Lab Soft News

Preparing for a Job in Research Administration at Eastern Michigan University

I recently struck up a conversation at a social event with Irwin Martin, PhD, who is now a professor in the Clinical Research Administration Program at Eastern Michigan University in Ypsilanti, MI. He has a background as an executive in the pharmaceutical industry. We discussed EMU's program to train personnel for positions as clinical research administrators. Some of the readers of Lab Soft News might benefit from hearing about it. Below is an excerpt from a document he sent to me:

Clinical research in the US and around the world continues to expand.  Studies are being conducted by multinational drug and medical devices companies as well as in many medical centers around the world.  There are many employers looking to fill open positions with trained professionals.  Eastern Michigan University in Ypsilanti, MI, offers training to individuals with a BA or BS degree and an aptitude for science. The mission of EMU’s Clinical Research Administration Program is to provide an academic experience which includes both didactic information and hands-on preceptorships that provide qualified new personnel to the drug and device development industry and to provide an opportunity for professionals currently participating in the drug/device development process to increase their knowledge base as well as their research/creative skills.

This training should provide a pathway for upward mobility in their professional careers. Toward this end, EMU has developed two interlinked programs.

The Post-Baccalaureate Certificate in Clinical Research Administration consists of four courses which provide information concerning the drug and device development process, good clinical practice (GCP), Federal regulations and guidelines..., [and] clinical research protocol development, implementation, and monitoring.....Upon satisfactory completion of the didactic component of the program, students may apply for admission into a hands-on preceptorship experience with contract research organizations, pharmaceutical firms, and clinical facilities which collaborate with the program.

The Master of Science in Clinical Research Administration is designed for individuals who are already employed or credentialed in the medicines, or device development field and desire increased perspective and competency and a higher level of responsibility....The four required courses in the certificate program are supplemented with program electives, cognate electives, and a research project or thesis. Students may focus their program to prepare them for employment opportunities in Clinical Trial Management or Regulatory Affairs or both through the selection of appropriate electives and specialized preceptorship opportunities.

Because of the centrality and constant expansion of clinical research and clinical trials in both academic institutions and the pharmaceutical industry, there is continuing need for administrative personnel to help manage drug and medical device clinical trials. Salaries are attractive and work settings vary. My work on an IRB at a medical school reinforced in my mind the criticality of these personnel. I have always been impressed by their talent and enthusiasm. Take a look at the EMU program if interested or those at other universities.

LabCorp Acquires PAML, One of the Last Large Non-Profit Reference Labs

LabCorp continues on its recent buying spree, having just purchased PAML which was a regional, Spokane based non-profit reference lab (see: LabCorp buying Spokane-based PAML). Below is an excerpt from the recent article about the purchase:

LabCorp is buying the 60-year-old medical-testing laboratory [PAML] from Providence Health & Services and Catholic Health Initiatives, two of the nation’s largest health care systems. Pathology Associates Medical Laboratories employs over 1,600 people, tests samples collected in eight states and generates about $300 million a year in revenue....LabCorp also is buying PAML’s interest in PACLAB Network Laboratories in Western Washington and Tri-Cities Laboratory, as well as three other joint ventures: Colorado Laboratory Services, Kentucky Laboratory Services and MountainStar Clinical Laboratories....PAML and its joint ventures provide laboratory services in Washington, Idaho, Montana, Oregon, Utah, California, Colorado and Kentucky. The sale expands LabCorp’s geographic scope in the Pacific Northwest, Midwest and South....Based in Burlington, North Carolina, Laboratory Corp. of America Holdings (LabCorp) has been on a buying spree. The company paid $371 million for genetic testing lab Sequenom last fall, and in January it reached a deal to buy several clinical laboratories from Mount Sinai (see: LabCorp to Acquire Assets of Mount Sinai Health System Clinical Outreach Laboratories), a major health system in New York City. In 2015, LabCorp acquired New Jersey-based drug development firm Covance (see: LabCorp to Acquire Covance for $6.1B) for about $5.7 billion. Earlier this month Reuters reported that LabCorp is in talks to acquire contract researcher Pharmaceutical Product Development LLC for more than $8 billion. That would be LabCorp’s largest acquisition ever.....Considered one of the top reference laboratories in the country, PAML has been an industry leader in joint venture partnerships with community-based hospitals. It also provides blood and diagnostic tests for clinics and employers across the West.

