Lab Soft News

Pharmaceutical Companies Continue to Experiment with Social Media

I have posted a number of previous notes about how pharmaceutical companies have been experimenting with social media despite indications that the FDA views such activities with great suspicion (see, for example: FDA Gearing Up to Regulate Smartphone Apps and Social Media? Or Not?; Limitations Placed on Big Pharma Facebook Pages; FDA Issues Warning Letter to Drug Company about Use of Instagram). I am personally opposed to any presence at all of pharma on the social media -- they are too tempted to use if for  marketing and the landscape is so vast that it would be difficult to monitor their activities. Now comes news that pharma is "getting social" as hosts of Twitter on-line "tweet chats" (see: Pharma gets social: Ten tweet chats transforming pharma digital engagement). Here is an excerpt from the this article:

The past few years have seen healthcare companies take to Twitter increasingly to host and participate in public online conversations with stakeholders, including healthcare professionals (HCPs) and patients. Even in the regulated pharmaceutical industry, open 'tweet chats' are now becoming popular tactics for engaging audiences on a particular topic. Tweet chats are usually time-limited conversations on Twitter in which anybody may take part by using a common 'hashtag' – a single word preceded by a hash (#) character. Pharma companies hosting a tweet chat do so by announcing the time and topic of a chat and typically stimulate engagement through a series of conversation-starting questions. 'Hashtags are like campfires: people gather around them to have conversations,' claims Twitter in its case study of Boehringer Ingelheim's (BI) COPD Twitter campaign. The 'fire' analogy is particularly appropriate: just like a tweet chat, a campfire can be a safe place where people share stories, but this environment needs good planning to keep it safe. The first ever pharma-hosted tweet chat was, I believe, AstraZeneca's (AZ) #rxsave chat, which took place in early 2011. The chat generated hundreds of tweets from a diverse group of stakeholders....Even before AZ's #rxsave chat, Pfizer was an early pioneer of using Twitter to engage patients on health topics. In 2010 it launched @ManMOTUK, a Twitter profile for UK audiences in collaboration with the Men's Health Forum. The company actively encouraged men to talk directly and confidentially with doctors about sensitive health matters during weekly live surgeries hosted on its ManMOT website. Although not strictly a tweet chat, Twitter hashtag #manmot was used to promote the initiative. 

There is a web site, TweetChat, where one can enter the relevant hashtag and see the isolated conversation comprising a Twitter conversation. Obviously, this can be done at an appointed day and time to participate in the live conversation or after the fact. Such apps make it very easy to focus on the content of a tweet chat and exclude all other distracting tweets. A question that arose in my mind is how a company like AstraZeneca would initially attract a sufficient number of Twitter followers such that they would be made aware of the date and time of a subsequent live chat. The obvious answer lies in the hashtag cited in the article above relating to AstraZeneca -- #rxsave. The company bait is a discussion about how to save on the sometimes ferocious costs of drugs. The irony is that the discussion is hosted by the company that is actually setting these prices. This reminds me of the so-called "patient assistance programs" launched by some pharma companies (see: Patient Assistance Programs Keep Drug Prices High and May Actually Be Illegal). Although nominally designed to help defray the cost of expensive drugs for low-income and uninsured patients, they are really designed for brand protection and to keep patients from drifting to lower-priced generic drugs.

Biggest Threats to Radiology According to Aunt Minnie Article

AuntMinnie.com is the key web site for current news and information about radiology. In a recent article containing various lists pertaining to the specialty (see: Minnies 2015 semifinal candidates), one was captioned as the Biggest Threat[s] to Radiology. Below is the list:

• Code bundling of radiology procedures
• Commoditization of radiology services
• Competition to local practices from teleradiology and national radiology groups
• Concerns about CT radiation dose
• Consolidation of healthcare systems
• Decline in Medicare and third-party reimbursement rates
• Declining job market for radiology professionals
• Declining number of medical students picking radiology in Match
• Increased use of medical imaging by physicians in other specialties (turf battles)
• Shift of radiology reimbursement away from fee-for-service mode
• Use of artificial intelligence to interpret medical images
• Utilization controls that could lead to lower procedure volume

This is a fascinating list and worth pondering. I think that it would be worthwhile if some influential publication in pathology were to publish a similar list for that speciality. Some of the points would probably be similar. Many of the threats in radiology are financial (e.g., Code bundling of radiology procedures; Decline in Medicare and third-party reimbursement rates; Shift of radiology reimbursement away from fee-for-service mode), some relate to the market and status for radiologists (e.g., Declining job market for radiology professionals; Declining number of medical students picking radiology in Match), some refer to professional competitive pressures (see: Competition to local practices from teleradiology and national radiology groups; Increased use of medical imaging by physicians in other specialties (turf battles), and some relate to scientific & safety issues  (e.g., Concerns about CT radiation dose).

