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   Jonathan Liff's research on the health effects of second-hand smoke was subpoenaed. |
That research, performed in collaboration with other major universities, had centered on the health effects of second-hand smoke on women diagnosed with cancer. "We employed only female staff to interview the women who volunteered," remembers Liff, who co-directs the Georgia Center for Cancer Statistics in the department of epidemiology at the Rollins School of Public Health. "It was very poignant work because many of these women were seriously ill yet very anxious to do what they could to help us understand their diseases." The research found an association between certain exposure levels and the development of lung cancer in women who had never smoked. The results were published in the Journal of the American Medical Association and other leading journals. In January 1993, the US Environmental Protection Agency (EPA) issued a report on the respiratory effects of passive smoking, based on data from a total of 80 epidemiologic studies conducted worldwide, including data that Liff and his colleagues had gathered. The EPA report concluded that environmental tobacco smoke causes an average of 3,000 cases of lung cancer per year in this country. Five years later, Liff was shocked that his data was being subpoenaed. "This is not a call that one engaged in this sort of basic epidemiological research expects to get," says Liff. Apparently, every other university with researchers involved in this project had received a similar subpoena. While Emory counsel assured him that they would fight the subpoena, they nevertheless asked Liff to review and retrieve the requested data. The prospect of being forced to provide raw research data to parties in lawsuits was likely to have a chilling effect on research in the state. "The privacy of patient medical and health records is fundamental to health care and to medical research," says Liff. "Without a guarantee of privacy, we would be hard-pressed to find volunteers and patients to allow us to gather vital personal information. Clinical researchers would have an even harder time enlisting people to participate in clinical trials of new medical therapies, devices, and techniques." There was little doubt that this maneuver was also sending a signal to scientists that their research lives would be made much more difficult by virtue of their choice of study areas and subjects. |
  Danette Joslyn-Gaul led the Emory effort to pass a law protecting research data.  |
 he subpoena had implications as well for Emory's Office of Governmental and Community Affairs, which was soon drawn into a protracted effort to change Georgia laws protecting privacy and research data. The eventual outcome demonstrates how important a strong governmental affairs office is to a university.
Unlike many other states, Georgia had no law shielding researchers' raw data from scrutiny in judicial proceedings. During several rounds of arguments, motions, and briefs, Emory lawyers vigorously argued the privacy concerns in Liff's case. But the courts said Phillip Morris could have the data, under the condition that all names and other identifying information be removed or blocked out from the documents. Even so, the identity and privacy of the study participants could not be guaranteed. Two months later, another tobacco company involved in a lawsuit subpoenaed the same records. Once again, without recourse to any law or precedent that would protect these records, the data had to be turned over to a tobacco company. Emory's Health Policy Advisory Group (HPAG) was concerned about the disastrous implications that type of subpoena power would have on research in Georgia. HPAG meets monthly to review public policy issues with potential to impact the Woodruff Health Sciences Center. The committee works closely with the governmental affairs office. Now it was necessary to assess what could be done to protect Emory and the greater public's interests. Clearly, the biggest problem was the lack of a law in Georgia to protect sensitive research data from subpoena in lawsuits unrelated to the interests of research subjects. The advisory group urged that Emory draft and work to pass such legislation. Leadership of this effort was given to Danette Joslyn-Gaul, the new director of state affairs in the Office of Governmental and Community Affairs. Her skills and experience would be the key to the success of such a legislative effort. Before joining Emory, she had graduated from Emory Law School and had been executive counsel to Governor Zell Miller. In that position, among other things, she drafted legislation and helped shepherd legislation through the General Assembly for the governor. Joslyn-Gaul teamed up with the late Joe Crooks, Emory's general counsel; Beth Clarke-Morrison, assistant counsel; and Jonathan Krawcheck, an Atlanta attorney retained by Emory to try to prevent the disclosure of Liff's data. Together they drafted a bill that would give Georgia a law that could protect researchers, research subjects, and volunteers from third parties in litigation gaining access to raw data provided or created in the course of research. Drafting a bill can be a delicate and demanding process. This one was no exception and took hours of work through many drafts. Far more difficult was steering the three-page bill through the legislative process and having it signed by Governor Roy Barnes. |
  Betty Willis heads Emory's Office of Governmental and Community Affairs.  |
 egislative advocacy can be extraordinarily complex, with many players and an array of interests and issues that must be addressed in order to succeed. "One of the first principles of legislative advocacy," says Joslyn-Gaul, "is knowing who your allies are and who will oppose you and why. You then have to line up your allies and leverage their support, while developing a strategy to deal with your adversaries." Much depends on the force of the issue and of the arguments you can marshal to support your effort.
