Technological Advances Linked to Medical Misadventures

For keen students of American politics, the unending intrigue of the 2016 presidential race has been riveting. With an assemblage of aspiring candidates that, at its start, included a bevy of U.S. senators and former governors, a media-savvy real estate mogul, a renowned Hopkins neurosurgeon and an ophthalmologist, political junkies among us have feasted on the endless buffet of debates, town hall meetings and candidate interviews. Seemingly every headline, video clip and Twitter feed is focused on the next state primary and the latest delegate tally, leaving us with precious spare time to peruse some of the equally engaging events in the world of healthcare and science that have impacts on our professional and personal lives.

Several such stories have been previously covered in this column. However, like the presidential race, some have taken a few unexpected twists and turns that deserve a second look.

The Debacle of Electronic Health Records (EHRs)

It was not so long ago that pen and paper were the favored tools used to scribble and store patient medical data. Notes were often lengthy, messy affairs, but worth a careful read in search of precious insights into the patient’s condition. Differential diagnoses were discussed, and opinions were rendered. Reading through a patient’s record was a useful exercise. But the lack of digitization kept the ink-and-paper medical record isolated from the rest of the connected universe (see “How Non-Transferable EHRs Have Affected Physician Practices,” The Rheumatologist, July 2015).

Physicians have long realized this state of affairs had to change. We are not Luddites. But getting a majority of the 600,000-plus American doctors to abandon their filing cabinets and replace them with hard drives and clouds was not going to be easy. By using plenty of carrots (e.g., about $35 billion in incentive payments) and a few sticks (e.g., threatened reductions in Medicare reimbursement), the Department of Health and Human Services succeeded in converting nearly five out of six physicians to an electronic record, a formidable achievement accomplished in less than a decade.1

Initially, most physicians welcomed this change. Why not? There were countless promises of how the EHR would revolutionize care by making records readable and readily accessible to doctors and patients alike. Patient flow would improve, and providers would be able to share the same electronic record, which would follow the patient wherever they received their care. Digital nirvana would be achieved.

Yet there was one critical error in this construct. We—the practicing physicians, the actual hands-on users of these systems—were never invited to sit at the table and actively participate in EHR development. Instead, a cabal of government bureaucrats, EHR company executives and their software developers hashed out the rules.² Now, we are paying dearly for this egregious error. Who knew that these technology mavens would devise such user-unfriendly products? Physicians anticipated that the EHR interface would be comparable to that found in smartphones and tablets; sleek, easy-to-use, well-designed layouts using pleasant-to-read fonts. Dream on. It’s as though the developers lived on some remote Pacific island and had never handled a smartphone or a tablet.

Sadly, moving from your smartphone to your EHR is like traveling backward through time.

It’s no wonder that a Google search of the phrase EHR problems generates in excess of 3.8 million results.³ Why? Virtually all the products suffer from the same issues: poor visual displays, redundancy of layout and a major lack of interoperability with competitors’ products. It makes one pine for the days of the fountain pen and parchment!

As many of our fellows have remarked, it can be a daunting task to perform a thorough chart biopsy on those complicated patients with multiple medical issues and myriad medical providers. Where are the data buried? Wasn’t the ability to easily find critical data a crucial raison d’être for this whole exercise? Is there a solution to this chart bloviation, a quick and easy way to find those critical lab results and important physical exam findings in the mush of template-generated notes?

Fear not. A whole new industry has recently emerged, one devoted to finding those needles in your patient-record haystacks. Based on data mining technology, large troves of notes and lab results can now be readily scanned, akin to performing a Google search of your patient’s record.

Having spent in excess of $1.2 billion to convert its hospitals to the dominant system in EHR, Epic, my employer is now a major investor in one of these data mining systems.⁴ Perhaps this will allow them to recoup some of their anticipated loss of an additional $200 million from expenses tied to the implementation of Epic.⁵ Does the financial bleeding ever end?

