The pieces of the recommendations that have generated the most controversy are as follows:

The USPSTF recommends against routine screening mammography in women aged 40 to 49 years. The decision to start regular, biennial screening mammography before the age of 50 years should be an individual one and take patient context into account, including the patient’s values regarding specific benefits and harms.

The USPSTF recommends biennial screening mammography for women aged 50 to 74 years.

Yesterday’s New York Times letters to the editor section and news section was typical of the unsophisticated coverage I’ve seen: a number of letters and quotes from women diagnosed in their 40s complaining that the new guidelines would have killed them, someone pointing out that cancer can grow a lot in two years, along with a couple people pointing out that a pile of anecdotes does not equal a well-conducted scientific study.

I’d like to see this discussion pushed to its logical conclusion. If the minimum screening age shouldn’t be increased to 50, why should it be left at 40? Why not lower it to 30? Or 20? Or even lower? And if two years is too long of an interval, are we sure one year is frequent enough? How about every 6 months? Or every 3 months? Or every day?

Surely it does make sense to have some guidelines. Mammography appears to have modest benefits, but there is also potential harm associated with screening. From the National Breast Cancer Coalition.

Myth #2: Mammograms can only help and not harm you.

False: What’ the risk? False positive results may lead to unnecessary, intrusive surgical interventions, while false negative results will not find cancerous tumors.

The American Cancer Society recommends annual screening mammograms, those performed without symptoms present, starting at age 40. But…  it has been estimated that a woman’s cumulative risk for a false-positive result after ten mammograms is almost 50%; the risk of undergoing an unnecessary biopsy is almost 20%. In addition, women who are screened with mammography often have more aggressive and unneeded treatments. It is estimated that mammography screening has increased the number of mastectomies by 20% and the number of mastectomies and lumpectomies combined by 30%.

USPSTF does not take cost into account, although many have jumped to the conclusion that cost and “ObamaCare” are behind the recommendations. Personally I think it’s a good idea to take cost into account, although it should be done as a separate, transparent step after the clinical evidence is considered.

Although we don’t like to admit it, cost has to play a role somewhere along the way. If a mammogram is reimbursed ~$100 as it is now, cost may not be a big deal. But what if the cost were $1000, $10,000, $100,000, or $1,000,000? Should that not impact the guidelines?

I understand why people are worried about changes to guidelines, and I don’t totally disagree with their concerns. But diagnostic screening in general has risks as well as benefits. The aggregate benefits are often overstated by those who feel they’ve gained from screening –and especially by physicians, equipment makers, hospitals and labs that earn their living this way– while risks are not recognized or are suppressed.

Prostate screening is another good example of this phenomenon. See my coverage from a few years ago when the push began to lower the recommended age for PSA testing from 50 to 40.


Posted in Patients, Policy and politics | 5 Comments »

A conversation with Practice Fusion CEO Ryan Howard

November 18th, 2009 by David E. Williams of the Health business blog

In May I interviewed Ryan Howard, CEO of Practice Fusion, a free web-based electronic health record (EHR). A lot has happened in the EHR world since then so I thought I’d check back in. (This interview was conducted via email.)

David Williams: How are things progressing at Practice Fusion since our last discussion six months ago?

Ryan Howard: Practice Fusion has grown significantly in the past six months. We brought on Salesforce.com as an investor, partnered with BioReference and Quest Diagnostics, passed the 22,000 user milestone and are in the process of launching our Patient Health Record (PHR). We’re now the fastest growing EHR community in the country with 400 new sign ups each week. It’s been a great period for us and we’ve more than doubled the team here in San Francisco.

Williams: With the definition of “meaningful use” coming into view, how is that shaping the way physicians are looking at EHR?

Howard: The Meaningful Use criteria as they stand in draft format are pretty extensive – the focus on interoperability, connecting with patients, eprescribing and reporting to CMS – well beyond just an electronic version of a patient chart.  These connection requirements exceed what a lot of the legacy vendors can provide. If you have a locally-installed EHR in your practice, you’re looking at a brutal year ahead trying to get that system to be interoperable. It would be like trying to turn a car into an airplane.

