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Showing posts with label health care ethics. Show all posts
Showing posts with label health care ethics. Show all posts

Some chiropractors also practice homeopathy. According to Frank King, D.C., many more should be doing just that:


Homeopathy is an energetic form of natural medicine that corrects nerve interferences, absent nerve reflexes, and pathological nerve response patterns that the chiropractic adjustment alone does not correct. The appropriate homeopathic remedies will eliminate aberrant nerve reflexes and pathological nerve responses which cause recurrent subluxation complexes.

Not only does homeopathy correct nerve interferences, it empowers the doctor of chiropractic to reach the entire nervous system. What this means is that we can now better affect the whole person, and all of the maladies that affect us. Homeopathy’s energetic approach reaches deep within the nervous system, correcting nerve interferences where the hands of chiropractic alone cannot reach. Homeopathy is the missing link that enables the chiropractor to truly affect the whole nervous system!

But that’s not all:


Financial Rewards

Homeopathy means a multiple increase in business. Personally, I have been able to see and effectively help more patients in less time. The additional cash flow from broadening your scope of practice, increasing your patient volume and selling the homeopathic remedies is a wonderful adjunct. Better yet are the secondary financial benefits:

  • Homeopathy is like an extension of you that the patient can take with them to apply throughout each day in between visits. The actual therapeutic benefits of homeopathy along with the inner comforts of the patient as they connect you with each dose they take.
  • The dynamic broadening of your effective scope of practice multiplies the number of patients you can help and the multiple problems that each patient usually has. As you correct one set of problems, there are commonly other problems most patients don’t even tell their chiropractors. This doesn’t have to be the case anymore. Homeopathy empowers the chiropractor to correct conditions ranging from allergies to warts with incredible effectiveness!
  • Obviously, the rule of multiples will exponentially increase when a homeopathic procedure is properly implemented into your practice. Many of the conditions people are suffering with have no viable solution without the dynamic duo of chiropractic and homeopathy.
You can be the doctor people will seek out, travel long distances to see, and pay cash for your valuable services. Take it from someone who has experienced it first hand, it’s a great position to be in.


This is no surprise. Most chiropractors relinquished whatever ethical integrity they might have had when they bought into the “subluxation” myth, and the field as a whole has a fine tradition of “practice building.”

Naturopaths, likewise, don’t mind winking at practice ethics in order to make an extra buck. Nor do MD quacks, of course. Hey, it’s getting harder and harder to make a living just by slogging through the morass of needy patients, onerous third-party billing requirements, diminishing payments, increasingly cumbersome practice guidelines, next-to-impossible-to-keep-up-with (nothing to say of tedious and technical!) medical literature, and all the rest. Why not sprinkle your practice with a little ‘diagnostic’ sugar that will appease those clingy patients—for a while, anyway—and that you won’t have to find billing codes for (because there aren’t any)? Heck, why not check out this offering from “bio-pro, inc. Amazing Anti-Aging Solutions (Healthier Patients, More Patients)”:


HOWW TOOOO ….
The “must do” seminars for those who own or are managing a Complimentary [sic]Medicine Practice.

Three day course teaches you:
How to relate to the patient, evaluate, test and diagnose
How to use solutions, mixtures, methods, supplies and equipment
How to protocol administration for Chelation, Oxidation, Chelox, TriOx, Ascorbates, UVBI
How to design and organize your office
How to hire and fire staff and to computerize
How to use public relations and marketing
How to manage compliance with Medicare, State Medical Boards and governmental regulatory agencies
Manuals included…
Each attendee receives one set of training materials, including:
Protocol Manual
Physicians Manual
Office Procedure Manual
Forms Book
Marketing Manual
Patient Results Manual
Employee Manual
Audio tapes
and other related material.
Bio-pro was founded in 1978 by the late Charles H. Farr, MD, PhD, the self-styled “father of oxidative medicine,” who was also a founder of the American College for Advancement in Medicine, the Mother of All Pseudomedical Pseudoprofessional Organizations (PPO). But none of this is surprising, right? After all, quacks quack.

What may have come as a surprise to beleaguered physicians who still play by the rules was this offering, just a few days ago, from Medscape Business of Medicine:


Six Ways to Earn Extra Income From Medical
Activities

You’re chasing after claims but watching reimbursement sink.

It’s a common story, and primary care doctors and even specialists are keeping their ears to the ground for other ways to boost their bottom line. Luckily, doctors have some fairly lucrative options that can help them maintain their income — and perhaps even increase it.

