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Medical Forum / General / Alternative / January 2008

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Deteriorating Ethics Behind Medical and Healthcare Press Releases

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Dave - 09 Jan 2008 20:11 GMT
As a writer in the medical and healthcare blogosphere, I read and
write about press releases all the time. I've seen a disturbing new
trend. Many of them, in an attempt to get noticed, read like this
"breakthrough" is happening tomorrow and that the crippled will walk,
etc.

You be the judge. Tell me if I am right or wrong to have written the
following letter to the two researchers behind a huge press release
that went out today. I don't think it does anyone any good to have
sensational headlines attached to press releases like this. Here's my
letter to Dr's Tobinick and Gross, followed by the full text press
release:

"As an Alzheimer's caregiver for a loved one, I must tell you that
sensationalized press releases of the kind that went out today
("Reversal of Alzheimer's Symptoms Within Minutes") are not only
damaging to families, but they are unethical.

You have allowed the University of Arkansas to publish something that
reads as if a cure for the disease is right around the corner. There
should have been a statement in that press release that describes the
"real world" effect and timing of your work. The headline should have
been cranked down significantly from the sensational and misleading
one that was used.

This, gentlemen, appears to be a sham. While your work is real and
quite meaningful, you have allowed it to be packaged and sold in a
manner that doesn't do credit to your science."

---
HEADLINE: REVERSAL OF ALZHEIMERS SYMPTOMS WITHIN MINUTES

An extraordinary new scientific study, which for the first time
documents marked improvement in Alzheimer's disease within minutes of
administration of a therapeutic molecule, has just been published in
the Journal of Neuroinflammation.

This new study highlights the importance of certain soluble proteins,
called cytokines, in Alzheimer's disease. The study focuses on one of
these cytokines, tumor necrosis factor-alpha(TNF), a critical
component of the brain's immune system. Normally, TNF finely regulates
the transmission of neural impulses in the brain. The authors
hypothesized that elevated levels of TNF in Alzheimer's disease
interfere with this regulation. To reduce elevated TNF, the authors
gave patients an injection of an anti-TNF therapeutic called
etanercept. Excess TNF-alpha has been documented in the cerebrospinal
fluid of patients with Alzheimer's.

The new study documents a dramatic and unprecedented therapeutic
effect in an Alzheimer's patient: improvement within minutes following
delivery of perispinal etanercept, which is etanercept given by
injection in the spine. Etanercept (trade name Enbrel) binds and
inactivates excess TNF. Etanercept is FDA approved to treat a number
of immune-mediated disorders and is used off label in the study.

The use of anti-TNF therapeutics as a new treatment choice for many
diseases, such as rheumatoid arthritis and potentially even
Alzheimer's, was recently chosen as one of the top 10 health stories
of 2007 by the Harvard Health Letter.

Similarly, the Neurotechnology Industry Organization has recently
selected new treatment targets revealed by neuroimmunology (such as
excess TNF) as one of the top 10 Neuroscience Trends of 2007. And the
Dana Alliance for Brain Initiatives has chosen the pilot study using
perispinal etanercept for Alzheimer's for inclusion and discussion in
their 2007 Progress Report on Brain Research.

The lead author of the study, Edward Tobinick M.D., is an assistant
clinical professor of medicine at the University of California, Los
Angeles and director of the Institute for Neurological Research, a
private medical group in Los Angeles. Hyman Gross, M.D., clinical
professor of neurology at the University of Southern California, was
co-author.

The study is accompanied by an extensive commentary by Sue Griffin,
Ph.D., director of research at the Donald W. Reynolds Institute on
Aging at the University of Arkansas for Medical Sciences (UAMS) in
Little Rock and at the Geriatric Research and Clinical Center at the
VA Hospital in Little Rock, who along with Robert Mrak, M.D., chairman
of pathology at University of Toledo Medical School, are editors-in-
chief of the Journal of Neuroinflammation.

