Scientists See Big Business on the Offensive

By Stephen Burd

When the R.J. Reynolds Tobacco Company demanded his research records -- including the names of children whom he had studied -- Paul Fischer expected his college to back him. The request, he says, violated "the principles of confidentiality and academic freedom."

Instead, the Medical College of Georgia sided with the tobacco company. Last year it turned over the documents, which, among other things, reported the results of Dr. Fischer's research on the impact on young children of advertisements that feature cartoon characters.

Consultants to the cigarette industry then started criticizing his research. In disgust over the college's response, Dr. Fischer resigned and entered private practice in medicine.

Dr. Fischer and other researchers see his case and similar ones as part of a concerted strategy in which businesses attack the credibility of scientists whose research threatens their interests.

What angers scientists about the attacks is that the most effective tools used by the companies are federal and state laws on research misconduct and open records. Those rules dictate that once someone charges a researcher with misconduct, his or her university must conduct a preliminary inquiry. If the inquiry finds merit to the charges, a formal investigation follows. No matter what the results, the Public Health Service's Office of Research Integrity must review the investigation and determine whether government sanctions should be imposed.

The rules are also designed to protect people who bring charges of misconduct and to give them access to research records during investigations.

Using those procedures, corporate officials have charged researchers with misconduct and then have won court orders to obtain scientists' research records, notes, and correspondence. Then the companies have hired consultants to criticize the research and mount public-relations campaigns to promote skepticism about the findings.

As a result, several scientists have been forced to defend themselves against charges of misconduct -- charges that they and others believe were baseless.

"When regulated industries see research that may lead to more regulation and cost them more money, what they've discovered is that you can harass the researchers to death," says Joel Schwartz, an associate professor of environmental epidemiology at Harvard University. "And they will do this until the scientist is discredited, until his work is discredited, or until that scientist is no longer willing to fight."

Some scientists say that their universities, when confronted by powerful corporate interests, do not leap to their scholars' defense. Instead, they say, the strengthening relationship between academe and industry, and all the financial interests tied up in that relationship, has weakened the universities' willingness to stand up for their researchers against charges by industry.

Several scholars, including Dr. Fischer, have provided The Chronicle with confidential documents to buttress their accounts of how they were attacked by corporations and how their universities responded. The scientists, who were subsequently cleared of misconduct, say that their experiences demonstrate a need to change the way the government goes about rooting out misconduct and fraud.

They say that investigations should look into whether "whistle blowers" who bring charges against them are sponsored by business interests and should subject to more scrutiny the charges brought by such people. They also say that the government should adhere to a strict definition of research misconduct as falsification, fabrication, or plagiarism. That way, they say, businesses could not point to minor errors in a study as evidence of misconduct.

The complaints come as the new Commission on Research Integrity studies ways to improve the government's policing of scientific misconduct. Members of the commission say one of their areas of focus will be the impact of academic-corporate links on misconduct allegations. Congress set up the commission in 1993 to advise the Public Health Service's Office on Research Integrity on misconduct procedures.

"The concern that people have is whether concerns about integrity have been and can be misused for commercial ends. This is a question that bears watching, and it is one that will certainly be an issue we will look at carefully," says C. Kristina Gunsales, a member of the commission and associate vice-chancellor for research at the University of Illinois at Urbana-Champaign.

Corporate officials say they are not doing anything wrong, but simply want to protect the public from bad research. Many of the researchers who have been criticized, they insist, have allowed political goals to bias their work.

"When a tobacco company makes a point, people assume that it is made only in our self-interest," says Peggy Carter, a spokeswoman for R.J. Reynolds. "But nobody bothers to examine the biases of researchers doing anti-smoking research. Skepticism should be a double-edged sword."

A number of people contend, however, that the researchers with the predetermined agenda are those working for industry. "Academic consultants who work with industry come up with answers that satisfy industry," says Barry Commoner, director of the Center for the Biology of Natural Systems at Queens College at the City of the University of New York.

Some government officials agree. Richard J. Jackson, director of the National Center for Environmental Health at the Centers for Disease Control and Prevention, says the way some companies use federal laws and regulations to attack scientists hurts public-health efforts.

