Lab Soft News

What Would Google Do in Today's Market; Relevance for Healthcare

It will come as no surprise that I am a fan of the web and all of the blogging tools and social networks that It has spawned. Google is a big part of this world -- the company helped to create many of the tools that I use on a daily basis. Jeff Jarvis was one of the early and most successful bloggers and he has now written a book entitled What Would Google Do?. In his blog, Buzz Machine, he recently provided his analysis of what Google does, and will continue to do, to survive in this new age (see: What Would Google Do? on sale today). Here is a list of these Google rules as understood by Jarvis:

• Customers are now in charge. They can be heard around the globe and have an impact on huge institutions in an instant.
• People can find each other anywhere and coalesce around you—or against you.
• The mass market is dead, replaced by the mass of niches.
• “Markets are conversations,....That means the key skill in any organization today is no longer marketing but conversing.
• We have shifted from an economy based on scarcity to one based on abundance. The control of products or distribution will no longer guarantee a premium and a profit.
• Enabling customers to collaborate with you—in creating, distributing, marketing, and supporting products—is what creates a premium in today’s market.
• The most successful enterprises today are networks—which extract as little value as possible so they can grow as big as possible—and the platforms on which those networks are built.
• Owning pipelines, people, products, or even intellectual property is no longer the key to success. Openness is.

I personally believe in all of these rules. I also think that all are applicable to how healthcare will be conducted and delivered by hospitals and by physicians. In our healthcare system, we are moving toward an era of patient empowerment in which physicians and nurses will be required to have "conversations" with patients rather than dictating to them the terms of a relationship. Patients, physicians, and hospitals, as noted above, will form health networks with the former making substantial contributions to their own health and wellness. I have written many previous notes about wellness and preventive medicine.The web will contribute, in part, to patients' knowledge and understanding about how to achieve such a goal.

I will return in later blogs to a more detailed discussion of how and why these Google rules apply to healthcare. For now, however, I refer you to Dr. Keith Kaplan's recent blog note in his Digital Pathlogy Blog about how the Mayo Clinic is making broad use of Health 2.0 tools to promote its mission (see: Mayo Clinic launches new culture blog). I will also mention that the University of Michigan Health System is posting Tweets on Twitter and engaging in "conversations" with other users of this service. This achieves several goals simultaneously: it provides valuable medical information, it publicizes Health system activities, and it also puts a human and friendly face on the institution.

Clinical Trials Information Integrated with Personal Health Records (PHRs)

I am a strong advocate of offering patients the opportunity to participate in clinical trials, particularly if they have serious problems like cancer. I briefly touched on this issue in a recent note (see: Some Tips for Selecting a "Good" Doctor and a "Good" Hospital). I served for five years on an Institutional Review Board (IRB) in a large teaching hospital, a committee within a hospital charged with the protection of the rights of research subjects. Participation in clinical trials is not for everyone. However, the opportunity should be presented to patients, when relevant, in a way that they can understand both the benefits and risks of the offer..

I have posted a number of previous notes about personal health records (PHRs). which are usually web-enabled repositories for family health records. They can be an extension of hospital electronic medical records (EMRs) or independent of them, in which case the responsibility falls to family members to keep them relevant and current. I personally favor the first approach. One of the benefits of the web-based PHR is that it provides ready access to any information available on the web. For example and ideally, one could click on the name of a lab test or disease embedded in the record and link to a reliable medical resources that can provide additional information. Two of the PHRs, Microsoft's HealthVault and Google's Google Health, have now created a partnership with TrialX.org such that "matching trials based on [a patient's] Personal Health Record" can be discovered and reviewed.

I found the TrialX web site to be professional and well organized, allowing a search by disease/condition or by major disease category such as breast cancer, HIV, diabetes, depression, obesity, asthma. To test the site, I searched for breast cancer and was presented with a tabular array showing the clinical trial "focus" in the left hand column and pull-down menus for age, sex, location, and trial phase (Phase 1-4). The Wikipedia has an excellent article on clinical trials with a detailed explanation of these phases. One final recommendation. If you are considering participation in a clinical trial, ask your physician for a copy of the entire research protocol. He or she may be surprised by such a request but must provide it to you. Many of them can run to 100 pages or more but it will provide all of the details about the trial. You may need to find a physician or medical researcher friend who can sit down with you and help you interpret the document, but it will be well worth your time and effort.