Fear not, my fellow rheumatologists, about the recent guidelines allowing patients easier and quicker access to their personal records.⁶ In the past, some of us may have been concerned about patients perusing their records and spotting less-than-flattering characterizations of their personality or body habitus, or gasping at some embarrassing and sloppy typographical errors (see “Patient Access to Electronic Health Records Yields Unexpected Results,” The Rheumatologist, October 2014). Since the EHR encourages the use of note templates replete with medical prose that is often cloned into subsequent notes, they will observe how redundant and boring records have become. Just as our fellows toil at separating the wheat from the medical record chaff, so, too, do those eager patients seeking to discover our personal observations of them hidden somewhere deep inside their records.

Is Technology Too Good to Be True?

You may recall the story of Elizabeth Holmes, the Stanford University engineering dropout who at the age of 19 had the brilliant idea of creating a form of nano­technology that would accurately and cheaply perform all sorts of laboratory tests by using just a few drops of blood (see “Can DIY Medicine Tame Rampaging Healthcare Costs?” The Rheumatologist, April 2015). An intense, highly focused and very disciplined woman, she pursued her dream with a visionary’s zeal, creating a startup company, Theranos, that achieved a valuation exceeding $9 billion.⁷

The company gained the backing of some of the foremost venture capitalists in Silicon Valley, and its board included several well-connected politicians, including three former cabinet secretaries, two former senators and several retired senior military officers.⁸

Ms. Holmes’ plan was to disrupt the world of laboratory medicine by collecting a few drops of blood from a patient via a simple finger prick and processing it using proprietary technology, which would reduce lab costs by as much as a 90%, resulting in huge savings for patients and insurers. Using direct-to-patient marketing and building hundreds of kiosks inside Walgreen’s pharmacies nationwide, Theranos was going to disrupt clinical laboratory medicine, a notable driver of medical costs. A brilliant plan!

But there were a few nettlesome issues that Theranos’ investors and Board of Directors somehow overlooked.⁹ The first was that the company never divulged the scientific basis of its proprietary method, code named Edison, believing that by exposing their technology to open scrutiny they might lose their technological advantage to competitors. The second was that federal lab inspectors were growing concerned about this mysterious methodology. They cited Theranos for several safety infractions as early as 2013, and by fall 2015, inspectors described the situation at their central lab in Newark, Calif., as “likely to cause, at any time, serious injury or harm, or death, to individuals served by the laboratory or to the health and safety of the general public.”⁹ (Note: Federal health regulators have since proposed banning Theranos Inc. founder Elizabeth Holmes from the blood-testing business for at least two years.) It may also not have helped that a dermatologist lacking board certification in pathology or laboratory science was the director listed on the Newark facility’s license. Being secretive and sloppy is rarely a formula for success. Secretaries of state and senators ought to know that simple fact.

A Lesson in Behavior Modification

The numbers are astounding. With less than 5% of the world’s population, the U.S consumes nearly 80% of the global supply of opioids.10 The No. 1 most prescribed drug for several years running is hydrocodone—not statins, not beta-blockers or diuretics. There are several theories for why our nation has a drug addiction issue, including the now-debunked belief that held sway in the 1990s claiming that patients suffering from chronic pain carried extremely low risks for developing opioid addiction (see “Fallout from False Assumptions in Medicine,” The Rheumatologist, December 2014). Recently, the U.S. Drug Enforcement Agency (DEA) moved hydrocodone-containing products from schedule III of the Controlled Substances Act to the more-restrictive schedule II, meaning patients could no longer obtain refills on prescriptions that now had to be submitted in person to the pharmacy each month.

