American Medical Schools Are "Only In It for the Money" Say Their Faculty

We recently discussed the plight of young medical faculty.  It appears that their plight is even worse than we imagined.

Last month, an abstract was presented at the Annual  Conference on Research in Medical Education at the Annual Meeting of the Association of American Medical Colleges, in a session entitled "Your Career is More than Your Specialty."  The citation would be: Pololi L, Ash A, Krupat E.  Faculty Values in the Culture of Academic Medicine: Findings of a National Faculty Survey.

The authors described a large survey, of over 5000 faculty at 26 US nationally representative medical schools, done as part of the National Initiative on Gender, Culture, and Leadership in Medicine (known as C ‐ Change) project.  The overall response rate was good (53%).   Here are the striking results:

51% agreed that 'the administration is only interested in me for the revenue I generate'; 31%; that 'the culture of my institution discourages altruism'; 31%, that other people have taken credit for my work'; and 30% that 'I am reluctant to express my opinion for fear of negative consequences.' Half perceived that the institution does not value teaching and 27% that it does not reward clinical excellence; Over half disagreed with the statement that their own values are aligned with those of the institution. Also, 30% had seriously considered leaving academic medicine and 46% their own institution, both in the prior year.

These results show that US medical education is in moral crisis, and probably close to catastrophe.  These results should provoke shame and outrage, and cause widespread discussion. On the other hand, it is remarkable that they were allowed to see the light of day at all, given the persistent strength of the anechoic effect.  Pololi and colleagues obviously never got the message that one is never ever supposed to discuss such things in public.

Instead of being about discovery and dissemination of knowledge, the fundamental mission of education, a majority of large sample of faculty surveyed says American medical schools are about making money.  Instead of putting teaching first, half of the faculty said their institutions explicitly do not value teaching. Instead of supporting free speech, free enquiry, and academic, a significant minority of faculty say that are afraid to speak out.

It is no wonder that nearly half of the faculty are considering leaving.

On Health Care Renewal, we have discussed evidence, mostly anecdotal, about the rot within the foundations of medicine and health care.  (Note, posts on conflicts of interest, often affecting medical school faculty and leadership, are here; we have posted about how academic medicine has often allowed suppression and manipulation of research;  posts on excessive compensation of health care executives, including those of academic institutions, not based on upholding the academic mission are here.)  Now it appears that the rot is so severe that the whole edifice is about to fall down.

Our foolish transformation of the calling and profession of medicine into a business (see posts here and here)  at a time when businesses were taken over by the arrogance, greed, unscrupulousness, and amorality that lead to the global financial collapse will surely also lead to a global health care collapse if something is not done very soon.

We need a new effort much bigger than but at least as influential as the Flexner Report to re-imagine academic medicine again as valuing teaching, learning, research and patient care, while regarding its financing only as the means to reach those ends.

The Carnegie Foundation sponsored the original Flexner Report, and the Rockefeller Foundation then hired Dr Flexner to reform medical education (see Mitka M.  he Flexner Report at the century mark:  a wake-up call for reforming medical education .  JAMA 2010; 303(15):1465-1466. Link here.) Will anyone or any organization have the courage to sponsor a new, bigger, and likely much more contentious effort?

Meanwhile, the academic leaders who have personally profited from and colluded with the transformation of the system into one that is only in it for the money should resign. The few remaining leaders will need to draw upon all their honesty, integrity, knowledge, and determination to rebuild the system.

Finally, shame on all of us for letting us get to this place.

With apologies to the late Frank Zappa and the Mothers of Invention.

Professional Integrity for Sale? “Sure,” Says Medscape!

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

Yale, Van Gogh's "The Night Cafe" and Personal Property: What's Mine is Mine, and What's Yours is Mine

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.

-- SS

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.

-- SS

6/10/09 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.

