Lab Soft News

Comparison of "Traditional" Lab Testing with Direct Access Testing

In the course of researching yesterday's note about a direct-access-testing (DAT) franchise (see: DAT Franchise in Fort Lauderdale Focuses on "Sex and Drugs"), I came across an article on the topic from Washington G-2 Reports that provided an estimate of the total U. S. lab testing market versus the direct-to-consumer (DTC) laboratory testing market (see: Direct-to-Consumer Testing and Its Impact on the Lab Market). Such estimates are hard to find from reputable sources. My problem with the article is that the definitions used for traditional lab-based testing, direct-to-consumer (DTC) testing, and direct-access-testing (DAT) are confusing. Below is a excerpt from the article:

The direct-to-consumer (DTC) laboratory testing market, including at-home genetic testing, is estimated at less than $100 million in annual revenue out of the overall $51.7 billion U.S. laboratory testing market, according to several industry experts and Washington G-2 Reports. It is defined here as being comprised of "traditional laboratory-based" DTC testing and at-home genetic testing. In the traditional laboratory DTC testing area (excluding at-home genetic testing), there are half a dozen companies operating with a combined annual revenue of $15 million to $20 million. Though a small segment, it appears to be growing at 15% to 20% annually, driven in part by the approximately 45 million uninsured Americans and the aging of the baby boomers as they begin to retire. This part of the DTC (sometimes also referred to as direct-access-testing or DAT) testing market consists of several overlapping components-including routine laboratory testing that does not require physician referral; point of care (POC) testing; and over the counter (OTC) testing such as CLIA-waived laboratory tests, pregnancy tests, and insulin test strips. POC and OTC testing, however, are very different markets with different revenue and business models than DTC testing.

In a previous note (see: Four Categories of Direct Access Testing), I took a stab at establishing a clear definition for direct-access-testing (DAT). Here's a quote from the note (boldface emphasis mine):

The process by which a healthcare consumer tests, or submits for analysis in a clinical laboratory, a biological specimen (e.g., blood, serum, cells, urine, stool) without using a trained healthcare practitioner (e.g., physician, nurse) as a known intermediary in the process.

Continuing in this same spirit and spurred by the Washington G2 article above,  I would like to attempt to establish definitions for the two major categories of lab testing. Let's start by that stating that the lion's share of clinical lab testing in the U.S. can be classified as traditional lab testing (TLT) and for which we have not previously had a good label. This category includes work performed in commercial reference labs, hospital labs, and physician office labs (POLs). All of these tests share the following characteristics. They are both ordered by physicians and are performed by someone other than the patient/consumer, usually a lab professional. The use of the term "traditional" is particularly apt with reference to this category.

Let's further state that the second category of clinical lab testing can be referred to as direct-access-testing (DAT) or direct-to-consumer (DTC). I personally view these two terms as being synonymous since they essentially mean the same thing and prefer the former term because it is in more common usage. As the name implies, the critical feature of tests in this category is that they are NOT ordered by physicians but rather by patients/consumers themselves. They may be performed by either a patient/consumer himself or by laboratory personnel. This category includes the following types of testing: home kits, home-based instruments such as glucometers, and routine lab testing or DNA testing ordered via the web or occasionally in DAT storefront operations and performed in reference labs such as LabCorp.

The key difference between traditional lab testing (TLT) and direct-access-testing (DAT) is that physicians order the former and they are always performed by someone other than the patient/consumer. Patients/consumers order and frequently pay out-of-pocket for the latter and they may or may not perform the tests themselves.

DAT Franchise in Fort Lauderdale Focuses on "Sex and Drugs"

A recent article about a Florida direct access testing (DAT) franchise operation provides more details than are generally available about this type of business but casts the field in a somewhat unsavory light (see: Store does walk-in lab tests). I have covered direct access testing in detail in many previous notes. Below is an excerpt from this article with boldface emphasis mine:

