Regarded

BY THCBist

— Should We Fear an Amazon Monopoly on Healthy Food?
— On the Ethics of Accountable Care Research
— Confessions of a Healthcare Super User
— How Can I Tell If Medical News is Fake or Not?
— A Mystery Mission in LA: Aetna, Apple and a Vision of Digital Health’s Future Part I
— Dear Humans, Diverse Social Networks are the Answer
— Our Guide to Pre-Approval Access to Drugs for Both Patients and Doctors

By ALISON-BATEMAN HOUSE

In April 2016, I published guidance, in the form of a mock case study, on how to access a drug before it has been approved by the FDA—what’s known as pre-approval (or expanded or compassionate) access. This is an updated version of that guidance, reflecting multiple important changes in the pre-approval landscape over the past year. In particular, the FDA rolled out a new, streamlined form for single-patient requests, and Congress passed the 21st Century Cures Act, which, among many other things, mandated that certain pharmaceutical companies provide public information about their pre-approval access policies.

Patients (and physicians) trying to access an unapproved drug outside of a clinical trial can feel as though they’re navigating uncharted waters. Many physicians don’t know that the FDA permits the use of unapproved drugs outside of clinical trials; those who do know often have no idea how to access such drugs for their patients. Those physicians who know about pre-approval access are largely specialists in certain areas—often, oncology or rare diseases—and they are generally self-taught: they didn’t learn about pre-approval access in medical school or in their residencies. Thus, while some physicians have become very accustomed to requesting pre-approval access to drugs, the majority lacks this knowledge. In this essay, I use a fictional case to trace the process for requesting access to an unapproved drug. I hope to explode several myths about the process, especially the beliefs that the FDA is the primary decision-maker in granting access to unapproved drugs and that physicians must spend 100 hours or more completing pre-approval access paperwork.

Imagine you are a physician, and you have a pregnant patient who has tested positive for the Zika virus. She is only mildly ill, but she’s terrified that the virus, which has been linked with microcephaly and other abnormalities, will harm her unborn child. She’s so concerned that she is contemplating an abortion, even though she and her husband have been trying to have a child and were overjoyed to learn she was pregnant.

Last night, you saw a news story about a pharmaceutical company with a drug in development that, in theory, could minimize the impact of Zika on fetuses. The story, while focused on the hope of a way to prevent fetal harm from Zika, also discussed the ethical concerns raised by the prospect of testing a new drug on pregnant women and their fetuses. Watching the story, you had thought it might be impossible to ethically test this drug in people, but now, with a distraught patient before you, you wonder if you can find a way for her to try this investigational drug.

In the best-case scenario, you would remember the name of the company developing the drug. After contacting the company, you would learn that it is enrolling participants in a well-designed clinical trial, that your patient is eligible for the trial, and that there is a trial site convenient to her. She would decide to enroll in the trial and have a healthy child — either because of the drug or because the infection did not affect the fetus — and her participation would aid in the development of a drug that may help others who find themselves in her situation. There are numerous reasons, however, why this best-case scenario may not come to pass. For example, you may be unable to recall or figure out which company is developing the drug you heard about; your patient may be uninterested in participating in a clinical trial; or she may be interested but is ineligible because of medical or geographic factors.

For the purposes of this essay, imagine that you cannot remember the name of the pharmaceutical company. So, you go to ClinicalTrials.gov and search the trials listed there using the keyword “Zika.” You look through the various trials listed, but, unfortunately, none of them will work for your patient because they have already completed enrollment or because she matches certain exclusion criteria or is unable to travel to a clinical trial site.

You know the FDA allows expanded access (its term) or compassionate use (the more colloquial term) of investigational drugs when patients without other treatment options are not eligible for clinical trials, but you’ve heard that it is a complicated and time-consuming process. You wonder whether it is even an option for your patient, who would need to decide quickly if she is going to have an abortion. Nevertheless, you decide to try. You do an internet search for “FDA expanded access” and send a message to the FDA email address you find. You quickly get a response informing you that you need to contact the company whose drug you wish to try on your patient to see if it is willing to provide its drug; if so, then you will work with that company to prepare an application for FDA review.

As you don’t remember the name of the company that was developing the drug, you can’t just directly contact it. Instead, on ClinicalTrials.org, you search for “expanded access” and get 719 results. You then try “compassionate use,” getting 602 results, and “pre-approval access,” with 4 results. Unfortunately, when you add “Zika” to your search, you get zero results, regardless of whether you use “expanded access,” “compassionate use,” or “pre-approval access.” Rather than giving up, you do a search using just the keyword “Zika,” intending to call all the listed clinical trials to see if one of the trial sponsors can help your patient, even though she isn’t eligible to join their trial.

