BLOGSCAN: Florida Doctors Endorse Ex- Columbia/ HCA CEO for Governor

Rick Scott was the CEO of for-profit hospital chain Columbia/ HCA.  The company ended up settling civil and criminal charges for $1.7 billion.  Like many other examples in the march of legal settlements about which we have often posted, no individual who authorized, directed, or implemented the relevant bad behavior suffered any sort of negative consequence or paid any penalty.  Rick Scott left the company, but with a golden parachute.  Now he his running for Governor of Florida, using a substantial amount of his own money (but money that probably mostly came from Columbia / HCA). (See post here.)  He may be in the lead.  And the Florida Medical Association has just endorsed him.  In the Health Beat blog, Maggie Mahar is all over this story.  Read it and weep.  Remember another good reason for the people who lead health care organizations to be truly accountable for their actions.

The “Gonzalez Trial” for Pancreatic Cancer: Outcome Revealed

The regimen advocated by Nicholas Gonzalez is a variation of a “detoxification” treatment for cancer that has been around, in one form or another, for more than 50 years ("Gerson Therapy” is another example). Here is the National Cancer Institute’s (NCI) description:

Patients receive pancreatic enzymes orally every 4 hours and at meals daily on days 1-16, followed by 5 days of rest. Patients receive magnesium citrate and Papaya Plus with the pancreatic enzymes. Additionally, patients receive nutritional supplementation with vitamins, minerals, trace elements, and animal glandular products 4 times per day on days 1-16, followed by 5 days of rest. Courses repeat every 21 days until death despite relapse. Patients consume a moderate vegetarian metabolizer diet during the course of therapy, which excludes red meat, poultry, and white sugar. Coffee enemas are performed twice a day, along with skin brushing daily, skin cleansing once a week with castor oil during the first 6 months of therapy, and a salt and soda bath each week. Patients also undergo a complete liver flush and a clean sweep and purge on a rotating basis each month during the 5 days of rest.

As unlikely as it may seem, in 1999 American taxpayers began paying for people with cancer of the pancreas to be subjected to that regimen, in a trial sponsored by the National Center for Complementary and Alternative Medicine (NCCAM) and the NCI, conducted under the auspices of Columbia University. Gonzalez provided the treatments. A few months ago, on Science-Based Medicine, I presented a multi-part treatise on the “Gonzalez regimen” and the trial. It demonstrated that all evidence, from basic science to clinical, including the case series that had supposedly provided the justification for the trial, failed to support any real promise for the treatment.

It showed that the impetus for the trial, as has been true for other regrettable trials of implausible health claims, can be traced not to science but to the reactionary politics of anti-intellectual populism: initially to Laetrile and to the “Harkinites,” and more recently to the Honorable Dan Burton (R-IN). It reported that there had been major problems with the Gonzalez trial from the outset, and that for at least one subject the regimen had been more torture than therapy. It reported that for unclear reasons the trial had come to a halt a couple of years ago, and that it appeared that there would never be a report of its findings.

That series of posts also argued what was later summarized here: that, for good reasons, the New York State Board for Professional Medical Conduct had nearly revoked Dr. Gonzalez’s medical license during the 1990s—only to retreat from that position after two misguided academics had testified that his regimen might benefit cancer patients.

The apparent non-outcome of the Gonzalez trial would be the final insult among its numerous, serious ethical violations. These were discussed, at some length, here and here; they include the fallacy of 'popularity,' which has been the NCCAM's primary rationale for human trials of implausible health claims. On June 2, 2008, one month after the last posting of the series, new information about the Gonzalez trial became available in the form of a determination letter from the federal Office of Human Research Protections (OHRP). In part, it stated:

The complainant alleged that a minimum of 72 subjects were to be enrolled under the IRB-approved protocol, but that the study was terminated with only 62 enrolled subjects, in violation of HHS regulations… CUMC [Columbia University Medical Center] reported that the Data Safety and Monitoring Committee (DSMC) for this protocol recommended that the study be terminated before it reached its full enrollment of 72 subjects. At its September 30, 2005 meeting, the DSMC recommended that the study be terminated due to predetermined stopping criteria. This information was submitted to the CUMC IRB on October 17, 2005, and the study termination was approved by the IRB.

What this means, in summary, is that the trial must have found the Gonzalez regimen to be either much better or much worse than standard treatment for cancer of the pancreas. It is certain that it was much worse, of course, because otherwise we would have heard about it years ago. I have offered additional evidence for that conclusion, and an explanation for why this information has not been reported by the responsible investigators, in a longer version of this posting.

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.

Did Politics Trump MCAT in an Admissions Decision at the University of Florida?

Several stories in the Gainesville (Florida) Sun and the Florida Alligator suggest issues with the leadership of the University of Florida College of Medicine. As first reported in the Sun,

In a move that breaks with the norms established by medical school accreditors, the dean of the University of Florida's College of Medicine has opted to admit a student from a politically connected family, even though the student didn't have the backing of the Medical Selection Committee.

