Re: Medical Research


"Herman Rubin" <hrubin@xxxxxxxxxxxxxxxxxxxx> wrote in message
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In article <ex%8g.726475$084.390023@attbi_s22>,
Skeptic <bcs002b@xxxxxxxxx> wrote:

"george conklin" <george@xxxxxxx> wrote in message
news:Ii%8g.3447$u4.1926@xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
The New York Times today has a long article on breast cancer research.
It
seems that current recommendations for chemotherapy were made before
anyone bothered to look at estrogen dependent tumors and non-estrogen
dependent tumors. Looking at the data with the one new variable, it
turns
out that most of the benefits of the chemotherapy were from those who
had
non-estrogen dependent tumors.

But guess what: the hidebound medical business states that since this
one
variable was not thought of IN ADVANCE, the results of the actual
chemotherapy sessions do not meet the 'gold standard,' and thus they
want
to start all over again. Now that is massive stupidity, but guess
what,
that is what is going to happen.

It definitely is massive stupidity; I do know the origin
of this type of restriction on jumping to conclusions, and
if done recklessly, MAJOR errors will be made.

You don't understand because you don't understand what is meant by a
scientific study or proof or study design.

He understands SOME of it; it is the medical profession
which does not understand how to use statistics. The
practitioners have had beginning cookbook courses which
do not get into the foundations at all; they get recipes,
but do not know whether they are cooking fish or fowl.


Let me add to Herman's comments. I've been teaching data processing for
30+ years, and of course we must use international data sets all the time.
The issue for medicine is that of great complexity, but it is still easier
to deal with than real-world issues like homicide and violent crime. Now
that is complex stuff, but still a lot of useful patterns have been shown
true many times in different places.


Statistical decision theory is not that old, but is not
often even taught. The problems need to be approached
as what action to take, not whether the effect is
"statistically significant"; that term, which is ancient,
needs to be eradicated, as it tells me nothing of
importance. The p value, by itself, is misleading.


It may be misleading only to the degree that a small sub-set of people
benefit from treatment, but most do not. Certainly with adult cancers so
little progress has been made (if you subtract out lead time advanced
detection gives you to know you are sick), then people simply are left with
treatment patterns based too much on feelings.



Suffice it to say, each
oncologist is free to decide for him/herself if chemo or hormone
treatment
is the way to go.

I have a great objection to this.

Herman and I have always agreed on this point.


Each oncologist needs
to inform the patient of the known risks and benefits,
and to give a probability assessment of the costs and
benefits of any available treatment, taking into account
the individual patient. Then the patient should decide
what action to take, based on his or her individual
weights of importance, and also individual contribution
to the assessment of probabilities.

But here is the problem: that requires good research and that is just
what we don't have. We have billions for treatments and nothing much to
evaluate outcomes.


However, until the proper studies are done, they must
inform their patients that although such a treatment is felt to be
effective, there have not been any studies to prove it.

One cannot "prove" anything with statistics, and can
definitely not prove that a treatment has no effect.
One can get information to better assess the risks and
benefits.

While I don't treat breast cancer, I do deal much with prostate cancer.
There are plenty of comparisons. We treat many men witth hormonal
therapy.
Many of the studies out there are old before newer diagnostic and
treatment
techniques were available. Those tests showed that early hormonal
treatment
made no difference vs. later hormonal treatment, so we might as well wait
for a patient to become symptomatic before giving a treatment with
significant side effects. Newer studies have shown, however, that early
hormone treatment probably does help in a selected patient population.
We'll probably NEVER be able to prove this because those older studies,
done
in the '70's, would be deemed unethical today. So we have studies that
suggest a difference but can't prove it. What do we do? Most
oncologists
who treat prostate cancer would start early hormone therapy in those
patients who will probably benefit from it. We're now waiting on a large
European study which, though it won't be exactly what we need, will
probably
help settle some of the debate.

This is the problem with MUCH of medicine. There are
ways to assess the current state of the information, and
act on it. Of course, mistakes will be made, as they are
being made now.

Prostate cancer treatments are being evaluated, such as the PIVOT
study. But some going on for 10 years have yielded no results yet, strongly
suggesting that all current modes of treatment cure those who would not die
of the disease anyway. Those who advocate PSA tests and aggressive
treatments now claim that the best results will show up AFTER 15 years!!!
But that is another 5 years out, and then it will be raised to 20.


I know you don't like much of medicine, but if you have a better way to
get
at the truth in such matters we'd love to hear it. Things move slowly in
medicine, and for a good reason. For every new treatment with a small
study
that shows that it works... and goes on to be a good treatment, there
will
be 10 that eventually end in failure or worse. We can't just jump at
every
fad.

This is the case; things like this were the reason why
one cannot just look at a study and see what else comes
out. However, one can do much more than is being done
now, but nowhere near what we would like.

Correct.


We need better studies, and more data collected on each
study. Continuous variables should be used as such, and
models based on biology used more often. All of the
studies I have seen on the use of statins are horribly
flawed; they do not take into account the actual
concentrations of the various lipids. As of this time,
there is not a single reasonable study showing that the
use of a low fat diet is beneficial.

I do not know how much followup can be done on drugs. A
physician is supposed to report adverse events reported
to him; how much is done? Also, what is adverse? I doubt
that the posters on this newsgroup will agree on which
actions of a particular drug are adverse. Some only occur
when the drug is started, or when dosage is changed, and
go away. I have seen little of this in the PDR material.

What can be easily done about these? One, more data can,
and should, be collected, and not just on drug trials.
The problem is that this can be very difficult, and the
opinions of physicians is VERY difficult to quantify.
If we had to do tests for all of this, the cost would be
very high.

Everyone needs to understand the concepts of probability
and statistical decision theory, but they do not need to
know how to carry out the calculations. Problems need to
be formulated first.

Of course, Herman, there is the emotional issue too. Just look at HRT.
When HRT raises some disease rates (cancer) but lowers hot flashes, who is
to decide what? But I do know doctors who have personally said to me that
cannot believe that HRT is not preventing disease and the large-scale
studies are wrong. They do not understand self-selection.

Now, of course, with prostate cancer all we have is self-selection. Men
get a 'choice,' depending on who they see. You have Hopkins graduates with
a knife. You have Harvard graduates who do not think operating cures
anything.... And they love to hate each other. Walsh writes books and
makes money, ST. Louis joins in, and away you go. This is not science, but
it sells books.


.

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