Along with ARUP and Mayo Medical Labs, PAML has been on my radar screen for decades as a high quality, non-profit reference lab. As noted above, LabCorp, with a market cap of $14.7B, has been expanding into genomic testing and contract research support. I indicated in a previous note posted about a year ago that LabCorp was "investing heavily in clinical trials, drug development, and speciality lab businesses (see: Quest and LabCorp Pursue Divergent Strategies; Which Will Succeed More?)." I found another recent reference to the diverging strategies of LabCorp and Quest (see: Quest, LabCorp forge divergent paths through M&A). Below is an excerpt from it:

And in recent years, both....[Quest and LabCorp] have made significant strides in expanding their businesses by partnering with hospitals. But Quest has concentrated on acquiring health systems' labs, while LabCorp has focused on acquisitions that shore up its technology and the sophistication of its diagnostic services....Quest's strategy will grow its core business of diagnostic services, while LabCorp's efforts are steering the company toward a future beyond clinical labs.....Quest has focused on acquiring health systems' laboratory outreach businesses, which are labs that perform services for customers outside of the health system, often for patients seeking a lab order from a personal physician or a provider at a different health system.

I am personally distressed to see PAML absorbed into LabCorp and become corporatized. However, I can also understand the desire of the PAML owners, Providence Health & Services and Catholic Health Initiatives, two of the nation’s largest health care systems, to perhaps focus on what they may perceive as their core businesses. However, PAML, as a unique entity will be sorely missed.

Fairview Health Services and the University of Minnesota Walk Away from Merger Talks

The University of Minnesota Medical School, in the face of serious financial problems twenty years ago, sold its hospital and clinics to a community health system, Fairview Health Services. In a number of ways, the relationship has not been a happy one in the sense that goals of a community hospital often do not always align with those of an academic teaching and research institution. A recent attempt has been made to negotiate a "merger" of Fairview with the U of M Medical School, creating a single management layer. But this effort has now collapsed with the Medical School casting about for a new hospital and clinic partner (see: Collapse of Fairview merger leaves U casting about for a partner). Below is an excerpt from the article:

On paper at least, Fairview was the most logical partner to extend the U's clinical reach beyond campus. The two have worked together for 20 years, ever since the U sold its hospital and clinics to Fairview. Now, ironically, that sale could hamper the U's efforts to find a new partner. While the U can offer suitors the clinical expertise of its 750 physicians, it can't bring to the table the facilities where they work."The university lost control of their university hospital, which is their primary teaching and research site," ...[said a faculty member]. "It is kind of like you sell your factory but you still make your parts there."The U sold the hospital to stem financial losses that were cutting its ability to fund research and education....Recognizing that the sale resulted in a partial alliance that was falling short of expectations, leaders began negotiations toward a complete merger of Fairview with the University's physician group. The Fairview name would have been replaced by University of Minnesota Health, or "M Health" for short. All seven hospitals and 42 clinics in the Fairview system would be rebranded. With top academic physicians on board, the system would offer patients the type of cutting-edge care they couldn't get elsewhere, at the same time generating money that could be invested in new research and education opportunities for the medical school. But when merger discussions dragged on beyond the self-imposed deadline of March 31, 2016], university officials eventually presented Fairview with a set of merger agreements that it had written itself....After studying the U's final offer, Fairview's interim chief executive knew that it would not get approval from the Fairview board.....In the meantime, both Fairview and the university say they will continue working together under several affiliation agreements. As the U considers other merger possibilities, leaders say new partnerships might focus more on outpatient care, which is replacing extended hospital stays for many procedures.

For me and more than anything, this is a cautionary tale that instructs us about the wide gap between the academic, medical/teaching culture and the community hospital culture. On paper and initially, the purchase by Fairview of the UM hospital and clinics seemed logical and integrative. The strength of the University of Minnesota was its prestigious brand, its large physician group, and its history of quality research. The strength of Fairview was its large footprint in the community, its real estate, and its solid financial status. In the final analysis, the executives and board of Fairview could not stomach having its facilities branded as "M Health" and the proposed combined management structure. I am not sure which of these factors was more important.

