Pharma-Cycle, Inc. (PCI)

1. Pharma-Cycle, Inc. (PCI) Presentation to Senator Sheldon Whitehouse Member Senate Committee on Environment & Public Works July 11, 2011

2. 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?

3. 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.

4. 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

5. 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.

6. This Drug May Cause: • Cancer • Heritable Genetic Damage • Harm to the Unborn Child • Very toxic by inhalation and if swallowed • Cytotoxic agent

7. How the drugs are madeDoxorubicin manufacturing from June 2008 Chemical and engineering news

8. 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 put workers' lives at risk Chemo could have a hidden deadly toll on pharmacists, nurses -MSNBC July 2010 • http://www.msnbc.msn.com/id/38114586/#slice-3

9. 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. 

10. 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

11. 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?

12. Excretion times

13. Google “Chemical Warfare” • Click on Wikipedia • Nitrogen Mustard definition • The nitrogen mustards are cytotoxicchemotherapy agents similar to mustard gas. Radioactive vs. Cytotoxic In 2000 EPA found mutated lower level species and traced the cause back to hospitals administering chemotherapy Cause cancer Mutates genes Birth defects Causes cancer Mutate Genes Birth Defects

14. 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

15. 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”

16. Size of the problem • There are an estimated 12 million people already in chemotherapy treatment • The table on the below indicates the number of estimated new cases from 2007 through 2010

17. Thank you. Jim Mullowney Pharma-Cycle, Inc. 359 Thames St. Newport, RI 02840 jmullowney@pharma-cycle.com