National Educational Conference On Biotech, Health and Safety, Labor And The Public

Higher Bar for Pathogens, but Adherence Is Issue-Enforcement Is Non-Existent For Pfizer & Pharma
http://www.nytimes.com/2010/05/28/business/28hazardside.html?ref=business
A Higher Bar for Pathogens, But Adherence Is an Issue
By ANDREW POLLACK and DUFF WILSON
Published: May 27, 2010

The federal Occupational Safety and Health Administration requires all companies to provide safe work environments for their employees. But when it comes to the special risks faced by biotechnology workers, OSHA’s current rules are spotty.
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Steven E. Frischling/Bloomberg News.
The Pfizer Global Research & Development facility in Groton, Conn.
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Safety Rules Can’t Keep Up With Biotech Industry (May 28, 2010)
The agency has specific standards for blood-borne pathogens, as a result of the H.I.V. and hepatitis scares of the 1980s, but not for other infectious agents that might be spread through skin contact or the air.

Much stricter and more specific guidelines have been spelled out by the National Institutes of Health, covering federal laboratories and other organizations that conduct genetic engineering work using federal funds. The rules are meant to protect workers and the public in general.

The N.I.H. guidelines specify four levels of safety measures for different organisms, depending on the danger level. Levels 3 and 4 are reserved for the most dangerous organisms.

But there can also be serious accidents in Level 2 labs — of the sort that harmed Malcolm Casadaban, the University of Chicago scientist who died last September after apparently being infected with a version of the bacterium that causes plague; Jeannette Adu-Bobie, who lost both legs and one arm to a meningococcal infection contracted in 2005, probably at a New Zealand lab; and Ru-ching Hsia, a scientist in an Agriculture Department food safety lab in Beltsville, Md., who went into a coma for a month after being infected by E. coli bacteria in 2003.

Becky McClain, who successfully sued Pfizer, worked in a Level 2 lab in Groton, Conn.

Pfizer, and many other companies, say they voluntarily adhere to these N.I.H. standards even if they do not receive government grants.

“We look to that as the gold standard,” said Elizabeth Gilman Duane, Pfizer’s associate director for biosafety and a past president of the American Biological Safety Association.

But how closely the N.I.H. rules are actually adhered to is open to question. One requirement is that institutions have biosafety committees to vet proposed experiments, with minutes of the committee’s meetings available to the public. Yet the Sunshine Project, a Texas watchdog group, said that when it sought such records in 2004 from 355 academic, government and industrial institutions, fewer than 20 percent provided meaningful information. In some cases, it turned out, there was no committee, or the committee had never met.

“The system is pure artifice,” said Edward Hammond, the director of the Sunshine Project.

As for private industry, Mr. Hammond found that only five of the top 20 biotechnology companies had biosafety committees registered with the N.I.H. And when he sought minutes from pharmaceutical companies that did have such committees, in 2006, 17 of them, including Pfizer, responded by withdrawing their committees’ N.I.H. registrations.

Christopher Loder, a Pfizer spokesman, said the company had withdrawn its registration “to clarify that it was not receiving N.I.H. funding.”

The N.I.H. also requires labs governed by guidelines to file immediate reports with the government whenever there is an accidental worker exposure to genetically modified material, whether or not anybody is hurt. Under OSHA, a company fills out a report, usually kept internally, only if it determines that a lab worker suffered a serious work-related injury or illness. OSHA is usually not notified at all of such incidents.

David Michaels, director of OSHA, said that making the N.I.H. rules mandatory for private laboratories was one possibility he would consider as the government drafted new regulations for biohazards.

Council For Responsible Genetics - GeneWatch Magazine; March-April 1010 issue Vol 23 No. 2 (28 page)
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PAGE 2- EDITORIAL:
This may be one of the most important GeneWatch issues in recent memory. In the early days, the Council for Responsible Genetics put a great deal of effort into laboratory safety questions as Harvard University prepared to set up a recombinant DNA lab.

Today, biolab safety is still an important issue for those who live near a current or planned high security laboratory, such as Boston University's plan to study highly pathogenic diseases in a Biosafety Level 4 lab nestled in the densely populated neighborhood of Roxbury. In this issue, we also focus on those directly in the line of fire: lab workers.