The first clinical trial listed is run by Big Successful Pharmaceutical. You go to its website and see that its pre-approval policy posted there. The policy directs you to send an email to a specified address or call a certain number. You call, and the person who answers takes down your request and says you will get a response within 5 business days.

It used to be rare for a company to make its pre-approval access policy public. According to an October 2016 report by Avalere Health, a search of 100 publicly traded pharmaceutical and biotechnology companies found that only 19 companies included their pre-approval access policies on their websites. However, legislation enacted in December 2016 (the 21st Century Cures Act) mandated that “the manufacturer or distributor of one or more investigational drugs for the diagnosis, monitoring, or treatment of one or more serious diseases or conditions make publicly available” its pre-approval access policy. This policy must include (1) contact information for the drug company; (2) procedures for making requests; (3) the general criteria the company uses to evaluate both the requests and its responses to such requests; (4) how long the company will take to acknowledge receipt of requests; and (5) a link or other reference to information about clinical trials for the drug. When Avalere re-ran its study in March 2017, it found that the number of companies with publicly available pre-approval access policies had more than doubled.

The impetus for this legislative requirement was the desire to make the pre-approval access process more patient-friendly. Prior to the 21st Century Cures provision, not only was information about how to submit pre-approval requests to specific companies lacking, but some companies simply did not respond to inquiries. The new rule requires companies to be more forthcoming about their policies and give requesters a timeline for when they can expect an answer. Importantly, the policy mandates that companies have a policy; however, this does not mean that they necessarily offer access: a company’s pre-approval access policy can be that it does not grant pre-approval access to its drugs.

In June 2017, another new tool was unveiled. This is the Expanded Access Navigator (http://navigator.reaganudall.org/), which offers physician- and patient-specific instructions on how to pursue expanded access. In addition to information about how to search ClinicalTrials.gov to find drugs that may be relevant, the Expanded Access Navigator has an alphabetical company directory with links the companies’ websites and information about their expanded access policies and contact information for placing a request. Thus far the Expanded Access Navigator mainly has information relevant to oncology, but it will be adding additional companies and expanding into different therapeutic areas.

One of the reasons that it is important for you to have a designated contact is because different pharmaceutical companies delegate pre-approval decision-making to different people. It could be the chief medical officer, the regulatory liaison, the CEO, the head of the team developing the new drug, the legal team, or some other staff member. Just as there is no industry-wide consensus on who should respond to such requests, there is no agreement on what the answer should be. Some companies feel strongly that they shouldn’t provide unapproved drugs to patients outside of clinical trials, while others are willing to do so as long as it wouldn’t interfere with their trials. Some companies may be willing to provide access in theory but do not have enough drug to make provision a reality, and still others might have policies stipulating that access will be granted only after a certain point in the clinical testing of the drug — for example, after it has been proven relatively effective in a Phase 2 trial, or perhaps after the trials are complete and the drug is under review by the FDA. Yet another area where there is no industry-wide consensus is what to do with patients who appeal a denial. These are the patients who might turn to the media, online petitions, and Twitter and Facebook to try to pressure a company into granting access to its unapproved drugs.

In your case, you get a response the next day informing you that  the company has received so many requests for their investigational drug that it has decided to open an expanded access program (EAP). This is like a clinical trial, in that it collects some data, but its inclusion criteria are less demanding than those of the “real” trials. Your patient, who couldn’t participate in the clinical trial because she has difficulty traveling and lived several hours away from the closest trial location, can participate in the EAP. Because the EAP is collecting less data than is the trial, your patient’s pre- and postnatal visits can be conducted at your hospital instead of her having to travel to the trial site.

Just as you’re breathing a sigh of relief about how easy the process turned out to be, you get bad news. Although the EAP is in the process of being set up, it will not be started in time for your patient, who needs treatment urgently, as she has decided that she would rather have an abortion that give birth to a Zika-affected child. The company informs you that it is still willing to provide its drug to your patient, but you’ll have to go through what is called the single-patient IND route.

Your contact at the company instructs you to complete form FDA 3926, which is available online. You say that you’ve heard that it can take 100 or more hours to complete and that your patient doesn’t have that kind of time. But your company contact tells you that the 100-hour estimate applied to the drug company, when it completed paperwork prior to beginning clinical trials. The form you need to submit, with the company’s help if necessary, should take 45 minutes, at most, to complete.

Once the form is filled out, you send it to the FDA, which will review it to see if it raises any red flags or if the agency has any suggestions on how to improve your proposed treatment plan. By law, the FDA must respond within 30 days; however, its reviewers understand that these requests are often time-sensitive, so they screen them as quickly as possible. In fact, emergency requests are typically reviewed in one day or less and non-emergency requests are usually reviewed within four days. Furthermore, the company tells you that historically the FDA has approved the vast majority of requests for expanded access. Indeed, online you find FDA statistics showing that it approves 99% of pre-approval access requests.

