Part 4 of a 4-Part Series
- View Part 1 here: What is Peer Review And How It Can Go Wrong?
- View Part 2 here: Peer Review, Reproducibility: How To Separate Good Science From Sketchy Tales
- View Part 3 here: Bad Science Thrives When Corporations & Government Regulators Deny Peer Review
More articles on this topic here:: INDEX: “Why You Can’t Trust Government Science”
“Private research produced by regulated parties under the pressure of future regulation is at significantly greater risk of under-reporting harms than corresponding publicly sponsored research.” — Equal Treatment for Regulatory Science
When millions — or billions — of dollars are at stake, corporations have a need for scientific studies that fit their marketing and regulatory goals. What’s more, scientists and corporations know that experiments can be carefully designed and biased to produce predictable conclusions when they are needed cor regulatory approval.
When the safeguards of peer review and transparency are absent, it creates a vacuum that invites mischief and biased studies. Corporations have a number of ways to accomplish their goals:
- Financial Influence.
- Selection of “friendly scientists” known to have the “proper” bias.
- Use of “hired gun scientists” and science-for-hire consulting firms to conduct multiple test designs until one produces the results desired.
- Using ghost-writing scientists to hide the corporate source of information.
Private labs have huge financial incentives to hide dangers so that chemicals can be approved. The use of private, science-for-hire labs is one of the primary reasons that regulatory science cannot be trusted.
Small wonder, then, that mainstream scientists — such as members of the American Association For The Advancement of Science — do not trust government science.
Private Science Valuable But Must Not Be Trusted For Regulation & Public Health
It is vital to recognize that most private labs perform invaluable work for their clients who use their data for internal research and to manage the monitoring of production and manufacturing.
But private science studies should not be acceptable for regulations and public health and safety because they have no public oversight, no transparency, and no controls over quality or integrity.
This warning is merited by the verified deceptions, bias, conflicts of interest and misbehavior of many private science mercenary firms.
Who Are The Science Mercenaries?
There are scores — perhaps hundreds — of hired-gun science labs. Many have been founded by former corporation scientists or government regulators who know precisely how to select each item in an experiment to bias the results in favor of their corporate clients.
Some of the science-for-hire companies are huge multinational corporations employing skilled scientists who prefer the higher compensation and security of a corporate job to the lower-paid, uncertainty of peer-reviewed academic research.
In addition to their work on behalf of corporations some consulting firms are also contractors to government agencies like the EPA and FDA. Their government work ranges from conducting research to helping create and evaluate regulations which can affect their corporate clients.
Currently, the most prominent science-for-hire firm is TERA, which stands for ” Toxicology Excellence for Risk Assessment.”
TERA is typical of larger firms which conduct private, unpublished science-on-demand, but which also have concocted elaborate mechanisms to hide their conflicts of interest with disguises of independence, creating fake public interest web sites aimed at consumers and even scientific journals guaranteed to be friendly to corporate interests.
TERA, like many of these firms, have borrowed heavily from — and improved upon — the scientific deceptions of the tobacco industry.
Former EPA toxicologist Michael Dourson founded TERA in 1995 and quickly leveraged his EPA regulatory expertise into contracts with tobacco companies, chemical corporations and industry groups like the American Chemical Council (ACC).
Toxic Science: Fiddling Facts For Profit & Legal Leverage illustrates a separate case not involvingTERA in which ACC helped other science mercenaries and Eastman Chemical launder their role in creating a sham scientific study.
Distorting Jesus To Defend Tobacco
In his flippant defense of his work for tobacco, Dourson offered a solid illustration of how science mercenaries like him twist reality to deceive: “Jesus hung out with prostitutes and tax collectors. He had dinner with them.” Dourson told investigative reporters.
According to the New Testament, Jesus worked with prostitutes and tax collectors to help them rise above their occupations and show them how to become better people.
Unlike Dourson’s deceptions on behalf of corporate clients, Jesus did not try to help these people become be better prostitutes and tax collectors as Dourson’s perverted analogy hints.
There is also the fact prostitutes and tax collectors did not kill millions of people like tobacco companies have done and continue to do.
While not directly connected to scientific issues, this example clearly illustrates the structure and dishonesty inherent in the offensive and intellectually bankrupt tactics that Dourson and others use to deliberately thwart honest, trustworthy science.
