Lab Soft News

The Secret to a Healthy Life; Few Americans Would Qualify

A recent brief article summarized the secret to a healthy life as being based on four main "pillars" (see: Few Americans Follow 4 Main Pillars of Heart Health). I quote it below:

Most Americans know that a heart-healthy lifestyle includes eating a healthful diet, not smoking, being physically active and keeping weight and body fat down. But a new study found that fewer than 3 percent of American adults could claim all four healthy elements. Only 2.7 percent of the Americans in the study were nonsmokers who ate a reasonably good diet, including eating plenty of vegetables and whole grains and avoiding saturated fat; got at least 150 minutes of moderate exercise a week; and had a healthy percentage of body fat, defined as up to 20 percent for men and 30 percent for women....The study, published in Mayo Clinic Proceedings, was based on data gathered from the National Health and Nutrition Examination Survey from 2003 to 2006 and included a nationally representative sample of 4,745 Americans. Eating habits were self-reported, which can be unreliable, but other measures were based on objective tests, including blood samples to verify smoking status, a sophisticated X-ray test to determine body fat, and accelerometers to measure physical activity.

I admit that I was surprised to learn that only 2.7% of Americans consumed a healthy diet, did not smoke, were physically active (at least 150 minutes of moderate exercise a week), and maintained low body fat (up to 20 percent for men and 30 percent for women). I began to ponder ways that one might develop a program to increase this percentage. There is a body of research that the most effective incentives to persuade people to lead a healthier life are financial. Based on this concept, I came up with the following idea:

• Health insurance companies would offer an insurance discount (30%. for example) to all adults who successfully attain these four goals. The discount would obviously need to be significant enough to attract subscribers to the program. Many of the first to enter would undoubtedly be those who already meet the criteria but the idea could spread to others. Also, many people are provided health insurance by their employer but the incentives could be used to offset the cost of high deductible plans that are now common (see: Trouble Ahead For High Deductible Health Plans?).
• A key issue that needs to be addressed for this proposal to succeed is how the insurance companies would validate the claim on the part of an interested person that he or she meets the four "pillar" criteria. One idea would be that the insurance companies could contract with medical clinics to validate the non-smoking requirement with, say, a finger stick, point-of-care test for cotinine (see: PTS DetectTM Cotinine System) and calculate the body fat requirement during a brief physical exam. Here's one example of a fat calculator based on body measurements (see: Body Fat Calculator). Physical activity of an applicant could be measured by a wrist monitor like Fitbit.
• How would one check an applicant for a healthy diet? Perhaps some blood tests could be used in this regard but lab testing could be supplemented by a smart phone app that the individual could use to periodically record his or her diet. It wouldn't be a daily log but some kind of overarching dietary overview.

I am sure that this idea is far from perfect it could be worth a try on a small scale. We need to attempt some novel ways to encourage a more physically fit population and financial rewards have proved in the past to be the most successful.

New Partnership for Training Bench Scientists between Johns Hopkins and MedImmune

According to a recent article, a partnership between Johns Hopkins University and biotech company MedImmune regarding the training of bench scientists is raising questions of conflict of interest (see: A new model for training scientists could create a conflict of interest). MedImmune, headquartered in Gaithersburg, Maryland, became a wholly owned subsidiary of AstraZeneca in 2007 (see: MedImmune). Below is an excerpt from it:

"The mission and culture of these two institutions are vastly different, one is academic, with emphasis on scholarship and teaching; the other is business, with emphasis on production and marketing. Such differences could easily yield unanticipated conflicts," Jerome Kassirer, a former editor-in-chief of the New England Journal of Medicine wrote in an email. "Moreover, given that the University has prided itself on its scholarly output, the narrow output of candidates for pharmaceutical positions might move it toward status as a trade school, thus injuring its exalted reputation." Industry has long partnered with academia in various ways, most notably by providing funding to support research. The new partnership takes that kind of collaboration to a new level: Johns Hopkins-MedImmune Scholars will have two research mentors -- one at the company, the Gaithersburg research arm of pharmaceutical giant AstraZeneca, and one at Johns Hopkins. Their thesis projects will be performed jointly between Johns Hopkins and MedImmune laboratories, and on top of the traditional academic curriculum, there will be courses co-taught by company scientists. The program is being jointly funded and designed by MedImmune and Johns Hopkins, but both institutions refused to disclose the details of the financial relationship....The joint training model has already been pursued in Europe. And the National Institutes of Health has long offered a training program in the U.S. in which students do a three-month internship with industry.....I imagine that this group is probably going to be dissuaded from doing anything that isn't relevant to MedImmune," Kassirer said in an interview. "I don't know that, but I assume that if the company is putting money into it, they want to get something out of it." 