In Defense of Psychiatric Diagnoses and Treatments

In Defense of Psychiatric Diagnoses and Treatments

The Boston Globe is out today with a story about conflicts of interest involving American Psychiatric Association guidelines for treating depression, mania, and schizophrenia – disorders for which the market in medications is said to be $25 billion annually. Conflicts abound, it seems, and the consequent implication is that industry influence has led to guidelines that “focus heavily on medications and give relatively little attention to nondrug treatments.”

The lead author of a forthcoming analysis, Lisa Cosgrove from the University of Massachusetts is quoted in the Globe as saying “…the lack of biological tests for mental disorders renders psychiatry especially vulnerable to industry influence." Maybe so, but it’s not just psychiatry. And this new study should not be taken to invalidate psychiatric diagnoses or to undermine the efficacy of psychiatric treatments.

The existence of disease is not predicated on having a biological test. It’s nice when we do have one, but there are many disorders throughout medicine, not just in psychiatry, for which there is no conclusively defining biological test. Think migraine. Think multiple sclerosis. Think chronic pain.

There is a distinguished tradition of clinical research, going back to the late 1950s, wherein disorders like depression, mania, and schizophrenia were studied for their genetic profiles, their clinically meaningful subtypes, their biological correlates, and their responses to treatments. This bottom-up approach yielded useful theories, which in turn led to better theories and to new treatments for depression, mania, and schizophrenia. Like any other branch of science, clinical science has a self-correcting function that distinguishes it from pseudo-science and propaganda. So, we welcome new theories even though most will not survive, and we welcome new diagnostic proposals and we welcome potential new treatments. All are subject to the test of independent confirmation, and nobody is surprised when many fall away.

Since around 1990 that tradition has been corrupted by Pharma and Pharma’s money. There is no shortage of examples regularly in the news. Academic key opinion leaders lost their ethical compass and, with or without a figleaf, devolved into spokespersons for industry. One is reminded of Julien Benda’s term la trahison des clercs. Instead of moving on from undistinguished and problematic new drugs, key opinion leaders work with the marketing departments of Pharma to promote and defend the brand. Remember the PsychNetters? Of course, psychiatry is not the only medical specialty corrupted in this way. Stents, anybody? Orthopedic devices, anybody?

Lost in the marketeering and propaganda since around 1990 is the discipline of clinical therapeutics. As one commentator put it, if there is no way to confirm biologically the existence of disease, then “…we cannot confirm with much confidence that this or that treatment treats mental disease.” It actually is possible to identify effective treatments for mental disease. We did it with lithium. We did it with the early antidepressant drugs. And we did it with the early antipsychotic drugs. There was room for improvement in all of these, but make no mistake – they were dramatic positive developments. Most of the work in the past 20 years, however, put marketing first and clinical therapeutics second. Humbug aside, the goal was not to improve the management of depression or mania or schizophrenia but to jump whatever bar the FDA was setting in order to get a product on the market. Indeed, the really hard clinical research issues were studiously avoided. Along the way, the clinical research enterprise became dominated by academic and for-profit contract research organizations in which, to put it gently, standards of recruitment of patients apparently suffered, so that response rates in placebo-treated patients skyrocketed. As a result, proving that a drug does work became harder, and the overall drug advantage over placebo in treating depression came into serious question. In effect, the corruption of clinical research standards has brought us to an epistemologic quagmire about the efficacy of today’s most popular antidepressant drugs.

As for the charge that psychiatrists and primary care physicians just throw drugs at mental health problems, that is nothing new. It is a reflection of the professional pragmatism that permeates medical practice. Think back to the 1950s when the new wonder drugs called antibiotics were handed out like Pez, mostly for people who did not really need them and who would not benefit from them. The working principle was misguided simplicity and pragmatism, which minimized and discounted the risks. Even today the over-use of antibiotics remains a public health concern. Just as in the 1950s patients with nonspecific upper respiratory symptoms were “given the benefit of the doubt” and were prescribed an antibiotic on the reasoning that it might help them while probably not hurting them, so today patients with nondescript depressive or anxiety symptoms are prescribed an SSRI drug on the same reasoning. The cost of this approach in wasted money, in unnecessary side effects, and in unproductive clinical management is non-trivial.

