In January, Ezekiel Emanuel – one of the country’s foremost health experts – threw a presumptive grenade into the national discourse: the annual physical is worthless. As we watched the initial burst of reactionary fervor following hisNew York Times opinion piece, we weren’t quite sure what to think.
Then we realized why: in our training and burgeoning careers in primary care, neither of us has ever scheduled an “annual physical” for a patient. To us, the notion of such a visit – for scheduled, non-urgent care, and one not specifically for chronic disease management – is already dated. Given current trends in American health care delivery and professional training, we argue it is one that may well soon be obsolete.
But does that obsolescence change the value of that time – whether 15 minutes or 60 – with a patient, on a regular interval? Our perspective from medicine’s emerging front line offers a resounding no.
The most obvious argument for regular primary care visits is preventive care. Dr. Emanuel bases much of his argument on the validity (or lack thereof) of annual physicals. Drawing off that same evidence base, the U.S. Preventive Services Task Force sets recommendations for evidence-based screening in various populations. Even the young and healthy benefit from cervical cancer screening, initiated at 21 years of age and continued every three years provided negative results until the age of 30 (when the recommendations change slightly). Patients with higher risk earn further screenings, based on whether they smoke, their weight, their age and their family history.
Last year, we soundly criticized the American Heart Association (AHA) on this blog for its proposal to lower the thresholds for treating cholesterol and getting larger numbers of Americans to swallow statins. We also exposed wellness vendor StayWell, for its mathematically impossible claims of success in British Petroleum’s wellness program. Proving that great minds aren’t the only ones that think alike, StayWell and the AHA have now joined forces. Specifically, the AHA invited the CEO of StayWell, Paul Terry, Ph.D., to help write its workplace wellness policy statement, sort of like Enron inviting Bernie Madoff to help design its financial plan. You don’t learn of this fox-in-the-henhouse conflict of interest unless you read the table on the penultimate page of text.
Naturally, Mr. Terry parlayed this windfall to StayWell’s advantage. The statement: “currently available studies indicate that employers can achieve a positive ROI through wellness” is footnoted to two studies authored by: Paul Terry, along with other Staywell executives. One wonders how a StayWell executive writing policy for the AHA based partly on StayWell’s own articles passes the AHA’s own test of “making every effort to avoid actual or potential conflicts of interest that may arise as a result of an outside relationship.”
How did this conflict of interest get by the peer reviewers? Look at the list of peer reviewers. Prominent among them is Ron Goetzel. Readers of THCB may recall Mr. Goetzel not just from his central role in the Penn State debacle, but also from the ”The Strange Case of the C. Everett Koop Award,” in which it was documented that his committee gave the ironically named award to a sponsor of the award (without disclosing that conflict), even though that sponsor had admitted lying about saving the lives of 514 cancer victims, who, as luck would have it, didn’t have cancer. (The sponsor, Health Fitness Corporation, a division of the equally ironically named Trustmark, has won the Koop award several times, thus proving the cost-effectiveness of their sponsorship.)
If this litany were not enough to dismiss the policy statement forthwith, there is small matter of the actual policy itself, a full employment act for wellness vendors and cardiologists alike, advocating more screening of more employees more often, while ignoring more self-evident facts than Sergeant Schultz. Specifically, they cherry-picked the available literature, continuing to cite the old “Harvard study” whose lead author has now walked it back three times. Except that they didn’t call it the “old Harvard study,” but rather a “recent [italics ours] meta-analysis,” despite the fact it was submitted for publication in 2009, and the average year of the analyses in the study was 2004. Some studies began in the 1990s and were able to use sleight-of-hand to “show savings” despite presumably — in accordance with the conventional wisdom of the era — getting people to eat more carbohydrates and less fat. No wonder Soeren Mattke of RAND Corporation dismissed the Harvard data as archaic in his interview with CoHealth radio in February 2014.
There is an old joke. What’s a radiologist’s favorite plant? The hedge.
Radiologists are famous for equivocating, or hedging.
“Pneumonia can’t be excluded, clinically correlate”. Or “probably a nutrient canal but a fracture can’t be excluded with absolute certainty, correlate with point tenderness”.
Disclaiming is satisfying neither for the radiologist nor the referring physician. It confuses rather than clarifies. So one wonders why legislators have decided to codify this singularly unclinical practice in the Breast Density Law.
The law requires radiologists to inform women that they have dense breasts on mammograms. So far so good.