Griffin and Mrak are pioneers in the field of neuroinflammation.
Griffin published a landmark study in 1989 describing the association
of cytokine overexpression in the brain and Alzheimer's disease. Her
research helped pave the way for the findings of the present study.
Griffin has recently been selected for membership in the Dana Alliance
for Brain Initiatives, a nonprofit organization of more than 200
leading neuroscientists, including ten Nobel laureates.

"It is unprecedented that we can see cognitive and behavioral
improvement in a patient with established dementia within minutes of
therapeutic intervention," said Griffin. "It is imperative that the
medical and scientific communities immediately undertake to further
investigate and characterize the physiologic mechanisms involved. This
gives all of us in Alzheimer's research a tremendous new clue about
new avenues of research, which is so exciting and so needed in the
field of Alzheimer's. Even though this report predominantly discusses
a single patient, it is of significant scientific interest because of
the potential insight it may give into the processes involved in the
brain dysfunction of Alzheimer's."

While the article discusses one patient, many other patients with mild
to severe Alzheimer's received the treatment and all have shown
sustained and marked improvement.

The new study, entitled "Rapid cognitive improvement in Alzheimer's
disease following perispinal etanercept administration," and the
accompanying commentary, entitled "Perispinal etanercept: Potential as
an Alzheimer's therapeutic," are available on the Web site of the
Journal of Neuroinflammation, at http://www.jneuroinflammation.com.

Author Hyman Gross, M.D., has no competing interests. Author Edward
Tobinick, M.D. owns stock in Amgen, the manufacturer of etanercept,
and has multiple issued and pending patents assigned to TACT IP LLC
that describe the parenteral and perispinal use of etanercept for the
treatment of Alzheimer's disease and other neurological disorders,
including, but not limited to, U.S. patents 6015557, 6177077, 6419934,
6419944, 6537549, 6982089, 7214658 and Australian patent 758523.

UAMS is the state's only comprehensive academic health center, with
five colleges, a graduate school, a medical center, six centers of
excellence and a statewide network of regional centers. UAMS has 2,538
students and 733 medical residents. Its centers of excellence include
the Winthrop P. Rockefeller Cancer Institute, the Jackson T. Stephens
Spine & Neurosciences Institute, the Myeloma Institute for Research
and Therapy, the Harvey & Bernice Jones Eye Institute, the Psychiatric
Research Institute and the Donald W. Reynolds Institute on Aging. It
is one of the state's largest public employers with about 9,600
employees, including nearly 1,000 physicians who provide medical care
to patients at UAMS, Arkansas Children's Hospital, the VA Medical
Center and UAMS' Area Health Education Centers throughout the state.
UAMS and its affiliates have an economic impact in Arkansas of $5
billion a year. Visit www.uams.edu.

END PRESS RELEASE

I believe that it is important to ask "Is this appropriate?" when
sending a press release out to the media as the example above. I can
only assume that the motivation for this release came from the
University of Arkansas, which may have been looking for some kind of
publicity. Others may see a more sinister connection between the lead
author and the commercial company which licenses his work.

Either way, I believe the way it was packaged was inappropriate and
unclear, both of which put this wonderful science into the "sham"
category for many of my readers. I have called and written the UAMS
and given them the opportunity to respond at the blog.

Dave

Full text article here extracted from http://shamvswham.blogspot.com/
The One True Zhen Jue - 09 Jan 2008 20:31 GMT
> As a writer in the medical and healthcare blogosphere, I read and
> write about press releases all the time. I've seen a disturbing new
> trend.

It would be a shame if their ethics were to deteriorate to your level,
Dave.
Fortunately, they have quite a way to fall before they sink to your
level.

Feel free to quit promoting your commercial site right now.
Dave - 09 Jan 2008 21:21 GMT
On Jan 9, 1:31 pm, The One True Zhen Jue <Andrew_King...@yahoo.com>
wrote:

> > As a writer in the medical and healthcare blogosphere, I read and
> > write about press releases all the time. I've seen a disturbing new
[quoted text clipped - 6 lines]
>
> Feel free to quit promoting your commercial site right now.

