Can Personalized Care Survive ObamaCare’s Assembly Line Medicine?
Previously, I wrote about some wondrous developments that are taking place in medical science. Implantable or attachable devices already exist — or soon will exist — that can monitor the conditions of diabetics, asthmatics, heart patients and patients with numerous other chronic conditions. These devices will allow patients and doctors to modify therapeutic regimes and tailor treatments to individual needs and responses. Genetic testing is reaching the point where patients can be directed to take certain drugs or avoid other drugs, based solely on the patient’s own genes.
Almost all HIV treatment these days involves therapy cocktails tailored for each individual patient. The FDA has approved a breast cancer drug only for women with a particular genetic makeup. Patients are being advised to steer clear of an ADHD drug and certain blood thinners if they have particular genetic variations.
We are entering the age of personalized medicine, where the therapy that’s best for you will be based on your physiology and genetic makeup — and may not be right for any other patient.
Let’s get personal.
Yet standing in the way of this boundless potential is an Obama administration whose entire approach to health reform revolves around the idea that patients are not unique and that bureaucrats can develop standardized treatments that will apply to almost everybody with a given condition. When former White House health adviser Ezekiel Emanueltold CNN recently that “personalized medicine is a myth,” he was fully reflecting the worldview of the authors of health reform.
Everything about ObamaCare — from its emphasis on pilot programs and demonstration projects to its faith in “evidence-based care” — is all about standardization. It’s about treating all patients with the same condition the same way. It’s about herd medicine. It’s about cookbook medicine. It’s about assembly line medicine. It’s as different from personalized care as different can be. As Dr. Richard N. Fogoros explains:
[T]he entire structure of ObamaCare is designed specifically to remove important (i.e., costly) medical decisions from the purview of the individual doctor and patient. The role of the doctor is now to relay expert-guided determinations of what is best for the herd down to the level of the individual patient, and to do it in such a way that their patients do not realize that the doctor’s recommendations are population-based, and not tailored to their own needs.
It’s not just the Obama administration, by the way. Underlying an enormous amount of medical research is the idea that we are all alike.
To make up an example, think about a clinical trial in which one group drinks coffee and the other group abstains. Then let’s suppose the non-drinkers turn out to have a statistically significantly higher rate of colon cancer. So doctors respond by telling everyone to drink a cup of coffee every morning. This would be called “evidence-based” advice.
What’s the implicit premise behind all this? That the two groups of people are alike in every important respect (other than their coffee consumption) and that the rest of us also are just like the people who’ve just been tested. I’ve written before why clinical trials like the one I just described are absurd. At least the way the results are used is absurd.
For present purposes, however, I’m making a different point: We are not all alike.
Think of the controversy surrounding the cancer drug Avastin. The clinical trials showed the drug doesn’t work. But individual doctors and their patients were convinced the drug worked for them. Both conclusions may be right. That is, the drug may not work for randomly selected individuals. But it may be a life saver for patients with the right genes.
The same issue applies to side effects. Vioxx, an anti-inflammatory drug, was taken off the market because of dangerous side effects. But if we had enough genetic information, we might discover that Vioxx is a safe remedy for many patients.
Quite apart from the Obama administration, personalized medicine faces five public policy hurdles.
First, in order to get paid for implanting a sensor or conducting a genetic test, there needs to be a billing code. If the sensor or the test is new, getting Medicare to create a code can take both significant time and money.
Second, even if there is a code, Medicare must agree to pay for the service. In general, Medicare has not been willing to pay for genetic testing, with two notable exceptions: tests to determine compatibility for kidney and bone marrow transplants.
By contrast, UnitedHealthcare spent $500 million on genetic and molecular testing for its members last year, including Medicare and Medicaid patients enrolled in the insurer’s private health plans. For Medicare Advantage, the company conducted 35 tests per 1,000 members on the average. For Medicaid, it conducted 329 tests per 1,000 members.
Third, Congress has imposed price controls on what Medicare can pay laboratories for conducting such tests.