Tom Noonan and son Travis stand outside their Any Lab Test Now store...in Fort Lauderdale. Their franchise conducts about 1,500 kinds of lab tests...."This is a business of sex and drugs.''...Since the May opening of the Any Lab Test Now store, tests for sexually transmitted diseases and illegal drugs have been the most common....Travis Noonan is the first franchisee of Atlanta-based Any Lab Test Now to open in Broward or Miami-Dade counties....[Any Lab Test Now] was founded in 1992, but only began offering franchise opportunities last year....Prices for tests, including cholesterol, hepatitis and PSA (prostate-specific antigen), to name a few, start at $49....Any Lab charges a franchise fee of $30,000 and estimates it takes another $50,000 to launch a store....Franchisees also pay a royalty fee to Any Lab of 6 percent in the first year and 8 percent after the first anniversary. The store employs two medical assistants who are trained to administer tests, including drawing blood. Specimens are then sent to a lab -- giants Quest Diagnostics and Laboratory Corp. are used -- for diagnostic testing....Any Lab has its share of competition. Besides hospitals and doctors' offices, there are online companies that arrange for low-cost testing. Among them is Miami's EconoLabs. EconoLabs has negotiated discounts with Quest and Laboratory Corp. of America because of the large volume of business it sends them, says Dr. Efrain Arroyave, EconoLabs' medical director. It sends customers directly to the labs for the tests.

I have the following comments about this article:

• It's true that a large component of DAT testing relates to STDs and illegal drugs. Because many companies screen job candidates as part of the interview process, individuals often test themselves using DAT sites to see if they are "clean" prior to applying for such jobs. Of course, home drug testing kits will also provide the same information. Here is a link to such a site that displays the following motto on its home page: Creating a Drug Free World Begins in the Home.
• Any Lab Test Now is the first company, to my knowledge, that offers franchises for "bricks and mortar" DAT sites. As noted in the article above, the company's business model differs from that of competitors such as EconoLabs, cited in the article, and web-based DAT sites. The Any Lab Test Now personnel perform their own blood draws for clients as opposed to sending them to the patient service centers (PSCs) maintained by the large national reference labs that actually perform the lab testing.
• Probably because of their higher cost structure, the Any Lab Test Now site described in the article above charges more for its lab tests. Note the charge of $49 for a cholesterol. EcnonoLabs in Miami charges $26 for a "Comprehensive Metabolic Panel (CMP-14) (AKA: SMAC-12)" that includes 14 individual tests.
• I was a little surprised that the article reveals that Lab Corp and Quest Diagnostics are the test performing labs for both Any Lab Test Now and EconoLabs and also that these lab giants discount their work for their DAT clients. Both of these companies have kept their involvement in the DAT world relatively quiet to avoid channel conflict with their physician clients. Quest had a DAT subsidiary called QuesTest but exited this market in 2006 (see: QuesTest Bails Out of the DAT Market).

Here's a recent and authoritative article on the DAT industry (see: Direct-to-Consumer Testing and Its Impact on the Lab Market) that has this to say about LabCorp's involvement:

... the primary lab provider for DTC companies is LabCorp. The reason for this is straightforward: DTC companies now operate nationally via the Internet and, as a result, need a national network of service centers where patients can have blood drawn or provide urine. [A provider of DAT services] says, "We primarily use LabCorp and have Quest as a backup, as needed. They're the only two labs we can work with because they're the only two labs that have a national network of patient service centers, and that's important for delivery."

More on the Epic Culture: Is This a Cult or a Company?

My recent blog note about Epic Systems (see: Epic Systems and Its Corporate Culture) seems to have stirred great interest and is currently the most popular individual entry page for Lab Soft News. Interestingly enough, many of the visitors have come from the Epic IP address. Perhaps I should label Lab Soft News as "not safe for work." Because of its strong corporate culture, Epic is not infrequently referred to as a cult. I am not the first to consider this idea -- a Google search for Epic Systems and cult yielded 779 hits.

Cult members are followers of an exclusive system of religious beliefs and practices. Describing a company such as Epic as a cult can perhaps be interpreted as an overzealous attempt by its competitors to cast it in a negative light and perhaps hinder its new employee recruiting efforts. On the other hand and drawing ideas from my original note, certain aspects of its culture may appear to be cult-like. Take the following Epic strategy, for example:

Rather than seeking experienced healthcare IT professionals, Epic relies on hiring a large corps of the brightest young, just-out-of-college IT professionals for its programming and implementation positions.

The Marine Corps has followed a similar strategy of attracting young recruits and then inculcating in them the culture of the organization. Everyone understands that young minds are generally more malleable and trainable. However, there is one major threat to establishing a cultish HIT company. After an initial training and indoctrination program, the newly minted acolytes are sent into the field to mingle with the unenlightened, otherwise know as employees of client hospitals. In such environments, there is the risk that the Epic doctrine can be questioned by more experienced hospital IT personnel. In order to avoid such confusion, it is necessary to establish a high degree of client-control. Evidence about how this is achieved can be found in three other elements of the Epic set of beliefs, copied from my original blog note with boldface emphasis mine:

Epic does retain salespeople, but they make no commissions on sales, and act more like advisers and consultants than traditional salespeople.