I admire Jerome Kassirer for taking a stand against this new relationship between Johns Hopkins and MedImmune/AstraZeneca. However, I need to add that this "horse left the barn" a long time ago. Nearly eight years ago, I opined in a blog note that medical school deans shared some of the blame regarding illegal payments from pharma companies to their faculty (see: Medical Schools Share Some Blame in Scandals Involving Pharma Payments to Faculty). Medical school deans are increasingly dependent on drug company grants for various types of research including, but not confined to, clinical trials. The relationship between some medical schools and Big Pharma long ago included direct collaboration on research projects including drug discovery (see: Big Pharma's Evolving Research Collaboration with Medical Schools). Here's a quote from Time Magazine published seven years ago pertaining to Harvard Medical School (see: Is Drug-Company Money Tainting Medical Education?):

Of Harvard's 8,900 professors and lecturers, 1,600 admit that either they or a family member have had some kind of business link to drug companies — sometimes worth hundreds of thousands of dollars — that could bias their teaching or research. Additionally, pharma contributed more than $11.5 million to the school last year for research and continuing-education classes. 

In my opinion, this newly announced joint program between Johns Hopkins and MedImmune/AstraZeneca merely regularizes and solidifies a relationship that has probably existed for years. It may be that Johns Hopkins is in more dire financial straits than other medical schools and needs to formalize its relationship with AstraZeneca in a way that other schools may not relish, at least in the short term (see: Budget cuts prompt layoffs at Johns Hopkins University). A senior university executive described its financial problems in the following way: "Growth has slowed in the university's largest source of revenue—federal research funding—while other costs, such as compliance with federal regulations, have increased." 

An Expanding Definition for Companion Diagnostics

I have been blogging about companion diagnostics for about nine years. Here are links to some of my notes over the years on this topic (see: More Details About Roche's Companion Diagnostics Strategy; Consideration of a Broader Definition for "Companion Diagnostics"; Some Interesting Insights into Companion Diagnostics). In the earlier years, companion diagnostics was defined as the use of biomarkers to screen for the most suitable patients for a particular chemotherapy given that patient's neoplasm. Let's refer to this approach as searching for the most appropriate therapy. A classic example is the use of the HER-2/neu assay prior to the initiation of treatment with Herceptin (see: A Closer Look at Companion Diagnostics Strategies). 

In a note posted in June 4, 2015, I suggested that the definition for companion diagnostics was broadening in the sense that biomarkers were being used in connection with cancer immunotherapy to monitor the patient's response to treatment (see: Cancer Immunotherapy Meets Companion Diagnostics). In a list of the various uses for companion diagnostics, I suggested the following: [to] monitor response to treatment with a particular therapeutic product for the purpose of adjusting treatment to achieve improved safety or effectiveness. We thus see the emergence of the new category of assessing the effectiveness of therapy with biomarkers. 

There are now new ways to test for appropriateness and effectiveness of therapy for cancer patients. For example, we are testing patients' serum both before and after therapy for circulating tumor DNA (ctDNA) (see: AstraZeneca Partners with Roche on Development of a Companion Diagnostic; Illumina Launches Company to Develop a Pre-symptomatic Cancer Test) and circulating tumor cells (see: "Liquid Biopsy" Used to Refer to Detection of Any Serum Cancer DNA; Rapid Adoption of the Term "Liquid Biopsy" on the Web; "Liquid Biopsy" Used to Refer to Detection of Any Serum Cancer DNA).

