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SCIENCE-FOR-THE-PEOPLE  April 2005

SCIENCE-FOR-THE-PEOPLE April 2005

Subject:

MannGram®: on whistle-blowing

From:

Robt Mann <[log in to unmask]>

Reply-To:

Science for the People Discussion List <[log in to unmask]>

Date:

Tue, 5 Apr 2005 12:15:27 +1300

Content-Type:

text/plain

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Parts/Attachments

text/plain (261 lines)

        MannGram®: on whistle-blowing
                        R Mann
                        July 2002


        The msg below was sent to me this month by a minor, low-profile
woman most wouldn't have heard of.  I comment on some aspects.  Three
decades of experience teaches me a few rueful lessons.


1   Some of those who appear to be doing wrong are merely ignorant.

         I turned in a medico who was using undergrad volunteers, whom he
was to grade in degree exams later that year, to test a method of measuring
blood flow in the human small intestine by slapping a radionuclide into the
blood and swallowing a counter.  The dean stopped this, on my urging.  I
later regretted not trying harder in private to persuade the offender to
desist.  I assumed he knew about Gofman & similar calculations of risk; too
late, I realised he probably didn't.  It is all very well that Mathias
"encourages potential whistleblowers to  ... exhaust their institution's
procedures on reporting of misconduct"; I'm pointing out an earlier phase
of action which is easily overlooked but in some cases may work fine, to
everyone's benefit compared with an official dispute.
                Even more probably explained by ignorance was the defence
of 2,4,5-T (1971-  ) by a key regulatory B.Sc bureaucrat who, I realised
too late, probably never understood the science as endorsed by S S Epstein,
outlined by myself in _NZ Envir. 2_(2) (1972).  It took 17y to shut down
the 2,4,5-T factory.  A major attempt was made in 1977 to purge me from my
senior lectureship, prompted partly by Dow.   A somewhat better process
might have resulted had my scientific & medical colleagues tried to discuss
in person with the B.Sc drongo how we saw the ethics of aerial spraying
(which was always our main issue).


2   Other motives can operate which are best dealt with by early, private
discussion.

        An early, rabid advocate in 1971 for 2,4,5-T was a senior local
pathologist, an expert on experimental teratogenesis.  I later learned he
had been spraying 2,4,5-T on a hobby/investment farmlet while his wife was
pregnant for the first time in a long marriage.  We should have tried
harder to discuss with him.  (He refused point-blank; but we shouldn't have
given up.)
        Lest I get too guilty, I note that 2 decades later, when the foetus
in question was adult and obviously healthy, the pathologist was still
machinating irrationally in defence of dioxin.  He may never have been open
to reason on the matter.  But I still say we should have tried harder.


I note Uraneck doesn't tell us where we can read details of the Mathias
complaints, or their disposition.  They are not evident on any of the
wesbites she directs us to.   She doesn't actually say Mathias was
dismissed.  She just wants to make out Mathias was right, & brave; maybe
she was, but why not point us to details?  She implies that Mathias lost
money on the caper, but this is not clear.  That her family was further
shattered may, for all we know, be gratifying to Mathias &/or Uraneck;
hatred of the family is far from rare at this stage of wimminsLib.

Uraneck just gives totals of turns-in, calling them "misconduct activity"
but then suggesting they were only gross complaints  -  she fails to
mention what fraction of the turns-in were confirmed, what frn rejected, &
what frn undetermined.   "Telling the truth" is in general too crude a
concept for such disputes; but Uraneck hardly hints at a humbler
assessment.

Note the peculiar slang 'survival' with no hint of evidence that Mathias'
life was actually at risk.  This is a well known feminazi emotive appeal.


I don't think it's a fluke that this odd Uraneck piece was sent to me by a
feminazi  -  a minor, low-profile one, but twisted & dogged enough to
prevent the formation of a group of physicians & scientists for control of
gene-tampering rather than allow such a group to be led by an open opponent
of feminazism.  It's also no fluke that the source wasn't conveyed.  On the
other hand, an email address was given for Uraneck; and I'm using that.

