EXPOSING the FDA and the USDA - Broad Casting here the things that they would prefer us NOT to know about our FOOD & DRUGS & Farming.

Tuesday, October 5, 2010

A Win for Whistle Blowers

by Ralph Nader

Why would Pfizer, the world’s largest drug company, so mistreat and silence one of their top molecular biologists that a federal jury in Connecticut awarded her $1.37 million in damages last week?The unraveling answer 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.



Becky McClain’s lawsuit against Pfizer claimed that the company’s sloppiness in 2002-03 exposed her to an engineered form of the lentivirus, a virus related to one that could lead to immune deficiencies. Pfizer denied any connection between its lab practices and Ms. McClain’s recurring paralysis and other illnesses.Back and forth over three years came the scientist’s claims and Pfizer’s denials during which she had to leave her job amidst the increasing retaliatory behavior of her ten-year employer.



Pfizer is known for playing hardball and violating laws. Last year it had to pay the Justice Department one of the largest fines – half civil, half criminal – for illegal promotion of its drugs for unapproved uses. The fine — $2.4 billion – avoided criminal charges and prosecution, either of the company or officials, and became just another cost of doing business.



Just last week, soon after buying Wyeth Labs for $68 billion, Pfizer’s CEO, Jeffrey B. Kindler, told a reporter for The New York Times that his company has “invented too few drugs and left its reputation in disrepair after two criminal cases.”



That record does not diminish Pfizer’s advantage over its imperiled lab workers, which is built on the absence of any available risk assessments, the very nature of possible latent, silent violence, and the cruel refusal to give afflicted employees their own exposure records on the grounds that they are company trade secrets.



Pfizer offered Ms. McClain a paltry sum with a gag order, which she promptly refused. She wanted her freedom of speech and her whistle-blowing rights under federal law. Her lawsuit was filed in 2006 in Hartford.



By dismissing the third count, which might be appealed, in her complaint alleging Pfizer’s wanton misconduct, U.S. District Judge Vanessa L. Bryant ruled that the plaintiff did not have available the evidence of causality and it was a worker’s compensation matter anyway. Herein started the chicken-egg problem. How could Ms. McClain obtain the evidence in order to prove her case when Pfizer said it was proprietary and secret?



The Council for Responsible Genetics (CRG), started by Harvard and MIT scientists, does not believe laboratory exposure records of workers should be trade secrets. Life, health and remedial rights should trump any such alleged, bizarre property right.



Becky McClain has already exhausted any remedies or assistance from the woeful Occupational Safety and Health Administration (OSHA). This agency has been without any regulations or disclosure requirements about biohazards in laboratories. This inertness might change with the appointment of David Michaels to head OSHA, which should bring the agency closer to its mission of preventing or diminishing tens of thousands of fatalities and injuries each year.



Mr. Michaels told the Times that “new biological materials, nanomaterials, there are many things where we don’t have adequate information, and we think workers need to have protection.” He indicated that OSHA will take another look at the McClain case.



Both Jeremy Gruber, president of CRG, and Steve Zeltzer, chair of the California Coalition for Workers Memorial Day, believe the McClain case will lead to broader scrutiny of biologic laboratories, where research is expanding rapidly with heavy federal funding.



It is well known that workers in these labs are inhibited from speaking out, either inside or outside their workplace, for fear of losing their jobs. OSHA has long known that companies in old and new industries often do not come close to fully reporting cases of their injuries and sickness either to their insurers or to state or federal job safety agencies. Some have been found to keep two sets of books.



The Bureau of Labor Statistics data are not at all comprehensive. Under-reporting can hide half or three-fourths of the actual traumatic injuries.



Mr. Zeltzer has denounced what he calls “the failure of top company officials to even report to OSHA and other government agencies that many workers were getting sick numerous times in their laboratories although this is required by the law.” He called on the US Attorney in Hartford to begin a criminal investigation. (see workersmemorialday.org)



As for Becky McClain, this is just the end of the beginning. She says she has lost her career, her health and her health insurance. But she recognizes her case is in the vanguard of many other cases and worker protests to come before enforceable and openly accessible standards and practices become the way of doing business for these labs.



For when it comes to developing materials that are inherently latent, subvisible forms of silent violence, business as usual can become cruel and unusual punishment for innocent, defenseless scientists, lab technicians and other workers.



Such is the weighty responsibility of David Michaels and the new managers of the long moribund, underfunded OSHA in the coming months.

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