Not with a bang but with a whimper

This is the way the world ends
This is the way the world ends

This is the way the world ends

Not with a bang but with a whimper
     -- T. S. Eliot, The Hollow Men, 1925

Those across the Commonwealth of Pennsylvania who lived through the disaster known as AHERF, the story of the Allegheny Health and Education Research Foundation, ending in one of the biggest non-profit health care bankruptcies in US history, may now note in passing the death some months ago--just recently announced--of its architect, one Sherif Abdelhak.

Many books and articles have been written about this hubristic exercise in go-go corporatism. It was a fiasco that left many endowments decimated and the remnants of two Philadelphia medical schools in shreds.

For those who lived through that era, the death of "the sheriff" is bittersweet. It has passed virtually unnoticed until now. But it's worth remarking, not just for its local but also its national meaning. By the high-rolling mid-1990s, tellingly, the Association of American Medical College's prestigious Cooper Lectureship led through the following roster. Here is the list for the decade commencing 1985 and leading to its 1995 apogee

• 1985 John A. D. Cooper
• 1986 Paul B. Beeson
• 1987 Uwe E. Reinhardt
• 1988 Henry G. Cisneros
• 1989 Lauro F. Cavazos
• 1990 John F. Sherman
• 1991 Margaret Catley-Carlson
• 1992 Leroy Hood
• 1993 Bruce M. Alberts
• 1994 Merwyn R. Greenlick
• 1995 Sherif S. Abdelhak

A nice progression. Three years later, in 1998, AHERF and Allegheny University of the Health Sciences, went belly up. Its successors are still recovering. But too many parts of our health educational and health care systems still show signs of the sheriff's avaricious behavior.

Academic Medicine Deploys a Logical Fallacy to Avoid Disclosing Inconvenient Truths

We recently discussed a simultaneous retreat from aggressive regulation and enforcement applied to big health care corporations by US government agencies.  Now a story published by Bloomberg (currently available without a subscription here on PharmaGossip) showed that the push for less disclosure of relationships with industry that generated conflicts of interest for academic medicine came not from industry, but from ... academic medicine:

The lobby for Harvard University and other research institutions drove the Obama administration to weaken draft rules for scientists to disclose potential conflicts of interest, according to U.S. records and watchdog groups.

In particular,

Universities objected to draft rules in a letter to NIH and in meetings with officials at the White House Office of Management and Budget, approver of the final version, said Carrie Wolinetz, associate vice president for federal relations at the Association of American Universities that represents 61 research universities.

Also,

The letter was co-signed with the Association of American Medical Colleges, American Council on Education and Association of Public and Land-Grant Universities.

The one example of the universities' reasoning to justify their objections to greater disclosure of conflicts of interest was striking.

Wolinetz’s organization wrote in the letter that 'there is a paucity of evidence that the disclosure and management of financial conflicts of interest affect objectivity and integrity.'

Recall that the disclosure to which they objected would be by federally funded researchers, and of financial relationships with organizations that had vested interests related to the particular research projects. The Institute of Medicine's landmark report, "Conflict of Interest in Medical Research, Education and Practice,"  stated:

Disclosure of financial relationships with industry is an essential, though limited, first step in identifying and responding to conflicts of interest.

One could also argue, as did Senator Grassley, (see here) that disclosure is owed to the tax-payers who support the research.

On the other hand, I do not think anyone would argue that disclosure and the ill-defined "management" proposed by the NIH would be sufficient to guarantee "objectivity and integrity" of the research.

In fact, the IOM report called for going far beyond disclosure.  Specifically, it called for banning most conflicts affecting most clinical research:

researchers should not conduct research involving human participants if they have a financial interest in the outcome of the research

This goes far beyond what the original NIH revision of its conflict of interest rules mandated. However, I am sure that banning such relationships was the last thing that the AAU and AAMC wanted.

So the academic institutions' argument seems to be a variant on the false dilemma logical fallacy. If the only alternative to doing nothing about conflicts of interest is disclosure, and if disclosure is really a poor solution to the problem, than perhaps doing nothing makes sense. However, if disclosure is just a necessary first step, as the IOM asserted, then it is a first step that should be taken in preparation for other steps to come.

Note that the academic institutions' argument also seems to be a version of what has been called the Nirvana fallacy, or the perfect is the enemy of the good fallacy. That is, if what one can do does not result in Nirvana, then one should do nothing.

Finally, in this case the academic medical institutions' argument seemed too extreme even for their pharmaceutical industry supporters. As the Bloomberg article reported,

Researchers have been lax making financial disclosures and there’s been an absence of oversight, said Peter Pitts, president of the Center for Medicine in the Public Interest, a nonprofit research institute in New York. 'When you don’t properly disclose, you give the impression that you’re trying to hide something.'

Institutes should instead disclose all financial interests without trying to judge whether they are conflicts, Pitts said.

As we have discussed previously, Peter Pitts' main occupation has been as a leader in public relations for the pharmaceutical industry. He is currently a senior partner, director, global regulatory & health policy for Porter Novelli. Even though we have previously criticized Pitts for deploying logical fallacies in support of industry positions, in this case the academic medical institutions' argument was too much for him to support.

