December 4

IRB Forum Not Inclined to Discuss the Most Serious Issue of All

I posted to the IRB Forum (a chatroom) the AHRP Infomail reporting about the Harvard study of 100 university-based IRBs that found conflicts of interest undermining the independence and integrity of the IRB research approval process.  See:

IRBs have received little conflict of interest scrutiny from independent analysts compared to medical journals, the other arbiters of medical research ethics and scientific standards. In large part this is due to the insularity in which IRBs function.

The Office of Human Research Protection issues numerous "letters of determination" outlining in language couched as to protect violators. These letters are seen by few–much as FDA letters of warning to pharmaceutical companies for deceptive marketing.

What is worse, IRBs, like the companies that receive written reprimands, do not even discuss the content and nature of the violations. Thus, the IRB community has evaded any rigorous self-examination. Instead, they attack the messenger, put their head in the sand, and rationalize notorious cases that escape their control into the wider world, primarily through press exposes.

The post was met with a chorus of angry hostile attacks and rationalizations. Here are snippets:

" I would tend to say that 80% (the overwhelming majority) seem to be going by the books.
Also, I disagree with the contention that the 20% who admit to being less
than conscientious constitute evidence that IRBs are "On the Take".

"I cannot recall reading anything on this discussion group that was offensive until I read Ms. Sharav’s posting.   It is an example of a not for profit, whose work should be in the public’s interest, distorting and disseminating “disinformation” to the benefit of no one.  Perhaps, this obviously biased review of Campbell’s work may be explained by the reviewer’s lack of understanding of research methods, or more onerously, to promote her personal agenda…"

"Wow!  Everyone is on the take?  How does one face the day with such a pathologic level of cynicism?  I

But then, Dr. John Bucek posted a thoughtful comment (below) to which I responded.
Unfortunately  the response did not make it through the IRB Forum gatekeeper–no doubt because of the hostile reception. However, I was assured that the url to this post would be  provided to  the Forum for those daring enough to read it. 

—–Original Message—–
From: [] On Behalf Of John Md Bucek
Sent: Sunday, December 03, 2006 7:41 PM
Subject: [IRB Discussion] Are Hospital IRBs "On the Take"–Tainted by Conflicts of Interest_NEJM

I have not read the full article, just the abstract.  My reaction is to the
few reactions that have been posted here on the forum.  I suspect there is
over statement and exaggeration in the article or a preachy tone maybe. 
However, this is self report data from the best I can tell.  So the
possibility exists that there is more financial gain from industry than even
reported.  If I was a layperson, any comments of a defensive nature or any
comments attacking the article could be seen as proof of guilt

When I participate in a study I would like to hear that none of the people
reviewing the study for merit and safety get their income from the people who
sponsor the trials.  Just a few dollars to just a few members would hardly be
reassuring.  We are trying to avoid the perception of influence.  Then we do
not have to argue about just how much influence was gained by taking money
from big pharma

A few studies I have read state clearly that taking small gifts and honoraria
from marketers and detail people change prescribing habits.  Everyone has a
price and ours is very low.  Why would drug companies bother doing these
things if they didn’t help them make money?  Is it possible that the same
thing happens in research as it does in clinical practice?  Yes it does.  It
happens at times in an even more direct way.  If a study is sponsored by a
manufacturer their sponsorship contracts sometimes indicate that the study can
 be quashed if the sponsor wishes. How can it be that these relationships
create influence every where else but not when the person being paid is on an IRB?

In a practical sense the only way to do certain research is to take money from
 manufacturers.  This is sad but true.  Should the local safety regulators be
financially benefiting from industry contact?  I know how I feel when I see
this in the FDA and the EPA, I can imagine how a non researchers feels when
they see even the appearance

John Bucek, MD
Somerset Medical Center IRB

Until  John’s thoughtful comments I frankly gave up on attempting to bring a dose of reality to the Forum-My purpose is to provoke debate by bringing relevant information not otherwise addressed by the Forum–or addressed only from the perspective of insider traders.

The response to the AHRP Infomail about a Harvard study  published in the NEJM reporting that IRBs are riddled with conflicts elicited a
chorus of attacks targeted at the messenger–rather than taking seriously the confirmatory study. This is a sad commentary on the prevailing mindset that rises to denounce messengers who dare to bring critical reports about IRB conflicts of interest and a tainted approval process.

Why is there no discussion on the Forum about how IRBs– both academic and CROs–regularly approved unethical experiments?

Bloomberg News Special Report: Big Pharma’s Shameful Secret, Nov. 2005, focused on CROs

But It can be argued that academic based IRBs deserve no less condemnation than do commercial IRBs–
I would say, perhaps even more so. Two cases illustrate:

1. Academic affiliations have been used to mislead the public into a false sense of trust.
A case in point is the highly controversial, government-approved ARDS experiment. It  was approved by at least 14 academic based IRBs who saw nothing wrong with exposing 861 critically ill patients with acute lung injury to unjustifiable increased risk of death.
The experiment was conducted without legally valid informed consent in most cases.

Where is the criticism from other IRB members about the uncontested evidence of violation
of the patients’ fundamental human right to informed consent?
In this $50 million experiment just about every federal regualtory research safeguard was violated resulting in preventable human casualties.

2. And what rationalization did the Yale IRB use when it approved a Zyprexa experiment that exposed HEALTHY youngsters
between the ages of 12 and 34–to Eli Lilly’s highly toxic, diabetes producing drug?
Read OHRP’s investigation following AHRP’s complaint:

Read what an indipendent  psychiatrist Jerold Block, MD–who is not "on the take"–wrote in the Hastings Center Report
(Incidentally, IRB Forum members may not know that On the Take is the title of a book by Dr. Jerome Kassirer, distinguished professor at Tufts and former editor of the NEJM): 

BIOETHICS FORUM  Hastings Center Report Thursday, October 19, 2006 Preventive Psychopharmacology? BY JERALD BLOCK
Thus, academia–which is hugely On the Take–does not confer higher ethical standards in clinical trials-

Contact: Vera Hassner Sharav

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