Epic turns away potential business. Indeed, prospective customers meeting with Epic representatives find they are being evaluated as much as they are evaluating.

Epic executives have evolved a very specific implementation process over time, one that involves intensive pre-implementation analysis and planning, but then focuses very strongly on meeting go-live dates.

Epic seems to choose its customers -- they do not choose it. Presumably this selection process is based on the willingness of the client to accept rules and processes set by the company. The company personnel function as advisers and consultants and not as a vendor at the beck and call of its customers. Finally, the specific implementation process, which is obviously enforced by the terms of the contract, imposes discipline on the client hospitals which presumably results in a successful go-live of the Epic software products in most cases. Cult of not, this is not the modus operandi of any other healthcare IT company.

For what's it's worth, here's  the opinion of Viktorcello abut Epic:

They are the devil! People get sucked into there and become totally arrogant and they change! And they really eff with you throughout the interview process, which takes like three months. And they make you work overtime all the time.

The Future of the Personal Health Record (PHR)

I have posted a number of previous notes about personal health records (PHRs). John Moore over at the Chilmark Research blog recently posted on the web one of his lectures about PHRs: Evolving PHR Market: Analysis and Trends. John has been providing some of the most perceptive comments I have seen on the evolution of the PHR. Below is a short list of some of his ideas contained in this specific lecture that caught my attention:

• The PHR market has moved to a B2B model with an employer-provided PHR (35%), provider provided (25%), and health plan-provided (15%).(Slide #5)
• First generation PHRs: isolated. The target was the end consumer and most third party PHRs remain stuck here.(Slide #8)
• Second generation PHRs: Online with some data. One of the major goals was to promote healthy behavior.(Slide #9)
• Third generation PHRs: Highly networked utility. Richer data and a richer experience.(Slide #10)

John is right on target with his remarks. Much of the PHR news recently has been about Google or Microsoft cutting some deal with a large health system or major health insurance company regarding their PHRs. This is a reflection of the increasing importance of the B2B model to which John refers above. John's idea about the third generation PHR as a highly networked utility is pitch-perfect. PHRs will only provide very high value for consumers when they are populated with important medical information. Hospitals, physician clinics, health plans, and health insurance companies control most such information. Therefore, the networked utilities that John describes will serve to connect consumers to providers to payors.

A number of conclusions can be drawn about the networked medical record architecture that John suggests. First of all, the goal of practical untethered PHRs (i.e., the non-networked PHR) that I have supported (see: Implications of the Kaiser-Microsoft PHR Deal) was probably a pipe dream. Secondly, the notion of consumer-space versus provider-space on these networked healthcare utilities is going to get a little fuzzy. I think that this blending and ambiguity will be helpful in the long run. For example, a health care consumer's observations about his or her own health status can be an important component of a health record whereas they are generally not considered to have great value. In addition and starting now, we need to set up standards such that the origin and authors of all data contained in a networked health record can be clearly delineated.

Epic Systems and Its Corporate Culture

Anyone deeply involved in lab computing needs to understand the companies supplying  LISs and EMRs to this market. Part of this understanding involves the "culture" of these companies. The term corporate culture is complex and incorporates a number of variables. As one measure of the complexity of the term, a Google search for it yields 4,450,000 hits. As only one example, some HIT companies are technology-driven whereas others are more marketing-driven. Probably no company is as interesting culture-wise as Epic Systems, currently the market leader in the EMR market. A recent article (see: Behind the Curtain) discusses the company in great detail. For me, the most interesting part of the article was the list of the differences between Epic and its competitors. Below is that portion of the article:

• Epic almost never advertises, and relies almost entirely on word-of-mouth recommendations to market itself.
• Epic does retain salespeople, but they make no commissions on sales, and act more like advisers and consultants than traditional salespeople.
• Epic turns away potential business. Indeed, prospective customers meeting with Epic representatives find they are being evaluated as much as they are evaluating.
• Epic executives have evolved a very specific implementation process over time, one that involves intensive pre-implementation analysis and planning, but then focuses very strongly on meeting go-live dates.
• Rather than seeking experienced healthcare IT professionals, Epic relies on hiring a large corps of the brightest young, just-out-of-college IT professionals for its programming and implementation positions.
• Epic never grows through acquisition, but rather relies on internal development, in extreme contrast to all its competitors among the largest clinical IS vendors.
• Most of all, Epic has a very unusual corporate culture, one that intrigues and sometimes puzzles those who encounter it or hear about it....That culture emanates to an extraordinary degree from the personality of the company's visionary, media-averse founder and CEO.

