Monday, January 19, 2009

2008 Book of the Year

Back in the 2005, the first book chosen here as Book of the Year was Jennifer Michael Hecht’s Doubt: A History, a no-brainer for The Daily Doubter given the book’s survey of the history of doubt as a creative force and an antidote to the stagnation of dogmatic certainty.

This year is another no-brainer, but for almost the opposite reason. Where as Hecht’s work followed doubt as a component of critical and open inquiry that leads to the improvement and acquisition of knowledge, the book chosen this year is about the misappropriation of doubt as an obfuscating tool to block and retard the advancement of human knowledge. And so the 2008 Book of the Year is:

Doubt Is Their Product: How Industry's Assault on Science Threatens Your Health by David Michaels

One of the key concepts that one should take away from a reading of Hecht’s Doubt is that it is that by recognizing that we can not obtain absolute certainty we leave open the avenue to the improvement of our understanding of the world around us. In Doubt Is Their Product, David Michaels explores how industry seeks to exploit this form of doubt in order to create what more properly should be understood as pseudo-doubt: the manufacturing of uncertainty in service of a predetermined conclusion.

The book is an extension of an article by Michaels in the June 2005 issue of Scientific American which is also titled "Doubt is their product." Both the book and article derive their title from an infamous Big Tobacco internal memo which perfectly epitomizes the production of pseudo-doubt and concisely sums up the decades long p.r. campaign to hide the deadly health consequences of cigarettes from the public. I'll quote the article's intro at length

Few scientific challenges are more complex than understanding the health risks of a chemical or drug. Investigators cannot feed toxic compounds to people to see what doses cause cancer. Instead laboratory researchers rely on animal tests, and epidemiologists examine the human exposures that have already happened in the field. Both types of studies have many uncertainties, and scientists must extrapolate from the evidence to make causal inferences and recommend protective measures. Because absolute certainty is rarely an option, regulatory programs would not be effective if such proof were required. Government officials have to use the best available evidence to set limits for harmful chemicals and determine the safety of pharmaceuticals.

Uncertainty is an inherent problem of science, but manufactured uncertainty is another matter entirely. Over the past three decades, industry groups have frequently become involved in the investigative process when their interests are threatened. If, for example, studies show that a company is exposing its workers to dangerous levels of a certain chemical, the business typically responds by hiring its own researchers to cast doubt on the studies. Or if a pharmaceutical firm faces questions about the safety of one of its drugs, its executives trumpet company sponsored trials that show no significant health risks while ignoring or hiding other studies that are much less reassuring. The vilification of threatening research as "junk science" and the corresponding sanctification of industry-commissioned research as "sound science" has become nothing less than standard operating procedure in some parts of corporate America.

In 1969 an executive at Brown & Williamson, a cigarette maker now owned by R. J. Reynolds Tobacco Company, unwisely committed to paper the perfect slogan for his industry's disinformation campaign: "Doubt is our product since it is the best means of competing with the 'body of fact' that exists in the mind of the general public." In recent years, many other industries have eagerly adopted this strategy. Corporations have mounted campaigns to question studies documenting the adverse health effects of exposure to beryllium, lead, mercury, vinyl chloride, chromium, benzene, benzidine, nickel, and a long list of other toxic chemicals and medications. What is more, Congress and the administration of President George W. Bush have encouraged such tactics by making it easier for private groups to challenge government-funded research. Although in some cases, companies may be raising legitimate arguments, the overall result is disturbing: many corporations have successfully avoided expense and inconvenience by blocking and stalling much needed protections for public health.
In the book, Michaels demonstrates that this pattern of attacking legitimate science as being too uncertain in favor of industry funded “sound science” - which always finds in favor of the industry client - is pervasive and dangerous to the nation’s health. Describing the product defense industry, Michaels writes

The range of their work is impressive. They have on their payrolls (or can bring in at a moment’s notice) toxicologists, epidemiologists, biostaticians, risk ascesors, and any other professionally trained, media-savvy experts deemed necessary. They and the larger, wealthier industries for which they work go through the motions we expect of the scientific enterprise, salting the literature with their questionable reports and studies. Nevertheless, it is all a charade. The work has one overriding motivation: advocacy for the sponsor’s position in civil court, the court of public opinion, and the regulatory arena. Often tailored to address issues that arise in litigation, they are more like legal proceedings than scientific papers. In the regulatory arena, the studies are useful not because they are good work that the regulatory agencies have to take seriously but because they clog the machinery and slow the process.
Michaels gives a typical example of this process in the book’s introduction. In 1986, a warning label was added to aspirin products noting the danger to children of developing Reyes syndrome if consumed while experiencing a viral illness. Before the FDA warning label there had been a substantial danger to children: in 1980, 555 cases were reported (and the actual number was likely under reported) with 1 in 3 of those diagnosed having died. The FDA’s warning label had been delayed by the efforts of aspirin manufacturers despite the CDC already having issued an alert about the risk. They argued that the science linking Reyes and aspirin was too uncertain and issued a public service announcement stating, “We do know that no medication has been proven to cause Reyes.” With the additional industry sympathetic efforts of the Reagan administration’s OMB, mandatory labels were delayed by four years, only to be enacted after the government’s hand was forced by litigation from the Public Citizen’s Health Research Group. Since the establishment of the warning label only a handful of cases of Reyes are now reported a year.