So I think physicians are shifting their focus to web-based EHR systems that already have his data exchange structure in place. We’ve seen a surprising increase in the number of customers who already had an EHR installed making the switch to Practice Fusion.

Williams: When we spoke you mentioned that Practice Fusion is not CCHIT certified. Why not?

Howard: The HITECH Act’s Meaningful Use and HHS certification plan has canceled out any other EHR certification process.   CCHIT is not going to be the only HHS-approved means for Meaningful Use certification. Practice Fusion is looking at independent organizations like the Drummond Group who have announced their intention to certify EHR’s and have an extensive history of outcomes-oriented evaluation.  Whatever emerges as the best way to be HHS-certified, we will pursue.

Williams: Will Practice Fusion users be able to meet the “meaningful use” test?

Howard: Absolutely yes. We’re confident that Practice Fusion will be HHS-certified before the HITECH stimulus incentives begin and we have a published road map based on the drafted criteria. Practice Fusion issued a certification guarantee in September.

Williams: With incentive payments coming, is the fact that Practice Fusion is free as much of a draw as it was originally, in the pre-ARRA days?

Howard: Why would a physician choose a system that will cost them tens of thousands of dollars up front and several thousands of dollars continuing each year when they could go with a free EHR that has the same or better features and pocket the $44,000 to spend however they wish? Our free model continues to be a huge advantage.

Williams: How does Practice Fusion compare with other Internet-based clinical systems such as Doctations and American Well?

Howard: I think they’re both viable technology solutions in the marketplace, each is pretty advanced on the technology side.  But they’re lacking the adoption rate and community size. In this “land-grab” environment, a lot comes down to usage.


Posted in e-health, Entrepreneurs | No Comments »

Pharmacogenomics: Podcast interview with Medco’s Felix Frueh (transcript)

November 17th, 2009 by David E. Williams of the Health business blog

This is the transcript of yesterday’s podcast interview with Medco’s Felix Frueh.

David Williams: This is David Williams, co-founder of MedPharma Partners and author of the Health Business Blog.  I’m speaking today with Felix Frueh.  He is VP of Personalized Medicine Research and Development at Medco Health Solutions.  Felix, thanks for speaking with me today.

Felix Frueh: Thank you for having me.

Williams: Felix, we’ll talk about pharmacogenomics today. So first what is pharmacogenomics?

Frueh: Pharmacogenomics in the broadest sense is the science of looking at your genetic profile and the influence of this profile on pharmaco therapy; so how do you metabolize drugs, how your body reacts to drug therapy.  You can expand that into a variety of other areas that people sometimes refer to as pharmacogenomics, including personalized medicine in really a much broader sense. You’re measuring biomarkers to guide therapy perhaps a little bit beyond genetics, but often the terms are used interchangeably.  So I would restrict it to measuring genetics: conducting a genetic test and using that information to guide your drug therapy.

Williams: I understand that Medco and the American Medical Association sponsored a survey of physicians on the topic of pharmacogenomics. Can you tell me a little bit about the background on that survey and what some of the key findings were?

Frueh:   At the end of last year, we conducted a survey with the American Medical Association. We faxed a series of questions to about 300,000 physicians in the United States. We wanted to know about  their knowledge and use of pharmacogenomics.

So we asked questions such as: “Do you think that genetics or genomics is an important component for drug therapy?” , “Are you using genetic testing?” , “Do you think you will be using genetic testing?” , “Why are you using it?” , “What is the information that you would like to know for using it?”

It was really interesting that 98% of physicians believe that genetic information is important for drug therapy.  That provides a really excellent base for what we want to do, namely bringing pharmacogenomic testing into clinical practice.  We have to contrast that number with the only about 10% of respondents that indicated that they’re actually using pharmaco-genetic testing today.  So there is a wide gap between what physicians believe is really important and the number of physicians who actually are using that information.