There has been some resistance in the pharmaceutical industry to companion diagnostics. Companies understand that testing for the appropriateness of a particular drug has the potential to reduce sales of the product. The FDA understands this and has pushed aggressively for the use of companion diagnostics when new drugs are approved by the agency (see: Companion Diagnostics Gains Wider Acceptance in FDA Despite Challenges; Personalized Medicine and Companion Diagnostics Go Hand-in-Hand). I suspect that the opposition to lab tests for the effectiveness of treatment may continue although this type of testing may result in more drug being administered rather than less if the patient's current dose is deemed insufficient. In other words, companion diagnostics could serve to increase drug sales.

Anthem Sues Express Scripts; "Big Medicine" Players Squabble among Themselves

We are now deeply enmeshed in the era of "Big Medicine" with large businesses and organizations in the process of dividing up the healthcare industry (see: Physician Private Practice Declines; the Last Barrier to Emergence of "Big Medicine";The Transition to "Big Med": Need for Emphasis on Standardization and Cost; The Institutionalization of Healthcare; Consequences of Big Medicine?; "Doc Binge Buying" by Hospitals Continues, Resulting in Ethical Lapses). As described in these blog notes, these "Big Med" organizations consist of large hospital systems, health insurance companies, large pharmaceutical companies, pharmacy benefit managers (PBMs), and, or course, the federal government which is the largest payer for healthcare in the country. I think that we are not witnessing a second stage of the evolution of "Big Med" beyond consolidation with the large players now squabbling among themselves over the share of profits. Part of this scenario was described in a recent article (see: Anthem sues Express Scripts for $15 billion over drug pricing). Below is an excerpt from it:

Health insurer Anthem has sued Express Scripts Holding Co., alleging the pharmacy benefits manager is not passing along billions of dollars in savings from negotiated drug prices. Anthem is seeking $15 billion in damages and the ability to end its contract with Express Scripts. An Anthem spokeswoman said the damages reflect drug price overpayments Anthem allegedly has made. It also factors in the remainder of Anthem's 10-year contract with Express Scripts, which runs through 2019....Anthem CEO...[said] that Anthem was overpaying for prescription drugs for its members by $3 billion annually through its Express Scripts contract and was "contractually entitled" to those savings. Insurers and self-insured employers hire PBMs like Express Scripts to work with drug companies to bring down the price of medications, which account for about 10% of the U.S. healthcare economy. PBMs get price discounts in part by guaranteeing access to their drug formularies, although the process lacks transparency, and many of those savings are supposed to be passed along to insurers, employers and consumers. Anthem alleges that Express Scripts is skimming a lot of the savings and is not offering wiggle room under Anthem's repricing provision....Anthem has some leverage in the case. The Indianapolis-based insurer is buying Cigna Corp. in a deal valued at more than $54 billion, including debt. If that deal closes, Anthem could shift its drug functions to Cigna's PBM, OptumRx. Cigna had used Catamaran Corp., but OptumRx, a subsidiary of health insurance giant UnitedHealth Group, bought out Catamaran last year in a $12.8 billion deal. Anthem also has toyed with the idea of bringing its pharmacy management in-house. 

Note the statement above that one of the expected advantages of a PBM is that some of the drug savings it has bargained for are passed on to "insurers, employers and consumers," Clearly, the goal of the Anthem lawsuit is to gain a larger share of such savings for itself. I suppose that it's possible that some of these savings will also be passed to employers. I would predict, however, that the chance of any such savings passed to consumers is near zero. That's not how the system works. Here's a link to another article on this same topic (see: Will the Anthem-Express Scripts battle change the PBM landscape?).

Note at the end of the excerpt above that the part of the leverage held by Anthem in the lawsuit is its purchase of Cigna for $54 billion dollars. Cigna had used Catamaran in the past as its PBM but the latter was bought by UnitedHealth Group's OptumRx. The fact that Anthem could potentially shift its PBM business to OptumRx/UnitedHealth Group and away from Express Scripts is no cause for cheer. I have followed the unethical and even illegal behavior of UnitedHealth Group for many years and documented it in a series of previous notes (see: UnitedHealth Settles Suit with New York Attorney General Cuomo; UnitedHealth Draws Criticism for Its Out-of-Network Reimbursement Policies; Recall of the United HealthCare Picis PulseCheck Emergency Department Software; The Medical Quack Reveals New Information about QSSI and UnitedHealth). 