We looked at 6 avenues that physicians have taken to earn extra revenue. None of these activities require a tremendous amount of time. Participating in just 1 or 2 activities can put enough money in your pocket to allow you to breathe a little easier when the bills come in.
So what are those ‘6 avenues’? Let’s see:
  • Work with Attorneys
  • See Nursing Home Patients
  • Serve as a Medical Director
So far, so not necessarily bad…
  • Team Up with Pharmaceutical Companies
What??! Team up with pharmaceutical companies? Couldn’t that mean, like, just doing legitimate research and trying like hell to do it right? Uh, nope:
Drug and device companies spend billions of dollars each year to discover and promote new medicines and treatments, and they rely heavily on doctors to participate in these endeavors whether through clinical trials or serving as a speaker or consultant. It’s not uncommon for physicians to earn a minimum of 5 figures a year either speaking or doing clinical studies within their medical practice. Some doctors make in excess of $100,000 annually — on top of their income from seeing patients.

O’course, you gotta watch out for those pesky ethics killjoys, warns Medscape:
Although some extra money is nice, too much can turn heads — and not in a good way. In late January, The Boston Globe reported on an allergy and asthma specialist who was issued an ultimatum by his hospital, the prestigious Brigham and Women’s Hospital (Boston, Massachusetts): Stop moonlighting on behalf of pharmaceutical companies or resign from your staff position.
What it all comes down to is this:
Pros: With typical payments running about $1500-$2500 for a single talk, there’s substantial opportunity to supplement your regular income…

Cons: These arrangements are coming under increasing scrutiny from hospitals, legislators, regulators, and the media. In fact, some of the doctors whom we contacted for this article declined to talk about their involvement with drug companies.
Uh, no kiddin’. Funny that the “increasing scrutiny” doesn’t seem to come from organized medicine, medical schools, mainstream medical journals, state medical boards, or doctors in general. A couple of years ago I lamented the publication of a couple of book reviews, in the lofty New England Journal of Medicine, that celebrated trendy pseudomedicine. Shortly thereafter I received this from an emeritus editor:
I think the incursion into the bastions of medicine has to do with the fact that everything nowadays—absolutely everything—has become a market. If quackery appeals to the readers of the NEJM, it will be there. ”Is it true?” is no longer the question anyone asks, but “Will it sell?” And I think that applies to the editors of most major journals, as well.
True, dat. As for Medscape, this isn’t its first ethical gaff, and I agree with Bernard Carroll that it seems to have “a right hand – left hand problem.”
Oh yeah: what were the other 2 “avenues”? Those would be:
  • Become a Media Personality
  • Consult for Wall Street

At Healthcare Renewal and at numerous other healthcare blogs, we write about academic and industry conflicts of interest, malfeasance, and other topics in the hopes that there are leaders within organizations who might correct the wrongs that result from such conflicts and behaviors. (That is, when it is not those same leaders behind the scandals in question.)

Our efforts are based on the assumption (perhaps, more correctly, a hope) that the problems within organizations are not organic and ideological, and that they are in some fashion amenable to correction internally and externally via exposure to sunlight.

What if we're wrong?

A story caught my eye about my Medical Informatics alma mater. A Frenchman, Pierre Konowaloff, is suing Yale for return of a famous Van Gogh painting that was confiscated from his family in the early 1900's by totalitarians, psychopaths who created what proved to be one of the most oppressive and murderous regimes in history (the Soviet Union).

In return, Mr. Konowaloff was countersued by Yale.

Yale alleges that the confiscation of the painting by the Soviets was A-OK because "international law was not violated" [by the confiscation - ed.], therefore Yale has legitimate and unchallengeable dibs on the painting.
"International law" was not violated? This response is beyond stunning.
I had to retrieve my jaw from the floor after reading the story:

Wall Street Journal
June 3, 2009

Yale Sued Over Van Gogh Painting Seized by Soviets

By JOSEPH PEREIRA
A descendant of the onetime owner of a famed Van Gogh painting has sued Yale University in an effort to reclaim the artwork from the Ivy League school.
In a lawsuit filed in U.S. District Court in New Haven, Conn., Pierre Konowaloff alleged that the university should have known the painting—"The Night Café"—had been confiscated from his great-grandfather, Ivan Morozov, a Russian industrialist and aristocrat, during the Communist takeover of Russia in the early 1900s.
The 1888 painting was subsequently sold by the Soviet government to a European gallery. Stephen Carlton Clark, a Yale alumnus, bought the painting from a gallery in New York in the early 1930s and bequeathed it to Yale in 1961.
In his suit, Mr. Konowaloff, who lives in France, accuses the university of engaging "in a policy of willful ignorance" that amounts to "art laundering," and asks the court to declare him the rightful owner. Aware of Mr. Konowaloff's intention to claim the painting, Yale filed a lawsuit of its own last March in federal court in New Haven.
In its suit, Yale asserted ownership of "The Night Café," claiming that the nationalization of the painting by Communist Russia -- while at odds with capitalism -- did not violate international law. Yale stated in its lawsuit that "it was accepted at the time, as it is now, that the sales by the Soviet government were valid, as were later acquisitions of the paintings."

