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His complaints got no traction with editor McClellan or then-publisher Informa Health, which Grandjean said reneged on promises to conduct an independent review. Taylor & Francis, the current publisher, declined to comment. In 2012, McClellan defended the journal’s disclosure policies and said that Grandjean’s complaint had been shared with other members of the editorial board, “none of [whom] shared the views expressed by Dr. Grandjean.”
Grandjean resigned in 2012, ending a positive relationship that began under founding editor Leon Golberg. “I thought if [McClellan] invited me, he thought my advice would be useful, but apparently this changed to a situation where it was useful to have my name on the masthead to justify this was a balanced journal.”
Like the journal he founded, Golberg’s career aligned closely with industry. A native of Cyprus who held academic positions in South Africa and Britain and spent the end of his career at Duke University, Golberg oversaw Critical Reviews from its inaugural issue in September 1971, published by The Chemical Rubber Co.
The journal was introduced as “the voice of reason” in an era of “chaos and turmoil.”
“Never before have so many regulatory actions been taken or proposed — some too late, others prematurely — that have bewildered the consumer and had a crushing impact on industry,” Golberg wrote.
That same year, a public health crisis unraveled when the U.S. Food and Drug Administration issued a warning against diethylstilbestrol (DES) — a synthetic hormone used for decades by pregnant women to combat morning sickness and prevent miscarriages or premature deliveries — which Golberg had co-created in 1938. As many as 10 million people were exposed to DES before it was linked to a rare vaginal cancer and other fertility problems, spawning myriad lawsuits.
Golberg’s role in the DES debacle is less well known than his later achievements. They include founding the Chemical Industry Institute of Toxicology (CIIT), now the Hamner Institutes for Health Sciences, a research group “founded and funded by the chemical industry,” according to the Research Triangle Regional Partnership. He also jump-started the British Industrial Biological Research Association, a consulting firm whose clients include ExxonMobil and Procter & Gamble.
In the 1970s, Golberg consulted for a now-discredited campaign for “safer” cigarettes by R.J. Reynolds, which still funds fellowships in his honor at Wake Forest and Duke. He died in 1987 from mesothelioma, an aggressive cancer linked to asbestos exposure.
McClellan succeeded Golberg as both Critical Reviews editor and CIIT leader, working with trade groups like the American Chemistry Council. Critical Reviews has since become one of the most-cited toxicology journals, at the same time drawing a spate of criticism.
Ruff, the anti-asbestos advocate, chastised Critical Reviews in May for what she alleged to be improper disclosure in a 2013 asbestos article. Testimony in a court case stated that an industry group paid the authors nearly $180,000 in writing fees, which were erroneously described as “grants.” She cited the incident as a reason for stricter disclosure reporting and enforcement.
As Critical Reviews editor, McClellan has been outspoken against regulation. By his own count, he has testified before Congress 20 times. In 2011, he argued against a proposal by the U.S. Environmental Protection Agency to curb ground-level ozone, or smog, as too expensive, calling for lawmakers to recognize that “a healthy economy with people employed is the cornerstone of a healthy population.”
Industry ties
Since its 1981 debut, Regulatory Toxicology has billed itself as a credible and objective source for a broad audience. Its co-editors promised to focus on science instead of politics and “mythology.”
“Safety is relative, not absolute,” AIDS researcher Frederick Coulston and FDA scientist Dr. Albert Kolbye Jr. wrote in the inaugural issue. “Safety is a moving target.”
The journal has been sympathetic to industry from the start. In its first issue, an associate editor lamented: “There has always been a sense of competition between government and industry, but always a high degree of mutual respect. In the seventies that spirit changed from competition to an adversary posture and from respect to distrust.”
Regulatory Toxicology is the official publication of the International Society of Regulatory Toxicology & Pharmacology, an association whose leaders include a Coca Cola executive, corporate consultants and lawyers.
In an email to the Center, President Sue Ferenc denied that the society plays any editorial role at the journal. Outside of the society, Ferenc heads the Council of Producers & Distributors of Agrotechnology, a pesticide group with its own political action committee.
But significant overlap at both the society and the journal has existed for years.
Gary Yingling, a former FDA attorney who now represents industry clients, has been an editorial board member of Regulatory Toxicology since 1981 while also serving as the society’s general counsel. Fellow board member Terry Quill is an industry lawyer and former society president, who led the society’s push against labeling chloroform as carcinogenic. The EPA has since classified chloroform, a byproduct of chlorinating water, as a probable human carcinogen.
Recipients of the society’s achievement award include well-known journal figures like McClellan, the Critical Reviews editor who also sits on Regulatory Toxicology’s board. The society credited the journal’s growing popularity as the “major” source of its success and “esteem.”
Responding to questions about industry’s financial support of the society, then-president Christopher Borgert wrote in a 2008 newsletter, “Science has an objective means of evaluating information, but it has nothing to do with who got the money and why . . . The process of science removes the scientist, with his numerous biases and conflicts of interest, as far as humanely [sic] possible from the process of data generation and interpretation.”
Regulatory Toxicology’s editors have also made headlines. Chain-smoking through an interview with The Wall Street Journal in 1997, Coulston claimed nicotine wasn’t addictive and smoking didn’t cause cancer. In 2001, his New Mexico chimpanzee lab was stripped of federal funding amid animal abuse claims.
Gori became editor of Regulatory Toxicology following Coulston’s 2003 death and has also served as society president. In 2013, he and 17 other toxicology journal editors penned an editorial criticizing the European Union’s plans to regulate chemicals known as endocrine disruptors. Of the 18 editors, only one did not have industry ties.
‘All that noise’
“If a call comes in and the number is withheld, you might become suspicious and ignore the call,” Grandjean wrote in 2012. “Scientific authorship should be just as simple so that we can concentrate our attention on the sources we trust.”
But representatives of the EPA, the FDA and the U.S. Occupational Safety and Health Administration said their agencies treat science equally, regardless of the funding source. Disclosure is encouraged by all three agencies but isn’t mandatory.
Speakers at FDA proceedings are asked to disclose relevant financial relationships but the agency doesn’t bar those who don’t comply from participating.
Science at the EPA and OSHA is evaluated on a case-by-case basis. Study authors are asked to disclose “funding sources and other pertinent interests” at the EPA, while OSHA asks those who comment on proposed rules to provide disclosures with their submissions.
What should or shouldn’t be disclosed is a matter of debate. “There is no agreement on what a conflict of interest is,” said Arthur Caplan, founding director of the Division of Medical Ethics at New York University’s Langone Medical Center. “The disclosures currently say, ‘I’m going to disclose industry funding because that is a potential source of bias. You, reader, have to decide for yourself whether it is or it isn’t. Good luck to you.’ ” Current sentiment “demonizes the industry side,” Caplan added, while ignoring potential biases created by private foundations or government money.