A testament to Dourson’s work for the tobacco industry can be found in the University of California Legacy Tobacco Document archives which has 460 documents found for him and his work.
Deceive, Hide The Money, Confuse The People, Lobby The Regulators
The art of conning the public through the use of deceptive organizations can also be strikingly illustrated by the activities of one of TERA’s first major clients: The Center for Indoor Air Research (CIAR).
While publicly misrepresenting itself as a valid scientific organization, tobacco company documents released in court actions show that CIAR was a fraudulent front group created by the tobacco industry whose goal was to debunk scientific claims showing the health risks of secondhand smoke.
Creating Fake Legitimacy
Like much of TERA’s work and clients, CIAR pretended to be a legitimate research organization and wrapped itself in the trappings of respectable science, claiming to offer a “balanced” assessment of tobacco smoke and trying to pass itself off as credible source of information.
But CIAR’s illegitimate subterfuge and its clever but dishonest operations were fully disclosed when a lawsuit forced the release of 40 million internal, once-secret tobacco company documents.
A major article in the American Journal of Public Health summarized that release and detailed CIAR’s role in attempting to defraud the American public, undermine trustworthy science and stall appropriate government regulations. (The Smoke You Don’t See: Uncovering Tobacco Industry Scientific Strategies Aimed Against Environmental Tobacco Smoke Policies).
According to that article, CIAR was:
“funded by the tobacco industry, played an essential role in developing “stronger arguments” to support the industry’s position that ETS (Exhaled Tobacco Smoke) represented an insignificant health risk. CIAR was founded in March 1988, allegedly for the purpose of ‘sponsoring high quality research on indoor air issues and to facilitate the communication of research findings to the broad scientific community.’ Founding members of CIAR included Philip Morris, R. J. Reynolds, and Lorillard.
Using Legitimate Scientists To Subvert Peer Review
In addition to the public relations bonanza conferred by CIAR’s true mission as an industry proxy, the fake legitimacy allowed CAIR to function as a slush fund to launder tainted tobacco money to legitimate scientists. Just as TERA uses its status as a non-profit to launder chemical industry contributions as grants to scientists that TERA vets as industry friendly.
Significantly, laundering industry funds to try and clean them of funding bias is often the only way to trick many scientists into doing studies. The scientists accepting the money know it’s tainted, but research grants are hard to come by so they are willing to take the money just as long as it’s sanitized through an “independent” non-profit like CIAR or TERA.
According to The Smoke You Don’t See:
“An attorney from the Washington, DC–based law firm Covington and Burling (counsel to the Tobacco Institute and Philip Morris) made the following statement in regard to CIAR:
[W]e all know that many scientists will not accept funding directly from the industry but will accept funding from entities like CIAR. We need to have access to the best qualified researchers at the most prominent institutions worldwide when deciding who should conduct research for which funds have been made available. CIAR should provide us with that access, now and into the future.
“This buffer allowed industry-funded scientists to produce seemingly independent results aimed at contradicting ETS findings and disclaiming the EPA report while keeping such research under industry control.”
The Smoke You Don’t See, published in the American Journal of Public Health, notes that, as a result of this subterfuge, the hidden conflicts of interest allowed legitimate scientific journals to publish illegitimate tobacco company promotions:
“From 1989 to 1999, CIAR funded at least 244 published studies, some of which, documents suggest, were central to the industry’s efforts aimed against the EPA and the US Occupational Safety and Health Administration (OSHA).”
It’s notable that CIAR was a client of TERA’s during the 1996-1999 time period when it was doing its best to thwart credible science into the deadly use of tobacco.
Since the publication of The Smoke You Don’t See, more than 80 million pages of tobacco company documents have been consolidated by the University of California into an online, keyword-searchable archive: Legacy Tobacco Documents Library.
TERA: Independent Peer Review? Not So Much
A major investigative piece by the Pulitzer Prize-winning Center For Public Integrity, found that more than 50% of all studies reviewed were TERA funding comes from he chemical industry. That belies the claims of independence.
In addition, the Public Integrity article found that TERA hand-pick its review panels and that Dourson himself is on 69 percent of the panels and usually chairs those.
“Dourson said TERA has a short list of people with a general toxicology background that it trusts to lead its panels,” said the Public Integrity article.
