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 listedWhat 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 Warfare?

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

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 afterlow-level exposures.” April, 4 2011 OSHA, Niosh and the Joint Commission.

• Cancer

• Heritable Genetic Damage

• Harm to the Unborn Child

• Very toxic by inhalation and if swallowed

• Cytotoxic agent

This Drug May Cause:

How the drugs are madeDoxorubicin manufacturing from June 2008

Chemical and engineering news

A Pharmacist prepares the drugs in a level 3 Biological safety cabinet

• OSHA has determined a OSHA has determined a pharmacist preparing pharmacist preparing chemotherapy drugs has chemotherapy drugs has the most dangerous job in the most dangerous job in AmericaAmerica

• Lifesaving cancer drugs Lifesaving cancer drugs may put workers' lives at may put workers' lives at risk Chemo could have a risk Chemo could have a hidden deadly toll on hidden deadly toll on pharmacists, nurses -pharmacists, nurses -MSNBC July 2010MSNBC July 2010

• http://www.msnbc.msn.com/http://www.msnbc.msn.com/id/38114586/#slice-3id/38114586/#slice-3

OSHA SECTION VI: CHAPTER 2 CONTROLLING OCCUPATIONAL

EXPOSURE TO HAZARDOUS DRUGS

•  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. 

Drugs and the Environment:Stewardship & SustainabilityChristian G. Daughton, PhDNational Exposure Research LaboratoryOffice of Research and DevelopmentU.S. Environmental Protection Agency944 East HarmonLas Vegas, NV 8911912 September 2010

Only 5% of the drugs in the environment come from dumping unused drugs. 85% comes from direct excretion and 10% from bathing

Pee Lab• Law enforcement periodically comes upon Law enforcement periodically comes upon

a type of clandestine lab operation called a type of clandestine lab operation called a “urine extraction lab” or “pee lab,” a “urine extraction lab” or “pee lab,” where methamphetamine that has been where methamphetamine that has been excreted unchanged in urine or feces is excreted unchanged in urine or feces is reclaimed with the use of chemical reclaimed with the use of chemical extraction; those engaged in this activity extraction; those engaged in this activity are called “tinkle tweakers.”are called “tinkle tweakers.”Christian Daughton PhD, US EPA Christian Daughton PhD, US EPA September 2010September 2010

• Could Cytotoxic chemotherapy drugs be Could Cytotoxic chemotherapy drugs be extracted and used as Chemical Weapons?extracted and used as Chemical Weapons?

Excretion timesMechlorethamine 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 WikipediaClick on Wikipedia• Nitrogen Mustard definitionNitrogen Mustard definition• The nitrogen mustards are cytotoxic 

chemotherapy agents similar to mustard gas.

Radioactive vs. Cytotoxic

1. Cause cancer

2. Mutates genes

3. Birth defects

1. Causes cancer

2. Mutate Genes

3. 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

• 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 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 in chemotherapy treatment

• The table on the below indicates the number ofestimated new cases from 2007 through 2010

Thank you.

Jim MullowneyJim MullowneyPharma-Cycle, Inc.Pharma-Cycle, Inc.359 Thames St. 359 Thames St.

Newport, RI 02840Newport, RI 02840jmullowney@pharma-cycle.comjmullowney@pharma-cycle.com