Lab Soft News

Private Donations Rescue Medical Technology Program at the U. of Hawaii

We are facing a major shortage of medical technologists in this country (see: Comments on the Medical Technologist Shortage; The Continuing Shortage of Medical Technologists: a Challenge for Hospital Labs). They constitute an absolutely essential component of the clinical labs. They are the front line troops who perform nearly all of the essential tasks including most new test development. Many medical schools and universities have walked away from their medical technology programs because they can be complex to organize and manage and faculty members may be difficult to recruit. Now comes the news that the University of Hawaii will once again admit students to its medical technology baccalaureate degree program (see: UH to admit medical technology students again). Below are the details:

Donations are enabling the University of Hawaii to once again admit students to its medical technology baccalaureate degree program. Clinical Laboratories of Hawaii and Diagnostic Laboratory Services saved the program with $100,000 in donations to the university. The money is allowing the John A. Burns School of Medicine to support a full-time faculty member for the next two years. State budget cuts forced the school's Medical Technology Department to stop admitting new baccalaureate students last summer.The university since sought private support for the program.

As we all know, many states like Hawaii are in severe financial stress and are thus cutting back on allocations to their state university programs. For various reasons, med tech programs seem to be particularly vulnerable to cutbacks and closure. I think that part of the problem is that the essential role of this group of healthcare professionals is not well understood by politicians and the various higher education officials. It's telling with regard to the University of Hawaii that: (1) the funding of only one faculty member for two years was sufficient to resurrect the program; and (2) the money was obtained from two local commercial reference labs. Of course, these labs have a significant vested interest in such a program, often hiring the graduates for their labs.

UC Berkeley "Adjusts" Its Freshman Genetic Testing Program

I previously raised the issue of an ill-conceived project at UC Berkeley whereby incoming freshmen were asked to undergo genetic testing using oral mucosa cells (see: UC Berkeley Offers DNA Testing to Incoming Freshmen; Does This Make Sense?).To quote from my note: This whole project sounds to me like it was cooked up in the mind of a UC Berkeley professor with an interest in genetics and who views the entire freshman class as potential lab rats. Now comes word that the program is being adjusted (see: UC Berkeley adjusts freshman orientation's gene-testing program). Also see: DNA test flip-flop stirs debate at UC. Below is an excerpt from the article:

UC Berkeley announced on Thursday a rollback in its controversial plan for voluntary genetics testing of incoming students, part of an orientation program called "Bring Your Genes to Cal." In response to a state Public Health Department ruling on how DNA samples should be handled, UC Berkeley scientists reluctantly abandoned the idea to have freshmen and transfer students individually and confidentially learn about three of their own genetic traits. Instead, only collective results for all the 1,000 or so participants will be available and discussed at the orientation seminars.... Mark Schlissel, UC Berkeley's dean of biological sciences and an architect of the DNA program, said he disagreed with the state Department of Public Health's ruling that the genetic testing required advance approval from physicians and should be done only by specially-licensed clinical labs, not by university technicians. The campus could not find labs willing to do the work and probably could not afford it anyway, Schlissel said. He also contended that the project deserved an exemption from those rules because it was an educational exercise....Berkeley officials contend that the test results would not be medically significant. But the program was controversial with privacy advocates and ethicists complaining that it presented an unprecedented and disturbing use of genetic data by a university....In a statement issued Thursday, Kevin Reilly, an official at the state Public Health Department, said only licensed laboratories are allowed to perform medical tests on human specimens if the results are to be released to an individual. That rule is "designed to protect the public by ensuring that testing provides accurate and reliable results."

So it appears the UC Berkeley dean of biological sciences who hatched this idea has been stymied by the California state public health department, one of the toughest in the country. He and his other team members appear to have been blissfully unaware of the CLIA regulations whereby only licensed labs can release test results to individuals. Putting this all together, the project was probably only feasible from a cost perspective if the specimens were analyzed in a local research lab and not a CLIA-certified lab. In fact, the costs may have been covered by a research grant. When individual reporting was ruled out by the state authorities, the back-up plan was to reveal only collective results to the students.

So what was probably the real reason for this project? As noted above, I suspect that one or more researchers wanted access to a large pool of normal student samples as part of their research agenda. This is still possible with the revised plan but the number of specimens may be reduced absent the appeal of individual reports to the students. Forget all of the hot air about the educational benefits of the program for the incoming freshmen. This was mainly window dressing, in my opinion. In fact, Dean Schlissel admitted as much in the second news link above by saying the following:

"We're very much afraid that if (the ruling) is interpreted as applicable for other teaching programs ..., it will have a real stultifying effect on our ability to conduct research," said Dr. Mark Schlissel....