The true test of the value of any corporate culture is the success of that company in the competitive market. There are clearly no rigid rules. And by this test, the Epic culture has been, and continues to be, a successful one. My guess is that its competitors may  review this list and then probably decide that their own cultures will triumph in the end.

Some New Insights into "Bypass Brain"

The cognitive and behavioral aspects of bypass brain are now in the news as a result of the presidential political campaign and Bill Clinton's behavior. Read more about this in a recent blog note (see: 'Bypass Brain': How Surgery May Affect Mental Acuity). Below is an excerpt from the story with boldface emphasis mine:

Aides to Bill Clinton last week vehemently denied speculation that the former president's intemperate remarks on the campaign trail were due to mild cognitive damage from his quadruple-bypass surgery in 2004....But the condition dubbed "pump head" or "bypass brain" has long been recognized by doctors, even if they seldom warn patients about it....Symptoms include short-term memory loss, slowed responses, trouble concentrating and emotional instability....[R]esearchers at Duke University Medical Center tested 261 patients before and after bypass surgery and found that 53% of them had significant cognitive decline when they were discharged -- and 42% still suffered from it five years later....One explanation is that when a patient's blood is pumped through a heart-lung machine during bypass, tiny air bubbles, fat globules and other particles may enter the bloodstream. The pump can also damage platelets, which form clumps, and clamping the aorta loosens bits of plaque. That debris can travel to the brain and clog tiny capillaries, forming microscopic strokes....There's little dispute that heart surgery does cause short-term cognitive problems -- anesthesia alone can do that, particularly in older patients. But recent studies suggest that the cognitive decline years later may be due more to the underlying artery disease than to the effects of surgery.

I don't think that it's fair that the cardiac surgeons need to bear the brunt of Clinton's off-the-cuff remarks on the campaign trail. I also understand that more research is needed to further delineate the true nature of bypass brain. Nevertheless, I suspect that all of us have grown far too complacent about the inherent risks of any surgical procedure and general anesthesia. Here's some food for thought from the U.K. (see: 'Care flawed' in many bypass ops):

Coronary artery bypass graft operations, the focus of their latest project, has approximately a 2% death rate, and over the three year period checked, there were 1,198 deaths reported....There were problems found in every step of the process, from delays after referral, to the way tests were carried out, doctors communicated with each other, and the way patients were cared for after their operations. Overall, they concluded that in two-thirds of cases which ended in the death of a patient, some aspect of care was flawed, due to poor organisation, communication or teamwork.

If the time comes, I guess that I will opt to have a cardiologist snake a catheter into my heart, steer the tip into the ostium of one of my coronary arteries, and drop off a small spring-like device to keep the vessel open. This seems to be the safest course of action.

Sometimes Consultants Surprise You with Their Reports

Reports from healthcare consultants can sometimes be warmed-over pap or merely external validation of decisions already made by hospital executives. On occasion, however, reports from consultants can surprise you. This was obviously the situation described in the following article with boldface emphasis mine (see: WVU dumps its consultant):

West Virginia University officials fired a $75,000-a-month consulting firm Friday, saying the consultants' scathing report about WVU's health science division and affiliated hospitals was full of errors and misunderstandings. The nine-page report, by R&V Associates of Pittsburgh, alleged that "serious," "intolerable" and "alarming" problems at WVU hospitals put patients' lives at risk.  The consultants cited the unexpected deaths of two children and an adult. They also criticized WVU for serious shortages of general surgeons, anesthesiologists and heart surgeons that forced hospitals to send patients to facilities in Columbus, Ohio, and Pittsburgh. WVU said R&V reached false conclusions, in some cases, and the university already was working to fix other problems brought up in the report....[The interim vice president of health sciences] said the university plans to hire another outside consultant that "has experience with academic medical centers." R&V Associates, which has been paid $321,789, plus expenses, for its work since March, has said the report is accurate.