The public service announcement issued by the aspirin manufacturers contrary to what was already known about their product is not atypical. Indeed, in example after example the same pattern repeats itself: industry issues public denials of danger from their product even long after they’d privately become aware of the dangers they were pretending (or managed to convince themselves) did not exist.

For example, on February 9, 1971 a public relations statement from B & W Tobacco said that cigarette health hazards were “not a statement of fact but merely an hypothesis.” Yet in 1964 the U.S. Surgeon General had issued a public warning about the health hazards of cigarettes which were already well known and documented by scientists. Internal documents now reveal that the tobacco industry was well aware of the dangers of cigarettes but lied about them in public as part of a deliberate p.r. strategy. This strategy continued into the 1980s when the tobacco industry created the “sound science” movement – always asserting that any science that reflects poorly on industry is "junk science" – in order to combat the regulation of secondhand smoke.

Nearly seven decades after the health hazards of cigarettes had been reported, in 1994 B & W CEO Thomas Sandefur testified before a U.S. House of Representatives committee that “I do not believe that nicotine is addictive;” a lie which became the final straw for B & W scientist Jeffrey Wigand who quit and then blew the whistle on his former employers to 60 Minutes. The incident was made into the film The Insider about the attempted censorship (which lasted 3 years) of the report by CBS’s then corporate parent company Westinghouse.

As far back as the '30s the investigative journalist George Seldes had already observed that the press was caving to advertising interests in not reporting the health hazards of tobacco, but it was not until the 1950s that the science was definitive enough to warrant a public warning (in 1954) about smoking while more research continued.

This illustrates an important principle of regulation: precaution should take precedence over demands for "proof." Given that the absolute certainty demanded by industry is a goal that can never be attained, public policy must reflect the best available science and if a risk is indicated the burden of demonstrated safety should be on industry. In Europe this is understood as the "precautionary principle."

Industry, however, in order to avoid policy discussion concentrates its efforts on the manufacture of uncertainty at the scientific level, an effort that extends not just to the public, but to itself. Michaels notes that while evidence linked abestos and cancer, industry executives used self-imposed uncertainty to avoid regulatory efforts. The executives purposefully did not conduct research that would demonstrate dangerous levels of asbestos exposure so that when regulations were proposed they could argue there was no evidence indicating asbestos dangers at the levels proposed to be regulated! Decades after the dangers of asbestos had been discovered and regulation proposed the industry still refused to self-regulate, while the government lacked the capacity to do so, either, which has led to a crisis of health effects resulting from asbestos exposures.

Minutes of an internal meeting show industry deceiving itself: "We do not believe there is enough evidence of cancer or asbestos, or cancer and asbestosis, in this industry to warrant this survey" of the dangers. By the time of the meeting - 1957 - this was simply an absurd statement given the evidence that was already available. Michaels speculates that the executives engaged in a process of self-justification to eliminate cognitive dissonance: they wanted to believe their product safe, therefore they used anecdotal thought (e.g. "I know workers exposed to asbestos for years who are perfectly healthy") to convince theirselves that it was safe in a process similar to that of William Clifford's shipowner who manages to stifle his doubts about the safety of his ship. This habit of thought, when combined with the profit motive to disbelieve and human difficulty in grasping the statistics of epidemiology, forms a powerful means of developing and maintaining beliefs not grounded in reality.

Reading Doubt is Their Product you will see the deadly product of this form of directionally manufactured uncertainty over and over again. Michaels examines psuedo-doubt campaigns from the industries of vinyl chlorides, lead, beryllium, mercury, aromatic amines, etc which all emulate the efforts of Big Tobacco which were so successful for nearly half a century. Indeed, many of the same scientists-for-hire who cut their teeth defending tobacco went on to do work for the other industries (including those that argue against taking action on anthropogenic global warming.)