So, the issues are more nuanced than today’s Boston Globe story would suggest. For good and for ill, psychiatry is not so very different from the rest of medicine. Corruption and compromise respect no subspecialty boundaries. We can have reliable and valid knowledge of disease without a biological test. We can show efficacy of treatments for disorders that lack a biological test. But when simplistic pragmatism and cutting corners dominate in therapeutics and in clinical trials, then we are in trouble.

Historic College of Pharmacy to Honor Homeopathy Leader

I want to call HCR readers' attention to a recent, disturbing post on Science-Based Medicine by one of my fellow bloggers, David Kroll:

I am a graduate of the institution known formerly as the Philadelphia College of Pharmacy and Science (PCP&S) - the first college of pharmacy in North America, established in 1821. The college, now called University of the Sciences in Philadelphia, counts among its alumni John Wyeth, Silas M. Burroughs, Sir Henry Wellcome, several members of the Eli Lilly and McNeil families, and other historical figures in pharmacy among founders of what have now become large pharmaceutical companies.

Although I was among the 35% of students in the “and Science” side of PCP&S, earning a BS in Toxicology, I was there at a time before Big Pharma had acquired much of the bad name it often carries today and we took great pride in our college’s rich history and contributions to modern medicine. In particular PCP&S graduates were critical players in combating snake oil hucksters in the early 1900s and establishing chemical standards, safety, and efficacy guidelines for therapeutic agents.

So it is with disbelief that I learned my alma mater plans to award an Honorary Doctorate of Science to a major leader in homeopathy - on Founders’ Day, no less. The press release is here.

Dr. Kroll's letter to University President Philip P. Gerbino and Provost Russell J. DiGate can be found here. Dr. Gerbino's disappointing response and Dr. Kroll's comments are here. Dr. Kroll also received a disappointing response from the president of the student government.

The NIH Trial to Assess Chelation Therapy (TACT): an unethical study sponsored by taxpayers

Two occasional HCR bloggers are co-authors of an article published this week:

Why the NIH Trial to Assess Chelation Therapy (TACT) Should Be Abandoned

Kimball C. Atwood IV, MD; Elizabeth Woeckner, AB, MA; Robert S. Baratz, MD, DDS, PhD; Wallace I. Sampson, MD

Medscape J Med. 2008;10(5):115. ©2008 Medscape
Posted 05/13/2008

Abstract:

The National Institutes of Health (NIH) Trial to Assess Chelation Therapy (TACT) was begun in 2003 and is expected to be completed in 2009. It is a trial of office-based, intravenous disodium ethylene-diamine-tetra-acetic acid (Na2EDTA) as a treatment for coronary artery disease (CAD). A few case series in the 1950s and early 1960s had found Na2EDTA to be ineffective for CAD or peripheral vascular disease (PVD). Nevertheless, a
few hundred physicians, almost all of whom advocate other dubious treatments, continued to peddle chelation as an office treatment. They claim that chelation dramatically improves symptoms and prolongs life in 80% to 90% of patients. In
response, academics performed 4 controlled trials during the 1990s. None favored chelation, but chelationists repudiated those findings.

We have investigated the method and the trial. We present our findings in 4 parts: history, origin and nature of the TACT, state of the evidence, and risks. We present evidence that chelationists and their organization, the American College for Advancement in Medicine, used political connections to pressure the NIH to fund the TACT. The TACT protocols justified the trial by misrepresenting case series and by ignoring evidence of risks. The trial employs nearly 100 unfit co-investigators. It conflates disodium EDTA and another, somewhat safer drug. It lacks precautions necessary to minimize risks. The consent form reflects those shortcomings and fails to disclose apparent proprietary interests. The trial's outcome will be unreliable and almost certainly equivocal, thus defeating its stated purpose.