What in the world is going on here? A consulting firm accuses the hospital that engages it of putting "patients' lives at risk." It then adds insult to injury by inserting this claim in only a nine-page report. However, the interim vice president of health sciences at WVU hospitals seems to be heading in the right direction when he says that the organization is now seeking another consultant with "experience with academic medical centers." The web site of R&V Associates describes the discharged firm as specializing in "business consulting and crisis management." It's not clear from the article whether the officials at WVU hospitals anticipated that the consulting firm that they first engaged would precipitate the crisis that now apparently needs to be managed by yet another set of consultants. 

Who "Owns" PACS: Radiology or Central IT in Hospitals?

Veteran readers of this blog will probably know that I am a strong proponent of having laboratory professionals "manage" their own LISs. Lab tests results are a strategic asset in hospitals, underlying about 70% of hospital diagnoses and constituting about 70% of the data contained in electronic medical records. How does one determine who manages (i.e., owns) the LIS? Easy! Who makes the decisions regarding access to lab information? Who formats that information? Who has the final word on policy issues regarding that information. Who has both de jure and de facto control (i.e., stewardship) over it? If you need to pull out an org chart to answer these questions, you are in trouble. Needless to say, I was interested in a recent article (see: Who owns PACS -- Radiology or IT?) about this same question as it applies to radiology information and images. Below is a longish excerpt from the article with boldface emphasis mine:

Should radiology or the IT department take responsibility for managing PACS in a hospital? It depends on the facility's corporate culture and the level of sophistication of the IT department, an animated "debate" at the 2008 Society for Imaging Informatics in Medicine (SIIM) meeting concluded. The premise of the argument presented by Dr. Paul J. Chang on behalf of IT department ownership is that PACS technology has become a component of the entire hospital informatics enterprise rather than its own unique entity. In an increasing number of hospital infrastructures, dedicated networks for PACS are unnecessary. Thick-client workstations are facing obsolescence....Modern healthcare IT should be structured as a matrix, according to Chang, who straddles both worlds as vice chairman of radiology informatics and director of pathology informatics at the University of Chicago Pritzker School of Medicine....Because PACS is the multimedia component of an electronic health record (EHR), the EHR must be optimized to support radiology workflow. Not only is this a complex undertaking, but it logically fits as the responsibility of the IT department -- as long as the IT department has a global vision and a progressive philosophy, Chang said.

Dr. David Channin, chief of imaging informatics at Northwestern Memorial Hospital and the Feinberg School of Medicine in Chicago, disagreed. "Radiology has led informatics technology innovation in hospitals and will continue to be the source of informatics leadership in healthcare," Channin said. "Domain expertise must take precedence over IT expertise. Tools don't drive domain innovation. If controlled in a central manner, such as a matrix structure, the priorities of a radiology department will be subjected to control by an IT department juggling priorities representing multiple domains in a hospital," he said. "If you don't have budgetary control of your bucket of allocated capital dollars, you have lost control. Your critically needed PACS upgrade will be competing with acquisition of a new laser doodad for OR." Radiology departments should wield the power they have as cash cows for hospitals, define their IT domain borders, provide access to them with standard interfaces, and demand autonomy, according to Channin. He recommended that radiology departments contract with IT departments for "commodity services" such as networks, virtual operating systems, and data storage.

Well, no one can say that Drs. Chang  and Channin did not speak their minds in this spirited exchange. There is too much interesting material here to cover at one time. Here are some of my initial reactions:

• Matrix shamtrix. You either own the LIS/RIS/PACS or you don't. See my discussion above about system management/ownership. Pathology owns (or should own) lab information and pathology images and radiology owns (or should own) radiology information and images. Central IT + clinical personnel should then negotiate with pathology and radiology for access to the information managed by the latter two groups.
• According to Dr. Channin, "radiology has led informatics technology innovation in hospitals." LISs were developed and commercialized in the late 1970s and thus preceded RISs by at least five years in hospitals. AIMCL, the LIS conference that preceded Lab InfoTech Summit, was launched in 1983. Radiologists are the acknowledged leaders in hospital image management and storage. Let's call it a draw.
• I agree with Dr. Channin regarding the IT capital and operating budget for the LIS and RIS. If you don't control the information system budget, you don't control the information system.
• I have no problem with the central IT departments providing "commodity services" to pathology and radiology. They are best able to provide institution-wide services like networks and generic data storage for the entire institution. However, I believe that the latter is now a commodity and best provided via a vertical cloud (see: A Closer Look at the Vertical Cloud in Healthcare Computing; The Potential for "Sereverless" Healthcare Computing).