The next morning you get a call from the FDA: the agency will permit you to try the investigational drug on your patient and her fetus. However, there is one more step to take before you can do so—you need to get permission from your hospital’s institutional review board (IRB). The IRB is charged with reviewing research projects proposed to be conducted at the institution, making sure they are ethically acceptable before human subjects can be enrolled. In this case, what they are reviewing is not a research project (even though it involves an investigational drug) but clinical care, albeit of a new, innovative sort that may not actually work. As such, you are not sure how to present your plan for trying this investigational drug to the IRB.

You call the drug company for advice, and a representative offers to send you its clinical trial consent form. You modify the form, removing language about the trial but keeping information about the potential risks and benefits of the drug to mother and fetus. You then call your hospital’s IRB and explain that you wish try an unapproved drug on one of your patients, as she has no approved therapeutic options; that the company is willing to provide the drug; that the FDA is willing to let the request proceed; and that now you need the IRB’s approval. The IRB staff member tells you to send him your proposed informed consent form and that the board will review it as quickly as possible. You know it normally takes a while for your IRB to review submissions, so you are relieved to hear that they will review it quickly. You are also a bit skeptical! Later that day, you call again to check on your submission and to emphasize its time-sensitivity, and you are informed that you’ll have an answer tomorrow. You call your patient to update her and then do the same to the pharmaceutical company, which tells you it will express ship the drug to you so you can use it as soon as you have permission from the IRB.

In our scenario, it all works out:  the IRB approves your submission, the drug arrives on time, the patient consents to receive the drug and takes it with no problems, and she goes on to deliver a healthy child. You have new, hard-won knowledge about how to request unapproved investigational drugs. Very likely you think the process was more complicated that it should be, especially given the time-sensitivity of your request, but upon reflection you realize that the biggest problem you encountered was figuring out what to do and in what order. You vow to share your knowledge with your colleagues and students. Overall, however, you are appreciative of the guidance provided by the company, the FDA, and your IRB, and your patient is grateful that you went above and beyond to try to help her have a healthy child.

The purpose of walking through the above scenario has been to demystify the process of seeking access to an investigational drug outside of a clinical trial through the FDA’s Expanded Access Program. Secondarily, the above scenario was intended to quash several myths. One such myth is that it requires 100 hours or more to complete the FDA’s expanded access paperwork. Another such myth is that the FDA has ultimate control over access to investigational drugs via expanded access. In this case, access to the drug hinged on the company’s willingness to provide it. If the company had said no, the FDA cannot “force” the company to provide an investigational drug. Once the company agreed to provide the drug, the FDA does have approval power, but over 99% of the time, the agency permits pre-approval access requests to proceed. The FDA review is no rubber stamp, however. The agency does important work reviewing the proposal and providing feedback on such issues as dosage, dose schedule, etc. Furthermore, the FDA requires that physicians notify them of any severe or unexpected adverse events that occur in the patient after the drug is administered. This allows the FDA staff to have better understanding of what may happen with the drug should it receive another request to use it in a patient. The physician’s IRB also has approval power over the plan to use an investigational drug in a patient.

Obviously, the above scenario is idealized. Despite recent efforts like the Expanded Access Navigator, physicians (particularly those who are not researchers) may not be able to figure out what investigational drugs may be promising or which company to contact for a specific drug. The company may not post its access policy (despite federal regulations requiring it to do so), or it may not respond to a request. Misunderstanding how to obtain access to investigational drugs outside of clinical trials may result in physicians spending time petitioning the FDA for access when, in reality, it is the companies that have the initial and most significant role in deciding whether to grant requests for access. And, as mentioned before, there is no industry-wide consensus on how to handle appeals when companies deny a request for access.

One byproduct of the lack of understanding of how to seek pre-approval access has been the proliferation of so-called “Right to Try” laws on the state level and, currently, as bills before Congress. Right to Try advocates incorrectly identify the FDA as the sticking point in efforts to obtain non-trial access to investigational medical products. Seeking to remedy the perceived problem, these laws state that FDA approval is not needed to use the products under certain circumstances (most commonly, in terminally ill patients, with informed consent, and on a doctor’s recommendation). The state laws raise constitutional issues in their effort to wrest from the federal government the power to regulate the use of unapproved medical products. More important, these laws fail to acknowledge that any obstacle to a patient achieving pre-approval access is far more likely to arise from companies being unwilling to give out their drugs than from the FDA refusing a submission.

