A preventive breast cancer vaccine developed by Professor Vincent Tuohy of the Cleveland Clinic will be brought forward to the FDA for permission to begin clinical trials to see if it is safe and effective for use in women.
The vaccine was shown to be completely safe and 100% effective in preventing breast cancer in three animal models, (see study in Nature Medicine), and was also found to slow the growth of tumors that had already formed. The vaccine is especially powerful in inhibiting the growth of triple-negative breast cancer, the most aggressive form of the disease with the lowest survival rate.
Triple-negative breast cancer lacks estrogen, progesterone and Her2 receptors. It occurs in approximately 15% of cases is the kind of breast cancer most common in women who carry a BRCA mutation.
The initial clinical trials, called Phase I studies, will be conducted in two groups of volunteers, women with triple-negative breast cancer who have completed their treatment and are free of disease, and women who will be vaccinated shortly before undergoing bilateral prophylactic mastectomy (typically these are women like Angelina Jolie with BRCA mutations who elect to remove their breasts to lower their risk for cancer.)
The first group of women will be studied to determine the dose and effectiveness of the vaccine; the second will be studied to make sure the vaccine does not trigger an untoward immune response in breast tissue.
The vaccine targets an unique protein normally made only by women who are breastfeeding, alpha lactalbumin (ALA). In the 12 years Tuohy spent developing and researching his vaccine, he discovered that the majority of breast tumors express, or make, ALA. Priming the immune system with a vaccine so that it attacks any cell that makes ALA is the method by which Tuohy’s vaccine works.
Because the vaccine targets ALA, a protein necessary for successful lactation in healthy women, the vaccine would not be appropriate for use in women who are still in their childbearing years.
However, the majority of women diagnosed with breast cancer in the United States and other western countries are post-menopausal: at least 60% of the cases in the United States occur in women over 55; thus, Tuohy’s vaccine holds great potential as a preventive vaccine for the majority of women.
Continue reading “Cleveland Clinic Trial of Breast Cancer Vaccine Moves Forward”
Filed Under: OP-ED, THCB
Tagged: Breast cancer, Breast Cancer Vaccine, Cancer, Cleveland Clinic, Clinical Trials, Kathleen Ruddy, prevention, Vincent Tuohy, Women's Health
Sep 21, 2013
A likely unanticipated consequence of the AMA’s decision to label obesity a disease, even though their own scientific council said not to, is that this might serve as the macguffin leading to furtherance of a protected class of people. This has serious implications not only for employment discrimination, but also for wellness programs, which often hinge vastly overblown claims of being able to help the obese who they almost universally label as “high risk” people.
Well, what if people who are obese, who are no doubt tired of being condescended to, first by wellness companies, and now by the AMA, decide that they are going to seek medical approval to opt out of wellness programs? A study recently published in the journal Translational Behavioral Medicine reports on a highly coercive, electronically monitored walking program for obese people: 17% opted not to participate and another 5% actually got their physician’s approval to opt out. The physician approval to opt out is key to any resistance strategy.
Under the final wellness rules issued by the federal government earlier this year, physician certification that it is medically unadvisable for an employee to participate in a wellness program creates a burden for the employer and wellness vendor. They must provide reasonable alternatives that do not disadvantage the employee in terms of either time or cost and that address the physician’s concerns.
Further, if the employee’s physician disagrees with offered alternative, the employer and wellness vendor must provide a second alternative. The coup de grace is that “adverse benefit determinations based on whether a participant or beneficiary is entitled to a reasonable alternative standard for a reward under a wellness program are considered to involve medical judgment and therefore are eligible for Federal external review.”
Targeting people based on body mass index (BMI) is an intellectually, morally, scientifically, and mathematically bankrupt approach. The AMA’s decision will actually help obese people and advocates for their dignified treatment in the workplace and society start to understand that they can refuse to opt in to these insulting programs and, simultaneously, be protected from penalties. Clearly, this is the opposite of what unsuspecting employers expect when vendors (and their own brokers) sell them these programs: more useless doctor visits, less leverage with penalties…and more employee disgruntlement. Not just the obese will be disgruntled, but also those who have to pay the penalties because their BMI is too high to get the reward but not high enough to get a doctor’s note.