I certainly wish both organizations well in the future. There is potential greatness in the alliance if they could have come up with a reasonable way forward. Despite the fact that the major direction of hospital care is largely toward outpatient delivery, this will not be be an adequate total strategy for the University of Minnesota. Any academic medical center obviously needs inpatient beds for training purposes and for clinical research. The two sides have worked closely for years while they retained separate leadership. The merger would have cemented the relationship under a combined management but the sides apparently haven't come to terms on governance and executive decisions (see: Merger of Fairview, U of M physicians group stalls). 

Scandal at M.D. Anderson -- Operating Loss and Then Watson Deep-Sixed

The second shoe recently dropped at the prestigious M.D. Anderson Cancer Center in Houston. First there was the news of the large operating loss for the first two months of FY 2017 (see: MD Anderson records $102.4M operating loss in first 2 months of FY 2017) followed by the recent suspension of the Oncology Expert Advisor project powered by Watson due to "audit irregularities" (see: Touted IBM supercomputer project at MD Anderson on hold after audit finds spending issues). Below is an excerpt from an article on this subject:

A University of Texas System audit has found irregularities involving more than $40 million paid for outside goods and services as part of M.D. Anderson Cancer Center's now stalled effort to enlist IBM supercomputer Watson in the battle against cancer. The audit, posted at the system's website, reported the cancer hospital didn't follow established purchase rules for the project, which executives had ballyhooed would tap Watson's encyclopedic memory and lightning information-processing speed to tailor optimal patient treatment. "Because this review was limited to procurement for (Watson), one cannot determine whether the issues noted are unique to this large, complicated project," William McRaven, the UT System chancellor, wrote in a response to the audit..."The irregularities included service agreements that didn't undergo a competitive process, fees consistently set just below the amount that would have required board approval, spending of donations before they were received and untimely payment of vendors. The project, which has incurred costs of $62 million, was placed on hold prior to the initiation of the audit, and remains so at this time, an MD Anderson spokeswoman said this week. It's unclear if any of the project's costs contributed to operating losses at the renowned cancer hospital that have exceeded $430 million the past 16 months and that in January led to the layoff of 778 employees ....The audit was undertaken following concerns raised at MD Anderson about questionable activities involving the project....The project — known as the Expert Oncology Adviser, powered by Watson — was unveiled by MD Anderson more than three years ago (see: The Oncology Expert Advisor).

To deepen the plot, here's an excerpt from a very hard-hitting article on this same topic from Forbes (see: MD Anderson Benches IBM Watson In Setback For Artificial Intelligence In Medicine):

Watson, IBM’s language-based computing project, gripped the world’s imagination in 2011 when the supercomputer won an exhibition of the game show Jeopardy! against the show’s two highest-rated players. In March 2012, IBM signed a deal with Memorial Sloan Kettering Cancer Center in New York to develop a commercial product that would use the same technology to analyze the medical literature and help doctors choose treatments for cancer patients. MD Anderson, Memorial’s longtime rival, entered the fray after this agreement was already in place. Lynda Chin, the former chair of the MD Anderson Department of Genomic Medicine and the wife of MD Anderson president Ronald DePinho, set up a collaboration with IBM to develop a separate project. Chin left MD Anderson for another job within the University of Texas system in 2015. In a strange twist, MD Anderson would pay for the whole thing, eventually giving $39.2 million to IBM and $21.2 million to PricewaterhouseCoopers, which was hired to create a business plan around the product. According to the Washington Post, at least $50 million of the money came from Low Taek Jho, a flamboyant Malaysian financier whose business dealings are reportedly now under investigation by the U.S. Department of Justice. Usually, companies pay research centers to do research on their products; in this case, MD Anderson paid for the privilege, although it would have apparently also owned the product. This was a “very unusual business arrangement,” says Vinay Prasad, an oncologist at Oregon Health & Science University.