As I was preparing this note, I came across and interview with Chintan Patel, a co-founder and CTO of TrialX (see: Guest Article: Google Health and HealthVault App Integration from the trenches). For my technical readers, here's what he has to say about the integration challenges he encountered with the two PHRs mentioned above:

In terms of technical integration both GH and MHV use standards-based REST and SOAP communication layers respectively. However, GH provides application development library support across multiple programming languages such Java, .NET, Ruby, Python and so on, whereas HealthVault is mainly available through .NET with a few open-source projects in Java and Ruby. At TrialX, we had to develop an in-house Python-based library to communicate with HealthVault that is now available as an open-source toolkit, pyHealthVault.

Chlamydia Reports to CDC Hit All Time High

I have not been paying too much attention to chlamydia infections lately so an article from the CDC in MedPage Today, a CE and CME accredited medical news service, about the incidence of the disease in 2007 caught me by surprise. Below is an excerpt from it with boldface emphasis mine (see: Chlamydia Reports Hit All-Time High):

More than 1.1 million cases of chlamydia were reported in 2007 -- the largest number ever for any reportable condition, the CDC said. The number is equivalent to a rate of 370.2 cases per 100,000 population, an increase of 7.5% compared with 2006, the agency said in its annual report on sexually transmitted diseases (STDs)....The increase in chlamydia is probably the result of increased screening, more sensitive tests, and more complete national reporting, the agency said,...[A spokesperson for the CDC added] that racial and sexual disparities in STD incidence are especially worrisome. For instance, the CDC found, the rate of chlamydia was 543.6 cases per 100,000 women, almost three times the 190 cases per 100,000 men. The gonorrhea rate was also higher among women at 123.5 per 100,000 women, compared with 113.7 per 100,000 among men. And -- although they represent only 12% of the U.S. population -- blacks had about 70% percent of reported gonorrhea cases and almost half of all chlamydia and syphilis cases (48% and 46%, respectively). For young black women, the situation is especially dire: Those between the ages of 15 and 19 had a chlamydia rate of 9,646.7 per 100,000 population and a gonorrhea rate of 2,955.7 per 100,000....But the consequences for women of both chlamydia and gonorrhea can be serious, the agency said. Up to 40% of untreated chlamydia and gonorrhea infections can result in pelvic inflammatory disease, which causes as many as 50,000 women to become infertile every year.

Here's some details about lab testing for chlamydia from Lab Tests Online:

The preferred method of testing currently is the molecular test also known as nucleic acid amplification tests (NAAT). This test is based on amplification of the DNA that is present in Chlamydia trachomatis. Molecular testing for Chlamydia trachomatis is currently the standard and is widely utilized..... Until the legal system changes, only a positive culture result proving infection with chlamydia is admissible in court. All positive molecular tests for Chlamydia trachomatis should be verified by the same or another methodology for confirmation. Molecular tests need to be validated for different sources of specimens. They have not been FDA approved for performance with ocular, pharyngeal, or rectal sites.

The Chlamydia Rapid Test, an immunoassay and rapid alternative to the nucleic acid amplification tests (PCR), has good sensitivity and specificity and can yield a result in 30 minutes  (see: New Rapid Chlamydia Test). In-clinic identification of chlamydia infection decreases the risk for transmission by allowing immediate treatment and potentially bettering partner notification and tracing. However, the Rapid Test's positive predictive value of 86% means that some cases will be missed....Positive predictive value is defined as the probability that a person with a positive test result has, or will develop, a disease or condition. The test's overall advantages, combined with its ease of performance, could improve chlamydia screening in many settings — especially when PCR is unavailable.

Book Premium for Early Registrants to Lab InfoTech Summit

We are offering a book premium to the first 100 registrants to the 27th annual Lab InfoTech Summit, which will be held on March 16-18, 2009, at the Venetian Hotel in Las Vegas. Each of them will receive a free copy of The Innovator's Prescription: A Disruptive Solution for Health Care by Clayton M. Christensen, Jerome H. Grossman M.D., and Jason Hwang M.D. Dr.Hwang will be one of the keynote speakers on the first afternoon of the conference. We have not yet reached the the level of 100 registrants so this book offer is still in force.

