By FRANK CARINI/ecoRI News staff
NEWPORT — For 25 years, Jim Mullowney worked to protect company employees from the dangers of industrial chemicals. When his mother was stricken with cancer, he quickly realized chemotherapy chemicals are much nastier, and that they are being unleashed in homes and on the environment largely unnoticed.
“We send people home with highly poisonous chemicals,” he said. “It’s criminal.”
About 85 percent of chemotherapy patients receive their infusions at a hospital or health-care facility. They are then sent home — typically without warning about the dangers the chemicals that soon will be exiting their bodies can pose to family members and caregivers for the next two to three days.
Despite being a University of Massachusetts-educated environmental chemist and having spent nearly three decades working with industry’s most vile chemicals, it had never occurred to Mullowney that some chemicals used in medical treatments were actually more dangerous than those that are regulated in factories.
“Industrial chemicals are bad, but they’re not designed to react with nature,” Mullowney said. “Pharmaceuticals are nasty, and specifically designed to interact with the human body.”
In 2008, his mother was diagnosed with breast cancer. He researched the drugs she was prescribed and looked into other cancer treatments. He found that the cornerstone chemotherapeutic drugs are genotoxic — they directly attack DNA and pass through cancer patients as active chemicals in urine, feces, vomit, saliva and sweat.
Both appalled and saddened by the lack of elaborate practices that deal with chemo drugs in the home or even warnings about the dangers they present to a patient’s family and friends, Mullowney set out to educate the public and, surprisingly, the health-care industry itself.
“Empty vials, empty IV bags, the gloves nurses wear, everything that comes into contact with these materials, even in trace amounts, is treated like it is a chemical weapon,” Mullowney said. “Yet, we inject it into a patient where it passes through the body in three or four days. There’s no thought to where it ends up or the impact these powerful chemicals have on a household.”
Five years ago, the Newport resident founded Pharma-Cycle Inc. The Thames Street-based company has developed a “Family Safe System” that is mailed to patients’ homes, and includes devices for collection and automatic sequestering of contaminated bodily wastes.
The supplies (cotton gloves, disposable utensils, vomit bags, wet wipes and disposable sheets) arrive in a 16-inch box painted with flowers — the artwork is courtesy of Pharma-Cycle’s first patient.
For the past year, the company has been beta testing the system. Eventually, Mullowney said the company will sell the kits for $1,000 — a cost, he said, should be part of chemo treatment (usually about $150,000, not including any surgery) and covered by insurance.
Used sheets, gloves, utensils and barf bags, and collected feces and urine are placed back into the flower-covered box, which includes five layers of protection. Implementing an easy-to-use matrix designed by Pharma-Cycle, liquids are turned into solids and made safe and legal to ship.
Boxes filled with chemo-tainted hazardous materials are shipped to one of 16 secure chemical landfills in the United States and Canada.
“These landfills are away from water, and you don’t want to put these packages into an incinerator because the chemicals used in chemotherapy are very water soluble,” said Theresa O’Keefe, Ph.D., the company’s chief scientific officer. “We don’t want those chemicals to be steam-delivered into the air.”
Chemo drugs kill … everything
Hundreds of drugs are used to fight cancer. The most powerful are cytotoxic, which kill cancer cells anywhere in the body and, unfortunately, fast-growing healthy cells anywhere in the body.
“The goal of chemo drugs is to poison the cancer before killing the patient,” O’Keefe said.
Of the 212 or so drugs used in various chemo treatments — the first were descendants of mustard gas — 27 are a real problem, according to O’Keefe. Among these 27 drugs, doxorubicin, cyclophosphamide, 5-FU and etoposide present an additional danger.
These drugs are excreted in active form, in the few days after each chemotherapy infusion, O’Keefe said. This means that during those two to three days, a patient’s sweat, saliva, vomit, urine and feces contain quantities of dangerous chemicals. Anyone who touches these contaminated fluids, say, by cleaning the toilet, helping the patient as they vomit or with any other task caregivers and family selflessly perform, can absorb dangerous amounts of an active cytotoxic drug.
Cancer professionals including hospitals, oncology doctors and nurses and cancer drug producers are well aware of these risks, according to Mullowney. He said drug producers and hospital officials understand the dangers accidental exposure to cytotoxic drugs pose to their employees. Every step along the way, from drug production through injection into a patient, is carefully controlled to minimize health risks.
In fact, the Occupational Safety and Health Administration (OSHA) in 1986 released recommendations for hospitals and their employees to always use high levels of protective equipment when working with chemotherapy patients and/or their bodily wastes.