Kone wouldn't name the student, but sources close to the situation identified him as Benjamin Mendelsohn, the son of Dr. Alan Mendelsohn, a Hollywood ophthalmologist and a Republican fundraiser who was a grassroots organizer for Gov. Charlie Crist during his 2006 campaign.

Before Kone took over as dean in May 2007, Gov. Crist sent a letter to UF in February 2007 on Mendelsohn's behalf. The letter, addressed to UF's admissions officer and copied to UF President Bernie Machen, urged UF to admit Mendelsohn to the Junior Honors Medical Program, an accelerated seven-year program that combines bachelor's and medical degrees.

'I have known Benjamin and his family for several years and know that Benjamin's affiliation with the University of Florida will mutually enhance the reputation of both Benjamin and the Medical Program,' Crist's letter states.

In 2006, the Mendelsohn family gave at least $33,257 to political candidates, 94 percent of which went directly to Republicans, according to the Florida Department of State's Division of Elections. Of that money, $1,682 went to Crist, including a $500 donation from Benjamin Mendelsohn himself.

Alan Mendelsohn is a known fundraiser in the medical community. In 2005, he held a fundraiser in his own home where more than 150 physicians raised more than $100,000 for Crist, according to a news release from the Florida Medical Political Action Committee.

The Dean denied that politics influenced his decision.

'I can't even comment that there were any political connections that this person had, but I certainly wasn't influenced by any outside forces,' Kone said Thursday.

'There was no political influence related to this thing,' Kone added in a second interview Thursday night. 'There never will be. There never has been. This was an exceptional student, and I wish to God I could even tell you about (the student's) credentials.'

The Dean also asserted that he had the power to admit the student against the wishes of the committee. It appears, however, that his action may have violated rules set by medical school accreditors.

The move breaks with procedures described by the Liaison Committee on Medical Education, which provides accreditation to UF and medical schools throughout the U.S. and Canada.

'The final responsibility for selecting students to be admitted for medical study must reside with a duly constituted faculty committee,' according to the accrediting body's standards.

Furthermore, the accreditation standards say 'the selection of individual students must not be influenced by any political or financial factors.'

Barbara Barzansky, co-secretary of the Liaison Committee on Medical Education at the American Medical Association in Chicago, said the central role of faculty in admissions is well-established in the medical community.

'I think the standard speaks for itself. It expects that there be a faculty decision around admission,' she said.

'Deans may be under pressure from groups, alums, sometimes the Legislature, depending on the type of school and the location,' she added.

A follow-up in the Gainesville Sun suggested more irregularities in the admissions process. First, it appears the student had never taken the MCAT, a test usually required as a prerequisite to medical school admission.

When the committee considered the 2008 application of Benjamin Mendelsohn, the son of a prominent Republican fundraiser and contributor, Mendelsohn had not taken the Medical College Admissions Test, or MCAT, according to three members of the selection committee and two other sources close to the situation. The MCAT is a standard admissions requirement for regular admission to the program, selection committee members said.

A peculiar memo to medical school administrators, and copied to University President Bernie Machen, suggested that the Dean's actions may have had even murkier origins.

In the e-mail, time-stamped Friday at 10:52 p.m., Kone said Machen's staff did not 'sho(o)t straight' when he met with them, adding that they were not sufficiently courteous to him when they discussed the admissions issue.

'I don't know if it was cowardice, a lack of compassion, or what, but it is symptomatic of why this university is stuck in mediocrity and has been since I left here 13 years ago,' wrote Kone, a former UF student and faculty member.

Kone said that he followed university precedent, 'delivered a great student. Took many bullets for the team. Protected the mother ship.'

Asked whether Kone's reference to protecting the 'mother ship' implied that he was pressured to accept the student, Machen responded Wednesday, 'Please don't make inferences that would be pure conjecture . . . I assure you neither I nor any member of my staff had any involvement in the medical student admission decision.'

Finally, it appears that faculty are disturbed, but fearful of speaking up.

Several faculty members who contacted The Sun said they feared what might happen to their careers if they were publicly critical of the dean's actions. As evidenced by his Friday e-mail, Kone has openly criticized those with whom he disagrees - even Machen's own staff.

Obviously, there are some fuzzy aspects to this story. We may not have heard anything like a final version yet.

What is most disturbing about it, however, are the implications that medical school leadership may have been acting at odds with the institution's mission. In particular, it appears that at least one admission decision may have been affected by politics rather than students' credentials, and faculty are afraid to criticize it. The integrity of the admissions process is fundamental to the integrity of the medical school. Suppression of dissent clashes with the academic ideal of free enquiry. Finally, power within this school seems to have centralized to an unusual extent. Transforming the corporate culture of academic medical institutions into central domination by an "imperial CEO," as is now common in business, is fraught with danger for institutions that are supposed to be about excellent patient care, and discovering the disseminating the truth.