IT Budget Allocation Categories for Healthcare CIOs

John Moore at the Chillmark Research blog introduced one of his recent blog notes (see: Tradition Grapples with Insatiable Demand) in the following way:

Dan Nigrin, the CIO from Children’s Hospital Boston ...is struggling with the insatiable demand for HIT among care providers ...at Children’s while concurrently dealing with an industry that is so bound by tradition. On one hand he must prioritize spending across any number of categories that he characterized as infinitely long (healthcare still spends a woefully low 1-3% of revenue on IT, as a comparison, manufacturing is spending between 4-6% and financial institutions spend even more). Yet on the other-hand, he needs to find new ways to more effectively leverage this spend to insure effective adoption occurs. Not an easy task in this tied to tradition industry.

Moore then goes on in the note to provide a detailed list the following HIT spending priorities that had been enumerated by John Halamka, the other CIO on the panel. John publishes his own excellent blog (Life as a Healthcare CIO) and is chief Information Officer of the Caregroup Health System and Chief Information Officer and Dean for Technology at Harvard Medical School, among many other things. CareGroup includes Beth Israel Deaconess Medical Center. Below is Halamka's list of high level priorities in addition to the obvious support for business and clinical applications.

• Getting non-affiliated doctors on-board in using an EMR throughout the New England region
• Addressing the demand for data storage
• Insuring secure communication throughout the network
• Tackling security
• Compliance
• Creating dynamic websites
• Disaster recovery

It's a good idea to take stock of the larger set of challenges facing healthcare CIOs today. However, the list is not much different than that of the CIO of any major enterprise. The only surprise for me in his list was the first point -- getting non-affiliated doctors on-board in using an EMR throughout the New England region. Clearly, getting "outsiders wired" would not be the goal of any corporate CIO outside of the healthcare enterprise. One wonders if John is pursuing such a goal as part of his overarching interest in the improvement of healthcare IT or whether connecting such non-affiliated physicians is a strategic goal to spur admissions at his own hospitals. In a previous note and pertaining to the challenge of data storage (see: A Closer Look at the Vertical Cloud in Healthcare Computing), I discussed how some hospitals are turning to external web-based storage solutions such as InsiteOne for PACS records.

Moving Resources from the Therapeutic to the Diagnostic Silo

I moderated a panel discussion at the recently completed Pathology Futurescape conference sponsored by the CAP Foundation. The panel members spoke to the topic of Corporate Innovation as an Engine for Change and included the following corporate representatives: Gene Cartwright (GE), David Okrongly (Siemens), Dirk Soenksen (Aperio), and Mark Newburger (Apollo PACS). During the course of the discussion about the future of integrated diagnostics, Gene Cartwright suggested that we need to move resources from the therapeutic to the diagnostic silo in order to achieve the promise of pre-symptomatic/pre-clinical diagnoses for patients. This basic idea is incorporated in the concept of the early health model being championed by both GE and Siemens and about which I have posted a number of previous notes. There was insufficient time during the panel discussion to discuss any of the practical details about how to achieve such a reallocation of resources and about which I would now like to speculate.

I have come to the conclusion that the key to increasing available resources for diagnostics in the U.S. healthcare delivery system is embedded in the concept of therapeutic efficacy. By this I mean that we need to begin to organize a broad diagnostic effort to determine whether the various drugs being prescribed and administered to patients, particularly expensive chemotherapeutic agents, are achieving their intended results. Put another way, is the chemotherapy being administered to patients inhibiting the course of the disease or curing the patient? Therapeutic efficacy can be measured by means of biomarker monitoring and  medical imaging.

The necessary first step in this process will be to determine criteria for measuring therapeutic efficacy by drug by disease and recommending the diagnostic tests and procedures used to measure efficacy. After these criteria have been developed, the program can proceed. A number of possible drug treatments will never be initiated because of negative results obtained from companion diagnostics. Other drugs will be discontinued at some point during therapy because of lack of measurable efficacy.  A portion of the dollar savings achieved by the termination of drugs can be reallocated to offset the increased cost of the diagnostics used to assess drug efficacy on a much broader basis.

Needless to say, broader scrutiny of the therapeutic efficacy of drug therapy and terminating proven ineffective therapy will not be greeted with enthusiasm by the pharmaceutical companies despite the fact that the technology exists to mount such programs and the idea aligns closely with a fundamental principle of medicine -- Primum, non nocerum (First, do no harm). Fortunately, neither GE or Siemens, as compared to Roche, has any stake in drug manufacturing. Perhaps they may be willing to throw their weight behind these efforts.