The conclusion is inescapable that both the management of the Oncology Expert Advisor at M.D. Anderson as well as perhaps the management of the entire cancer center has been less than ideal. There are also hints about nepotism and international intrigue with the involvement of Low Taek Jho. My view of IBM throughout my career in healthcare IT has been that the company over-prices, over-promises, and under-delivers. Also causing extreme eye-rolling on my part is the $21.2M bill from PricewaterhouseCoopers for a "business plan" for the project. Why does M.D. Anderson need a multi-million dollar business plan for a scientific, oncology/genomic initiative?

The Oncology Expert Advisor project may have seemed clever when launched but rather bizarre through the rear view mirror. It will be interesting to speculate about the fate of Watson and IBM at Memorial Sloan Kettering (see: IBM Watson, Quest Diagnostics, Memorial Sloan Kettering Cancer Center, MIT, Harvard combine forces for massive oncology, precision medicine initiative)? Will there be some Texas shock waves. MSK does not seem to have much exposure in that the hospital has been providing mainly access to its oncology database, OncoKB. This will be a topic for future blog notes as details become available. 

Addressing Patients' Social Problems Can Reduce ED Visits and Healthcare Costs

A recent article discussed how addressing the social problems of hospital emergency department (ED) super-users can results in substantial savings for hospitals (see: Tackling Patients’ Social Problems Can Cut Health Costs). Below is an excerpt from it:

[S]uper-utilizers of healthcare services] cost public and private insurers dearly — making up just five percent of the U.S. population, but accounting for 50 percent of health care spending. As health care costs continue to rise, hospitals and doctors are trying to figure out how to find these patients and get to the root of their problems. An effort to do just that started in New Jersey’s poorest city, Camden, more than a decade ago. Inspired by the way police departments mapped crime data to detect “hot spots,” family physician Dr. Jeffrey Brenner dug into ambulance records and emergency department data to show how high-cost patients were shuttling between city hospitals (see: Addressing the One Percent: An Interview with Jeffrey Brenner, MD).....To steer patients away from expensive emergency care and push health systems to change the way they do business, the Affordable Care Act funds programs called Accountable Care Organizations. These are networks of hospitals, physicians and others who team up to improve care, lower costs and reap the savings. Jeffrey Brenner has sought to change the way the health care industry treats people with complex problems.....This high touch, data-driven approach [of addressing super-utilizers' social problems] has yielded big savings. ER visits for ...[a study group of them] dropped by 40 percent, cutting monthly hospital bills from $1.2 million dollars to $500,000. Since then, Brenner has sought to spread the model around the country. One example is the Patient Care Intervention Center [PCIC] in Houston....Tackling that problem took unprecedented planning among typically disjointed city and county agencies, hospitals and nonprofits.

There is no big surprise here. A large number of hospital ED super-users have major social problems such as homelessness, mental illness, and alcoholism. Addressing some of these problems in collaboration with agencies and non-profits can improve hospital budgets. Although hospitals may reap most of the benefits of this reduction of unnecessary ED visits, they are not in a position to independently intervene. However, ACOs working in concert with "disjointed" city and county agencies and non-profits can improve the situation.

Click through to the web page of the Patient Care Intervention Center in Houston for more information about how one successful organization is taking steps to help solve this problem. As the excerpt above indicates, part of its approach entails data analysis to identify the super-users. Recall that hospitals control access to some of the most important data in this regard. Here's some information about the Unified Care Continuum Portal (UCCP) from the web site of the PCIC:

...[The UCCP] is a web based system that is being developed to provide a single point of access to a client's plan, which would span services rendered to the client from multiple organizations. This will enable providers and coordinators to view the entire continuum of care being provided to a client, rather than just their own care plans. It will enable better coordination between systems, and reduce any overlap in services that might currently exist due to a lack in coordination. It will also establish a more streamlined and coordinated case management process with the client. The UCCP will be built on top of PCIC's web-based Electronic Medical Record (EMR) system, integrating into existing care coordination and care plan functionality that is already present in the system.