The item that I found the most interesting was the following: Use of artificial intelligence to interpret medical images. I referred to image analysis software in radiology in a recent note (see: IBM Buys Merge Healthcare; Integrates Watson into CAD Services). This makes sense as a threat because, at some distant time, the interpretation of images could be performed totally by software. However, the likely consequence of the adoption of image analysis software, at least in the short-term, is higher quality reports and greater work efficiency for radiologists. Image analysis software will be used to highlight for the radiologist the abnormal features of an image that are worthy of special attention. In short, the deployment of artificial intelligence, a term that seems to be no longer in broad use, is a mixed bag for radiologists and not exclusively a threat.

Epic Wins EHR Contract Covering Most of Helsinki, Finland

I have been assuming that Epic would turn to other countries for sales, given that its EHR has already been deployed or chosen in many of the large, complex U.S. hospitals where it has found great favor. Epic was recently  selected to supply the EHR for the Hospital District of Helsinki and Uusimaa and four municipalities at a price of 384 million euros (see: American software developer to supply patient data system). Here is a very interesting quote from the article in the Finnish press describing the selection criteria used in the process:

Price was weighted at 40 per cent in the evaluation process. Both of the supplier candidates were also given a score for the functionality, ease of adoption and maintainability of their proposals. Epic Systems Corporation fared well in the evaluation, winning the contract with 92.23 points against [the competing vendor] CGI's 89.76.

Obviously, a functionality scoring system can be tweaked so that a favored vendor comes out the winner. However, this is the first time I have seen press coverage about a healthcare IT contract that quoted the scores of the competing vendors. Note also that they calculate their point system to two decimal places.

Here's a quote from a Finnish colleague's email about this contract:

[Epic] was just selected as the EHR vendor for the (almost) entire Capital (Helsinki) region public health care system - a population base of about 1.5 million. This is a significant development locally as the market has thus far been dominated by local vendors or international vendors with local products.

It would be tempting to view this news as relatively insignificant. If you look at the initial contract price and the population base covered, I think that it's important. In a recent note about Cerner/Leidos/Accenture winning the huge military EHR contract, I made the following comment (see: Cerner/Leidos/Accenture Secure EHR Contract for a Global Military EHR):

As to Epic "failure" to win the [military EHR] contract, I suspect that there were a lot of smiles of relief in Verona when the winner was announced. I think that Epic was competing in the contest because everyone expected it to do so. The Epic culture and emphasis on client control was probably a non-starter for the military brass

Epic is going to be a lot happier with a contract covering a whole city. A major win in a smaller European country will give the company "street credibility" within neighboring countries. As detailed above, this contract also signifies a new direction for Finland in terms of its overarching healthcare IT strategy.

Details of Cleveland Clinic's MyCare Online Virtual Telemedicine Visits

In a previous note, I discussed how the Cleveland Clinic is now offering 24/7, no-appointment, telemedicine visits under their MyCare Online program to any Ohio resident for $49 (see: Cleveland Clinic Launches Web Site to Offer Physician Visits to Ohio Residents). At that time, I signed up for an account. I recently received an email from the Clinic detailing a MyCare Online visit. Below are a number of salient points about it, in part, extracted from a Youtube introductory video, a link to which was provided in the email:

• Patients are linked to  a family practice physician whose professional profile can be viewed prior to entering the patient queue.
• The video suggests that the typical wait time for connection to a physician is "less than a couple of minutes" with prompts to indicate that he or she is seeing another patient when relevant to assess the wait-time
• The consulting physician can write an e-prescription at the end of the visit and send it electronically to the patient's drug store of choice.
• The video also, appropriately, provides many details about the necessary technology to launch a virtual visit such as the type of mobile device that can be used. A plug-in is offered for a laptop or desktop computer to enable high-definition video. Wi-fi connection is preferred, providing higher quality service over cellular. I use the term "appropriately" above because such technical details may be a barrier for the use of the service by some patients.
• The email provides a list of the relatively minor conditions that might prompt a a visit including the following: allergies; asthma; bronchitis; burns; colds; cough symptoms; earaches; eye conditions such as pinkeye; fever; flu; lacerations; minor back pain; minor trauma; rashes; shoulder pain; sinus infections; skin conditions; sore throat; urinary tract infections.

I have the following reaction to the program as it stands at this time:

• I am impressed with the quality of the marketing program. It's all very slick and very professional, as I would have expected from the Cleveland Clinic.
• The conditions covered would not be very different from those treated on a daily basis by a family physician, many of which can be adequately diagnosed without a physical examination. Visits are estimated in the introductory video to last "about ten minutes."
• Although I had suggested that the Cleveland Clinic was launching this service to prompt referrals of more complex cases, it now strikes me that this is intended to be largely a revenue-generating program using family practice physicians. It's also in line with the Clinic's history of rapid adoption of new IT and other technologies to deliver healthcare.
• To restate the obvious, the physicians seeing patients with a video link will be very able to triage the more seriously ill patients who log-in and refer them to a local emergency department or perhaps even to the Clinic itself in some cases.
• Given the limits of service to perhaps a dozen family medicine practitioners, the necessity for physician training to launch the program has probably not been that daunting. However, the initiative will provide an experience base for the Cleveland Clinic that can extend at a later time to other medical specialists. 
• I will reiterate my previous statement that this is a game-changer for telemedicine. We see a very prestigious hospital going "all-in" for virtual e-visits. This can't be ignored by other health systems, certainly by other Ohio healthcare providers. I personally don't see how this program can fail.

What Motivates Scientists to Align with Coke Regarding Sugary Drinks?

Coca-cola continues to take a page out of the tobacco company playbook. They are funding academics specializing in exercise physiology to support the company position that exercise is more important than cutting calories in combating obesity (see: Coca-Cola Funds Scientists Who Shift Blame for Obesity Away From Bad Diets). In do doing, they oppose efforts such as those on the part of states or cities to tax sugary drinks. (see: Consumption of Soda Begins to Decline but What Beverages Are Being Substituted?; Federal Tax on Soda Pop Proposed: Can This Be Justified?). Below is an excerpt from this article:

Coca-Cola, the world’s largest producer of sugary beverages, is backing a new “science-based” solution to the obesity crisis: To maintain a healthy weight, get more exercise and worry less about cutting calories. The beverage giant has teamed up with influential scientists who are advancing this message in medical journals, at conferences and through social media. To help the scientists get the word out, Coke has provided financial and logistical support to a new nonprofit organization called the Global Energy Balance Network, which promotes the argument that weight-conscious Americans are overly fixated on how much they eat and drink while not paying enough attention to exercise....Health experts say this message is misleading and part of an effort by Coke to deflect criticism about the role sugary drinks have played in the spread of obesity and Type 2 diabetes.

They contend that the company is using the new group to convince the public that physical activity can offset a bad diet despite evidence that exercise has only minimal impact on weight compared with what people consume....In response to requests based on state open-records laws, two universities that employ leaders of the Global Energy Balance Network disclosed that Coke had donated $1.5 million last year to start the organization. Since 2008, the company has also provided close to $4 million in funding for various projects to two of the organization’s founding members: Dr. [Steven N.] Blair, a professor at the University of South Carolina whose research over the past 25 years has formed much of the basis of federal guidelines on physical activity, and Gregory A. Hand, dean of the West Virginia University School of Public Health. Records show that the network’s website, gebn.org, is registered to Coca-Cola headquarters in Atlanta, and the company is also listed as the site’s administrator. The group’s president, James O. Hill, a professor at the University of Colorado School of Medicine, said Coke had registered the website because the network’s members did not know how.