Fourth, the FDA has authority to regulate sensors and apparently is now requiring full clinical trials before it will approve new ones. Clinical trials are time consuming and expensive. But the bigger problem is that with personalized medicine, doctors are going to react to the information the sensor provides and change their therapy accordingly. As a result, every patient in the clinical trial could be treated differently — which defeats the whole purpose of a trial.
Finally, personalized medicine is running up against out-of-date and inflexible malpractice laws. In essence, an electronic sensor can confront the doctor with a data dump and, in principle, this could happen at any time day or night. Some doctors worry that buried in the data could be information that the doctor doesn’t see. If a problem later develops, a lawyer might argue that he should have seen it.
Bottom line: we need to bring public policy into the modern age.
“Life is a series of natural and spontaneous changes. Don’t resist them; that only creates sorrow. Let reality be reality. Let things flow naturally forward in whatever way they like.”
― Lao Tzu
Informative–well said and helps point the way forward in healthcare.
esg
A good cook doesn’t need a cookbook, neither does a good physician.
“Evidence based” medicine is a collectivist horror that presupposes that we are all identical beings. This is not scientific because knowledge grows daily about the variations in the human genome and how different individuals can respond differently to different stimuli (eg. medications). This does not even begin to address the infinite psychosocial differences that exist amongst us. I was once at a presentation by Sidney Goldstein MD who is said to be the “godfather” of cardiology clinical trials. He made the point that the conclusion from any clinical trial is only applicable to a strictly defined subset of patients and should not be broadly extrapolated.
“Evidence Based Medicine”, better known as “cook book medicine” is an attempt to predict outcomes of treatments so that one day the folks who trouble shoot your Dell computer, will be able to treat you from a call center using WebMD
Most physicians will tell you that,from their experience with patients, some drugs work for some patients and not for others. As a result for many conditions, such as depression and various types of arthritis, pharmacologic treatment is a trial and error process. Prima facie evidence for a probably genetic and certainly a personal approach to medicine.
Throughout my adult life I have thought that one of the principles of the U.S. constitution was the importance of preserving individual rights. Collectivism has been a failure throughout history. Yet here we are in 2012 trying to collectivize one of the most individualistic of all needs, medical care.
Hi John,
In principle, it is hard to be against “evidence-based” medicine. After all, the scientific method that underlies all of medicine requires evidence of the relative efficacy of treatments. But the relative efficacy is the key to the art of medicine. That is why physicians are trained for years.
So, as I ‘ve said for years, medicine that is based on statistical norms will work as soon as they standardize the human body and all the agents of disease and injury that can affect it.
In fact, even before the dawning of genetic medicine, all medicine has been and will be “personalized medicine.”
As we redefine medicine, however, we do have an opportunity to redefine standards of care and liability for medical negligence. As we do so, we can redefine methods of compensating patients for medical accidents. We should not let this moment pass without making the maximum effort to create a more rational system for the future.
First party medical accident insurance would provide a free-market method of reform, not requiring the intervention of the government. We already write disability, life and health insurance. This new product would simply amalgamate those benefits and make them payable in the event of a medical accident. Members of the public could buy this first-party insurance at whatever monetary levels they wish, on condition they waive their right to sue for medical malpractice. This would provide “personalized protection” to go along with personalized medicine.
Cheers,
Charlie Bond
Personalized medicine is a myth? Considering the wide variation is body sizes, shapes, personality and health status among Americans, it’s hard to see how medicine personalize to the individual could be a myth.
Great, informative post. Personalized medicine seems like the most logical way to effectively care for people.
John,
Differentiate personalized care from concierge medicine. For most folks they are the same. With all the advances which will allow medicine to be by prediction and prevention, I don’t think that “assembly line” medicine will be part of the MO in health care delivery for every one whether it be Obama or Romney (remember insurance for all in Massachusetts) when he was governor. Assembly line medicine has been the way health care has been delivered for the last 15-20 years. Don’t blame Obama; blame the insurance industry, the hospital systems, and the greed of physicians and the demise of primary care.