In other words, rather than doing the right thing, Yale is claiming that the theft of personal property by the Soviets was OK by them. (While Yale is well known to have a culture far to the left and many of its leaders and faculty probably sympathize with communists, Hitler also "nationalized" the artwork and other property of individuals. Would Yale find those actions in accordance with "International law?" One can only wonder.)
Van Gogh's "The Night Cafe"

Now, if this were a one-off event, it would not be as illustrative of a systematic ethical decay that I fear exists in the hallowed Ivy halls. However, Yale has recently been fined $7.6 million after an investigation by NIH, NSF, DOD and others into misuse of research money by faculty. I wrote about that event at "Lux et Veritas, or Trust But Verify? Yale discovers eDiscovery", and the powerpoint from within Yale outlining the issues was eye-opening.

Here is a synopsis of the outcome:
Yale University Pays $7.6 Million to Resolve False Claims Act Allegations (PDF)
—excerpted from U.S. Dept. of Justice press release, Dec. 23, 2008

Yale University has entered into a civil settlement agreement with the federal government in which it will pay $7.6 million to resolve allegations that it violated the False Claims Act and the common law in the management of federally-funded research grants awarded to the university between January 2000 and December 2006. The grant awards were made by approximately 30 federal agencies and entities, including NIH, NSF, DOE, DOD, and NASA.

The investigation focused on allegations involving two types of mischarges to federal grants. Both types of mischarges arose as violations of the basic principle that recipients of federal grants are allowed to charge to each grant account only “allocable” costs, which are costs that relate to the specific objectives of that grant project.

The first allegation involved cost transfers and the requirement that costs transferred to a federal grant account must be allocable to that particular grant account. The settlement resolves allegations that some Yale researchers at times improperly transferred charges to a federal grant account to which those charges were not allocable. Researchers allegedly were motivated to carry out these wrongful transfers when the federal grant was near its expiration date and they needed to spend down the remaining grant funds. Federal regulations require that unspent grant funds be returned to the government.

The second allegation involved salary charges and the requirement that charges to federal grant accounts for researcher time and effort must reflect actual time and effort spent on a particular grant. It was alleged that some Yale researchers submitted time and effort reports, for summer salary paid from federal grants, that wrongfully charged 100 percent of their summer effort to federal grants when, in fact, the researchers expended significant effort on unrelated work.

Researchers allegedly were motivated to carry out these wrongful salary charges by the fact that they are not paid their academic-year salary by Yale during the summer. The only salary received by these researchers during the summer was the result of the effort they charged to federal grants. Absent the alleged grant mischarges, the researchers would not have been paid.

The $7.6 million payment comprises two components: $3.8 million in actual damages for the false claims, and $3.8 million assessed as penalties for the false claims.

Taxpayer money was used as they pleased until caught. What's mine is mine, and what's yours is mine.

Yale's clinical operations have seen federal investigation once before which I wrote about at "Insufficient IT Management Depth Results in Justice Dept. Investigation, Millions of Dollars in Fines." That story was more about IT incompetence rather than malfeasance, however.

I've had my own personal experiences with these "what's mine is mine, and what's yours is mine" property-rights attitudes at Yale. Perry Miller, Director of Informatics, Kenneth Kidd, Professor of Genetics, and Carolyn Slayman, Deputy Dean for Academic and Scientific Affairs, waged a rather one-sided and extortionary battle to misappropriate my intellectual property, a computer program I'd authored as faculty, assisted by a lawyer in Yale's Office of General Counsel -- who for good measure was in fact unauthorized to practice law in Connecticut at that time. Ex-colleague faculty Richard Shiffman "purged" me, Stalin style, by telling recruiters who called that I didn't exist - one of those recruiters, unfortunately for him, happened to be a detective I retained. I wrote up the story in detail at this site. Dr. Kidd in particular was a principal in the now-defunct Human Diversity Genome Project in which he and others promised indigenous tribes their genetic materials would not be misappropriated for others' gain and profit. (I found that position risible considering my circumstances. Kidd's research raised further issues as I wrote at "Informed consent, exploitation and developing a SNP panel for forensic identification of individuals.")

University officials right up to President Richard Levin (in the WSJ recently lamenting the decrease in the value of Yale's endowment from $24 billion to $17 billion), said they could do nothing to help me, even though I was being badgered for my software and actually blackmailed (through denial of confirmation of my training and faculty time at Yale to potential employers).
You would think a university with an endowment in the billions of dollars could have protected its own junior faculty from senior faculty predators, and you'd also think it could return a Van Gogh to the heir of a man who had it stolen by thugs who later murdered tens of millions of their own citizens.
Ironically, when I was Yale School of Medicine junior faculty in Yale Center for Medical Informatics, I was charged with teaching postdoctoral fellows about NIH ethics guidelines. The tenured senior faculty I was working for just didn't have the time.
Now, I may simply be a "disgruntled former Yale faculty member" after nearly having my career destroyed by these people in what was the most disappointing experience in my life, bar none, but the pattern of "what's mine is mine, and what's yours is mine" seems to be all too commonplace in Yale's case. From Bloomberg's coverage of the same Van Gogh story:

Yale Sued Over Van Gogh Work By Man Claiming to be Russian Heir
June 4, 2009
By Cary O’Reilly

... Konowaloff’s claim is the latest litigation accusing Yale of improperly possessing artwork or historic artifacts. The Republic of Peru sued Yale in December seeking a collection of artifacts excavated from Machu Picchu and other sites by university scientists and researchers.