Coca-Cola has a history of establishing relationships with professional societies and academics in order to promote their unhealthy products (see, for example: American Academy of Family Physicians Cozies Up to Coke). Here's a quote from that blog note:

I think that there is a need to try to explain how a professional physician society [like the American Academy of Family Physicians could accept a grant from a company such as Coca-Cola. Surely every physician member in the group would immediately understand that this was a big mistake. I suspect that the short answer is money....

In the case of Drs. Blair and Hand working closely with Coca-Cola and establishing the pro-sugary-beverage Global Energy Balance Network, there is no question in my mind that incentive for them is the funding of their research by the company. However, I am going to give them the benefit of the doubt and suggest that they hold the belief that exercise is very important in relation to the challenge of fighting obesity. Perhaps they believe it is even more important than calorie intake although I personally believe that this is incorrect. I do wonder, however, whether they would have chosen to get involved with this project if they had anticipated that it would provoke such broad negative coverage in the media (front of the business section of the NYT). I also won't comment further on Professor James Hill's assertion that none of the Global Energy Network members knew how to register a web site, thus ceding the task to Coca-Cola. Here's a cut-and-paste from the GEBN web site. It provides fodder to my belief that "evidence-based" anything has become a meaningless trope.

The Global Energy Balance Network (GEBN) is a newly formed, voluntary public-private, not-for-profit organization dedicated to identifying and implementing innovative solutions – based on the science of energy balance – to prevent and reduce diseases associated with inactivity, poor nutrition and obesity. It is a premier world-wide organization led by scientists working on the development and application of an evidence-based approach to ending obesity.

IBM Buys Merge Healthcare; Integrates Watson into CAD Services

It seems to me that IBM has been trying forever to engage its supercomputer Watson in some meaningful activity in healthcare. The latest initiative is the purchase of Merge Healthcare by IBM with the goal of integrating the power of Watson with the Merge radiology software (see: IBM Promises To Read Your X-Rays With $1 Billion Deal. Can It Really Do That?). Below is an excerpt from the article:

IBM continued its big push to use its Watson artificial intelligence technology to revolutionize medicine by buying Merge Healthcare, a $227 million (sales) company that helps doctors and hospitals store and analyze CAT scans, X-rays, and other medical images. The goal, literally, is for Watson to be able to see and analyze those scans, along with written medical records....What...[Watson previously] lacked was the access to clients, and the images. What Merge brings...[to IBM] is that access and that capacity....The deal is the latest in a series of big moves by IBM to make real Watson’s promise in healthcare....Will it be able to prove that patients whose records are analyzed using Watson are more likely to get a correct diagnosis? That health problems that are missed by conventional radiologists will be found by IBM’s computers? Healthcare is different. Vaporware doesn’t sell.vRight now, as with so much about Watson in healthcare, we have enticing questions, few answers, and lots of confidence from IBM...[An IBM spokesperson] swears that, where necessary, he will get approval from the Food and Drug Administration, and that he will prove the usefulness of Watson’s software solutions disease by disease until doctors, hospitals, and insurers are all convinced.

The Merge CADStream product is currently used to provide workflow support, interpretation, and reporting of breast, prostate, and liver MRI studies. The CAD in the name of the product refers to "computer aided detection." Algorithm-driven computer analysis of digital breast imaging studies is well accepted and used to highlight potentially pathologic lesions in an image that may have been overlooked. The case is then marked  for re-review by the radiologist. This is sometimes referred to as a spell-checker for radiologists. The Watson capabilities could potentially be integrated with the CADstream platform to provide even more sophisticated interpretive services than are currently provided. Here's some additional information about the IBM purchase of Merge (see: IBM buys Merge for $1 billion, gives Watson medical imaging heft):

IBM is hoping to take Watson's image analytics and combine them with Merge's medical management platform. The company could combine Watson's cloud applications to give electronic health records more intelligence....With images added to Watson, the system should be able to see more patterns and help radiologists interpret results. IBM wants to cross reference medical images with lab results, genetic testing and other data.

So, in addition to providing enhanced interpretive capabilities to the Merge CADstream product, IBM also hopes to integrate image reporting with patients' entire health record including, I would assume, previous pathology and radiology reports. This would provide the capability of determining whether previous suspicious lesions noted in pathology and radiology reports have been followed-up or whether a patient is a candidate for future screening studies. This is a tall order so stay tuned for reports about the success of this venture.