However, general toxicologists tend to have experience and education in older, tried-and-true toxicological techniques with expected outcomes such as lesions, disability and death. This bias in favor of older science means that they are frequently unfamiliar with recent advances concerning the cellular molecular pathways affected by low dose concentrations of hormone disruptors.
For that reason, chemical companies and other industrial corporations most often hire general toxicologists who can be relied on to be skeptical of — or even deny — more modern techniques for assessing the risks low-dose effects resulting from hormone disrupting compounds.
TERA’s peer review process has more in common with a crooked science fair than it does with a proper peer review one might find at the journal, Nature.
Chemicals For Your Children: Another Deceptive Non-Profit To Create Customer Profits
CIAR represented itself as an independent, balanced organization and wrapped itself in the “feel good” clothing of a charitable, tax-exempt non-profit. The fact that CIAR was set up as a fake front to advance the profitability of for-profit corporations violated the spirit — if not the letter — of the 501(c)3 regulations of the federal tax code.
TERA took the laundering process for Kids + Chemical Safety one step farther. While it purports to be a family friendly site to provide a “go-to source for balanced, scientifically accurate chemical health information.” In reality, it is actually a propaganda machine bought and paid for by the American Chemistry Council, the chemical industry’s biggest trade group.
But, how was it laundered? Pretty much like the tobacco industry’s CIAR, but slicker and designed to trick ordinary people into making donations.
Unraveling A Complicated Scheme To Deceive
TERA engaged in an elaborate scheme to make sure that anyone who stumbled into Kids + Chemical Safety could not know it was a captive of TERA.
For a diagram, see image below, or click this link.
To summarize the diagram:
- TERA formed the Alliance for Risk Assessment (ARA).
- ARA, along with TERA, The American Chemistry Council trade association, and another private lab with the misleading name of NSF International formed Kids + Chemical Safety. In a laundering operation to add a sheen of legitimacy, the Cincinnati Children’s Hospital Drug & Poison Control Center was added as window dressing. Why is NSF International misleading? Because to scientists and to many n the public, “NSF” is the acronym for the National Science Foundation. This reflects a calculated effort, along with using “.org” top level domains, to manipulate psychological touchstones and create credibility when none is merited.
- NONE of the previous information was actually revealed on the Kids + Chemical Safety web site.
- To add another layer of deception to make Kids + Chemical Safety look legitimate, TERA added a “Donate Button” to solicit donations from ordinary citizens. The donate button goes to a page that finally tells people that their money goes to TERA.
This sham organization technique builds on the deceptive lessons pioneered by CIAR and other tobacco industry schemes designed to create doubts about solid science and fool people into trusting sketchy tales.
Final Words Of Caution On Private Science
“Use of this compromised research for regulation could lead to protections that are not adequate to protect health and the environment.
Yet despite these inherent problems with some sponsored science, current regulatory approaches continue to treat private research gingerly, often immunizing it from any external scrutiny at the behest of the regulated party.
Even publicly accessible private research is not subjected to the quality control that applies to public research.
Private research should be subject to at least the same controls as public research. At the same time, other deficiencies specific to private research, such as sponsor-induced bias and suppression of adverse results, should be counteracted through more rigorous regulatory oversight.”
Conflicts of Interest: Getting Caught Is Rare
It’s also vital to recognize that most scientific consulting firm personnel are surrounded by temptation without the safeguards of public peer review to quell the urge to fiddle with the data. This is compounded by the need to please paying customers so that they will continue to bring business to the lab.
When the consultants get caught, it’s mostly by accident and whistleblowing rather than robust and continual scrutiny. In addition, there are few penalties for getting caught.
Corporate Studies Exempt From Federal Misconduct Law
Corporate and regulatory science suffers from a severe hypocrisy problem. University and other respectable scientists who receive funding from government agancies must adhere to a rigid set of ethics, honesty, and rules that are enforced by the Office of Research Integrity (ORI).
While the ORI has been accused of shirking some of its duties, the National Institutes of Health enforces the strictest rules of conduct, of ethics. In addition, it also enforces standards of experiment design and the qualifications of scientists receiving its grants.
Corporations Use Ethics Rules To Harass & Discredit Honest Science
None of the ORI or NIH rules apply to corporate scientists or those who work for for-profit, pay-for-play labs.