NEJM's Quick Take Videos: New Approach to Transferring Knowledge

There are few aspects of healthcare and medicine that have remained static in the many decades that I have been a physician except for the content and format of the articles in refereed print journals. Things are beginning to change, however. The New England Journal of Medicine is offering quick-take videos that consist of two minute animated summaries of some of its scientific articles (see: Browse NEJM Quick Take Videos). It's also possible to "mouse over" each of the selections to see a six-line written summary of each article. When the video link is clicked, advertisements are displayed. It's thus possible to use this revenue as a means to cover the cost of the production of the videos. 

A related article addressed the issue of whether pharmaceutical companies might want to copy the Quick Take Videos of NEJM as a way of presenting knowledge about drugs to physicians (see: Nuts, Science and YouTube: How Medical Publications Videos Are Adding Value). Here is an excerpt from that article:

The NEJM is only getting its feet wet with its Quick Take campaign, but it is not too soon for pharma to follow suit. Most companies already have YouTube channels they use to communicate customer support, company happenings and drug benefits to consumers, but few have extended these digital marketing techniques into the medical affairs sphere. Perhaps they should. It can be difficult for pharma to communicate scientific studies to healthcare professionals because physicians may not have time to digest a dense journal article or pamphlet. Worse yet, a rushed physician may skim through an article and miss the messages the company hoped to convey.  In many cases, the dense text of any scientific article can bog down a reader and detract from the study’s overall value....[C]ompanies can track how many viewers have seen their videos; as a result, they can assess a videos potential impact on the scientific community. Despite these benefits, however, YouTube videos can be a little daunting for many companies because pharma has little control over the related videos and comments section.  On occasion, viewers may post comments about adverse events or off-label uses. 

Pharma companies have aggressively pursued direct-to-consumer (DTC) ads on television and print publications  (see, for example: How Pharmaceutical Companies Fool Consumers with Me-Too Drugs; Pressure Mounting to Ban Pharmaceutical Direct-to-Consumer Ads). The TV ads are designed to coax consumers to request various prescription drugs from their physicians. The AMA has urged that such TV drug ads be banned because they can inappropriately manipulate consumers (see: American Medical Association urges ban on TV drug ads). Obviously, a TV spot consists of one-way communication to lay healthcare consumers. It's fascinating that the excerpt above cites one of the disadvantages of YouTube videos for pharma companies is that viewers can post unfavorable comments about the content of the video. In other words, it's harder to control the message with two-way, web-based communication such as YouTube videos.

Details about CVS' MinuteClinic POCT Strategy

The Association for Pathology Informatics (API) and Sunquest Information Systems presented an interesting webinar yesterday entitled: Consumerism in Diagnostics: Retail Testing and the Future of Providers. The main portion of the presentation was delivered by Dan Kerls who is the Director of Ambulatory Operations for MinuteClinics. Mickey Urdea of Halteres Associates, longtime executive and consultant in the IVD industry, also participated and asked a number of key questions and provided background commentary. Bob McGonnagle, publisher of CAP Today acted as the host. Here is the link to the recording of the session. 

Dan Kerls discussed various part of MinuteClinic's POCT strategy. Given the fact that there are 1,126 of these facilities in 33 states, lab testing in walk-in clinics will surely be of interest to all lab professionals. For the purpose of this note, I want to focus on the physical size and staffing of these clinics as a major driver for the company's lab testing strategy. Examining rooms for the MinuteClinics measure 12x9 ft. and are staffed by either a nurse practitioner (NP) or physician assistant (PA). 

As Kerls explained, the physical space for the examining rooms contains a refrigerator that is used mainly to store vaccines. There is not much extra room for, say, test reagents. Also, there would not be extra space in the room for multiple POCT devices. The company has also decided to only use finger-stick blood samples for lab testing. There are no dedicated bathrooms for MinuteClinic patients so no urine samples are collected. Urine pregnancy tests are performed with a test strip provided to the patient. Only FDA-approved CLIA-waived tests are offered in the test menu and not all of them. Examples of tests that are performed include: cholesterol, HbA1c, strep B, mononucleosis. hepatitis C, and HIV.