FDA Issues Warning Letter to Drug Company about Use of Instagram

I was under the impression that the pharmaceutical industry, at least the larger companies, were staying away from social media, having been warned by the FDA that this would be a source of friction (see: AstraZeneca Pays for Personal Health Coaches, Develops Other Health App). But it turns out that not all the companies were in accord here as I learned in a recent article (see: F.D.A. Warns Company Over Kardashian Instagram Marketing). Below is an excerpt from it:

The Food and Drug Administration issued a warning letter to a drug company, saying a celebrity’s promotion of its morning sickness product on Instagram failed to give information about the drug’s risks. The F.D.A. sent the letter to the company, Duchesnay ..., on Aug. 7 after Kim Kardashian West, the reality star who is currently pregnant, posted a picture of herself holding a bottle of Diclegis, its drug for morning sickness. The image appeared on her Instagram page with a message saying she had used it and was “partnering” with the company to “raise awareness” about the morning-sickness treatment. Ms. Kardashian West’s post was linked to her other social media accounts, potentially reaching tens of millions of followers. In the warning letter to ....Duchesnay’s executive vice president, the F.D.A. published Ms. Kardashian West’s post in full....The post included links to the drug’s website and its safety information, but Robert T. Dean, a director at the F.D.A.’s Office of Prescription Drug Promotion, said that was not enough. He said the post neglected to mention the drug’s risks and that it had not been tested in women with hyperemesis gravid arum  a condition marked by severe nausea and vomiting....Ms. Kardashian West’s Instagram post was reported through the agency’s “Bad Ad” program that takes tips about misleading advertising and promotions.The F.D.A.’s warning letter represents a wider challenge the federal agency faces with the proliferation of online content. Thomas Abrams, the director of the drug promotion office, said in a 2013 interview that social media had complicated the agency’s ability to monitor drug promotions, citing the sheer volume of materials online and the speed with which they can be changed. He said the agency had taken action against other posts on Facebook and YouTube, including one involving a television celebrity.

There is no question that social media could provide some pharmaceutical companies the opportunity for marketing mischief. This initiative by Duchesnay is illustrative of this fact. Because of policy constraints on the FDA, the agency is focusing on the lack of appropriate mention of the risks of Diclegis in the Instagram post. The drug is used to alleviate morning sickness in pregnant women. In my opinion, the far larger problem is to associate the use of a drug with a celebrity for marketing purposes. Diclegis has been in hot water with the FDA previously regarding this drug (see: FDA busts Kim Kardashian selfie for leaving out drug side effects):

This isn't the first complaint levied against the makers of Diclegis, either: Duchesnay (the drug's producer) was notified of an infraction in November 2013 when the drug was first announced. "OPDP [Office of Prescription Drug Promotion]  is concerned that Duchesnay is continuing to promote Diclegis in a violative manner," the FDA wrote.

Unfortunately, Duquesnay comes out of all of this looking like a winner (see: FDA Rebukes Kim Kardashian for Morning-Sickness Drug Ad on Instagram But pharma marketer Diclegis wins big anyway):

The entire brouhaha appears to be a big victory for Diclegis, though, according to Treato, an Internet-based intelligence company focused on the health sector. The Princeton, N.J.-based company, which analyzes social media and other online channels to come to its findings, concluded that Kardashian helped get Diclegis a more than 500 percent increase in digital buzz in July. Kardashian's Instagram post alone garnered 450,000 likes. It appears highly likely that the Kardashian-FDA dustup will only create more brand awareness for Diclegis. Consequently, it's reasonable to assume that the 2-year-old brand, which is marketed by Blainville, Québec-based Duchesnay Inc., will see a nice uptick in sales.

Microsoft Publishes Guidelines for "Health Wearables"

I have come to the conclusion that "health wearables" will evolve into a significant component of our healthcare delivery system, monitoring our health status on a daily basis and perhaps even periodically offering advice about the problems that we all experience. By health wearable, I mean devices with sensors that monitor our physical or physiologic parameters. Such sensors are embedded in devices like smart phones which can also support sensors that are plugged into them. Fitness bands also fall into this category although I think that majority of consumers will opt to use their smart phones for heath monitoring. One obvious example of this category is the iPhone Health app.