We conclude that the TACT is unethical, dangerous, pointless, and wasteful. It should be abandoned.

The entire article is available at: http://journal.medscape.com/viewarticle/570625_print

You may be asked to "register"; don't worry, it's free. The article is very long, but the Introduction, Executive Summary, Discussion, and Conclusion are reasonably succinct and make the important points. Readers who want to learn more details, who want to see more evidence for our assertions, or who are compelled by an odd fascination with crackpotism (my own weakness) will want to read more.

I've posted a similar announcement on Science-Based Medicine.

The debasement of science by an "academia-industrial complex"

From Bloomberg in "Merck Masked Vioxx Risk, Hired Study Ghostwriters":

Jim Fitzpatrick, an attorney with Hughes, Hubbard and Reed who helped represent Merck in its Vioxx litigation, said all authors on Merck studies had input on them. It is part of the scientific process to list authors with varying degrees of involvement, he said in a telephone interview. ``Merck's expectation is if a scientist is an author on a paper, then he or she agrees with the paper, has had the opportunity to comment and make revisions,'' Fitzpatrick said. ``I think it does give the paper more credibility if there is a respected outside author that has reviewed and edited the content of the paper.''

If those are Merck's "expectations" for authorship, then Merck science seems seriously troubled, indeed.

This seems typical of the kind of debased "science" I experienced in the pharmaceutical industry, where, for example, IT personnel decided on what information assets drug discovery scientists could utilize, and in fact rationed and eliminated those assets based on their own idiosyncratic, science-ignorant whims, e.g., determine which specialty information repositiories to eliminate on the basis of "cost per user per database."

(Anyone who wants to better understand the dysfunctional "inner workings" of big pharma science might study the stories here, here and here.)

Fortunately, on the issue of biomedical authorship, there are "higher authorities" than a lawyer or a pharma company:

International Committee of Medical Journal Editors

Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication

Updated October 2007

... II.A Authorship and Contributorship

II.A.1. Byline Authors

An “author” is generally considered to be someone who has made substantive intellectual contributions to a published study, and biomedical authorship continues to have important academic, social, and financial implications. (1) In the past, readers were rarely provided with information about contributions to studies from those listed as authors and in acknowledgments. (2) Some journals now request and publish information about the contributions of each person named as having participated in a submitted study, at least for original research. Editors are strongly encouraged to develop and implement a contributorship policy, as well as a policy on identifying who is responsible for the integrity of the work as a whole.

While contributorship and guarantorship policies obviously remove much of the ambiguity surrounding contributions, it leaves unresolved the question of the quantity and quality of contribution that qualify for authorship. The International Committee of Medical Journal Editors has recommended the following criteria for authorship; these criteria are still appropriate for those journals that distinguish authors from other contributors.

Authorship credit should be based on 1) substantial contributions to conception and design, or acquisition of data, or analysis and interpretation of data; 2) drafting the article or revising it critically for important intellectual content; and 3) final approval of the version to be published. Authors should meet conditions 1, 2, and 3.

Note the statement: Authors should meet conditions 1, 2, AND 3. I don't believe prominent acacemics who add some "spit and polish" to ghostwritten articles qualify.

... When a large, multi-center group has conducted the work, the group should identify the individuals who accept direct responsibility for the manuscript (3). These individuals should fully meet the criteria for authorship/contributorship defined above and editors will ask these individuals to complete journal-specific author and conflict of interest disclosure forms.

When submitting a group author manuscript, the corresponding author should clearly indicate the preferred citation and should clearly identify all individual authors as well as the group name.

Journals will generally list other members of the group in the acknowledgements.

The National Library of Medicine indexes the group name and the names of individuals the group has identified as being directly responsible for the manuscript.

Acquisition of funding, collection of data, or general supervision of the research group, alone, does not justify authorship.