So we have come this far. Universities are ostensibly about finding and disseminating the truth. Yet universities' academic medical subsidiaries now deploy illogic to avoid revealing particular truths that they find uncomfortable, and which might raise questions about relationships with industry that are increasingly lucrative. Universities seem now willing to jettison their mission to make more money.

True health care reform would require academic medicine to put its mission ahead of its revenues.

New AAMC Principles for Protecting Research Integrity: A Small Step For Medical Research

In last month's American Association of Medical Colleges (AAMC) Reporter was a notice of the new AAMC Principles for Protecting Integrity in the Conduct and Reporting of Clinical Trials (The full document is here.)

The Principles contain some good bits. For example, they insist that a multi-site randomized controlled trial should have a publication and analysis committee which should have a right to access "any data generated druing the study that the committee deems necessary to ensure the integrity and validity of the study and any presentations based on it." The Principles also declare "ghost or guest authorship is unacceptable."

Had these Principles been in force in the UK (although, admittedly, they were written for the US), they might have averted the messy case at Sheffield University that we just addressed here and here.

However, the Principles are also notable for what they do not say.

In a previous post on Health Care Renewal, we discussed the study bv Mello et al of contracts between commercial sponsors and academic research institutions. The study identified a number of contract provisions that could let sponsors manipulate the design, execution, analysis, dissemination, and discussion of research.

Most of these contract provisions were not addressed by the new Principles.

To illustrate, I will list the provisions mentioned in this previous post (in italics), with comments on how the new Principles do or do not address them. (The percentages after each provision refer to the proportion of medical school contracting officials who would permit that provision in a contract with a research sponsor.)

• The sponsor will own the data produced by the research - 80%
  The principles implicitly allow the sponsors to own the data, but they say that a publication and analysis (P&A) committee should have access to any part of the data it "deems necessary to ensure the integrity and validity of the study...." This committee, in turn, should have a majority of academic members, but can include sponsors' representatives. How the committee should function is not specified.
• The sponsor will store the data and release portions to the investigator - 35%
  Again, the Principles implicitly allow this practice, as noted above.
• The investigators (whether at your site or any other site) are not permitted to alter the study design after the agreement is executed - 68%
  The Principles do not address who designs studies, nor who may alter them. They only state that "any deviations to the pre-specified plan should be identified and discussed."
• The sponsor is permitted to alter the study design after the agreement is executed - 62%
  Again, since alterations of the study are allowed, but who may alter them is not discussed, this is not directly addressed.
• The sponsor may prohibit individual site investigators from publishing manuscripts independently of the sponsor or group - 15%
  The Principles state "individual site investigators in a multisite trial should be free to analyze and publish data from the individual site, consistent with sound principles of analysis, but only after publication of the study as a whole and after review and comment (but not approval) by the P&A committee, or, in the absence of acceptance of the full publication, within 18 months from the specified end points or earlier termination of the study." So the Principles seem to prohibit this provision.
• The sponsor may include its own statistical analysis in manuscripts - 24%
  The Principles include a statement that "the P&A committee of multisite clinical trials (or the principle investigator of a single site study) should require that the sponsor of the study perform its analysis of trial data in a defined period of time." Thus, the Principles implicitly allow the sponsor to do the primary analyses of study data, and hence do not directly contradict this provision.
• The sponsor will write up the results for publication and the investigators may review the manuscript and suggest revisions - 50%
  Although the Principles state that all people who have a role in authoring manuscripts accurately disclose these roles, they do not specify who should be primarily responsible for manuscripts. They also explicitly say "it is acceptable for an employee of the sponsor to participate in drafting and publication activity, if fully disclosed." Thus the Principles do not contradict this provision.
• While the trial is going on, the investigators may not discuss research results (including presentations at scientific meetings) with people not involved in the trial - 66%
  The Principles do not address this provision at all.
• After the trial is over, the investigators may not discuss research results (including presentations at scientific meetings) until the sponsor consents to dissemination - 21%
  The Principles state that "the P&A committee or PI should make a good faith effort to disseminate results of the study through peer reviewed mechanisms," and that "researchers and their institutions have an ethical obligation when conducting human research to seek to make the results available publicly," and that "all trials meeting the ICMJE requirements for registration should make their results publicly available ... within 18 months of submission of a manuscript for publication." However, nothing in the document prevents the sponsor from otherwise exerting control over dissemination.
• The terms of the clinical-trial agreement are confidential - 62%
  The Principles do not address this provision.
• After the trial is over, the industry sponsor may prohibit investigators from sharing raw research data with third parties - 41%
  The Principles state "the sponsor, the investigators, and their institutions should a adopt a model for data sharing, post publication, similar to that of NIH." They do not further specify the NIH model.

Although these new AAMC Principles for Protecting Integrity in the Conduct and Reporting of Clinical Trials are a step forward, they are but one small step. Unfortunately, these principles fail to address many of the egregious contract provisions that commercial firms that sponsor research insert in contracts made between them and medical schools or academic medical centers in the US. Until more is done, commercially sponsored clinical research done in the US remains potentially under the control of the sponsors, rather than the academic "principle investigators."
I wonder how many patients would sign up as research subjects if they knew that the research was controlled by the company who made the drug or device being studied, rather than by the white-coated academic researchers?