Tuesday, July 08, 2008

Latest on VCU and Philip Morris Controversy

Richmond.com posted a very detailed article about the continuing controversy at VCU over the arrangements with Philip Morris USA. The Biotech Park and the PMUSA Research and Technology Center are mentioned several times.

In Pursuit of the Golden Leaf

VCU's controversial research contracts with Philip Morris USA are part of a larger story: Richmond and VCU have been courting the money-minting tobacco giant for years.

Peter Galuszka
Friday, July 04, 2008

Virginia Commonwealth University's ties to tobacco research date back as far as the 1930s and '40s -- the days when the now-defunct American Tobacco Co. wore a smoky halo. Soldiers fighting the Germans and Japanese preferred the company's Lucky Strike filterless cigarettes made in Richmond, and the Tobacco Festival parades down Broad Street featured such marquee celebrities such as Frank Sinatra.

Times have changed since then, as the deadly effects of cigarette smoking became well known. While Richmonders don't celebrate the golden leaf like they once did, they still regard tobacco companies with a less jaundiced eye than other Americans. After all, two of the regions' leading corporate citizens are Philip Morris USA, the largest cigarette manufacturer in the United States, and Universal Corp., one of the world's largest independent traders of tobacco leaf.

At VCU, tobacco is anything but taboo. President Eugene P. Trani, who serves on the Universal board of directors, worked out plans with Philip Morris to provide "accommodations for smokers" in 1991 in all VCU buildings but the medical school. The university takes pride in its ties to tobacco. A 2006 "Campaign for VCU" fund-raising report praised Philip Morris as an "old friend" for its $2.2 million for VCU's business and engineering schools and smaller grants to help students with career choices.

"The School of Engineering is most fortunate to have such a long-standing relationship with Philip Morris USA," said Dr. Robert Mattauch, engineering school dean, in the report.

Unfortunately for Trani and his school, VCU is now the focus of national attention regarding the nature of the research deals it has cut with Philip Morris. Following disclosure of its controversial agreements with the tobacco company in the New York Times, Trani has appointed an internal task force to review VCU's research contract policies. The school will hold two open meetings this month to discuss the matter, with the first slated for July 16.

The controversy has huge implications for Richmond and VCU, which are struggling to become respected venues for scientific research, especially in medicine and biotechnology. While the city's daily newspaper has downplayed the issue and no major public figure has yet expressed misgivings, the issue is attracting national attention. Anti-tobacco activists and scholars concerned about the integrity of sponsored research are tracking the issue on websites, blogs and even Wikipedia.

Meanwhile, since the publication of the Times article, a number of VCU faculty, researchers and students have picked up on the controversy. The have broadened the debate from the propriety of the research agreements to the ethics of a research university collaborating in any way with tainted tobacco money.

Richmond.com has interviewed dozens of individuals at VCU and elsewhere in an effort to nail down the facts of a story, the outlines of which have been obscured on the one hand by secrecy on the part of Philip Morris and VCU about aspects of the contracts, and on the other by spread of unsubstantiated, sometimes inaccurate, information by critics.

The narrative that emerges is painted in shades of gray.

One fact seems indisputable: VCU has aggressively pursued a relationship with Philip Morris over the past decade.

This is the story of that relationship.

THE ROOTS OF VCU'S current controversy can be traced to a research debacle that struck the university nine years ago. Although little mention of it was made locally, the fiasco captured the attention of the global research community. The consequences were serious, including a temporary ban on all research on human subjects at VCU and its medical school.

In 1999, the father of a woman involved in a VCU study of twins happened to open his daughter's mail. Inside was a questionnaire asking highly personal questions about other family members, including the father, according to a Jan. 10, 2001 article in the Journal of the American Medical Association. Angered about the breach of privacy, the man contacted the National Institutes of Health which in turn called the Food and Drug Administration. NIH and FDA determined that VCU's institutional review board erred in protecting privacy. They suspended all human subject research at VCU in 1999, including its graduate schools and at the Medical College of Virginia. The implications were huge. How could VCU bill itself as a major research institution if federal regulators had forbidden it from dealing with any human subjects?

