Karl: I was
wondering if you could share with the group any alternative treatments or
clinics that you've tried, if any worked or didn't work, and what your
observations were?
Reply:
There are many reasons why I was not prepared to
objectively evaluate medical claims when my spouse was first diagnosed
with follicular lymphoma. The
first, being I had no formal medical or scientific training.
I didn't get off to a good start either. I bought into the conspiracy
theory described in a book called "Options." Coincidently, a neighbor gave
us this book when Joanne was first diagnosed in 1996. It planted mistrust
in the medical system - in the so-called "chemotherapy concession." I began
to look at alternative medicines in earnest.
Instead of watchful waiting, "we" decided to try Burzynski's
antineoplastons, mainly because we talked to patients who said it helped
them. Some said they were cured. Burzynski also said he could cure Joanne. A non-toxic therapy that can cure! How could we not try that? Which illustrates my second deficit: I did not understand that
testimonials
are not evidence.
A second reason we chose Burzynski, it was one of the alternative
protocols listed as potentially useful by Dr. Ralph Moss, PhD, in a
personalized Moss report we purchased. It's worth noting that Dr. Moss's background and degree was not in medicine.
A third skill is knowing what you do not know. I lacked this too.
Burzynski peptide theory seemed plausible to me, and I had an arrogance
that I was able to recognize good and bad theories about treatments for cancer.
After all, I spent many *months* reading up on it! And since the
Options book made it very clear that the medical establishment could not be trusted, I had better take this on
myself.
The event that began to slowly awaken me was Joanne's medical crisis. The
necessity to treat with CHOP to deal with fast progression in 1997. Joanne's brain was in a fog from 10 months on the 24-hour pump infusion of Buryzinski's peptides (which smelled like urine). Although she had a 30%
response* at one point (or was it?), the lymphoma began to progress rapidly
and was now bulky. New nodes were appearing almost daily. When "we" finally went off study, the gallium scan lit up like a Christmas tree. I
recall that the liver involvement scared me the most.
* We can anticipate that the
temporary response to antineoplastons is being cited by others as
"evidence" that this therapy works, ignoring what happened
later ( the transient nature of the response), and that indolent
lymphomas will wax and wane spontaneously.
Thankfully, CHOP therapy put the lymphoma into remission, even at this advanced
stage. Clearly, without effective standard medicine she would have died...
and so, with our crisis, my firm belief in the conspiracy theory began to
erode.
Unfortunately, the remission from CHOP was short lived, perhaps a cost of
delaying treatment. Thankfully the
biopsy indicated the lymphoma was still indolent.
But I was not yet a convert to evidence-based medicine. Slow learner.
Believing myself capable of doing my own research (I still did not know what
I did not know), I spent perhaps thousands of hours reviewing the literature
for promising natural compounds. My research led to trying many alternative
practices during my spouse's short remission, and for a short time after her
relapse.
Still she progressed. Again, she started her next standard treatment,
Rituximab, with bulky disease - that is to say, at a disadvantage.
For indolent lymphomas the *variable* natural history of the disease could easily account for the outcomes reported in testimonials. This is the
context that we *must use* to more objectively review study reports and
testimonials. It's documented that some people with fNHL have never needed
treatment. Others need it quickly. Recently, evidence from gene profiling
research (LLMP) has shown that fNHL is not one disease, but at least four
diseases affecting the same cell type. ...
It's estimated from clinical records that ~70% of people with indolent
lymphomas have a truly indolent course, and that 30% will regress spontaneously. The jargon for the underlying
variability of a disease is heterogeneity. Follicular lymphoma is a heterogeneous disease.
See
http://content.nejm.org/cgi/content/full/351/21/2159
for a description (free registration req.)
So I think it follows that if 100 people with follicular lymphoma tried alternative
strategies, 70 could easily *feel* that it's helping, and 30 would be
absolutely convinced. Testimonials would soon follow. But the same results would be expected from use of a placebo, or if you followed any group of 100
patients with the same diagnosis.