All persons designated as authors should qualify for authorship, and all those who qualify should be listed. Each author should have participated sufficiently in the work to take public responsibility for appropriate portions of the content.

Some journals now also request that one or more authors, referred to as “guarantors,” be identified as the persons who take responsibility for the integrity of the work as a whole, from inception to published article, and publish that information.

Increasingly, authorship of multi-center trials is attributed to a group. All members of the group who are named as authors should fully meet the above criteria for
authorship/contributorship.

The group should jointly make decisions about contributors/authors before submitting the manuscript for publication. The corresponding author/guarantor should be prepared to explain the presence and order of these individuals.

It is not the role of editors to make authorship/contributorship decisions or to arbitrate conflicts related to authorship.II.A.2.

Contributors Listed in Acknowledgments

All contributors who do not meet the criteria for authorship should be listed in an acknowledgments section.

Examples of those who might be acknowledged include a person who provided purely technical help, writing assistance, or a department chair who provided only general support.

Editors should ask corresponding authors to declare whether or not they had assistance with study design, data collection, data analysis, or manuscript preparation. If such assistance was available, the authors should disclose the identity of the people that provided this assistance and the entity that supported it in the published article.

Financial and material support should also be acknowledged. Groups of persons who have contributed materially to the paper but whose contributions do not justify authorship may be listed under a heading such as “clinical investigators” or “participating investigators,” and their function or contribution should be described—for example, “served as scientific advisors,” “critically reviewed the study proposal,” “collected data,” or “provided and cared for study patients.”Because readers may infer their endorsement of the data and conclusions, all persons must give written permission to be acknowledged.

It seems many of the so-called "authors" of these ghost authored papers should have been listed not as authors but as "participating investigators" or "scientific advisors." An example might be this person:

... Steven H. Ferris, a neuropsychologist at New York University School of Medicine who is listed as the second author, said [the charges of ghost authorship were] ... not true. He said he was on a committee that reviewed the clinical records of 195 patients who received diagnoses of Alzheimer's during the study -- a task that took many hours, and for which he was paid.'I was directly involved in a very substantive way,' he said this week.

While such a person may have been involved "in a substantive way", it does not appear to me that this rises to the level of authorship per the ICMJE requirements. "Scientific advisor" would have been a more precise term.

Perhaps the most unfortunate issue is that I believe the academics who've listed themselves as authors, and who stand behind that assignment in the recent articles on this controversy, actually feel entitled to such a designation. I truly believe that they believe they qualify as authors and that they lack an understanding of - or don't care about - guidelines such as those of the International Committee of Medical Journal Editors.

That these academics also benefit substantially, both in their academic careers and financially, from accreditation as senior authors in prominent journals once again demonstrates the ethics-debasing effects of conflict of interest.

Besides such self-delusion, part of the problem may also be that those that believe themselves member of an elite class, such as some high-powered academics in biomedicine and lavishly paid executives in industry, do not believe themselves subject to such standards.

Peter Kim's statement that "We are disappointed that such false and misleading statements about Merck from trial lawyers have made their way into a medical journal" suggests Kim, a former academic in a small lab, is not highly familiar with the ICMJE guidelines.

This would not be inconsistent with the debased state of scientific attributionship in academia in general that I have noted in my writings. Academia itself lacks a pristine reputation on handling of intellectual property matters. For example, several years ago bitter authorship disputes were found to be increasingly frequent by the Ombud of Harvard Medical School and felt to affect other academic institutions as well. Even worse, the Harvard Ombud wrote that “it is unreasonable for institutions to promise that they can protect individuals from retaliation for coming forward to complain through formal grievance procedures.”[1] In my response in JAMA I indicated alarm at the latter opinion.[2]

I've had a personal taste of this debasement. Yale professors tried to misappropriate my intellectual property, assisted by a Yale lawyer who was in fact unauthorized to practice law in Connecticut, and tried to use extortionary methods and blacklisting in order to do so. That story is here. (Attached at that link is a pdf presentation on a government investigation of Yale's inability to manage their government grants transparently as well.)