I'd written about Machu Picchu here:

... Peripherally related in the scientific sense but perhaps closely related in the ethical and ideological sense, I've just discovered via a recent newspaper that Yale has some additional problems of late regarding property: "Peru demands return of Machu Picchu treasures by Yale", Miami Herald, July 25, 2007, by Tyler Bridges (now a Peruvian resident). Yale apparently went so far as to interpret the laws of a foreign nation, which is, of course, Yale's right as a sovereign entity, the People's Republic of Yale, it would seem:

Key documents include a 1912 Peruvian decree stating that Peru reserved the right to request the objects' return, and a 1916 letter that [Yale professor/explorer Bingham] wrote to the National Geographic Society about the artifacts from the 1914-15 expedition. ''Now they do not belong to us, but to the Peruvian government, who allowed us to take them out of the country on condition that they be returned in 18 months,'' Bingham wrote. Yale officials have said that Peruvian law in force in 1912 does not require the university to return objects from Bingham's expedition that year.
Perhaps less credible is this additional allegation from Bloomberg:

... Yale and a secretive student society known as the Order of Skull & Bones were sued in February by the descendants of the 19th century Apache Indian warrior Geronimo. The family claims a group of Yale students may have stolen some of Geronimo’s remains in 1918 and taken them to Yale’s campus. The university denies the allegation and says it has no connection to Skull & Bones.

Then there's Yale's Taliban Man incident per John Fund at the WSJ. The former deputy foreign secretary of the Taliban was taken as a student at Yale in 2006 while at the same time the school blocked ROTC training from its campus and argued for the right of its law school to exclude military recruiters.

I fear other Ivy universities also lack a sense of basic ethics, both at the individual faculty level and collectively, i.e., including the leadership. I'd written about the ghastly events regarding the Duke lacrosse team affair at "A Truly Appalling Lawsuit Against Duke University." Harvard Medical Schools's own ombud had written an article in JAMA in the late 1990's entitled "Authorship: the coin of the realm, the source of complaints", outlining the commonality of fights over IP between faculty and students, and admitted in a response to my Letter to the Editor that this could not be prevented by administration (which in my view translates to, "the administration's worse than the faculty in this regard.")

Others at Healthcare Renewal and related blogs have written about ethical lapses at other major universities as well.

In summary, if both the majority of the faculty as well as the administration of our major universities never learned as children about respecting others' property, and pass these attitudes along to future academics and future captains of industry, the bloggers will be unable to teach them very much. We will continue on a course of periodic academic and industry healthcare (and other) scandals of increasing scale, along with the wasted talent, resources and opportunity these scandals represent.

Addendum: after such a grim report, I thought I'd throw in something pleasant. Here is a friend I feed at the nearby park, one of six, in fact, Mute Swan cygnets (babies). The parents like me so much, they've offered me food in return - lovely clumps of fresh tender grass, which to them is a delicacy:


Cygnus olor - click to greatly enlarge these adorable fuzzballs

It's a great picture, but it's not a Van Gogh. Since I once worked at Yale, however, let's hope they don't claim the photo is theirs.

Addendum:

Remarkably, there is apparently someone in the health IT community who was offended by the posting of the photo of the cygnet I feed (done, of course, as "comic relief"), as I have been informed. One can only wonder if violations of intellectual property and civil rights by universities, or patent safety concerns by faulty EHR's cause equal offense.

At an interview of Barry Chaiken, MD, MPH, FHIMSS, former Chairman of the Board of health IT trade group HIMSS and chief medical officer of Imprivata, a company specializing in healthcare IT security, Chaiken pleads for the following special accommodations for Health IT relative to other medical sectors:

... We’re still learning, in healthcare, about that user interface. We’re still learning about how to put the applications together in a clinical workflow that’s going to be valuable to the patients and to the people who are providing care. Let’s be patient. Let’s give them a chance to figure out the right way to do this. Let’s give the application providers an opportunity to make this better.

[Why are the health IT applications bad to begin with, I ask? - ed.]

I note the following.