At the time Trani, who had been VCU's president for about nine years, was working to boost the standing of VCU from its pre-1968 standing as Richmond Professional Institute, essentially a third-tier commuter school, to a major university. But, according to interviews with past and present VCU faculty, Trani was spending so much effort expanding the university's physical plant and his personal influence with the city that he dropped the ball on research. (Richmond.com attempted to contact Trani Wednesday to address this and other issues in the story, but he was not available.)

VCU scrambled to deal with the damage from the federal regulators' decree. Dr. Bill Dewey, who had been vice president for research, retired. Dr. Francis Macrina, a VCU microbiologist and oral disease specialist who had written a textbook on the ethics of scientific research, was named the interim head of research.

"We were notified of the human subject situation in late 1999 and we were shut down for about a month," says Macrina, who worked on resuscitating VCU's research controls for nine months. Privacy was upgraded and federal regulators relented. VCU was back in the game.

Trani, wanting to take the corrective measures one step further, launched a national search for a new head of research who could take VCU to a new level. On Aug. 4, 2000, VCU announced that a ringer had been found. She was Dr. Marsha Torr, a physicist originally from South Africa. Nationally known, Torr had won respect for her work at such top-drawer schools as Cornell and the University of Michigan. She had spent years working with the National Aeronautics and Space Administration, heading the Atomic Physics Branch at NASA's Marshall Space Flight Center in Huntsville, Ala. More recently, she had been head of research at the University of South Carolina and the University of Nebraska at Lincoln.

Torr came to VCU with high hopes. Between 2000 and 2005, when she left, the level of research funding at at the university doubled, from roughly $100 million to roughly $200 million. R&D at VCU seemed to be gaining traction.

ABOUT THE TIME TORR arrived at VCU, cigarette giant Philip Morris USA was undergoing a crisis in its own R&D programs. The medical evidence that linked cigarette smoking with cancer and heart disease was widely regarded as irrefutable, and the scientific credibility of Big Tobacco, which had steadfastly denied the connection, was totally shredded. The biggest hit occurred in 1998 when the four major cigarette makers capitulated to lawsuits and public opinion, agreeing to pay out $206 billion as part of the so-called Master Settlement Agreement (MSA) to resolve health-related lawsuits among 46 states.

The MSA was a watershed for the Altria Group, the corporate parent of Philip Morris. In the decade since, the consumer products holding company has radically reshaped its strategy. Recognizing that the association with its cigarette business harmed its large, non-cigarette brands in food and beer, the company divested itself of Kraft Foods and Miller Brewing. More recently, Altria spun off its prosperous international cigarette operation, Philip Morris International, so it could grow unconstrained by U.S. regulatory policies. Meanwhile, it repositioned the domestic cigarette business, Philip Morris USA, so it could adapt to the shrinking U.S. market for cigarettes in a hostile legal and public-opinion environment.

Conducting an about-face from its previous belligerent defense of cigarettes, Philip Morris USA now acknowledges the health risks associated with its products, providing detailed information on its website and funding anti-smoking campaigns for youth. The company has undertaken development of "less harmful" tobacco products, and it seeks regulation of the industry by the Food and Drug Administration to ensure that all tobacco companies operate at the "same high standards" and also to provide a framework for developing less harmful products.

The new approach has not won over all of the tobacco giant's critics. Suspicious of this seemingly contradictory approach, anti-smoking activists have continued to bird-dog the company: tracking its research activities on blogs and websites, and shaming universities and researchers that collaborate with it.

Meanwhile, to maintain profitability in a U.S. cigarette market that was eroding one percent a year, Altria and Philip Morris USA planned to conduct radical surgery on itself: consolidating its U.S. manufacturing operations and moving Philip Morris' corporate headquarters from its pricey Park Avenue address in Manhattan to somewhere more affordable.