Having Your Thyroid Removed? Seek an Experienced Surgeon

Thyroid gland surgery is increasing in frequency, partly as a result of more common lab testing and imaging of the gland (see: How to Explain the Surge in the Diagnosis of Cancer of the Thyroid). If contemplating such surgery, it's a good idea to pick an experienced surgeon (see: The Most Important Question to Ask When Picking a Surgeon; Academic Medical Centers Eliminate Low Volume Surgical Procedures). A recent article focused on this topic (see: Need Your Thyroid Removed? Seek a Surgeon with 25+ Cases a Year: Duke Health). Below is an excerpt from it:

A new study from Duke Health suggests that patients who need to have their thyroid gland removed should seek surgeons who perform 25 or more thyroidectomies a year for the least risk of complications. Thyroidectomy is one of the most common operations performed in the U.S, often due to cancer, over-activity, or enlargement of the gland, which is located at the base of the throat and produces hormones that regulate metabolism. But most consumers would be surprised to learn that about half (51 percent) of surgeons who perform thyroidectomy do so just once a year....“This is a very technical operation, and patients should feel empowered to ask their surgeons how many procedures they do each year, on average,” said Julie A. Sosa, M.D., senior author and chief of endocrine surgery at Duke. “Surgeons have an ethical responsibility to report their case numbers. While this is not a guarantee of a positive outcome, choosing a more experienced surgeon certainly can improve the odds that the patient will do well.” Although total thyroidectomy is generally safe, it can cause life-altering complications that were seen in some study patients, such as bleeding, problems with the parathyroid glands, and damage to the laryngeal nerve that can lead to difficulty speaking, breathing and swallowing. Any complication can require more care, driving up patient costs and potentially compromising quality of life....As many as 68 percent of healthy adults have thyroid nodules, and this, in part, has significantly increased the number of biopsies and surgeries performed in the U.S.

To summarize the key points in this article, experience counts in terms of the success of thyroid surgery, not only on the part of the surgeon but also the entire surgical team. It's useful to have a target number in terms of the number of thyroid cases one should expect a surgeon and his/her team to have performed yearly and the article quoted above provides one -- 25. An unstated but implied point here is that, as a general rule, it's best to avoid smaller hospitals for complex surgery. It's usually the larger hospitals and academic referral centers where the surgeons are most likely to accumulate the number of cases to meet this target. In general, this advice about experience also extends to the treatment of all complex diseases, particularly cancer. In a prior note, I have recommended seeking cancer treatment mainly in cancer hospitals to take advantage of their greater experience (see: Patients with a Cancer Should Seek Treatment in Cancer Hospitals).

One more point the was also touched on above. Some patients may be reluctant to ask a surgeon about his/her experience with a particular operation, perhaps fearing that it might cause offense. Put such fears aside. I have never seen this fact stated so boldly but Dr. Sosa says the following: Surgeons have an ethical responsibility to report their case numbers. Although experience is no guarantee of a good result, it increases the odds of such. If a surgeon beats around the bush in such a discussion, look for another referral. The question is a simple one. How many thyroid operations do you perform a year?

Positive Role Identified for Twitter in Cancer Clinical Trial Recruitment

I envision a much larger role in the future for Twitter in all things medical. I personally obtain many ideas for blog notes from it. A recent article discussed how this social media site has been shown to be important in the recruitment of subjects for cancer clinical trial recruitment (see: Role for Twitter in Cancer Clinical Trial Recruitment?). Below is an excerpt from it:

When English-speaking people tweet about lung cancer, they surprisingly discuss clinical trials about 18% of the time....The findings suggest a role for Twitter in spreading the word about cancer clinical trials and recruitment....[According to one of the authors of an article of this topic,] "social media may be this new infrastructure for cancer centers, researchers, and physicians to interact with the public in new and productive ways, including stimulating interest in clinical trials with targeted messages that connect patients, caregivers, and families to specific trials and trial enrollment websites,"....Cancer clinical trials are important for translating scientific breakthroughs into FDA-approved treatments, but only 5% of adult cancer patients participate in therapeutic clinical trials. Recruitment relies heavily on physician recommendations. More than 70% of patients say they choose to enroll in a cancer clinical trial because a physician recommended it to them....Although cancer care organizations already use Twitter for health promotion and education, until now, no studies had looked out how people use Twitter to share information about cancer clinical trials.....[It's possible to use] "bid data science" in further studies to analyze millions of tweets in order to identify influential tweeters, how people are talking about clinical trials, and how researchers and physicians can be part of the conversation. Clinical trial recruitment campaigns and retention programs might even consider employing social media experts.

