Secondhand chemo

Workers at Beth Israel Deaconess Medical Center prepare chemotherapy drugs in a clean room.

NOT TOO LONG ago people smoked everywhere and gave little thought to how their smoke might be affecting others. Then scientific studies began exploring the danger of secondhand smoke, and in 1993 the Environ­mental Pro­tec­tion Agency concluded that secondhand smoke was causing 3,000 lung cancer-related deaths each year. It took another decade before a scientific and legal consensus emerged on the issue, triggering laws banning smoking in workplaces, restaurants, and many public areas.

Now a similar debate is emerging about a phenomenon some are calling secondhand chemotherapy. Concern is growing that powerful chemotherapy drugs used to fight cancer may be having a secondhand effect on drug company personnel who manufacture the drugs, the pharmacists who compound them, the nurses who administer them, the friends and family members who interact with cancer patients, and the environment in general.

Manufacturers and hospitals are already taking precautions with their own personnel, and the hospitals are advising their patients on how to guard against secondhand chemotherapy effects when they head home. A Rhode Island-based company called Pharma-Cycle says these precautions don’t go far enough. The company, which manufactures a kit it says will prevent secondhand chemo­therapy, is pushing legislation in Massachusetts that would create a commission to study the problem. A resolution similar to the Massachusetts legislation passed last year in Rhode Island.  

Pharma-Cycle says secondhand chemotherapy is especially dangerous to unborn babies and young children, whose systems are particularly vulnerable because of their fast-developing cells. The company also says still-active chemotherapy drugs are being found in the urine, feces, and vomit of cancer patients and making their way into the environment through sewage systems.

“There is a growing body of scientific evidence showing that toxic chemotherapy drugs are entering public and private water supplies intact, threatening humans and wildlife,” Pharma-Cycle founder and president James Mullowney says on the company’s website.

Some experts say Mullowney is overstating the public health and environmental threats posed by chemotherapy drugs. But the reality is that no one knows for sure.  

The Environmental Protection Agency says studies indicate pharmaceuticals of all types are present in the nation’s water bodies. “Further research suggests that certain drugs may cause ecological harm,” the EPA says on its website. “More research is needed to determine the extent of ecological harm and any role it may have in potential human health effects. To date, scientists have found no evidence of adverse human health effects from [pharmaceuticals] in the environment.”

The EPA does not require testing for drugs in the water supply, nor has it specified any acceptable limits. Most experts think drugs are there in at least trace amounts. “There’s about 100,000 chemicals in commercial use,” says James Shine, an environmental scientist at the Harvard School of Public Health. “And if we try hard enough, if we have a really good analytical chemist, we can measure all of those in any sample. I could take a cup of coffee I drank this morning and take it to a really good chemist somewhere, and we could measure Prozac in there. We could measure Viagra in there.”

In a broad sense, chemotherapy refers to the use of any drug to treat any disease.  But, in common usage, it refers to the use of drugs to combat cancer—any one of more than 100 diseases characterized by the development of abnormal cells that divide uncontrollably and can invade other parts of the body.

The chemotherapy drugs used to treat cancer are called cytotoxins. They work by killing the cancer cells or by stopping them from multiplying, often achieving significant benefits for patients, including a cure or remission (the cancer can no longer be detected), control (keeping the cancer from spreading or slowing its growth), or palliation (easing symptoms when the outlook is poor).

But these cytotoxins are not selective, meaning they also kill healthy cells. They are, in essence, poisons that can cause very uncomfortable, short-term side effects (includ­ing fatigue, nausea, vomiting, constipation, diarrhea, loss of appetite, and hair loss) and some very serious long-term side effects (including damage to the heart, lungs, nervous system, kidneys, and reproductive organs). Paradoxically, cytoxins can themselves cause cancer that shows up years later.  

By the very handling of some cytotoxins, individuals can experience secondhand chemotherapy by inhaling the agents or getting them on their skin or in their eyes.  

Harold DeMonaco, director of innovation and support at Massachusetts General Hospital and the former head of a hazardous drug safety task force, says the hospital has had difficulty completely removing trace amounts of cytotoxins from the environment. He says chemotherapy residue has been found on computer keys and on elevator buttons.

Pharmaceutical companies take extensive precautions to protect their employees who are involved in the manufacture of chemotherapy agents, sometimes using robots to handle the drugs. Hospital workers also follow strict protocols. Pharmacists, for example, must wear gloves and impermeable gowns when handling cytotoxins. Prepara­tion of the drugs is done in special “clean rooms” that are environmentally controlled for heating, ventilation, and air conditioning.

Nurses also take rigorous precautions when working with chemotherapy agents. The Oncology Nursing Society recommends nurses wear double gloves, goggles, and protective gowns for all activities associated with the administration of chemotherapy agents.

Hospitals are alerting patients about secondhand chemo­therapy dangers. After doing their job, certain cytotoxins—cyclophosphamide, methotrexate, and gemcitabine are some examples—pass out of the patients’ bodies as unmetabolized chemicals in their feces, urine, vomit, sweat, saliva, tears, semen, and vaginal secretions, and remain active for up to 48 hours. This presents a possible danger to anyone who comes in contact with the patient’s excretions as well as to the environment when the waste is flushed down the toilet.  

CANCER SOCIETY GUIDELINES

The American Cancer Society has issued guidelines on what patients should do. Patients are told to flush the toilet twice after use to make sure all waste is gone. Men are advised to sit on the toilet to avoid splashes. Condoms are recommended during sex and deep kissing is not advised. Caregivers are told to wear disposable waterproof gloves and to wash their hands after helping a patient even if gloves are worn.

