An Open Letter To the Editor of the Cancer Letter

An Open Letter To the Editor of the Cancer Letter


Leonard Zwelling

Dear Paul:

With all due respect to all of the superior physicians and
scientists who commented for the Cancer Letter on October 31, I beg to differ
with their assessments. Most of the comments appeared to be broad appeals for
additional funding from the federal government, aligning the great “progress”
made against cancer with the increases in funding that are now being eroded as appropriations dwindle and the stimulus money ends.  This is a free issue.

If I understood the graphs in the Cancer Letter, these numbers
represent the contribution from the NIH and NCI to research support. Many academic
institutions support a great deal of research with funds from patient care and
from the pharmaceutical industry, so at best this is a partial picture of
research funding. Nonetheless, it is pretty dismal. 

While more funding for research is always something I support, I
believe that the first step in addressing the cancer problem is correctly
articulating what the problem is. This starts by admitting what we really KNOW
and what do not KNOW. (Know means know, not what we think is true).

First, while it appears that cancer is a disease with its
origins in genetic malfunction, epigenetic, aberrant immunology, and abnormal biochemical
responses in the microenvironment to newly arising carcinogenesis are every bit
as likely to be the primary causes of any given cancer in any given patient.
Sequencing every patients’ cancer will thus not necessarily identify the cause
of that individual patient’s illness or the most beneficial path to treatment.
Other approaches than genomic ones may be required to truly personalize cancer
therapy. It is even likely that a pharmacologic approach that targets the
immune system may be more efficacious than one that targets the cancer.

Second, as long as we insist on having thousands of competing
strategies seek the solution to the nation’s cancer epidemic, it is not likely
that the whole will be any greater than the sum of its parts. There simply is
not enough money in the RO1 pool to go on with the current system and expect a
whole lot of progress.

Third, as long as the current system of drug approval remains in
place with the FDA insisting it knows the best way to design clinical trials
and with both the FDA and the members of its advisory boards having clear
conflicts of interest when overseeing the system of new drug access to the
market, we should not be surprised that we have such a convoluted and
relatively unsuccessful result.  

Fourth, as long as the current American system of health care
delivery and financing is the one now in place (ObamaCare not withstanding), which
is no system at all, but four systems depending on whether or not one has
insurance and, if so, who is paying for it, you, your employer or the
government, we will never get the best care to each patient and that includes
situations in which the best “care” is really a clinical trial.

Fifth, the current pharmaceutical and biotech industries, that
fund more research than the NIH but spend even more on marketing, are solely
based on the companies’ desire to make money. Is that really the goal of the
national effort against cancer? That the current flap about drug prices in the
US has made it all the way to 60 Minutes suggests making money in the private
sector is a far more powerful force than is grant money from the public sector.

Sixth, reduce the regulatory burden to get drugs approved and
clinical trials started. Why do we believe that the FDA is the sole site of
clinical research wisdom in the land? The IRB system is also broken as informed
consent documents are exploding in size such that they are not read and are
thus not serving their ethical purpose anyway. Furthermore, some of the recent
decisions by the MD Anderson IRB are truly bizarre and suggest that the lawyers
have hijacked the committee.

Why not get drugs for potentially fatal diseases to the market
sooner and intensify and incentivize post-approval marketing by limiting the
period of approval for new drugs so that they have to prove their worth in
populations of real patients, not just “human subjects” or come off
the market?

Seventh, recent articles have suggested that the reproducibility
of a significant number of putatively important academic research findings are
not reproducible in the hands of the pharmaceutical industry. This industry
depends on the veracity of these findings to identify targets for new drug
development. If these findings are not reliable, there are large amounts of
money wasted chasing false leads. Our preliminary investigation into reasons
for this non-reproducibility at MD Anderson revealed pressure from laboratory
supervisors for post-docs and students to get specific results in the lab is a
factor. This cannot be tolerated, but in the climate of shrinking research
dollars and human nature being what it is, perhaps this should not be

Finally, if we really want to reduce the cancer risk to
Americans we know several things that we can do right now without spending
another dime on research. Outlaw tobacco, period. Teach kids how to eat, shop
for food, exercise and use the health care system in grade school. And have
them go home and teach their parents as my kids taught me how to recycle and
use Facebook (Okay, I haven’t quite got that one down yet). Incentivize super
markets to open in urban food deserts where fresh vegetables and fruits cannot
be found. Incentivize Americans to get cancer screening as recommended by the
USPSTF and pay to treat those in need of interventions to keep localized
cancers localized. (Paying for the colonoscopy without a co-pay but not for the
full cost of the polyp removal makes no sense).

These things can be done right now and many do not need more
research dollars to implement. To be blunt, why is any one over 50 in Houston,
Texas still dying of colon cancer?

If the cancer problem is viewed as one of insufficient research funds,
cancer researchers will always be depicted as having their hands out. They will
also be charging up Capitol Hill once a year to “lobby” Congress for more
research funding. Congress cannot be lobbied once a year. As someone who was on both sides of these lobbying efforts, I can assure you that Congressmen and
Senators are not receptive to a once a year game of trick or treat from the colored ribbon of the month club.

If the cancer problem is divided into what we know, what we know
will work and can do now, and then what we don’t know, a very different system
might be formulated that might both save money and time and be more productive
than another American non-system.

We can no longer fight the war on cancer like we do the war on
drugs, terrorism or ISIS, let alone Ebola by careening from fad to fad and
making every challenge a crisis. Just consider how the War on Terror would look
if we had correctly labeled 9/11 as what it was, a horrible and massive crime
warranting a police response a la Zero Dark Thirty, as opposed to a “war” that
was used as a false pretense to invade Iraq with an Army of uniformed soldiers
who, once successful then turned over the spoils of their hard work to
additional criminals which gave birth to ISIS.

Make a plan. Identify the metrics of success. Measure key
parameters and be ready to change if the first plan isn’t working.

Cancer is not just about the money and neither is finding the
best way to approach its eventual eradication—if that is even possible under
evolutionary and biologic principles.

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