By the way, this same CLIA lab issue poses one of the major obstacle to the release of genetic test data to research subjects recruited for clinical trials. Most of this lab testing is performed in research labs similar to the one involved in the Berkeley project.

The Future of Healthcare and the Four P's: Preventive, Predictive, Personalized, Participatory

I have posted a number of previous notes on the topics of preventive, predictive, personalized, and participatory medicine (see: Preventive and Predictive Medicine as Components of the Healthcare Continuum; Some Encouraging News About New Federal Funding for Preventive Medicine Initiatives; Wellness, Preventive Medicine, and the Classic Disease Model; The Need for a Preventive Medicine Infrastructure in the U.S.; A Key Link Between Predictive and Preventive Medicine; Further Consideration of the Definition for Personalized Medicine; Recruiting Office Patients into a Participatory Model of Healthcare Delivery; "Participatory Medicine" and Its Relationship to Clinical Lab Testing). There are more but you get the idea.

Putting it all together, they together constitute a blueprint for the healthcare development arc in the near term. Tony Killeen, who blogs over at iPathology, makes reference to a recent lecture by Leroy Hood about P4 Medicine (see: P4 Medicine: Predictive Preventive Personalized and Participatory). Below is an excerpt from his note:

One of the best talks at the recent AACC Annual Meeting was given by Leroy Hood from the Institute for Systems Biology. His topic was P4 Medicine, a term he coined for "predictive, preventive, personalized, and participatory". What he's describing will, I believe, have significant and exciting implications for Laboratory Medicine because the concepts are based on the idea of clinical laboratory genomic analysis for identification of disease risk alleles, blood analysis for early detection of disease by measurement of disease specific biomarkers, and interpretation of data by knowledgeable experts. With the prospect of a $1000 genome sequence in the not-too-distant future, and rapid advances in protein analysis by mass spectrometry, it seems realistic to think that many of the technical limitations are surmountable. The question in my mind is how does one deal with the enormous amount of data from these analyses and distill it into something intelligible to physicians and patients alike?  And will patients really take an interest in modifying their lifestyle in response to new risk factors when it's so difficult for many people to adjust to well known disease risk factors today, such as smoking, diet, lack of exercise, and so on? But back to Laboratory Medicine. What is being described as P4 Medicine is obviously very reliant on clinical laboratory analysis, and could bring about a new era for advanced Lab Medicine in specialized centers that can offer such testing.

One "deals" with the enormous amount of data that will be accessible to us using information technology, but Tony already knows this. I think the question that he is really asking here is how the IT tools that will be at the disposal of both physicians and patients will be integrated into healthcare delivery. What's most revolutionary about the Four P's is the last one -- participatory. The truly unique aspect of this formula will be the nearly unfettered access by patients to the same information about their health status as the healthcare professionals (see: Should Patients Be "Allowed" to Read Their Medical Records?; Paging Dr. Google! We Are Waiting for a Second Opinion.; Teaching Consumers to Say "No" to Physicians' Recommendations). The most engaged of them will become key partners in the quest for continuing wellness.

Bariatric Surgery Cures Adult-Onset Diabetes; Is This a Problem?

Three years ago, I discussed early reports that bariatric surgery can cure adult-onset diabetes through a mechanism not solely related to weight loss (see: "Curing" Diabetes with Bariatric Surgery). Now comes more information confirming these initial observations (see: Study: Surgery May Reduce Diabetics' Need for Drugs; subscription required). Below is an excerpt from the article

The majority of people with diabetes who had bariatric surgery to lose weight were able to stop taking their diabetes medications, which led to a significant decline in health-care costs, according to a [recent] study....Researchers at Johns Hopkins in Baltimore, looked at 2,235 adults who had the stomach-reducing surgery and who also had Type 2 diabetes, a common form of the disease often associated with weight gain. Six months after surgery, nearly 75% of patients had eliminated their diabetes medications and after two years 84.5% of patients were off medicine....Many patients were able to stop taking their medications almost immediately after surgery and before they'd lost large amounts of weight, backing theories that stomach hormones altered by surgery are better able to control blood glucose levels than weight loss alone....About 86% of the patients, who were covered by Blue Cross and Blue Shield insurance, were on at least one diabetes medication before surgery, with an average of 4.4 medications per patient. About 23% of patients were on insulin.