Continue reading “Obesity and the AMA, Part Two”
Filed Under: THCB
Tagged: Al Lewis, AMA, Body Mass Index (BMI), Obesity, prevention, Vik Khanna, Wellness
Sep 10, 2013
The general practice of oncology seems to come in waves of disease. One week every breast cancer patient is in trouble, another sees multiple new cases of lymphoma or leukemia, the next it as if someone is giving away lung cancer (or perhaps cigarettes) and then three patients with pancreatic cancer end up in the ICU. This week a portion of the 240,000 yearly USA cases of prostate cancer walked in our door. The rush of cases served as a reminder that when it comes to this illness, we have a long way to go.
First, Allen. He is 73 years old and has prostate cancer in one out of twelve biopsies. The cancer has a Gleason’s Score of 6 (a measure of aggressiveness of the cancer tissue: more then 7 is particularly bad), which means it is not fast growing. We recommended that given the small amount of slow growing cancer, Allen should be watched without treatment (“Active Surveillance”). What Allen found so difficult about this recommendation is that his son was diagnosed with prostate cancer just one month ago and his son, who is 49, has a Gleason’s 8 Prostate Cancer on both sides of the prostate, and is scheduled for robotic surgery. More than having cancer, Allen is hurt by the feeling it should have been him.
Then there was Robert and Mike. Robert was in the office at 10:00am for evaluation of his newly diagnosed prostate cancer, PSA blood test 32 (high), Gleason’s 7, with evidence of invasion through the capsule of the prostate gland. Fortunately, because prostate cancer likes to spread to bone, his bone scan is normal. Despite Robert’s relatively young age (66), the surgeon recommends external beam radiation therapy (RT) instead of operating. What is bizarre and makes my head spin, was that at1:00pm, in the same exam room, in the same chair, I saw Mike. He has recurrence of prostate cancer, previously treated with surgery. Now Mike needs RT. Although Robert and Mike do not know that the other has cancer, they have worked together in the same small company for 28 years, and consider each other friends.
Continue reading “Prostate Cancer: Not a Good Week”
Filed Under: OP-ED
Tagged: Cancer, Cancer Screening, James Salwitz, Oncology, prevention, Prostate Cancer
Aug 30, 2013
The wellness emphasis in the Affordable Care Act is built around the Centers for Disease Control and Prevention’s (CDC) 2009 call to action about chronic disease: The Power to Prevent, the Call to Control. On the summary page we learn some shocking statistics:
“Chronic diseases cause 7 in 10 deaths each year in the United States.”
“About 133 million Americans—nearly 1 in 2 adults—live with at least one chronic illness.”
“More than 75% of health care costs are due to chronic conditions.”
Shocking, that is, in how misleading or even false they are. Take the statement that “chronic diseases cause 7 in 10 deaths,” for example. We have to die of something. Would it be better to die of accidents? Suicides and homicides? Mercury poisoning? Infectious diseases? As compared to the alternatives, it is much easier to make the argument that the first statistic is a good thing rather than a bad thing.
The second statistic is a head-scratcher. Only 223 million Americans were old enough to drink in 2009, meaning that 60% of adults, not “nearly 1 in 2 adults,” live with at least one chronic illness — if their language is to be taken literally. Our suspicion is that their “133-million Americans” figure includes children, and the CDC meant to say “133-millon Americans, including nearly 1 in 2 adults, live with at least one chronic illness.” Sloppy wording is not uncommon at the CDC, as elsewhere they say almost 1 in 5 youth has a BMI > the 95th percentile, which of course is mathematically impossible.
More importantly, the second statistic begs the question, how are they defining “chronic disease” so broadly that half of us have at least one? Are they counting back pain? Tooth decay? Dandruff? Ring around the collar? “The facts,” as the CDC calls them, are only slightly less fatuous. For instance, the CDC counts “stroke” as a chronic disease. While likely preceded by chronic disease (such as hypertension or diabetes) and/or followed by a chronic ailment in its aftermath (such as hemiplegia or cardiac arrhythmias), a stroke itself is not a chronic disease no matter what the CDC says. Indeed it is hard to imagine a more acute medical event.