I have discussed clinical trial recruitment in previous notes and also the fact that many cancer patients are not provided the opportunity in participate in them (see: New Approach to Clinical Trials; Emphasis on Individual Patient Response; The Diversity Gap in Clinical Trials; Can It Be Closed?; Low-Income, Uninsured Patients Often Excluded from Clinical Trials; Genetic Testing and "Basket" Trials Provide Superior Experience for Cancer Patients). This is a significant problem because clinical trials can provide access to the most current therapy for many cancer patients. The study cited above indicates that Twitter can be a useful site to extend the reach of clinical trials.

By choosing the people or organizations one follows on Twitter, it's possible to filter the information in an account to a manageable stream. However, Twitter is surely not for everyone. It's 140 character limit for tweets causes them often to be cryptic. Some of the other features of Twitter are complex compared to, say, Facebook so it can be hard to get engaged. Despite these problems, I still think that Twitter has potential for publicizing clinical trials and recruiting subjects for them. It's probably not going to be an effective, broad solution for access to most trials but it's better than many of the other web-based options.

Upcoming Free Webinar on the Use of Big Data in Lab and Healthcare Analysis

The Association for Pathology Informatics (API) and Sunquest Information Systems are pleased to present another webinar in their continuing pathology informatics series entitled the Use of Big Data in the Laboratory and Healthcare, The lecture will be delivered by Sonny Varadan, IT Management Consultant at Nichols Management Group. The date and time of the event is Thursday, March 17, at 1 PM – 2 PM ET. Register today to ensure a spot.

Sonny Varadan has held senior IT positions including Chief Information Officer at both Providence Health Care and PAML, the latter being the largest network of outreach clinical laboratories in the United States.  At PAML he was instrumental in transforming the IT department from a cost center to a revenue center by developing innovative software solutions. At Providence, he was responsible for a $17 million budget and operations staff of 75 team members where he implemented an operational improvement plan which resulted in significant laboratory cost reductions with service level improvements (see: Sonny Varadan).

Big data has become a kind of cliche in many industries including healthcare. However, Forbes had this to say about its use in healthcare (see: How Big Data Is Changing Healthcare):

Beyond improving profits and cutting down on wasted overhead, Big Data in healthcare is being used to predict epidemics, cure disease, improve quality of life and avoid preventable deaths. With the world’s population increasing and everyone living longer, models of treatment delivery are rapidly changing, and many of the decisions behind those changes are being driven by data. The drive now is to understand as much about a patient as possible, as early in their life as possible – hopefully picking up warning signs of serious illness at an early enough stage that treatment is far more simple (and less expensive) than if it had not been spotted until later.

Needless to say, hospital clinical labs are responsible for one of the biggest caches of data in a hospital and are well positioned to make much better use of it through sophisticated analysis. Find out Sonny Varadan's ideas about how to pursue this goal. You can resister here to participate. Also, don't forget to register for the Pathology Informatics Summit, the largest conference of its kind in the country. I will be held on May 23-May 26, 2016, in Pittsburgh, PA.

Copy-and-Paste Errors with EHRs; Some Possible Solutions to the Problem

Although EHRs provide many benefits to patients and physicians, one of their negative aspects is that they provide the opportunity to erroneously copy-and-paste entries from older records into current records. I have addressed some of these copy-and-paste problems in previous notes (see: OIG Says Cut-and-Paste in EHRs Can Lead to Medicare Overcharges; Veteran Clinician Critiques the Current EHR -- Both Good and Bad). A recent article provides some new insights into this issue as well as some possible solutions (see: Report highlights errors caused by copying, pasting in medical records). Below is an excerpt from it:

Copying and pasting electronic text in health care documents can perpetuate initial errors or introduce new mistakes, according to a report from the group, known as the Partnership for Health IT Patient Safety. "It's a huge problem," said Dr. Dean Sittig, a professor at UT-Health School of Biomedical Informatics in Houston and a member of the group....Many physicians use a template for entering patient information, copying it into the record and then changing the entries for each patient. But if one of those entries is not updated, it can lead to a missed diagnosis.That's in part what happened with the Ebola case in Dallas in 2014....A review of Veterans Affairs medical records between 1993 and 2002 found that 9 percent of notes included copied information, and 13 percent of the copied material was deemed so misleading or incorrect that it posed a significant risk to the patient. Experts say cut and paste errors have become more prevalent with the push toward electronic medical records and the need to provide detailed documentation for billing purposes....A recent federal report found that only 24 percent of hospitals had cut-and-paste policies, and fewer than half used software that captured the method used to enter text into a medical record....Malpractice attorneys, meanwhile, are mining medical records for copied material....Copying and pasting in medical records can save the time of physicians burdened by documentation requirements. Often, a patient's situation doesn't change much from visit to visit.....[It is recommended that] physicians use highlighting or quotation marks so that copied material is easily identified. He also recommends that hospitals monitor how much physicians copy and paste.

First of all, lets suggest that the copy-and-paste feature of EHRs was initially developed to allow physicians to work more efficiently. It enabled the copying of relevant information from previous notes into new notes without laboriously entering the data via keyboard. Let's agree that the feature is now causing major problems with EHR records. As noted above, physicians may copy templated data or previous text into the current record and then not make the necessary edits so that it's accurate. Another problem is that physicians may copy-and-paste previous data into the current record, perhaps for billing documentation, which may not be relevant or accurate. Most agree that all of this constitutes a significant problem. The article quoted above provides some concrete steps that can be take to help correct this problem. They are the following:

• Every hospital needs policies governing copy-and-paste features into their EHR that may compromise patient welfare.
• Every EHR entry should "capture the method used to enter text into a medical record." In other words, which type of text entry was used: keyboard, a phrase from a pick list, a copy-and-paste from a previous EHR note, or some other option? In addition, copied material could be highlighted or enclosed in quotation marks. Adoption of such an approach could suppress the inappropriate use of the copy-and-paste feature.
• In addition, hospitals need to "monitor [on a continuing basis] how physicians copy-and-paste." It may be that they continue to develop workarounds to the hospital rules and these need be understood as they occur in order to prevent future EHR errors.

Notes Field in E-Prescriptions Are Source of Ambiguity and Confusion

This article about confusion in the filling of e-prescriptions by pharmacists caught my attention (see: Errors, Confusion Common in Notes Field in e-Prescriptions). Below is an excerpt from it:

The free-text Notes field in electronic prescriptions frequently contains information that should be conveyed in other existing standard data fields, and leads to confusion or errors, according to a retrospective, qualitative study published online...in JAMA Internal Medicine. Other data from the notes field present an opportunity to develop additional fields in e-prescription messages to reduce confusion....The optional, 210-character, free-text Notes field available in the e-prescription message is a well-documented source of potential miscommunication between prescribers and pharmacists....This field is intended to allow prescribers the option of including additional patient-specific information that is relevant to the prescription but for which a dedicated field does not exist in the currently implemented version of the SCRIPT standard (version 10.6)....[S]ome potential reasons for inappropriately used free-text notes include restrictive or difficult electronic health record systems, insufficient user training, or the 140-character limit in the Patient Direction...field....Vague, ambiguous, or conflicting patient directions in the Notes field are...disruptive to pharmacy workflow and can result in dispensing errors if unnoticed, ignored, or misinterpreted by pharmacy staff.