The libertarian Goldwater Foundation is the architect and main proponent of the Right to Try movement. This group continues to cite the 100-plus-hours-to-complete FDA-forms assertion in explaining why it has targeted the FDA. Although that figure was never accurate, in 2016 the FDA rolled out form FDA 3926, which was created only for single-patient requests and takes just 45 minutes to complete. Supporters of Right to Try laws also frequently say that the problem with the FDA is that it is slow: that patients are dead or too ill to be helped by the time the FDA approves a submission. While there may be a range of FDA response times to requests, by law the agency must respond within 30 days or the request is allowed to proceed. As mentioned above, the FDA normally reviews emergency requests in a day or less and non-emergency requests in a median of four days. Thus, FDA foot-dragging is not a problem. The right to try movement’s identification of the FDA as the chief obstacle to patients being able to access investigational drugs outside of clinical trials is the product of libertarian anti-regulatory ideology rather than fact.

It may be that the main barrier to patients getting access to pre-approval drugs is lack of familiarity with the process. Hopefully this essay has illuminated and demystified that process. However, seeking investigational drugs outside of clinical trials will still be challenging, and there is much work to be done: educating patients and physicians, guiding the pharmaceutical industry in the development of best practices concerning how to respond to requests, and assisting IRBs in providing appropriate and timely reviews of proposals. But the mere fact that this article needed to be significantly updated a year after publication is indication that change is happening quickly.

By SABAH PERVEZ

Bright ideas are nothing without those who enable action.  For every bright idea in the digital health space, developers are needed to turn that idea into a reality.  We’ll be kicking of this year’s Annual Health 2.0 Fall Conference  on October 1st (1-5pm) with Dev Day, a day dedicated to the developers, data scientists, and coders in the health tech space.

Expect your day to be filled with strong technical sessions in relation to interoperability and user testing, as well as opportunities to meet and learn from others in the industry.  We’ll be showcasing the latest developer product and platform updates and chatting about exciting plans on the horizon for innovators working on blockchain, artificial intelligence, and FHIR.

Come kick off the Health 2.0 11th Annual Fall Conference with us at this year’s Dev Day and celebrate the new technologies made possible by all of the amazing developers in our community!  We’ll be having a workshop on How to Accelerate the Development of Your Blockchain Project led by, Siva Kannan, VP of Engineering at Gem HQ and rapid-fire “dev talks” from innovators like Aashima Gupta, Global Head of Healthcare Solutions at Google Cloud, Ayin Vala, Co-Founder and Chief Data Scientist at the Foundation for Precision Medicine, Andrew Shults, Senior Director of Engineering at Oscar Insurance, and many more!

REGISTRATION
This half-day pre-conference event is free to attendees who have purchased a standard admission ticket. Registration includes access to the Dev Day programming in Grand Ballroom A&B as well as access to a cocktail reception that evening. Please register for Developer Day here.

Sabah Pervez is a Senior Program Manager at Catalyst @ Health 2.0.

By NIRAN AL-AGBA, MD

There is a grassroots movement, 4300 strong, known as “Save Our Hospital” gaining notoriety in Albert Lea, Minnesota.  This story is symptomatic of the fact that hospital consolidation has slowly become a national pastime.  With declining revenue under the Affordable Care Act, mergers increased by 70%, leaving small communities scrambling for healthcare access.  The latest casualty in the ‘hospital-consolidation-for-sport’ trend is Albert Lea, a small city located in Freeborn County, Minnesota.

Known affectionately as the ‘Land between the Lakes,’ it has a population of 18,000 spread over 14 square miles.  Not surprisingly, Mayo is their largest employer; the 70-bed hospital serves almost 60,000 in a region including patients who live in Iowa.  In Rochester, MN, the Mayo Clinic is regarded by many as one of the premier medical facilities in the country.  Originally of humble origins, founder William Mayo opened a practice during the Civil War and later, passed it down to his sons; today, the Mayo Clinic flagship is located in Rochester, Minnesota and plans to become a renowned premier medical destination for the world. 

Corporations with such lofty ambitions tend to make “small” sacrifices along the way; often, on the back of a beloved rural town.  On June 12, Mayo clinic administrators announced they would transition all inpatient services to Austin, more than 20 miles away.  Mayo cited ongoing staff shortages, reduced inpatient censuses, and ongoing financial difficulties as their reasons for hospital closure.  Rural care was mentioned to be at a crisis point, which is an altogether callous assessment of the troubling situation facing communities across this country. 

