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» How tough are state chemical disclosure rules?

When several unrelated patients visited McMurray, Pa.-based plastic surgeon Amy Paré, MD, she initially was unsure what to make of the bleeding, oozing legions covering their faces.

The wounds were not cancerous, but the inflammation was severe and becoming worse. Dr. Paré’s suspicions grew when she learned that the patients lived near the same natural gas drilling site. Tests later found that the patients had phenol and hippuric acid in their urine, two contact irritants rarely found in humans. The patients improved after they stopped drinking water from their underground wells.

“Knowing what chemicals they had been exposed to would have sped up the process” of treating the patients, said Dr. Paré, who specializes in treating skin conditions.

But at the time, no official route existed for doctors to learn what chemicals patients may have been exposed to near drilling sites, information that remains protected as trade secrets unless lawmakers dictate otherwise. Under a new Pennsylvania law, natural gas companies must tell physicians the substances patients might have come into contact with. But doctors must sign confidentiality agreements promising they will use the information only for those patients’ treatment.

Some doctors say the agreements amount to gag orders that interfere with their ability to treat patients and to share information freely with colleagues and medical researchers. The conflict has led to a legal challenge by Pennsylvania nephrologist Alfonso Rodriguez, MD, against the Pennsylvania Dept. of Environmental Protection. He claims that the law’s doctor-contract provision is vague and violates physicians’ First Amendment rights.

The issue is not limited to Pennsylvania. Across the nation, doctors are being drawn into the controversy over induced hydraulic fracturing, more commonly called fracking. The technique involves drilling and injecting water, sand and chemicals at a high pressure to release natural gas from deep underground rock formations.

Natural gas drilling is being conducted in at least 30 states, with nine out of every 10 gas wells using fracking, according to a July analysis by OMB Watch, a Washington-based research and government watchdog group. Supporters say fracking produces a cleaner energy source, creates jobs and provides an economic benefit to landowners who lease property rights to gas exploration firms. Critics argue that the chemicals used pose direct health risks to workers and indirect risks to many others, including through potential ground water contamination.

Concerns about fracking have led to more than a dozen state laws requiring drilling companies to make certain disclosures about the chemicals they use to state agencies or online. Like the Pennsylvania law, several include requirements that doctors receiving the information sign confidentiality agreements.

What can doctors say?

Some doctors think the confidentiality clauses put them in a tough spot.

“Once we sign the disclosure, who can we tell?” asked Mehernosh Khan, MD, a family physician in Monroeville, Pa. Dr. Khan is a plaintiff in a separate lawsuit against the state over local governments’ ability to regulate fracking zoning. “How do you refer [patients] and treat them if you can’t share the information?”

The Pennsylvania law’s health professional disclosure portion, modeled after a Colorado law, provides doctors with necessary chemical information never before required, said Patrick Henderson, energy executive for Pennsylvania Gov. Tom Corbett’s office. Silencing physicians “was never the intent,” he said. “We think it does the exact opposite.”

Gas companies are concerned about competitors having access to trade secrets, not physicians, said Dan Weaver, spokesman for the Pennsylvania Independent Oil and Gas Assn., an energy company trade group. Under the law, doctors clearly have access to all necessary information on chemicals, he said. The issue “has gotten blown out of proportion. ... It’s a lot of misunderstanding. We’re dealing with a lot of that when it comes to this industry.”

But Dr. Rodriguez, the physician leading the most recent lawsuit and the president of the Gas Drilling Awareness Coalition in northern Pennsylvania, said the requirement takes advantage of physicians’ ethical obligations.

The plaintiff, who practices in Dallas, Pa., has treated patients directly exposed to hydraulic fracturing fluid. One patient had low platelet levels, anemia, a rash and acute renal failure that required dialysis and chemotherapeutic agents, said Dr. Rodriguez’s suit, filed July 27 in U.S. District Court in Scranton, Pa. Doctors are ethically required to secure information necessary to provide competent treatment to patients, he said, and the law forces physicians to waive their First Amendment rights to fulfill this duty.

“In an emergency situation, you don’t have time to litigate about [what] is confidential,” said Paul Rossi, Dr. Rodriguez’s attorney. “The law does not specify how broadly the confidentiality agreement goes.”

Questions from the Pennsylvania Medical Society about the scope of the confidentiality agreements led to the Pennsylvania Dept. of Health clarifying the law’s intent in an April letter. State Secretary of Health Eli N. Avila, MD, assured doctors that proprietary information can be utilized in whatever manner is necessary to respond to the “medical needs asserted,” including sharing the information with patients, other physicians involved in the patients’ care and public health agencies. The society said it was satisfied with the response but will continue to monitor the issue.

“As the unconventional gas drilling industry matures in Pennsylvania, and our understanding of this technology evolves, we’re confident that the administration and Legislature will continue to be responsive to physicians’ concerns for protecting patient health,” said Marilyn J. Heine, MD, the medical society’s president.

But assurances from state regulators are not enough to protect doctors in court, said Barry Furrow, director of the Health Law Program at Drexel University Earle Mack School of Law in Philadelphia. He wants the law changed to reflect such clarifications.

“Physicians get very nervous about these things, because they’re worried about being sued,” Furrow said. “It doesn’t give me any comfort unless you put it in” the statute.

Precedents in other states, industries

Ohio physicians expressed similar concerns when faced with their state’s hydraulic fracturing disclosure law, first enacted in June. The Ohio State Medical Assn. worried that the trade secrets language would keep physicians from complying with public health reporting laws, said Tim Maglione, the group’s senior director of government relations. So Ohio physicians went to the Legislature and received a clarifying amendment to the law, which goes into effect in September.

The Texas Medical Assn. supported a state law with drilling disclosure language that follows the Occupational Safety & Health Administration’s regulations for disclosure of chemicals to doctors. If a treating physician demonstrates that a medical emergency affects a worker and that the identity of a chemical is necessary to determine the patient’s treatment, the manufacturer immediately must disclose it to the physician, OSHA rules say. The manufacturer later may require a written statement of need and a confidentiality agreement.

But applying an OSHA policy to potential environmental medical risks from fracking is dangerous, said Bernard D. Goldstein, MD, a professor in the Dept. of Environmental and Occupational Health at the University of Pittsburgh’s Graduate School of Public Health.

“That’s a worker issue; this is a public health issue,” he said. “If you suspect a health problem in your community, you’re supposed to report it.”

Rules that apply to other natural resources industries also might not be the best examples for fracking, a relatively new practice involving multiple substances whose long-term health effects largely are unknown. Coal extraction, for instance, “is a pretty straightforward mining operation,” Dr. Goldstein said. “Here, you have lots of new and evolving chemicals.”

New York State may be the newest front over hydraulic fracturing. With the state at this article’s deadline on the verge of lifting a moratorium on fracking, doctors were mobilizing against the move. The Medical Society of the State of New York has asked that the practice not be permitted until a health assessment can be authorized and completed, said Patricia Clancy, the society’s vice president for public health and education.

“Our physicians are very concerned about the chemicals that are going to be used in the ground and its potential impact on ground water,” she said. “From our perspective, physicians feel very strongly that they need to have a voice.”