“Every day in healthcare settings across America, workers are exposed to hundreds of powerful drugs used for cancer chemotherapy, antiviral treatments, hormone regimens and other therapies,” according to a 2011 letter written jointly by OSHA and the National Institute for Occupational Safety and Health (NIOSH) to health-care professionals. “While these drugs are used to relieve and heal patients, many of them present serious hazards to the health and safety of your workers. 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 exposure.”
Cyclophosphamide is among the most powerful and dangerous chemo drug. Accidental contamination of health-care workers by this drug has been proven in studies to cause cancer, birth defects and miscarriages. Nurses who worked with chemotherapy patients were having babies with 4.7 times the number of birth defects as other nurses who didn’t work with such patients.
The main use of cyclophosphamide is with other chemotherapy agents in the treatment of lymphomas, some forms of brain cancer and leukemia. Cyclophosphamide has severe and life-threatening effects, including acute myeloid leukemia, bladder cancer and permanent infertility, especially at higher doses, according to O’Keefe.
Problem can’t be flushed away
While industrial chemicals are highly regulated, pharmaceuticals are not — at least when it comes to disposal. Since the 1970s, it has been illegal, for example, to dump paint thinners and PCBs down the drain, because, as Mullowney noted, “our lakes caught fire.” But we routinely flush the waste of chemo-treated patients down the toilet.
The American Cancer Society even recommends flushing the toilet twice when getting rid of such waste. That practice does nothing but waste water. Hospitals also flush the waste of chemotherapy patients down the hopper.
The American Cancer Society also warns that toilets being used by patients undergoing chemotherapy can be a hazard for children and pets, it recommends that chemo patients use a separate bathroom and that men sit down when urinating, and it suggests to avoid kissing and sharing food or drinks with chemotherapy patients.
But what happens when these chemicals are unleashed on the environment? Nobody can say for sure, but the evidence is mounting, and quickly.
“We have to stop putting these dangerous chemicals into the environment,” Mullowney said. “Only a quarter of what was used on a patient may leave the body, but it doesn’t take a large amount of these chemicals to have an impact.”
Chemotherapy chemicals are known to cause birth defects, immune dysfunction such as myelodysplastic syndrome (pre-leukemia) and miscarriages. Patients can even develop other cancers that don’t appear for several years. For example, cyclophosphamide, which is used to treat breast cancer, can cause bladder cancer, according to O’Keefe. In fact, patients must be warned that the drug can do just that.
The unborn, babies and children have huge numbers of fast-growing cells that can be attacked by post-patient chemotherapy drugs. When chemo patients are sent home, they are unintentionally bringing DNA-mutating drugs into their homes and dumping them into the environment.
The Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA) can’t even agree on how to deal with the problem. The EPA says it is the FDA’s responsibility to come up with standards, because chemo chemicals are drugs. The FDA, of course, says it’s up to the EPA, because the chemicals leave the body as waste. Around and around this conversation goes, as hospitals and homes continue to flush dangerous chemicals down the toilet.
A 2002 study found 80 percent of the streams sampled in 30 states contained prescription and non-prescription drugs, steroids and/or reproductive hormones.
Tainted drinking water?
A handful of life-saving cytotoxic chemotherapy drugs exit cancer patients as active and dangerous chemicals. Septic systems and wastewater treatments plants can’t remove 98 percent of them, so these dangerous chemicals migrate intact into lakes, rivers and ponds, and eventually into drinking water supplies.
Active chemotherapy chemicals in water are a problem for all living organisms, but they are a profound risk for humans, other mammals and fish. Cytotoxic chemicals work by causing DNA breaks and mutation, triggering tumors and other abnormalities. They are genotoxic and classified as contaminates of emerging concern.
Rhode Island lawmakers want to know if the state can prevent pharmaceuticals from polluting the state’s water supply. A commission, consisting of lawmakers and representatives from health and environmental agencies, is studying the problem. It was created to recommend ways to reduce pharmaceutical contamination. The commission is tentatively scheduled to report its findings to the Senate early next year.
In Massachusetts, cancer patients would have to collect their urine and feces for a few days after chemotherapy treatments to be disposed as hazardous waste, under a proposal filed last year by a state senator. The bill would order health-care professionals to give chemotherapy patients the means to collect and dispose of bodily wastes following treatment.
“Fifteen years from now we won’t be using such nasty chemicals to treat cancer,” O’Keefe said. “But some of the chemicals we are using now are a real problem. Even in minuscule amounts these drugs are dangerous and highly carcinogenic.”