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Can occupational exposure to chemo cause cancer? Studies point in that direction

This article first appeared in the St. Louis Beacon, July 11, 2010 - Sue Crump braced as the chemo drugs dripped into her body. She knew treatment would be rough. She had seen its signature countless times in the ravaged bodies and hopeful faces of cancer patients in hospitals where she had spent 23 years mixing chemo as a pharmacist.

Bruce Harrison had been an oncology pharmacist since the late 1970s. He had seen the evolution -- or lack of it -- in safety awareness during that time, but he spent much of his career trying to change attitudes toward safe practices through research.

Harrison, who for years was a clinical pharmacy specialist with the Department of Veterans Affairs Medical Center in St. Louis, was also one of the authors of the strictest set of voluntary guidelines, issued in 2004 by the National Institute for Occupational Safety and Health, for the safe handling of chemo and other hazardous drugs for health-care workers.

Practices that, had they been in place throughout his career, might have saved his own life.

Harrison died at age 59 in St. Louis in August of a rare form of oral cancer. He had never smoked or chewed tobacco. He had no other known risk factors, except he had mixed a lot of chemo for other people in his career as a pharmacist.

He discussed it with his doctor.

"There was no way they could prove it, but the two of them decided it could be related," said his widow, Kathy Harrison. "Bruce absolutely believed it was triggered by his exposure."

She's grateful her husband had a long career doing something he loved. She's also sad, and frustrated, that it may have cost him his life.

And she worries it will cost others theirs.

"What frustrated him the most, there was not enough done -- not enough studies done to prove it was the danger it was," said Harrison. "I think there needs to be more done to provide more providers with safe handling techniques.

"It doesn't exist in enough places," she said. "There's not enough education about it. Education and training, and right equipment are key."

At the same time, though, she wondered whether those same drugs -- experienced as a form of "secondhand chemo" over a career mixing the drugs as a pharmacist -- may have caused her cancer to begin with.

Crump knew she had her own war on her hands. She wanted to live long enough to see her 21-year-old daughter, Chelsea, graduate college.

And she wanted something else: She wanted young pharmacists and nurses to pay attention to her story.

Crump, who died of pancreatic cancer in September at age 55, was one of thousands of health-care workers who were chronically exposed to chemotherapy agents on the job for years before even voluntary safety guidelines were in place.

Now some of those workers are being diagnosed with cancers that occupational health specialists say could be linked to exposure to those same powerful drugs that have saved hundreds of thousands of patient lives.

An InvestigateWest investigation has found that the federal Occupational Safety and Health Association does not regulate exposure to these toxins in the workplace, despite multiple studies documenting ongoing contamination and exposures. Studies as far back as the 1970s have linked increased rates of certain cancers to nurses and physicians. Occupational health experts believe that's because when nurses, pharmacists, technicians and increasingly, even veterinarians, mix and deliver the drugs, accidental spills, sprays and punctures put them in close, frequent contact with hazardous drugs.

A just-completed study from the U.S. Centers for Disease Control, 10 years in the making and the largest to date, confirms that chemo continues to contaminate the work spaces where it's used, and in some cases is still being found in the urine of those who handle it, despite knowledge of safety precautions.

Chemo agents -- powerful cancer-fighting toxins descended from deadly mustard gas first used against soldiers in World War I -- have been classified as hazardous by the Occupational Safety and Health Association (OSHA) since the mid-1980s. Hazardous drugs are those known, or suspected to cause cancer, miscarriages, birth defects or other serious health consequences.

Deputy Assistant Secretary of Labor for OSHA Jordan Barab said in written response to questions from InvestigateWest that the agency doesn't have the resources to regulate workplace drug exposures, although it is concerned about the issue.

OSHA has no regulatory authority to enforce safety practices with fines or sanctions, other than under its "General Duty" clause -- a catch-all regulation that allows OSHA inspectors to warn an employer if they see something that concerns them.

According to documents obtained by InvestigateWest through the Freedom of Information Act, OSHA has only used the General Duty clause once in 10 years to cite any health-care institution, including hospitals, clinics, dental and veterinary offices, for their handling of hazardous drugs.

"There is no other occupation population (that handles) so many known human carcinogens," said Thomas Connor, a research biologist with the National Institute for Occupational Safety and Health. Connor has spent 40 years studying the effect of chemo agents on workers and is one of the lead authors on the latest study.

Tracing an individual's cancer to a particular exposure is difficult. It's one of the main reasons safety advocates have been thwarted in their efforts to get stricter regulations. But the ranks of those who have became symbols for increased safety includes pharmacists Bruce Harrison of St. Louis and Karen Lewis of Baltimore, veterinarian Brett Cordes of Scottsdale and nurse Sally Giles of Vancouver, B.C.

Like Crump, all of them eventually got cancer, or in Lewis' case a pre-cancerous condition. Cordes was diagnosed four years ago at age 35. Giles was in her 40s, and Lewis and Harrison were in their 50s when diagnosed. All but Lewis and Cordes are now dead.

On an afternoon in May 2009, Crump sat in a coffee shop near her suburban Seattle home and perused a list of chemo drugs now deemed hazardous for health-care workers to handle. She runs her fingers down the page. It's a long list: cyclophosphamide, doxorubicin, fluorouracil, methotrexate. And the list went on.

"Yeah, I worked with all of them," she said.

Crump started at Swedish Medical Center in the early 1980s, before pharmacists used special protective "hoods" over countertops to contain spray and chemo contamination. They didn't use gowns or gloves.

They had no reason to think they should.

Occasionally, drugs would spill on the countertops.

"We would wipe if off and throw (the towels) in the garbage," said Crump. Most of the chemo came in vials, and "we would transfer it into plastic IV bags."

Sometimes there would be spray when they punctured the vials.