They also count obesity, which was only designated as a chronic disease by the American Medical Association in June–and even then many people don’t accept that definition. Cancer also receives this designation, even though most diagnosed cancers are anything but chronic – most diagnosed cancers either go into remission or cause death. “Chronic disease” implies a need for and response to ongoing therapy and vigilance. If cancer were a chronic disease, instead of sponsoring “races for the cure,” cancer advocacy groups would sponsor “races for the control and management.” And you never hear anybody say, “I have lung cancer but my doctor says we’re staying on top of it.”
Continue reading “The Biggest Urban Legend in Health Economics–and How It Drives Up Our Spending”
Filed Under: THCB
Tagged: Al Lewis, Body Mass Index (BMI), Cancer, CDC, chronic disease, Obesity, overdiagnosis, Overtreatment, prevention, Vik Khanna, Wellness
Aug 24, 2013
I am known in the disease management and wellness fields as a naysayer, critic, curmudgeon, and/or traitor…and those are only the nouns that are allowed to be blogged across state lines. This is because I am driven not by wishful thinking but rather by data. The data usually goes the wrong way, and all I do is write down what happened. Then the vendors blame me for being negative — sort of like blaming the thermometer because the room is too hot — because they can’t execute a program.
However, the nonprofit Iowa Chronic Care Consortium (ICCC) apparently can execute a program. They reduced total diabetes events by 6% in the rural counties they targeted. This success supports a hypothesis that in rural (presumably underserved) areas, disease management fulfills a critical clinical gap: it provides enough basic support that otherwise would not be provided even to those who actively seek it to reduce near-term complications and exacerbations.
This result will likely produce its own unanticipated consequence: because many people now believe (thanks, ironically, to some of my own past work) that disease management doesn’t produce savings, there will be widespread skepticism about the validity of this study. Quite the opposite: this “natural experiment” is as close to pristine as one could hope for in population health, for five reasons:
- There was no participation/self-selection bias because outcomes were measured on all Iowa Medicaid members.
- The program was offered in some Iowa counties but not others, so there was no eligibility or benefits design bias, Medicaid being a statewide program.
- The program encompassed only one chronic condition (diabetes) rather than all five common chronic conditions normally managed together (asthma, CAD, CHF, and COPD being the other four). Since all five conditions were tracked concurrently, whatever confounders affected the event rate in one of those conditions should have affected all of them. And event rates in the four other conditions did indeed move together in both the control and study counties. Just not diabetes.
- The data was collected exactly the same manner by the same (unaffiliated) analysts using exactly the same database so there is no inter-rater reliability issue.
- Both groups contained hundreds of thousands of person-years and thousands of events.
As one who has reviewed another high-profile “natural experiment,” North Carolina Medicaid, and found that the financial outcomes were the reverse of what the state’s consultants originally claimed (incorrectly, as they later acknowledged by changing their answer), I can also say that natural experiments in population health don’t harbor some as-yet-unidentified confounder that causes the study population to outperform the control population.
Continue reading “Stop the Presses: A Disease Management Program Worked”
Filed Under: THCB
Tagged: Al Lewis, Disease Management, Iowa Chronic Care Consortium, Medicaid, Population Health, prevention, Wellness
Jul 30, 2013
Every now and then the title of a book influences your thinking even before you read the first page.
That was the case for me with Thomas Moore’s “Care of the Soul” and with “Shadow Syndromes” by Ratley and Johnson. The titles of those two books jolted my mind into thinking about the human condition in ways I hadn’t done before and the contents of the books only echoed the thoughts the titles had provoked the instant I saw them.
This time, it wasn’t the title, “Cultivating Chi”, but the subtitle, “A Samurai Physician’s Teachings on the Way of Health“. The book was written by Kaibara Ekiken (1630-1714) in the last year of his life, and is a new translation and review by William Scott Wilson. The original version of the book was called the Yojokun.
