Transcript Pharma-Cycle_Senator

Pharma-Cycle, Inc. (PCI)
Presentation to Senator
Sheldon Whitehouse
Member Senate Committee on Environment
& Public Works
July 11, 2011
USED Pharmaceuticals
U listed and P listed
What about process waste?
How do you use a drug?
Did you ever take a vitamin and a couple of hours later your urine looks like
you ate your highlighter? That is the vitamin passing through your body
unaltered. What if that drug was also used in Chemical Warefare?
The Problem
• The drugs we are developing to aid in cancer
treatments are polluting our eco system. The same
chemicals are used in chemical warfare and can be
considered “weapons of mass destruction”
Dr. Nick Anastas PhD head of the drinking water program Mass DEP
• Up to 99% pass through body unaltered and are
being flushed down the toilet.
• They continue to do what they were developed to
do, alter DNA in doing so pollute our ecosystem.
Background
• Cytotoxic drugs do not stop working
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after excretion
There is no safe exposure limit (OSHA)
Carcinogenic (causes cancer) mutanagenic
(alters DNA) and Teratogenic (Alters future
generations, causes birth defects)
EPA estimates 95% of the drugs in the water
come from excretion
Dose Response are extreme (little does a lot)
Mechanism of Action is to break into the cell
and alter the genetic make up of the cell
Who is watching
“Some of these drugs have been known to cause cancer,
reproductive and developmental problems, allergic reactions,
and other adverse effects that can be irreversible even after
low-level exposures.” April, 4 2011 OSHA, Niosh and the
Joint Commission.
This Drug May Cause:
• Cancer
• Heritable
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Genetic
Damage
Harm to the
Unborn Child
Very toxic by
inhalation and
if swallowed
Cytotoxic
agent
How the drugs are made
Doxorubicin manufacturing from June 2008
Chemical and engineering news
A Pharmacist prepares the drugs in a level 3
Biological safety cabinet
• OSHA has determined a
pharmacist preparing
chemotherapy drugs has the
most dangerous job in
America
• Lifesaving cancer drugs may
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put workers' lives at risk
Chemo could have a hidden
deadly toll on pharmacists,
nurses -MSNBC July 2010
http://www.msnbc.msn.com/id/3
8114586/#slice-3
OSHA SECTION VI: CHAPTER 2
CONTROLLING OCCUPATIONAL EXPOSURE
TO HAZARDOUS DRUGS
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Reproductive effects associated with
occupational exposure to CD's have been
well documented. Hemminki et al.32 found
no difference in exposure between nurses
who had spontaneous abortions
and those who had normal pregnancies.
However, the study group consisted of
nurses who were employed in surgical or
medical floors of a general hospital. When
the relationship between CD exposure and
congenital malformations was explored,
the study group was expanded to include
oncology nurses, among others,
and an odds ratio of 4.7 was found
for exposures of more than once per
week. This observed odds ratio is
statistically significant.
Only 5% of the drugs in the
environment come from
dumping unused drugs.
85% comes from direct
excretion and 10% from
bathing
Drugs and the Environment:
Stewardship & Sustainability
Christian G. Daughton, PhD
National Exposure Research Laboratory
Office of Research and Development
U.S. Environmental Protection Agency
944 East Harmon
Las Vegas, NV 89119
12 September 2010
Pee Lab
• Law enforcement periodically comes upon a
type of clandestine lab operation called a
“urine extraction lab” or “pee lab,” where
methamphetamine that has been excreted
unchanged in urine or feces is reclaimed with
the use of chemical extraction; those engaged
in this activity are called “tinkle tweakers.”
Christian Daughton PhD, US EPA
September 2010
• Could Cytotoxic chemotherapy drugs be
extracted and used as Chemical Weapons?
Excretion times
Mechlorethamine hydrochloride excreted in urine in 48 hrs.
Chlorambucil excreted in urine in 48 hrs.
Cistplatin excreted in urine in 7 days
Megestrol Acetate excreted in urine 57-78%
Citrate excreted in feces and urine
Melphalan excreted in urine 48 hrs.
Mercaptopurine excreted in urine in 72 hrs.
Cyclophosphamide excreted in urine 72 hrs. (i.v.)
Methotrexate excreted in the urine 72 hrs.
Mitomycin excreted in urine first day
Cytarabine hydrochloride excreted in the urine within 1st day
Mitoxantrone-Hydrochloride excreted in urine
Dacarbazine excreted in the urine 30-46% within 6 hrs.
Plicamycin excreted in urine 40% in 15 hrs.
Dactinomycin excreted in urine in 5 days 20% in first 24 hrs.
Tamoxifen Research not completed
Daunorubicin excreted in feces 7 days 48 hrs.
Thiotepa excreted in urine in 72 hrs.
Doxorubicin excreted in feces 7 days urine 6 days
Thioguanine excreted in urine in 72 hrs.
Epirubicin Hydo excreted in urine 7 days and feces 5 days
Streptozocin excreted principally in urine
Etoposide excreted in urine in 4 days feces in 7 days
Vincristine sulfate excreted in urine 4 days
Fluorouracil excreted in urine in 48 hrs.
Google “Chemical Warfare”
• Click on Wikipedia
• Nitrogen Mustard definition
• The nitrogen
mustards are cytotoxic chemotherapy agents
similar to mustard gas.
Radioactive vs. Cytotoxic
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2.
3.
Cause cancer
Mutates genes
Birth defects
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Causes cancer
Mutate Genes
Birth Defects
In 2000 EPA found mutated
lower level species and traced
the cause back to hospitals
administering chemotherapy
The collection of human excrement
with cytotoxic drugs will happen
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Based on testimony by Jim Mullowney to
the EPA in 2009 The EPA has prohibited
the incineration of pharmaceuticals at
medical waste incinerators and
determined the incinerators are not
capable of destroying these chemicals
(EPA October 2009)
He is currently working with state and
federal officials to identify the risks and
those responsible
There are no treatments a sewer
treatment facility can add to neutralize
The Pharma-Cycle, Inc. solution
The Pharma-Cycle, Inc. Solution
• The waste is collected by the patient
• The waste is mixed with a re-agent that
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chemically reduces the drug and
sequesters the remnants indefinitely
The remaining waste is safely handled
for disposal
“We put a car on the moon, we
can handle this problem”
Size of the problem
• There are an estimated 12 million people already
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in chemotherapy treatment
The table on the below indicates the number of
estimated new cases from 2007 through 2010
Thank you.
Jim Mullowney
Pharma-Cycle, Inc.
359 Thames St.
Newport, RI 02840
[email protected]