Given that each MinuteClinic is staffed by only an NP or PA and the run-time for a visit is no longer than 15 minutes, the following limitations are placed on POCT testing:

• Lab testing is performed only while the patient is with the provider in the examining room.
• The patient waiting area is unattended. Venipunctures could lead to patients fainting.
• The interpretation of any lab test must be within the scope of practice of the NP or PA. MinuteClinic is the largest employer of NPs in the country.
• Rules governing the scope of practice for NPs and PAs vary from state to state. 

For additional information, here is a link to a transcript of an interview of Dan Kerls about POCT testing published in 2017 (see: POINT-OF-CARE DIAGNOSTICS IN CVS' MINUTECLINICS).

Patients with Lung Cancer (NSCLC) Refusing Treatment; Pessimism about Cancer

Some patients with cancer will occasionally refuse therapy, particularly when their situation is considered hopeless. I thought that this was largely an attitude of the past until I came across a recent article about patients saying "no" to therapy (see: Lung Cancer Survival Shortens as Patients No' to Tx). Below is an excerpt from it:

The number of patients with advanced lung cancer who decide not to undergo treatment is increasing despite better systemic treatments that are more tolerable and that significantly improve overall survival....Analysis of data from the National Cancer Database reveals that from 1998 to 2012, 21% of patients with primary non–small cell lung cancer (NSCLC) received no treatment, resulting in significantly shorter overall survival....regardless of disease stage....The proportion of untreated patients with NSCLC ranges from 7% to 45% depending on stage. However, up to 90% of older, medically inoperable patients do not receive treatment....There are many factors that influence the decision not to undergo treatment for NSCLC, including patient and disease characteristics, as well as physician referral patterns and preferences,....Physicians should make sure that "patients from disparate populations are evaluated and counseled thoroughly by multidisciplinary teams before choosing to forego treatment for NSCLC...." Many patients who are diagnosed with NSCLC may not be aware of the dramatic differences in survival between treated and untreated patients and believe that cancer treatment is worse than the disease....For a lot of patients, that isn't true anymore, so treatment options should be fully explored before patients decide not to have any treatment....It is also important for clinicians "to recognize the stigma that NSCLC still carries despite efforts to fight it and the negative influence that the stigma can have on perception of the disease and treatment.

A patient's cultural background and personality play a highly significant role in his or her attitude toward cancer and its treatment. Such attitudes are also present for caregivers and need to be taken into consideration. Here's an interesting quote from an article on medical decision-making (see: Role of Culture in Healthcare Decision-Making):

Conflict related to cultural beliefs within healthcare commonly arises during times of significant life change....Our American principles of bioethics are based on Western beliefs, principally that of autonomy, having respect for the individual and honoring their ability to make decisions on their own behalf. However, other cultures such as those from Eastern origins are very sociocentric and are family-centered. There is a greater sense of collectivism, interdependence, and community. These values highly influence decision-making.

In the case of lung cancer, some cultures may signal that it's hopeless to fight, resulting in a refusal of therapy. Other factors may come into play such as the anticipated quality of life during treatment, fear of one's family being burdened by the cost of care, or devaluing the extra months of life gained under treatment. It's also the bias of most healthcare professionals to treat and extend life even for patients who express reservations about treatment. This can cause friction with treating physicians and nurses when therapy is refused.

Pharmaceutical Lobbying Organization Begins "Go Boldly" Campaign

The high cost of drugs and the lobbying by pharmaceutical companies to generate public support for these high prices has been a topic of discussion for many months. The topic has also been a continuing focus of notes here on Lab Soft News (see, for example: Researching the Cost of Stellara, a Drug Used to Treat Plaque Psoriasis; Pharma Money Flows into California Opposing Proposition 61; The Challenge of High Drug Prices in U.S.; Physicians' Use of Generics). Now comes news that the pharmceutical lobby, under fire for high drug prices, has launched a media campaign to combat negative opinions about the industry (see: Drug Lobby, Under Criticism, Starts Media Campaign). Below is an excerpt from the article:

The largest lobbying organization for pharmaceutical companies began running TV ads...to improve the industry's image as criticism from U.S. President Donald Trump increases. The industry is touting developments in science by pharmaceutical companies and will spend "tens of millions" on television commercials....Pharmaceutical companies may be facing their most difficult time ahead as criticism about the price of drugs continues to increase. In a news conference this month, Trump said drug manufacturers were "getting away with murder" because of their pricing. Additionally, drug manufacturers were considered winners when the Affordable Care Act became law because more people had increased access to prescriptions. A repeal of the law often known as Obamacare could mean many people losing insurance could not afford to purchase drugs...[T]he "Go Boldly" campaign...[is] an effort to refocus the discussion about the strides in research....Like many organizations, the [pharma lobbying] group signaled it expected Democrat Hillary Clinton was going to win and began planning to push back at her calls for capping drug prices....(This campaign) is not aimed at any one legislative issue....

