By Lee Howard
Publication: The Day
Federal regulators' oversight of private biotech companies has been problematic
Former Pfizer Inc. scientist Becky McClain's victory in federal court this month has raised the issue of laboratory safety throughout the country, but biotech workers aren't the only potential victims of engineered viruses - the public at large should be concerned as well, some public policy and science experts say.
"The Becky McClain case is by no means isolated," Jeremy Gruber, president of the privately funded Council for Responsible Genetics in New York, said in a phone interview. "It's indicative of a systemic failure."
Gruber said that while regulators have focused on labs that deal with high-level biohazards, they have let private biotech companies operate largely unregulated, even as the engineered viruses and bacteria these lower-level facilities experiment with have become more sophisticated - and potentially more dangerous.
He added that it's "an open question" whether the types of biological material routinely used for experiments at the growing number of biotech facilities across the United States could be released into the atmosphere and cause widespread health problems.
"The potential is certainly there," he said.
But Louise Proud, head of environmental health and safety for the research and development division of Pfizer Inc., said in an interview last week at the company's New London campus that the pharmaceutical firm goes far beyond regulatory requirements in ensuring lab safety.
Proud, who oversees a staff of about 100 at various R&D campuses companywide, said "there is no impact to the community" from viruses or bacteria emanating from the Groton lab. That's because of continuous efforts to decontaminate labs by using biological hoods and filters to trap biological materials, she said, as well as bleach to clean surfaces and chemicals such as formaldehyde or, more recently, vaporized hydrogen peroxide to destroy contaminants when filters are changed.
During testimony at McClain's trial, Pfizer officials admitted that they had released foul-smelling air from one of the company's laboratories into the atmosphere near its Groton campus after several scientists, including McClain, became sick. Pfizer, which said the air had been released after being put through a filter, later buried the biological containment hood that had been tied to the foul smell, according to testimony, but McClain has raised the possibility that the apparatus - or the foul-smelling air that had been released - might have contained dangerous experimental viruses that could have posed a public health risk.
Viruses raise concern
Michael J. Siciliano, a retired professor at the University of Texas in Houston who was to be an expert witness for McClain before his testimony was barred by U.S. District Court Judge Vanessa Bryant, said in an e-mail that the types of viruses Pfizer was using at the lab could have led to "biological mayhem." He elaborated in a phone interview by saying that these viruses, which are created so as not to replicate, have the potential, when combined with other viruses, to regain their ability to reproduce, though he allowed that such a situation would be "a low-level possibility."
Testimony at McClain's trial last month indicated that the Deep River resident faced intimidation, harassment and eventual firing after complaining to the U.S. Occupational Safety & Health Administration about lab safety on Pfizer's Groton campus. A jury awarded McClain $1.37 million for what it decided were Pfizer's retaliation and interference with her right to free speech, but the New York-based pharmaceutical giant is expected to appeal the ruling.
McClain, hospitalized with back pain last Sunday after another attack of intermittent paralysis related to the virus that she believes infected her while at a Pfizer lab, had no further comment on her case, per instructions from her attorneys.
While the public-health dangers of unregulated private laboratories may have been one of the more explosive issues illuminated at McClain's trial, it was hardly the only lesson to be learned in what consumer advocate Ralph Nader termed, in a commentary on the case, the "silent violence" that scientists and lab technicians face from biohazards.
Public-policy and worker-safety advocates pointed out several other concerns the trial helped illustrate:
• The need for stronger Occupational Safety & Health Administration regulations and better enforcement of regulations, adding new protections for biotech workers who find it difficult to prove a direct cause for their injuries in a field that deals with microscopic organisms.
• The question of whether private companies such as Pfizer should be required to do risk assessments before conducting potentially dangerous experiments.
• The question of whether trade-secrets laws should supersede the need of workers to obtain records about their exposure to hazardous viruses and bacteria needed to help manage their health care.
• The question of whether companies should take a more proactive stance toward worker safety rather than abide by only their legal requirements.
Nader said McClain's trial, believed to be the first successful federal civil suit involving a biotech worker injured on the job, "promises to tear open the curtain covering hazards confronting tens of thousands of scientists and assistants in corporate and university labs doing genetic engineering work with viruses and bacteria."
OSHA faces criticism
Nader also took issue with Pfizer's "cruel refusal to give afflicted employees their own exposure records on the grounds that they are company trade secrets," saying such "alleged, bizarre property right(s)" should be trumped by concerns over the life and health of injured workers.
Adam M. Finkel, a former OSHA official who later turned agency whistle-blower, said in a statement that the McClain case "is emblematic of the utter failure of OSHA to achieve its mission."
"What happened to Becky McClain shows above all that OSHA is not an occupational health agency," said Finkel, now a faculty member at the University of Pennsylvania School of Law. "The best independent estimates of the number of premature deaths caused by occupational overexposures each year run between 40,000 and 60,000, making worker health hazards the eighth leading cause of death in the nation. And yet, OSHA devotes less than 5 percent of its resources in rule making, enforcement and education to health hazards as opposed to safety hazards."
In a telephone interview, Finkel added that he has high hopes for the future of OSHA now that David Michaels has been named to lead the agency, but he fears that the entrenched bureaucracy could make it difficult to change directions.
OSHA, in response to e-mailed questions, said "we are definitely increasing the numbers of inspection(s) conducted in the health area."
Michaels, in an interview with The New York Times, acknowledged that the McClain case has begun to show up on his radar and that he was considering improved regulation of the biotech and nanotech industries. "We do not have industry specific standards for these two industries," OSHA acknowledged in response to a request for elaboration.
Safety advocates added that OSHA will have to shore up its knowledge base as well, adding personnel who understand the complicated technologies - nanotech, involving the exploration of atomic and molecular entities to create new materials and devices; and biotech, generally dealing with the discovery of new medicines - and their potential health and safety risks.
Proud, the environmental health and safety expert at Pfizer, said she couldn't address the competencies of OSHA inspectors, but she gave assurances that agency officers regularly show up for scheduled and surprise visits - including one or two audits a year, in which policies and procedures are reviewed.
"Our doors have to always be open to OSHA," she said. "We never turn away any inspectors."
Mitigating any dangers
Proud added that, while the labs in Groton have varied configurations, she believes all of them are safe and that Pfizer goes above and beyond industry standards to ensure their workers are well protected.
Although Pfizer officials in testimony indicated they did not routinely conduct risk assessments, Proud, who has been in her current position for two years, said every Pfizer experiment is accompanied by a rigorous analysis to determine how to mitigate any experimental dangers.
These assessments - not required unless labs are receiving federal funds - are developed by committees to predict any risks that might arise from the beginning to the end of the process, she said, including how to dispose of biological waste products.
Pfizer adheres to all federal guidelines and, according to Proud, "we in many cases exceed the requirements they have in place."
Pfizer spokeswoman Liz Power pointed out that OSHA cleared the company of any wrongdoing after an extensive investigation of the McClain case, and that a judge had thrown out McClain's health claims for lack of evidence.
Gruber, the public-policy expert, said the McClain case may have illuminated problems that occurred at Pfizer seven or eight years ago, but the issue of private companies policing themselves remains a problem today.
"Pfizer is by no means the first or last place that dealt with a health and safety issue improperly," he said. "Our hope is that Becky McClain can serve as a reminder of the lack of sufficient regulation in this area."