  • If 'we're' still learning (and I don't include people with genuine clinical computing expertise in that subgroup, but it does include the plethora of amateurs in the commercial health IT industry), then the technology is experimental.
  • Worse, it's unregulated - a major special accommodation in and of itself.
  • These sentiments about "being patient" would be appropriate - if the subjects of this experimental technology that vendors need to be "given a chance" to make better were experimental lab rats.

Instead, the subjects of the experimental technology are unwitting, unconsenting human beings, who are being used as experimental test subjects for software development, and being put at risk, injured and indeed killed by the disruptions these experimental technologies cause.

Under these realities, the position presented by Chaiken is, in my opinion, ethically perverse.

That such sentiments come from someone who holds the MD degree and who I assume took the Hippocratic oath in some form is stunning.

In the health IT industry, "Primum non nocere" seems to have been replaced with "Kybernetik über alle."

Further, the commercial health IT vendors have had the good part of five decades to "get it right." How long is long enough?

Their software is unavailable for detailed evaluation and open critique of the user experience by impartial experts, unlike open source EHR's like VistA CPRS, demo version available at this link where anyone can:

  • Download the latest version of CPRS today and get access to new features including graphing functionality
  • Use the software as if you were a provider by entering orders, entering documentation, retrieving reports (and graphs) and viewing alerts and notifications that help with decision support
  • Learn first hand how VA’s electronic health record system works

Personally, I've had to use stealth simply to obtain and post graphical representations of some simply inexcusable commercial HIT interface sins (link). Why should a secretive industry be given additional special accommodation?

Dr. Chaiken goes on to state:

Let’s hold them accountable if they don’t [make the applications better]. Absolutely, hold them accountable if they don’t; and the marketplace, I hope, will be able to make those choices and hold them accountable when they don’t. But, we’re still learning.

Again, I'm not sure who the "we're" refers to, but "holding companies accountable" will not really help victims of the experiments who are seriously injured or killed.

A better solution, as I have written on this blog (such as at my Nov. 2008 post "Should The U.S. Call A Moratorium On Ambitious National Electronic Health Records Plans?" and at other sites as well:

Protect patients. Constrain the health IT experiment temporally and geographically, and apply the laws, customs and regulations of medical experimentation until this industry "has learned" whatever lessons Chaiken thinks they need to learn, e.g., from decades of Medical Informatics, Social Informatics, Computer Science, HCI and other research. None of these fields - last time I looked - are classified or protected intellectual property. Share information on patient adverse outcomes and near misses, instead of concealing them and contractually gagging users from openly speaking about problems.

That would be the ethical approach.

Further, how many more decades should we wait for the health IT industry to figure out how to look for better leaders beyond the "school of hard knocks" bias that's existed for at least the past decade? How many substandard health IT leaders were placed in hospitals the past few decades as a result of outrageous attitudes like these below from the major recrutiers, centered on spreading the wealth?

I don't think a degree gets you anything," says healthcare recruiter Lion Goodman, president of the Goodman Group in San Rafael, California about CIO's and other healthcare MIS staffers. Healthcare MIS recruiter Betsy Hersher of Hersher Associates, Northbrook, Illinois, agreed, stating "There's nothing like the school of hard knocks." In seeking out CIO talent, recruiter Lion Goodman "doesn't think clinical experience yields [hospital] IT people who have broad enough perspective. Physicians in particular make poor choices for CIOs. They don't think of the business issues at hand because they're consumed with patient care issues," according to Goodman. Healthcare Informatics, "Who's Growing CIO's."

[No, that line about 'being consumed with patient care issues' as a strike against health IT leadership didn't come from a Scott Adams business-idiot parody cartoon - ed.]

As in clinical medicine itself, if you're going to be anywhere near patient care and making decisions affecting its delivery, a degree damn well "gets you something."

At about the same time the above appeared in Healthcare Informatics, a generalist IT recruiter wrote me this:

... What is happening to MDs trying to change careers is providing a window into broader issues about professionals in society today - narrow training, pigeonholing in the marketplace, difficulty making lateral and cross-industry transition, what a handicap it is to be creative, entrepreneurial, or cross-disciplinary in the current marketplace, and the wasted intellectual capital represented by the high caliber of individuals who can't find ways to fruitfully plug themselves into the marketplace.

I continue to be amazed at this general phenomenon...the remarkable quality of a number of candidates I've met, and the lack of recruiters' ability to get them in the door of good companies. The interesting part of the story is that when I am able to get access to high level execs in some of these companies (not just IT, but devices, pharmaceuticals, etc. also) they are dismayed at the quality of those that they hire. They know that something is wrong in how the recruitment process is working. (eg, one of the major device cos. just devoted the time of 1 FTE in Human Resources to 'finding innovative ways of identifying and recruiting good talent into the company.')

Whose fault were the outrageous, deleterious hiring practices prevalent in this industry that contributed materially to its production of substandard products, hiring practices that persist to this day? (See example here.)