That gap is largely due to what we’ve learned from that survey: the lack of education and the lack of adequate information provided to physicians about the genetic tests.  If we take that survey and parse out some of the key responses, we can learn a lot about where we have to take the next steps for making pharmacogenomics medicine into reality.  It’s interesting to note that about 25% of respondents indicated that they will be using genetic testing in the near future; that’s more than twice the number of physicians that are using such tests today.  To me that indicates that the awareness is out there and physicians really want to use it, but we need to find a way to provide information better to that community.

Williams: What can we learn from the low percentage of physicians that actually use pharmaco-genomic tests in their practice today?  How are they different from the physicians who think that genetics are important but aren’t using the tests?

Frueh: For example, whether the physicians had formal training during medical school makes a big difference.  The therapeutic area makes somewhat of a difference, too.  So if you’re talking to oncologists, they’re more aware of the potential of genetic guided therapy than a dermatologist.  One of the other interesting points in this context was that if you ask whether or not they believe that their patient actually benefited from the use of a genetic test, you also get a little bit of an idea of who the doctors are who are perhaps somewhat more reluctant.

For example if you ask if they believe that the drug has an improved effectiveness or reduced toxicity depending on what the specialty is and what the application is you see different answers.  As we move forward and we find a way to provide more information to the physician, I think many of the physicians will move into the well-informed group. or a not informed group would move from the latter to the former.  So the most distinguishing factor really is the level of education.

Williams: Obviously most physicians have been out of medical school for a while, but they do continuing medical education, so I’m wondering what the specific mechanisms are that you’re thinking about to educate some of the physicians that are perhaps less knowledgeable about the application of such tests in their practice.

Frueh: There are many venues that I believe need to be explored.  Some of them have already been set up.  Others we’re going to see over the next couple of years. For example we have developed brochures and online materials together with the Personalized Medical Coalition and with the American Medical Association to help physicians get up to speed on “pharmacogenomics 101.”

Prior to starting working at Medco, I was working at the U.S. Food and Drug Administration. While in that capacity we also collaborated with the American Medical Association and with the American College of Clinical Pharmacology on creating two online courses that are available for free over the Internet to help physicians and practitioners get up to speed on why genetic information is useful in pharmaco-therapy.  So there are many different venues that we need to explore, but I think most important is to look at the vehicles that physicians are mostly using to obtain their information from to make or change their clinical practice directions.

What we found was that providing information to clinical guidelines in discussions, peer discussion and through product labeling and peer reviewed literature are the four most important venues that physicians look for.  So perhaps the education piece needs to be integrated in these venues rather than in standalone education efforts that say you need to know something about genetics.  If there is a new drug coming out for which there is a genetic test available and drive that information flow through clinical guidelines or peer-reviewed literature, that would probably be the more effective way to do it.

Williams: When you have a new drug and it has a companion diagnostic, what is the role of the drug manufacturer relative to the genetic test maker?  Do they tend to work hand in hand?  Do they tend to be the same companies?  What’s the dynamic like between the two?

Frueh: That varies depending on the product.  You have very close interactions; for example there is a drug Herceptin for breast cancer that is very closely tied to the performance of a test –the HerceptTest or FISH test–  to see whether the profile of the patient fits the pharmaco-therapy with Herceptin.  Then you have situations where there’s literally no connection between the drug manufacturer and the provider of a genetic test, like warfarin, where the drug has been on the market for 50 years while the genetics of the drug therapy and metabolism only were discovered over the last decade and so the test came to the market much, much later.  The drug obviously is generic.  There are now five or six different FDA approved tests out there.

So you have both extremes. I believe that over the next five to ten years it’s very, very likely that we’ll see many more close drug/test combinations coming to the market. I wouldn’t be surprised if we also –because of that– see tighter interaction between the pharma industry and the developers of the tests.