The images of a samurai – a self-disciplined warrior, somehow both noble master and devoted servant – juxtaposed with the idea of “physician” were a novel constellation to me. I can’t say I was able to predict exactly what the book contained, but I had an idea, and found the book in many ways inspiring.
The translator, in his foreword, points out the ancient sources of Ekiken’s inspiration during his long life as a physician. Perhaps the most notable of them was “The Yellow Emperor’s Classic on Medicine”, from around 2500 B.C., which Ekiken himself lamented people weren’t reading in the original Chinese in the early 1700′s, but in Japanese translation. One of his favorite quotes was:
“Listen, treating a disease that has already developed, or trying to bring order to disruptions that have already begun, is like digging a well after you’ve become thirsty, or making weapons after the battle is over. Wouldn’t it already be too late?”
Ekiken’s own words, in 1714, really describe Disease Prevention the way we now see it:
“The first principle of the Way of Nurturing Life is avoiding overexposure to things that can damage your body. These can be divided into two categories: inner desires and negative external influences.
Inner desires encompass the desires for food, drink, sex, sleep, and excessive talking as well as the desires of the seven emotions – joy, anger, anxiety, yearning, sorrow, fear and astonishment. (I see in this a reference toarchetypal or somatic medicine.)
The negative external influences comprise the four dispositions of Nature: wind, cold, heat and humidity.
If you restrain the inner desires, they will diminish.
If you are aware of the negative external influences and their effects, you can keep them at bay.
Following both of these rules of thumb, you will avoid damaging your health, be free from disease, and be able to maintain and even increase your natural life span.”
On the topic of Restraint, the Yellow Emperor text states:
In the remote past, those who understood the Way followed the patterns of yin and yang, harmonized these with nurturing practices, put limits on their eating and drinking, and did not recklessly overexert themselves. Thus, body and spirit interacted well, they lived out their naturally given years, and only left this world after a hundred years or more.
Continue reading “The Samurai Physician’s Teachings on the Way of Health”
Filed Under: Physicians, THCB
Tagged: Country Doctor, Disease Management, Personal responsibility, Physicians, practice of medicine, prevention, The Yellow Emperor's Classic on Medicine
Jul 17, 2013
It’s fitting that this year’s ACOG meeting was held in New Orleans, because navigating the 2013 ASCCP Pap Smear Management Guidelines presented there feels like trying to make my way through the Mississippi bayou. The guidelines include 18 different algorithms encompassing almost any combination of pap and HPV abnormality we docs are likely to encounter among our patients. But all tributaries lead to the same place, where we achieve optimal reduction in cervical cancer with minimal harm.
Cervical cancer prevention is a process with benefits and harms. Risk cannot be reduced to zero with currently available strategies, and attempts to achieve zero risk may result in unbalanced harms, including over treatment. …optimal prevention strategies should identify those HPV-related abnormalities likely to progress to invasive cancers while avoiding destructive treatment of abnormalities not destined to become cancerous. Adopted management strategies provide what participants considered an acceptable level of risk of failing to detect high-grade neoplasia or cancer in a given clinical situation.
I’m not even going to try to spell out everything in the guidelines, which come from the American Society of Colposcopy and Cervical Pathology (ASCCP), except to say that they represent further movement away from aggressive screening and treatment of pap smear abnormalities, especially in younger women, in whom treatment carries small but real childbearing risks. The guidelines are increasingly reliant upon HPV testing to determine who and how often to screen, and when to treat. They also acknowledge the role of testing for HPV 16 and 18 as a way to be sure that those women with adenocarcinoma of the cervix (which is less likely to show up as cancer on a pap smear) are identified and treated.
From the guidelines-
Continue reading “The New HPV Guidelines. Balancing Benefits and Harms of Cervical Cancer Screening”
Filed Under: Uncategorized
Tagged: Apps, Cancer, Cervical Cancer Screening, HPV, Margaret Polaneczky, Pap Smears, prevention, USPSTF
Jul 9, 2013
There is a certain irony in the nearly immediate juxtaposition of the rare introduction of a new FDA-approved drug for weight loss (Belviq) to the marketplace and the recognition of obesity as a “disease” by the AMA. A line from the movie Jerry Maguire comes to mind: “You complete me!” Drugs need diseases; diseases need drugs.