Here are more details about the pharma "Go Boldly" marketing campaign (see: What’s the Story Behind the New “Go Boldly” Big Pharma Ads?):

The publicity campaign will continue for at least four, and possibly five years. According to an industry spokesperson, [the drug lobbying organization] PhRMA will be spending tens of millions of dollars ever year in order to convince the public that the industry is not the blood-sucking, exploitative corporate monster that America thinks it is. PhRMA head Stephen Ubl says, “This industry is the crown jewel of the American economy…we have a great story to tell and we’re going to do a better job telling it.”

It's no surprise that this advertising campaign makes no mention of drug prices because there is no room to maneuver along these lines. All U.S. consumers understand that drug prices are out of control and that we have our politicians, in part, to thank for this situation. CMS is not allowed by law to negotiate for the drugs that this agency purchases though Medicare. It's probably unlikely that a marketing campaign focusing on the cost of research by the pharma industry will pacify the public in this regard, or even Trump for that matter. I also need to mention that there is some controversy whether allowing CMS to negotiate with drug companies would lower the overall cost of drugs (see: The Fight Trump Faces Over Drug Prices). There is no doubt, however, the pharmaceutical industry will hardly miss the hundreds of millions of dollars that will be spent on the "Go Boldly" campaign, so why not try?

The Changing Role of Clinical Pathologists; Analogy with Hospital Pharmacists

The first webinar lecture in the API-Sunquest series for 2017 (see: Third Annual API/Sunquest Webinar Series Focusing on Pathology Informatics) was delivered by Dr. Brian Jackson who is the VP, Chief Medical Informatics Officer of  ARUP Laboratories. His lecture was entitled "The Shifting Value Equation Between Hospital Labs and Reference Labs." It was an extremely interesting and stimulating presentation, discussing in detail what he envisions as the future of lab testing, the future role of hospital labs and pathologists, and the relationship between hospital-based clinical labs and reference labs. Click here to view the webinar recording. It is well worth your time.

I will be returning to some of Dr. Jackson's points in some of my forthcoming notes in Lab Soft News. For this note, however, I want to focus on his analogy between hospital-based clinical pathologists and hospital pharmacists. Hospital pharmacies have become almost totally automated with most drugs prepackaged by the manufacturer or distributor. Electronic drug orders are received via the EHR with the unit doses dispensed in patient care units with automated devices like Pixis. Because of this high degree of automation, the role of hospital pharmacists has radically changed from previous eras. Now, the major role of hospital-based pharmacists, in addition to management, is education and consultation with hospital physicians about topics such as drug dosages, the merits of different drugs including generics, and adverse drug reactions. 

Dr. Jackson believes, as I do, that a large percentage of routine testing will move to point-of-care devices and even to the homes of healthcare consumers. Such decentralized testing holds the advantage over centralized lab testing of better integration into clinical care processes and consumer lifestyle. The cost of such decentralized testing will always be greater than that of central lab testing because of economies of scale. However, decentralized testing also has the advantages of rapid TAT (e.g., often minutes) and that clinicians can totally control testing processes. I hasten to add here that high level oversight and QC control over all hospital decentralized POCT devices will remain with the labs but most such supervision will be performed by medical technologists. 

One of the major future roles of clinical pathologists, both in academic centers and community hospitals. will first be to act as consultants to clinicians about the selection and interpretation of lab tests. This particularly applies to molecular and genomic testing. Secondly, they will function as lab information managers in concert with the other major diagnostics specialty group, the radiologists. The dominant theme for test selection will be picking the right test at the right time for the right patient.