The Albert Lea City and County Hospital Association formed in 1905 when concerned citizens raised funds to build a community hospital.  Renamed Naeve Hospital, after a prominent donor, it became the lifeblood of this rural community.  Physician groups collaborated to start the Albert Lea Clinic and Albert Lea Medical and Surgical Centers.  For financial reasons, on Jan. 1, 1997, Albert Lea’s Clinics and Naeve Hospital merged with the Mayo Medical Center in Rochester.  At that time, a now-retired local physician expressed concern about the challenges of recruiting physicians to the rural locale.  Mayo, however, scoffed at his assertion.  Recently, Dr. Bobbie Gostout, Vice President of Mayo Health Clinics, confirmed it was indeed difficult to recruit newly trained physicians to small areas with a heavy night call burden.

It is estimated the facility in Albert Lea sees 500 patients per day including office visits, dialysis, cancer care, and other outpatient services.  Approximately 7 patients per day will be affected by this move.   Freeborn County Attorney David Walker is evaluating if Mayo violated their bylaws by not holding a vote for the consolidation decision.  Mayo is denying a vote was necessary.  Walker has asked the state Attorney General to weigh in on the debate. 

Hospitals across the nation are focusing on efficiency while trying to improve care quality and maximize revenue.  Consolidation can help lower overhead expenses; however, over time, the heartland and the people being served suffer for a variety of reasons.  Mayo administrators blame $13 million in losses over the last two years at the Austin and Albert Lea campuses as the cause for hospital closure.   Prior to making this pivotal move, Mayo conducted an 18-month internal review; unfortunately, neither the City Council nor County Commissioners were consulted.  In July, Albert Lea City Council unanimously approved a resolution requesting Mayo halt the process until 2018, in order to solicit feedback from the community impacted by this decision.  The Freeborn County Board also called for a six-month moratorium from Mayo.  Both requests were denied by the behemoth that is Mayo. 

Not every community member in Albert Lea is opposed to hospital closure.  Some physicians working at Mayo feel they are stretched too thin and cannot survive with two rural facilities to staff.  Recruiting nurses and physicians has been extremely challenging, according to them.  The hospital in Austin is 20 minutes away, which they feel is adequate, alternatively, Owatonna is 25 minutes north, and Mankato is 35 minutes away and has a Mayo helicopter stationed there for medical evacuation needs.

Mariah Lynne, co-founder of Save Our Hospital, said “Our mission for Save Our Hospital is to maintain a full service, acute hospital in Albert Lea, Minn., for the benefit of our citizens and our surrounding citizens.”  This grassroots organization is asking Mayo to return the hospital facility to Albert Lea so they can find another company interested in providing hospital services for their residents.  The Service Employees International Union (SEIU), which covers healthcare workers, is also supporting this community effort. 

Mayo plans to move intensive care, labor and delivery, and surgery services to the Austin facility, which is more than 20 minutes away.  Reduced access to timely medical care can actually translate into higher mortality in rural areas overall.  Since 1990, maternal mortality in the United States has been increasing steadily.  Today, more American women are dying of pregnancy-related complications than in any other developed country throughout the world. Rural hospitals, which are financially struggling, are less prepared for maternal emergencies today than they were two decades ago.  Potentially fatal complications which are initially treatable may become lethal in the setting of fewer resources and longer travel distance when seeking care.     

Mayo appears to be sacrificing a rural hospital in Albert Lea to pursue ‘champagne wishes and caviar dreams.’  Mayo plans to invest in the Destination Medical Center Project, focused on drawing foreign visitors who will bring with them not only champagne and caviar, but also open wallets.  Two major projects in Rochester are currently under way – the expansion of the Mayo Civic Center to the tune of $84 million and $93 million in upgrades at Mayo’s St. Mary’s Hospital.   When asked about complaints regarding the loss of services in Albert Lea while making elaborate plans in Rochester, Dr. Gastout said investments are helping to shore up Mayo’s long term survival.   She denies allegations the exorbitant Destination project is related to the Albert Lea Hospital closure, stating “Growth should not be misinterpreted as easy sailing in one place, and difficulties in another.”   

Reflecting on the loss of rural hospitals across the nation, my thoughts circle back to residents in Lee County, Georgia and my hometown in Kitsap County, Washington.  All three groups are engaged in clashes of David and Goliath-esque proportion against conglomerate hospital corporations threatening to destroy their respective healthcare landscapes.   While they might make strange bedfellows, City and County leaders are finding common interests aligning with local unions supporting healthcare workers, such as the SEIU (Minnesota) and UFCW-21 (Washington State.)  Together, these innovative alliances are making significant progress which may turn the tide.   For some of the large hospital systems, “easy sailing” may soon look like nautical navigation during a tropical storm.  While corporate headquarters is distracted with their dwindling bottom lines, betting on the underdogs seems prudent; after all, they are the ones gambling with their lives.   