Although not as well publicized, these campaigns have also been quite successful; for instance, it was known as early as 1895 that exposure to aromatic amines causes bladder cancer, but industry fought regulations well into the 20th century, despite the cases of cancer that followed. And beryllium beat regulation in 1978 and in 2002 despite the dangers associated with it. The book is rife with such examples.

These campaigns are facilitated with captured journals designed to provide the prestige of peer review, where the reviewers are in reality carefully chosen by industry in advance. Mercenary scientists manipulate the parameters of studies to dilute or dissappear risk so that regulation can be challenged. Given the dubious nature of such science-for-hire, this is largely a stall tactic. The real benefit of such pseudoscience is that it can be used in courts to confuse juries that are not familiar with research methods and statistics. Industries are willing to pay millions to mercenary scientists to reanalyze critical studies in such a way that undesired results go away. In one instance Michaels cites, industry was willing to pay as much as $22 million because they knew in advance what the conclusion of the study would be!

And to illustrate how product defense firms are only interested in servicing their client, Michaels points out that while working for the Chromium Coalition, Exponent Inc denounced an EPA funded John Hopkins University study but when working for a different industry praised the same study!

Speaking of chromium, the book covers some particularly dirty tricks from the industry, which would complain in public that there is not enough low exposure research while secretly hiding its own damning low exposure research until it could doctor the results to dissapper the risk.

The book also documents the serious governmental regulatory deficiency we have here. The example that jumps out is that of diacetyl, a popcorn butter flavoring agent responsible for a lung disease so deadly it's named bronchiolitis obliterans. OSHA simply declined to take action despite the NIOSH having made recommendations in recognition of clear danger. OSHA instead entered into a collaborative "alliance" with popcorn flavor maufacturers where OSHA consults with industry rather than regulates it.

But wait - haven't we heard from Market fundamentalists about the crippling regulations that industry faces? Michaels counters

Workers wait for OSHA at their peril. It is as simple as that. New workplace health standards are rare, and it makes little difference whether the White House is in Democratic or Republican hands. In the last ten years OSHA has issued workplace standards for a total of two new chemicals. Two Indeed, since its inception it has issued comprehensive standards for only thirty toxic materials. Additionally, the agency enforces permissable exposure limits for fewer than two hundred of the approximately three thousand chemicals the EPA characterizes as high-production volum (HPV) because more than a million pounds of the substance is produced or imported each year. Of these OSHA standards, all but a handful were borrowed whole from the voluntary levels established by industry consensus groups prior to the agency's creatio in 1971. Many are now hopelessly, dangerously out of date; new science has had no impact on these regulations. Because OSHA has been so beaten down by the opponents of regulation, it has virtually given up on developing new regulations or strengthening outdated ones.
And in some instances, OSHA has itself become the opponent of regulation. Eugene Scalia became OSHA's top lawyer when he was named solicitor of the Department of Labor, having previously worked as an opponent of ergonomics regulations.

In March 2003 OSHA came up with an extremely effective way to control the rate of reported RSIs: The agency revoked a planned regulation that would have required employers to report annually the number of musculoskeletal disorders occurring among their employees. In other words, just don't collect data, and the injury numbers will go down drastically. Obviously OSHA must be doing a great job.
This sort of capture of government regulatory agencies extends elsewhere. The PDUFA, when passed in 1992 (a somewhat reformed version was apparently passed in '07, although Michaels argues that this should only be a temporary fix), transformed the FDA into a semi-de facto front for Big Pharma. User fees from Big Pharma became a revenue source for the FDA while Congress cut the agency's budget, but the money was dependent on the agency approving drugs in the review process rather than regulating for safety after approval.

Rezulin stands out as an example of the ability of Big Pharma to influence the regulatory process. This liver drug was approved after the lead FDA investigator who opposed it was removed and his report shelved, thanks to pressure to approve the drug. This led to 100s of deaths and the drug's removal from the market 2.5 years after it had already been taken off the market in Britain. In another instance, the product defense firm the Weinberg Group bragged about being able to delay phenylpropanolamine's (PPA) removal from the market for ten years.

Industry has several other major tools to delay or prevent regulation. One such hurdle for regulators is the Daubert Supreme Court case which allows judges to throw out evidence using the industry standard of uncertainty (pseudo-doubt.) Michaels explains some of the problems with the decision, here. Another is the Data Quality Act, which was dreamed up by Big Tobacco (although their role in its creation was far from transparent.) This bill has been used by the Bush administration to allow industry to put a virtual halt to the regulatory process by challenging the legitimacy of scientific reports. All done under the pretense of - you guessed it - formulating "sound science." The Washington Post described the act as the "nemesis of regulation." A companion movement that would give industry additional power to handcuff regulators is the OMB's peer review proposal.