Why should we be "patient", and "give them [yet more chances] to figure out the right way to do this", and why should patients permit themselves to continue to be guinea pigs to such a sloppy, cavalier industry?

I note that Chaiken's credentials appear to fit the template, as colleague Roy Poses describes at various posts including here, of an "executive isolated from the real world of health care" and member of the superclass. From the interview linked above:

... According to your LinkedIn profile, you’re CMO for Imprivata, CMIO for Symphony Corporation, and CMO of DocsNetwork. You’re on a couple of advisory boards, you own a vineyard, and you just finished your term as chair of the HIMSS board.

Perhaps that helps explain the mantra of "computers [and profit] first, patients second."

Finally, in answer to my own question above "Why are the health IT applications bad to begin with", I suggest complacency, incompetence, willful ignorance, and negligence (including criminal negligence) as possible answers.

-- SS

Addendum:

The following in today's WSJ caught my eye ("What we've learned from the Gulf spill", Michio Kaku, July 20, 2010):

The nagging question is: Why did it take so long? Why couldn't they have capped the leak months ago? For three agonizing months, BP's engineers and executives were essentially making things up as they went along, conducting a billion dollar science project with the American people as guinea pigs. The basic science of stopping oil leaks at 5,000 feet below sea level should have been done years ago.

Concepts are similar. With just a few edits, we have this:

The nagging question is: Why is it taking so long? Why couldn't they have learned to create useful health IT decades ago? For at least thirty agonizing years, Health IT vendors' engineers and executives were essentially making things up as they went along, conducting a multibillion dollar science project with the American people as guinea pigs. The basic science of producing safe, effective, usable health IT should have been done years ago.

On July 7, President Obama appointed Dr. Donald Berwick as Administrator of the Centers for Medicare and Medicaid Services (CMS). Dr. Berwick, a pediatrician, is well known as the CEO of the non-profit Institute for Healthcare Improvement (IHI), which "exists to close the enormous gap between the health care we have and the health care we should have — a gap so large in the US that the Institute of Medicine (IOM) in 2001 called it a 'quality chasm'.” Dr. Berwick was one of the authors of that IOM report. His IHI has been a major player in the patient safety movement, most notably with its "100,000 Lives Campaign" and, more recently, its "5 Million Lives Campaign."

Berwick's CMS gig is a "recess appointment": it was made during the Senate's July 4th recess period, without a formal confirmation hearing---although such a hearing must take place before the end of this Senate term, if he is to remain in the position. A recent story suggested that Obama made the recess appointment in order to avoid a reprise of "last year's divisive health care debate." The president had originally nominated Berwick for the position in April, and Republicans have opposed "Berwick's views on rationing of care," claiming that he "would deny needed care based on cost."

A "Patient-Centered Extremist"

If there is a problem with the appointment, it is likely to be roughly the opposite of what Republicans might suppose: Dr. Berwick is a self-described "Patient-Centered Extremist." He favors letting patients have the last word in decisions about their care even if that means, for example, choosing to have unnecessary and expensive hi-tech studies. In an article for Health Affairs published about a year ago, he explicitly argued against the "professionally dominant view of quality of health care":



I think it wrong for the profession of medicine—or any other health care profession, for that matter—to “reserve to itself the authority to judge the quality of its work.” I eschew compromise words like “partnership.” For better or worse, I have come to believe that we—patients, families, clinicians, and the health care system as a whole—would all be far better off if we professionals recalibrated our work such that we behaved with patients and families not as hosts in the care system, but as guests in their lives. I suggest that we should without equivocation make patient-centeredness a primary quality dimension all its own, even when it does not contribute to the technical safety and effectiveness of care.

A new definition. My proposed definition of “patient-centered care” is this: The experience (to the extent the informed, individual patient desires it) of transparency, individualization, recognition, respect, dignity, and choice in all matters, without exception, related to one’s person, circumstances, and relationships in health care.

Does this mean that Dr. Berwick would also eschew professional, i.e., expert, judgment in favor of patients' wishes? In a word, yes:

Evidence-based medicine sometimes must take a back seat. First, leaving choice ultimately up to the patient and family means that evidence-based medicine may sometimes take a back seat. One e-mail correspondent asked me, “Should patient ‘wants’ override professional judgment about whether an MRI is needed?” My answer is, basically, “Yes.” On the whole, I prefer that we take the risk of overuse along with the burden of giving real meaning to the phrase “a fully informed patient.”

Dr. Berwick is not so naive as this opinion might suggest. He envisions a "mature dialogue" in such a case, and argues that "if, over time, a pattern emerges of scientifically unwise or unsubstantiated choices...then we should seek to improve our messages..." He also admits that there might be an occasional patient whose demands are so unreasonable that "it is time to say, 'No'." That exception, he argues, should not dictate the rule.