"Industries have discovered that name-calling is very effective in intimidating public-health scientists," Dr. Jackson says. "All they have to do is say, 'That scientist does bad science.' Then that scientist is stuck with the label."

Dr. Jackson points to the case of Herbert L. Needleman, a professor of psychiatry at the University of Pittsburgh. Dr. Needleman has spent thousands of dollars over 15 years, fighting to clear his name after two scientists accused him of manipulating data to get the results he desired in a study he conducted. Even after the Office of Research Integrity cleared him last March of scientific misconduct, says Dr. Jackson, Dr. Needleman is still haunted> by the charges.

Dr. Needleman's tiny office at the University of Pittsburgh is lined with scrapbooks filled with the transcripts of misconduct hearings, legal briefs, and correspondence. When he speaks about his experiences, he often talks in a hushed monotone, having repeated the same stories many times. But occasionally, his voice rises in anger, as he recounts the tactics that his critics used.

"These charges are a continuation of a long campaign by the lead industry to retard regulation and harass proponents of lead control," Dr. Needleman says.

The controversy dates from 1979, when Dr. Needleman published the findings of a study he had conducted for three years to determine how children are affected by exposure to lead. Even low levels of exposure, his report said, could damage a child's brain, and he called for a federal ban on the use of lead-based paint in the nation's schools.

Since then, the lead industry has campaigned to discredit Dr. Needleman's research.

In 1982, the International Lead Zinc Research Organization complained to the Environmental Protection Agency that Dr. Needleman had committed misconduct. At that time, the E.P.A. was beginning to rewrite its lead-safety standards. In response to the charges, the E.P.A. convened a special committee of experts to examine Dr. Needleman's work.

The committee said that Dr. Needleman's study had not proved a connection between lead exposure and a child's mental development. Sandra Scarr, a psychology professor at the University of Virginia, sat on that committee. Later, she and another scientist asserted to the National Institute of Health's Office of Scientific Integrity that Dr. Needleman should be charged with scientific misconduct. The N.I.H. office was the precursor of the Office of Research Integrity.

On reviewing the committee's report, Dr. Needleman discovered that it contained a number of serious mistakes in its interpretation of his data. After examining Dr. Needleman's complaints, the E.P.A. reversed the committee's finding and concluded in 1983 that Dr. Needleman's work was "a pioneering study" that had confirmed a "significant association" between lead exposure and childhood intelligence.

At the same time, however, the International Lead Zinc Research Organization hired Hill & Knowlton, a public-relations company, to publicize the original committee's report. The report was sent to major news organizations around the country and articles questioning Dr. Needleman's research began to appear.

While Dr. Needleman blames the lead industry for many of his problems over the last 15 years, he has spent considerable time fighting two academics: Claire B. Ernhart, a professor of psychology at Case Western Reserve University, and Ms. Scarr of Virginia.

Ms. Ernhart published an article in 1981 that disputed the link between lead exposure and health problems in children. She wrote then that Dr. Needleman's work (and her own previous research) had failed to take adequately into account such variables as parental intelligence and home environment.

In 1983, Ms. Ernhart began receiving salary and research support through a grant from the lead and zinc organization. Her grant, she says, continued through 1991, at about $50,000 a year. The money, she adds, paid for expenses in her laboratory.

Ms. Ernhart and Ms. Scarr brought allegations of misconduct against Dr. Needleman after a dispute in 1990. At that time, Dr. Needleman testified for the Department of Justice in a lawsuit against three corporations that were accused of violating the Superfund Act by leaving lead deposits near a residential area in Utah. Testifying for the defense were Ms. Ernhart and Ms. Scarr.

The companies eventually settled with the Justice Department and paid fines totaling $63-million. But Ms. Ernhart and Ms. Scarr did not feel that everything had been resolved. Based on Dr. Needleman's research, which they had obtained during the trial, they brought charges of scientific misconduct to the Office of Scientific Integrity. They accused Dr. Needleman of organizing his study to reach a predetermined conclusion.