However, those paying for unethical science with pre-selected conclusions often use the ORI and NIH rules to harass honest scientists whose studies are inconvenient for corporate marketing and regulatory purposes.
[T]here are anecdotes of industry using the misconduct provisions to harass and discredit scientists whose research is adverse to their interests. Again the disparate oversight of the quality of public versus private research repeats itself,”– Equal Treatment for Regulatory Science
“Publicly sponsored research is governed by scientific misconduct regulations that withdraw funding and stigmatize the offending researchers; private research is exempt from this form of regulatory oversight, even when private research forms the primary basis for federal health and safety regulation.
“Equal Treatment for Regulatory Science: Extending the Controls Governing the Quality of Public Research to Private Research,” American Journal of Law & Medicine, 30 (2004): 119-54, 2004 American Society of Law, Medicine & Ethics Boston University School of Law, by Wendy Wagner & David Michaels
Glenn W. Suter II & Susan M. Cormier (2014): The Problem of Biased Data and Potential Solutions for Health and Environmental Assessments, Human and Ecological Risk Assessment: An International Journal, DOI: 10.1080/10807039.2014.974499
Footnotes from Equal Treatment for Regulatory Science on use of misconduct laws to harass honest scientists.
Scientific Misconduct Regulations, 40 C.F.R. pt. 50, subpt. A; see generally Robert M. Anderson, The Federal Government’s Role in Regulating Misconduct in Scientific and Technological Research, 3 J. L. & TECH. 121 (1988).
120 Herbert Needleman (whose research on child lead poisoning was pivotal in EPA’s lead phase-out of gasoline) was alleged to have engaged in misconduct. The accusations of misconduct, brought by scientists who consulted with the lead industry, turned out to be meritless, and he was cleared of wrongdoing. See, e.g., Herbert L. Needleman, Salem Comes to the National Institute of Health: Notes from Inside the Crucible of Scientific Integrity, 90 PEDIATRICS 977 (1992); Joseph Palca, Lead Researcher Confronts Accusers in Public Hearing, 256 SCIENCE 437 (1992); Gary Putka, Professor’s Data on Lead Levels Cleared by Panel, WALL ST. J., May 27, 1992, at B5.
Scientific misconduct allegations were also brought against researchers documenting how the “Joe Camel” logo appealed to young adolescents. The charges were brought by an academic affiliated with RJR Reynolds, the holder of the Joe Camel trademark. Paul M. Fischer, Science and Subpoenas: When Do the Courts Become Instruments of Manipulation?, 59 LAW & CONTEMP. PROBS. 159, 160 (1996).
A few notable results from the lack of scrutiny that have come to light:
- FDA Approval Is Often Based on Drug Company Information
- FDA staff travels on drug industry dollars
- EPA Contaminated by Conflict of Interest
- Old ways, new means: tobacco industry funding of academic and private sector scientists since the Master Settlement Agreement
- Sciences International (NIH Drops Private Lab Contractor For Conflict of Interest)
- As drug industry’s influence over research grows, so does the potential for bias
- Association of funding and conclusions in randomized drug trials: a reflection of treatment effect or adverse events?
- Scope and Impact of Financial Conflicts of Interest in Biomedical Research
- Reported Outcomes in Major Cardiovascular Clinical Trials Funded by For-Profit and Not-for-Profit Organizations
- Tobacco Industry Influence on Science and Scientists in Germany
- Do Seed Companies Control GM Crop Research?
- Big tobacco and science: Uncovering the truth
- Report Claims Industry Influence at European Food Watchdog Persists
- How Basic Scientists Help the Pharmaceutical Industry Market Drugs
- Lies, Damned Lies, and Medical Science
- A Case Study on Influences on Scientific Publication: Avandia and the New England Journal of Medicine
A Small Sample of Private Science Companies
- Sciences International (Part of TetraTech Since 2001)
- Scientific & Regulatory Consultants, Inc. (SRC)
- TechLaw, Inc
- Scientific Strategies
Other Links of Interest:
- 84,000 Legal Chemicals. Fewer Than 200 Tested. Only 5 Ever Banned. Here’s Where Those Numbers Come From
- How a handful of consultants used Big Tobacco’s tactics to sow doubt about science and hold off regulation of BPA, a chemical in hundreds of products that could be harming an entire generation.
More Links Of Interest And For Future Investigation