According to Greg Wingfield, executive director of the Greater Richmond Partnership, several events were driving Philip Morris' thinking. New York City had raised its taxes on tobacco sales in the city and had ended the exemption from city no-smoking laws at Philip Morris' office, creating an embarrassing situation in which its products were banned from use in its own offices. Independently, a Realtor had approached the corporation with the idea of taking over the vacant, architecturally significant Reynolds Metals building just off West Broad Street in Richmond.

As Philip Morris pondered where to relocate, Richmond was a leading contender. The largest of the company's three major manufacturing facilities was the Bells Road plant in the city. Employing more than 5,000, the plant had a history of friendly relations with the Richmond community. Philip Morris was considering investing $300 million to expand cigarette production there, even as it closed a plant in Louisville and would later close another in North Carolina.

Recalls Wingfield: "I got the idea of pitching Richmond to them as a package deal – their headquarters and the $300 million plant expansion."

Philip Morris finally broke the big news in the spring of 2003: It would move its headquarters to Richmond. State and regional economic development officials reveled in the economic development coup. Then-Gov. Mark R. Warner approved a $3 million grant from the Governor's Opportunity Fund to facilitate the deal on the grounds that cumulative 10-year state and local tax revenue from the project would amount to $85 million.

Soon after, Philip Morris hatched another plan: building a $350 million research facility to accelerate the development of new, less harmful tobacco products. By the fall of 2004, that initiative was well underway. The two candidates, says Wingfield, were Richmond's Virginia Biotechnology Research Park and the Research Triangle area near Durham and Chapel Hill, N.C.

The idea of locating a major R&D facility in downtown Richmond piqued the interest of Trani and other top VCU administrators. The Biotech Park in VCU's backyard had been launched in the 1994 but was slow in taking off. Lagging established biotech centers such as San Francisco, San Diego, Boston, Maryland and even North Carolina, the Richmond region simply did not have a large life sciences sector to draw from. In the autumn of 2004, Richmond business leaders launched a secret initiative, called "Operation Peat Moss" (with the "P" and M" in "peat moss" standing for "Philip Morris"), with the mission of convincing PM to make a major R&D investment in Richmond' biotech park. Leading the effort for VCU were Trani, Dr. Tom Huff, VCU vice provost for life sciences, and Robert Skunda, president of the biotech park, sources say.

In April 2005, Philip Morris made another big announcement: It would build the research facility in Richmond. Again, the economic development community was ecstatic. To help seal the deal, Gov. Warner approved $15 million in state incentives. In a press release announcing the new facility, Trani was quoted as saying: "This project is a testament to the productive teamwork of government, business and higher education that has happened time and time again in Virginia, and especially here in Richmond. It's the collaboration of the best we each have to offer for the benefit of the entire region and state."

TYPICALLY CLOSED MOUTHED, Philip Morris provides few details about its research program, which encompasses both its Richmond R&D facility and a university outreach component. PM spokesmen say the R&D facility is looking into the use of smokeless tobacco such as snus, but an investigation of patents and recruitment ads indicates that the research is multi-faceted and broad ranging.

Philip Morris has sought to eliminate harmful substances from tobacco at various stages, from understanding the genetic makeup of the tobacco plant to investigating the interaction of chemical compounds with human cells. The company has researched cancer-causing nitrosamines created during the tobacco-curing process, and studied the chemical processes associated with tobacco combustion. Researchers have looked for ways to eliminate carbon dioxide, implicated in heart disease, from tobacco smoke, and they have filed patents on nano-scale filters to block dangerous components such as aldehydes, furans, pyrroles, aromatics and ketones. Another plan of attack has been to probe what happens when smoke is inhaled into the lungs and chemicals are absorbed into the blood stream. Philip Morris donated $25 million to the University of Virginia to study the genesis and progression of smoking-related diseases at the molecular level.