No one should be surprised that a free text field in an e-prescription has been a source of confusion to the pharmacists filling the prescriptions. What is surprising is that such a field was even available in the first place in e-prescriptions. Perhaps the designers of the e-forms wanted to give physicians as much latitude as possible when completing such forms. Many physicians get frustrated with the rigidity of fixed fields in EHRs and other medical applications but structured content is far preferable in e-forms (see: Structuring for the Future of Clinical Decision Support (CDS)):

....[T[here are two approaches to content when designing point-of-care IT infrastructures—structured and unstructured. While both have the potential to standardize care and improve decision-making, industry preference leans toward greater integration and use of structured content for its ability to lay a foundation of improved accuracy, efficiency and ability to drive clinical decision support and analytics. Because structured content is tagged or coded data that resides in a fixed field, it can be easily located, identified and understood, simplifying the process of integrating content into existing systems and sharing between disparate systems. In contrast, unstructured content, such as free text, often results in irregularities and ambiguities that make it harder to interpret.

I suspect that one of the major reasons that a free-text field was allowed in e-prescriptions was that it was assumed that pharmacists would be able to understand and interpret the physician entries. However, the conclusion in the article cited above that the interpretation of the information in such fields was often challenging for the pharmacists and disruptive of workflow probably should have been anticipated.

Can Interest in the Molecular Autopsy Rekindle Interest in the Classic Autopsy?

Like clockwork, one sees periodic articles lamenting the decline of the classic autopsy like this one from the op-ed page of the New York Times (see: Bring Back the Autopsy). The usual argument cited in favor of a return to the preeminence of the autopsy is that it serves to identify diseases missed by clinical observation and imaging. In my opinion, these pieces will had little success in resurrecting the autopsy for the following reasons: autopsies are an unreimbursed activity so many pathologists prefer to devote their energies to reimbursed ones and don't actively campaign for an increase in autopies; clinicians may believe that today's sophisticated diagnostics identify most diseases antemortem; those clinicians who emphasize defensive medicine are happy to avoid a procedure that may highlight errors in care delivery; requesting an autopsy from grieving family members may be difficult for some physicians and junior hospital house officers; and, finally, healthcare consumers don't necessarily understand the merits of autopsies because they are becoming less frequent.

I have held the opinion for more than eight years that the adoption of the virtopsy might help to increase interest in the post-mortem study of the causes of death (see: Introducing the Virtopsy, a Variant of the Catopsy Theme; NYT Highlights the "Virtopsy" Used for All Military Autopsies; The Classic Forensic Autopsy on the Verge of Being Obsolete). Unfortunately, there is little enthusiasm for the virtopsy in this country even though it's far superior to the classic autopsy. I believe that the reasons for this are the following: (1) a reluctance to invest more capital in an unreimbursed and dwindling procedure; and (2) a reluctance on the part of pathologists, and particularly forensic pathologists, to promote a procedure for which they are currently untrained, which is to say the interpretation of post-mortem whole-body CT scans that are a key element of the virtopsy.

I believe that emerging interest in the molecular autopsy (i.e., post-mortem molecular testing) may rekindle interest in the classic autopsy which is defined in the following way (see: Molecular autopsy):

Molecular autopsy or postmortem molecular testing is a set of molecular techniques used in forensic medicine to attempt to determine the cause of death in unexplained cases, in particular sudden unexplained deaths (for example sudden cardiac death). About 30% of sudden cardiac deaths in young people are not explained after full conventional autopsy, and are classified as sudden unexplained deaths. The use of a panel of genetic markers for long QT syndrome, catecholaminergic polymorphic ventricular tachycardia and cardiac channel miopathies elucidated around 40 to 45% of the cases.

Healthcare consumers are increasingly aware of genomics and precision medicine. I propose that we now begin to promote molecular autopsies in hospitals, particularly teaching and research institutions, defined in the following way: a classic autopsy to determine the cause of death plus the harvesting of various tissues, including tumor tissue when present, to better elucidate genetic aspects of the disease(s) discovered or suspected. This effort should be tightly linked to the biobanking/biorepository program in the same or regional hospitals (see: Quest Diagnostics' Biorepository Receives CAP Accreditation).

This connection between biobanking and the molecular autopsy is very important because it not only advances science but provides the opportunity to possibly offset the incremental costs of molecular autopsies through tissue sharing. The opportunity is also presented by this means to engage research labs in the genomic testing associated with molecular autopsies at lower or no cost. None of this will happen overnight but I think that pathology is now being presented with a rare opportunity to reposition the classic autopsy as a key element in today's healthcare delivery system and precision medicine.