Other drugs came in ampules, glass vessels sized for a single infusion. "I'd file the neck off of it, then snap real fast, she said. "A lot of times, I got cuts."

"But the feeling at the time was -- whatever little vapors or splash -- it was such a low exposure through the skin, it was insignificant."

That was a common attitude then -- and now, said Dr. Melissa McDiarmid, director of occupational health at the University of Maryland.

"So many people think it's just a 'little bit.' They don't understand, it's a little bit of something designed to be toxic, and to be highly absorbed biologically."

Danish epidemiologists used cancer registry data from the 1940s through the late 1980s to report beginning in 1975 a significantly increased risk of leukemia among oncology nurses and later physicians. Last year, another Danish study of more than 92,000 nurses found an elevated risk for breast, thyroid, nervous system and brain cancers in the nursing population.

"It's been a silent threat for a long time with very little attention by the government," said Bill Borwegen, occupational health and safety director for the Service Employees International Union, the labor union that represents nurses nationally.

"We are concerned how they are handled. There's such a dearth of info on how to sample these agents. People don't know how to clean surfaces."

Chemotherapy agents, when dispersed in the air, or onto surfaces, are invisible, difficult to clean, long-lasting, easily spread, and capable of causing genetic damage. They've been found on the outsides of the drug vials shipped from manufactures, on floors and countertops, on keyboards, garbage cans and door knobs.

Researchers at NIOSH, a division of the CDC, were so concerned, they issued an extensive alert about handling high-risk drugs. The guidelines, published in 2004, urge strict precautions, including use of impervious chemo gowns, double-gloving, use of sophisticated "closed-system" devices and specialized ventilation hoods, face shields and respirators, clean rooms and other precautions.

But the NIOSH guidelines outlined in the alert are voluntary.

That's wrong, said McDiarmid. "We can no longer have these be optional.... We're talking human carcinogens here."

Ten years into Crump's career, reports of health effects related to chemo exposure began to surface in Europe and health-care workers started adopting rudimentary safety procedures.

Her pharmacy manager at Swedish took the warnings seriously and installed special ventilated hoods in the workspaces -- considered state-of-the-art at the time.

The trouble was the hoods were designed to keep chemicals sterile by blowing contaminants away from them and back out of the hood. That meant the worker standing outside the hood was still getting exposed, Crump said.

Lanny Turay worked in the same pharmacy as Crump and recalled many of the same experiences. He now manages pharmacy operations at Swedish Cancer Institute.

Safety practices have evolved over the years. Swedish now has a special dedicated area for mixing chemo and uses a different type of hood that no longer blows air back at the workers. Workers wear special gowns, gloves and sleeves, and take other precautions to keep chemo from spreading around, he said.

Still, Crump wondered whether those early, ongoing exposures had contributed to the cancers she and her peers have gotten. She first recalled getting alarmed after a pharmacy tech -- someone with whom she mixed a lot of chemo -- died at age 29 of a brain tumor. Around the same time, several colleagues experienced miscarriages.

Since that time, a number of studies have shown an association between exposure to chemo agents and adverse reproductive effects, including miscarriage, birth defects and low birth weights. A 2005 survey found significant associations with infertility and miscarriage in nurses who handled chemo before the age of 25. Nurses, who occasionally spill the chemo drugs on their clothing or splash it on their skin, had a greater chance of premature labor or having children with learning disabilities if they administered nine or more doses of chemo a day. "Now all these people about my age are getting cancer -- cervical, ovarian, prostate, endometrial, brain," Crump said. "All of us, at one time or another, worked with chemo -- we wondered, well, is there a connection?"

Safety advocates are especially worried about workers in smaller clinics, where awareness is not as high, and expensive equipment may be less available.

More than 5.5 million workers are involved in nursing, pharmacy, transport and cleanup of chemo waste. Of those, experts estimate about 2 million actually mix or dispense chemo. It can be a messy job. McDiarmid, the occupational health expert, got interested after she saw a nurse spill the contents of a bottle of chemo drugs on herself and become violently ill.

Those numbers will grow as the ranks of cancer patients climb by a projected 50 percent in the next decade as the population ages. More people will be required to prepare and deliver their treatment. And more of those people will likely be in non-hospital settings, such as outpatient clinics or private homes.

In addition, chemo drugs themselves, have found wider application -- in the treatment of arthritis, multiple sclerosis and other diseases.

And veterinarians are now increasingly using these drugs to treat animals, putting those who work in vet's offices in contact with chemo.

Generic drugs have made the treatment more affordable for pet owners, said Cordes, who became a safety consultant after he was diagnosed with thyroid cancer. Cordes said he, like many vets he's spoken with, handled chemo without understanding its dangers. More safety info is made available to practitioners of human medicine, he said. "We slip through the cracks."

On a sunny day in June 2009, Sue Crump has a list of things to do.

She needs to teach her daughter, Chelsea, about mortgages and schedule an appointment with a financial planner. They are going through boxes of old photographs.

Crump has already outlived various prognoses -- 3 to 6 months, then 6 months to a year. It's been over a year now.

But her tumor markers are on the march. They've quadrupled in a few months. By last fall, the cancer was on its final assault.

Chelsea Crump took a semester off from school to take care of her mom through her final illness. She nursed her in the house her mother built, on land her mother bought as a single pharmacist before she got married, and cleared herself -- a foundation for her daughter.

Sue Crump died, surrounded by her family and her beloved dogs, in her own living room on Sept. 13.

Shortly before her death, she said she hoped talking about her experiences would make a new health-care worker pay a little more attention.

"Safety needs to be revisited," she said. "People don't take this seriously enough."

Carol Smith writers for InvestigateWest, a non-profit investigative news organization based in Seattle. Find out more at www.invw.org .