The law then mandates that radiologists tell women with dense breast that they may still harbor a cancer and that further tests may be necessary.
You may quibble whether this disclaimer is an invitation or commandment for more tests, or just shared decision-making, the healthcare equivalent of consumer choice.
But it’s hard to see why any woman would forego supplementary tests such as breast ultrasound, magnetic resonance imaging and 3 D mammogram, or all three, when their anxiety level is driven off the scale.
What piece of incontrovertible evidence inspired this law, you ask?
Perhaps a multi-center trial run over 10-15 years that randomized women with dense breasts to (a) mammograms plus additional screening and (b) screening mammograms alone, show that additional screening saves lives, not just find lots of small inconsequential cancers.
No. The law was instigated by a heart-rending anecdote, which avalanched into the “breast density awareness” movement, cloaked by an element of scientific plausibility: women with dense breasts may have a higher incidence of cancer; a conjecture of considerable controversy.
Wasn’t the Affordable Care Act (ACA) supposed to usher an era of rational policy-making, guided by p values, statistics not anecdotes?
Last month an intriguing new decision support app launched, created by experts in geriatrics and palliative care. It’s meant to help with an important primary care issue: cancer screening in older adults.
Have you ever asked yourself, when considering cancer screening for an older adult, whether the likely harms outweigh the likely benefits?
Maybe you have, maybe you haven’t. The sentence above, after all, is a bit of wonky formulation for the following underlying questions:
- How long is this person likely to live, given age and health situation?
- Given this person’s prognosis, does cancer screening make sense?
The first question seems like one that could easily occur to a person — whether that be a patient, a family member, or a clinician – although I suspect it doesn’t occur to people perhaps as often as it should.
As for the second question, I’m not sure how often it pops up in people’s minds, although it’s certainly very important to consider, given what we now know about the frequent harms of cancer screening in the elderly, and usually less frequent benefits.
Furthermore, there is abundant evidence that “inappropriate” cancer screening remains common. “Inappropriate” meaning the screening of people who are so unwell and/or old that they’re unlikely to live long enough to benefit from screening.
For instance, one astounding study found that 25% of physicians said they’d order colon cancer screening for an 80 year old with inoperable lung cancer. So it’s clear that improving the decision-making around cancer screening would help improve healthcare safety, quality, and value.
Health-contingent workplace wellness, the two-time darling of federal legislation codified in both the Health Insurance Portability and Affordability Act (HIPAA) and the Affordable Care Act (ACA), is now plagued by doubts about effectiveness and validity that are inexorably grinding away its legitimacy. This puts employers, particularly large employers who have committed to it so vocally and visibly, in an awkward spot. In the style of politicians nervously trying to change the terms of debate, wellness advocates are now walking back the assertions that have undergirded their entire construct for more than a decade. While some business leaders are apparently either unwilling or unable to back away from this self-inflicted wound, staying the present course is neither inevitable nor required. A course correction might actually prove quite liberating, especially for leaders of smaller and mid-sized businesses who must scratch their heads wondering how they’re supposed to reproduce a big-company style workplace wellness program or even why they should, given the dearth of data on effectiveness.
As a case in point, we offer GE, an iconic American multinational with 305,000 employees, $147BN in revenues, and $16.1BN in earnings worldwide in 2012. The company offers its employees a much-lauded wellness program, saluted by the National Business Group on Health (NBGH) in a fawning 2009 case study. GE’s wellness program has several things to recommend it:
- A top line focus on environmental change
- An emphasis on strong and consistent positive health messaging to employees
- The “Health By The Numbers” strategy that asks employees to commit to essential behavior changes (don’t smoke, eat more produce, walk more, and maintain a healthy body mass index [BMI]; there is wisdom in these choices, as they are the baseline activities for good health)
Beyond these obviously beneficial wellness program components, the GE wellness program veers off into a compendium of wellness convention, with encouragement for employees to take HRAs and get screenings, in particular, mammography, colonoscopy, cholesterol, and blood pressure. Some of the affection for diagnostics springs, of course, from GE’s corporate commitment to health care, which includes selling a broad variety of diagnostic devices to medical care providers who must, in turn, induce demand in order to pay for their contribution to GE Healthcare’s $18.2BN revenue stream.