Becky McClain's case against Pfizer is central to this issue. While a researcher in a Pfizer lab, Becky became severely ill. all of the evidence suggests that a mishandled genetically engineered virus was the culprit, but Pfizer will not release the records that could prove this - and help Becky's doctors determine the best course of treatment.

Aside from Pfizer's mistreatment of their own worker after she became ill, Becky's case demonstrated how easily companies can get away with shockingly poor safety measures in labs. This was even more clear in the case of David Bell, who contracted a mysterious infection while working in a pesticide company lab where potentially hazardous experiments were conducted with on a bathroom fan for ventilation and where the researchers gathered each day for afternoon tea-not in a break room, but in the lat, among the researchers' malaria experiments and exotic soil cultures.

At Pfizer, the hallway doubled as a lunch room. Workers ate while dangerous materials were carried past, and on several occasions Becky McClain says they discovered biological samples sitting where employees ate their lunches. Her complaints on the matter fell on deaf ears, as did David's at his lab (he was told biohazard signs would not look goof for tours). Becky compares safety hazards in biolabs to "a roach in the kitchen"-when you see one, you can bet it's only the tip of the iceberg.

The same could be said of Becky McClain and David Bell themselves. These are no isolated incidents. Now that we have seen these two cases, one has to wonder: how many more are out there?

GeneWatch Magazine; March-April 1010 issue Vol 23 No. 2 - pages 16 & 17:

DAVID BELL:
*TEATIME IN THE LAB
By Sam Anderson

The cautionary tale of David Bell begins when he was a college student in 1998, a biology major and aspiring biotech researcher at California State University, Sacramento. In his final year of college, he was hired to work for AgraQuest, a venture biotechnology company in Davis. His stay at the company would not be long, but its impact would be long-lasting. Over a decade later, he and his mother, Sandi Trend, are still looking for justice.

David had worked at AgraQuest just over five months when he fell ill. Earlier that week he had been asked to clean a barrel used for a previous fermentation experiment, containing a gallon of leftover materials. Although he was assured at the time that the barrel would be safe to work with, the researcher who helped him wore a HEPA mask. The barrel's contents were dumped into a storm drain next to the building and David cleaned it with household bleach.

Early the next week David had to leave work with serious sinus problems, and shortly afterward was admitted to an emergency care clinic. He would later discover that the rest of the office became ill too, and that within the week AgraQuest sent its employees home and locked its doors. David would not discover this until later-much later, because he was unable to return to work for five weeks. But David's sinus problems lingered, his immune system was seriously weakened, and he continued to show some rather graphic symptoms involving, as David bluntly puts it, "the crap coming out of my face." After four sinus surgeries, David's health is still in question-and AgraQuest has yet to accept any responsibility. In court, its lawyers openly questioned whether David had even received those surgeries, and if he had, whether they were really necessary. It would seem David has earned the right to be blunt.

From where Sandi and David sit, the deck was stacked against them from the start. When David first visited the hospital with mysterious symptoms, he asked the doctor to run a culture in order to discover what might be infecting him; later, the doctor said she had forgotten to run the culture. It happens that AgraQuest founder Pam Marrone sat on the board of that hospital, and that David's doctor would have known Marrone from sitting on the same community women's council.

When they eventually went to court in an attempt to get workers' compensation, the judge assigned to David's case had previously worked for a firm that represented Liberty Mutual - the defendant. David's own attorney had trained under the opposing lawyer, and she asked David to dismiss her. David says that his eventual lawyer, John Overton, was so dismayed by what he called a "kangaroo court" that he considered leaving the legal profession.

All of this may very well have been coincidence. The more compelling-and more serious-accusations of misconduct are reserved for David's employer, AgraQuest.

AgraQuest was founded in 1995 by Pam Marrone, a former Monsanto pesticide researcher. Marrone aimed to discover and commercialize biopesticides as alternatives to chemical pesticides. The company's approach, in the words of Marrone: "We move very fast. We focus on getting things to the market quickly." AgraQuest still exists today-sans Marrone-and appears to have shifted much of its focus toward agrichemicals. The company's website touts a corporate culture which encourages employees to "maintain an environmentally conscious work environment." It may be true today, but in 1998, when David Bell began work at AgraQuest as a college senior, this was not exactly the case.