Niran Al-Agba, MD is a pediatrician based in Washington state.

By RICHARD DUSZAK, MD 

The online membership forum of the Society of Interventional Radiology (SIR) blew up this week in response to an email announcement by the American Board of Radiology (ABR) that it will effectively be doing away with lifetime diagnostic radiology certificates for interventionalists whose original certificates pre-dated the introduction of time-limited certificates. Interventionalists were given two choices:

1.     You can keep your lifetime diagnostic certificate if you give up your (earned) interventional subspecialty certification, or

2.     You can keep your interventional certification, if you give up your lifetime diagnostic certification.

Talk about choice.

Keeping your lifetime certificate in diagnostic radiology and your time-limited certificate in interventional radiology—the option I chose 20 years ago when I voluntarily became one of the ABR’s new interventional certification guinea pigs—is no longer an option.

Interventional radiologists are trained in diagnostic radiology, just as interventional cardiologists are trained in general cardiology, and many interventionalists still interpret imaging – indeed it’s hard not to, if you’re using imaging to reach organs.

This latest top down mandate by the ABR is another example of the ongoing proclamations of the many American Board of Medical Specialties (ABMS) member boards that have infuriated so many well-meaning practicing physicians. It is yet another step in the insidious push by the ABMS to force physicians into increasingly onerous Maintenance of Certification (MOC) programs. Coincidentally (or not), these have turned out to be quite profitable for its member boards, whose asset war chests have grown quite handsomely—all funded by a new stream of MOC dollars from practicing physicians.

I’m not an ABR hater. In fact, I’m a staunch supporter of the board certification — so much so that the ABR recently recognized me with a Volunteer Service Award. I have served for many years as an oral examiner in both diagnostic and interventional radiology, on the ABR’s non-interpretive skills committee, and regularly on its Angoff Panel (a panel which tests the test) before each year’s electronic examinations. They’re time-consuming commitments, but ones that I view as my civic duty. Physicians are held to a very high standard—and rightfully so—and need to continually earn public trust. That’s the reason that I—like many other interventional radiologists—am upset. Our collective commitments to the public and to our profession only work if we can trust our boards.

The ABR proclaims in its volunteer manual that public trust is the first pillar of our profession. Public trust is, in fact, prioritized so much that the ABR includes professionalism as one of its six key MOC competencies—and something that’s now part of all of our electronic examinations. But, as reflected in the online comments of a number of interventional radiologists (e.g., “They cannot be trusted. Period.”), the ABR is failing the examination of real life—and losing the trust of its own diplomates.

When an organization listing public trust as its first professional pillar grants lifetime certification, it is not selling a widget. It is entering a covenant with that diplomate, who buys into ABR’s and ABMS’s word that lifetime means lifetime.

Almost 30 years ago, I entered another lifetime covenant, when I said “until death do us part.” If I told my wife that I’m no longer honoring that lifetime covenant, and just want to stay friends and continue our relationship in a transactional manner, conditional upon her meeting whatever “Maintenance of Companionship” requirements I decided arbitrarily, she would kick me to the curb. And, rightfully so. Telling her that maybe someday down the road, if she asks nicely, I’ll reinstitute that lifetime covenant would probably infuriate her even more. Based on several dozens of posts (and still climbing) on the SIR’s forum, that’s how many respected interventionalists are interpreting the ABR’s latest missive—as emotionally and passionately as victims of cheating spouses.

But, there’s a silver lining to this cloud. With my lifetime certification partner telling me that her over two-decade “until death do us part” promise secretly came with an asterisk, I am now free to explore other certification partners.For the last two years, I’ve watched closely the growth—and growing acceptance—of the National Board of Physicians and Surgeons (NBPAS).  Its Board of Trustees includes luminary thought leaders like Eric Topol and Michael Gibson with whom I’ve connected on social media. They, and their trustee colleagues, are forward thinking physicians who have chosen to prioritize patients, physicians, and integrity over ABMS bureaucracy. Shortly after receiving notification of “we changed the rules—take it or leave it” choices from the ABR, I applied for board recertification from NBPAS. I look forward to continuing my conversation with their leadership about how competition and transparency in the board marketplace can make board certification better for all of us—in the radiology community and beyond.

Public trust isn’t proclaimed. It is earned. If physicians can’t trust their boards, how can we expect the public to trust them?

About the author:

Richard Duszak, Jr., MD (@RichDuszak) is Professor and Vice Chair of Radiology at Emory University and Associate Editor of the Journal of the American College of Radiology.

By JAMES DOULGERIS, MD

Kip Sullivan posted an op-ed in “The Health Care Blog,” “On the Ethics of Accountable Care Research,” on August 25, 2017.