Philip Morris is also channeling some of its efforts to find new, non-threatening products through Chrysalis Technologies, a subsidiary it created in 2000, now housed in Chesterfield County. Philip Morris has revealed little about Chrysalis' activities, but a 10-K filing by another firm with U.S. Securities & Exchange Commission gives clues about its activities.

Philip Morris has gotten a leg up in the use of aerosol spray devices originally used to test the effects of cigarette smoke. In the past, for example, the company tied beagles to breathing apparatus to see the long-term effects of tobacco smoke. The same types of devices can be used to dispense aerosol drugs to fight diabetes and other diseases by introducing them into the human body through the lungs.

According to SEC filings, Chrysalis entered into a strategic alliance with Discovery Laboratories of Warrington, Penn., in December 2005 to develop and commercialize aerosol platform technologies that employ substances that can replace surfactants, which are produced naturally in the lungs and are needed for proper breathing. If the surfactants do not function properly, a patient can have serious respiratory diseases. The replacement chemicals can address such serious respiratory conditions such as acute lung injury, neonatal respiratory failure, chronic obstructive pulmonary disorder, asthma, cystic fibrosis and others, according to a filing by Discovery Laboratories.

The two firms will focus on therapies for hospital patients in neonatal intensive care units, pediatric intensive care units and adult intensive care. According to the structure of the alliance, Chrysalis is responsible for developing the design for the aerosol device platform and disposable dose packets. Discovery Laboratories will produce aerosolized drug formulations, clinical and regulatory activities, and the manufacturing and commercialization of the drug-device products. Discovery has exclusive rights to Chrysalis technology for use with pulmonary surfactants for all respiratory diseases and conditions in hospital and ambulatory settings, according to the filing.

Philip Morris won't say if this is similar to the types of research it does at the Biotech Park. But if it is, it opens up the possibility that it become far more than a tobacco company.

AS THE TOP VCU BRASS worked behind-the-scenes on Operation Peat Moss, faculty and researchers at VCU noticed a change in the working environment on campus, according to interviews with several VCU professors and administrators. "Philip Morris people started showing up in our offices," says one administrator who declines to be identified. Some researchers were puzzled and concerned by the perceived increase in the Philip Morris presence.

In lawsuits and testimony before Congressional committees over the years, evidence had surfaced suggesting that the cigarette companies were excessively secretive in their research, repressing findings they did not like. If scientists in the employ of tobacco firms came up with results that displeased the company, the research was often disregarded. Given the industry's track record, many universities have approached tobacco funded research gingerly. At least 15 major research universities, including the world-famous Johns Hopkins University in Baltimore, have refused to accept tobacco money. Others, such as Duke University and the University of Virginia, accept tobacco-funded research only if they control the research completely and have patent and publication rights to the results.

Yet starting in 2001 and continuing at least through 2006, VCU entered into restrictive "research service agreements," also known as "work for hire" agreements. Few on campus knew about the research agreements, including contracts signed in 2006 that called for VCU to research pulmonary disease and wastewater treatment for Philip Morris. The agreements take the unusual step of forbidding faculty and students from discussing the contracts openly and order the school to contact Philip Morris if the news media or a regulatory agency makes inquiries about the research. VCU can publish research involving such contracts, but only after Philip Morris holds a review to delete material it deems proprietary. The terms of the contracts give PM up to four times as long as usual to do so.

Knowledge of the agreements was restricted largely to 150 faculty members who had access to a special data base. VCU never disseminated copies of the agreements, much less open them up to general scrutiny.

"I don't think many of us were aware of these contracts," says Dr. Tom Eissenberg, an associate professor of psychology.

Richmond.com obtained copies of the master services agreement under the Virginia Freedom of Information Act, but critical details of the research projects were contained in so-called "task orders." Richmond.com could not obtain copies of the task agreements. Pam Lepley, head of communications at VCU, says they are exempt under the FOIA.