Who would have thought, say, five years ago that we would have been discussing a surgical cure for adult-onset diabetes? However, we still need to study this issue on an even longer-term basis. It's possible that the body may adapt to the surgery-induced hormonal effects and that the disease may recur at a later time. However and as noted above, the beneficial effects do appear to last for more than two years for most patients. We  have known for many years that weight loss can cure or ameliorate adult-onset diabetes. For example, the metabolic syndrome is a pre-diabetic state that can be cured with weight loss (see: Metabolic Syndrome: The Problem You May Never Have Heard About; Visfatin, A "Belly Fat" Hormone, and Its Relationship to the Metabolic Syndrome).

Her's something to keep in mind. A physician told me recently that some of his patients do not show improvements in their lipid "numbers" when he prescribes statins for them. It turns out that many of them are unable or unwilling to alter their diets to correct a lipid problem. They view the statin treatment as a "quick fix" which permits them to avoid making the necessary lifestyle changes. I am therefore nervous about the use of bariatric surgery to cure Type 2 diabetes. Here's the choice being offered to these patients in my opinion: (1) surgical intervention with its attendant risks to create a greatly altered physiologic state and uncertain long-term consequences; (2) increased physical activity and an altered diet leading to gradual weight loss with certain long-term gains.

For me the choice would be obvious. Opt for less intervention. However and with bariatric surgery, the insurance companies gain with long-term reduced costs and hospitals and surgeons gain with the revenue from the procedures. With these types of returns now available for the healthcare establishment, I think that I know what the future holds. All of the incentives seem to be lined up in favor of bariatric surgery.

Too Much Management May Account for Lack of Innovation in Big Pharma Companies

In a recent note, I cited evidence for the lack of innovation in Big Pharma, at least from the perspective of stock market investors (see: Some Evidence that Big Pharma Has Lost Its Innovation Mojo). I did not go into issues of causality for this observation other than to cite the bloated cost structures of these companies. A recent article discusses the lack of an entrepreneurial spirit in many U.S. companies and suggests that the problem is that they suffer from excessive management (see: The End of Management). In other words, they employ too many managers with oversight over resources and new product development. The subtitle of this article is: Corporate bureaucracy is becoming obsolete. Why managers should act like venture capitalists. This says it all. Here is a key excerpt from this article:

In recent years, however, most of the greatest management stories have been not triumphs of the corporation, but triumphs over the corporation. General Electric's Jack Welch may have been the last of the great corporate builders. But even Mr. Welch was famous for waging war on bureaucracy. Other management icons of recent decades earned their reputations by attacking entrenched corporate cultures, bypassing corporate hierarchies, undermining corporate structures, and otherwise using the tactics of revolution in a desperate effort to make the elephants dance. The best corporate managers have become, in a sense, enemies of the corporation. The reasons for this are clear enough. Corporations are bureaucracies and managers are bureaucrats. Their fundamental tendency is toward self-perpetuation. They are, almost by definition, resistant to change. They were designed and tasked, not with reinforcing market forces, but with supplanting and even resisting the market.

The era of the block-buster drug with huge profits for Big Pharma seems to be long gone (see: Pharma industry prepares for end of 'blockbuster medicines'). Along the lines of the article cited above, I think that many of the managers in Big Pharma are bureaucrats who are primarily interested in self-perpetuation. Absent the potential for blockbuster drugs, they have little interest in the arduous and risky task of shepherding new drugs with smaller prospects for profit through the clinical trial and regulatory process. They would rather sell foot power with a smaller, but steady, profit and then purchase the smaller companies that are innovative enough to develop the new drugs. However, I fear that the innovative spirit of these smaller companies will be smothered when their fate is in the hands of the managers in these larger companies after purchase.

Roche's Ventana Acquires BioImagene

Roche Holding... said it will buy closely held BioImagene for $100 million, helping the Swiss drug company to extend its diagnostics business (see: Roche to Buy BioImagene, U.S. Diagnostics Firm). As part of the deal, Roche's unit Ventana Medical System Inc. will acquire 100% of the California-based company, which specializes in tissue-based cancer diagnostics and research. The U.S. company makes digital images from glass microscope slides that can be processed with computers, thus helping researchers and doctors save costs and time....The takeover is part of Roche's efforts to boost activities in personalized medicine, whereby companies develop diagnostic tests to help determine which therapy is the best for a patient....Efforts in the realm of diagnostics should also give pharmaceutical companies a better understanding of the molecular structure of diseases, enabling them to develop new ways to produce drugs.

Important Deadline Approaching for the Pathology Informatics 2010 Conference in Boston

The Pathology Informatics 2010 conference will take place on 19-22 September at the Westin Copley Place Hotel in Boston. It's an amalgam of three previous pathology informatics conferences: (1) APIII, held for 14 years, mainly in Pittsburgh; (2) Lab InfoTech Summit, presented for six years in Lab Vegas; and (3) AIMCL with a 21 year tenure in Ann Arbor.