Marrone set up shop in an office suite in a residential neighborhood of Davis, California. Whether the businesses renting the adjacent offices knew at the time that their neighbor had converted Suite 4 into a lab is unclear, but David says that at one point other offices did complain about the smell from a project he had been assigned. David was assigned to conduct experiments using an evaporator set up in a room with only an open window for ventilation. After neighbors complained about the smell, the device was moved into a bathroom, which featured an upgraded ventilation system: the bathroom fan. Neither David nor anyone else, save one coworker, wore protective masks.

If these do not sound like descriptions of a high security biolab, that's because this wasn't one. The Center for Disease Control "recommends" a Biosafety Level 3 setup for the type of work AgraQuest was doing, but does not require it. David supposes the office suite was "technically" a Level 2 lab; however, CDC guidelines on Level 2 labs call for the use of biological safety cabinets to contain potential airborne contaminants, and a bathroom with a fan hardly qualifies.

Much of the work happening in the AgraQuest lab involved a sort of biological treasure hunt. Researchers brought in soil samples from around the world, then combed through them, searching for natural pesticides. David recalls AgraQuest coworkers pulling bags of soil out of a briefcase, boasting about getting the samples through airport security.

The hunt for exotic pest-killing organisms went on amid safety precautions David compares to those of a high school chemistry lab. The company did not provide its workers with a safety manual, although it created a short manual in time for David's workers compensation trial. In addition to the lax use of protective masks and the potentially hazardous experiments conducted without the benefit of a safety hood, employees were allowed to wear their lab clothes home without cleaning them first. The waste disposal system was no better, as AgraQuest workers often dumped leftover materials into a storm drain outside the building. After David 's illness, Sandi went to 1105 Kennedy Place and took pictures of the drain. She found, ominously, a dead crow crumpled beneath a faucet covered with chemical deposits. Even more ominously, when she returned two weeks later with mold expert Doug Haney, the bird was still there-and showed no signs of decomposition. Haney was surprised: "After two weeks I would have expected to see almost bones and a little bit of feather."

Many of AgraQuest's slipshod safety controls might have been corrected had there been any federal regulatory oversight; but David and Sandi say the CDC failed to investigate David's claims, and OSHA waited months before making a visit to the company, citing them only for a few faulty hoods. In fact, the one agency which followed up David and Sandi's reports was the Department of Agriculture's Animal and Plant Health Inspection Service, which did not take the matter of soil smuggling lightly.

In the absence of inspections, the culture in AgraQuest's Davis lab was nonchalant about safety. Almost any place within the office suite was inbounds for lab work, from the bathroom to the break room. Employees ate and experimented in the same space, washing dishes and lab equipment in the same sinks. David was particularly surprised to discover a workplace tradition at the lab: each afternoon the researchers would gather, there in the workspace amongst tropical soil cultures and anti-malaria experiments, and have teatime.

Sandi and David filed complaints with over a dozen agencies, from the Yolo County Health Department to the Attorney General of California to the National Institute for Occupational Safety and Health. First they reported the lab conditions and the company's treatment of David; then they reported the lack of investigation into these issues. To this day David has not received compensation for his illness; AgraQuest has not admitted fault in David's condition and has not been formally reprimanded; and Sandi and David still do not know exactly what made David sick.

"God only knows what he was exposed to," Sandi says. "Doctors don't even know what to look for."

David's research career is long over and his immune system has yet to recover, but he has started looking for jobs in a new field. Yet all this time, even after all legal avenues for compensation seem to have closed, Sandi has lost none of her drive to expose what happened to David and warn other workers of what they are up against. "We can sit around and get mad all we want," she says, "but somebody's got to change this."

David remembers a professor telling his class not to be concerned about the safety hazards of lab work. "My old professor assured me: 'Don't worry. Your scientist brethren are going to take care of you, because it could be them instead of you.'

That's not what happened in my case. Not at all."

Sam Anderson is Editor of GeneWatch.