In effect, academic's dysfunction and industry's interests and lack of ethics may have reached an ideal stage of co-dependency, forming an "academia-industrial complex" that has led to today's debasement of biomedicine.

That the inner workings of this "complex" are now being exposed comes at a critical juncture and offers a chance at remediation. With this exposure and with the new information dissemination tools enabled by the Internet (the effects of which were painfully learned by people such as Dan Rather and John Kerry), there may yet be hope for reform.

References:

1. "The Coin of the Realm, The Source of Complaints", Linda J. Wilcox, EdM, CAS, Ombud, Harvard Medical School, Journal of the American Medical Association. 1998;280:216-217, http://jama.ama-assn.org/cgi/content/full/280/3/216

2. "Academic and Legal Aspects of Authorship Disputes" (letter), Journal of the American Medical Association. 1999;281:135-136, http://jama.ama-assn.org/cgi/content/full/281/2/135-a (subscription required)

Dr. Stossel Sounds Off

DR. STOSSEL SOUNDS OFF

Thomas Stossel, MD, Professor of Medicine at Harvard Medical School, has released another opinionated piece this week on academics’ conflicts of interest. It appears in this week’s British Medical Journal. Like his previous rants, this one combines tangentiality, circumstantial thinking, illogical thinking, false assumptions, smears, insults, and the demonizing of those with contrary opinions. Roy Poses did an excellent job of exposing Stossel’s rhetorical smoke and mirrors, so I will not belabor this point.

The central pathology in Dr. Stossel’s rant is his denial or minimization of current ethical problems in academic-corporate relationships in medicine. If he wishes to be taken seriously, he should familiarize himself with case studies of the corporate corruption of medicine. Contrary to Stossel’s assertion that these problems don’t exist, here is a link that describes the corruption of a major journal by key opinion leaders in cahoots with Pharma executives: http://hcrenewal.blogspot.com/2008/01/antipsychotic-drugs-for-depression.html . Every sleazy deceit in the book was in play here.

There are similar problems in continuing medical education events that are funded by drug and device corporations. See here: http://hcrenewal.blogspot.com/2008/01/variations-on-theme-of-sleaze.html

The main player in these unsavory instances is a member of the Institute of Medicine of the U.S. National Academy of Sciences. This individual is an ethical recidivist who has been outed multiple times for failure to disclose salient conflicts of interest; who was forced to resign the editorship of a major medical journal; and who was forced to retract false statements that favored his corporate clients (otherwise known as shilling). Dr. Stossel notwithstanding, the rest of us are appalled by such tastelessly venal spectacles at the highest level of American medicine. Is it any wonder that the likes of Dr. Stossel are viewed as challenged?

A Truly Appalling Lawsuit Against Duke University

Most everyone is aware of the Duke lacrosse team scandal, the debacle about alleged rape by Duke lacrosse team students that led to the resignation of prosecutor Nifong for prosecutorial misconduct, exoneration of the accused, an expose of the radical agendas of a subset of Duke's faculty, and a great deal of national publicity, or, I should say, notoriety.

Now, in Dec. 2007 several of the team members have filed a civil suit. The lawsuit filing documents are downloadable from these links (PDF files):

Part 1 (100 kb PDF)
Part 2 (1.3 Mb PDF)

I recommend downloading and perusing these in their entirely. Stunning - and frightening.

Using Adobe Acrobat, a search in them upon the term "medical" is of great concern. Named in the suit as defendants are Duke University Health Systems, a private diagnostic clinic contracted to Duke, a number of physicians and RN's, and unversity officials overseeing medical affairs.