The whole NZ medical trade was cowed by the Cartwright travesty, a
"judicial" inquiry vilifying a much-respected senior male medico (the late
G H Green).  In numerous perversions of science and of law, these harpies
framed up Green on false accusations of withholding treatment from women
(for microscopic anomalies in Pap smears  -  still today of unclear
significance).  This year the feminazis have ratcheted up a notch their
filthy sexist actions by special retroactive legislation blocking Prof R B
Elliott from continuing his decade-long developments in xenotransplantation
for treatment of type 1 diabetes.  Fiddler Bunkum was again involved  -
this time as a member of the cttee of parliament; the prime mover was K
Poutasi M.B, head of the health ministry, hardly mentioned by the media let
alone asked why she was crippling this good line of knowledge-economy
biotech.
         In such a context of such vicious power-plays, I don't accept
Uraneck's 'innocent truth-teller' image for Mathias; it might be fair, but
it also might not, and the several suspicious features I've pointed to
should cause readers to suspend judgement.  "Just telling the truth" is far
from the intention, or in certain cases the ability, of some who want to be
seen as mere wide-eyed innocent whistle-blowers.


R





    When You Must Report  Misconduct

Experts advise whistleblowers to maintain  objectivity, learn the rules,
and get early legal counsel
 By Katherine Uraneck

  Cherlynn Mathias agonized over whether to report  her allegations of
scientific misconduct to the government and sought help from  her parish
priest.  She still recalls the image of the church's art deco rectory,
where she told the priest what she had learned about the ethics of research
during her year at the University of Oklahoma (OU) in Tulsa and about her
fear of retribution should she report the wrongdoing.
At the end of the day, the  priest asked, "What's the worst they could do
to you?"  She replied, "I could lose my job, lose my license,  become
bankrupt, lose my home."  "And if you don't turn them in?"  "I can't live
with myself," she said.
    A week later, Mathias sent documents titled  "Allegations of
Misconduct" to the US Department of Health and Human Service's  Office for
Human Research Protections (OHRP).  She had linked alleged wrongdoing  by
Michael McGee, the primary investigator of a melanoma vaccine trial based
at  OU's Health Science Center in Tulsa, to the Institutional Review Board
(IRB),  and to the institution itself.  She also sent documentation of
improper  production and safety testing of the vaccine, improper monitoring
of patients,  and overstatement of the treatment benefits.
    The subsequent fallout brought national attention as the university's
federally funded medical research trials were temporarily  shut down.
McGee was fired, the head of the IRB retired, and both the dean and
director of research at the Tulsa campus were forced to resign.  Mathias,
who  testified before the US Senate this past April, would never again work
at OU.  Nevertheless, how she blew the whistle and survived provides
insight into the perils and potential benefits of reporting on wrongdoing.

   Risking Reports
Last month, research  institutions reported the highest incidence of
misconduct activity since 1997,  according to the Office of Research
Integrity (ORI).1 In 2001, sixty-one  institutions opened 72 new cases to
investigate 127 allegations.  The previous high mark had been 60
institutions reporting 103 allegations.  Chris B. Pascal,  director of the
ORI, attributes the rise to institutions' growing  sophistication, and to
the heightened awareness of scientific misconduct, rather  than to an
actual increase in incidences of wrongdoing.
The government  relies a great deal on whistleblowers in identifying and
stopping such  misconduct, according to Peter Poon, who is responsible for
overseeing potential  research misconduct at the Veterans Administration.
"The whistleblower occupies a vital role in ensuring the ethical conduct of
research," Poon says. "However,  the scientific community maintains an
ambivalent attitude toward the  whistleblower."

   Whistleblowing is a risky activity.
Thomas Devine,  legal director for the Government Accountability Project,
says whistleblowers  should expect some reprisal.  The ORI, part of the US
Department of Health and  Human Services, found in a 1995 survey that more
than two-thirds of  whistleblowers to scientific misconduct experienced
some sort of negative  consequences for their actions.  Retaliation can
include marginalization,  firings, loss of promotions, and even death
threats.    Those at the greatest risk for retaliation were  academics with
PhDs conducting research in the basic sciences as opposed to  clinically
oriented physician researchers.
    "Before sticking their necks out,  whistleblowers should carefully plan
a survival strategy," cautions Devine, "so  that they are not reacting to
bureaucratic harassment, but rather that the  system is reacting to their
charges."    Mathias made no spur-of-the-moment decision, though  she
suspected research protocol violations from June 1999 when she began
working  in OU's surgery department. She observed improper enrollment of
patients in  clinical trials and inconsistent storage of the vaccine, which
was manufactured  by an assistant to McGee. "My knowledge was incremental,"
Matthias relates. "Not  only my knowledge of what was wrong with the study,
but also what the regulations were."
   Mathias immersed herself in the Food and Drug Administration's
regulations concerning laboratory, manufacturing, and clinical  practices.
She educated herself on informed consent and protection of human  subjects.
As her knowledge increased, so did her certainty about the research
misconduct.  But still, she did not blow the whistle.  In October 1999,
Matthias contacted the OU's IRB, which oversees research on human subjects.
Determined to  work through the chain of command, Mathias met frequently
with university  officials over the next eight months, before she decided
to take her allegations  to the government.