“The patients are given both oral and written instructions that are typed out at the time of discharge and individualized for each patient,” says Cathy Rowland, a nurse educator at Dana-Farber/Brigham and Women’s Cancer Center. The information follows the American Cancer Society guidelines. Mass General and Beth Israel Deaconess Medical Center offer similar advice.

Mullowney, the founder and president of Pharma-Cycle, says that hospitals aren’t doing enough to alert chemo­therapy patients and their caregivers about the precautions they should be taking at home. He also says the hospitals should tell their patients not to flush their waste down the toilet.

Mullowney’s company, whose slogan is “Pharma-Cycle, Stopping the Spread of Cancer & Birth Defects,” says a cancer patient’s bodily fluids will contain strong chemicals that are dangerous to others the first few days after a chemotherapy treatment. “They can cause damage to the DNA of healthy cells and trigger cancer,” a company promotional sheet says. “They can badly injure, even kill, unborn babies and children.”

The Pharma-Cycle kit contains a variety of items, including 12 receptacles that hang on the toilet bowl to capture the cancer patient’s waste. There are also vomit collection bags, protective gloves, zip lock bags, wet wipes, and disposable sheets. When the waste comes into contact with a chemical packet glued inside the collection devices, the company says it is converted into a “neutralized” solid. The kit also contains shipping materials for sending the waste back to Pharma-Cycle, which then forwards it to a chemical disposal facility. The kit has one patent and a second pending, Mullowney says.

The price of the kit is $1,200. How long it would last depends on how often the patient throws up or goes to the bathroom. Patients often go through many rounds of chemotherapy.

With a degree in chemistry from the University of Massa­chusetts, Mullowney claims to have pioneered the field of cytotoxic sanitary waste. He says he has 26 years of experience in the hazardous waste business and is “out to save the planet” with his company, which is based in Newport, RI.

Mullowney calls cytotoxic drugs in the water supply a “developing time bomb,” saying their presence has caused “great alarm” among environmental scientists.

Mullowney hired a lobbyist and got legislation introduced in Massachusetts in 2011 that would have required physicians and other health care professionals who are directly involved with the prescribing or administering of chemotherapy drugs to provide patients with the means of properly collecting and disposing of their bodily waste.

The lobbyist, Stephen Mulloney, who touts his client as “kind of like the Rachel Carson of this era,” a reference to the author of Silent Spring, the book that launched the environmental movement, says the proposed legislation went too far and was pulled back. “It might have been a leap forward without enough substantive background,” he says.

BILL WOULD CREATE COMMISSION

New legislation introduced this year by Rep. Tackey Chan of Quincy calls for the establishment of a special 14-member commission to “study the levels and effects of cytotoxic drugs in the environment.” The ultimate goal, according to Mullowney, is to get a legislative mandate that would require health insurance to pay for his company’s kit.

To aid him in advancing his cause, Mullowney created a board of advisors that lists as members two people from the federal Environmental Protection Agency and one from the University of Massachusetts. All three—Nicholas Anastas and Christian Daughton, both EPA authorities on drugs in the water supply, and Thomas Zoeller of the University of Massachusetts Amherst biology department —say they talked with Mullowney but never agreed to be on his advisory board. The EPA issued a statement asking Mullowney “to stop making statements asserting an association between the company and EPA scientists and to refrain from misrepresenting EPA research.”

Mullowney says he asked the two EPA scientists to serve on his advisory board and they agreed. He says he will comply with what EPA wants, but does not see the conflict. “We are working on the same thing,” he says.

Although there are apparently no studies indicating cytotoxins have created health problems for family members of patients or caregivers, there has been some research into on-the-job exposure to workers. A study published in 2010 found that nurses who worked in a cancer center or an oncology nursing unit had an increased risk of breast cancer. The findings of an earlier study in 2005 suggest that chemotherapy nurses are more likely to experience infertility, miscarriage, and preterm births, and their offspring have a higher risk of learning disabilities.

Joel Tichner, an environmental scientist at UMass Lowell, says he would buy the Pharma-Cycle kit if someone in his family came down with cancer to be safe rather than sorry. “If we can reduce the amount going into the environment by even a little bit, that would be a good thing while we’re trying to figure out how to deal with this problem,” he says. “It’s short-term solution.”
But most other experts contacted by CommonWealth were wary or outright hostile to the idea. Holly Dowling, a nurse educator at Beth Israel Deaconess, says that before anyone plops down $1,200 for the Pharma-Cycle kit, more information is needed. “The kit is interesting food for thought,” she says. “But I think there needs to be more exploration what risk human waste possesses.”

DeMonaco of Mass General agrees. “Should we work to reduce the environmental exposure and potential patient and family-member exposure to these agents,” he says. “I think the answer is yes. Is there a significant risk to patients’ families as it relates to these agents? There’s absolutely no data to support that contention.”

DeMonaco is also troubled by the promotional literature put out by Pharma-Cycle. “They’re trying to scare people into buying their kits,” he says. “And these people are already scared enough.…Fear-mongering and absolutism really don’t have any place in this discussion.”

James Hammitt of the Harvard Center for Risk Analysis says key variables to consider are how much benefit is gained by reducing exposure to cytotoxins and how much is spent or given up to attain that benefit. “I’m skeptical that what they’re [Pharma-Cycle] doing with the waste is a lot better than putting it through a sewage treatment plant,” he says.