Some Tips for Selecting a "Good" Doctor and a "Good" Hospital

The New York Times provide a wealth of good information in a recent article about how to select a good physician and hospital (see: In Search of a Good Doctor) I can't do it justice in this short note so read the whole thing, if you are interested. It lists a number of key web sites that can be utilized for information. Listed below are a few of the recommendation that I have distilled from the article about how to seek top quality medical care:

• You can use Hospital Compare, a service of HHS, to evaluate the quality of hospitals in your neighborhood. I have discussed this web site in a previous note (see: Reduced Cost of Offshore Surgical Procedures Puts Pressure on U.S. Hospitals to Compete).
• Browse the web to gain knowledge about various diseases and current methods of treatment in order to become "part of the medical team" and therefore engage with your healthcare providers in a meaningful way.
• Choose a high quality primary care physician (PCP) to provide advice and "help you navigate through our challenging but complex healthcare system."
• One way to help assess the quality of individual physicians is to establish whether he or she is board certified. However, board certification is only one indication of quality and it’s certainly no guarantee.
• Ask your local hospital for a list of board-certified internists or other types of specialists who have admitting admitting privileges to that hospital.
• The last and most critical part of selecting a physician is the first appointment, at which time you can evaluate his or her style and knowledge.

If I were personally seeking care for cancer, I would get myself to a specialized cancer hospital or clinic, even if it involved some travel. In my personal opinion, there are four criteria to keep in mind when seeking the best cancer treatment: (1) physicians and staff at the facility should treat many patients per week with the same or similar diagnosis as yours; (2) the physicians should pride themselves on being up-to-date on the latest research and treatment of your disease as well as available clinical trials; (3) there should be little or no direct connection between the treatment being offered to you and the salary of the treating physicians, and (4) your treatment plan should be developed by a multi-specialty panel of physicians working in the facility, resulting in a more nuanced and balanced approach.

Who Should Not Receive Chemotherapy: The Next Step in Healthcare Reform

As we enter an era of healthcare reform with increased pressure to reduce costs, the issue of  "who not to treat" will begin to loom as large in our minds as the therapeutic imperative. I have addressed one aspect of this question in a recent post (see: A Look at Deloitte's Healthcare Reform Pyramid: A Strategy for Reducing Costs) with the references to the comparative effectiveness of diagnosis and treatment. Physicians will be increasingly asked whether a lower cost treatment will be just as effective as a higher cost one or whether treatment is even justified, as in the terminally ill. The increasing use of lower-cost generic drugs is a reflection of this same question.

I will be lecturing on this topic at Lab InfoTech Summit 2009. My lecture title will be the following: Biomarkers as a Key Enabler for Monitoring and Modifying Drug Therapy. Companion diagnostics will be increasingly used to select candidates for treatment with expensive biotech drugs. A recent article on the web (see: The Next Step in Cancer Drugs: Who Should NOT Get Them) raised the interesting and challenging topic of which cancer patients NOT to treat or which to treat differently. Below is an excerpt from the article with boldface emphasis mine:

Lots of patients with advanced colon cancer shouldn’t get some of the most advanced drugs used to treat the disease, according to a new recommendation from the American Society of Clinical Oncology (ASCO). It may seem odd that a group of cancer docs is recommending against a popular treatment for many patients. But figuring out which patients are unlikely to benefit from cancer drugs — which are not only very expensive but can also be toxic — is a high priority in cancer research these days....The new ASCO recommendation says patients whose tumors have certain mutations in a gene called KRAS should not receive a class of drugs that includes Erbitux, co-marketed in this country by Eli Lilly...and Bristol-Myers Squibb, as well as Amgen’s Vectibix. Studies have shown pretty clearly that patients with the mutations — which occurred in about 35% of cases this large study — don’t benefit from the drugs. Not using Erbitux as a first-line drug for these patients could save about $600 million a year, the WSJ reports. Amgen said the data warrant a label change for Vectibix, and a Bristol spokesman told the WSJ that Bristol and Lilly look forward to working with the FDA.

Interestingly enough, KRAS, mentioned in this excerpt, is the only biomarker that I know of with its own web site. It's very professionally done. A few clicks reveals that the sponsor or this web site is Merck, the developer of Erbitux.