One top VCU official who did know about the growing relationship with Philip Morris and was troubled by it was Dr. Torr, the ringer who had restored VCU's research reputation after the 1999 research debacle. She left the university in 2005 and colleagues claim her protests against tobacco research were part of the reason for her departure.

"Dr. Torr wasn't too happy about the tobacco research," acknowledges Macrina, who replaced her as vice president for research after she left. Contacted at her retirement home in Southern Pines, N.C., Torr declined comment.

HISTORY SHOWS THAT BIG TOBACCO has maintained extremely close ties with VCU and its predecessor institutions over the years. A close relationship had been the norm from the 1930s to the 1960s. Tobacco links went into a hiatus from the 1970s to the 1990s before being revived by Trani.

So intense was the early collaboration at the Medical College of Virginia, VCU's predecessor institution and tobacco firms, that Robert Proctor, a Harvard-trained historian who teaches at Stanford University, is devoting an entire chapter to VCU in his upcoming book about the tobacco industry's impact on scientific research.

"Since about 1935 there was massive collaboration between VCU and tobacco," says Proctor, whose book is due to be published next year. At the time, American Tobacco Company, co-founded by Richmond millionaire Lewis Ginter, took the lead in funding research at the Medical College of Virginia and the Richmond Professional Institute. American funded entire salaries of professors in MCV's pharmacology department, including two highly paid consultants, Proctor says.

"The whole university was an appendage of American Tobacco," says Proctor. In fact, he is titling his VCU chapter "Sold, American!" after the well-known radio advertisements of the 1930s and 1940s in which a tobacco auctioneer shouts the phrase when he buys a tobacco bale.

In the 1930s and later, American's research at MCV centered around the health concerns of the day, including cancer, lead and other harmful chemicals found in tobacco smoke. In 1954, Big Tobacco launched its Tobacco Research Council to fund research into its products on their terms. The payments to MVC researchers and a librarian continued. At the time, the relationship seemed perfectly acceptable for a medical school: The link between tobacco and lung cancer had not been made conclusively.

Moreover, tobacco was a big part of the local culture well into the 1960s. A major event each year was the Richmond Tobacco Festival and its parade down Broad Street. Frank Sinatra was the star attraction in 1948. High schools welcomed smoking just as they tolerated students bringing a hunting rifle to school as long as it was left in a rack in the pickup.

Tobacco research waned at VCU in the 1970s and 1980s. By 1998, the Master Settlement Agreement with the tobacco firms dissolved the Tobacco Research Council on the grounds that its research was tainted. According to the court settlement, its documents were cached in national public depositories such as one at the University of California at San Francisco Medical School and other sites. Companies such as Philip Morris USA continued research on their own or by contracting it out.

AT VCU, TOBACCO RESEARCH was dormant for years. But when the opportunity came to revive it, there were few protests. Objections like those raised by Dr. Torr's didn't reach very far in an environment that critics describe as conservative, even authoritarian. Academics who arrived from other institutions say privately they were surprised by the lethargic mood at VCU and the lack of will to say anything that might upset Trani. The local media was, for the most part, highly supportive of VCU and worshipful of its president.

The cozy atmosphere came to a crashing end on May 22 when The New York Times printed a front-page story titled, "At One University, Tobacco Money is Secret." The article outlined the "highly unusual" conditions of the Philip Morris contracts such as the requirements banning discussion of them. The Times quoted a number of national experts, such as Tufts University's Sheldon Krimsky, who said that when universities sign such agreements, they compromise "their values as a university."

Word of VCU's research ties had reached a national audience. The university's reputation, and the region's, was at stake. Trani's reaction was defensive. Declining to be interviewed by the Times, the VCU president insisted that the "research service contracts" were different from basic research agreements. The Richmond Times-Dispatch buried the story, noting that other institutions, such as the University of Louisville, had contracts with similar restrictions. VCU spokesperson Pam Lepley points out that the University of Virginia last year accepted $20 million from Philip Morris.

