Jim Mullowney spent 25 years in the hazardous waste industry. He operated a hazardous waste disposal facility where his employees often handled medical waste in syringes.
“And lo and behold,” he said, “the chemical inside that syringe was a medicine called Mustargen.”
Mustargen is a highly toxic drug used to treat cancer. Many cancer drugs are classified as cytotoxic, because they target cancer cells but also kill healthy cells - which is why people undergoing chemotherapy often lose their hair. While new drugs are being developed that target only cancer cells, the older, cytotoxic drugs are still very much in use. Of the 300 available today, 27 are known to cause cancer, miscarriages and birth defects. One of the most potent is cyclophosphamide. Mullowney said a typical dose is 4 grams.
“I mean, that’s a lotta cyclophosphamide. 25% comes out in the urine in 24 hours. That’s 1,000 parts per million.”
Today, 85% of chemotherapy is done on an outpatient basis. The drugs a cancer patient receives can remain toxic for 24 to 48 hours after an infusion - and can enter the environment through a patient’s waste. According to Mullowney, caregivers and family member could be in danger of exposure through improper handling of that waste. So he founded a company called Pharma-Cycle, which markets a kit with supplies for safely handling and containing waste, so it doesn’t enter the water supply through flushing.
“The waste can be solidified. There’s a series of reactions that go on. There’s 3 different polymers and 2 different chemical reactions, that make it safe - effectively turn it into a rock,” Mullowney said.
The solidified waste is placed inside a box, which is then returned to Pharma-Cycle for disposal at a secure landfill. Mullowney believes there’s a regulatory hole - and a lot of finger-pointing - between government agencies who he believes should have tighter policies regulating disposal of cytotoxic waste.
“In 1970, when the EPA was formed, their directive was to regulate every chemical that wasn’t already regulated,” he said. “Prior to that we had the FDA. So EPA has a history of 40 years of ignoring drugs as chemicals and environmental pollutants. That’s because it’s the FDA’s problem. The FDA regulates every drug that goes into a person. But they really don’t regulate what comes out of a person.”
At present, there is no specific EPA policy governing the disposal of cytotoxic waste. (The EPA declined to comment for this story.)
According to Theresa O’Keefe, Pharma-Cycle’s Chief Scientific Adviser, OSHA has strict rules about protective equipment that hospital workers are required to wear around chemotherapy drugs. But family members don’t fall under those regulations.
“Family members are not covered by OSHA. They’re not an employee of the hospital. So they’re not covered,” she said.
O’Keefe acknowledges that some hospitals tell patients they could be excreting dangerous drugs in the 48 hours after infusion. However, she claims they tend to bury that information in lots of other complicated data.
“If you’ve ever gone through oncology treatment, or cared for somebody in oncology treatment, you’re overwhelmed,” O’Keefe said. “You are absolutely, completely overwhelmed by ‘What’s gonna happen to my family member?’ ‘How do I take care of them - how do I keep them safe?’ ‘Are they going to die?’ A toilet flushing? It’s not on your bandwidth.”
But according to Adrienne Sullivan, Nurse Manager for Cancer Services at Cape Cod Healthcare, Cape Cod Hospital provides patients with specific instructions for after-care at home.
“We actually tailor for every patient receiving chemotherapy a dedicated education plan. We tell all patients to employ the basic principles after they receive chemotherapy to have the toilet seat down when they flush, and to flush the toilet twice. And then hand washing is paramount,” Sullivan said.
Sullivan claims that 90% of the chemo drugs Cape Cod Hospital administers are cleared from the body within 24 hours. If a patient is going to need help at home, hospital personnel provide special instructions for caregivers and family members. In addition to things like using double gloves when handling waste, pads or diapers, Sullivan outlined other recommended procedures.
“Throwing them into a separate trash bag - and actually they can go out with the regular trash,” she said. “And then as far as the linen goes, we request that they wash the linen separately, not with other clothing. but it’s still to be washed with a regular machine cycle and dried regularly - no special precautions. As far as the actual washing and handling it, wearing the 2 sets of gloves.”
Typically, Cape Cod Hospital’s chemotherapy programs involve a combination of targeted and non-targeted drugs. This means the patient can be especially vulnerable to infection.
“The chemotherapy patient themselves is more at risk than the caregivers, is how we feel,” Sullivan said.
Jim Mullowney enlisted the help of a lobbyist to get a bill introduced in the Massachusetts House to further study the effects of cytotoxic drugs. Representative Tackey Chan of Quincy sponsored the bill, and hearings were held this past November.
“There are a lot of life-saving drugs out there that are quite old that may have or may have had a negative impact in the environment we live in because of the way it’s been disposed in the past,” said Chan. “It would seem to make sense for us to try to figure out how long they’ve been used and the way they’ve been disposed of and how they’ve impacted the environment in the past and in the future.”
If the bill passes, it would fund new research at the University of Massachusetts. Dr. David Reckhow is a Professor of Civil and Environmental Engineering at the University of Massachusetts, Amherst. His lab already conducts research into various pharmaceuticals and their effects on the environment.
“Many wastewater treatment systems do a pretty good job of removing a broad range of pharmaceuticals. The one chemotherapeutic drug that has been studied a little bit is florouracil, and that one seems to be well removed through conventional biological wastewater treatment,” Reckhow said.
Still, Reckhow said there's much more work to be done.
“We’ve spent very little effort and time researching what happens in the home with individual septic systems. so there’s a gap there - there’s a real need to learn more, and we need to do due diligence on this issue,” he said.
There are no definitive studies stating that cytotoxic drugs cause medical problems in either family members or caregivers of chemotherapy patients. And while it’s generally agreed that cytotoxic drugs can pose dangers, further research is needed to determine the actual scope of that danger.