A key date is approaching for those interested in registering for this conference -- August 27. This marks the deadline for the reduced conference registration fee for the event and also for making a reservation at the Copley. A block of rooms have been set aside at the hotel by the conference organizers for registrants at a special price but there is no guarantee that rooms will be available after this date. On-line registration is available at the conference web site as well as details about how to reserve a room at the hotel.

Early indications are that the conference will provide a very valuable educational experience for registrants. A record has been set this year for the number of scientific presentations on the basis of abstract submissions (see: New Record Set for Scientific Abstract Submissions to Pathology Informatics 2010). In addition, a record number of exhibitors, 41, will be demonstrating their products in the large exhibitor ballroom. Forty-eight faculty members will participate in three workshops, three separate content tracks, and three plenary sessions.

Managing Your Daily Interactions with Selected Pathologists

There is the old joke about how you can distinguish between an introverted pathologist and an extroverted one. The former looks at his own shoes when talking to you and the latter looks at your shoes. Many of us are familiar with the common daily habit of the pathologist who takes a stack of slide trays into his or her office, shuts the door, and spends the rest of the day dictating cases, exiting only for a coffee refill. These are people who enjoy their solitude, In short, they like being alone, if you do not define a stack of glass surgical pathology slides as company. It turns out the the brain anatomy and physiology of introverts may actually be different than that of the extrovert (see: Brains of Introverts Reveal Why They Prefer Being Alone). Below is an excerpt from this article:

Human faces may hold more meaning for socially outgoing individuals than for their more introverted counterparts, a new study suggests. The results show the brains of extroverts pay more attention to human faces than do introverts. In fact, introverts' brains didn't seem to distinguish between inanimate objects and human faces. The findings might partly explain why extroverts are more motivated to seek the company of others than are introverts, or why a particularly shy person might rather hang out with a good book than a group of friends. The study also adds weight to idea that underlying neural differences in people's brains contribute to their personality....The researchers studied a particular change in the brain's electrical activity known as P300. The change, which shows up as a deflection on a person's EEG, can be elicited by certain tasks or by a change in the environment, such as when the room is very quiet and you all of a sudden hear a loud nose. The brains' reaction occurs within 300 milliseconds, before the person is aware of the change....There was no link between [P300] scores on extroversion and the P300 response to flowers. Introverts had very similar P300 responses to both human faces and to flowers.

So as to the best way to manage your relations with such a pathologist, here's my best advice. He or she will generally not be interested in hearing about what you watched on TV last night nor how you will be spending your vacation. If encountered in a hallway, what he really wants to do is get back to his office and get the day's work done. If you are trying to engage him in a conversation and he looks slightly flummoxed, you may not doing anything wrong. He may just be trying to distinguish you from the flowers in the nearby vase.

More than 30,000 Pharmacists Now Administering Flu Shots in Neighborhood Drug Stores

Pharmacies and pharmacists seem to be evolving into neighborhood healthcare centers. I have posted previous notes about this phenomenon (see: Local Pharmacies Emerge as Centers for Care of Diabetics; Pharmacist-Staffed Coagulation Clinics in a Large Health System). I have also discussed the deployment of retail, walk-in clinics staffed by physicians and nurses in retail pharmacy chains like CVS and Walgreens (see: Cleveland Clinic Partners with Minute Clinic in Retail Health Services; Growth of Walk-In Clinics Slows Down; Study of Patients Patronizing Walk-In Retail Clinics). However, I have not been tracking the extent to which pharmacists have been trained to administer flu shots. Some details about the trend were revealed in a recent article (see: Suntan Lotion, Flip-Flops... and Flu Shots; registration required). Below is an excerpt from it:

Drugstores, still struggling with a weak economy, are pushing flu vaccinations earlier and harder than ever. They've bolstered the ranks of pharmacists certified to give shots and are promoting the service through TV commercials, in-store displays, Facebook and Twitter. CVS Caremark Corp., which is reaching out to some of its 64 million loyalty-card members via e-mail, is letting customers book an appointment by computer, phone or in-person. Walgreen Co. is even advertising flu-shot gift cards, for $29.99, aimed at kids headed off to college and other family members,....Rite Aid Corp. this year tripled to 7,400 the number of pharmacists who can administer flu shots. Walgreen has 25,000 pharmacists trained to give flu shots, up from 16,000 last year. Until recently, retail pharmacists couldn't get state certification to provide flu shots. This is the first season all 50 states will allow pharmacists to provide vaccinations. In the past, drugstores brought in outside vendors. Stores are generally charging $25 to $30 for shots....Pharmacies could use a sales boost, as prescriptions have shrunk as people cut back on doctor visits in the poor economy. Fewer visits to the pharmacy mean fewer chances to sell toothpaste, mascara and potato chips. CVS recently trimmed its fiscal-year outlook amid a 12% drop in pharmacy claims, while both Rite Aid and Walgreen saw sales dips.