There are situations in which most civilized people would agree with Dr. Berwick's view of 'patient-centeredness'. In both the Health Affairs article and in his recent address to the 2010 graduating class of the Yale School of Medicine, he offered real examples of petty, arbitrary hospital rules causing unnecessary sorrow for patients and their loved ones. It is in such contexts that he makes a convincing case that health professionals ought to behave "as guests in their lives." In an interview for the New York Times, he argued:


We don’t have a standard of services or processes that are comfortable for patients. We have built a technocratic castle, and when people come into it, they are intimidated.

Nothing to disagree with there. To create that standard, moreover, would not undermine settled medical practice ethics---it would celebrate them, even as it rightly embarrasses the profession for having taken so long to do so.


Enter the Woo

Eschewing the scientific basis for modern medical practice, however, is another matter. In February of 2009, Dr. Berwick gave a 'keynote' address at the IOM and Bravewell Collaborative-sponsored Summit on Integrative Medicine and the Health of the Public. He shared the podium with Mehmet Oz, Dean Ornish, Senator Tom Harkin, and other advocates of pseudoscientific health claims. I wrote about the conference at the time, mainly to call attention to its misleading use of the term "integrative medicine": literature emanating from the Summit characterized it as "preventive" and "patient-centered," whereas the only characteristic that distinguishes it from modern medicine is an inclusion of various forms of pseudomedicine.


I noticed that Dr. Berwick was on the speaker roster, which I found disappointing: I imagined that he had either gone over to the Dark Side or, perhaps, was sufficiently naive about the topic to have been duped; or, more likely, that he had cynically accepted the offer to further his ambitions. I didn't bother to listen to his speech until the CMS appointment was announced a few days ago.

It is troubling, to say the least. Dr. Berwick did not argue, as he had in the NYT piece, that "If we doctors feel a person is going to make unwise choices, we have to take on the responsibility of being teachers, educators and informers." Rather, he praised his fellow speakers, most of whom were spouting nonsense, for their "reach" and "eloquence." He praised the IOM for its "glorious record...in pursuit of better designs in health care...traditional, allopathic curative care and now migrating into this distinguished and important new arena." He mentioned homeopathy and acupuncture, not to wonder why they should be promoted as effective, but merely to warn that they will fail---presumably in some economic sense---if they try to compete with each other for reimbursement.

Such language, and Dr. Berwick's very presence at the Summit, were a far cry from advocating "patient-centeredness." What they amounted to was a generous endorsement of pseudoscientific practices and of the socio-political movement that promotes them. Even granting some naivete on his part (he called himself "an amateur at this topic"), he must have known this. Such an endorsement, unlike tearing down the "technocratic castle," has ethical implications at least as profound as those that Dr. Berwick tacitly or explicitly relies upon to support his arguments for patient-centeredness.

"Physicians have no Immunity to Moral or Ethical Constraints"

The relevant medical ethics treatises (reviewed here) are in substantial agreement that it is unethical for physicians to prescribe scientifically implausible methods or to refer patients to other practitioners for the same purpose. They are also in agreement that it is unethical to prescribe a placebo to a patient while claiming that the treatment has specific biologic activity---a point that has been vigorously argued in the UK this year, with regard to homeopathy. These ethical tenets are not mere odes to nerdy, sciency thinking; they are matters of honesty and integrity---fundamental bases for ethical interactions between physicians and patients.

In 1983, philosophers Clark Glymour and Douglas Stalker published an article in the New England Journal of Medicine titled “Engineers, cranks, physicians, magicians.” They framed modern medicine as follows, comparing it to what was then called "holistic medicine" (the article is quoted extensively here):



Medicine in industrialized nations is scientific medicine. The claim tacitly made by American or European physicians, and tacitly relied on by their patients, is that their palliatives and procedures have been shown by science to be effective. Although the physician’s medical practice is not itself science, it is based on science and on training that is supposed to teach physicians to apply scientific knowledge to people in a rational way.

The practice of medicine in the United States and in other industrialized nations is a form of consultant engineering...

That statement is just as accurate now---even more so, in this era of Evidence-Based Medicine---as it was nearly 30 years ago, even if some might find the likening of medicine to engineering displeasing. Nor is it at odds with almost any definition of "patient-centeredness," other than one that presumes that the patient's desires trump the physician's ethics:



A physician engineer can act as consoler; nothing in either logic or social psychology forbids it. But certain combinations are impossible or extraordinarily unlikely. A physician engineer cannot honestly claim powers of magic or occult knowledge. The principles governing scientific reasoning and belief are negative as well as positive, and they imply that occult doctrines are not worthy of belief. Moreover, physician engineers have no immunity to moral or ethical constraints. On the contrary, they are by training and by culture enmeshed in a tradition of rational thought about
the obligations and responsibilities of their profession.