What caught my attention were:

• A massive conspiracy to deprive three young men of their rights under the U.S. Constitution, of Stalin-police state proportions
• Sections on production of falsified medical records to support fabrications regarding sexual assault examinations
• The naming of a number of Duke medical center and medical center-associated officials including the Chancellor for Health Affairs (a physician Victor Dzau MD) as direct participants by commission and/or omission (e.g., indifference to, and failure to act against obvious impropriety)
• The collusion or tepid reactions of the most senior Duke officials right up to the Chairman of the Board of Trustees.

Overall, this story would make for the most stunning of movies of Serpico proportions - and probably will be, and should be.

If the allegations are even partially true, we have the most candid expose of the severe state of moral decay that afflicts our educational system (a system that produces our leaders of other organizations), our healthcare system, our justice system, and our culture.

More on the Duke situation can be found at this extensive, well-written fellow blogspot site, put together by one non-Duke professor named KC Johnson, Durham-in-Wonderland.

How I became aware of this is a story unto itself.

I noted the following passage in a polemical November 2007 article most ironically entitled Academic Freedom: The 'Danger' of Critical Thinking", International Studies Perspectives 8 (4), 396–400, doi:10.1111/j.1528-3585.2007.00306.x by Duke Professor of Asian and African Languages and Literature Miriam Cooke (fulltext here):

In this time of war that allows some people to lie and cheat, it is taboo for others to think critically ... It is dangerous even "to speculate about the relation between this war (in Iraq) and the geopolitical interests of Israel." These are the words of Paul Gilroy, who, at the time of speaking, was chair of African-American studies at Yale. Enraged, his colleague Scott Siluerstein compared him with Hitler and claimed that his words "illustrated the moral psychosis and perhaps psychological sadism that appears to have infected leftist academia." (Younge 2006).

This discovery led me to a literature search that led me to the Duke lawsuit documents. Cooke is profiled here.

Cooke actually misquotes a misquote by writer Gary Younge in the British newspaper The Guardian in an article "Silence in Class", April 4, 2006. In turn, Younge had misquoted an editorial authored by me that appeared in the Wall Street Journal on April 17, 2003 (see this link for my original.)

To be more precise, I should say that Younge used the "art of political war" rhetorical ploy utilized to discredit anyone who even writes about history's worst figures and any favored academic/politican/etc. in the same essay. As an act of obfuscation and diversion in the interests of ideological/political warfare, the ploy is to say the author is comparing the subject to history's worst figures, or even equating them. Cooke then parroted Younge's rhetoric.

Why the diversion and obfuscation? To obscure that I was actually pointing out that dangerous ideas -- especially crackpot conspiratorial ideas held by numerous very notorious historical figures dating back centuries -- have dangerous consequences. I was also commenting on the proven bigotry, cruelty, crassness, and insensitivity of statements made by deGenova, Baraka, Gilroy and others towards Israel, Holocaust victims and their families. (If you want a flavor of what many radical academics write, say, or think of as brilliant work, see here and here as examples.)

This ploy and lexical, semantic, contextual, and other games often seem the limit of the capability for debate of far too many of today's academics and mainstream media writers. (Where they learn these tactics, I do not know, but perhaps there is some sort of training fellowship.)

Duke Prof. Cooke didn't bother to contact me, a fellow academic, nor apparently do a simple google search or utilize the considerable informatics resources of her own university's library to find my original Wall St. Journal letter and my online response to Younge, on AOL at the time and now here. (Another possibility is that she did find them and ignored them, of course.) Cooke simply parroted Younge plus for literary effect invented my being "enraged" at my "colleague" (in fact, I rolled my eyes at Gilroy's statements, as one does towards the drivel coming from the Ivy League these days, and a simple fact check would have shown that I was not Gilroy's "colleague" and that our times at Yale did not intersect).

In summary, academic research for this tenured professor and Oxford graduate consists of parroting secondary sources such as The Guardian as fact, inventing events and relationships that did not exist, and not bothering to check primary sources either directly or indirectly, a fundamental tenet of reputable academic research. Or perhaps Cooke chose to ignore primary sources, a rather shoddy and irreputable approach to scholarly research. To Cooke, "critical thinking" apparently means "semantic legerdemain and reckless criticism of everything she does not agree with."