As Joslyn-Gaul points out, "Personal relationships matter a great deal as do knowledge of the issues, skills to communicate them, and ability to solve complex problems." Joslyn-Gaul's first answer as to who might oppose the newly drafted measure was trial lawyers, a group represented by a strong professional association in the state. Joslyn-Gaul thought trial lawyers might see the proposed measure as an impediment to their abilities to get access to evidence that they can use in court. She knew it would be important to address the potential opposition from their point of view and considered that when identifying a sponsor of the bill. After review, though, by the state trial lawyers association, there were no major objections to the proposed measure. Finding the right sponsor is also critical to a bill's success. Generally, bill authors look for legislative sponsors who have a good combination of knowledge and interest in the bill's objectives. Representative Jim Stokes, a lawyer and freshman representative from Oxford, Georgia, agreed to sponsor the legislation. Stokes, though a new legislator, was an excellent choice not only because he was keenly aware of the importance of research but also because he is popular with other legislators. "Yes, even this sort of sentiment can be important to a bill's prospects," Joslyn-Gaul says, and is one of the many variables that a good legislative advocate must get a feel for during a legislative session. The bill had few problems in the House as Liff and others with an interest in the legislation testified and attended committee hearings. The measure passed out of the House Judiciary Committee and the House of Representatives with only one dissent and was sent to the Senate Judiciary Committee. There the bill, now a measure with some real prospects for moving through the legislature, received more intensive scrutiny. Once it passed that committee and was put on the Senate calendar by the Rules Committee, it seemed inevitable that the bill would fly through the process without a hitch. The day that the bill was on the calendar in the Senate, however, a lobbyist for a large pharmaceutical association approached Joslyn-Gaul. He told her for the first time - literally an hour before the bill was to be voted on in the Senate - that his client was strongly opposed to the legislation and wanted it to be amended in a manner that would essentially gut the legislation by excluding all pharmaceutical research from the bill's protections. This came as a complete surprise to Joslyn-Gaul. "I was really shocked at the time," she says. "It hadn't occurred to me that the pharmaceutical industry would have any concerns with this legislation. Indeed, I thought they would be delighted with the prospect of having protections they had never possessed in this state before." There was not enough time to determine what amendments would satisfy all parties before the legislation passed the Senate. But there was still a bit more time prior to the Senate bill being reconciled with the House-approved version. That weekend a large meeting was held among the concerned lobbyists, Joslyn-Gaul, and Joe Tanner, a governmental affairs consultant to Emory. Joslyn-Gaul explained the rationale for the legislation and emphasized that the bill provided much more protection to research than existing laws. As a result, the lobbyists for the pharmaceutical industry felt more comfortable with the measure. The bill passed the General Assembly. |
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wo weeks passed, yet the bill had not been signed into law. Joslyn-Gaul called the governor's office and found that the same organization had contacted the office and had asked for a veto of the legislation. Joslyn-Gaul was surprised and disappointed. "I thought they understood the merits of the bill, but again they were trying to kill it."
Again her response was to organize a conference call with the association's attorneys, but this time she included the bill's sponsors and other interested parties. The pharmaceutical association expressed its concerns. But after the sponsors, Georgia lawyers, and Joslyn-Gaul reiterated why the concerns were unwarranted and why the bill was needed, the governor signed the legislation into law. Emory was pleased with the outcome. The long and difficult effort had paid off in the end. |
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wo days after the bill was signed into law, Joslyn-Gaul received a copy of a memo that one drug company had sent to all its researchers in the state. The memo suggested that the company would no longer be able to do research in the state because the bill prevented it from conducting audits required by the FDA. The memo was distributed under the assumption that the governor had not yet signed the measure and with hopes that researchers would contact his office and urge that it be vetoed. Since the legislation had already been signed, the memo just alarmed some researchers who feared that the company would pull its research out of the state.
For Joslyn-Gaul, this was a potential crisis. "What was so completely frustrating about this experience was that there was this snowball effect - they were simply misinterpreting Georgia law." She contacted every resource she could think of to head off this latest crisis. Finally the drug company retained a Georgia attorney to look at the legislation. The attorney, who was familiar with Georgia law, independently determined that drug companies would have absolutely no problem conducting audits required by federal law. The legislation, in fact, provides additional protection for research in the state. Nevertheless, to dissipate concern, all parties have agreed to try to amend the law this upcoming session to reaffirm that the bill applies only to litigation. |
  Jeremy Berry tracks federal legislation. |
ooking back, Joslyn-Gaul acknowledges one especially important rule of advocacy: sometimes those whom you think will support your efforts will be your opponents. "I am simply grateful that so many people around this state acknowledged the real need to have such legislation. I am also grateful that this is not merely an Emory issue - this legislation will benefit all research efforts throughout the state," says Joslyn-Gaul.