Mr. Sullivan’s questioning the ethicality of health system generated research papers touting statistically insignificant results as triumphs, while perfectly valid and well-reasoned, is like questioning the validity of a teacher’s grading curve while missing that the class is gaming the system.

A system ginned up in the only policy factory in the country with policy-makers naïve enough to actually believe that hospital systems would actually cannibalize their core business to split the results with CMS, then split a legally mandated two thirds with the doctors, then pay its costs out of the rest, would ever work. Commercial payers do it, too, but for far more practical reasons.

The Accountable Care initiative, far more vulnerable than Obamacare, is being circled as easy prey for elimination by D.C. policy lions and pundits. It is undeserving of this fate for one, single, compelling reason. The program theory is valid and, with the right partners, is thriving as a win-win.

Its advantaged design partnership to exactly the wrong partners is the ill-conceived – and failing – part.

Who are the right partners? Independent physicians, for example. The ones that are focused on providing better value for their patients and are incentivized because the new money in healthcare is in delivering value. The broad delta between a bloated, wasteful, ineffective system and the improved one you create can restore fiscal stability to primary care physicians, who are on the verge of being price-cut out of business. Primary care physicians are the key because they can be very effective, and less costly, clinical managers for a patient’s overall care.

Physician ACOs’, however, are destined to be small and relatively inconsequential because hospital systems have been buying up their potential participants for years. After 45 years in healthcare, mostly hospitals, I know that one quite well. If you’re four times the cost of the competition and can’t control the prescription pad, own the pen to own the market.

So as not to be misunderstood, hospitals have their place. They are essential community assets, and, you need big institutions to do big things.

Prevailing upon them to cannibalize their customer base and revenue stream, risking their long-term survivability on some “do your fair share” ideology, however, clashes with reality so starkly that it begs rationalizing survival in the public interest and acting exactly as hospital leaders have.

Let’s be real. Looking for savings from the people who are responsible for managing health crisis is exactly the wrong place to look.

Looking for savings from the people who are responsible for managing patients’ health is exactly the right place.

That’s why non-hospital affiliated, physician governed, professionally managed ACOs’ consistently and substantially outperform hospitals by managing utilization and site of service based on value and having and taking long term responsibility for their patients. Physicians understand that improving health status – keeping people healthy by preventing and managing chronic disease by slowing, stopping or reversing its progression – is the only way to succeed long term.

That is the fundamental problem not only with the ACO system, but, with the entire governmental concept of healthcare. Healthcare is not paying for services. It is providing them.

In a truly American tradition – put providing that care in the right hands by equipping, enabling and empowering their healthcare representatives – physicians. They are not going to spin and sell. They are just going to get the job done.

The mechanism to do so is both simple and fair. Disqualify ACOs’ that chronically have not or cannot generate statistically meaningful savings in areas that they can and should control to make room for a proven entity to fill the void.

The rest will take care of itself.

James Doulgeris is the CEO of Osler Health

By JASON CHUNG

Two months ago, I wrote about the potential impact of the Amazon purchase of Whole Foods on grocery prices.  Both here and in the Boston Globe, I hoped and predicted that Amazon would use its famed distribution network to drive down prices on the healthy and organic foodstuffs that made Whole Foods famous.

I’m happy to say that I was right. Today, on Day 1 of Amazon’s official ownership of Whole Foods, Americans got to see the first tangible impacts of Amazon ownership and, as predicted, it was lower prices.  As noted by journalists, the chain once derided as Whole Paycheck should now be referred to as “3/4 Paycheck” given deep discounts averaging 25% on a wide range of products ranging from bananas to butter.

Though terrifying for Amazon’s competitors such as Kroger, Walmart and Costco, Amazon’s major foray into brick-and-mortar groceries may end up being a boon for consumers – at least in the short term.  It’s no secret that Amazon retains its web startup mentality in aggressively promoting loss leaders to drive out competition.  And increased competition will better serve consumers who have been squeezed by recovering inflation on food prices.

Soon, Amazon intends to install more of its Amazon lockers into Whole Foods locations, thereby facilitating deliveries for goods bought on the Amazon website while also increasing foot traffic to its stores.  Analysts also speculate that Amazon’s grocery delivery service, Amazon Fresh, may get a much-needed shot in the arm with goods from Whole Foods.  The corporate synergy of this deal is palpable – and just beginning.

This makes people nervous.  Already, journalists and think tanks have sounded alarms about how Amazon’s growing power may make it a monopoly.  They argue that Amazon is an antitrust problem given that it already captures nearly half of U.S. online sales, is the leader in providing cloud computing through Amazon Web Services and has a robust marketing and logistics division.