Representing Ms. Ernhart and Ms. Scarr in their battle with Dr. Needleman was Hunton & Williams, a Washington law firm that had previously represented lead companies.

Ms. Ernhart says that their legal fees were paid through a trust fund. She declines to elaborate, saying, "I was asked to keep this matter in confidence."

After receiving the complaint against Dr. Needleman, the Office of Scientific Integrity in 1991 ordered the University of Pittsburgh to conduct an inquiry into the charges. The university's investigation concluded that Dr. Needleman was not guilty of misconduct.

It did, however, find that Dr. Needleman had made a number of mistakes in describing his methods. Those mistakes, the university concluded, had had no effect on his results.

The Office of Research Integrity reviewed the university's investigation and agreed that no misconduct had taken place. "The evidence is insufficient to support a finding of scientific misconduct under federal regulation," the office stated in a report issued last March.

Dr. Needleman says that the office left grist for his detractors by focusing much of its attention on his mistakes and little on the conclusion that he had not committed misconduct. "This has been used with a great deal of energy by the lead industry and its public-relations firms to confuse the overwhelming case that lead is toxic in very low doses," he says.

As for Ms. Scarr, she stands by her accusations and denies that she and Ms. Earnhart were used by the lead industry, as Dr. Needleman has claimed. "I don't do lead research and I have never received a grant from the lead industry. As far as being paid to be an expert witness, sure I was paid for my time," Ms. Scarr says. "But to say that I have any connection to the lead industry is ludicrous."

Ms. Ernhart also denies that her links to the industry had anything to do with her whistle blowing. "I have received a grant from the lead industry," she says, "but that does not give them control over me."

Dr. Needleman disagrees. "If my case illuminates anything, it shows that the federal investigative process can be rather easily exploited by commercial interests to cloud the consensus about a toxicant's dangers, can slow the regulatory pace, can damage an investigator's credibility, and can keep him tied up almost to the exclusion of any scientific output for long stretches of time, while defending himself," Dr. Needleman wrote in an August 1992 edition of the journal Pediatrics.

The tobacco industry has also devoted considerable attention to questioning research. In 1981, consultants to R.J. Reynolds produced a memo outlining a strategy "to stand up to the industry's detractors." Major components of the strategy, according to a memo obtained by The Chronicle, would be to "attack bad research" and to "attack researchers themselves where vulnerable."

In December 1991, The Journal of the American Medical Association published three studies that demonstrated the attraction to school-age children of Camel cigarettes' smooth-talking, party-going "Joe Camel" cartoon character. The studies found that the character was memorable to children, increasing the likelihood that they might find smoking attractive.

R.J. Reynolds acted quickly. It hired two researchers -- J. Howard Beales, then an associate professor of strategic management and public policy at George Washington University, and Richard W. Mizerski, professor of marketing at Florida State University -- to analyze the three studies.

A memorandum based on their conclusions was then sent to the company's sales personnel. The memo says that "new evidence validates our position that Camel is not directed at youth, that it does not cause them to smoke, and that the 'research' reported by The Journal of the American Medical Association is seriously flawed."

At the same time, R.J. Reynolds subpoenaed the research records of the scientists who had conducted the original studies: Dr. Fischer, then a professor of family medicine at the Medical College of Georgia; Joseph DiFranza, an associate professor of family and community medicine at the University of Massachusetts at Worcester; and John Pierce, a professor and head of the Cancer Prevention and Control Program at the University of California at San Diego.

R.J. Reynolds sought the records to fight a lawsuit filed in California by a woman seeking to force the company to place health warnings on promotional products such as caps and T-shirts. The woman cited the medical-journal articles.

The company demanded that the researchers supply the names and telephone numbers of all of the children who had participated in the studies; all drafts of the studies' design; all notes pertaining to the studies; and the names and telephone numbers of all respondents who had been excluded.

R.J. Reynolds says the records were needed because it wanted to determine whether the three scientists had committed misconduct. In a 1992 article in Science, Ms. Carter, the R.J. Reynolds spokeswoman, said: "There have been a number of stories that have come up in recent years where scientists claimed to have conducted research that was never done at all. We simply wanted to verify that they did do it."

