Glaucoma Research 2004
Chat Highlights
April 21, 2004
Norma Devine, Editor
On Wednesday, April 21, 2004, Dr.
Jeff Henderer, a glaucoma specialist at Wills, and the
glaucoma chat group discussed "Glaucoma Research 2004."
Moderator:
Welcome, Dr. Henderer. Tonight's topic is "Glaucoma
Research 2004."
P: Doctor,
what are the phases of clinical trials and what are their purposes?
Dr. Jeff Henderer:
That is a great question. Phase 1 trials are
to determine toxicity; Phase 2 are to determine dosing (I think
I have that right), Phase 3 are the ones you hear about where
the drug is tried in patients to see how it works, and Phase 4
are trials after FDA approval that are used for further clarification
of how the drug works.
P: What's
new in normal-tension glaucoma research?
Dr. Jeff Henderer:
Normal-tension glaucoma is still about
the same. I'm not aware of any real big breakthroughs since
the normal-tension glaucoma study and the blood flow studies.
P: How
different do you think the results of the big normal-tension glaucoma
study might have been had corneal thickness been taken into account?
Dr. Jeff Henderer:
You know, that issue comes into play with all the studies
done to date. Most people, I think, believe that if
the participants in the NTG study had had their corneal thickness
measured, some of them would have turned out not really to
have had normal-tension glaucoma. But the evidence still
really argues that lowering IOP helps.
P: How
is research funded? Who conducts research?
Dr. Jeff Henderer:
Research is funded by private foundations, industry,
and grants from the government. Anyone can do research,
but usually it's doctors who devote part of their time to it as
it does require a lot of time.
P: Does
the government fund more studies than private industry?
Dr. Jeff Henderer:
No. Unfortunately, industry vastly outspends
the government.
P: Do
doctors get funding for research from the Glaucoma Foundation
and similar groups, and from universities or hospitals?
Dr. Jeff Henderer:
Yes, the Glaucoma Foundation does fund researchers.
Universities and hospitals usually don't sponsor the grants; they
seek the grants (and then charge indirect costs so they make money,
too).
Moderator:
Dr. Henderer, what research presented at the recent
symposium at Wills was the most exciting to you?
(http://www.willsglaucoma.org/2003symp/index1.html)
Dr. Jeff Henderer:
I'll tell you what I thought was fantastic! It
was a swab for detecting pink eye (conjunctivitis) in primary
care doctors' offices!
Moderator:
Does that help glaucoma patients, too?
Dr. Jeff Henderer:
No, it really doesn't, but it is a big problem that
anyone can get. Most "pink" eyes are not viral pink eye,
but even so, most people get treated with a medication that itself
can cause pink eye. So with all the confusion, you
can see where a simple, rapid test can be so helpful -- like detecting
strep throat in the pediatrician's office. [Editor's note:
There are many causes of conjunctivitis, "pink eye."]
P: What
current research projects are you working on?
Dr. Jeff Henderer:
The main thrust of the research is glaucoma screening
and developing new ways of classifying and detecting glaucoma.
P: Is
it possible for doctors to do research without sources of outside
funding?
Dr. Jeff Henderer:
It is possible to do work without funding, but not
much for long. We always have cheap (free) labor from medical
students and such, but it really doesn't result in a sustainable
research program.
P: Anything
new in the area of optic nerve regeneration?
Dr. Jeff Henderer:
The things I have heard are about a year old. A
group at Harvard (if I recall correctly) has managed to get the
nerve to regrow in mice. Very impressive. It's not
clear if vision results, but it's an exciting first step. The
next thing might be stem cells. The previous work was with growth
factors.
P: Dr.
Jeff, I've heard you refer to the DDLS. What does that
stand for?
Dr. Jeff Henderer:
The DDLS is short for Disc Damage Likelihood Scale.
It's a new staging system for disc damage developed by Dr. Spaeth
and tested by me and a lot of Fellows and other members of the
staff. We also have developed a scale for staging visual
field damage called the FDLS, Field Damage Likelihood Scale. The
work is continuing! In the works is a companion field
interpretation scale, the VDLS, Visual Field Damage Likelihood
Scale.