As far as is discernible from publicly available documents, the wellness program targets GE worksites with over 100 employees, and GE claims in the NBGH case report that over 90% of employees worldwide participate. Beyond these data, however, it is remarkably difficult to understand what results GE gets and at what cost. The only publicly available insight on expense comes from GE wellness leader Rachel Becker in an essay published online by EHS Journal, in which she reports $100,000 per site as the wellness startup cost. Extrapolating this figure to GE’s more than 600 global worksites produces a wellness capitalization expense of about $60M, which presumably does not include annual wellness program operating costs. This might be why GE makes absolutely no mention of the cost or results of its wellness program in either its annual report or its 10K filing, although the NBGH quotes GE as saying the implementation was “inexpensive”. Even though $60M is equal to only 0.38% of GE’s 2012 earnings, it nonetheless might seem an untidy sum to skeptical shareholders.
What if the next time you step into your doctor’s office for an examination, she reaches into her white coat pocket and pulls out an iPhone instead of a stethoscope? That’s the idea behind The Smartphone Physical, a re-imagination of the physical exam using only smartphones and a few devices that connect to them. These include a weight scale, blood pressure cuff, pulse oximeter, ophthalmoscope, otoscope, spirometer, ECG, stethoscope, and ultrasound. Want to know more? I’ve answered some questions here for THCB. And have a few myself.
What are the pros and cons of using smartphones for clinical data collection?
Smartphone penetration in virtually every market has exceeded expectations, and healthcare is no exception. More than 80% of physicians in the US have smartphones, and of those three-quarters use them at work. Much of this is currently personal communication, but increasingly physicians are using smartphones as reference tools; between 30-40% report using their smartphones for clinical decision support. It seems like a logical next step to go beyond reference apps and to start using peripheral devices, such as cases that convert the smartphone into an ECG or otoscope as well as peripherals such as pulse oximeters and ultrasound probes, for easy and reliable data collection.
At TEDMED we found that using our smartphones and the clinical devices actually improved our ability to engage with the “patient,” because we were able to share and explain the physical exam findings directly at the point of care. We could take a quick snapshot of the carotid arteries and tympanic membrane and, for the first time ever, show the patient what theirs looked like and field any questions they may have. Ideally in the near future we’d be able to go one step further and upload this data to the patient record. That is one of the most powerful aspects of the Smartphone Physical because we will be able to establish baselines for individuals. For example, instead of the current model of a primary care ophthalmologic exam, where a physician will write “W.N.L” or “unremarkable” for a patient without a concerning optic disc finding, we will be able to take and store an actual image of what the patient’s optic disc looked like at an earlier time-point. This may be particularly useful for patients who present years later with concerning visual changes.
Furthermore, smartphone-based collection of clinically-relevant data will help patients become their own data collectors. This may abstract away the mundane and standardize the unreliable aspects of the physical exam, and allow for trending data that needs to be taken in context and not just at once-yearly visits (e.g. blood pressure, temperature, etc).
Dear Ms. Jolie,
Thank you for your bravery and leadership in the battle against breast cancer. In a small way, through my patients, I understand the challenge and pain it took not only to undergo prophylactic mastectomies, because you carry the BRCA1 cancer gene, but also to reveal this deeply personal part of your life to the world (NYT, 5/14/13; My Medical Choice). You had no obligation to open your soul; your selfless act leaves those of us that treat the dread disease, in awe.
Your action will save more lives than all the patients I could help, even if I were to practice oncology for hundreds of years. By opening up the conversation, by educating and by boldly stating that beauty, strength and health are possible, even when radical choices are made, you open up life saving opportunities for many. Mastectomies may not be the answer for all women, but the very idea that cancer can be prevented, instead of simply waiting in fear, is earth shattering.
Women and men will now better understand the genetic risks for cancer, be exposed to the different options which are available in the prevention of cancer and know that it is possible, whatever path is taken, to continue with full lives. You have made it easier for patients, their families and physicians to have vital discussions.
The announcement of your surgery coincides with a critical legal battle, the deliberations of the United States Supreme Court regarding BRCA genetic testing. You have put pressure on the Court to find against Myriad Genetics Corporation in the company’s attempt to protect their expensive monopoly of the breast cancer genetic assay. Thus, the Court will have the opportunity to reduce the cost of testing, which as you note, can run thousands of dollars per patient.
Your action changes the war against breast cancer. You have prevented the suffering of thousands and given them the opportunity to go on with life and be part of what is truly important, families and communities.
Thank you for your remarkable sacrifice.
James C. Salwitz, MD
James C. Salwitz, MD is a Medical Oncologist in private practice for 25 years, and a Clinical Professor at Robert Wood Johnson Medical School. He frequently lectures at the Medical School and in the community on topics related to cancer care, Hospice and Palliative Medicine. Dr. Salwitz blogs at Sunrise Rounds in order to help provide an understanding of cancer.