I have been a little surprised that the evolution of chain drug stores into mini-heath centers has not proceeded more rapidly. I attribute part of this slow-down to the general lack of success of some of them. Some of these in-store clinics are now in the process of refining their business models to a more appropriate mix of services and staffing. However and as emphasized in the excerpt above, the poor economy is causing pharmacy chain executive to look for new medical services to raise revenue and increase foot traffic -- flu shots seem to fit the bill.

The question then remains whether retail pharmacies will seek to expand to other healthcare services such as blood drawing for lab testing. The local drug stores could operate as convenient patient service centers (PSCs) and draw blood for the national reference labs such as Quest and LabCorp. LabCorp has already used such a strategy within Duane Reed drug stores in New York City (see: LabCorp To Offer Medical Tests At Duane Reade Drugstores In New York City). Of course, these national reference labs are a high-volume, low-margin business and already have their own blood-drawing facilities. They may have no incentive to expand into higher-priced drug stores merely for the sake of greater customer convenience.

Some Evidence that Big Pharma Has Lost Its Innovation Mojo

Think quickly when I say "innovation" in relation to healthcare. What types of organizations come quickly to your mind. Hospitals? No. The pharmaceutical industry? No. I personally think of sectors such as medical devices, molecular diagnostics, genomics, medical imaging, biotech. Well, recent trends in the market cap of various healthcare sectors bear out this conclusion (see: The Net Innovation Trend), Below is an excerpt from the article making this point, including pie charts illustrating the comparative value of sectors for 2000 compared to 2008:

The relative absence of innovation set against a bloated cost structure has led to a rapid decline in value of large-cap pharmaceuticals, from nearly two-thirds of the market cap of healthcare in 2000 to less than one-third today. Over the past eight years, the pharmaceuticals sector has lost a stunning $593 billion (-65%) in market cap while the two sectors with innovation—biotech and med tech—have each added $71 billion (+46%) and $19 billion (+6%) in market cap, respectively....Generic drugs have also fared well (+$27 billion or +139% in market cap) as generics represent a low-cost solution to high drug costs. Furthermore, the generic companies have aggressively launched generics “at risk” or negotiating settlements with large-cap companies.

Here's a definition for "at-risk generic drugs" mentioned in this excerpt, a reflection of the extent to which the generic drug manufacturing companies, some of them off-shore, are willing to take risks in the pursuit of new products:

"At-risk" generic launches refer to generic pharmaceuticals that are approved by FDA based on the review of an abbreviated new drug application (ANDA) and are subsequently launched while patent litigation is ongoing. Launching these generics is risky because they can be pulled from the market if courts determine that patents protecting a branded reference product are violated or infringed, thus allowing the brand company to seek triple monetary damages.

If you share my belief that Big Pharma has lots its ability to innovate, the logical next question is why this has occurred. I think that the answer is multifactorial. First of all and as noted in the quote above, the industry has a "bloated cost structure" with too many layers of bureaucracy and too many mouths to feeds. In its quest for profits, it keeps shedding/outsourcing the costly, but key, development and manufacturing components (see: CROs Continue to Prosper; Benefits of Big Pharma Outsourcing). What the executives really want to sell to you is foot powder (see: Why Drug Companies Want to Sell You Foot Powder). Accordingly, the companies devote their resources to marketing rather than scientific discovery and clinical trials (see: Drug Company Emphasis on Marketing an Unfavorable Shift for Consumers). By way of contrast, listen to a lecture from a scientist from smaller company with a focus on, say, molecular diagnostics or genomics. You will hear much less about blockbuster products, marketing, and reimbursement and much more about the scientific basis for the company's R&D efforts.

Where does all of this leave us? Well from my point of view, it reinforces my idea that we are entering the golden era of diagnostics (see: Interpreting the Tea Leaves: Ten Trends in Healthcare, Lab Medicine, and Pathology Informatics; slide #30). The most complex and sophisticated part of the workup of a patient with a complex disease such as cancer is arriving at the diagnosis. This process will increasingly involve the interpretation of both serum and tissue biomarkers and various types of medical imaging. Once the diagnosis is arrived at, the appropriate treatment will be determined by referring to a table of available drugs with dosages and treatment cycles. And where will our "new" drugs come from. Largely from small, innovative drugs companies with a scientific culture and emphasis on a small number of products.