I further believe that such "health wearables" will enable us sometimes to "jump over" the first step in the delivery of services which is to diagnose an illness or injury and then perhaps to triage the problem to the relevant specialists. The "health wearable" may be able to perform this diagnosis/triage step. In the light of these developments, companies like Microsoft are eyeing the health wearable market and trying to develop guidelines to manage the accession and management of personal health data. The details were provided in a recent article (see: Microsoft eyes guidelines for consumer health wearables) and below is an excerpt from the article:

Microsoft is joining the effort to create guidelines for developers of wearables and mHealth apps.The company has joined forces with the University of California, San Diego and the Vitality Institute to create "responsibility guidelines" that target six important issues in the use of personalized health technology. The guidelines are designed to not only help developers and healthcare providers in promoting everything from apps to smartwatches to interactive pill bottles, but to help consumers know which technology to trust. “Innovative personal health technology products are producing completely new categories of data and creating completely new challenges for developers, clinicians and users,” Dennis Schmuland, MD, Microsoft’s chief health strategy officer for the U.S. Health and Life Sciences division and an author of the guidelines, said....The six points addressed in the guidelines are:

• The privacy of a user's health data.
• Defining who owns...[health] data.
• Guidelines for interpreting... [health] data.
• Integrating product design with validated scientific evidence.
• Integrating evidence-based methods to health behavior improvement.
• Making the technology available to underserved populations.

Here's more information about the Vitality Group with which Microsoft is aligned on this project:

The Vitality Group is a member of South Africa-based Discovery Limited, a leading international financial services organization and the originator of the Vitality well-being program. With more than 15 years of experience and an established global record of success, the program today has over 6 million members worldwide.

There are really no real surprises in these six points. The one thing that does jump out in the list is the idea of "making the technology available to underserved populations." Relatively inexpensive health wearables could potentially substitute in some cases for the absence of adequate healthcare services. This does not seem to me to be a readily attainable goal in the short term. The inclusion of this idea seems to be more of a politically correct addition to the list.

The Democratization of Healthcare; Eric Topol's Perspective

The term "democratization" of healthcare has come to mean greater access to, and control of, personal health data by consumers/patients. I support this position for two main reasons. First of all, federal and state laws make this right very clear. Secondly, patients need to take more personal ownership of their health in order to prevent or forestall "lifestyle" diseases such as cardiovascular disease and Type 2 diabetes. In order to achieve this goal, patients need broad access to their medical records. These same points were reinforced in a recent interview with Dr. Eric Topol (see: Exclusive Interview: Dr. Eric Topol on the Democratization of Medicine). Below is an excerpt from it:

[Patients] cannot get to their information and they are the rightful owner of their information.... [I]t started with doctors knowing best and patients shouldn’t get their information because it can hurt them or they can get sick from the information.  That’s from the philosophy of more than two millennia, and that is what sets ups policies which constrain the abilities for people to rightfully access and have the rightful ownership of their data.  It should be the other way around that “I have all my data anytime, I want it, and by the way doctor, would you like me to share with you!", rather than the doctors and hospitals owning the data....

...I don’t believe....[that confidentiality/privacy] concerns [about sharing health data with patients] are grounded in reality. I think there are technological solutions to dealing with privacy and security.  For example, in Switzerland, there is a thing called “Health Bank”. The Swiss are notable for their banking capabilities and leadership and now they have HealthBank and every citizen can opt to have complete unfettered access and, more importantly, ownership of their data.  If they can do that, why can’t Canada, the US and every other country around the world? It doesn’t have to be central, not necessarily.  It can be set up for individual or family members. There is no good excuse here. They emanate, in my view, from the traditions and infringement of paternalism.

I agree with Dr. Topol that our current system in the U.S. of placing barriers to health record access is based on a long-standing sense of paternalism and notion that "doctors know best." These attitudes are in the process of changing. I also think that this paternalism is reinforced by the competitive nature of our healthcare system with hospital executives reluctant to make health data portable and thus facilitate the ability of patients to "shop" for higher quality, lower cost care. This is the goal of value-based care.