Dr Bob Kramer
It’s about time. I find it distasteful that, despite many advances in science, biology, medicine, etc; many courses of treatment ended up being more or less a system of guess work in which doctors throw drugs at a patient one after another until something works.
As discussed in an earlier blog post last week. The one-size-fits-all approach doesn’t work. Personalized healthcare is the best solution
If the private insurers are paying for it, then it obviously can happen under the ACA. Medicare can’t pay for it because it is still relatively experimental. If we can obtain a better under standing of the human body then perhaps personal medicine can be turned into evidence based medicine.
Having graduated from Columbia College of Physicians and Surgeons in 1976, I’m extremely grateful that in the old days, we were always taught to think out of the box and fight for what was best for our outlier patients. When your medical center, like Presbyterian, draws off a large international population and includes many American patients who have failed 1st, 2nd and 3rd line standard of care – it’s your duty to your patient to deliver exceptional and innovative solutions, not cookbook care.
I worry that the current med school grads are exposed to too much “group think”. . .multiple choice exam type answers that can’t be applied to the bedside. Every day I see patients who are nowhere, only because all the physicians they have seen somehow believed that they can deliver the same standard of care as the previous doctors and somehow in their hands, they irrationally expect the results to be different.
Yesterday, I saw a new patient who had called “code H” – at one of our best Orange County CA hospitals. A second “team” of doctors came in and affirmed the first. Finally, the patient was transferred to another hospital, where the physician was an expert in outliers and the proper diagnosis was inexplicably never made. It was not an obscure diagnosis – just one that was never given any proper consideration by the first two teams. . . who were blinded by “group think.”
The first things they teach you at P & S are –
1. you start from scratch – whenever time allows – so you don’t bring forward the mistakes and blind spots of the previous physicians and
2. when the standard of care doesn’t work. . .you rethink everything – diagnosis, pathophysiology, treatment etc. until you get it right.
Why would bureaucrats want to force our medical residents and fellows into “group think” after they’ve completed 3 or more years of post graduate training? Why do bureaucrats believe that patients need to be protected from the doctors they trust who oppose bureaucratic “group think” approaches to diagnosis and treatment? Who gave these bureaucrats the right to essentially force a particular way to practice medicine without a license? Isn’t the standard of care the responsibility of our state medical boards – and in our case the Medical Board of California – which encourages and protects our doctors who deliver excellent care for our patients who need something way beyond “group think”?
Dorothy Calabrese M.D.
Allergy & Immunology, San Clemente, CA
It’s never been a big secret that the government is terrible about picking winners.
The libertarian approach to healthcare espoused by your article and responders risks discarding the baby with the bath water. In this case, the patient is the baby and evidence-based medicine, the bath water. Mike Ainslie is correct that “a good cook does not need a cookbook.” As is true for cooks in the kitchen, however, is also true for physicians in the clinic. Neither all cooks nor all clinicians are equal. Many, if not most physicians can benefit from a medical cookbook derived from clinical studies with volumes of patients well beyond those in any individual practice. Structured protocols are even more valuable to the physician extenders upon whom we rely more and more. In 30 years of practice, it was my observation that the “good doctor” was the one who coupled evidence-based medicine with his or her own experience to build personalized care plans for individual patients. Science was tempered by art. He or she was not threatened by scientific evidence. Few of my peers in primary care doubted that newer asthma or diabetic protocols had improved patient care. To those of your bloggers who agree with Lee Kurisko that “evidence-based medicine is a collectivist horror,” I would point to the recent advances in the chemotherapy of breast cancer which rely increasingly on the genetic personalization of tumors. The newer regimens promise better survival and fewer side effects, less horror. None would have been possible without data from dedicated clinical trials. Thus, while I agree that healthcare should be personalized, I would argue that personalization should include solid evidence of efficacy as well as a physician’s experience and the individuality of the patient. Personalized care should not be anecdotal. The patient can and should be bathed in evidence-based medicine prepared to his or her individual needs.
Thomas W. Newsome, M.D.
