Editorial
Bringing New Systemic Anti-Cancer Agents from Test Tube to the Clinical Practice
Maria Stack and Muhyi Al-Sarraf*
Department of Oncology, Wayne State University, USA
*Corresponding author: Muhyi Al-Sarraf, Department of Oncology, Wayne State University, 6849 Grenadier Blvd. #1105, Naples FL 34108-7235 USA
Published: 16 Dec, 2016
Cite this article as: Stack M, Al-Sarraf M. Bringing New
Systemic Anti-Cancer Agents from
Test Tube to the Clinical Practice. Clin
Oncol. 2016; 1: 1164.
Editorial
Systemic treatments/agents: (Hormonal, Chemical, Immunotherapy, etc.) are important for
the prevention and treatment of patients with malignant cancers. The process of bringing these
agents from the time of discovery to the market for the indications of benefits/use is long and costly
process. This process should be and must be kept outside the political and the commercial arenas.
Recently in the news media about former President Jimmy Carter’ cancer “Cure”. He was
ongoing battle with metastatic malignant melanoma with lesions in his brain and liver. Nothing
was mentioned of the fact that he under went surgery to remove the lesion in the liver. And the
fact he underwent brain irradiation. But the public heard that he received a treatment with a newly
approved immunotherapy drug called Keytruda. And of course the later great news that brain MRI
scan did not show any signs of his original lesion melanoma spots nor new lesion(s).
Also, recently in the media news about the unfortunate premature lost of VP Biden son
to cancer. And the fact that the President did allocated one billion US dollars for the VP to seek
cure for cancers. The VP took his plane all over the USA, meeting the specialists from well known
Universities/Institutions to find the magic cure. By sure accident he and his family found them
selves in Hollywood, California on the second Sunday of February 2016 and they attendant the
Oscar, Why not??
Three important facts where not presented to the VP. One: when former first lady Mrs. Nixon
had cancer, President Nixon in about 1973-74 had a vision of and made statement and plans of:
Curing Cancer by 1980, Balance the Budget by 1980, and be energy self sufficient by 1980. He
ordered the establishment of Comprehensive Cancer Centers for that purpose.
Second, that in the USA only, cancers cause the premature death of more than 650,000 US
citizens annually and they are ALL important to their family and to the Medical Scientists and
physicians.
Third, that more than 50% of the cancers in the USA are preventable, and this is doable. To
accomplish this, is by stopping:
Tobacco (all types)
Alcohol
Artificial sweetener, Aspartame
Refine white sugar
Reducing Obesity, and encouraging regular and proper exercise.
Add on proper early detection and timely screening, we will discover many in early stage(s) of
cancers that are treatable and highly curable.
Beside the fact it is less time consuming and much cheaper to invite the proper researchers to the
White House for two days working conference to bring their recommendations to the VP.
Many processes enter into the discovery of possible active agent. Some even by chance and
others are by long process of search and research. The initial testing of the activity of an agent may
vary according to type and what is known about that agent. The in vitro process will follow extensive
in vivo process in animal systems when possible activity is suggested. It is a long and costly process.
When activity is reported and accepted toxicities are indicated, the same intensive process may enter
into the human investigation. This is also lengthy from possible acceptable and reversible toxicities, to many phases of re-checking activities, dosing, best dose schedule,
to possible human and patient benefits.
Acceptable and reversible side effects, definite activities and
possible patient’s benefits as such or as compared to available
standard treatment may end in the process for approval to market the
agent. Most of the time, with indication to be used in patients with
metastatic and incurable disease.
But the process of further evaluation will continue in many
directions. The use of this active agent in combination therapy, the
use in adjuvant setup Vs. standard therapy in patients with locally
advanced disease after local treatment made them disease free, but
still at high risk of recurrence.
At all time this process has to stay academic and clean research
not influenced by concerned company, Institution, political entity, or
other(s).
The cost of cancer care is of course now increasing and is now
untenable, this is due in the most part to the significant costs of
bringing new Cancer Drugs to market.
Thus the cost of the developing these new drugs and their
approval and costs of further development to market must be reduced
so as not to have a huge negative impact on patient care and overall
health costs.
Efforts have been made to harmonize the regulatory processes in
America and Europe.
But this harmonization may be in jeopardy because of the fall out
from the UK referendum.
FDA commissioner Robert Califf recently stated that despite the
recent events in the UK regulators need smooth and efficient systems
to continue because of the global nature of the pharmaceutical
industry.
There is the pro brexit view that Brexit will give the UK an
opportunity to take the better regulation agenda forward faster than
is possible at present through the European Union.
Ultimately post brexit efforts will have to be made to align
practices in America the EU AND the UK and this will help to reduce
costs of new drug development…. mutually agreed protocols will
lower barriers to new drug development.
At all time the patients should be completely informed and the
decision of using any agent(s) or treatment should be left completely
to the well-informed practicing physicians (oncologists) and their
patients.
In dealing with human lives and their health, there is absolutely
no place for political and/or commercial use or abuse. Decisionmaking
should be and must be left between the proper physicians and
their patients and family.