Eventually, I gave up hunting for leads on natural approaches, but it was
not because of our negative personal experience, or because the light went
on about what it takes to know if an intervention is really helping ...
.. the bright light came on when I learned that in vitro (cell culture)
experiments are unreliable as sources of evidence. The literature is
littered with articles on the anti-cancer activity of natural compounds in test tube experiments. The problem is that cancer cells are no more like
themselves when removed from the body than a fish is itself in soda water.
...
And this serious limitation of in vitro "evidence" is compounded by the
second hurdle, which is bioavailability: it is many times not feasible to
take the oral dose needed to reach levels in the blood that showed activity in cell culture experiments. Often the body changes, or merely excretes,
the active compounds.
The promise of natural medicine gets even thinner
when you examine the track record. The odds of success is roughly 1 in 5,000 that any compound showing activity in assays will win marketing
approval (PHRMA report).
So for all of these reasons I think we are better served by first
discussing with our doctors the efficacy of standard therapies,
which can be curative and/or highly effective for many types of
lymphoma.
If standard therapies are not
optimal or effective, we can seek expert advice on participating in
trials testing new
agents that have reached at least phase I *clinical-phase* testing. That is,
human testing. The compounds don't get this far without having shown activity and
some evidence of activity in assays and animal models. Here the
odds of reaching the market (being clinically useful - the benefits outweigh
risks) improve to about 1 in 10.
(However,
even when a study reaches clinical phase testing,
the investigators have an obligation to report their findings in a
timely manner (and to our knowledge Burzynski has never published
outcome data on lymphoma) - this to allow for peer review and
planning for continuation or discontinuation of the protocol for the
indication. )
We all want to believe that a non-toxic, "natural" way to treat lymphomas is
out there somewhere. It's a myth that natural compounds are ignored by researchers and
the pharmaceutical industry. Vincristine to name just one. There is an
NCI department of Natural Products,
which is dedicated to this work.
The conspiracy theory raises the level and urgency of our personal
pursuit to find natural medicines; it leads to reliance on untrained
persons to find the way. The people who take the lead are sometimes
sincere and intelligent, but this does not make them correct. A
signal of their inner doubt, I think, is a reluctance to publish or
share their ideas with professional scientists for review, and the
tendency to form CLOSED like-minded groups that will rarely discuss other
perspectives.
The conspiracy theory does not hold up to
scrutiny. It can't address the 80% cure rate of childhood cancers with
standard chemotherapy; or the fact that everyone gets cancer,
including researchers, doctors, regulators ... and their children. Or that
a conspiracy would require the complicity of the parents of children with
cancer.
It's a myth that natural medicines are kept from us to protect the profits
of the industry. The profits are a necessary driver of the research.
Patent law was designed to make the risky path of drug development worth trying. Most often they fail, and lose incredible sums of money. Only a few
new compounds make it through the independent FDA review process.
Yes, the drug industry has a bias -
a clear profit motive. Yes, the industry is prone to overstating the
benefits of a drug and will be happy if it's products are used for
new indications, even if not fully tested. This is why the role of
FDA is vital, and why we need patients to participate in the
development and review of best practice guidelines.
I know that belief in the "evidence" supporting natural medicine can
provide comfort. However, *strong belief* in unproven therapies can
do harm if a person delays, or avoids, proven treatments because of
it. Further, to maintain such belief can require that we
abstain from using our critical judgment ... on how to evaluate
medical claims and recognize information that is weakly supported.
What is evidence? Why does it matter?
The appeal of alternative medicine is understandable, particularly for cancers that have no
effective treatments, but it's a red herring. There are many more promising
directions in clinical research to review and consider - plausible ideas
that account for levels of the compound in the blood - that are
monitored for activity and side effects by trained scientists and
investigators.
We might better exercise our energy and apply our
intelligence to advocate for standardized bio-banks and advanced
testing to identify new targets and biomarkers that may predict
response to therapy. We might routinely consider
participation in clinical
trials ... We might inform the industry about obstacles
to trial participation, or help to increase investments in cancer research.
~ KarlS