One True Jue's comments are, as usual, inappropriate to respond to,
but here's some commentary from one of the top medical ethics
specialists in the country, from a personal email sent to me this
morning after I forwarded the press release:

"Wow, that's totally over the top.  The headline is wildly
inappropriate (sounds like something from a late-night tv
infomercial).  It looks to me like an example of the med center's
communications folks vastly overplaying the importance of a very early
study (one patient!).  I wonder whether the articles authors saw this
before it was issued as a press release--I'd guess not, but it would
be interesting to know.  Just fyi, the recent death of a woman in a
gene transfer trial for rheumatoid arthritis was in research using
anti-TNFs (the agent used in the below)--it's not clear what caused
her death but it seemed to be from a overly suppressed immune
response. So in short, I totally agree with you."

As an Alzheimer's caregiver, I can tell you that this kind of press
release is extremely painful. Medical journals and institutions need
to pay closer attention to what they send out to the media, as people
in real, live situations can be hurt by their "enthusiasm."

Dave
Dave - 10 Jan 2008 00:18 GMT
> On Jan 9, 1:31 pm, The One True Zhen Jue <Andrew_King...@yahoo.com>
> wrote:
[quoted text clipped - 33 lines]
>
> Dave

There is another comment on this topic, from Vernon O., who replied in
a different thread because I had inadvertently posted the message with
a typo and so I removed it and placed it here again. I guess that
Google's "remove" feature only works on Google newsreaders?

Anyway, Vernon makes the point that "anything to do with Professors
always has to do with M-O-N-E-Y," and I'll respond to Vernon O. in
this thread to keep it cohesive.

Vernon, while I don't quite understand your aggressive "if you had a
clue" posturing (have we had previous flames together you and I? I
thought we were bud's), I disagree vehemently with you about the
comment you made. I am generally quite convinced that academia keeps
itself fairly distanced from the "money" side of industry. The ties
between researchers and drug companies do exist, but I don't believe
that a generalization branding all professors as corrupt would be a
good thing. Besides, it isn't "corrupt" to have an association as long
as it is disclosed. Putting a sensational headline on a press release
for the intent of pushing a stock would be WAY over the top, if that
were the case, and I don't think that anyone could prove that was the
case.

Dave
vernon O - 10 Jan 2008 01:51 GMT
> On Jan 9, 1:31 pm, The One True Zhen Jue <Andrew_King...@yahoo.com>
> wrote:
[quoted text clipped - 35 lines]
>
> Dave

There is another comment on this topic, from Vernon O., who replied in
a different thread because I had inadvertently posted the message with
a typo and so I removed it and placed it here again. I guess that
Google's "remove" feature only works on Google newsreaders?

Anyway, Vernon makes the point that "anything to do with Professors
always has to do with M-O-N-E-Y," and I'll respond to Vernon O. in
this thread to keep it cohesive.

Vernon, while I don't quite understand your aggressive "if you had a
clue" posturing (have we had previous flames together you and I? I
thought we were bud's), I disagree vehemently with you about the
comment you made. I am generally quite convinced that academia keeps
itself fairly distanced from the "money" side of industry. The ties
between researchers and drug companies do exist, but I don't believe
that a generalization branding all professors as corrupt would be a
good thing. Besides, it isn't "corrupt" to have an association as long
as it is disclosed. Putting a sensational headline on a press release
for the intent of pushing a stock would be WAY over the top, if that
were the case, and I don't think that anyone could prove that was the
case.

Dave

Sorry
Why does a professor write a book or article?
They actually have information?
No way.
Do drug companies push their products?  Of course.
I have dealt in the scientific world for decades (few in medical) and have
NEVER seen a variation regarding "scientific" articles and books.  The
general exception is text books.

NOTE: I didn't say professors were "Corrupt".
 
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