And that’s part of what has me completely worried. The notion that obesity is a disease will inevitably invite a reliance on pharmacotherapy and surgery to fix what is best addressed through improvements in the use of our feet and forks, and in our Farm Bill.
Why is the medicalization of obesity concerning? Cost is an obvious factor. If obesity is a disease, some 80 percent of adults in the U.S. have it or its precursor: overweight. Legions of kids have it as well. Do we all need pharmacotherapy, and if so, for life? We might be inclined to say no, but wouldn’t we then be leaving a “disease” untreated? Is that even ethical?
On the other hand, if we are thinking lifelong pharmacotherapy for all, is that really the solution to such problems as food deserts? We know that poverty and limited access to high quality food are associated with increased obesity rates. So do we skip right past concerns about access to produce and just make sure everyone has access to a pharmacy? Instead of helping people on SNAP find and afford broccoli, do we just pay for their Belviq and bariatric surgery?
If so, this, presumably, requires that everyone also have access to someone qualified to write a prescription or wield a scalpel in the first place, and insurance coverage to pay for it. We can’t expect people who can’t afford broccoli to buy their own Belviq, clearly.
There is, of course, some potential upside to the recognition of obesity as a disease. Diseases get respect in our society, unlike syndromes, which are all too readily blamed on the quirks of any given patient and other conditions attributed to aspects of character. Historically, obesity has been in that latter character, inviting castigation of willpower and personal responsibility and invocation of gluttony, sloth, or the combination. Respecting obesity as a disease is much better.
And, as a disease, obesity will warrant more consistent attention by health professionals, including doctors. This, in turn, may motivate more doctors to learn how to address this challenge constructively and compassionately.
But overall, I see more liabilities than benefits in designating obesity a disease. For starters, there is the simple fact that obesity, per se, isn’t a disease. Some people are healthy at almost any given BMI. BMI correlates with disease, certainly, but far from perfectly.
Continue reading “Is Obesity a Disease? I Vote No”
Filed Under: OP-ED, THCB
Tagged: AMA, David Katz, Obesity, Physicians, practice of medicine, prevention, public health
Jun 22, 2013
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.
Continue reading “GE’s Wellness Program: Bright Shining Light or Dim Bulb?”
Filed Under: THCB, The Business of Health Care
Tagged: Costs, Employees, Employers, General Electric, prevention, Screening, The ACA, workplace wellness programs
May 26, 2013
This past week, Google had its annual developers conference, Google I/O. One of the more provocative talks, called “The End of Search as We Know It,” was by Amit Singhal, who is in charge of search for Google.
The vision, as described by Amit, is that instead of typing words into a box on a website or mobile app, we will have conversations with Google, enabling a much more personalized, refined experience. The holy grail, of course, is that Google analytics become both predictive and prescriptive, serving you content that is just right for you and anticipates your needs.
It seems there is a race on now to achieve this vision. One could argue that Amazon, Apple, Facebook, Pandora and others are all in the same mode. Best I can tell, the promise these companies are floating to advertisers is that their ads will be served up to that focused slice of the population that will find their product relevant in the moment.
If you apply this thinking to healthcare, several controversies/topics come to the fore.
Is Google competing with IBM’s Watson? Undoubtedly yes. On the other hand, I’m guessing Google is disenchanted with the consumer health space after the demise of its personal health record (PHR). And IBM seems to be focused on clinician decision support. So early in the game, with respect to healthcare anyway, maybe there is not much competition. The path for clinician decision support is clear and the market obvious, whereas the path and market for consumer health decision support are blurry.
Continue reading “Is the End of Search the Beginning of Personalized Prevention?”
Filed Under: Tech
Tagged: FutureMed, Google, IBM, Joseph Kvedar, Personalized Medicine, PHR, prevention, Watson
May 23, 2013