In previous notes (see: Moving Resources from the Therapeutic to the Diagnostic Silo, Genetic Testing to Cull Out the "Un-Right Patient" as a Candidate for a Particular Drug Therapy), I commented on the feasibility and desirability of moving resources from the treatment silo to the diagnostic silo and sometimes making the decision of withholding treatment from the "un-right" patients. In the article cited above, we learn that not using Erbitux as a first-line drug for certain patients could save about $600 million a year. That's a fairly good start in moving resources, considering that the KRAS testing itself would consume only a tiny fraction of the resources that will be saved by not using the drug as the first-line agent. Look for more attention to drug label changes as directives from the FDA become more common requiring the use companion diagnostics to properly select patients for the use of certain chemotherapeutic agents.

Two New Pathology Blogs Launched

Keith Kaplan, who posts over at at the Digital Pathology Blog, calls our attention to two new pathology blogs about which I was unaware (see: Another pathologist joins the blogosphere). They are the following: The Daily Sign-Out and Neuropathology Blog. The author of the former is generous enough to credit me in his first note with being part of the inspiration for launching his blog (see: Propositum). Both of these new blog offerings are great. Take a look at them!

A Look at Deloitte's Healthcare Reform Pyramid: A Strategy for Reducing Costs

Paul Keckley and Howard Underwood of the Deloitte Center for Health Solutions present what they call the Healthcare Reform Pyramid in a recent article. It's a graphic representation of the goals we need to pursue in order to reform our outmoded healthcare delivery system while reducing costs (see: Reducing Costs While Improving the U.S. Health Care System: The Health Care Reform Pyramid). Their illlustration is worth some attention. As one might expect, the base layer is healthcare information technology (HIT). This will not come as a surprise to any reader of this blog. The second layer toward the top is labeled comparative effectiveness/ evidence-based medicine. The third is coordination of care with a special focus on the Primary Care 2.0 Model, also called the Medical Home. The pinnacle of the pyramid is healthcare consumerism with emphasis on CDHPs (consumer-driven health plans), transparency, PHRs (personal health records), incentives, and value.

The Medical Home is defined by the Wikipedia in the following way:
The basic premise of the medical home concept is continual care that is managed and coordinated by a personal physician with the right tools will lead to better health outcomes.

I have a particular interest in the notion of Comparative Effectiveness in the healthcare delivery process. The Deloitte article provides the following explanation of this concept (boldface emphasis mine):

Building on the HCIT [healthcare information technology] foundation, the Comparative Effectiveness focus may be implemented as a means to shift incentives from doing more things to doing right things that are evidence-based and cost-effective. An important feature of this domain is continued investment in funding three to seven new personalized therapeutics/companion diagnostics annually. The advantages of personalized medicine in tandem with comparative effectiveness and HCIT could achieve NPV savings as high as $140 billion over 10 years. 

I have blogged about this idea of Comparative Effectiveness in two previous notes (see: Moving Resources from the Therapeutic to the Diagnostic Silo; Biomarkers Used to Assess Treatment Efficacy), referring to it as therapeutic efficacy. The idea that I put forward in this note is that we can reduce unnecessary and inappropriate drug therapy using lab test monitoring and, in so doing, we can shift resources from the therapeutic silo to the diagnostic/monitoring silo as well as reduce the overall cost of healthcare. The Deloitte authors arrive at the same conclusion based on their phrase: doing right things that are evidence-based and cost-effective.

One key element in the effectiveness monitoring of the emerging biotech drugs, as emphasized in the pull quote above, is companion diagnostics. These are lab tests, often developed in tandem with the development of a biotech drug, that can select the patient candidates for the drug as well as assess the ongoing effectiveness of treatment with the drug. These decisions are determined by the genetic characteristics of a tumor, in the case of chemotherapy, and/or the genomic/proteomic characteristics of the patient being treated. The topic of companion diagnostics has been extensively covered in previous notes.

Another Look at UCR Rates as They Affect Healthcare Consumers

In a recent note, I reported the story of how UnitedHealth was penalized for the action of Ingenix, its subsidiary, that developed the reference databases used to establish usual, customary, and reasonable (UCR) rates. UCRs are used by health insurance companies to bill consumers who venture "out of network" for their healthcare (see: UnitedHealth Settles Suit with New York Attorney General Cuomo). UnitedHealth has been forced to divest itself of Ingenix and pay a fine for its alleged misdeeds. Dave Williams, who blogs over at Health Business Blog, has raised some interesting questions about this Ingenix story (see: Is the Ingenix settlement usual, customary and reasonable?). Below is an excerpt from his note:

UCR [usual, customary, and reasonable charges] is a squishy concept and insurers have leeway to establish their own levels. If an insurance company sets a low UCR that transfers costs to the patient. It effectively takes money out of the pocket of providers, too, since they have a hard time collecting from patients. This is the basis for the recent dispute between United Healthcare’s Ingenix and the New York Attorney General. The AG accused Ingenix of publishing artificially low UCRs that were then used by many health plans to hurt providers and patients. Ingenix’s parent, UnitedHealth Group will have to pay $50 million and get out of the UCR database business. Much of the news coverage on this topic has taken the angle that patients and physicians are getting ripped off by the insurers. I don’t see it that way. A big problem is that a lot of the “usual and customary” charges are not “reasonable.” There is huge variation in pricing for no logical reason. As one cost containment company executive explained to me recently, a chest x-ray can vary between $120 and $600 within a single metro area....Unfortunately with health care it’s very hard to find out ahead of time what a given provider is charging, and often the patient has little real choice of where to go.

Dave's points are very reasonable. It's true that when charges are set too low and consumers balk at paying the difference, it pushes the collection burden onto the providers (i.e., the hospitals or clinics). He is also correct in stating that there is a huge variation in pricing for the same procedure by different providers. Such variation in a community makes the establishment of the usual-and-customary charges a complex matter. In a previous post (see: Why the Prices Charged by Hospital for Inpatient Care Are Irrelevant), I described why the charges by hospitals for inpatient care are totally out of touch with reality. The UCR story is merely another manifestation of the absurdity of billing practices in our healthcare system.

However, none of these facts apparently provided a sufficient alibi for UnitedHealth/Ingenix in their discussions with the attorney general of of the state of New York. I doubt whether the settlement by the company would have occurred unless there was good evidence that the UCRs were being set inappropriately low even in the face of the wide range of charges for a given medical procedure. In other words, if the company had been able to make a reasonable case for the UCRs that Ingenix established, they would have done so. Let's push for more transparency and more competition in the pricing of healthcare services.

A Strategy for Saving Our Hometown Newspapers

I am an enthusiast about all newspapers, both those with a national reputation such as the New York Times and the Wall Street Journal as well as my local paper -- the Ann Arbor News. The latter is, unfortunately, beginning to circle the drain like many others of its kind. I have read the comments by journalists and other experts about how to save our hometown newspapers. Many of these critiques have stuck me as inadequate, irrelevant, or self-serving. That was the case until I read a blog note by Dana Blankenhorn entitled: Ending the Paper. Here is an excerpt from his note with boldface emphasis mine:

The newspapers decided long ago that they would only organize their own advertisers and their own readers, thank you, that the rest of the market was too much work for them. So they slowly circled the drain and now they're going in. Good. The opportunity, however, remains open. A company with the technical chops to build a good online city directory, to give every shop and individual in that city their own page, to populate the pages of non-advertisers with links to whatever is out there on them (including maps), and only after building community to build traffic and business for those who will pay can still make money. Google could do this through local editions. So, too, could Yahoo or Microsoft. The existing directory players could have, but like the newspaper people declined because they didn't know what their business was. You build advocacy on top of organization, not underneath it. If you're not providing organization you can't provide context. An online newspaper that isn't building a directory is no better than a blog. And not very different.

What a great idea! This is the first suggestion for saving our newspapers that has really made sense to me. They should seek to copy the business model of our telephone directories of the past and present but using a digital format on steroids. The foundation of this new info-structure for our "local newspapers" should be a comprehensive, on-line directory listing all businesses and organizations in the community and, ideally, the names of all of the residents. Layered on top of this, taking advantage of the advertising model as the source of revenue, will be ads from the local business promoting current sales and services. Readers can click on any of these advertisements to generate a Google Map for directions to the business. Layered on top of this will be fresh news about current events like movies, sports, and concerts. This news content layer can also be positioned to go "hyperlocal" with syndicated features from, say, the New York Times about, say, ecological issues with links to the local organizations and individuals with a special interest in the environment. Food and recipe stories could link to local restaurants that feature similar menus. You get the idea. As Blankenhorn says above: You build advocacy on top of organization, not underneath it.

My disagreement with the prescriptive measures advocated by journalists and their editors is that thy have been trying to recreate their failing paper publications of the present rather than a new type of more comprehensive media based an understanding of the capabilities of digital technology.