All of this helps to explain why countries like Switzerland have developed a "free, secure, citizen-owned, global health data transaction platform for research and safe data sharing and storage" (see: HealthBank).  Right now, this is only a dream in the U.S. Unfortunately, healthcare executives have used data security, privacy, confidentiality, and HIPAA for nearly two decades as excuses for not democratizing patients' access to their own heath data. In fact, HIPAA has always required that patients be provided access to their personal information (see: New HIPAA Rules Clarify Patients' Right to Access Their Health Data):

The HIPAA Privacy Rule has always provided individuals with the right to access and obtain copies of health information maintained in provider or health plan records.  Under the existing regulations, when a patient makes such a request, the provider or plan has up to 30 days to provide the requested access or copy; however, the provider or plan can take up to an additional 60 days if the information requested is stored off-site.

Biomarker Proposed to Detect Traumatic Brain Injury; Possible Future Scenarios

It has been long recognized that a biomarker to detect traumatic brain injury (TBI) would be very useful (see: NFL Physician Says Diagnosis of "Chronic Traumatic Encephalopathy" Lacks Validity; Pro Football Team Experiments with Cone Beam CT Imaging). Current diagnostic methods include the Glasgow coma scale and imaging (see: Traumatic brain injury). Ideally, a biomarker could be made available as a kit or running on a point-of-care device (POCT) to increase the speed of diagnosis. I have generally refrained from discussing news about proposed new biomarkers because most of them don't usually pan out. However, I am making an exception with regard to a recent article about a possible new test for TBI (see: New Blood Test May Detect Traumatic Brain Injury). Below is an excerpt from it:

A new quick blood test may be able to diagnose traumatic brain injury (TBI) and even determine its severity....The test could help determine the best type of treatment for each TBI patient....Until now, most doctors have relied on CT scans and patients’ symptoms to determine whether to send them home and have them resume their usual activities or take extra precautions. However, CT scans can only detect bleeding in the brain, not damage to brain cells, which can occur without bleeding....[R]esearchers wanted to know if a blood test could better predict which patients would have ongoing brain injury-related problems. So they measured the levels of three proteins that they suspected play a role in brain cell activity in more than 300 patients with a TBI and 150 patients without brain injuries. Then, they followed those with a TBI for the next six months.The found that levels of one particular protein, called brain-derived neurotrophic factor (BDNF), taken within 24 hours of someone’s head injury, could predict the severity of a TBI and how a patient would fare.

While healthy people averaged 60 nanograms per milliliter (ml) of BDNF in their blood, patients with brain injuries had less than one-third of that amount, averaging less than 20 nanograms per ml. Those with the most severe TBIs had even lower levels, around 4 nanograms per ml. Furthermore, patients with high levels of BDNF had mostly recovered from their injuries six months later. But in patients with the lowest levels of BDNF, symptoms still lingered at follow-up. The findings strongly suggest that a test for BDNF levels, administered in the emergency room, could help stratify patients.....More research is needed to determine why, at a molecular level, brain injuries decrease levels of BDNF in the blood and whether things known to increase BDNF levels ...could help treat TBIs....[The lead author] also wants to know whether changes in BDNF levels over time can be a proxy for recovery and if they could be used to "gauge the effectiveness of a particular treatment.

The politics and financial implications of a biomarker for TBI are fascinating. Let's say, for example, that BDNF proves to be an accurate predictor of acute TBI. Let's further hypothesize that the BDNF being measured decreases rapidly but transiently in most football players who are in major collisions, which is to say all NFL linemen during the course of a game. One could predict that team owners would probably object to any large-scale testing of their players because such testing could mean that the majority of them could be benched during most games. The owners could respond that one or two transient decreases of BDNF are irrelevant because the levels quickly return to normal and do not serve as a marker for an eventual chronic condition. Obviously, questions like these would need to be explored in future clinical studies. 

As noted above, the availability of a biomarker for TBI also raises the feasibility that it could be used to "gauge the effectiveness of a particular treatment." This reminds me of the search for an accurate biomarker for Alzheimer's disease (see: Biomarkers could predict Alzheimer's before it starts). Clinical trials for drugs to treat the disease would be made much easier if subjects could be enrolled on the basis of a lab test rather than the more complex, and perhaps more subjective, methods being used today. Needless to say, some relatives of patients with the disease would appreciate early diagnosis, particularly if a drug was available for treatment.