A woman’s mother dies at age 56. A blood test is done. The woman finds out she has a genetic pre-disposition to cancer. She takes what action she thinks she needs to take. A familiar story repeated over and over again every day. I’ve met many women who have made this choice. While not “normal”, it is a familiar situation. These women’s difficult choices go unheralded. But not Angelina. She has a voice and she’s not afraid to use it.
I am of two minds about Ms. Jolie’s announcement. Unlike double mastectomies for ductal carcinoma in situ (DCIS), which isn’t necessarily a cancer and can be treated with a lumpectomy, BRCA1 gene mutations can’t be treated any other way. Unless I hear differently from my breast surgeon friends, I’d say she probably did the right thing. Her decision to talk about it is probably encouraging to women who have or will have to make that choice. It raises awareness of the gene mutation. It puts breast cancer on the front page of the New York Times. Again.
Here’s my problem: double mastectomy is not a benign procedure. Ms. Jolie seems to have had a remarkably easy time of it. Yes, she says she was right back to her normal life soon after, but since Jolie’s life is not normal that’s hard to generalize. The truth is there is significant pain involved, a long period of waiting while the tissue expanders do their work, then there’s further procedures for the implants, which can develop capsules around them, or rupture, or get infected. If Angelina had chosen breast reconstructive surgery there would be the risk of the flap losing blood flow, multiple drains, overnight stays in recovery rooms or ICUs, and many many surgeries for revision, nipple creation, etc. And the results are not always beautiful. I understand that it is not Ms. Jolie’s role to scare people, but to encourage them. I would just warn against falsely rosy expectations.
I am not trying to discourage double mastectomy. Sometimes it is necessary. I do think that people who have extraordinary access to public attention must pay extraordinary attention to what they say. I wish Angelina all the best for a complete, and beautiful, recovery.
Shirie Leng, MD is a practicing anesthesiologist at Beth Israel Deaconess Medical Center in Boston. She blogs regularly at medicine for real.
The U.S. Preventive Services Task Force formally published its recommendation for routine HIV testing for all individuals age 15 to 65 in the Annals of Internal Medicine this week. An editorial and patient materials are all available free to anyone with an Internet connection. Many people who work in HIV hoped that this would finally move HIV into mainstream medicine.
With a U.S. Preventive Services Task Force Recommendation, patients don’t need to ask for the test, it would become a routine blood test like many others, stigma would be reduced, and insurance would likely cover it. The evidence backs it. However, within 24 hours of the Task Force Recommendation going up online, the American Academy of Family Physicians questioned age 15 as the logical starting point, instead urging that testing begin at age 18. This is just some of the resistance that the medical community is putting forward now.
Several months ago, I spoke with Roger Chou, MD, MPH, associate professor of internal medicine at Oregon Health and Science University, Portland, Oregon, who headed the evidence review for the U.S. Preventive Services Task Force. “About 25% of people who have HIV and are not aware of it,” Chou said. “They have no identifiable risk factors.”
Other reasons why data to back routine HIV testing are in, include that “the screening test is highly accurate, we have direct evidence from randomized controlled trials that we can reduce the risk of transmission by 90%, and that you can’t trust what your patient says, , or that patients don’t always think that they are at risk,” said Chou.
The exponential growth in wellness programs indicates that Corporate America believes that medicalizing the workplace, through paying employees to participate in health risk assessments (“HRAs”) and biometric screens, will reduce healthcare spending.
It won’t. As shown in my book Why Nobody Believes the Numbers and subsequent analyses, the publicly reported outcomes data of these programs are made up—often to a laughable degree, starting with the fictional Safeway wellness success story that inspired the original Affordable Care Act wellness emphasis. None of this should be a surprise: in addition to HRAs and blood draws, wellness programs urge employees to go to the doctor, even though most preventive care costs more than it saves. So workplace medicalization saves no money – indeed, it probably increases direct costs with these extra doctor visits – but all this medicalization at least should make a company’s workforce healthier.
Except when it doesn’t — and harms employees instead, which happens altogether too often.
Yes, you read that right. While some health risk assessments just nag/remind employees to do the obvious — quit smoking, exercise more, avoid junk food and buckle their seat belts — many other HRAs and screens, from well-known vendors, provide blatantly incorrect advice that can potentially cause serious harm if followed.