Of course, regulation never really had much of a chance with Bush 43 as president.

From the moment George W. Bush took the oath of office in January 2001, his political appointees, working at the bidding of the corporate polluters who in many cases were their former and subsequen employers, have gutted, evaded, and opposed environmental regulations.
With the regulatory agencies under assault, under-funded, and under-staffed, litigation is one of the last lines of defense for the public. Michaels notes that the tide was turned against the tobacco industry's disinformation campaign not by regulators (although they helped) but by the judicial system. In "industry after industry" litigation has forced the disclosure of damning industry documents. With this in mind, Michaels offers four proposals to make the judicial system a critical component of the public health system:

1. "No more court sanctioned secrecy." Industry uses the trade-off of settlement for secrecy in order to hide the health consequences of its product from the public. A solution would be to use settlements as the basis for future punitive precedent.

2. "Allow injured workers to sue their employers." Workers compensation can sometimes preclude litigation. Michaels gives the example of a window washer company which was fined merely $2, 700 by OSHA for negligence leading to the death of an employee. The family was awarded $7.2 million in compensation by court.

3. "Develop better compensation systems." Industry favors compensation schemes which preclude litigation, but non-exclusive schemes which allow choice of litigation or compensation would better protect the ability of workers to pursue just compensation.

4. "End 'preemption by preamble.': Bad public policy and bad for public health." Industry argues that compliance with pertinent regulations should preclude litigation, but many regulations are either too weak or written by industry lobbyists in the first place. A classic example of this is the Titantic, which didn't have enough lifeboats for its passengers but actually exceeded the existing number required by regulation,because the regulation had been written 30 years earlier back when cruise ships were smaller. Despite the obvious negligence of the company responsible for the Titantic, it was not held legally responsible for the lack of lifeboats under the "preemption by preamble" princple.

The Bush administration has itself been a big fan of this principle. In 2006 the FDA stated that a drug label "preempts conflicting or contrary state laws." Remembering that the labels are heavily influenced by Big Pharma in the first place, that's not a comforting thought. Michaels calls this principle "catastrophic" for public health, given that it would leave no incentive for the improvement of public safety.

Returning to the central premise of the book, Michaels observes that the manufacturing of uncertainty by industry might also be described as the "Enronization of science," with product defense firms paralleling the actions of Arthur Anderson for Enron. This is indicative of the reality that "the seperation betwen academic science and the business world is disappearing." Thomas Frank described the problem of the merging/confusing of the academic and business conception of a "marketplace of ideas" in The Wrecking Crew.

Like many winger ideas – anticommunism, for example – it sounds good at first. A “free market of ideas” sounds like “free inquiry,” or a "free exchange of ideas”; an environment in which hypothesis are tested and bad ones are weeded out while good ones go on to earn the respect of the community of scholars. But this is not what the phrase means at all. Markets do not determine the objective merit of things, only their price, which is to say, their merit in the eyes of capital or consumers. To cast intellectual life as a “market” is to set up a standard for measuring ideas quite different from the standard of truthfulness. Here ideas are bid up or down depending on how well they please those with the funds to underwrite inquiry – which effectively means, how well they please large corporations and the very wealthy.
The "funding effect" demonstrates the validity of Frank's observation.

Michaels closes the book with twelve recommendations to remedy this situation:

  • 1. "Require full disclosure of any and all sponsor involvement in scientific studies"
  • 2. "In this stuff safe? Manufaturers must test chemicals before exposing workers and the public"
  • 3. "No more secret science: Manufacturers must disclose what they know about the toxicity of their products"
  • 4. "Put and end to rigged data analysis"
  • 5. "The Lessons of Enron: Hold real people accountable"
  • 6. "Level the playing field: Require equal treatment for public and private science"
  • 7. "Protect the independence of federal scientists and the science advisory committees"
  • 8. "Regulation by shaming: Increase the public disclosure of hazards"
  • 9. "Require corporations to make a plan and stick to it."
  • 10. "Embrace ALARA ('As low as reasonably achievable')"
  • 11. "Take down the stovepipes: Integrate the control of environmental and workplace toxic exposures"
  • 12. "Make the states public health protection 'laboratories'"
I've simply listed them, but it goes without saying that the book should be consulted for a detailed explanation of each. This is definitely the most important Book of the Year to date.

Previous Doubter Books of the Year:


Alan said...


Very nice review and summary. I will definitely check the book out.


P.S. - I've caught up today on all your posts. Keep up the good work.

Hume's Ghost said...

Thanks for the feedback.