P: Do you know if the
FDLS has been published and the researcher named, so I can search
for it on the Internet?
Dr. Jeff Henderer: No, unfortunately,
we haven't published the FDLS. It was presented at the American
Glaucoma Society meeting in 2003, but we haven't finished the
paper yet. It's very slow, I'm afraid. We'll
get there though. You can find a description of the FDLS
in the Review of Ophthalmology from October 2001, I believe.
P: Are there any new
eye drops coming out soon? Or are any of the ones we know
and love (Alphagan, Cosopt, Travatan, etc.) going to become generic
drugs anytime soon?
Dr. Jeff Henderer: The buzz
is about combination drops. I know that Pfizer has been trying
to get a combination of Xalatan and Timoptic, but hasn't yet released
it. Alphagan is available as a generic in the original strength,
0.2% [Editor's note: Xalcom is approved in Europe.]
P: A generic for Cosopt
will be available in Brazil.
P: I have a list of
published studies related to glaucoma development and treatment.
Some involve nutrition. Let me quote from one, which happens
to be Japanese: "Glaucoma patients treated with vitamin B-12 for
over 5 years demonstrated better visual acuity and better overall
control of their disease . . . . " Why are we not benefiting
from these studies?
Dr. Jeff Henderer: You raise
an excellent question. The main issue has always been in the details.
I am not familiar with that B-12 study, but if you can believe
the way in which it was conducted, then it seems reasonable.
I know that we often suggest anti-oxidant vitamins and things;
ginkgo might be helpful, too.
P: Any news about treating
uveitic glaucoma?
Dr. Jeff Henderer: Uveitic
glaucoma is still one of the toughest of all glaucomas.
It is not very common, and perhaps for that reason I'm not aware
of any news. The glaucoma is also generally secondary to
the uveitis. Since most of the research would concern treating
the uveitis, not the complication of it, I may miss some of that
literature.
P: Dr. Jeff, what percentage
of your practice is devoted to research?
Dr. Jeff Henderer: Well,
officially I have one day a week set aside for research.
In practice, it rarely works that way any more. I guess
I might get half a day, but I'm doing surgery or something else
most of the time lately. The good news is that we have a
team that can carry on even if I'm not there.
P: There is a study
in progress using stem cells from a person's nose to regenerate
cells in other areas of the body. (http://www.theage.com.au/articles/2003/01/30/1043804464986.html)
It seems to be working in rats. Have you heard of that study?
Dr. Jeff Henderer: I have
not, but I didn't even know you could grow stem cells from your
nose! I thought that people had cloned stem cells from fetal
tissue, but had not yet found or cloned adult stem cells.
I guess that would be very exciting. One of the problems
with the eye is that it's tough to get to. You can't just
squirt the cells on the eye like a drop. They have to get
to the optic nerve, and that is a bit hard to get to.
P: Are there any studies
about genetic influences in glaucoma?
Dr. Jeff Henderer: There
is loads of stuff about genetics and glaucoma. There is
work identifying genes (like optineuron), and in family history,
and even in gene therapy and gene "profiling" to see if you might
respond to a certain drug.
P: Do doctors have
deadlines for research studies?
Dr. Jeff Henderer: Well,
not really. You have to complete a study in the time frame
you said you would if you're getting money, and there are always
deadlines for meetings to present the work. You don't want to
get scooped either, so you try to work as fast as you can.
P: I don't think it's
being too cynical to think that the reason certain interventions
are not given greater play in the clinical arena is that, for
one reason or another, they're not lucrative for the big drug
companies. To say that research by the government is outspent
by research by industry is an understatement. I think it's
unhealthy that researchers are so beholden to the drug companies,
which sponsor research, symposia, etc. I know that's not
a question, but you can add your thought to that.
Dr. Jeff Henderer: You are
correct, but on the other hand, someone has to do research.