Dr. Berwick---if he really believes what his presence and words at the "Integrative Medicine" Summit imply---is playing with ethical fire. (If, as I hope, he doesn't really believe those things, he's playing with ethics of another kind). Will we begin to see pseudomedicine "integrated" into Medicare and Medicaid? That is certainly the expectation of those who observed Dr. Berwick's performance at the Summit, and who appear intent to hold him to his word.

KA

Two other blogs that have addressed this issue are:

Dr. RW: Not only evidence based medicine but science based medicine may take a back seat in Donald Berwick's vision for patient centered care

Dr. David Gorski: Dr. Donald Berwick and “patient-centered” medicine: Letting the woo into the new health care law?

For five years now, we have been writing about concentration and abuse of power in health care, and on specific tactics used predominantly by large health care organizations that threaten the values that physicians and other health care professionals once swore to uphold.

Pharmaceutical companies may not have been the worst offenders when it came to threatening these values, but they have not been laggards. Specific issues we have discussed included (in a peculiar order that I will explain in a minute): failure of the companies' boards of directors to be accountable for misbehavior by its management, sometimes associated with conflicts of interest affecting these board members (e.g., this recent case); outright crime and corruption (e.g., this case); use of key opinion leaders paid by the company to market products cloaked in the mantle of academia; payments made by the companies to patient advocacy groups (e.g., this one), medical societies, and academic institutions that induce institutional conflicts of interest, and enlist these well-reputed organizations as stealth marketers; ridiculously high prices charged for particular medicines, often to particularly vulnerable patients (e.g., this case); suppression and manipulation of clinical research evaluating the companies' products; and deceptive drug marketing practices.

Many other bloggers have written about these issues. Some of them have been widely taken up in the mainstream media. A few have even made it into the medical and health care literature.

But those of us who bring them up have been attacked as a tiny group of pharmascolds (e.g., here), who get in the way of the needed innovation and scientific advances that the pharmaceutical industry generously brings to the public. Despite such attacks, it may be that our concerns are somewhat more universal, although those with vested interests in maintaining the status quo might not want that publicized too much.

A new issue of PLoS Medicine included several articles on drug companies' responsibilities for human rights. One was by a former United Nations Special Rapporteur on the right to the highest attainable standard of health. I, and I suspect most of even our Health Care Renewal readers were not familiar with that office. I also confess to being unaware that he had published a report to the UN General Assembly entitled Human Rights Guidelines for Pharmaceutical Companies in Relation to Access to Medicines, which included 47 specific guidelines.

Amazingly enough, it turns out that some of these guidelines seemed to directly address the issues raised above, to wit:

Board of Directors' Accountability
11. The company should have a governance system that includes direct board level responsibility and accountability for its access to medicines policy.

Anti-Corruption
15. A company should publicly adopt effective anti-corruption policies and measures, and comply with relevant national law implementing the United Nations Convention against Corruption.

Disclosure of Financial Support
18. The company should annually disclose its financial and other support to key opinion leaders, patient associations, political parties and candidates, trade associations, academic departments, research centres and others, through which it seeks to influence public policy and national, regional and international law and practice. The disclosure should extend to amounts, beneficiaries and channels by which the support is provided.

19. When providing any financial or other support, the company should require all recipients to publicly disclose such support on all appropriate occasions.

Drug Pricing
33. When formulating and implementing its access to medicines policy, the company should consider all the arrangements at its disposal with a view to ensuring that its medicines are affordable to as many people as possible. In keeping with Guideline 5, the company should give particular attention to ensuring its medicines are accessible to disadvantaged individuals, communities and populations, including those living in poverty and the very poorest in all markets. The arrangements should include, for example, differential pricing between countries, differential pricing within countries, commercial voluntary licences, not-for-profit voluntary licences, donation programmes, and public private partnerships.

34. The arrangements should take into account a country’s stage of economic development, as well as the differential purchasing power of populations within a country. The same medicine, for example, may be priced and packaged differently for the private and public sectors within the same country.

35. The arrangements should extend to all medicines manufactured by the company, including those for non-communicable conditions, such as heart disease and diabetes.

Suppression and Manipulation of Clinical Research
39. The company should take effective measures to ensure that all information bearing upon the safety, efficacy and possible side effects of a medicine are easily accessible to individuals so they can make informed decisions about its possible use.

Deceptive Drug Marketing
41. The company should publicly disclose its promotional and marketing policies and activities, including costs.

Needless to say, I can see no evidence that any big pharmaceutical companies are trying to adhere to any of these guidelines. Somehow I suspect that those who are supporting the vested interests of big pharmaceutical corporations may not all have that much respect for the United Nations. However, I think that the Special Rapporteur's guidelines lend more credibility to the argument that we need better leadership of health care organizations, and specifically that such organizations should follow clear ethical precepts, and their leadership should be held accountable when they do not.

So the next time someone calls you a "pharmascold," you can say, "yeah, yeah, so is the UN Special Rapporteur."