 A Strategy of Calm
Composure and self-education  can aid a would-be whistleblower, according
to Pascal. "[My] advice for the  whistleblower is stay calm and keep your
head about you," Pascal says.  But few whistleblowers carefully plan their
actions. "Most of the people don't think  about it because they only view
it as telling the truth," says Don Soeken, a  Maryland-based therapist who
consults with whistleblowers.  "Telling the truth,  you don't need a book
to do that, so they don't think about  it."

Additionally, few whistleblowers have any education about the  process.
Even when whistleblowers have knowledge, they may not avoid  retaliation.
Mathias was aware of the risks, she had extensive documentation,  she had
educated herself about the regulations, she had support from her priest,
and she had attempted working within the system.  But a year after she blew
the  whistle, Mathias found herself unemployed, depressed, and overwhelmed
with legal fees.  Mathias had not obtained legal advice before she
contacted the OHRP, nor  had she anticipated the swiftness of OU's
disapproval.  Mathias says that access  to her building was denied, and she
was placed on immediate administrative  leave.  "I had this fantasy that
once the government got involved and Oklahoma City found out, they would
realize I had done the right thing" Mathias relates.
    Obtaining early legal counsel can help whistleblowers avoid some
problems with administrations and can acquaint them  with federal and state
statutes for the protection of whistleblowers, says Ann  Lugbill, an Ohio
attorney who specializes in such cases. A person can also face  suits for
defamation and contract violations. "One of the reasons ... to get a
lawyer early on is because there are some things that you could do that
would  preclude [you] from bringing a law suit later," Lugbill says.
"There are some  things ... that might seem to be legal but aren't, such as
violating  trade-secret rules."
   Although federal regulations aim to prevent retaliation against
whistleblowers, they do not allow a whistleblower to sue for reinstatement,
damages, or back pay.  "In those instances, the whistleblower's  primary
rights would be under the False Claims Act," said Devine, adding that
false-claims cases are time consuming and laborious.  "Scientific
misconduct is in the statute."
   Mathias eventually reached a settlement with her  employers.  She
decided not to pursue a more significant suit because she wanted  to
maintain the focus on the patients and not on herself as the wronged
whistleblower.  "I didn't see myself as a victim," she said.  "I approached
it as I knew what I was doing, took the consequences and made the best of
it."
    Eventually Mathias was hired as the manager of clinical trials for
Harris Methodist Hospital in Fort Worth.  The job required  her to move
away from her two sons, who are finishing high school, and she now
maintains two mortgages.  But she does not regret her decision.  "If
[whistleblowers] look at it a little more as a third party, that this is
the right thing to do for the scientific community," Pascal says, "then you
make the  allegation, you cooperate and provide the information that you
can, but it is  somebody else's responsibility to make the decision, not
the whistleblower's."
     Mathias has counseled several potential  whistleblowers.  "You have to
be willing to risk, and if you aren't willing to take the risk, then don't
do it," she advises.  She encourages potential whistleblowers to "document,
document, document," and to exhaust their institution's procedures on
reporting of misconduct. "Only go to the government  as the last resort,
and be willing to accept the consequences of your actions,"  she cautions.
    Soeken, who says he usually sees whistleblowers  only after they have
suffered consequences, advises others to maintain their  anonymity for
self-protection.  "Truth and honesty cost too much," he says.  "They
should tell the truth, but they should do it in such a way that it gets
done  without endangering themselves.  Saying all that, it does me no good
to tell a  whistleblower to not do it," he relates.  "I go to bed at night
and sleep nicely  because I know that there are these people out there that
are going to find all  kinds of corruption and graft, and I've always said
that they might save the  world."

    Katherine Uraneck ([log in to unmask]) is a physician  and freelance
writer in New York.
1. "Institutions Report Increased Misconduct  Activity in 2001 Annual
Reports," Office of Research Integrity Newsletter, 10:3,  June 2002.
--------------------------------------------------------------------------------
Internet  Resources
Office Of Research Integrity
www.ori.dhhs.gov/   The National Whistleblower Center
www.whistleblowers.org   Government Accountablity Project
www.whistleblower.org   Integrity International
www.whistleblowing.us
---

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