I must say that the drug companies are a for-profit industry,
but my experience is that they are willing to explore ideas.
P: What corporations
in America do not try to make as much profit as possible?
P: None.
P: You may perhaps
be familiar with the work of Dr. Francis Pottenger. From
1932 to 1942, he experimented with food for cats. One group
was given raw milk and raw meat, the other, processed food. The
first group maintained optimum health for generations, but the
group fed processed food developed various diseases within the
first generation. Disease rates for the processed-food group
also increased in subsequent generations, and blindness (owing
to lack of taurine) was one of the problems that came along in
the third generation. The study was extremely important
for a number of reasons, not only because of the discovery of
taurine's role, but also because it showed the devastating effects
of poor nutrition and the acceleration of problems over generations.
I cannot understand why this kind of research is not being sustained
on behalf of those with glaucoma. Can you comment, please?
Dr. Jeff Henderer: Well,
we can't control people's diets. We also have to wait at
least seven years before knowing if a treatment can help.
But those are excuses. It is probably possible, but studying
human beings involves a lot of uncontrolled variables. It
is not so easy.
P: Hey, I'm a believer
in flaxseed oil, which someone here recommended. I've been
taking one pill a day for over a month now, and my eyes have not
been nearly as dry as they usually are.
P: Dr. Rick Wilson mentioned
using a tablespoon of flaxseed oil or two tablespoons of milled
flax seed a day to combat dry-eye syndrome. I threw
away the first bottle of the oil, because I suspected it had not
been kept refrigerated. I use two tablespoons of milled
flax seed a day sprinkled on cereal, fruit, and salads.
The milled seeds are cheaper than the capsules and provide fiber.
*
[Editor's note: Dr. Wilson said, "I would take a tablespoon
of flaxseed oil or two tablespoons of ground flaxseed. That
improves the comfort of the eye significantly. Allow six
weeks for the flaxseed to work. If that does not make the
dry eyes comfortable, then the new drop, Restasis, can be tried,
with the help of your doctor."]
P: Are there any new
types of glaucoma medications undergoing clinical trials?
Dr. Jeff Henderer: There
are several new drugs in the pipeline. I don't know what
they are (industry secret).
P: Has the possibility
of improving deteriorated retina cells using medicine, injections,
or laser been studied?
Dr. Jeff Henderer: I know
that there has been a lot of recent work with intraocular steroid
injections for retinal swelling. Laser has been around for
a long time, but mostly that's to relieve swelling or to destroy
tissue. I'm not sure I know of any medication to help the
retinal cells.
P: Will we ever see
the day when optic nerve damage can be stopped and damage to the
optic nerve repaired?
Dr. Jeff Henderer: Yes,
I have no doubt that will happen. But it will be tricky
to make sure that we first identify the cause of the damage, so
we can block it (and there might be several causes). Then
we must be able to deliver the treatment so that it doesn't cause
unwanted side effects. Then we need to see if the cells
can be tricked into regenerating. That is a very tall order,
but if Christopher Reeve can regain some function, then it is
possible.
Moderator: Thank you,
Dr. Henderer. We hope you will return soon.
End of highlights for April 21, 2004.
[Postscript: Dr. Rick Wilson has asked
that the following information be added to the Chat Highlights.
"I started taking flaxseed oil and ground flaxseed for my
arthritis, for which it did nothing, but I found it abolished
my dry eyes, dropped my triglycerides an unbelievable 40%, and
lowered my total cholesterol 15%. Since I had many years of serum
lipid profiles before and now after the start of flax, it even
convinced my cardiologist, who is using it for his patients. This
experience has been replicated for most of my patients and even
some of my fellows who have tried it."
A patient sent Dr. Rick an interesting article, entitled "What's
the Scoop on Flaxseeds?," which appeared in "Health
Extra" on the Web site of the Cleveland Clinic. http://www.clevelandclinic.org/healthextra/]
On April 28, Dr. Werner discussed "Potentially Unsafe Medications
for Glaucoma Patients" in the Chat room. Click here for highlights
of that meeting.
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