Lab Certification - Summary

U27111 at U27111 at
Tue Jul 11 12:40:13 EST 1995

>The 6/23/95 issue of Science has some articles on "Conduct in
>Science" which should interest participants in this discussion
>thread.  In short the point is made that conflicts between the
>need for researchers to work together in groups and the drive for
>individual glory have been responsible for significant delays in
>scientific advances.

>Convenient access to a WWW reprint of these articles can be had

 Well, I finally got around to reading this series... it's somewhat
interesting - but IMHO, it's nothing more than a whitewash of the
problems and putting them in a context so that a greedy,
egotistical scientific community can begin to accept what is
unacceptable practices and maybe slightly alter some practices to
make them look 'publicly' a little bit more acceptable.

And I especially liked the 'balancing' articles which shows what is
supposedly 'right' about our field?

I think, overall, this series did little to really find solutions
to the major problems... but definitely did help by targeting some
people and changing some of their practices?  The question is...
was this selective targeting?

In truth, I always felt Science was a publication which pretty much
*told* American scientist what it is they should be thinking and
what is important... in short, a political body which directs the
politics of science in general.

Notice how this series of articles failed to mention the
controversy over the Witte verses Gallo debate which Science
refused to publish and thus ended up in JAMA last year.

"Rival Scientists Question Research on AIDS Lesions/Gallo critics
say tests of drug may be invalid"  by John Crewdson, Chicago
Tribune, June 9, 1994.

An article, published in a June issue of JAMA (June 2nd or 9th?,
1994) by a husband and wife research team from the University of
Arizona (Doctors Witte), questions the veracity of a Gallo article
published 2 years ago in Science on Kaposi's sarcoma and a drug
named SP-PG.  The JAMA article "dismisses a central conclusion of
the Gallo piece as 'highly dubious' and declares that 'the validity
of the peer review process and self-correcting nature of scientific
inquiry are also called into question."

Gallo's Science article reports that SP-PG appears to inhibit the
development of KS in mice.  "It really prevents the development of
lesions, " Gallo had said at the time.

In this Science paper, Gallo's lab injected some mice varying doses
of SP-PG, some with different drugs and a control group with none
at all.  It was thought that this would help to show that SP-PG had
the ability to prevent whatever growth factors might cause KS
lesions from leaking out of the blood vessels and forming lesions
in surrounding tissue.

They then infected the mice with KS cells, waited a few hours and
then injected the mice with blue dye via the tail vein.  According
to the Science article, when measuring the amount of blue dye which
had leaked from blood vessels, it was greatest in the non-SP-PG
mice and least in those mice which had received the highest dosage
of SP-PG.

As for the Witte's paper in JAMA criticizing this paper:

At close examination of the Science pictures of the mice, the
Witte's saw something odd... the tails of the untreated mice were
an intense blue color, while the tails of the SP-PG treated mice
were not.

This suggested, to the Witte's, that the results were that from
botched tail vein injections.

Witte's also questioned Gallo's claim that a sizable amount of
dye-containing mouse blood had leaked into a small KS lesion in
just a few minutes.  According to the Witte's, "Even a localized
scalding burn of that tiny dimension would not cause the loss of so
much blood in such a short amount of time."

Additionally, they wondered how Gallo's lab was able to extract the
dye from the mouse lesions overnight... they noted that dye
extraction from soft tissue is "notoriously difficult".

Finally, they were 'surprised' on the "smoothness" of Gallo's graph
showing the blood vessel leakage decreased in step with increases
in the SP-PG dosages.

Well they sent all this in a letter to Science, entitled "The Tell-
Tale Blue Tail".  The letter was sent to Gallo who dismissed it "as
an extraordinary waste of time and effort".  Science did not
publish the letter.

"More than 2 years have passed since the article was published and
our efforts to address the validity of the data and conclusions in
an open scientific forum were initiated.  No follow-up studies by
these authors have appeared in print that might clarify the points
in question." said Marlys Witte.

She went on to explain that they turned to JAMA only after both
Science and Gallo had refused to publicly acknowledge their

Dr. Rummond Kennie (deputy editor of JAMA), stated that the Witte's
questions seemed valid to him and that the earlier letter the
Witte's had sent to Science raising these questions "had been
rejected for reasons that didn't hold scientific water."

For all the criticisms the Witte's have faced in this endeavor, the
main one being that they have not attempted to duplicate Gallo's
actually experiment.  Well, this JAMA article does just that... it
contains a report on the 'many' attempts they have made to
duplicate Gallo's results... even to go as far as using Gallo's
exact KS cell line - all with the same results... they were unable
to come up with the same results as Gallo's Science paper.

As the JAMA article concluded, "Perhaps the most serious aspect of
the whole matter has been the reticence and obstacles encountered
to public airing of our questions and the inability of the peer
review process to correct itself once errors and inconsistencies
were pointed out and bolstered by further experimentation."

Finally, in additional information Crewdson provided in this
article... the National Cancer Institute struck a commercial
development deal with Daiichi Pharmaceutical, the Japanese Company
that owns the US-patent on SP-PG, which quickly began plans to try
the drug on American AIDS patients.

The NCI declined to disclose the amount of money Gallo's lab
received from Daiichi, but inside sources put the figure close to
$75,000.  After the deal was announced, Gallo told the Wall Street
Journal that he did not stand to earn anything personally.

Daiichi's stock gained 6 percent on the Tokyo Stock exchange the
day Gallo's Science article came out.

Meanwhile, SP-PG is currently only being tested in 7 patients at
the University of Southern California... where researchers have
recently reported that several of the participates have suffered
from unexpected bleeding and other side effects.  Only 2 of the 7
have appeared to improved since taking the drug.

Then Todd Miller wrote on 29 Sep 1994 13:24:53 -0500 in

        Anyone interested in the response of Dr. Gallo to questions
of his scientific integrity (Witte et al, JAMA 271: 1769) should
read the series of letters in the latest issue of JAMA (272:
916-924).  There are 9 letters (mostly from colleagues of Gallo,
one from Dan Koshland, editor of Science magazine) including a
response from the Witte group.  As I read these, it seems like the
issue is escalating so I think we haven't heard the last of this.
Koshland seemed particularly defensive and angry with his
counterparts at JAMA for publishing the Witte article.
        For those who missed the first few episodes, Gallo
published an article in Science (255: 1437) that appeared to have
some questionable data (you need to read this one first).  The
paper was challenged by the Witte group, but their comments were
rejected twice by the editors of Science.  Frustrated, they went to
JAMA, who agreed to publish their objections to the Gallo paper if
they could provide documented proof of their rejections by Science.

Ahhh, politics.

Todd Miller

Thus, I fail to take anything Science writes on the subject of
misconduct very seriously (or shall I say I take it more as a grain
of salt).... especially when they have still failed to clean their
own house on this subject?

And is this invitation to send ethical dilemmas to their home page
for a board of panelist to help resolve... is this just another way
of getting problems discussed behind closed doors instead of having
dirty laundry aired in public?  Ummm, something to think about.


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