Thanks to Dr. Newsome for an excellent post to which I respectfully respond:
Responders to this wonderful blog include independents and partisans of all stripes. . . not just libertarians.
Responders tend to believe that the patient should be in charge and not bureacrats. . . and they represent most American physicians.
Responders know the best evidence-based clinical medicine and science infuses our profession with reproducible miracles. . . and sanctifies life. We love it!
Responders know that this blog focuses on how political science infuses medical science. Responders of this blog are constantly made aware of this – particularly when generally accepted ideas turn out to have terrible disparate impact on the most vulnerable patients.
Responders are smart and can differentiate between the “anecdote” and the non-reproducible “single case report” such as:
Transfer of Peanut Allergy by a Liver Allograft
N Engl J Med 1998; 338:202-203 January 15, 1998
Many excellent case reports like this are the only way outliers will ever be properly included in any representative way in the peer-reviewed literature.
This “Allergic Allergist” responder totally disagrees with: “Few of my peers in primary care doubted that newer asthma. . . protocols had improved patient care.” In my field newer protocols are all to frequently “finger-in-the dike” symptom suppressing medications. These newer protocols can frequently be shown to help the majority based on different statistical paradigms that are subject to further analysis. But newer protocols can be ineffective for some asthmatics and make many asthmatics worse. When this happened to me the newer protocols offered nothing. . . my impending death was only a month or two from lying six feet under with petunia roots growing down to my toes. The newer protocols all made me so much worse. What has been lost for brittle asthmatics is sitting down and working very hard to coach them to clean up their diet and environment, decrease social stressors, simplify their life and to employ older safe immunotherapies so they can safely eat foods they are allergic to and tolerate their environment. Peer-reviewed EBM older immunotherapies like this are routinely not taught and are thrown out by bureaucrats and abacus-mentality reimbursers only because they are “old.” We as physicians do this at our own peril. Old-timers, like me, use safer environmental and scientific peer-reviewed EBM techniques BEFORE recommending the high revenue generating shiny and new therapies such as the black-boxed monoclonal antibody therapies . . .and other “latest greatest” therapies. . . that are a great safety net in a pinch but greatly overused. Not a day goes by that my reliance on old-fashioned approaches isn’t criticized by other physicians – who assume that shiny and new is inherently better. . . .when patients should be making those decisions.
Dorothy Calabrese MD
Allergy & Immunology San Clemente, CA
Clearly, I stirred at least a portion of the pot. Knowing John, I feel certain that he respects constructive comments which may be contrary to his thesis. This is indicated in his responses to the opinions of Uwe Reinhart.
In this vein, I offered a defense of evidence-based medicine as the basis of medical care but not the end-all. I very carefully noted, as Dr. Calabrese has, that the best physicians are the ones with the experience and confidence to recognize and treat patients who are outliers. She states well that, while newer protocols may benefit the majority of her patients, others require the skill and cunning of an “old school” physician. In her field of allergy this is especially true.
The intent of my comment was not to minimize the role of physician experience and appropriate individualization of care. Rather, I sought to temper a tenor that appeared to me to denigrate the use of scientific knowledge. I recognize that protocols are often an anathema to the “old school” of which I am a member, but today’s medical school graduates are inundated with a multitude of diagnostic and therapeutic modalities of which we could not conceive 40 years ago. No physician can apply these without the assistance of protocols which collate them into manageable algorithms. This is even truer for physcian extenders who will play a greater role in the delivery of care in the market place envisioned by John. The challenge for physicians of Dr. Calabrese’s and my generation is to impress upon the next generation of practicioners the need to critically reevaluate the patient who does not respond to the protocol and teach them how to develop a treatment plan which is “outside of the box.” While evidence-based medicine is invalualable in modern patient care, the risk is that the individual physician may become so reliant on it that he or she no longer possesses the skill to go beyond it.
If the bio-sensors which John has discussed in a previous column allow us to apply evidence-based medicine to individual patients, they would offer the ultimate in personalized care.
Thomas W. Newsome, M.D.