To bolster their point, it is true that Americans can now spend a large part of their day using Amazon services without even knowing it.  You could wake up on a Saturday, go to Whole Foods for groceries, order supplies off Amazon, read a book with your Kindle, watch TV on Netflix (powered by Amazon Web Services) or catch a movie on Amazon Prime Video.  All of your needs met by Jeff Bezos and company.

It is understandable that this makes people uneasy.  While America has faced more pervasive monopolies, Amazon’s reach is more insidious given that it reaches, and controls, much of our daily lives.

But when it comes to food, does any of this matter?  I would argue, no.

A key responsibility of any government or society is provide a secure food supply to everyone.  And in this regard, America has failed miserably.  As noted in my previous piece, 2.3 million Americans live in extreme food deserts – areas more than one mile from their nearest supermarket and with no access to a vehicle.  And even where food deserts do not exist, eating healthy has progressively become more expensive than eating junk food.

Much of this increase in healthy food prices can be attributed to the increasingly niche treatment of fresh food.  Tack the label of “superfood” on a product and the price seems to mysteriously skyrocket.  A key example is kale, a food blogger favorite, where heightened demand has led to annual price increases of more than 30%.

With Amazon’s purchase of Whole Foods driving prices on fresh foods down in-store, and perhaps online, we might be on the verge of the democratization of fresh and healthy foods.  And that’s a good thing.

It’s time to stop treating healthy eating as a choice.  The truth is that healthy eating has gotten too expensive and too difficult for those in lower income brackets.  And to blame lower-income Americans for failing to eat right, when junk food is fast and ridiculously inexpensive, smacks of out-of-touch elitism.

Instead of fearing the monopoly implications of Amazon-owned Whole Foods, the Trump administration should view it as an opportunity for public-private partnership.  With grocery prices likely to fall in the near to medium future, the administration should be looking to expand the scope of SNAP (formerly known as food stamps) into direct food delivery so that low-income families can get fresh foods delivered directly to their homes.

Such programs are not new but they previously faced three major problems: (1) technological, (2) marketing and (3) cost.

Luckily, the technological hurdles to using SNAP online seems to finally have been dealt with.  But the other two questions of marketing and cost remained in the pre-Amazon Whole Foods world.  However, with Amazon’s new pricing and renewed commitment to the food business and marketing prowess, such a program could finally take off and deal with the issue of food deserts once and for all.

Instead of relying on Amazon or its competitors to figure out the online SNAP model, government should coordinate the process and streamline the required elements in a general Request for Proposals, including pricing controls.  Doing so should alleviate concerns about the government enabling the creation of an Amazon monopoly while ensuring that lower-income Americans can get healthy food at reasonable prices.

If, at the end, only Amazon can comply with the RFP then so be it.  More Americans desperately need healthy food, whatever the source.

Jason Chung is currently the senior researcher and attorney at NYU Sports and Society, in New York. He tweets at @ChungSports.

By ALEX EPSTEIN

As if 100+ deaths on U.S. highways every day isn’t horrific enough, we are all too often reading and hearing about cars being intentionally used as weapons and seeing unbelievable images of victims on sidewalks that have been turned into killing fields.

Unfortunately, the list of these instances is growing. The attack Aug. 17 in Barcelona that saw 13 killed was just the most recent; Charlottesville, NC, and Columbus, OH, have been the scene of attacks as well. Since July of last year, vehicle-related assaults have claimed more than 100 lives in Nice, Berlin, Stockholm and London.

It may come as small comfort to know that advanced automotive safety technology, while not eliminating these instances, might be able to reduce the bloodshed. Automatic emergency braking systems monitor what is in front of a vehicle and apply the brakes when collisions appear imminent. This feature already may have saved lives.

The truck used in the attack in Berlin last December had AEB technology. Tragically, a dozen people were killed in the incident, but reports indicate the AEB system stopped the vehicle about 250 feet after initial impact, likely preventing additional fatalities.

These systems will be on more cars in the future. Last year, the U.S. Department of Transportation, the National Safety Council and the Insurance Institute for Highway Safety announced that 20 automakers have committed to making AEB a standard feature on new cars by 2022.

Admittedly, this is a longshot. It will be decades before AEB systems are found on most vehicles on our nation’s roads. And, as AEB is presumably not being designed with this use in mind, many current systems do not detect pedestrians or bicyclists. Finally, at least to this stage of AI development, technology is still not a match for human ingenuity; these devices can be disabled and misused.

But maybe a side benefit of this technology, deployed to shield us against distracted driving and other human errors, is that it might also protect us when more sinister circumstances arise.

Epstein is a former editor with THCB. This blog post first appeared in Safety First: The Blog of the National Safety Council. 

BY BRIAN KLEPPER