This effort was a good exercise as well for the entire staff of the Office of Governmental and Community Affairs, because the office is small, shares the work load, and exchanges ideas as much as possible. "Danette really did a fabulous job on this legislation," says Betty Willis, a veteran of Washington politics who was recently promoted to associate vice president for governmental and community affairs. She closely followed the effort. "This was one of those that looked pretty straightforward, but then it took some really unexpected turns. What's important is that we pulled together, kept our wits about us, kept our allies up to speed on the bill, kept talking to our opposition, and finally got the law on the books." "But," Willis is quick to caution, "even now, this isn't necessarily over. Once you have legislation on the books, you have to make sure that the law remains the way you want it to. Each session brings new challenges, but we feel confident that we have a good law that provides the right kind of protection for research efforts in Georgia." |
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his unpredictable aspect of governmental affairs work is one reason why Joslyn-Gaul and the rest of the staff spend much of their time building knowledge as well as relationships with a wide range of potential partners and even potential adversaries. It is also why they work to solicit input and support of various kinds from within the Emory community. |
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"Often," points out Joslyn-Gaul, "I think people underestimate the role they can play in the legislative process. When we ask people to write letters, to testify, or to provide input in some other way, these things can look like just another chore that won't amount to much. But they are a vital part of the process of having the right relationships and of giving us the ability, the standing, the legitimacy, to make a difference on their behalf and on behalf of the university." For Willis, there is no more compelling work. "We live in an era when many people are skeptical of the idea of turning to government to solve problems," says Willis. "That's understandable, given much of what people read and hear about the political process and about the behavior of some politicians. But, in reality, the government and our laws and even our local communities have an impact and a stake in virtually everything we do. That's why this work is so important to the university and so compelling for those of us who do this work." This sentiment is echoed by Jeremy Berry, only two years out from his BA in political science from Emory College. He was recently promoted to assistant director of federal affairs for the university. His enthusiasm for working to influence the federal agenda as it relates to the university's interests is contagious. In conversation, Berry displays an impressive facility with a broad range of federal issues that he is tracking and working to influence on Emory's behalf. "We deal with a whole range of issues that can directly affect important work at the university," Berry explains. "Probably the biggest ones right now from an economic perspective involve health care, with a variety of budget measures pending that could affect millions of dollars in hospital revenues and federal research support. But there are many other issues that are important to Emory as well." There is a strong sense of calling behind his dedication to his work. "I like working with these complex issues. You get to be involved in the vital issues of the day. You work with people from all walks of life. And you have the opportunity to make a difference."
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 mory's Office of Governmental and Community Affairs is closely monitoring the following legislation:
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  Laws considered under the Capitol dome can affect important work at Emory. |
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mory's Health Policy Advisory Group meets monthly to review public policy issues and activities at the local, state, and federal levels with potential to impact The Robert W. Woodruff Health Sciences Center. The advisory group includes these members:
David Blake (co-chair), Associate Director, Woodruff Health Sciences Center Larry Minnix (co-chair), President, Wesley Woods Claudia Adkison, Executive Associate Dean, School of Medicine |
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Anne Bavier, Director of Development, School of Nursing Karon Bowden, Joe Tanner and Associates John Bryan, Professor, Department of Pathology Danette Joslyn-Gaul, Director of State Government Affairs Art Kellermann, Director, School of Public Health Center for Injury Control; Chair, Department of Emergency Medicine Kathy Miner, Associate Dean, Applied Public Health, School of Public Health Al Plummer, Associate Professor, Department of Medicine Bob Rich, Executive Associate Dean for Research, School of Medicine Jon Saxton, Consultant, Health Policy and Communications, Woodruff Health Sciences Center Jack Shulman, Executive Associate Dean, School of Medicine Don Speaks, Director, Community Affairs and Market Development Joe Tanner, Tanner and Associates Betty Willis, Associate Vice President, Government and Community Relations Toni Wimby, Assistant Administrator, Auxiliary Services, Emory Hospitals Sylvia Wrobel, Assistant Vice President, Health Sciences Communications |
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Web version by Jaime Henriquez.