R.J. Reynolds dropped its subpoena of Dr. Pierce because it obtained his data tapes through an open-records request to the State of California. Dr. DiFranza, however, lost a court battle against the subpoena in Massachusetts Superior Court. And the Medical College of Georgia gave the company Dr. Fischer's records.

It didn't take long for R.J. Reynolds to find something to discredit the researchers.

In a letter to a colleague before carrying out the study, Dr. DiFranza had written, "To those of us in the tobacco control field it is obvious this guy [Joe Camel] has maximum appeal to boys about 11 years old." He then wrote that he had been frustrated by the lack of evidence to show that the advertising was aimed at influencing young children, but that he thought he had an answer to that problem.

"Well I have an idea for a project that will give us a couple of smoking guns to bring to the national media," he wrote.

R.J. Reynolds released the letter to The Winston-Salem Journal and the Associated Press. The story then ran in newspapers across the country, reporting that one of the researchers in the "Joe Camel" studies had committed misconduct by predetermining his results.

R.J. Reynolds itself filed a formal complaint of fraud against Dr. DiFranza with The Journal of the American Medical Association in November 1992, Dr. DiFranza says. The journal was then obliged under federal regulations to report the allegation to the University of Massachusetts at Worcester, which began an inquiry into the charges.

In early 1993 the university found Dr. DiFranza innocent of charges of misconduct. "All scientists who set out to study something are biased; they start out with a hypothesis to test," Dr. DiFranza says. "While the design of my study was pre-ordained, my results weren't."

Dr. DiFranza adds, "The fact that they made their allegations of fraud so public felt like harassment to me. For a while, I couldn't sleep. Fighting their charges diverted my time from research."

For a while, Dr. Fischer was able to stave off attempts by R.J. Reynolds to get his records, despite the fact that his college opposed his stance. Dr. Fischer says he fought the attempt to get his records because he feared the company would harass the children who had participated in his study.

"The tobacco industry wants whatever it can find to destroy the research," he says. "And it can only find things if it has all the research records."

Officials at the Medical College of Georgia urged Dr. Fischer to hand over his research documents because they believed that the state's open-record laws required him to do so.

However, the tobacco company did not realize it could request the records under Georgia's open-records laws. Instead, lawyers for R.J. Reynolds argued that his research was relevant to the California lawsuit.

In February 1993, the Court of Appeals in Georgia ruled in favor of Dr. Fischer. Three weeks after the decision, however, a Medical College of Georgia lawyer was quoted in a local newspaper saying that the college would have been obliged to release the records if the company had made an open-records request.

R.J. Reynolds then made such a request. The college gave Dr. Fischer 48 hours to comply with it.

When Dr. Fischer continued to balk, the college sued him for the documents. The suit was joined by R.J. Reynolds, Dr. Fischer says, which "put a medical school and tobacco company together against a faculty member."

In September 1993 the college won the suit and the records were handed over to R.J. Reynolds.

Attacks on Dr. Fischer's research had begun even before the records were released. In March 1993, Bernard M. Wagner, a professor at the New York University School of Medicine, alleged in a letter to a research partner of Dr. Fischer that Dr. Fischer had committed fraud. "I have a major commitment to maintaining and safe-guarding the integrity of scientific publications," he wrote. He added in the letter that he was a consultant to R.J. Reynolds.

Dr. Fischer is angry not only at the tobacco company, but also at his former college. The Medical College of Georgia, he says, was more interested in cooperating with R.J. Reynolds than in supporting the integrity of its own research mission.

Officials at the Medical College of Georgia defend their conduct in the case. "We had no option but to give up the records. The State of Georgia's public-records laws required it," says Francis J. Tedesco, the college's president. "We couldn't pick and choose who could get the records."

Dr. Fischer disagrees.

"Industry has powers over the academic arm that it did not in the past," Dr. Fischer says. "Universities have been forced to do the bidding of big business, because if they don't they will lose a great deal of their revenue."