I think that’s a really good thing because the sooner we know that a particular biomarker or genetic test is going to be useful for drug therapy, the better the uptake of that test will be in the market. Again looking at the two extremes that I described, when a Herceptin came to the market at the same time as the HercepTest came to the market the combination of the two really led to an immediate uptake of both.  So the oncologist who is prescribing Herceptin never was really asking the question if the HercepTest should be done.  It was just part of what he would do when prescribing Herceptin.

Bringing a test to the market after a drug already has been used and faces an established clinical practice is a very tricky thing, but within that context I think you see examples where evidence accumulates in such a compelling way that clinical practice actually adapts fairly quickly.  So if a drug comes to the market without a test, the first reports come out that testing could really help prevent adverse events and after a clinical trial was performed that clearly showed a significant reduction in adverse events.  Everybody started to use genetic testing.  So it is also important is that we conduct appropriate studies that further our understanding in what these biomarkers can do and how they can be deployed into the clinical practice. If we can do that I have very little doubt that clinical practice will change and adapt and we’ll see many more of these tests being utilized.

Williams: Why is pharmacogenomics specifically of interest for Medco?

Frueh: If you look at Medco as a pharmacy benefit provider and the mission of our core business and the fact that we are a pharmacy, it’s probably not a stretch to imagine that in order to practice good pharmacy, you want to make sure the drugs we’re either filling prescriptions for or managing the benefits for are going to be utilized in the best possible way. Therefore providing access to genetic testing, brokering the access to genetic testing and being involved in the benefit management of the genetic testing is really another piece of providing good pharmacy practice.

We want to make sure that whoever gets the pharmacy benefits through us and gets their prescriptions filled through Medco is also having access to the latest technology that helps guide pharmaco-therapy.  It’s really the next logical step to a personalized medicine environment, making sure that the pharmacy, the drug, is used in an appropriate way.

Williams: I know that some of your competitors are taking an interest as well. I think it was actually just a couple of days ago that CVS Caremark announced that it had invested in Generation Health, which bills itself as a genetic benefit management company. The founder of that company used to be CEO of Medco.  So I’m curious: is Medco planning something along those lines as well?

Frueh: First of all I think that Caremark’s approach is a great approach. It certainly validates what we’ve been doing over the last two years at Medco with both our research and our clinical programs in pharmacogenomics.  It really underlines the importance of pharmacy benefit management companies in personalized medicine.  So the fact that Caremark and Generation Health have been teaming up is a very, very positive development.

From our perspective as I mentioned we actually are doing this already for two years.  We already have commercial programs for certain drugs that you’ll hear about later this year.  We definitely are very innovative in this space.  We’re leading the personalized medicine field with respect to the translation of that science into clinical practice.  We have commercial programs.  We have 200 or so clients signed up already for these programs and we are actively involved in the translation of this.

Williams: I’ve been speaking today with Felix Frueh.  He is Vice President of Personalized Medicine Research and Development at Medco Health Solutions.  Felix, thanks so much.

Frueh: Thank you very much.


Posted in Pharma, Physicians, Podcast, Research | 1 Comment »

Grand Rounds is up at Colorado Insurance Insider

November 17th, 2009 by David E. Williams of the Health business blog

Check out the latest edition of Grand Rounds at Colorado Health Insurance Insider.


Posted in Announcements, Blogs | No Comments »

Pharmacogenomics: Podcast interview with Medco’s Felix Frueh

November 16th, 2009 by David E. Williams of the Health business blog

Medco Health Solutions and the American Medical Association sponsored a survey of 10,000 physicians in the US regarding pharmacogenomics (PGx). Almost all physicians think genetics play an important role in how patients respond to a drug, yet only 13 percent had ordered these tests for their patients. Better informed physicians were more likely to order the tests than others.

In this podcast interview with Felix Frueh, vice president of personalized medicine research and development at Medco, we discuss the varying definitions of PGx, how the tests are being used today and how that’s likely to change over time, and the role Medco and its competitors are playing.

Survey results are available online.


Posted in Pharma, Physicians, Podcast, Research | 2 Comments »

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