I subscribe to a different definition, consistent with the teachings of my early mentor Victor P Satinsky, inventor of the Satinsky clamp and many other cardiothoracic surgery tools and techniques used to this day. Dr. Satinsky ran ran rigorous programs emphasizing critical thinking, responsibility, and clear, direct language in the interests of patient care:

Critical thinking means correct thinking in the pursuit of relevant and reliable knowledge about the world. Another way to describe it is reasonable, reflective, responsible, and skillful thinking that is focused on deciding what to believe or do. A person who thinks critically can ask appropriate questions, gather relevant information, efficiently and creatively sort through this information, reason logically from this information, and come to reliable and trustworthy conclusions about the world that enable one to live and act successfully in it.

(It's not a simple matter of incompetence. "Quackademics" who do not believe in reason and logic - the tools of the "oppressors" - are largely incapable of true critical thinking. Hysterical rants, semantic trickery, obfuscation they can do. Distortions and mistruths are no problem for them, since in their minds the means justifies the ideological ends. Put plainly, they are deceptive liars. But they are not incompetent. In the Art of Political War, they are actually quite competent. It does, however, scare the daylights out of such academics when people who do think rationally have "got their number" on that particular skill. Thanks to advances in information and communication technologies, an increasing number of ordinary people are "getting their number." Of that they are truly terrified. But I digress.)

Not surprisingly, I discovered that Cooke was a member of the "Group of 88", a group of Duke professors who apparently gave the accused students a behind-closed-doors fair trial (of course, defendants' presence not required), then lined them up and had them figuratively shot with a well-publicized statement implying their guilt. From the Inside Higher Ed article linked above:

... The 88 signatories affirmed that they were “listening” to a select group of students troubled by sexism and racism at Duke. Yet 8 of the 11 quotes supplied from students to whom these professors had been talking, 8 contained no attribution — of any sort, even to the extent of claiming to come from anonymous Duke students. Nonetheless, according to the faculty members, “The disaster didn’t begin on March 13th and won’t end with what the police say or the court decides.” It’s hard to imagine that college professors could openly dismiss how the ultimate legal judgment would shape this case’s legacy. Such sentiments perhaps explain why no member of the Duke Law School faculty signed the letter.

I contacted Cooke, pointing out her errors and providing rather sarcastic commentary on how I was part of the Great Walt and Mearsheimer Cabal against academic freedom (a metaphor for another rather tenuous and tendentious piece of 'research' from yet another Ivy, Harvard). I have not received any reply. This is typical of academic tyrants, who are cowards when confronted outside of their power base. I contacted by email and phone the office of Duke President Richard H. Brodhead inquiring if Brodhead believed citing secondary sources constituted good research practice. He also has not replied.

Finally, I wonder if current Duke president Brodhead, who was an official at Yale until 2004 and implicated in this Duke lawsuit for sins of omission and commission, was involved in events covered in the previous post about an ongoing Federal investigation of Yale research grant accounting ("Lux et Veritas, or Trust But Verify? Yale discovers eDiscovery"). An interesting Powerpoint presentation on that matter is here (PPS file).

I think a comment made on the Duke-in-Wonderland site is particularly apropos:

"Another development on the local Duke scene is the “raised consciousness” of sensible alumni and institutional friends ... Any intelligent Duke alumnus of whatever age should now realize that he or she probably has more sensible and constructive ideas that many prominent Duke faculty."

This Duke disgrace is perhaps an epitaph for today's tenured, $100,000+ annually, pot-smoking, "oppressed" 1960's misfit-dominated academia.

-- SS

Addendum: there is much wisdom in this posting by KC Johnson regarding intellectual decay in academia. Many of the points raised also apply to the matters discussed on this blog. That academia sets the tone through its influence on students suggests that one path to "healthcare renewal" is via "academic renewal."