UVA School of Medicine did in fact accept the money but officials have said that Philip Morris's role will be only to be appraised of the "broad outlines" of the research, which will involve devising programs to get youths to not smoke, studying addiction and creating public health messages against smoking. The money is a grant, not a contract as in the VCU case. Duke University has received $30 million in an arrangement similar to UVA's and Duke's website makes it plain that Philip Morris has no control over the research, which isn't true with VCU's contracts.

By comparison with the large sums it was steering to Duke and UVA, the Philip Morris' funding of its home-town university was meager. VCU confirms that it has performed research for the tobacco company since 2001. But there are only two work-for-hire contracts totaling $284,000 in place right now – one for research into pulmonary disease and another to examine wastewater runoff from a Philip Morrs facility.

At VCU, some faculty members were annoyed that their school had gotten involved with Philip Morris with no input from them. Concern spread to the point where 20 or so faculty, researchers and students gathered June 19 in a public meeting to discuss the issues raised by the contracts. Tipped off, Richmond.com attended meeting, but only on the condition that the attendees not be identified. Several said they were so worried about the consequences of speaking out that they used cell phones rather than their office phones to communicate.

Meanwhile, Trani has announced a "task force" to review the school's corporate research contracts. To head it, he appointed Macrina, the microbiologist who took over as vice president for research after Torr left in 2005. Macrina had trained at Cornell and Syracuse Universities spent most of his career at VCU.

Macrina has become controversial on campus. Faculty accused him of having close ties to the tobacco industry and pointed to a document filed as part of the Master Settlement Agreement with Big Tobacco. The document listed Macrina as being a member of a "Scientific Advisory Board," but it turned out that the board was formed by the U.S. Environmental Protection Agency to study indoor air pollution and not by a tobacco company. "I have never done tobacco research," he says.

Some faculty still believe that Macrina might be in a conflict of interest as head of the review task force because, as vice president of research, he had purview over the negotiation of the contracts in question. He did not handle the negotiations personally. Lepley says those were handled by Michael E. Katz, director of VCU's Office of Industry Partnerships. Although Katz was the one to handle the negotiations, he reported either directly or indirectly to Macrina. (In June 2007, Katz's office was merged into the Office of Sponsored Programs within the Office of Research. Katz no longer works for VCU.)

On a June 24 meeting of the task force, members concluded that Macrina had no conflict as head of the committee. However, according to minutes of the meetings, task force members based that finding on the fact that Macrina had no ties to Philip Morris or the tobacco industry, as some critics had claimed. The task force did not appear to address the fact that Macrina would be passing judgment on actions of an employee under him in the chain of command.

Other allegations circulated by critics include the prospect of Philip Morris funding a new Women's Health Center, which would be named for it, and the possibility that the tobacco firm would be involved with the new School of Public Health. In the public meeting attended by Richmond.com, some faculty argued that having Philip Morris fund a women's center as it markets its cigarettes to low-income women in ghettoes would be a travesty. Likewise, some claim that the public health school would suffer as it seeks accreditation if it has significant ties to Philip Morris whose products damage public health.

But it's not clear where the critics are getting their information about VCU's plans. Lepley says she doesn't know of any new women's health center, although a women's health unit has been around for years. The school of public health got underway two years ago, but is still in search of a dean and a faculty and is several years away from accreditation, she says. Lepley says she knows of no influence or funding by Philip Morris in either case.

Indeed, one of the biggest problems at VCU this summer seems to be confusion. Perhaps the "town hall meetings" will help sort matters out. But Trani is spending the summer on sabbatical at Harvard in the Boston area. He won't return until September and expects the task force's report by Oct. 1.

The fervor at VCU could die down over the summer. But if the controversy keeps mounting, it could turn out that Trani wasn't around when his school needed him the most. VCU's reputation and that of Greater Richmond's economic development efforts hang in the balance.

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