How has this strategy worked? For patients living in rural communities, far from their prescribing physician or those who rely on an overburdened Veterans Administration for their care, this can be problematic.¹¹ A recent study conducted by the U.S. Food and Drug Administration found that dispensed hydrocodone-combination product prescriptions decreased substantially after rescheduling, with 26.³ million fewer hydrocodone-combination product prescriptions and 1.1 billion fewer hydrocodone-combination product tablets dispensed in 2015.¹² That’s about four fewer pills for every woman, man and child in America. Interestingly, the data also demonstrated that physicians did not game the system by substituting non-hydrocodone-combination product opioid analgesics. Although this law can be an inconvenience for patients and rheumatology practices, the stark numbers speak for themselves.

When Science Gets Ugly

In a unanimous U.S. Supreme Court verdict written by Justice Clarence Thomas in 2013, human genes may not be patented, but technologies that modify genes can.¹³ Perhaps no greater biosciences patent war has ever been waged than the one currently underway, pitting two research behemoths, the University of California (UC) at Berkeley and the Broad Institute in Cambridge, Mass., surrounding the ownership of CRISPR-Cas9 technology. Determining the inventor could have multi-billion dollar implications for the biotech companies that have already been spun off by these two institutions. There will definitely be winners and losers (see “Gene Manipulation Has Potential to Alter Genomes, Impact Society,” The Rheumatologist, January 2016).

With less than 5% of the world’s population, the U.S consumes nearly 80% of the global supply of opioids. The No. 1 most prescribed drug for several years running is hydrocodone—not statins, not beta-blockers or diuretics.

The CRISPR-Cas9 editing technology was publicly described in the journal, Science, in 2012 by Jennifer Doudna, a biologist at UC Berkeley, and the French microbiologist Emmanuelle Charpentier. But Feng Zhang, a scientist at the Broad Institute, was first to win a patent on the technique after submitting lab notebooks he says prove he invented it first.¹⁴ The system uses a cutting protein, Cas9, attached to a short RNA molecule that guides it to precise locations in a genome. Already, scientists have used it to disable HIV, cure muscular dystrophy in mice and make wheat that is resistant to crop diseases.

Under current rules, known as first to file, patent rights go to whoever submits a patent application first. That would mean an easy victory for Doudna and Charpentier, because their earliest application is dated May 2012, seven months before Zhang’s. But because of the dates of the discoveries, the case is being carried out under older, first to invent, rules, in which the winner is whoever is able to show by any means that they were first to make an invention work or simply conceive of it.

The patent dispute began in 2014 when Zhang appeared as the lone inventor on a broad patent covering CRISPR-Cas9. To win it, he filed a declaration with the patent office saying he had invented the idea on his own and offered lab notebooks to back up the claim.15 (This would not be the first time that lab notebooks could play such a prominent role in a biomedical research case.¹⁶)

In counterclaims filed with the patent office, lawyers for UC Berkeley say pages and diagrams from Zhang’s lab notebooks show only some related experiments and don’t prove he invented the system. “Dr. Zhang is wrong,” they conclude. UC Berkeley won the next round by claiming a suggestion of interference, an arcane procedure used to show that their patent claim may be superior to the Broad’s. But the final phase of the trial is only getting started, and no doubt it will be a highly entertaining spectacle. As one patent attorney quipped, “It’ll be like watching Nobel Prize winners defend themselves in traffic court.”¹⁷

Lessons Learned

Decisions lacking thoughtful, rigorous scientific analysis can be hazardous to everyone’s health.

Beware of strangers or familiar faces bearing gifts. These may be in the form of new technologies that promise to improve your EHR, enhance the quality of your care and lower healthcare costs; untested, proprietary methodologies that purport to disrupt the way we order lab tests; or false assurances, such as those claiming that opioids are not addictive when used to manage chronic pain.

And to researchers everywhere, a final plea. Save your lab notebooks! Their data are precious. One day, they may be far, far more valuable than you could ever imagine.

Simon M. Helfgott, MD, is associate professor of medicine in the Division of Rheumatology, Immunology and Allergy at Harvard Medical School in Boston.

Updated 4/21/2016 to reflect new Theranos information.

References

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